Valve repair device and valve repair system

Abstract

The utility model provides a kind of valve repair device and valve repair system, the valve repair device includes: anchor, drive part and adjusting part;The adjusting part includes pedestal, support piece and sliding member;The pedestal is rotatably connected with the sliding member by first rotary joint;The sliding member is movably connected with the support piece along the extension direction of the support piece;One end of the support piece is free end, and the other end is rotatably connected with the drive part by second rotary joint;The drive part is configured to move along its axial direction relative to the pedestal, to adjust the opening angle between the support piece and the drive part by the movement of the sliding member, the rotation of the first rotary joint and the rotation of the second rotary joint;The anchor is used for clamping leaflet, and adapt to the opening angle of the support piece.So configure, the pulling force required for moving support piece is small, and the closing force is large, and clamping is firm.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a valve repair device and valve repair system. Background Technology

[0002] Mitral or tricuspid regurgitation occurs when the mitral or tricuspid valves fail to close properly, causing blood to flow backward from the ventricles back into the atria. This backflow can lead to heart failure and severely impact a patient's daily life and work. One treatment for mitral or tricuspid regurgitation is transcatheter interventional surgery. This involves implanting a device into the heart via a catheter delivery system to achieve edge-to-edge repair of the mitral or tricuspid valve leaflets, thereby suppressing the regurgitation and treating the condition.

[0003] Current mitral or tricuspid valve implantation devices typically use mechanical or elastic clamps to clamp the valve leaflets and achieve edge-to-edge repair, thereby suppressing mitral or tricuspid regurgitation and achieving a therapeutic effect. Due to structural limitations, mechanical clamps have a relatively small range of motion during clamping (usually not exceeding 120°), making operation relatively difficult. Elastic clamps, on the other hand, require greater tensile force for actuation, which is detrimental to system stability, affects clamping effectiveness, and can negatively impact the final therapeutic outcome for mitral or tricuspid regurgitation after implantation. Utility Model Content

[0004] The purpose of this invention is to provide a valve repair device and valve repair system to solve the problems of inconvenient operation or the need for large pulling force to actuate existing implantable devices.

[0005] To solve the above-mentioned technical problems, this utility model provides a valve repair device, which includes: an anchor, a driving part, and an adjusting part;

[0006] The adjustment unit includes a base, a support, and a sliding component;

[0007] The base and the sliding member are rotatably connected via a first rotary joint; the sliding member is movably connected to the support member along the extending direction of the support member; one end of the support member is a free end, and the other end is rotatably connected to the drive unit via a second rotary joint.

[0008] The drive unit is configured to move relative to the base along its own axis to adjust the opening angle between the support member and the drive unit's axis by moving the sliding member, rotating the first rotating joint, and rotating the second rotating joint.

[0009] The anchor is used to clamp the leaflets and is adapted to the opening angle of the support.

[0010] Optionally, the adjustment unit includes two support members and two sliding members; the base includes two support arms, which are symmetrically arranged about the drive unit; the distal ends of the two support arms are fixedly connected to each other; and the distal ends of the two support arms are respectively connected to one of the sliding members through the first rotary joint.

[0011] Optionally, the two arms form a V-shape or U-shape with an opening toward the proximal end.

[0012] Optionally, the two support members are rotatably connected to the drive unit via two second rotating joints.

[0013] Optionally, the valve repair device has a closed state, an open state, and a reverse state depending on the different opening angles of the support member;

[0014] When the valve repair device is in the closed state, the distance between the driving part and the base is at its minimum, and the opening angle of the support member is an acute angle.

[0015] When the valve repair device is in the open state, the distance between the sliding member and the second rotating joint is at its minimum, and the opening angle of the support member is a right angle.

[0016] When the valve repair device is in the reverse state, the distance between the driving part and the base is at its maximum value, and the opening angle of the support member is an obtuse angle.

[0017] Optionally, when the valve repair device is in the closed state, the opening angle of the support member is not greater than 15°; when the valve repair device is in the reverse state, the opening angle of the support member is not less than 150°.

[0018] Optionally, the anchor is disposed on the support member, and the anchor has an open state and a clamped state for clamping the leaflet.

[0019] Optionally, the anchor includes two connected clamping arms that close elastically when not subjected to external force, so that the anchor is in the clamped state.

[0020] Optionally, one of the clamping arms is disposed on the support member, and the other clamping arm is detachably connected to the actuating wire and is used to open under the pull of the actuating wire to switch the anchor to the open state, allowing the leaflet to enter the anchor.

[0021] To solve the above-mentioned technical problems, this utility model also provides a valve repair system, which includes the valve repair device as described above, and further includes a delivery device; the delivery device is detachably connected to the valve repair device, and is used to deliver the valve repair device and to drive the drive unit to move relative to the base.

[0022] In summary, the valve repair device and valve repair system provided by this utility model include: an anchor, a drive unit, and an adjustment unit; the adjustment unit includes a base, a support member, and a sliding member; the base and the sliding member are rotatably connected via a first rotating joint; the sliding member is movably connected to the support member along the extending direction of the support member; one end of the support member is a free end, and the other end is rotatably connected to the drive unit via a second rotating joint; the drive unit is configured to move relative to the base along its own axial direction, so as to adjust the opening angle between the axial direction of the support member and the drive unit by the movement of the sliding member, the rotation of the first rotating joint, and the rotation of the second rotating joint; the anchor is used to clamp the valve leaflet and is adapted to the opening angle of the support member.

[0023] This configuration, on the one hand, decouples the relative displacement and rotation between the support and the base through the sliding component, resulting in less tension required to move the support, a more stable system, and thus more stable performance in capturing and clamping the leaflets, greater closing force, and more reliable clamping. On the other hand, the sliding component reduces the structural interference and conflict between the drive unit and the adjustment unit, allowing for a larger adjustable angle of the support. Attached Figure Description

[0024] Those skilled in the art will understand that the accompanying drawings are provided to better understand the present invention and do not constitute any limitation on the scope of the present invention.

[0025] Figure 1 This is a schematic diagram of the valve repair system according to an embodiment of the present invention.

[0026] Figure 2 This is a schematic diagram of the valve repair device in the closed state according to an embodiment of the present invention.

[0027] Figure 3 This is a schematic diagram of the valve repair device in the open state according to an embodiment of the present invention.

[0028] Figure 4 This is a schematic diagram of the valve repair device in the reverse state according to an embodiment of the present invention.

[0029] In the attached figures: 1-anchor; 11-clamping arm; 2-drive unit; 3-adjustment unit; 301-first rotating joint; 302-second rotating joint; 31-base; 311-support arm; 32-support member; 33-sliding member; 41-actuating wire. Detailed Implementation

[0030] To make the objectives, advantages, and features of this utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the objectives of the embodiments of this utility model. Furthermore, the structures shown in the drawings are often part of the actual structure. In particular, different drawings may emphasize different aspects and sometimes use different scales.

[0031] As used herein, the singular forms “a,” “an,” “one,” and “the” include plural objects; the term “or” is generally used to include the meaning of “and / or”; the term “a number” is generally used to include the meaning of “at least one”; and the term “at least two” is generally used to include the meaning of “two or more”. Furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature; “one end” and “the other end,” and “proximal end” and “distal end” generally refer to two corresponding parts, which include not only endpoints. The terms “proximal end” and “distal end” are defined herein with respect to a valve repair device having an end for connection to a delivery device extending outside the body. The term “proximal end” refers to the position closer to the end connected to the delivery device, and the term “distal end” refers to the position further away from the end connected to the delivery device. Optionally, in applications involving manual or hand-operated manipulation, the terms "proximal" and "distal" are defined herein in relation to the operator, such as a surgeon or clinician. The term "proximal" refers to a position closer to the operator, and the term "distal" refers to a position closer to the patient's lesion and therefore further away from the operator. Furthermore, as used in this invention, terms such as "installed," "connected," "attached," and "set" of one element on another should be interpreted broadly, generally indicating only a connection, coupling, cooperation, or transmission relationship between the two elements, which can be direct or indirect through an intermediate element. It should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located inside, outside, above, below, or to one side of another element, unless otherwise explicitly stated. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances. Furthermore, directional terms such as above, below, up, down, upward, downward, left, right, etc., are used relative to exemplary embodiments as they are shown in the figures, with upward or up direction pointing towards the top of the corresponding figure, and downward or down direction pointing towards the bottom of the corresponding figure.

[0032] The purpose of this invention is to provide a valve repair device and valve repair system to solve the problems of inconvenient operation or the need for large pulling force to actuate existing implantable devices.

[0033] The inventors discovered that implantable valve repair devices typically require delivery and manipulation via a catheter. However, catheters are limited in diameter due to factors such as blood vessels. Therefore, valve repair devices often need to be folded or contracted during delivery to reduce their radial dimensions. Once delivered to the target location (such as the mitral valve), the delivery device is then manipulated to switch to a usable state, for example, by extending radial clamping arms to clamp onto the valve leaflets.

[0034] Furthermore, because valve repair devices need to "clamp" the valve leaflets, the clamping process may not be successful on the first attempt, or the clamping position may be unsuitable, requiring multiple attempts. The clamping operation is powered by the manipulator extending from the delivery device to the proximal end of the body. Therefore, the ease of operation and the amount of force required both affect the clamping effect. For example, with existing elastic clamps, the operator needs to apply significant force at the proximal manipulator to overcome the elasticity of the clamp to adjust its position or clamping angle. This is detrimental to stable operation and easily affects the clamping effect. When the clamping arm of the elastic clamp reaches the critical point between the open and reverse states (the meaning of which can be understood in the explanation below), its elasticity reverses, suddenly applied to the clamping arm, causing it to abruptly move to the reverse state. This reverse change in elasticity causes undesirable bouncing of the elastic clamp. All of these factors affect the stability of the operation and the clamping effect.

[0035] Based on the above research, please refer to Figures 1 to 4 This utility model provides a valve repair device, which includes an anchor 1, a driving part 2, and an adjusting part 3; the adjusting part 3 includes a base 31, a support 32, and a sliding part 33; the base 31 and the sliding part 33 are rotatably connected via a first rotating joint 301; the sliding part 33 is movably connected to the support 32 along the extending direction of the support 32; one end of the support 32 is a free end, and the other end is rotatably connected to the driving part 2 via a second rotating joint 302; the driving part 2 is configured to move along its own axial direction ( Figures 1 to 4 The vertical direction of the support member 32 moves relative to the base 31, thereby adjusting the opening angle between the support member 32 and the drive unit 2 via the movement of the sliding member 33, the rotation of the first rotating joint 301, and the rotation of the second rotating joint 302. The anchor 1 is used to clamp the leaflet (not shown) and is adapted to the opening angle of the support member 32. The adjustment unit 3 is used to adjust the position and angle of the anchor 1 (referring to the angle relative to the axis of the drive unit 2), so that after the anchor 1 clamps the leaflet, the adjustment requirements for the position and angle of the leaflet are met.

[0036] This configuration, on the one hand, decouples the relative displacement and rotation between the support and the base through the sliding component, resulting in less tension required to move the support, a more stable system, and thus more stable performance in capturing and clamping the leaflets, greater closing force, and more reliable clamping. On the other hand, the sliding component reduces the structural interference and conflict between the drive unit and the adjustment unit, allowing for a larger adjustable angle of the support.

[0037] The support member 32 can be rod-shaped, sheet-shaped, or plate-shaped, and its extension direction refers to the direction from the second rotating joint 302 towards the free end away from the drive unit 2. The opening angle of the support member 32 refers to the angle between the extension direction of the support member 32 and the axial direction of the drive unit 2. Since the anchor 1 is adapted to the opening angle of the support member 32, the position and angle of the anchor 1 can be adjusted by adjusting the opening angle of the support member 32.

[0038] Optionally, the valve repair device has a closed state (e.g., depending on the different opening angles of the support member 32) Figure 2 As shown), open state (as shown) Figure 3 (as shown) and reverse state (as shown) Figure 4 (As shown); when the valve repair device is in the closed state, the distance between the driving part 2 and the base 31 is at its minimum, and the opening angle of the support member 32 is an acute angle; when the valve repair device is in the open state, the distance between the sliding member 33 and the second rotating joint 302 is at its minimum, and the opening angle of the support member 32 is a right angle; when the valve repair device is in the reverse state, the distance between the driving part 2 and the base 31 is at its maximum, and the opening angle of the support member 32 is an obtuse angle.

[0039] Please refer to the reference. Figures 2 to 4 When the drive unit 2 moves relative to the base 31 along its own axial direction, the opening angle of the support member 32 can be adjusted within a certain range by the axial movement of the drive unit 2. During the transition from the closed state to the open state, the drive unit 2 moves axially towards the proximal end ( Figures 2 to 4 The upper end of the support member 32 moves, causing the end of the support member 32 connected to the second rotating joint 302 to move proximally. At this time, the sliding member 33 moves along the extension direction of the support member 32 toward the direction closer to the second rotating joint 302. Under the action of the sliding member 33 and the base 31, the support member 32 rotates around the second rotating joint 302, and the opening angle gradually increases. When the opening angle of the support member 32 reaches 90°, the sliding member 33 moves to the position closest to the second rotating joint 302 (e.g., the upper end of the support member 32 moves to the position closest to the second rotating joint 302). Figure 3(As shown). Then the drive unit 2 continues to move axially toward the proximal end, the support member 32 continues to rotate around the second rotation joint 302, the opening angle increases, and the sliding member 33 moves away from the second rotation joint 302 along the extension direction of the support member 32.

[0040] Therefore, it can be understood that the valve repair device can actually remain in any of the closed, open, and reverse states, or in a transitional state between the above states. The valve repair device can remain in a form between the closed and open states, or between the open and reverse states, to adapt to actual clamping or movement requirements.

[0041] Preferably, when the valve repair device is in the closed state, its radial dimension is relatively the smallest among all states, which can be used as the delivery configuration. That is, the valve repair device can be configured in the closed state during transcatheter delivery. When clamping the leaflet, the valve repair device may need to be repeatedly adjusted and tried in different states, such as switching to the open state to allow the leaflet to enter the anchor 1, and further adjusting the opening angle of the support 32 to moderately reduce it to match the actual angle of the leaflet, ultimately achieving reliable clamping. For example, the valve repair device can be switched to the reverse state to allow the valve repair device to exit from the valve annulus for retrieval or redeployment.

[0042] Preferably, when the valve repair device is in the closed state, the opening angle of the support member 32 is no greater than 15°; when the valve repair device is in the reverse state, the opening angle of the support member 32 is no less than 150°. Considering the structural space occupied by the base 31, the size of the blood vessel, and the anatomical size of the valve, the opening angle of the support member 32 in the closed state is limited to no more than 15°. Of course, the opening angle of the support member 32 in the closed state can be even smaller. If the base 31 has a certain elasticity, the opening angle of the support member 32 can even be reduced to 0°, that is, the support member 32 can be parallel to the driving part 2. In the reverse state, the opening angle of the support member 32 is related to the length of the support member 32. Considering the structural space occupied by the base 31 and the anatomical dimensions of the valve and heart, the length of the support 32 cannot be extended indefinitely. With a certain length of the support 32, when the maximum opening angle of the support 32 in the reverse state is not less than 150°, the valve repair device in the reverse state can be satisfactorily allowed to pass through the valve annulus and other structures, which is convenient for recycling or redeployment.

[0043] Furthermore, the adjustment unit 3 includes two support members 32 and two sliding members 33; the base 31 includes two support arms 311, which are symmetrically arranged along the axial direction of the drive unit 2; the distal ends of the two support arms 311 are fixedly connected to each other; the distal ends of the two support arms 311 are respectively connected to one of the sliding members 33 through the first rotating joint 301. For valve repair devices, the main application scenarios are mitral and tricuspid valves. Clamping of the leaflets of the mitral and tricuspid valves generally needs to be performed symmetrically in the radial direction of the valve annulus. Therefore, the entire valve repair device is preferably configured symmetrically about the drive unit 2 to adapt to actual needs.

[0044] Preferably, the two arms 311 form a V-shape or U-shape facing the proximal opening. Due to the sliding member 33, the relative displacement and rotation between the support member 32 and the base 31 are decoupled. The two arms 311 of the base 31 can be fixed structures without relative movement, and may not require elasticity. This helps maintain better stability during implantation.

[0045] Optionally, the two support members 32 are rotatably connected to the drive unit 2 via two second rotation joints 302. In some embodiments, the connection ends of the two support members 32 and the drive unit 2 can be connected in parallel, that is, connected to the drive unit 2 via two different second rotation joints 302. The two second rotation joints 302 are located at the same axial position of the drive unit 2, and preferably are equidistant from the axis of the drive unit 2. While maintaining the same structure for the base 31 and the drive unit 2, the separate second rotation joints 302 are advantageous for increasing the adjustment range of the opening angle of the support members 32, i.e., a smaller opening angle in the closed state and a larger opening angle in the reverse state. In other embodiments, to simplify the structure, the connection ends of the two support members 32 and the drive unit 2 can be configured to overlap, i.e., the two support members 32 are connected to the drive unit 2 via the same second rotation joint 302. In this case, the second rotation joint 302 is preferably located on the axis of the drive unit 2.

[0046] Optionally, the drive unit 2 has a connection structure that is detachably connected to the delivery device. It is understood that the delivery device needs to be connected to the valve repair device during catheter delivery and during the adjustment and clamping process after intervention. After clamping, the delivery device needs to be able to separate from the valve repair device so that the delivery device can be removed from the blood vessel, leaving the valve repair device in the heart. Therefore, the delivery device and the drive unit 2 need to be provided with a matching detachable connection structure. This embodiment does not limit the specific form of the connection structure; it can be, for example, a snap-fit ​​connection, a threaded connection, or a magnetic connection, etc., which can be understood and configured by those skilled in the art based on existing technology.

[0047] Optionally, the anchor 1 is disposed on the support 32, and the anchor 1 has an open state and a clamping state for clamping the leaflets. In application, the anchor 1 can clamp the leaflets by switching between the open state and the clamping state, while the opening angle of the support 32 is used to adjust the position of the anchor 1 and the axial angle of the anchor 1 relative to the drive part 2.

[0048] Please refer to Figure 1 Optionally, the anchor 1 includes two connected clamping arms 11, which close elastically when not subjected to external force, so that the anchor 1 is in the clamped state. For ease of implementation and structural simplification, the anchor 1 can utilize elasticity to close the two clamping arms 11. Preferably, one clamping arm 11 is disposed on the support 32, and the other clamping arm 11 is detachably connected to the actuating wire 41 and is used to open under the pull of the actuating wire 41, so that the anchor 1 is switched to the open state, allowing the leaflet to enter the anchor 1. In one example, one end of the two clamping arms 11 is connected to each other, and the other end extends to form a free end. When not subjected to external force (such as the pull of the actuating wire 41), the two clamping arms 11 elastically approach and fit together around the connecting end, thus being in the clamped state for clamping the leaflet. When driven by an external force (pulled by the actuating wire 41), one of the clamping arms 11 rotates around the connecting end and moves away from the other clamping arm 11, forming a space between the two clamping arms 11, allowing the leaflet to enter. Figure 1 The state shown in the right half.

[0049] In some embodiments, the conveying device includes an actuating wire 41, the distal end of which is detachably connected to the anchor 1 (referring to one of its clamping arms 11), and the proximal end extending out of the body for operator manipulation. Of course, the actuation of the anchor 1 is not limited to the use of the actuating wire 41. In other embodiments, magnetic attraction, rack and pinion drives, etc., may also be used. Those skilled in the art can configure it according to actual needs, and this embodiment is not limited in this regard.

[0050] This embodiment of the invention also provides a valve repair system, which includes the valve repair device as described above, and a delivery device; the delivery device is detachably connected to the valve repair device, used to deliver the valve repair device, and used to drive the drive unit 2 to move relative to the base 31. The specific structure of the delivery device can be found in the prior art, and this embodiment does not impose any particular limitation.

[0051] In summary, the valve repair device and valve repair system provided by this utility model include: an anchor, a drive unit, and an adjustment unit; the adjustment unit includes a base, a support member, and a sliding member; the base and the sliding member are rotatably connected via a first rotating joint; the sliding member is movably connected to the support member along the extension direction of the support member; one end of the support member is a free end, and the other end is rotatably connected to the drive unit via a second rotating joint; the drive unit is configured to move relative to the base along its own axial direction, so as to adjust the opening angle between the support member and the drive unit's axial direction by the movement of the sliding member, the rotation of the first rotating joint, and the rotation of the second rotating joint; the anchor is used to clamp the leaflet and is adapted to the opening angle of the support member. This configuration, on the one hand, decouples the relative displacement and rotation between the support member and the base through the sliding member, making the pulling force required to move the support member smaller, the system more stable, and thus the performance of capturing and clamping the leaflet more stable, the closing force greater, and the clamping more reliable. On the other hand, the sliding component reduces the structural encroachment and conflict between the drive unit and the adjustment unit, allowing for a larger adjustable angle of the support component.

[0052] It should be noted that the above embodiments can be combined with each other. The above description is only a description of preferred embodiments of the present utility model and is not intended to limit the scope of the present utility model in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present utility model.

Claims

1. A valve repair device, characterized in that, include: Anchors, drive unit, and adjustment unit; The adjustment unit includes a base, a support, and a sliding component; The base and the sliding member are rotatably connected via a first rotating joint; The sliding member is movably connected to the support member along the extending direction of the support member; one end of the support member is a free end, and the other end is rotatably connected to the driving part through a second rotating joint; The drive unit is configured to move relative to the base along its own axis to adjust the opening angle between the support member and the drive unit's axis by moving the sliding member, rotating the first rotating joint, and rotating the second rotating joint. The anchor is used to clamp the leaflets and is adapted to the opening angle of the support.

2. The valve repair device according to claim 1, characterized in that, The adjustment unit includes two support members and two sliding members; the base includes two support arms, which are symmetrically arranged about the drive unit; the distal ends of the two support arms are fixedly connected to each other; the distal ends of the two support arms are respectively connected to one of the sliding members through the first rotating joint.

3. The valve repair device according to claim 2, characterized in that, The two arms form a V-shape or U-shape with the proximal end opening.

4. The valve repair device according to claim 2, characterized in that, The two support members are rotatably connected to the drive unit via two second rotating joints.

5. The valve repair device according to claim 1, characterized in that, The valve repair device has a closed state, an open state, and a reverse state depending on the different opening angles of the support member; When the valve repair device is in the closed state, the distance between the driving part and the base is at its minimum, and the opening angle of the support member is an acute angle. When the valve repair device is in the open state, the distance between the sliding member and the second rotating joint is at its minimum, and the opening angle of the support member is a right angle. When the valve repair device is in the reverse state, the distance between the driving part and the base is at its maximum value, and the opening angle of the support member is an obtuse angle.

6. The valve repair device according to claim 5, characterized in that, When the valve repair device is in the closed state, the opening angle of the support member is not greater than 15°; when the valve repair device is in the reverse state, the opening angle of the support member is not less than 150°.

7. The valve repair device according to claim 1, characterized in that, The anchor is disposed on the support member, and the anchor has an open state and a clamped state for clamping the leaflets.

8. The valve repair device according to claim 7, characterized in that, The anchor includes two connected clamping arms that close elastically when not subjected to external force, so that the anchor is in the clamped state.

9. The valve repair device according to claim 8, characterized in that, One of the clamping arms is disposed on the support member, and the other clamping arm is detachably connected to the actuating wire and is used to open under the pull of the actuating wire to switch the anchor to an open state, allowing the leaflet to enter the anchor.

10. A valve repair system, characterized in that, The valve repair device includes any one of claims 1 to 9, and further includes a delivery device; the delivery device is detachably connected to the valve repair device and is used to deliver the valve repair device and to drive the drive unit to move relative to the base.

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