Clutch assembly, conveying system and interventional therapy system

Abstract

The invention relates to the technical field of medical instruments, and discloses a clutch assembly, a conveying system and an interventional therapy system.The clutch assembly is arranged at the far end of a catheter and comprises at least two cohesion pieces, and the at least two cohesion pieces are opened relative to the central axis of the clutch assembly in the natural state. A connecting part is arranged at the far end of each cohesion piece, the at least two cohesion pieces are encircled under the action of external force, so that the connecting part can be connected with a connecting seat on the implant in a clamping manner, and a contact structure is arranged at the near end and / or the far end of the connecting part and can abut against the connecting seat, so that a contact position is formed between the connecting part and the connecting seat. Through the arrangement of the contact structure, separation of the connecting part and the connecting seat is facilitated; meanwhile, tiny relative displacement between the connecting part and the connecting seat can be limited, so that the implant is kept stable and does not deviate from the relative position of the implant part in the implanting process, unexpected movement of the implant is avoided, and smooth operation is promoted.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a clutch assembly, a delivery system and an interventional treatment system. Background Art

[0002] Structural heart disease in a broad sense refers to any abnormality of the heart structure and any disease related to the heart and large blood vessel structure, except for primary coronary artery disease and electrocardiographic disease (such as coronary heart disease, arrhythmia, etc.). Among them, valvular heart disease is a common type of disease, such as blood reflux caused by valvular disease between the atrium and ventricle. Taking mitral regurgitation as an example, moderate to severe mitral regurgitation can lead to increased left atrial blood flow and increased blood pressure, which may cause pulmonary hypertension, pulmonary edema, atrial fibrillation, heart failure, and even death.

[0003] With the development of interventional cardiology, transcatheter cardiac interventional treatment techniques with the main characteristics of minimal trauma, less pain and rapid recovery are increasingly being used in clinical practice. The interventional treatment technology for mitral regurgitation is derived from surgical techniques. Interventional treatment of mitral regurgitation is suitable for patients with moderate to severe mitral regurgitation who cannot tolerate traditional surgical operations. The main types include annular repair, leaflet repair and chord repair. The corresponding procedures include annuloplasty, edge-to-edge repair and chord repair, among which edge-to-edge repair is a relatively mainstream method. Due to the diversity of the anatomical structures of the annulus, leaflets and their adjacent areas, continuous improvement needs to be made to the device design, such as the detachment performance of implanted medical devices (referred to as implants) and the synchronization of torque transmission of implanted catheters, which need to be improved. Summary of the invention

[0004] The purpose of the present application is to provide a clutch assembly, a delivery system and an interventional treatment system, which can achieve rapid detachment between the implant and the delivery system. At the same time, the implant can remain stable during the implantation process, thereby promoting the smooth progress of the operation.

[0005] The technical solution provided by the present invention is as follows:

[0006] A clutch assembly is arranged at the distal end of a catheter and is used for connecting and removing an implant, characterized in that it comprises: at least two embracing members, and the at least two embracing members are opened relative to the central axis of the clutch assembly in a natural state;

[0007] A connecting portion is provided at the distal end of the embracing member, and under the action of external force, the at least two embracing members are enclosed so that the connecting portion is suitable for being snap-connected with the connecting seat on the implant; a contact structure is provided at the proximal end and / or the distal end of the connecting portion, so that after the at least two embracing members are enclosed, a contact position is formed between the connecting portion and the connecting seat.

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

[0009] The connection seat is provided with a groove, the groove is adapted to the connection arc profile, and the connection seat is provided with an avoidance groove at the proximal end of the groove suitable for avoiding the connection arm;

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

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

[0012] In some embodiments, the contact structure includes protrusions, and at least one protrusion is 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, and the spherical surface contacts the connecting seat to form a point contact; or,

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

[0015] One end of the contact structure away from the connecting portion is in the form of a plane or an inclined surface, and the plane or the inclined surface abuts against the connecting seat to form a surface contact.

[0016] In some embodiments, the embracing member further comprises an elastic portion, wherein the elastic portion is connected between the distal end of the catheter and the main body, so that the embracing member is opened relative to the central axis of the clutch assembly in a natural state.

[0017] In some embodiments, a mating piece is provided on one side of the embracing piece close to the central axis of the clutch assembly;

[0018] The mating piece has a through hole, and when the through holes of the mating pieces of the at least two embracing pieces are butted together, the at least two embracing pieces are enclosed.

[0019] The present application also discloses a delivery system, comprising:

[0020] a catheter, the catheter comprising an implant catheter having a central passage extending axially therethrough;

[0021] A clutch assembly, disposed at the distal end of the implant catheter, for connecting and detaching the implant;

[0022] The main body of the implantable catheter includes a multi-lumen tube and a support tube, the multi-lumen tube has an axially penetrating central channel, and the support tube is inserted into the central channel of the multi-lumen tube; the multi-lumen tube and the support tube extend between the proximal end and the distal end of the main body of the implantable catheter and cover at least part of the length of the main body.

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

[0024] In some embodiments, the spring coil at least partially adopts a double-layer structure in its own axial direction; and,

[0025] The spring coil has a double-layer structure and has a first spring coil and a second spring coil in sequence from the inside to the outside along its own radial direction, and the spiral rotation direction of the first spring coil is opposite to the spiral rotation direction of the second spring coil.

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

[0027] In some embodiments, the reinforcement layer is made of braided metal wires, extends between the proximal end and the distal end of the main body, and covers at least a portion of the length of the main body;

[0028] and / or

[0029] The outer tube has at least two sections in its 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 implant catheter is provided with an insert, which covers a portion of the distal end surface of the main body and has at least one central channel.

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

[0032] The hub is arranged between the reinforcing layer and the multi-lumen tube; the end portion is arranged around the distal end of the connector, covers a portion of the distal end surface of the main body, and has at least one central channel.

[0033] In some embodiments, the plug-in further includes a fixing device, which is inserted into the hub and fixedly connected to the side wall of the hub;

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

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

[0036] In some embodiments, the clutch assembly adopts the clutch assembly provided in any of the above embodiments, which is disposed at the distal end of the implant catheter and is used to connect and detach the implant;

[0037] The conveying system also includes a delivery rod, which is inserted into the implant catheter. When delivering the implant, the distal end of the delivery rod applies the external force to the engaging part of the clutch assembly so that the at least two engaging parts are surrounded. When removing the implant, the distal end of the delivery rod withdraws from the engaging part of the clutch assembly.

[0038] The present application further discloses an interventional treatment system, characterized in that it comprises:

[0039] An implant, wherein a connecting seat is disposed at the proximal end of the implant;

[0040] The delivery system provided in any of the above embodiments is used to deliver the implant. When delivering the implant, at least two engaging members of the clutch assembly are surrounded and connected to the connecting seat.

[0041] The technical effects of this application are:

[0042] 1. In the present application, a contact structure is provided on the connection part that cooperates with the connection seat, and the connection part contacts the connection seat through the contact structure, limiting the small relative displacement between the connection part and the connection seat, so that the implant remains stable during the implantation process, neither deviates from the relative position with the implantation site, nor does it undergo unexpected movement, thus promoting the smooth progress of the operation. At the same time, a gap is maintained between the connection part and the connection seat to facilitate the rapid separation between the connection part and the connection seat, thereby realizing the rapid removal of the implant.

[0043] 2. In the present 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 arranged on the connecting arc, which can abut against the proximal and / or distal ends of the groove on the connecting seat when the embracing parts are closed, which not only limits the slight relative displacement between the connecting part and the connecting seat, but also is more conducive to maintaining the balance of the implant and facilitating the smooth progress of the operation.

[0044] 3. In the present application, by providing an independent multi-lumen tube to integrate multiple axial channels into one tube structure, different functions can be realized within a smaller diameter, which is more suitable for minimally invasive surgery. Moreover, when designing the multi-lumen tube, compared with opening multiple channels on the tube body, the balance of internal and external pressures will be taken into consideration, which is conducive to improving the consistency of the tube body performance. In addition, this embodiment also provides a support tube in the multi-lumen tube, which is conducive to balancing the force of the multi-lumen tube, so that the response of the distal end of the implanted catheter is more synchronized with the torque received by the proximal end, and is more controllable.

[0045] 4. In the present application, the support tube adopts a spring coil and a double-layer structure, and the double-layer structure has a clockwise and counterclockwise spiral direction. That is, the double-layer structure part of the spring coil has a first spring coil and a second spring coil in sequence 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 of the first spring coil and the second spring coil adopts a counterclockwise spiral. When subjected to torque, the component forces of the clockwise spiral and the counterclockwise spiral can offset each other, 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 the present application, a plug-in is provided at the distal end of the implantable catheter, which can strengthen the connection strength between the various levels of the implantable catheter. At the same time, the central channel of the centrally located firmware in the plug-in is coaxial with the central channel of the implantable catheter, and the internal diameters of the two are roughly the same, so that the synchronization performance between the distal end of the implantable catheter and the tube body is further enhanced, that is, the synchronization of torque transmission is further enhanced. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] The present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments:

[0048] Figure 1 is a schematic diagram of an application scenario of transcatheter interventional therapy provided in an embodiment of the present application;

[0049] Figure 2 is a schematic structural diagram of an interventional treatment system provided in one embodiment of the present application;

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

[0051] Figure 4 It is a schematic structural diagram of a clutch assembly detachable implant provided in one embodiment of the present application;

[0052] Figure 5 It is a structural schematic diagram of a clutch assembly connected to an implant connection seat provided in another embodiment of the present application;

[0053] Figure 6yes Figure 5 A partial enlarged view of point A shown;

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

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

[0056] Fig. 9 is a cross-sectional view of an implantation catheter provided in one embodiment of the present application;

[0057] Fig.10 is a partial perspective view of an implant catheter provided in one embodiment of the present application;

[0058] Fig.11 is a partial schematic diagram of an interventional treatment system provided in one embodiment of the present application;

[0059] Fig.12 is a structural schematic diagram of a control device provided in an embodiment of the present application;

[0060] Fig.13 is a schematic structural diagram of a driving assembly provided in one embodiment of the present application;

[0061] Fig.14 is a schematic structural diagram of an implantation catheter, a clutch assembly, and a valve clamping device provided in another embodiment of the present application;

[0062] Fig.15 is a schematic diagram of the far end of a drive assembly provided in one embodiment of the present application;

[0063] Fig.16 is a side view of a drive assembly provided in one embodiment of the present application;

[0064] Fig.17 is a schematic structural diagram of a driving component and a connecting component provided in an embodiment of the present application;

[0065] Fig.18 It is a structural schematic diagram of a control device provided in another embodiment of the present application. DETAILED DESCRIPTION

[0066] In the following description, specific details such as specific system structures, technologies, etc. are provided for the purpose of illustration rather than limitation, so as to provide a thorough understanding of the embodiments of the present application. However, it should be clear to those skilled in the art that the present application may also be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to prevent unnecessary details from obstructing the description of the present application.

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

[0068] In order to simplify the drawings, only the parts related to the present application are schematically shown in each figure, and they do not represent the actual structure of the product. In addition, in order to simplify the drawings and facilitate understanding, in some figures, only one of the parts with the same structure or function is schematically drawn or marked. In this article, "one" not only means "only one", but also means "more than one".

[0069] It should be further understood that the term “and / or” used in the specification and appended claims refers to any combination and all possible combinations of one or more of the associated listed items, and includes these combinations.

[0070] In this document, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two parts. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0071] In the embodiments shown in the drawings, the indications of directions (such as up, down, left, right, front and back) used to explain the structure and movement of various components of the present application are not absolute but relative. 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, the indications of these directions also change accordingly.

[0072] In the embodiments of the present application, "proximal end" refers to the end of the associated object close to the operator; "distal end" refers to the end of the associated object away from the operator. "Proximal end" and "distal end" refer to the position or direction of the associated object (e.g., a component of a medical device) relative to the operator from the perspective of the operator (e.g., a doctor) who uses the device (e.g., a medical device) where the associated object is located. For example, "proximal end" refers to the end close to the doctor during the doctor's normal operation of the medical device, while "distal end" refers to the end away from the doctor during the doctor's normal operation of the medical device, that is, the end that first enters the patient's body.

[0073] In addition, in the description of the present application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0074] Transcatheter interventional therapy can introduce implants such as materials, medical devices, or drugs into the body through a catheter to perform minimally invasive diagnosis and / or treatment of diseases. Transcatheter interventional therapy can achieve better treatment effects through smaller wounds and is more conducive to postoperative recovery, so it is increasingly used in clinical practice. For example, transcatheter interventional therapy can be used for intravascular specimen collection or angiography and other diagnoses; for example, it can be used for drug infusion, embolization, vascular dilatation and shaping, intravascular stent placement, vascular filter placement, intravascular foreign body or thrombus removal, or intravascular plaque grinding and other treatments; for example, it can be used to implant medical devices into organs such as the heart to treat heart diseases.

[0075] For example, for heart disease treatment, please refer to Figure 1 , which is a schematic diagram of an application scenario of transcatheter interventional treatment provided in an embodiment of the present application. Figure 1 The structure of the heart is shown, as Figure 1 As shown, the heart is a hollow muscular organ with four chambers, namely the left atrium (LA) 11, the right atrium (RA) 21, the left ventricle (LV) 12, and the right ventricle (RV) 22. There is an atrioventricular valve (hereinafter referred to as the valve) between the atrium and the ventricle. When the ventricle relaxes, the valve opens and blood flows from the atrium to the ventricle; when the ventricle contracts, the valve closes to prevent blood from flowing back from the ventricle to the atrium. 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, which are perpendicular to the ventricular cavity and connected to the left ventricular wall through chordae tendineae 14 and papillary muscles 15; the tricuspid valve 23 has three leaflets, which are perpendicular to the ventricular cavity and connected to the right ventricular wall through chordae tendineae 24 and papillary muscles 25. The large blood vessels connected to the heart mainly include the aorta 31, the pulmonary artery 32, the superior vena cava 41 and the inferior vena cava 42. The heart and the large blood vessels work together to achieve blood circulation.

[0076] For example, transcatheter interventional therapy can be applied to structural heart diseases, such as diseases caused by abnormal cardiac structure or abnormal large blood vessel structure. For example, valve diseases or defect diseases. For example, valve diseases include blood regurgitation caused by valve lesions between the atria and ventricles (such as mitral regurgitation or tricuspid regurgitation), aortic stenosis, aortic regurgitation, pulmonary stenosis, or pulmonary regurgitation. Defect diseases include, for example, ventricular septal defect (VSD), atrial septal defect (ASD), or patent ductus arteriosus. For valvular diseases such as mitral regurgitation or tricuspid regurgitation, transcatheter interventional therapy technology can be used to deliver implanted medical devices such as valve clamping devices to the lesion site to perform edge-to-edge repair of the mitral valve or tricuspid valve. For defect diseases such as ventricular septal defect (VSD), atrial septal defect (ASD), or patent ductus arteriosus, transcatheter interventional treatment can be used. Medical devices such as occluders are implanted and delivered to the lesion site via catheter to block defects in the left or right ventricles, or between the left and right atria, or to block the passage between the aorta and the pulmonary artery.

[0077] Due to the complexity of the biological body's internal environment, such as the diversity of the anatomical structures of the valve ring, valve leaflets and their adjacent areas, the operator's operation requirements are high when manipulating the implant, and there may be problems such as insufficient control stability, thereby affecting the effect of interventional treatment. The present application embodiment provides a clutch assembly 215 that can achieve rapid detachment between the implant and the delivery system. At the same time, the implant can remain stable during the implantation process, promoting the smooth progress of the operation.

[0078] The following is a description with reference to the accompanying drawings:

[0079] Please refer to Figure 2 , which is a schematic diagram of the structure of an interventional treatment system provided in an embodiment of the present application. Figure 2 As shown, the interventional treatment 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 is used to provide a delivery channel for the implant 100, and the control mechanism 220 is used to control the distal movement of the catheter 210; the control mechanism 220 can also be used to control the implant 100, for example, to control the connection and detachment of the implant 100 and the distal end of the catheter 210, and for example, to control 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 to change its state, which is conducive to the control of the implantation process of the implant 100, so that the implant 100 can be more accurately implanted in the lesion position.

[0080] The catheter 210 may adopt a multi-layer catheter structure, which includes, for example, at least two layers of catheters, wherein the outer layer of the catheter provides an operation channel for other catheters, and the other catheters are used to deliver the implant 100. The control mechanism 220 includes, for example, a plurality of control devices for controlling the distal end movement of the catheter 210. For example, Figure 2 As shown, the delivery system 200 includes, for example, a three-layer catheter structure and a control device corresponding to the three-layer catheter. For example, the catheter 210 includes a delivery catheter 211, a control catheter 212, and an implantation catheter 213; the control mechanism 220 includes a control device 221, a control device 222, and a control device 223, which are 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, and the loader 224 includes a base 2241 and a loading catheter 2242. When in use, the loading catheter 2242 penetrates the proximal end of the control device 221, becomes 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 through the control device 221. In order to complete the implantation operation, the distal ends of the delivery catheter 211 and the control catheter 212 should have navigation settings, so that the operator can adjust the distal curvature according to the needs of the procedure, control the direction of the distal end of the catheter 210, and make it easier for the implant 100 to reach a relatively 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 detaching the implant 100. The proximal end of the implant 100 is provided with a connecting seat 110 for cooperating with the clutch assembly 215 to achieve the connection and detachment of the implant 100. The delivery system 200 also includes a delivery rod 214, which is inserted into the implantation catheter 213, and when delivering the implant 100, the distal end of the delivery rod 214 applies an external force to the clutch assembly 215, so that the clutch assembly 215 is stably connected to the implant 100; when detaching the implant 100, the delivery rod 214 withdraws the external force from the clutch assembly 215, so that the implant 100 and the clutch assembly 215 are quickly separated.

[0081] The above description of the delivery system is only an example. The present application does not limit the shape and number of the catheters of the delivery system, nor does it limit the shape and number of the 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 by this application, see Figure 3 and Figure 4A clutch assembly 215 is provided at the distal end of the catheter 210, and includes at least two embracing members 2152, and the at least two embracing members 2152 are open relative to the central axis of the clutch assembly 215 in a natural state. A connecting portion 2153 is provided at the distal end of the embracing member 2152. Under the action of an external force, the at least two embracing members 2152 are surrounded, so that the connecting portion 2153 is suitable for engaging and connecting with the connecting seat 110 on the implant 100, thereby realizing a stable connection between the clutch assembly 215 and the implant 100.

[0083] After the engagement, there are gaps between the proximal edge and the distal edge of the connection portion 2153 and the connection seat 110, which facilitates the separation of the connection portion 2153 and the connection seat 110, and realizes the rapid detachment between the implant 100 and the delivery system 200. However, when the implant 100 is manipulated, a slight relative displacement may occur between the connection portion 2153 and the connection seat 110, such as a rotation at a certain angle. Even if the rotation is a relatively limited small angle, it will still affect the surgical process and even the surgical effect.

[0084] Therefore, this embodiment also provides a contact structure 2156 at the proximal and / or distal ends of the connecting portion 2153, so that a contact position is formed between the connecting portion 2153 and the connecting seat 110 after at least two embracing members 2152 are enclosed. In this way, while retaining the gap, the relative displacement between the connecting portion 2153 and the connecting seat 110 due to the existence of the gap can be limited, so that the implant 100 can remain stable when being manipulated, thereby facilitating a smooth surgical procedure.

[0085] For example, see Figure 4 , the embracing member 2152 further includes a main body 2157, and the connecting portion 2153 is disposed at the distal end of the main body 2157. The connecting portion 2153 may specifically include a connecting arc 2154 and a connecting arm 2155 arranged at an angle, wherein the connecting arm 2155 connects the connecting arc 2154 and the main body 2157. Relatively speaking, 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 is provided with an avoidance groove 112 at the proximal end of the groove 111 for avoiding the connecting arm 2155. When at least two embracing members 2152 are enclosed under the action of an external force, the connecting arc 2154 is located in the groove 111, and at the same time, the connecting arc 2154 can form a mutual limit with the proximal end of the groove 111, so as to limit the connecting arc 2154 from being separated 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, a gap can be formed between the proximal edge and the distal edge of the connecting arc 2154 and the side wall of the groove 111 .

[0086] In this embodiment, the contact structure 2156 is protruding from the edge of the connecting arc 2154 along the width extension direction of the connecting arc 2154, so as to abut against the proximal and / or distal walls of the groove 111 of the connecting seat 110, thereby forming a contact position. Specifically, the contact structure 2156 may be provided only at the proximal or 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 may be provided at both the proximal and distal ends of the connecting arc 2154, so that it abuts against the proximal and distal walls of the groove 111, respectively.

[0087] The end of the contact structure 2156 away from the connecting portion 2153 may be a convex spherical surface, the apex of which contacts the proximal and / or distal walls of the groove 111 of the connecting seat 110 to form a point contact. Figure 6 , the end of the contact structure 2156 away from the connection part 2153 can also be a convex arc surface, and the highest point of the arc surface conflicts with the wall of the groove 111 of the connection seat 110 facing the proximal end and / or the distal end to form a line contact. Of course, in some embodiments, the end of the contact structure 2156 away from the connection part 2153 can also be a plane or an inclined surface, and the plane or inclined surface conflicts with the wall of the groove 111 of the connection seat 110 facing the proximal end and / or the distal end to form a surface contact, which is not limited here and is within the protection scope of this application.

[0088] As a preference, see Figure 5 The projection of the connecting portion 2153 on the central axis plane is T-shaped, and the connecting arc 2154 and the connecting arm 2155 are arranged substantially vertically. 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 distal end of the main body 2157.

[0089] In this embodiment, by setting the connecting portion 2153 in a T-shape, a snap connection can be formed on both sides of the connecting portion 2153 when engaged. Compared with a single-sided engagement (for example, the connecting portion 2153 is L-shaped), the connection is more stable and balanced. In this way, it is easier for the implant 100 to remain stable when being manipulated, and it will not deviate from the relative position with the implantation site, nor will it undergo unexpected movement, thereby facilitating a smooth surgical procedure.

[0090] Furthermore, at least two embracing members 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 promoting 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 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 arranged at the center position 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 arranged on both sides of the arc length of the connecting arc 2154 and are respectively located at the proximal end and the distal end of the connecting arc 2154; when there are three protrusions on the connecting arc 2154, one of the protrusions is arranged in the middle section of the distal end of the connecting arc 2154, and the remaining two protrusions are respectively arranged on both sides of the arc length of the proximal end of the connecting arc 2154; when there are four protrusions on the connecting arc 2154, two of the protrusions are respectively arranged on both sides of the arc length of the distal end of the connecting arc 2154, and the remaining two protrusions are respectively arranged on both sides of the arc length of the proximal end of the connecting arc 2154.

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

[0092] Specifically, see Figure 3 and Figure 4 The embracing member 2152 further includes an elastic portion 2159, which is connected between the distal end of the catheter 210 and the main body 2157, so that the embracing member 2152 can be opened relative to the central axis of the clutch assembly 215 in a natural state. In addition, a counter-engagement member 2151 is provided on one side of the embracing member 2152 close to the central axis of the clutch assembly 215. The counter-engagement member 2151 is generally annular, has a through hole 2160, and is connected to the embracing member 2152 through a handle connecting arm 2161. When the through holes 2160 of the counter-engagement members 2151 of at least two embracing members 2152 are butt-jointed together, the at least two embracing members 2152 are enclosed.

[0093] Specifically, see Figure 6When the matching pieces 2151 are roughly overlapped, the delivery rod 214 passes through the matching pieces 2151 of at least two embracing pieces 2152 in sequence, and the connecting portion 2153 is engaged 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 the implant 100 needs to be removed, the delivery rod 214 moves proximally and leaves the matching piece 2151, and the embracing piece 2152 returns to an open state under the rebound action of the elastic portion 2159, and the connecting portion 2153 is separated from the connecting seat 110, thereby realizing the removal of the implant 100.

[0094] Preferably, the mating piece 2151 , especially the main body 2157 on the mating piece 2151 , is provided with a hollow structure 2162 , which is beneficial to the lightweight of the clutch assembly 215 .

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

[0096] In a preferred embodiment, see Figures 8 to 10 The implant catheter 213 adopts a multi-layer catheter structure, and its main body mainly includes a multi-lumen tube 2131 and a support tube 2134. The multi-lumen tube 2131 has an axially penetrating central channel 2132 and a plurality of auxiliary channels 2133 arranged around the central channel 2132. The number of auxiliary channels 2133 is preferably 6, and the 6 auxiliary channels 2133 are evenly spaced. The support tube 2134 is arranged in the central channel 2132 of the multi-lumen tube 2131. The support tube 2134 and the multi-lumen tube 2131 extend between the proximal end and the distal end 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, which can be used for the delivery rod 214 to pass through.

[0097] In this embodiment, by providing an independent multi-lumen tube 2131 to integrate multiple axial channels into one tube structure, different functions can be realized within a smaller diameter, which is more suitable for minimally invasive surgery. Moreover, when designing the multi-lumen tube 2131, compared with opening multiple channels on the main body, the balance of internal and external pressures will be taken into consideration, which is conducive to improving the consistency of the main body performance. In addition, in this embodiment, a support tube 2134 is provided in the multi-lumen tube 2131, which is conducive to balancing the force of the multi-lumen tube 2131, so that the response of the distal end of the implanted catheter 213 is more synchronized with the torque received by the proximal end, and is more controllable.

[0098] Among them, the multi-lumen tube 2131 can be made of one or more materials selected from the group consisting of polyether block amide thermoplastic elastomer material, PI (polyimide), stainless steel, etc., preferably made of polyether block amide thermoplastic elastomer material, which has excellent toughness, fatigue resistance and resilience. During the torque transmission process, it can withstand repeated stress changes without fatigue damage. At the same time, it can quickly return to its original state, reduce energy loss, and enhance the torque transmission performance of the implanted catheter 213, so that after passing through multiple curved paths, the distal end of the implanted catheter 213 can still transmit the torque applied from the proximal end relatively synchronously, and the synchronization of torque transmission is further enhanced.

[0099] As a preference, see Fig. 9 and Fig.10 The support tube 2134 includes a spring coil made of elastic metal materials 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. Relatively, the multi-lumen 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 adopts a double-layer structure in its own axial direction, and the double-layer structure has a clockwise and counterclockwise spiral direction. That is, the double-layer structure part of the spring coil has a first spring coil and a second spring coil in sequence 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 of the first spring coil and the second spring coil adopts a counterclockwise spiral. When subjected to torque, the component forces of the clockwise spiral and the counterclockwise spiral can offset each other, 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 spring coils as a whole adopt a double-layer structure, that is, the spring coils have a first spring coil and a second spring coil in sequence from the inside to the outside along their own radial direction, one of the first spring coil and the second spring coil adopts a clockwise spiral, and the other of the first spring coil and the second spring coil adopts a counterclockwise spiral. Such a configuration further enhances the torque transmission performance of the implant catheter 213, so that the torque applied from the proximal end of the implant catheter 213 can be transmitted to the distal end relatively synchronously without obvious delay, with good synchronization and more controllable.

[0102] Specifically, the main body also includes an outer tube 2136, which is sleeved outside the multi-lumen tube 2131 and is made of a polyether block amide thermoplastic elastomer material. It can include different hardness sections or a single hardness. No restrictions are made here, and all are within the scope of protection of this application. A reinforcement layer 2137 is provided between the outer tube 2136 and the multi-lumen tube 2131. The reinforcement layer 2137 can be woven from metal wires such as stainless steel, extending between the proximal and distal ends of the main body, covering the entire or partial length of the main body, thereby providing the required pressure bearing capacity for the implanted main body and ensuring the stability of the implanted main body when subjected to internal pressure. At the same time, the reinforcement layer 2137 in this embodiment is axially extended, 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 reinforcement layer 2137 are closely fitted to each other, and the reinforcement layer 2137 covers the entire length from the proximal end to the distal end of the main body.

[0103] In a specific embodiment, see Fig.10 The distal end of the implant catheter 213 is provided with an insert, which is inserted between the reinforcing layer 2137 and the multi-lumen tube 2131, and the insert can at least cover part of the distal end surface of the main body, such as the reinforcing layer 2137 and the outer tube 2136, so as to strengthen the connection strength between the multi-level structure of the implant catheter 213 and the proximal end of the clutch assembly 215, especially the connection strength between the implant catheter 213 and the clutch assembly 215; at the same time, it effectively prevents the distal end of the implant catheter 213 from returning to the internal channel of the distal part of the control catheter 212 during the implantation process, thereby promoting the progress of the implantation operation. The center of the insert 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, wherein the hub 2139 is inserted between the reinforcing layer 2137 and the multi-lumen tube 2131, and the proximal end of the clutch assembly 215 can be connected to the hub 2139; the end ring 2138 is disposed at the distal end of the hub 2139, and can cover part of the distal end surface 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 an integral part or a fixed connection part.

[0105] In actual production, the fixed connection between the various levels of the implanted catheter 213, the plug-in 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 welding and reinforcing the implant catheter 213. After the components of the implant 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 utilizing thermal rheology.

[0107] Specifically, the plug-in may further include a fixture 2143, which is inserted into the hub 2139 and fixedly connected to the side wall of the hub 2139. The fixture 2143 has a central channel 2144 for the delivery rod 214 to pass through, and the central channel 2144 is coaxial with the central channel of the implant catheter 213 (i.e., the central channel 2135 of the spring coil). At least one handle 2145 is extended radially from the outer wall of the fixture 2143, and a groove 2142 corresponding to the handle 2145 is provided on the proximal side wall of the hub 2139 to accommodate the handle 2145 of the fixture 2143, so as to achieve the connection and fixation between the fixture 2143 and the hub 2139.

[0108] The number of the handles 2145 is preferably two, symmetrically arranged along the axis of the main body. Of course, in actual production, the number of the handles 2145 can also be 3, 4, etc., evenly spaced, which will not be described here one by one, and are all within the protection scope of this application.

[0109] Preferably, the proximal surface of the fixture 2143 and the proximal surface of the hub 2139 are roughly located on the same plane, the distal end of the spring coil can be arranged on the proximal surface of the fixture 2143, the spring coil and the fixture 2143 are coaxial, and the central channel of the fixture 2143 and the central channel of the spring coil have roughly the same diameter, 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] The present application improves the implant catheter 213 so that during the delivery of the implant, the entire delivery system 200, especially the implant catheter 213 directly connected to the implant, has sufficient stability. Specifically, after the implant catheter 213 of the delivery system 200 passes through multiple curved paths, its distal end should still be able to relatively synchronously transmit the torque applied from the proximal end of the catheter 210. At the same time, during the implantation process, when the implant 100 is subjected to a control driving force, the implant 100 also has a synchronous response, and the implant as a whole does not move or shake relative to the implantation environment.

[0111] See also 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 capture device 430 (also referred to as a capture arm). The capture device 430 is located between the clamping element 420 and the main body 410. Both the clamping element 420 and the capture device 430 can perform opening and closing movements 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 can also include an inverted state. The proximal end of the main body 410 can be detachably connected to the distal end of the implant catheter 213 through the clutch assembly 215. The distal end of the delivery rod 214 extends from the distal end of the implant catheter 213 and is inserted into the engaging member 2151 of the clutch assembly 215, so that the engaging member 2152 of the clutch assembly 215 is engaged together, thereby clamping the valve clamping device 400 to the distal end of the implant catheter 213. When the distal end of the delivery rod 214 is withdrawn from the engaging member 2151, the engaging member 2152 is opened, and the valve clamping device 400 is detached from the distal end of the implant catheter 213. A transmission assembly 440 may be provided in the main body 410, and the distal end of the delivery rod 214 may apply a driving force to the transmission assembly 440, and the axial movement of the transmission assembly 440 is used to drive the opening and closing movement of the clamping element 420, so that the state of the valve clamping device 400 is changed.

[0112] Among them, see Figure 7 and Figure 8 , the capture device 430 on the valve clamping device 400 is connected to a control element 450, and the operator can change the state of the capture device 430 by manipulating the control element 450. For example, after the valve clamping device 400 is sent into the left ventricle, the operator can adjust the position of the valve clamping device 400 through the image and judge whether the position and opening state of the valve clamping device 400 are suitable for capturing the valve leaflets. When the valve clamping device 400 is not suitable for capturing the valve leaflets, the control element 450 can be pulled to make the capture device 430 close to the main body 410; when the valve clamping device 400 is suitable for capturing the valve leaflets, the control element 450 can be relaxed to make the capture device 430 open quickly and move toward the clamping element 420 on the same side to capture the valve leaflets between the capture device 430 and the clamping element 420. Specifically, the proximal end of the control element 450 passes through the auxiliary channel 2133 of the multi-lumen tube 2131 in the implant catheter 213 and is connected to the implant catheter control device 300 disposed at the proximal end of the implant catheter 213 .

[0113] See also Figure 11 to Figure 12The implant catheter manipulation device 300 may specifically include a housing 310 and a manipulation assembly 320. The housing 310 is provided with a channel 311 for the delivery rod 214, and the channel 311 is used to accommodate the proximal end of the delivery rod 214. The manipulation assembly 320 is used to drive the delivery rod 214 so that the delivery rod 214 generates movement (including rotation or axial displacement).

[0114] Specifically, see Fig.13 and Fig.14 The manipulation assembly 320 includes a manipulation handle 322 and a driving element. The manipulation handle 322 of the manipulation assembly 320 extends out of the housing 310 to receive a driving force. The distal end of the driving element of the manipulation assembly 320 has a component that can be inserted into the channel 311 and connected to the proximal end of the delivery rod 214. The manipulation handle 322 is used to drive the rotation and axial movement of the driving element. In this way, the manipulation assembly 320 can drive the delivery rod 214 to move through the driving element, thereby controlling the state of the valve clamping device 400, and controlling the connection and detachment of the valve clamping device 400 with the distal end of the implantation catheter 213.

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

[0116] The sleeve 321 has a first internal space S1, and the control handle 322 is connected to the proximal end of the sleeve 321 and has a second internal space S2, and the second internal space S2 is connected to the first internal space S1. The driving rod 323 includes a first section 3232 at the distal end and a second section 3231 at the proximal end, and the radial dimension of the first section 3232 is greater than the radial dimension of the second section 3231. The second section 3231 is arranged in the first internal space S1 and the second internal space S2, and can rotate relative to the first internal space S1 and the second internal space S2; the first section 3232 is partially arranged in the first internal space S1, extends from the distal end of the sleeve 321 out of the sleeve 321 and extends into the channel 311 to connect the proximal end of the delivery rod 214. The first section 3232 can limit the relative rotation between the driving rod 323 and the sleeve 321, so that the control handle 322 drives the sleeve 321 and the driving rod 323 to rotate synchronously.

[0117] The present application does not limit the specific shape of the outer contour of the first section 3232 or the inner contour of the distal end of the sleeve 321, which may be a regular shape or an irregular shape, for example, it may be an ellipse, a rectangle, a triangle, or other polygons; for another example, it may be a racetrack shape, including two parallel sides and symmetrical arc sides connecting the two sides. Fig.15The outer contour of the first section 3232 or the inner contour of the distal end of the sleeve 321 includes an arc-shaped edge, such as an elliptical or racetrack shape, which can reduce the friction of the axial movement between the first section 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 manipulation assembly 320, the manipulation handle 322 is connected to the proximal end of the sleeve 321. When the operator rotates the manipulation handle 322, the manipulation handle 322 can drive the sleeve 321 to rotate together; that is, the manipulation handle 322 receives torque and transmits the torque to the sleeve 321. Since the relative rotation between the sleeve 321 and the driving rod 323 is limited by the first section 3232, the sleeve 321 can drive the driving rod 323 to rotate; that is, the sleeve 321 can further transmit the torque to the driving rod 323, and the driving rod 323 further transmits the torque to the delivery rod 214.

[0119] A floating adjustment mechanism for axial displacement is provided for the driving rod 323. Fig.13 The control assembly 320 may further include a first elastic member 325, which is sleeved on the second section 3231 of the driving rod 323 in the first space S1, and the second section 3231 of the driving rod 323 has no obvious contact with the first elastic member 325, and can freely move axially and rotate relative to the first elastic member 325. The proximal end of the first elastic member 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 section 3232.

[0120] In the preset state, the first elastic member 325 is in a compressed state, and elastic force is applied to both ends. At this time, the proximal end of the first section 3232 is subjected to force, so that the driving rod 323 tends to be fed to the distal end, and the distal end of the delivery rod 214 tends to be fed to the distal end, so as to avoid the distal end of the delivery rod 214 from retracting to the proximal end during the implantation process, so as to maintain 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. The driving rod 323 feeds to the distal end, and the first section 3232 also feeds to the distal end, and the first elastic member 325 extends accordingly, and can reach the internal limit at the distal end of the first space S1 at the far end.

[0121] When delivering the implant, due to the complex biological environment, the distal end of the delivery rod 214 may also be blocked during the delivery process because it cannot continue to extend, causing the main body of the delivery rod 214 to retract. When the resistance is greater than the elastic force applied by the first elastic member 325 to the first section 3232, the delivery rod 214 and the driving rod 323 are synchronously displaced toward the proximal end. In this way, the main body of the delivery rod 214 is immediately free from the influence of the distal resistance, so that the torque can be transmitted without external force, and the synchronization of the torque transmission can be maintained more easily. It can be understood that when the first elastic member 325 is compressed, it will apply a greater elastic force to the first section 3232 to resist the retraction of the delivery rod 214, so that when the resistance at the distal end of the delivery rod 214 is released, the trend of feeding toward the distal end is immediately restored.

[0122] During this process, the length of the first section 3232 of the driving rod 323 extending out of the sleeve 321 floats within a micro range, which is equivalent to setting a floating length for the delivery rod 214, and has more flexible applicability. In this way, on the one hand, spontaneous floating adjustment can be performed according to the implantation environment to enhance the safety and effectiveness of the implantation process; on the other hand, when facing different implants, a suitable floating length can be set to reduce the difficulty of operation, which is conducive to the promotion and application of transcatheter intervention technology.

[0123] Optionally, a mounting handle 324 is further connected to the proximal end of the second section 3231 of the driving rod 323, and the mounting handle 324 is located in the second space S2, and the mounting handle 324 and the control handle 322 do not constrain each other. The provision of the mounting handle 324 is more conducive to assembling the driving rod 323 in 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 Fig.16 and Fig.17 The control device 300 may further include a connecting assembly 360 for connecting the control assembly 320 and the housing 310. The connecting assembly 360 may specifically include a limiting track 361 and a limiting element 362, wherein the limiting element 362 matches the limiting track 361 and can slide axially relative to the limiting track 361. The limiting track 361 may extend along the axial direction of 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 a limiting track 361, and the distal end of the sleeve 321 can rotate relative to the limiting element 362.

[0125] Preferably, the number of the limiting elements 362 is two, which are symmetrically arranged on both sides of the distal end of the sleeve 321. At this time, the number of the limiting rails 361 is also two, which are symmetrically arranged on the housing 310. The limiting rails 361 and the limiting elements 362 cooperate with each other, which can not only realize the sliding cooperation between the sleeve 321 and the housing 310, but also limit the radial shaking of the sleeve 321, so that it can move axially more smoothly, thereby driving the driving rod 323 and the delivery rod 214 to move axially stably. At the same time, there is no radial limit between the sleeve 321 and the limiting element 362, and the sleeve 321 can rotate relative to the limiting element 362.

[0126] Specifically, the connection assembly 360 further includes a connection piece 363, which is used to connect the two limiting elements 362 and is sleeved on the distal end of the sleeve 321, and is axially limited with the distal end of the sleeve 321, and is not radially limited. The number of the connection pieces 363 can be two, and the two limiting elements 362 are respectively connected to different connection pieces 363, and the two connection pieces 363 and the two limiting elements 362 are jointly sleeved on the distal end of the sleeve 321, and the sleeve 321 is not radially limited. Alternatively, preferably, the two limiting elements 362 are connected to the same connection piece 363, and the connection piece 363 and the two limiting elements 362 are jointly sleeved on the distal end of the sleeve 321, and the sleeve 321 is not radially limited. Furthermore, the connection assembly 360 further includes a limit ring 364, the number of which is two, which are rotatably connected to the distal end of the sleeve 321, and the connection member 363 is axially limited between the two. In a preferred embodiment, the distal end of the sleeve 321 is provided with two grooves 3213, and the two limit rings 364 are respectively embedded in the two grooves 3213, and the connection member 363 is arranged between the two grooves 3213. In this way, a stable connection and a stable axial displacement direction between the sleeve 321 and the housing 310 are achieved, and when a torque is applied to the control handle 322, the sleeve 321 can rotate to transmit the torque, and when an axial force is applied to the control handle 322, the sleeve 321 can stably displace axially relative to the housing.

[0127] Preferably, see Fig.12 The manipulation device 300 may further include a locking assembly 330, which has a locked state and an unlocked state, and is used to lock or unlock the axial movement of the manipulation assembly 320 relative to the housing 310. Specifically, when the locking assembly 330 is in the locked state, the manipulation handle 322 is rotated to drive the delivery rod 214 to rotate, thereby driving the state change of the valve clamping device 400. When the locking assembly 330 is in the unlocked state, the manipulation handle 322 can be pulled toward the proximal end, so that the manipulation handle 322 drives the sleeve 321 and the driving rod 323, and then drives the delivery rod 214 to move toward the proximal end, so that the valve clamping device 400 can be quickly detached from the implantation catheter 213.

[0128] In an exemplary embodiment, the locking assembly 330 may include a locking member 331, wherein the locking member 331 is provided with an opening suitable for the sleeve 321 to pass through, and the locking member 331 has a locking side 3311 around the corresponding opening. During use, the locking member 331 can be selectively in a first position and a second position, in which the locking side 3311 is against the sleeve 321 to limit the axial movement of the sleeve 321; in the second position, the locking side 3311 is away from the sleeve 321, suitable for the manipulation handle 322 to drive the sleeve 321 and the driving rod 323 to move toward the proximal end.

[0129] Specifically, see Fig.12 , Fig.15 and Fig.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 the proximal end. The base 3211 at the proximal end of the sleeve 321 is clamped to the proximal end of the housing 310, and can move axially toward 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, and the outer contour of the first limiting structure 3212 is substantially the same as the outer contour of the base 3211. At this time, a limiting slot 3213 is formed between the first limiting structure 3212 and the base 3211, and the locking assembly 330 can be arranged in the limiting slot 3213, and is substantially perpendicular to the sleeve 321.

[0130] Furthermore, the locking assembly 330 further 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 are respectively in contact with the outer wall of the locking member 331 and the inner wall of the housing 310. The opening on the locking member 331 is an elliptical hole that is generally similar to a runway, and its long diameter is consistent with the distribution direction of the locking assembly 330, which is approximately 1.5-2.5 times the outer diameter of the base 3211 or the first limiting structure 3212, and the 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 proximal to distal orientation, the locking member 331 can be divided into a locking side 3311 on the left half and an unlocking side 3312 on the right half along the extension direction of the short diameter, and the locking side 3311 is provided with a second limiting structure along the shape of the inner wall.

[0131] In this embodiment, the locking state of the locking assembly 330 is a preset state. In the locked state, the second elastic member 333 is in a compressed state and has an outward elastic force. The locking member 331 is located in the first position, and its locking side 3311 is close to 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 to further compress the second elastic member 333, and the locking member 331 is located in the second position, and its locking side 3311 is away from the sleeve 321, and the unlocking side 3312 is close to the sleeve 321. The first limiting structure 3212 on the sleeve 321 can pass through the locking member 331 and pull the control handle 322 toward the proximal end, so as to drive the sleeve 321 and the driving rod 323 to move toward the proximal end.

[0132] Specifically, see Fig.11 and Fig.18 The manipulation device 300 may also include a capture device control handle 370, which is disposed at the distal end of the housing 310, and the housing 310 has a channel 312 for the control element 450, and the control element 450 can be withdrawn from the channel 312. The capture device control handle 370 is connected to the control element 450, so that the operator can control the capture device 430 to open through the capture device control handle 370. In practical applications, the number of the capture devices 430 is preferably two, and the number of the capture device control handles 370 in the manipulation device 300 is also two, which are located on opposite sides of the distal end of the housing 310. By pushing the two capture device control handles 370 toward the distal end respectively, the two capture devices 430 can be controlled to open respectively, so that the leaflets can be captured respectively. After the leaflet capture is completed, the clamping element 420 moves to a closed state to make the leaflets apposed.

[0133] See also Figure 2 The present application also provides an interventional treatment system 1, comprising an implant 100 and a delivery system 200 provided in any of the above embodiments. Figure 3 A connecting seat is provided at the proximal end of the implant 100, and 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 are engaged in parallel and connected to the connecting seat.

[0134] Taking the implant 100 as a valve clamping device as an example, during the implantation process, the delivery catheter 211 is equipped with a dilator and enters the right atrium along the guidewire through the femoral vein, and the distal end of the delivery catheter 211 passes through the atrial septum and enters the left atrium. Then the dilator is withdrawn, and the control catheter 212 is equipped with the implantation catheter 213213 and the valve clamping device 400, and enters the left atrium along the inner cavity of the delivery catheter 211. The valve clamping device 400 is connected to the distal end of the implantation catheter 213213; during the process of delivering the valve clamping device 400, the valve clamping device 400 is in a closed state. At this time, the valve clamping device 400 enters the patient's body with the minimum radial size, which can effectively reduce the damage of the valve clamping device 400 to the patient and alleviate the patient's discomfort.

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

[0136] After the valve clamping device 400 is delivered into the left ventricle, if the valve clamping device 400 is suitable for capturing the valve leaflets, the capture device 430 can be controlled to open by the capture device control handle 370 to achieve the capture of the valve leaflets. After the valve leaflet capture is completed, the driving handle 322 is rotated to drive the delivery rod 214 through the driving assembly to control the clamping element 420 to close to the main body 410. Since the capture device 430 is located between the clamping element 420 and the main body 410, the clamping element 420 can drive the capture device 430 to close, so that the valve clamping device 400 is restored to the closed state. Then, the push rod 332 of the locking assembly 330 is pressed to release the lock on the driving assembly; the driving handle is pulled toward the proximal end to drive the delivery rod 214 to leave the matching piece 2151 of the clutch device 215; so that the valve clamping device 400 is separated from the distal end of the implant catheter 213 and remains in the patient's body.

[0137] The angle between the clamping elements 420 facing the proximal end can be further increased. In this way, when the leaflet capture fails, the driving handle can be rotated to control the valve clamping device 400 to an inverted state through the delivery rod 214. In the inverted state, the angle between the clamping elements 420 facing the proximal end can be an obtuse angle, which is conducive to the valve clamping device 400 to retreat from the ventricle side to the atrial side and not to entangle the tendons connecting the leaflets. In this way, it is convenient for the operator to control and reduce the damage to the patient's body tissue caused by the valve clamping device 400. Afterwards, the position and state of the valve clamping device 400 can be readjusted, and the above leaflet capture and clamping steps are repeated until the leaflet is clamped.

[0138] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described or recorded in detail in a certain embodiment, reference can be made 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 only preferred implementations of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application, and these improvements and modifications should also be regarded as the protection scope of the present application.

Claims

1. A clutch assembly, arranged at the distal end of a catheter, for connecting and detaching 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 a natural state; A connecting portion is provided at the distal end of the embracing member, and under the action of external force, the at least two embracing members are enclosed so that the connecting portion is suitable for being snap-connected with the connecting seat on the implant; a contact structure is provided at the proximal end and / or the distal end of the connecting portion, so that after the at least two embracing members are enclosed, a contact position is formed between the connecting portion and the connecting seat.

2. The clutch assembly according to claim 1, characterized in that: The embracing member further comprises a main body, the connecting portion is arranged at the distal end of the main body; the connecting portion comprises a connecting arc and a connecting arm arranged at an angle, the connecting arm connecting the connecting arc and the main body; The connection seat is provided with a groove, the groove is adapted to the connection arc profile, and the connection seat is provided with an avoidance groove at the proximal end of the groove suitable for avoiding the connection arm; The contact structure is arranged on the connection arc along the width extension direction of the connection arc to form the contact position with the proximal end and / or the distal end of the groove.

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

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

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

6. The clutch assembly according to any one of claims 1 to 4, characterized in that: The engaging member further comprises an elastic portion, wherein the elastic portion is connected between the distal end of the catheter and the main body, so that the engaging member is opened relative to the central axis of the clutch assembly in a natural state.

7. The clutch assembly according to any one of claims 1 to 4, characterized in that: A mating piece is provided on one side of the engaging piece close to the central axis of the clutch assembly; The mating piece has a through hole, and when the through holes of the mating pieces of the at least two embracing pieces are butted together, the at least two embracing pieces are enclosed.

8. A conveying system, characterized in that: include: a catheter, the catheter comprising an implant catheter having a central passage extending axially therethrough; A clutch assembly, disposed at the distal end of the implant catheter, for connecting and detaching the implant; The main body of the implantable catheter includes a multi-lumen tube and a support tube, the multi-lumen tube has an axially penetrating central channel, and the support tube is inserted into the central channel of the multi-lumen tube; the multi-lumen tube and the support tube extend between the proximal end and the distal end of the main body of the implantable catheter and cover at least part of the length of the main 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 from the proximal end to the distal end of the main body.

10. The conveying system according to claim 9, characterized in that The spring coil at least partially adopts a double-layer structure in its own axial direction; and, The spring coil has a double-layer structure and has a first spring coil and a second spring coil in sequence from the inside to the outside along its own radial direction, and the spiral rotation direction of the first spring coil is opposite to the spiral rotation direction 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 outside the multi-lumen tube; and a reinforcement layer is provided between the outer tube and the multi-lumen tube.

12. The conveying system according to claim 11, characterized in that The reinforcement layer is woven from metal wires, extends between the proximal end and the distal end of the main body, and covers at least a portion of the length of the main body; and / or The outer tube has at least two sections in its 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 implant catheter is provided with an insert, which covers a portion of the distal end surface of the main body and has at least one central channel.

14. The conveying system according to claim 13, characterized in that The insert includes an end ring and a hub; The hub is arranged between the reinforcing layer and the multi-lumen tube; the end portion is arranged around the distal end of the connector, covers a portion of the distal end surface 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 further includes a fixing piece, which is inserted into the hub and fixedly connected to the side wall of the hub; The fixture has a central channel and is coaxial with the central channel of the implant catheter; The distal end of the support tube is connected to the proximal end of the fixture.

16. The conveying system according to any one of claims 8 to 15, characterized in that: The clutch assembly adopts the clutch assembly as described in any one of claims 1 to 7, which is arranged at the distal end of the implant catheter and is used for connecting and removing the implant; The conveying system also includes a delivery rod, which is inserted into the central channel of the implant catheter. When delivering the implant, the distal end of the delivery rod applies the external force to the engaging part of the clutch assembly so that the at least two engaging parts are surrounded. When removing the implant, the distal end of the delivery rod withdraws from the engaging part of the clutch assembly.

17. An interventional treatment system, characterized in that: include: An implant, wherein a connecting seat is disposed at the proximal end of the implant; The delivery system as described in any one of claims 8 to 16 is used to deliver the implant. When delivering the implant, at least two engaging members of the clutch assembly are surrounded and connected to the connecting seat.

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