Delivery system for artificial implant

Abstract

The invention discloses a conveying system used for conveying an artificial implant, the conveying system comprises a catheter assembly and a control handle, the catheter assembly comprises a first shaft, a guide head is fixedly arranged at the far end of the first shaft, and the guide head is further provided with a guide wire cavity penetrating through the guide head and used for allowing a guide wire to penetrate through; the guiding head comprises a guiding part which is arranged at the far end of the guiding head, and the far end of the guiding part is provided with a conical structure which extends in the axial direction and is gradually folded from the near end to the far end; the connecting part is connected with the first shaft and is arranged at the near end of the guide head; and the deformation part is connected between the guide part and the connecting part. The conveying system can improve the passing smoothness of the guide head during conveying in the body.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a delivery system for artificial implants. Background Art

[0002] With the development of medical conditions, artificial implants have been used to treat heart valve disorders. Common treatment methods generally include repairing or replacing the valve through surgery, or implanting artificial implants through catheter intervention.

[0003] In interventional technology, a compressed artificial implant is loaded into the distal portion of a catheter assembly and delivered to a predetermined location. After the artificial implant is radially expanded and released, the catheter assembly is withdrawn from the body.

[0004] Regarding the connection between the artificial implant and the catheter assembly, the existing technology can adopt direct snap-on or wire control methods. The wire control method uses a flexible part to restrain the artificial implant to the distal end of the catheter assembly and lock the flexible part to maintain the compression state of the artificial implant. When the artificial implant needs to be released, the lock of the flexible part is released, and the flexible part is then loosened until it is separated from the artificial implant to complete the release of the artificial implant. However, due to the tortuous path of the human blood vessels, the smoothness of the existing delivery system passing through the blood vessels in the body, especially the smoothness at the guide head, still needs to be improved. Summary of the Invention

[0005] In order to optimize the control and / or processing process, the present application provides a delivery system for an artificial implant.

[0006] The present application provides a delivery system for delivering an artificial implant, the delivery system comprising a catheter assembly and a control handle, the catheter assembly comprising a first shaft, a guide head fixedly disposed at the distal end of the first shaft, the guide head further comprising a guide wire lumen penetrating the guide head and for inserting a guide wire.

[0007] A guide portion is provided at the distal end of the guide head, wherein the distal end of the guide portion has a tapered structure extending along the axial direction and gradually converging from the proximal end to the distal end;

[0008] a connecting portion connected to the first shaft and disposed at a proximal end of the guide head;

[0009] The deformation portion is connected between the guide portion and the connection portion.

[0010] Optionally, the deformation portion has a smaller deflection than the guide portion and the connecting portion.

[0011] Optionally, the deformation portion is at least partially radially retracted relative to the guide portion and the connecting portion.

[0012] Optionally, the number of the deformation portion is one or a plurality of deformation portions distributed at intervals along the axial direction, and transition portions are provided between adjacent deformation portions.

[0013] Optionally, the guide head is further provided with a guide wire cavity which passes through the guide head and is used for passing a guide wire.

[0014] Optionally, the circumferential surface of the guide head is smooth and continuous.

[0015] Optionally, the deflections of the deformation parts are the same or different.

[0016] Optionally, the deflection of each deformation portion gradually decreases from near to far.

[0017] Optionally, in the axial direction, the deflections of various parts of a single deformation portion are the same or different.

[0018] Optionally, in the axial direction, the deflection of a single deformation portion at a location with the smallest diameter is lower than that at two sides thereof.

[0019] Optionally, the minimum diameters of the deformation portions are the same or different.

[0020] Optionally, the materials of the deformable parts are the same or different.

[0021] Optionally, the guide head is an integrated structure or each part of the guide head is a separate structure.

[0022] Optionally, the proximal end of the guide portion has a first extension portion extending with equal diameter, the distal end is the conical structure, and the distal end of the connecting portion has a second extension portion extending with equal diameter.

[0023] Optionally, the diameters of the first extension portion and the second extension portion are equal.

[0024] Optionally, the axial distance of the first extension portion is L3, the axial distance of the second extension portion is L4, and the axial distance of the deformation portion is L5, wherein L3:L4=1, L5:L3=4-8.

[0025] Optionally, the minimum diameter of the deformation portion is D1, the maximum diameter is D2, and D2 / D1=1.5-2.5.

[0026] The present application also provides a catheter assembly for facilitating the recovery of an artificial implant, comprising:

[0027] An intermediate shaft assembly for connecting an artificial implant releasably by wire control;

[0028] The first shaft extends through the interior of the intermediate shaft assembly to the distal end, and the extended portion is provided with a loading section, the loading section being tubular and open toward the proximal end, and the loading section adopts a radially deformable structure to adapt to being wrapped by the artificial implant when the artificial implant is retrieved;

[0029] The catheter sheath is slidably arranged on the outer periphery of the intermediate shaft connecting shaft assembly, and is used to cooperate with the loading section to accommodate the artificial implant during interventional delivery, and to accommodate the artificial implant and wrap the loading section during recovery.

[0030] Optionally, the loading section has a development mark.

[0031] Optionally, the loading section includes a composite multi-layer structure, and the development mark is located in an interlayer of the multi-layer structure.

[0032] Optionally, the developing mark itself or a matching molding material is pre-formed into a strip structure and placed in the interlayer.

[0033] Optionally, the developer marker is a powdered material and premixed into the raw materials in the loading section.

[0034] Optionally, the loading section is provided with a plurality of pre-formed portions along the circumference to guide its own radially deformable structure.

[0035] Optionally, the pre-formed portion is a radially inwardly recessed fold and / or thinning area.

[0036] Optionally, the loading section is made of elastic polymer materials such as Pebax, TPU, and nylon.

[0037] Optionally, the intermediate shaft assembly includes:

[0038] The third shaft is a hollow structure, and the distal end is connected to a base, the base is provided with a lock hole that cooperates with the lock element, the first shaft movably extends out of the distal end of the third shaft, and the lock element is also installed on the first shaft;

[0039] A second shaft, movably sleeved on the outer periphery of the third shaft;

[0040] The pull wire is connected to the second shaft and cooperates with the base and the locking element to control the artificial implant in a wire-controlled manner.

[0041] Optionally, the locking element is located between the base and the loading section, and is linked to the first shaft in a clutch manner.

[0042] The present application also provides a catheter assembly, comprising at least one tube for manipulating an artificial implant, wherein a support frame is provided at the proximal end of the tube, and the support frame is a metal tube with a hollow area.

[0043] The delivery system includes a control handle and a catheter assembly, wherein the control handle is provided with a connecting seat, and the part of the pipe with the supporting frame is fixed to the connecting seat.

[0044] The present application also provides a catheter sheath based on long-distance intervention, having opposite distal and proximal ends, the catheter sheath comprising a tube body and a hemostatic valve, the tube body comprising:

[0045] The main body segment, the hemostatic valve is connected to the proximal end of the main body segment, and the wall of the main body segment is provided with a structural reinforcement layer at least near the distal end, the reinforcement layer being a metal tube with a hollow structure;

[0046] The deformation section is located at the distal end of the main section, and the deformation section includes a metal mesh connected to the metal tube and a coating wrapped around the metal mesh. The metal mesh has a relative initial state and an expanded state. In the expanded state, the deformation section as a whole has a flared structure. Relative to the initial state, the axial shortening rate of the metal mesh in the expanded state is adapted to the deformation amount of the coating.

[0047] Optionally, the axial shortening rate of the metal mesh in the expanded state is equal to the deformation of the coating.

[0048] Optionally, the material of the coating at the deformation section is elastic polymer material such as TPU and PET.

[0049] Optionally, the thickness of the coating at the deformation section is 0.1 to 0.3 mm.

[0050] Optionally, the length of the tube is at least 60 cm.

[0051] Optionally, the length of the tube body ranges from 60 to 90 cm.

[0052] Optionally, the distal end of the tube has a pre-molded shape that matches the shape of the aortic arch.

[0053] Optionally, the metal tube is made of memory alloy.

[0054] The present application also provides a control handle with a bending adjustment mechanism, wherein the control handle has a support body, and the bending adjustment mechanism includes:

[0055] A winding wheel, rotatably mounted on the support body, for driving the bending adjusting member;

[0056] a knob, linked to the winding wheel;

[0057] The one-way engaging structure acts between the support body and the knob and has a relative limiting state and a releasing state. In the limiting state, the winding wheel is only allowed to rotate in one direction.

[0058] Optionally, at least a portion of the support body serves as a support, the knob is rotatably mounted on the support, and the one-way engaging structure includes:

[0059] A first tooth surface is located on one side of the axial direction of the knob;

[0060] a second tooth surface, located on the support and meshing with the first tooth surface, wherein the first tooth surface and the second tooth surface adopt mutually matching and one-way transmission tooth shapes;

[0061] The first elastic member drives the knob to axially abut against the support to maintain the engagement between the first tooth surface and the second tooth surface. When the knob moves axially, the first tooth surface and the second tooth surface are disengaged.

[0062] Optionally, the linkage between the knob and the winding wheel can be disengaged in case of overload.

[0063] Optionally, the knob and the winding wheel are linked to each other via a transmission shaft, and the transmission between the knob and the transmission shaft, or between the transmission shaft and the winding wheel, can be separated in case of overload.

[0064] Optionally, the knob, the winding wheel, and the transmission shaft are coaxially arranged, wherein the knob and the transmission shaft are circumferentially fixed and axially slidably fitted, and the first elastic member acts between the knob and the transmission shaft;

[0065] The transmission shaft and the winding wheel are engaged with each other using overload-separated protective tooth surfaces, and a second elastic member is also provided between the transmission shaft and the winding wheel to maintain the engagement of the protective tooth surfaces.

[0066] Optionally, the winding wheel is provided with an axial through hole, the transmission shaft is passed through the axial through hole, one end of the transmission shaft has a shoulder, the inner wall of the axial through hole is provided with a step which is axially abutted against the shoulder, and the protective tooth surface is arranged at the abutment position between the shoulder and the step.

[0067] Optionally, the support and the support body are an integral or separate structure, the support comprises two supports arranged side by side and each having a mounting hole therein, and the winding wheel comprises along its own axial direction:

[0068] Working section, used for winding the bending parts;

[0069] The mounting sections are located on both sides of the working section and are rotatably fitted into the mounting holes on the corresponding sides.

[0070] Optionally, the second tooth surface is located on one of the supports and is arranged around the mounting hole of the support.

[0071] Optionally, the knob includes:

[0072] A gripping portion, exposed on the outside of the control handle for gripping and applying force;

[0073] an inner sleeve, fixed to one side of the grip portion and extending into the axial through hole of the winding wheel;

[0074] The outer sleeve is fixed to the holding portion and is located on the outer periphery of the inner sleeve, and the first tooth surface is located on the end surface of the outer sleeve.

[0075] Optionally, the mounting section of the winding wheel facing the holding portion further extends into the radial gap between the inner sleeve and the outer sleeve.

[0076] Optionally, the knob and the winding wheel are linked to each other via a transmission shaft, and the first elastic member acts between the knob and the transmission shaft.

[0077] The transmission shaft extends into the inner sleeve, and a connecting pin is provided between the transmission shaft and the knob and passes through the axis. Both ends of the connecting pin are respectively restricted by the knob and the transmission shaft, and the first elastic member is axially pressed between the connecting pin and the transmission shaft.

[0078] Optionally, a head is installed at one end of the axial through hole of the winding wheel, and two ends of the second elastic member are respectively pressed between the transmission shaft and the head.

[0079] The present application also provides a bending adjustment sheath having relative distal and proximal ends, a portion of which includes multiple segments distributed along its own axial direction, the hardness of each segment increasing from far to near, and a splicing part between adjacent segments. The bending adjustment sheath also includes a support bar extending axially through each splicing part, and the hardness value of the support bar is greater than or equal to the maximum hardness value in each segment.

[0080] Optionally, when the bending adjustment sheath is in a straight state, the support bar extends in an axial straight line along the bending adjustment sheath.

[0081] Optionally, the bending adjustment sheath has relative inner and outer sides in a bent state, and the support bar is located on the outer side.

[0082] Optionally, the distal end of the support bar extends to the distal end of the bending adjustment sheath.

[0083] Optionally, in a radial cross section, the ratio of the outer circumference of the bending sheath to the circumferential width of the support bar is 4.0 to 6.0, for example, 5.0.

[0084] Optionally, the radial inner and outer surfaces of the bending adjustment sheath are smooth and the radial cross-section is a complete circle.

[0085] Optionally, the bending adjustment parts of the bending adjustment sheath are the first section, the second section and the third section from far to near, with hardnesses of 40D, 55D and 63D respectively, and the hardness of the support bar is 72D.

[0086] The present application also provides a method for processing a bending sheath tube, comprising:

[0087] splicing the multiple sections of raw material tubes of the bending sheath tube in sequence to obtain a semi-finished product;

[0088] Cutting a designated area of ​​the semi-finished product along the axial direction to form an incision, wherein the incision extends to all joints of each section of the raw material pipe;

[0089] A support bar is provided, and the support bar is embedded in the incision and fixed with the surrounding parts to obtain the bending adjustment sheath.

[0090] The control mechanism of the artificial implant of the present application greatly improves the processing convenience and processing accuracy of the base, and enhances the smoothness and accuracy of the wire control. BRIEF DESCRIPTION OF THE DRAWINGS

[0091] Figure 1 This is a schematic diagram of the structure after the guide head is installed according to an embodiment of the present application;

[0092] Figure 2 for Figure 1 Main view of the middle loading section;

[0093] Figure 3 for Figure 1 Exploded view of the middle loading section;

[0094] Figure 4 for Figure 1 Schematic diagram of the structure of the middle loading section when conveying in a tortuous area;

[0095] Figures 5A to 5I This is a schematic diagram of the operating steps for releasing an artificial implant according to an embodiment of the present application;

[0096] Figure 5J to Figure 5L This is a schematic diagram of the operation steps for recovering an artificial implant according to an embodiment of the present application;

[0097] Figure 6 This is a schematic structural diagram of a conveying system according to an embodiment of the present application;

[0098] Figure 7 for Figure 6 Schematic diagram of the structure of the midline catheter sheath;

[0099] Figure 8A A structural diagram of a coating and a metal grid according to an embodiment of the present application;

[0100] Figure 8B This is a structural diagram of a coating according to an embodiment of the present application when it expands from an initial state to an expanded state;

[0101] Figure 8CA schematic diagram of one of the diamond cells of the metal grid according to an embodiment of the present application expanding from an initial state to an expanded state;

[0102] Figure 9 A schematic diagram of a bending adjustment method according to an embodiment of the present application;

[0103] Figure 10 A schematic diagram of a bending adjustment mechanism according to an embodiment of the present application;

[0104] Figure 11 for Figure 10 Exploded view of the center adjustment bending mechanism;

[0105] Figure 12 for Figure 11 Exploded view from another perspective;

[0106] Figures 13 to 16 They are Figure 11 Structural view of the center support, knob, winding wheel and transmission shaft;

[0107] Figure 17 for Figure 10 The main view of the center bending mechanism;

[0108] Figure 18 for Figure 17 Cross-sectional view in the HH direction;

[0109] Figure 19 A schematic diagram of a bending adjustment mechanism according to another embodiment of the present application;

[0110] Figure 20 for Figure 19 Exploded view of the center adjustment bending mechanism;

[0111] Figure 21 for Figure 20 Exploded view from another perspective;

[0112] Figure 22 for Figure 19 The main view of the center bending mechanism;

[0113] Figure 23 and Figure 24 They are Figure 20 Structural view of the middle transmission shaft and winding reel;

[0114] Figure 25 for Figure 22 Cross-sectional view in the LL direction;

[0115] Figure 26 This is a schematic diagram of the structure of the bending adjustment sheath tube during bending adjustment according to one embodiment of the present application;

[0116] Figure 27 for Figure 26Radial cross-sectional view of the mid-bend sheath with support bars;

[0117] Figure 28 This is a schematic structural diagram of a pipe in a catheter assembly according to an embodiment of the present application;

[0118] Figure 29 This is a partial structural diagram of a conveying system according to an embodiment of the present application.

[0119] The reference numerals in the figures are described as follows:

[0120] 21, first axis; 211, loading section; 2111, linkage slot;

[0121] 212, support member;

[0122] 215. Guide head; 2151. Guide portion; 2152. Connecting portion; 2153. Deformable portion; 2154. Conical structure; 2155. Guidewire lumen; 2156. First extension portion; 2157. Second extension portion; 2158. Guide slope; 2159. Step;

[0123] 216, loading unit;

[0124] 23. Second axis; 25. Third axis; 27. Extension tube; 28. Bending adjustment piece;

[0125] 29. Bending sheath; 2901. First section; 2902. Second section; 2903. Third section; 2904. Fourth section; 294. Connecting section; 2951. Support frame; 2952. Hollow structure;

[0126] 300, control handle; 31, proximal end; 32, distal end;

[0127] 310, support body; 311, support; 3111, second tooth surface; 3112, mounting hole; 320, connecting seat; 330, driving member;

[0128] 371, winding wheel; 3711, working section; 3712, mounting section; 3713, second protective tooth surface; 3714, step; 3715, axial through hole;

[0129] 372, knob; 3721, first tooth surface; 3722, limiting hole; 3723, gripping portion; 3724, inner sleeve; 3725, outer sleeve;

[0130] 373, first elastic member; 374, transmission shaft; 3741, first protective tooth surface; 3742, shoulder;

[0131] 375, second elastic member; 376, head; 377, connecting pin; 379, fifth elastic member; 378, dial button;

[0132] 400, artificial implant; 401, wire control terminal; 403, eyelet;

[0133] 70. Catheter sheath; 720. Hemostatic valve; 730. Tube body; 731. Main section; 732. Deformation section; 733. Coating; 734. Metal mesh; 735. Diamond grid. DETAILED DESCRIPTION

[0134] 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.

[0135] 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.

[0136] 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.

[0137] 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.

[0138] This specification describes an artificial implant and a delivery system for delivering the artificial implant to a predetermined location. The delivery system includes a control handle and a catheter assembly, wherein the control handle can be connected to and control the catheter assembly used to perform interventional surgery. The catheter assembly includes multiple control components, and the distal ends of each control component cooperate with each other to operate the artificial implant, such as releasing, retrieving, locking the position, adjusting the spatial posture, etc. Each control component itself can be a hollow tube, a solid rod, a flexible wire, or a combination of multiple forms. 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 around the axial direction. The force-applying component on the control handle used to operate each control component (the part that the user directly operates and contacts) can be directly fixedly transmitted to the corresponding control component, or can be transmitted by means of threads, gear racks, etc.

[0139] In the following, various improvements to the control handle or local structure can be implemented on the same control handle without obvious technical contradictions, but are not strictly limited to being implemented on the same control handle. For different numbers of controlled components and movement characteristics, or for control handles with further simplified structures, each embodiment can also be implemented separately or in appropriate combination.

[0140] There are no strict restrictions on the application site and structure of artificial implants. In some drawings or texts, an artificial heart valve is taken as an example. The artificial heart valve generally includes a deformable stent and leaflets connected to the stent. The stent is cylindrical as a whole, and the side wall is a hollow grid structure. Unless otherwise stated, the shape or size of the grid structure is not strictly limited. The inside of the stent is a blood flow channel, and the multiple leaflets cooperate with each other to control the degree of opening and closing of the blood flow channel in the stent. In order to position it in the body, a positioning structure that can interact with the surrounding native tissue can be set on the periphery of the stent, such as anchor spikes, arms, etc. In order to prevent peripheral leakage, a skirt or anti-peripheral leakage material can be set on the inner and / or outer sides of the stent.

[0141] Depending on the release mode, the stent is processed using corresponding materials, such as nickel-titanium alloy with shape memory that can self-expand in the body, or stainless steel that is released by balloon expansion, etc. The stent itself can be formed by cutting tubes or weaving wires, and the leaflets can be connected to the stent by sewing, bonding or integral mold molding.

[0142] Taking a self-expanding stent as an example, its release and recovery can be controlled by a sheath wrapped around the periphery of the stent. The release and recovery can be controlled accordingly by varying the location of the stent exposed to the sheath. Pull wire control can also be used, where the pull wire passes through the structural gap (or wire hole structure) of the stent. The expansion degree of the stent can be changed by adjusting the tension of the pull wire with a control handle. When the pull wire is pulled out of the stent, the stent is allowed to be fully released. Of course, the control of the pull wire is also accomplished through the various controlled components in the catheter assembly.

[0143] The stent of an artificial implant may generally have a connection structure that cooperates with the catheter assembly to limit the position of each other and prevent unnecessary positional displacement during delivery. The artificial implant is in a radially compressed state, i.e., a loaded state, when introduced. After being freed from the constraints of the catheter assembly and radially expanded in the body, it is in a released state. Unless otherwise specified, the shape of the artificial implant is understood to be in the released state, and the local deformation caused by the pressure of the surrounding tissue is not taken into account.

[0144] Due to the complexity of the structure in the body, catheter components often need to be bent. The corresponding bending parts can be in the form of tubes or wires, with the distal end acting on the bent part and the proximal end operating the bending amplitude or direction through a control handle.

[0145] When used to indicate direction, the proximal end in the text generally refers to the side adjacent to the operator (such as a doctor), and the distal end is the side relatively farther 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 indicates the endpoint of the structure, or a point or area on that side, or a specific structure connected to that point or area.

[0146] The present application provides a delivery system for delivering an artificial implant 400, which includes a catheter assembly and a control handle 300. The catheter assembly includes a first shaft 21, and a guide head 215 is fixedly provided at the distal end of the first shaft 21. The guide head 215 is provided with a guide wire cavity that passes through the guide head and is used to pass a guide wire 2155.

[0147] See Figures 1 to 4 In one embodiment, the guide head 215 includes:

[0148] The guide portion 2151 is provided at the distal end of the guide head 215. The distal end of the guide portion 2151 has a tapered structure 2154 extending axially and gradually narrowing from the proximal end to the distal end.

[0149] The connecting portion 2152 is provided at the proximal end of the guide head 215 and is connected to the delivery system, and in this embodiment is connected to the first shaft 21;

[0150] The deformation portion 2153 is connected between the guide portion 2151 and the connection portion 2152 , and the deformation portion 2153 is at least partially radially retracted;

[0151] The guide wire cavity 2155 passes through the guide head 215 and is used to insert a guide wire. In this embodiment, the guide wire cavity 2155 is communicated with the interior of the first shaft 21.

[0152] When the guide head 215 advances and passes through a curved portion within a blood vessel, the guide portion 2151 first abuts against the vessel wall. The reaction force from the vessel wall causes the deformable portion 2153 to adaptively deform, thereby adapting to the curved portion. This facilitates the guide head 215 guiding the delivery system across the curved portion until it reaches the predetermined position. The deformation of the guide head 215 is primarily concentrated at the deformable portion 2153 and the distal end of the guide portion 2151. Both are primarily small enough in radial dimension to undergo deformation. Further optimization of the material and structure is certainly possible. Of course, the deformation of the guide head 215 is not limited to the deformable portion 2153 and the guide portion 2151; the remaining portions can also undergo adaptive deformation, albeit with a smaller degree of deformation than the first two.

[0153] In one embodiment, the circumferential surface of the guide head 215 is continuous and smooth, maintaining the continuity of the circumferential surface during deformation changes, and avoiding the generation of sharp parts or small gaps that may damage the blood vessel wall.

[0154] In one embodiment, the deformation portions 2153 are multiple and extend along the axial direction, and the deformation portions 2153 are connected by transition portions, wherein the transition portions extend with equal diameters.

[0155] The minimum diameter (distance from its own axis) of each deformable part 2153 is the same or different; the material of each deformable part 2153 is the same or different, wherein the material of the deformable part 2153 can be a combination of at least one or more of spring, silicone, thermoplastic polyurethane or nylon elastomer, in order to improve the deformation ability.

[0156] In the axial direction, the deflections of the deformable portions 2153 may be the same or different, for example, the deflection gradually decreases from proximal to distal. The deflections of the individual deformable portions 2153 along the axial direction may be the same or different, for example, the deflection of the deformable portion 2153 at the smallest diameter may be lower than that at its two sides. Lower deflection may be achieved by one or more of the following combinations:

[0157] In terms of size: the minimum diameter of the deformation portion 2153 is D1, the maximum diameter is D2, D2 / D1=1.5~2.5, for example, D2 / D1=2.0; or the wall thickness of the deformation portion 2153 is different, for example, gradually thickening axially toward both sides at D1.

[0158] In terms of material: the deformation portion 2153 is composed of multiple sections spliced ​​together by different materials along the axial direction, and the axial dimensions of each section are the same or different.

[0159] In another embodiment, the deformation portion 2153 has a lower deflection than the transition portions, connecting portions, or guiding portions on both sides thereof, which can be achieved by one or more of the following combinations:

[0160] In terms of size: the wall thickness of the deformation portion 2153 is different from that of the transition portion, the connecting portion and the guiding portion. For example, the wall thickness of the deformation portion 2153 is smaller than that of the other three portions.

[0161] In one embodiment, the deformable portion 2153 is at least partially radially inward relative to the guide portion 2151 and the connecting portion 2152. In the figure, there is only one deformable portion 2153, and its two axial ends gradually expand radially outward, resulting in a lower flexibility than the guide portion 2151 and the connecting portion 2152. The proximal end of the guide portion 2151 has a first extension portion 2156 extending in diameter, and the distal end has a tapered structure 2154. The deformation of the guide portion 2151 primarily occurs at the tapered structure 2154. The distal end of the connecting portion 2152 has a second extension portion 2157 extending in diameter. The first extension portion 2156 and the second extension portion 2157 have equal diameters.

[0162] The axial distance of the first extension portion 2156 is L3, the axial distance of the second extension portion 2157 is L4, and the axial distance of the deformation portion 2153 is L5, wherein L3:L4=1. L5:L3=4-8, preferably 5.

[0163] In one embodiment, the loading portion 216 is a cylinder, and the corresponding connecting portion 2152 has a cylindrical column for the cylinder to be inserted into. The loading portion 216 and the connecting portion 2152 are tightly matched, and the proximal end of the connecting portion 2152 has a guide slope 2158 for the insertion of the loading portion 216. In a preferred embodiment, the connecting portion 2152 has a radially outwardly protruding step 2159 to limit the installation of the loading portion 216.

[0164] In one embodiment, the guide head 215 is an integrated structure, and the materials of various parts are the same or different.

[0165] An embodiment of the present application further provides a method for controlling an artificial implant based on a wire control method, comprising:

[0166] A control mechanism is provided for controlling engagement or disengagement with an artificial implant by wire control. In the control mechanism, a free end of a pull wire passes through the artificial implant and is restrained to a base by a locking member.

[0167] The pull wire has a control end opposite to the free end. When the artificial implant is released, the control end moves distally, so that the portion of the pull wire exposed outside the base gradually stretches and allows the artificial implant to deform radially.

[0168] When the artificial implant is deformed to a desired extent, the fit between the locking element and the base is released and the free ends are released;

[0169] Move the control end proximally to pull the free end away from the artificial implant.

[0170] Detailed description is given with reference to the accompanying drawings:

[0171] After the artificial implant is delivered to the predetermined position in the body, the components in the sheath are first pushed distally to push the entire sheath forward or the sheath is moved proximally to expose the arm 430 and the control mechanism. At this time, the proximal end of the artificial implant is controlled by the control mechanism, and the distal end is constrained by the loading section 211.

[0172] like Figure 5A , and then push the first shaft 21 toward the distal end to release the restraint of the loading section 211 on the artificial implant, that is, the distal end of the artificial implant loses its restraint and expands radially outward, preparing to release the proximal end of the artificial implant.

[0173] like Figures 5B to 5E , keep the third axis stationary, push the second axis toward the distal end, and move the control end of the pull wire 11 toward the distal end, so that the part of the pull wire 11 exposed outside the base gradually stretches, allowing the artificial implant 400 (mainly the proximal part) to gradually expand, and the pull wire outside the base 10 will gradually stretch along the direction of the arrow until Figure 5F , the artificial implant 400 is in an expanded state (ie, the expected amplitude), and after it is confirmed that it is in accordance with the expected fit with the surrounding tissue, the pull wire can be released.

[0174] When releasing the pull line, Figure 5G to Figure 5I , rotate the first shaft to drive the lock to rotate relative to the base, and release the restrictions of each pull wire 11, so that each free end is completely separated from the lock. Figure 5H , withdraw the second axis toward the proximal end, so that the control end of each pull wire moves toward the proximal end, so that the free end 111 is separated from the artificial implant 400; finally, Figure 5I After re-docking the loading section and the sheath, the control mechanism is withdrawn out of the body as a whole.

[0175] In addition, before the cable is unlocked, a retraction operation can be performed as needed, see Figure 5J ( Figure 5G )~ Figure 5L The corresponding operation:

[0176] The control end of the pull wire is driven proximally, thereby retracting the proximal end of the artificial implant through the pull wire, while the distal end of the artificial implant remains expanded. The first shaft is driven to move proximally, along with the loading section 211, until the loading section 211 is radially inward of the artificial implant. The artificial implant and the sheath are then moved relative to each other, for example, by driving other components outside the sheath proximally relative to the sheath, or by pushing the sheath distally until the sheath completely encloses the artificial implant.

[0177] It should be noted that the position of the axis in the figure has no limiting meaning, and the control end can be very long or very short, or the pull wire can be directly connected to the control handle for direct retraction and extension.

[0178] For the control of the pull wire, the control end of the pull wire may be extended and directly controlled by the control handle.

[0179] An embodiment of the present application further provides an artificial implant loading method implemented in a wire-controlled manner, comprising:

[0180] A control mechanism according to the aforementioned embodiment is provided, wherein the free end of the pull wire passes through the proximal end of the artificial implant, is coupled to the locking member, and is restrained to the base by the locking member;

[0181] The pull wire has a control end opposite to the free end, and the control end is moved to gradually shrink the portion of the pull wire exposed outside the base and drive the proximal end of the artificial implant to deform radially;

[0182] A sheath is provided, and the sheath moves relative to the artificial implant from the proximal end to the distal end around the artificial implant until the sheath completely covers the artificial implant.

[0183] The specific operation is carried out in vitro. First, the free end of the pull wire is passed through the proximal end (such as the eyelet) of the artificial implant, and then the free end is guided by an instrument (such as the wire holding device described below) and extended into the locking area of ​​the base.

[0184] The first shaft is driven to move the loading section proximally to complete the engagement with the locking element. The loading section is now radially inward of the artificial implant. The first shaft is then driven to rotate, thereby driving the locking element to rotate through the free end into the locking hole of the base, thereby completing the binding of the pull wire.

[0185] The first shaft and the loading section are pushed distally until the loading section exits the artificial implant, and the control end of the driving wire moves proximally to compress the proximal end of the artificial implant.

[0186] The distal end of the artificial implant (the distal end of the inner frame) is compressed by an instrument (such as a crimper), driving the loading section to move proximally and wrap around the distal end of the inner frame, and then the artificial implant and the sheath are moved relative to each other, for example, driving other components outside the sheath to move proximally relative to the sheath, or pushing the sheath toward the distal end until the sheath completely wraps around the artificial implant.

[0187] The pull wire, artificial implant and control mechanism are pre-installed.

[0188] The present application also provides a catheter assembly that is easy to recover, comprising:

[0189] The intermediate shaft assembly is used for releasably connecting the artificial implant 400 by wire control. The intermediate shaft assembly may include the second shaft, the third shaft and the control mechanism in the aforementioned embodiment, or adopt other existing wire control methods.

[0190] The first shaft 21 extends through the interior of the intermediate shaft assembly to the distal end. The extended portion includes a loading section 211. The loading section 211 is tubular and open toward the proximal end. The loading section 211 utilizes a radially deformable structure to accommodate being enclosed by the artificial implant 400 during retrieval. The structure of the first shaft 21 may refer to the aforementioned embodiments or other existing structures.

[0191] The catheter sheath 70 is slidably disposed on the outer periphery of the intermediate shaft assembly, and is used to cooperate with the loading section 211 to accommodate the artificial implant 400 during interventional delivery, and to accommodate the artificial implant 400 and wrap part or all of the loading section 211 during retrieval.

[0192] Before releasing the artificial implant 400, the loading section 211 and the catheter sheath 70 dock with each other and wrap the artificial implant 400; Figures 5F to 5H When the artificial implant 400 is recovered, at least the distal end of the artificial implant 400 expands outward. At this time, the first shaft 21 is operated to drive the loading section 211 to move proximally and at least partially be located within the artificial implant 400 in the axial position. If the proximal end of the artificial implant expands, the first shaft 21 is driven to retract the pull wire 11 until the proximal end of the artificial implant is compressed; then the guide sheath 70 is driven to move distally to drive the artificial implant 400 to radially retract. During the retraction process, the artificial implant 400 will radially press against the loading section 211 and cause it to deform. The final axial position of the guide sheath 70 passes over the distal end of the artificial implant 400, or passes over the distal end of the loading section 211.

[0193] The loading section 211 utilizes a radially deformable structure, enabling a new recovery step. Compared to existing systems, this eliminates the need for docking with the catheter sheath 70. Furthermore, the loading section 211 experiences no resistance during proximal movement, improving operational convenience and smoothness. This also eliminates sharp points at the docking location. Furthermore, when the artificial implant radially presses against the loading section, the loading section will not rupture. After recovery, the radial forces acting on the catheter sheath are reduced, maintaining a substantially identical outer diameter to the existing one, facilitating subsequent removal from the body.

[0194] The radial deformation of the loading section 211 can be achieved by using a relatively soft material, such as an elastic polymer material such as Pebax, TPU, or nylon, and / or by adopting a corresponding structure, such as at least partially hollowing out the loading section 211. Furthermore, during recovery, a relatively large space exists within the loading portion 216 for deformation, thereby allowing for greater radial compression of the artificial implant 400.

[0195] In one embodiment, the loading section 211 is provided with a plurality of pre-formed portions along the circumference to guide its own radially deformable structure, and the pre-formed portions are radially inwardly recessed folds and / or thinned areas.

[0196] The artificial implant 400 includes an inner frame 410 with multiple arms 430 around its periphery. Each arm 430 forms a first gap with the inner frame 410 to accommodate native tissue. During preoperative loading, the number of pre-formed sections and arms 430 is the same, allowing for verification of circumferential alignment and slight deformation to avoid the arms 430, minimizing the outer diameter. During retrieval, the loading section 211, located within the inner frame 410 and driven radially by the distal end of the inner frame 410, folds in an orderly manner under the guidance of the pre-formed sections to minimize interference with the deformation of the inner frame 410.

[0197] In one embodiment, the locking element 13 is located between the base 10 and the loading section 211, and is coupled to the first shaft 21 in a clutch-type manner. The coupling method may refer to the aforementioned embodiment.

[0198] In one embodiment, the loading section 211 is provided with a display mark for the operator to observe the position of the loading section 211. In some embodiments, the loading section 211 is provided with a display mark along the entire axial direction, or is provided with a display mark near its proximal end.

[0199] The loading section 211 comprises a composite multi-layer structure, with the development mark positioned within a sandwich layer. The development mark can be composed of a relatively small powdered material, such as metal powder, such as gold powder, or a preformed strip-like structure with a molding material. The strip-like structure can be a mesh structure or partially hollowed-out, and is a radially non-rigid structure. For example, the loading section 211 includes at least a first layer, a second layer, and a third layer from the inside out. The second layer is the development mark, and at least one of the first and third layers is a thermoplastic material. During processing, metal powder is applied to the first or third layer, or a preformed ring or strip is loaded.

[0200] See Figures 6 to 8A The present application also provides a catheter sheath 70 for long-distance intervention, having a distal end and a proximal end relative to each other. The catheter sheath 70 includes a tubular body 730 and a hemostatic valve 720. The tubular body 730 includes:

[0201] The main body section 731 has a hemostatic valve 720 connected to the proximal end of the main body section 731 . The main body section 731 has a structural reinforcement layer at least near the distal end. The reinforcement layer is a metal tube with a hollow structure.

[0202] The deformation section 732 is located at the distal end of the main section 731. The deformation section 732 includes a metal mesh 734 connected to the metal tube and a coating 733 that wraps the metal mesh 734. The metal mesh 734 has a relative initial state and an expanded state. In the expanded state, the deformation section 732 as a whole has a flared structure. Relative to the initial state, the axial shortening rate of the metal mesh in the expanded state is adapted to the deformation of the coating 733. The axial shortening rate of the metal mesh 734 is mainly the rate of change from the initial state to the expanded state. Correspondingly, the axial elongation rate of the metal mesh 734 is adapted to the deformation of the coating 733, and the axial elongation rate is mainly the rate of change from the expanded state to the initial state (hereinafter referred to as reset).

[0203] It should be noted that the axial shortening rate is the ratio of the axial length of the metal grid 734 between two time points during the expansion process. The axial shortening amount can also be used, that is, the difference in the axial length of the metal grid 734 between two time points during the expansion process.

[0204] The coating 733 is made of an elastic material, for example, TPU, PET, or other elastic polymer materials at the deformation section, with a thickness of 0.1 to 0.3 mm. Furthermore, the coating 733 is connected to the metal mesh 734 and is subject to the constraints of the metal mesh 734 during the actual expansion or reduction process. Therefore, the shape and material of the metal mesh 734 must be considered to ensure that the metal mesh 734 maintains the same axial deformation as the coating 733 during the expansion or reduction process, thereby preventing the coating 733 from tearing or breaking during the expansion of the deformation section 732 and after the deformation section 732 returns to its initial state.

[0205] Since the deformation amount of the coating 733 at each axial position is different, for ease of understanding, the following description is made by taking the axial shortening amount of the metal grid 734 and the coating 733 at the axial distal end as an example:

[0206] like Figure 8B and Figure 8C As shown, the coating 733 is in the process of expansion at the deformation section 372, and the coating 733 is deformed and the axial deformation amount is X1. The metal grid 734 has multiple circles along the axial direction, and each circle includes multiple diamond grids 735. Figure 8C In the figure, one side (thick line) of one of the diamond grids 735 (the dotted line represents the initial state, and the solid line represents the expanded state) is taken as an example, and its axial deformation during the expansion process is observed along the radial projection. The axial deformation of the side is X2, and X2 is approximately equal to X1. Preferably, X2 = X1.

[0207] Among them, the metal grid adopts memory alloy.

[0208] In one embodiment, the length of the tube 730 is at least 60 cm, for example, in the range of 60 to 90 cm.

[0209] The distal end of the tube body 730 has a pre-shaped configuration that matches the shape of the aortic arch. This reduces safety risks associated with the catheter sheath 70 during interventional delivery and provides better shape matching once in place. The pre-shaped tube body 730 establishes a delivery channel for the bending adjustment assembly and the inner shaft assembly, facilitating their in vivo bending and simplifying the structure of the bending adjustment assembly, for example by eliminating the number of bending parts. The pre-shaped tube body 730 can also work in conjunction with the bending adjustment assembly to achieve more precise bending and centering.

[0210] See Figures 6 to 10 The present application provides a control handle 300 with a bending mechanism. The control handle 300 includes a bending assembly, which includes a bending sheath 29 and a bending piece 28. The proximal end is fixed to the control handle 300. The bending sheath 29 is located in the catheter sheath 70 and is slidable relative to the catheter sheath 70. One end of the bending piece 28 extends to the distal end of the bending sheath 29 and acts on the catheter sheath 70 to bend it and pass through the body. The other end is controlled by the bending mechanism. The distal end of the bending piece can be fixed to the distal end of the bending sheath 29, or relatively movable. The bending piece can be a wire, a tube, or a combination of a wire and a tube. For example, the bending piece is a bending wire fixed to the bending sheath, which makes the bending sheath bend, or the bending piece includes a bending tube and a bending wire connected to the bending tube, and the bending wire drives the bending tube to drive the bending sheath to bend.

[0211] The control handle 300 has a support body 310, and the bending mechanism includes:

[0212] The winding wheel 371 is rotatably mounted on the support body 310 to drive the bending member 28;

[0213] Knob 372, linked to the winding wheel 371;

[0214] The one-way engaging structure acts between the support body 310 and the knob 372 and has a relative limiting state and a releasing state. In the limiting state, the winding wheel 371 is only allowed to rotate in one direction.

[0215] The bending range is related to the amount of change in the bend adjustment member 28. The bend adjustment member 28 rotates and winds around the proximal end, reducing the axial length of the control handle 3 and increasing the bending range. The one-way locking structure is in a limited position when no force is applied, preventing accidental knob movement and limiting rotation to maintain the directional orientation of the bend adjustment sheath 29.

[0216] The rotation axis of the winding wheel 371 is perpendicular to the axial direction of the control handle, wherein the winding wheel 371 has a first direction of bending when rotating, and a second direction of resetting by the bending member 28. The direction of unidirectional rotation is the first direction, and the unidirectional locking structure can limit the rotation of the winding wheel 371 in the second direction before being released.

[0217] See Figures 11 to 14 In one embodiment, at least a portion of the support body 310 serves as a support 311, and the knob 372 is rotatably mounted on the support 311. The one-way engaging mechanism includes:

[0218] The first tooth surface 3721 is located on one side of the axial direction of the knob 372;

[0219] The second tooth surface 3111 is located on the support 311 and meshes with the first tooth surface 3721. The first tooth surface 3721 and the second tooth surface 3111 adopt mutually matching tooth shapes and one-way transmission;

[0220] The first elastic member 373 forces the knob 372 and the support 311 to axially abut against each other, maintaining the meshing of the first tooth surface 3721 and the second tooth surface 3111, thereby restricting the knob 372 from rotating in the second direction. When the knob 372 rotates in the first direction, the two tooth surfaces drive the knob 372 to move axially, disengaging the first tooth surface 3721 from the second tooth surface 3111. The first elastic member 373 then re-engages the two tooth surfaces. In the figure, the first elastic member 373 is a spring.

[0221] In one embodiment, the linkage between the knob 372 and the winding wheel 371 can be separated by overload, and the overload separation is manifested in that the winding wheel 371 cannot rotate due to overload, while the knob 372 can continue to rotate. Specifically, "overload" occurs when the winding wheel 371 continues to rotate in the first direction until the bending adjustment sheath 29 bends to the limit and reacts on the bending adjustment member 28, restricting the winding wheel 371 from continuing to rotate in the first direction. "Overload separation" is manifested in that when an overload occurs, the knob 372 and the winding wheel 371 are released from engagement, allowing the knob 372 to continue to rotate in the first direction, thereby reducing the risk of damage to the bending adjustment mechanism due to excessive force during the bending adjustment operation and improving safety. Among them, the linkage between the knob 372 and the winding wheel 371 includes direct linkage or indirect linkage through a transmission member.

[0222] In one embodiment, the knob 372 and the reel 371 are interconnected via a transmission shaft 374, and the transmission between the knob 372 and the transmission shaft 374, or between the transmission shaft 374 and the reel 371, can be disengaged in the event of an overload. The transmission shaft 374 is circumferentially fixed to one of the two and can be in either a disengaged or engaged state relative to the other.

[0223] See Figures 11 to 18The knob 372, the winding wheel 371, and the transmission shaft 374 are arranged coaxially, wherein the knob 372 and the transmission shaft 374 are fixed circumferentially and slidably matched axially, and the first elastic member 373 acts between the knob 372 and the transmission shaft 374; the transmission shaft 374 and the winding wheel 371 are engaged with an overload-separated protective tooth surface, and the transmission shaft 374 and the winding wheel 371 are also acted upon by a second elastic member 375 to maintain the engagement of the protective tooth surfaces. The protective tooth surface includes a first protective tooth surface 3741 provided on the transmission shaft 374, and a second protective tooth surface 3713 provided on the winding wheel 371 and engaged with the first protective tooth surface 3741. The protective tooth surface is V-shaped. When not overloaded, the transmission shaft 374 engages with the winding wheel 371 under the action of the second elastic member 375, and the knob 372 drives the two to rotate synchronously in the same direction; once overloaded, the transmission shaft 374 can slide along the axial direction of the knob to release the engagement with the winding wheel 371.

[0224] The winding wheel 371 is provided with an axial through hole 3715 extending along the axial direction of the knob, and the transmission shaft 374 is passed through the axial through hole 3715. One end of the transmission shaft 374 has a radially outwardly extending shoulder 3742. The inner wall of the axial through hole 3715 is provided with a step 3714 that abuts against the shoulder 3742 along the axial direction. The first protective tooth surface 3741 is arranged on the shoulder 3742, and the second protective tooth surface 3713 is arranged at the abutment portion of the step 3714. The winding wheel 371 is provided with a head 376. The two ends of the second elastic member 375 abut against the head 376 and the transmission shaft 374 respectively. The head 376 is detachably connected (threaded) to the end of the axial through hole 3715 of the winding wheel 371.

[0225] The knob 372 is provided with a retaining hole 3722 that cooperates with the transmission shaft 374 to maintain the circumferential fixation of the two. The end of the transmission shaft 374 away from the shoulder 3742 is slidably inserted into the retaining hole 3722 to maintain the circumferential fixation and axial sliding fit of the two. The cross-sectional profile of the retaining hole 3722 is a regular polygon.

[0226] In one embodiment, the support 311 and the support body 310 are an integral or separate structure. The support 311 includes two supports arranged side by side and each has a mounting hole 3112 therein. The winding wheel 371 includes:

[0227] The working section 3711 is used for winding the bending adjusting member 28;

[0228] The mounting sections 3712 are located on both sides of the working section 3711 and are rotatably fitted into the mounting holes 3112 on the corresponding sides.

[0229] In one embodiment, the knob 372 includes:

[0230] The grip portion 3723 is exposed on the outside of the control handle for gripping and applying force;

[0231] An inner sleeve 3724 is fixed to one side of the grip portion 3723 and extends into the axial through hole 3715 of the winding wheel 371;

[0232] The outer sleeve 3725 is fixed to the holding portion 3723 and is located on the outer periphery of the inner sleeve 3724 . The first tooth surface 3721 is located on the end surface of the outer sleeve 3725 .

[0233] The mounting section 3712 of the reel 371, which faces the grip portion 3723, extends into the radial gap between the inner sleeve 3724 and the outer sleeve 3725. A transmission shaft 374 extends into the inner sleeve 3724. A connecting pin 377 extends along the axis between the transmission shaft 374 and the knob 372. The connecting pin 377 is constrained at both ends by the knob 372 and the transmission shaft 374, respectively. A first elastic member 373 is axially pressed between the connecting pin 377 and the knob 372.

[0234] Combined with the movement of the knob 372 , it can slide along the axial direction of the connecting pin 377 to release the engagement between the first tooth surface 3721 and the second tooth surface 3111 .

[0235] See Figures 19 to 25 In another embodiment, the knob 372 and the transmission shaft 374 are relatively fixed in the axial and circumferential directions. The circumferential fixation is similar to the above embodiment, and the axial relative fixation is achieved, for example, by bolting. The transmission shaft 374 passes through the axial through-hole 3715 and is provided with a shoulder 3742. A step 3714 is formed corresponding to the axial through-hole 3715 and abuts against the shoulder 3742 along the axial direction. The first protective tooth surface 3741 is arranged on the shoulder 3742, and the second protective tooth surface 3713 is arranged at the abutment portion of the step 3714.

[0236] One end of the transmission shaft 374 passing through the axial through hole 3715 is connected and fixed with the head 376, and the one-way clamping mechanism includes a fifth elastic member 379 with two ends acting on the head 376 and the winding wheel 371 respectively.

[0237] In another embodiment, a dial button 378 with a second tooth surface 3111 is movably provided on the support body 310. Specifically, the dial button 378 is rotatably mounted on the support body 310. Turning the dial button 378 releases the engagement between the first tooth surface 3721 and the second tooth surface 3111. The first tooth surface 3721 is provided on the circumferential surface of the transmission shaft 374.

[0238] In this embodiment, the limiting hole 3722 is defined on the transmission shaft 374 .

[0239] Most bending sheaths use a pebax tube with lower hardness or a gradual transition method of splicing pebax tubes of different hardness, that is, the part of the sheath head that needs to be bent uses a pebax tube with lower hardness, and the middle and rear ends use a pebax tube with higher hardness. On the one hand, this structure causes the bending sheath to partially bend during bending (the bending part mentioned below), and it will shrink, which will cause the position of the head end (distal end) that was originally aligned when used with other pipes to be offset by a large deviation, affecting the surgical effect; on the other hand, when it is retrieved, it needs to be straightened and withdrawn, and some artificial implants need to be retrieved into the sheath for retrieval. Since the hardness of the pebax tube at the adjustable part of the bending sheath is relatively low, the large bend side of the bending part is easily squeezed by the squeezing force generated when the sheath is straightened and retrieved, causing wrinkles, affecting the retrieval / retrieval operation of the delivery system.

[0240] See Figure 26 and Figure 27 The present application also provides a bending adjustment sheath 29, wherein a portion of the bending adjustment sheath 29 (i.e., the bending adjustment portion) includes multiple segments distributed along its own axial direction, and the hardness of each segment increases from far to near. There is a splicing portion 2905 between adjacent segments, and the splicing method between adjacent segments is that the axial ends of each other abut against each other, and the splicing seam is covered by a connecting sleeve; or they are plugged into each other and radially overlap at the plug-in portion. The splicing portion 2905 can be fixed by fusion or bonding.

[0241] The bending sheath 29 also includes a support bar 291 extending axially through the joint 2905. The hardness of the support bar 291 is greater than or equal to the maximum hardness of the segments. The support bar 291 can extend through the segments by resting against the inner or outer circumference of each segment while maintaining the integrity of the original segments, or it can replace part of the original tubing.

[0242] The bending sheath plays a role in buffering, relieving pressure and supporting during the bending, straightening and recovery operations. For example, on the one hand, it alleviates and reduces the relative displacement change of the bending sheath 29 and the internal fittings during bending. On the other hand, the high-hardness support bar provides better support strength to ensure that the conveying system and the bending sheath avoid the extrusion force generated on the large bend side of the bending sheath during straightening and recovery, which will squeeze the large bend side of the sheath into wrinkles.

[0243] In which, when the bending adjustment sheath 29 is in a straight state, the support bar 291 extends in a straight line along the axial direction of the bending adjustment sheath. Preferably, the bending adjustment sheath 29 is bent during delivery and has a relative inner side 292 and an outer side 293 (the aforementioned large bend side), and the support bar 291 is located on the outer side 293.

[0244] In one embodiment, the support strip 291 is strip-shaped and circumferentially joined to the segments. The support strip 291 has the same wall thickness as the segments, and the inner and outer circumferences of the bending sheath 29 are smooth. In one embodiment, the ratio of the outer circumference of the bending sheath 29 to the circumferential length of the support strip is 4.0 to 6.0, preferably 5.0. The thin, elongated strips of high-hardness PEBAX material are used in a smaller amount, achieving the aforementioned effects without compromising the bending performance and usability of the overall bending sheath.

[0245] The bending adjustment parts of the bending adjustment sheath 29 in the figure are the first section 2901, the second section 2902 and the third section 2903 from far to near, and the proximal end of the bending adjustment part in the figure is connected to the control handle through the fourth section 2904, wherein the hardness of the first section 2901 to the fourth section 2904 are 40D, 55D, 63D and 72D respectively, and the hardness of the support bar 291 is 72D, corresponding to the distal end of the support bar 291 extending to the distal end of the first end 2901, and the proximal end extending to at least the proximal end of the third section 2903.

[0246] The present application also provides a method for processing a bending sheath tube, comprising:

[0247] S100, splicing multiple sections of raw tubes of the bending sheath tube in sequence to obtain a semi-finished product;

[0248] S200, cutting along the axial direction to form an incision in a designated area of ​​the semi-finished product, and the incision extends to all the splicing parts of each section of the raw pipe;

[0249] S300: Provide a support bar, embed the support bar into the incision and fix it to the surrounding parts to obtain a bending sheath.

[0250] In S100, raw pipes of varying hardness are arranged in order from farthest to closest and from lowest to highest hardness. Adjacent sections of raw pipe are then joined end to end, or abutted against each other end to form a joint sleeve. In S100, the processing method further includes providing a mandrel, over which the sections of raw pipe are sleeved.

[0251] In S200, the designated area is located on the large bend side of the semi-finished product, and the circumferential width is 0.15 to 0.25 of the outer circumference of the semi-finished product, preferably 0.2.

[0252] In S300, after the support strip is inserted into the cutout, heat shrink tubing is applied to form the tube body to be heat-fused. A heat-fusion device is used to heat-fuse the assembled tube body. After cooling, the surface consumable heat shrink tubing is peeled off and the central core rod is removed to obtain the desired bending sheath. The specific structure of the finished bending sheath and support strip is referenced to the previous embodiment.

[0253] Artificial implants inevitably require circumferential twisting to achieve precise positioning before delivery at the lesion site. Therefore, some tubing must possess sufficient torsional resistance. However, existing tubing often suffers from deficiencies in achieving this torsional resistance. To achieve superior bending flexibility, large-logarithmic tubing utilizes braided mesh or spring tubing as the rigid support in the center, with the surface layer constructed from softer PEBAX tubing. During surgical procedures, the delivery system's control handle provides significant grip and torque during circumferential twisting of the delivery tubing, resulting in a lack of torque resistance. This can directly or indirectly cause rotational delays or even damage during the twisting operation.

[0254] See Figure 28 The present application also provides a catheter assembly comprising at least one tubular member for manipulating an artificial implant 400. A support frame 2951 is provided at the proximal end of the tubular member. The support frame is a metal tube with a hollowed-out area 2952. Support frame 2951 provides high structural strength to withstand the clamping and twisting of the tubular member by the control handle, reducing or avoiding radial deformation of the tubular member and thereby reducing the size of its internal passage. The tubular member includes the aforementioned intermediate shaft assembly and first shaft, ensuring smooth relative sliding of the tubular members while also taking into account the responsiveness of the twisting operation.

[0255] The tube has opposing distal and proximal ends, with the proximal end having a connecting section 294 connected to the control handle. The tube is a composite multilayer structure, with a support frame 2951 positioned within the interlayer. For example, the tube comprises three layers radially from the inside out: the first layer is a PTFE inner membrane, the third layer is a PEBAX tube, and the second layer comprises the support frame 2951 at the connecting section 294, and an intermediate support spring tube or braided mesh tube connected to the distal end of the support frame 2951. The hollow structure facilitates the bonding of the first and third layers, which can be achieved by thermoplastic bonding.

[0256] In one embodiment, the metal tube 2951 can be made by punching holes in a stainless steel tube.

[0257] See Figure 28 and Figure 29 The present application also provides a delivery system, including a control handle and a catheter assembly, wherein the control handle 300 includes a support body 310, a connecting seat 320 slidably mounted on the support body 310, and a driving member 330 movably mounted on the support body 310 for driving the connecting seat 320 to move; the catheter assembly includes at least one tube for manipulating the artificial implant 400 (the first axis 21 is shown as an example), and a support frame 2951 is provided at the proximal end of the tube, and the support frame 2951 is fixed to the connecting seat 320.

[0258] The technical features of the above embodiments may be combined in any manner. To simplify the description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there are no conflicts in the combination of these technical features, they should be considered to be within the scope of this specification. When technical features in different embodiments are reflected in the same figure, it can be regarded as that figure also discloses the combination examples of the various embodiments involved.

[0259] The above embodiments merely illustrate several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person skilled in the art could make numerous variations and improvements without departing from the spirit of the present application, all of which fall within the scope of protection of the present application.

Claims

1. A delivery system for delivering an artificial implant, characterized in that: The delivery system includes a catheter assembly and a control handle. The catheter assembly includes a first shaft. A guide head is fixedly provided at the distal end of the first shaft. The guide head is further provided with a guidewire cavity penetrating the guide head and used to pass a guidewire. The guide head includes: A guide portion is provided at the distal end of the guide head, wherein the distal end of the guide portion has a tapered structure extending along the axial direction and gradually converging from the proximal end to the distal end; a connecting portion connected to the first shaft and disposed at a proximal end of the guide head; The deformation portion is connected between the guide portion and the connection portion.

2. The conveying system according to claim 1, characterized in that The deformation portion has a smaller deflection than the guide portion and the connection portion.

3. The conveying system according to claim 1, characterized in that The deformation portion is at least partially radially retracted relative to the guide portion and the connecting portion.

4. The conveying system according to claim 1, characterized in that The number of the deformation portion is one or a plurality of portions spaced apart along the axial direction, and transition portions are provided between adjacent deformation portions.

5. The conveying system according to claim 4, characterized in that The deflections of the deformation parts are the same or different.

6. The conveying system according to claim 1, characterized in that The guide head is an integrated structure or each part of the guide head is a separate structure.

7. The conveying system according to claim 1, characterized in that The proximal end of the guide portion has a first extension portion extending in equal diameter, the distal end is the conical structure, and the distal end of the connecting portion has a second extension portion extending in equal diameter.

8. The conveying system according to claim 7, characterized in that The first extension portion and the second extension portion have the same diameter.

9. The conveying system according to claim 7, characterized in that The axial distance of the first extension portion is L3, the axial distance of the second extension portion is L4, and the axial distance of the deformation portion is L5, wherein L3:L4=1, L5:L3=4-8.

10. The conveying system according to claim 1, characterized in that The minimum diameter of the deformation portion is D1, the maximum diameter is D2, and D2 / D1=1.5-2.5.

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