Catheter implant systems and related devices, prosthetic heart valves and methods incorporated therein

Abstract

A catheter implant system (61) and related devices, prosthetic heart valves (65, 7200) and methods included therein, relating to the technical field of medical instruments wherein an interventional delivery system (1, 51) included therein comprises a catheter assembly (30, 54, 64) and a control handle (9, 20, 53, 63, 63a, 63b) connected to the catheter assembly (30, 54, 64), the catheter assembly (30, 54 and 64) is provided with a far end and a near end which are opposite to each other and comprises an inner sheathing canal (320) and an outer sheathing canal (310, 544 and 644) which are sleeved with each other in a sliding mode, the outer sheathing canal (310, 544 and 644) sequentially comprises a loading section (3102) and a sheathing canal section (3103) from the far end to the near end, and the loading section (3102) is used for wrapping the interventional instrument and keeping the interventional instrument in a compressed state; the control handle (9, 20, 53, 63, 63a, 63b) comprises: a main handle (10) to which the proximal end of the inner sheath (320) is connected; the auxiliary handle (20) is arranged on the periphery of the inner sheath tube (320) in a sliding and sleeving mode, and the near ends of the outer sheath tubes (310, 544 and 644) are connected to the auxiliary handle (20).

Description

Catheter implant system and related devices, artificial heart valves and methods included therein Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a catheter implant system and related devices, artificial heart valves and methods contained therein. Background Art

[0002] In the prior art, transcatheter implant systems mainly include artificial implants and interventional delivery systems for delivering artificial implants into the subject's body. Common artificial implants include artificial heart valves, which can be artificial aortic valves, artificial pulmonary valves, artificial mitral valves, artificial tricuspid valves, etc. depending on their specific application sites. They are usually compressed to a smaller diameter outside the body and delivered to a predetermined position using an interventional delivery system.

[0003] Existing interventional input systems primarily consist of a control handle, a catheter assembly, a locking wire mechanism, a bend adjustment assembly, and other functional components. The control handle operates the catheter assembly, delivering the implant loaded within it to the lesion. The implant can be released through self-expansion or by expanding the implant from the inside out using a balloon catheter. The interventional input system also includes multiple control units, whose distal ends collaborate to operate the implant, such as releasing, retrieving, locking its position, and adjusting its spatial posture.

[0004] Balloon expansion does not strictly require precise control of the outer sheath's movement, so the control handle needs further improvement to increase the flexibility of outer sheath operation. During some balloon expansion procedures, the artificial implant has safety risks such as displacement during the initial release, and some existing solutions have not been ideal.

[0005] Summary of the Invention

[0006] The present application provides an interventional delivery system that is more flexible in operating the outer sheath.

[0007] The present application provides an interventional delivery system, comprising a catheter assembly and a control handle connected to the catheter assembly. The catheter assembly has opposite distal and proximal ends and includes an inner sheath and an outer sheath that are slidably sleeved on each other. The outer sheath includes a loading section and a sheath section in sequence from the distal end to the proximal end. The loading section is used to wrap an artificial implant and maintain the artificial implant in a compressed state.

[0008] The control handle comprises:

[0009] a main handle, to which the proximal end of the inner sheath is connected;

[0010] A secondary handle is slidably sleeved on the outer periphery of the inner sheath tube, and the proximal end of the outer sheath tube is connected to the secondary handle.

[0011] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution. They are merely further supplements or optimizations. Under the premise that there are no technical or logical contradictions, each optional method can be combined separately for the above-mentioned overall solution, and can also be combined between multiple optional methods.

[0012] Optionally, the secondary handle includes:

[0013] The housing has an axial direction and a distal end and a proximal end opposite to each other in the axial direction, and the housing has an axially penetrating through-channel;

[0014] A connecting sleeve is fixed in the outer shell and arranged around the guide channel, and the distal end of the connecting sleeve is for the outer sheath to be plugged in and fitted with;

[0015] a positioning member movably mounted in the housing, the positioning member having a locking position for interfering with the threading channel and an unlocking position for releasing the threading channel;

[0016] The driving member cooperates with the positioning member to drive the positioning member to switch positions.

[0017] Optionally, the shell is a split buckle structure, and a mutually cooperating snap-fit ​​positioning structure is provided between the inner wall of the shell and the outer periphery of the connecting sleeve.

[0018] Optionally, the outer shell includes two half shells that are radially buckled together along the connecting sleeve, and heads respectively located at the axial ends of the two half shells; each head is fixed to the two half shells by snapping or screwing.

[0019] Optionally, the sliding stroke of the secondary handle relative to the main handle is 10 to 40 cm.

[0020] Optionally, the side wall of the connecting sleeve is provided with a first exhaust hole connected to the through-channel, a first pipe joint is fixedly connected to the first exhaust hole, the first exhaust hole and the first pipe joint define a first exhaust channel, and a one-way valve core is provided in the first exhaust channel.

[0021] Optionally, a first annular seat is provided on the edge of the first exhaust hole, and the first pipe joint is plug-fitted to the first annular seat, and mutually cooperating anti-rotation structures are provided between them.

[0022] Optionally, a first protective sleeve located at the outer periphery of the first pipe joint is embedded in the outer shell, and a pipe plugging gap is formed between the outer wall of the first pipe joint and the inner wall of the first protective sleeve.

[0023] Optionally, the anti-rotation structure includes:

[0024] a slot extending along an insertion direction of the first pipe joint, the slot being provided on a side wall of one of the first pipe joint and the first annular seat;

[0025] A positioning rib cooperates with the slot, and the positioning rib is arranged on the side wall of the other of the first pipe joint and the first annular seat.

[0026] The present application also provides an exhaust structure on a control handle, wherein the control handle is provided with a first exhaust hole, a first pipe joint is fixedly connected to the first exhaust hole, the first exhaust hole and the first pipe joint define a first exhaust channel, and a one-way valve core is provided in the first exhaust channel.

[0027] The one-way valve core can be applied to the secondary handle. For example, optionally, the one-way valve core has a relatively sealed state and an open state, and the one-way valve core specifically includes:

[0028] a limiting rod slidably mounted in the inner cavity of the first pipe joint, with a fluid gap between the outer periphery of the limiting rod and the inner wall of the first pipe joint;

[0029] The sealing sheet is connected to the limiting rod. In a sealed state, the sealing sheet closes the fluid gap. In an open state, the sealing sheet opens the fluid gap.

[0030] Optionally, the inner wall of the first pipe joint is provided with a clamping ring surrounding the outer periphery of the limiting rod, and the fluid gap is located between the outer periphery of the clamping ring and the inner wall of the first pipe joint;

[0031] The end of the limiting rod away from the sealing plate passes through the retaining ring and has a head. In the open state, the head is against the retaining ring, the sealing plate is away from the retaining ring and the fluid gap is opened; in the sealed state, the head is away from the retaining ring, the sealing plate is away from the retaining ring and the retaining ring is closed.

[0032] Optionally, the inner wall of the first pipe joint is provided with a clamping ring surrounding the outer periphery of the limiting rod, and the fluid gap is located between the outer periphery of the clamping ring and the inner wall of the first pipe joint;

[0033] The end of the limiting rod away from the sealing plate passes through the clamping ring and has a head restricted by the clamping ring. The head and the sealing plate clamping portion are fixed on two opposite sides of the clamping ring. The edge of the sealing plate can be elastically deformed to open or close the fluid gap accordingly.

[0034] Optionally, the positioning member is an elastic claw, one end of which is fixed to the connecting sleeve, and the other end is a free end that swings radially along the connecting sleeve.

[0035] Optionally, the elastic claw and the connecting sleeve are an integral structure.

[0036] Optionally, there are two to six (for example, four) elastic claws distributed along the circumference of the connecting sleeve.

[0037] Optionally, the driving member is cylindrical and is slidably sleeved on the outer periphery of the connecting sleeve, and the inner wall of the driving member acts on the elastic claw.

[0038] Optionally, along the radial direction of the connecting sleeve, a guide ramp is provided on the outer side of the elastic claw, and the inner wall of the driving member acts on the guide ramp.

[0039] Optionally, an elastic liner is provided inside the connecting sleeve, and the elastic claws act on the outer wall of the elastic liner and interfere with the threading channel by squeezing the elastic liner.

[0040] Optionally, the distal end of the elastic liner extends out of the connecting sleeve, and a radially outwardly protruding positioning step is provided on the extended portion. Along the axial direction, the positioning step is axially positioned and matched with the end face of the connecting sleeve and / or the inner wall of the outer shell.

[0041] Optionally, a mutually cooperating guide structure is provided between the inner wall of the driving member and the outer wall of the connecting sleeve.

[0042] The guide structure comprises:

[0043] a slide groove provided on one of the inner wall of the driving member and the outer wall of the connecting sleeve;

[0044] The guide rib cooperates with the slide groove and is provided on the other of the inner wall of the driving member and the outer wall of the connecting sleeve.

[0045] Optionally, an operating button is provided on the outer wall of the driving member, and a first avoidance opening corresponding to the position of the operating button is opened on the outer shell.

[0046] Optionally, the side wall of the driving member is provided with a second avoidance opening, and the side wall of the connecting sleeve is provided with an exhaust hole that cooperates with the guide channel; along the axial direction of the connecting sleeve, the position of the second avoidance opening corresponds to the position of the exhaust hole.

[0047] Optionally, the catheter assembly further includes a balloon catheter, and the balloon catheter includes:

[0048] a balloon body, disposed at the distal end of the inner sheath tube and switching between an expanded state and a folded state under the action of a fluid, wherein the artificial implant in the loaded state is located at the periphery of the balloon body;

[0049] The catheter body is sleeved on the outer periphery of the inner sheath or arranged in parallel with the inner sheath. The distal end of the catheter body is communicated with the balloon body, the proximal end of the catheter body is connected to the main handle, and the catheter body contains a fluid channel.

[0050] Optionally, a fluid guide is provided in the balloon body and is located on the periphery of the inner sheath tube. The fluid guide defines a diversion channel that connects the distal end and the proximal end of the balloon body.

[0051] Optionally, the fluid guide is tubular, and the position of the fluid guide channel relative to the fluid guide is at least one of the following:

[0052] Located on the outer wall of the fluid guide;

[0053] being located inside the fluid guide;

[0054] Located in the side wall interlayer or hollow area of ​​the fluid guide.

[0055] Optionally, the guide channel is a guide groove opened on the outer peripheral wall of the fluid guide component.

[0056] Optionally, the distal side and the proximal side of the fluid guide are adjacent to the distal side and the proximal side of the balloon body, respectively.

[0057] Optionally, there are multiple guide grooves, which are arranged along the circumference of the fluid guide component, and the same guide groove extends along the axial direction of the fluid guide component or is spirally wound.

[0058] Optionally, along the circumference of the fluid guide, the wrap angle of the same guide groove is 0 to 180 degrees.

[0059] Optionally, a connecting groove is provided between two adjacent guide grooves.

[0060] Optionally, there are multiple communicating grooves arranged at intervals, and the communicating grooves corresponding to the axial positions constitute an annular groove.

[0061] Optionally, a fluid guide is provided on the outer periphery of the inner sheath tube, which is tubular and located inside the balloon body. The tube wall of the fluid guide has a hollow area, and the hollow area extends continuously or at intervals from the distal end of the fluid guide to the proximal side of the fluid guide.

[0062] Optionally, there is a radial gap between the fluid guide and the inner sheath tube, and the radial gap serves as the guide channel.

[0063] When the fluid guide is tubular, that is, a drainage tube located outside the inner sheath tube, the longitudinal gap between the drainage tube and the inner sheath tube serves as a fluid channel for conveying fluid to inflate the balloon.

[0064] In view of the related improvements of drainage tubes, the present application also provides an interventional delivery device based on balloon expansion and release, which has opposite distal and proximal ends and includes an inner shaft and a balloon catheter located on the outer periphery of the inner shaft. The balloon catheter includes a balloon body and a catheter body connected to the proximal end of the balloon body. The balloon body includes a first part, a middle part, and a second part from the distal end to the proximal end. The middle part is used for loading and fixing an artificial implant. The catheter body has a main channel.

[0065] A drainage tube is provided in the radial gap between the inner shaft and the balloon body. At least a portion of the fluid output from the main channel to the balloon body passes through the second part and the middle part through the drainage tube and enters and inflates the first part.

[0066] The inner shaft is typically a tube, which can be used to thread a guide wire during intervention. This tube is also called a core tube or inner sheath. The interventional delivery device is suitable for balloon expansion, which is equivalent to a balloon device.

[0067] The present application also provides an interventional delivery device based on balloon expansion and release, which has opposite distal and proximal ends and includes an inner shaft and a balloon catheter located on the periphery of the inner shaft, wherein the balloon catheter includes a balloon body and a catheter body connected to the proximal end of the balloon body, wherein the balloon body includes a first portion, a middle portion, and a second portion from the distal end to the proximal end, wherein the middle portion is used for loading and fixing an artificial implant;

[0068] A drainage tube is provided in the radial gap between the inner shaft and the balloon body, the distal end of the drainage tube is fixed to the distal end of the inner shaft, and the remaining portion of the drainage tube is suspended between the inner shaft and the balloon catheter;

[0069] Among the fluid output from the catheter body to the balloon body, at least a portion of the fluid passes through the drainage tube, passes through the second part and the middle part, and then enters and inflates the first part.

[0070] Optionally, the radial gap between the inner shaft and the catheter body serves as a main flow channel, and the main flow channel is an integrated flow channel.

[0071] Optionally, a portion of the fluid output from the main channel to the balloon body enters and inflates the second portion, and another portion enters the drainage tube, passes through the second portion and the middle portion, and then enters and inflates the first portion.

[0072] Optionally, the proximal end of the drainage tube has an open port and serves as a fluid inlet.

[0073] Optionally, the axial position of the fluid inlet is adjacent to the junction of the balloon body and the catheter body.

[0074] Optionally, in the loaded state, the artificial implant is radially compressed and wrapped around the periphery of the middle portion, and the first portion and the second portion are exposed at both ends of the artificial implant; the proximal end of the drainage tube has a fluid inlet, and the fluid inlet is located in the second portion.

[0075] Optionally, at the proximal port of the drainage tube, there is a first gap with a radial span of L1 between the inner shaft and the drainage tube, and a second gap with a radial span of L2 between the inner shaft and the catheter body; and L1:L2=1:1.25~1.6 is satisfied.

[0076] Optionally, the balloon body is inflated after being perfused with fluid, and in the inflated state, the fluid inlet is located at a position where the flow channel cross-sectional area of ​​the second portion relative to the catheter body suddenly changes.

[0077] Optionally, the drainage tube includes a distal section, a middle section and a proximal section from the distal end to the proximal end, and corresponds to various parts of the balloon body respectively. The distal section of the drainage tube has a first fluid outlet connected to the first part, and the first fluid outlet is located on the tube wall of the distal section and / or the end face of the distal section.

[0078] Optionally, the tube wall of the distal section is provided with a plurality of first fluid outlets.

[0079] Optionally, the plurality of first fluid outlets are distributed along the circumference of the drainage tube.

[0080] Optionally, along the length direction of the drainage tube, the multiple first fluid output ports are located in the middle portion of the distal section.

[0081] Optionally, the proximal end of the drainage tube and the distal end of the catheter body are interconnected as one body, and a second fluid outlet communicating with the second portion is opened on the tube wall of the proximal end section.

[0082] Optionally, the proximal end of the drainage tube has a gradually converging beveled section, and at least a portion of the beveled section extends into the distal end of the catheter body.

[0083] Optionally, the beveled section has one or two beveled surfaces.

[0084] Optionally, the inner lumen of the drainage tube is open to the beveled surface and is communicated with the inner lumen of the catheter body and the inner lumen of the second part at the same time.

[0085] Optionally, an isolation piece is provided between the inner shaft and the drainage tube in the radial direction to maintain a radial gap between them.

[0086] Optionally, the isolation member is a rib located on the inner wall of the drainage tube.

[0087] Optionally, the isolation member is a hollow structural member fixed radially between the inner shaft and the drainage tube.

[0088] Optionally, a guide head is fixed to the distal end of the inner shaft, and the distal end of the drainage tube is fixed to the proximal side of the guide head.

[0089] Optionally, the distal end of the drainage tube is closed by the guide head.

[0090] Optionally, the proximal side of the guide head is provided with a positioning structure adapted to the distal end of the drainage tube, and the positioning structure is a coupling groove for inserting the drainage tube, or a coupling column for inserting the drainage tube.

[0091] The interventional delivery device of the present application is mainly aimed at the ball expansion method, which improves the fluid delivery and diversion method. During the release process of the artificial implant, axial slippage can be avoided to ensure the positioning effect.

[0092] The present application provides a method for driving a balloon catheter using fluid, wherein the balloon catheter has opposite distal and proximal ends and includes a balloon body and a catheter body, wherein the distal end of the catheter body is connected to the proximal end of the balloon body, and the balloon body includes a first portion, a middle portion, and a second portion from the distal end to the proximal end, wherein the middle portion is used for loading and fixing an artificial implant, and the catheter body has a main flow channel. The method includes:

[0093] injecting fluid into the main channel from the proximal end of the catheter body;

[0094] Dividing the fluid output from the main channel to the balloon body, allowing only a portion of the fluid to enter and inflate the second part;

[0095] Another portion of the fluid is drained, passes through the second portion and the middle portion, and then enters and fills the first portion.

[0096] Optionally, all fluids used to inflate the balloon come from the main channel before being diverted.

[0097] Optionally, the diversion method is:

[0098] The fluid is divided into two paths at the junction of the catheter body and the second part, one of which enters and inflates the second part, and the other enters and inflates the first part after passing through the second part and the middle part through an independent flow channel.

[0099] Optionally, the fluid enters the independent flow channel from the main flow channel, and the independent flow channel is connected to a branch flow channel, wherein a part of the fluid enters and fills the second part through the branch flow channel when flowing through the second part, and the other part enters and fills the first part after passing through the second part and the middle part through the independent flow channel.

[0100] Optionally, the method further includes:

[0101] The fluid is controlled so that the first and second parts are inflated before the middle part, and the balloon body enters a transitional state in which both ends are inflated and the middle part is relatively contracted; the fluid is continuously injected into the catheter body until the balloon body is fully inflated and the artificial implant is radially expanded.

[0102] Optionally, the fluid is split into two paths, each path including one or more streams.

[0103] Optionally, the distribution is radial between the strands of the same route.

[0104] Optionally, the artificial implant is a cylindrical structure, and the fluid entering the independent flow channel passes through the interior of the cylindrical structure and over the middle portion.

[0105] Optionally, the balloon body has an axial direction extending between the distal end and the proximal end and corresponding radial and circumferential directions, and the manner of inflating the first portion includes:

[0106] outputting the liquid along the radial direction of the balloon body through the independent flow channel and inflating the first portion;

[0107] And / or output along the axial direction of the balloon body through the independent flow channel and inflate the first part.

[0108] Optionally, the catheter assembly further includes a bending adjustment tube and a traction member for driving the bending adjustment tube, wherein the bending adjustment tube is sleeved on the outer circumference of the inner sheath tube, the distal ends of the bending adjustment tube and the traction member are fixedly connected, and the proximal ends of both are connected to the main handle and slide relative to each other.

[0109] Optionally, the bending adjustment tube and the traction member are both located on the periphery of the catheter body.

[0110] Optionally, the catheter assembly further includes a bending adjustment tube and a traction member for driving the bending adjustment tube, wherein the bending adjustment tube is sleeved on the outer circumference of the inner sheath tube, the distal ends of the bending adjustment tube and the traction member are fixedly connected, and the proximal ends of both are connected to the main handle and slide relative to each other.

[0111] Optionally, the traction member is arranged as follows:

[0112] The traction member is a traction tube, and is located inside or outside the bending adjustment tube; or

[0113] The traction member is a traction wire and is located on the inner side, outer side or inside the wall of the bending adjustment pipe.

[0114] Optionally, the wall of the bending pipe has a sandwich structure, a liner is fixed in the sandwich, and the traction member is movably arranged in the liner.

[0115] Optionally, the main handle includes:

[0116] The support body has a spatial axial direction, the proximal end of the bending adjustment tube is fixedly connected to the support body, and the inner sheath tube and the catheter body of the balloon catheter are both extended and connected to the proximal side of the support body;

[0117] a first sliding seat, slidably engaged with the support body in the axial direction, and the proximal end of the pulling member is fixed to the first sliding seat;

[0118] A first drive sleeve is rotatably mounted on the support body and is located on the outer periphery of the first slide, wherein the first drive sleeve and the first slide are engaged with each other by a threaded transmission;

[0119] A housing fixedly sleeved on the support body, at least a portion of which is an indicator section located outside the bending drive sleeve;

[0120] The identification member is axially slidably mounted on the indicating section and is located on the outer periphery of the first driving sleeve. The first driving sleeve and the identification member are matched with each other through threaded transmission.

[0121] Optionally, the first drive sleeve has an internal thread and an external thread, the first slide seat has external teeth that match the internal thread, and the identification member has internal teeth that match the external thread.

[0122] Optionally, the identification member and the first slide seat move synchronously under the action of the first drive sleeve.

[0123] Optionally, a window corresponding to the position of the identification member is provided on the side wall of the indicating section.

[0124] Optionally, the support body is provided with an axially extending mounting groove, a guide cylinder is fixed in the mounting groove, the first slide is slidably sleeved on the guide cylinder, and a guide structure is provided between the first slide and the outer wall of the guide cylinder for cooperating to guide the axial movement.

[0125] Optionally, the proximal end of the bending adjustment tube is inserted into and fixed to the guide cylinder.

[0126] Optionally, when the sub-handle slides proximally to an extreme position, the distal end of the bending adjustment tube is exposed to the outer sheath tube, and the exposed length is 0 to 20 cm.

[0127] The present application also provides an exhaust structure on a control handle, wherein the control handle is provided with a second exhaust hole, a second pipe joint is fixedly connected to the second exhaust hole, the second exhaust hole and the second pipe joint define a second exhaust channel, and a one-way valve core is provided in the second exhaust channel.

[0128] The one-way valve core can be applied to the main handle. For example, optionally, a second exhaust hole is provided on the side wall of the guide cylinder, and the radial gap between the bend adjustment tube and the catheter body is connected to the second exhaust hole. The proximal end of the catheter body passes through the proximal end of the bend adjustment tube and further extends through the guide cylinder.

[0129] A second pipe joint is fixedly connected to the second exhaust hole. The second exhaust hole and the second pipe joint define a second exhaust channel. A one-way valve core is provided in the second exhaust channel.

[0130] Optionally, the one-way valve core has a relatively sealed state and an open state, and the one-way valve core specifically includes:

[0131] a limiting rod slidably mounted in the inner cavity of the second pipe joint, with a fluid gap between the outer periphery of the limiting rod and the inner wall of the second pipe joint;

[0132] The sealing sheet is connected to the limiting rod. In a sealed state, the sealing sheet closes the fluid gap. In an open state, the sealing sheet opens the fluid gap.

[0133] Optionally, a second annular seat is provided on the edge of the second exhaust hole, and the second pipe joint is plug-fitted to the second annular seat, and mutually cooperating anti-rotation structures are provided between them.

[0134] Optionally, a second protective sleeve is provided on the outer periphery of the second pipe joint, and a pipeline plugging gap is formed between the outer wall of the second pipe joint and the inner wall of the second protective sleeve.

[0135] Optionally, the anti-rotation structure includes:

[0136] a slot extending along an insertion direction of the second pipe joint, the slot being provided on a side wall of one of the second pipe joint and the second annular seat;

[0137] A positioning rib cooperates with the slot, and the positioning rib is arranged on the side wall of the other of the second pipe joint and the second annular seat.

[0138] Optionally, the inner wall of the second pipe joint is provided with a clamping ring surrounding the outer periphery of the limiting rod, and the fluid gap is located between the outer periphery of the clamping ring and the inner wall of the second pipe joint;

[0139] The end of the limiting rod away from the sealing plate passes through the clamping ring and has a head restricted by the clamping ring. The head and the sealing plate clamping portion are fixed on two opposite sides of the clamping ring. The edge of the sealing plate can be elastically deformed to open or close the fluid gap accordingly.

[0140] Optionally, the main handle includes:

[0141] The support body has a spatial axial direction, and the inner sheath and the catheter body of the balloon catheter are both extended and connected to the proximal side of the support body;

[0142] A second sliding seat is axially slidably engaged with the support body;

[0143] A second drive sleeve is rotatably mounted on the support body and is located on the outer periphery of the second slide, and the second drive sleeve and the second slide are engaged with each other by a threaded transmission;

[0144] A multi-way connector is connected to the proximal side of the second slide, the proximal ends of both the balloon catheter and the inner sheath are connected to the multi-way connector, the interior of the inner sheath is a through guidewire channel, and the multi-way connector has at least an interface that is respectively connected to the guidewire channel and the fluid channel.

[0145] Optionally, the multi-way connector is rotationally engaged with the proximal side of the second slide and is axially limited.

[0146] Optionally, the second slide is a cylindrical structure as a whole, and at least a part of it is located in the second drive sleeve. The outer wall of the second slide is threadedly engaged with the inner wall of the second drive sleeve, and the support body has a guide groove for guiding the second slide to move axially.

[0147] Optionally, the distal end of the multi-way connector and the proximal end of the second slide are rotatably plugged into each other, and a mutually matching axial limiting structure is provided between the two, and the axial limiting structure includes:

[0148] a latching tooth, fixed to one of the two and protruding radially toward the other;

[0149] The latching slot is arranged on the other one of the two and receives the latching teeth.

[0150] Optionally, the interventional delivery system may also be combined with an artificial implant to form a transcatheter implant system, and the artificial implant is radially compressed and then wrapped by an outer sheath.

[0151] The present application also provides an improved artificial implant, comprising a stent and a valve leaflet, wherein the stent has a cell structure, the two ends of the stent are respectively an inflow side and an outflow side, and the interior of the stent is a blood flow channel;

[0152] The leaflets are multiple and each leaflet cooperates with each other in the blood flow channel to relatively open or close the blood flow channel; the edge of the leaflet includes a fixed edge fixed to the bracket and a free edge that cooperates with other leaflets to control the blood flow channel.

[0153] The bracket is connected to an anti-leakage component, which is an integrated structure including a base located inside the bracket and an anti-leakage component fixed to the outside of the base. The anti-leakage component is a plurality of spaced blocks and its position corresponds to the hollow area of ​​the bracket cells.

[0154] Optionally, the base is made of PET material, and the anti-leakage component is made of PU material.

[0155] Optionally, according to different axial positions of the cells, the anti-circular leakage components include at least one of a second circle of anti-circular leakage components and a third circle of anti-circular leakage components, and a first circle of anti-circular leakage components, wherein: the first circle of anti-circular leakage components covers the entire cell;

[0156] The second circle of anti-circumferential leakage components is adjacent to the inflow side of the first circle of anti-circumferential leakage components and is distributed in a local area of ​​the entire cell;

[0157] The third circle of anti-circumferential leakage components is adjacent to the outflow side of the first circle of anti-circumferential leakage components and is distributed in a local area of ​​the entire unit cell.

[0158] Optionally, the axial lengths of the second circle of anti-circular leakage components and the third circle of anti-circular leakage components only occupy half a unit cell, and are adjacent to the first circle of anti-circular leakage components.

[0159] Optionally, in the same anti-circular leakage component, the thickness gradually increases from the outflow side to the inflow side, and gradually becomes thinner after reaching the highest convex part.

[0160] Optionally, in the same anti-leakage component, the highest convex part is closer to the inflow side of the cell.

[0161] Optionally, in the same anti-leakage component, the distance between the maximum convex height and the inflow side of the cell in which it is located is S1, and the distance between the maximum convex height and the inflow and outflow sides of the cell in which it is located is S2, where S1:S2 is 0.2 to 0.8.

[0162] Optionally, the diameter of the loading section is larger than the diameter of the sheath section.

[0163] Optionally, the distal end of the inner sheath is provided with a guide head, the outer periphery of the guide head is provided with an annular step, and the distal end surface of the loading section is abutted against the annular step for limiting position.

[0164] The interventional delivery system of the present application separates the movement of the outer sheath from other internal tubes, while also releasing the restriction on the length of the main handle, making the operation of the outer sheath more flexible.

[0165] The present application provides a limiting mechanism, namely a stop mechanism, which provides a relatively long-lasting stop effect during the interventional delivery and initial release of an artificial heart valve.

[0166] The present application provides a limiting mechanism for an interventional delivery system, comprising:

[0167] A coupling portion, configured to connect to an interventional delivery system, wherein the coupling portion has an axial direction and corresponding circumferential and radial directions;

[0168] The deformation portion includes a plurality of slender rods arranged in sequence along the circumferential direction, each rod having:

[0169] a first end connected to the coupling portion;

[0170] The second end is located on one side of the axial direction of the coupling part relative to the first end. Based on elastic deformation, each rod has a compressed state suitable for interventional delivery and a relative expanded state. In the expanded state, the second end of each rod diverges outward in the radial direction of the coupling part relative to the compressed state.

[0171] Optionally, the coupling portion is in a straight cylindrical shape, the rods are distributed radially, and the convergence position of the first ends of the rods is one axial end of the coupling portion.

[0172] Optionally, the coupling portion is a radially deformable ring.

[0173] Optionally, the coupling portion is an axially undulating wave structure having relative crests and troughs, and the first end of each rod is connected to the corresponding crest.

[0174] Optionally, the coupling portion and the deformation portion are an integral structure.

[0175] Optionally, the coupling portion and the deformation portion are cut integrally from a pipe.

[0176] Optionally, the second end of each rod moves independently.

[0177] Optionally, the rod has a tendency to extend spirally around the axis of the coupling portion.

[0178] Optionally, the number of the rods is 4 to 10.

[0179] Optionally, the second end of the rod has a smooth outer contour and / or is covered with a protective layer.

[0180] Optionally, a portion of the rod member close to the second end has a radially inward bending tendency.

[0181] Optionally, the portion of the rod member close to the second end has lower radial stiffness than the rest of the rod member.

[0182] The present application provides another limiting mechanism for an interventional delivery system, which is installed in a balloon body. The balloon body has a relatively folded state and an inflated state. In the folded state, the balloon body has multiple folds. The limiting mechanism includes:

[0183] A coupling portion, configured to connect to an interventional delivery system, wherein the coupling portion has an axial direction and corresponding circumferential and radial directions;

[0184] The deformation part includes a plurality of rods arranged in sequence along the circumferential direction. Each rod is configured to have a compressed state suitable for interventional delivery and a relatively expanded state based on elastic deformation. In the compressed state, each rod is placed in a corresponding fold.

[0185] Optionally, the balloon body is rolled in a first direction along the circumferential direction in a folded state, and the spiral direction of each rod is the same as the first direction.

[0186] Optionally, when the balloon body is in the folded state, the second end of at least one rod is not lower than the artificial implant in the radial direction.

[0187] The present application provides another limiting mechanism for an interventional delivery system, comprising:

[0188] A coupling portion, configured to connect to an interventional delivery system, wherein the coupling portion has an axial direction and corresponding circumferential and radial directions;

[0189] The deformation part includes a plurality of rods arranged in sequence along the circumferential direction, each rod having:

[0190] a first end connected to the coupling portion;

[0191] The second end is located on one side of the axial direction of the coupling part relative to the first end, and each rod is configured to have a compressed state suitable for interventional delivery and a relative expanded state based on elastic deformation. In the expanded state, the second end of each rod diverges outward in the radial direction of the coupling part relative to the compressed state; the rod is made of memory alloy, and in the expanded state and compressed state, the distance between the second end of the rod and the axis of the coupling part is R1 and R2 respectively, and satisfies R1:R2=2~20:1.

[0192] The present application provides a balloon device for delivering an artificial implant, comprising an inner shaft and a balloon body located on the periphery of the inner shaft, wherein the inner shaft is equipped with any of the above-mentioned limiting mechanisms located inside the balloon body.

[0193] The inner shaft can generally be a tube, and the interior of the tube can be used to pass a guide wire during intervention. The tube can also be called a core tube or an inner sheath tube.

[0194] In response to the various limiting mechanisms provided in this application, the present application provides an interventional delivery system based on balloon expansion for delivering an artificial implant. The interventional delivery system includes a balloon device and an outer sheath. The balloon device includes an inner shaft and a balloon body located on the outer periphery of the inner shaft. The distal end of the inner shaft is equipped with a plurality of rods arranged in sequence along the circumferential direction. Each rod is configured to have a compressed state suitable for interventional delivery and a relatively expanded state based on elastic deformation. Each rod has:

[0195] a first end connected to the inner shaft;

[0196] a second end located on one side of the first end and suspended relative to the inner shaft, wherein in the expanded state, the second end of each rod diverges radially outward relative to that in the compressed state;

[0197] The artificial implant can be installed on the balloon body in a radially compressed loading state and is located at the proximal end of the rod. The rod acts on the balloon body so that the outer circumference of the balloon is not lower than the outer circumference of the distal end of the artificial implant.

[0198] Optionally, the rod acts on the balloon body so that the outer peripheral surface of the balloon body is substantially flush with the outer peripheral surface of the distal end of the artificial implant.

[0199] In response to the various limiting mechanisms provided in this application, this application provides another balloon-expansion-based interventional delivery system for delivering an artificial implant, the interventional delivery system having a distal end and a proximal end relative to each other, and an axial direction extending between the proximal end and the distal end, the interventional delivery system comprising:

[0200] A balloon device, comprising an inner shaft and a balloon body disposed on the outer periphery of the inner shaft, wherein a first limiting mechanism (which may be the limiting mechanism described in this application) is mounted on the distal end of the inner shaft and disposed within the balloon body;

[0201] an intermediate shaft, the intermediate shaft being located outside the inner shaft, a second limiting mechanism being installed on the outside of the balloon body at a distal end of the intermediate shaft, the second limiting mechanism being located proximal to the first limiting mechanism, the artificial implant being capable of being installed on the balloon body in a radially compressed loaded state and being located between the first limiting mechanism and the second limiting mechanism, the two limiting mechanisms being configured to limit axial movement of the artificial implant relative to the balloon body;

[0202] An outer sheath is slidably fitted on the outer periphery of the balloon device. The outer sheath has an extreme position of proximal movement on its own sliding path. At this extreme position, the first limiting mechanism and the artificial implant are exposed outside the outer sheath, and the second limiting mechanism is inside the outer sheath.

[0203] In view of the various limiting mechanisms provided in this application, this application provides another interventional delivery system based on balloon expansion for delivering artificial implants, the interventional delivery system comprising:

[0204] A balloon device comprising an inner shaft and a balloon body disposed on the outer periphery of the inner shaft; a plurality of rods disposed circumferentially within the balloon body are mounted at the distal end of the inner shaft; each rod is configured to have a compressed state suitable for interventional delivery and a relatively expanded state based on elastic deformation; each rod has a first end connected to the inner shaft and a second end located to one side of the first end and suspended relative to the inner shaft; in the expanded state, the second end of each rod diverges radially outward relative to the compressed state; the artificial implant can be mounted on the balloon body in a radially compressed loaded state and is located at the proximal end of each rod;

[0205] an adjustment wire for releasably fixing the artificial implant to the balloon body, wherein one end of the adjustment wire can remain fixed to the balloon body, and the other end can pass through the artificial implant and has a lock hole;

[0206] The locking wire has a relative locking state and an unlocking state. In the locking state, the locking wire passes through each locking hole to restrict the artificial implant. In the unlocking state, the locking wire is disengaged from each locking hole to release the artificial implant.

[0207] Optionally, the first end of the rod is connected to a coupling portion connected to the inner shaft, and all the rods constitute a deformation portion.

[0208] Optionally, the interventional delivery system further includes a control handle, which is connected to and controls the balloon device, and the balloon device adopts the above-mentioned balloon device.

[0209] Optionally, a fluid guide is provided in the balloon body and is located on the outer periphery of the inner shaft. The fluid guide defines a flow guide channel that connects the distal end and the proximal end of the balloon body.

[0210] The rods in the limiting mechanism of the present application are relatively independent. On the one hand, the artificial implant can be deformed and expanded during the expansion process to extend the effectiveness of the stop, thereby better limiting the axial displacement of the artificial implant. In addition, the rods can also reduce the radial traction on each other, thereby further ensuring the positioning effect of the artificial implant in the eccentric state.

[0211] The present application provides a balloon device for delivering an artificial heart valve, which provides a relatively long-lasting stopping effect during the interventional delivery and initial release of the artificial heart valve.

[0212] The present application provides a balloon device for delivering an artificial heart valve, comprising:

[0213] a catheter body, wherein the extending direction of the catheter body serves as an axial direction;

[0214] a balloon body, connected to the catheter body, capable of receiving fluid from the catheter body, thereby changing from a folded state to an inflated state, and the artificial heart valve correspondingly expands from a radially compressed state to a radially expanded state based on the change of the balloon body;

[0215] The limiting mechanism is configured to limit the movement of the artificial heart valve in the axial direction at least when the artificial heart valve is mounted on the balloon body in a radially compressed state, and the limiting mechanism specifically includes:

[0216] The limiting body includes a plurality of rods, which extend as a whole from the first end in the axial direction to the second end in the axial direction and gather at the first end and the second end to form a hollow cage structure.

[0217] Optionally, the plurality of rods are configured to form side walls of the cage-shaped structure, and a gap between two adjacent rods on the side walls forms a hollow area.

[0218] Optionally, the hollow area includes a main hollow area and an auxiliary hollow area, and the span of the main hollow area along the axial direction is greater than the span of the auxiliary hollow area along the axial direction.

[0219] Optionally, the main hollow area spans the first end and the second end.

[0220] Optionally, the cage-shaped structure has an outwardly expanding portion, the outwardly expanding portion has the maximum outer diameter of the cage-shaped structure, and the main hollow area spans the outwardly expanding portion.

[0221] Optionally, in the circumferential direction, the main hollow area and the auxiliary hollow area are distributed in sequence at intervals along the circumferential direction.

[0222] Optionally, the limiting mechanism is located inside or outside the balloon body.

[0223] Optionally, at least one of the catheter body and the balloon body is directly fixed to the limiting mechanism, or is indirectly fixed to the limiting mechanism via an intermediate piece.

[0224] Optionally, the balloon device further includes an inner shaft (serving as the intermediate member), the inner shaft being disposed inside the catheter body and the balloon body; the limiting mechanism further includes:

[0225] At least one coupling member is fixed to the inner shaft and connected to the gathering portion of the limiting body.

[0226] Optionally, the coupling member is located inside or outside the limiting body.

[0227] Optionally, the coupling member is located at at least one end of the limiting body in the axial direction.

[0228] Optionally, the outer diameter ratio of the outward expansion portion to the coupling member is 2 to 4:1, preferably 3:1.

[0229] The present application also provides a balloon device for delivering an artificial heart valve, comprising:

[0230] a catheter body, wherein the extending direction of the catheter body serves as an axial direction;

[0231] a balloon body, connected to the catheter body, capable of receiving fluid from the catheter body, thereby changing from a folded state to an inflated state, and the artificial heart valve correspondingly expands from a radially compressed state to a radially expanded state based on the change of the balloon body;

[0232] The limiting mechanism is configured to limit the movement of the artificial heart valve in the axial direction at least when the artificial heart valve is mounted on the balloon body in a radially compressed state, and the limiting mechanism specifically includes:

[0233] The limiting body is a cage-shaped structure as a whole, wherein a portion of the cage-shaped structure is an outward expansion portion, which has the largest radial outward expansion degree relative to other portions of the cage-shaped structure. Along the axial direction, one end of the limiting body is a first end facing the artificial heart valve in the use state, and the other end is an opposite second end, and the outward expansion portion is adjacent to the first end of the limiting body.

[0234] Optionally, the balloon device further includes an inner shaft, which is passed through the catheter body and the balloon body; the limiting mechanism further includes: a coupling member, which is fixed to the inner shaft and connected to the limiting body.

[0235] Optionally, a concave area for accommodating the end of the artificial heart valve is formed in the limiting body between one side of the first end and the coupling member on this side.

[0236] The present application also provides a balloon device for delivering an artificial heart valve, comprising:

[0237] a catheter body, wherein the extending direction of the catheter body serves as an axial direction;

[0238] a balloon body, connected to the catheter body, capable of receiving fluid from the catheter body, thereby changing from a folded state to an inflated state, and the artificial heart valve correspondingly expands from a radially compressed state to a radially expanded state based on the change of the balloon body;

[0239] The limiting mechanism is configured to limit the movement of the artificial heart valve in the axial direction at least when the artificial heart valve is mounted on the balloon body in a radially compressed state, and the limiting mechanism specifically includes:

[0240] The limiting body includes a plurality of rods that form a cage-shaped structure as a whole, wherein a portion of the cage-shaped structure is an outward expansion portion, and the outward expansion portion has the largest radial outward expansion degree relative to other portions of the cage-shaped structure. In a cross section passing through the outward expansion portion, the rods are arranged at intervals along the circumference of the limiting mechanism and the enclosed area approaches a polygon.

[0241] Optionally, the polygon is a regular polygon with 4 to 12 sides.

[0242] Optionally, the number of sides of the regular polygon is 6 to 8.

[0243] Optionally, one end of the limiting body is a first end facing the artificial heart valve in use, and the other end is an opposite second end, and both ends of the limiting body are retracted toward the central axis of the limiting body.

[0244] Optionally, each rod extends spatially from the first end to the second end and forms a sphere or an ellipsoid.

[0245] Optionally, the cross-section of the ellipsoid is an elliptical surface, and the major axis of the elliptical surface is consistent with the axial direction.

[0246] Optionally, the cage-shaped structure is surrounded by a plurality of rods, and each rod extends spatially from the first end to the second end to form a cone.

[0247] Optionally, the cone includes a first cone and a second cone.

[0248] Optionally, the first cone and the second cone are located on both sides or the same side of the expanded portion.

[0249] Optionally, when the first cone and the second cone are located on both sides of the outwardly expanding portion, the first cone and the second cone gradually converge in shape from the outwardly expanding portion, and the convergence trends are different.

[0250] Optionally, one end of the limiting body is a first end facing the artificial heart valve in use, and the other end is an opposite second end. The first cone is connected to the first end, and the first cone has a faster contraction trend.

[0251] Optionally, the first cone and the second cone interact with each other at the outward expansion portion, and an angle between them at the intersection is 20 to 120 degrees.

[0252] Optionally, when the first cone and the second cone are on the same side of the outward expansion portion, one end of the limiting body is the first end facing the artificial heart valve in use, and the other end is the opposite second end, and the first cone is connected to the first end, and the first cone is retracted in the direction away from the first end.

[0253] Optionally, the balloon device further includes an inner shaft, which is passed through the catheter body and the balloon body; the limiting mechanism further includes a coupling member, which is connected to the inner shaft, and the coupling member is a radially compressible tubular member.

[0254] Optionally, the coupling member has a wave structure that undulates along the axial direction or has a deformable grid.

[0255] Optionally, there are two coupling members, and the cage-shaped structure is surrounded by multiple rods, all of which spatially limit the side walls of the cage-shaped structure, and all of the rods extend from one coupling member to another coupling member and have at least one fork in the extension path, or intersect with adjacent rods.

[0256] Optionally, a plurality of intersection points between two rods are distributed at intervals along the circumference of the outward expansion portion.

[0257] Optionally, the rods are arranged in pairs and extend side by side from one of the coupling members.

[0258] Optionally, the number of the main hollow areas is 4 to 12.

[0259] Optionally, the number of the main hollow areas is 6 to 8.

[0260] Optionally, the main hollow areas have the same shape and are evenly arranged along the circumference.

[0261] Optionally, the main hollow area is strip-shaped.

[0262] Optionally, along the axial direction, the length of the main hollow area is at least 40% of the total length of the limiting body.

[0263] Optionally, the length of the main hollow area is at least 60% of the total length of the limiting body.

[0264] Optionally, the length of the main hollow area is 75% to 100% of the total length of the limiting body.

[0265] Optionally, along the axial direction, the main hollow area extends to both sides of the outward expansion portion, and the extended length is at least 20% of the total length of the limiting body.

[0266] Optionally, the main hollow area is in the shape of a diamond.

[0267] Optionally, the hollow portion of the cage-shaped structure includes the main hollow area and a corresponding auxiliary hollow area, wherein the auxiliary hollow area avoids the outward expansion portion.

[0268] Optionally, the limiting mechanism is formed by integrally cutting a pipe.

[0269] Optionally, the tube has an initial outer diameter D1, the couplings have an outer diameter D2, and the outer diameter D2 of at least one coupling is smaller than D1.

[0270] The present application also provides a balloon device for delivering an artificial heart valve, having opposite distal and proximal ends, comprising:

[0271] a catheter body, wherein the extending direction of the catheter body serves as an axial direction;

[0272] a balloon body, connected to the catheter body, capable of receiving fluid from the catheter body, thereby changing from a folded state to an inflated state, and the artificial heart valve correspondingly expands from a radially compressed state to a radially expanded state based on the change of the balloon body;

[0273] an inner shaft, the inner shaft being disposed inside the catheter body and the balloon body;

[0274] The limiting mechanism is configured to limit the movement of the artificial heart valve in the axial direction at least when the artificial heart valve is mounted on the balloon body in a radially compressed state, and the limiting mechanism specifically includes:

[0275] A limiting body, which is a cage-shaped structure as a whole;

[0276] A guide tube connected to the limiting body and integrally cut and formed with the limiting body by a tube made of shape memory alloy;

[0277] The coupling member is connected to the inner shaft, and the coupling member is also connected to at least one of the limiting body and the guide tube.

[0278] Optionally, the guide tube is connected to the proximal side of the limiting body.

[0279] Optionally, there are two limiting bodies, which are respectively connected to the proximal side and the distal side of the guide tube.

[0280] Optionally, the cage structures of the two limiting bodies are independent of each other.

[0281] Optionally, the balloon body comprises a first portion, a middle portion and a second portion from the distal end to the proximal end, and the middle portion is used for loading and fixing the artificial heart valve;

[0282] The guide tube is arranged in a radial gap between the inner shaft and the balloon body, and a guide channel for fluid to pass through is reserved between the guide tube and the inner shaft.

[0283] Optionally, the coupling member includes a first coupling member and a second coupling member located at the distal end of the first coupling member, both coupling members are located on the periphery of the inner shaft, and at least one coupling member is fixed to the inner shaft, and the distal end of the balloon body also wraps the second coupling member.

[0284] Optionally, the second coupling member is located at the proximal end of the guide tube and is adjacent to the connection portion between the balloon body and the catheter body.

[0285] Optionally, the proximal end of the guide tube has a reduced diameter section and is connected to the coupling member on the corresponding side through the reduced diameter section.

[0286] Optionally, the drainage tube has a fluid inlet, and the fluid inlet is distributed on the reduced diameter section and / or the peripheral wall of the drainage tube.

[0287] Optionally, the peripheral wall of the drainage tube has a hollow gap as a whole.

[0288] Optionally, the limiting mechanism is formed by integrally cutting a pipe.

[0289] Optionally, the tube has an initial outer diameter D1, the outer diameter of the drainage tube is D1, the coupling piece has an outer diameter D2, and the outer diameter D2 of at least one coupling piece is smaller than D1.

[0290] The present application also provides a transcatheter implant intervention system, comprising the balloon device described in the present application and an artificial implant. For example, the balloon device comprises:

[0291] catheter body;

[0292] a balloon body in communication with the catheter body;

[0293] The limiting mechanism is such that the artificial implant is mounted on the balloon body in a radially compressed loading state and is blocked by the limiting mechanism in the axial direction.

[0294] Optionally, the transcatheter implant intervention system further comprises an outer sheath slidably fitted on the outside of the balloon device, and the limiting body comprises a loaded state, an intermediate state, and an expanded state;

[0295] Wherein, in the loaded state, the limiting body is located inside the balloon body and the outer sheath tube, and is subjected to radial forces from both the balloon body and the outer sheath tube;

[0296] In the intermediate state, the limiting body is free from the radial restraint of the outer sheath and is subjected to the radial force of the balloon body;

[0297] In the expanded state, the balloon body is inflated and the limiting body is expanded.

[0298] Optionally, the outer sheath is a catheter sheath.

[0299] Optionally, the artificial implant is an artificial heart valve.

[0300] The present application improves the limiting mechanism to make it more suitable for interventional delivery of artificial implants and to cooperate with the release method of ball expansion.

[0301] The present application provides an artificial heart valve, comprising a first stent and leaflets, wherein the first stent is a radially deformable cylindrical structure, the interior of the first stent is a blood flow channel, and the leaflets are multiple and cooperate with each other to control the blood flow channel;

[0302] The first bracket has a grid structure surrounded by frame bars. The first bracket is straight cylindrical. The grid structure includes a diamond-shaped grid. The end of the first bracket has a hole structure protruding from the end. The hole structure is composed of frame bars at the end. The first bracket has a relative expansion state and a compression state. In the compression state, the distance that the hole structure protrudes from the end is L1; in the expansion state, the distance that the hole structure protrudes from the end is L2, and L1>L2≥0.

[0303] Optionally, the grid structure of the first bracket forms a plurality of grid nodes at the end, and in the expanded state, the hole structure is substantially flush with the surrounding grid nodes; in the compressed state, the hole structure is significantly higher than the surrounding grid nodes.

[0304] Optionally, L1:L2 is 1.2 to 1.6:1.

[0305] Optionally, L1 is 0.6-0.8 mm, and L2 is 0.4-0.6 mm.

[0306] Optionally, the hole structure is an arc-shaped structure as a whole in the expanded state, and is close to a circular structure in the compressed state.

[0307] Optionally, the artificial heart valve is an artificial pulmonary valve or an artificial aortic valve.

[0308] Optionally, in the expanded state, the frame strip at the end is bent and wound in an arc shape to define the edge of the hole structure.

[0309] Optionally, both axial ends of the first bracket have the hole structure, and the circumferential positions of the hole structures at both ends are the same or staggered.

[0310] Optionally, the grid with the pore structure is a first grid, and the grid circumferentially adjacent to the first grid is a second grid. In the first grid, the frame strips around the pore structure include:

[0311] an arcuate segment defining an edge of the aperture structure;

[0312] The connecting segment extends from two ends of the arc segment in opposite directions to the grid nodes on both sides of the first grid in the circumferential direction.

[0313] Optionally, the angle between the connecting segments on both sides of the arc segment is A1, the inner angle of the grid node located at the axial end in the second grid is A2, and A1 is greater than A2 in the expanded state.

[0314] Optionally, in the expanded state, the central angle of the arc segment itself is 150 to 210 degrees.

[0315] Optionally, in the expanded state, the span of the arc segment in the circumferential direction of the first stent accounts for 1 / 4 to 1 / 2 of the span of the first grid, for example, about 1 / 3.

[0316] Optionally, in the first grid, the strength of the frame strips around the hole structure is less than the strength of the frame strips at other locations in the first grid.

[0317] Optionally, the grid in the first stent comprises multiple circles, with adjacent axial circles staggered circumferentially and sharing some of the frame bars. For example, there may be 3 to 6 circles, or even 5 circles. In the expanded state, the internal angle of each grid node is 75 to 105 degrees, for example, 90 degrees, which is essentially a square.

[0318] Optionally, the artificial heart valve further comprises a skirt connected to and surrounding the inner wall of the first stent, and one axial side of the skirt is engaged with the leaflet.

[0319] Optionally, the artificial heart valve further includes a blocking piece arranged circumferentially along the first stent, wherein the blocking piece is fixed to the skirt and protrudes from the radial inner side of the first stent to the radial outer side of the first stent via a corresponding grid.

[0320] Optionally, the skirt and the blocking piece are integrally formed or bonded and fixed, and both are made of PU material.

[0321] Optionally, the blocking member includes:

[0322] A plurality of blocking blocks are arranged along the circumference of the first bracket, and each blocking block is made of foam material and embedded in a grid structure corresponding to a position.

[0323] Optionally, the blocking member further includes:

[0324] The lining film, the plurality of blocking blocks are fixed on one side of the lining film, and the lining film and the plurality of blocking blocks are made of the same material.

[0325] Optionally, the skirt is made of biological pericardial material, and the lining membrane is sutured to the skirt.

[0326] Regarding the improvement of the connection method of the leaflets, the present application also provides an artificial heart valve, comprising a stent (i.e., the first stent) and a plurality of leaflets connected to the stent, wherein the stent is a cylindrical structure and has a blood flow channel inside;

[0327] At least a portion of the stent is a support bar, and along the circumference of the stent, at least one side of the support bar has a recessed area, and the leaflet is fixed to the support bar by sutures, and all knots in the sutures are located in the corresponding recessed areas.

[0328] Optionally, the leaflet includes:

[0329] The body has opposite transverse and longitudinal directions in a flattened state, the outer edge of the body including free edges and fixed edges distributed on two opposite longitudinal sides, the multiple leaflets being fixed to the support via respective fixed edges, and the free edges of the multiple leaflets cooperating with each other to control the blood flow channel within the artificial heart valve;

[0330] Ears are arranged on two opposite sides of the body in a transverse direction, and the free edge and the fixed edge meet at the ear pieces on the corresponding sides;

[0331] The ears between two adjacent leaflets are connected to each other through a first suture, and are also connected to the support bar through a second suture and a third suture, wherein all the knots in the second suture and the third suture are located in corresponding recessed areas.

[0332] Optionally, the portion where the ears between two adjacent leaflets are connected to each other through the first suture rests against the radial inner side of the support strip.

[0333] Optionally, the ears between two adjacent lobes cooperate with each other to wrap the support bar.

[0334] Optionally, the knot in the second suture is wrapped by the ear piece, and the knot in the third suture is exposed to the ear piece.

[0335] Optionally, the two axial sides of the bracket are opposite inflow sides and outflow sides, wherein a circle of hexagonal cells is arranged circumferentially on the outflow side, and the support bar serves as a common side between two adjacent cells.

[0336] Optionally, the extension direction of the support bar is the axial direction of the bracket.

[0337] The present application also provides a transcatheter implant system, including a balloon device and an artificial heart valve. The balloon device and the artificial heart valve can respectively adopt the various solutions described in the present application. As an improved solution, the balloon device includes:

[0338] catheter body;

[0339] a balloon body, connected to the catheter body, capable of receiving fluid from the catheter body, thereby changing from a folded state to an inflated state, and the artificial heart valve correspondingly expands from a compressed state to an expanded state based on the change of the balloon body;

[0340] The inner shaft is inserted into the catheter body and the balloon body, and a guide head is fixed at the distal end;

[0341] The transcatheter implant system further includes a locking wire structure for limiting the relative axial position of the artificial heart valve and the balloon body, and the locking wire is used to pass through the hole structure of the first stent.

[0342] Optionally, the locking structure includes:

[0343] a first adjustment line for releasably fixing the artificial implant to the balloon body, wherein one end of the first adjustment line can remain fixed to the catheter body, and the other end can pass through the eyelet structure and has a first locking hole;

[0344] a second adjustment line, one end of which is connected to the guide head and the other end of which can pass through the eyelet structure and has a second lock hole;

[0345] A locking wire having a relative locking state and an unlocking state, wherein in the locking state, the locking wire is inserted into each locking hole to restrain the artificial implant, and in the unlocking state, the locking wire is disengaged from each locking hole to release the artificial implant;

[0346] The guide head is provided with an insertion hole, and the end portion of the locking wire extends into the insertion hole in the locked state.

[0347] Optionally, there are at least two coupling parts between the adjustment line and the locking line, wherein at least one coupling part restricts the movement of the artificial implant in the distal direction, and at least one coupling part restricts the movement of the artificial implant in the proximal direction.

[0348] Optionally, the first adjustment line and the second adjustment line match each other in axial length so that the first stent is maintained in the middle area of ​​the balloon body.

[0349] The present application also provides a transcatheter implant system, comprising a balloon device and the artificial heart valve as described above, wherein the balloon device comprises:

[0350] catheter body;

[0351] a balloon body, connected to the catheter body, capable of receiving fluid from the catheter body, thereby changing from a folded state to an inflated state, and the artificial heart valve correspondingly expands from a compressed state to an expanded state based on the change of the balloon body;

[0352] The limiting mechanism is configured to limit the movement of the artificial heart valve in the axial direction at least when the artificial heart valve is installed on the balloon body in a compressed state. The limiting mechanism specifically includes a limiting body, which can be any of the limiting bodies described above, such as a plurality of rods forming a hollow cage structure.

[0353] Optionally, the limiting mechanism includes at least one limiting body, and at least the distal end of the first bracket is blocked by the limiting body.

[0354] Optionally, the distal end of the first bracket has a hole structure protruding from the end, and when the first bracket is in a compressed state, the hole structure abuts against the limiting body.

[0355] Optionally, both ends of the first stent have a hole structure protruding from the end, and the limiting mechanism includes at least two limiting bodies respectively located at the proximal and distal ends of the balloon body. When the first stent is in a compressed state, the hole structures respectively abut against the corresponding limiting bodies.

[0356] Optionally, the balloon device is further configured with a locking wire structure for axial limitation for the first stent.

[0357] Optionally, the limiting mechanism includes a limiting body, and at least the distal end of the first bracket is blocked by the limiting body;

[0358] The locking structure includes:

[0359] a first adjustment line for releasably fixing the artificial heart valve to the balloon body, wherein one end of the first adjustment line can remain fixed to the catheter body, and the other end can pass through the eyelet structure and has a first locking hole;

[0360] a second adjustment line, one end of which is connected to the guide head and the other end of which can pass through the eyelet structure and has a second lock hole;

[0361] The locking wire has a relative locking state and an unlocking state. In the locking state, the locking wire passes through each locking hole to restrict the artificial heart valve. In the unlocking state, the locking wire disengages from each locking hole to release the artificial heart valve. The guide head is provided with an insertion hole. In the locking state, the end portion of the locking wire extends into the insertion hole.

[0362] The present application also provides an artificial heart valve assembly, comprising:

[0363] Artificial heart valves (e.g. artificial pulmonary valves);

[0364] An anchoring stent is sleeved on the radially outer side of the artificial heart valve after assembly, the artificial heart valve and the anchoring stent both have an expanded state and a compressed state, and in the expanded state, the artificial heart valve and the anchoring stent abut against each other;

[0365] The anchoring bracket has a grid structure surrounded by frame bars, and the grid structure includes:

[0366] The middle part includes two circles of fishbone mesh;

[0367] The end portion includes two circles of diamond-shaped grids, one on each side of the middle portion in the axial direction;

[0368] The anchor stent further has a pre-expanded state before assembly, wherein the anchor stent has a first diameter in the pre-expanded state and a second diameter in the expanded state, wherein the second diameter is larger than the first diameter.

[0369] Optionally, in the expanded state, the axial length of the anchoring stent is greater than the length of the first stent.

[0370] Optionally, the first bracket is located in the middle of the axial direction of the anchor bracket.

[0371] Optionally, the fishbone grid is a concave hexagon with opposite convex tips and concave tails, and the concave tails of two circles of fishbone grids are symmetrically facing each other and the convex tips are facing away from each other;

[0372] The two circles of diamond grids are respectively located on both sides of the middle portion in the axial direction, and each diamond grid is located between the convex tips of two adjacent fishbone grids.

[0373] Optionally, the axial position of the first bracket does not exceed the middle portion.

[0374] Optionally, the first support has a denser mesh than that of the anchoring support.

[0375] Optionally, the number of circumferential grids in the first bracket is 1.2 to 2 times the number of circumferential grids in the anchor bracket.

[0376] Optionally, in the diamond grid at the end of the anchor bracket, the two frame bars facing away from the middle part have lower strength than the two frame bars shared with the middle part.

[0377] Optionally, the artificial heart valve and anchoring stent are both released based on balloon expansion.

[0378] Optionally, the artificial heart valve is released based on a balloon expansion method, and the anchoring stent is released based on a self-expansion method.

[0379] The present application also provides a transcatheter implant system, comprising:

[0380] The artificial heart valve assembly as described above;

[0381] A first delivery system is provided with a first balloon for delivering and expanding the artificial heart valve.

[0382] Optionally, the transcatheter implant system further comprises a second delivery system for expanding the anchor stent.

[0383] Optionally, the first delivery system and the second delivery system may use the same or different intervention pathways to implement interventional delivery.

[0384] Optionally, the first delivery system further includes a second balloon for expanding the anchoring stent.

[0385] Optionally, the first balloon body and the second balloon body are respectively configured with fluid channels (to avoid mutual interference), and the two balloon bodies are arranged axially, respectively loaded with an artificial heart valve and an anchoring stent, and the anchoring stent released first is at the distal end of the first stent.

[0386] Optionally, a limiting mechanism is configured for the distal end or both ends of the anchoring stent in the second delivery system.

[0387] Optionally, the second balloon body is configured with a limiting mechanism for the distal end or both ends of the anchoring stent.

[0388] Optionally, the limiting mechanism is configured to limit axial movement of the anchoring stent at least when the anchoring stent is mounted on the corresponding balloon body in a radially compressed state. The limiting mechanism specifically includes a limiting body, which can be any of the limiting bodies described above, such as a plurality of rods forming a hollow cage-shaped structure.

[0389] Optionally, a limiting mechanism is configured in the first balloon body for the distal end or both ends of the artificial heart valve.

[0390] Optionally, the limiting mechanism is configured to limit axial movement of the artificial heart valve at least when the artificial heart valve is mounted on the first balloon body in a radially compressed state. The limiting mechanism specifically includes a limiting body, which can be any of the limiting bodies described above, such as a plurality of rods forming a hollow cage-shaped structure.

[0391] Optionally, in the second delivery system, locking wire structures for axial limitation are configured at both ends of the anchoring stent.

[0392] Optionally, the end of the first bracket and / or the anchor bracket has a hole structure protruding from the end.

[0393] Optionally, the locking structure includes:

[0394] a first adjustment line for releasably securing the artificial heart valve or the anchoring stent to the corresponding delivery system, wherein one end of the first adjustment line can remain secured to the catheter body and the other end can pass through the eyelet structure and has a first locking hole;

[0395] a second adjustment line, one end of which is connected to the guide head and the other end of which can pass through the eyelet structure and has a second lock hole;

[0396] The first locking wire has a relative locking state and an unlocking state. In the locking state, the locking wire passes through each locking hole to restrict the anchoring stent. In the unlocking state, the locking wire disengages from each locking hole to release the artificial heart valve or the anchoring stent.

[0397] Optionally, when the transcatheter implant system includes two delivery systems, the locking wire structure is also configured in two sets for the two delivery systems.

[0398] Optionally, when the first delivery system includes a first balloon body and a second balloon body, the locking wire structure includes:

[0399] The third adjustment line and the fourth adjustment line are used to releasably fix the artificial heart valve to the first balloon body, and have a lock hole that can pass through the eyelet structure;

[0400] The fifth and sixth adjustment lines are used to releasably fix the anchoring stent to the second balloon body, and have a lock hole through which the anchoring stent can pass;

[0401] The second locking wire has a relative locking state and an unlocking state. In the locking state, the second locking wire passes through each locking hole to restrict the artificial heart valve and the anchoring stent. In the unlocking state, the second locking wire disengages from each locking hole to release the artificial heart valve and the anchoring stent.

[0402] Optionally, the locking wire includes a first locking wire and a third locking wire. In the locked state, the first locking wire passes through the locking hole to restrict the artificial heart valve, and the third locking wire passes through the locking hole to restrict the anchoring stent.

[0403] Optionally, the anchoring bracket includes a hole structure, and the second locking wire or the third locking wire passes through the hole structure of the anchoring bracket.

[0404] Optionally, the first delivery system is provided with locking wire structures for axial limitation at both ends of the artificial heart valve.

[0405] Optionally, a locking wire structure is configured for the anchoring stent in the transcatheter implant system.

[0406] Optionally, the transcatheter implant system is provided with a locking wire structure for the artificial heart valve and the anchoring stent.

[0407] Optionally, the first delivery system further comprises an outer sheath tube, the anchoring stent is accommodated in the outer sheath tube in a compressed state, and the anchoring stent is released based on a self-expansion manner.

[0408] The present application also provides a method for detaching an artificial heart valve assembly from an interventional delivery system, wherein the artificial heart valve assembly includes an artificial heart valve and an anchoring stent, both of which have an expanded state and a compressed state;

[0409] The interventional delivery system comprises at least an interventionally deliverable inner shaft, wherein both the artificial heart valve and the anchoring stent are connected to the inner shaft in a compressed state;

[0410] The disengagement method comprises:

[0411] Step S100, releasing the connection between the anchoring stent and the inner shaft, so that the anchoring stent enters an expanded state;

[0412] Step S200, delivering the artificial heart valve to the interior of the anchoring stent;

[0413] Step S300: releasing the connection between the artificial heart valve and the inner shaft, so that the artificial heart valve enters an expanded state and presses against the inner wall of the anchoring stent.

[0414] Optionally, the interventional delivery system further comprises an outer sheath tube, which is relatively slidably mounted on the outer periphery of the inner shaft, and the anchoring stent is connected to the inner shaft and wrapped by the outer sheath tube;

[0415] When releasing the connection between the anchoring stent and the inner shaft, the outer sheath and the inner shaft are first moved relative to each other, so that the anchoring stent is exposed to the outer sheath and enters an expanded state in a self-expanding manner.

[0416] Optionally, the inner shaft is one, and the interventional delivery system further comprises:

[0417] Two balloon bodies are arranged in sequence along the inner axis, and the artificial heart valve and the anchoring stent are respectively connected to the outer periphery of the corresponding balloon body;

[0418] A locking wire, used to simultaneously limit the axial positions of the artificial heart valve and the anchoring stent relative to the respective balloon bodies;

[0419] When the connection between the anchoring stent and the inner shaft is released, the method further includes moving the locking wire before or after the balloon body corresponding to the anchoring stent is inflated to release the axial restriction of the anchoring stent and maintain the axial restriction of the artificial heart valve;

[0420] When the artificial heart valve is released from the inner shaft, the method further includes moving the locking wire along the original movement direction before or after the balloon body corresponding to the artificial heart valve is inflated to release the axial limitation of the artificial heart valve.

[0421] Optionally, the interventional delivery system further comprises a bending adjustment component, wherein the bending adjustment component can at least act on the inner shaft to change the distal end direction of the inner shaft;

[0422] Before the artificial heart valve assembly is separated from the inner shaft, the inner shaft has a smooth turning part in space through the action of the bending adjustment assembly, or has at least two smooth turning parts, and the directions of the two turning parts are opposite (taking S as an example).

[0423] The portion of the inner shaft corresponding to the turning portion is made of a metal cutting tube.

[0424] This application improves the artificial heart valve and the interventional delivery system, and the two cooperate with each other during the interventional delivery and expansion process of the artificial heart valve, resulting in a more ideal operating effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0425] FIG1 is a schematic diagram of a secondary handle of a delivery system in an embodiment of the present application, with the secondary handle away from the primary handle;

[0426] FIG2 is a schematic diagram of the auxiliary handle in FIG1 close to the main handle;

[0427] FIG3a is a schematic diagram of the cooperation between the distal end of the outer sheath and the inner sheath in FIG1 ;

[0428] FIG3 b is a schematic diagram of distal-side bending adjustment of a delivery system in one embodiment of the present application;

[0429] FIG4 is a three-dimensional view of a secondary handle in one embodiment of the present application;

[0430] FIG5 is an exploded view of the housing and the head of the auxiliary handle in FIG4 ;

[0431] FIG6 is an assembly view of the housing, the first head, and the second head of the auxiliary handle in FIG4 ;

[0432] FIG7 is an assembly view of FIG6 from another perspective;

[0433] FIG8 is an exploded view of the remaining components of the auxiliary handle except the outer shell and the head in one embodiment of the present application;

[0434] FIG9 is a structural view of a secondary handle in one embodiment of the present application;

[0435] FIG10a is an enlarged view of section A in FIG9 (the sealing sheet seals the fluid gap);

[0436] FIG10b is an enlarged view of the open fluid gap of the sealing plate in FIG10a;

[0437] FIG11 is an exploded view of the first protective sleeve and the connecting sleeve in one embodiment of the present application;

[0438] FIG12 is a perspective view of a driving member sliding and locking in accordance with an embodiment of the present application;

[0439] FIG13 is a structural view of a connecting sleeve in one embodiment of the present application;

[0440] FIG14 is a perspective view of the operating button of the secondary handle in an embodiment of the present application being unlocked by sliding;

[0441] FIG15a is a perspective view of the operating button in FIG14 after sliding and locking;

[0442] FIG15 b is a three-dimensional view of the secondary handle and the outer sheath;

[0443] Figures 16a to 16d are schematic diagrams showing the positioning principle of the distal end of the balloon after inflation when the outer sheath is at different positions;

[0444] FIG17a is a structural view of the distal end of a catheter assembly in one embodiment of the present application;

[0445] FIG17b is a partial cross-sectional enlarged view of the fluid guide in FIG17a;

[0446] FIG18 is a schematic diagram of a balloon loaded with an artificial implant and in a folded state according to an embodiment of the present application;

[0447] FIG19a is a schematic diagram of the flow path of the fluid when the balloon is filled with water and expanded in one embodiment of the present application;

[0448] FIG19b is a schematic diagram of the balloon in FIG18 being expanded by water;

[0449] FIG20 a is a three-dimensional view of a fluid guide in one embodiment of the present application;

[0450] FIG20 b is a front view of the fluid guide in FIG20 a ;

[0451] FIG21 a is a three-dimensional view of a fluid guide in another embodiment of the present application;

[0452] FIG21 b is a front view of the fluid guide in FIG21 a ;

[0453] FIG22 a is a three-dimensional view of a fluid guide in another embodiment of the present application;

[0454] FIG22 b is a front view of the fluid guide in FIG22 a ;

[0455] FIG23 a is a three-dimensional view of a fluid guide in another embodiment of the present application;

[0456] FIG23 b is a front view of the fluid guide in FIG23 a ;

[0457] FIG24 a is a three-dimensional view of a fluid guide in another embodiment of the present application;

[0458] FIG24 b is a front view of the fluid guide in FIG24 a ;

[0459] FIG25 is a schematic diagram of the internal structure of a balloon body according to an embodiment of the present application;

[0460] FIG26a is an enlarged view of one embodiment of portion C in FIG25;

[0461] FIG26b is a schematic diagram of FIG26a during bending adjustment;

[0462] FIG27a is an enlarged view of another embodiment of portion C in FIG25;

[0463] FIG27b is a schematic diagram of FIG27a during bending adjustment;

[0464] FIG28 is an exploded view of the main handle in one embodiment of the present application;

[0465] FIG29 is a front view of the main handle in one embodiment of the present application;

[0466] FIG30 a is a cross-sectional view of section AA in FIG29 ;

[0467] Figure 30b is a cross-sectional view of section BB in Figure 29;

[0468] FIG31 is a partial enlarged view of the first slide seat in FIG30b;

[0469] FIG32 is a partial exploded view of an identification member in one embodiment of the present application;

[0470] FIG33 is a diagram showing the coordination of the identification member and the indicator segment in one embodiment of the present application;

[0471] FIG34 is a diagram illustrating the cooperation between the first slide and the guide cylinder in one embodiment of the present application;

[0472] FIG35 is an exploded view of the second joint in one embodiment of the present application;

[0473] FIG36 is an assembled view of FIG35;

[0474] FIG37 is an enlarged view of portion E in FIG30b;

[0475] FIG38 is an enlarged view of portion D in FIG30a;

[0476] FIG39 is a partial cross-sectional view of the multi-way connector in FIG30b;

[0477] FIG40 is an exploded view of a multi-way connector and a second slide in one embodiment of the present application;

[0478] FIG41 is an assembled view of FIG40;

[0479] FIG42 is a schematic diagram of a distal locking wire of a delivery system according to an embodiment of the present application;

[0480] FIG43 is a front view of an artificial implant according to an embodiment of the present application;

[0481] FIG44 is a perspective view of the artificial implant of FIG43;

[0482] FIG45 is a front view of an artificial implant according to another embodiment of the present application;

[0483] FIG46 is a front view of an artificial implant according to another embodiment of the present application;

[0484] 47 and 48 are schematic structural diagrams of a balloon catheter in the prior art;

[0485] FIG49 is a flow chart of a method for driving a balloon catheter using fluid in one embodiment of the present application;

[0486] FIG50 a is a schematic diagram of a balloon catheter before fluid is injected according to an embodiment of the present application;

[0487] FIG50 b is a schematic diagram showing the principle of a method for driving a balloon catheter using fluid in one embodiment of the present application;

[0488] FIG51 is a schematic diagram of injecting fluid into the balloon catheter to bring the balloon catheter to a transition state;

[0489] FIG52 is a schematic diagram of a balloon catheter after being fully inflated;

[0490] FIG53 is a schematic diagram of an artificial implant placed in the body (taking the aortic valve as an example);

[0491] FIG54 is an enlarged view of portion A in FIG50a , wherein the fluid has not yet begun to be diverted;

[0492] FIG55 a is a schematic diagram of a first flow diversion method for fluid;

[0493] FIG55 b is an enlarged view of portion B in FIG55 a , wherein the fluid is diverted according to the first diversion method;

[0494] FIG56 is a schematic diagram showing the principle of a second flow diversion method for fluid;

[0495] FIG57 a is a schematic diagram of a second flow diversion method for fluid;

[0496] FIG57 b is an enlarged view of portion C in FIG57 a , wherein the fluid has not yet begun to be divided;

[0497] FIG57c is a schematic diagram showing the flow direction of the fluid in FIG57a after being diverted;

[0498] FIG58 is a schematic structural diagram of a fully expanded balloon catheter provided by the present application;

[0499] FIG59 is a schematic structural diagram of a flow channel cross section of a balloon catheter provided by the present application;

[0500] FIG60 is a schematic structural diagram of an embodiment of an interventional device delivery device provided by the present application;

[0501] FIG61a is a schematic diagram showing the principle of fixing the distal end of the drainage tube relative to the core tube in the interventional instrument delivery device provided by the present application;

[0502] FIG61b is a schematic diagram of the structure in which the distal end of the drainage tube is fixed relative to the core tube in the interventional instrument delivery device provided by the present application;

[0503] FIG62 is a partial cross-sectional view of the drainage tube and the catheter in the interventional device delivery device provided by the present application;

[0504] FIG63 is a schematic structural diagram of a drainage tube in an interventional device delivery device provided by the present application;

[0505] FIG64 is a schematic structural diagram of another embodiment of the interventional device delivery device provided by the present application;

[0506] FIG65 a is a partial cross-sectional view of a beveled section of an embodiment of an interventional instrument delivery device provided by the present application;

[0507] FIG65 b is a partial cross-sectional view of a beveled section of another embodiment of the interventional instrument delivery device provided by the present application;

[0508] FIG66 is a schematic structural diagram of a spacer in the interventional device delivery device provided by the present application;

[0509] FIG67a is a schematic structural diagram of a positioning structure of an embodiment of an interventional instrument delivery device provided by the present application;

[0510] FIG67b is a schematic structural diagram of a positioning structure of another embodiment of the interventional instrument delivery device provided by the present application;

[0511] FIG68 is a schematic structural diagram of an interventional delivery system according to an embodiment of the present application;

[0512] FIG69 is a schematic structural diagram of the distal end portion in FIG68;

[0513] FIG70 is a schematic structural diagram of the rod member of the limiting mechanism in FIG69 in an expanded state;

[0514] FIG71 is a schematic structural diagram of the rod member of the limiting mechanism in FIG70 in a compressed state;

[0515] FIG72 is a schematic structural diagram of the adaptation between the limiting mechanism and the inner shaft according to an embodiment of the present application;

[0516] FIG73 is a schematic structural diagram of the limiting mechanism in FIG72;

[0517] FIG74 is a schematic structural diagram of the limiting mechanism in FIG72 when it is in a straight cylindrical shape;

[0518] FIG75 is a front view of the limiting mechanism in FIG72 in a compressed state or an intermediate state;

[0519] FIG76 is a side view of the balloon body in a folded state cooperating with the limiting mechanism in FIG75 ;

[0520] FIG77a is a schematic structural diagram of the distal end (with a balloon device) of a delivery system with a sheath according to another embodiment of the present application;

[0521] FIG77b is a schematic diagram of the structure of the sheath tube in FIG77a after it moves toward one end;

[0522] FIG77c is a schematic diagram of the structure of the balloon in FIG77a after inflation;

[0523] FIG77 d is an enlarged schematic diagram of a step generated by installing a conventional artificial implant on a balloon body;

[0524] Figure 77e is an enlarged view of part A in Figure 77b;

[0525] FIG78 a is a schematic structural diagram of the distal end of a delivery system according to another embodiment of the present application;

[0526] FIG78b is a schematic structural diagram of the sheath tube moving and wrapping the proximal end limiting mechanism in FIG78a;

[0527] FIG78c is a schematic diagram of the structure of the balloon in FIG78b after inflation;

[0528] 79 to 83 are schematic structural diagrams of the limiting mechanisms of other embodiments of the present application;

[0529] FIG84 is a front view of the limiting mechanism of FIG83;

[0530] Figures 85a to 85c are schematic structural diagrams of the distal end of the delivery system in different embodiments of the present application;

[0531] FIG86 is a schematic structural diagram of a limiting mechanism according to an embodiment of the present application;

[0532] 87 to 89 are schematic diagrams of the structure of the coupling member distribution in one embodiment of the present application;

[0533] FIG90 is a schematic longitudinal cross-sectional view of the limiting mechanism of FIG86;

[0534] 91 and 92 are schematic structural diagrams of the collapsed portion of the cage structure in some embodiments of the present application;

[0535] FIG93 is a schematic structural diagram of a limiting mechanism according to another embodiment of the present application;

[0536] FIG94 is a schematic structural diagram of a balloon device according to an embodiment of the present application;

[0537] FIG95 is a schematic structural diagram of the limiting mechanism in FIG94;

[0538] FIG96 is a schematic longitudinal cross-sectional view of the limiting mechanism in FIG95 ;

[0539] FIG97 is a schematic transverse cross-sectional view of the limiting mechanism of FIG86;

[0540] FIG98 is a schematic structural diagram of a balloon device according to another embodiment of the present application;

[0541] FIG99 is a schematic structural diagram of the limiting mechanism in FIG98;

[0542] FIG100 is a longitudinal cross-sectional diagram of a limiting mechanism according to another embodiment of the present application;

[0543] FIG101 is a schematic structural diagram of a coupling member according to another embodiment of the present application;

[0544] FIG102 is a perspective view of a stopper according to another embodiment of the present application;

[0545] Figure 103 is a partial cross-sectional view of the limiting body in Figure 102

[0546] FIG104 is a schematic diagram of the limiting mechanism of FIG102 integrally cutting a pipe;

[0547] 105 and 106 are schematic structural diagrams of a position limiting mechanism according to another embodiment of the present application;

[0548] FIG107 is a schematic diagram of the inflation of the balloon device with the limiting mechanism in FIG106;

[0549] FIG108 is a partial enlarged view of point F in FIG107;

[0550] FIG109 is a partial enlarged view of point G in FIG107;

[0551] FIG110 is a perspective view of a stopper according to another embodiment of the present application;

[0552] FIG111 is a schematic structural diagram of a stopper according to another embodiment of the present application;

[0553] FIG112 is a schematic structural diagram of a stopper according to another embodiment of the present application;

[0554] FIG113 is a schematic structural diagram of a stopper according to another embodiment of the present application;

[0555] FIG114 is a schematic structural diagram of a stopper according to another embodiment of the present application;

[0556] FIG115 is a schematic diagram of the limiting mechanism of FIG110 integrally cutting a pipe;

[0557] FIG116 is a schematic diagram of the structure of the coupling member and the pin in accordance with an embodiment of the present application;

[0558] FIG117 is a schematic structural diagram of a transcatheter implant system according to an embodiment of the present application;

[0559] FIG118 is a schematic structural diagram of an artificial heart valve according to an embodiment of the present application;

[0560] FIG119 is a schematic diagram of a partial structure of the first bracket in FIG118 ;

[0561] FIG120 is a partial schematic diagram of the first stent in FIG118 being radially compressed;

[0562] FIG121 is a schematic structural diagram of the eyelet structure of the first bracket in FIG118;

[0563] FIG122 is a second schematic diagram of the partial structure of the first bracket in FIG118;

[0564] FIG123 is a schematic structural diagram of the hole structure in FIG122;

[0565] FIG124 is a schematic diagram of the first bracket in FIG123 from another perspective;

[0566] FIG125 is a schematic structural diagram of an artificial heart valve in another embodiment of the present application;

[0567] FIG126 is a schematic diagram of the integrally formed blocking member in FIG125;

[0568] FIG127 is a schematic structural diagram of the delivery system of the present application;

[0569] FIG128 is a schematic diagram of the structure of the balloon in FIG127 in an inflated state;

[0570] 239

[0571] FIG129 is a schematic diagram of the structure of the leaflet in the prior art in an expanded state;

[0572] FIG130 is a schematic diagram of the structure of the multiple leaflets in FIG129 after suturing;

[0573] FIG131 is a schematic diagram of the structure of an artificial heart valve in the prior art;

[0574] FIG132 is a schematic structural diagram of the leaflets of an artificial heart valve provided in an embodiment of the present application in a flattened state;

[0575] FIG133 is a schematic diagram of the structure of the outer protrusion and the opening area in FIG132;

[0576] FIG134 is a schematic diagram of the structure of suturing the joint using the first suture;

[0577] FIG135a is a schematic structural diagram of a bracket according to an embodiment of the present application;

[0578] Figure 135b is an enlarged view of A in Figure 135a;

[0579] FIG135c is a schematic diagram of the structure of suturing the two joints and the support bar using a plurality of second sutures;

[0580] FIG136 is a schematic diagram of the structure of using multiple third sutures to wrap the ear piece of the valve leaflet around the support bar and sew it;

[0581] 137 to 139 are schematic diagrams of a transcatheter implant system with a locking wire structure according to an embodiment of the present application;

[0582] FIG140 is a schematic structural diagram of a transcatheter implant system according to an embodiment of the present application;

[0583] FIG141 is a schematic diagram of the balloon of FIG140 in an inflated state;

[0584] FIG142 is a schematic structural diagram of a transcatheter implant system according to another embodiment of the present application;

[0585] 143 to 144 are schematic diagrams of a transcatheter implant system with a locking wire structure and a limiting mechanism according to an embodiment of the present application;

[0586] FIG145 is a schematic structural diagram of an artificial heart valve in another embodiment of the present application;

[0587] FIG146 is a schematic structural diagram of the anchor bracket in FIG145;

[0588] FIG147 is a schematic structural diagram of the first bracket in FIG145;

[0589] FIG148 is a schematic diagram of a partial structure of FIG146;

[0590] FIG149 is a schematic diagram of the hole structure of the anchor bracket in FIG148;

[0591] FIG150 is a schematic diagram of the anchor stent of FIG146 being radially compressed;

[0592] 151 to 156 are schematic structural diagrams of transcatheter implant systems in other embodiments of the present application;

[0593] FIG157 is a schematic structural diagram of a transcatheter implant system with a bending adjustment component in other embodiments of the present application;

[0594] Figure 158 is a schematic diagram of the structure of the bending pipe in Figure 156 in a bent state.

[0595] The reference numerals in the figures are described as follows:

[0596] 1. Interventional delivery system;

[0597] 8. Artificial implant; 800. Stent; 811. First eyelet; 812. Second eyelet; 82. Waist structure; 83. Leaflet; 831. Fixed edge; 832. Free edge; 833. Outflow side; 834. Inflow side; 84. Base; 841. Leakage prevention component; 8411. First ring of leakage prevention components; 8412. Second ring of leakage prevention components; 8413. Third ring of leakage prevention components; 85. Blood flow channel; 86. Raised step;

[0598] 9. Control handle; 10. Main handle; 100. Support body; 1001. Mounting slot; 1002. Guide slot;

[0599] 110, first slide; 1101, slide groove; 111, first drive sleeve;

[0600] 112, guide cylinder; 1121, guide strip; 1122, second exhaust hole; 1123, second annular seat; 1124, slot;

[0601] 113. Second pipe joint; 1131. Second exhaust channel; 1132. Positioning rib;

[0602] 114, one-way valve core; 115, sealing ring; 116, second protective sleeve; 116a, first part; 116b, second part;

[0603] 120, housing; 121, frame; 1211, slide; 122, identification member; 1221, inner teeth; 123, transparent cover;

[0604] 130, second slide; 1301, latching gear; 131, second drive sleeve;

[0605] 140, multi-way connector; 1401, slot; 141, interface; 142, interface;

[0606] 20. Auxiliary handle; 200. Housing; 201. Passageway; 202. Half housing; 2021. Screw-on slot; 2022. Insertion slot; 2023. Positioning slot;

[0607] 203, head; 203a, first head; 203b, second head; 2031, through hole; 2032, latching teeth; 2033, elastic buckle;

[0608] 210, connecting sleeve; 2101, positioning boss; 2102, first exhaust hole; 2103, first exhaust channel; 2104, first annular seat; 2105, positioning rib; 2106, reinforcement hole; 2107, slide groove;

[0609] 211, first pipe joint; 2111, slot; 2112, snap ring; 212, first protective sleeve; 213, sealing ring; 214, fluid gap;

[0610] 220, positioning member; 2201, free end; 2202, fixed end; 2203, guide ramp; 2204, hollow area; 221, elastic claw;

[0611] 230, driving member; 2301, guide rib; 2302, first avoidance opening; 2303, second avoidance opening; 240, elastic liner; 2401, positioning step; 250, operating button;

[0612] 26, one-way valve core; 261, limit rod; 2611, head; 262, sealing piece;

[0613] 30. Catheter assembly; 310. Outer sheath; 3101. Connecting section; 3102. Loading section; 3103. Sheath section; 320. Inner sheath; 321. Guidewire channel; 322. Fluid channel; 323. Second developing ring; 324. Third developing ring;

[0614] 330. Balloon catheter; 331. Balloon body; 332. Catheter body;

[0615] 340, bending pipe; 341, traction parts;

[0616] 350, fluid guide; 351, guide groove; 352, connecting groove; 353, hollow area; 354, guide channel;

[0617] 360, lock line; 370, guide head; 3701, annular step; 381, first pull ring; 382, ​​second pull ring.

[0618] 41. Artificial implant; 42. Balloon catheter; 421. Proximal end; 422. Distal end; 423. Balloon body; 4231. Second part; 4232. Middle part; 4233. First part; 424. Catheter body; 4241. Main channel; 425. Drainage tube; 4251. Proximal section; 42511. Fluid outlet; 4252. Middle section; 4253. Distal section; 4254. Fluid inlet; 4255. First fluid outlet; 4256. Second fluid outlet; 4257. Bevel section; 4258. Bevel surface; 426. Independent flow channel; 43. Guide head; 431. Positioning structure; 44. Inner shaft; 441. Isolation piece; 45. Fluid.

[0619] 51. Interventional delivery system; 5101. Proximal end; 5102. Distal end;

[0620] 52, limiting mechanism; 521, coupling portion; 5211, crest; 5212, trough;

[0621] 523, deformation portion; 525, rod; 5251, first end; 5252, second end; 5253, spiral; 5254, abutment portion; 5255, end portion; 5256, hole;

[0622] 53. Control handle; 54. Catheter assembly; 541. Balloon device; 542. Balloon body; 5421. Proximal segment; 5422. Intermediate segment; 5423. Distal segment; 5424. Fold; 5425. Protrusion; 5425. Distal portion; 5426. Proximal portion; 543. Intermediate shaft; 544. Outer sheath; 545. Inner shaft; 546. First direction;

[0623] 55. Artificial implant; 551. Step; 552. Eyelet;

[0624] 5710, adjustment line; 5711, keyhole; 5720, lock line.

[0625] The reference numerals in the figures are described as follows:

[0626] 61. Transcatheter implant system; 6101. Proximal end; 6102. Distal end; 611. First delivery system; 612. Second delivery system; 613. Bending module; 614. Bending tube; 6141. Bending portion;

[0627] 62, limiting mechanism; 62a, internal space; 62b, external space; 621, coupling member; 621a, coupling member; 621b, coupling member; 621c, coupling member; 621d, coupling member; 6211, first coupling member; 6212, second coupling member; 62121, sleeve; 6213, crest; 6214, trough; 622, limiting body; 622a, limiting body; 622b, limiting body; 6221, rod; 62211, bifurcation; 62212, intersection; 6222, main hollow area; 6223, auxiliary hollow area 6224, first end; 62241, concave area; 6225, second end; 6226, slit; 623, flared portion; 623a, rod; 623b, rod; 623c, rod; 623d, rod; 623e, rod; 624, cage structure; 624a, gathered portion; 624b, gathered portion; 624c, gathered portion; 624d, gathered portion; 6241, cone; 62411, first cone; 62412, second cone; 625, guide tube; 6251, fluid inlet; 6252, reduced diameter section;

[0628] 63, control handle; 63a, control handle; 63b, control handle; 631, interface; 631a, interface; 631b, interface;

[0629] 64. Catheter assembly; 641. Balloon device; 6411. Catheter body; 642. Balloon body; 642a. Second balloon body; 642b. First balloon body; 6421. First portion; 6422. Middle portion; 6423. Second portion; 6424. Folding portion; 643. Inner shaft; 644. Outer sheath; 645. Fluid inlet; 646. Guide tip;

[0630] 65. Artificial heart valve; 65a. Artificial implant; 651. First stent; 6511. Frame bar; 6511a. Frame bar; 6511b. Frame bar; 6511c. Frame bar; 6511d. Frame bar; 6511e. Frame bar; 6511f. Frame bar; 65111. Grid node; 65111a. Grid node; 65111b. Grid node; 65111c. Grid node; 65112. Arc segment; 65113. Connecting segment; 65113 a, connecting section; 65113b, connecting section; 65113c, connecting section; 65113d, connecting section; 6512, mesh structure; 6512a, mesh structure; 6512b, mesh structure; 6512c, mesh structure; 6513, inflow side; 6514, outflow side; 652, leaflet; 6521, fixed edge; 6522, free edge; 653a, eyelet structure; 653b, eyelet structure; 654, first mesh; 655, second mesh.

[0631] 656, anchor bracket; 6561, frame bar; 6562, grid structure; 65621, middle portion; 65622, end portion; 6563, fishbone grid; 65631, convex tip; 65632, concave tail; 65633, frame bar; 6564, diamond grid; 65641, frame bar; 65642, frame bar; 65643, frame bar; 65644, frame bar;

[0632] 657, skirt; 658, lining membrane; 659, plugging piece;

[0633] 66. Tooling; 67. Stopper;

[0634] 68. Locking line structure; 681. First adjustment line; 6811. First lock hole; 682. Locking line; 6821. First locking line; 6822. Second locking line; 683. Second adjustment line; 6831. Second lock hole; 684. Third adjustment line; 685. Fourth adjustment line; 686. Fifth adjustment line; 687. Sixth adjustment line.

[0635] 7100, leaflet; 7110, body; 7120, free edge; 7130, fixed edge; 7131, opening area; 7140, ear; 7150, protrusion; 7151, inner edge; 7152, outer edge; 7170, junction; 7171, first bend; 7172, second bend; 7173, suture hole; 7174, first suture; 7175, suture hole; 7175a, suture hole; 7175b, suture hole; 7175c, suture hole; 7176, second suture; 7178, third suture; 7180, knot; 7181, knot; 7182, knot;

[0636] 7200, artificial heart valve; 7210, stent; 7220, support bar; 7221, recessed area; 7222, first recessed area; 7223, second recessed area. DETAILED DESCRIPTION

[0637] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0638] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be an intermediate component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be an intermediate component.

[0639] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0640] In this application, the terms "first," "second," etc. are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly indicate the number or order of the technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0641] For ease of understanding of the present application, the "distal end" and "proximal end" mentioned in the following embodiments are commonly used terms in the field of interventional medical devices. When used to indicate direction, the "distal end" refers to the side away from the operator during surgery, and the "proximal end" refers to the side close to the operator during surgery. When used to refer to a structure, the "end" in the text refers to the endpoint of the structure, or a point or area in the direction of that side, or a specific structure connected to that point or area.

[0642] Unless otherwise specified, the axial direction mentioned in the embodiments of this application refers to the theoretical direction when the catheter assembly and the control handle are fully straightened, and the straight line between the proximal end and the distal end determines the axial direction, and correspondingly determines the radial direction perpendicular to the axial direction and the circumferential direction arranged around the axial direction.

[0643] See Figure 3b, which shows a schematic diagram of the instrument posture at the aortic arch during cardiac interventional surgery. In order to adapt to the physiological structure of this area, the distal end of the catheter assembly 30 presents a significant bend, and the distal end posture of the catheter assembly is usually actively intervened with the help of bending adjustment means. After the artificial implant is basically in place, whether it is self-expanding or balloon expansion, the artificial implant is exposed by retracting the outer sheath to facilitate the complete release of the artificial implant.

[0644] The proximal end of the catheter assembly is connected to and controlled by a control handle. Limited by the size (length) of the control handle, the relative range of motion of each tube is limited. Therefore, during the withdrawal of the outer sheath, the distal end of the outer sheath generally remains within the aortic arch. For the catheter assembly as a whole, the stiffness of each part (the part exposed to the outer sheath and the part still within the outer sheath) varies greatly, and the spatial posture is no longer stable and may need to be readjusted, which brings unnecessary cumbersome operations to the surgery. Especially in the scenario of releasing artificial implants by balloon expansion, the outer sheath is allowed to be withdrawn quickly in order to improve efficiency.

[0645] 1 to 3a , the present application provides an interventional delivery system 1 , comprising a catheter assembly 30 and a control handle 9 connected to the catheter assembly 30 . The catheter assembly 30 has opposing distal and proximal ends and includes an inner sheath 320 and an outer sheath 310 that are slidably disposed relative to each other. The outer sheath 310 includes, from the distal end to the proximal end, a loading section 3102 and a sheath section 3103 . The loading section 3102 is used to wrap an artificial implant and maintain the artificial implant in a compressed state.

[0646] The control handle 9 includes:

[0647] A main handle 10, to which the proximal end of the inner sheath 320 is connected;

[0648] The auxiliary handle 20 is slidably mounted on the outer periphery of the inner sheath 320 , and the proximal end of the outer sheath 310 is connected to the auxiliary handle 20 .

[0649] In this application, a sub-handle 20 is independently configured for the outer sheath in the catheter assembly. The entire sub-handle 20 has a threading channel. On the one hand, it is used to insert the docking outer sheath, and on the other hand, it allows other tubes in the catheter assembly to extend from the proximal end of the outer sheath and slide through the sub-handle 20. As far as the entire interventional delivery system is concerned, the outer sheath is controlled by the sub-handle, and the remaining tubes are controlled by the main handle (the main and sub here are understood as relative concepts).

[0650] Setting the auxiliary handle and the main handle separately can further improve the flexibility of the outer sheath control. More importantly, the stroke of the outer sheath is no longer limited by the length of the main handle. When retracting the outer sheath, the distal end of the outer sheath can also be withdrawn from the aortic arch, minimizing the impact on the spatial posture of other pipes.

[0651] Depending on the loading and release methods of the artificial implant, the inner sheath and the outer sheath can be directly installed (i.e., directly adjacent in the radial direction) or other pipes can be added between the two radially. The artificial implant itself can adopt conventional technology. Taking the artificial heart valve as an example, it generally includes a radially deformable stent and multiple leaflets connected to the stent. The stent is a tubular structure with hollow cells. The inside of the stent is a blood flow channel, and the leaflets cooperate with each other to control the opening and closing of the blood flow channel.

[0652] Taking self-expanding release as an example, the inner sheath has a mounting head near the distal end, and the radially compressed artificial implant is connected to the mounting head. The distal end of the outer sheath is an expanded loading section, which surrounds the outer circumference of the artificial implant and confines the artificial implant in a compressed state. When the outer sheath is withdrawn toward the proximal end, the artificial implant is gradually exposed and released.

[0653] When released in a balloon expansion manner, a balloon catheter is also provided between the inner sheath and the outer sheath. The radially compressed artificial implant is located on the periphery of the balloon body 331 and is wrapped by the loading section of the outer sheath. When the outer sheath is withdrawn proximally to expose the artificial implant, the balloon catheter is expanded by injecting fluid, thereby radially expanding the artificial implant to complete the release.

[0654] An adjustment bend tube can also be set between the inner sheath and the outer sheath according to operational needs, which will be further described below. In order to cooperate with the operation and obtain the position and posture of the catheter assembly in the body in real time, each tube can also be configured with a development mark. For example, a first development ring is set at the distal end of the loading section, and a second development ring 323 and a third development ring 324 are set at the position of the balloon body on the inner sheath (as can be seen in Figure 19a).

[0655] The material of each pipe fitting can be conventional materials, for example, the loading section 3102 of the outer sheath 310 is made of Pebax, and the other parts such as the sheath section 3103 are made of PTFE. The bending tube can be made of metal sea wave tube, and the cutting density of different parts is slightly changed. For example, the density at the distal end is high and the density at the proximal end is low, so that the distal end is more flexible than the proximal end.

[0656] The diameter of the loading section 3102 is larger than that of the sheath section 3103 to accommodate artificial implants of different specifications. When the artificial implant is loaded, it is radially compressed into a tubular shape and is accommodated and wrapped inside the loading section 3102. In order to facilitate the delivery of the loading section 3102 into the body, it can be implemented in conjunction with a catheter sheath. The catheter sheath can establish a temporary channel in the blood vessel for the catheter assembly 30 to penetrate. The wall of the catheter sheath is preferably an expandable structure to accommodate the loading section 3102 with a slightly larger diameter. For example, the cross-section of the catheter sheath wall has a tortuous portion. Through the deformation and resetting of the tortuous portion, the temporary channel can be changed, expanding at the position where the loading section 3102 passes, and resetting and contracting after the loading section 3102 passes.

[0657] To limit the distal end position of the outer sheath 310, the inner sheath 320 is provided with a guide head 370 at its distal end. The outer periphery of the guide head 370 has an annular step 3701. The distal end surface of the loading section 3102 abuts against the annular step 3701, achieving axial position limiting. This also ensures that the outer periphery of the guide head 370 is flush with the outer periphery of the loading section 3102, reducing the safety risk of scratches.

[0658] 1 to 5 , the secondary handle 20 includes:

[0659] The housing 200 has an axial direction, and a distal end and a proximal end opposite to each other in the axial direction. The housing 200 has an axially penetrating through passage 201.

[0660] The connecting sleeve 210 is fixed in the housing 200 and arranged around the guide channel 201. The distal end of the connecting sleeve 210 is plugged into the outer sheath 310.

[0661] A positioning member 220 is movably mounted in the housing 200. The positioning member 220 has a locking position for interfering with the threading channel 201 and an unlocking position for releasing the threading channel 201.

[0662] The driving member 230 cooperates with the positioning member 220 to drive the positioning member 220 to switch positions.

[0663] Among them, the positioning member 220 and the driving member 230 are mainly set to adjust and lock the relative position of the auxiliary handle 20 and the main handle 10, to avoid unnecessary sliding and dislocation of the outer sheath 310 relative to other pipes, so as to reduce safety hazards.

[0664] When used in combination, all the other pipes except the sheath 310 are in the threading channel 201. Since the positioning member 220 interferes with the threading channel 201, it also means that a force can be applied to the other pipes, and then the relative position of the sub-handle 20 and the other pipes is locked. Similarly, releasing the threading channel 201 means reducing or completely releasing the force applied to the other pipes, allowing the sub-handle 20 to drive the outer sheath 310 and the other pipes to slide relative to each other. The driving member 230 and the positioning member 220 can be an integrated structure, separately fixed, or transmission-coordinated, so as to drive the positioning member 220 to switch between the locked position and the unlocked position.

[0665] In this embodiment, the movement direction of the positioning member and the driving member relative to the auxiliary handle is not strictly limited. As a positioning member, it has at least a movement component along the radial direction of the guide channel to change the force acting on other pipes or the radial relative position.

[0666] The force exerted by the positioning part on other pipe fittings can be the friction force generated by radial abutment with each other, or it can be a structure that cooperates with each other to generate axial phase force, such as latching teeth, axial blocking parts, etc. The movement mode of the driving part can be axial sliding, radial pressing, or circumferential rotation, etc.

[0667] The housing 200 provides an environment for installing and accommodating the remaining components and is generally held directly during operation for ease of assembly. Referring to Figures 4 and 5, in one embodiment, the housing 200 is a split, snap-fit ​​structure, and a mutually cooperating snap-fit ​​positioning structure is provided between the inner wall of the housing 200 and the outer periphery of the connecting sleeve 210.

[0668] The split fastening can be a radial multi-petal fastening, and can also be combined with an axial multi-stage structure. In this embodiment, the outer shell 200 includes two half shells 202 radially fastened along the connecting sleeve 210, and heads 203 respectively located at the axial ends of the two half shells 202; each head 203 is fixed to the two half shells 202 by snapping or screwing.

[0669] 6 and 7 , the buckling parts of the two half shells 202 are against or engaged with each other, and the heads 203 at both ends clamp the two half shells 202 together and fix them to each other. In addition, they can be fixed by bonding, fasteners, buckles, etc. Each head has a through hole 2031 to avoid the through-channel 201, wherein the inner circumference of the first head 203a has a latch tooth 2032, and the outer circumference of each half shell 202 is provided with a screw-on latch groove 2021 that cooperates with the latch tooth 2032, and the second head 203b at the other end is provided with an elastic buckle 2033 on the axial end face, and the axial end face of each half shell 202 is provided with a plug-in slot 2022 that cooperates with the elastic buckle 2033.

[0670] The locking structure between the outer shell 200 and the connecting sleeve 210 includes a positioning groove 2023 arranged on the inner circumference of each half shell, and a positioning boss 2101 fixed to the outer circumference of the connecting sleeve. After the two half shells 202 are buckled together, the positioning boss 2101 is inserted into the positioning groove 2023 to achieve axial positioning, while also limiting the displacement of the connecting sleeve in the radial direction.

[0671] In order to ensure the positioning effect, multiple ribs 2024 can be set on the inner wall of the half shell 202. Each rib 2024 surrounds and supports the outer periphery of the connecting sleeve 210 to assist in positioning. Along the axial direction of the connecting sleeve, the positioning boss 2101 and each rib 2024 are respectively located at both ends of the connecting sleeve 210.

[0672] There is a radial gap between the outer sheath 310 and the other internal tubing. Before surgery, the air in this radial gap needs to be expelled to reduce safety hazards. For example, physiological saline can be injected into the radial gap from the proximal end of the outer sheath 310 to expel the air from the distal end. Conventional technology would configure a pipeline connected to this radial gap and additionally provide a control valve on the pipeline. One embodiment of the present application also provides an improved method.

[0673] 8 and 9 , the side wall of the connecting sleeve 210 is provided with a first exhaust hole 2102 connected to the guide channel 201 , and a first pipe joint 211 is fixedly connected to the first exhaust hole 2102 . The first exhaust hole 2102 and the first pipe joint 211 define a first exhaust channel 2103 , and a one-way valve core 26 is provided in the first exhaust channel 2103 .

[0674] From distal to proximal, they are:

[0675] The sealing portion between the inner wall of the connecting sleeve and the outer sheath 310;

[0676] first exhaust hole 2102;

[0677] The sealing and matching part of other pipe fittings in the outer sheath 310 of the inner wall of the connecting sleeve is roughly the interference part between the positioning member 220 and the guide channel 201. When the positioning member 220 locks the internal pipe fitting, this part can be sealed and matched with the internal pipe fitting;

[0678] The arrangement of the above-mentioned parts can ensure that the physiological saline injected through the first exhaust hole 2102 can only enter the radial gap between the outer sheath 310 and the inner tube, and flow toward the distal side to achieve exhaust.

[0679] This embodiment omits an external control valve. Instead, a one-way valve core is installed within the first exhaust channel, floating under the influence of a fluid pressure differential. When saline is injected, the one-way valve core pushes against the valve core to open the first exhaust channel. If a reverse flow occurs, the one-way valve core pushes back against the valve core to close the first exhaust channel, preventing fluid from escaping. This adaptive one-way valve core improves overall system integration and eliminates the tedious operation of a control valve.

[0680] In order to connect the first pipe joint 211 , a first annular seat 2104 is provided on the edge of the first exhaust hole 2102 . The first pipe joint 211 and the first annular seat 2104 are plug-fitted together, and a mutually cooperating anti-rotation structure is provided between them.

[0681] One end of the first pipe joint 211 may have a threaded structure to facilitate quick disassembly and assembly with the external pipeline, and the other end is inserted into the first annular seat 2104. A sealing ring 213 arranged around the first exhaust hole 2102 may be provided in the first annular seat 2104. The end face of the first pipe joint 211 inserted into the first annular seat 2104 is sealed against the sealing ring 213. The sealing ring 213 is elastic to ensure the sealing effect.

[0682] In order to ensure the strength of the docking part when docking with external pipelines, a first protective sleeve 212 is embedded in the outer periphery of the first pipe joint 211 on the housing 200, and a pipeline plugging gap is formed between the outer wall of the first pipe joint 211 and the inner wall of the first protective sleeve 212.

[0683] The anti-rotation structure can prevent the first pipe joint 211 from unnecessary movement when the external pipeline is disassembled and assembled. The anti-rotation structure includes:

[0684] The slot 2111 extends along the insertion direction of the first pipe connector 211 , and is disposed on a sidewall of one of the first pipe connector 211 and the first annular seat 2104 ;

[0685] The positioning rib 2105 cooperates with the slot 2111 and is disposed on the side wall of the other of the first pipe joint 211 and the first annular seat 2104 .

[0686] In FIG8 and FIG11 , three slots 2111 are shown on the inner wall of the first annular seat, and three positioning ribs 2105 are provided at corresponding positions on the outer wall of the first pipe joint.

[0687] The one-way valve core 26 has a relatively sealed state and an open state, and the one-way valve core 26 specifically includes:

[0688] The limiting rod 261 is slidably mounted in the inner cavity of the first pipe joint 211, with a fluid gap between the outer periphery of the limiting rod and the inner wall of the first pipe joint 211 (the fluid gap also serves as part of the first exhaust channel 2103);

[0689] The sealing piece 262 is connected to the limiting rod 261 . In the sealed state, the sealing piece 262 closes the fluid gap. In the open state, the sealing piece 262 opens the fluid gap 214 .

[0690] The one-way valve core is generally designed to float, and the limit rod 261 is movably mounted and its position is constrained by the first pipe joint 211, thereby limiting the travel of the sealing plate 262. In particular, when in the open position, excessive travel of the sealing plate 262 could directly block the first exhaust hole 2102. For example, the inner wall of the first pipe joint 211 is provided with a retaining ring 2112 surrounding the outer periphery of the limit rod, and a fluid gap is located between the outer periphery of the retaining ring 2112 and the inner wall of the first pipe joint 211.

[0691] The end of the limiting rod 261 away from the sealing piece 262 passes through the retaining ring 2112 and has a head 2611. In the open state, the head 2611 is against the retaining ring 2112, the sealing piece 262 is away from the retaining ring 2112 and the fluid gap 214 is opened; in the sealed state, the head is away from the retaining ring 2112, the sealing piece 262 is against the retaining ring 2112 and the fluid gap 214 is closed.

[0692] In another embodiment, referring to Figures 9 to 10b , the one-way valve core can also be fixed as a whole, with the limiting rod 261 fixedly mounted, and the fluid gap opened or closed solely by the deformation of the edge of the sealing sheet 262. For example, the inner wall of the first pipe joint 211 is provided with a retaining ring 2112 surrounding the outer periphery of the limiting rod, and the fluid gap is located between the outer periphery of the retaining ring 2112 and the inner wall of the first pipe joint 211;

[0693] The end of the limiting rod 261 away from the sealing sheet 262 passes through the clamping ring 2112 and has a head 2611. The head 2611 is clamped and fixed to two opposite sides of the clamping ring 2112 with the sealing sheet. The edge of the sealing sheet 262 can be elastically deformed to open or close the fluid gap 214 accordingly.

[0694] In the open state, the edge of the sealing sheet 262 is away from the retaining ring 2112 and opens the fluid gap 214 (as shown in FIG. 10 b , where the dotted line represents the fluid flow path).

[0695] In the sealed state ( FIG. 10 a ), the edge of the sealing sheet 262 abuts against the retaining ring 2112 and closes the fluid gap 214 .

[0696] The following embodiments provide specific structures of the positioning member. For example, referring to Figures 8 to 13, the positioning member 220 is an elastic claw, one end of which is fixed to the connecting sleeve 210, and the other end is a free end 2201 that swings radially along the connecting sleeve.

[0697] The driving member 230 is linked with the free end 2201 of the elastic claw 221, so that the free end 2201 moves radially inward along the connecting sleeve (i.e., interferes with the threading channel 201 and holds the internal pipe fitting), or releases the elastic claw 221. The elastic claw 221 has a reset tendency (i.e., moves away from the threading channel and reduces the effect on the internal pipe fitting), allowing the auxiliary handle 20 to slide relative to the internal pipe fitting, thereby changing the relative position of the distal end of the outer sheath.

[0698] The fixed end 2202 of the elastic claw 221 and the connecting sleeve 210 may be fixed separately, or the elastic claw and the connecting sleeve 210 may be an integrated structure.

[0699] The connecting sleeve 210 is generally tubular, with a U-shaped hollow area 2204 formed on its wall. The area surrounding the U-shaped hollow area serves as an elastic claw 221. The elastic claw 221 is generally strip-shaped, with its fixed end 2202 at the distal end and its free end 2201 at the proximal end. To achieve a relatively uniform tightening force, multiple elastic claws can be provided, for example, two to six (e.g., four) distributed circumferentially around the connecting sleeve 210.

[0700] In order to synchronously drive the elastic claws and simplify the component structure, the driving member 230 is cylindrical and slidably sleeved on the outer periphery of the connecting sleeve 210, and the inner wall of the driving member 230 acts on the elastic claws.

[0701] The sliding direction of the driving member 230 is the length direction of the connecting sleeve 210. When the driving member 230 moves to different positions, the radial force applied to the elastic claw will change, causing the positioning member 220 to switch between the locked position and the unlocked position. In order to make the elastic claw obtain a more uniform radial force change trend, the elastic claw and the driving member 230 can cooperate with each other through inclined surfaces. For example, along the radial direction of the connecting sleeve 210, a guide ramp 2203 is provided on the outer side of the elastic claw 221, and the inner wall of the driving member 230 acts on the guide ramp 2203.

[0702] Along the radial direction of the connecting sleeve 210, the height of the guide ramp 2203 gradually increases from the distal end to the proximal end. Without considering changes in the inner wall of the driver, when the driver 230 moves toward the proximal end, the free end 2201 of the elastic claw 221 can be further moved inward, increasing the force on the internal tubular fitting until it is locked. To achieve cushioning, protection, and better tightening and sealing effects, an elastic component can be provided between the elastic claw 221 and the internal tubular fitting. This can also provide a damping effect when the secondary handle 20 slides, improving the operating experience. For example, an elastic liner 240 is provided within the connecting sleeve 210. The elastic claw 221 acts on the outer wall of the elastic liner, squeezing the elastic liner 240 to interfere with the guide channel 201.

[0703] When inserted into the internal tubing, the elastic claws 221 press the elastic liner 240 inward, tightening the internal tubing through the elastic liner 240. To prevent unwanted loosening, the elastic liner 240 can be inserted into the connecting sleeve using an interference fit. For further axial positioning, the distal end of the elastic liner 240 extends beyond the connecting sleeve 210. A radially outwardly projecting positioning step 2401 is provided on the extended portion. Axially, the positioning step 2401 engages with the end surface of the connecting sleeve 210 and / or the inner wall of the housing 200 for axial positioning.

[0704] In order to guide the movement of the driving member 230, a mutually cooperating guiding structure is provided between the inner wall of the driving member 230 and the outer wall of the connecting sleeve 210. The guiding structure includes:

[0705] A sliding groove 2107 is provided on one of the inner wall of the driving member 230 and the outer wall of the connecting sleeve 210;

[0706] The guide rib 2301 cooperates with the slide groove 2107 and is provided on the other of the inner wall of the driving member 230 and the outer wall of the connecting sleeve 210 .

[0707] In FIG8 , the slide grooves 2107 are located on the outer wall of the connecting sleeve, and there are three of them. The guide ribs 2301 are located on the inner wall of the driving member 230 , and their positions and numbers match those of the slide grooves.

[0708] For ease of operation, referring to FIG. 14 and FIG. 15 a , in one embodiment, an operating button 250 is provided on the outer wall of the driving member 230 , and a first avoidance opening 2302 corresponding to the position of the operating button 250 is opened on the housing 200 .

[0709] The operating button 250 is exposed at the first avoidance opening 2302 , and the first avoidance opening 2302 may be further extended along the radial direction of the connecting sleeve 210 . The length of the first avoidance opening 2302 is configured accordingly according to the sliding stroke of the driving member 230 .

[0710] In order to ensure stable sliding of the driving member 230 and the necessary structural strength, it should have sufficient axial length. Based on this, the interference with the first exhaust channel must also be considered. The side wall of the driving member 230 is provided with a second avoidance port 2303, and the side wall of the connecting sleeve 210 is provided with a first exhaust hole that cooperates with the through-channel 201; along the axial direction of the connecting sleeve 210, the position of the second avoidance port 2303 corresponds to the position of the first exhaust hole.

[0711] The one-way valve core 26 at the exhaust hole and the components connected to the first pipe joint 211 are all located at the second avoidance port 2303. In order to facilitate assembly, the distal end side of the second avoidance port 2303 is an open structure.

[0712] In combination with the auxiliary handle 20 of each embodiment above, referring to FIG15b , an embodiment of the present application further provides an intervention control assembly, including:

[0713] The outer sheath 310, in which the artificial implant in the loaded state (not visible in the loaded state) is located;

[0714] Based on the control handle (ie, the sub-handle 20 ) that directly drives the outer sheath tube 310 , one end of the outer sheath tube 310 is fixedly connected to the connecting sleeve 210 .

[0715] In terms of specific connection method, the proximal end of the outer sheath 310 is the plug-in section 3101 (located at the proximal end of the sheath section 3103 and can also be regarded as a part of the sheath section 3103) and is extended from the distal end of the connecting sleeve 210 and fixed to the connecting sleeve (not visible in the assembled state).

[0716] 9 , in order to ensure the connection strength, the side wall of the connecting sleeve 210 is provided with a reinforcement hole corresponding to the position of the plug section 3101 , and is fixed through the reinforcement hole 2106 by at least one of gluing, welding, and anchoring.

[0717] Regarding the release of the artificial implant, the following uses a balloon expansion method as an example. This method can also be used in conjunction with the separation of the main and auxiliary handles in this application to achieve better results. Referring to Figures 16a to 17a, in one embodiment, the catheter assembly 30 also includes a balloon catheter 330, which includes:

[0718] The balloon body 331 is disposed at the distal end of the inner sheath tube 340 and switches between an expanded state and a folded state under the action of a fluid. The artificial implant 8 in the loaded state is located on the outer periphery of the balloon body 331.

[0719] The catheter body 332 is sleeved on the outer periphery of the inner sheath 340 or arranged in parallel with the inner sheath 320. The distal end of the catheter body 332 is connected to the balloon body 331, and the proximal end of the catheter body 332 is connected to the main handle 10. The catheter body 332 contains a fluid channel.

[0720] During operation, the artificial implant 8 and the balloon body 331 are wrapped in the outer sheath 310. In some cases, the outer sheath may be withdrawn proximally before reaching the lesion location. At this time, the balloon body 331 is still in a folded state. Therefore, the distal end of the artificial implant 8 will form a raised step 86 with the outer periphery of the balloon body 331, which will create a safety risk of puncturing the tissue during the subsequent delivery process. This embodiment provides a method, that is, after the distal end of the balloon body 331 is exposed to the outer sheath 310, fluid can be injected to expand it first. Since the proximal end of the balloon body 331 is still wrapped by the outer sheath, it can be maintained in a folded state; when injecting fluid, if more parts of the artificial implant 8 are exposed to the outer sheath 310, appropriate fluid pressure can be used to make only the distal end of the balloon body 331 exposed to the artificial implant 8 expand, while the other parts remain in a folded state under the restraint of the artificial implant 8.

[0721] After the distal end of the balloon body 331 is inflated, the raised step 86 can be eliminated or compensated, so that the outer periphery of the balloon body 331 and the end surface of the artificial implant 8 have a smooth transition or the height difference is reduced to avoid safety hazards.

[0722] The proximal end of the catheter body can be connected to a perfusion device to inject fluid (such as saline) into the balloon body 331 to inflate the balloon body 331. In the prior art, when the balloon body switches to the expanded state, the outward expansion trends of different axial parts are different.

[0723] For example, if the fluid first enters the proximal part of the balloon and gradually inflates it, the artificial implant is still in a compressed state, and the fluid cannot smoothly reach the distal part of the balloon. The release of the distal part of the artificial implant is bound to be later than the proximal part, and may slip toward the distal side relative to the balloon, or even deviate from the balloon, affecting the release effect.

[0724] The present application provides an improved approach to this problem. Referring to FIG17a , in one embodiment, a fluid guide 350 is provided inside the balloon body 331 and is located on the periphery of the inner sheath. The fluid guide 350 defines a guide channel 354 that connects the distal end and the proximal end of the balloon body.

[0725] Referring to Figures 17a to 19b, the axial length of the balloon body 331 is slightly larger than the artificial implant 8 in the loaded state. Under the action of the fluid guide 350, the fluid can reach the distal part of the balloon body 331 as quickly as possible. Therefore, the distal part and the proximal part of the balloon body 331 are basically inflated synchronously (the dotted line in Figure 19a is the flow path of the fluid), and the corresponding two ends of the artificial implant 8 expand before the middle part. During this process, the artificial implant 8 forms a waist structure 81 as a whole, and the waist structure 81 can also limit the slippage of the artificial implant 8 in the axial direction.

[0726] The fluid guide 350 is tubular, and the position of the fluid guide channel 354 relative to the fluid guide 350 is at least one of the following:

[0727] Located on the outer wall of the fluid guide 350;

[0728] Located inside the fluid guide 350;

[0729] The fluid guide 350 is located in the sidewall interlayer or hollow area 353. The specific structure of the hollow area 353 is described below.

[0730] The specific structure of the flow guide channel is further described in the following embodiments.

[0731] The flow guiding channel 354 is a flow guiding groove 351 formed on the outer peripheral wall of the fluid guiding member.

[0732] The radially outwardly protruding groove walls between adjacent guide grooves 351 can support the inner wall of the balloon body in the folded state, so that when the balloon body 331 is folded, the guide grooves 351 connect the distal and proximal sides of the balloon body. To ensure effective flow diversion, the fluid guide 350 should be of sufficient length, for example, with the distal and proximal sides of the fluid guide 350 adjacent to the distal and proximal sides of the balloon body 331, respectively.

[0733] In one embodiment, there are multiple guide grooves 351, which are arranged along the circumference of the fluid guide 350. The same guide groove 351 extends along the axial direction of the fluid guide 350 (as shown in Figures 20a and 20b) or is spirally wound (as shown in Figures 21a to 22b).

[0734] The angle during spiral winding should not be too large, otherwise it will affect the flow guiding effect. For example, along the circumference of the fluid guide 350, the wrap angle of the same guide groove 351 is 0 to 180 degrees. For example, in Figure 21a, the wrap angle (the offset angle of the circumferential positions at both ends) of the same guide groove 351 is about 60 degrees.

[0735] 20a to 21b, in one embodiment, a connecting groove 352 is provided between two adjacent guide grooves 351. The connecting grooves 352 are arranged in a plurality at intervals, and the connecting grooves 352 corresponding to each other in the axial direction form an annular groove.

[0736] The plurality of guide grooves 351 and the connecting grooves 352 intersect with each other to form a guide network.

[0737] In another embodiment, a fluid guide 350 is provided on the outer periphery of the inner sheath 320. The fluid guide 350 is tubular and is located in the balloon body 331. The tube wall of the fluid guide 350 has a hollow area 353, and the hollow area 353 extends continuously or intermittently from the distal end of the fluid guide 350 to the proximal side of the fluid guide 350.

[0738] The hollow area 353 can take various forms, such as those shown in FIG. 23 a to FIG. 24 b .

[0739] In another embodiment, there is a radial gap between the fluid guide 350 and the inner sheath 320, and the radial gap serves as a flow guide channel 354 (as shown in FIG17 b ). Of course, the above-mentioned flow guide modes can also be used in combination.

[0740] In a complex in vivo environment, the distal end of the catheter assembly 30 sometimes needs to be actively bent in order to smoothly intervene or maintain a specific posture. For example, the catheter assembly 30 also includes a bending tube 340 and a traction member 341 that drives the bending tube 340. The bending tube 340 is sleeved on the outer periphery of the inner sheath 320. The distal ends of the bending tube 340 and the traction member 341 are fixedly connected, and the proximal ends of both are connected to the main handle 10 and slide relative to each other.

[0741] When combined with a balloon catheter, the bend adjustment tube 340 and the traction member 341 are both located on the periphery of the catheter body 332, and the distal end of the bend adjustment tube 340 avoids the balloon body 331. Under the action of the traction member, the distal end of the bend adjustment tube 340 itself can bend, thereby driving the surrounding pipes to bend together. The distal end of the bend adjustment tube and other pipes (except the traction member) are not strictly required to be fixed to each other.

[0742] Regarding the arrangement of the traction member 341, in different embodiments, the traction member 341 is arranged in the following manner:

[0743] The traction member 341 is a traction tube, and is located inside or outside the bending tube 340 (as shown in FIG. 26 a and FIG. 26 b ); or

[0744] The traction member 341 is a traction wire and is located on the inner side (as shown in FIG. 27 a and FIG. 27 b ), the outer side or the inner wall of the bending adjustment tube 340 .

[0745] The wall of the bending pipe 340 has a sandwich structure, a liner pipe is fixed in the sandwich (not visible in the assembled state), and the pulling member 341 is movably arranged in the liner pipe.

[0746] 28 to 34 , the main handle 10 includes:

[0747] The support body 100 has a spatial axial direction, the proximal end of the bending adjustment tube 340 is fixedly connected to the support body 100, and the inner sheath tube 340 and the catheter body 332 of the balloon catheter are both extended and connected to the proximal side of the support body 100;

[0748] The first slide 110 is axially slidably engaged with the support body 100 , and the proximal end of the pulling member 341 is fixed to the first slide 110 ;

[0749] The first drive sleeve 111 is rotatably sleeved on the support body 100 and is located on the outer periphery of the first slide 110. The first drive sleeve 111 and the first slide 110 are engaged with each other by a threaded transmission;

[0750] The housing 120 is fixedly mounted on the support body 100, and at least a portion of the housing 120 is an indicator section located outside the first driving sleeve;

[0751] The identification member 122 is axially slidably mounted on the indicating section and is located on the outer periphery of the first driving sleeve 111 . The first driving sleeve 111 and the identification member 122 are engaged with each other by threaded transmission.

[0752] When the first drive sleeve 111 rotates, it drives the first slide 110 to slide axially, pulling the proximal end of the traction wire (i.e., the traction member), which is fixedly connected to the proximal end of the bend adjustment tube 340 relative to the support body 100. Therefore, the traction wire pulls the distal end of the bend adjustment tube 340, causing it to change its direction. The bend adjustment angle is not easy to observe inside the body, so the identification member 122 can be further combined to predict the bend adjustment effect based on the displacement of the first slide 110.

[0753] Although the identification member 122 can be fixedly connected to the first slide 110, it is necessary to bypass the first drive sleeve 111 or open a window on the first drive sleeve 111 for observation, which will result in wasted space and reduced structural strength. In this embodiment, the first drive sleeve 111 is used to synchronously drive the identification member 122 and the first slide 110, which can ensure accurate indication and overcome the existing defects. In terms of specific connection, the first drive sleeve 111 has internal and external threads, the first slide 110 has external teeth that match the internal threads, and the identification member 122 has internal teeth that match the external threads.

[0754] The identification member 122 and the first slide 110 move synchronously under the action of the first driving sleeve 111. In order to observe the identification member 122, a window corresponding to the position of the identification member 122 is provided on the side wall of the indicating section.

[0755] To guide the identification member 122, a guide structure can be used on the inner edge of the window or on the support body 100 to limit the movement direction of the identification member 122. For example, two sliding grooves 1211 are defined in the side wall of the indicator segment. The identification member 122 is located outside the side wall and spans between the two sliding grooves 1211. The end of the identification member 122 extends inward through the sliding grooves 1211 and serves as internal teeth 1221, which mate with the external threads of the first drive sleeve 111. Referring to Figure 28, in one embodiment, a transparent cover 123 can be provided on the outside of the identification member 122 and fixedly embedded in the outer wall of the indicator segment. For ease of installation, a frame 121 can be provided.

[0756] After the first drive sleeve moves to the appropriate position, it needs to be positioned to avoid interference with other operations. In one embodiment, a positioning ring is provided along the axial sliding sleeve on the outer periphery of the first drive sleeve. The first drive sleeve has a positioning state in which it is engaged with the positioning ring and a free state in which it is disengaged from the positioning ring. In the positioning state, the positioning ring restricts the rotation of the first drive sleeve.

[0757] Among them, locking teeth that engage with each other are provided between the first drive sleeve and the positioning ring to keep the first drive sleeve in a positioned state.

[0758] Regarding the guidance of the first slide 110, an axially extending mounting groove 1001 can be provided in the support body 100, a guide cylinder 112 is fixed in the mounting groove 1001, the first slide 110 is slidably sleeved on the guide cylinder 112, and a guiding structure that cooperates with the outer wall of the first slide 110 and the guide cylinder 112 to guide the axial movement is provided.

[0759] 31 and 34 , the outer wall of the guide cylinder 112 has an axially extending guide bar 1121, and the inner side of the first slide 110 has a slide groove 1101 that cooperates with the guide bar 1121. The proximal end of the bending tube 340 is inserted into and fixed to the guide cylinder 112.

[0760] 35 to 37 , to facilitate exhaust, a second exhaust hole 1122 is provided on the side wall of the guide cylinder 112. The radial gap between the bend adjustment tube 340 and the catheter body 332 is connected to the second exhaust hole 1122. The proximal end of the catheter body 332 passes through the proximal end of the bend adjustment tube 340 and further extends through the guide cylinder 112.

[0761] The second exhaust hole 1122 is fixedly connected with the second pipe joint 113 . The second exhaust hole 1122 and the second pipe joint 113 define a second exhaust channel 1131 . A one-way valve core 114 is provided in the second exhaust channel 1131 .

[0762] From distal to proximal, they are:

[0763] The sealing portion between the proximal end of the bending adjustment tube 340 and the guide cylinder 112;

[0764] a second exhaust hole 1122;

[0765] The sealing fitting portion between the inner wall of the guide cylinder and the catheter body 332;

[0766] The arrangement of the above-mentioned parts can ensure that the physiological saline injected through the second exhaust hole 1122 can only enter the radial gap between the bending tube 340 and the catheter body 332 and flow toward the distal side to achieve exhaust.

[0767] In this embodiment, the external control valve is omitted, and the working principle of the one-way valve core 114 is the same as that of the one-way valve core 26 in the above embodiment, which will not be further elaborated here.

[0768] A second annular seat 1123 is provided at the edge of the second exhaust hole 1122 . The second pipe joint 113 is plug-fitted to the second annular seat 1123 , and a mutually cooperating anti-rotation structure is provided between them.

[0769] One end of the second pipe joint 113 may have a threaded structure to facilitate quick disassembly and assembly with the external pipeline, and the other end is inserted into the second annular seat 1123. A sealing ring 115 arranged around the second exhaust hole 1122 may be provided in the second annular seat 1123. The end face of the second pipe joint 113 inserted into the second annular seat 1123 is sealed against the sealing ring 115. The sealing ring 115 is elastic to ensure the sealing effect.

[0770] The anti-rotation structure can prevent the second pipe joint 113 from unnecessary movement when the external pipeline is disassembled and assembled. The anti-rotation structure includes:

[0771] The slot 1124 extends along the insertion direction of the second pipe joint 113 and is disposed on a side wall of one of the second pipe joint 113 and the second annular seat 1123 ;

[0772] The positioning rib 1132 cooperates with the slot 1124 and is disposed on a sidewall of the other of the second pipe joint 113 and the second annular seat 1123 .

[0773] In Figures 35 and 36, three slots 1124 are shown on the inner wall of the second annular seat 1123, and three positioning ribs 1132 are provided at corresponding positions on the outer wall of the second pipe joint.

[0774] To ensure the strength of the connection when connecting to external pipelines, a second protective sleeve 116 is provided on the outer periphery of the second pipe joint 113. A pipe connection gap is formed between the outer wall of the second pipe joint 113 and the inner wall of the second protective sleeve 116. The second protective sleeve 116 is divided into two parts (a first part 116a and a second part 116b in Figures 35 and 36), which are fixed to the support body 100 and the guide cylinder 112 respectively.

[0775] In order to inflate the balloon 331, an interface connected to the catheter body 332 is configured at the proximal end of the main handle 10. In addition, in order to fine-tune the position of the balloon 331 axially in an in vivo environment, referring to Figures 28 and 38 to 41, in one embodiment, the main handle 10 further includes:

[0776] The second sliding seat 130 is axially slidably engaged with the support body 100;

[0777] The second driving sleeve 131 is rotatably sleeved on the support body 100 and is located on the outer periphery of the second slide 130. The second driving sleeve 131 and the second slide 130 are engaged with each other by threaded transmission;

[0778] The multi-way connector 140 is connected to the proximal side of the second slide 130. The proximal ends of both the balloon catheter 330 and the inner sheath tube 320 are connected to the multi-way connector 140. The interior of the inner sheath tube 320 is a through guidewire channel 321. The multi-way connector 140 has at least an interface connected to the guidewire channel 321 and the fluid channel 322 respectively, as shown in Figure 39, an interface 141 connected to the guidewire channel 321, and an interface 142 connected to the fluid channel 322.

[0779] When the second drive sleeve 131 rotates, the second slide 130 slides axially relative to the support body 100 through threaded transmission. Since the multi-way connector 140 is connected to the proximal side of the second slide 130, it also drives the movement of the balloon catheter 330 and the inner sheath tube 320. As a further improvement, the multi-way connector 140 is rotationally engaged with the proximal side of the second slide 130 and is axially limited.

[0780] The axial position limiting of the multi-way connector 140 and the second slide 130 ensures that the axial movement of the second slide 130 is synchronously transmitted to the balloon body 331 and the artificial implant 8. The rotational cooperation between the multi-way connector 140 and the second slide 130 allows the balloon body 331 and the artificial implant 8 to be rotated relative to the support body 100, thereby achieving precise adjustment of the spatial posture of the artificial implant 8. In terms of the specific cooperation structure, the second slide 130 is generally cylindrical in structure, and at least a portion is located within the second drive sleeve 131. The outer wall of the second slide 130 is threadedly engaged with the inner wall of the second drive sleeve 131. The support body 100 is provided with a guide groove 1002 to guide the axial movement of the second slide 130.

[0781] 40 and 41 , the distal end of the multi-way connector 140 and the proximal end of the second slide 130 are rotatably plugged into each other, and a mutually cooperating axial limiting structure is provided between the two. The axial limiting structure includes:

[0782] The latching tooth 1301 is fixed to one of the two and protrudes radially toward the other;

[0783] The latching slot 1401 is provided on the other of the two and receives the latching tooth 1301 .

[0784] The multi-way connector 140 can be configured with multiple interfaces, corresponding to the guidewire channel 321, the fluid channel 322, and in a further improved manner, a locking wire channel 143 is also configured. The locking wire 360 ​​directly driven at the proximal end can be passed through the locking wire channel 143. The locking wire 360 ​​extends to the distal end and is located on the outside of the balloon body 331. In conjunction with the wire loop structure on the balloon body 331, the locking wire 360 ​​can further lock the axial position of the artificial implant 8.

[0785] For example, in FIG42 , the distal end of the catheter assembly is provided with a first pull ring 381 and a second pull ring 382 . The first pull ring 381 passes through a first hole 811 at the distal end of the artificial implant 8 , and the second pull ring passes through a second hole 812 at the proximal end of the artificial implant 8 .

[0786] The distal end of the locking wire 360 ​​passes through the second pull ring 382 and the first pull ring 381 in sequence and then extends into the guide head 370 (with a lock hole for inserting the locking wire) at the distal end of the inner sheath tube, so that the axial position of the artificial implant 8 can be further locked. The locking wire can be withdrawn proximally as needed to release the restraint on the artificial implant 8.

[0787] The artificial implants of the following embodiments take artificial heart valves as an example. Referring to Figures 43 and 44 , one embodiment provides an artificial heart valve comprising a stent 800 and leaflets 83. The stent 800 has a cell structure, with the stent's two ends defining an inflow side 834 and an outflow side 833, respectively. The interior of the stent defines a blood flow channel 85. The leaflets 83 are multiple, each positioned within the blood flow channel and cooperating with one another to relatively open or close the blood flow channel 85. The edges of the leaflets 83 include a fixed edge 831 secured to the stent 800 and a free edge 832 that cooperates with the other leaflets 83 to control the blood flow channel 85.

[0788] In order to solve the problem of peripheral leakage, an anti-peripheral leakage component is connected to the bracket 800. The anti-peripheral leakage component is an integrated structure, including a base 84 on the inner side of the bracket and an anti-peripheral leakage component 841 fixed to the outer side of the base. The anti-peripheral leakage component 841 is a plurality of spaced-apart blocks and its position corresponds to the hollow area of ​​the bracket cells.

[0789] In the expanded state after the stent 800 is released, the anti-circumferential leakage component 841 extends radially outward from the corresponding unit cell along the stent, or is higher than the outer periphery of the stent in the radial direction.

[0790] The base 84 and the anti-leakage component 841 can be formed by infiltration fusion. The base 84 can be made of PET, and the anti-leakage component 841 can be made of porous material, such as PU. The holes are the structural gaps of the material itself or are formed by external processing.

[0791] Referring to FIG. 43 , in one embodiment, according to the different axial positions of the cells, the anti-circular leakage component 841 includes:

[0792] The first circle of anti-circular leakage components 8411 covers the entire cell;

[0793] The second circle of anti-circular leakage components 8412 is adjacent to the inflow side 834 of the first circle of anti-circular leakage components 8411 and is distributed in a local area of ​​the entire cell.

[0794] The third circle of anti-circular leakage components 8413 is adjacent to the outflow side 833 of the first circle of anti-circular leakage components 8411 and is distributed in a local area of ​​the entire unit cell.

[0795] Referring to FIG. 45 , in another embodiment, the anti-circular leakage component 841 includes:

[0796] The first circle of anti-circular leakage components 8411 covers the entire cell;

[0797] The second circle of anti-circular leakage components 8412 is adjacent to the inflow side 834 of the first circle of anti-circular leakage components 8411 and is distributed in a local area of ​​the entire unit cell.

[0798] Referring to FIG. 46 , in another embodiment, the anti-circumferential leakage component 841 includes:

[0799] The first circle of anti-circular leakage components 8411 covers the entire cell;

[0800] The third circle of anti-circular leakage components 8413 is adjacent to the outflow side 833 of the first circle of anti-circular leakage components 8411 and is distributed in a local area of ​​the entire unit cell.

[0801] The axial length of the second circle of anti-circular leakage components 8412 and the third circle of anti-circular leakage components 8413 only occupies half a unit cell.

[0802] In the same anti-leakage component, the thickness gradually increases from the outflow side 833 to the inflow side 834 until it reaches the highest point of the convexity (along the radial direction of the stent), and then gradually becomes thinner. The change in thickness facilitates the recovery of the highest convex point. The point with the largest convexity is closer to the inflow side 834. As can be seen in the figure, the distance between the maximum convexity of the anti-leakage component 841 and the inflow side 834 of the cell is S1, and the distance between the maximum convexity of the anti-leakage component 841 and the outflow side 833 of the cell is S2. The ratio of S1:S2 ranges from 0.2 to 0.8. For example, in Figure 46, S1:S2 = 0.8.

[0803] After the anti-leakage component bulges outward, it can fill the space enclosed by the rods of the cell where it is located in terms of area. In terms of the degree of bulging, the anti-leakage component and the side edge of the rod of the cell where it is located are in contact with each other, that is, the lowest position of the anti-leakage component is not lower than the outer peripheral surface of the cell rod, avoiding the gap between the anti-leakage component and the side edge of the rod, and avoiding the gap absorbing the deformation of the anti-leakage component and reducing the sealing effect, wherein the side edge of the rod is understood as the side of the rod facing the inside of the cell.

[0804] The control handle of the present application can independently operate the outer sheath, so that the movement of the outer sheath is separated from other internal tubes, and at the same time, the restriction on the length of the main handle is released. When retracting the outer sheath, the sub-handle can be directly driven, and the stroke is sufficient to make the distal end of the outer sheath separate from the aortic arch. For example, when the sub-handle is retracted to the extreme position proximally, the distal end of the remaining tubes in the catheter assembly, especially the bending tube, is exposed (freed from the restraint of the outer sheath) for a longer section, such as 0 to 20 cm. When measured by the overall stroke of the sub-handle, the stroke is generally 10 to 40 cm to avoid the aortic arch or the bending part at the distal end of the catheter assembly, so as to facilitate adjustment of the artificial implant or other operations.

[0805] Referring to Figure 47 , existing balloon-expandable valve interventional delivery systems generally include a slidably sleeved inner shaft 44 and a balloon catheter 42. The distal end of balloon catheter 42 contains a balloon body 423, which is inflated with fluid to release the prosthetic implant. After loading, the prosthetic implant 41 (e.g., a prosthetic heart valve, hereinafter referred to as the valve) is compressed to a smaller diameter and placed around the outer periphery of balloon body 423, roughly in the axial center of balloon body 423. When prosthetic implant 41 reaches a predetermined position within the human body, fluid is injected into balloon body 423 from the proximal end to inflate it, ultimately completing balloon expansion and release of prosthetic implant 41 within the body.

[0806] During surgery, fluid needs to be injected into the balloon body 423. Since the middle part of the balloon body 423 is compressed by the artificial implant 41 and basically fits the outer periphery of the inner shaft 44, that is, the flow channel in this part is blocked, the fluid generally inflates the proximal part of the balloon body 423 first, resulting in the risk of the artificial implant 1 deviating toward the distal end, thereby affecting the alignment of the artificial implant's position in the body.

[0807] Referring to Figure 48, other existing balloon catheters introduce a support member in the middle of the balloon body 423, which can maintain the radial gap between the balloon body 423 and the inner shaft 44 to a certain extent, play a role in supporting the internal flow channel, and improve the problem of severe delay in inflation of the distal end of the balloon catheter. However, due to the limitation of the size of the support member, after the fluid enters the balloon body 423, it is mainly inflated at the proximal end first, and only a part of the fluid enters and inflates the distal end of the balloon body 423 at the same time as or slightly delayed when the proximal end of the balloon body 423 is inflated. Although it can shorten the inflation time difference at both ends of the balloon body 423, the effect still needs to be improved.

[0808] In actual circumstances, we expect the balloon to form a "dog bone" shape (or "8-shape"), that is, the two axial ends of the balloon body 423 expand first, and then the middle part expands. This can not only position the valve and prevent the valve from sliding on the balloon body 423 during the expansion of the balloon body 423, but also make the two ends of the balloon body 423 expand evenly, which helps to provide uniform expansion force to the valve.

[0809] 49 to 53 , an embodiment of the present application discloses a method for driving a balloon catheter using fluid. The balloon catheter 42 has a distal end 422 and a proximal end 421 relative to each other. The distal end 422 is the end away from the operator, and the proximal end 421 is the end close to the operator.

[0810] The balloon catheter 42 of this embodiment includes a balloon body 423 and a catheter body 424. The catheter body 424 is connected to the proximal end of the balloon body 423. The balloon body 423 includes, from the distal end to the proximal end, a first portion 4233, a middle portion 4232, and a second portion 4231. The inner lumens of these three portions are interconnected internal flow channels for fluid injection. The middle portion 4232 is used to load and fix the artificial implant 41. That is, in the loaded state shown in Figure 50a, the artificial implant 41 is radially compressed and wrapped around the outer circumference of the middle portion 4232. The catheter body 424 has a main flow channel 4241.

[0811] The operation process of the method in this embodiment includes the following steps:

[0812] Injecting fluid into the main channel 4241 from the proximal end of the catheter body 424;

[0813] The fluid output from the main channel 4241 to the balloon body 423 is diverted, allowing only part of the fluid to enter and inflate the second part 4231 , while the other part of the fluid is drained, and this part of the fluid passes through the second part 4231 and the middle part 4232 and then enters and inflate the first part 4233 .

[0814] To avoid complicating the flow path, a method can be adopted in which all fluid used to inflate the balloon 423 originates from the main flow path 4241 before being diverted. Regarding the source of the fluid, all fluid used to inflate the balloon 423 is supplied from the proximal end of the catheter body 424 through the main flow path 4241. Diversion is only performed for the different directly inflated areas (i.e., the first portion 4233 and the second portion 4231). Aside from the main flow path 4241, no other pipelines or flow paths for supplying fluid are configured within the catheter body 424. Furthermore, the main flow path 4241 does not need to be partitioned (e.g., using multiple parallel lumens).

[0815] As shown in FIG50b, the fluid in the main channel 4241 (in order to illustrate the diversion in the subsequent process, the figure schematically includes fluid Q1 and fluid Q2. In fact, fluid Q1 and fluid Q2 are in a mixed state before diversion) is diverted when it is output to the balloon body 423. A portion of the fluid Q1 enters and inflates the second portion 4231, and another portion of the fluid Q2 is drained through the independent channel 426 and enters and inflates the first portion 4233 after passing the second portion 4231 and the middle portion 4232. The fluid Q2 flows inside the independent channel 426 and is isolated from the fluid in the second portion 4231 and the middle portion 4232 when passing these two portions to avoid pressure loss and diffusion. Since each portion of the fluid after diversion comes from the delivery of the catheter body 424, the fluid delivery space provided in the catheter body 424 is called the main channel.

[0816] Since the material of the balloon body 423 generally has better compliance or elasticity than the catheter body 424, that is, it is easy to expand and deform radially under the action of fluid, after the fluid enters the balloon body 423 from the catheter body 424, as the balloon body 423 deforms, the fluid will present a relatively more obvious turbulent state relative to that in the catheter body 424, and then directly act on the second part 4231 to implement inflation. In this embodiment, the fluid entering the balloon body is diverted when it has not completely entered the turbulent state to implement inflation, allowing at least a part of the fluid to directly implement inflation on the second part 4231.

[0817] In this embodiment, the flow diversion is directed toward the fluid flowing through main channel 4241. The radial gap between the catheter body 424 and the inner shaft 44 forms main channel 4241. Main channel 4241 is a one-piece flow channel, meaning it no longer utilizes multiple cavities or parallel pipelines for internal isolation. To streamline the structure, all fluid within the catheter body 424 is discharged from main channel 4241 to the balloon body 423.

[0818] The diverted part can use an independent flow channel 426. The independent flow channel can be understood as an additional relatively closed drainage channel, which can avoid the fluid entering the independent flow channel 426 from participating in or excessively participating in the inflation of the second part 4231, and reduce unnecessary diffusion when flowing through the second part 4231 and the middle part 4232. This part of the fluid can reach the first part 4233 as quickly as possible along the independent flow channel 426 with less resistance, so as to reduce the time difference between the inflation and deformation of the first part 4233 and the second part 4231.

[0819] The main purpose of diversion is to partially intercept the fluid coming from the main channel 4241 and flowing into the inner cavity of the second part 4231, that is, to divert all the fluid into two paths, inject them into the first part 4233 and the second part 4231 as synchronously as possible, and act on the inner wall of the balloon body 423 respectively to make the first part 4233 and the second part 4231 expand at the same time, thereby overcoming the defect of the proximal end inflating first in the prior art, and further solving the problem of position offset during the release of the artificial implant.

[0820] 54 , before the fluid 45 in the main channel 4241 is injected into the balloon catheter 423 , the entire balloon catheter 423 is still in a compressed state because the artificial implant 41 is radially compressed and wrapped around the outer periphery of the middle portion 4232 .

[0821] Regarding the timing or relative position of diversion, referring to Figures 55a to 55b, in one embodiment, the fluid 45 flowing out of the distal end of the main channel 4241 and about to flow into the inner cavity of the second part 4231 is partially intercepted, that is, the fluid is divided into two paths at the junction of the catheter body 424 and the second part 4231, one of which enters and inflates the second part 4231, and the other passes through the diversion channel formed by the independent flow channel 426, passes through the second part 4231 and the middle part 4232, and enters and inflates the first part 4233.

[0822] In another embodiment, referring to Figures 56 and 57a to 57c, the fluid 45 (including fluid Q1 and fluid Q2) exiting the distal end of the main channel 4241 and about to enter the second portion 4231 can be completely intercepted. That is, all fluid output from the distal end of the main channel 4241 enters the independent channel 426. The independent channel 426 is connected to a branch channel 4261, which is connected to the second portion 4231. When flowing through the second portion 4231, a portion of the fluid Q1 enters and inflates the second portion 4231 through the branch channel 4261, while the other portion of the fluid Q2 passes through the independent channel 426, passes through the second portion 4231 and the middle portion 4232, and enters and inflates the first portion 4233. In this embodiment, the proximal end of the independent channel can be directly connected to the distal end of the catheter body 424, and can even be an integral structure, which can further delay the inflation time of the second portion 4231 and facilitate consistent deformation with the first portion 4233.

[0823] After the first portion 4233 and the second portion 4231 are inflated and deformed almost synchronously, the middle portion 4232 is more constrained by the radial direction of the artificial implant and its deformation lags behind. Consequently, the balloon body 423 enters a transitional state in which both ends are inflated and the middle portion is relatively contracted. In this state, the position of the artificial implant can still be adjusted or confirmed, and fluid can be continuously injected into the catheter body 424 until the balloon body 423 is fully inflated and the artificial implant 41 is radially expanded, as shown in FIG58. The above-described operation is equivalent to a method for releasing an artificial implant through balloon expansion.

[0824] As mentioned above, during the diversion process, the fluid is diverted into two paths, and the first part 4233 and the second part 4231 are inflated respectively. Each path may include one or more streams. Figure 59 is a schematic diagram of the part of the fluid Q2 that inflates the first part 4233 being divided into three streams (i.e., forming three streams of fluid Q21, fluid Q22, and fluid Q23).

[0825] The radial distribution between the branches of the same path can be achieved by using a diverter or a branch channel 4261, so that the balloon body 423 can expand to the same or similar extent at different circumferential positions during deformation, thereby reducing the control requirements for flow rate or flow velocity.

[0826] In order to ensure the synchronous deformation effect, the flow ratio of the fluid directly acting on the second part 4231 and the fluid directly acting on the first part 4233 is 1:0.6~1.5, and the flow rate can be adjusted accordingly by changing the cross-sectional area of ​​the flow channel.

[0827] The artificial implant 41 is a cylindrical structure. The fluid entering the independent flow channel 426 passes through the interior of the cylindrical structure, over the middle portion 4232, and into the first portion 4233, thereby preventing the artificial implant from interfering with the diversion flow channel after deformation.

[0828] The balloon body 423 has an axial direction extending between the distal end and the proximal end, as well as corresponding radial and circumferential directions. After the fluid is output from the diversion channel, it enters and inflates the first part 4233 in different directions, including:

[0829] The liquid is output along the radial direction of the balloon body 423 through the independent flow channel 426 and inflates the first portion 4233 ;

[0830] And / or output along the axial direction of the balloon body 423 through the independent flow channel 426 and inflate the first part 4233.

[0831] The portion of the independent flow channel 426 located within the first portion 4233 may be provided with corresponding output holes or flow guides according to the fluid output direction.

[0832] Some embodiments below also provide an interventional delivery device based on balloon expansion release, which can be used to implement the above method.

[0833] Referring to Figure 60 , one embodiment of the present application provides an interventional delivery device based on balloon expansion and release, having opposing distal and proximal ends 422 and 421. Distal end 422 is the end away from the operator, while proximal end 421 is the end closer to the operator. The interventional delivery device includes an inner shaft 44 and a balloon catheter 42 positioned around the outer periphery of the inner shaft 44. A radial gap exists between the inner shaft 44 and the balloon catheter 42, serving as an internal passage for fluid injection.

[0834] Balloon catheter 42 includes a balloon body 423 and a catheter body 424. Catheter body 424 is connected to the proximal end of balloon body 423. Balloon body 423 comprises, from distal to proximal, a first portion 4233, a middle portion 4232, and a second portion 4231. Middle portion 4232 is used to load and secure artificial implant 41. Catheter body 424 has a main flow channel 4241. A drainage tube 425 is disposed in the radial gap between inner shaft 44 and balloon body 423. At least a portion of the fluid output from main flow channel 4241 to balloon body 423 flows through drainage tube 425, passes through second portion 4231 and middle portion 4232, and then enters and inflates first portion 4233. Drainage tube 425 diverts the fluid output from the distal end of catheter body 424. The specific principles, processes, and corresponding effects are described above.

[0835] The drainage tube 425 can be used to divide the fluid from the main channel 4241 into two parts. One part enters and fills the second part 4231, and the other part enters the interior of the drainage tube 425 (i.e., the independent flow channel 426 mentioned above. Since the drainage tube 425 is located on the outer periphery of the inner shaft 44, the independent flow channel 426 is the radial gap between the drainage tube 425 and the inner shaft 44) and is directly transported to the first part 4233, avoiding diffusion in the second part 4231 and the middle part 4232. This embodiment uses simple pipe fittings to implement the diversion, which is not only low-cost and easy to assemble, but also can be made of the same material as the surrounding components according to strength requirements, reducing the difficulty of material selection.

[0836] Some embodiments below also provide an interventional delivery device based on balloon expansion release, which can be used to implement the above method.

[0837] Referring to Figures 61a and 61b, an embodiment of the present application provides an interventional device based on balloon expansion and release, having a distal end 422 and a proximal end 421 relative to each other. The interventional device includes an inner shaft 44 and a balloon catheter 42 located on the periphery of the inner shaft 44. The balloon catheter 42 includes a balloon body 423 and a catheter body 424. The catheter body 424 is connected to the proximal end of the balloon body 423. The balloon body 423 includes, from the distal end to the proximal end, a first portion 4233, a middle portion 4232, and a second portion 4231. The middle portion 4232 is used to load and secure the artificial implant 41. The inner shaft 44 and the proximal end of the catheter body 424 can be connected to and controlled by a control handle for operation. The control handle itself can adopt both conventional technology and the solutions provided in various embodiments of the present application.

[0838] A drainage tube 425 is provided in the radial gap between the inner shaft 44 and the balloon body 423 . The distal end of the drainage tube 425 is fixed to the distal end of the inner shaft 44 , and the remaining portion of the drainage tube 425 is suspended between the inner shaft 44 and the balloon catheter 423 .

[0839] Among the fluid outputted from the inner shaft 44 to the balloon body 423 , at least a portion of the fluid passes through the second portion 4231 and the middle portion 4232 via the drainage tube 425 and then enters and inflates the first portion 4233 .

[0840] When the interventional delivery device is delivered in the body, it will bend and turn to adapt to the physiological structure of the body, which will cause the drainage tube 425 to be displaced. In addition, the drainage tube 425 may also be displaced under the action of the fluid, affecting the diversion effect. In this embodiment, the principle of the previous article can be used to divert the fluid using the drainage tube. The key point is that the distal end of the drainage tube 425 is fixed relative to the inner shaft 4, and the drainage tube 425 can be limited as a whole. At the same time, the remaining parts adopt a suspended setting, which allows a certain range of relative movement. The suspended setting can be understood as no longer having components or matching structures that are connected (or limited) to each other in the radial gap between the drainage tube 425 and the inner shaft 44. The drainage tube 425 and the inner shaft 44 can move relative to each other in the radial direction within the range of the gap.

[0841] The suspension setting is beneficial to improving the overall compliance of the balloon catheter. In addition, in the early stage of balloon expansion, the fluid inlet of the drainage tube 425 may be squeezed by the inner wall of the balloon and cause local blockage. The suspension setting is beneficial to the adaptive radial offset of the proximal end of the drainage tube 425 relative to the inner axis 44 to ensure the necessary exposure area of ​​the fluid inlet.

[0842] 62 and 63 , the proximal end of the drainage tube 425 has an open port serving as a fluid inlet 4254. Fluid output through the catheter body 424 (the portion to be diverted) enters the interior of the drainage tube 425 directly through the fluid inlet 4254. The fluid inlet 4254 can be a proximal port on the drainage tube 425 or an opening in the sidewall. The diameter (cross-sectional area) can be the same as the inner diameter of the drainage tube 425 or slightly larger, both of which can achieve a diversion effect.

[0843] The fluid inlet 4254 is axially positioned adjacent to the junction of the balloon body 423 and the catheter body 424. In the inflated state, the inner diameter of the junction of the balloon body 423 and the catheter body 424 varies significantly. Therefore, prior to inflation, this is also the location where the fluid flow state is most likely to change. The axial position of the fluid inlet 4254 adjacent to this location ensures optimal flow diversion timing and effectiveness. After being infused with fluid, the balloon body 423 is inflated. In this inflated state, the fluid inlet 4254 is located at the location where the cross-sectional area of ​​the second portion 4231 relative to the catheter body 424 suddenly changes.

[0844] At the proximal port of the drainage tube 425, there is a first gap with a radial span of L1 between the inner shaft 44 and the drainage tube 425. The first gap affects the flow rate of the part of the fluid diverted into the drainage tube 425, that is, the passing capacity of the diversion channel; there is a second gap with a radial span of L2 between the inner shaft 44 and the catheter body 424. The second gap affects the total flow rate of the fluid. Since the inner diameter of the drainage tube 425 is small, the waterway entering the drainage tube 425 requires a slightly larger flow rate to achieve the same flow rate as the other waterway. Therefore, the radial span ratio of the two gaps satisfies L1:L2=1:1.25~1.6, which ultimately makes the filling and expansion speeds of the two waterways after diversion roughly the same.

[0845] In the loaded state, the artificial implant is radially compressed and wrapped around the periphery of the middle portion 4232, and the first portion 4233 and the second portion 4231 are exposed to the artificial implant 41, so as to reduce the deformation starting pressure and avoid the risk of slipping of the artificial implant.

[0846] In FIG63 , the proximal end of the drainage tube has a fluid inlet 4254 located in the second portion 4231 , and the fluid delivered to the first portion 4233 is output through the first fluid outlet 4255 located in the first portion 4233 .

[0847] The drainage tube 425 includes a distal section 4253, a middle section 4252 and a proximal section 4251 from the distal end to the proximal end, and corresponds to various parts of the balloon body 423 respectively. The distal section 4253 of the drainage tube 425 has a first fluid outlet 4255 connected to the first part 4233. The first fluid outlet 4255 is located on the tube wall of the distal section 4253 and / or the end face of the distal section 4253.

[0848] To achieve a radiation delivery effect, the distal end section 4253 is provided with multiple, for example, two to four, first fluid outlets 4255. These multiple first fluid outlets are distributed circumferentially around the drainage tube 425, allowing fluid to flow evenly from all sides of the drainage tube to the first portion of the balloon, thereby providing a more uniform expansion force on the balloon.

[0849] Along the length direction of the drainage tube 425, multiple first fluid output ports 4255 are located in the middle part of the distal section 4253, thereby shortening the path of the water channel along the periphery of the drainage tube and making the middle part of the corresponding first part 4233 of the balloon body receive the expansion force first, which helps to evenly expand the balloon body.

[0850] 64 , the proximal end of the drainage tube 425 and the distal end of the catheter body 424 are connected to each other as a whole, and a second fluid outlet 4256 communicating with the second portion 4231 is formed on the tube wall of the proximal end section 4251 .

[0851] The fluid output from the distal end of the catheter body 424 can all enter the drainage tube 425, and then be redistributed through the drainage tube 425 to enter and inflate different parts of the balloon body 423. This embodiment can improve the controllability of the deformation process of the second part 4231 and the first part 4233 by adjusting the position and effective area of ​​the first fluid outlet 4255 and the second fluid outlet 4256 and regulating the flow rate.

[0852] 65a and 65b , in order to further stabilize the spatial position of the proximal end of the drainage tube 425 , the proximal end of the drainage tube 425 has a gradually converging beveled section 4257 , and at least a portion of the beveled section 4257 extends into the distal end of the catheter body 424 .

[0853] The beveled section 4257 can extend into the catheter body 424 at least near the tip portion, thereby limiting the radial spatial position. The distal end of the beveled section 4257 can be opened for direct drainage. The beveled section 4257 has one or two beveled surfaces. As shown in Figure 65a, a beveled surface 4258 is provided at the distal end of the beveled section 4257 to drain the fluid output from the distal end of the catheter body 424.

[0854] As shown in Figure 65b, to reduce radial eccentricity, two symmetrically shaped beveled surfaces can also be used. The lumen of drainage tube 425 opens onto beveled surface 4258 and communicates with both the lumen of catheter body 424 and the lumen of second portion 4231. This allows for both positioning and direct flow diversion at the port. Depending on the angle of the beveled surface, different flow rates can be achieved between the two paths.

[0855] In some scenarios, in order to maintain the radial relative position of the drainage tube 425 and the circumferential uniformity of the diversion flow channel, an isolation member 441 is provided between the inner shaft 44 and the drainage tube 425 to maintain a radial gap therebetween.

[0856] The isolation member 441 can be a separate component or a corresponding integrally formed part. For example, as shown in FIG66 , ribs are distributed on the inner wall of the drainage tube to achieve the purpose of isolation.

[0857] The isolation member 441 may also be a hollow structural member fixed between the inner shaft 44 and the drainage tube 425 in the radial direction.

[0858] In order to position the distal end of the drainage tube 425, referring to Figures 67a to 67b, a guide head 43 is fixed to the distal end of the inner shaft 44, and the distal end of the drainage tube 425 is fixed to the proximal side of the guide head 43. After the distal end of the drainage tube 425 is effectively fixed, the distal end of the drainage tube 425 is closed to the guide head 43, so that when the fluid enters the distal end of the drainage tube 425, it can only enter the balloon body from multiple fluid output ports, which helps to uniformly expand the balloon body.

[0859] The proximal side of the guide head 43 has a positioning structure 431 that is adapted to the distal end of the drainage tube 425. The positioning structure 431 is a coupling groove for inserting the drainage tube 425 (as shown in Figure 67a), or a coupling column for inserting the drainage tube 425 (as shown in Figure 67b).

[0860] The present application achieves synchronous deformation of the balloon body 423 at both ends of the artificial implant by distributing the fluid entering the balloon body 423, thereby reducing the risk of position displacement of the artificial implant during release and omitting the axial positioning structure of the artificial implant.

[0861] Figure 68 provides an interventional delivery system 51, which includes a control handle 53, and a catheter assembly 54 controllably connected to the control handle 53, and a device provided in the catheter assembly 54 for loading and delivering an artificial implant 55. When balloon expansion is used for release, the catheter assembly 54 may include a balloon device, and a limiting mechanism 52 may be applied to the balloon device. The catheter assembly 54 may include an outer sheath that slides fit outside the balloon device and an intermediate shaft inside the outer sheath as needed. The interventional delivery system 1 as a whole has a proximal end 5101 and a distal end 5102 as shown in the figure.

[0862] The artificial implant has a loaded state and an expanded state loaded on the catheter assembly 54. The artificial implant can be a heart valve, such as an artificial aortic valve, an artificial pulmonary valve, etc. The artificial implant below takes an artificial heart valve as an example, including a stent and leaflets arranged on the stent, wherein the stent is made of stainless steel that is released by balloon expansion, etc., and the stent itself can be cut and formed using a pipe.

[0863] 68 to 71 , the present application provides a limiting mechanism 52 for an interventional delivery system, comprising a coupling portion 521 and a deformation portion 523. The coupling portion 521 is used to be connected to the interventional delivery system 51, and the coupling portion 521 has the same axial direction as the delivery system 51 and the corresponding circumferential and radial directions; the deformation portion 523 comprises a plurality of rods arranged along the circumferential direction, each rod having a first end 5251 and a second end 5252, the first end 5251 being connected to the coupling portion 521; the second end 5252 is located on one side of the axial direction of the coupling portion 521 relative to the first end 5251, and each rod has a compressed state suitable for interventional delivery and a relative expanded state based on elastic deformation. In the expanded state, the second end 5252 of each rod diverges outward in the radial direction of the coupling portion 521 relative to the compressed state.

[0864] The existing structures have poor stopping effects, especially after the balloon is slightly inflated, that is, in the early stage of release of the artificial implant, the stopping effect is lost. In addition, some structures are complex and require corresponding unlocking operations.

[0865] The rods in this embodiment are generally slender structures. On the one hand, multiple rods, especially at the second end 5251, can reduce mutual traction to avoid affecting the overall effect when local failure occurs. The effect is more prominent when it is relatively eccentric to the artificial implant. On the other hand, it can have a relatively large expansion amplitude in the radial direction and better compliance when the balloon body is folded and deformed below.

[0866] The lengths of the rods 525 may be the same or different. A slender structure can be understood as a rod 525 having a length that is at least five times its diameter, preferably 20 times its diameter. The length of the rod 525 is the distance between the first and second ends. If the cross-section of the rod 525 is circular, the rod diameter corresponds to the diameter. If the cross-section of the rod has other shapes, the rod diameter should be understood as the diameter of a circle of equal area.

[0867] In order to facilitate contraction and expansion, the rod has elasticity, for example, nickel-titanium shape memory alloy is used, and heat treatment is performed to obtain a predetermined shape state, at which time the rod is not constrained and stretches naturally.

[0868] The expanded state of the rod can be understood as the state in which the end of the rod expands to the maximum extent when the limiting mechanism is in use. For example, when the limiting mechanism is used in conjunction with a balloon, after the balloon is inflated, the end of the rod expands accordingly, which is the expanded state.

[0869] In practice, after the balloon is inflated, the radial restraint on the second end of the rod may be completely released, so that the expanded state of the rod is consistent with its own pre-set state. As shown in Figure 77a, when the rod is not restrained by the inflated balloon, the expanded state is the pre-set state.

[0870] In addition, after the balloon is inflated, the shape of the balloon end may still radially constrain the second end of the rod. At this time, the expansion angle of the rod in the expanded state is smaller than the expansion angle in the pre-shaped state.

[0871] In this embodiment, the expanded state of the rods is consistent with the pre-formed state, facilitating the radial contraction of the rods during the balloon's folding and collapsing process when the delivery system is withdrawn. The compressed state of the rods refers to the radial contraction of the second ends of the rods, which is at least suitable for transcatheter delivery. The external force applied to maintain the radial contraction of the second ends can be applied to at least one of the balloon device or the outer sheath.

[0872] For example, in another embodiment, to achieve a larger expansion range, the distance between the second end of the rod and the axis of the coupling portion in the expanded state is R1; in the compressed state, the distance between the second end of the rod and the axis of the coupling portion is R2, and R1:R2 = 2 to 20:1 is satisfied. For example, R1:R2 = 2 to 10:1. The shape of the rod in this embodiment is not strictly limited; of course, a slender structure can achieve better results.

[0873] The coupling portion 521 is connected to the catheter assembly 54. The rods 525 can be gathered together to form a straight cylindrical structure with the coupling portion 521. The rods 525 are radially distributed, and the convergence position of the first end 5251 of each rod 525 is one end of the axial direction of the coupling portion. The rods 525 have an expansion angle α relative to the axial direction. For example, the expansion angle α in the compressed state (Figure 71) is smaller than the expansion angle α in the expansion angle (Figure 70). In the corresponding state, the expansion angles of the rods are the same or different, and the axial positions of the second ends can be relatively aligned or staggered, that is, the lengths of the rods can be different. The angle α and the rod length can be converted into the distance R2 between the second end and the axis of the coupling portion.

[0874] The rod 525 radially protrudes beyond the artificial implant 55 in the loaded state, or at least is not lower than the artificial implant 55, and the second end 5252 faces the artificial implant 55 to restrict the artificial implant 55 from moving toward the side where the limiting mechanism 52 is located. The limiting mechanism 52 can be disposed on both axial sides of the artificial implant 55 to further restrict the axial displacement of the artificial implant 55 relative to the catheter assembly 54.

[0875] The rod 525 can adapt to changes in the surrounding environment. For example, when the artificial implant 55 is in a loaded state, the rod 525 can deform and contract radially to facilitate the loading operation of the artificial implant; and after loading is completed, the rod 525 adaptively deforms to limit the displacement of the artificial implant 55.

[0876] The limiting mechanism of this embodiment has a simpler structure and does not require a control handle to perform an unlocking operation, thereby avoiding increasing the radial dimension of the distal end of the delivery system.

[0877] As shown in Figure 72, the catheter assembly includes at least one pipe, and the coupling portion 521 is connected to the pipe (illustrated as the inner shaft 545 below), wherein the coupling portion 521 is a radially deformable annular structure, and the coupling portion 521 is sleeved on the outside of the inner shaft 545. When assembling the limiting mechanism, the coupling portion 521 is first radially expanded outward, sleeved on the inner shaft 545 and moved to a predetermined position, and then the coupling portion 521 is radially retracted and affixed to the outer circumference of the inner shaft 545 to connect the two. The method of driving the coupling portion 521 to expand or retract radially can be to apply a corresponding driving force, or to rely on the elastic deformation ability of the coupling portion 521 itself to retract radially. For example, once the driving force is released, the coupling portion 521 can retract inward on its own. Accordingly, the coupling portion 521 can be made of a material such as a memory alloy. This eliminates damage to the inner shaft caused by the coupling portion during the assembly process.

[0878] The radial deformation of the coupling portion 521 can be achieved by forming the coupling portion into a spring-like configuration. As shown in FIG73 , in one embodiment, the coupling portion 521 has an axially undulating wave structure with opposing crests 5211 and troughs 5212. The crests 5211 are located on the side connected to the first end 5251 of the deformable portion 523. This wave structure facilitates accommodating radial deformation of the coupling portion 521 during assembly, and the spaced crests 5211 further reduce the mutual traction between the rods.

[0879] The limiting mechanism 52 can be cut as a whole from a tube, the inner diameter of which is larger than the outer diameter of the inner shaft. For example, the inner diameter of the tube is 3.5-4.5 mm, and the outer diameter of the inner shaft is 1-2 mm. Generally speaking, the inner diameter of the tube is 2-5 times the outer diameter of the inner shaft.

[0880] Each rod (especially the second end) can be made relatively wide in the circumferential direction to reduce damage to the balloon. For example, the coupling portion 521 can be cut from a tube with an outer diameter of approximately 5 mm (with a wall thickness of 0.3-0.7 mm), which is then compressed and mounted to fit within an inner shaft with an outer diameter of approximately 1.3 mm. Alternatively, the coupling portion 521 can be pressed tightly against the outer circumference of the inner shaft to increase friction between the two, and then secured with glue. When the coupling portion 521 is assembled with the balloon, it can be inserted into the pins at the end of the balloon and then welded to secure it within the pins.

[0881] In FIG69 , there are two limiting mechanisms for limiting the distal and proximal ends of the artificial implant 55 . In some embodiments, when only the distal or proximal end of the artificial implant needs to be limited, only one limiting mechanism is required.

[0882] Regarding the connection between the coupling portion 521 and the deformation portion 523 , as shown in FIG74 , the two are separate or integral structures. Preferably, the two are integral structures, and the corresponding wave structure and multiple rods 525 are formed by integrally cutting the pipe.

[0883] Each rod 525 of the deformable portion 523 has a tendency to extend spirally around the axis of the coupling portion. As shown in FIG74 , one of the rods extends along a spiral line 5253 (dashed line in the figure), and the starting point of the spiral line 5253 is located at the corresponding wave crest 5211.

[0884] The spiral extension is beneficial for further expanding the length of the rod 525 while maintaining the same axial span, and is also beneficial for insertion into the fold of the balloon:

[0885] In combination with the characteristics that multiple rods are independent of each other, in another embodiment, when the limiting mechanism 52 is installed in the balloon body 542, the balloon body 542 has a relatively folded state and an inflated state. In the folded state, the balloon body 542 has multiple folds 5424, and each rod 525 is placed in the corresponding fold 5424.

[0886] As shown in Figures 77a to 77d, based on the limiting mechanism 52 of the above embodiments, an embodiment of the present application also provides a balloon device 541 for delivering an artificial implant, including an inner shaft 545 and a balloon body 542 located on the outer periphery of the inner shaft, and the inner shaft 545 is equipped with a limiting mechanism 52 located inside the balloon body 542.

[0887] The inner shaft can be a hollow structure, for example, for passing a guidewire. The balloon body 542 can be inflated by a fluid to release the artificial implant. The fluid used to inflate the balloon body can be delivered through the inner shaft, or the delivery system can further include an intermediate shaft 543 sleeved around the outer circumference of the inner shaft. The distal end of the intermediate shaft 543 can dock with the proximal end of the balloon body 542, and the two are connected so that the radial gap between the intermediate shaft 543 and the inner shaft 545 is connected to the proximal end of the balloon body 542 for fluid delivery. The intermediate shaft 543 and the inner shaft 545 are both tubular fittings and can be connected to the control handle and configured with corresponding interfaces.

[0888] As shown in FIG77a, the catheter assembly in the interventional delivery system may further include an outer sheath 544, the distal end of the outer sheath 544 being slidably sleeved on the periphery of the balloon body 542, and the proximal end of the outer sheath 544 being controlledly connected to the control handle. The outer sheath 544 acts on the balloon body 542 to further compress the rod 525 of the limiting mechanism 52, thereby keeping the distal peripheral surface of the delivery system smooth, which is beneficial for interventional delivery in the body and avoiding damage to surrounding tissues. After the artificial implant is delivered to the preset position, the restraint of the outer sheath 544 can be released, as shown in FIG77b and FIG77c. The limiting mechanisms at the distal and proximal ends are exposed outside the outer sheath 544. Accordingly, the rod 525 slightly expands radially outward based on its own elasticity, and then returns to the expanded state as the balloon body 542 is inflated.

[0889] In this embodiment, when the limiting mechanism is wrapped and restrained by the outer sheath 544, the rod is in a compressed state. After the outer sheath is retracted to release the restraint on the limiting mechanism, the rod is only restrained by the balloon body 542, that is, the overall radial restraint force is reduced, so that the second end expands radially outward, but because the balloon body has not yet been inflated, the rod has not been fully expanded and is also in a compressed state. In order to distinguish it from the aforementioned compressed state, it is referred to here as an intermediate state.

[0890] Referring to Figure 77d, when the balloon body, especially the artificial implant, is exposed to the outer sheath or the system is not equipped with an outer sheath and a limiting mechanism, before the balloon body 542 is inflated, the axial end face of the artificial implant 55 is radially higher than the outer periphery of the balloon body 542, which will produce a more obvious radial height turning point, forming a step 551, posing a safety hazard.

[0891] As shown in Figure 77e, in one embodiment, there is one limiting mechanism 52 and it is arranged at the distal end of the inner shaft 545. The artificial implant 55 is located at the proximal end of the limiting mechanism 52. The rod 525 acts on the balloon body 542 so that the outer peripheral surface of the balloon body (understood as the part adjacent to the distal side of the artificial implant) is not lower than the outer peripheral surface of the distal side of the artificial implant, which is equivalent to compensating for the above-mentioned step, reducing risks, and facilitating cross-valve movement.

[0892] Of course, this arrangement can also be adopted at the proximal end as needed. Although this embodiment does not strictly limit the rods to be slender structures, since the rods are independent of each other, they have a larger radial deformation span, which is more conducive to compensating for the step 551. It is more versatile for artificial implants or balloons of different diameters. The other structural features of this embodiment can be combined with other embodiments herein.

[0893] Among them, "not lower than" the outer peripheral surface of the distal side of the artificial implant is understood to allow the protruding part of the balloon body 542 to be slightly higher than the outer peripheral surface of the distal side of the artificial implant, and can also be roughly flush. When "higher than", due to the relatively soft texture of the balloon body 542 and its adaptable radial deformation, it will not cause safety hazards similar to the step 551.

[0894] The inner shaft 545 may have a guidewire channel extending therethrough. The balloon body 542 is located at the distal end of the inner shaft 545 and has a relatively folded state (Figure 77b) and an inflated state (Figure 77c). The balloon body 542 includes, from distal to proximal, a distal segment 5423, an intermediate segment 5422, and a proximal segment 5421. The periphery of the intermediate segment 5422 is provided for placement of the artificial implant 55. The limiting mechanism 52 is comprised of two sets, located within the distal segment 5423 and the proximal segment 5421 of the balloon body 542, respectively. The deformation portions 523 of the two sets of limiting mechanisms 52 are arranged facing each other to limit the axial position of the artificial implant 55.

[0895] In the folded state, the length of the middle section 5422 is substantially equal to the axial length of the artificial implant 55 in the compressed state. The balloon body 542 wraps around the periphery of the retaining mechanism. When the balloon body 542 is folded, the rods are also gathered together. After loading, the retaining mechanism 52 enters the compressed state, and the artificial implant is radially deformed by compression and positioned outside the balloon body 542.

[0896] Each rod 525 in the limiting mechanism 52 is inserted into a corresponding fold 5424. The balloons 542 are stacked in an orderly manner, reducing the number of layers between the artificial implant and the deformable portion 523 that would result from disordered stacking. For example, in this embodiment, only one layer of balloon is present between the artificial implant and the deformable portion, making the radial outward projection of the rod 525 more pronounced and improving the stopping effect. In the folded state, the balloons 542 are coiled in a first circumferential direction 546, and the spiral direction of each rod is the same as the first direction 546.

[0897] The wider the second end 5252 of the rod 525 is, the more conducive it is to reducing damage to the balloon body 542. However, considering that the rod 525 cannot interfere with the corresponding adjacent fold 5424, the width (or diameter) of the second end 5252 of the rod 525 is 0.7 to 1.8 mm.

[0898] The number of rods 525 is a common divisor of the number of creases 5424. Here, the number of rods 525, the expansion angle, and the size of the second end are described:

[0899] The stopping effect is related to the deployment angle. A larger deployment angle improves the stopping effect, but it can also damage the balloon. A larger number of rods improves the stopping effect, but the size of the second end decreases, which can damage the balloon. In some embodiments, the number of rods 525 is 4 to 10, specifically, for example, 4 rods 525 in FIG. 79 or 8 rods 525 in FIG. 80. The rods 525 are 7 to 17 mm long.

[0900] Considering that the expansion angle of the rod 525 is related to its elastic properties, in one embodiment, the wall thickness of the deformation portion 523 and the coupling portion 521 is 0.3-0.7 mm. The wall thicknesses of the two can be the same or different.

[0901] When the balloon body 542 is folded, the second end 5252 of at least one rod 525 is radially no lower than the outer circumferential surface of the artificial implant 55. The second end 5252 acts on the balloon body 542 to form a step 5425 that limits the axial movement of the artificial implant. The situation of "no lower than" includes:

[0902] When the inner diameter of the outer sheath 544 is close to the outer diameter of the artificial implant, the second end 5252 of the rod 525 can be understood to be equal to the outer diameter of the artificial implant in the radial direction;

[0903] After the restraint of the outer sheath is released, the rod 525 is allowed to expand radially outward, and the second end 5252 thereof is slightly larger than the implant 55 in the radial direction.

[0904] As shown in Figures 78a to 78c, in another embodiment, the delivery system further includes an intermediate shaft 543, which is located outside the inner shaft. Two limiting mechanisms are provided, including a first limiting mechanism 5210 and a second limiting mechanism 5220. The first limiting mechanism 5210 is mounted at the distal end of the inner shaft 545 and is located inside the balloon body 542 (bold lines in the figure); the second limiting mechanism 5220 is mounted at the distal end of the intermediate shaft 543 and is located outside the balloon body 542, proximal to the first limiting mechanism. The artificial implant 55 is located between the two limiting mechanisms. The first limiting mechanism 5210 can adopt the limiting mechanism of each embodiment of the present application, and the second limiting mechanism 5220 is used to fill the radial gap between the outer sheath 544 and the intermediate shaft 543 to prevent the artificial implant from moving proximally. The second limiting mechanism 5220 can adopt the limiting mechanism of each embodiment of the present application or other existing limiting mechanisms.

[0905] When the outer sheath 544 is released from its restraints, it reaches a limit position on its sliding path. In this limit position, the first limiting mechanism 5210 and the artificial implant 55 are exposed outside the outer sheath 544, while the second limiting mechanism 5220 is located inside the outer sheath 544. This embodiment can further improve safety by preventing the second limiting mechanism 5220 from scratching internal tissues after being exposed. The second limiting mechanism 5220 is preferably located completely inside the outer sheath 544.

[0906] The control handle injects fluid, ie, a filling medium (eg, saline) into the balloon assembly 55 through the catheter assembly, so that the balloon body 542 expands, thereby driving the artificial implant to expand.

[0907] The injected fluid can pass through the intermediate shaft, and the intermediate shaft can also slide relative to the balloon body, that is, the second limiting mechanism 220 is movable, and the axial position with the balloon body can be adjusted according to the timing or stroke requirements to act as a stop. At this time, in order to transport fluid to inflate the balloon body, the proximal end of the balloon body can be connected to a catheter body, and the catheter body can be sleeved on the outside of the inner shaft, which is conducive to the radial gap with the inner shaft as a fluid channel, or the catheter body and the inner shaft are arranged side by side (independently configured pipes or using multi-lumen tubes), and the proximal end of the catheter body is connected to the control handle and is configured with a corresponding fluid interface.

[0908] In some embodiments, the middle section 5422 can guide the filling medium injected into the balloon body 542 from the proximal section 5421 to the distal section 5423, so that the positions corresponding to the balloon body 542, the distal section 5423 and the proximal section 5421 are injected with the filling medium at the same time, so as to reduce the probability of the artificial implant causing axial displacement relative to the balloon body 542 when the balloon body 542 expands the artificial implant, and to obtain the expected posture change during the release process.

[0909] As shown in Figures 80 to 83, in some embodiments, the second end 5252 of the rod has a smooth outer contour;

[0910] and / or the second end 5252 of the rod is covered with a protective layer;

[0911] And / or the portion of the rod close to the second end 5252 is bent radially inward so that the second end 5252 has a tendency to bend radially inward.

[0912] All three structures are used to prevent the inner circumference of the balloon body 542 from being scratched by the rods 525 of the deformation portion 523 during the folding / inflating process of the balloon body 542 .

[0913] Among them, the second end 5252 can be coated with a polymer layer to form a protective layer. Preferably, as shown in Figure 80, a hole 5256 is opened in the part of the rod 525 close to the second end 5252, and the protective layer is partially embedded in the hole 5256 and fixed by dispensing or other means.

[0914] To improve compliance near the second end and better conform to and shape the balloon, as shown in Figures 81 and 82, the portion of the rod near the second end has a lower radial stiffness than the rest of the rod. Specifically, the abutment portion 5254 is grooved to form a wave-like structure, which can undergo elastic deformation after being acted upon by the balloon 542, such as radial inward bending and / or circumferential twisting. After the action of the balloon 542 is released, the abutment portion 5254 elastically deforms, causing the rod to return to its original extension trend. The width of the groove is 0.02 to 0.2 mm.

[0915] For another example, in Figure 83 , when not subjected to external force, the abutment portion 5254 bends radially inward. As shown in Figure 84 , preferably, when the rod 525 is in the deployed state, the end 5255 of the abutment portion 5254, which is close to the first end 5251, is at the maximum radial dimension of the deformable portion 523. That is, during the folding and inflation of the balloon 542, the rounded portion where the end 5255 is located acts on the balloon 542, thereby preventing damage to the balloon 542.

[0916] As shown in FIG85a , in another embodiment, a balloon-expansion-based interventional delivery system is provided for delivering an artificial implant. The interventional delivery system includes a balloon device 54, an adjustment wire 5710, and a locking wire 5720. The balloon device 54 includes an inner shaft and a balloon body 542 disposed on the outer periphery of the inner shaft 545. The distal end of the inner shaft 545 is provided with a limiting mechanism (which may adopt the aforementioned embodiments) disposed within the balloon body 542, such as a plurality of rods 525 arranged in sequence along the circumference. The specific structure of the rods 525 and other components may refer to the aforementioned embodiments. The adjustment wire 5710 is used to releasably fix the artificial implant 55 on the balloon body 542. One end of the adjustment wire 5710 can remain fixed to the balloon body 542, and the other end can pass through the hole 552 on the artificial implant 55. The passed end has a locking hole 5711; the locking wire 5720 has a relative locking state and an unlocking state. In the locked state, the locking wire 5720 passes through each locking hole 5711 to restrict the artificial implant 55. In the unlocked state, the locking wire 5720 disengages from each locking hole 5711 to release the artificial implant 55.

[0917] There is at least one locking hole 5711, one of which is located at the proximal end of the artificial implant 55. There is at least one adjustment wire 5710, one of which is located on the proximal side of the rod 525 and at least partially outside the balloon body 542. The proximal end of the locking wire 5720 is controlled by the control handle. In the locked state, the distal end of the locking wire 5720 is fixed to the distal end of the inner shaft 545, for example, plugged into the guide head. In the unlocked state, the control handle drives the locking wire 5720 to move to the unlocked state.

[0918] Before being unlocked, the locking wire 5720 can provide axial limitation for the artificial implant 55 during the entire process of balloon expansion. Combined with the rod 525 to compensate for the radial drop between the balloon and the artificial implant 55, it has a wider range of applications.

[0919] FIG85a shows only one adjustment wire, which is arranged at the distal end. As shown in FIG85b , in other embodiments, the adjustment wire 710 can be two, respectively arranged at the distal end and the proximal end of the artificial implant 55. As shown in FIG85c , another embodiment can also be used in conjunction with an outer sheath 544.

[0920] During delivery, the artificial implant 55 and the balloon body 542 are wrapped by the outer sheath 544. According to the progress of the operation, the outer sheath 544 can be withdrawn proximally to expose the artificial implant 55 and the balloon body 542, and then the balloon body 542 can be inflated to expand and release the artificial implant.

[0921] The present invention's position-limiting mechanism optimizes the structure of the deformable portion to provide elastic deformation, thereby extending the retention period of the implant and facilitating assembly of the implant in a compressed state. The rod deforms to accommodate changes in the balloon during folding and inflation, minimizing damage to the balloon. Furthermore, radial traction is reduced, further ensuring effective positioning of the implant in an eccentric position.

[0922] An embodiment of the present application provides a balloon device 641 for delivering an artificial heart valve, which can be used to deliver and expand an artificial implant 65a, which can be the artificial heart valve 65 or the anchoring stent 656 in other embodiments.

[0923] Balloon device 641 comprises a catheter body 6411 and a balloon body 642. The catheter body extends in an axial direction. When straightened, the catheter body 6411 defines a radial direction perpendicular to the axial direction and a circumferential direction around the axial direction. The balloon body communicates with the catheter body and can receive fluid from the catheter body. The balloon body has a folded state and an inflated state under the action of the fluid. As shown in FIG127 , in the folded state, the balloon body is connected to the distal end of the catheter body, with the artificial heart valve 65 pressed against the exterior of the balloon body. As shown in FIG128 , the proximal end of the catheter body 6411 is provided with a fluid inlet 645. In the inflated state, fluid can enter the balloon body through this fluid inlet 645 and inflate the balloon body. Based on the changes in the balloon body, the artificial implant expands from a radially compressed state to a radially expanded state, allowing the artificial implant 65a to expand and release. In some cases, a fluid inlet may also be provided on the distal end or sidewall of the balloon body, though this is not shown.

[0924] Referring to Figures 86-89, the balloon device also includes a limiting mechanism 62 for limiting axial movement of the artificial implant 65a. Specifically, the limiting mechanism can limit axial movement of the artificial implant in at least one axial direction, for example, proximal and / or distal axial movement of the artificial implant. The limiting mechanism can be located inside or outside the balloon body, with at least one of the catheter body and the balloon body being directly secured to the limiting mechanism or indirectly secured to the limiting mechanism via an intermediate component.

[0925] The limiting mechanism includes a limiting body 622, which includes multiple rods (such as rod 221). The multiple rods extend as a whole from the first axial end to the second axial end, and gather at the first end and the second end respectively to form a hollow cage structure (having an internal space 62a). One side of the cage structure (i.e., the side facing the artificial implant in use) is used to limit the axial position of the artificial implant 65a.

[0926] Multiple rods form the side walls of the cage-shaped structure, and the gaps between the rods form a hollow area on the side wall. For example, a hollow area is formed between rods 6221a and 6221b in the figure, so that the internal space 62a and the external space 62b of the cage-shaped structure are connected through the hollow area, that is, the hollow area can serve as a fluid filling channel.

[0927] One part of the cage structure is the outward expansion portion 623, which has the largest radial outward expansion degree relative to other parts of the cage structure, as shown in Figure 88 (the cage structure is longitudinally sectioned using the plane where the axis is located to obtain the longitudinal section of the cage structure). From the outer contour of the cage structure, the outward expansion portion is the area with the largest radial dimension. In the axial direction, the outward expansion portion can be a point position or a section of area.

[0928] Some of the hollow areas are main hollow areas 6222. For the main hollow areas:

[0929] For example, the difference between the main hollow area 6222 and other hollow areas is that these main hollow areas 6222 can be the outward expansion part with the maximum outer diameter along the axial direction spanning the cage-shaped structure. For example, the hollow area between the rod 623a and the rod 623b in Figure 86 is the main hollow area 6222, and the hollow area between the rod 623b and the rod 623e is also the main hollow area 6222.

[0930] For another example, the main hollow area 6222 may be a hollow area with a larger axial span than other hollow areas. Referring to FIG. 102 , other hollow areas may be auxiliary hollow areas 6223 , and the main hollow area 6222 may also be a hollow area with a larger axial span than the auxiliary hollow areas 6223 .

[0931] For another example, the main hollow area may also be a hollow area spanning the first end and the second end of the limiting body.

[0932] Along the circumference of the limiting mechanism, the two main hollow areas 6222 are spaced apart in the circumference of the expansion portion. In addition, the hollow parts in the same main hollow area extend continuously (ie, the interior is no longer divided into smaller areas by solid components).

[0933] In use, the balloon wraps around the outer periphery of the retaining body. The side of the cage structure facing the implant restricts the axial position of the implant 65a. The side of the cage structure facing away from the implant provides a guiding angle for the distal end of the balloon, facilitating smoother in-vivo delivery of the implant. When fluid enters the balloon through the fluid inlet 645, it flows from the internal space 62a through the main hollow region 6222 to the external space, thereby inflating the balloon.

[0934] The balloon device also includes an inner shaft 643 (which can serve as an intermediate piece), a guide head 646 being fixed to the distal end of the inner shaft, and the inner shaft is passed through the catheter body and the balloon body. For example, the inner shaft can be a guidewire shaft for accommodating a guidewire.

[0935] The limiting mechanism 62 also includes a coupling member 621. The coupling member 621 can be fixed to the inner shaft and connected to the limiting body. It can be understood that when the balloon device is loaded with an artificial implant (i.e., in use), the coupling member 621 can be sleeved outside the inner shaft, and the positions of the two are relatively fixed. In addition, the coupling member and the limiting body can be directly or indirectly connected, so that the positions of the coupling member, the catheter body, and the limiting body are relatively fixed in use. In addition, when the limiting mechanism of this embodiment is used, the limiting mechanism is assembled into the balloon body 642 of the balloon device. The balloon body 642 has a relatively folded state and an inflated state. As shown in Figure 97, in the folded state, the balloon body 642 has multiple folding parts 6424, each of which can be placed in a corresponding main hollow area. It can be seen that the balloon body 42 can be folded in an orderly manner through the main hollow area, and the outer periphery of the expanded part is only covered with a layer of balloon body, avoiding disordered stacking that increases the maximum radial size of the limiting body.

[0936] In addition, during the process of loading the artificial implant into the balloon device, different circumferential positions of the limiting body will be subject to radial restraint forces, but the force directions at different positions are not consistent. Therefore, a main hollow area is set in the outer expansion part, which makes it easier for the rods on both sides of the main hollow area to adapt to each other in the circumferential direction, that is, to adjust the spacing according to the radial restraint forces of different directions and sizes (that is, the rods adaptively adjust the size of the main hollow area), which is convenient for loading.

[0937] As shown in FIG86 , the cage structure 624 has two gathering (or collapsing) portions (gathering portion 624a and gathering portion 624b) spaced apart along the axial direction. The sidewall of the cage structure extends between the two gathering portions (i.e., multiple rods extend between the two gathering portions), and each gathering portion surrounds and is located adjacent to the inner axis. Gathering portion 624a and gathering portion 624b are the starting and ending points of the rod extension path, respectively, and both surround and are adjacent to the catheter body. In some embodiments, as shown in FIG91 and FIG92 , additional gathering portions, such as gathering portion 624d and gathering portion 624c, may exist during the extension of the rod between the two gathering portions (gathering portion 624a and gathering portion 624b). Since this embodiment does not expect the limiting mechanism to produce radial compression when the artificial implant is being restrained, the introduction of multiple gathering portions can enhance the circumferential strength of the cage structure.

[0938] In some embodiments, along the axial direction of the limiting mechanism, at least one side of the main hollow area extends adjacent to the coupling member on that side. Adjacent can be understood as the two being relatively close, and the rods constituting the main hollow area can be directly or indirectly connected. For example, as shown in Figure 87, the coupling member can be disposed within the cage structure 624, indirectly connected to and supporting the cage structure through the rods; as shown in Figure 88, there is at least one coupling member 621, which is connected to one of the retracted portions, which can be understood as at least one end of each rod being retracted into the coupling member.

[0939] As shown in Figure 89, there are two coupling parts 621, namely the first coupling part 6211 and the second coupling part 6212, which are distributed at intervals along the axial direction, and the first coupling part 6211 and the second coupling part 6212 are respectively connected to the corresponding retracted parts. The main hollow area spans the outer expansion part of the cage structure along the axial direction and extends on both sides close to the first coupling part 6211 and the second coupling part 6212 respectively. The main hollow area 6222 corresponds to the span range W1 in the figure.

[0940] As shown in Figure 93, there are two coupling members 621: a first coupling member 6211 and a second coupling member 6212, spaced apart along the axial direction. The proximal end (right side in the figure) of the main hollow region 6222 extends adjacent to the first coupling member 6211. The main hollow region 6222 corresponds to the span W2 in the figure. Furthermore, each of the aforementioned coupling members can be connected to the inner shaft by bonding, welding, or clamping. The outer diameter of the outer expansion portion of the limiter body is greater than the outer diameter of the coupling member. For example, the outer diameter ratio of the outer expansion portion to the coupling member is 2 to 4:1, preferably 3:1.

[0941] 93 to 96 , the present application also provides a balloon device 641 for delivering an artificial implant. The balloon device 641 includes a catheter body 6411 , a balloon body 642 , and a limiting mechanism 62 . The catheter body, balloon body, and limiting mechanism mentioned in this embodiment can be combined with other embodiments.

[0942] The limiting mechanism is configured to limit the axial movement of the artificial implant at least when the artificial implant is installed on the balloon body in a radially compressed state. The limiting mechanism specifically includes a limiting body. The limiting body is a cage-shaped structure 624 as a whole, which can be formed by gathering multiple rods. One part of the cage-shaped structure is an outward expansion part, which has the largest radial outward expansion degree relative to other parts of the cage-shaped structure. The structure of the cage-shaped structure and the outward expansion part can also be combined with other embodiments.

[0943] Along the axial direction of the limiting mechanism, one end of the limiting body is the first end 6224 facing the artificial implant 65a in the use state, and the other end is the opposite second end 6225. The outward expansion portion 623 is adjacent to the first end of the limiting body, as shown in Figure 95. When the artificial implant 65a is loaded on the balloon device, the limiting body is in the use state, the first end 6224 faces the artificial implant 65a, and the second end 6225 is axially spaced from the first end 6224. The limiting body has a certain span in the axial direction, that is, the distance between the first end 6224 and the second end 6225. Relative to the second end 6225, the outward expansion portion is closer to the first end.

[0944] The balloon device 641 further includes an inner shaft 643 , which passes through the catheter body 6411 and the balloon body. The limiting mechanism further includes a coupling member 621 , which is fixed to the inner shaft and connected to the limiting body.

[0945] The outward expansion portion 623 is adjacent to the first end 6224 of the limiting body. It can also be understood that the axial distance H2 between the outward expansion portion and the second end 6225 is greater than the axial distance H1 between the outward expansion portion and the first end 6224 .

[0946] Overall, rod 623d, located between the outwardly flared portion and the second end, and rod 623c, located between the outwardly flared portion and the first end, extend more gently, facilitating guided interventional delivery. Rod 623c has a more pronounced steepening tendency, providing a better stopping effect and reducing axial misalignment between the limiting body and the artificial implant.

[0947] According to the change in the extension trend of the rod 623c, an inner concave area 62241 for accommodating the end of the artificial implant 65a is formed between the first end 6224 and the coupling part on that side (i.e., the first coupling part 6211) in the limiting body as shown in Figure 95. The inner concave area 62241 is roughly prism-shaped and converges toward the second end 6225.

[0948] The cage-shaped structure is shown in FIG96 (the longitudinal section of the cage-shaped structure is obtained by longitudinally sectioning the cage-shaped structure in the plane where the axis is located). From the extension direction of the two ends of the outward expansion portion, the cage-shaped structure is formed by radially extending inward from the outward expansion portion 623. As shown in the figure, the two ends of the outward expansion portion 623 extend radially inward to the first end 6224 and the second end 6225, and the position of the outward expansion portion is offset axially toward the first end 6224 and may even exceed the first end, thereby forming the concave area 62241 mentioned above.

[0949] Another embodiment of the present application further provides a balloon device for delivering artificial implants. The balloon device 641 includes a catheter body 6411, a balloon body 642, and a limiting mechanism 62. The catheter body, balloon body, and limiting mechanism mentioned in this embodiment can be combined with other embodiments.

[0950] As shown in Figures 86 and 90, the limiting mechanism 62 specifically includes a limiting body, which includes multiple rods 6221 that form a cage-shaped structure as a whole. One part of the cage-shaped structure is the outward expansion part 623, which has the largest radial outward expansion degree relative to other parts of the cage-shaped structure. As shown in Figure 86, various parts on the rods 6221a and 6221b have different degrees of outward expansion, and there is a certain distance between them and the central axis of the limiting body. The position on the rod where the distance from the central axis reaches the maximum is the outward expansion part.

[0951] From an overall perspective, the main hollow area 6222 is formed between rods 6221a and 6221b. In a cross section through the expanded portion, as shown in FIG97 , the rods 6221 are spaced apart along the circumference of the limiting mechanism (e.g., rods 6221a and 6221b in the figure), and the area enclosed by the center points of the rods approaches a polygon.

[0952] During the loading process of the artificial implant, different circumferential locations of the restraining body exhibit slightly different resistance to radial restraint. This allows each rod to adapt circumferentially, adapting to loading based on local deformation without causing overall deformation of the cage structure. Furthermore, the spaces between adjacent polygonal vertices (corresponding to the main hollow areas described above) accommodate the folding areas of the balloon, allowing for orderly folding and reducing the radial dimensions of the balloon after loading.

[0953] The polygon surrounded by the center points of each rod is a regular polygon, and the number of sides can be 4 to 12 according to the number of rods in this part, preferably 6 to 8, to ensure circumferential strength while taking into account good deformation adaptability.

[0954] Along the axial direction of the limiting mechanism, one end of the limiting body is the first end 6224 facing the artificial implant 65a in the use state, and the other end is the opposite second end 6225. Both ends of the limiting body are converged toward the central axis of the limiting body. Compared with the limiting body with one end open in the prior art, the cage-shaped structure with both ends converged can provide better radial support force.

[0955] In some embodiments, the cage structure 624 is surrounded by multiple rods, and each rod 6221 can extend along a spherical surface or an ellipsoidal surface in space, so that the cage structure 624 as a whole roughly forms a sphere or an ellipsoid, wherein the cross-section of the ellipsoid is an ellipsoidal surface, and the major axis of the ellipsoidal surface is consistent with the axial direction. As shown in Figure 86, the circumferentially spaced rods extend along the sphere or ellipsoid (each rod rotates around the axis of the limiting body to form a continuous sphere or ellipsoid, and the radial dimensions of the outward expansion part mentioned above can also be measured with reference to the rotating body constructed in this way), and the line connecting the center points of each rod in the radial cross section is still polygonal.

[0956] In some embodiments, as shown in Figures 93 and 95, the cage-shaped structure is surrounded by multiple rods, and each rod can extend along the cone 6241 in space. It can be understood as a cone formed by rotating each rod around the axis of the limiting body, wherein the cone includes a first cone 62411 and a second cone 62412. The first cone and the second cone can be on both sides or on the same side of the outward expansion part (the two cones in Figure 93 are on both sides of the outward expansion part, and the two cones in Figure 95 are on the same side of the outward expansion part). The first cone and the second cone can have the same taper or different tapers.

[0957] When the first cone and the second cone adopt different tapers, it can also be understood that the first cone and the second cone gradually converge in shape from the outward expansion portion, and the convergence trends are different. The intersection of the first cone and the second cone is the position of the outward expansion portion (as shown in Figure 93).

[0958] Referring to Figures 94 to 99, when the artificial implant 65a is loaded on the balloon device, the limiting body is in use. Along the axial direction of the limiting body, one end of the limiting body is the first end 6224 facing the artificial implant, and the other end is the opposite second end 6225. The first cone 62411 is connected to the first end 6224, and the first cone has a faster contraction trend.

[0959] The offset direction and radial convergence tendency of the two cones affect the overall shape of the cage structure. For example, in Figure 99, the second cone 62412 offsets axially toward the second end 6225 and relatively slowly converges radially, while the first cone 62411 offsets toward the first end (i.e., away from the first end) and relatively quickly extends and converges radially. For example, in Figure 96, the second cone 62412 offsets axially toward the second end 6225 and relatively slowly converges radially, while the first cone 62411 also offsets toward the second end and relatively quickly extends and converges radially. For example, the second cone 62412 offsets axially toward the second end 6225 and relatively slowly converges radially, while the first cone 62411 converges radially.

[0960] As shown in Figure 96, the radial offset angle A of the first cone 62411 relative to the limiting body is less than 45 degrees, preferably less than 30 degrees. The radial offset angle B of the second cone 62412 relative to the limiting body is greater than 60 degrees.

[0961] The first cone and the second cone are intertwined at the outward expansion portion, and the outward expansion portion is the maximum radial dimension of the two cones, and the angle C between the two cones at the intersection is 20 to 120 degrees.

[0962] Regarding the connection structure between the coupling part and the conveying system, as shown in Figures 127 and 101, the balloon device 641 of the conveying system includes a catheter body 6411, a balloon body 642 and an inner shaft 643. The inner shaft is arranged inside the catheter body and the balloon body, and the limiting mechanism also includes a coupling part connected to the inner shaft.

[0963] The limiting mechanism 62 is installed inside the balloon body 642 and is sleeved outside the inner shaft 643. The coupling part 621 is a radially compressible tubular structure. Compressibility can be understood as the coupling part being radially compressible during the assembly process, but the shape of the coupling part remains fixed when in use.

[0964] For example, the inner diameter of the coupling member 621 before assembly may be larger than the outer diameter of the catheter body. During assembly, the coupling member 621 is driven to shrink radially inward to be tightened and fixed to the catheter body.

[0965] To achieve radial deformation, coupling member 621 can employ a grid-like or wavy structure. As shown in Figure 101, coupling member 621 exhibits an axially undulating wave structure with opposing crests 6213 and troughs 6214. The troughs are spaced circumferentially around the coupling member, with the crests located on the side connected to the retaining body. This wavy structure facilitates adapting to radial deformation during coupling assembly, and the spaced crests 6213 further reduce mutual traction between the rods.

[0966] Regarding the distribution of the rods, the cage structure 624 is surrounded by multiple rods 6221, all of which spatially define the side walls of the cage structure. To ensure the necessary support strength, it is preferred that no isolated rods extend between the two coupling members. That is, a single rod intersects with an adjacent rod at least once during its extension, with the intersection between adjacent rods being the intersection point. Compared to existing limiting mechanisms formed by braided metal wires, although there are intersections between the wires, the two wires at this intersection are relatively movable. In this application, the intersection points of adjacent rods are all fixed nodes, which improves radial support strength.

[0967] As shown in Figure 95, all the rods extend from the first coupling member 6211 to the second coupling member 6212, and have at least one fork 62211 on the extension path, or as shown in Figure 93, the rods extend from the second coupling member 6212 to the first coupling member 6211, and the rods intersect with adjacent rods in the circumferential direction to form an intersection 62212.

[0968] Along the circumference of the outward expansion part, multiple intersection points 62212 are distributed at intervals on the cage-shaped structure 624. Through multiple bifurcations or intersections, the contact area between the outward expansion part and the balloon body is increased, making the circumferentially expanded shape of the balloon body more ideal. At the same time, it avoids the problem of insufficient rigidity of the limiting mechanism and easy damage to the balloon caused by overly thin rods.

[0969] For wider rods, in order to adjust their stiffness, slits can be made. As shown in Figure 93, the slits 6226 generally do not expand in the cage structure and are therefore not understood as hollow areas.

[0970] Regarding the distribution of the main hollow areas, referring to Figures 86 and 102, the number of main hollow areas is 4 to 12, and the preferred number is 6 to 8. Each main hollow area has the same shape and is evenly arranged along the circumference. Preferably, the main hollow areas are strip-shaped.

[0971] Referring to Figure 103 , along the axial direction of the stopper body, the projected length of the main hollow area on the axis is L1, and the projected length of the stopper body on the axis is L2. L1 accounts for at least 40% of L2, and even at least 60% or more. Preferably, the projected length L1 of the main hollow area is 75% to 100% of the total projected length of the stopper body. Furthermore, along the axial direction of the stopper body, the main hollow area may extend to both sides of the outward expansion portion, and the extended length is at least 20% of the total length of the stopper body.

[0972] If the main hollow area is projected radially onto the plane where the axis is located, the main outward expansion portion is the widest part of the projected area. In order to increase the contact area between the outward expansion portion and the balloon body, the number of main hollow areas is 6 to 9.

[0973] In some embodiments, the hollowed portion of the cage structure may include a main hollow area 6222 and a corresponding auxiliary hollow area 6223, wherein the auxiliary hollow area avoids the outward expansion portion 623. For example, the auxiliary hollow area 6223 may be formed by two rods bifurcating and then rejoining along the extension path. Regarding the circumferential spans of the main and auxiliary hollow areas, the maximum circumferential span S1 of the main hollow area corresponds to the position of the outward expansion portion, while the maximum circumferential span S2 of the auxiliary hollow area 6223 avoids the outward expansion portion and is smaller than the span S1 of the main hollow area. The limiting mechanism may be formed by integrally cutting a tubular material. When the tubular material is integrally cut, the slit corresponding to the auxiliary hollow area 6223 may extend to the coupling portion. In conjunction with Figures 102 and 104, the slit portion extending to the coupling portion is not expanded, ultimately resulting in the auxiliary hollow area having a smaller maximum circumferential span than the main hollow area.

[0974] When using a tube for integral cutting, as shown in FIG104 , the tube has an initial outer diameter D1, and the outer diameter D2 after the coupling is assembled is smaller than D1. The tube with an outer diameter D1 of the cage structure can provide a longer circumferential distance, and can more flexibly configure the number of rods (which can be counted circumferentially along a certain part of the limiting body) and obtain a larger rod width and strength, and can avoid the rod width being too thin to easily scratch the balloon.

[0975] 105 to 106 , an embodiment of the present application further provides a balloon device for delivering an artificial implant, having relative distal and proximal ends. The balloon device 641 includes an inner shaft 643, a balloon body 642, a catheter body 6411, and a limiting mechanism 62. The catheter body, balloon body, and inner shaft mentioned in this embodiment can be combined with the above embodiments.

[0976] The limiting mechanism includes a coupling 621, a limiting body 622, and a guide tube 625. The coupling is connected to the inner shaft, and is also connected to at least one of the limiting body and the guide tube. The coupling and limiting body mentioned below can be combined with the above embodiments.

[0977] The limiting body is a cage-shaped structure as a whole. The cage-shaped structure can be formed by extending multiple rods along a spherical surface or a cone in space. The rods are arranged at intervals in the circumferential direction of the limiting body, and a main hollow area is formed between adjacent rods. The structures of the cage-shaped structure, rods and hollow area can also be combined with the above embodiments.

[0978] The guide tube 625 is connected to the proximal side of the limiting body. The guide tube 625 and the limiting body are cut and formed as a whole with a tube made of shape memory alloy material (such as nickel-titanium alloy). For example, the tube has an initial outer diameter D1, which is cut to form a guide tube and a limiting body having multiple rods. The outer diameter of the guide tube is the outer diameter D1 of the tube. The multiple rods can be made into a cage-shaped structure through a pre-forming process such as a mold. Based on the characteristics of shape memory alloy, the limiting body can be restored to a tubular shape during the assembly process of the limiting mechanism.

[0979] The coupling parts can be distributed in various ways. As shown in Figure 105, the coupling part 621a can be arranged inside the guide tube and connected to the inner wall of the guide tube; or the coupling part 621b can be arranged at the proximal end of the guide tube; or the coupling part 621d can be arranged at the distal end of the limiting body; or the coupling part 621c can be arranged inside the limiting body. Several coupling parts can be used individually or in combination.

[0980] As shown in Figure 106, the coupling part may include a first coupling part 6211 and a second coupling part 6212 arranged at intervals along the axial direction, which are respectively used to connect to the limiting body and the guide tube. Both coupling parts are on the outer periphery of the inner shaft, and at least one coupling part is fixed to the inner shaft. The distal end of the balloon body also wraps the second coupling part.

[0981] 107 to 108 , the radial gap between the inner shaft 643 and the catheter body 6411 is a fluid channel connected to the interior of the balloon body. When the artificial implant is expanded and released, the fluid in the fluid channel enters the balloon body and combines with the above-mentioned guide channel to inflate the balloon body.

[0982] The second coupling member 6212 is located at the proximal end of the guide tube 625 and is adjacent to the connection portion between the balloon body 642 and the catheter body 6411. The second coupling member 6212 can divert the fluid in the fluid channel, and before the balloon body is inflated, divert part of the fluid to the inside of the drainage tube, and this part of the fluid eventually inflates the first part through the hollow area of ​​the cage-shaped structure.

[0983] The proximal end of the guide tube 625 has a reduced diameter section 6252 and is connected to the coupling piece on the corresponding side through the reduced diameter section, so as to be suitable for the connection between coupling pieces of different diameters and the guide tube.

[0984] The guide tube has a fluid inlet 6251, which is located in the reduced diameter section and / or the peripheral wall of the drainage tube. Preferably, the peripheral wall of the guide tube has a hollow gap as a whole. The gap can be a long strip hollow as shown in Figure 105 or a circular hollow as shown in Figure 110. When the artificial implant is still in the compressed and gripped state, the gap between the middle part of the balloon body and the catheter body is fully utilized to allow the fluid to pass through the gap more quickly, thereby achieving the simultaneous inflation of the first and second parts of the balloon body. In some embodiments, the guide tube is connected to the proximal side of the limiting body. During use, the limiting body limits the distal end of the artificial implant. The interior of the guide tube serves as a flow channel for the inflated fluid in the delivery system, playing a drainage role.

[0985] Referring to FIG111 , in order to further limit the proximal end of the artificial implant, there are two limiting bodies, namely a limiting body 622a located at the proximal end of the guide tube and a limiting body 622b located at the distal end of the guide tube.

[0986] The limiting body 22a and the limiting body 22b are both cage-shaped structures, and the two cage-shaped structures are independent of each other. For example, the two cage-shaped structures in Figure 111 are formed by multiple rods extending along the spherical surface in space, and the two cage-shaped structures in Figure 112 are formed by multiple rods extending along the cone in space; the limiting body 622a in Figure 113 is formed by multiple rods extending along the spherical surface in space, and the limiting body 22b is formed by multiple rods extending along the cone in space; the first cone 62411 of the two cage-shaped structures in Figure 114 has a different tendency of radial offset relative to the limiting body (i.e., offset angle).

[0987] The interventional delivery system includes a control handle 63 and a catheter assembly 64 controllably connected to the control handle 63, with an artificial implant 65a loaded on the catheter assembly 64. In a balloon-expandable interventional delivery system, the catheter assembly 64 may include a balloon device 641 and an outer sheath 644 that is slidably fitted onto the outside of the balloon device.

[0988] The balloon device 641 includes a balloon body 642 , and includes a first portion 6421 , a middle portion 6422 , and a second portion 6423 from the distal end to the proximal end. The middle portion 6422 is used for loading and fixing the artificial implant 65 a .

[0989] The limiting mechanism is entirely disposed within the balloon body 642. As shown in FIG107 , the limiting body is located in the first portion 6421. The guide tube 625 is sleeved over the inner shaft and extends from the proximal end of the limiting body toward the middle portion of the balloon body and the second portion. A fluid passageway is provided between the guide tube 625 and the inner shaft 643. Preferably, the guide tube has a length ranging from 36 mm to 50 mm and an inner diameter ranging from 1.6 mm to 2.3 mm. The proximal end of the guide tube is fixed relative to the inner shaft. Improved methods for fixing the two are provided below.

[0990] The limiting mechanism of the present application has a simple structure and can be formed by integrally cutting a tube. The specific structures of the coupling member and the limiting body can be combined with the above embodiments. For example, the tube in Figure 115 has an initial outer diameter D1, which is cut to form two corresponding wave structures and multiple rods and a guide tube with a hollow gap, corresponding to the three-part structure of two coupling members, the limiting body, and the guide tube. The outer diameter of the guide tube is the outer diameter D1 of the tube. The multiple rods can be made into a cage-shaped structure through a molding process such as a mold, and at least one coupling member is used after radial compression molding. The outer diameter D2 of at least one coupling member is smaller than D1.

[0991] In the case where a limiting mechanism is not installed on the delivery system, the artificial implant is pressed and gripped on the catheter of the delivery system (such as a balloon). Since the outer diameter of the artificial implant in the pressed and gripped state is larger than the outer diameter of the catheter, the proximal and distal ends of the artificial implant will form steps with the catheter, which will cause certain risks. The limiting body of the limiting mechanism can fill the step, especially the distal step, which is beneficial for implantation. For example, when the artificial implant is an artificial heart valve, it is beneficial for cross-valve. In addition, the circumferential strength and step effect of the limiting body (the outward expansion portion forms a blocking step relative to the artificial heart valve) are related to the wall thickness of the tube, and the wall thickness of the tube is selected to be 0.1mm to 0.25mm.

[0992] Referring to Figures 107 to 116, one embodiment of the present application further provides a balloon device 641 for delivering an artificial implant, comprising an inner shaft 643, a catheter body 6411, and a balloon body 642. The balloon body 642 comprises, from distal to proximal, a first portion 6421, a middle portion 6422, and a second portion 6423. The middle portion 6422 is used to load and secure an artificial implant 65a. The inner shaft 643 is equipped with a limiting mechanism 62, as described in the aforementioned embodiments, within the balloon body. The limiting mechanism comprises a coupling 621, a limiting body 622, and a guide tube 625. The coupling, limiting body, and guide tube structures described below may be combined with those of other embodiments.

[0993] The coupling part includes a first coupling part 6211 (located at the proximal end) and a second coupling part 6212 (located at the distal end) arranged along the axial direction. The two coupling parts are inserted into the inner shaft 643. The coupling part and the inner shaft 643 can be bonded, or a sleeve 62121 can be installed outside the coupling part as shown in Figure 116 to facilitate the use of tooling 66 to push the stopper into the balloon body.

[0994] The limiting body is used to fill the first portion 6421 of the balloon body 642 without interfering with the loading area in the middle of the balloon body, thus providing a guiding angle for the distal end of the balloon body. Rods are arranged at intervals along the circumference of the limiting body, forming a main hollow area between adjacent outwardly expanded portions. The structure of the rods and hollow area can be combined with the structures of the above embodiments.

[0995] The balloon body 642 has two relative states: folded and inflated. As shown in FIG97 , in the folded state, the balloon body 642 has multiple folds 6424. Each fold 6424 is embedded within the cage structure, i.e., within the corresponding main hollow area. The outer periphery of the expanded portion is only covered by a single layer of balloon body. Without the main hollow area, the folds 6424 could form a three-layered outer structure, increasing the size of the expanded portion of the retaining body and making loading unfavorable. A guide tube 625 extends through the loading area in the middle of the balloon body and can be provided with a fluid inlet 6251 on its peripheral wall, allowing for simultaneous inflation of the first portion 6421 and the second portion 6423 during balloon inflation.

[0996] The limiting mechanism of this embodiment is formed by integrally cutting a tube, wherein the tube can be made of a material such as a memory alloy, and is pre-shaped into a cage structure before being assembled into the balloon body. During assembly, the stopper can be straightened to facilitate assembly.

[0997] The assembly process of the whole balloon device is as follows:

[0998] 1. First, fix the first coupling member 6211 to the inner shaft 643 by gluing, and straighten the limiting mechanism to form a straight tube shape;

[0999] 2. Push the limiting mechanism 62 and the inner shaft 643 into the balloon body 642 from the distal end of the balloon body, and the limiting body returns to the predetermined cage-shaped structure. The limiting body can also be shaped by applying axial pushing. As shown in FIG116 , the limiting mechanism can be pushed or squeezed by the tooling 66.

[1000] 3. After pushing the balloon body in, fix the second coupling member 6212 on the inner shaft 643 by bonding, or welding the second coupling member 6212 to the distal pin of the balloon body, or adding a sleeve 62121 to the second coupling member 6212 to fix it to the distal pin of the balloon body.

[1001] Referring to Figure 117, the present application also provides a transcatheter implant system, including a balloon device 641 and an artificial implant 65a, the balloon device 641 includes a limiting mechanism 62, a catheter body 6411 for conveying fluid, and a balloon body 642 connected to the catheter body, the artificial implant 65a is installed on the balloon body in a radially compressed loading state, and is blocked by the limiting mechanism in the axial direction, and at least the distal end of the artificial implant 65a is blocked by the limiting mechanism, wherein the catheter body, the balloon body, and the limiting mechanism can be combined with the limiting mechanisms of the above embodiments.

[1002] The balloon body 642 has two relative states: a folded state and an inflated state. During interventional delivery of the artificial implant, the balloon body is in the folded state. The operator injects fluid, i.e., an inflation medium (e.g., saline), into the balloon body 642, causing the balloon body 642 to expand and release the artificial implant 65a. During the release process, i.e., the inflation process, the radial gap between the catheter body 6411 and the inner shaft 643 forms a fluid channel connected to the interior of the balloon body. A guide channel for fluid flow is provided between the guide tube 625 and the inner shaft 643. The guide tube 625 can divert the fluid in the channel and simultaneously inflate the first and second portions of the balloon body through the guide channel. Upon completion of the artificial implant release, the balloon body is in the inflated state. During delivery, a stopper body is used to fill the first portion of the balloon body 642. The side of the stopper body facing the first end blocks the distal end of the artificial implant 5a, effectively positioning the artificial implant during inflation. The side of the retaining body facing the second end provides a guiding angle for the distal end of the balloon body, facilitating smoother delivery of the implant within the body. To achieve adequate guidance, the radial dimension of the retaining body should be larger than the radial dimension of the implant gripping the balloon body, but not too large to prevent assembly problems. Preferably, the radial dimension of the retaining body is 7.5 mm to 9.5 mm.

[1003] During the delivery process, a stopper 67 can be provided on the proximal exterior of the balloon body to further limit the proximal end of the artificial implant, or a conventional locking wire structure in the art can be used to further limit the proximal end of the artificial implant.

[1004] The transcatheter implant system in each of the above embodiments further includes a control handle 63 and an outer sheath 644, wherein the proximal end of the control handle has an interface 631 (as shown in FIG. 127 ) communicating with the catheter body for injecting fluid.

[1005] The outer sheath 644 slides over the periphery of the balloon device, with its proximal end connected to a control handle. The outer sheath and balloon body are configured to move relative to each other, allowing the outer sheath to enclose or expose the implant. During the interventional delivery of the implant, the outer sheath 644 is sheathed over the outer layer of the balloon device and the implant to provide protection. After the implant is delivered to the preset position, the outer sheath 644 can be released by operating the control handle.

[1006] During implantation, the limiting body includes a loaded state, an intermediate state, and an expanded state. In the loaded state, the limiting body is located inside the balloon body and the outer sheath, and is subjected to radial forces from both the balloon body and the outer sheath. The outer sheath herein can be an outer sheath 644 (i.e., a catheter sheath), or can be distinguished from other devices of the delivery system, such as a catheter sheath or an outer sheath of a sheath protector.

[1007] In the intermediate state, the limiting body is free from the radial restraint of the outer sheath and is only subjected to the radial force of the balloon body. At this time, the limiting body is appropriately expanded, which is equivalent to the loaded state, but is not fully expanded due to the radial force of the balloon body.

[1008] When the delivery system and the artificial implant reach the appropriate position in the body, the fluid can be injected into the balloon to fill it. When the balloon is filled to the point where it no longer exerts radial force on the limiting body, the limiting body enters the expanded state and is fully expanded.

[1009] Some embodiments of the present application improve the structure of the artificial heart valve to enhance the compatibility of the artificial heart valve and the interventional delivery system, and also to enhance the control effect.

[1010] 118 to 127 , some embodiments of the present application provide an artificial heart valve 65, which can be released by balloon expansion or self-expansion. The artificial heart valve specifically includes a first stent 651 and leaflets 652. The first stent is a radially deformable cylindrical structure. The interior of the first stent 651 is a blood flow channel. The leaflets 652 are multiple and cooperate with each other to control the blood flow channel. As shown in FIG118 , the fixed edge 6521 of each leaflet is sutured and fixed to the first stent, and the free edges 6522 of the multiple leaflets cooperate with each other to control the blood flow channel. The leaflets can be made of biological materials (such as porcine pericardium or bovine pericardium) or synthetic materials.

[1011] The first bracket can be in the shape of a hollow straight cylinder, and the side wall of the hollow straight cylinder can be formed into a frame bar 6511 by carving, and a plurality of grid structures 6512 are defined by the frame bar structure. The grid structure can be in the shape of a diamond, hexagon, fishbone, etc., and the intersection of adjacent frame bars is a grid node 65111.

[1012] The first stent has a corresponding axial direction (axial direction, such as the X direction in Figure 119), a radial direction perpendicular to the axial direction, and a circumferential direction arranged around the axis. The first stent has a radially opposite expansion state (as shown in Figure 119) and a compression state (as shown in Figure 120). During the radial compression process, the grid and frame bars also deform accordingly, and in the compressed state, the first stent can be loaded into the transcatheter implant system.

[1013] In the axial direction of the first stent, taking the artificial heart valve 65 as an aortic valve or pulmonary valve as an example, the normal blood flow direction in the body is represented by the inflow side 6513 and the outflow side 6514. The first stent has ends on both sides, and the ends can be understood as the locations of the outermost grid nodes 65111. For example, the projection point P of grid node 65111a in Figure 119 is the projection of the outflow end of the first stent. Similarly, the inflow end is the projection point Q of grid node 65111b.

[1014] The inflow side and / or outflow side of the first stent has a hole structure 653 protruding from the end. Taking the outflow side as an example, as shown in FIG120, in the compressed state, the highest point N of the projection of the hole structure 653a protrudes from the end (projection point P) by a distance of L1; as shown in FIG119, in the expanded state, the highest point M of the projection of the hole structure 653 protrudes from the end (projection point P) by a distance of L2, and L1>L2≥0. It can be understood that in the expanded state, the hole structure expands through the deformation of the frame bar, and the hole structure is basically flush with the grid nodes around it, so that the end of the first stent remains basically flush. In addition, the hole structure in this embodiment is not a closed hole. As shown in FIG119, the hole structure 653a is an arc-shaped structure as a whole, with an opening facing the inflow side. As the expansion form of the first stent changes to the compressed state (as shown in FIG120), the opening is also compressed. When the first bracket is compressed to a large extent, the two sides of the opening will also come into contact, resulting in a hole structure that is basically close to a closed circular structure, such as the hole structure 653 in Figure 120. In the compressed state shown in Figure 120, the hole structure 653 is significantly higher than the surrounding grid nodes.

[1015] In one embodiment, L1:L2 is approximately 1.2 to 1.6:1. Specifically, L1 may be 0.6 to 0.8 mm, preferably 0.7 mm; L2 may be 0.4 to 0.6 mm, preferably 0.5 mm.

[1016] Artificial heart valves are typically implanted using a delivery system. When a balloon-expandable interventional delivery system is used, the first stent is installed in a radially compressed state within the balloon body 642. The protruding eyelet structure facilitates the connection and control of the delivery system's locking wire structure, facilitating the insertion of the locking wire structure through the eyelet structure and assisting in axially positioning the artificial heart valve within the delivery system. Furthermore, as the first stent deforms and expands, the eyelet structure also expands and deforms, becoming substantially flush with the end of the first stent, thereby avoiding the risk of puncturing a blood vessel due to the protruding eyelet structure after implantation of the artificial heart valve.

[1017] The artificial heart valve of this embodiment can be an artificial pulmonary valve. Preferably, it is released by balloon expansion. In the compressed state, the hole structure 653a is more prominent, which is convenient for axial positioning with the balloon body. In the expanded state, the protrusion tendency is reduced, thereby reducing the risk.

[1018] In some embodiments, the first bracket has a grid structure surrounded by frame bars, and the hole structure is formed by winding the frame bars at the end. For example, in Figure 121, the grid structure 6512c is surrounded by frame bars 6511a, 6511b, 6511c, 6511d, 6511e, and 6511f at the end, and the hole structure 653a is formed by winding the frame bars 6511a and 6511b. Preferably, the frame bars can be bent and wound into an arc shape to limit the edge of the hole structure 653a.

[1019] Both ends of the first bracket have a hole structure in the axial direction, that is, a hole structure 653a is provided on the outflow side and a hole structure 653b is provided on the inflow side as shown in Figure 119, and the circumferential positions of the hole structures at both ends can be the same (that is, the hole structures 653a and the hole structures 653b are arranged facing each other as shown in Figure 119); or the hole structures at both ends are staggered.

[1020] In some embodiments, the first bracket 651 is a straight cylinder and includes multiple rings of mesh structures along the axial direction. The mesh structure is roughly diamond-shaped or diamond-like in shape. As shown in FIG122 , the mesh with the hole structure 653 is the first mesh 654, and the mesh circumferentially adjacent to the first mesh is the second mesh 655. In the first mesh 654, the frame strips around the hole structure include:

[1021] Arc segment 65112, defining the edge of the eyelet structure;

[1022] The connecting segment 65113 extends from two ends of the arc segment 65112 in opposite directions to the grid nodes on both sides of the circumference of the first grid 654 (such as the grid node 65111b and the grid node 65111c in the figure).

[1023] As shown in Figure 123, the angle between connecting segments 65113a and 65113b on either side of the arc segment is A1. The internal angle of mesh node 65111a at the axial end of the second mesh is A2. In the expanded state, A1 is greater than A2 to accommodate a greater axial convergence at the end of the perforated structure, which facilitates further axial bulging of the perforated structure in the compressed state. The central angle C of the arc segment itself is between 150 and 210 degrees.

[1024] 124 , the span of the arc segment 65112 in the circumferential direction of the first bracket is L1, and the span of the first grid in the circumferential direction is L2. L1 occupies 1 / 4 to 1 / 2 of L2, for example, about 1 / 3.

[1025] In some embodiments, in the first grid 654, the strength of the frame strips around the hole structure is less than the strength of the frame strips in other parts of the first grid, making the hole structure easier to deform. Specifically, for example, in the first grid 654 of Figure 123, the strength of the connecting segments 65113c and 65113d is greater than the strength of the connecting segments 65113a and 65113b. Reducing the strength of the frame strips can be achieved by reducing the amount of metal and thickness, etc., so that the angle A1 formed after the expansion of the connecting segments 65113a and 65113b is larger, that is, the hole structure is easier to deform.

[1026] The grid in the first stent is arranged in multiple circles, for example, 3 to 6 circles. For example, the grid shown in Figure 122 has five circles. Axially adjacent circles are circumferentially staggered and share some frame bars. In the expanded state of the first stent, the internal angle of each grid node is 75 to 105 degrees, with 90 degrees, for example, essentially forming a square.

[1027] 125 , the present application also provides an artificial heart valve, including a first stent 651 , leaflets 652 , a skirt 657 , and a sealing member 659 to enhance the anti-leakage effect, wherein the first stent 651 and leaflets 652 can be combined with other embodiments.

[1028] The skirt 657 is connected to and surrounds the inner wall of the first stent, and one axial side of the skirt is connected to the leaflet 652. The skirt can be sutured or bonded to the stent and the leaflet, thereby closing the blood flow channel.

[1029] The blocking member 659 is fixed to the radial outer side of the skirt 657 and protrudes from the radial inner side of the first stent through the corresponding grid to the radial outer side of the first stent. The blocking member is made of foam material and plays an adaptive blocking role to reduce paravalvular leakage.

[1030] In one embodiment, the skirt and the blocking piece are integrally formed or bonded together. For example, the skirt may be made of PET material, and the blocking piece may be made of PU foam material. For another example, both the skirt and the blocking piece may be made of PU material.

[1031] On the one hand, the PU skirt has the advantages of high elongation and thin thickness, and can prevent the risk of the above-mentioned skirt tearing. Based on the advantage of high elongation, the PU skirt can adapt to grids of various shapes and areas, such as diamond grids with smaller area and smaller deformation, and fishbone grids with larger area and larger deformation.

[1032] On the other hand, due to the compressibility and self-expandability of the PU occluding device, when it is subjected to uneven external forces on all sides, it can automatically adjust the foam height and thickness, fit tightly to the valve ring, and achieve the function of preventing paravalvular leakage. At the same time, the PU occluding device will not increase the size of the delivery system too much.

[1033] When the occluding part and the skirt are made of the same material PU (the molecular weight or hardness ratio is not required to be strictly the same when processed separately), the occluding part and the skirt are bonded or processed as one piece, which can obtain a greater peel strength. Therefore, when the occluding part is exposed, it is not easy to fall off even if it contacts and rubs against the catheter component of the interventional delivery system or the tissue in the body, thus avoiding safety risks.

[1034] As shown in FIG125 , the blocking member 659 may be in the form of a plurality of blocking blocks arranged along the circumference of the first bracket, and each blocking block is made of foam material and embedded in a grid structure corresponding to a position.

[1035] In another embodiment, the skirt may also be made of a biological pericardial material, such as porcine pericardium or bovine pericardium. To facilitate the installation of multiple occluding blocks, the occluding member 659 further includes an inner lining membrane 658. The inner lining membrane and the occluding blocks may be made of the same material to facilitate bonding or integral processing of the two. As shown in FIG126 , the occluding blocks and the inner lining membrane are integrally formed. When the artificial heart valve is in use, the inner lining membrane 658 is located on the inner side of the first stent. The inner lining membrane and the skirt are sutured and spliced. Each occluding block is fixed to the inner lining membrane and embedded in the corresponding grid structure and protrudes outward. The thickness of the inner lining membrane can be set to be very thin so as not to have a significant impact on the diameter of the artificial implant after compression.

[1036] In some embodiments, the transcatheter implant system can utilize a locking wire structure 68 connected to the balloon device to interpenetrate with the eyelet structure and restrict axial movement of the prosthetic heart valve, thereby limiting the proximal and distal ends of the first stent. The locking wire structure 68 can be configured as an adjustment wire and a locking wire, with the function of locking the first stent and releasing it to an unlocked state. This will be described in detail later.

[1037] The present application also provides an embodiment of a transcatheter implant system. For example, FIG. 127 shows a transcatheter implant system 61 comprising an artificial heart valve 65 and an interventional delivery system for delivering and expanding the artificial heart valve. The interventional delivery system comprises a control handle 63 and a catheter assembly 64 connected to the control handle 63 in a controlled manner. The artificial heart valve 65 is loaded on the catheter assembly 64. The catheter assembly includes a plurality of control components, the distal ends of which cooperate with each other to operate the artificial heart valve, such as releasing, retrieving, locking position, adjusting bend, adjusting spatial posture, etc. Each control component itself can be a hollow tube, a solid rod, a flexible wire, or a combination of these. There are multiple control components, and at least two of them (for example, the proximal end) can slide relative to each other along the axial direction or rotate relative to each other about the axial direction. The force-applying component on the control handle (the part that the user directly contacts) used to operate each control component can be directly fixedly transmitted to the corresponding control component, or can be transmitted by means of threads, gear racks, etc. The artificial heart valve may be an artificial aortic valve, an artificial pulmonary valve, an artificial mitral valve, an artificial tricuspid valve, etc., and has a loaded state (ie, a compressed state) and an expanded state loaded on the catheter assembly 64 .

[1038] The transcatheter implant system 61 as a whole has relative proximal and distal ends 6101 and 6102. When used to indicate direction, the proximal end generally refers to the side adjacent to the operator (e.g., a doctor), and the distal end refers to the side relatively far away. Along the interventional pathway, each component has relative distal and proximal ends. In theory, when the catheter assembly and the control handle are fully straightened, the straight line between the proximal and distal ends determines the axial direction, and correspondingly, the radial direction perpendicular to the axial direction and the circumferential direction arranged around the axial direction are also determined. When used to refer to a structure, the "end" in the text refers to the endpoint of the structure or a point or area in the lateral direction or a specific structure connected to the point or area. The axial direction mentioned in the embodiments above and below, unless otherwise specified, refers to the theoretical direction when the catheter assembly and the control handle are fully straightened, the straight line between the proximal and distal ends determines the axial direction, and correspondingly, the radial direction perpendicular to the axial direction and the circumferential direction arranged around the axial direction are also determined.

[1039] The catheter assembly 64 generally includes a balloon device 641 and, if desired, an outer sheath 644 that slidably fits over the balloon device. FIG127 shows the outer sheath 644 slid proximally, exposing the balloon device. The balloon device 641 primarily comprises a catheter body 6411 and a balloon body 642. The catheter body extends in the axial direction, and when the catheter body 6411 is straightened, it defines a radial direction perpendicular to the axial direction and a circumferential direction around the axial direction. The balloon body is connected to the catheter body and can receive fluid from the catheter body. It has a collapsed state and an inflated state under the action of the fluid. As shown in Figure 127, in the collapsed state, the balloon body is connected to the distal end of the catheter body, and the artificial heart valve 65 is pressed and gripped on the outside of the balloon body. As shown in Figure 128, the proximal end of the catheter body 6411 is provided with a fluid inlet 645. In the inflated state, fluid can enter the balloon body through this fluid inlet 645 and inflate the balloon body. Based on the changes in the balloon body, the artificial heart valve expands from a radially compressed state to a radially expanded state, allowing the artificial heart valve 65 to expand and release. In some cases, a fluid inlet may also be provided on the distal end or sidewall of the balloon body, which is not shown in the figure.

[1040] The transcatheter implant system may also include a limiting structure 62 and a locking wire structure 68 for limiting the movement of the artificial heart valve. For example, the locking wire structure is applied to the outside of the balloon device, and the limiting mechanism 62 can be applied to the inside or outside of the balloon device, both of which can limit the axial movement of the artificial heart valve 65. Some of the following embodiments improve the limiting structure and the locking wire structure.

[1041] Referring to Figures 129 to 131, the top side of the leaflet 7100 in the existing artificial heart valve 7200 is a free edge 7120, and the bottom side is a fixed edge 7130. The intersection of the free edge 7120 and the fixed edge 7130 is an ear piece 7140. During processing, the ear pieces 7140 of the two adjacent leaflets are first sutured with sutures, and then the whole is connected to the stent 7210. However, the tightened sutures during suturing will cause a certain deformation of the free edge, which may cause a loose closure in the vicinity of the stent, affecting the sealing effect of the blood flow channel. Referring to Figures 132 to 133, an embodiment of the present application provides a leaflet 7100 of an artificial heart valve, and an artificial heart valve using the leaflet. The artificial heart valves of each embodiment of the present application can be wet leaflets stored in a solution or dry leaflets that have been dried according to the processing process or storage conditions.

[1042] The leaflet 7100 comprises a body 7110 having opposite transverse and longitudinal directions when flattened. The outer edge of the body 7110 comprises a free edge 7120 and a fixed edge 7130 disposed on opposite longitudinal sides. The free edge 7120 controls blood flow within the artificial heart valve by deforming. A tab 7140 is disposed on opposite transverse sides of the body 7110. The free edge 7120 and the fixed edge 7130 intersect at the tab 7140 on the corresponding side. The portion where the tab 7140 meets the free edge 7120 is provided with an outer protrusion 7150 extending longitudinally relative to the free edge 7120. The transverse and longitudinal directions referred to in this application may be referred to in the X and Y directions in FIG132. Specifically, the X direction is the transverse direction and the Y direction is the longitudinal direction. The leaflet 7100 is generally symmetrical in structure. The following description and some of the accompanying drawings use one side as an example, with the other side being similarly described.

[1043] During suturing, the tabs 7140 of the two leaflets 7100 are folded and fitted together for suturing, and finally tightened and knotted to secure. The knot is specifically set on the protrusion 7150. When the suture is tightened and knotted, the protrusion 7150 deforms and absorbs stress, greatly reducing the impact on the free edge 7120. In other words, the tightening and knotting of the suture does not significantly interfere with the free edge 7120, thus solving the problem of poor blood flow channel closure caused by deformation of the free edge 7120 during suturing of the leaflet 7100. The protrusion 7150 also increases the area of ​​the connection suture site, providing additional strength.

[1044] In this embodiment, the outer protrusion 7150 intersects the extension line of the fixed edge 7130. The inner side of the extension line substantially defines the working area of ​​the leaflet 7100. This position of the outer protrusion 7150 allows for both connection strength and the size of the leaflet ...

Claims

1. An interventional delivery system, comprising a catheter assembly and a control handle connected to the catheter assembly, characterized in that: The catheter assembly has opposite distal and proximal ends and includes an inner sheath and an outer sheath that are slidably sleeved on each other. The outer sheath includes a loading section and a sheath section in sequence from the distal end to the proximal end. The loading section is used to wrap the interventional instrument and keep the interventional instrument in a compressed state. The control handle comprises: a main handle, to which the proximal end of the inner sheath is connected; A secondary handle is slidably sleeved on the outer periphery of the inner sheath tube, and the proximal end of the outer sheath tube is connected to the secondary handle.

2. The interventional delivery system according to claim 1, wherein: The secondary handle comprises: The housing has an axial direction and a distal end and a proximal end opposite to each other in the axial direction, and the housing has an axially penetrating through-channel; A connecting sleeve is fixed in the outer shell and arranged around the guide channel, and the distal end of the connecting sleeve is for the outer sheath to be plugged in and fitted with; a positioning member movably mounted in the housing, the positioning member having a locking position for interfering with the threading channel and an unlocking position for releasing the threading channel; The driving member cooperates with the positioning member to drive the positioning member to switch positions.

3. The interventional delivery system according to claim 1, wherein: The sliding stroke of the sub-handle relative to the main handle is 10 to 40 cm or more.

4. The interventional delivery system according to claim 2, wherein: The side wall of the connecting sleeve is provided with a first exhaust hole connected to the guide channel, a first pipe joint is fixedly connected to the first exhaust hole, the first exhaust hole and the first pipe joint define a first exhaust channel, and a one-way valve core is provided in the first exhaust channel.

5. The interventional delivery system according to claim 4, wherein: A first annular seat is provided at the edge of the first exhaust hole, and the first pipe joint is plug-fitted with the first annular seat, and a mutually cooperating anti-rotation structure is provided between them.

6. The interventional delivery system according to claim 4, wherein: Optionally, a first protective sleeve located at the outer periphery of the first pipe joint is embedded in the outer shell, and a pipe plugging gap is formed between the outer wall of the first pipe joint and the inner wall of the first protective sleeve.

7. The interventional delivery system according to claim 5, wherein: Optionally, the anti-rotation structure includes: a slot extending along an insertion direction of the first pipe joint, the slot being provided on a side wall of one of the first pipe joint and the first annular seat; A positioning rib cooperates with the slot, and the positioning rib is arranged on the side wall of the other of the first pipe joint and the first annular seat.

8. The interventional delivery system according to claim 4, wherein: The one-way valve core has a relatively sealed state and an open state, and the one-way valve core specifically includes: a limiting rod slidably mounted in the inner cavity of the first pipe joint, with a fluid gap between the outer periphery of the limiting rod and the inner wall of the first pipe joint; The sealing sheet is connected to the limiting rod. In a sealed state, the sealing sheet closes the fluid gap. In an open state, the sealing sheet opens the fluid gap.

9. The interventional delivery system according to claim 8, wherein: The inner wall of the first pipe joint is provided with a clamping ring surrounding the outer periphery of the limiting rod, and the fluid gap is located between the outer periphery of the clamping ring and the inner wall of the first pipe joint; The end of the limiting rod away from the sealing plate passes through the retaining ring and has a head. In the open state, the head is against the retaining ring, the sealing plate is away from the retaining ring and the fluid gap is opened; in the sealed state, the head is away from the retaining ring, the sealing plate is away from the retaining ring and the retaining ring is closed.

10. The interventional delivery system according to claim 8, wherein: The inner wall of the first pipe joint is provided with a clamping ring surrounding the outer periphery of the limiting rod, and the fluid gap is located between the outer periphery of the clamping ring and the inner wall of the first pipe joint; The end of the limiting rod away from the sealing plate passes through the clamping ring and has a head restricted by the clamping ring. The head and the sealing plate clamping portion are fixed on two opposite sides of the clamping ring. The edge of the sealing plate can be elastically deformed to open or close the fluid gap accordingly.

11. The interventional delivery system according to claim 2, wherein: The positioning member is an elastic claw, one end of which is fixed to the connecting sleeve, and the other end of which is a free end that swings along the radial direction of the connecting sleeve.

12. The interventional delivery system according to claim 11, wherein: The elastic claws and the connecting sleeve are an integral structure; there are two to six elastic claws distributed along the circumference of the connecting sleeve.

13. The interventional delivery system according to claim 11, wherein: The driving member is cylindrical and is slidably sleeved on the outer periphery of the connecting sleeve; along the radial direction of the connecting sleeve, a guide ramp is provided on the outer side of the elastic claw, and the inner wall of the driving member acts on the guide ramp.

14. The interventional delivery system according to claim 11, wherein: An elastic liner is provided inside the connecting sleeve, and the elastic claws act on the outer wall of the elastic liner and interfere with the guide channel by squeezing the elastic liner.

15. The interventional delivery system according to claim 14, wherein: The distal end of the elastic liner extends out of the connecting sleeve, and a radially outwardly protruding positioning step is provided on the extended portion. Along the axial direction, the positioning step is axially positioned and matched with the end face of the connecting sleeve and / or the inner wall of the outer shell.

16. The interventional delivery system according to claim 2, wherein: The driving member is cylindrical and is slidably sleeved on the outer periphery of the connecting sleeve. A mutually cooperating guide structure is provided between the inner wall of the driving member and the outer wall of the connecting sleeve; the guide structure includes: a slide groove provided on one of the inner wall of the driving member and the outer wall of the connecting sleeve; The guide rib cooperates with the slide groove and is provided on the other of the inner wall of the driving member and the outer wall of the connecting sleeve.

17. The interventional delivery system according to claim 1, wherein: The catheter assembly further comprises a balloon catheter, which comprises: The balloon body is arranged at the distal end of the inner sheath tube and switches between an expanded state and a folded state under the action of a fluid, and the interventional instrument in the loaded state is located on the periphery of the balloon body; The catheter body is sleeved on the outer periphery of the inner sheath or arranged in parallel with the inner sheath. The distal end of the catheter body is communicated with the balloon body, the proximal end of the catheter body is connected to the main handle, and the catheter body contains a fluid channel.

18. The interventional delivery system according to claim 17, wherein: A fluid guide is provided in the balloon body and is located on the outer periphery of the inner sheath. The fluid guide defines a flow guiding channel that connects the distal end and the proximal end of the balloon body.

19. The interventional delivery system according to claim 18, wherein: The fluid guide is tubular, and the position of the fluid guide channel relative to the fluid guide is at least one of the following: Located on the outer wall of the fluid guide; being located inside the fluid guide; Located in the side wall interlayer or hollow area of ​​the fluid guide.

20. The interventional delivery system according to claim 19, wherein: The guide channel is a guide groove opened on the outer peripheral wall of the fluid guide; there are multiple guide grooves, which are arranged along the circumference of the fluid guide, and the same guide groove extends along the axial direction of the fluid guide or is spirally wound.

21. The interventional delivery system according to claim 20, wherein: Along the circumference of the fluid guide, the wrap angle of the same guide groove is 0 to 180 degrees.

22. The interventional delivery system according to claim 20, wherein: A connecting groove is provided between two adjacent guide grooves; a plurality of connecting grooves are arranged at intervals, and the connecting grooves corresponding to the axial positions form an annular groove.

23. The interventional delivery system according to claim 19, wherein: A fluid guide is provided on the outer periphery of the inner sheath tube. The fluid guide is tubular and located in the balloon body. The tube wall of the fluid guide has a hollow area, which extends continuously or intermittently from the distal end of the fluid guide to the proximal side of the fluid guide.

24. The interventional delivery system according to claim 19, wherein: There is a radial gap between the fluid guide and the inner sheath tube, which serves as the flow guide channel.

25. The interventional delivery system according to claim 17, wherein: The catheter assembly also includes a bending adjustment tube and a traction member that drives the bending adjustment tube. The bending adjustment tube is sleeved on the outer circumference of the inner sheath tube. The distal ends of the bending adjustment tube and the traction member are fixedly connected, and the proximal ends of both are connected to the main handle and slide relatively together. The bending adjustment tube and the traction member are both located on the outer circumference of the catheter body.

26. The interventional delivery system according to claim 25, wherein: The traction member is a traction tube and is located on the inner side or the outer side of the bending adjustment tube.

27. The interventional delivery system according to claim 25, wherein: The traction member is a traction wire and is located on the inner side, outer side or inside the wall of the bending adjustment pipe.

28. The interventional delivery system according to claim 26, wherein: The wall of the bending pipe has a sandwich structure, a liner is fixed in the sandwich, and the traction member is movably arranged in the liner.

29. The interventional delivery system according to claim 17, wherein: The main handle comprises: The support body has a spatial axial direction, and the inner sheath and the catheter body of the balloon catheter are both extended and connected to the proximal side of the support body; A second sliding seat is axially slidably engaged with the support body; A second drive sleeve is rotatably mounted on the support body and is located on the outer periphery of the second slide, and the second drive sleeve and the second slide are engaged with each other by a threaded transmission; A multi-way connector is connected to the proximal side of the second slide, the proximal ends of both the balloon catheter and the inner sheath are connected to the multi-way connector, the interior of the inner sheath is a through guidewire channel, and the multi-way connector has at least an interface that is respectively connected to the guidewire channel and the fluid channel.

30. The interventional delivery system according to claim 29, wherein: The multi-way connector is rotationally matched with the proximal end side of the second slide and is axially limited.

31. The interventional delivery system according to claim 29, wherein: The second slide is a cylindrical structure as a whole, and at least a part of it is located in the second drive sleeve. The outer wall of the second slide is threadedly engaged with the inner wall of the second drive sleeve, and the support body is provided with a guide groove for guiding the second slide to move axially.

32. The interventional delivery system according to claim 29, wherein: The distal end of the multi-way connector and the proximal end of the second slide are rotatably plugged into each other, and a mutually matching axial limiting structure is provided between the two. The axial limiting structure includes: a latching tooth, fixed to one of the two and protruding radially toward the other; The latching slot is arranged on the other one of the two and receives the latching teeth.

33. The interventional delivery system according to claim 1, wherein: The catheter assembly also includes a bending adjustment tube and a traction member that drives the bending adjustment tube. The bending adjustment tube is sleeved on the outer circumference of the inner sheath tube. The distal ends of the bending adjustment tube and the traction member are fixedly connected, and the proximal ends of both are connected to the main handle and slide relative to each other.

34. The interventional delivery system according to claim 33, wherein: The main handle comprises: The support body has a spatial axial direction, the proximal end of the bending adjustment tube is fixedly connected to the support body, and the inner sheath tube is extended and connected to the proximal end side of the support body; a first sliding seat, slidably engaged with the support body in the axial direction, and the proximal end of the pulling member is fixed to the first sliding seat; A first drive sleeve is rotatably mounted on the support body and is located on the outer periphery of the first slide, wherein the first drive sleeve and the first slide are engaged with each other by a threaded transmission; A housing fixedly sleeved on the support body, at least a portion of which is an indicator section located outside the bending drive sleeve; The identification member is axially slidably mounted on the indicating section and is located on the outer periphery of the first driving sleeve. The first driving sleeve and the identification member are matched with each other through threaded transmission.

35. The interventional delivery system according to claim 34, wherein: The first drive sleeve has an internal thread and an external thread, the first slide has external teeth that match the internal thread, and the identification piece has internal teeth that match the external thread; the identification piece and the first slide move synchronously under the action of the first drive sleeve.

36. The interventional delivery system according to claim 34, wherein: A window corresponding to the position of the identification piece is provided on the side wall of the indication section.

37. The interventional delivery system according to claim 34, wherein: An axially extending mounting groove is provided in the support body, a guide cylinder is fixed in the mounting groove, the first slide is slidably sleeved on the guide cylinder, and a guide structure that cooperates with the outer wall of the guide cylinder to guide the axial movement is provided; the proximal end of the bending adjustment tube is inserted into and fixed on the guide cylinder.

38. The interventional delivery system according to claim 33, wherein: When the auxiliary handle slides toward the proximal end to the extreme position, the distal end of the bending adjustment tube is exposed to the outer sheath tube, and the exposed length is 0 to 20 cm.

39. The interventional delivery system according to claim 37, wherein: A second exhaust hole is provided on the side wall of the guide cylinder, and the radial gap between the bend adjusting tube and the catheter body is connected to the second exhaust hole. The proximal end of the catheter body passes through the proximal end of the bend adjusting tube and further extends through the guide cylinder. A second pipe joint is fixedly connected to the second exhaust hole. The second exhaust hole and the second pipe joint define a second exhaust channel. A one-way valve core is provided in the second exhaust channel.

40. The interventional delivery system according to claim 39, wherein: The one-way valve core has a relatively sealed state and an open state, and the one-way valve core specifically includes: a limiting rod slidably mounted in the inner cavity of the second pipe joint, with a fluid gap between the outer periphery of the limiting rod and the inner wall of the second pipe joint; The sealing sheet is connected to the limiting rod. In a sealed state, the sealing sheet closes the fluid gap. In an open state, the sealing sheet opens the fluid gap.

41. The interventional delivery system according to claim 40, wherein: A second annular seat is provided at the edge of the second exhaust hole, and the second pipe joint is plug-fitted to the second annular seat, and a mutually cooperating anti-rotation structure is provided between them.

42. The interventional delivery system according to claim 41, wherein: A second protective sleeve is provided on the outer periphery of the second pipe joint, and a pipe plugging gap is formed between the outer wall of the second pipe joint and the inner wall of the second protective sleeve.

43. The interventional delivery system according to claim 41, wherein: The anti-rotation structure includes: a slot extending along an insertion direction of the second pipe joint, the slot being provided on a side wall of one of the second pipe joint and the second annular seat; A positioning rib cooperates with the slot, and the positioning rib is arranged on the side wall of the other of the second pipe joint and the second annular seat.

44. The interventional delivery system according to claim 40, wherein: The inner wall of the second pipe joint is provided with a clamping ring surrounding the outer periphery of the limiting rod, and the fluid gap is located between the outer periphery of the clamping ring and the inner wall of the second pipe joint.

45. The interventional delivery system according to claim 44, wherein: The end of the limiting rod away from the sealing plate passes through the clamping ring and has a head restricted by the clamping ring. The head and the sealing plate clamping portion are fixed on two opposite sides of the clamping ring. The edge of the sealing plate can be elastically deformed to open or close the fluid gap accordingly.

46. ​​The interventional delivery system according to claim 1, wherein: The interventional delivery system is used to deliver an artificial implant, which includes a stent and a valve leaflet. The stent has a cell structure, and the two ends of the stent are respectively an inflow side and an outflow side, and the interior of the stent is a blood flow channel; The leaflets are multiple, and each leaflet cooperates with each other in the blood flow channel to relatively open or close the blood flow channel. The edge of the leaflet includes a fixed edge fixed to the bracket and a free edge that cooperates with other leaflets to control the blood flow channel; The bracket is connected to an anti-leakage component, which is an integrated structure including a base located inside the bracket and an anti-leakage component fixed to the outside of the base. The anti-leakage component is a plurality of spaced blocks and its position corresponds to the hollow area of ​​the bracket cells.

47. The interventional delivery system according to claim 46, wherein: The substrate is made of PET.

48. The interventional delivery system according to claim 47, wherein: The anti-leakage component is made of PU material.

49. The interventional delivery system according to claim 46, wherein: According to the different axial positions of the cells, the anti-circular leakage components include at least one of a second circle of anti-circular leakage components and a third circle of anti-circular leakage components, and a first circle of anti-circular leakage components, wherein the first circle of anti-circular leakage components covers the entire cell; The second circle of anti-circumferential leakage components and the third circle of anti-circumferential leakage components are distributed in a local area of ​​the entire unit cell.

50. The interventional delivery system according to claim 49, wherein: The second ring of the peripheral leakage prevention component is adjacent to the inflow side of the first ring of the peripheral leakage prevention component.

51. The interventional delivery system according to claim 49, wherein: The third circle of anti-circumferential leakage components is adjacent to the outflow side of the first circle of anti-circumferential leakage components.

52. The interventional delivery system according to claim 49, wherein: The axial lengths of the second circle of anti-circumferential leakage components and the third circle of anti-circumferential leakage components only occupy half a unit cell, and are adjacent to the first circle of anti-circumferential leakage components.

53. The interventional delivery system according to claim 49, wherein: In the same anti-leakage component, the thickness gradually increases from the outflow side to the inflow side, and then gradually becomes thinner after reaching the highest convex part.

54. The interventional delivery system according to claim 53, wherein: In the same anti-leakage component, the part with the highest convexity is closer to the inflow side of the cell.

55. The interventional delivery system according to claim 54, wherein: In the same anti-leakage component, the distance between the maximum convex height and the inflow side of the cell is S1, and the distance between the maximum convex height and the inflow and outflow sides of the cell is S2, where S1:S2 is 0.2~0.

8.

56. The interventional delivery system according to claim 1, wherein: The diameter of the loading section is larger than the diameter of the sheath section.

57. The interventional delivery system according to claim 1, wherein: The distal end of the inner sheath tube is provided with a guide head, the outer periphery of the guide head is provided with an annular step, and the distal end surface of the loading section is abutted against the annular step for limiting position.

58. An interventional delivery device based on balloon expansion release, characterized in that: A balloon catheter having opposite distal and proximal ends and including an inner shaft and a periphery of the inner shaft, the balloon catheter including a balloon body and a catheter body connected to the proximal end of the balloon body, the balloon body including a first portion, a middle portion, and a second portion in sequence from the distal end to the proximal end, the middle portion being used for loading and fixing an artificial implant; A drainage tube is provided in the radial gap between the inner shaft and the balloon body, the distal end of the drainage tube is fixed to the distal end of the inner shaft, and the remaining portion of the drainage tube is suspended between the inner shaft and the balloon catheter; Among the fluid outputted from the conductor to the balloon body, at least a portion of the fluid passes through the drainage tube, passes through the second portion and the middle portion, and then enters and inflates the first portion.

59. The interventional delivery device according to claim 58, wherein: The radial gap between the inner shaft and the catheter body serves as a main flow channel, and the main flow channel is an integrated flow channel.

60. The interventional delivery device according to claim 58, wherein: Of the fluid output from the main channel to the balloon body, a portion enters and inflates the second portion, and another portion enters the drainage tube, passes through the second portion and the middle portion, and then enters and inflates the first portion.

61. An interventional delivery device based on balloon expansion release, characterized in that: A balloon catheter having opposite distal and proximal ends and including an inner shaft and a periphery of the inner shaft, the balloon catheter including a balloon body and a catheter body connected to the proximal end of the balloon body, the balloon body including a first portion, a middle portion, and a second portion from the distal end to the proximal end, the middle portion being used for loading and fixing an artificial implant, and the catheter body having a main flow channel; A drainage tube is provided in the radial gap between the inner shaft and the balloon body. At least a portion of the fluid output from the main channel to the balloon body passes through the second part and the middle part through the drainage tube and enters and inflates the first part.

62. The interventional delivery device according to claim 61, wherein: The proximal end of the drainage tube has an open port and serves as a fluid inlet.

63. The interventional delivery device according to claim 62, wherein: The axial position of the fluid inlet is adjacent to the junction of the balloon body and the catheter body.

64. The interventional delivery device according to claim 62, wherein: The balloon body is inflated after being perfused with fluid, and in the inflated state, the fluid inlet is located at a position where the cross-sectional area of ​​the flow channel of the second portion relative to the catheter body suddenly changes.

65. The interventional delivery device according to claim 61, wherein: In the loaded state, the artificial implant is radially compressed and wrapped around the outer periphery of the middle portion, and the first portion and the second portion are exposed at both ends of the artificial implant; the proximal end of the drainage tube has a fluid inlet, and the fluid inlet is located in the second portion.

66. The interventional delivery device according to claim 61, wherein: At the proximal end of the drainage tube, a first gap with a radial span of L1 is provided between the inner shaft and the drainage tube, and a second gap with a radial span of L2 is provided between the inner shaft and the catheter body; and L1:L2=1:1.25-1.6 is satisfied.

67. The interventional delivery device according to claim 61, wherein: The drainage tube includes a distal section, a middle section and a proximal section from the distal end to the proximal end, and corresponds to the various parts of the balloon body respectively. The distal section of the drainage tube has a first fluid outlet connected to the first part, and the first fluid outlet is located on the tube wall of the distal section and / or the end face of the distal section.

68. The interventional delivery device according to claim 67, wherein: The tube wall of the distal end section is provided with a plurality of first fluid outlets.

69. The interventional delivery device according to claim 68, wherein: The plurality of first fluid outlets are distributed along the circumference of the drainage tube.

70. The interventional delivery device according to claim 68, wherein: Along the length direction of the drainage tube, the plurality of first fluid output ports are located in the middle portion of the distal end section.

71. The interventional delivery device according to claim 61, wherein: The proximal end of the drainage tube and the distal end of the catheter body are connected to each other as a whole, and a second fluid outlet connected to the second part is opened on the tube wall of the proximal end section.

72. The interventional delivery device according to claim 61, wherein: The proximal end of the drainage tube is provided with a gradually converging beveled section, and at least a portion of the beveled section extends into the distal end of the catheter body.

73. The interventional delivery device according to claim 72, wherein: The beveled section has one or two beveled surfaces.

74. The interventional delivery device system according to claim 73, wherein: The inner cavity of the drainage tube is open to the oblique cut surface and is communicated with the inner cavity of the catheter body and the inner cavity of the second portion at the same time.

75. The interventional delivery device according to claim 61, wherein: An isolating piece is provided between the inner shaft and the drainage tube in a radial direction to maintain a radial gap between them.

76. The interventional delivery device according to claim 75, wherein: The isolating member is a rib located on the inner wall of the drainage tube.

77. The interventional delivery device according to claim 75, wherein: The isolating member is a hollow structural member fixed between the inner shaft and the drainage tube in a radial direction.

78. The interventional delivery device according to claim 61, wherein: A guide head is fixed to the distal end of the inner shaft, and the distal end of the drainage tube is fixed to the proximal end of the guide head.

79. The interventional delivery system according to claim 78, wherein: The distal end of the drainage tube is closed by the guide head.

80. The interventional delivery device according to claim 78, wherein: The proximal end side of the guide head is provided with a positioning structure adapted to the distal end of the drainage tube. The positioning structure is a coupling groove for inserting the drainage tube, or a coupling column for inserting the drainage tube.

81. A method for driving a balloon catheter using fluid, characterized in that: The balloon catheter has a distal end and a proximal end opposite to each other and includes a balloon body and a catheter body. The distal end of the catheter body is connected to the proximal end of the balloon body. The balloon body includes a first portion, a middle portion, and a second portion from the distal end to the proximal end. The middle portion is used for loading and fixing an artificial implant. The catheter body has a main flow channel. The method includes: injecting fluid into the main channel from the proximal end of the catheter body; Dividing the fluid output from the main channel to the balloon body, allowing only a portion of the fluid to enter and inflate the second part; Another portion of the fluid is drained, passes through the second portion and the middle portion, and then enters and fills the first portion.

82. The method of claim 81, wherein All the fluid used to inflate the balloon comes from the main channel before being diverted.

83. The method of claim 81, wherein The diversion method is: The fluid is divided into two paths at the junction of the catheter body and the second part, one of which enters and inflates the second part, and the other enters and inflates the first part after passing through the second part and the middle part through an independent flow channel.

84. The method of claim 83, wherein The fluid enters the independent flow channel from the main flow channel, and the independent flow channel is connected to a branch flow channel. When a part of the fluid flows through the second part, it enters and fills the second part through the branch flow channel, and the other part passes through the independent flow channel, crosses the second part and the middle part, and then enters and fills the first part.

85. The method of claim 81, wherein The method further comprises: The fluid is controlled so that the first and second parts are inflated before the middle part, and the balloon body enters a transitional state in which both ends are inflated and the middle part is relatively contracted; the fluid is continuously injected into the catheter body until the balloon body is fully inflated and the artificial implant is radially expanded.

86. The method of claim 81, wherein The fluid is divided into two paths, each path including one or more streams.

87. The method of claim 86, wherein Radiating distribution between the branches of the same route.

88. The method of claim 81, wherein The artificial implant is a cylindrical structure, and the fluid entering the independent flow channel passes through the interior of the cylindrical structure and over the middle portion.

89. The method of claim 81, wherein The balloon body has an axial direction extending between the distal end and the proximal end and corresponding radial and circumferential directions, and the method of inflating the first part includes: outputting the liquid along the radial direction of the balloon body through the independent flow channel and inflating the first portion; And / or output along the axial direction of the balloon body through the independent flow channel and inflate the first part.

90. A limiting mechanism for an interventional delivery system, characterized in that: include: A coupling portion, configured to connect to an interventional delivery system, wherein the coupling portion has an axial direction and corresponding circumferential and radial directions; The deformation portion includes a plurality of slender rods arranged in sequence along the circumferential direction, each rod having: a first end connected to the coupling portion; The second end is located on one side of the axial direction of the coupling part relative to the first end. Based on elastic deformation, each rod has a compressed state suitable for interventional delivery and a relative expanded state. In the expanded state, the second end of each rod diverges outward in the radial direction of the coupling part relative to the compressed state.

91. The limiting mechanism as claimed in claim 90, characterized in that: The coupling portion is in a straight cylindrical shape, the rods are distributed in a radial shape, and the convergence position of the first ends of the rods is one axial end of the coupling portion.

92. The limiting mechanism as claimed in claim 91, characterized in that: The coupling portion is in the shape of a radially deformable ring.

93. The limiting mechanism as claimed in claim 92, characterized in that: The coupling portion is an axially undulating wave structure having relative wave crests and wave troughs, and the first end of each rod is connected to the corresponding wave crest.

94. The limiting mechanism as claimed in claim 90, characterized in that: The coupling portion and the deformation portion are an integrated structure.

95. The limiting mechanism as claimed in claim 94, characterized in that: The coupling portion and the deformation portion are cut integrally from a pipe.

96. The limiting mechanism as claimed in claim 90, characterized in that: The second ends of the rods move independently.

97. The limiting mechanism as claimed in claim 90, characterized in that: The rod has a tendency to extend spirally around the axis of the coupling portion.

98. The limiting mechanism as claimed in claim 90, characterized in that: The number of the rods is 4 to 10.

99. The limiting mechanism as claimed in claim 90, characterized in that: The second end of the rod has a smooth outer contour and / or is covered with a protective layer.

100. The limiting mechanism as claimed in claim 90, characterized in that: The portion of the rod member close to the second end has a radially inward bending tendency.

101. The limiting mechanism as claimed in claim 90, characterized in that: The portion of the rod member close to the second end has lower radial stiffness than the remaining portion of the rod member.

102. A limiting mechanism for an interventional delivery system, adapted to be installed in a balloon, characterized in that: The balloon body has a relatively folded state and an inflated state. In the folded state, the balloon body has a plurality of folds. The limiting mechanism includes: A coupling portion, configured to connect to an interventional delivery system, wherein the coupling portion has an axial direction and corresponding circumferential and radial directions; The deformation part includes a plurality of rods arranged in sequence along the circumferential direction. Each rod is configured to have a compressed state suitable for interventional delivery and a relatively expanded state based on elastic deformation. In the compressed state, each rod is placed in a corresponding fold.

103. The limiting mechanism according to claim 102, characterized in that: The balloon body is rolled in a first direction along the circumferential direction in a folded state, and the spiral direction of each rod is the same as the first direction.

104. The limiting mechanism according to claim 102, wherein: When the balloon body is in a folded state, the second end of at least one rod is not lower than the artificial implant in the radial direction.

105. A limiting mechanism for an interventional delivery system, characterized in that: include: A coupling portion, configured to connect to an interventional delivery system, wherein the coupling portion has an axial direction and corresponding circumferential and radial directions; The deformation part includes a plurality of rods arranged in sequence along the circumferential direction, each rod having: a first end connected to the coupling portion; The second end is located on one side of the axial direction of the coupling part relative to the first end, and each rod is configured to have a compressed state suitable for interventional delivery and a relative expanded state based on elastic deformation. In the expanded state, the second end of each rod diverges outward in the radial direction of the coupling part relative to the compressed state; the rod is made of memory alloy, and in the expanded state and compressed state, the distance between the second end of the rod and the axis of the coupling part is R1 and R2 respectively, and satisfies R1:R2=2~20:

1.

106. A balloon device for delivering an artificial implant, characterized in that It comprises an inner shaft and a balloon body located on the outer periphery of the inner shaft, wherein the inner shaft is equipped with a limiting mechanism located inside the balloon body and as described in any one of claims 90 to 105.

107. An interventional delivery system based on balloon expansion for delivering artificial implants, characterized in that: The interventional delivery system includes a balloon device and an outer sheath. The balloon device includes an inner shaft and a balloon body located on the outer periphery of the inner shaft. The distal end of the inner shaft is equipped with a plurality of rods arranged in sequence along the circumferential direction. Each rod is configured to have a compressed state suitable for interventional delivery and a relatively expanded state based on elastic deformation. Each rod has: a first end connected to the inner shaft; a second end located on one side of the first end and suspended relative to the inner shaft, wherein in the expanded state, the second end of each rod diverges radially outward relative to that in the compressed state; The artificial implant can be installed on the balloon body in a radially compressed loading state and is located at the proximal end of the rod. The rod acts on the balloon body so that the outer circumference of the balloon is not lower than the outer circumference of the distal end of the artificial implant.

108. The interventional delivery system of claim 107, wherein: The rod acts on the balloon body so that the outer peripheral surface of the balloon body is substantially flush with the outer peripheral surface of the distal end of the artificial implant.

109. An interventional delivery system based on balloon expansion for delivering artificial implants, characterized in that: The interventional delivery system has a distal end and a proximal end relative to each other, and an axial direction extending between the proximal end and the distal end, and the interventional delivery system includes: A balloon device, comprising an inner shaft and a balloon body located on the outer periphery of the inner shaft, wherein a first limiting mechanism located inside the balloon body is installed at the distal end of the inner shaft; an intermediate shaft, the intermediate shaft being located outside the inner shaft, a second limiting mechanism being installed on the outside of the balloon body at a distal end of the intermediate shaft, the second limiting mechanism being located proximal to the first limiting mechanism, the artificial implant being capable of being installed on the balloon body in a radially compressed loaded state and being located between the first limiting mechanism and the second limiting mechanism, the two limiting mechanisms being configured to limit axial movement of the artificial implant relative to the balloon body; An outer sheath is slidably fitted on the outer periphery of the balloon device. The outer sheath has an extreme position of proximal movement on its own sliding path. At this extreme position, the first limiting mechanism and the artificial implant are exposed outside the outer sheath, and the second limiting mechanism is inside the outer sheath.

110. An interventional delivery system based on balloon expansion for delivering an artificial implant, characterized in that: The interventional delivery system comprises: A balloon device comprising an inner shaft and a balloon body disposed on the outer periphery of the inner shaft; a plurality of rods disposed circumferentially within the balloon body are mounted at the distal end of the inner shaft; each rod is configured to have a compressed state suitable for interventional delivery and a relatively expanded state based on elastic deformation; each rod has a first end connected to the inner shaft and a second end located to one side of the first end and suspended relative to the inner shaft; in the expanded state, the second end of each rod diverges radially outward relative to the compressed state; the artificial implant can be mounted on the balloon body in a radially compressed loaded state and is located at the proximal end of each rod; an adjustment wire for releasably fixing the artificial implant to the balloon body, wherein one end of the adjustment wire can remain fixed to the balloon body, and the other end can pass through the artificial implant and has a lock hole; The locking wire has a relative locking state and an unlocking state. In the locking state, the locking wire passes through each locking hole to restrict the artificial implant. In the unlocking state, the locking wire is disengaged from each locking hole to release the artificial implant.

111. The interventional delivery system according to any one of claims 107 to 110, wherein: The interventional delivery system further includes a control handle connected to and controlling the balloon device.

112. The interventional delivery system of claim 111, wherein: A fluid guide is provided in the balloon body and is located on the outer periphery of the inner shaft. The fluid guide defines a flow guiding channel that connects the distal end and the proximal end of the balloon body.

113. A balloon device for delivering an artificial heart valve, characterized in that: include: a catheter body, wherein the extending direction of the catheter body serves as an axial direction; a balloon body, connected to the catheter body, capable of receiving fluid from the catheter body, thereby changing from a folded state to an inflated state, and the artificial heart valve correspondingly expands from a radially compressed state to a radially expanded state based on the change of the balloon body; The limiting mechanism is configured to limit the movement of the artificial heart valve in the axial direction at least when the artificial heart valve is mounted on the balloon body in a radially compressed state, and the limiting mechanism specifically includes: The limiting body includes a plurality of rods, which extend as a whole from the first end in the axial direction to the second end in the axial direction and gather at the first end and the second end to form a hollow cage structure.

114. The balloon device of claim 113, wherein: The plurality of rods are configured to form side walls of the cage-shaped structure, and on the side walls, the gaps between two adjacent rods form hollow areas.

115. The balloon device of claim 114, wherein: The hollow area includes a main hollow area and an auxiliary hollow area, and the span of the main hollow area along the axial direction is greater than the span of the auxiliary hollow area along the axial direction.

116. The balloon device of claim 115, wherein: The main hollow area spans the first end and the second end.

117. The balloon device of claim 115, wherein: The cage-shaped structure has an outward expansion portion, the outward expansion portion has the maximum outer diameter of the cage-shaped structure, and the main hollow area spans the outward expansion portion.

118. The balloon device of claim 115, wherein: In the circumferential direction, the main hollow area and the auxiliary hollow area are distributed in sequence at intervals along the circumferential direction.

119. The balloon device of claim 113, wherein: The limiting mechanism is located inside or outside the balloon body.

120. The balloon device of claim 113, wherein: At least one of the catheter body and the balloon body is directly fixed to the limiting mechanism, or is indirectly fixed to the limiting mechanism through an intermediate piece.

121. The balloon device of claim 113, wherein: The balloon device further comprises an inner shaft, wherein the inner shaft is disposed inside the catheter body and the balloon body; The limiting mechanism further includes at least one coupling member, which is fixed to the inner shaft and connected to the gathering portion of the limiting body.

122. The balloon device of claim 121, wherein: The coupling component is located inside or outside the limiting body.

123. The balloon device of claim 121, wherein: The coupling member is located at at least one end of the limiting body in the axial direction.

124. The balloon device of claim 121, wherein: The cage-shaped structure has an outward expansion portion, the outward expansion portion has a maximum outer diameter of the cage-shaped structure, and the outer diameter ratio of the outward expansion portion to the coupling member is 2-4:

1.

125. The balloon device of claim 124, wherein: The outer diameter ratio of the outward expansion portion to the coupling member is 3:

1.

126. The balloon device of claim 121, wherein: The coupling is in the shape of a radially compressible tube.

127. The balloon device of claim 126, wherein: The coupling element has a wave structure undulating along the axial direction or has a deformable grid.

128. The balloon device of claim 126, wherein: The limiting mechanism is formed by integrally cutting a pipe, the pipe has an initial outer diameter D1, the coupling members have an outer diameter D2, and the outer diameter D2 of at least one coupling member is smaller than D1.

129. The balloon device of claim 121, wherein: There are two coupling members, and the cage-shaped structure is surrounded by multiple rods. All rods spatially define the side walls of the cage-shaped structure. All rods extend from one coupling member to another coupling member and have at least one fork on the extension path, or intersect with adjacent rods.

130. The balloon device of claim 129, wherein: The cage-shaped structure has an outward expansion portion, which has the maximum outer diameter of the cage-shaped structure. A plurality of intersection points of two rods are distributed at intervals along the circumference of the outward expansion portion.

131. The balloon device of claim 115, wherein: The number of the main hollow areas is 4 to 12.

132. The balloon device of claim 131, wherein: The number of the main hollow areas is 6 to 8.

133. The balloon device of claim 115, wherein: The main hollow areas have the same shape and are evenly arranged along the circumference.

134. The balloon device of claim 115, wherein: The main hollow area is strip-shaped.

135. The balloon device of claim 115, wherein: Along the axial direction, the length of the main hollow area is at least 40% of the total length of the limiting body.

136. The balloon device of claim 135, wherein: The length of the main hollow area is at least 60% of the total length of the limiting body.

137. The balloon device of claim 116, wherein: The length of the main hollow area is 75% to 100% of the total length of the limiting body.

138. The balloon device of claim 115, wherein: The main hollow area is in a diamond shape.

139. The balloon device of claim 117, wherein: Along the axial direction, the main hollow area extends to both sides of the outwardly expanding portion, and the extended length is at least 20% of the total length of the limiting body.

140. The balloon device of claim 139, wherein: The auxiliary hollow area avoids the outward expansion portion.

141. The balloon device of claim 113, wherein: One end of the limiting body is a first end facing the artificial heart valve in the use state, and the other end is an opposite second end. Both ends of the limiting body are retracted toward the central axis of the limiting body.

142. The balloon device of claim 141, wherein: Each rod extends spatially from the first end to the second end and forms a sphere or an ellipsoid.

143. The balloon device of claim 141, wherein: The cross section of the ellipsoid is an elliptical surface, and the major axis of the elliptical surface is consistent with the axial direction.

144. The balloon device of claim 113, wherein: The cage-shaped structure is surrounded by a plurality of rods, and each rod extends spatially from the first end to the second end to form a cone.

145. The balloon device of claim 144, wherein: The cage-shaped structure has an outward expansion portion, which has the maximum outer diameter of the cage-shaped structure. The cone includes a first cone and a second cone; the first cone and the second cone are located on both sides or the same side of the outward expansion portion.

146. The balloon device of claim 145, wherein: The first cone and the second cone are located on both sides of the outwardly expanding portion. The first cone and the second cone gradually converge in shape from the outwardly expanding portion, and have different convergence trends.

147. The balloon device of claim 146, wherein: One end of the limiting body is a first end facing the artificial heart valve in the use state, and the other end is an opposite second end. The first cone is connected to the first end, and the first cone has a faster contraction trend.

148. The balloon device of claim 146, wherein: The first cone and the second cone are intertwined at the outward expansion portion, and an included angle at the intersection is 20 to 120 degrees.

149. The balloon device of claim 145, wherein: The first cone and the second cone are located on the same side of the outward expansion portion. One end of the limiting body is the first end facing the artificial heart valve in the use state, and the other end is the opposite second end. The first cone is connected to the first end, and the first cone is retracted in the direction away from the first end.

150. A balloon device for delivering an artificial heart valve, characterized in that: include: a catheter body, wherein the extending direction of the catheter body serves as an axial direction; a balloon body, connected to the catheter body, capable of receiving fluid from the catheter body, thereby changing from a folded state to an inflated state, and the artificial heart valve correspondingly expands from a radially compressed state to a radially expanded state based on the change of the balloon body; The limiting mechanism is configured to limit the movement of the artificial heart valve in the axial direction at least when the artificial heart valve is mounted on the balloon body in a radially compressed state, and the limiting mechanism specifically includes: The limiting body is a cage-shaped structure as a whole, wherein a portion of the cage-shaped structure is an outward expansion portion, which has the largest radial outward expansion degree relative to other portions of the cage-shaped structure. Along the axial direction, one end of the limiting body is a first end facing the artificial heart valve in the use state, and the other end is an opposite second end, and the outward expansion portion is adjacent to the first end of the limiting body.

151. The balloon device of claim 150, wherein: The balloon device further comprises an inner shaft, wherein the inner shaft is disposed inside the catheter body and the balloon body; The limiting mechanism further includes: a coupling member fixed to the inner shaft and connected to the limiting body.

152. The balloon device of claim 151, wherein: An inner concave area for accommodating the end of the artificial heart valve is formed in the limiting body between one side of the first end and the coupling member on this side.

153. A balloon device for delivering an artificial heart valve, characterized in that: include: a catheter body, wherein the extending direction of the catheter body serves as an axial direction; a balloon body, connected to the catheter body, capable of receiving fluid from the catheter body, thereby changing from a folded state to an inflated state, and the artificial heart valve correspondingly expands from a radially compressed state to a radially expanded state based on the change of the balloon body; The limiting mechanism is configured to limit the movement of the artificial heart valve in the axial direction at least when the artificial heart valve is mounted on the balloon body in a radially compressed state, and the limiting mechanism specifically includes: The limiting body includes a plurality of rods that form a cage-shaped structure as a whole, wherein a portion of the cage-shaped structure is an outward expansion portion, and the outward expansion portion has the largest radial outward expansion degree relative to other portions of the cage-shaped structure. In a cross section passing through the outward expansion portion, the rods are arranged at intervals along the circumference of the limiting mechanism and the enclosed area approaches a polygon.

154. The balloon device of claim 153, wherein: The polygon is a regular polygon with 4 to 12 sides.

155. The balloon device of claim 154, wherein: The number of sides of the regular polygon is 6 to 8.

156. A balloon device for delivering an artificial heart valve, having opposed distal and proximal ends, characterized in that: include: a catheter body, wherein the extending direction of the catheter body serves as an axial direction; a balloon body, connected to the catheter body, capable of receiving fluid from the catheter body, thereby changing from a folded state to an inflated state, and the artificial heart valve correspondingly expands from a radially compressed state to a radially expanded state based on the change of the balloon body; an inner shaft, the inner shaft being disposed inside the catheter body and the balloon body; The limiting mechanism is configured to limit the movement of the artificial heart valve in the axial direction at least when the artificial heart valve is mounted on the balloon body in a radially compressed state, and the limiting mechanism specifically includes: A limiting body, which is a cage-shaped structure as a whole; A guide tube connected to the limiting body and integrally cut and formed with the limiting body by a tube made of shape memory alloy; The coupling member is connected to the inner shaft, and the coupling member is also connected to at least one of the limiting body and the guide tube.

157. The balloon device of claim 156, wherein: The guide tube is connected to the proximal end side of the limiting body.

158. The balloon device of claim 156, wherein: There are two limiting bodies, which are respectively connected to the proximal side and the distal side of the guide tube.

159. The balloon device of claim 158, wherein: The cage structures of the two limiting bodies are independent of each other.

160. The balloon device of claim 156, wherein: The balloon body comprises a first portion, a middle portion and a second portion from the distal end to the proximal end, wherein the middle portion is used for loading and fixing the artificial heart valve; The guide tube is arranged in a radial gap between the inner shaft and the balloon body, and a guide channel for fluid to pass through is reserved between the guide tube and the inner shaft.

161. The balloon device of claim 156, wherein: The coupling member includes a first coupling member and a second coupling member at the distal end of the first coupling member. Both coupling members are located on the outer periphery of the inner shaft, and at least one coupling member is fixed to the inner shaft. The distal end of the balloon body also wraps the second coupling member.

162. The balloon device of claim 161, wherein: The second coupling member is located at the proximal end of the guide tube and is adjacent to the connection portion between the balloon body and the catheter body.

163. The balloon device of claim 156, wherein: The proximal end of the guide tube is provided with a reduced diameter section and is connected to a coupling member on a corresponding side through the reduced diameter section.

164. The balloon device of claim 163, wherein: The drainage tube is provided with a fluid inlet, and the fluid inlet is distributed on the reduced diameter section and / or the peripheral wall of the drainage tube.

165. The balloon device of claim 156, wherein: The peripheral wall of the drainage tube is provided with a hollow gap as a whole.

166. The balloon device of claim 156, wherein: The limiting mechanism is formed by integrally cutting a pipe; the pipe has an initial outer diameter D1, the outer diameter of the drainage tube is D1, the coupling member has an outer diameter D2, and the outer diameter D2 of at least one coupling member is smaller than D1.

167. A transcatheter implant intervention system, characterized in that: The invention comprises an artificial implant and the balloon device according to any one of claims 106, 113 to 166, wherein the balloon device comprises: catheter body; a balloon body in communication with the catheter body; The limiting mechanism is such that the artificial implant is mounted on the balloon body in a radially compressed loading state and is blocked by the limiting mechanism in the axial direction.

168. The transcatheter implant interventional system of claim 167, wherein: The transcatheter implant intervention system further comprises an outer sheath slidably fitted on the outside of the balloon device, and the limiting body in the limiting mechanism comprises a loading state, an intermediate state and an expanded state; Wherein, in the loaded state, the limiting body is located inside the balloon body and the outer sheath tube, and is subjected to radial forces from both the balloon body and the outer sheath tube; In the intermediate state, the limiting body is free from the radial restraint of the outer sheath and is subjected to the radial force of the balloon body; In the expanded state, the balloon body is inflated and the limiting body is expanded.

169. The transcatheter implant intervention system of claim 167, wherein: The artificial implant is an artificial heart valve.

170. An artificial heart valve, characterized in that: The device comprises a first stent and a leaflet, wherein the first stent is a radially deformable cylindrical structure, the interior of the first stent is a blood flow channel, and the leaflet is a plurality of leaves that cooperate with each other to control the blood flow channel; The first bracket has a grid structure surrounded by frame bars. The first bracket is straight cylindrical. The grid structure includes a diamond-shaped grid. The end of the first bracket has a hole structure protruding from the end. The hole structure is composed of frame bars at the end. The first bracket has a relative expansion state and a compression state. In the compression state, the distance that the hole structure protrudes from the end is L1; in the expansion state, the distance that the hole structure protrudes from the end is L2, and L1>L2≥0.

171. The artificial heart valve according to claim 170, wherein: The grid structure of the first bracket forms a plurality of grid nodes at the end. In the expanded state, the hole structure is substantially flush with the surrounding grid nodes; in the compressed state, the hole structure is higher than the surrounding grid nodes.

172. The artificial heart valve according to claim 170, wherein L1:L2 is 1.2~1.6:

1.

173. The artificial heart valve according to claim 170, wherein: L1 is 0.6~0.8mm, L2 is 0.4~0.6mm.

174. The artificial heart valve according to claim 170, wherein In the expanded state, the hole structure is an arc-shaped structure as a whole, and in the compressed state, the hole structure is close to a circular structure.

175. The artificial heart valve according to claim 170, wherein The artificial heart valve is an artificial pulmonary valve or an artificial aortic valve.

176. The artificial heart valve according to claim 170, wherein In the expanded state, the frame strip at the end is bent and wound in an arc shape to define the edge of the hole structure.

177. The artificial heart valve according to claim 170, wherein Both axial ends of the first bracket are provided with the hole structures, and the circumferential positions of the hole structures at both ends are the same or staggered.

178. The artificial heart valve according to claim 170, wherein: The grid with the pore structure is a first grid, and the grid circumferentially adjacent to the first grid is a second grid. In the first grid, the frame strips around the pore structure include: an arcuate segment defining an edge of the aperture structure; The connecting segment extends from two ends of the arc segment in opposite directions to the grid nodes on both sides of the first grid in the circumferential direction.

179. The artificial heart valve according to claim 178, wherein The angle between the connecting segments on both sides of the arc segment is A1, and the internal angle of the grid node located at the axial end in the second grid is A2. In the expanded state, A1 is greater than A2.

180. The artificial heart valve according to claim 178, wherein In the expanded state, the central angle of the arc segment itself is 150 to 210 degrees.

181. The artificial heart valve according to claim 178, wherein In the expanded state, the span of the arc segment in the circumferential direction of the first stent accounts for 1 / 4 to 1 / 2 of the span of the first grid.

182. The artificial heart valve according to claim 178, wherein In the first grid, the strength of the frame strips around the hole structure is lower than the strength of the frame strips in other parts of the first grid.

183. The artificial heart valve according to claim 170, wherein: The grid in the first bracket is composed of multiple circles, and two axially adjacent circles are staggered in the circumferential direction and share some frame bars; In the expanded state, the internal angle of each grid node is 75 to 105 degrees.

184. The artificial heart valve according to claim 170, wherein: The artificial heart valve further comprises a skirt connected to and surrounding the inner wall of the first stent, and one axial side of the skirt is engaged with the leaflet.

185. The artificial heart valve according to claim 184, wherein: The artificial heart valve further includes a blocking piece arranged circumferentially along the first stent. The blocking piece is fixed to the skirt and protrudes from the radial inner side of the first stent to the radial outer side of the first stent via the corresponding grid.

186. The artificial heart valve according to claim 185, wherein The skirt and the blocking piece are integrally formed or bonded and fixed, and are both made of PU material.

187. The artificial heart valve according to claim 185, wherein The blocking member comprises: A plurality of blocking blocks are arranged along the circumference of the first bracket, and each blocking block is made of foam material and embedded in a grid structure corresponding to a position.

188. The artificial heart valve according to claim 187, wherein: The blocking member further comprises: The lining film, the plurality of blocking blocks are fixed on one side of the lining film, and the lining film and the plurality of blocking blocks are made of the same material.

189. The artificial heart valve according to claim 188, wherein The skirt is made of biological pericardial material, and the lining membrane is sutured to the skirt.

190. The artificial heart valve according to claim 170, wherein: At least a portion of the stent is a support bar, and along the circumference of the stent, at least one side of the support bar has a recessed area, and the leaflet is fixed to the support bar by sutures, and all knots in the sutures are located in the corresponding recessed areas.

191. The artificial heart valve according to claim 190, wherein: The leaflets include: The body has opposite transverse and longitudinal directions in a flattened state, the outer edge of the body including free edges and fixed edges distributed on two opposite longitudinal sides, the multiple leaflets being fixed to the support via respective fixed edges, and the free edges of the multiple leaflets cooperating with each other to control the blood flow channel within the artificial heart valve; Ears are arranged on two opposite sides of the body in a transverse direction, and the free edge and the fixed edge meet at the ear pieces on the corresponding sides; The ears between two adjacent leaflets are connected to each other through a first suture, and are also connected to the support bar through a second suture and a third suture, wherein all the knots in the second suture and the third suture are located in corresponding recessed areas.

192. The artificial heart valve according to claim 191, wherein: The portion where the ears between two adjacent leaflets are connected to each other through the first suture rests against the radial inner side of the support bar; The ear pieces between two adjacent lobes cooperate with each other to wrap around the support bar.

193. The artificial heart valve according to claim 192, wherein: The knot in the second suture is wrapped by the ear, and the knot in the third suture is exposed to the ear.

194. The artificial heart valve according to claim 190, wherein: The two axial sides of the bracket are opposite inflow sides and outflow sides, wherein a circle of hexagonal cells is arranged circumferentially on the outflow side, and the support bar serves as a common side between two adjacent cells.

195. The artificial heart valve according to claim 190, wherein: The extending direction of the support bar is the axial direction of the bracket.

196. The artificial heart valve according to claim 190, wherein: The two side edges of the support bar are respectively M-shaped, and the M-shaped undulating structure correspondingly constitutes the concave area; The M-shaped portions corresponding to the two side edges are arranged symmetrically or staggered along the axial direction.

197. A transcatheter implant system, characterized in that A device comprising a balloon and an artificial heart valve according to any one of claims 170 to 196, wherein the balloon device comprises: catheter body; a balloon body, connected to the catheter body, capable of receiving fluid from the catheter body, thereby changing from a folded state to an inflated state, and the artificial heart valve correspondingly expands from a compressed state to an expanded state based on the change of the balloon body; The inner shaft is inserted into the catheter body and the balloon body, and a guide head is fixed at the distal end; The transcatheter implant system further includes a locking wire structure for limiting the relative axial position of the artificial heart valve and the balloon body, and the locking wire is used to pass through the hole structure of the first stent.

198. The transcatheter implant system of claim 197, wherein: The locking structure includes: a first adjustment line for releasably fixing the artificial implant to the balloon body, wherein one end of the first adjustment line can remain fixed to the catheter body, and the other end can pass through the eyelet structure and has a first locking hole; a second adjustment line, one end of which is connected to the guide head and the other end of which can pass through the eyelet structure and has a second lock hole; A locking wire having a relative locking state and an unlocking state, wherein in the locking state, the locking wire is inserted into each locking hole to restrain the artificial implant, and in the unlocking state, the locking wire is disengaged from each locking hole to release the artificial implant; The guide head is provided with an insertion hole, and the end portion of the locking wire extends into the insertion hole in the locked state.

199. The transcatheter implant system of claim 198, wherein: There are at least two joints between the adjustment line and the locking line, wherein at least one of the joints limits the movement of the artificial implant in the distal direction, and at least one of the joints limits the movement of the artificial implant in the proximal direction.

200. The transcatheter implant system of claim 199, wherein: The first adjustment line and the second adjustment line match each other in axial length, so that the first stent is maintained in the middle area of ​​the balloon body.

201. The transcatheter implant system of claim 197, wherein: The balloon device adopts the balloon device described in any one of claims 106 and 113 to 166.

202. An artificial heart valve assembly, characterized in that include: An artificial heart valve comprises a first stent and leaflets, wherein the first stent is a radially deformable cylindrical structure, the interior of the first stent is a blood flow channel, and the leaflets are multiple and cooperate with each other to control the blood flow channel; An anchoring stent is sleeved on the radially outer side of the artificial heart valve after assembly, the artificial heart valve and the anchoring stent both have an expanded state and a compressed state, and in the expanded state, the artificial heart valve and the anchoring stent abut against each other; The anchoring bracket has a grid structure surrounded by frame bars, and the grid structure includes: The middle part includes two circles of fishbone mesh; The end portion includes two circles of diamond-shaped grids, one on each side of the middle portion in the axial direction; The anchor stent further has a pre-expanded state before assembly, wherein the anchor stent has a first diameter in the pre-expanded state and a second diameter in the expanded state, wherein the second diameter is larger than the first diameter.

203. The artificial heart valve assembly according to claim 202, wherein: In the expanded state, the axial length of the anchoring stent is greater than the length of the first stent.

204. The artificial heart valve assembly according to claim 202, wherein: The first bracket is located in the middle of the anchor bracket in the axial direction.

205. The artificial heart valve assembly according to claim 202, wherein: The fishbone grid is a concave hexagon with opposite convex tips and concave tails, and the concave tails of the two circles of fishbone grid are symmetrically facing each other and the convex tips are facing away from each other; The two circles of diamond grids are respectively located on both sides of the middle portion in the axial direction, and each diamond grid is located between the convex tips of two adjacent fishbone grids.

206. The artificial heart valve assembly according to claim 202, wherein: The axial position of the first bracket does not exceed the middle portion.

207. The artificial heart valve assembly according to claim 202, wherein: The first stent has a denser mesh than the anchor stent.

208. The artificial heart valve assembly according to claim 202, wherein: The number of circumferential grids in the first bracket is 1.2 to 2 times the number of circumferential grids in the anchor bracket.

209. The artificial heart valve assembly according to claim 202, wherein: In the diamond grid at the end of the anchor bracket, the two frame bars facing away from the middle portion have lower strength than the two frame bars shared with the middle portion.

210. The artificial heart valve assembly of claim 202, wherein: The artificial heart valve and anchoring stent are both released based on a balloon expansion method.

211. The artificial heart valve assembly according to claim 202, wherein: The artificial heart valve is released based on a balloon expansion method, and the anchoring stent is released based on a self-expansion method.

212. The artificial heart valve assembly according to claim 202, wherein: The artificial heart valve is the artificial heart valve according to any one of claims 170 to 196.

213. A transcatheter implant system, characterized in that include: The artificial heart valve assembly according to any one of claims 202 to 212; A first delivery system is provided with a first balloon for delivering and expanding the artificial heart valve.

214. The transcatheter implant system of claim 213, wherein: Also includes: A second delivery system is used to expand the anchor stent.

215. The transcatheter implant system of claim 214, wherein: The first delivery system and the second delivery system use the same or different intervention pathways to implement interventional delivery.

216. The transcatheter implant system of claim 213, wherein: The first delivery system further comprises a second balloon for expanding the anchoring stent; Or the first delivery system further includes an outer sheath tube, the anchoring stent is accommodated in the outer sheath tube in a compressed state, and the anchoring stent is released based on a self-expansion manner.

217. The transcatheter implant system of claim 216, wherein: The first balloon body and the second balloon body are respectively configured with fluid channels, and the two balloon bodies are arranged axially and respectively loaded with the artificial heart valve and the anchoring stent. The anchoring stent released first is located at the distal end of the artificial heart valve.

218. The transcatheter implant system of claim 213, wherein: The first balloon body is provided with a limiting mechanism for the distal end or both ends of the artificial heart valve; The limiting mechanism is configured to limit the axial movement of the artificial heart valve at least when the artificial heart valve is mounted on the first balloon body in a radially compressed state.

219. The transcatheter implant system of claim 217, wherein: The second balloon body is provided with a limiting mechanism for the distal end or both ends of the anchoring stent; The limiting mechanism is configured to limit the axial movement of the anchoring stent at least when the anchoring stent is mounted on the corresponding balloon body in a radially compressed state.

220. The transcatheter implant system of claim 213, wherein: The first stent of the artificial heart valve and / or the anchoring stent have eyelet structures protruding from both axial ends. The transcatheter implant system is configured with a locking wire structure for the artificial heart valve and / or the anchoring stent, and the locking wire structure includes: a first adjustment line, wherein one end of the first adjustment line can be fixed to the conveying system, and the other end can pass through the eyelet structure at the corresponding end, and the exit portion has a first lock hole; a second adjustment line, one end of which can be fixed to the conveying system and the other end of which can pass through the eyelet structure at the corresponding end, with the exit portion having a second lock hole; The first locking wire has a relative locking state and an unlocking state. In the locking state, the locking wire passes through each locking hole to restrict the artificial heart valve and / or the anchoring stent. In the unlocking state, the locking wire disengages from each locking hole to release the artificial heart valve and / or the anchoring stent.

221. A method for detaching an artificial heart valve assembly from an interventional delivery system, characterized in that: The artificial heart valve assembly includes an artificial heart valve and an anchoring stent, both of which have an expanded state and a compressed state; The interventional delivery system comprises at least an interventionally deliverable inner shaft, wherein both the artificial heart valve and the anchoring stent are connected to the inner shaft in a compressed state; The disengagement method comprises: Step S100, releasing the connection between the anchoring stent and the inner shaft, so that the anchoring stent enters an expanded state; Step S200, delivering the artificial heart valve to the interior of the anchoring stent; Step S300: releasing the connection between the artificial heart valve and the inner shaft, so that the artificial heart valve enters an expanded state and presses against the inner wall of the anchoring stent.

222. The detachment method according to claim 221, wherein: The interventional delivery system further comprises an outer sheath tube, which is relatively slidably mounted on the outer periphery of the inner shaft, and the anchoring stent is connected to the inner shaft and wrapped by the outer sheath tube; When releasing the connection between the anchoring stent and the inner shaft, the outer sheath and the inner shaft are first moved relative to each other, so that the anchoring stent is exposed to the outer sheath and enters an expanded state in a self-expanding manner.

223. The detachment method according to claim 221, wherein: There is one inner shaft, and the interventional delivery system further includes: Two balloon bodies are arranged in sequence along the inner axis, and the artificial heart valve and the anchoring stent are respectively connected to the outer periphery of the corresponding balloon body; A locking wire, used to simultaneously limit the axial positions of the artificial heart valve and the anchoring stent relative to the respective balloon bodies; When the connection between the anchoring stent and the inner shaft is released, the method further includes moving the locking wire before or after the balloon body corresponding to the anchoring stent is inflated to release the axial restriction of the anchoring stent and maintain the axial restriction of the artificial heart valve; When the artificial heart valve is released from the inner shaft, the method further includes moving the locking wire along the original movement direction before or after the balloon body corresponding to the artificial heart valve is inflated to release the axial limitation of the artificial heart valve.

224. The detachment method according to claim 221, wherein: The interventional delivery system further includes a bending adjustment component, which can act on at least the inner shaft to change the distal end direction of the inner shaft; Before the artificial heart valve assembly is separated from the inner shaft, the inner shaft has a smooth turning portion in space due to the action of the bending adjustment assembly, or has at least two smooth turning portions, and the directions of the two turning portions are opposite.

225. The detachment method according to claim 224, characterized in that The portion of the inner shaft corresponding to the turning portion is made of a metal cutting tube.

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