A valve clip with a locking mechanism

Abstract

This invention relates to the field of medical devices, and more particularly to a valve clip with a locking mechanism, comprising a first clamping arm, a second clamping arm, a connecting member, a push-pull device, and a locking device. The locking device partially cooperates with the connecting member, and includes a locking head and a self-locking rod. The connecting member is hinged to the first clamping arm and the second clamping arm respectively. The clamping arm includes a long arm and a short arm. One end of the long arm is hinged to the push-pull device, and one end of the short arm is provided with a locking part. When the push-pull device is operated to increase the angle between the long arms of the first and second clamping arms, the locking part on the first clamping arm and the locking part on the second clamping arm are partially misaligned. When the push-pull device is operated to decrease the angle between the long arms of the first and second clamping arms, the locking device is moved to allow the locking head to engage with the locking part and lock.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a valve clip with a locking mechanism. Background Technology

[0002] The mitral valve has a complex anatomy, comprising leaflets, annulus, chordae tendineae, and papillary muscles, each playing a crucial role in maintaining the function of the left and right ventricles. Any disease affecting the structural integrity and normal function of the leaflets, annulus, chordae tendineae, papillary muscles, and left ventricle can lead to severe mitral regurgitation (MR), which can cause left ventricular failure, pulmonary hypertension, atrial fibrillation, stroke, and death. According to the latest epidemiological data from the United States and other developed Western countries, mitral regurgitation is the leading cause of valvular disease in people over 65 years of age. While authoritative epidemiological data is currently unavailable in my country, the sheer number of mitral regurgitation patients in the country is undeniable given the aging population. Mitral regurgitation can be classified as degenerative MR or functional MR. Degenerative MR is caused by pathological changes in one or more of the leaflets, annulus, chordae tendineae, and papillary muscles; functional MR typically involves abnormal left ventricular function, such as annular enlargement, but the mitral valve itself is usually normal.

[0003] Currently, treatment options for mitral regurgitation (MR) mainly include medication, surgery, and interventional therapy. Medication can only improve symptoms but cannot prolong survival. Surgery, primarily valve repair or replacement, is widely recognized as the preferred treatment for mitral regurgitation and has been proven to alleviate symptoms and extend lifespan. However, for many elderly, high-risk patients with multiple systemic diseases, surgery carries high risks and offers little survival benefit. European data shows that the success rate for surgery in these patients is only 50%, and for those with severe functional MR, the success rate is as low as 16%. Therefore, transcatheter interventional mitral valve repair and replacement could theoretically benefit high-risk patients who cannot undergo surgery. Interventional therapy involves loading an artificial implant onto a delivery system outside the body, delivering it along a vascular pathway or through a puncture at the apex of the heart to the mitral valve annulus, and then releasing and fixing it to completely or partially replace the function of the original valve. Currently, mitral valve interventional therapy has become a hot research topic in this field, with numerous products under development. However, due to the complexity of the mitral valve itself and its surrounding structures, the development of mitral valve interventional devices faces many unique challenges.

[0004] Patent CN103826548A provides a method for fixing tissue, the method comprising: providing an implantable fixation device including a pair of fixation elements, each fixation element having a first end, a free end opposite to the first end, and an engagement surface located between the first end and the free end to engage tissue, the first ends being movably coupled together such that the fixation elements are movable between a closed position and a first open position, in which the engagement surfaces face each other, and in the first open position, the engagement surfaces are positioned away from each other; the locking mechanism of the patent includes one or more wedge-shaped elements, such as rolling elements; the rolling elements include a pair of barbell elements arranged on opposite sides of a stud, the barbell elements being operated by a release device with a hook end, the hook end resisting a spring to raise the barbell elements when an upward force is applied to the device through a locking line, the barbell elements being pulled upward along a sidewall or inclined surface. The mechanism releases the barbell from the stud by releasing the upward force on the barbell component via the hook end. The spring forces the component downward and weds the barbell component between the instrument surface and the stud, restricting the movement of the stud and locking the braking mechanism and distal components into place. The technical drawbacks of the MitraClip locking mechanism are: the locking structure design is relatively complex, requiring the cooperation of a rolling element, spring, locking line, wedge-shaped instrument surface, and stud, demanding high assembly standards; the spring is initially deformed under stress and returns to its original shape after the locking line is released, therefore the locking structure lacks reversibility. If an operational error occurs during surgery before valve clamping is completed, the locking mechanism cannot unlock, meaning the surgery has failed; postoperatively, with the implanted instrument remaining in the body, the spring will fatigue due to prolonged stress, affecting the valve clamping force, thus posing a safety hazard to the unlocking mechanism.

[0005] Patent CN201880066104.9 discloses a valvular clip device including a spacer member configured to be disposed between the leaflets of a natural heart valve located between the first and second chambers 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 their respective anchoring members and the spacer member, such that the prosthetic device is held between the leaflets. When the leaflet is captured between the anchoring member and the spacer member, the spacer member is configured to provide a flow path through the prosthesis between the first and second cavities, allowing blood to flow back from the second cavity to the first cavity via the spacer member. The patented technical solution uses pre-molded metal material to clamp and fix the native leaflet, which simplifies its transmission system. However, due to the lack of a reliable locking device and the continuous contraction and relaxation of the heart, the native leaflet is prone to slipping out between the spacer member and the anchoring member. Furthermore, using pre-molded metal material to clamp and fix the native leaflet is prone to fatigue damage, affecting its service life.

[0006] In summary, due to the relatively complex design of the locking structure in the existing technology, the assembly process is extremely demanding, and the spring will fatigue over time, affecting the clamping force. Therefore, a locking mechanism with a relatively simple structural design, convenient assembly, and the ability to maintain the clamping force for a long time is needed. Summary of the Invention

[0007] The purpose of this invention is to provide a valve clip with a locking mechanism, which has the following advantages: simple structure, low requirements for assembly process, and can maintain clamping force for a long time.

[0008] To solve the above-mentioned technical problems, the present invention provides the following technical solution: a valve clip with a locking mechanism, comprising a first clamping arm, a second clamping arm, a connecting member, a push-pull device, and a locking device. The locking device partially cooperates with the connecting member and includes a locking head and a self-locking rod. The connecting member is hinged to the first clamping arm and the second clamping arm respectively. The clamping arm includes a long arm and a short arm. One end of the long arm is hinged to the push-pull device, and one end of the short arm is provided with a locking part. When the push-pull device is operated to increase the angle between the long arms of the first clamping arm and the second clamping arm, the locking part on the first clamping arm and the locking part on the second clamping arm are partially misaligned. When the push-pull device is operated to decrease the angle between the long arms of the first clamping arm and the second clamping arm, the locking device is moved to allow the locking head to cooperate with the locking part and lock.

[0009] This invention can also be further implemented through the following technical solutions:

[0010] In one embodiment, a locking region is formed between the locking part and the connecting member. The size of the locking region changes with the opening angle of the clamping arms. When the opening angle of the first clamping arm and the second clamping arm decreases, the locking region gradually increases. When the locking head enters the locking region and completes the locking engagement with the locking part, the valve clamp is locked.

[0011] In one embodiment, the long arm is provided with an offset structure, which divides the long arm into a fitting part and a transmission part. When the angle between the long arms of the first clamping arm and the long arms of the second clamping arm decreases and they are in a closed state, the fitting part is located closer to the central axis of the valve clamp than the transmission part.

[0012] In one embodiment, a rotating structure is provided between the self-locking rod and the locking head, allowing the self-locking rod and the locking head to rotate relative to each other.

[0013] In one embodiment, the connector includes a connecting block and a connecting lug disposed on the connecting block. The connecting block is connected to the locking device, and the connecting lug is hinged to the first clamping arm and the second clamping arm, respectively.

[0014] In a preferred embodiment, the connector is an arc-shaped structure or a "V"-shaped structure; the purpose of this design is to shorten the loading length of the valve clip during pre-installation.

[0015] In a preferred embodiment, the connecting lug is axially symmetrical about the axis of the connecting block.

[0016] In a preferred embodiment, the connecting block is provided with a mounting groove, and at least part of the locking head is always disposed in the mounting groove. The mounting groove restricts the circumferential rotation of the locking head. The purpose of this design is that when the locking head is configured with an irregular structure, during the process of operating the self-locking rod to move the locking head axially to engage with the locking part, the mounting groove restricts the circumferential rotation of the locking head, thereby allowing the locking head to enter the locking area at a predetermined position and engage with the locking part.

[0017] In a preferred embodiment, the connecting block is provided with an axial through hole, and the mounting groove is provided on the distal side of the through hole.

[0018] In one embodiment, the locking head is restricted to move proximally by the mounting groove, the diameter of which is larger than the diameter of the through hole.

[0019] In one embodiment, the self-locking lever is solid or hollow.

[0020] In a preferred embodiment, when the locking area formed by the locking part is a wedge-shaped structure or the locking area is a conical structure, the locking head is correspondingly set to a wedge-shaped structure or a conical structure; when both the locking area and the locking head are wedge-shaped or conical structures, the locking force is stronger and the valve clip is more stable and reliable.

[0021] In one embodiment, the locking head is a bracket-shaped self-expanding structure, and the locking head cooperates with the locking part to achieve locking.

[0022] In one embodiment, the locking head has a conical, spindle-shaped, rhomboid, prismatic, or arrowhead-shaped structure.

[0023] In a preferred embodiment, the locking head is hollow and made of an elastic metal material. The locking head has a hollow internal region that serves as a buffer zone. When the valve clip is implanted into the heart, the compression and relaxation of the heart valve itself will cause stress on the clamping arm, affecting the clamping degree between the clamping arm and the pushing device, resulting in some degree of backflow. However, when the locking head is made of an elastic metal material and has a buffer zone inside, the stress from the valve's movement is transmitted from the long arm of the clamping arm to the short arm. The force on the short arm is then transmitted to the locking head, causing it to deform to some extent and decompose the stress. This ensures the clamping force and tightness between the clamping arm and the pushing device, thereby preventing backflow.

[0024] In one embodiment, the short arm is arc-shaped or "L"-shaped. When the angle between the first clamping arm and the second clamping arm increases, the locking part on the first clamping arm and the locking part on the second clamping arm are misaligned. The design of the locking part as an arc segment or "L" shape is beneficial to increase the lever arm of the locking part and enhance the locking force. At the same time, the misalignment between the locking parts is beneficial to save loading space.

[0025] In one embodiment, the connector is provided with an anti-reverse device that cooperates with the self-locking rod; the anti-reverse device can enhance the stability of the locking device and ensure the locking effect over a long period of time.

[0026] In a preferred embodiment, the anti-retraction device is a thread or a groove.

[0027] In one embodiment, the push-pull device includes a leaflet grasping device, a leak-proof tube, and a first linkage rod and a second linkage rod hinged to the leak-proof tube and disposed on the left and right sides of the leak-proof tube. The first linkage rod and the second linkage rod are respectively hinged to the first clamping arm and the second clamping arm. The leaflet grasping device is disposed on the first linkage rod and the second linkage rod. The leaflet grasping device has a preset shape. In its natural state, the leaflet grasping device is close to the linkage rod. During pre-installation, the leaflet grasping device is always in contact with the leak-proof tube. When the valve clamp captures the leaflet, the leaflet grasping device returns to the preset shape to clamp the leaflet.

[0028] In a preferred embodiment, the petal-grabbing device can be controlled independently to clamp and anchor individual petals, thereby reducing the difficulty of operation.

[0029] In one embodiment, the locking part includes a plurality of arc-shaped support rods arranged in a comb-like pattern. When the angle between the first clamping arm and the second clamping arm increases, the arc-shaped support rods on the first clamping arm and the arc-shaped support rods on the second clamping arm are misaligned. The plurality of arc-shaped support rods arranged in a comb-like pattern help to increase the point of force application of the short arm, making the locking more stable and reliable.

[0030] In a preferred embodiment, the end of the arc-shaped support rod is bent inward, and the end of the arc-shaped support rod provides a force point to the locking device when the first clamping arm and the second clamping arm are closed.

[0031] In one embodiment, the cross-section of the long arm is concave. The purpose of this design is that when the valve clip is in the closed state, the long arm plays a certain role in wrapping the leak-proof tube, making its leak-proof effect better. At the same time, the concave shape also greatly reduces the weight of the long arm, effectively preventing the valve clip from slipping out of the heart due to excessive weight. This is beneficial to the stability of the valve clip anchored in the heart and will not cause excessive tearing or damage to the original valve leaflets or intracardiac tissue.

[0032] In one embodiment, the end of the long arm connected to the push-pull device is provided with an arc-shaped buffer section; the advantage of this design is that when the valve clamp captures the leaflet and completes clamping, the arc-shaped buffer section can protect the original leaflet from damage.

[0033] In one embodiment, the clamping arm is provided with a fitting structure at the hinge point; the advantage of designing the fitting structure is that the short arm drives the long arm with the hinge point lever, so the force at the hinge point is relatively large when locking, and the fitting structure can increase the contact surface with the connecting parts, so that the locking torque is more balanced.

[0034] Compared with the prior art, the advantages of the present invention are as follows:

[0035] 1. Unlike existing technologies, in this invention, when the push-pull device is operated to increase the angle between the long arms of the first and second clamping arms and put them in an open state, the locking part on the first clamping arm and the locking part on the second clamping arm are partially misaligned, which does not interfere with or affect the angle between the clamping arms. This is beneficial for capturing and clamping the valve leaflets. When the valve clamp needs to be locked, the locking device is moved so that the locking head and the locking part cooperate and lock, thus completing the locking. By utilizing the lever principle, a torque balance is generated between one end of the locking device and the locking part, controlling the angle between the first and second clamping arms to no longer increase, achieving the locking effect. At the same time, the locking structure is a mechanical lock, which is simple in structure, easy to operate, and has no fatigue risk, and can ensure its clamping effect for a long time.

[0036] 2. Unlike the prior art, the short arm of the present invention is arc-shaped or "L"-shaped. The purpose of this design is that the arc segment can increase the lever arm of the locking part, thereby ensuring the locking force of the valve clip, making the locking state of the valve clip more stable and reliable. At the same time, the staggered fit method helps to save loading space.

[0037] 3. Unlike existing technologies, the connector in this invention is provided with an installation groove, and at least part of the locking head is always set in the installation groove. The installation groove restricts the circumferential rotation of the locking head. The purpose of this design is that when the locking head is set with an irregular structure, during the process of operating the self-locking rod to move the locking head axially to engage with the locking part, the installation groove restricts the circumferential rotation of the locking head, so that the locking head enters the locking area according to the predetermined position and engages with the locking part. At the same time, the installation groove on the connector can reduce the weight of the valve clip, effectively preventing the valve clip from slipping out of the heart due to excessive weight, which is beneficial to the stability of the valve clip anchored in the heart.

[0038] 4. Unlike existing technologies, the cross-section of the long arm is concave. The purpose of this design is that when the valve clip is in the closed state, the long arm plays a certain role in wrapping the leak-proof tube, making its leak-proof effect better. At the same time, the concave shape also greatly reduces the weight of the long arm, effectively preventing the valve clip from slipping out of the heart due to excessive weight. This is conducive to the stability of the valve clip anchored in the heart and will not cause excessive tearing or damage to the original valve leaflet or intracardiac tissue.

[0039] 5. Unlike existing technologies, the locking head of this invention is a support-shaped self-expanding structure with a hollow area inside, which serves as a buffer zone. When the valve clip is implanted into the heart, the compression and relaxation of the heart valve itself will cause the clamping arm to be subjected to certain stress, thereby affecting the degree of clamping between the clamping arm and the pushing device and causing a certain degree of backflow. However, when the locking head is made of elastic metal material and a buffer zone is formed inside the locking head, the stress caused by the movement of the valve itself is transmitted from the long arm of the clamping arm to the short arm. Subsequently, the force on the short arm is transmitted to the locking head, causing the locking head to deform to a certain extent and decompose the stress it receives. This ensures that the clamping force and tightness between the clamping arm and the pushing device are always maintained, thereby avoiding backflow.

[0040] 6. Unlike existing technologies, this invention features an offset structure. When the long arms of the first clamping arm and the long arms of the second clamping arm are closed, the fitting part is located closer to the central axis of the valve clamp than the transmission part. This allows the long arms of the valve clamp to fit tightly against the leak-proof fitting when the valve clamp is closed, further ensuring the closing force of the valve clamp and improving the leak-proof effect. Attached Figure Description

[0041] Figures 1a-1dThis is a schematic diagram illustrating the process of locking the valve clip of the present invention.

[0042] Figures 2a-2h This is a schematic diagram of the clamping arm, locking part, and arc-shaped support rod of the present invention.

[0043] Figures 3a-3g This is a schematic diagram of the locking device and locking block of the present invention, wherein... Figures 3c-3g This describes various implementations of the locking block.

[0044] Figures 4a-4d This is a schematic diagram of the connecting component of the present invention.

[0045] Figures 5a-5b This is a schematic diagram illustrating the process of disassembling the delivery catheter and valve clip of the present invention.

[0046] Figures 6a-6g This is a schematic diagram illustrating the process of the delivery catheter entering the heart according to the present invention.

[0047] Figures 7a-7c This is a schematic diagram illustrating the process of the valve clamp opening in the left atrium according to the present invention.

[0048] Figures 8a-8h This is a schematic diagram illustrating the process by which the valve clamp of the present invention moves to the optimal position for capturing the valve.

[0049] Figures 9a-9c This is another embodiment of the valve clamp locking device of the present invention.

[0050] Figures 10a-10c This is another embodiment of the valve clamp locking device of the present invention.

[0051] Figures 11a-11g This is another embodiment of the valve clamp locking device of the present invention.

[0052] The parts referred to by the numbers in the attached diagram are as follows: 1-First clamping arm, 11-Short arm, 12-Long arm, 13-Fitting structure, 111-Locking part, 121-Arc buffer section, 122-Offset structure, 123-Fitting part, 124-Transmission part, 1111-Arc segment, 1112-Arc support rod, 2-Second clamping arm, 3-Connector, 31-Connecting block, 311-Through hole, 312-Mounting groove, 32-Connecting ear, 33-Locking area, 34-Anti-reverse device, 4-Locking device, 41-Locking head, 42-Self-locking rod, 43-Rotating structure, 431-Groove, 432-Boss, 5-Leak-proof fitting, 51-Leak-proof pipe connection, 6-First linkage rod, 7-Second linkage rod, 8-Conveying conduit, 9-Push-pull device, 91-Petal capture device. Detailed Implementation

[0053] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments.

[0054] In this invention, the proximal end refers to the end closer to the surgeon, and the distal end refers to the end farther away from the surgeon. Specific Implementation Example 1:

[0056] When used to treat mitral valve disease, such as Figures 1a-1d As shown, a valve clip with a locking mechanism includes a first clamping arm 1, a second clamping arm 2, a connecting member 3, a push-pull device 9, and a locking device 4. The locking device 4 partially cooperates with the connecting member 3. The locking device 4 includes a locking head 41 and a self-locking rod 42. The connecting member 3 is hinged to the first clamping arm 1 and the second clamping arm 2 respectively. The clamping arm includes a long arm 12 and a short arm 11. One end of the long arm 12 is hinged to the push-pull device 9, and one end of the short arm 11 is provided with a locking part. 111. When the push-pull device 9 is operated to increase the angle between the long arm 12 of the first clamping arm 1 and the long arm 12 of the second clamping arm 2 and put them in an open state, the locking part 111 on the first clamping arm 1 and the locking part 111 on the second clamping arm 2 are partially misaligned; when the push-pull device 9 is operated to decrease the angle between the long arm 12 of the first clamping arm 1 and the long arm 12 of the second clamping arm 2 and put them in a closed state, the locking device 4 is moved so that the locking head 41 engages with the locking part 111 and locks them.

[0057] The composition and connection method of the valve clip with locking mechanism of the present invention will be described in detail below with reference to the accompanying drawings.

[0058] In this embodiment, a locking region 33 is formed between the locking part 111 and the connecting member 3. The size of the locking region 33 changes with the opening angle of the clamping arms. When the opening angle of the first clamping arm 1 and the second clamping arm 2 decreases, the locking region 33 gradually increases. When the locking head 41 enters the locking region 33 and completes the locking engagement with the locking part 111, the valve clamp is locked. Figure 2e and 2f As shown.

[0059] In this embodiment, the long arm 12 is provided with an offset structure 122, such as... Figure 2hAs shown, the bias structure 122 divides the long arm 12 into a fitting part 123 and a transmission part 124. When the angle between the long arm 12 of the first clamping arm 1 and the long arm 12 of the second clamping arm 2 decreases and they are in a closed state, the fitting part 123 is located closer to the central axis of the valve clamp than the transmission part 124. The advantage of this design is that when the valve clamp is in a closed state, the long arm 12 can fit tightly against the push-pull device 9, further increasing the clamping effect and improving the leak-proof function.

[0060] In this embodiment, the locking part 111 includes an arc-shaped segment 1111, such as... Figure 2a and 2b As shown, when the angle between the first clamping arm 1 and the second clamping arm 2 increases, the arc-shaped segment 1111 on the first clamping arm 1 and the arc-shaped segment 2111 on the second clamping arm 2 are misaligned and engaged. Designing the locking part 111 as an arc-shaped segment 1111 helps increase the lever arm of the locking part 111, enhancing the locking force. Simultaneously, the misaligned engagement method helps save loading space. Similarly, the locking part 111 can also be configured as an "L" shape, such as... Figure 2g As shown.

[0061] In this embodiment, the locking part 111 includes a plurality of arc-shaped support rods 1112, such as Figure 2c As shown, when the angle between the first clamping arm 1 and the second clamping arm 2 increases, the arc-shaped support rod 1112 on the first clamping arm 1 and the arc-shaped support rod 1112 on the second clamping arm 2 are misaligned and fastened together; multiple arc-shaped support rods 1112 help to increase the force application point of the short arm 11, making the locking more stable and reliable.

[0062] In this embodiment, the first clamping arm 1 has three arc-shaped support rods 1112, and the second clamping arm 2 has two arc-shaped support rods 2112, such as... Figure 2b and 2d As shown, under the premise of ensuring the strength of the arc-shaped support rod 1112, the end of the arc-shaped support rod 1112 touches the locking head 41.

[0063] In this embodiment, the clamping arm is provided with a fitting structure 13 at the hinge point, such as... Figure 2c As shown, the advantage of the fitting structure 13 is that the short arm 11 drives the long arm 12 with the hinge point lever. Therefore, when locking, the force at the hinge point is relatively large. The fitting structure 13 can increase the contact surface with the connecting piece 3, making the locking torque more balanced.

[0064] In this embodiment, the locking device 4 includes a locking head 41 and a self-locking rod 42, such as Figure 3a and 3bAs shown; the locking head 41 and the locking part 111 on the short arm 11 are in a trapezoidal fit, wedge fit, conical fit, circular surface fit, or cubic fit, such as... Figures 3c-3g As shown.

[0065] In this embodiment, the connector 3 includes a connector block 31 and a connector lug 32 disposed on the connector block 31, such as Figure 4a and 4b As shown, the connecting block 31 is connected to the locking device 4, and the connecting ear 32 is hinged to the first clamping arm 1 and the second clamping arm 2 respectively.

[0066] In this embodiment, the connector 3 can be an arc-shaped structure or a "V"-shaped structure, such as... Figure 4c and 4d As shown; the purpose of this design is to shorten the loading length of the valve clip during pre-installation.

[0067] In this embodiment, the connector 3 is provided with an anti-retraction device 34 that cooperates with the self-locking rod 42; the anti-retraction device 34 can enhance the stability of the locking device 4 and ensure the locking effect for a long time.

[0068] In this embodiment, the anti-reverse device 34 is a thread or a groove.

[0069] In this embodiment, the push-pull device 9 includes a leaflet grasping device 91, a leak-proof tube 5, and a first linkage rod 6 and a second linkage rod 7 hinged to the leak-proof tube 5 and disposed on the left and right sides of the leak-proof tube 5. The first linkage rod 6 and the second linkage rod 7 are respectively hinged to the first clamping arm 1 and the second clamping arm 2. The leaflet grasping device 91 is disposed on the first linkage rod 6 and the second linkage rod 7. The leaflet grasping device 91 has a preset shape. In its natural state, the leaflet grasping device 91 is close to the linkage rod. During pre-installation, the leaflet grasping device 91 is always close to the leak-proof tube 5. When the valve clamp captures the leaflet, the leaflet grasping device 91 returns to the preset shape to clamp the leaflet.

[0070] In this embodiment, one end of the long arm 12 connected to the push-pull device 9 is provided with an arc-shaped buffer section 121, such as... Figure 2a and 2b As shown, when the valve clamp captures the leaflet and completes clamping, the arc-shaped buffer section 121 can protect the original leaflet from damage.

[0071] In this embodiment, the cross-section of the long arm 12 is concave. The purpose of this design is that when the valve clip is in the closed state, the long arm 12 plays a certain role in wrapping the anti-leakage tube 5, making its anti-leakage effect better. At the same time, the concave shape also greatly reduces the weight of the long arm 12, effectively preventing the valve clip from slipping out of the heart due to excessive weight. This is beneficial to the stability of the valve clip anchored in the heart and will not cause excessive tearing or damage to the original valve leaflet or intracardiac tissue.

[0072] In this embodiment, the valve clip further includes a valve clip delivery system, which includes a control handle and a delivery catheter 8 connected to the control handle, such as... Figures 5a-5b As shown, the distal portion of the delivery catheter 8 is detachably connected to the valve clip. During pre-installation, the delivery catheter 8 is connected to the valve clip. After the valve clip is implanted into the target position, the delivery catheter 8 and the valve clip can be separated.

[0073] The working principle of this invention is as follows:

[0074] 1. The valve clip delivery catheter 8 is inserted into the heart through the inferior vena cava, and then the delivery catheter 8 is manipulated to allow the valve clip to pass through the interatrial septum, as follows. Figures 6a-6e As shown; continue the operation by bending the delivery catheter 8 so that the valve clamp is aligned with the mitral valve, as shown. Figure 6f and 6g As shown;

[0075] 2. By operating the control handle, retract the outer sheath to expose the valve clamp in the left atrium. Then, operate the control handle to move the locking device 4 distally relative to the leak-proof fitting 5 until the angle between the first clamping arm 1 and the second clamping arm 2 is at its maximum. Figures 7a-7c As shown;

[0076] 3. Operate the control handle to pass the valve clamp through the mitral valve, such as... Figure 8a As shown, the image is used to determine whether the valve clip is in the optimal valve clamping position. If it is in the optimal position, proceed directly to step 5; if it is not in the optimal position, proceed to step 4.

[0077] 4. Operate the control handle to pull the locking device 4 to its furthest point. At this point, the radial space occupied by the valve clamp is minimized. Pull the valve clamp towards the left atrium, as... Figures 8b-8d As shown, the clamping arm and the linkage rod form an obtuse angle, which conforms to physiological structure and will not damage tissues such as the chordae tendineae in the heart; the operation control handle rotates and delivers the valve clamp to the optimal valve clamping position, such as... Figures 8e-8h As shown;

[0078] 5. Operate the control handle to clamp the petals so that the front petal and the rear petal enter the petal grasping device 91 and are respectively fixed between the leak-proof pipe 5 and the first linkage rod 6 and between the leak-proof pipe 5 and the second linkage rod 7.

[0079] 6. Operate the control handle to move the locking device 4 towards the proximal end until the angle between the first clamping arm 1 and the second clamping arm 2 is at its minimum, such as... Figure 1c As shown;

[0080] 7. Operate the locking device 4 to move it axially along the connector 3 towards the distal end until the locking head 41 abuts against the first locking part 111 and the second locking part 111, thereby achieving the purpose of locking the valve clip. Figure 1d As shown;

[0081] 8. Operate the control handle to separate the delivery catheter 8 from the valve clamp, such as... Figure 5a and 5b As shown, delivery catheter 8 is withdrawn from the body. Specific Implementation Example 2:

[0083] In another implementation, such as Figure 9a and 9b As shown, a valve clip with a locking mechanism includes a first clamping arm 1, a second clamping arm 2, a connecting member 3, and a locking device 4. The locking device 4 is connected to the connecting member 3, and the connecting member 3 is hinged to the first clamping arm 1 and the second clamping arm 2 respectively. The clamping arm includes a long arm 12 and a short arm 11. The short arm 11 drives the long arm 12 by a lever at the hinge point. One end of the short arm 11 is provided with a locking part 111. When the angle between the first clamping arm 1 and the second clamping arm 2 increases, the locking part 111 on the first clamping arm 1 and the locking part 111 on the second clamping arm 2 are misaligned and engaged. When the angle between the first clamping arm 1 and the second clamping arm 2 decreases, a locking area 33 is formed between the locking part 111 and the connecting member 3. One end of the locking device 4 enters the locking area 33 and completes the locking engagement with the locking part 111.

[0084] The valve clamp also includes a push-pull device 9, which includes a leaflet grasping device 91, a leak-proof tube 5, and a first linkage rod 6 and a second linkage rod 7 hinged to the leak-proof tube 5 and disposed on the left and right sides of the leak-proof tube 5. The first linkage rod 6 and the second linkage rod 7 are respectively hinged to the first clamping arm 1 and the second clamping arm 2. The leaflet grasping device 91 is disposed on the first linkage rod 6 and the second linkage rod 7. The leaflet grasping device 91 has a preset shape. In its natural state, the leaflet grasping device 91 is close to the linkage rod. During pre-installation, the leaflet grasping device 91 is always close to the leak-proof tube 5. When the valve clamp captures the leaflet, the leaflet grasping device 91 returns to the preset shape to clamp the leaflet.

[0085] In this embodiment, the locking device 4 and the connecting member 3 are threadedly connected. The locking device 4 cannot rotate when not subjected to external force. Therefore, after the locking device 4 abuts against the first locking part 111 and the second locking part 211, it cannot move axially. The first locking part 111 and the second locking part 211 receive opposite radial supports from the locking device 4, such as... Figure 9c As shown, the first clamping arm 1 receives a radial support force to the left, and the second clamping arm 2 receives a radial support force to the right, so that the first clamping arm 1 and the second clamping arm 2 cannot open. The composition and connection method of each component of the valve delivery system with locking mechanism of the present invention will be described in detail below with reference to the accompanying drawings.

[0086] In this embodiment, the locking part 111 includes an arc segment 1111. When the angle between the first clamping arm 1 and the second clamping arm 2 increases, the arc segment 1111 on the first clamping arm 1 and the arc segment 2111 on the second clamping arm 2 are misaligned and fastened together. The design of the locking part 111 as an arc segment 1111 is beneficial to increase the lever arm of the locking part 111 and enhance the locking force. At the same time, the misaligned fastening method is beneficial to save loading space.

[0087] In this embodiment, the lengths of the first arc-shaped support rod 1112 and the second arc-shaped support rod 2112 are different from those in the previous embodiment. When the first clamping arm 1 and the second clamping arm 2 are closed, a hole is formed between the first arc-shaped support rod 1112 and the second arc-shaped support rod 2112. The locking head 41 on the locking device 4 has a conical structure. The diameter of the proximal portion of the locking head 41 on the locking device 4 is larger than the distance between the ends of the first arc-shaped support rod 1112 and the second arc-shaped support rod 2112. By operating the locking device 4, the distal portion of its locking head 41 enters / passes through the hole between the first arc-shaped support rod 1112 and the second arc-shaped support rod 1112. At the same time, the locking head 41 also abuts against the first arc-shaped support rod 1112 and the second arc-shaped support rod 1112 to limit the movement and achieve the locking purpose. Figure 9b and 9c As shown. Specific Implementation Example 3:

[0089] In another implementation, such as Figure 10a and 10b As shown, a valve clip with a locking mechanism includes a first clamping arm 1, a second clamping arm 2, a connecting member 3, and a locking device 4. The locking device 4 is connected to the connecting member 3 and includes a locking head 41 and a self-locking rod 42. The connecting member 3 is hinged to the first clamping arm 1 and the second clamping arm 2 respectively. The clamping arm includes a long arm 12 and a short arm 11. The short arm 11 drives the long arm 12 by a lever at the hinge point. One end of the short arm 11 is provided with a locking part 111. When the angle between the first clamping arm 1 and the second clamping arm 2 increases, the locking part 111 on the first clamping arm 1 and the locking part 111 on the second clamping arm 2 are misaligned and engaged. When the angle between the first clamping arm 1 and the second clamping arm 2 decreases, a locking area 33 is formed between the locking part 111 and the connecting member 3. One end of the locking device 4 enters the locking area 33 and completes the locking engagement with the locking part 111.

[0090] The valve clamp also includes a push-pull device 9, which includes a leaflet grasping device 91, a leak-proof tube 5, and a first linkage rod 6 and a second linkage rod 7 hinged to the leak-proof tube 5 and disposed on the left and right sides of the leak-proof tube 5. The first linkage rod 6 and the second linkage rod 7 are respectively hinged to the first clamping arm 1 and the second clamping arm 2. The leaflet grasping device 91 is disposed on the first linkage rod 6 and the second linkage rod 7. The leaflet grasping device 91 has a preset shape. In its natural state, the leaflet grasping device 91 is close to the linkage rod. During pre-installation, the leaflet grasping device 91 is always close to the leak-proof tube 5. When the valve clamp captures the leaflet, the leaflet grasping device 91 returns to the preset shape to clamp the leaflet.

[0091] In this embodiment, the self-locking rod 42 and the connecting member 3 are threadedly connected. The locking device 4 cannot rotate when there is no external force inside. Therefore, the locking head 41 cannot move axially after abutting against the first locking part 111 and the second locking part 211. The first locking part 111 and the second locking part 211 receive opposite radial supports from the locking head 41, such as... Figure 10c As shown, the first clamping arm 1 receives a radial support force to the left, and the second clamping arm 2 receives a radial support force to the right, so that the first clamping arm 1 and the second clamping arm 2 cannot open. The composition and connection method of each component of the valve delivery system with locking mechanism of the present invention will be described in detail below with reference to the accompanying drawings.

[0092] Unlike the above embodiments, in this embodiment, the locking head 41 is a bracket-shaped self-expanding structure, and the locking head 41 cooperates with the locking part 111 to achieve locking.

[0093] In this embodiment, the locking head 41 may have a conical structure, a spindle-shaped structure, a rhomboid structure, a prismatic structure, or an arrowhead-shaped structure, and the distal end of the locking head 41 is divided into a conical structure.

[0094] In this embodiment, the locking head 41 is arranged in a rhomboid structure and is hollow. The locking head 41 is made of elastic metal material and has a hollow area inside, which serves as a buffer area. When the valve clip is implanted into the heart, the compression and relaxation of the heart valve itself will cause the clamping arm to be subjected to a certain stress, thereby affecting the clamping degree between the clamping arm and the pushing device and causing a certain degree of backflow. However, when the locking head 41 is made of elastic metal material and has a buffer area inside, the stress on the long arm 12 of the clamping arm caused by the movement of the valve itself is transmitted to the short arm 11. Subsequently, the force on the short arm 11 is transmitted to the locking head 41, causing the locking head 41 to deform to a certain extent and decompose the stress it receives. This ensures that the clamping force and tightness between the clamping arm and the pushing and pulling device 9 are always maintained, thereby avoiding backflow.

[0095] In this embodiment, the locking part 111 includes a plurality of arc-shaped support rods 1112. When the angle between the first clamping arm 1 and the second clamping arm 2 increases, the arc-shaped support rods 1112 on the first clamping arm 1 and the arc-shaped support rods 2112 on the second clamping arm 2 are misaligned and fastened together. The plurality of arc-shaped support rods 1112 helps to increase the point of force application of the short arm 11, making the locking more stable and reliable. Specific Implementation Example 4:

[0097] In another implementation, such as Figures 11a-11c As shown, a valve clip with a locking mechanism includes a first clamping arm 1, a second clamping arm 2, a connecting member 3, and a locking device 4. The locking device 4 is connected to the connecting member 3 and includes a locking head 41 and a self-locking rod 42. The connecting member 3 is hinged to the first clamping arm 1 and the second clamping arm 2 respectively. The clamping arm includes a long arm 12 and a short arm 11. The short arm 11 drives the long arm 12 by a lever at the hinge point. One end of the short arm 11 is provided with a locking part 111. When the angle between the first clamping arm 1 and the second clamping arm 2 increases, the locking part 111 on the first clamping arm 1 and the locking part 111 on the second clamping arm 2 are misaligned and engaged. When the angle between the first clamping arm 1 and the second clamping arm 2 decreases, a locking area 33 is formed between the locking part 111 and the connecting member 3. One end of the locking device 4 enters the locking area 33 and completes the locking engagement with the locking part 111.

[0098] The valve clamp also includes a push-pull device 9, which includes a leaflet grasping device 91, a leak-proof tube 5, and a first linkage rod 6 and a second linkage rod 7 hinged to the leak-proof tube 5 and disposed on the left and right sides of the leak-proof tube 5. The first linkage rod 6 and the second linkage rod 7 are respectively hinged to the first clamping arm 1 and the second clamping arm 2. The leaflet grasping device 91 is disposed on the first linkage rod 6 and the second linkage rod 7. The leaflet grasping device 91 has a preset shape. In its natural state, the leaflet grasping device 91 is close to the linkage rod. During pre-installation, the leaflet grasping device 91 is always close to the leak-proof tube 5. When the valve clamp captures the leaflet, the leaflet grasping device 91 returns to the preset shape to clamp the leaflet.

[0099] In this embodiment, a rotating structure 43 is provided between the self-locking rod 42 and the locking head 41, allowing the self-locking rod 42 and the locking head 41 to rotate relative to each other. Figure 11d As shown.

[0100] In this embodiment, the rotating structure 43 includes a groove 431 and a boss 432. The groove 431 is disposed near the locking head 41, and the boss 432 is disposed at the distal end of the self-locking rod 42. The groove 431 and the boss 432 cooperate with each other, as follows: Figure 11d As shown.

[0101] In this embodiment, the connector 3 is provided with a mounting groove 312, and at least part of the locking head 41 is always disposed in the mounting groove 312, the mounting groove 312 restricting the circumferential rotation of the locking head.

[0102] In this embodiment, the shape of the mounting groove 312 matches the shape of the locking head 41, and the locking head 41 has a conical structure, a wedge-shaped structure, a spindle-shaped structure, or an arrowhead-shaped structure, such as... Figures 11e-11g As shown.

[0103] In this embodiment, the connector 3 includes a connector block 31 and a connecting lug 32 disposed on the connector block 31. The connector block 31 is connected to the locking device 4. The connecting lug 32 is hinged to the first clamping arm 1 and the second clamping arm 2 respectively. The connector block 31 is axially provided with a through hole 311 and a mounting groove 312. The mounting groove 312 is disposed on the distal side of the through hole 311. After the connector 3 is provided with the mounting groove 312, the weight of the valve clip can be reduced, effectively preventing the valve clip from slipping out of the heart due to excessive weight, which is beneficial to the stability of the valve clip anchored in the heart.

[0104] In this embodiment, the connecting ear 32 is symmetrical about the central axis of the connecting block 31.

[0105] In this embodiment, the connecting block 31 is provided with a mounting groove 312, and at least part of the locking head 41 is always set in the mounting groove 312. The mounting groove 312 restricts the circumferential rotation of the locking head 41. During pre-installation, all of the locking heads 41 are located in the mounting groove 312, which can save loading space. When the locking head 41 and the locking part 111 are engaged and locked, part of the locking head 41 is still in the mounting groove 312. The purpose of this design is that when the locking head 41 is set as an irregular structure, during the process of operating the self-locking rod 42 to move the locking head 41 axially to engage and lock with the locking part 111, the mounting groove 312 restricts the circumferential rotation of the locking head 41, so that the locking head 41 enters the locking area 33 at a predetermined position and engages with the locking part.

[0106] In this embodiment, the mounting groove 312 is disposed on the distal side of the through hole 311.

[0107] In this embodiment, the locking head 41 is restricted to move toward the proximal end by the mounting groove 312, and the diameter of the mounting groove 312 is larger than the diameter of the through hole 311.

[0108] The above description is only a preferred embodiment of the present invention. For those skilled in the art, there will be changes in the specific implementation and application scope based on the ideas of the present invention. The content of this specification should not be construed as a limitation of the present invention.

Claims

1. A valve clip with a locking mechanism, characterized in that: The device includes a first clamping arm, a second clamping arm, a connecting member, a push-pull device, and a locking device. Part of the locking device engages with the connecting member. The locking device includes a locking head and a self-locking rod. The connecting member is hinged to both the first and second clamping arms. Both the first and second clamping arms include a long arm and a short arm. One end of the long arm is hinged to the push-pull device, and one end of the short arm has a locking part. When the push-pull device is operated to increase the angle between the long arms of the first and second clamping arms (opening state), the locking part on the first clamping arm and the locking part on the second clamping arm are in a partially misaligned engagement state. When the push-pull device is operated to decrease the angle between the long arms of the first and second clamping arms (closing state), the locking device is moved to engage and lock the locking head and locking part.

2. A valve clip with a locking mechanism according to claim 1, characterized in that: The short arm is arc-shaped or "L"-shaped.

3. A valve clip with a locking mechanism according to claim 1, characterized in that: The locking head is a bracket-shaped self-expanding structure, and the locking head cooperates with the locking part to achieve locking.

4. A valve clip with a locking mechanism according to claim 3, characterized in that: The locking head has a conical, spindle-shaped, or prismatic structure.

5. A valve clip with a locking mechanism according to claim 1, characterized in that: A rotating structure is provided between the self-locking rod and the locking head, allowing the self-locking rod and the locking head to rotate relative to each other.

6. A valve clip with a locking mechanism according to claim 5, characterized in that: The connector is provided with a mounting groove, and at least part of the locking head is always positioned in the mounting groove, which restricts the circumferential rotation of the locking head.

7. A valve clip with a locking mechanism according to claim 1, characterized in that: The long arms of the first clamping arm and the long arms of the second clamping arm are provided with an offset structure. The offset structure divides the long arms of the first clamping arm and the long arms of the second clamping arm into a fitting part and a transmission part. When the angle between the long arms of the first clamping arm and the long arms of the second clamping arm becomes smaller and enters a closed state, the fitting part is located closer to the central axis of the valve clamp than the transmission part.

8. A valve clip with a locking mechanism according to claim 1, characterized in that: The connector is an arc-shaped structure or a "V"-shaped structure.

9. A valve clip with a locking mechanism according to claim 1, characterized in that: The cross-sections of the long arms of the first clamping arm and the long arms of the second clamping arm are concave.

10. A valve clip with a locking mechanism according to claim 1, characterized in that: The long arms of the first clamping arm and the long arms of the second clamping arm are provided with an arc-shaped buffer section at the end where they are connected to the push-pull device.

Images