A compression sleeve set for guiding the deformation of an artificial implant

Abstract

The application relates to a compression sleeve set for guiding deformation of an artificial implant, comprising a supporting assembly including an auxiliary guide tube and an inner tube, the inner tube having a lumen for the auxiliary guide tube to pass through, one end of the auxiliary guide tube being provided with a coupling structure which can be exposed to the inner tube and establish a detachable temporary connection with the artificial implant; a guiding assembly including an outer tube and a guide cylinder which is connected to the outer tube in a docking mode, the guide cylinder having a guiding cavity which is gradually tapered towards the outer tube, the auxiliary guide tube driving the artificial implant to enter the outer tube via the guiding cavity, and the artificial implant being radially compressed under the action of the guiding assembly. The application can improve the loading efficiency of the artificial implant and reduce the operation difficulty by improving the components in the compression sleeve set and the auxiliary device and the adaptive method.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more particularly to a pressure gripping kit for guiding the deformation of artificial implants. Background Technology

[0002] In the field of interventional medicine, the application of artificial implants (such as artificial blood vessels, artificial heart valves, etc.) requires the use of interventional delivery systems to complete in vivo delivery. Generally, the artificial implant is first deformed radially to reduce its diameter, then loaded into the catheter assembly of the interventional delivery system, and finally delivered to the designated location and released by the catheter assembly.

[0003] To achieve radial compression and loading of artificial implants, existing technologies generally use gripping devices or guiding devices as tooling. However, the tooling consists of a large number of components, and some components have complex structures, which not only increases manufacturing costs but also makes the compression operation cumbersome and poses a risk of failure during operation.

[0004] The shortcomings of the aforementioned device structure and operation directly result in a cumbersome and time-consuming implant loading process, which not only reduces the efficiency of clinical interventional surgery but also adversely affects subsequent in vivo delivery and treatment outcomes. Therefore, simplifying the structure of the implant gripping device and optimizing the loading process have become urgent technical problems to be solved in this field. Summary of the Invention

[0005] This application provides an auxiliary guide tube that establishes a detachable temporary connection with an implant to facilitate rapid and uniform entry of the implant tip into a guide assembly. The guide assembly guides the deformation of the inflated implant, thereby loading it into the interventional delivery catheter in a compressed state.

[0006] Optionally, the artificial implant is a radially deformable tubular structure having a compressed state with a first diameter and an expanded state with a diameter greater than a second diameter, such as an artificial heart valve, vascular stent, or occluder.

[0007] Optionally, the auxiliary guide tube includes a tube body, and the tube body is provided with a coupling structure for establishing a temporary connection with the artificial implant.

[0008] Optionally, the coupling structure is provided at one or both ends of the tube.

[0009] Optionally, the coupling structure and the auxiliary guide tube can be integrated or separate structures.

[0010] Optionally, the auxiliary guide tube is a solid rod or a hollow tube.

[0011] Optionally, the auxiliary guide tube is a hollow tube, and the coupling structure is provided by the tube wall of the hollow tube.

[0012] Optionally, the auxiliary guide tube has axial and / or circumferential markings for registration with the relative position of the artificial implant.

[0013] Optionally, the artificial implant has a first end and a second end that are axially and axially opposite each other, the coupling structure acting on the first end, and the second end having a plurality of connecting ears for connecting to an interventional delivery system.

[0014] Optionally, the artificial implant includes a radially deformable stent, wherein the stent has multiple mating portions arranged circumferentially at intervals at the first end, and the coupling structure acts on each of the mating portions.

[0015] Optionally, each of the mating parts is mounted on the coupling structure.

[0016] Optionally, the bracket has a grid structure, with each mating part located at the apex of the corresponding grid.

[0017] Optionally, the coupling structure is located at the end of the auxiliary guide tube.

[0018] Optionally, the coupling structure is movably mounted on the auxiliary guide tube.

[0019] Optionally, the auxiliary guide tube has two opposite ends along the axial direction, with the coupling structure located at one end and the opposite end serving as a control end for operating the movement of the coupling structure.

[0020] Optionally, the coupling structure has the following relative characteristics:

[0021] The auxiliary guide tube protrudes outward in the circumferential and / or radial direction for connection to the artificial implant.

[0022] The release position, which is recessed in the circumferential and / or radial direction of the auxiliary guide tube relative to the engagement position, allows the artificial implant to be released.

[0023] Optionally, the auxiliary guide tube is also equipped with a reset component that drives the coupling structure toward the engagement position.

[0024] Optionally, the reset element is an elastic element and rests against or is pulled against the coupling structure.

[0025] Optionally, the auxiliary guide tube shaft is provided with a receiving groove, and the coupling structure is located in the receiving groove in the disengaged position and protrudes outward from the receiving groove in the engaged position.

[0026] Optionally, the coupling structure is rotatably mounted in the receiving groove and can be switched between an engaged position and a disengaged position by rotation.

[0027] Optionally, the receiving groove is open on the outer peripheral wall of the auxiliary guide tube.

[0028] Optionally, the coupling structure itself is a deformable component.

[0029] Optionally, the coupling structure deforms based on at least one of the following: material elasticity, electrical signal, or magnetic signal.

[0030] Optionally, the operating end is provided with a control component that is linked to the coupling structure. The control component operates the movement and / or deformation of the coupling structure by means of mechanical transmission and / or electrical signals.

[0031] Optionally, the control element is connected to the coupling structure via a traction shaft.

[0032] Optionally, the traction shaft is a flexible component.

[0033] Optionally, the coupling structure may be a combination claw and / or a slot.

[0034] Optionally, the coupling structure is an eyelet located on the side wall of the auxiliary guide tube.

[0035] Optionally, the connecting claw is fixedly connected to the auxiliary guide tube or movably connected to the auxiliary guide tube.

[0036] Optionally, the coupling structure may be multiple and arranged circumferentially along the auxiliary guide tube.

[0037] Optionally, the slot is open at the end of the auxiliary guide tube.

[0038] Optionally, the connecting claw extends at a constant cross-section in the axial direction of the auxiliary guide tube or gradually converges towards the end shape.

[0039] Optionally, the connecting claws are divided into at least two groups, and the axial positions of the ends of the connecting claws in different groups are different.

[0040] Optionally, the connecting claws may have different lengths.

[0041] Optionally, the card slots are divided into at least two groups, and the axial positions of the slot openings in different groups are different.

[0042] Optionally, the card slots may have different depths.

[0043] Optionally, the coupling structure does not extend beyond the outer periphery of the auxiliary guide tube in the radial direction.

[0044] Optionally, the coupling structure is provided at both ends of the auxiliary guide tube.

[0045] Optionally, the coupling structures at both ends of the auxiliary guide tube can be configured differently to accommodate different artificial implants.

[0046] Optionally, the auxiliary guide tube has 2 to 6 connecting claws arranged at circumferential intervals at both ends, and the number of connecting claws at the two ends is different.

[0047] Optionally, the auxiliary guide tube adopts a split structure, including a tube body and an end cap detachably connected to the tube body, and the coupling structure is disposed on the tube body and / or the end cap.

[0048] Optionally, the tube body and the end cap are axially movable and interlocked.

[0049] Optionally, the end cap has two opposing sides, one side being a head with a converging shape, and the coupling structure is a plurality of coupling claws fixed to the other side.

[0050] Optionally, the axial end face of the tube body is provided with multiple insertion holes, and each of the connecting claws extends into the corresponding insertion hole.

[0051] Optionally, the coupling structure consists of multiple coupling claws fixed to the end of the tube body. The end cap has two opposing sides, one side of which is a head with a converging shape, and the other side is provided with multiple insertion holes that cooperate with the coupling claws.

[0052] Optionally, at least a portion of the connecting claw is exposed in the insertion hole, and the mating part is attached to the exposed portion of the corresponding connecting claw.

[0053] Optionally, the axial end face of the tube body is detachably connected to a connector;

[0054] The insertion hole is located on the connector, and the engagement claw is located on the end cap, or

[0055] The insertion hole is located on the end cap, and the connecting claw is located on the connector.

[0056] Optionally, the tube body is a pipe fitting, the connector has two opposite sides, one side of the connector is detachably inserted into the cavity of the pipe fitting, and the insertion hole or the connecting claw is provided on the other side of the connector.

[0057] Optionally, the connecting claw is in the shape of a straight rod.

[0058] This application also provides a pressure grip kit, including an auxiliary guide tube and a guide tube.

[0059] Optionally, the auxiliary guide tube is used to establish a detachable temporary connection with the artificial implant, and then guides the deformation of the expanded artificial implant through a guide component or guide tube, thereby loading the artificial implant into the interventional delivery catheter in a compressed state.

[0060] Optionally, the auxiliary guide tube includes a tube body, one or both ends of which have coupling structures that can establish a detachable temporary connection with the artificial implant.

[0061] Optionally, the guide tube has a guide cavity that gradually narrows in shape, and the auxiliary guide tube drives the artificial implant into the guide cavity, with each part of the artificial implant being gradually radially compressed.

[0062] The present invention also provides another pressure gripping kit for guiding the deformation of artificial implants, the pressure gripping kit comprising:

[0063] The support assembly includes an auxiliary guide tube, one end of which is used to extend into the artificial implant and establish a detachable temporary connection with the artificial implant.

[0064] A guiding assembly includes an outer tube and a guide cylinder connected to the outer tube. The guide cylinder has a guide cavity that gradually converges toward the outer tube. An auxiliary guiding tube drives the artificial implant through the guide cavity into the outer tube, and the artificial implant is radially compressed under the action of the guiding assembly.

[0065] Optionally, the support assembly further includes an inner tube having a lumen through which the auxiliary guide tube passes, one end of the auxiliary guide tube having a coupling structure that can be exposed to the inner tube and establish a detachable temporary connection with the artificial implant.

[0066] Optionally, the artificial implant is a radially deformable tubular structure.

[0067] Optionally, the artificial implant is an artificial heart valve, having an inflow end and an outflow end, including a stent and leaflets sewn into the stent. The stent is a radially deformable tubular structure with a blood flow channel inside. The leaflets are installed on the stent to control the blood flow channel. According to the normal blood flow direction of the environment in which the leaflets are located, the auxiliary guide tube acts on the stent and the point of action is located on the outflow side of the leaflets.

[0068] Optionally, the artificial implant has two axially opposite ends (i.e., the stent has two axially opposite ends), one end of which has a plurality of connecting ears for connecting to the interventional delivery system, and the coupling structure acts on the other end or on the end where the connecting ears are located.

[0069] Optionally, the coupling structure acts directly on the connecting ear.

[0070] Optionally, at least one of the two ends of the artificial implant is a bare frame structure and the coupling structure acts on that end.

[0071] Optionally, the artificial implant has a first end and a second end that are axially and axially opposed (i.e., the stent has a first end and a second end that are axially and axially opposed), the coupling structure acts on the first end, and the second end has a plurality of connecting ears for connecting to the interventional delivery system; the first end is located on the outflow side of the leaflet, and the second end is located on the inflow side of the leaflet.

[0072] Optionally, along the interventional delivery path, the artificial implant has a distal and a proximal end, wherein the connecting ear is located at the proximal end and the coupling structure acts at the distal end.

[0073] Optionally, the artificial implant is an artificial pulmonary artery heart valve.

[0074] Optionally, at least a portion of the interventional pathway is from the right ventricle into the pulmonary artery.

[0075] Optionally, the artificial implant has a first end and a second end that are axially and axially opposed (i.e., the stent has a first end and a second end that are axially and axially opposed), the first end is located on the inflow side of the leaflet, the second end is located on the outflow side of the leaflet, and the second end has a plurality of connecting ears for connecting to the interventional delivery system, and the coupling structure acts on the second end.

[0076] Optionally, the artificial implant may be a human aortic heart valve.

[0077] Optionally, at least a portion of the interventional pathway involves accessing the native aortic valve from the aortic arch.

[0078] Optionally, one end of the bracket has an enlarged diameter structure in the axial direction, and the coupling structure acts on the end of the enlarged diameter structure.

[0079] Optionally, one axial end of the bracket has an expanded diameter and a tapered structure after the expansion, and the coupling structure acts on the end of the tapered structure.

[0080] Optionally, the coupling structure is unidirectionally coupled to the artificial implant along the axial direction.

[0081] Optionally, after establishing a temporary connection, the auxiliary guide tube guides the artificial implant into the guiding component along a first direction; when the temporary connection is released, the auxiliary guide tube disengages from the artificial implant along a second direction opposite to the first direction.

[0082] Optionally, during the establishment of a temporary connection, the support component passes through the blood flow channel and through the leaflet from the inflow portion to the outflow portion.

[0083] Optionally, the artificial implant comprises, in sequence according to the process of radial compression deformation:

[0084] The artificial implant is in an inflated state before it enters the guiding component;

[0085] In the pre-compressed state, the artificial implant is in a pre-compressed state after entering the outer tube, and the artificial implant is generally cylindrical in the pre-compressed state.

[0086] Optionally, the artificial implant has an axial direction and two opposite ends along the axial direction, and the artificial implant enters a pre-compression state unidirectionally from one end of the axial direction to the other end.

[0087] Optionally, the support component further includes:

[0088] An inner tube that can extend into the artificial implant.

[0089] Optionally, the inner tube has a lumen through which the auxiliary guide tube passes.

[0090] Optionally, the inner tube is a straight tube.

[0091] Optionally, the coupling structure of the auxiliary guide tube is exposed at one end of the inner tube and establishes a temporary connection with the artificial implant.

[0092] Optionally, the auxiliary guide tube and the inner tube are inserted into the blood flow channel together and pass through the valve leaflet from the inflow portion to the outflow portion.

[0093] Optionally, when the temporary connection is released, the auxiliary guide tube is withdrawn from the inner tube, and the inner tube remains in the blood flow channel to isolate the auxiliary guide tube from the valve leaflet.

[0094] Optionally, the pre-compressed implant is located on the outer periphery of the inner tube.

[0095] Optionally, the outer tube and the guide cylinder are detachably connected.

[0096] Optionally, the outer tube and the guide cylinder are connected by a rotary engagement method.

[0097] Optionally, the outer tube is a straight tube.

[0098] Optionally, the outer tube is provided with a rotating engagement structure that cooperates with the guide cylinder.

[0099] Optionally, the guide cylinder has a conical structure, gradually increasing in diameter in the direction away from the outer tube.

[0100] Optionally, a first radial gap exists between the outer tube and the inner tube, the first radial gap at least accommodating the artificial implant.

[0101] Optionally, the pre-compressed implant is housed within the outer tube.

[0102] This application also provides a method for guiding the deformation of an artificial implant, the artificial implant having a first end and a second end that are axially and positioned opposite each other along the axial direction, the method comprising:

[0103] Applying force to the first end causes the artificial implant to enter a guide cavity that gradually narrows in shape towards the first end;

[0104] The artificial implant is further guided into a tube via the guide cavity, so that the artificial implant is gradually compressed radially from the first end to the second end until it is in a cylindrical shape.

[0105] Optionally, the method further includes:

[0106] An auxiliary guide tube is provided, which extends through the second end and is connected to the first end inside the artificial implant, and when force is applied, force is applied towards the first end through the auxiliary guide tube.

[0107] Optionally, the method further includes:

[0108] A guiding assembly is provided, the guiding assembly including an outer tube and a guide cylinder connected to the outer tube, the guide cylinder providing the guiding cavity, and the outer tube providing the cavity.

[0109] Optionally, the method further includes:

[0110] An inner tube is provided, which is supported inside the artificial implant. An auxiliary guide tube passes through the inner tube, and one end of the auxiliary guide tube has a coupling structure and is exposed to the inner tube, and is connected to the first end through the coupling structure.

[0111] This application also provides a method for guiding the deformation of an artificial implant, the artificial implant having a first end and a second end that are axially and positioned opposite each other along the axial direction, the method comprising:

[0112] An auxiliary guide tube is provided, which is inserted into the artificial implant and temporarily connected to the first end of the artificial implant.

[0113] A guiding assembly is provided, the guiding assembly including an outer tube and a guide cylinder connected to the outer tube, the guide cylinder having a guide cavity that gradually converges toward the outer tube, the first end of the artificial implant being driven into the outer tube through the guide cavity by the auxiliary guiding tube, so that the artificial implant is gradually radially compressed from the first end to the second end under the action of the guiding assembly.

[0114] Optionally, the method further includes:

[0115] An inner tube is provided, and the inner tube is placed inside the artificial implant. One end of the auxiliary guide tube is provided with a coupling structure. The auxiliary guide tube is inserted into the inner tube and the coupling structure is exposed to the inner tube. A temporary connection is established with the first end through the coupling structure. The inner tube, together with the auxiliary guide tube and the artificial implant, enters the outer tube.

[0116] Optionally, the artificial implant is an artificial heart valve, including the stent and leaflets installed in the stent. The stent has a blood flow channel inside, with the first end located on the outflow side of the leaflet and the second end located on the outflow side of the leaflet according to the blood flow direction controlled by the leaflet.

[0117] This application also provides an auxiliary device for loading artificial implants into an interventional delivery system, comprising:

[0118] A compression and holding device for compressing and storing the artificial implant, wherein the compression and holding device described in this application is used;

[0119] A protective tube, movably fitted onto the interventional delivery system, receives the implant from the gripping sleeve, enabling the implant to be loaded into the interventional delivery system.

[0120] Optionally, the protective tube is a straight tube.

[0121] Optionally, the interventional delivery system includes a catheter assembly, the catheter assembly comprising:

[0122] A core tube having a connector for connecting the artificial implant;

[0123] An outer sheath is slidably fitted around the outer periphery of the core tube, and a second radial gap is provided between the core tube and the outer sheath for loading the artificial implant.

[0124] Optionally, the core tube extends through the connecting portion and further distally, with a guide head provided at the distal end, and the axial position of the artificial implant is located between the connecting portion and the guide head.

[0125] Optionally, the lumen of the protective tube can at least accommodate an artificial implant from the gripping kit.

[0126] Optionally, the lumen of the protective tube can at least accommodate a pre-compressed artificial implant.

[0127] Optionally, a first radial gap is provided between the outer tube and the inner tube, the first radial gap accommodating at least the artificial implant and the protective tube located on the periphery of the artificial implant.

[0128] This application also provides a method for loading an artificial implant into an interventional delivery system, the interventional delivery system including a core tube and a slidably sleeved outside the core tube, the radial gap between the core tube and the outer sheath being used for loading the artificial implant, the artificial implant having a first end and a second end axially and opposite to each other along the axial direction, the method comprising:

[0129] Applying force to the first end causes the artificial implant to enter a guide cavity that gradually narrows in shape towards the first end;

[0130] The artificial implant is further guided into a tube through the guide cavity, so that the artificial implant is gradually compressed radially from the first end to the second end until it is in a straight cylindrical shape and in a pre-compressed state.

[0131] The pre-compressed implant is transferred and loaded into the interventional delivery system.

[0132] Optionally, the method further includes:

[0133] Provide a protective tube, and fit the protective tube onto the outside of the outer sheath tube;

[0134] When transferring the artificial implant to the interventional delivery system, the protective tube is first slid relative to the outer sheath to the periphery of the artificial implant in a pre-compressed state, and then the outer sheath is moved into the radial gap between the protective tube and the artificial implant until the outer sheath wraps around the artificial implant to complete the loading.

[0135] This application also provides a method for loading an artificial implant into an interventional delivery system, the interventional delivery system including a core tube and a sliding outer sheath sleeved outside the core tube, the radial gap between the core tube and the outer sheath being used for loading the artificial implant, the method comprising:

[0136] The auxiliary device is provided to pre-compress the artificial implant into the radial gap between the inner and outer tubes of the auxiliary device;

[0137] The protective tube is fitted over the outside of the outer sheath.

[0138] The distal portion of the core tube is exposed to the outer sheath and inserted into the inner tube until the implant is entirely located on the periphery of the core tube while maintaining the axial relative position of the implant to the core tube.

[0139] The protective tube is pushed distally relative to the core tube until the artificial implant is received;

[0140] The outer sheath is pushed distally relative to the core tube, so that the outer sheath enters the radial gap between the protective tube and the artificial implant, until the outer sheath encloses the artificial implant and completes loading.

[0141] Optionally, after pre-compressing the artificial implant into the radial gap between the inner tube and the outer tube, the guide tube is separated from the outer tube.

[0142] Optionally, after pre-compressing the artificial implant into the radial gap between the inner tube and the outer tube, the auxiliary guide tube is removed from the inner tube.

[0143] Optionally, when the distal portion of the core tube is inserted into the inner tube, it is also moved distally out of the inner tube to avoid interfering with the connection.

[0144] Optionally, the core tube is provided with a connecting portion, and the artificial implant has a first end and a second end that are axially and opposite to each other along the axial direction, wherein the first end cooperates with the auxiliary guide tube, and the second end has a connecting ear; the artificial implant and the core tube are kept in axial relative position by engaging the connecting ear with the connecting portion.

[0145] Optionally, after the connecting ear and the connecting part are engaged, the outer sheath is moved distally to cover the engagement portion of the connecting ear and the connecting part.

[0146] Optionally, when the protective tube is pushed distally relative to the core tube, at least a portion of the protective tube extends into the radial gap between the outer tube and the artificial implant.

[0147] Optionally, when the protective tube is pushed to the distal end relative to the core tube, the outer tube is also removed to the distal end accordingly.

[0148] Optionally, after the outer sheath encapsulates the artificial implant and completes loading, the protective tube is removed distally.

[0149] This application also provides an interventional system, including the interventional delivery system, auxiliary device, and artificial implant described in this application.

[0150] This application improves the loading efficiency of artificial implants and reduces operational difficulty by modifying components in the gripping kit and auxiliary device, as well as by making adaptive improvements. Attached Figure Description

[0151] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0152] Figure 1 A schematic diagram of an artificial implant in an interventional system according to an embodiment of this application;

[0153] Figure 2 for Figure 1 A schematic diagram of an artificial implant from another angle;

[0154] Figure 3 A schematic diagram of the support component in a gripping kit according to an embodiment of this application;

[0155] Figure 4 for Figure 3 A magnified view of the auxiliary guide tube and its partial section;

[0156] Figure 5 for Figure 4 Another angle of the auxiliary guide tube and its enlarged section;

[0157] Figure 6 A schematic diagram of a guide component in a gripping kit according to an embodiment of this application;

[0158] Figure 7 This is a schematic diagram of a gripping kit according to an embodiment of this application;

[0159] Figure 8 for Figure 7 A schematic diagram of the outer tube and guide cylinder of the middle guide assembly after they are separated from each other;

[0160] Figure 9 This is a schematic diagram illustrating the use of the pressure-gripping kit of this application to guide the deformation of an artificial implant (in which the auxiliary guide tube has been temporarily connected to the artificial implant);

[0161] Figure 10 for Figure 9 A schematic diagram of the auxiliary guide tube driving the artificial implant toward the guide component;

[0162] Figure 11 for Figure 10 A schematic diagram showing the artificial implant inserted into the outer tube and in a pre-compressed state;

[0163] Figure 12 for Figure 11 A schematic diagram showing the guide tube after it has separated from the outer tube;

[0164] Figure 13 This is a schematic diagram of a catheter assembly in an interventional system according to an embodiment of this application;

[0165] Figure 14 for Figure 13 Enlarged view of the distal portion of the central catheter assembly;

[0166] Figure 15 This is a schematic diagram of the protective tube in the auxiliary device;

[0167] Figure 16 This is a schematic diagram and a partial enlarged view showing the cooperation of various components during the loading of an intervention system according to an embodiment of this application;

[0168] Figure 17 for Figure 16 Enlarged view of the mid-to-distal region;

[0169] Figure 18 for Figure 17 A schematic diagram showing the protective tube moving distally and retracting towards the proximal side of the implant;

[0170] Figure 19 for Figure 18 Enlarged view of the mid-to-distal region;

[0171] Figure 20 for Figure 19 A schematic diagram showing the protective tube moving distally to completely accommodate the artificial implant;

[0172] Figure 21 for Figure 20 Enlarged view of the mid-to-distal region;

[0173] Figure 22 for Figure 21 A schematic diagram showing the outer sheath moving distally and completely accommodating the artificial implant, indicating that loading is complete.

[0174] Figure 23 This is a schematic diagram of an artificial implant in an interventional system according to another embodiment of this application;

[0175] Figure 24 for Figure 23 A schematic diagram showing the interaction between the artificial implant and the auxiliary guidance tube;

[0176] Figure 25 This is a schematic diagram of an auxiliary guide tube according to an embodiment of this application;

[0177] Figure 26 This is a schematic diagram of an auxiliary guide tube according to another embodiment of this application;

[0178] Figure 27 for Figure 26 A schematic diagram showing the auxiliary guidance tube working in conjunction with the artificial implant;

[0179] Figure 28 This is a schematic diagram of an auxiliary guide tube according to another embodiment of this application;

[0180] Figure 29 This is a schematic diagram of an auxiliary guide tube according to another embodiment of this application.

[0181] The component labels are as follows:

[0182] 100. Artificial heart valve; 110. Stent; 111. Connecting lug; 112. Fitting part; 120. Leaflet; 121. Inflow portion; 122. Outflow portion; 130. Inner skirt;

[0183] 200. Support component; 210. Auxiliary guide tube; 211. Connecting claw; 212. Slot; 213. Tube body; 214. End cap; 215. Head; 216. Insertion hole; 217. Connector; 218. Insertion post; 220. Inner tube;

[0184] 300. Protective pipe; 310. Reinforced section;

[0185] 400. Guide assembly; 410. Outer tube; 411. Protrusion; 420. Guide cylinder; 421. Tapered section; 422. Connecting section; 423. Connecting groove;

[0186] 500. Catheter assembly; 510. Core tube; 511. Connector; 512. Protrusion; 513. Settling zone; 514. Guide head; 520. Outer sheath; 521. Loading section. Detailed Implementation

[0187] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0188] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on the other component or there may be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application's specification are for illustrative purposes only and do not represent the only possible implementation.

[0189] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0190] When indicating direction, the proximal end in this manual generally refers to the side closest to the operator (e.g., a physician), and the distal end is the side relatively far away. Along the interventional path, each component has its own relative distal and proximal ends. Theoretically, when the catheter assembly and 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 term "end" in this manual indicates the endpoint of the structure or a point or region in that lateral direction, or a specific structure connected to that point or region.

[0191] There are no strict restrictions on the application sites and structures of artificial implants. Taking artificial heart valves as an example in some illustrations or texts, artificial heart valves generally include a deformable stent and leaflets connected within the stent. The stent is cylindrical in shape with a perforated mesh structure on the side walls. Unless otherwise stated, there are no strict restrictions on the shape or size of the mesh structure. The stent contains blood flow channels, and multiple leaflets work together to control the opening and closing of the blood flow channels within the stent. For positioning within the body, positioning structures that can interact with the surrounding native tissues can be set on the periphery of the stent, such as anchors, arms, etc. To prevent leakage, skirts or anti-leakage materials can be set on the inner and / or outer sides of the stent.

[0192] Depending on the release mode, different materials are selected during stent manufacturing, such as shape-memory, self-expanding nickel-titanium alloys. The stent itself can be formed using tubing cutting or wire braiding, while the leaflets can be connected to the stent through stitching, bonding, or integral molding. Stents generally have a connection structure that mates with the catheter assembly to define their positions and prevent unnecessary displacement during delivery.

[0193] See Figure 1 , Figure 2 In some embodiments, the artificial heart valve 100, taking the artificial pulmonary valve as an example, includes a stent 110 and leaflets 120 connected within the stent 110. The stent 110 is a radially deformable tubular structure. To adapt to radial deformation, a grid structure formed by frame strips is specifically adopted. The inner side of the stent 110 is also covered with an inner skirt 130 to form a closed blood flow channel. The leaflets 120 are two or multiple leaflets that cooperate with each other to control the degree of opening and closing of the blood flow channel.

[0194] The artificial heart valve 100 has an axially and axially opposed first end and second end. It can also be understood that the stent 110 has an opposing first end and second end, one end of which has a connecting ear 111 and the other end has a mating part 112. The mating part 112 can form a detachable temporary connection with the auxiliary guide tube in this application for guidance when the artificial heart valve 100 is compressed.

[0195] Along Figure 1 The arrow points in the diagram, and the structure includes an inflow portion 121, a middle portion, and an outflow portion 122. The first end of the support 110 is located at the end of the outflow portion 122, and the first end has at least one mating part 112.

[0196] The mating portion 112 can be formed from the end cells of the outflow portion 122. For example, the bracket 110 can form multiple mating portions 112 at its first end through the convergent deformation of a mesh structure, or at the intersection or corner of the frame strips at the end of the bracket 110. In this embodiment, the outflow portion 122 can have a larger diameter than the middle portion, forming a flared or trumpet-shaped shape. For example, the outflow portion 122 has multiple petal-shaped cells, the ends of which are the mating portions 112.

[0197] The second end of the bracket 110 is located at the end of the inflow section 121, and the second end has a plurality of connecting ears 111 for connecting to the conveying system. The connecting ears 111 can be lugs or hanging rings that can engage with the conveying system. For example, the connecting ears 111 can be lugs formed by axial extension of the apex of the end cell or additional fixing components.

[0198] In this embodiment, the artificial pulmonary valve is delivered via catheter through the vena cava into the right atrium, then through the right ventricle into the pulmonary artery. Along the delivery path, the connecting ear 111 is located at the proximal end of the stent 110, closer to the handle of the delivery system, while the mating part 112 is located at the distal end of the stent 110, further away from the handle of the delivery system.

[0199] When other transcatheter delivery routes are used, or when other connection methods are used with the delivery system, the distal and proximal ends of the artificial heart valve 100 can be adaptively exchanged. Of course, the connecting ear 111 may also be adaptively located in the outflow portion 122 of the stent 110.

[0200] See Figures 3-12 , Figures 25-29 One embodiment of this application provides a gripping kit for guiding the deformation of an artificial implant, including a support component 200 and a guide component 400. The support component 200 is used to support and drive the artificial implant to move relative to the guide component 400, while the guide component 400 compresses the artificial implant through its own inner cavity to deform it, i.e., to radially contract it.

[0201] The support assembly 200 includes an auxiliary guide tube 210, one end of which is used to extend into the artificial implant and establish a detachable temporary connection with the artificial implant. This temporary connection allows the auxiliary guide tube 210 to apply force and move the artificial implant when it moves in a certain direction. The auxiliary guide tube 210 can be a solid rod or a hollow tube, and at least a portion of its outer diameter can be adapted to the size of the blood flow channel. The cross-sectional shape of the auxiliary guide tube 210 as a whole is not strictly limited. A portion of the auxiliary guide tube 210 may also have a handle or anti-slip structure for easy application of force.

[0202] One or both ends of the auxiliary guide tube 210 are provided with coupling structures to establish a temporary connection with the artificial implant. For example... Figures 3-5 As shown, the coupling structure can be integral with the auxiliary guide tube 210, for example, by machining the end of the auxiliary guide tube 210. The auxiliary guide tube 210 can also be a separate structure, wherein the coupling structure and other parts of the auxiliary guide tube 210 are detachable, such as... Figures 25-29 As shown.

[0203] When the auxiliary guide tube 210 and the artificial implant are released from temporary connection, they can move relative to each other along the axial direction, rotate relative to each other in the circumferential direction, or the coupling structure itself can deform and detach from the artificial implant. When the auxiliary guide tube 210 adopts a split structure, the coupling structure can also be separated from other parts of the auxiliary guide tube 210 (the separation method can be relative movement in the circumferential and / or axial direction) to release the temporary connection.

[0204] As one embodiment of the present invention, such as Figures 3-12The auxiliary guide tube 210 includes a tube body and a coupling structure located at the end of the tube body. The coupling structure can adaptably adopt a connecting claw 211 according to the structural characteristics of the mating part 112. The frame strip or hole structure of the mating part 112 is attached to the connecting claw 211. Similarly, the coupling structure can also adopt a slot 212. The protrusion or expansion part of the mating part 112 can be combined with the slot 212. Of course, the connecting claw 211 and the slot 212 can be used together, or in other words, a slot 212 is naturally formed between adjacent connecting claws 211.

[0205] Taking the connecting claw 211 as an example, multiple claws are arranged along the circumference of the auxiliary guide tube 210. Each connecting claw can extend with equal cross section or gradually converge towards the end shape. The converged shape makes it easier to release the temporary connection.

[0206] In some embodiments, the connecting claws 211 are divided into at least two groups, with different axial positions at the ends of the connecting claws 211 in different groups. For example, different connecting claws 211 have different lengths, which can establish temporary connections with artificial implants one by one or in pairs, making the operation more convenient. Similarly, the slots 212 can also be divided into at least two groups, with different axial positions at the openings of the slots 212 in different groups, for example, different slots 212 have different depths.

[0207] In one embodiment, the coupling structure does not extend radially beyond the outer periphery of the auxiliary guide tube 210, thus avoiding unnecessary interference with the artificial implant or other peripheral components.

[0208] Figure 4 , Figure 5 As can be seen, in one embodiment, both ends of the auxiliary guide tube 210 are provided with coupling structures. In particular, the coupling structures at both ends are configured differently to adapt to different artificial implants. For example, one end has 5 connecting claws 211 and the other end has 4 connecting claws 211. When the number of mating parts 112 of the artificial implant changes, the applicable direction of the auxiliary guide tube 210 can be adaptively adjusted.

[0209] The compression kit of this application embodiment also includes a guide component 400, which provides an inner cavity that gradually narrows at one end, allowing the artificial implant to be compressed and deformed as it passes through and enters the inner cavity. The guide component 400 includes at least a guide cylinder 420, which has a gradually narrowing guide cavity. The guide cavity is generally frustum-shaped and has a relatively large end and a relatively small end. The support component 200 drives the artificial implant to enter from the large end and exit from the small end. During this process, the artificial implant can undergo radial deformation under pressure.

[0210] In other embodiments, to facilitate the storage and temporary holding of the compressed implant, the guiding assembly 400 includes an outer tube 410 and a guide cylinder 420 connected to the outer tube 410. The guide cylinder 420 has a guiding cavity that gradually narrows towards the outer tube 410. The auxiliary guiding tube 210 drives the implant from its wider end into the guiding cavity and then into the outer tube 410. During this process, the implant is radially compressed under the action of the guiding assembly 400. The smooth transition between the guiding cavity and the lumen of the outer tube 410 reduces resistance and avoids scratching the implant.

[0211] To facilitate subsequent operations, the outer tube 410 and the guide tube 420 are detachably connected. After the artificial implant is basically placed in the outer tube 410, the guide tube 420 can be removed. For example, the outer tube 410 and the guide tube 420 are connected by a rotating engagement method. Of course, the outer tube 410 and the guide tube 420 are equipped with a matching rotating engagement structure.

[0212] Figure 7 , Figure 8 As can be seen, the outer tube 410 is a straight tube as a whole, with a protrusion 411 on the outer wall of one end. The guide cylinder 420 has a tapered section 421, which gradually expands in diameter away from the outer tube 410. The end of the tapered section 421 facing the outer tube 410 has a connecting section 422. The connecting section 422 has an L-shaped connecting groove 423. The connecting section 422 is inserted and sleeved on one end of the outer tube 410 along the axial direction, so that the protrusion 411 is inserted into the opening of the connecting groove 423. By rotating the outer tube 410 and the guide cylinder 420 relative to each other, the protrusion 411 can be prevented from detaching from the connecting groove 423 along the axial direction. When disassembly is required, it can be rotated in the opposite direction and separated along the axial direction.

[0213] In one embodiment, the support assembly 200 further includes an inner tube 220 slidably sleeved outside the auxiliary guide tube 210, i.e., the inner tube 220 has a lumen through which the auxiliary guide tube 210 passes. The inner tube 220 is a straight tube, facilitating the sliding insertion and removal of the auxiliary guide tube 210. When establishing a temporary connection, both the auxiliary guide tube 210 and the inner tube 220 are within the blood flow channel of the implant. The inner tube 220 can provide necessary radial support during subsequent compression, preventing unintended deformation of the implant. It can also isolate the auxiliary guide tube 210 from the leaflets and inner skirt, preventing leaflet damage or unnecessary folding during removal of the auxiliary guide tube 210, and reducing the risk of incomplete leaflet closure. For example, for Figure 1The connecting lugs and mating parts of the artificial heart valve are located at both ends of the stent axis. During use, the auxiliary guide tube 210 is inserted into the inner tube 220 and the coupling structure of the auxiliary guide tube 210 is exposed at one end of the inner tube 220. After the mating part of the artificial heart valve is attached to the coupling structure, both the auxiliary guide tube 210 and the inner tube 220 are located in the blood flow channel of the artificial heart valve. Then, under the push of the auxiliary guide tube 210, the artificial heart valve is compressed and stored in the outer tube 410 through the guide tube 420.

[0214] While maintaining the relative positions of the artificial heart valve, inner tube 220, and outer tube 410, the auxiliary guide tube 210 is moved to the side where the connecting ear is located. Its coupling structure separates from the mating part of the artificial heart valve, and the auxiliary guide tube 210 is further moved out of the inner tube 220. The artificial heart valve is left in the radial gap between the inner tube 220 and the outer tube 410, which can be transferred to the interventional delivery system in subsequent operations.

[0215] An embodiment of this application also provides a guide. Figure 1 A method for deforming an artificial implant, the artificial implant having an axially oriented first end and a second end positioned opposite each other along the axial direction, the method comprising:

[0216] Applying force to the first end, the artificial implant is guided towards the first end into a guide cavity that gradually narrows in shape;

[0217] The artificial implant is further guided into a tube through the guide cavity, so that the artificial implant is gradually compressed radially from the first end to the second end until it takes on a straight cylindrical shape.

[0218] See Figures 9-12 The method for guiding the deformation of artificial implants can be implemented using the gripping kits of the various embodiments of this application.

[0219] See Figure 9 First, a support component is provided, wherein the auxiliary guide tube 210 is inserted into the inner tube 220 and at least one end of the coupling structure is exposed in the inner tube 220. In the stent 110 of the artificial implant, the first end has a mating part 112 and the second end has a connecting ear 111. The auxiliary guide tube 210 and the inner tube 220 are inserted into the blood flow channel together and pass through the leaflet from the inflow part to the outflow part, that is, from the second end to the first end. When the connecting claw 211 of the coupling structure is close to the mating part 112, the first end of the stent 110 is slightly radially gathered and the mating part 112 is attached to the corresponding connecting claw 211, thus establishing a temporary connection.

[0220] See Figure 10 A guide assembly is provided, in which the outer tube 410 and the guide cylinder 420 can be pre-assembled together, and the auxiliary guide tube 210 is along... Figure 10The arrow direction drives the artificial implant and the inner tube 220 into the guide cavity and further into the outer tube 410. The stent 110 is gradually squeezed by the guide tube 420 and the inner wall of the outer tube 410 from the first end, that is, it is radially compressed and deformed.

[0221] See Figure 11 and Figure 12 Artificial implants, in accordance with the process of radial compression deformation, include the following:

[0222] The implant is in an inflated state before it enters the guide component (and is not restricted to local compression).

[0223] In the pre-compressed state, after the artificial implant enters the outer tube 410, it is in a pre-compressed state. In the pre-compressed state, most of the artificial implant is inside the outer tube 410 and on the outer periphery of the inner tube 220. In the pre-compressed state, the artificial implant is generally cylindrical.

[0224] After the artificial implant is basically housed inside the outer tube 410, the guide tube 420 can be removed. The guide tube 420... Figure 11 The direction of the middle arrow indicates separation from the outer tube 410.

[0225] At this point, the auxiliary guide tube 210 can also be removed. Its coupling structure is unidirectionally coupled to the artificial implant; that is, after a temporary connection is established, the auxiliary guide tube 210 can move the artificial implant along the first direction, and detach from the artificial implant when moving along the second direction opposite to the first direction. Figure 12 When the auxiliary guide tube 210 moves to the left (from the first end to the second end), the connecting claw 211 can disengage from the mating part 112, and the auxiliary guide tube 210 is pulled out of the inner tube 220 as a whole. Since the inner tube 220 remains in the blood flow channel during this process, the auxiliary guide tube 210 is isolated from the valve leaflet, which can avoid adverse interference to the valve leaflet when the auxiliary guide tube 210 moves.

[0226] There is a first radial gap between the inner tube 220 and the outer tube 410. At this time, the pre-compressed artificial implant is stored in the first radial gap. The inner tube 220 and the outer tube 410 can carry the artificial implant for later use or for subsequent operations. If a suitable environment is provided, the pre-compressed state can be maintained, and the inner tube 220 and the outer tube 410 can even be removed.

[0227] Based on the gripping kit of this application, one embodiment of this application also provides an auxiliary device for loading artificial implants into an interventional delivery system, for compressing and loading the artificial implant into the catheter assembly of the interventional delivery system to facilitate subsequent interventional surgery.

[0228] See Figure 13 , Figure 14The interventional delivery system includes a catheter assembly 500. A control handle (not shown) can be connected to the proximal end of the catheter assembly 500 for controlling its movement. In this embodiment, the catheter assembly 500 includes a core tube 510 and a sliding outer sheath 520 sleeved outside the core tube 510. The distal end of the outer sheath 520 is a loading section 521. A second radial gap exists between the core tube 510 and the loading section 521 for loading an implant. When the outer sheath 520 moves proximally and exposes the implant, the implant can self-expand and be released. For non-self-expanding implants, balloon inflation can be used, for example, by placing a balloon around the core tube 510 and using the inflated balloon to expand the implant.

[0229] To facilitate interventional delivery and positioning of the implant, the core tube 510 is provided with a connecting portion 511 for the implant. The connecting portion 511 is used to connect the implant; for example, the connecting ear of the implant is connected to the connecting portion 511 by hooking, embedding, or inserting. The core tube 510 extends through the connecting portion 511 and further distally, with a guide head 514 at the distal end. The core tube 510 can provide a guide wire channel. The distal end of the guide head 514 is tapered to facilitate passage along the guide wire within the body. The axial position of the implant is located between the connecting portion 511 and the guide head 514. In some embodiments, a second connecting portion is also provided at the proximal end of the guide head 514. The axial positioning of the implant is achieved through the two axially arranged connecting portions.

[0230] In this embodiment, the connecting part 511 has a protrusion 512, and a settling area 513 is provided around the protrusion 512. The connecting ear of the artificial implant (such as the artificial pulmonary valve mentioned above) is ring-shaped and can be hung on the protrusion 512 to achieve axial positioning between the core tube 510 and the artificial implant. The connecting ear is located in the settling area 513, which can make the outer periphery of the connecting part 511 smooth and avoid the connecting ear from bulging outward in the radial direction, thus affecting the loading.

[0231] Further integration Figure 15 The auxiliary device in this embodiment includes:

[0232] The compression kit, which can be used in any of the embodiments described above, is used to compress artificial implants;

[0233] The protective tube 300 is movably sleeved on the interventional delivery system. When in use, it is slidably sleeved on the outside of the outer sheath 520. The protective tube 300 receives the artificial implant from the gripping sleeve so that the artificial implant can be loaded into the interventional delivery system.

[0234] The lumen of the protective tube 300 can accommodate at least the implant from the compression kit, i.e., the implant in a pre-compressed state. The protective tube 300 is a straight tube as a whole, with one end reinforced to accommodate the implant, i.e., it has a reinforcing section 310. This end can also be set as a flared structure to facilitate guiding the implant into the protective tube.

[0235] Further integration Figures 16-22 An embodiment of this application also provides a method for loading an artificial implant into an interventional delivery system. The interventional delivery system includes a core tube and an outer sheath that is slidably sleeved outside the core tube. The radial gap between the core tube and the outer sheath is used for loading the artificial implant. The artificial implant has an axial first end and a second end that are axially opposed to each other. The method for loading the artificial implant is detailed below.

[0236] First, the implant can be housed in the outer tube 410 and pre-compressed using the method and gripping kit described in any of the above embodiments to guide the deformation of the implant. For example, force is applied to the first end, causing the implant to enter a guide cavity that gradually narrows towards the first end. The implant is then further guided into a lumen through the guide cavity, causing it to be gradually compressed radially from the first end to the second end until it is in a straight cylindrical shape and pre-compressed. The pre-compressed implant is then transferred and loaded into the interventional delivery system.

[0237] See Figure 16 , Figure 17 The process of transferring and loading a pre-compressed implant into an interventional delivery system specifically includes providing a protective tube 300 and fitting the protective tube 300 onto the outside of the outer sheath 520, exposing the distal portion of the core tube 510 to the outer sheath 520 and extending it into the inner tube 220. During this process, the connecting portion 511 gradually approaches the connecting ear 111 of the implant, while the inner tube 220 can be moved distally according to the relative position of the connecting portion 511 to avoid interfering with the connecting portion 511.

[0238] After the connecting portion 511 approaches the connecting ear 111, the connecting ear 111 and the connecting portion 511 engage with each other. As shown in the figure, the connecting ear 111 is fitted onto the protrusion 512, enabling axial positioning of the implant and the core tube 510. After the connecting ear 111 and the connecting portion 511 engage, relative to the core tube 510 along... Figure 17 The protective tube 300 is pushed distally in the direction of the middle arrow, with the aim of using the protective tube 300 to receive and transfer the artificial implant.

[0239] Before pushing the protective tube 300 to the distal side, the outer sheath tube 520 can be moved to the distal side and wrapped around the locking part of the connecting ear 111 and the connecting part 511 to prevent them from loosening. At the same time, the proximal side of the bracket 110 can be slightly gathered and wrapped by the outer sheath tube 520 so that the outer sheath tube 520 can further accommodate the artificial implant in the subsequent process.

[0240] See Figure 18 , Figure 19 As the protective tube 300 moves toward the distal side, it can gradually wrap around the engaging part of the connecting ear 111 and the connecting part 511, as well as the proximal side of the support 110, and further extend into the outer tube 410. For example, at least a portion of the protective tube 300 can extend into the radial gap between the outer tube 410 and the artificial implant.

[0241] See Figure 20 , Figure 21 The protective tube 300 is moved further distally until the implant is fully contained. During this process, the outer tube 410 can be gradually removed distally according to the distal position of the protective tube 300, completing the transfer of the implant from the gripping sleeve to the protective tube 300. Subsequently, the outer sheath 520 can be further moved along... Figure 21 The direction of the middle arrow is moved toward the distal end in order to gradually enclose the artificial implant.

[0242] See Figure 22 As the outer sheath 520 moves distally, it enters the radial gap between the protective tube 300 and the implant until the loading section 521 of the outer sheath 520 completely encloses the implant, thus completing the loading. After this, the protective tube 300 can be removed distally.

[0243] See Figures 23-24 The artificial heart valve 100 has an alternative structure, including a stent 110 and leaflets 120 connected to the inside of the stent. The artificial implant has a first end and a second end that are axially and axially opposed. The second end is provided with a plurality of mating parts 112, which can form a detachable temporary connection with the auxiliary guide tube of this application for guidance when the artificial heart valve 100 is compressed.

[0244] In this embodiment, the mating part 112 is formed by the frame strip of the cell where the second end of the bracket 110 is located converging at the end, for example, it can be the inner corner of a V-shape. The coupling structure of the auxiliary guide tube 210, namely the connecting claw 211, acts on the mating part 112 at the second end. Figure 24 There are three mating parts 112, and the number of mating claws 211 corresponds to the number of mating parts 211. In this embodiment, the mating parts 112 can also serve as connecting ears 111 for connecting to the intervention delivery system.

[0245] Along the blood flow direction indicated by the arrow in the figure, the artificial heart valve 100 has an inflow portion 121 and an outflow portion 122. A first end is located in the inflow portion (on the inflow side of the leaflet 120), and an inner skirt and / or an inner skirt 130 are provided in the inflow portion. A second end is located in the outflow portion (on the outflow side of the leaflet 120), and a coupling structure acts on the end of the outflow portion 122. The outflow portion 122 is a bare stent (without a skirt), and the bare stent portion has an expansion structure. In some embodiments, along the blood flow outflow direction, the outflow portion has a closing structure after expansion, and the coupling structure acts on the end of the closing structure. Taking the implantation path of the human aortic heart valve as entering the heart along the aortic arch as an example, the mating part 112 is located proximal to the stent 110.

[0246] See Figure 25 One embodiment of this application provides a split-type auxiliary guide tube 210, which can be used in conjunction with the guide components applied in the above embodiments to form a gripping kit, an auxiliary device, and an intervention system.

[0247] In this embodiment, the auxiliary guide tube 210 adopts a split structure, including a tube body 213 and an end cap 214 that is detachably connected to the tube body 213. The tube body 213 and the end cap 214 can be axially inserted and fitted together, and their relative movement direction can also have radial or circumferential components. The coupling structure can be set in the tube body 213 and / or the end cap 214.

[0248] In other embodiments, the coupling structure may also be provided by both the tube body 213 and the end cap 214, with the parts of the two cooperating to establish a detachable temporary connection with the artificial implant.

[0249] In this embodiment, the coupling structure consists of connecting claws 211 disposed on the end cap 214. For example, the end cap 214 has two opposing sides, one of which is a tapered head 215, such as a tapered shape with a gradually decreasing diameter. This design facilitates the movement of the implant through the guide assembly after it is connected to the coupling structure of the auxiliary guide tube. Multiple connecting claws 211 are fixed on the other side. The specific shape of the connecting claws 211 can be determined by referring to the embodiments described above. The connecting claws 211 and the end cap 214 can be an integral structure or separate components. When fixed separately, mounting holes can be opened on the end cap 214, and the cylindrical connecting claws 211 are fixed into the corresponding mounting holes using threaded engagement or insertion.

[0250] The axial end face of the tube body 213 is provided with multiple insertion holes 216. Each connecting claw 211 extends into the corresponding insertion hole 216. After the artificial implant is attached to the connecting claw 211, the end cap 214 is inserted and connected to the tube body 213. Alternatively, the mating part of the artificial implant is aligned with the insertion hole 216, and then the connecting claw 211 is inserted into the corresponding insertion hole 216 to prevent the mating part from disengaging and maintain a temporary connection with the artificial implant. When the auxiliary guide tube 210 needs to be removed in subsequent steps, the end cap 214 is pulled out first, and then the tube body 213 is pulled out.

[0251] In other embodiments, to facilitate the connection of the mating parts, the mating claw 211 may also extend radially, making it easier to mount the mating parts, while the end cap 214 may wrap around the positioning pin to prevent the mating parts from disengaging from the positioning pin.

[0252] To improve versatility, both ends of the tube body 213 are movably connected to end caps 214, and the number of engaging claws 211 at each end is different. For example, one end has 5 and the other end has 4, or one end has 3 and the other end has 5. The length of the engaging claws 211 can be exactly the same as the depth of the insertion hole 216, or the length of the engaging claws 211 can be greater than the depth of the insertion hole 216. After assembly, at least a portion of the engaging claws 211 is exposed in the insertion hole 216. The engaging claws 211 on the same side of the tube body 213 can be configured with different lengths to facilitate individual connection with the mating part 112, making operation more convenient. For example, the lengths of multiple engaging claws 211 can vary sequentially along the circumferential direction.

[0253] See Figure 26 , Figure 27 Another embodiment of this application provides an auxiliary guide tube 210, relative to Figure 25 In one embodiment, a connecting claw 211 is disposed on one axial end face of the tube body 213, and an insertion hole 216 is disposed on the end cap 214. The mating part 112 of the artificial implant can be mounted on the corresponding connecting claw 211. One side of the end cap 214 is a head with a converging shape, such as a tapered shape with a gradually decreasing diameter. This design facilitates the passage of the artificial implant through the guide assembly after it is connected to the coupling structure of the auxiliary guide tube. The other side of the end cap is provided with a plurality of insertion holes 216, for example, 3 to 6, that engage with the connecting claw 211. In one embodiment, the length of the connecting claw 211 is greater than the depth of the insertion hole 216, and at least a portion of the connecting claw 211 is exposed in the insertion hole 216 after assembly. In another embodiment, the length of the connecting claw 211 is almost the same as the depth of the insertion hole 216.

[0254] To improve versatility, both ends of the tube body 213 are movably connected with end caps 214, and the number of connecting claws 211 at each end is different. For example, one end has 5 claws and the other end has 4 claws, or one end has 3 claws and the other end has 5 claws.

[0255] See Figure 28Another embodiment of this application provides an auxiliary guide tube 210. Since a core tube may need to be inserted inside the tube body 213, the tube body 213 is a pipe fitting. When a coupling structure is set on the end face, higher requirements are placed on its local strength, such as more stringent requirements on material, wall thickness, and pipe diameter. In this embodiment, a detachable pluggable connector 217 is configured on the axial end face of the tube body 213. The connector 217 can be a solid structure to provide ideal structural strength, and the coupling structure is set on the connector 217 based on this.

[0256] In this embodiment, the auxiliary guide tube includes an end cap 214, a connector 217, and a tube body 213. A connecting claw 211 is disposed on the connector 217, and an insertion hole 216 is disposed on the end cap 214. The connector 217 has a insertion post 218 on its side facing away from the end cap 214, and is inserted into the lumen of the tube body 213 (the fitting) through this insertion post 218. Removing the end cap 214 releases the artificial implant, and further removing the connector 217 opens the lumen of the tube body 213 for the core tube to pass through.

[0257] Regarding whether to set the connector 217 and where the connecting claw 211 is located, the two ends of the tube body 213 can be configured using the same structural principle or different configuration methods.

[0258] See Figure 29 Another embodiment of this application provides an improved structure for the auxiliary guide tube 210, relative to... Figure 28 In this embodiment, the connecting claw 211 is disposed on the end cap 214, the insertion hole 216 is disposed on the connector 217, and other structures are similar.

[0259] Based on the above embodiments, one embodiment of this application also provides an interventional system, including the interventional delivery system, auxiliary device, and artificial implant of the above embodiments.

[0260] This application optimizes the structure of the compression kit and auxiliary device. An auxiliary guide tube located within the blood flow channel applies force to the implant, allowing for gradual compression from one end to the other in a single operation. This eliminates the need for separate compression from both ends, simplifying the procedure and reducing operational difficulty. Even for larger diameter implants, multiple stages of compression are unnecessary; pre-compression can be completed in one step. The external tube can also temporarily store the implant, maintaining it in a pre-compressed state with a preset diameter, balancing valve leaflet deformation and storage period.

[0261] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0262] The embodiments described above are merely illustrative of several implementation methods of this application, and 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 those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Therefore, the patent protection scope of this application should be determined by the appended claims.

Claims

1. A pressure gripping kit for guiding the deformation of artificial implants, characterized in that, The artificial implant is a radially deformable tubular structure, and the pressure-gripping kit includes: A support assembly includes an auxiliary guide tube and an inner tube, the inner tube extending into the artificial implant and having a lumen through which the auxiliary guide tube passes, one end of the auxiliary guide tube having a coupling structure that is exposed to the inner tube and establishes a detachable temporary connection with the artificial implant. A guiding assembly includes an outer tube and a guide cylinder connected to the outer tube. The guide cylinder has a guide cavity that gradually converges toward the outer tube. An auxiliary guiding tube drives the artificial implant into the outer tube through the guide cavity, and the artificial implant is radially compressed under the action of the guiding assembly. The artificial implant has an axial first end and a second end that are axially opposite to each other. The coupling structure acts on the first end and applies force to the first end when the artificial implant is deformed, causing the artificial implant to enter the guide cavity in the direction of the first end, so that the artificial implant is gradually compressed radially from the first end to the second end until it is in a straight cylindrical shape.

2. The pressure gripping kit for guiding the deformation of artificial implants as described in claim 1, characterized in that, The coupling structure is a combination of claws and / or slots; The coupling structure is multiple and arranged circumferentially along the auxiliary guide tube, and the coupling structure is unidirectionally coupled to the artificial implant along the axial direction.

3. The pressure gripping kit for guiding the deformation of artificial implants as described in claim 1, characterized in that, The auxiliary guide tube adopts a split structure, including a tube body and an end cap that is detachably connected to the tube body, and the coupling structure is disposed on the tube body and / or the end cap.

4. The pressure gripping kit for guiding the deformation of artificial implants as described in claim 3, characterized in that, The tube body and the end cap are axially movable and inserted into each other; The end cap has two opposite sides, one of which is a head with a converging shape. The coupling structure consists of multiple connecting claws fixed to the other side. The axial end face of the tube body is provided with multiple insertion holes, and each connecting claw extends into the corresponding insertion hole.

5. The pressure gripping kit for guiding the deformation of artificial implants as described in claim 4, characterized in that, The coupling structure consists of multiple coupling claws fixed to the end of the tube body. The end cap has two opposite sides, one side of which is a head with a converging shape, and the other side is provided with multiple insertion holes that cooperate with the coupling claws.

6. The pressure gripping kit for guiding the deformation of artificial implants as described in claim 5, characterized in that, The axial end face of the tube is detachably connected to a connector; The insertion hole is located on the connector, and the engagement claw is located on the end cap, or The insertion hole is located on the end cap, and the connecting claw is located on the connector.

7. The pressure gripping kit for guiding the deformation of artificial implants as described in claim 1, characterized in that, The outer tube and the guide cylinder are detachably connected.

8. The pressure gripping kit for guiding the deformation of artificial implants as described in claim 7, characterized in that, The outer tube and the guide cylinder are connected by a rotary locking method.

9. The pressure gripping kit for guiding the deformation of artificial implants as described in claim 1, characterized in that, The guide tube has a conical structure and gradually increases in diameter in the direction away from the outer tube.

10. The pressure gripping kit for guiding the deformation of an artificial implant as described in claim 1, characterized in that, After a temporary connection is established, the auxiliary guide tube guides the artificial implant into the guiding component along a first direction; when the temporary connection is released, the auxiliary guide tube disengages from the artificial implant along a second direction opposite to the first direction.

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