Heart valve edge-to-edge anastomosis device

Abstract

The application belongs to the technical field of heart mitral valve regurgitation surgery instruments, and particularly relates to a heart valve edge-to-edge anastomosis device which comprises a gas supply pipe, a sleeve ring, a clamping part and an expansion part. The sleeve ring and the clamping part are designed in an integrated manner. The clamping part comprises a first clamping leaf and a second clamping leaf. The first clamping leaf and the second clamping leaf are respectively fixedly connected to the two side surfaces of the sleeve ring. The expansion part comprises a first expansion sac and a second expansion sac. The gas supply pipe is provided in a hollow tube mode, and an internal part is used for inserting a guide wire. The application has the advantages of simple structure, convenient operation, high intuitiveness, no need of applying external force in the clamping process, no damage caused by pulling, extrusion and friction on the additional tension of the veins and the heart, clamping through expansion of the expansion part, easier operation compared with pulling to realize clamping, lower requirement for the experience of operators, and better suitability for promotion.

Description

Technical Field

[0001] This invention belongs to the technical field of surgical instruments for mitral regurgitation, specifically a device for edge-to-edge anastomosis of heart valves. Background Technology

[0002] With continuous economic and social development and increased life expectancy, the incidence of valvular heart disease has increased significantly. Traditional surgeries for mitral regurgitation, such as surgical valve repair or valve replacement, often result in numerous surgical complications due to the large surgical wound and long operation time, making it impossible for many patients with severe valvular heart disease and poor cardiopulmonary function to receive effective treatment.

[0003] Interventional treatment for valvular heart disease is widely welcomed by clinicians and patients due to its minimally invasive nature and postoperative efficacy similar to that of surgery. However, the high price and complexity of interventional devices hinder the widespread adoption of new technologies, resulting in most eligible patients still being unable to receive interventional treatment.

[0004] The existing edge-to-edge anastomosis devices for heart valves mainly adjust the direction of the clamps in the body through an adjustable delivery sheath. The delivery sheath has a complex structure and high manufacturing cost. At the same time, due to its complex structure, there are many precautions to take when using it, making it difficult to operate.

[0005] Furthermore, its release mechanism is achieved by mechanical / surgical suture traction between the clamp and the delivery sheath. Due to the interventional treatment method, the guidewire is inserted a long distance and has many bends, which can easily cause damage to the patient's veins during traction. At the same time, it requires a high level of operational experience from the doctor and is not easy to promote.

[0006] Therefore, developing a mitral valve edge-to-edge repair device that is cheaper, easier to operate, and safer has become a new hot topic in medical needs. Summary of the Invention

[0007] To address the shortcomings of existing mitral valve edge-to-edge repair devices, which are expensive to manufacture and require a high level of experience from doctors during actual use, making them difficult to promote, and causing harm to patients due to the complexity of the procedures performed by inexperienced doctors.

[0008] The technical solution adopted by the present invention to solve its technical problem is: a cardiac valve edge-to-edge anastomosis device according to the present invention includes an air supply tube, a collar, a clamping part and an expansion part; the collar and the clamping part are integrated into a single design; The clamping part includes a first clamping leaf and a second clamping leaf; the first clamping leaf and the second clamping leaf are respectively fixed to the two sides of the collar, and the first clamping leaf and the second clamping leaf are symmetrically arranged with respect to the collar; multiple first clamping leaves and multiple second clamping leaves are provided, preferably four or more. Before the device is used, one end of the air supply pipe needs to be placed inside the expansion section manually or mechanically, and then the expansion section needs to be placed between the corresponding clamping parts to form a ready-to-use state for sealing. Alternatively, it can be produced and packaged separately and installed before use.

[0009] The expansion part includes a first expansion bladder and a second expansion bladder; after the expansion part is installed on the clamping part, the first expansion bladder and the second expansion bladder are symmetrically arranged relative to the collar, and the first expansion bladder is located between the first clamping leaf and the second expansion bladder is located between the second clamping leaf. The air supply pipe is a hollow tube with a guide wire inserted inside. The air supply pipe passes through the first expansion bladder and the second expansion bladder and is connected to the first expansion bladder and the second expansion bladder respectively. An external air pump supplies air to the first expansion bladder and the second expansion bladder through the air supply pipe.

[0010] Preferably, a diaphragm is fixedly connected inside the air supply pipe; the diaphragm divides the space inside the air supply pipe into a first air supply zone and a second air supply zone; the first air supply zone is connected to a first expansion bladder; the second air supply zone is connected to a second expansion bladder; the first and second air supply zones are supplied with air by different air pumps, achieving separate control.

[0011] Preferably, the ends of the first and second expansion bladders furthest from the collar are divided into A and B, and the middle part is C. The thickness of part A is greater than the thickness of part B, which is greater than the thickness of part C.

[0012] Preferably, the thickness of portion C gradually decreases from portion A to portion B.

[0013] Preferably, the surfaces of the first and second clamping blades near the collar and away from the center line of the collar are both provided with curved grooves.

[0014] Preferably, the bottom angle of the groove is 90°, so that the angle of the first and second clamping blades after being fully bent with the groove as the center is 90°.

[0015] Preferably, the first and second clamping blades are fixedly connected to the surface of the curved groove with uniformly arranged protrusions; the protrusions are located on the side of the corresponding curved groove away from the collar.

[0016] Preferably, after the first clamp leaf and the corresponding second clamp leaf are completely bent around the groove, the protrusions are arranged in an alternating pattern.

[0017] Preferably, after the first clamping blade and the second clamping blade are completely bent around the groove, the shortest distance between the first clamping blade and the corresponding second clamping blade is ≤2mm.

[0018] The beneficial effects of this invention are as follows: The present invention discloses a cardiac valve edge-to-edge anastomosis device. After clamping the mitral valve with the first and second clamping leaflets, air is pumped out to cause the first and second expansion balloons to contract. After complete contraction, the expansion part is pulled out along the guide wire through the air supply tube. The structure is simple, the operation is more convenient and intuitive, and no external force is required during clamping. It will not cause additional pulling, squeezing and friction damage to the veins and heart. At the same time, clamping is achieved by expanding the expansion part, which is easier to implement than clamping by pulling. It requires less experience from the operator and is more suitable for widespread application.

[0019] 2. The edge-to-edge anastomosis device for heart valves described in this invention applies force directly to the air supply tube via a guidewire, thereby adjusting the spatial position of the clamping part through the expansion part. This simplifies the current method of adjusting the spatial position of the clamping part during edge-to-edge anastomosis, improves the release efficiency of the clamping part, and increases the spatial stability of the clamping part at the valve position after release. Attached Figure Description

[0020] The invention will now be further described with reference to the accompanying drawings.

[0021] Figure 1 This is a perspective view of the edge-to-edge mating device of the present invention before it is opened; Figure 2 This is a cross-sectional view of the edge-to-edge mating device of the present invention before it is opened; Figure 3 This is a cross-sectional view of the edge-to-edge mating device of the present invention after it has been opened; Figure 4 This is a perspective view of the air supply pipe of the present invention.

[0022] In the diagram: air supply pipe 1, diaphragm 11, collar 2, clamping part 3, clamping blade 1 31, clamping blade 2 32, groove 33, protrusion 34, expansion part 4, expansion bladder 1 41, expansion bladder 2 42. Detailed Implementation

[0023] The following is combined Figures 1-4 As shown, the present invention is further illustrated through specific embodiments.

[0024] Example 1 A heart valve edge-to-edge anastomosis device includes an air supply tube 1, a collar 2, a clamping part 3, and an expansion part 4; The clamping part 3 includes a first clamping leaf 31 and a second clamping leaf 32; the first clamping leaf 31 and the second clamping leaf 32 are respectively fixed to the two sides of the collar 2, and the first clamping leaf 31 and the second clamping leaf 32 are symmetrically arranged with respect to the collar 2; multiple first clamping leaves 31 and second clamping leaves 32 are provided. The expansion part 4 includes a first expansion bladder 41 and a second expansion bladder 42. After the expansion part 4 is installed on the clamping part 3, the first expansion bladder 41 and the second expansion bladder 42 are symmetrically arranged relative to the collar 2, and the first expansion bladder 41 is located between the first clamping leaf 31, and the second expansion bladder 42 is located between the second clamping leaf 32. The air supply pipe 1 is a hollow tube with a guide wire inserted inside. The air supply pipe 1 passes through the first expansion bladder 41 and the second expansion bladder 42 and is connected to the first expansion bladder 41 and the second expansion bladder 42 respectively. An external air pump supplies air to the first expansion bladder 41 and the second expansion bladder 42 through the air supply pipe 1.

[0025] During operation: The collar 2 and the clamping part 3 are integrated into one piece. The air supply pipe 1 and the expansion part 4 are fixedly connected. The tail of the air supply pipe 1 can be spirally increased with multiple sections of air supply pipe 1, or it can be composed of a single long section of air supply pipe 1. The tail of the air supply pipe 1 is connected to an air pump. After the expansion part 4 is fully contracted by evacuation, the second expansion bladder 42 of the expansion part 4 is passed through the collar 2 and placed between the second clamping blades 32. At this time, air is supplied by the air pump, causing the first expansion bladder 41 and the second expansion bladder 42 to expand and connect respectively. Touch clip 31 and clip 32. At this point, clip 31 and clip 32 do not deform. Then, loop the air supply tube 1 onto the guidewire and guide clip 32 to below the mitral valve and clip 31 to above the mitral valve. At this time, supply air through an external air pump to continuously inflate balloons 41 and 42, opening clip 31 and clip 32 until clip 31 is fully opened. With the second clamp leaflet 32, the first clamp leaflet 31 and the second clamp leaflet 32 ​​effectively clamp the mitral valve above and below, providing a good therapeutic effect for regurgitation caused by mitral valve insufficiency. Because the mitral valve is clamped by the first clamp leaflet 31 and the second clamp leaflet 32 ​​to form a support point, the mitral valve can effectively close during the heart's pumping process, reducing blood regurgitation. After clamping the mitral valve with the first clamp leaflet 31 and the second clamp leaflet 32, air is pumped out, causing the first expansion balloon 41 and the second expansion balloon 42 to contract until fully contracted. The expansion part 4 is then pulled out along the guidewire through the air supply tube 1. The structure is simple, the operation is more convenient and intuitive, and no external force needs to be applied during clamping, avoiding damage to the veins and heart from additional pulling, squeezing, and friction. Simultaneously, clamping is achieved through the expansion of the expansion part 4, which is easier to implement than clamping by pulling, requires less operator experience, and is more suitable for widespread application.

[0026] Meanwhile, when adjusting the spatial position of the clamping part 3, the guide wire can be directly applied to the air supply tube 1, thereby adjusting the spatial position of the clamping part 3 through the expansion part 4. This simplifies the current method of adjusting the spatial position of the clamping part 3 during edge-to-edge anastomosis, improves the release efficiency of the clamping part 3, and increases the spatial stability of the clamping part 3 at the valve position after release.

[0027] Example 2 Based on Embodiment 1, a diaphragm 11 is fixedly connected inside the air supply pipe 1; the diaphragm 11 divides the space inside the air supply pipe 1 into a first air supply zone and a second air supply zone; the first air supply zone is connected to a first expansion bladder 41; the second air supply zone is connected to a second expansion bladder 42; the first and second air supply zones are supplied with air by different air pumps, so as to achieve separate control; During operation, after the second clamp leaflet 32 ​​reaches below the mitral valve, the air pump can be controlled to supply air to the second air supply area to open the second clamp leaflet 32. During the opening process, the position of the clamping part 3 can be adjusted at any time, and the opening speed of the clamping part 3 can be flexibly controlled. The operation has a higher error tolerance, can be more accurately applied to the ideal position of the mitral valve, has a better treatment effect, and has a wider range of applications.

[0028] Example 3 Based on Embodiment 2, the ends of the first expansion bladder 41 and the second expansion bladder 42 that are away from the collar 2 are divided into A and the ends that are close to the collar 2 are divided into B. The middle part is C. The thickness of part A is greater than the thickness of part B, which is greater than the thickness of part C. The thickness of part C gradually decreases from part A to part B.

[0029] During operation, when the air pump supplies air, part C has the lowest thickness, so it expands first, followed by part B which stretches and expands. Since part C faces the clamping part 3, its expansion compresses and expands towards the clamping part 3, effectively opening it. Simultaneously, because the air supply pipe 1 is fixed to the expansion part 4, the positions of the first expansion bladder 41 and the second expansion bladder 42 away from the collar 2 do not change. Under the air supply, the first expansion bladder 41 and the second expansion bladder 42, due to their different thicknesses, expand even more towards the clamping part 3, fully opening it and increasing its clamping force. This also increases the pressure of the expansion part 4 on the clamping part 3, further facilitating clamping. The opening of part 3 effectively reduces the air supply. Combined with the fact that the thickness of part C gradually decreases from part A to part B, the pressure on the end of the expansion part 4 near the collar 2 is greater and it expands more preferentially during the expansion process. This further increases the contact area between the expansion part 4 and the clamping part 3, improving the effect of the expansion part 4 on the clamping part 3. It prevents the expansion part 4 from no longer facing the clamping part 3 after the clamping part 3 has opened to a certain angle, which would reduce the force of the expansion part 4 on the clamping part 3, resulting in the clamping part 3 not opening completely and having low clamping strength. Thus, the design of the thickness of part C gradually decreasing from part A to part B effectively improves the clamping effect of the clamping part 3.

[0030] Example 4 Based on Embodiment 3, the surfaces of the first clamping leaf 31 and the second clamping leaf 32 near the collar 2 and away from the center line of the collar 2 are both provided with curved grooves 33. When the clamping part 3 is subjected to the pressure of the expansion part 4, the clamping part 3 bends at the curved grooves 33. The curved grooves 33 effectively prevent the problem of inconsistent bending areas of the clamping part 3 causing a reduction in clamping effect. In addition, the curved grooves 33 effectively reduce the upper limit of the force exerted by the expansion part 4 on the clamping part 3, further reducing the difficulty of operation. Furthermore, the bottom angle of the curved grooves 33 is 90°, so that the angle of the first clamping leaf 31 and the second clamping leaf 32 after being fully bent with the curved grooves 33 as the center is 90°, preventing the angle of the first clamping leaf 31 or the second clamping leaf 32 from being too large or too small, which would reduce the clamping effect.

[0031] Example 5 Based on embodiment 4, the first clamping leaf 31 and the second clamping leaf 32 are fixedly connected with uniformly arranged protrusions 34 on the surface of the curved groove 33. The protrusions 34 are located on the side of the corresponding curved groove 33 away from the collar 2. Through the uniformly arranged protrusions 34, after the first clamping leaf 31 and the corresponding second clamping leaf 32 are completely bent with the curved groove 33 as the center, the protrusions 34 are staggered, so that the shape of the mitral valve after being clamped between the first clamping leaf 31 and the second clamping leaf 32 is wavy. Through the staggered arrangement of the protrusions 34, the friction between the first clamping leaf 31, the second clamping leaf 32 and the mitral valve is further improved, and the clamping effect is improved. After the first clamping leaflet 31 and the second clamping leaflet 32 ​​are completely bent around the groove 33, the shortest distance between the first clamping leaflet 31 and the corresponding second clamping leaflet 32 ​​is ≤2mm, to prevent the mitral valve from being unable to be clamped, which would lead to unstable clamping.

[0032] The above are merely preferred embodiments of the present invention and do not limit the scope of the patent. Any equivalent structural transformations made using the contents of the specification and drawings of the present invention under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the scope of patent protection of the present invention.

Claims

1. A device for edge-to-edge anastomosis of heart valves, characterized in that, It includes an air supply pipe (1), a collar (2), a clamping part (3), and an expansion part (4); The clamping part (3) includes a first clamping leaf (31) and a second clamping leaf (32); the first clamping leaf (31) and the second clamping leaf (32) are respectively fixed to the two sides of the collar (2), and the first clamping leaf (31) and the second clamping leaf (32) are symmetrically arranged with respect to the collar (2); multiple first clamping leaves (31) and second clamping leaves (32) are provided; The expansion part (4) includes a first expansion bladder (41) and a second expansion bladder (42); after the expansion part (4) is installed on the clamping part (3), the first expansion bladder (41) and the second expansion bladder (42) are symmetrically arranged relative to the collar (2), and the first expansion bladder (41) is located between the first clamping leaf (31), and the second expansion bladder (42) is located between the second clamping leaf (32); The air supply pipe (1) is a hollow tube with a guide wire inserted inside. The air supply pipe (1) passes through the first expansion bladder (41) and the second expansion bladder (42) and is connected to the first expansion bladder (41) and the second expansion bladder (42) respectively. An external air pump supplies air to the first expansion bladder (41) and the second expansion bladder (42) through the air supply pipe (1).

2. The cardiac valve edge-to-edge anastomosis device according to claim 1, characterized in that: A diaphragm (11) is fixedly connected inside the gas supply pipe (1); the diaphragm (11) divides the space inside the gas supply pipe (1) into a first gas supply zone and a second gas supply zone; The first gas supply zone is connected to the first expansion bladder (41); the second gas supply zone is connected to the second expansion bladder (42); the first and second gas supply zones are supplied with gas by different air pumps, and are controlled separately.

3. The cardiac valve edge-to-edge anastomosis device according to claim 2, characterized in that: The first expansion bladder (41) and the second expansion bladder (42) are divided into A at the end away from the collar (2) and B at the end close to the collar (2), with the middle part being C. The thickness of part A is greater than the thickness of part B and the thickness of part C.

4. The cardiac valve edge-to-edge anastomosis device according to claim 3, characterized in that: The thickness of part C gradually decreases from part A towards part B.

5. A cardiac valve edge-to-edge anastomosis device according to claim 4, characterized in that: The first clamping leaf (31) and the second clamping leaf (32) are both provided with curved grooves (33) on the surface of the first clamping leaf (31) and the second clamping leaf (32) that are close to the end of the collar (2) and far away from the center line of the collar (2).

6. A cardiac valve edge-to-edge anastomosis device according to claim 5, characterized in that: The bottom angle of the groove (33) is 90°, so that the first clamp leaf (31) and the second clamp leaf (32) are completely bent at an angle of 90° with the groove (33) as the center.

7. A cardiac valve edge-to-edge anastomosis device according to claim 6, characterized in that: The first clamping blade (31) and the second clamping blade (32) are fixedly connected to the surface of the curved groove (33) with uniformly arranged protrusions (34); the protrusions (34) are located on the side of the corresponding curved groove (33) away from the collar (2).

8. A cardiac valve edge-to-edge anastomosis device according to claim 7, characterized in that: After the first clamp leaf (31) and the corresponding second clamp leaf (32) are completely bent around the groove (33), the protrusions (34) are arranged in an alternating manner.

9. A cardiac valve edge-to-edge anastomosis device according to claim 8, characterized in that: After the first clamping blade (31) and the second clamping blade (32) are completely bent around the groove (33), the shortest distance between the first clamping blade (31) and the corresponding second clamping blade (32) is ≤2mm.

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