Valve clippers and valve repair systems
By adopting a snap-fit design between the locking spring and the sliding component in the valve clamp, the problem of the locking mechanism occupying axial space is solved, the clamping effect is improved and the operation is convenient, and the burden on the patient's heart is reduced.
Patent Information
- Application Number
- CN202111499550.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-12-09
- Publication Date
- 2025-09-12
- Estimated Expiration
- 2041-12-09
AI Technical Summary
The locking mechanism of the existing valve clamp occupies too much axial space, resulting in insufficient size of the clamp arm and affecting the clamping effect.
The locking spring and the sliding component are connected by a design, and locking is achieved through the window of the central shaft tube to avoid additional axial space occupation. The control component is used to control the elastic deformation of the locking spring to release the connection and realize the rotation of the clamping arm.
The clamping effect is improved, the structure is simple and the operation is convenient, the burden on the patient's heart is reduced, and the overall weight is lighter.
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Figure CN114176838B_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 great trauma, significant postoperative pain, slow recovery, and high risk. In recent years, interventional treatment of heart valve disease has developed rapidly due to its advantages such as less trauma, relative safety, and good efficacy. Among them, the valve repair method developed based on the principle of surgical valve edge-to-edge suturing technology has been recognized for its high safety, simple technical principles, and high feasibility. During this operation, the valve repair system needs to be disengaged after the clamp arm of the valve clip is locked, so that the valve clip remains in the patient's body.
[0004] However, the locking mechanism of the valve clamp in the related art includes multiple components, such as a baffle, a baffle frame, and an elastic member. Under the premise of using the baffle frame to limit the position, the elastic member is used to push the baffle to tilt the baffle to prevent the clamp arm from rotating. Such a locking mechanism has a large axial dimension and occupies too much axial space of the valve clamp, resulting in a correspondingly shorter clamp arm of the valve clamp and a poor clamping effect. Summary of the Invention
[0005] The present invention aims to at least address the problem of poor clipping performance of valve clippers. This objective is achieved through the following technical solutions:
[0006] A first aspect of the present invention provides a valve clipper, comprising:
[0007] A central shaft cylinder, wherein a window is provided on a side wall of the central shaft cylinder;
[0008] A plurality of clamping arms, wherein the plurality of clamping arms are arranged around the periphery of the central shaft cylinder;
[0009] a sliding member, the sliding member being slidably disposed within the central shaft cylinder, the sliding member being connected to the clamping arm via a pivot mechanism so that the clamping arm rotates according to the axial sliding of the sliding member, and a clamping portion being provided on a side wall of the sliding member;
[0010] The locking mechanism includes a control member and a locking spring, the locking spring has a movable section and a fixed section connected to the central shaft tube, the locking spring is provided with a clamping piece, the clamping piece extends into the window and is clamped with the clamping portion, the control member is connected to the locking spring, and can control the clamping piece to move away from the clamping portion to release the clamping.
[0011] The valve clamper proposed in the embodiment of the present invention is provided with a locking spring sheet, and a window is provided on the side wall of the central shaft tube. The clamping piece on the locking spring sheet extends into the window and is engaged with the clamping part on the sliding member, thereby preventing the sliding member from sliding axially and further preventing the clamping arm from rotating. As a result, the locking mechanism does not occupy additional axial space of the valve clamper, thereby facilitating the growth of the clamping arm of the valve clamper, improving the clamping effect, and solving the problem of poor clamping effect of the valve clamper. In addition, when the clamping arm needs to be rotated to open and close, the control member can be used to control the locking spring sheet to produce elastic deformation away from the sliding member, thereby releasing the engagement between the locking spring sheet and the sliding member. Not only is the structure simple, but the operation is also convenient.
[0012] In addition, the valve clipper according to the embodiment of the present invention may also have the following technical features:
[0013] In some embodiments of the present invention, a mounting seat is provided on the central shaft, and the fixing section is connected to the mounting seat.
[0014] In some embodiments of the present invention, a slot is provided on the mounting seat, the fixing section is snapped into the slot, and / or the fixing section is welded to the slot.
[0015] In some embodiments of the present invention, the fixed segment is located on the proximal side of the movable segment, the control member is configured as a pulling member, and the pulling member is connected to the movable segment.
[0016] In some embodiments of the present invention, the pulling member is configured as a metal wire or a non-metal wire.
[0017] In some embodiments of the present invention, the clamping portion includes a plurality of first engaging teeth, the clamping member includes a boss and a plurality of second engaging teeth arranged on the boss, and the plurality of first engaging teeth and the plurality of second engaging teeth are arranged axially and engage with each other.
[0018] In some embodiments of the present invention, the locking spring is configured as a shape memory alloy spring, and / or the locking spring is provided with a hollow portion, and at least part of the hollow portion is located between the fixing section and the clamping member.
[0019] In some embodiments of the present invention, two locking elastic sheets are provided, and the two locking elastic sheets are symmetrically arranged on both sides of the central shaft.
[0020] In some embodiments of the present invention, there are multiple sliding components, each of which includes a sliding rod and at least one sliding cylinder sleeved outside the sliding rod. The clamping portion is provided on the sliding rod, and the sliding cylinder is provided with an opening corresponding to the window.
[0021] A second aspect of the present invention provides a valve repair system, which includes a valve clipper according to any of the above embodiments and a delivery device, 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.
[0022] 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
[0023] 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.
[0024] Figure 1 Schematic diagram of the structure of the valve clipper (a sliding member) according to an embodiment of the present invention Figure 1 ;
[0025] Figure 2 Schematic diagram of the structure of the valve clipper (a sliding member) according to an embodiment of the present invention Figure 2 ;
[0026] Figure 3 Schematic diagram of the partial structure of the valve clipper (locked state) according to an embodiment of the present invention;
[0027] Figure 4 Schematic diagram of the partial structure of the valve clipper (unlocked state) according to an embodiment of the present invention;
[0028] Figure 5 for Figure 3 The main view;
[0029] Figure 6 for Figure 5 Cross-sectional view in the AA direction;
[0030] Figure 7 Schematic diagram of the structure of the valve clipper (two sliding components) according to an embodiment of the present invention Figure 1 ;
[0031] Figure 8 Schematic diagram of the structure of the valve clipper (two sliding components) according to an embodiment of the present invention Figure 2 ;
[0032] Figure 9 for Figure 7 A front view of the partial structure of the valve clip (locked state) shown;
[0033] Figure 10 for Figure 9 Cross-sectional view in the middle BB direction;
[0034] Figure 11 Schematic diagram of the structure of a valve repair system according to an embodiment of the present invention;
[0035] Figure 12 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.
[0036] The symbols in the accompanying drawings represent the following:
[0037] 1000, valve repair system;
[0038] 100. Valve clip;
[0039] 10. Center shaft; 101. Window; 11. Mounting seat;
[0040] 20. Clamping arm; 201. Avoidance groove; 202. Connecting ear;
[0041] 30. Sliding member; 301. Clamping portion; 3011. First engaging tooth; 31. First sliding rod; 32. Second sliding rod; 33. Sliding cylinder; 331. Opening;
[0042] 40. Pivoting mechanism; 41. Base; 42. Linkage arm;
[0043] 50. Locking mechanism; 51. Control member; 52. Locking spring; 5201. Hollow portion; 5202. Connecting hole; 521. Movable section; 522. Fixed section; 523. Connecting member; 5231. Boss; 5232. Second engaging tooth;
[0044] 60. Capture components;
[0045] 710. Handle; 720. Sheath; 730. Bending mechanism; 740. Driving component. DETAILED DESCRIPTION
[0046] As described in the background technology, taking mitral valve repair surgery as an example, the clamping arms of the valve clamp need to be locked after clamping the valve, that is, to prevent the clamping arms from rotating and unfolding. In some existing valve clamps, the locking mechanism includes multiple components. Since the valve clamp is an implant with limited volume, the overall axial dimension of the valve clamp is generally less than 16 mm. Therefore, when multiple components are combined to achieve locking, the locking mechanism will occupy a larger axial space, resulting in the axial dimension of the clamping arm needing to be reduced accordingly, affecting the clamping effect of the clamping arm. In response to the above problems, the present invention proposes a valve clamper and a valve repair system, in which a locking spring is provided in the valve clamper, and a window is provided on the side wall of the central shaft tube. The clamping piece on the locking spring extends into the window and engages with the sliding member, thereby preventing the sliding member from sliding and further preventing the clamping arm from rotating. As a result, the locking mechanism does not occupy additional axial space of the valve clamper; when the clamping arm needs to rotate open and close, the control member can be used to control the locking spring to produce elastic deformation away from the sliding member, thereby releasing the engagement between the locking spring and the sliding member. It is not only simple in structure but also easy to operate.
[0047] 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.
[0048] See also Figures 1 to 6The embodiment of the present invention provides a valve clipper 100, which includes a central shaft cylinder 10, a sliding member 30, a locking mechanism 50, and a plurality of clamping arms 20. A window 101 is provided on the side wall of the central shaft cylinder 10; the plurality of clamping arms 20 are arranged around the periphery of the central shaft cylinder 10; the sliding member 30 is slidably arranged in the central shaft cylinder 10, and the sliding member 30 and the clamping arms 20 are connected by a pivot mechanism 40 so that the clamping arms 20 can slide in accordance with the axial direction of the sliding member 30. Now rotate, the side wall of the sliding member 30 is provided with a clamping portion 301; the locking mechanism 50 includes a control member 51 and a locking spring 52, the locking spring 52 has a movable section 521 and a fixed section 522 connected to the central shaft tube 10, and a clamping member 523 is provided on the locking spring 52, the clamping member 523 extends into the window 101 and is clamped with the clamping portion 301, the control member 51 is connected to the locking spring 52, and can control the clamping member 523 to move away from the clamping portion 301 to release the clamping.
[0049] The valve clip 100 proposed in this embodiment can be used as an edge-to-edge repair implant in the field of interventional cardiac disease treatment. The valve clip 100 proposed in this embodiment can be delivered to a designated location via a minimally invasive portal and blood vessels, thereby achieving heart valve repair treatment (including but not limited to the mitral valve, tricuspid valve, aortic valve, and pulmonary valve). As will be appreciated, since the valve clip 100 needs to be implanted inside the patient's heart, particularly when introduced via a minimally invasive portal and blood vessels, the size of the valve clip 100 is strictly limited. In this embodiment, a window 101 is provided on the central shaft 10, and a locking spring 52 is connected to the central shaft 10. The locking spring 52's engaging member 523 can extend into the window 101 and engage with the sliding member 30, preventing the sliding member 30 from sliding axially and thus achieving locking. Furthermore, since the locking spring 52 can elastically deform, under the control of the control member 51, the locking spring 52 can be controlled to lock the sliding member 30. By withdrawing from the window 101 in a direction away from the sliding member 30, the engagement between the latching member 523 and the latching portion 301 is released, allowing the sliding member 30 to slide freely. The operator can then manipulate the locking spring 52 via the control member 51. Thus, the locking mechanism 50 of this embodiment is not only simple in structure and easy to operate, but also the locking spring 52 is located on the outer circumference of the central shaft 10, eliminating the axial space of the valve clipper 100. This facilitates the extension of the clamping arm 20 of the valve clipper 100, improving the clamping effect and resolving the problem of poor clamping effect of the valve clipper 100. Furthermore, compared to the prior art, the valve clipper 100 of this embodiment is lighter overall, which can reduce the burden on the patient's heart after implantation.
[0050] like Figure 1 、 Figure 2 and Figure 3As shown, in this embodiment, the locking mechanism 50 includes a control member 51 and a locking spring 52. The operator uses the control member 51 to drive the locking spring 52 to elastically deform, as shown in FIG. Figure 4 As shown, the engaging member 523 of the locking spring 52 is moved away from the engaging portion 301 of the sliding member 30, i.e., the engaging portion is released. After the engaging member 523 is released from the engaging portion 301, the sliding member 30 can slide axially, thereby driving the clamping arm 20 to rotate, expand, or close. When the engaging portion is not released, the locking mechanism 50 prevents the clamping arm 20 from rotating by preventing the sliding member 30 from sliding axially. The linkage relationship between the sliding member 30 and the clamping arm 20 is described in detail below in the embodiment of the overall structure and principle of the valve clipper 100.
[0051] It can be understood that in this embodiment, the locking spring 52 is a sheet-like structure with a certain thickness, such as Figure 2 and Figure 3 As shown, the locking spring piece 52 is axially extended and arranged on the periphery of the central shaft tube 10. The locking spring piece 52 is provided with a side of the clip 523 facing the central shaft tube 10. For example, the locking spring piece 52 is a rectangular sheet in a straight state. The clip 523 is arranged on a side with a larger width of the locking spring piece 52. On this basis, the thickness of the clip 523 along the radial direction of the central shaft tube 10 is the width of the other side adjacent to the side where the clip 523 is located. This arrangement makes the thickness of the locking spring piece 52 smaller, thereby avoiding excessive radial size.
[0052] In this embodiment, the number of the locking springs 52 can be one or more. In some embodiments of the present invention, for example, Figure 2 and Figure 3 As shown, two locking springs 52 are provided, and the two locking springs 52 can be symmetrically arranged on both sides of the central shaft tube 10. It can be understood that the locking springs 52 are axially arranged on the outside of the central shaft tube 10. When two locking springs 52 are provided, two windows 101 are provided on the central shaft tube 10, and two clamping parts 301 are provided on the sliding member 30. Correspondingly, the two windows 101 are symmetrically arranged, and the two clamping parts 301 are symmetrically arranged. Therefore, the clamping parts 523 of the two locking springs 52 are respectively clamped with the two clamping parts 301, which further improves the locking stability. In addition, the symmetrical manner is beneficial to the stability of the overall structure of the valve clipper 100.
[0053] Please continue to see Figure 3 and Figure 4In this embodiment, the locking spring piece 52 has a fixed section 522 and a movable section 521. The fixed section 522 is connected to the central shaft tube 10, and the movable section 521 can rotate around the connection between the fixed section 522 and the central shaft tube 10. It should be noted that in this embodiment, the locking spring piece 52 is an integrally formed structure, that is, the fixed section 522 and the movable section 521 are integrally formed, and there is no obvious dividing line between the two. In order to facilitate understanding of the structure of the locking spring piece 52, this embodiment describes the fixed section 522 and the movable section 521 separately, and does not specifically limit the length ratio of the fixed section 522 and the movable section 521 to the length of the locking spring piece 52.
[0054] There are many ways to connect the fixed section 522 to the central shaft tube 10, such as being able to be set to be clamped, being able to be set to be connected by fasteners, or being able to be set to be welded, which is not specifically limited in this embodiment. Figure 2 and Figure 3 As shown, in some embodiments of the present invention, a mounting seat 11 is provided on the central shaft tube 10, and the fixed section 522 is connected to the mounting seat 11. The mounting seat 11 can be provided on the outer wall of the central shaft tube 10 by welding or integral molding. The fixed section 522 of the locking spring clip 52 is connected to the mounting seat 11, and the connection method can be snap-fitting, welding or connection through fasteners. It can be understood that since the outer wall of the central shaft tube 10 is a cylinder, the way in which the locking spring clip 52 is connected to the central shaft tube 10 through the mounting seat 11 in this embodiment is not only convenient for assembly, but also improves the reliability of the connection between the locking spring clip 52 and the central shaft tube 10.
[0055] Furthermore, if Figure 3 As shown, in some embodiments of the present invention, a slot is provided on the mounting base 11. The slot can be provided through the mounting base 11 or recessed from the surface of the mounting base 11. Exemplarily, the slot is recessed inward from the side of the mounting base 11 facing away from the central shaft 10. This arrangement facilitates assembly. Furthermore, in an alternative embodiment, the fixing section 522 of the locking spring 52 is snapped into the slot, that is, the fixing section 522 has an interference fit with the slot. In another alternative embodiment, the fixing section 522 is welded into the slot only during assembly, and the welding ensures the reliability of the connection between the locking spring 52 and the central shaft 10. In another alternative embodiment, the fixing section 522 has an interference fit with the slot and is welded, thereby further improving the reliability of the connection between the locking spring 52 and the central shaft 10. When the valve clip 100 includes two symmetrical locking springs 52, two slots are symmetrically provided on the mounting base 11, with each locking spring 52 engaging with one slot.
[0056] Based on the above implementation, please continue to refer to Figure 3 and Figure 4 The control member 51 is connected to the movable section 521. Under the control of the control member 51, the movable section 521 can rotate. There are many ways to control the control member 51, such as pulling control or pushing control. Figure 3 As shown, in some embodiments of the present invention, the control mode of the control member 51 is set to traction control. The control member 51 is connected to the movable segment 521 and can pull the movable segment 521. At this time, the fixed segment 522 is located on the proximal side of the movable segment 521, that is, during the process of clamping the valve clip 100 in the patient's body, the fixed segment 522 is located above the movable segment 521. The traction member needs to pull to rotate the movable segment 521 in the direction away from the central shaft tube 10, so that the clamping piece 523 on the locking spring 52 is no longer clamped with the clamping portion 301 of the sliding member 30.
[0057] In some embodiments of the present invention, the pulling member is configured as a metal wire or a non-metallic wire, such as a nylon wire or a suture thread, and the locking spring 52 can be provided with a connecting ring or a connecting hole 5202, which is provided on the movable section 521, so as to facilitate the pulling member to pull. Figure 3 and Figure 4 As shown, a connecting hole 5202 is provided on the movable section 521, and the pulling member passes through the connecting hole 5202 to be connected with the locking spring piece 52. Furthermore, the number of connecting holes 5202 can be set to one or more. When there is one connecting hole 5202, the pulling member passes through the proximal side of the connecting hole 5202, passes out from the distal side and extends toward the proximal end; when there are two connecting holes 5202, the pulling member can pass through the proximal side of one of the connecting holes 5202, pass out from the distal side, and then pass through the distal side of the other connecting hole 5202, pass out from the proximal side and extend toward the proximal end. This method facilitates the withdrawal of the pulling member.
[0058] In other embodiments of the present invention, the control mode of the control member 51 is set to push control, and the control member 51 can be set to a pushing member, such as a metal rod, etc. The pushing member is connected to or abuts against the movable segment 521 of the locking spring 52. At this time, the fixed segment 522 is located on the distal side of the movable segment 521, that is, during the process of clamping the valve clip 100 in the patient's body, the fixed segment 522 is located below the movable segment 521. It can be understood that the pushing member needs to push the movable segment 521 to rotate in the direction away from the central shaft tube 10, so that the clamping member 523 on the locking spring 52 is no longer clamped with the clamping portion 301 of the sliding member 30.
[0059] Furthermore, in this embodiment, there are multiple ways for the clamping member 523 to be clamped with the clamping portion 301. For example, the clamping member 523 can be configured as a protrusion formed on the locking spring 52, and the clamping portion 301 can be configured as a groove formed on the sliding member 30; or, the clamping member 523 can be configured as a groove formed on the locking spring 52, and the clamping portion 301 can be configured as a protrusion formed on the sliding member 30. This embodiment does not specifically limit this, and it is sufficient to ensure that the sliding member 30 cannot slide axially after the clamping member 523 is clamped with the clamping portion 301. Figure 3 and Figure 4 As shown, in some embodiments of the present invention, the clamping portion 301 includes a plurality of first engaging teeth 3011, and the plurality of first engaging teeth 3011 are axially arranged on the side wall of the sliding member 30. The clamping member 523 includes a boss 5231 and a plurality of second engaging teeth 5232. The boss 5231 is arranged on the side of the locking spring 52 facing the central shaft cylinder 10 and can extend from the window 101 of the central shaft cylinder 10. The plurality of second engaging teeth 5232 are axially arranged on the boss 5231, so as to engage one by one with the plurality of first engaging teeth 3011 on the sliding member 30. This embodiment does not specifically limit the number of the first engaging teeth 3011 and the second engaging teeth 5232.
[0060] Exemplarily, the first engaging teeth 3011 can be integrally formed on the sliding member 30, and can be protruding from the side wall of the sliding member 30, or can be formed by opening grooves on the side wall of the sliding member 30 to form the first engaging teeth 3011 between adjacent grooves. This embodiment does not specifically limit this. At least part of the second engaging teeth 5232 can be inserted into the gap between two adjacent first engaging teeth 3011. Since the first engaging teeth 3011 and the second engaging teeth 5232 are arranged axially, after engagement, the sliding member 30 cannot slide axially due to the obstruction of the locking spring 52, thereby ensuring the stability of the locking.
[0061] Furthermore, in some embodiments of the present invention, the locking spring 52 is configured as a shape memory alloy spring, for example, it can be configured as a nickel-titanium alloy spring. By utilizing its shape memory property, after the control member 51 pulls it to release the engagement with the sliding member 30, it is ensured that it can return to its original state, thereby engaging with the sliding member 30 again and locking the sliding member 30. Such a configuration facilitates operation by the operator and ensures the reliability of the locking mechanism 50 of the valve clipper 100.
[0062] Furthermore, if Figure 3 and Figure 4As shown, a hollow portion 5201 is further provided on the locking spring piece 52, and at least part of the hollow portion 5201 is located between the fixed section 522 and the clamping member 523. It can be understood that the clamping member 523 is provided on the movable section 521, and the movable section 521 can rotate around the connection between the fixed section 522 and the central shaft tube 10. In this embodiment, the hollow portion 5201 is provided at a position between the fixed section 522 and the clamping member 523, thereby further improving the elastic deformation speed and deformation range of the locking spring piece 52, reducing the pulling force required by the operator to pull the movable section 521, and further reducing the difficulty of operation. Exemplarily, when the locking spring 52 is set to a nickel-titanium alloy spring, the clip 523 includes a boss 5231 extending toward the window 101 of the central shaft tube 10 and a second engaging tooth 5232 formed on the boss 5231. A grid-like hollow portion 5201 can be formed between the fixed section 522 and the boss 5231 by wire cutting or other methods, thereby reducing the pulling force required for pulling. As the pulling force is reduced, the risk of breakage and failure of the pulling member is reduced, thereby further improving the reliability of the valve clipper 100.
[0063] Please continue reading Figure 1 and Figure 2 、 Figure 7 and Figure 8 , the following is described in conjunction with the overall structure of the valve clipper 100. In this embodiment, a plurality of clamp arms 20 are provided. For example, if the valve clipper 100 is applied to mitral valve repair treatment, the number of clamp arms 20 can be set to two accordingly. If the valve clipper 100 is applied to tricuspid valve repair treatment, the number of clamp arms 20 can be set to three accordingly. Accordingly, in this embodiment, the number of sliding members 30 can be set to one or more, and each sliding member 30 can be connected to one or more clamp arms 20 via a pivot mechanism 40. For example, as Figure 1 and Figure 2 As shown, the number of the sliding member 30 is set to one, and the sliding member 30 is connected to the two clamping arms 20 respectively through a pivot mechanism 40, or as shown in FIG. Figure 7 and Figure 8 As shown, the number of sliding members 30 is set to two, and each sliding member 30 is connected to a clamping arm 20 through a pivot mechanism 40. This embodiment does not specifically limit the number of sliding members 30 and clamping arms 20, and can be set according to actual needs.
[0064] Furthermore, if Figure 2As shown, the central shaft 10 is located in the middle of the valve clamp 100, the sliding member 30 is slidably arranged in the central shaft 10, and a plurality of clamp arms 20 are arranged around the periphery of the central shaft 10. One end of the clamp arm 20 is rotatably connected to the central shaft 10. When the sliding member 30 and the clamp arm 20 are linked, the clamp arm 20 can rotate around the connection with the central shaft 10. In this embodiment, the distal end of the clamp arm 20 is rotatably connected to the central shaft 10. When the number of the clamp arms 20 is set to two, the two clamp arms 20 are symmetrically arranged on both sides of the central shaft 10. When the two clamp arms 20 are closed, they are in an embraced state, thereby facilitating the clamping of the valve. On this basis, the mounting seat 11 and the window 101 are arranged at the position of the central shaft 10 between the two clamp arms 20, making full use of the space between the clamp arms 20. Figure 2 As shown, a avoidance groove 201 is provided near the distal end of the clamping arm 20, and two connecting ears 202 are extended from the distal end of the clamping arm 20. The two connecting ears 202 are respectively located on both sides of the avoidance groove 201, and extend to the outer wall of the central shaft tube 10 to be connected to the central shaft tube 10. For example, the connection can be rotated by a rotating shaft.
[0065] Based on the above implementation, please continue to refer to Figure 1 and Figure 2 、 Figure 7 and Figure 8 The pivot mechanism 40 drives the clamp arm 20 to rotate around the connection with the central shaft tube 10 according to the sliding of the sliding member 30. In some embodiments of the present invention, one end of the pivot mechanism 40 is fixedly connected to the sliding member 30, and the other end is rotatably connected to the clamp arm 20. It can be understood that when the sliding member 30 slides axially toward the distal end, the pivot mechanism 40 moves toward the distal end and drives the clamp arm 20 rotatably connected thereto to rotate in a direction away from the central shaft tube 10, that is, drives the clamp arm 20 to expand; when the sliding member 30 slides axially toward the proximal end, the pivot mechanism 40 moves toward the proximal end and drives the clamp arm 20 rotatably connected thereto to rotate in a direction close to the central shaft tube 10, that is, drives the clamp arm 20 to close.
[0066] Furthermore, the pivot mechanism 40 includes a base 41 and a linkage arm 42. The base 41 is fixedly connected to the sliding member 30. For example, in some embodiments of the present invention, the sliding member 30 extends from the distal end of the central shaft 10, and the base 41 can be connected to the end of the sliding member 30. The linkage arm 42 in the pivot mechanism 40 is rotatably connected to the base 41 and the clamping arm 20, respectively. When the base 41 slides axially with the sliding member 30, the linkage arm 42 rotates between the base 41 and the clamping arm 20, thereby driving the clamping arm 20 to rotate. For example, the end of the linkage arm 42 away from the base 41 is rotatably connected to the middle portion of the clamping arm 20, so that the linkage arm 42 can apply a pulling force or a pushing force to the clamping arm 20 during rotation, thereby driving the clamping arm 20 to rotate and achieve expansion or closure.
[0067] Based on the above implementation, please continue to refer to Figure 1 and Figure 2 , and refer to Figure 7 and Figure 8 The number of sliding members 30 in the valve clipper 100 can be one or more, and the locking mechanism 50 can be correspondingly provided with one or more. Thus, the locking spring piece 52 of the locking mechanism 50 cooperates with one or more sliding members 30. Depending on the number of sliding members 30, the cooperation method of the locking spring piece 52 and the sliding member 30 is also different.
[0068] In an alternative embodiment, see Figure 1 and Figure 2 、 Figure 5 and Figure 6 The number of sliding members 30 is set to one. For example, the sliding member 30 is configured as a first sliding rod 31, which is slidably disposed in the central shaft tube 10. A locking portion 301 is provided on the side wall of the first sliding rod 31, and a window 101 is provided on the central shaft tube 10. On this basis, the valve clipper 100 includes two clamping arms 20 and two pivoting mechanisms 40. The specific structures of the clamping arms 20 and the pivoting mechanisms 40 are shown in the previous embodiment and are not repeated here. On this basis, the locking member 523 of the locking spring 52 extends into the central shaft tube 10 through the window 101 and engages with the locking portion 301. As a result, the sliding member 30 is locked and cannot slide axially, and cannot drive the two clamping arms 20 to rotate. When the operator pulls the movable section 521 of the locking spring 52 using the control member 51, the locking member 523 is disengaged from the locking portion 301. At this time, the sliding member 30 can slide axially, thereby driving the two clamping arms 20 to rotate and open.
[0069] In another optional embodiment, the number of sliding members 30 is set to be multiple, and the multiple sliding members 30 are sequentially sleeved. For example, the multiple sliding members 30 include a sliding rod and at least one sliding cylinder 33 sleeved outside the sliding rod. On this basis, the clamping portion 301 is provided on the sliding rod, and each sliding cylinder 33 is provided with an opening 331 corresponding to the window 101. As a result, the clamping piece 523 on the locking spring 52 can extend into the window 101 and pass through the multiple openings 331 and then engage with the clamping portion 301 on the sliding rod. At this time, the sliding rod is locked and cannot slide axially, and the sliding cylinder 33 correspondingly cannot slide axially. For example, please refer to Figures 7 to 10The number of sliding members 30 is set to two, and the two sliding members 30 include a second sliding rod 32 and a sliding cylinder 33 sleeved outside the second sliding rod 32. The sliding cylinder 33 is provided with an opening 331 corresponding to the window 101. The clamping piece 523 on the locking spring 52 can extend into the window 101 and, after passing through the opening 331, engage with the clamping portion 301 on the second sliding rod 32. The second sliding rod 32 and the sliding cylinder 33 cannot slide, so the two clamping arms 20 cannot rotate; when the operator uses the control member 51 to pull the movable section 521 of the locking spring 52, the clamping piece 523 is disengaged from the clamping portion 301. At this time, the sliding rod and the sliding cylinder 33 can slide axially, thereby driving the clamping arm 20 connected thereto to rotate and open and close.
[0070] In another optional embodiment, the number of the sliding members 30 is set to two, and the two sliding members 30 include a sliding rod and a sliding cylinder 33 sleeved outside the sliding rod, and two locking mechanisms 50 are also provided. When the cam 32 is in the unlock state, the locking cam 32 is in the unlock state, and the locking cam 32 is in the unlock state, so the cam 32 is locked and the two locking arms 20 are locked.
[0071] In some embodiments of the present invention, see Figure 1 and Figure 2The valve clipper 100 further includes a capture member 60, which is mounted between the central shaft 10 and the clamping arms 20. The capture member 60 is provided with barbs on a side facing the clamping arms 20 for capturing the valve. Accordingly, the valve clipper 100 further includes a control wire, such as a nylon thread, suture thread, or metal wire, connected to the capture member 60. The control wire is used to drive the capture member 60 to rotate. Thus, during the process of clamping the valve by the valve clipper 100, the valve can be first captured by the capture member 60 and then clamped by the clamping arms 20. Exemplarily, the capture member 60 can be configured as a capture spring formed from a shape memory alloy, such as a nickel-titanium alloy. The capture spring includes a plurality of springs, for example, two springs located on either side of the central shaft 10. The two springs can be configured as an integrally formed structure with a predetermined angle between them. A single control wire can be provided to simultaneously control both springs, or a plurality of control wires can be provided, each of which is connected to and controls one spring. In this embodiment, barbs are provided on the capture member 60 to facilitate the capture of the valve by the capture member 60 when in contact with the valve, thereby improving the accuracy of subsequent clamping of the clamping arms 20.
[0072] See also Figure 11 The embodiment of the second aspect of the present invention proposes a valve repair system 1000, which includes a delivery device and a valve clipper 100 according to any of the above embodiments. The delivery device is detachably connected to the valve clipper 100, and the delivery device is used to deliver the valve clipper 100 to a set position. In this embodiment, the delivery device includes a handle 710, a sheath assembly, and a connecting mechanism, wherein the sheath assembly includes a bending mechanism 730 and a plurality of sheaths 720 that are sequentially connected. The handle 710 is connected to the sheath assembly and can control part or all of the sheaths 720 in the sheath assembly to reach a set position in the patient's body. The bending mechanism 730 can control part or all of the sheaths 720 in the sheath assembly to bend at the set position. The control member 51 of the locking mechanism 50 in the valve clipper 100 can be connected to the handle. 710, so that the operator can operate the control member 51 through the handle 710; the connecting mechanism is connected to the distal end of the innermost sheath 720 and is used to be detachably connected to the valve clamp 100, so that when the valve clamp 100 is delivered to the set position, the valve clamp 100 adjusts its position according to the bending and movement of the sheath 720. When the valve clamp 100 clamps the valve and locks it, the connecting mechanism disengages from the valve clamp 100, so that the valve clamp 100 remains in the patient's body.
[0073] Further, see Figure 12In some embodiments of the present invention, the delivery device includes at least one driving member 740, which is connected to the sliding member 30 to drive the sliding member 30 to slide. In this embodiment, the number of driving members 740 is set according to the number of sliding members 30. Exemplarily, when the sliding member 30 is set to one, the driving member 740 is also set to one. According to the above embodiment, a channel is provided in the innermost sheath 720 of the sheath assembly, and the driving member 740 is passed through the channel. The distal end of the driving member 740 extends from the distal end of the sheath 720 and cooperates with the sliding member 30 of the valve clipper 100. Therefore, the operator can pull or push the sliding member 30 by pulling or pushing the driving member 740, thereby causing the sliding member 30 to slide axially.
[0074] like Figure 12 As shown, taking the sliding member 30 as a first sliding rod 31 as an example, in an optional embodiment, the first sliding rod 31 is provided with a blind hole at one end near the delivery device, with an internal thread provided therein. The driving member 740 can be provided as a metal wire, and the outer wall of the driving member 740 near the distal end is provided with an external thread that mates with the internal thread, thereby connecting the distal end of the driving member 740 to the sliding member 30. The proximal end of the driving member 740 can be connected to the handle 710, and the operator can control the movement and rotation of the driving member 740 via the handle 710. It can be understood that when the sliding member 30 needs to be moved axially, the operator can move the driving member 740 via the handle 710. When the delivery device needs to be separated from the valve clipper 100, the operator can rotate the driving member 740 via the handle 710 to disengage the internal thread from the external thread, thereby withdrawing the driving member 740.
[0075] Based on the above embodiments, the valve repair system 1000 proposed in this embodiment is operated as follows: the operator operates the handle 710 to move the sheath assembly and the valve clipper 100 connected to the sheath 720 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, first use the handle 710 to pull the control member 51, such as Figure 4 As shown, the locking spring 52 is elastically deformed away from the sliding member 30, releasing the engagement between the clamping member 523 and the clamping portion 301, that is, releasing the locking spring 52 from locking the sliding member 30; then the handle 710 is used to push the driving member 740, so that the sliding member 30 connected thereto moves toward the distal end, as shown in FIG. Figure 2As shown, the clamping arm 20 connected to the sliding member 30 via the pivot mechanism 40 is unfolded, and the position of the valve clipper 100 is adjusted to align with the portion of the mitral valve to be clipped. Then, the driving member 740 is pulled by the handle 710 to move the sliding member 30 toward the proximal end, so that the clamping arm 20 closes and clamps the valve. The control member 51 is released from pulling the locking spring 52, so that the locking spring 523 is restored to be engaged with the clip 301 of the sliding member 30. Finally, the driving member 740 and the sliding member 30 are disengaged, and the connection mechanism and the valve clipper 100 are disengaged. The driving member 740 and the sheath assembly are withdrawn, so that the valve clipper 100 remains in the patient's body in a state of clamping the valve.
[0076] 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: A central shaft cylinder, wherein a window is provided on a side wall of the central shaft cylinder; A plurality of clamping arms, wherein the plurality of clamping arms are arranged around the periphery of the central shaft cylinder; a sliding member, the sliding member being slidably disposed within the central shaft cylinder, the sliding member being connected to the clamping arm via a pivot mechanism so that the clamping arm rotates according to the axial sliding of the sliding member, and a clamping portion being provided on a side wall of the sliding member; The locking mechanism includes a control member and a locking spring, the locking spring has a movable section and a fixed section connected to the central shaft tube, the movable section is provided with a clamping piece, the clamping piece extends into the window and is clamped with the clamping portion, the control member is connected to the movable section, and the control member is configured to drive the movable section to rotate in a direction away from the central shaft tube, driving the clamping piece away from the clamping portion to release the clamping.
2. The valve clip according to claim 1, characterized in that: A mounting seat is provided on the central shaft, and the fixing section is connected to the mounting seat.
3. The valve clipper according to claim 2, characterized in that: The mounting seat is provided with a slot, the fixing section is clamped in the slot, and / or the fixing section is welded to the slot.
4. The valve clipper according to claim 1, characterized in that: The fixed section is located at the proximal side of the movable section, the control member is configured as a pulling member, and the pulling member is connected to the movable section.
5. The valve clipper according to claim 4, characterized in that: The pulling member is configured as a metal wire or a non-metal wire.
6. The valve clipper according to claim 1, characterized in that: The clamping portion includes a plurality of first engaging teeth, and the clamping member includes a boss and a plurality of second engaging teeth arranged on the boss. The plurality of first engaging teeth and the plurality of second engaging teeth are arranged along the axial direction and engage with each other.
7. The valve clipper according to claim 1, characterized in that: The locking spring is configured as a shape memory alloy spring, and / or a hollow portion is provided on the locking spring, and at least a portion of the hollow portion is located between the fixing section and the clamping member.
8. The valve clip according to any one of claims 1 to 7, characterized in that: There are two locking springs, which are symmetrically arranged on both sides of the central shaft.
9. The valve clipper according to claim 1, characterized in that: There are multiple sliding components, each of which includes a sliding rod and at least one sliding cylinder sleeved outside the sliding rod. The clamping portion is provided on the sliding rod, and the sliding cylinder is provided with an opening corresponding to the window.
10. 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 9; A delivery device is detachably connected to the valve clip to deliver the valve clip to a set position. The delivery device includes a driving member connected to a sliding member of the valve clip to drive the sliding member to slide.
Citation Information
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