An integrally detachable valve clip and its delivery system

Abstract

The present invention relates to the field of medical devices, and particularly to a valve clip that can be integrally disassembled and its delivery system, which includes a control handle, a delivery catheter connected to the control handle, and a valve clip connected to the delivery catheter. The valve clip is provided with an inner tube and an outer connecting tube, and both the inner tube and the outer connecting tube are provided with detachable connection mechanisms. The delivery catheter includes a first delivery tube, a central control member, and a second delivery tube. 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 preloading, the detachable connection mechanism on the inner tube is connected to the detachable release mechanism on the first delivery tube through the central control member, serving as the first disassembly portion, and the detachable connection mechanism on the outer connecting tube 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 inner tube, and the second delivery tube is disengaged and separated from the outer connecting tube.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a valve clip that can be detachably integrated and its delivery system. Background Art

[0002] The mitral valve has a complex anatomical structure, 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. 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 therapy, surgical operation and interventional therapy. Drug therapy can only improve the symptoms of patients and cannot extend their survival time. Surgical operations mainly include 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 patients with severe functional MR 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 therapy is to load an artificial implant onto a delivery system outside the body, deliver it to the mitral annulus along the vascular path or through 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 therapy has become one of the research hotspots in the relevant field, and many products are under development. However, due to the complex structure of the mitral valve itself and its surrounding structures, etc., the development of mitral valve interventional devices faces many special difficulties.

[0004] Patent 201280044346.0 provides a method for fixing tissue, which 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 fastening surface located between the first end and the free end for binding tissue. The first ends are movably connected together such that the fixing elements can move between a closed position and a first open position. In the closed position, the fastening surfaces face each other, and in the first open position, the fastening surfaces are positioned away from each other. The detachable connection structure design between the delivery system and the valve clip is relatively complex, and situations such as difficult release may occur during actual operation.

[0005] Patent CN201880066104.9 discloses a valvular clip device, which includes 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 member components, which are coupled to the spacer member and configured to capture the leaflets between respective anchoring member components and the spacer member, such that the prosthetic device is held between the leaflets. When the leaflets are captured between the anchoring member components 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 retrogradely from the second chamber to the first chamber through the spacer member; after the valvular clip in this patent is implanted into the target position, the delivery system needs to first rotate the inner tube to disengage the inner tube from the threads on the valvular clip, then withdraw the inner tube proximally, and then flick the detachable component proximally to separate it from the valvular clip; its operation steps are relatively cumbersome. At the same time, the structural design of the detachable component is complex, with high requirements for the assembly process and great implementation difficulty.

[0006] In summary, the detachable connection structure design between the delivery system and the valvular clip in the prior art is relatively complex, with high requirements for the assembly process. At the same time, the complex structure further makes its operation process cumbersome. Summary of the Invention

[0007] The advantage of the present invention is to provide a valvular clip and its delivery system that can be disassembled integrally. The valvular clip has the following advantages: The delivery catheter will not damage the heart tissue when passing through the inferior vena cava and the atrial septum during the delivery of the valvular clip. The first delivery tube and the second delivery tube provide support for the movement of the valvular clip in the heart. After the leaflets are clamped and locked, the first delivery tube and the second delivery tube are disassembled and separated from the valvular clip, reducing the burden on the heart by the valvular clip and enabling the valvular clip to better maintain the leaflet clamping state.

[0008] To solve the above technical problems, the present invention is solved by the following technical solutions:

[0009] An integrally detachable valve clip and its delivery system, comprising a control handle, a delivery catheter connected to the control handle, and a valve clip connected to the delivery catheter. The valve clip is provided with an inner tube and an outer connecting tube, and both the inner tube and the outer connecting tube are provided with detachable connection mechanisms. The delivery catheter includes a first delivery tube, a central control member, and a second delivery tube. 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 inner tube is connected to the detachable release mechanism on the first delivery tube through the central control member, serving as the first detachable portion. The detachable connection mechanism on the outer connecting tube is connected to the detachable release mechanism on the second delivery tube through the central control member, serving as the second detachable portion. When the central control member moves away from the first and second detachable portions, the first delivery tube is disengaged and separated from the inner tube, and the second delivery tube is disengaged and separated from the outer connecting tube.

[0010] The present invention can be further realized by the following technical solutions:

[0011] In one embodiment, the valve clip further includes an adapter, a first clamping arm, a second clamping arm, a first linkage rod, and a second linkage rod. The first clamping arm and the second clamping arm are hinged to the adapter and are arranged on the left and right sides of the outer connecting tube. The adapter is connected to the inner tube. One end of the first linkage rod is connected to the first clamping arm, and the other end of the first linkage rod is connected to the outer connecting tube. One end of the second linkage rod is connected to the second clamping arm, and the other end of the second linkage rod is connected to the outer connecting tube.

[0012] In one embodiment, when relative displacement occurs between the first detachable portion and the second detachable portion, the relative position between the central control member and the inner tube always remains unchanged; when relative displacement occurs between the first detachable portion and the second detachable 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 inner tube always remains unchanged can ensure that during the opening and closing process of the valve clip, the first detachable portion will not be prematurely disassembled. 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.

[0013] In one embodiment, the central control member restricts the relative radial displacement between the detachable connection mechanism and the detachable release mechanism to prevent the detachable connection mechanism from disengaging from the detachable release mechanism.

[0014] In one embodiment, when the detachable release mechanism is connected to the detachable connection mechanism, the outer peripheral surfaces of the first detachable portion and the second detachable portion are closed.

[0015] In one embodiment, the detachable connecting mechanism includes a first connecting section, a second connecting section and an inclined section, and the inclined section is arranged between the first connecting section and the second connecting section; the inclined section can make the detachable connecting mechanism and the releasable connecting mechanism smoother when disassembling and separating, effectively avoiding unnecessary hooking between the two during the disassembly process, thereby causing separation failure.

[0016] In one embodiment, the inclined section includes an inclined surface, and an angle between the inclined surface and the central axis of the inner tube is between 0° and 90°.

[0017] In a preferred embodiment, the smaller the included angle between the inclined surface and the central axis of the inner tube, the smoother the disassembly of the detachable connecting mechanism and the releasable connecting mechanism.

[0018] In one embodiment, the middle control is a pipe fitting, and the wall thickness of the middle control is greater than or equal to half of the radial distance between the first connecting section and the second connecting section on the detachable connecting mechanism of the inner tube. The advantage of this is that there will be no interference when the detachable connecting mechanism on the inner tube is separated from the detachable connecting mechanism on the first conveying tube.

[0019] In one embodiment, the detachable connecting mechanism and the releasable connecting mechanism are in a centrally symmetrical relationship. This has the advantage of making the detachable connecting mechanism and the releasable connecting mechanism more tightly engaged, and the connection between the two is more stable and reliable.

[0020] In one embodiment, when the releasable connection mechanism is connected to the detachable connection mechanism through the middle control, the first delivery tube and the second delivery tube can transmit torque and pushing force to the inner tube and the outer connecting rod tube respectively.

[0021] In one embodiment, on the axial cross section of the delivery catheter, the first detachment portion and the second detachment portion are at the same position or at different positions.

[0022] In another embodiment, the detachable connecting mechanism and the releasable connecting mechanism are in a “concave” shape, a “convex” shape, a “U” shape or other shapes.

[0023] In another embodiment, the detachable connection mechanism of the inner tube is in an outwardly expanded state in a natural state, and the detachable connection mechanism of the outer connecting rod is in a retracted state in a natural state.

[0024] In one embodiment, the inner tube 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 the inner tube is axially moved to make the included angle between the long arms of the first clamping arm and the second clamping arm increase to an open state, the locking portions on the first clamping arm and the second clamping arm are partially in a misaligned mating state. When the inner tube is axially moved to make the included angle between the long arms of the first clamping arm and the second clamping arm decrease to a closed state, the self-locking rod is moved so that the locking head and the locking portion are engaged and locked.

[0025] In one embodiment, the locking head is a bracket-shaped self-expanding structure, and the locking head and the locking portion cooperate to achieve locking.

[0026] In a preferred embodiment, the self-locking rod is a solid rod. The advantage of this design is that it enhances the strength of the inner tube and avoids the breakage between the detachable connection mechanism on the inner tube and the releasable connection mechanism on the first delivery tube during locking of the valve clip, resulting in locking failure.

[0027] In another embodiment, the self-locking rod can be a hollow rod. Such a design can reduce the weight of the entire valve clip device.

[0028] In one embodiment, the inner tube, the outer connecting tube, the central control member, the connecting piece, the clamping arm, and the linkage rod are all made of rigid materials. The advantage of this design is that when the central control member and the outer connecting tube move axially, the structure of the entire implantable prosthesis has good support and will not deform during the operation, which is beneficial to surgical operation. On the other hand, it can ensure a lasting clamping force and will not cause problems such as fatigue.

[0029] Compared with the prior art, the advantages of the present invention are as follows:

[0030] 1. Different from the prior art, when the delivery system of the present invention is pre-loaded, the central control member restricts the relative radial displacement between the detachable release mechanism and the releasable connection mechanism to prevent the detachable release mechanism from detaching from the releasable connection mechanism. When the central control member is operated away from the first disassembly portion and the second disassembly portion, the circumferential position restriction of the releasable connection mechanism is lost, causing the first disassembly portion and the second disassembly portion to be separated sequentially / simultaneously. The structural design is simple and very ingenious, and only by moving the central control member can the two connection structures be disassembled one by one / simultaneously.

[0031] 2. Different from the prior art, the detachable connection mechanism and the releasable connection mechanism of the present invention are in a centrosymmetric relationship, making the engagement between the detachable connection mechanism and the releasable connection mechanism closer and the connection between the two more stable and reliable.

[0032] 3. Different from the prior art, the present invention is provided with an inclined section, making the detachable connection mechanism and the releasable connection mechanism more smooth when disassembling and separating, effectively avoiding the accident that they cannot be normally separated due to unnecessary hook connection or interference between the two during the disassembly process;

[0033] 4. 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 buckled in a dislocation manner, without interfering with / influencing the included angle size between the clamping arms, which is beneficial to capturing and clamping the leaflets. When the valve clip needs to be locked, the inner tube moves axially along the connecting piece towards the distal end until one end of the inner tube completes the locking fit with the fixed area, that is, the locking is completed; using the lever principle, a moment balance is generated between the locking head on the inner tube 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;

[0034] 5. Different from the prior art, when the first disassembly part and the second disassembly part have relative displacement, the opening and closing of the valve clip can be controlled, and the relative positions of the central control part and the inner tube always remain unchanged, which can ensure that the first disassembly part will not be disassembled in advance during the opening and closing process of the valve clip. At the same time, the central control part fills the gaps between the first delivery tube and the inner tube, and the second delivery tube and the outer connecting tube, making the whole device more stable during operation. When the first disassembly part is disassembled, the first delivery tube can be withdrawn from the body along the pipeline of the central control part. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figures 1a to 1e is a schematic diagram of the overall structure of the integrally detachable valve clip of the present invention, where Figures 1c to 1d is a schematic diagram of the process of the disassembly part of the valve clip realizing disassembly.

[0036] Figures 2a to 2g is a schematic diagram of the structure of the releasable connection mechanism and the detachable connection mechanism of the present invention.

[0037] Figures 3a to 3g is a schematic diagram of the structure of the inner tube of the present invention.

[0038] Figures 4a to 4f is a schematic diagram of the relationship between various mechanisms of the present invention and the structure of the clamping arm.

[0039] Figures 5a to 5b is a schematic diagram of the structure of the connecting piece of the present invention.

[0040] Figures 6a to 6h is another embodiment of the integrally detachable valve clip of the present invention.

[0041] Figures 7a to 7g This is a schematic diagram of the process of the delivery catheter of the present invention entering the heart.

[0042] Figures 8a to 8c This is a schematic diagram of the process of the valve clip of the present invention opening in the left atrium.

[0043] Figures 9a to 9h This is a schematic diagram of the process of the valve clip of the present invention moving to the optimal position for capturing the valve.

[0044] The names of the parts referred to by the numbers in the drawings are as follows: 1 - clamping arm, 11 - first clamping arm, 111 - first locking part, 12 - second clamping arm, 121 - second locking part, 13 - fixing area, 14 - long arm, 15 - short arm, 2 - linkage rod, 21 - first linkage rod, 22 - second linkage rod, 3 - connecting piece, 31 - connecting block, 311 - through hole, 312 - mounting groove, 32 - connecting ear, 4 - inner tube, 41 - self-locking rod, 42 - locking head, 43 - inner detachable connection mechanism, 5 - outer connecting tube, 51 - outer detachable connection mechanism, 6 - delivery catheter, 61 - first delivery tube, 62 - second delivery tube, 63 - central control part, 611 - first releasable connection mechanism, 621 - second releasable connection mechanism, 612 - first disassembly part, 622 - second disassembly part, 71 - first connection segment, 72 - second connection segment, 73 - inclined segment, 731 - inclined surface, 8 - valve clip. Detailed implementation mode

[0045] The present invention will be further described in detail below in conjunction with the drawings and embodiments.

[0046] In the present invention, the proximal end refers to the end close to the surgeon, and the distal end refers to the end far from the surgeon. Specific embodiment 1:

[0048] A valve clip 8 and its delivery system that can be detachably integrated, as Figures 1a to 1eAs shown, it includes a control handle, a delivery catheter 6 connected to the control handle, and a valve clip 8 connected to the delivery catheter 6. The valve clip 8 is provided with an inner tube 4 and an outer connecting tube 5. Both the inner tube 4 and the outer connecting tube 5 are provided with detachable connection mechanisms. The delivery catheter 6 includes a first delivery tube 61, a central control member 63, and a second delivery tube 62. Detachable release mechanisms that cooperate with the detachable connection mechanisms are provided at the distal portions of both the first delivery tube 61 and the second delivery tube 62. During pre-installation, the inner detachable connection mechanism 43 on the inner tube 4 is connected to the first detachable release mechanism 611 on the first delivery tube 61 through the central control member 63, serving as the first disassembly portion 612. The outer detachable connection mechanism 51 on the outer connecting tube 5 is connected to the second detachable release mechanism 621 on the second delivery tube 62 through the central control member 63, serving as the second disassembly portion 622. When the central control member 63 moves away from the first disassembly portion 612 and the second disassembly portion 622, the first delivery tube 61 is disengaged and separated from the inner tube 4, and the second delivery tube 62 is disengaged and separated from the outer connecting tube 5.

[0049] Next, the composition and connection methods of the components of the integrally detachable valve clip 8 delivery system of the present invention will be described in detail with reference to the accompanying drawings;

[0050] In this embodiment, as Figure 1b shown, the valve clip 8 further includes a connecting member 3, a first clamping arm 11, a second clamping arm 12, a first linkage rod 21, and a second linkage rod 22. The first clamping arm 11 and the second clamping arm 12 are hinged to the connecting member 3 and are arranged on the left and right sides of the outer connecting tube 5. The connecting member 3 is connected to the inner tube 4. One end of the first linkage rod 21 is connected to the first clamping arm 11, and the other end of the first linkage rod 21 is connected to the outer connecting tube 5. One end of the second linkage rod 22 is connected to the second clamping arm 12, and the other end of the second linkage rod 22 is connected to the outer connecting tube 5.

[0051] In this embodiment, when the first disassembly portion 612 and the second disassembly portion 622 undergo relative displacement, the relative position between the central control member 63 and the inner tube 4 always remains unchanged; when the first disassembly portion 612 and the second disassembly portion 622 undergo relative displacement, the opening and closing of the valve clip can be controlled, and the fact that the relative position between the central control member 63 and the inner tube 4 always remains unchanged can ensure that during the opening and closing process of the valve clip, the first disassembly portion 612 will not be disassembled in advance. At the same time, the central control member 63 fills the gaps between the first delivery tube 61 and the inner tube 4, and between the second delivery tube 62 and the outer connecting tube 5, making the entire device more stable during operation.

[0052] In this embodiment, the central control member 63 restricts the relative radial displacement between the detachable connection mechanism (referring to the inner detachable connection mechanism 43 and the outer detachable connection mechanism 51) and the releasable connection mechanism (referring to the first releasable connection mechanism 611 and the second releasable connection mechanism 621) to prevent the detachable connection mechanism from detaching from the releasable connection mechanism; and when the releasable connection mechanism (referring to the first releasable connection mechanism 611 and the second releasable connection mechanism 621) is connected to the detachable connection mechanism (referring to the inner detachable connection mechanism 43 and the outer detachable connection mechanism 51), the outer peripheral surfaces of the first disassembly portion 612 and the second disassembly portion 622 are closed, as Figures 2a to 2e shown.

[0053] In this embodiment, the detachable connection mechanism (referring to the inner detachable connection mechanism 43 and the outer detachable connection mechanism 51) includes a first connection segment 71, a second connection segment 72, and an inclined segment 73, as Figure 2f shown (in the figure, L is the radial distance between the first connection segment 71 and the second connection segment 72), and the inclined segment 73 is arranged between the first connection segment 71 and the second connection segment 72; the inclined segment 73 can make the detachable connection mechanism (referring to the inner detachable connection mechanism 43 and the outer detachable connection mechanism 51) and the releasable connection mechanism (referring to the first releasable connection mechanism 611 and the second releasable connection mechanism 621) more smooth during disassembly separation, effectively avoiding unnecessary snagging between the two during the disassembly process, resulting in separation failure.

[0054] In this embodiment, the central control member 63 is a pipe fitting, and the wall thickness h of the central control member 63 is greater than or equal to half of the radial distance L between the first connection segment and the second connection segment of the detachable connection mechanism 43 of the inner pipe 4, as Figure 1c shown, to avoid interference due to insufficient space when the detachable connection mechanism (referring to the inner detachable connection mechanism 43 and the outer detachable connection mechanism 51) is separated from the releasable connection mechanism (referring to the first releasable connection mechanism 611 and the second releasable connection mechanism 621).

[0055] In this embodiment, the inclined segment 73 includes an inclined surface 731, and the angle between the inclined surface 731 and the central axis of the inner pipe 4 is between 0° and 90°, as Figure 2g shown.

[0056] In this embodiment, the detachable connection mechanism (referring to the inner detachable connection mechanism 43 and the outer detachable connection mechanism 51) and the releasable connection mechanism (referring to the first releasable connection mechanism 611 and the second releasable connection mechanism 621) are centrosymmetric, as Figure 2e making the detachable connection mechanism and the releasable connection mechanism more tightly joined when they are engaged, and the connection between the two is more stable and reliable.

[0057] In this embodiment, the first disassembly part 612 is located at the distal end of the second disassembly part 622. When the central control part 63 is operated to move towards the proximal end, the first disassembly part 612 and the second disassembly part 622 are separated in sequence. The advantage of this is that when the first disassembly part 612 and the second disassembly part 622 are separated, there is sufficient separation space for the releasable connection mechanisms (referring to the first releasable connection mechanism 611 and the second releasable connection mechanism 621), and the situation where the first releasable connection mechanism 611 and the second releasable connection mechanism 621 are hooked to each other will not occur.

[0058] In this embodiment, the inner tube 4 includes a self-locking rod 41 and a locking head 42 (as Figure 3a shown) connected to the connecting piece 3, the clamping arms include a long arm 14 and a short arm 15 (as Figure 4c shown), and a first locking part 111 (as Figure 4d shown) is provided at one end of the short arm 15. When the inner tube 4 is axially moved to make the included angle between the long arms 14 of the first clamping arm 11 and the second clamping arm 12 become larger and in an open state, the first locking part 111 on the first clamping arm 11 and the second locking part 121 on the second clamping arm 12 are in a misaligned mating state (as Figure 4a and 4b shown); when the outer connecting tube 5 is axially moved along the inner tube 4 to make the included angle between the long arms 14 of the first clamping arm 11 and the second clamping arm 12 become smaller and in a closed state (as Figure 4e shown), the self-locking rod 41 is moved so that the locking head 42 and the locking parts (referring to the first locking part 111 and the second locking part 121) are mated and locked (as Figure 4f shown); by using the lever principle, a moment balance is generated between the locking head 42 and the locking parts (referring to the first locking part 111 and the second locking part 121), controlling the included angle between the first clamping arm 11 and the second clamping arm 12 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.

[0059] In this embodiment, a fixed area 13 is formed between the locking parts (referring to the first locking part 111 and the second locking part 121) and the connecting piece 3, and the locking head 42 enters the fixed area 13 and completes the locking fit with the locking parts (referring to the first locking part 111 and the second locking part 121).

[0060] In this embodiment, the locking head 42 and the fixed area 13 are correspondingly arranged in a wedge structure or a conical structure or a trapezoidal structure or other shapes.

[0061] In this embodiment, the connecting member 3 includes a connecting block 31 and connecting ears 32 provided on the connecting block 31, as Figure 5a and 5b shown. The connecting block 31 is connected to the inner tube 4, and the connecting ears 32 are respectively hinged to the first clamping arm 11 and the second clamping arm 12. An axial through hole 311 and a mounting groove 312 are provided on the connecting block 31. The mounting groove 312 is provided on the distal side of the through hole 311. Internal threads are provided in the through hole 311, and external threads mating with the internal threads are provided on the distal side of the inner tube 4.

[0062] In this embodiment, the self-locking rod 41 is a solid rod, as Figure 3b shown. The advantage of such a design is that it enhances the strength of the inner tube 4 and avoids breakage between the detachable connection mechanism on the inner tube 4 and the releasable connection mechanism on the first delivery tube 61 during the locking process of the valve clip 8, resulting in locking failure.

[0063] In this embodiment, the cross-section of the locking head 42 in the axial direction is in a wedge shape or a conical shape or a trapezoidal shape or other shapes, as Figures 3c to 3g shown.

[0064] The working principle of the present invention is as follows:

[0065] 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 7a to 7e shown; continue to operate the delivery catheter 6 to bend so that the valve clip faces the mitral valve, as Figures 7f to 7g shown;

[0066] 2. Operate the control handle of the valve delivery catheter 6 to retract the outer sheath so that the valve clip is exposed in the left atrium, and operate the control handle to the position where the included angle between the first clamping arm 11 and the second clamping arm 12 is the largest, as Figures 8a to 8c shown;

[0067] 3. Operate the control handle to make the valve clip pass through the mitral valve, as Figure 9a shown, and judge whether the valve clip is in the optimal valve clamping 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;

[0068] 4. Operate the control handle to pull the valve clip back into the left atrium, as Figures 9b to 9d shown. The clamping arm 1 and the linkage rod 2 form an obtuse angle, which conforms to the physiological structure and will not damage tissues such as intracardiac chordae tendineae; operate the control handle to rotate and deliver the valve clip to the optimal valve clamping position, as Figures 9e to 9h shown;

[0069] 5. Operate the control handle to make the linkage rod 2 retract towards the outer connecting tube 5 until the valve leaflets are clamped between the linkage rod 2 and the outer connecting tube 5;

[0070] 6. Operate the inner tube 4 to move axially towards the distal end along the adapter 3 until the locking head 42 enters the fixed area 13 to achieve the locking of the valve clip, as Figure 4f shown;

[0071] 7. When the central control member 63 is operated to move proximally relative to the first delivery tube 61 and the second delivery tube 62, the releasable connection mechanism (referring to the first releasable connection mechanism 611 and the second releasable connection mechanism 621) is separated from the detachable connection mechanism (referring to the outer detachable connection mechanism 51 and the inner detachable connection mechanism 43), as Figure 1d shown. Specific Embodiment Two:

[0073] When used for the treatment of mitral valve diseases, as Figure 1a and 1b shown, it includes a control handle, a delivery catheter 6 connected to the control handle, and a valve clip 8 connected to the delivery catheter 6. The valve clip 8 is provided with an inner tube 4 and an outer connecting tube 5. Both the inner tube 4 and the outer connecting tube 5 are provided with detachable connection mechanisms. The delivery catheter 6 includes a first delivery tube 61, a central control member 63, and a second delivery tube 62. The distal portions of both the first delivery tube 61 and the second delivery tube 62 are provided with releasable connection mechanisms that cooperate with the detachable connection mechanisms. During pre-installation, the inner detachable connection mechanism 43 on the inner tube 4 is connected to the first releasable connection mechanism 611 on the first delivery tube 61 through the central control member 63, serving as the first disassembly portion 612. The outer detachable connection mechanism 51 on the outer connecting tube 5 is connected to the second releasable connection mechanism 621 on the second delivery tube 62 through the central control member 63, serving as the second disassembly portion 622. When the central control member 63 moves away from the first disassembly portion 612 and the second disassembly portion 622, the first delivery tube 61 is disengaged and separated from the inner tube 4, and the second delivery tube 62 is disengaged and separated from the outer connecting tube 5;

[0074] In this embodiment, in the natural state, the outer diameter of the releasable connection mechanism on the first delivery tube 61 is greater than the outer diameter of the detachable connection mechanism on the inner connecting tube (as Figure 6c shown), and the outer diameter of the releasable connection mechanism on the second delivery tube 62 is smaller than the outer diameter of the detachable connection mechanism on the outer connecting tube 5 (as Figure 6fAs shown, when the central control member 63 is located between the first delivery pipe 61 and the second delivery pipe 62, the first delivery pipe 61 is compressed by the central control member 63 such that the detachable connection mechanism on the first delivery pipe 61 is buckled with the inner detachable connection mechanism 43 on the inner pipe 4 to form a detachable connection, and the second delivery pipe 62 is expanded by the central control member 63 such that the detachable connection mechanism on the second delivery pipe 62 is buckled with the outer detachable connection mechanism 51 on the outer connection pipe 5 to form a detachable connection (as Figures 6c to 6h shown); when the central control member 63 moves proximally relative to the first delivery pipe 61 and the second delivery pipe 62, the detachable connection mechanism of the first delivery pipe 61 expands to its original form, and the detachable connection mechanism of the second delivery pipe 62 retracts to its original form, and the detachable connection mechanism is separated from the detachable connection mechanism (as Figure 6b shown).

[0075] In this embodiment, the first detachable connection mechanism 611 is compressed by the central control member 63 to form a detachable connection with the inner detachable connection mechanism 43. The outer diameter of the first detachable connection mechanism 611 is equal to the outer diameter of the inner detachable connection mechanism 43. After the first detachable connection mechanism 611 is engaged with the inner detachable connection mechanism 43, the surface is cylindrical, as Figures 6c to 6e shown.

[0076] In this embodiment, the second detachable connection mechanism 621 is expanded by the central control member 63 to form a detachable connection with the outer detachable connection mechanism 51. The outer diameter of the second detachable connection mechanism 621 is equal to the outer diameter of the outer detachable connection mechanism 51. After the second detachable connection mechanism 611 is engaged with the outer detachable connection mechanism 51, the surface is cylindrical, as Figures 6f to 6h shown.

[0077] In this embodiment, the valve clip 8 further includes an adapter 3, a first clamping arm 11, a second clamping arm 12, a first linkage rod 21 and a second linkage rod 22. The first clamping arm 11 and the second clamping arm 12 are hinged to the adapter 3 and are arranged on the left and right sides of the outer connection pipe 5. The adapter 3 is connected to the inner pipe 4. One end of the first linkage rod 21 is connected to the first clamping arm 11, and the other end of the first linkage rod 21 is connected to the outer connection pipe 5. One end of the second linkage rod 22 is connected to the second clamping arm 12, and the other end of the second linkage rod 22 is connected to the outer connection pipe 5.

[0078] In this embodiment, the inner pipe 4 includes a self-locking rod 41 and a locking head 42 connected to the adapter 3 (as Figure 3a shown), and the clamping arm includes a long arm 14 and a short arm 15 (as Figure 4cAs shown in the figure, a locking portion 111 is provided at one end of the short arm 15 (such as Figure 4d As shown in the figure, when the inner tube 4 is axially moved to make the long arms 14 of the first clamping arm 11 and the long arms 14 of the second clamping arm 12 open with an increased included angle, the locking portion 111 on the first clamping arm 11 and the locking portion 121 on the second clamping arm 12 are in a misaligned mating state (such as Figure 4a and 4b As shown in the figure); when the outer connecting tube 5 is axially moved along the inner tube 4 to make the long arms 14 of the first clamping arm 11 and the long arms 14 of the second clamping arm 12 close with a decreased included angle (such as Figure 4e As shown in the figure), the self-locking rod 41 is moved so that the locking head 42 and the locking portion (referring to the first locking portion 111 and the second locking portion 121) are engaged and locked (such as Figure 4f As shown in the figure); by using the lever principle, a moment balance is generated between the locking head 42 and the locking portion (referring to the first locking portion 111 and the second locking portion 121), controlling the included angle between the first clamping arm 11 and the second clamping arm 12 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.

[0079] In this embodiment, a fixed area 13 is formed between the locking portion (referring to the first locking portion 111 and the second locking portion 121) and the connecting member 3, and the locking head 42 enters the fixed area 13 and completes the locking cooperation with the locking portion (referring to the first locking portion 111 and the second locking portion 121).

[0080] In this embodiment, the locking head 42 and the fixed area 13 are correspondingly arranged in a wedge-shaped structure or a conical structure or a trapezoidal structure or other shapes.

[0081] The above content is only a preferred embodiment of the present invention. For those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation manners and application scopes. The content of this specification should not be construed as a limitation to the present invention.

Claims

1. A detachable valve clip and its delivery system, comprising a control handle, a delivery catheter connected to the control handle, and a valve clip connected to the delivery catheter, characterized in that: The valve clip is provided with an inner tube and an outer connecting tube, and the inner tube and the outer connecting tube are both provided with a detachable connecting mechanism. The delivery catheter includes a first delivery tube, a middle control and a second delivery tube. The first delivery tube is located in the second delivery tube, and the middle control is a hollow tube. The distal end portion of the first delivery tube and the distal end portion of the second delivery tube are both provided with a detachable connecting mechanism that cooperates with the detachable connecting mechanism. During pre-installation, the detachable connecting mechanism on the inner tube is connected to the detachable connecting mechanism on the first delivery tube through the middle control to form a first disassembly portion, and the detachable connecting mechanism on the outer connecting tube is connected to the detachable connecting mechanism on the second delivery tube through the middle control to form a second disassembly portion. The middle control fills the gap between the second delivery tube and the interior of the outer connecting tube and the first delivery tube and the outside of the inner tube. When the middle control moves away from the first disassembly portion and the second disassembly portion, the first delivery tube is detached from the inner tube, and the second delivery tube is detached from the outer connecting tube.

2. The integrally detachable valve clip and its delivery system according to claim 1, characterized in that: When the first disassembly portion and the second disassembly portion are relatively displaced, the relative positions of the center control and the inner tube remain unchanged.

3. The integrally detachable valve clip and its delivery system according to claim 1, characterized in that: On the axial cross-section of the delivery conduit, the first disassembly portion and the second disassembly portion are at the same position or different positions. When the middle control moves away from the first disassembly portion and the second disassembly portion respectively / simultaneously, the first delivery tube and the inner tube, and the second delivery tube and the outer connecting tube are also correspondingly released and separated in sequence / simultaneously.

4. The integrally detachable valve clip and its delivery system according to claim 1, characterized in that: The valve clip also includes a connecting piece, a first clamping arm, a second clamping arm, a first linkage rod and a second linkage rod. The first clamping arm and the second clamping arm are hinged to the connecting piece and are arranged on the left and right sides of the outer connecting tube. The connecting piece is connected to the inner tube, one end of the first linkage rod is connected to the first clamping arm, and the other end of the first linkage rod is connected to the outer connecting tube, one end of the second linkage rod is connected to the second clamping arm, and the other end of the second linkage rod is connected to the outer connecting tube.

5. The integrally detachable valve clip and its delivery system according to claim 1, characterized in that: The middle control limits the relative radial displacement between the detachable connecting mechanism and the releasable connecting mechanism to prevent the detachable connecting mechanism from being separated from the releasable connecting mechanism.

6. The integrally detachable valve clip and its delivery system according to claim 1, characterized in that: The detachable connecting mechanism includes a first connecting segment, a second connecting segment and an inclined segment, and the inclined segment is arranged between the first connecting segment and the second connecting segment.

7. The integrally detachable valve clip and its delivery system according to claim 6, characterized in that: The wall thickness of the middle control is greater than or equal to half of the radial distance between the first connecting section and the second connecting section on the detachable connecting mechanism of the inner tube.

8. The integrally detachable valve clip and its delivery system according to claim 1, characterized in that: When the releasable connection mechanism is connected to the detachable connection mechanism through the middle control, the first delivery pipe and the second delivery pipe can transmit torque and pushing force to the inner pipe and the outer connection pipe respectively.

9. The integrally detachable valve clip and its delivery system according to claim 4, characterized in that: The inner tube includes a self-locking rod and a locking head connected to the connecting piece, and the first clamping arm and the second clamping arm both include a long arm and a short arm, and a locking part is provided at one end of the short arm. When the inner tube is operated to move axially so that the opening angle of the long arm of the first clamping arm and the long arm of the second clamping arm becomes larger and is in an open state, the locking part on the first clamping arm and the locking part on the second clamping arm are in a partially staggered matching state; when the inner tube is operated to move axially so that the opening angle of the long arm of the first clamping arm and the long arm of the second clamping arm becomes smaller and is in a closed state, the self-locking rod is moved so that the locking head and the locking part are matched and locked.

10. The integrally detachable valve clip and its delivery system according to claim 9, characterized in that: The locking head is a stent-shaped self-expanding structure, and the locking head cooperates with the locking portion to achieve locking.

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