A delivery system for an implantable tissue fixation device

Abstract

The application discloses a delivery system for an implantable tissue fixation device, the tissue fixation device comprising a second connecting part, the delivery system comprising a first connecting part, a limiting part and a separation assembly, the separation assembly comprising a separation part; the limiting part is used to prevent the relative movement between the first connecting part and the separation part when the first connecting part is connected with the second connecting part, so that the delivery system keeps a locked state; the separation part is used to apply a force to the first connecting part to deform the first connecting part when the first connecting part is driven to move to the separation part against the resisting force of the limiting part on the first connecting part, so that the first connecting part is separated from the second connecting part. The delivery system is provided with a clever structure, so that the delivery pipe can be safely removed when the implantable fixation device in the pipe connecting pipe reaches a target position, and the damage to the adjacent tissue is minimized.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and more particularly to a delivery system for an implantable tissue fixation device. BACKGROUND

[0002] Surgical repair of human tissue often involves plication of tissue to approximate and secure the tissue. When repairing a valve, plication involves joining the leaflets in the treatment, which can then be maintained by securing or fixing the leaflets. This joining can be used to treat regurgitation, most commonly in the mitral valve.

[0003] Mitral regurgitation is characterized by the backward flow from the left ventricle of the heart into the left atrium through a dysfunctional mitral valve. During a normal cardiac contraction cycle (systole), the mitral valve functions as a one-way valve to prevent oxygenated blood from flowing back into the left atrium. In this way, oxygenated blood passes through the aortic valve into the aorta. Mitral regurgitation can significantly reduce the efficiency of the heart in delivering oxygenated blood, leaving the patient at risk for severe, further heart failure.

[0004] Mitral regurgitation can be caused by a number of different mechanism defects in the mitral valve or left ventricular wall. The leaflets, chordae tendinae that connect the leaflets to the papillary muscles, the papillary muscles, or the left ventricular wall can be damaged or dysfunctional. Often, the annulus can be damaged, dilated, or weakened, which limits the ability of the mitral valve to fully close under high pressure in the left ventricle.

[0005] The most common treatment for mitral regurgitation is valve replacement or repair, including leaflet and annulus reconstruction, the latter often referred to as valvuloplasty. A recent technique for mitral valve repair is to suture adjacent portions of the opposite leaflet together, known as the "bow tie" or "edge-to-edge" technique. While all of these techniques are very effective, they often rely on open-heart surgery, i.e., opening the patient's chest, often through a sternal incision, and placing the patient on cardiopulmonary bypass. Both the opening of the patient's chest and the placement on cardiopulmonary bypass are very painful and are associated with high mortality and morbidity.

[0006] There are also alternative and additional methods, devices, or systems in the art that do not require an open chest pathway and can perform mitral and other heart valve repair endovascularly or through a minimally invasive approach, such as by performing valve repair with implantable fixation devices, which then need to be delivered and deployed to the desired location through a catheter for the next steps of the procedure.

[0007] While some implantable tissue fixation devices are available in the prior art, such as the system described in Chinese Patent CN102395331B, the delivery system in this patent relies solely on overcoming tension to disengage the device by having the user pull the control handle or the inlet catheter proximally. Furthermore, since the driving force of the method described in CN102395331B is not easily controlled within the safe and effective range of allowable deployment, there is a possibility that excessive tension may damage the tissue in contact with the clamp.

[0008] Therefore, there is an urgent need in the art to develop a delivery system for implantable tissue fixation devices that can overcome at least one of the above-mentioned disadvantages. Summary of the Invention

[0009] To address one or more of the above-mentioned problems, the present invention provides a delivery system for an implantable tissue fixation device, the tissue fixation device including a second connecting portion.

[0010] The conveying system includes a first connecting part, a limiting part, and a separating component, wherein the separating component includes a separating part;

[0011] The limiting part is used to prevent the first connecting part and the separating part from moving relative to each other when the first connecting part and the second connecting part are connected, thereby keeping the conveying system in a locked state;

[0012] The separating part is used to apply a force to the first connecting part when the first connecting part is driven to move toward the separating part against the resistance force of the limiting part, so as to deform the first connecting part and thereby separate the first connecting part from the second connecting part.

[0013] In another preferred embodiment, the conveying system includes a conveying member, the separating portion is located at the distal end of the conveying member, and the conveying member and the separating portion together define an internal conveying space, wherein the limiting portion is disposed in the internal conveying space;

[0014] The tissue fixation device includes a connector that defines a connection internal space, wherein at least the distal portion of the first connector is disposed within the connection internal space when the delivery system is held in a locked state.

[0015] In another preferred embodiment, the separation assembly further includes a control rod passing through the conveying interior space; the control rod is used to move the first connecting portion toward the separation portion.

[0016] In another preferred embodiment, the limiting part is an elastic member, the proximal end of which is fixedly connected to the inner wall of the conveying member, and the distal end of which is fixedly connected to the first connecting part.

[0017] In another preferred embodiment, the elastic member is a compression spring, and the compression spring is sleeved on the control rod.

[0018] In another preferred embodiment, the first connecting part comprises a first control arm and a second control arm, the first control arm comprises a first control arm proximal end and a first control arm distal end, and the second control arm comprises a second control arm proximal end and a second control arm distal end.

[0019] The first control arm proximal end and the second control arm proximal end are fixedly connected with the distal end of the elastic member and the distal end of the control rod, thereby forming a fixed connection point.

[0020] The first control arm distal end and the second control arm distal end are away from each other.

[0021] In another preferred embodiment, the second connecting part comprises a first locking groove and a second locking groove, and in the locked state of the conveying system, the first control arm distal end is locked in the first locking groove, and the second control arm distal end is locked in the second locking groove.

[0022] In another preferred embodiment, the first control arm distal end comprises a first protruding part, and the second control arm distal end comprises a second protruding part, and in the locked state of the conveying system, the first protruding part is locked in the first locking groove, and the second protruding part is locked in the second locking groove.

[0023] In another preferred embodiment, the limiting part is an elastic member, and in the locked state of the conveying system, the elastic member is in a natural state, or the elastic member is in a compressed state, so that the first connecting part and the second connecting part are tightly fitted, that is, when the elastic member is in a compressed state, a slight acting force is generated to make the first connecting part and the second connecting part more tightly fitted.

[0024] In another preferred embodiment, the first connecting part comprises a plurality of control arms, and the second connecting part comprises a plurality of locking grooves, the proximal ends of the control arms are fixedly connected together, the distal ends of the control arms are away from each other, and the distal ends of the control arms are capable of being clamped with the locking grooves.

[0025] In another preferred embodiment, the distal ends of the plurality of control arms define a minimum circumscribed circle radius greater than a minimum circumscribed circle radius defined by the locking grooves, so as to provide a pre-tightening force between the control arms and the locking grooves.

[0026] In another preferred embodiment, the first connecting portion comprises a maximum radial dimension and a minimum radial dimension, the radial dimension of the space defined by the separation portion is between the maximum radial dimension and the minimum radial dimension of the first connecting portion, and the first connecting portion is configured to pass through the space defined by the separation portion.

[0027] In another preferred embodiment, the separation portion is ring-shaped or cylindrical, and the first connecting portion is connected to the second connecting portion after passing through the separation portion.

[0028] In another preferred embodiment, the first connecting portion comprises a plurality of control arms, proximal ends of the control arms are fixed together, distal ends of the control arms are away from each other, and an inner diameter of the separation portion is smaller than a maximum diameter defined by the distal ends of the plurality of control arms.

[0029] In another preferred embodiment, when the delivery system is in the locked state, the inner diameter of the separation portion is greater than a minimum circumscribed circle diameter of the part of the control arms in the separation portion.

[0030] It should be understood that, within the scope of the present application, each of the technical features described above and each of the technical features described in detail below (e.g., in the examples) can be combined with each other to form new or preferred technical solutions. Due to the limited space, they will not be listed one by one here. BRIEF DESCRIPTION OF DRAWINGS

[0031] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below. It should be understood that the drawings described below are only some of the embodiments of the present application, and those of ordinary skill in the art can also obtain other embodiments from these drawings without creative labor.

[0032] Figure 1 is a schematic diagram of the connection between the delivery system and the tissue fixation device according to an embodiment of the present application;

[0033] Figure 2 is a schematic diagram between the delivery system and the tissue fixation device when released according to an embodiment of the present application;

[0034] Figure 3 is a schematic diagram between the delivery system and the tissue fixation device after release according to an embodiment of the present application;

[0035] Figure 4(a) is a schematic diagram of the structure of the delivery member of the delivery system and the connecting member of the tissue fixation device according to an embodiment, wherein the separation portion is integrally formed with the delivery member;

[0036] Figure 4(b) is a structural schematic of a delivery member of a delivery system and a connecting tube of a tissue fixation device according to another embodiment, wherein the separation component is coaxially arranged with the delivery member and the separation component is proximal to the connecting tube;

[0037] Figure 5 Figure 1 shows a structural schematic of a state of an implantable tissue fixation device according to the present application;

[0038] Figure 6 Figure 2 shows a structural schematic of another state of an implantable tissue fixation device according to the present application;

[0039] Figure 7 Figure 3 shows a structural schematic of a delivery system and a tissue fixation device according to the present application.

[0040] In the various figures, the following designations apply:

[0041] 1 - delivery system

[0042] 11 - handle

[0043] 12 - delivery member

[0044] 121 - delivery interior space

[0045] 13 - compression spring

[0046] 14 - control arm

[0047] 140 - fixed connection point

[0048] 141 - first control arm

[0049] 141 1 - first control arm proximal end

[0050] 141 2 - first control arm distal end

[0051] 141 21 - first protrusion

[0052] 142 - second control arm

[0053] 142 1 - second control arm proximal end

[0054] 142 2 - second control arm distal end

[0055] 142 21 - second protrusion

[0056] 15 - separation component

[0057] 151 - separation

[0058] 152 - control rod

[0059] 5 - tissue fixation device

[0060] 51 - gripping member

[0061] 52-clamp arm

[0062] 53-Connector

[0063] 531 - Connecting the Internal Space

[0064] 532-Locking Groove

[0065] 5321 - First Locking Groove

[0066] 5322 - Second Locking Groove

[0067] 6-lobed Detailed Implementation

[0068] In the following description, many technical details are presented to help the reader better understand this application. However, those skilled in the art will understand that the technical solutions claimed in this application can be implemented even without these technical details and various variations and modifications based on the following embodiments.

[0069] the term

[0070] Implantable tissue fixation devices

[0071] In interventional medicine, interventional tools are needed to achieve minimally invasive treatment effects. Generally, interventional tools include a delivery system and an implantable tissue fixation device. The delivery system delivers the implantable tissue fixation device to the target tissue through natural body cavities or artificial pathways. The tissue fixation device is then fixed to the target tissue to resolve or alleviate the patient's symptoms. For example, in vascular diseases, the tissue fixation device is a stent prosthesis; in structural heart disease, the tissue fixation device is a left atrial appendage occluder, mitral valve clip, or tricuspid valve clip.

[0072] See Figure 3 , Figures 5-6 This application provides an example of an implantable tissue fixation device, which includes a connector 53 defining a connection interior space 531, in which a second connection portion is provided for connection with a first connection portion of a delivery system.

[0073] The terms "comprise", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can also include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element preceded by "comprises a" does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that includes the element. In the patent application file, if it refers to performing an act with respect to a component, it means at least performing the act with respect to the component, including both performing the act with respect to the component only and performing the act with respect to the component and other components. The expressions multiple, multiple times, multiple kinds, etc. include 2, 2 times, 2 kinds, and more than 2, more than 2 times, more than 2 kinds.

[0074] In the present application, all directional indications (such as up, down, left, right, front, back, etc.) are used only to explain the relative positional relationship, motion condition, etc. between components in a certain specific posture (as shown in the drawings), and if the specific posture changes, the directional indications will also change accordingly.

[0075] In the present application, unless otherwise specified, "distal" and "distal side" refer to the side close to the patient and away from the operator, and correspondingly, "proximal" and "proximal side" refer to the side close to the operator and away from the patient.

[0076] The present application provides a delivery system for delivering an implantable tissue fixation device. The tissue fixation device includes a second connection portion; the delivery system includes a first connection portion, a limiting portion, and a separation assembly. The separation assembly includes a separation portion; the limiting portion is configured to prevent relative movement between the first connection portion and the separation portion when the first connection portion is connected to the second connection portion, so that the delivery system is in a locked state; the separation portion is configured to apply a force to the first connection portion to deform the first connection portion when the first connection portion is driven to move towards the separation portion against the resistance of the limiting portion, so that the first connection portion is disconnected from the second connection portion.

[0077] In the following embodiments, a mitral valve clip for preventing mitral regurgitation is exemplarily described.

[0078] Embodiments

[0079] For treating mitral regurgitation, one interventional treatment method is to connect the leaflet portions of the human mitral valve together by an interventional medical device, similar to a surgical "edge-to-edge" operation. As shown in Fig. 1, the leaflet portions of the mitral valve are connected together by a clip 1, and the clip 1 is connected to the leaflet portions by a plurality of connecting members 2. Figure 7As shown, the interventional medical device includes a tissue fixation device 5 for clamping the leaflet edge of the mitral valve. The tissue fixation device 5 can be a mitral valve clamp. The interventional medical device also includes a delivery system 1 for delivering the tissue fixation device 5 to the vicinity of the mitral valve. The delivery system 1 includes a proximal handle 11 and a distal delivery element 12. The handle 11 controls the orientation of the distal end of the delivery element 12, allowing the delivery element 12 to move along a natural body cavity or artificial pathway to the mitral valve in a desired orientation. The handle 11 also controls the functional movements of the tissue fixation device 5, such as opening and closing movements to clamp the mitral valve leaflets; separation of the tissue fixation device 5 from the delivery system 1, etc.

[0080] On the one hand, such as Figures 5-6 As shown, the tissue fixation device 5 includes a gripper 51 and a clamping arm 52. The clamping arm 52 and the gripper 51 can swing independently to clamp the leaflet 6. In this embodiment, the clamping arm 52 includes two clamping arm extensions extending to opposite sides. The gripper 51 includes two gripping extensions extending to both sides. Figure 5 As shown, when clamping leaflet 6, the clamping arm extension of clamping arm 52 rotates distally, and the gripping extension of gripper 51 rotates proximally to increase the clamping space between the clamping arm extension and the gripping extension, making it easier for the leaflet to enter the clamping space. Figure 6 As shown, after the leaflet enters the clamping space, the clamping arm extension of the clamping arm 52 rotates proximally in the opposite direction, and the grasping extension of the grasping member 51 rotates distally in the opposite direction, until the leaflet is clamped by the clamping arm extension and the grasping extension. In some other embodiments, there may be three, four, or more clamping arm extensions and grasping extensions. The number of clamping arm extensions and grasping extensions can be determined according to the anatomical structure of human tissue and the requirements of the surgical procedure. Furthermore, the tissue fixation device 5 also includes a connector 53, and the grasping member 51 and the clamping arm 52 swing around the axis of the connector 53. The specific connection method between the grasping member 51, the clamping arm 52, and the connector 53 is not limited. For example, the gripper 51, clamping arm 52, and connecting member 53 can be directly rotatably connected to achieve the swinging of the gripper 51 and clamping arm 52. Alternatively, the gripper 51 and clamping arm 52 can be indirectly connected to the connecting member 53, and a conversion mechanism can be used to convert the axial movement of the connecting member 53 into the swinging of the gripper 51 and clamping arm 52. Or, the connecting member 53 can be directly inserted through the gripper 51 and clamping arm 52, and the gripper 51 and clamping arm 52 can swing through their own elasticity. Furthermore, the proximal end of the connecting member 53 includes a second connecting portion for detachable connection with the first connecting portion of the conveying system. Exemplarily, the second connecting portion is a groove, a through hole, or a blind hole.

[0081] In the embodiment, the material of the clamping arm 52 is not particularly limited, as long as it is a biocompatible material. Preferably, the material of the clamping arm 52 is cobalt-chromium alloy. Similarly, the material of the gripping member 51 is not particularly limited in the embodiment. Preferably, the material of the gripping member 51 is nickel-titanium alloy, which has good biocompatibility and resilience.

[0082] In another aspect, the delivery system 1 further comprises a first connecting portion, a limiting portion 13 and a separation assembly 15, wherein the separation assembly 15 comprises a separation portion 151. The limiting portion is configured to prevent relative movement between the first connecting portion and the second connecting portion of the tissue fixation device 5 when the first connecting portion is connected to the second connecting portion, so that the delivery system 1 remains in a locked state. The separation portion 151 is configured to apply a force to the first connecting portion to deform the first connecting portion when the first connecting portion is driven to move towards the separation portion 151 against the resistance of the limiting portion, so that the first connecting portion is disconnected from the second connecting portion.

[0083] Referring to Figures 1-3 , the first connecting portion is a plurality of control arms 14. The proximal ends of the plurality of control arms 14 are connected, and the distal ends are away from each other. Preferably, the control arms 14 are made of biocompatible metal, more preferably, cobalt-chromium alloy. In the embodiment, the control arms 14 are two, i.e. a first control arm 141 and a second control arm 142. The first control arm 141 comprises a first control arm proximal end 1411 and a first control arm distal end 1412, and the second control arm 142 comprises a second control arm proximal end 1421 and a second control arm distal end 1422. The first control arm proximal end 1411 of the first control arm 141 and the second control arm proximal end 1421 of the second control arm 142 are fixedly connected to a fixed connection point 140, and the first control arm distal end 1412 and the second control arm distal end 1422 are away from each other and are configured to be locked with a locking groove in the locked state of the delivery system. In this way, the first control arm 141 and the second control arm 142 are arranged in a V shape. In other embodiments, the control arms 14 can be more than two, for example, three or four. By connecting the distal ends of the control arms to the locking groove, the delivery system 1 is connected to the tissue fixation device 5. Thus, the delivery system 1 is in a locked state.

[0084] Further, the first control arm distal end 1412 comprises a first protrusion 14121, and the second control arm distal end 1422 comprises a second protrusion 14221. Correspondingly, the second connection part is a plurality of locking grooves 532 provided on the inner wall of the proximal end of the connecting member 53. The number of the locking grooves 532 matches the number of the control arms 14, and the relative positions of the locking grooves 532 match the relative positions of the distal ends of the control arms 14. In this embodiment, the number of the locking grooves 532 is two, i.e. a first locking groove 5321 and a second locking groove 5322. The first protrusion 4121 and the second protrusion 4221 can be locked in the first locking groove 5321 and the second locking groove 5322 respectively. Through the cooperation of the two, the connection between the delivery system 1 and the tissue fixation device 5 is achieved, i.e. the delivery system is in a locked state. Preferably, the minimum circumscribed circle radius defined by the first protrusion 4121 and the second protrusion 4221 is slightly larger than or equal to the radius of the minimum circumscribed circle defined by the first locking groove 5321 and the second locking groove 5322. By slightly deforming the control arm 14, the pre-tightening force between the protrusion and the locking groove 532 is increased, and the stability of the connection between the two is increased.

[0085] After the delivery system 1 sets the tissue fixation device 5 near the mitral valve, the delivery system 1 needs to be separated from the tissue fixation device 5. When the first connection part moves towards the separation part 151, the separation part 151 exerts a force on the first connection part due to the contact between the separation part 151 and the first connection part, so that the first connection part deforms and is separated from the second connection part. In one embodiment, the separation part defines a space, the first connection part is arranged to pass through the space defined by the separation part, the first connection part comprises a maximum radial dimension and a minimum radial dimension, and the radial dimension of the space defined by the separation part is between the maximum radial dimension and the minimum radial dimension of the first connection part. For details, see Figure 2In the present embodiment, the separation portion 151 is a hollow tube. Since the proximal end of the control arms is fixed, the minimum radial dimension is twice the width of the control arms, and the inner diameter of the tube is configured to be smaller than the minimum circumscribed circle diameter (i.e. the maximum radial dimension) defined by the first and second protrusions 4121 and 4221, so that the control arms 14 will be interfered by the separation portion 151 when moving towards the separation portion 151 and thus deformed. At the same time, the inner diameter of the tube cannot be too small, so that the separation portion 151 will interfere with the control arms 14 when the delivery system 1 is in the locked state, i.e. when the first and second protrusions 4121 and 4221 are locked in the first and second locking grooves 5321 and 5322, respectively. A person skilled in the art can obtain the minimum inner diameter of the tube by geometric relationship according to the length of the control arms 14, the angle between the control arms 14, and the length of the control arms 14 in the connecting channel 53. More specifically, when the first and second protrusions 4121 and 4221 are locked in the first and second locking grooves 5321 and 5322, respectively, there is a gap between the first and second control arms 141 and 142 and the separation portion 151, i.e. the inner diameter of the tube is larger than the diameter of the minimum circumscribed circle defined by the control arms 14 at the corresponding position. In this way, since the delivery system and the tissue fixation device can rotate to a certain extent without the separation portion 151 accidentally acting on the control arms 14 due to the movement between the two, the undesired disengagement between the delivery system 1 in the locked state and the tissue fixation device 5 is avoided. Preferably, the radial deformation resistance of the separation portion 151 is greater than that of the control arms 14. In an alternative embodiment, the separation portion can also be annular or other similar shapes that can define a space. When the control arms 14 are locked in the locking grooves 532, at least the distal part of the control arms 14 is located in the inner space 531, and the proximal end of the control arms 14 can be located in the delivery inner space 121, the connecting inner space 531, or the gap between the delivery inner space 121 and the connecting inner space 531. In this regard, the present embodiment is not limited in particular. In the present embodiment, the separation portion 151 is integrally formed with the delivery member 12 (see Figure 4a ). In an alternative embodiment, the separation portion 151 is directly or indirectly arranged at the distal end of the delivery member 12 as a separate part by assembly (for example Figure 4b ).

[0086] Further, the separating assembly further comprises a control rod 152, the distal end of the control rod 152 is fixedly connected to the fixed connection point 140 of the control arm 14, and the proximal end of the control rod 152 is connected to the handle 11 of the delivery system. In this way, when it is needed to separate the delivery system 1 from the tissue fixation device 5, the operator can operate the handle 11 to move the control rod 152 proximally, and then move the control arm 14 towards the separating part 151, and due to the contact interference between them, the control arm 14 is deformed to be retracted and separated from the locking groove 532. In this embodiment, the control rod 152 is arranged in the delivery inner space 121 and extends along the axis of the delivery member 12 from the distal end to the proximal end to be connected to the handle 11.

[0087] After the delivery system 1 is in the locked state, it is needed to keep the delivery system in the locked state when delivering the tissue fixation device 5 to the target position of the mitral valve and clamping the tissue fixation device 5 to the leaflets of the mitral valve. When the first connecting part of the delivery system 1 is connected to the second connecting part of the tissue fixation device 5, the limiting part prevents the first connecting part from moving towards the separating part 151 to avoid the first connecting part being deformed by the separating part 151 so that the first connecting part and the second connecting part are disconnected. As shown in Figures 1-3 the limiting part is an elastic member arranged in the delivery inner space 121, and the proximal end of the elastic member is fixed to the delivery inner space 121 and the distal end is fixed to the fixed connection point 140 of the control arm 14. The elastic member is further configured to be in a natural state without generating force or slightly generating force (within 10 N) to make the control arm 14 and the locking groove 532 fit more closely when the control arm 14 is locked with the locking groove 532. When the control arm 14 moves towards the separating part 151, the elastic member generates an elastic force to prevent the control arm 14 from further moving towards the separating part 151. Preferably, the elastic member is a compression spring 13 which is sleeved on the control rod 3. When the control arm 14 is locked with the locking groove 532, the compression spring 13 is in a natural length.

[0088] The following exemplary brief description of the operation method of the delivery system in the above embodiment.

[0089] The delivery system has two states, a locked state (also called a pre-release state) and a disconnected state (also called a post-release state).

[0090] Aligning the distal end of the delivery system with the proximal end of the tissue fixation device, slightly compressing the control arm 14, and then moving the delivery system relative to the tissue fixation device to make the compressed control arm 14 enter the connecting inner space 531 of the connecting member 53, align the control arm 14 with the locking groove 532 of the connecting member 53 and release the control arm 14, so that the control arm 14 is locked with the locking groove 532, and then the delivery system is in the locked state, as shown in Figure 1 ;

[0091] The locked delivery system is used for various surgical procedures, such as delivering the tissue fixation device 5 to the target position of the mitral valve and clamping the mitral valve leaflets with the tissue fixation device 5.

[0092] like Figures 2-3 As shown, when it is necessary to separate the delivery system from the tissue fixation device, the separation part remains stationary. The control arm 14 is driven by the control lever 152 to overcome the elastic force of the elastic element and move towards the separation part. Due to the force exerted by the separation part on the control arm 14, the control arm 14 deforms and converges, causing the control arm 14 to disengage from the locking groove 532. This, in turn, separates the delivery system from the tissue fixation device, placing the delivery system in a disengaged state. Finally, the delivery system is removed from the body, completing the surgical procedure.

[0093] The advantages of this invention include one or more of the following:

[0094] (a) The delivery system of the present invention can be used in surgeries that require access to tissue locations or intravascular access, especially in distal treatment sites where the instruments used must be reached through narrow and tortuous paths.

[0095] (b) The delivery system of the present invention is suitable for withdrawal and removal from any position of the patient without disturbing internal tissues or damaging wound tissues;

[0096] (c) The delivery system of the present invention can be used in a variety of therapeutic surgeries, including vascular and open surgeries, and can be used in multiple anatomical regions, including organs, blood vessels and tissues such as the abdomen, thoracic cavity, cardiovascular system, heart, intestines, stomach, urethra, bladder, and lungs;

[0097] (d) The delivery system of the present invention, through its ingenious structural design, allows the delivery system to be safely withdrawn after the implantable fixation device reaches the target position, with minimal damage to adjacent tissues;

[0098] (e) The delivery system of the present invention has good stability and is easy to control because the control lever is operated by a handle at the proximal end. It does not require applying tension directly to the implant or the connecting tissue, nor does it rely solely on tension (pulling proximally) to detach the delivery component. It also does not damage the tissue in contact with the tissue fixation device due to excessive tension.

[0099] (f) The conveying system of the present invention provides a limiting part, such as a compression spring, so that the control arm is locked in the locking groove of the connector, thereby preventing the control arm from being accidentally or accidentally unfolded.

[0100] All documents mentioned in this application are incorporated herein by reference in their entirety to provide public access to the teachings of this application to the extent necessary to practice it. In addition, it should be understood that various modifications and substitutions can be made by those skilled in the art who have the benefit of the teachings of this application without departing from the spirit and scope of the application.

Claims

1. A delivery system for an implantable tissue fixation device, the tissue fixation device comprising a second connecting portion, characterized in that, the delivery system comprises a first connecting portion, a limiting portion and a separating assembly, the separating assembly comprising a separating portion; the limiting portion is configured to prevent relative movement between the first connecting portion and the separating portion when the first connecting portion is connected to the second connecting portion, so that the delivery system remains in a locked state; the separating portion is configured to apply a force to the first connecting portion to deform the first connecting portion when the first connecting portion is driven to move towards the separating portion against the resistance of the limiting portion, so that the first connecting portion is disconnected from the second connecting portion; the delivery system comprises a delivery member, the separating portion is located at a distal end of the delivery member, and the delivery member and the separating portion together define a delivery internal space, the limiting portion is arranged in the delivery internal space; the tissue fixation device comprises a connecting member, the connecting member defines a connecting internal space, a proximal end of the connecting member comprises the second connecting portion, the second connecting portion is arranged in the connecting internal space, and at least a distal end portion of the first connecting portion is arranged in the connecting internal space when the delivery system remains in the locked state; the limiting portion is an elastic member, a proximal end of the elastic member is fixedly connected to an inner wall of the delivery member, and a distal end of the elastic member is fixedly connected to the first connecting portion; the first connecting portion comprises a plurality of control arms, the second connecting portion comprises a plurality of locking grooves, proximal ends of the control arms are fixed together, distal ends of the control arms are away from each other, and the distal ends of the control arms are capable of being engaged with the locking grooves, the separating assembly further comprises a control rod, when it is necessary to separate the delivery system from the tissue fixation device, the separating portion is kept stationary, the control rod is used to drive the control arms to move towards the separating portion against the elastic force of the elastic member, the control arms are deformed to gather together due to the force of the separating portion, the control arms are disconnected from the locking grooves, and the delivery system is disconnected from the tissue fixation device.

2. The delivery system of claim 1, wherein, the tissue fixation device comprises a gripping member and a clamping arm, the clamping arm and the gripping member are capable of swinging independently to clamp a leaflet.

3. The delivery system of claim 1, wherein, the control rod passes through the delivery internal space, and the control rod is used to drive the first connecting portion to move towards the separating portion.

4. The delivery system of claim 2, wherein, the gripping member and the clamping arm swing around an axis of the connecting member.

5. The delivery system of claim 3, wherein, the elastic member is a compression spring, and the compression spring is sleeved on the control rod.

6. The delivery system of claim 4, wherein, the first connecting portion comprises a first control arm and a second control arm, the first control arm comprises a first control arm proximal end and a first control arm distal end, and the second control arm comprises a second control arm proximal end and a second control arm distal end; the first control arm proximal end, the second control arm proximal end, a distal end of the elastic member, and a distal end of the control rod are fixedly connected together to form a fixed connection point; the first control arm distal end and the second control arm distal end are away from each other.

7. The delivery system of claim 6, wherein, The second connecting part comprises a first locking groove and a second locking groove, in the locking state of the delivery system, the first control arm distal end is locked in the first locking groove, and the second control arm distal end is locked in the second locking groove.

8. The delivery system of claim 7, wherein, The first control arm distal end comprises a first protrusion, and the second control arm distal end comprises a second protrusion, in the locking state of the delivery system, the first protrusion is locked in the first locking groove, and the second protrusion is locked in the second locking groove.

9. The delivery system of claim 1, wherein, The limiting part is an elastic member, in the locking state of the delivery system, the elastic member is in a natural state, or the elastic member is in a compressed state, so that the first connecting part and the second connecting part are tightly matched.

10. The delivery system of claim 1, wherein, The tissue fixation device is a left atrial appendage occluder, a mitral valve clip, and / or a tricuspid valve clip.

11. The delivery system of claim 10, wherein, The minimum circumscribed circle radius defined by the distal ends of the plurality of control arms is greater than the minimum circumscribed circle radius defined by the locking groove, so as to provide a pre-tightening force between the control arms and the locking groove.

12. The delivery system of claim 1, wherein, The first connecting part comprises a maximum radial dimension and a minimum radial dimension, the space limited by the separation part has a radial dimension between the maximum radial dimension and the minimum radial dimension of the first connecting part, and the first connecting part is configured to pass through the space limited by the separation part.

13. The delivery system of claim 12, wherein, The separation part is annular or cylindrical, and the first connecting part is connected to the second connecting part after passing through the separation part.

14. The delivery system of claim 13, wherein, The first connecting part comprises a plurality of control arms, the proximal ends of the control arms are fixed together, the distal ends of the control arms are away from each other, and the inner diameter of the separation part is smaller than the maximum diameter defined by the distal ends of the plurality of control arms.

15. The delivery system of claim 13 or 14, wherein, When the delivery system is in the locking state, the inner diameter of the separation part is greater than the minimum inscribed circle diameter of the part of the control arms in the separation part.

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