A valve clip convenient for loading and conveying

Abstract

The present invention relates to the field of medical devices, and particularly to a valve clip that is convenient for loading and conveying, including a telescopic sleeve, a connecting piece, clamping arms, and a linkage rod. The clamping arms are connected to the connecting piece, one end of the linkage rod is connected to the telescopic sleeve, and the other end of the linkage rod is connected to one end of the clamping arm. The valve clip has a first form and a second form. When the valve clip is in the first form, the minimum angle is formed between the clamping arms, the linkage rod is attached to the clamping arm, and the telescopic sleeve is in a compressed form; when the valve clip changes from the first form to the second form, the telescopic sleeve gradually elongates, driving the angle between the clamping arms to gradually increase so as to facilitate the linkage rod to capture the autologous valve leaf; after the valve clip completes capturing the autologous valve leaf, the telescopic sleeve is shortened again to the compressed form, and the valve clip returns from the second form to the first form; the structure is simple, the stability performance is good, and it is convenient for bending and conveying at the same time. When the valve clip is loaded, it can be shortened to the shortest stroke, which is convenient for coping with the curvature of blood vessels.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a valve clip that is convenient for loading and transportation. Background Art

[0002] The mitral valve anatomical structure is complex, including valve leaflets, annulus, chordae tendineae and papillary muscles, which respectively play important roles in maintaining the functions of the left and right ventricles. Any disease that affects the structural integrity and normal function of the valve leaflets, annulus, chordae tendineae, papillary muscles and left ventricle may lead to severe mitral regurgitation (MR), which can cause left ventricular failure, pulmonary hypertension, atrial fibrillation, stroke and death. According to the latest epidemiological survey data in Western developed countries such as the United States, the type of valvular disease with the highest incidence in the elderly population over 65 years old is mitral regurgitation. At present, although there is no authoritative epidemiological survey data in China, with the advent of population aging, the large number of mitral regurgitation patients in China is beyond doubt. Mitral regurgitation can be divided into degenerative MR and functional MR. Degenerative MR is caused by pathological changes in one or more of the valve leaflets, annulus, chordae tendineae and papillary muscles; functional MR is usually due to abnormal left ventricular function, such as annulus dilation, but the mitral valve is usually normal.

[0003] Currently, the treatment methods for MR mainly include drug treatment, surgical operation and interventional treatment. Drug treatment can only improve the symptoms of patients and cannot extend the survival time of patients. Surgical operations are mainly valve repair or valve replacement, which are recognized as the preferred treatment methods for mitral regurgitation and have been proven to relieve the symptoms of patients and extend their lifespan. However, for many high-risk patients with advanced age and multiple systemic diseases, the surgical risk is high and the survival benefit is small. According to European data, the surgical success rate of such patients is only 50%, and the surgical success rate of severe functional MR patients is even as low as 16%. Therefore, transcatheter mitral valve repair and replacement can theoretically benefit high-risk patients who have lost the opportunity for surgery. Interventional treatment is to load an artificial implant onto a delivery system outside the body, deliver it to the mitral annulus along the vascular path or by puncturing the apex of the heart, and then release and fix it to completely or partially replace the function of the autologous valve. Currently, mitral valve interventional treatment has become one of the research hotspots in the related fields, and many products are under development. However, due to problems such as the complexity of the mitral valve itself and its surrounding structures, the development of mitral valve interventional devices faces many special difficulties.

[0004] Patent CN103826548A provides a method for fixing tissues, and the method includes: providing an implantable fixing device, which includes a pair of fixing elements, each fixing element having a first end, a free end opposite to the first end, and a joint surface located between the first end and the free end for joining tissues. The first ends are movably coupled together such that the fixing elements can move between a closed position and a first open position. In the closed position, the joint surfaces face each other, and in the first open position, the joint surfaces are positioned away from each other. In the technical solution of this patent, the length of the valve clip is too long during loading and transportation. Moreover, the blood vessel paths in the human body are winding and tortuous, especially when entering the right atrium from the superior vena cava, the bending degree is relatively large, and the valve clip is likely to scrape the blood vessel wall and its intracardiac tissues during bending, which is not conducive to loading and transportation.

[0005] Patent CN201880066104.9 discloses a valve clip device including a spacer member configured to be disposed between the leaflets of a native heart valve located between a first chamber and a second chamber of the heart. The prosthetic device further includes a plurality of anchoring members coupled to the spacer member and configured to capture the leaflets between the respective anchoring members and the spacer member such that the valve clip is held between the leaflets. When the leaflets are captured between the anchoring members and the spacer member, the spacer member is configured to provide a flow path through the prosthetic device between the first chamber and the second chamber such that blood can flow refluxly from the second chamber to the first chamber through the spacer member; in the technical solution of this patent, the frame structure is supported by a preformed metal material. Although it can conform to the curvature of the blood vessel due to the characteristics of the material during loading and transportation, it may cause capture failure due to insufficient support of the stent itself when capturing the valve leaflets, and at the same time, the stability of the structure is relatively poor, and problems such as stress fatigue may occur during long-term use.

[0006] In summary, there are still many problems with the valve clip in terms of loading and transportation and structural stability in the prior art, and it is necessary to provide a valve clip with a simple structure, good stability, and convenient bending and transportation. Summary of the Invention

[0007] The object of the present invention is to provide a valve clip that is convenient for loading and transportation. The valve clip has the following advantages: simple structure, good stability, and convenient bending and transportation. When the valve clip is loaded, it can be shortened to the shortest stroke, which is convenient for its delivery system to cope with the curvature of the blood vessel during bending and transportation, and at the same time, it can enhance the structural stability and will not cause problems such as stress fatigue.

[0008] To solve the above technical problems, the present invention is solved by the following technical solutions: A valve clip convenient for loading and conveying, comprising a telescopic sleeve, a connecting piece connected to one end of the telescopic sleeve, clamping arms, and a linkage rod. The clamping arms are connected to the connecting piece. One end of the linkage rod is connected to the telescopic sleeve, and the other end of the linkage rod is connected to one end of the clamping arm. The valve clip has a first form and a second form. When the valve clip is in the first form, the included angle between the clamping arms is the smallest, the linkage rod fits against the clamping arms, and the telescopic sleeve is in a compressed form. When the valve clip changes from the first form to the second form, the telescopic sleeve gradually elongates, driving the included angle between the clamping arms to gradually increase so as to facilitate the linkage rod to capture the autologous valve leaf. When the valve clip completes the capture of the autologous valve leaf, the telescopic sleeve is shortened again to the compressed form, and the valve clip returns from the second form to the first form.

[0009] The present invention can also be further realized by the following technical solutions:

[0010] In one embodiment, the telescopic sleeve, the connecting piece, the clamping arms, and the linkage rod are all made of rigid materials. The advantage of such a design is that when the stroke of the telescopic sleeve changes, the structure of the entire valve clip has good support and will not deform during the operation, which is beneficial to the surgical operation. On the other hand, it can ensure a lasting clamping force and will not cause problems such as fatigue.

[0011] In one embodiment, the telescopic sleeve is composed of several sleeves, and an anti-disconnection structure is provided between adjacent sleeves.

[0012] In one embodiment, when the telescopic sleeve is in the compressed form, the length of the telescopic sleeve is the length of the outermost sleeve.

[0013] In one embodiment, regardless of whether the valve clip is in the first form, the second form, or in the process of converting between the two forms, one end of the telescopic sleeve is always connected to the connecting piece.

[0014] In one embodiment, the innermost sleeve of the telescopic sleeve is connected to the connecting piece. The clamping arms include a first clamping arm and a second clamping arm. The linkage rod includes a first linkage rod and a second linkage rod. The first clamping arm and the second clamping arm are respectively hinged to the connecting piece and are arranged on the left and right sides of the telescopic sleeve. One end of the first linkage rod is hinged to the first clamping arm, and the other end of the first linkage rod is hinged to the outermost sleeve of the telescopic sleeve. One end of the second linkage rod is hinged to the second clamping arm, and the other end of the second linkage rod is hinged to the outermost sleeve of the telescopic sleeve.

[0015] In one embodiment, the valve clip further includes a self-locking structure, which includes a limiting member disposed on the connecting member and a locking member disposed on the outermost sleeve of the telescopic sleeve. When the valve clip is in the first configuration, the locking member cooperates with the limiting member to achieve self-locking; the limiting member is a self-expanding structure.

[0016] In one embodiment, the telescopic sleeve includes a first sleeve, a second sleeve, and a third sleeve. The second sleeve is sleeved between the first sleeve and the third sleeve. The first sleeve is connected to the connecting member, and the third sleeve is connected to the linkage rod.

[0017] In a preferred embodiment, the length of the second sleeve is less than the length of the third sleeve, and the length of the first sleeve is less than the length of the third sleeve; the advantage of such a design is that when the telescopic sleeve is shortened to the shortest stroke, the first sleeve and the second sleeve will not exceed the third sleeve, thereby increasing the length of the telescopic sleeve in the body and avoiding scraping and damaging the heart valve and the tissues in the heart.

[0018] In one embodiment, the valve clip further includes a locking device, which includes a self-locking rod and a locking head connected to the connecting member. The clamping arm includes a long arm and a short arm. A locking portion is provided at one end of the short arm. When operating the locking device to axially move to make the included angle between the long arms of the first clamping arm and the second clamping arm become larger and in an open state, the locking portion on the first clamping arm and the locking portion on the second clamping arm are partially in a misaligned mating state; when operating the locking device to axially move to make the included angle between the long arms of the first clamping arm and the second clamping arm become smaller and in a closed state, move the self-locking rod so that the locking head and the locking portion are in cooperation and locked.

[0019] In one embodiment, the length of the locking rod is less than the length of the third sleeve; to avoid increasing the length when the valve clip is implanted into the heart, thereby scraping the tissues in the heart.

[0020] In one embodiment, the shape of the short arm is arc-shaped or "L"-shaped. When the included angle between the first clamping arm and the second clamping arm becomes larger, the short arm on the first clamping arm and the short arm on the second clamping arm are in misaligned mating.

[0021] In one embodiment, a through hole and a mounting groove are axially provided on the connecting block. The mounting groove is provided on the distal side of the through hole. Internal threads are provided in the through hole, and external threads are provided on the distal side of the locking rod for mating and screwing with the internal threads.

[0022] In one embodiment, during loading and transportation, the lock head is located within the installation groove. The maximum diameter of the lock head is greater than the diameter of the through hole, the diameter of the installation groove is greater than the diameter of the through hole, and the lock head is restricted from moving towards the proximal end by the through hole.

[0023] In one embodiment, the valve clip further includes a valve clip delivery system. The valve clip delivery system includes a control handle, a first delivery tube connected to the control handle, a central control member, and a second delivery tube. Detachable connection mechanisms are provided on both the self-locking rod and the outermost sleeve of the telescopic sleeve. Detachable release mechanisms that cooperate with the detachable connection mechanisms are provided at the distal portions of both the first delivery tube and the second delivery tube. During pre-installation, the detachable connection mechanism on the self-locking rod is connected to the detachable release mechanism on the first delivery tube through the central control member, serving as the first disassembly portion. The detachable connection mechanism on the outermost sleeve of the telescopic sleeve is connected to the detachable release mechanism on the second delivery tube through the central control member, serving as the second disassembly portion. When the central control member moves away from the first and second disassembly portions, the first delivery tube is disengaged and separated from the self-locking rod, and the second delivery tube is disengaged and separated from the outermost sleeve of the telescopic sleeve.

[0024] In one embodiment, when relative displacement occurs between the first disassembly portion and the second disassembly portion, the relative position between the central control member and the first delivery tube always remains unchanged. The advantage of this design is that when relative displacement occurs between the first disassembly portion and the second disassembly portion, the opening and closing of the valve clip can be controlled, and the fact that the relative position between the central control member and the first delivery tube always remains unchanged can ensure that the first disassembly portion is not prematurely disassembled during the opening and closing of the valve clip. At the same time, the central control member fills the gaps between the first delivery tube and the inner tube, and between the second delivery tube and the outer connecting tube, making the entire device more stable during operation.

[0025] Compared with the prior art, the advantages of the present invention are as follows:

[0026] 1. Different from the prior art, the present invention adopts a telescopic sleeve structure. During loading, the telescopic sleeve is shortened to the shortest stroke, which is beneficial for the valve clip to cope with various bending degrees in the blood vessel during loading and transportation, and will not scrape or damage the blood vessel wall. When it is necessary to capture the valve leaflet, the telescopic sleeve is stretched to the target stroke to facilitate capturing the valve leaflet. At the same time, the telescopic sleeve provides sufficient supporting force for the valve clip. When the valve leaflet is located on the linkage rod, the telescopic sleeve is compressed to the shortest stroke again, so that the valve leaflet is clamped between the linkage rod and the telescopic sleeve. The valve clip is implanted into the target position. The structure of the telescopic sleeve stacked layer by layer enables the valve clip to have a better anti-leakage effect;

[0027] 2. Different from the prior art, the telescopic sleeve in the present invention adopts a superposition of three sleeves, which is close to the optimal effective length (the optimal effective distance refers to the vertical length from the connecting piece to one end of the clamping arm), so that the diameter of the telescopic sleeve will not be too thick, affecting its access path and causing unnecessary damage to blood vessels;

[0028] 3. Different from the prior art, when the included angle between the first clamping arm and the second clamping arm in the present invention becomes larger, the locking parts on the first clamping arm and the second clamping arm are misaligned and buckled with each other, which will not interfere with / affect the included angle between the clamping arms, and is beneficial to capturing and clamping the valve leaflets. When the valve clip needs to be locked, one end of the locking rod moves axially along the connecting piece towards the distal end until one end of the locking rod completes the locking fit with the locking area, that is, the locking is completed; using the lever principle, a moment balance is generated between one end of the locking rod and the locking part, controlling the included angle between the first clamping arm and the second clamping arm from increasing further, achieving the locking effect. At the same time, the locking structure is a mechanical locking, with a simple structure, simple operation and no fatigue risk, and can ensure its clamping effect for a long time;

[0029] 4. Different from the prior art, in the present invention, no matter whether the valve clip is in the first form or the second form or in the process of converting between the two forms, one end of the telescopic sleeve is always connected to the connecting piece. The purpose of this design is that when the included angle between the clamping arms of the valve clip gradually increases, the telescopic sleeve improves the structural stability of the valve clip and avoids the valve clip shaking left and right in the heart during operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figures 1a - 1d It is a schematic diagram of the overall structure of a valve clip for easy loading and transportation according to the present invention.

[0031] Figures 2a - 2f It is a schematic diagram of the structure of the telescopic sleeve according to the present invention.

[0032] Figures 3a - 3c It is a schematic diagram of the structure of the locking device according to the present invention.

[0033] Figures 4a - 4c It is a schematic diagram of the structure of the clamping arm according to the present invention

[0034] Figures 5a - 5d It is a schematic diagram of the structure of the locking part and the principle diagram of the locking head locking the clamping arm.

[0035] Figures 6a - 6f It is a schematic diagram of the structure of the connecting piece and the self-locking structure according to the present invention.

[0036] Figures 7a - 7c It is a schematic diagram of the structure of the buckling connection between the disassembly part and the connection part according to the present invention.

[0037] Figures 8a - 8gSchematic diagram of the process of the delivery catheter of the present invention entering the heart.

[0038] Figures 9a - 9c Schematic diagram of the process of the valve clip of the present invention opening in the left atrium.

[0039] Figures 10a - 10h Schematic diagram of the process of the valve clip of the present invention moving to the optimal anchoring position.

[0040] The names of the parts referred to by the numbers in the drawings are as follows: 1 - clamping arm, 11 - first clamping arm, 12 - second clamping arm, 111 - short arm, 112 - long arm, 1111 - first locking part, 1112 - arc segment, 1211 - second locking part, 2 - linkage rod, 21 - first linkage rod, 22 - second linkage rod, 3 - connecting piece, 31 - connecting block, 311 - through hole, 312 - installation groove, 32 - connecting ear, 4 - locking device, 41 - self-locking rod, 42 - locking head, 43 - inner disassembly part, 5 - telescopic sleeve, 51 - first sleeve, 511 - first limiting part, 52 - second sleeve, 521 - second limiting part, 522 - third limiting part, 53 - third sleeve, 54 - outer disassembly part, 55 - anti-detachment structure, 6 - delivery catheter, 61 - first delivery tube, 62 - second delivery tube, 63 - central control part, 611 - first release part, 621 - second release part, 64 - first disassembly part, 65 - second disassembly part, 7 - self-locking structure, 71 - limiting member, 72 - locking member. Detailed Description of the Invention

[0041] The present invention will be further described in detail below with reference to the drawings and embodiments.

[0042] The proximal end of the present invention refers to the end close to the surgeon, and the distal end refers to the end far from the surgeon. Specific Embodiment:

[0044] The present invention will be further described in detail below with reference to the drawings and embodiments.

[0045] The proximal end of the present invention refers to the end close to the surgeon, and the distal end refers to the end far from the surgeon. Specific Embodiment 1:

[0047] When used for the treatment of mitral valve diseases, such as Figures 1a - 1dAs shown, a valve clip that is convenient for loading and conveying includes a telescopic sleeve 5, a connecting piece 3 connected to one end of the telescopic sleeve 5, clamping arms 1, and a linkage rod 2. The clamping arms 1 are connected to the connecting piece 3. One end of the linkage rod 2 is connected to the telescopic sleeve 5, and the other end of the linkage rod 2 is connected to one end of the clamping arm 1. The valve clip has a first form and a second form. When the valve clip is in the first form (i.e., the form when the valve clip is loaded), the angle between the clamping arms 1 is the smallest, the linkage rod 2 fits against the clamping arm 1, and the telescopic sleeve 5 is in a compressed form. This is beneficial for the valve clip to cope with various bending degrees in the blood vessel during loading and conveying, and will not scrape or damage the blood vessel wall. When the valve clip changes from the first form to the second form, the telescopic sleeve 5 gradually elongates, driving the angle between the clamping arms 1 to gradually increase so as to facilitate the linkage rod 2 to capture the autologous valve leaf. At the same time, the telescopic sleeve 5 provides sufficient support force for the valve clip. The telescopic sleeve 5, the connecting piece 3, the clamping arms 1, and the linkage rod 2 are all made of rigid materials. The advantage of this design is that when the stroke of the telescopic sleeve 5 changes, the structure of the entire valve clip has good support and will not deform during the operation, which is beneficial for the surgical operation. On the other hand, it can ensure a lasting clamping force and will not cause problems such as fatigue. When the valve clip has completed capturing the autologous valve leaf, the telescopic sleeve 5 shortens again to the compressed form, and the valve clip returns from the second form to the first form. The structure of the telescopic sleeve 5 with layers stacked makes the valve clip have a better anti-leakage effect.

[0048] Next, the composition and connection method of each component of the valve clip with a shortened loading stroke of the present invention will be described in detail with reference to the accompanying drawings;

[0049] In this embodiment, the telescopic sleeve 5 is composed of several sleeves, and an anti-disconnection structure 55 is provided between adjacent sleeves, as Figure 2a shown.

[0050] In this embodiment, when the telescopic sleeve 5 is in the compressed form, the length of the telescopic sleeve 5 is the length of the outermost sleeve (i.e., the third sleeve 53), as Figure 2a shown.

[0051] In this embodiment, regardless of whether the valve clip is in the first form or the second form or in the process of converting between the two forms, one end of the telescopic sleeve 5 is always connected to the connecting piece 3.

[0052] In this embodiment, the innermost sleeve (i.e., the first sleeve 51) of the telescopic sleeve 5 is connected to the connecting member 3. The clamping arm 1 includes a first clamping arm 11 and a second clamping arm 12. The linkage rod 2 includes a first linkage rod 21 and a second linkage rod 22. The first clamping arm 11 and the second clamping arm 12 are respectively hinged to the connecting member 3 and are arranged on the left and right sides of the telescopic sleeve 5. One end of the first linkage rod 21 is hinged to the first clamping arm 11, and the other end of the first linkage rod 21 is hinged to the outermost sleeve of the telescopic sleeve 5. One end of the second linkage rod 22 is hinged to the second clamping arm 12, and the other end of the second linkage rod 22 is hinged to the outermost sleeve of the telescopic sleeve 5.

[0053] In this embodiment, the telescopic sleeve 5 includes a first sleeve 51, a second sleeve 52, and a third sleeve 53. The second sleeve 52 is sleeved between the first sleeve 51 and the third sleeve 53. The first sleeve 51 is connected to the connecting member 3, and the third sleeve 53 is connected to the linkage rod 2 (as Figures 2a - 2c shown). A first limiting member 511 radially outward is provided at the proximal end of the first sleeve 51. A second limiting member 521 radially outward is provided at the proximal end of the second sleeve 52. A third limiting member 522 radially inward is further provided at the distal end of the second sleeve 52. A fourth limiting member 532 radially inward is provided at the proximal end of the third sleeve 53, as Figures 2d - 2f shown.

[0054] In this embodiment, the shortest stroke of the telescopic sleeve 5 is the length of the third sleeve 53. The length of the second sleeve 52 is less than the length of the third sleeve 53, and the length of the first sleeve 51 is less than the length of the third sleeve 53, as Figure 2a shown; The advantage of such a design is that when the telescopic sleeve 5 is shortened to the shortest stroke, the first sleeve 51 and the second sleeve 52 will not exceed the third sleeve 53, thereby increasing the length of the telescopic sleeve 5 in the body and avoiding scraping and damage to the heart valve and the tissues in the heart.

[0055] In this embodiment, the valve clip further includes a locking device 4, as Figures 3a - 3c shown. The locking device 4 includes a self-locking rod 41 and a locking head 42 connected to the connecting member 3. The clamping arm 1 includes a long arm and a short arm, as Figure 4a and 4bAs shown, a locking portion 1111 is provided at one end of the short arm 111. When the locking device 4 is axially moved to make the long arms 112 of the first clamping arm 11 and the long arms 122 of the second clamping arm 12 open with an increased included angle, the locking portion on the first clamping arm 11 and the locking portion on the second clamping arm 12 (i.e., the first locking portion 1111 and the second locking portion 1211) are in a misaligned mating state, as Figure 5a and 5b shown; when the locking device 4 is axially moved to make the long arms 112 of the first clamping arm 11 and the long arms 122 of the second clamping arm 12 close with a decreased included angle, the self-locking rod 41 is moved so that the locking head 42 and the locking portion (i.e., the first locking portion 1111 and the second locking portion 1211) are mated and locked, as Figure 5c and 5d shown.

[0056] In this embodiment, the length of the locking device 4 is less than the length of the third sleeve 53; this avoids increasing the length when the valve clip is implanted into the heart, thereby scraping the heart tissue.

[0057] In this embodiment, the short arm 111 is in an arc shape or an "L" shape. When the included angle between the first clamping arm 11 and the second clamping arm 12 increases, the first locking portion 1111 and the second locking portion 1211 are misaligned and mated, as Figure 5b shown.

[0058] In another embodiment, when the valve clip captures the valve leaflet, the telescopic sleeve 5 is stretched to the target stroke, enters from the left atrium to below the left ventricle and captures the valve leaflet. At this time, there may be a problem of angle adjustment. The telescopic sleeve 5 can be stretched to the maximum stroke, and the first clamping arm 11 and the second clamping arm 12 cooperate with the first linkage rod 21 and the second linkage rod 22 to form a rhombus structure with the telescopic sleeve 5, as Figure 1d shown, which is convenient for the valve prosthesis to be withdrawn from the complex environment below the mitral valve, and at the same time will not hook the chordae tendineae or valve leaflets, avoiding damage to the heart tissue; since the telescopic sleeve 5, the adapter 3, the clamping arm 1, and the linkage rod 2 are all made of rigid materials, when the stroke of the telescopic sleeve 5 changes, problems such as deformation will not occur due to insufficient support strength, which is more conducive to operation. On the other hand, a lasting clamping force can be ensured, and problems such as fatigue will not occur.

[0059] In this embodiment, as Figures 6a - 6bAs shown, a through hole 311 and a mounting groove 312 are axially provided on the connecting block 31. The mounting groove 312 is arranged on the distal side of the through hole 311. Internal threads are provided in the through hole 311, and external threads that are screwed in cooperation with the internal threads are provided on the distal side of the locking rod 43. During loading and conveying, the locking head 41 is located in the mounting groove 312. The maximum diameter of the locking head 41 is greater than the diameter of the through hole 311. The diameter of the mounting groove 312 is greater than the diameter of the through hole 311. The locking head 41 is restricted from moving proximally by the through hole 311.

[0060] In this embodiment, the valve clip further includes a self-locking structure 7. The self-locking structure 7 includes a limiting member 71 provided on the connecting member 3 and a locking member 72 provided on the outermost sleeve of the telescopic sleeve 5. As Figures 6c - 6f shown, when the valve clip is in the first form, the locking member 72 cooperates with the limiting member 71 to achieve self-locking.

[0061] In this embodiment, the limiting member 71 is a self-expanding structure. As Figures 6d - 6f shown, the limiting member 71 deforms as the locking member 72 moves distally. The limiting member 71 is in a diamond shape, a triangular shape or other shapes. The locking member 72 is in a diamond shape, a triangular shape or other shapes. The shapes of the limiting member 71 and the locking member 72 cooperate with each other to achieve locking.

[0062] In this embodiment, the valve clip further includes a valve clip delivery system. The valve clip delivery system includes a control handle (not labeled), a first delivery tube 61, a central control member 63 and a second delivery tube 62 connected to the control handle (not labeled). Detachable connection mechanisms (i.e., an internal detachable portion 43 and an external detachable portion 54) are provided on both the self-locking rod 41 and the outermost sleeve of the telescopic sleeve 5 (i.e., the third sleeve 53). Detachable connection mechanisms (i.e., a first release portion 611 and a second release portion 621) that cooperate with the detachable connection mechanism are provided on the distal portions of the first delivery tube 61 and the second delivery tube 62. During preloading, the internal detachable portion 43 is connected to the first release portion 611 through the central control member 63 to form a first detachable portion 64. The external detachable portion 54 of the telescopic sleeve 5 is connected to the second release portion 621 through the central control member 63 to form a second detachable portion 65. When the central control member 63 moves away from the first detachable portion 64 and the second detachable portion 65, the first delivery tube 61 is detached from the self-locking rod 41, and the second delivery tube 62 is detached from the outermost sleeve (third sleeve 53) of the telescopic sleeve 5. As Figures 7a - 7c shown.

[0063] The working principle of the present invention is:

[0064] 1. Operate the valve clip delivery catheter 6 to enter the heart from the inferior vena cava, and then operate the delivery catheter 6 to make the valve clip pass through the atrial septum, as Figures 8a - 8e shown; continue to operate the delivery catheter 6 to bend so that the valve clip faces the mitral valve, as Figure 8f and 8g shown;

[0065] 2. Operate the control handle to retract the outer sheath so that the valve clip is exposed in the left atrium. Gradually increase the stroke of the telescopic sleeve 5 to the target stroke by operating the control handle, as Figures 9a - 9c shown;

[0066] 3. Operate the control handle to make the valve clip pass through the mitral valve, as Figure 10a shown. When the valve clip is anchored to the native valve leaflet, the native valve leaflet is located on the linkage rod 2. Judge whether the valve clip is in the optimal anchoring position through imaging. If it is the optimal position, directly proceed to step 5; if it is not the optimal position, proceed to step 4;

[0067] 4. Operate the control handle to stretch the telescopic sleeve 5 to the maximum stroke. The clamping arm 1 and the linkage rod 2 form an obtuse angle conforming to the physiological structure and cooperate with the telescopic sleeve 5 to form a rhombus structure, which is convenient for the valve clip to be withdrawn from the complex environment under the mitral valve, and at the same time will not hook the chordae tendineae or valve leaflets, avoiding damage to the intracardiac tissues; since the telescopic sleeve 5, the adapter 3, the clamping arm 1, and the linkage rod 2 are all made of rigid materials, the stroke of the telescopic sleeve 5 will not be deformed due to insufficient support strength when changing, which is more conducive to operation. Pull the valve clip into the left atrium, operate the control handle to rotate, and make the valve clip reach the optimal anchoring position, as Figures 10b - 10h shown;

[0068] 5. Operate the control handle to shorten the telescopic sleeve 5 to the shortest stroke again until the linkage rod 2 is between the clamping arm 1 and the telescopic sleeve 5 and tightly fits the clamping arm 1. The native valve leaflet is clamped between the telescopic sleeve 5 and the linkage rod 2;

[0069] 6. Operate the self-locking lever 41 to axially move along the adapter 3. When the locking head 42 enters the locking area, the locking head 42 completes the locking cooperation with the locking part (the first locking part 1111 and the second locking part 1211), achieving the purpose of locking the valve clip, as Figure 5d shown;

[0070] 7. When operating the central control member 63 to move proximally, the first disassembly part 64 and the second disassembly part 65 are separated successively / simultaneously, as Figure 7b shown.

[0071] The above content is only a preferred embodiment of the present invention. For those of ordinary skill in the art, based on the idea of the present invention, there will be changes in the specific implementation manner and application scope. The content of this specification should not be construed as a limitation on the present invention.

Claims

1. A valve clip facilitating loading and conveying, characterized in that: It includes a telescopic sleeve, a connecting piece connected to one end of the telescopic sleeve, clamping arms, and linkage rods. The clamping arms are connected to the connecting piece. One end of the linkage rod is connected to the outermost sleeve of the telescopic sleeve, and the other end of the linkage rod is connected to one end of the clamping arm. The valve clip has a first form and a second form. When the valve clip is in the first form, the angle between the clamping arms is the smallest, the linkage rod fits against the clamping arm, and the telescopic sleeve is in a compressed form. When the valve clip changes from the first form to the second form, the telescopic sleeve gradually elongates, driving the angle between the clamping arms to gradually increase so as to facilitate the linkage rod to capture the autologous valve leaf. When the valve clip has completed capturing the autologous valve leaf, the telescopic sleeve shortens again to the compressed form, and the valve clip returns from the second form to the first form. The telescopic sleeve is composed of several sleeves, and an anti-detachment structure is provided between adjacent sleeves. The innermost sleeve of the telescopic sleeve is connected to the connecting piece.

2. The valve clip facilitating loading and conveying according to claim 1, characterized in that: When the telescopic sleeve is in the compressed form, the length of the telescopic sleeve is the length of the outermost sleeve.

3. The valve clip facilitating loading and conveying according to claim 1, characterized in that: Regardless of whether the valve clip is in the first form, the second form, or in the process of converting between the two forms, one end of the telescopic sleeve is always connected to the connecting piece.

4. The valve clip facilitating loading and conveying according to claim 2, characterized in that: The clamping arms include a first clamping arm and a second clamping arm, and the linkage rods include a first linkage rod and a second linkage rod. The first clamping arm and the second clamping arm are respectively hinged to the connecting piece and are arranged on the left and right sides of the telescopic sleeve. One end of the first linkage rod is hinged to the first clamping arm, and the other end of the first linkage rod is hinged to the outermost sleeve of the telescopic sleeve. One end of the second linkage rod is hinged to the second clamping arm, and the other end of the second linkage rod is hinged to the outermost sleeve of the telescopic sleeve.

5. The valve clip facilitating loading and conveying according to claim 1, characterized in that: The valve clip further includes a self-locking structure, which includes a limiting member provided on the connecting piece and a locking member provided on the outermost sleeve of the telescopic sleeve. When the valve clip is in the first form, the locking member cooperates with the limiting member to achieve self-locking.

6. The valve clip facilitating loading and conveying according to claim 4, characterized in that: The valve clip further includes a locking device, which includes a self-locking rod and a locking head connected to the connecting piece. The clamping arm includes a long arm and a short arm. A locking portion is provided at one end of the short arm. When operating the locking device to axially move to make the included angle between the long arms of the first clamping arm and the second clamping arm become larger and in an open state, the locking portions on the first clamping arm and the second clamping arm are partially in a misaligned cooperation state. When operating the locking device to axially move to make the included angle between the long arms of the first clamping arm and the second clamping arm become smaller and in a closed state, move the self-locking rod so that the locking head and the locking portion are in cooperation and locked.

7. The valve clip facilitating loading and conveying according to claim 6, characterized in that: The form of the short arm is arc-shaped or "L"-shaped. When the included angle between the first clamping arm and the second clamping arm becomes larger, the short arms on the first clamping arm and the second clamping arm are in misaligned cooperation.

8. The valve clip facilitating loading and conveying according to claim 6, characterized in that: The valve clip further includes a valve clip delivery system, which comprises a control handle, a first delivery tube connected to the control handle, a central control member, and a second delivery tube. Detachable connection mechanisms are provided on both the self-locking rod and the outermost sleeve of the telescopic sleeve. Detachable release mechanisms that cooperate with the detachable connection mechanisms are provided at the distal portions of both the first delivery tube and the second delivery tube. During pre-installation, the detachable connection mechanism on the self-locking rod is connected to the detachable release mechanism on the first delivery tube through the central control member, serving as the first detachment portion, and the detachable connection mechanism on the outermost sleeve of the telescopic sleeve is connected to the detachable release mechanism on the second delivery tube through the central control member, serving as the second detachment portion. When the central control member moves away from the first detachment portion and the second detachment portion, the first delivery tube is detached from the self-locking rod, and the second delivery tube is detached from the outermost sleeve of the telescopic sleeve.

9. The valve clip facilitating loading and conveying according to claim 8, characterized in that: When relative displacement occurs between the first detachment portion and the second detachment portion, the relative position between the central control member and the first delivery tube always remains unchanged.

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