Valve clippers and valve repair systems
By using the design of the central shaft cylinder, clamp arm and elastic member in the valve clamp, the self-locking function is realized, solving the problems of cumbersome operation and excessive volume in the prior art, and improving the surgical efficiency and success rate.
Patent Information
- Application Number
- CN202210201648.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-03-02
- Publication Date
- 2025-08-15
- Estimated Expiration
- 2042-03-02
AI Technical Summary
The existing valve clamp cannot be locked actively, and multiple components need to be set up separately for locking, resulting in excessive volume and cumbersome operation, affecting surgical efficiency.
A valve clamper is designed, adopting the structure of a central shaft cylinder, a clamp arm, a sliding member and an elastic member. The elastic member applies a force to the clamp arm without being subjected to external force, keeping it closed, realizing self-locking, and reducing the operating steps and equipment volume.
The surgical efficiency is improved, the volume and mass of the valve clamping device is reduced, the clamping area is increased, and the surgical success rate is improved.
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Figure CN114569288B_ABST
Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a valve clipper and a valve repair system. Background Art
[0002] Heart valves refer to the valves between the atria and ventricles or between the ventricles and arteries. The atrioventricular valves include the mitral valve and the tricuspid valve. The mitral valve is two valves attached to the periphery of the left atrioventricular orifice, connected to the papillary muscles by chordae tendineae, and has the function of preventing blood from the left ventricle from flowing back to the left atrium. Mitral regurgitation is a poor anastomosis of the anterior and posterior leaflets of the mitral valve due to organic or functional changes in the mitral valve leaflets and their related structures. During mitral regurgitation, blood will flow back from the left ventricle to the left atrium, causing a series of pathophysiological changes.
[0003] Surgical valve repair or replacement is considered the standard treatment for this type of disease. However, surgery has disadvantages such as high trauma, significant postoperative pain, slow recovery, and high risk. In recent years, interventional treatment for heart valve disease has rapidly developed due to its advantages such as minimal trauma, relative safety, and good efficacy. Among them, valve repair methods developed based on the principle of surgical valve edge-to-edge suturing technology have been recognized for their high safety, simple technical principles, and high feasibility. During this operation, the valve repair system needs to be disengaged after the clamping arms of the valve clip are locked, allowing the valve clip to remain in the patient's body. In related technologies, the valve clip cannot be actively locked and requires multiple components to be separately provided for locking. However, the structure of multiple components combined with locking not only makes the valve clip too large, but also the locking steps are cumbersome, affecting the efficiency of the operation. Summary of the Invention
[0004] The present invention aims to at least resolve the problem of the valve clipper being unable to actively lock. This objective is achieved through the following technical solutions:
[0005] A first aspect of the present invention provides a valve clipper, comprising:
[0006] Center shaft;
[0007] A plurality of clamping arms, the plurality of clamping arms being arranged around the periphery of the central shaft cylinder, the distal ends of the clamping arms being rotatably connected to the central shaft cylinder;
[0008] a sliding member, the sliding member being axially slidably disposed in the central shaft cylinder, the sliding member partially extending from a distal end of the central shaft cylinder;
[0009] Multiple elastic components, the proximal end of the elastic component is movably connected to the clamp arm, the elastic component is configured to apply a force directed to the central shaft cylinder to the clamp arm under the condition of not being subjected to external force, the distal end of the elastic component is connected to the sliding component, and the elastic component is configured to move and / or deform as the sliding component slides to drive the clamp arm to rotate.
[0010] The valve clipper proposed in an embodiment of the present invention, due to the preloaded elastic force of the elastic member, can apply a force directed toward the central shaft to the clamping arms in the absence of external forces, thereby compressing the clamping arms and maintaining their closed position. This actively locks the clamping arms, eliminating the need for the operator to perform a separate locking step, reducing operational difficulty and thereby improving surgical efficiency. Furthermore, the provision of the elastic member in this embodiment not only drives the clamping arms to rotate but also achieves self-locking, eliminating the need for an additional locking mechanism. This reduces the size and weight of the valve clipper and improves the success rate of the procedure. Furthermore, since no additional locking mechanism is required, the axial dimension of the clamping arms of the valve clipper can be increased, thereby further increasing the contact area with the valve, thereby increasing the clamping area and further improving the clamping effect.
[0011] In addition, the valve clipper according to the embodiment of the present invention may also have the following technical features:
[0012] In some embodiments of the present invention, the valve clamp further includes a pulling member and a capturing member, the capturing member having a movable segment and a fixed segment, a capturing tooth being provided on the side of the movable segment facing the fixed segment, the movable segment being connected to the pulling member, and the fixed segment being connected to the clamp arm.
[0013] In some embodiments of the present invention, a first avoidance hole is provided on the clamping arm, the fixed section passes through the first avoidance hole and is connected to the side of the clamping arm away from the central shaft tube, and the movable section is located on the side of the clamping arm facing the central shaft tube.
[0014] In some embodiments of the present invention, at least one second avoidance hole is provided on the clamping arm, and the capturing tooth can be inserted into the second avoidance hole.
[0015] In some embodiments of the present invention, the capture member has a preloaded closing force, and when not subjected to external force, the movable section is parallel to the fixed section.
[0016] In some embodiments of the present invention, the elastic member is shaped as an arc that bulges away from the central shaft tube, or the elastic member is provided with a bent portion that bulges away from the central shaft tube.
[0017] In some embodiments of the present invention, a slider is provided at the distal end of the sliding member, the elastic member is configured as a U-shaped memory alloy wire, the arc end of the U-shaped memory alloy wire is connected to the clamping arm, and the open end of the U-shaped memory alloy wire is connected to the slider.
[0018] In some embodiments of the present invention, a connection hole is provided through the clamp arm, and the U-shaped memory alloy wire is passed through the connection hole to be rotatably connected to the clamp arm.
[0019] In some embodiments of the present invention, the proximal end of the central shaft is provided with a flange, and when the clamp arm is closed, the valve can be clamped between at least one of the proximal end of the elastic member and the proximal end of the clamp arm and the flange.
[0020] In some embodiments of the present invention, when the clamp arm is closed, the cross-sectional shape of the clamp arm is set to be an arc shape, with the plane perpendicular to the axial direction as the cross-section.
[0021] In some embodiments of the present invention, the number of the clamping arms is set to two, and when the clamping arms are closed, the valve can be clamped between the opposite edges of the two clamping arms.
[0022] A second aspect of the present invention provides a valve repair system, comprising:
[0023] According to any of the above embodiments, a valve clipper and a delivery device are provided, wherein the delivery device is detachably connected to the valve clipper to deliver the valve clipper to a set position, and the delivery device includes at least one driving member, which is connected to the sliding member of the valve clipper to drive the sliding member to slide.
[0024] The valve repair system proposed in the embodiment of the present invention has the same advantages as the valve clipper proposed in any of the above embodiments, which will not be described in detail here. BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The following is a brief introduction to the drawings in the implementation manner. Those skilled in the art can also derive other drawings based on these drawings without making any creative efforts.
[0026] Figure 1 Schematic diagram of the structure of the valve clipper according to an embodiment of the present invention Figure 1 ;
[0027] Figure 2 for Figure 1 A front view of the valve clip shown;
[0028] Figure 3 for Figure 1 Left side view of the valve clip shown;
[0029] Figure 4 for Figure 3 Cross-sectional view in the AA direction;
[0030] Figure 5 Schematic diagram of the structure of the valve clipper according to an embodiment of the present invention Figure 2 ;
[0031] Figure 6 Schematic diagram of the structure of the valve clipper according to an embodiment of the present invention Figure 3 ;
[0032] Figure 7 for Figure 6 A front view of the valve clip shown;
[0033] Figure 8 for Figure 6 a bottom view of the valve clip shown;
[0034] Figure 9 Schematic diagram of the structure of the capture member in the valve clipper according to an embodiment of the present invention Figure 1 ;
[0035] Figure 10 Schematic diagram of the structure of the capture member in the valve clipper according to an embodiment of the present invention Figure 2 ;
[0036] Figure 11 Another schematic front view of the valve clipper according to an embodiment of the present invention;
[0037] Figure 12 Schematic diagram of the structure of a valve repair system according to an embodiment of the present invention;
[0038] Figure 13 It is a cross-sectional schematic diagram of the cooperation between the driving component and the sliding component in the valve repair system according to an embodiment of the present invention.
[0039] The symbols in the accompanying drawings represent the following:
[0040] 1000, valve repair system;
[0041] 100. Valve clip;
[0042] 10. Center shaft; 11. Mounting seat; 101. Flange;
[0043] 20. Clamping arm; 201. First avoidance hole; 202. Connecting ear; 203. Second avoidance hole; 204. Connecting hole; 205. Edge;
[0044] 30. Sliding member;
[0045] 40. Slider;
[0046] 50, elastic member; 501, bending portion; 51, U-shaped memory alloy wire; 511, arc end; 512, open end;
[0047] 60. Capturing member; 61. Movable segment; 611. Capturing teeth; 62. Fixed segment;
[0048] 70. Pulling member;
[0049] 810. Handle; 820. Sheath; 830. Bending adjustment mechanism; 840. Driving component. DETAILED DESCRIPTION
[0050] The following will refer to the drawings in the embodiments of the present invention. The terms used in the text are only for the purpose of describing specific example implementation methods and are not to be understood as limiting the present invention. For example, the terms "including" and "having" not only indicate the existence of the stated features, but also do not exclude the existence of other features; the terms "first" and "second" do not imply a sequence or order; the terms "inside", "outside", "above", and "below" are only for the convenience of describing the relationship of one feature relative to another feature shown in the drawings, and do not indicate that they must have a specific orientation. It should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device in its natural state. In the description of the present invention, the above definitions are only for the convenience of expression and are not to be understood as limiting the present invention.
[0051] See also Figures 1 to 5 An embodiment of the first aspect of the present invention provides a valve clipper 100, which includes a central shaft 10, a sliding member 30, a plurality of clamping arms 20, and a plurality of elastic members 50. The plurality of clamping arms 20 are arranged around the periphery of the central shaft 10, and the distal ends of the clamping arms 20 are rotatably connected to the central shaft 10. The sliding member 30 is axially slidably arranged in the central shaft 10, and the sliding member 30 partially extends from the distal end of the central shaft 10. The proximal end of the elastic member 50 is movably connected to the clamping arms 20. The elastic member 50 is configured to apply a force directed toward the central shaft 10 to the clamping arms 20 in the absence of external force. The distal end of the elastic member 50 is connected to the sliding member 30. The elastic member 50 is configured to move and / or deform as the sliding member 30 slides to drive the clamping arms 20 to rotate.
[0052] The valve clipper 100 proposed in this embodiment can be used as an edge-to-edge repair implant in the field of interventional treatment of heart disease. The valve clipper 100 proposed in this embodiment can reach a designated position through a minimally invasive entrance through the body surface and blood vessels to achieve repair treatment of heart valves (including but not limited to the mitral valve, tricuspid valve, aortic valve, and pulmonary valve).
[0053] In this embodiment, the elastic member 50 has a preloaded elastic force. In the initial state, it can apply a force directed toward the central shaft cylinder 10 to the clamp arm 20, that is, a force along the closing direction of the clamp arm 20, thereby pressing the clamp arm 20 to keep it in a closed state. When the operator controls the sliding member 30 to slide, the elastic member 50 can rotate or deform, or deform while rotating, thereby driving the clamp arm 20 connected thereto to rotate and open, and then the clamp arm 20 can be used to clamp the valve; when the valve clipper 100 completes clamping, the elastic member 50 can rotate and deform as the sliding member 30 slides. When the shape of the elastic member 50 returns to the initial state, it can continue to compress the clamp arm 20, so that the clamp arm 20 remains in a closed state. In this way, the elastic member 50 can actively lock the clamp arm 20, eliminating the need for the operator to perform a separate locking step, reducing the difficulty of operation and thereby improving surgical efficiency. Furthermore, it is understandable that because the valve clip 100 needs to be implanted inside the patient's heart, particularly when introduced via minimally invasive access or vascular access, the size of the valve clip 100 is severely limited. In this embodiment, the provision of an elastic member 50 within the valve clip 100 not only drives the clamping arm 20 to rotate but also achieves self-locking, eliminating the need for a locking mechanism. This reduces the size and weight of the valve clip 100 and improves the success rate of the procedure. Furthermore, while maintaining the same axial dimensions, the absence of a locking mechanism allows the axial dimensions of the clamping arm 20 of the valve clip 100 to be increased, thereby further increasing the contact area with the valve, thereby increasing the clamping area and further improving the clamping effect.
[0054] See also Figure 2 、 Figure 4 and Figure 5 In this embodiment, the central shaft cylinder 10 is located at the center of the valve clipper 100. The central shaft cylinder 10 is used to connect the clamping arms 20 and to provide a sliding channel for the sliding member 30. For example, the central shaft cylinder 10 can be set to a cylindrical shape, with a cavity inside the central shaft cylinder 10. The sliding member 30 can slide axially in the cavity. A plurality of clamping arms 20 are connected to the outer wall of the central shaft cylinder 10. Specifically, the distal ends of the clamping arms 20 are rotatably connected to the central shaft cylinder 10. There are many ways of rotatable connection, which can be hinged or connected by a rotating shaft. This embodiment does not specifically limit this. Further, as Figure 5 As shown, a mounting seat 11 can be provided at the distal end of the central shaft tube 10 along the circumferential direction. In this embodiment, the mounting seat 11 can be integrally formed on the central shaft tube 10, and the end of the clamping arm 20 can be connected to the mounting seat 11, which not only facilitates assembly but also improves the reliability of the connection between the clamping arm 20 and the central shaft tube 10. Figure 1 and Figure 2As shown, taking the example of two clamping arms 20, in an optional embodiment, the distal end of each clamping arm 20 can extend to be provided with two connecting ears 202, and the two connecting ears 202 extend to both sides of the central shaft tube 10 respectively, and are connected to the mounting seat 11 on the central shaft tube 10 through a rotating shaft.
[0055] Furthermore, in this embodiment, the distal end of the elastic member 50 is connected to the sliding member 30, and the proximal end of the elastic member 50 is movably connected to the clamp arm 20. Therefore, when the sliding member 30 slides axially, it drives the elastic member 50 to move, and the elastic member 50 applies a pulling force or a pushing force to the clamp arm 20, thereby driving the clamp arm 20 to rotate and expand or close. For example, when the valve clipper 100 proposed in this embodiment is used, the operator operates the sliding member 30 to slide distally, driving the elastic member 50 and the clamp arm 20 to rotate until the clamp arm 20 opens, thereby positioning the valve between the central shaft 10 and the clamp arm 20. The operator operates the sliding member 30 to slide proximally, driving the elastic member 50 and the clamp arm 20 to rotate until the clamp arm 20 closes, thereby clamping the valve between the central shaft 10 and the clamp arm 20.
[0056] For further information, please refer to Figure 4 and Figure 5 , and refer to Figure 9 and Figure 10 In some embodiments of the present invention, the valve clipper 100 further includes a capture member 60 and a pulling member 70. The pulling member 70 is connected to the capture member 60 and is used for the operator to pull the pulling member 70 to drive the capture member 60 to move. The pulling member 70 can be set as a non-metallic wire or a metal wire; the capture member 60 can be set between the clamping arm 20 and the central shaft tube 10 to capture the valve and improve the accuracy and stability of the valve clipper 100 in clamping the valve. Figure 4 、 Figure 9 and Figure 10 As shown, in an optional embodiment, the capture member 60 includes a movable segment 61 and a fixed segment 62, wherein the movable segment 61 is connected to the pulling member 70, and the fixed segment 62 is connected to the clamping arm 20. It is understandable that the capture member 60 can be pre-molded to have a preloaded closing force, whereby the fixed segment 62 and the clamping arm 20 are relatively fixed, and the movable segment 61 can move under the pull of the pulling member 70, that is, the movable segment 61 can rotate relative to the fixed segment 62, thereby capturing the valve, so that the valve is captured between the movable segment 61 and the fixed segment 62, that is, the valve is captured between the movable segment 61 and the clamping arm 20.
[0057] Furthermore, if Figure 4 、 Figure 9 and Figure 10As shown, in this embodiment, a capture tooth 611 is provided on the side of the movable segment 61 facing the fixed segment 62. The capture teeth 611 may be provided in multiple numbers, for example, as a plurality of barbed structures integrally formed on the capture member 60. Exemplarily, the movable segment 61 and the fixed segment 62 are integrally formed and have a preloaded closing force. For example, the capture member 60 may be provided as a memory alloy sheet, pre-formed and bent to form the connected movable segment 61 and fixed segment 62, as well as the capture teeth 611 on the movable segment 61. During use of the valve clipper 100, the capture member 60 is initially in a closed state. When the valve is positioned between the clamping arm 20 and the central shaft 10, the operator can pull the movable segment 61 of the capture member 60 using the pulling member 70. The rotation of the movable segment 61 controls the position of the capture teeth 611, causing the capture teeth 611 to engage with the valve, thereby closing the clamping arm 20 and completing valve clipping.
[0058] For further information, please refer to Figure 3 and Figure 4 , the movable section 61 is located on the side of the clamping arm 20 facing the central shaft cylinder 10, and can move between the clamping arm 20 and the central shaft cylinder 10. The fixed section 62 is connected to the clamping arm 20. In this embodiment, there are many ways to connect the fixed section 62 to the clamping arm 20. For example, the fixed section 62 can be connected to the side of the clamping arm 20 facing the central shaft cylinder 10, that is, the inner side of the clamping arm 20, or it can be connected to the side of the clamping arm 20 away from the central shaft cylinder 10, that is, the outer side of the clamping arm 20. For example, in an optional embodiment, a first avoidance hole 201 is provided on the clamping arm 20, and the fixed section 62 passes through the first avoidance hole 201 and is connected to the side of the clamping arm 20 away from the central shaft cylinder 10. The first avoidance hole 201 is close to the distal end of the clamping arm 20, such as Figure 2 and Figure 3 As shown, when two connecting ears 202 are provided at the distal end of the clamping arm 20, the first avoidance hole 201 can be set as a gap located between the two connecting ears 202, and the fixing section 62 extends from the gap to the outside of the clamping arm 20 and can be attached to the outer surface of the clamping arm 20. The fixing section 62 is connected to the clamping arm 20, and the connection method can be welding, riveting, etc.
[0059] In an optional embodiment, a welding post is protruding from the side of the fixed segment 62 facing the movable segment 61. Accordingly, a hole is provided on the clamp arm 20 to mate with the welding post. During assembly, the welding post mates with the hole and further connects the fixed segment 62 to the clamp arm 20 through welding, thereby saving radial space and improving the reliability of the connection. This embodiment, by positioning the fixed segment 62 of the capture member 60 outside the clamp arm 20, saves space between the clamp arm 20 and the central shaft 10, thereby reducing the overall radial dimension of the valve clip 100. Furthermore, in this embodiment, the connection between the fixed segment 62 and the movable segment 61 extends in the direction that coincides with the thickness of the clamp arm 20, fully utilizing space and making the structure more compact. This further reduces the volume of the valve clip 100, thereby facilitating implantation of the valve clip 100.
[0060] On the basis of the above implementation mode, Figure 4 and Figure 8 As shown, the clamp arm 20 is provided with at least one second avoidance hole 203, into which the capture teeth 611 can be inserted. It is understood that the movable segment 61 and the fixed segment 62 of the capture member 60 are relatively rotatable. When the fixed segment 62 is connected to the clamp arm 20, the movable segment 61 can move toward or away from the clamp arm 20. The capture teeth 611 provided on the movable segment 61 face the clamp arm 20. Therefore, by providing the second avoidance hole 203 on the clamp arm 20, this embodiment allows the capture teeth 611 to be inserted into the second avoidance hole 203, thereby preventing interference or wear between the capture teeth 611 and the clamp arm 20. This further reduces the overall radial dimension of the valve clipper 100, facilitating its implantation. In this embodiment, one or more second avoidance holes 203 may be provided. The number of second avoidance holes 203 is determined by the number and position of the capture teeth 611, and this is not specifically limited in this embodiment.
[0061] Furthermore, based on the above embodiment, Figure 4 and Figure 9 As shown, the capture member 60 has a preloaded closing force when not subject to external force, and the movable segment 61 is parallel to the fixed segment 62. Therefore, the fixed segment 62 is in contact with and connected to the clamp arm 20, and the movable segment 61 is parallel or nearly parallel to the clamp arm 20. This arrangement not only ensures that the capture teeth 611 on the movable segment 61 cooperate smoothly with the second avoidance holes 203 on the clamp arm 20, thereby reducing the radial size of the valve clipper 100, but also ensures that after the clamp arm 20 is closed, the valve located between the clamp arm 20 and the movable segment 61 is firmly clamped, thereby ensuring the reliability of the clamping.
[0062] Please continue reading Figure 1 and Figure 2In the valve clipper 100 proposed in this embodiment, one end of the elastic member 50 is connected to the sliding member 30, and the other end is connected to the clamping arm 20. The number of elastic members 50 is equal to the number of clamping arms 20, and each elastic member 50 drives one clamping arm 20 to open and close. For example, when the clamping arm 20 is in the closed state, the elastic member 50 is also in the closed state and can apply a thrust to the clamping arm 20 toward the central shaft 10 to prevent the clamping arm 20 from opening; see Figures 5 to 8 When the sliding member 30 slides, the elastic member 50 is driven to move, and the elastic member 50 gradually opens, or gradually opens and then gradually closes, and continues to pull the clamping arm 20, so that the clamping arm 20 gradually opens. During this process, the elastic member 50 applies a pulling force to the clamping arm 20 until the clamping arm 20 opens to the set maximum angle, such as Figure 6 and Figure 7 As shown, the maximum angle is greater than 180°; when the valve is captured successfully and the clamp arm 20 needs to be closed, the sliding member 30 drives the elastic member 50 to move, so that the elastic member 50 gradually closes, or gradually opens to the maximum angle and then gradually closes, and continues to push the clamp arm 20, so that the clamp arm 20 gradually closes. During this process, the elastic member 50 applies a thrust to the clamp arm 20, so that the clamp arm 20 eventually returns to the initial closed state, and the elastic member 50 has elastic force in this state and continuously presses the clamp arm 20 to prevent the clamp arm 20 from opening, thereby completing the valve clamping.
[0063] On the basis of the above embodiment, the connection between the elastic member 50 and the sliding member 30 can be welding, the shape of the sliding member 30 is set to be rod-shaped, the sliding member 30 is slidably set in the central shaft cylinder 10, and the distal end of the sliding member 30 can extend out of the central shaft cylinder 10, such as Figure 5 and Figure 6 As shown, in an optional embodiment, a slider 40 is provided at the distal end of the sliding member 30. The slider 40 is located outside the central shaft 10. Thus, the distal end of the elastic member 50 can be connected to the slider 40, specifically by welding to ensure a reliable connection. When the sliding member 30 slides, the slider 40 moves axially and drives the elastic member 50 to move.
[0064] Furthermore, the elastic member 50 can be arranged in a variety of ways. For example, the elastic member 50 can be arranged as a sheet, rod or other elastic member, such as a memory alloy. In some embodiments of the present invention, for example Figures 5 to 7 As shown, the shape of the elastic member 50 is set to be an arc convex in the direction away from the central shaft cylinder 10, for example, it can be set to be an arc-shaped sheet, or as shown in FIG. Figures 1 to 4As shown, the elastic member 50 is provided with a bending portion 501 protruding in a direction away from the central shaft tube 10. The bending portion 501 can be set to an arc-shaped bend. In this embodiment, the elastic member 50 can be pre-formed with a preloaded elastic force. Therefore, when the clamping arm 20 and the elastic member 50 are both in a closed state, the proximal end of the elastic member 50 presses the clamping arm 20 inward to keep the clamping arm 20 in a closed state.
[0065] In some embodiments of the present invention, the elastic member 50 is configured as a U-shaped memory alloy wire 51, for example, a U-shaped nickel-titanium alloy wire. Figures 5 to 7 As shown, the two ends of the U-shaped memory alloy wire 51 are respectively an arc end 511 and an open end 512. Between the arc end 511 and the open end 512, the shape of the U-shaped memory alloy wire 51 is set to be an arc convex in the direction away from the central shaft cylinder 10, or as shown in FIG. Figures 1 to 4 As shown, the U-shaped memory alloy wire 51 is provided with a bent portion 501 that protrudes in a direction away from the central shaft tube 10. It can be understood that the U-shaped memory alloy wire 51 includes two connected sections of alloy wire, the two sections of alloy wire are equal in length, and are both arranged in an arc shape or have a bent portion 501. On this basis, the arc end 511 of the U-shaped memory alloy wire 51 is connected to the clamping arm 20, and the open end 512 of the U-shaped memory alloy wire 51 is connected to the slider 40. For example, the slider 40 can be provided with a mounting hole, and the two ends of the open end 512 of the U-shaped memory alloy wire 51 extend into the mounting hole to connect to the slider 40. The connection reliability can be further improved by welding.
[0066] Furthermore, if Figure 2 and Figure 3 As shown, in some embodiments of the present invention, a connecting hole 204 is provided through the clamp arm 20, and the penetrating direction of the connecting hole 204 is the same as the thickness direction of the clamp arm 20. The U-shaped memory alloy wire 51 is passed through the connecting hole 204 and is rotatably connected to the clamp arm 20. In an optional embodiment, as Figure 2 As shown, each clamping arm 20 is provided with two connecting holes 204. During the assembly process, the two ends of the open end 512 of the U-shaped memory alloy wire 51 can extend from the inner side of the clamping arm 20 through the two connecting holes 204 to the outer side of the clamping arm 20, until the arc end 511 of the U-shaped memory alloy wire 51 abuts against the inner side of the clamping arm 20. In another optional embodiment, as Figure 11 As shown, each clamp arm 20 is provided with four connecting holes 204. During the assembly process, the two ends of the open end 512 of the U-shaped memory alloy wire 51 can extend from the outside of the clamp arm 20 through the two connecting holes 204 near the proximal end to the inside of the clamp arm 20, and then extend from the inside of the clamp arm 20 through the remaining two connecting holes 204 to the outside of the clamp arm 20.
[0067] In this embodiment, the clamp arm 20 rotates around the connection with the central shaft tube 10 under the drive of the elastic member 50. The shape of the clamp arm 20 can be set in various ways. For example, it can be set as a rectangular sheet or as an arc-shaped sheet. In some embodiments of the present invention, when the clamp arm 20 is closed, the cross-section of the clamp arm 20 is an arc-shaped, with the plane perpendicular to the axial direction as the cross-section. When the valve clamper 100 proposed in this embodiment is in use, the valve can be clamped between the central shaft tube 10 and the clamp arm 20. The arc-shaped clamp arm 20 can increase the contact area with the valve and improve the clamping effect. At the same time, a accommodating space can be formed on the inner side of the clamp arm 20 to accommodate the capture member 60 and the central shaft tube 10.
[0068] Please continue reading Figures 1 to 5 In some embodiments of the present invention, the number of the clamping arms 20 is set to two, and the two clamping arms 20 are symmetrical about the central shaft tube 10. When the clamping arms 20 are closed, the valve can be clamped between the opposite edges of the two clamping arms 20. It can be understood that Figure 2 As shown, each clamp arm 20 has two edges 205 . The opposite edges 205 of the two clamp arms 20 can contact or form a gap, and can clamp the valve between the two edges 205 , thereby further improving the clamping effect on the valve.
[0069] Furthermore, if Figure 2 and Figure 4 As shown, in some embodiments of the present invention, a flange 101 is provided at the proximal end of the central shaft tube 10, and the cross-sectional shape of the flange 101 can be circular, rectangular or irregular in shape, with the plane perpendicular to the axial direction as the cross-section. This embodiment does not make any specific limitation on this. In an optional embodiment, the opposite side walls of the flange 101 are respectively set to planes or arc surfaces. When the clamp arm 20 is closed, the valve can be clamped between the proximal end portion of the elastic member 50 and the proximal end portion of the clamp arm 20 and the flange 101, that is, the proximal end portion of the elastic member 50 (for example, the arc end 511 of the U-shaped memory alloy wire 51) contacts the flange 101 or forms a gap smaller than the thickness of the valve, thereby clamping the valve; or, the proximal end portion of the clamp arm 20 contacts the flange 101 or forms a gap smaller than the thickness of the valve, thereby clamping the valve; or, the proximal end portion of the elastic member 50 (for example, the arc end 511 of the U-shaped memory alloy wire 51) and the proximal end portion of the clamp arm 20 respectively contact the flange 101 or form a gap smaller than the thickness of the valve, thereby clamping the valve, thereby further improving the clamping effect of the valve.
[0070] See also Figure 12The second embodiment of the present invention provides a valve repair system 1000, which includes a delivery device and the valve clip 100 according to the embodiment of the first embodiment. The delivery device is detachably connected to the valve clip 100 to deliver the valve clip 100 to a set position. The delivery device includes at least one driving member 840, which is connected to the sliding member 30 of the valve clip 100 to drive the sliding member 30 to slide. Figure 13 As shown, taking the sliding member 30 as a rod-shaped example, the proximal end of the sliding member 30 can be provided with a blind hole, and an internal thread is provided in the blind hole. The driving member 840 can be specifically provided as a metal wire, and the outer wall of the driving member 840 near the distal end is provided with an external thread that matches the above-mentioned internal thread, thereby connecting the distal end of the driving member 840 to the sliding member 30.
[0071] like Figure 12 As shown, the delivery device in this embodiment may include a handle 810, a sheath assembly and a connecting mechanism, wherein the sheath assembly includes a bending mechanism 830 and a plurality of sheaths 820 that are sequentially sleeved, the handle 810 is connected to the sheath assembly and can control part or all of the sheaths 820 in the sheath assembly to reach a set position in the patient's body, the bending mechanism 830 can control part or all of the sheaths 820 in the sheath assembly to bend at a set position, and the pulling member 70 of the capture mechanism in the valve clip 100 can be connected The valve clip 100 is inserted into the handle 810, thereby facilitating the operator's operation of the capture member 60 through the handle 810. The connecting mechanism is connected to the distal end of the innermost sheath 820 and is detachably connected to the valve clip 100. Thus, when the valve clip 100 is delivered to a set position, the valve clip 100 adjusts its position according to the bending and movement of the sheath 820. After the valve clip 100 clamps the valve and locks, the connecting mechanism disengages from the valve clip 100, allowing the valve clip 100 to remain in the patient's body. Based on the above embodiment, the connecting mechanism and the valve clip 100 can be detachably connected by interlocking a mortise and tenon structure.
[0072] The working process of the valve repair system 1000 proposed in this embodiment is described in detail below. The following embodiment is described by taking the valve clipper 100 including two clamping arms 20 as an example.
[0073] The operator operates the handle 810 to move the sheath assembly and the valve clipper 100 connected to the sheath 820 according to the set steps, through the minimally invasive entrance on the body surface and the blood vessels to the set position of the mitral valve, and first uses the handle 810 to push the driving member 840, such as Figure 5 and Figure 6As shown, the sliding member 30 of the valve clipper 100 is moved distally, driving the elastic member 50 connected thereto to rotate and deform, thereby gradually opening the clamping arms 20 under the pull of the elastic member 50. The pulling member 70 is then pulled by the handle 810, causing the movable segment 61 of the capture member 60 to rotate closer to the central shaft 10. When the valve is in the set position, the pulling member 70 is released, causing the capture teeth 611 on the movable segment 61 to engage with the valve to complete the capture. Finally, the driving member 840 is pulled by the handle 810, causing the sliding member 30 to move proximally, driving the elastic member 50 to return to its initial closed state, thereby gradually closing the two clamping arms 20 under the push of the elastic member 50 to clamp the valve. Finally, the driving member 840 is disconnected from the sliding member 30, the connecting mechanism is disconnected from the valve clipper 100, and the driving member 840 and sheath assembly are withdrawn, leaving the valve clipper 100 in the patient's body in a valve-clamping state.
[0074] The above are merely preferred embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included in the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.
Claims
1. A valve clipper, characterized in that: include: Center shaft; A plurality of clamping arms, the plurality of clamping arms being arranged around the periphery of the central shaft cylinder, the distal ends of the clamping arms being rotatably connected to the central shaft cylinder; A sliding member is axially slidably disposed in the central shaft cylinder, wherein the sliding member partially extends from a distal end of the central shaft cylinder and is provided with a slider; Multiple elastic members, the proximal end of the elastic member is movably connected to the clamp arm, the elastic member has a protrusion facing away from the central axis tube, and is configured to apply a force directed to the central axis tube to the clamp arm under working conditions without external force, the distal end of the elastic member is connected to the sliding member, and the elastic member is configured to move and / or deform as the sliding member slides to drive the clamp arm to rotate.
2. The valve clipper according to claim 1, characterized in that: The valve clipper further includes a pulling member and a capturing member, wherein the capturing member has a movable section and a fixed section, and a capturing tooth is provided on a side of the movable section facing the fixed section. The movable section is connected to the pulling member, and the fixed section is connected to the clamp arm.
3. The valve clipper according to claim 2, characterized in that: The clamp arm is provided with a first avoidance hole, the fixed section passes through the first avoidance hole and is connected to the side of the clamp arm away from the central shaft tube, and the movable section is located on the side of the clamp arm facing the central shaft tube.
4. The valve clipper according to claim 2, characterized in that: At least one second avoidance hole is provided on the clamping arm, and the capturing tooth can be inserted into the second avoidance hole.
5. The valve clip according to any one of claims 2 to 4, characterized in that: The capture member has a preloaded closing force, and when not subject to external force, the movable section is parallel to the fixed section.
6. The valve clipper according to claim 1, characterized in that: The elastic member is configured to be in the shape of an arc that bulges in a direction away from the central shaft tube, or the elastic member is provided with a bent portion that bulges in a direction away from the central shaft tube.
7. The valve clip according to claim 1 or 6, characterized in that: The elastic component is configured as a U-shaped memory alloy wire, the arc end of the U-shaped memory alloy wire is connected to the clamping arm, and the open end of the U-shaped memory alloy wire is connected to the slider.
8. The valve clip according to claim 7, characterized in that: A connecting hole is provided through the clamping arm, and the U-shaped memory alloy wire is passed through the connecting hole to be rotatably connected with the clamping arm.
9. The valve clipper according to claim 1, characterized in that: The proximal end portion of the central shaft is provided with a flange, and when the clamp arms are closed, the valve can be clamped between at least one of the proximal end portion of the elastic member and the proximal end portion of the clamp arms and the flange.
10. The valve clipper according to claim 1, characterized in that: When the clamp arm is closed, the cross-sectional shape of the clamp arm is set to be an arc, with the plane perpendicular to the axial direction as the cross-section.
11. The valve clip according to claim 10, characterized in that: The number of the clamping arms is set to two, and when the clamping arms are closed, the valve can be clamped between the opposite edges of the two clamping arms.
12. A valve repair system, characterized in that: The valve repair system comprises: A valve clipper, wherein the valve clipper is the valve clipper according to any one of claims 1 to 11; A delivery device is detachably connected to the valve clipper to deliver the valve clipper to a set position. The delivery device includes at least one driving member connected to the sliding member of the valve clipper to drive the sliding member to slide.
Citation Information
Patent Citations
Valve holder
CN112826639A