Clutch assembly, delivery system and interventional therapy system

Abstract

This application relates to the field of medical device technology, and discloses a clutch assembly, a delivery system, and an interventional treatment system. The clutch assembly is disposed at the distal end of a catheter and includes at least two engaging members. In their natural state, the at least two engaging members are open relative to the central axis of the clutch assembly. A connecting portion is provided at the distal end of each engaging member. Under external force, the at least two engaging members close together, allowing the connecting portion to engage with a connector on the implant. The proximal and / or distal ends of the connecting portion have contact structures that abut against the connector, creating a contact position between the connecting portion and the connector. By providing these contact structures, this application facilitates the separation of the connecting portion and the connector while simultaneously limiting minute relative displacement between them. This ensures the implant remains stable during implantation, preventing deviation from its relative position to the implantation site and avoiding unintended movement, thus promoting a smooth surgical procedure.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more particularly to a clutch assembly, delivery system, and interventional treatment system. Background Technology

[0002] Structural heart disease, broadly defined, refers to any abnormality in the structure of the heart and any disease related to the structure of the heart and great vessels, excluding primary coronary artery disease and electrocardiographic diseases (such as coronary artery disease and arrhythmias). Valvular heart disease is a common type of lesion, such as blood regurgitation caused by valvular lesions located between the atria and ventricles. Taking mitral regurgitation as an example, moderate to severe mitral regurgitation can lead to increased blood flow to the left atrium, elevated blood pressure, and may cause pulmonary hypertension, pulmonary edema, atrial fibrillation, heart failure, and even death.

[0003] With the development of interventional cardiology, transcatheter cardiac interventional techniques, characterized by minimal invasiveness, less pain, and rapid recovery, are increasingly being used in clinical practice. Interventional treatment for mitral regurgitation originates from surgical techniques. Mitral regurgitation interventional treatment is suitable for patients with moderate to severe mitral regurgitation who cannot tolerate traditional surgery. The main types include annular repair, leaflet repair, and chordae tendineae repair, with corresponding surgical procedures including annulusoplasty, edge-to-edge repair, and chordae tendineae repair, among which edge-to-edge repair is the relatively mainstream approach. Due to the diversity of the anatomical structures of the valve annulus, leaflets, and adjacent areas, continuous improvement is needed in device design. For example, the dislodgement performance of implanted medical devices (implants) and the synchronicity of torque transmission through the implanted catheter require further improvement. Utility Model Content

[0004] The purpose of this application is to provide a clutch assembly, a delivery system, and an interventional treatment system that enable rapid detachment of the implant from the delivery system, while maintaining stability of the implant during implantation and facilitating the smooth progress of the surgery.

[0005] The technical solution provided by this utility model is as follows:

[0006] A clutch assembly disposed at the distal end of a catheter for connecting and disconnecting an implant, characterized in that it comprises at least two clamping members, wherein the at least two clamping members are open relative to the central axis of the clutch assembly in their natural state.

[0007] The distal end of the clamping member is provided with a connecting portion. Under the action of external force, the at least two clamping members close together so that the connecting portion is adapted to engage with the connector on the implant. The proximal and / or distal ends of the connecting portion are provided with contact structures so that after the at least two clamping members close together, a contact position is formed between the connecting portion and the connector.

[0008] In some embodiments, the clamping member further includes a main body portion, and the connecting portion is disposed at the distal end of the main body portion; the connecting portion includes a connecting arc and a connecting arm arranged at an angle, and the connecting arm connects the connecting arc and the main body portion;

[0009] The connecting seat is provided with a groove that is adapted to the connecting arc contour, and the connecting seat is provided with a clearance groove near the groove to avoid the connecting arm;

[0010] The contact structure is provided on the connecting arc along the width of the connecting arc to form the contact position with the proximal end and / or distal end of the groove.

[0011] In some embodiments, the projection of the connecting portion onto the central axis plane is T-shaped, the connecting arc and the connecting arm are arranged perpendicularly, and one end of the connecting arm is located in the middle section of the connecting arc, while the other end is connected to the center position of the far end of the main body.

[0012] In some embodiments, the contact structure includes protrusions, with at least one protrusion provided on each of the connecting arcs.

[0013] In some embodiments, the end of the contact structure away from the connecting portion is a convex spherical surface, which abuts against the connecting seat to form a point contact; or,

[0014] The end of the contact structure away from the connecting portion has an outwardly convex arc surface, which abuts against the connecting seat to form a line contact; or,

[0015] The end of the contact structure away from the connecting part is a plane or an inclined plane, which abuts against the connecting seat to form a surface contact.

[0016] In some embodiments, the engaging member further includes an elastic portion connected between the distal end of the conduit and the main body, such that the engaging member opens relative to the central axis of the clutch assembly in its natural state.

[0017] In some embodiments, the engaging member has an engaging member on the side near the central axis of the clutch assembly;

[0018] The mating member has a through hole, and when the through holes of the mating members of the at least two clamping members are aligned, the at least two clamping members enclose each other.

[0019] This application also discloses a conveying system, including:

[0020] The catheter, including an implantable catheter having an axially penetrating central channel;

[0021] A clutch assembly, located at the distal end of the implantation catheter, is used to connect and disconnect the implant;

[0022] The implantable catheter body includes a multi-lumen tube and a support tube. The multi-lumen tube has an axially penetrating central channel, and the support tube passes through the central channel of the multi-lumen tube. The multi-lumen tube and the support tube extend between the proximal and distal ends of the implantable catheter body and cover at least a portion of the length of the body.

[0023] In some embodiments, the support tube includes a spring coil that covers the entire length of the body from the proximal end to the distal end.

[0024] In some embodiments, the spring coil is at least partially double-layered in its axial direction; and,

[0025] The spring coil has a first spring coil and a second spring coil in a double-layer structure, arranged radially from the inside to the outside. The helical direction of the first spring coil is opposite to that of the second spring coil.

[0026] In some embodiments, the main body further includes an outer tube sleeved over the multi-lumen tube; and a reinforcing layer is provided between the outer tube and the multi-lumen tube.

[0027] In some embodiments, the reinforcing layer is woven from metal wires, extends between the proximal and distal ends of the body, and covers at least a portion of the length of the body;

[0028] and / or

[0029] The outer tube has at least two sections along its own axial direction, and the hardness of the at least two sections is inconsistent, or the hardness of the outer tube is equal everywhere.

[0030] In some embodiments, the distal end of the implanted catheter is provided with a plug that covers a portion of the distal end face of the body and has at least one central channel.

[0031] In some embodiments, the plug-in includes an end ring and a hub;

[0032] The hub is disposed between the reinforcing layer and the multi-cavity tube; the end is circumferentially disposed at the distal end of the connector, covering part of the distal end face of the main body, and has at least one central channel.

[0033] In some embodiments, the plug-in further includes firmware, which passes through the hub and is fixedly connected to the sidewall of the hub;

[0034] The firmware has a central channel and is coaxial with the central channel of the implanted catheter;

[0035] The distal end of the support tube is connected to the proximal end of the firmware.

[0036] In some embodiments, the clutch assembly is a clutch assembly as provided in any of the above embodiments, disposed at the distal end of the implantation catheter, for connecting and disconnecting the implant;

[0037] The delivery system also includes a delivery rod inserted into the implantation catheter. When delivering the implant, the distal end of the delivery rod applies the external force to the clutch assembly's clamping members, causing the at least two clamping members to close. When removing the implant, the distal end of the delivery rod withdraws from the clutch assembly's clamping members.

[0038] This application discloses another interventional therapy system, characterized in that it includes:

[0039] An implant, wherein a connector is provided at the proximal end of the implant;

[0040] The delivery system provided by any of the above embodiments is used to deliver the implant, wherein, during delivery of the implant, at least two engaging members of the clutch assembly surround and connect with the connector.

[0041] The technical advantages of this application are as follows:

[0042] 1. In this application, the connecting part that mates with the connecting seat is provided with a contact structure. The connecting part abuts against the connecting seat through this contact structure, limiting the slight relative displacement between the connecting part and the connecting seat. This ensures that the implant remains stable during implantation, neither deviating from its relative position to the implantation site nor undergoing unexpected movement, thus facilitating the smooth progress of the surgery. Simultaneously, a gap is maintained between the connecting part and the connecting seat to facilitate rapid separation between them, thereby achieving rapid removal of the implant.

[0043] 2. In this application, the connecting part includes a connecting arc and a connecting arm, which can form a double-sided engagement with the groove on the connecting seat; at the same time, the contact structure is provided on the connecting arc, which can abut against the proximal end and / or distal end of the groove on the connecting seat when the clamping part is closed, which not only restricts the small relative displacement between the connecting part and the connecting seat, but also helps the implant maintain balance and facilitates the smooth progress of the surgery.

[0044] 3. In this application, by setting up independent multi-lumen tubes to integrate multiple axial channels into a single tube structure, different functions can be achieved within a smaller diameter, making it more suitable for minimally invasive surgery. Moreover, the design of multi-lumen tubes takes into account the balance of internal and external pressures compared to opening multiple channels on the tube body, which helps to improve the consistency of tube performance. In addition, this embodiment also sets up a support tube inside the multi-lumen tube, which helps to balance the force on the multi-lumen tube, making the response of the distal end of the implanted catheter more synchronized with the torque experienced by the proximal end, and more controllable.

[0045] 4. In this application, the support tube employs a spring coil and a double-layer structure, with the double layer structure having clockwise and counterclockwise helical directions respectively. That is, the double-layer structure of the spring coil has a first spring coil and a second spring coil sequentially from the inside to the outside along its own radial direction. One of the first spring coil and the second spring coil has a clockwise helix, and the other of the first spring coil and the second spring coil has a counterclockwise helix. When subjected to torque, the component forces acting on the clockwise and counterclockwise helical coils can cancel each other out, which is more conducive to improving the stability of the implanted catheter and enhancing the torque transmission performance of the implanted catheter.

[0046] 5. In this application, the distal end of the implanted catheter is provided with a plug, which can strengthen the connection strength between the layers of the implanted catheter. At the same time, the central channel of the firmware located in the center of the plug is coaxial with the central channel of the implanted catheter, and the two have approximately the same internal diameter, which further enhances the synchronization performance between the distal end of the implanted catheter and the tube body, that is, further enhances the synchronization of torque transmission. Attached Figure Description

[0047] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0048] Figure 1 This is a schematic diagram of a transcatheter interventional therapy application scenario provided in one embodiment of this application;

[0049] Figure 2 This is a schematic diagram of the structure of an interventional therapy system provided in one embodiment of this application;

[0050] Figure 3 This is a schematic diagram of the structure of the clutch assembly connected to the implant provided in one embodiment of the present application;

[0051] Figure 4 This is a schematic diagram of the structure of the clutch assembly for detaching the implant provided in one embodiment of this application;

[0052] Figure 5 This is a schematic diagram of the structure of the clutch assembly connecting to the implant connector in another embodiment of this application;

[0053] Figure 6 yes Figure 5 A magnified view of a portion of point A shown;

[0054] Figure 7 This is a schematic diagram of the implantable catheter, clutch assembly, and valve clamping device provided in one embodiment of the present application in one state;

[0055] Figure 8 This is a schematic diagram of the implantable catheter, clutch assembly, and valve clamping device provided in one embodiment of the present application in another state;

[0056] Figure 9 This is a cross-sectional view of the implantable catheter provided in one embodiment of this application;

[0057] Figure 10 This is a partial perspective view of the implantable catheter provided in one embodiment of this application;

[0058] Figure 11 This is a partial schematic diagram of an interventional treatment system provided in one embodiment of this application;

[0059] Figure 12 This is a schematic diagram of the structure of a control device provided in one embodiment of this application;

[0060] Figure 13 This is a schematic diagram of the structure of a driving component provided in one embodiment of this application;

[0061] Figure 14 This is a schematic diagram of the implantable catheter, clutch assembly, and valve clamping device provided in another embodiment of this application;

[0062] Figure 15 This is a remote schematic diagram of a driving component provided in one embodiment of this application;

[0063] Figure 16 This is a side view of a driving component provided in one embodiment of this application;

[0064] Figure 17 This is a schematic diagram of the structure of a driving component and a connecting component provided in one embodiment of the present application;

[0065] Figure 18 This is a schematic diagram of a control device provided in another embodiment of this application. Detailed Implementation

[0066] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of this application. However, those skilled in the art will understand that this application can also be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, circuits, and methods have been omitted so as not to obscure the description of this application with unnecessary detail.

[0067] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the specific implementation methods of this application will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without creative effort.

[0068] To keep the drawings concise, each drawing only schematically shows the parts relevant to this application, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some drawings, only one of the components with the same structure or function is schematically shown, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0069] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0070] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0071] In the embodiments shown in the accompanying drawings, the directional indications (such as up, down, left, right, front, and back) used to explain the structure and movement of the various components of this application are relative rather than absolute. These descriptions are appropriate when these components are in the positions shown in the drawings. If the descriptions of the positions of these components change, these directional indications also change accordingly.

[0072] In the embodiments of this application, "proximal end" refers to the end of the associated object closer to the surgeon; "distal end" refers to the end of the associated object farther from the surgeon. "Proximal end" and "distal end" are the position or orientation of the associated object (e.g., a component of a medical device) relative to the surgeon from the perspective of the surgeon (e.g., a doctor) using the device (e.g., a medical device). For example, "proximal end" refers to the end closer to the doctor during normal operation of the medical device, while "distal end" refers to the end farther from the doctor during normal operation of the medical device, that is, the end that first enters the patient's body.

[0073] Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0074] Transcatheter interventional therapy (TCA) involves introducing implants such as materials, medical devices, or drugs into the body via catheters for minimally invasive diagnosis and / or treatment of diseases. TCA can achieve better therapeutic effects with smaller incisions and facilitates better postoperative recovery, thus its increasing clinical application is a growing trend. For example, TCA can be used for endovascular specimen retrieval or angiography; it can also be used for drug infusion, embolization, angioplasty, endovascular stent placement, vascular filter placement, removal of foreign bodies or thrombi from blood vessels, or rotational atherectomy of plaques; and it can be used to implant medical devices into organs such as the heart for the treatment of heart diseases.

[0075] For example, regarding the treatment of heart disease, please refer to... Figure 1 This is a schematic diagram of a transcatheter interventional therapy application scenario provided in an embodiment of this application. Figure 1 The structure of the heart is shown, such as Figure 1 As shown, the heart is a hollow muscular organ with four chambers: the left atrium (LA) 11, the right atrium (RA) 21, the left ventricle (LV) 12, and the right ventricle (RV) 22. Atrioventricular valves (hereinafter referred to as valves) connect the atria and ventricles. During ventricular diastole, the valves open, allowing blood to flow from the atria into the ventricles; during ventricular systole, the valves close, preventing blood from flowing back from the ventricles into the atria. The valve between the left atrium 11 and the left ventricle 12 is the mitral valve (MV) 13, and the valve between the right atrium 21 and the right ventricle 22 is the tricuspid valve (TV) 23. The mitral valve 13 has two leaflets that hang downwards into the ventricular cavity and is connected to the left ventricular wall via chordae tendineae 14 and papillary muscles 15. The tricuspid valve 23 has three leaflets that hang downwards into the ventricular cavity and is connected to the right ventricular wall via chordae tendineae 24 and papillary muscles 25. The major blood vessels connected to the heart mainly include the aorta 31, pulmonary artery 32, superior vena cava 41, and inferior vena cava 42. The heart and major blood vessels work together to achieve blood circulation.

[0076] For example, transcatheter interventional therapy can be applied to structural heart diseases, such as those caused by abnormalities in the structure of the heart or great vessels. These include valvular diseases and valve defects. Valvular diseases include regurgitation caused by valvular lesions between the atria and ventricles (e.g., mitral or tricuspid regurgitation), aortic stenosis, aortic regurgitation, pulmonary stenosis, or pulmonary regurgitation. Valvular defects include ventricular septal defect (VSD), atrial septal defect (ASD), or patent ductus arteriosus. For valvular diseases such as mitral or tricuspid regurgitation, transcatheter interventional therapy can be used to deliver implantable medical devices such as valve clamping devices to the lesion site for edge-to-edge repair of the mitral or tricuspid valves. For defects such as ventricular septal defect (VSD), atrial septal defect (ASD), or patent ductus arteriosus, transcatheter interventional therapy can be used. This involves implanting medical devices such as occluders and delivering them to the lesion site via a catheter to close the defects in the left or right ventricles or the left or right atria, or to block the passage between the aorta and the pulmonary artery.

[0077] Due to the complexity of the internal environment of a living organism, such as the diversity of anatomical structures of the valve annulus, leaflets, and adjacent areas, the surgeon's operation skills are highly demanding when manipulating the implant, and problems such as insufficient maneuverability may occur, thus affecting the interventional treatment effect. This application provides a clutch assembly 215 that enables rapid detachment of the implant from the delivery system, while maintaining stability of the implant during implantation, facilitating a smooth surgical procedure.

[0078] The following description is in conjunction with the accompanying drawings:

[0079] Please refer to Figure 2 This is a schematic diagram of the structure of an interventional treatment system provided in an embodiment of this application. Figure 2 As shown, the interventional therapy system 1 includes a delivery system 200 and an implant 100. The delivery system 200 is used to deliver the implant 100; the implant 100 includes, for example, an implantable medical device. The delivery system 200 includes, for example, a catheter 210 and a control mechanism 220. The catheter 210 provides a delivery channel for the implant 100, and the control mechanism 220 controls the distal movement of the catheter 210; the control mechanism 220 can also be used to control the implant 100, for example, controlling the connection and disconnection of the implant 100 from the distal end of the catheter 210, and, for example, controlling the state of the implant 100. By controlling the state of the distal end of the implant 100 through the control mechanism 220, the implant 100 can adapt to the distal environment and change its state, which is beneficial for controlling the implantation process of the implant 100, allowing the implant 100 to be implanted more accurately at the lesion site.

[0080] The catheter 210 may employ a multi-layer catheter structure, such as including at least two layers of catheters, where the outer layer provides an operating channel for the other catheters used for delivery of the implant 100. The control mechanism 220 includes, for example, multiple control devices for controlling the distal movement of the catheter 210. For example, such as... Figure 2 As shown, the delivery system 200 includes, for example, a three-layer catheter structure and corresponding control devices for the three layers of catheters. For example, catheter 210 includes a delivery catheter 211, a control catheter 212, and an implantation catheter 213; the control mechanism 220 includes control devices 221, 222, and 223, respectively used to control the distal movement of the delivery catheter 211, the control catheter 212, and the implantation catheter 213. The control mechanism 220 may also include a loader 224, which includes a base 2241 and a loading catheter 2242. In use, the loading catheter 2242 passes through the proximal end of the control device 221, becoming a channel for the control catheter 212, the implantation catheter 213, and the implant 100 to enter the delivery catheter 211, and the implant 100 is loaded into the delivery catheter 211 via the control device 221. To complete the implantation procedure, the distal ends of the delivery catheter 211 and the control catheter 212 should have navigation settings so that the surgeon can adjust the distal curvature according to the surgical requirements and control the direction of the distal end of the catheter 210, making it easier for the implant 100 to reach a more ideal relative position with the repair tissue. The distal end of the implantation catheter 213 is provided with a clutch assembly 215 for connecting or disconnecting the implant 100. The proximal end of the implant 100 is provided with a connector 110 for engaging with the clutch assembly 215 to achieve connection and disconnection of the implant 100. The delivery system 200 also includes a delivery rod 214, which passes through the implantation catheter 213. When delivering the implant 100, the distal end of the delivery rod 214 applies external force to the clutch assembly 215, ensuring a stable connection between the clutch assembly 215 and the implant 100. When disconnecting the implant 100, the delivery rod 214 removes external force from the clutch assembly 215, enabling rapid disengagement of the implant 100 from the clutch assembly 215.

[0081] The above description of the delivery system is merely an example. This application does not limit the shape and number of catheters in the delivery system, nor does it limit the shape and number of control devices included in the control mechanism; delivery systems with different structures can be set according to different implants.

[0082] According to a specific embodiment provided in this application, see [link to specific embodiment]. Figure 3 and Figure 4A clutch assembly 215 is disposed at the distal end of a catheter 210, comprising at least two engaging members 2152, wherein the at least two engaging members 2152 are open relative to the central axis of the clutch assembly 215 in their natural state. The distal end of each engaging member 2152 is provided with a connecting portion 2153. Under external force, the at least two engaging members 2152 close together, allowing the connecting portion 2153 to engage with a connecting seat 110 on the implant 100, thereby achieving a stable connection between the clutch assembly 215 and the implant 100.

[0083] After engagement, gaps exist between the proximal and distal edges of the connector 2153 and the connector seat 110. These gaps facilitate the separation of the connector 2153 and the connector seat 110, enabling rapid detachment of the implant 100 from the delivery system 200. However, when the implant 100 is manipulated, a slight relative displacement may occur between the connector 2153 and the connector seat 110, such as a rotation at a certain angle. Even a relatively limited small-angle rotation can still affect the surgical process and even the surgical outcome.

[0084] Therefore, this embodiment also provides a contact structure 2156 at the proximal and / or distal ends of the connecting portion 2153, so that after at least two clamping members 2152 surround it, a contact position is formed between the connecting portion 2153 and the connecting seat 110. In this way, while retaining the gap, the relative displacement of the connecting portion 2153 and the connecting seat 110 due to the presence of the gap can be restricted, so that the implant 100 can remain stable when it is manipulated, and promote the smooth progress of the surgery.

[0085] For example, see Figure 4 The engaging member 2152 also includes a main body 2157, and a connecting portion 2153 is disposed at the distal end of the main body 2157. Specifically, the connecting portion 2153 may include a connecting arc 2154 and a connecting arm 2155 arranged at an angle, with the connecting arm 2155 connecting the connecting arc 2154 and the aforementioned main body 2157. Correspondingly, the connecting seat 110 is provided with a groove 111, which is adapted to the contour of the connecting arc 2154, and the connecting seat 110 has a clearance groove 112 near the proximal end of the groove 111 suitable for avoiding the connecting arm 2155. When at least two engaging members 2152 are closed under external force, the connecting arc 2154 is located within the groove 111, and simultaneously, the connecting arc 2154 can mutually limit the movement of the connecting arc 2154 with the proximal end of the groove 111, thereby preventing the connecting arc 2154 from disengaging from the groove 111 along the central axis direction of the clutch assembly 215. The outline size of the groove 111 should be slightly larger than the outline size of the connecting arc 2154 so that when engaged, the proximal and distal edges of the connecting arc 2154 can form a gap with the sidewall of the groove 111.

[0086] In this embodiment, the contact structure 2156 protrudes along the width extension direction of the connecting arc 2154 and is disposed on the edge of the connecting arc 2154 so as to abut against the wall of the groove 111 of the connecting seat 110 facing the proximal end and / or the distal end, forming a contact position. Specifically, the contact structure 2156 can be provided only at the proximal end or the distal end of the connecting arc 2154 so that it can adapt to the gap between the connecting arc 2154 and the connecting seat 110 in the width extension direction of the connecting arc 2154, thereby limiting the relative displacement between the connecting arc 2154 and the connecting seat 110. Alternatively, the contact structure 2156 can be provided at both the proximal end and the distal end of the connecting arc 2154 so that it abuts against the wall of the groove 111 facing the proximal end and the distal end, respectively.

[0087] In this design, the end of the contact structure 2156 furthest from the connecting portion 2153 may be a convex spherical surface. The highest point of this spherical surface abuts against the wall of the groove 111 of the connecting seat 110 facing the proximal end and / or the distal end, thereby forming a point contact. See also... Figure 6 The end of the contact structure 2156 away from the connecting portion 2153 may also be a convex arc surface. The highest point of this arc surface abuts against the wall of the groove 111 of the connecting seat 110 facing the proximal and / or distal ends to form a line contact. Of course, in some embodiments, the end of the contact structure 2156 away from the connecting portion 2153 may also be a plane or an inclined plane. This plane or inclined plane abuts against the wall of the groove 111 of the connecting seat 110 facing the proximal and / or distal ends to form a surface contact. No further limitations are imposed here, and all are within the protection scope of this application.

[0088] As a preferred option, see Figure 5 The projection of the connecting part 2153 onto the central axis plane is T-shaped, and the connecting arc 2154 and the connecting arm 2155 are arranged approximately perpendicularly. One end of the connecting arm 2155 is located in the middle section of the connecting arc 2154, and the other end is connected to the center position of the far end of the main body 2157.

[0089] In this embodiment, by setting the connecting part 2153 in a T-shape, a locking connection can be formed on both sides of the connecting part 2153 when locked. This connection is more stable and balanced than a single-sided locking (e.g., the connecting part 2153 is L-shaped). This makes it easier for the implant 100 to remain stable when manipulated, without deviating from its relative position to the implantation site or undergoing any unexpected movement, thus promoting the smooth progress of the surgery.

[0090] Furthermore, at least two engaging elements 2152 are evenly spaced around the central axis of the clutch assembly 215, which is more conducive to maintaining the balance of the implant 100 and facilitating the smooth progress of the surgery. In addition, the contact structure 2156 may specifically include protrusions, and each connecting arc 2154 is provided with at least one protrusion. The protrusions on the connecting arc 2154 are preferably symmetrically arranged along the central axis of the connecting arm 2155 or centrally symmetrically arranged along the center of the connecting arc 2154. For example, when there is one protrusion on the connecting arc 2154, the protrusion is preferably located at the center of the distal end of the connecting arc 2154; when there are two protrusions on the connecting arc 2154, the two protrusions can be respectively located on both sides of the arc length of the connecting arc 2154 and located at the proximal end and distal end of the connecting arc 2154; when there are three protrusions on the connecting arc 2154, one protrusion is located in the middle section of the distal end of the connecting arc 2154, and the other two protrusions are respectively located on both sides of the proximal end of the connecting arc 2154 along the arc length; when there are four protrusions on the connecting arc 2154, two protrusions are respectively located on both sides of the distal end of the connecting arc 2154 along the arc length, and the other two protrusions are respectively located on both sides of the proximal end of the connecting arc 2154 along the arc length.

[0091] See Figure 5 and Figure 6 In this embodiment, protrusions are provided at both the proximal and distal ends of the connecting arc 2154, and the multiple protrusions are arranged in an axially symmetrical or centrally symmetrical manner, which is more conducive to maintaining the balance of the implant 100 and promoting the smooth progress of the surgery.

[0092] Specifically, see Figure 3 and Figure 4 The engaging member 2152 also includes an elastic portion 2159, which is connected between the distal end of the conduit 210 and the main body 2157, allowing the engaging member 2152 to open relative to the central axis of the clutch assembly 215 in its natural state. Furthermore, an engaging member 2151 is provided on the side of the engaging member 2152 closest to the central axis of the clutch assembly 215. The engaging member 2151 is generally annular and has a through hole 2160, connected to the engaging member 2152 via a handle-type connecting arm 2161. When the through holes 2160 of the engaging members 2151 of at least two engaging members 2152 are aligned, the at least two engaging members 2152 close together.

[0093] Specifically, see Figure 6When the mating parts 2151 are approximately overlapping, the delivery rod 214 passes through the mating parts 2151 of at least two clamping parts 2152 in sequence, and the connecting part 2153 engages with the connecting seat 110 of the implant 100, so that the implant 100 and the clutch assembly 215 remain in a connected state. When it is necessary to remove the implant 100, the delivery rod 214 moves proximally away from the mating parts 2151, and the clamping parts 2152 return to the open state under the rebound action of the elastic part 2159. The connecting part 2153 separates from the connecting seat 110, thereby realizing the removal of the implant 100.

[0094] Preferably, the mating part 2151, especially the main body 2157 on the mating part 2151, has a hollow structure 2162, which is beneficial to the weight reduction of the clutch assembly 215.

[0095] See Figure 2 and Figure 7 This application also provides a delivery system 200 for delivering an implant 100, including a catheter 210 and a clutch assembly. The clutch assembly may be the clutch assembly 215 provided in any of the above embodiments. The catheter 210 further includes an implantation catheter 213 having an axially extending central channel, and the clutch assembly 215 is disposed at the distal end of the implantation catheter 213 for connecting and disconnecting the implant 100.

[0096] In a preferred embodiment, see Figures 8 to 10 The implantable catheter 213 adopts a multi-level catheter structure. Its main body includes a multi-lumen tube 2131 and a support tube 2134. The multi-lumen tube 2131 has an axially penetrating central channel 2132 and multiple auxiliary channels 2133 located around the central channel 2132. Preferably, there are six auxiliary channels 2133, which are evenly spaced. The support tube 2134 is located within the central channel 2132 of the multi-lumen tube 2131. The support tube 2134 and the multi-lumen tube 2131 extend between the proximal and distal ends of the main body, covering all or part of the length of the main body. The support tube 2134 has an axially penetrating central channel 2135 through which the delivery rod 214 can pass.

[0097] In this embodiment, by setting up independent multi-lumen tubes 2131 to integrate multiple axial channels into a single tube structure, different functions can be achieved within a smaller diameter, making it more suitable for minimally invasive surgery. Moreover, the design of multi-lumen tubes 2131 takes into account the balance of internal and external pressures compared to opening multiple channels on the main body, which helps to improve the consistency of the main body's performance. In addition, this embodiment also sets up a support tube 2134 inside the multi-lumen tube 2131, which helps to balance the force on the multi-lumen tube 2131, making the response of the distal end of the implanted catheter 213 more synchronized with the torque experienced by the proximal end, and more controllable.

[0098] The multi-lumen tube 2131 can be made of one or more materials such as polyether block amide thermoplastic elastomer, PI (polyimide), and stainless steel. It is preferably made of polyether block amide thermoplastic elastomer, which has excellent toughness, fatigue resistance and resilience. During torque transmission, it can withstand repeated stress changes without fatigue failure. At the same time, it can quickly return to its original shape, reduce energy loss, and enhance the torque transmission performance of the implanted catheter 213. After the implanted catheter 213 passes through multiple tortuous paths, its distal end can still transmit the torque applied from the proximal end relatively synchronously, and the synchronicity of torque transmission is further enhanced.

[0099] As a preferred option, see Figure 9 and Figure 10 The support tube 2134 includes a spring coil made of an elastic metal material such as stainless steel or nickel-titanium alloy, and the spring coil preferably covers the entire length from the proximal end to the distal end of the main body. Conversely, the multi-cavity tube 2131 preferably covers the entire length from the proximal end to the distal end of the main body.

[0100] Furthermore, the spring coil at least partially employs a double-layer structure along its own axial direction, and the double-layer structure has clockwise and counterclockwise helical directions respectively. That is, the double-layer structure of the spring coil has a first spring coil and a second spring coil sequentially from the inside to the outside along its own radial direction, one of the first spring coil and the second spring coil adopts a clockwise helix, and the other of the first spring coil and the second spring coil adopts a counterclockwise helix. When subjected to torque, the component forces of the clockwise helix and the counterclockwise helix can cancel each other out, which is more conducive to improving the stability of the implanted catheter 213 and enhancing the torque transmission performance of the implanted catheter 213.

[0101] Preferably, the entire spring coil adopts a double-layer structure, that is, the spring coil has a first spring coil and a second spring coil sequentially from the inside to the outside along its own radial direction. One of the first spring coil and the second spring coil adopts a clockwise spiral, and the other adopts a counterclockwise spiral. This configuration further enhances the torque transmission performance of the implanted catheter 213, so that the torque applied from the proximal end of the implanted catheter 213 can be transmitted to the distal end more synchronously, without significant delay, with good synchronization and greater controllability.

[0102] Specifically, the main body also includes an outer tube 2136, which is sleeved outside the multi-lumen tube 2131 and is made of polyether block amide thermoplastic elastomer material. It can contain different hardness ranges or a single hardness; no further limitations are imposed, all of which are within the scope of protection of this application. A reinforcing layer 2137 is provided between the outer tube 2136 and the multi-lumen tube 2131. This reinforcing layer 2137 can be woven from stainless steel or other metal wires and extends between the proximal and distal ends of the main body, covering all or part of the length of the main body, thereby providing the required pressure-bearing capacity for the implanted body and ensuring the stability of the implanted body when subjected to internal pressure. Simultaneously, in this embodiment, the reinforcing layer 2137 extends axially, which can improve the transmission efficiency of the axial force of the implanted catheter 213 and optimize the transmission performance of the implanted catheter 213. Preferably, the spring coil, the multi-lumen tube 2131, and the reinforcing layer 2137 are tightly fitted together, and the reinforcing layer 2137 covers the entire length of the main body from the proximal to the distal end.

[0103] In one specific embodiment, see Figure 10 The distal end of the implantable catheter 213 is provided with a plug, which passes between the reinforcing layer 2137 and the multi-lumen tube 2131. This plug at least covers a portion of the distal end face of the main body, such as the reinforcing layer 2137 and the outer tube 2136, thereby strengthening the connection between the multi-level structure of the implantable catheter 213 and the proximal end of the clutch assembly 215, especially the connection between the implantable catheter 213 and the clutch assembly 215. Simultaneously, it effectively prevents the distal end of the implantable catheter 213 from returning to the distal portion of the control catheter 212's internal channel during implantation, thus facilitating the implantation procedure. The plug has at least one central channel 2140 for the delivery rod 214 to pass through.

[0104] For example, the plug-in includes an end ring 2138 and a hub 2139, the hub 2139 being disposed between the reinforcing layer 2137 and the multi-cavity tube 2131, and the proximal end of the clutch assembly 215 being able to connect to the hub 2139; the end ring 2138 is disposed at the distal end of the hub 2139, covering part of the distal end face of the main body, such as the reinforcing layer 2137 and the outer tube 2136, and the end ring 2138 has at least one central channel. The end ring 2138 and the hub 2139 can be a single piece or a fixed connection.

[0105] In actual production, the fixed connection between each layer of the implanted catheter 213, the insert, and the proximal end of the clutch assembly 215 can be achieved by melting.

[0106] Specifically, a hole 2141 is provided on the side wall of the hub 2139, which is suitable for the welding reinforcement of the implanted catheter 213. After the components of the implanted catheter 213 are installed, the connection strength between the multi-lumen tube 2131, the reinforcing layer 2137, the outer tube 2136, the hub 2139 and the proximal end of the clutch assembly 215 can be strengthened by melting and using thermorheology.

[0107] Specifically, the insert may further include a fastener 2143, which passes through the hub 2139 and is fixedly connected to the side wall of the hub 2139. The fastener 2143 has a central channel 2144 through which the delivery rod 214 passes. The central channel 2144 is coaxial with the central channel of the implantation catheter 213 (i.e., the central channel 2135 of the spring coil). The outer side wall of the fastener 2143 extends radially with at least one shank 2145. A slot 2142 corresponding to the shank 2145 is formed on the proximal side wall of the hub 2139 to accommodate the shank 2145 of the fastener 2143, thereby achieving the connection and fixation between the fastener 2143 and the hub 2139.

[0108] Preferably, there are two handles 2145, symmetrically arranged along the axis of the main body. Of course, in actual production, the number of handles 2145 can also be three, four, etc., and they can be evenly spaced. These are all within the protection scope of this application and will not be elaborated here.

[0109] Preferably, the proximal end face of the fastener 2143 and the proximal end face of the hub 2139 are approximately on the same plane. The distal end of the spring coil can be arranged on the proximal end face of the fastener 2143. The spring coil and the fastener 2143 are coaxial, and the diameter of the central channel of the fastener 2143 is approximately the same as that of the central channel of the spring coil, so that the synchronization performance between the distal end of the implanted catheter 213 and the main body is further enhanced, that is, the synchronization of torque transmission is further enhanced.

[0110] This application improves the implantation catheter 213 to ensure sufficient stability of the entire delivery system 200, especially the implantation catheter 213 directly connected to the implant, during implant delivery. Specifically, after traversing multiple bends, the distal end of the implantation catheter 213 in the delivery system 200 should still be able to transmit the torque applied from the proximal end of the catheter 210 relatively synchronously. Simultaneously, during implantation, when the implant 100 is subjected to a manipulating force, the implant 100 also responds synchronously, and the implant as a whole remains stationary and does not move or shake relative to the implantation environment.

[0111] See Figure 3 , Figure 4 , Figure 7 and Figure 8Taking the implant 100 as a valve clamping device as an example, the valve clamping device 400 includes a main body 410, a clamping element 420 (also referred to as a clamping arm), and a grasping device 430 (also referred to as a grasping arm). The grasping device 430 is located between the clamping element 420 and the main body 410. Both the clamping element 420 and the grasping device 430 can open and close relative to the main body 410, and their opening and closing movements can be independent of each other. The valve clamping device 400 has a closed state and an open state; optionally, the open state may also include an inverted state. The proximal end of the main body 410 can be detachably connected to the distal end of the implantation catheter 213 via a clutch assembly 215. The distal end of the delivery rod 214 extends from the distal end of the implantation catheter 213 and inserts into the engaging member 2151 of the clutch assembly 215, causing the engaging member 2152 of the clutch assembly 215 to engage together, thereby clamping the valve clamping device 400 to the distal end of the implantation catheter 213. When the distal end of the delivery rod 214 is withdrawn from the engaging member 2151, the engaging member 2152 opens, and the valve clamping device 400 is detached from the distal end of the implantation catheter 213. A transmission assembly 440 may be provided within the main body 410. The distal end of the delivery rod 214 can apply a driving force to the transmission assembly 440. The axial movement of the transmission assembly 440 drives the opening and closing movement of the clamping element 420, thereby changing the state of the valve clamping device 400.

[0112] Among them, see Figure 7 and Figure 8 The valve clamping device 400 has a capture device 430 connected to a control element 450. The surgeon can change the state of the capture device 430 by manipulating the control element 450. For example, after the valve clamping device 400 is inserted into the left ventricle, the surgeon can adjust the position of the valve clamping device 400 through imaging and determine whether the position and opening state of the valve clamping device 400 are suitable for capturing the leaflets. When the valve clamping device 400 is not suitable for capturing the leaflets, the control element 450 can be pulled to bring the capture device 430 closer to the main body 410. When the valve clamping device 400 is suitable for capturing the leaflets, the control element 450 can be released to make the capture device 430 open quickly and move towards the clamping element 420 on the same side, capturing the leaflets between the capture device 430 and the clamping element 420. Specifically, the proximal end of the control element 450 extends through the auxiliary channel 2133 of the multi-lumen tube 2131 inside the implantation catheter 213 and is connected to the implantation catheter control device 300 located at the proximal end of the implantation catheter 213.

[0113] See Figures 11 to 12The implantable catheter manipulation device 300 may specifically include a housing 310 and a manipulation component 320. The housing 310 has a channel 311 for receiving the proximal end of the delivery rod 214. The manipulation component 320 is used to drive the delivery rod 214, causing the delivery rod 214 to move (including rotation or axial displacement).

[0114] Specifically, see Figure 13 and Figure 14 The control assembly 320 includes a control handle 322 and a drive element. The control handle 322 extends out of the housing 310 to receive driving force. The distal portion of the drive element has a component that can extend into a channel 311, connecting to the proximal end of the delivery rod 214. The control handle 322 is used to drive the rotation and axial movement of the drive element. Thus, the control assembly 320 can drive the delivery rod 214 to move via the drive element, thereby controlling the state of the valve clamping device 400 and controlling the connection and disconnection of the valve clamping device 400 from the distal end of the implanted catheter 213.

[0115] Specifically, see Figure 13 and Figure 14 The driving element may further include a sleeve 321 and a drive rod 323. A control handle 322 is connected to the proximal end of the sleeve 321. The control handle 322 can drive the sleeve 321 and the drive rod 323 to rotate and move axially upward toward the proximal end.

[0116] The sleeve 321 has a first internal space S1, a control handle 322 connected to the proximal end of the sleeve 321, and a second internal space S2 communicating with the first internal space S1. The drive rod 323 includes a first segment 3232 at its distal end and a second segment 3231 at its proximal end, with the radial dimension of the first segment 3232 being larger than that of the second segment 3231. The second segment 3231 passes through the first internal space S1 and the second internal space S2 and is rotatable relative to both. The first segment 3232 partially passes through the first internal space S1, extends from the distal end of the sleeve 321, and enters the channel 311 to connect to the proximal end of the delivery rod 214. The first segment 3232 restricts relative rotation between the drive rod 323 and the sleeve 321 so that the control handle 322 drives the sleeve 321 and the drive rod 323 to rotate synchronously.

[0117] This application does not limit the specific shape of the outer contour of the first segment 3232 or the inner contour of the distal end of the sleeve 321. It can be a regular or irregular shape; for example, it can be an ellipse, rectangle, triangle, or other polygon. Or, it can be a racetrack shape, including two parallel sides and symmetrical arcuate edges connecting the two sides. See also... Figure 15The outer contour of the first segment 3232 or the inner contour of the distal end of the sleeve 321 includes an arc-shaped edge, such as an ellipse or a racetrack shape, which can reduce the frictional force of axial movement between the first segment 3232 and the sleeve 321, making the axial movement between the drive rod 323 and the sleeve 321 smoother, while also limiting the relative rotation between the drive rod 323 and the sleeve 321.

[0118] In the above-described control assembly 320, the control handle 322 is connected to the proximal end of the cannula 321. When the operator rotates the control handle 322, the control handle 322 can drive the cannula 321 to rotate together; that is, the control handle 322 receives torque and transmits torque to the cannula 321. Since the relative rotation between the cannula 321 and the drive rod 323 is restricted by the first section 3232, the cannula 321 can drive the drive rod 323 to rotate; that is, the cannula 321 can further transmit torque to the drive rod 323, and the drive rod 323 can then transmit torque to the delivery rod 214.

[0119] Specifically, a floating adjustment mechanism for axial displacement is provided for the drive rod 323. See details... Figure 13 The control component 320 may further include a first elastic element 325, which is sleeved within the second segment 3231 of the drive rod 323 in the first space S1. The second segment 3231 of the drive rod 323 has no obvious contact with the first elastic element 325 and can move and rotate freely axially relative to the first elastic element 325. The proximal end of the first elastic element 325 is axially limited at the proximal end of the first space S1, and the distal end is axially limited at the distal end of the first space S1 or the proximal end of the first segment 3232.

[0120] In the preset state, the first elastic element 325 is compressed, applying elastic force to both ends. At this time, the proximal end of the first segment 3232 is subjected to force, causing the drive rod 323 to tend to advance distally, which in turn causes the distal end of the delivery rod 214 to tend to advance distally. This prevents the distal end of the delivery rod 214 from retracting proximally during implantation, thereby maintaining the effective connection between the implantation catheter 213 and the valve clamping device 400, and the effective control of the valve clamping device 400 by the delivery rod 214. As the drive rod 323 advances distally, the first segment 3232 also advances distally, and the first elastic element 325 extends accordingly, reaching as far as the internal limit point at the distal end of the first space S1.

[0121] During implant delivery, due to the complex biological environment, the distal end of the delivery rod 214 may become obstructed during delivery, causing the main body of the delivery rod 214 to retract. When the resistance exceeds the elastic force exerted by the first elastic element 325 on the first segment 3232, the delivery rod 214, along with the drive rod 323, synchronously displaces proximally. This keeps the main body of the delivery rod 214 immediately free from the influence of distal resistance, allowing torque transmission without external force and making it easier to maintain the synchronicity of torque transmission. Understandably, while the first elastic element 325 is compressed, it applies a greater elastic force to the first segment 3232 to resist the retraction of the delivery rod 214. Thus, when the resistance at the distal end of the delivery rod 214 is relieved, the tendency to advance distally is immediately restored.

[0122] During this process, the length of the first section 3232 of the drive rod 323 extending out of the cannula 321 fluctuates within a small range, which is equivalent to setting a floating length for the delivery rod 214, providing greater flexibility. This allows for spontaneous floating adjustment based on the implantation environment, enhancing the safety and effectiveness of the implantation process. Furthermore, it enables the setting of appropriate floating lengths for different implants, reducing operational difficulty and facilitating the widespread application of transcatheter interventional techniques.

[0123] Optionally, a mounting handle 324 is also connected to the proximal end of the second section 3231 of the drive rod 323. The mounting handle 324 is located within the second space S2, and the mounting handle 324 and the control handle 322 are not mutually constrained. The mounting handle 324 is more conducive to assembling the drive rod 323 into the sleeve 321, and can reduce the gap between the second section 3231 and the second space S2 to a certain extent, thereby improving the stability of the overall structure.

[0124] In one example embodiment, see Figure 16 and Figure 17 The control device 300 may further include a connecting assembly 360 for connecting the control assembly 320 and the housing 310. Specifically, the connecting assembly 360 may include a limiting track 361 and a limiting element 362. The limiting element 362 matches the limiting track 361 and is axially slidable relative to the limiting track 361. The limiting track 361 can extend axially along the housing 310. The distal end of the sleeve 321 is axially limited by the limiting element 362, the inner wall of the housing 310 is provided with the limiting track 361, and the distal end of the sleeve 321 can rotate relative to the limiting element 362.

[0125] Preferably, there are two limiting elements 362, symmetrically arranged on both sides of the distal end of the sleeve 321. At this time, there are also two limiting tracks 361, symmetrically arranged on the housing 310. The limiting tracks 361 and the limiting elements 362 work together to not only achieve a sliding fit between the sleeve 321 and the housing 310, but also to limit the radial wobble of the sleeve 321, allowing it to move more smoothly axially, thereby driving the drive rod 323 and the delivery rod 214 to move axially stably. Simultaneously, there is no radial limitation between the sleeve 321 and the limiting elements 362, allowing the sleeve 321 to rotate relative to the limiting elements 362.

[0126] Specifically, the connecting assembly 360 further includes a connector 363, which connects two limiting elements 362 and is fitted onto the distal end of the sleeve 321, providing axial limitation with the distal end of the sleeve 321 without radial limitation. There can be two connectors 363, with the two limiting elements 362 connected to different connectors 363. Both connectors 363 and the two limiting elements 362 are fitted together onto the distal end of the sleeve 321, without radial limitation on the sleeve 321. Alternatively, preferably, the two limiting elements 362 are connected to the same connector 363, which is fitted together onto the distal end of the sleeve 321 without radial limitation on the sleeve 321. Furthermore, the connecting assembly 360 also includes two limiting rings 364, which are rotatably connected to the distal end of the sleeve 321, axially limiting the connector 363 between them. In a preferred embodiment, the distal end of the sleeve 321 has two grooves 3213, and the two limiting rings 364 are respectively embedded in the two grooves 3213, with the connector 363 arranged between the two grooves 3213. This achieves a stable connection between the sleeve 321 and the housing 310, as well as a stable axial displacement direction, and allows the sleeve 321 to rotate to transmit torque when torque is applied to the control handle 322, and allows the sleeve 321 to stably displace relative to the housing when axial power is applied to the control handle 322.

[0127] Preferably, see Figure 12 The control device 300 may further include a locking component 330, which has a locked state and an unlocked state, used to lock or unlock the axial movement of the control component 320 relative to the housing 310, respectively. Specifically, when the locking component 330 is in the locked state, rotating the control handle 322 can drive the delivery rod 214 to rotate, thereby driving the state change of the valve clamping device 400. When the locking component 330 is in the unlocked state, the control handle 322 can be pulled proximally, causing the control handle 322 to drive the cannula 321 and the drive rod 323, thereby driving the delivery rod 214 to move proximally, so that the valve clamping device 400 can be quickly detached from the implanted catheter 213.

[0128] In one example embodiment, the locking assembly 330 may include a locking member 331, which has an opening for the sleeve 321 to pass through, and a locking side 3311 corresponding to the periphery of the opening. During use, the locking member 331 can be selectively positioned in a first position and a second position. In the first position, the locking side 3311 is abutted against the sleeve 321 to restrict axial movement of the sleeve 321; in the second position, the locking side 3311 is away from the sleeve 321, suitable for the operating handle 322 to move the sleeve 321 and the drive rod 323 proximally.

[0129] Specifically, see Figure 12 , Figure 15 and Figure 16 The sleeve 321 also includes a base 3211, the outer contour of which is larger than other parts, and the base 3211 is connected to the control handle 322 at its proximal end. The base 3211 at the proximal end of the sleeve 321 is engaged with the proximal end of the housing 310 and can move axially towards the proximal end relative to the housing 310; a first limiting structure 3212 is provided at the proximal end of the sleeve 321 near the base 3211, the outer contour of the first limiting structure 3212 being approximately the same as the outer contour of the base 3211. At this time, a limiting groove 3213 is formed between the first limiting structure 3212 and the base 3211, and the locking assembly 330 can be arranged in the limiting groove 3213 and is approximately perpendicular to the sleeve 321.

[0130] Furthermore, the locking assembly 330 also includes a push rod 332 and a second elastic member 333, wherein the push rod 332 and the locking member 331 are connected to each other, and the two ends of the second elastic member 333 abut against the outer wall of the locking member 331 and the inner wall of the housing 310, respectively. The opening on the locking member 331 is an elliptical hole that is roughly similar to a racetrack. Its long diameter is consistent with the distribution direction of the locking assembly 330 and is approximately 1.5-2.5 times the outer diameter of the base 3211 or the first limiting structure 3212, and its short diameter is approximately 1.2-1.8 times the outer diameter of the base 3211 or the first limiting structure 3212. According to the orientation from the proximal end to the distal end, the locking member 331 can be divided into a left half locking side 3311 and a right half unlocking side 3312 along the extension direction of the short diameter. The locking side 3311 is provided with a second limiting structure along the inner wall shape.

[0131] In this embodiment, the locking state of the locking component 330 is a preset state. In the locked state, the second elastic member 333 is compressed and has an outward elastic force. The locking member 331 is located in the first position, with its locking side 3311 abutting against the sleeve 321. Under the restriction of the second limiting structure on the inner wall of the locking side 3311, the first limiting structure 3212 and the base 3211 on the sleeve 321 cannot pass through the locking member 331, so that the sleeve 321 is locked in the preset position and cannot move axially. In the unlocked state, the push rod 332 is pressed inward, further compressing the second elastic member 333. The locking member 331 is located in the second position, with its locking side 3311 away from the sleeve 321 and its unlocking side 3312 close to the sleeve 321. The first limiting structure 3212 on the sleeve 321 can pull the control handle 322 towards the proximal end through the locking member 331, which can drive the sleeve 321 and the drive rod 323 to move towards the proximal end.

[0132] Specifically, see Figure 11 and Figure 18 The control device 300 may further include a capture device control handle 370 located at the distal end of the housing 310, and the housing 310 has a channel 312 for a control element 450, from which the control element 450 can be withdrawn. The capture device control handle 370 is connected to the control element 450, allowing the operator to control the capture device 430 to open via the capture device control handle 370. In practical applications, the number of capture devices 430 is preferably two, and the number of capture device control handles 370 in the control device 300 is also two, located on opposite sides at the distal end of the housing 310. Pushing the two capture device control handles 370 distally respectively allows the two capture devices 430 to open separately, enabling the petals to be captured individually. After the petals are captured, the clamping element 420 moves to a closed state, causing the petals to align.

[0133] See Figure 2 This application also provides an interventional treatment system 1, including an implant 100 and a delivery system 200 provided in any of the above embodiments. Specifically, see... Figure 3 The implant 100 is provided with a connector at its proximal end. The delivery system 200 is used to deliver the implant 100. When delivering the implant 100, at least two engaging members 2152 of the clutch assembly 215 engage in parallel and connect with the connector.

[0134] Taking the implant 100 as a valve clipping device as an example, during implantation, the delivery catheter 211, carrying a dilator, enters the right atrium via the femoral vein along the guidewire. The distal end of the delivery catheter 211 passes through the interatrial septum into the left atrium. The dilator is then withdrawn, and the manipulator catheter 212, carrying the implantation catheters 213 and 213 and the valve clipping device 400, enters the left atrium along the lumen of the delivery catheter 211. The valve clipping device 400 is connected to the distal end of the implantation catheters 213 and 213; during delivery of the valve clipping device 400, the valve clipping device 400 is in a closed state. At this time, the valve clipping device 400 enters the patient's body with minimal radial dimension, effectively reducing harm to the patient and alleviating discomfort.

[0135] When the valve clamping device 400 is delivered to the target position, the drive handle 322 is rotated to drive the delivery rod 214 via the drive assembly. The delivery rod 214 is inserted into the body 410 of the valve clamping device 400, and the clamping element 420 is gradually opened by the delivery rod 214. For example, the valve clamping device 400 in the open state can be delivered into the left ventricle, or the valve clamping device 400 in the closed state can be delivered into the left ventricle, and then the clamping element 420 is controlled to open.

[0136] After the valve clamping device 400 is inserted into the left ventricle, if the valve clamping device 400 is suitable for capturing the valve leaflets, the capturing device 430 can be opened by controlling the capturing device control handle 370 to capture the valve leaflets. After the valve leaflets are captured, the drive handle 322 is rotated to drive the delivery rod 214 through the drive assembly, thereby controlling the clamping element 420 to close towards the body 410. Since the capturing device 430 is located between the clamping element 420 and the body 410, the clamping element 420 can drive the capturing device 430 to close, so that the valve clamping device 400 returns to the closed state. Then, the push rod 332 of the locking assembly 330 is pressed to release the lock on the drive assembly; the drive handle is pulled proximally to drive the delivery rod 214 away from the engagement member 2151 of the clutch device 215; so that the valve clamping device 400 is detached from the distal end of the implantation catheter 213 and remains in the patient's body.

[0137] The angle between the clamping elements 420 facing proximal to the leaflet can be further increased. This allows the drive handle to be rotated to control the valve clamping device 400 to an inverted state via the delivery rod 214 in the event of leaflet capture failure. In the inverted state, the angle between the clamping elements 420 facing proximal to the leaflet can be an obtuse angle, which facilitates the valve clamping device 400's retraction from the ventricular side to the atrial side without entanglement with the chordae tendineae connecting the leaflets. This improves operator control and reduces damage to the patient's tissues caused by the valve clamping device 400. Afterward, the position and state of the valve clamping device 400 can be readjusted, and the leaflet capture and clamping steps can be repeated until leaflet occlusion and clamping are complete.

[0138] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0139] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of this application. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principles of this application, and these improvements and modifications should also be considered within the scope of protection of this application.

Claims

1. A clutch assembly disposed at the distal end of a catheter for connecting and disconnecting an implant, characterized in that, include: At least two engaging members, and the at least two engaging members are open relative to the central axis of the clutch assembly in their natural state; The distal end of the clamping member is provided with a connecting portion. Under the action of external force, the at least two clamping members close together so that the connecting portion is adapted to engage with the connector on the implant. The proximal and / or distal ends of the connecting portion are provided with contact structures so that after the at least two clamping members close together, a contact position is formed between the connecting portion and the connector.

2. The clutch assembly according to claim 1, characterized in that, The clamping component further includes a main body, and the connecting portion is located at the distal end of the main body; the connecting portion includes a connecting arc and a connecting arm arranged at an angle, and the connecting arm connects the connecting arc and the main body; The connecting seat is provided with a groove that is adapted to the connecting arc contour, and the connecting seat is provided with a clearance groove near the groove to avoid the connecting arm; The contact structure is provided on the connecting arc along the width of the connecting arc to form the contact position with the proximal end and / or distal end of the groove.

3. The clutch assembly according to claim 2, characterized in that, The projection of the connecting part on the central axis plane is T-shaped. The connecting arc and the connecting arm are arranged perpendicularly, and one end of the connecting arm is located in the middle section of the connecting arc, while the other end is connected to the center position of the far end of the main body.

4. The clutch assembly according to claim 2, characterized in that, The contact structure includes a protrusion, and at least one of the protrusions is provided on each of the connecting arcs.

5. The clutch assembly according to any one of claims 1-4, characterized in that, The end of the contact structure away from the connecting portion is a convex spherical surface, which abuts against the connecting seat to form a point contact; or, The end of the contact structure away from the connecting portion has a convex arc surface, which abuts against the connecting seat to form a line contact; or, The end of the contact structure away from the connecting part is a plane or an inclined plane, which abuts against the connecting seat to form a surface contact.

6. The clutch assembly according to any one of claims 2-4, characterized in that, The engaging component further includes an elastic portion connected between the distal end of the conduit and the main body, such that the engaging component opens relative to the central axis of the clutch assembly in its natural state.

7. The clutch assembly according to any one of claims 1-4, characterized in that, The engaging member is provided with a mating member on the side of the engaging member close to the central axis of the clutch assembly; The mating member has a through hole, and when the through holes of the mating members of the at least two clamping members are aligned, the at least two clamping members enclose each other.

8. A conveying system, characterized in that, include: The catheter, including an implantable catheter having an axially penetrating central channel; A clutch assembly, located at the distal end of the implantation catheter, is used to connect and disconnect the implant; The implantable catheter body includes a multi-lumen tube and a support tube. The multi-lumen tube has an axially penetrating central channel, and the support tube passes through the central channel of the multi-lumen tube. The multi-lumen tube and the support tube extend between the proximal and distal ends of the implantable catheter body and cover at least a portion of the length of the body.

9. The conveying system according to claim 8, characterized in that, The support tube includes a spring coil, and the spring coil covers the entire length of the main body from the proximal end to the distal end.

10. The conveying system according to claim 9, characterized in that, The spring coil at least partially employs a double-layer structure along its own axial direction; and... The spring coil has a first spring coil and a second spring coil in a double-layer structure, arranged radially from the inside to the outside. The helical direction of the first spring coil is opposite to that of the second spring coil.

11. The conveying system according to claim 8, characterized in that, The main body also includes an outer tube, which is sleeved on the outside of the multi-cavity tube; and a reinforcing layer is provided between the outer tube and the multi-cavity tube.

12. The conveying system according to claim 11, characterized in that, The reinforcing layer is woven from metal wires, extends between the proximal and distal ends of the body, and covers at least a portion of the length of the body; and / or The outer tube has at least two sections along its own axial direction, and the hardness of the at least two sections is inconsistent, or the hardness of the outer tube is equal everywhere.

13. The conveying system according to claim 11, characterized in that, The distal end of the implanted catheter is provided with a plug that covers part of the distal end face of the body and has at least one central channel.

14. The conveying system according to claim 13, characterized in that, The plug-in includes an end ring and a hub; The hub is disposed between the reinforcing layer and the multi-cavity tube; the end is circumferentially disposed at the distal end of the hub, covering part of the distal end face of the main body, and has at least one central channel.

15. The conveying system according to claim 14, characterized in that, The plug-in also includes firmware, which is inserted into the hub and fixedly connected to the side wall of the hub; The firmware has a central channel and is coaxial with the central channel of the implanted catheter; The distal end of the support tube is connected to the proximal end of the firmware.

16. The conveying system according to any one of claims 8-15, characterized in that, The clutch assembly is the clutch assembly as described in any one of claims 1-7, disposed at the distal end of the implantation catheter, for connecting and disconnecting the implant; The delivery system also includes a delivery rod inserted into the central channel of the implantation catheter. When delivering the implant, the distal end of the delivery rod applies the external force to the clutch members of the clutch assembly, causing the at least two clutch members to close. When removing the implant, the distal end of the delivery rod withdraws from the clutch members of the clutch assembly.

17. An interventional therapy system, characterized in that, include: An implant, wherein a connector is provided at the proximal end of the implant; The delivery system according to any one of claims 8-16 is used to deliver the implant, wherein, during delivery of the implant, at least two engaging members of the clutch assembly surround and connect with the connector.

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