Valve clippers and valve repair systems
By using the elastic deformation of the bent spring sheet in the valve clamp to achieve locking, the problems of excessive volume and mass are solved, the clamping effect is improved, the burden on the heart is reduced, and the operation and assembly are simplified.
Patent Information
- Application Number
- CN202111499306.2
- 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 existing valve clippers are too large in size and weight, resulting in poor surgical results and heavy burden on the patient's heart. In addition, the existing locking method is complex and unstable.
A bent spring sheet is used as a locking mechanism, and the elastic deformation of the bent spring sheet prevents or allows the sliding component from sliding under different working conditions, thereby locking the clamping arm, simplifying the structure and reducing the occupied space.
The volume and weight of the valve clipper are reduced, the clamping effect is improved, the burden on the heart is reduced, and the operation and assembly process are simplified.
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Figure CN114176836B_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 method of the valve clamp in the related art is mostly to add multiple components to the original structure, such as adding a baffle, a baffle frame and an elastic member, etc. Under the premise of the baffle frame limiting, the elastic member is used to push the baffle to prevent the clamp arm from rotating. This locking method combined with multiple components is unstable during use, and the assembly of multiple components is difficult and takes up a lot of space, which easily leads to the valve clamp being too large in size and weight. Summary of the Invention
[0005] The present invention aims to at least address the problem of excessive size and mass of the valve clip. This objective is achieved through the following technical solutions:
[0006] A first aspect of the present invention provides a valve clipper, comprising:
[0007] Multiple clamping arms;
[0008] at least one sliding member connected to the clamping arm via a pivot mechanism so that the clamping arm rotates according to the axial sliding of the sliding member;
[0009] A locking mechanism, wherein the locking mechanism includes a control member and a bent spring sheet, wherein the control member controls the bent spring sheet to switch between a first working condition and a second working condition, wherein the bent spring sheet abuts against at least one of the sliding members in the first working condition to prevent the sliding member from sliding, and wherein the bent spring sheet allows the sliding member to slide in the second working condition.
[0010] The valve clipper provided in the embodiment of the present invention has the following advantages:
[0011] In the embodiment of the present invention, the bent spring piece can produce elastic deformation, so it can switch the working condition under the control of the control component, and prevent or allow the sliding component to slide under different working conditions. The structure is simple and easy to operate. The bent spring piece in this embodiment is small in size and does not take up too much space in the valve clamp. Compared with the existing technology, it is beneficial to reduce the overall volume and weight of the valve clamp, and solves the problem of excessive volume and mass of the valve clamp; it can also make the clamping arm increase in volume according to demand when the overall volume and mass are constant, thereby further improving the clamping effect.
[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, at least one locking hole is provided on the bent spring sheet, and the sliding member is inserted into the locking hole. In the first working condition, the inner wall of the locking hole abuts against the side wall of the sliding member.
[0014] In some embodiments of the present invention, in the first working condition, an angle is formed between the axis of the locking hole and the axis of the sliding member.
[0015] In some embodiments of the present invention, the bent spring sheet includes a fixed section and a movable section connected to each other, an angle is formed between the fixed section and the movable section, the movable section can rotate relative to the fixed section, the locking hole is arranged through the movable section, and the locking hole abuts or releases the abutment with the sliding component according to the rotation of the movable section.
[0016] In some embodiments of the present invention, the valve clamp further comprises a central shaft, the plurality of clamp arms are arranged around the periphery of the central shaft, the sliding member is slidably arranged in the central shaft, and the fixed section is connected to the central shaft.
[0017] In some embodiments of the present invention, a mounting seat is provided on the outer wall of the central shaft, the fixed section is connected to the mounting seat, and a limiting block for stopping the movable section is extended from the mounting seat.
[0018] In some embodiments of the present invention, the control member is detachably connected to the movable section, and the control member extends toward the proximal end away from one end of the bent spring sheet for the operator to pull or push so that the bent spring sheet can be switched between the first working condition and the second working condition.
[0019] In some embodiments of the present invention, the control member is configured as a metal wire or a non-metal wire.
[0020] In some embodiments of the present invention, at least one connecting hole is provided on the movable section, and the control member is passed through the connecting hole to be connected with the bent elastic sheet.
[0021] In some embodiments of the present invention, there are multiple sliding components, and the multiple sliding components are sequentially socketed. The bent spring sheet abuts against the innermost sliding component under the first working condition, and the bent spring sheet allows all sliding components to slide under the second working condition.
[0022] In some embodiments of the present invention, a avoidance hole is provided through the bent elastic sheet, and the avoidance hole is used for allowing at least one of the pivoting mechanisms to pass through.
[0023] A second aspect of the present invention provides a valve repair system, which includes a conveying device and a valve clamp according to any of the above embodiments; the conveying device is detachably connected to the valve clamp to convey the valve clamp to a set position, and the conveying device includes at least one driving member, which is connected to the sliding member of the valve clamp 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 (a sliding member) 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 Schematic diagram of the structure of the valve clipper (a sliding member) according to an embodiment of the present invention Figure 2 ;
[0029] Figure 4 for Figure 3 A front view of the valve clip shown;
[0030] Figure 5 Schematic diagram of the structure of the valve clipper (two sliding components) according to an embodiment of the present invention Figure 1 ;
[0031] Figure 6 for Figure 5 A front view of the valve clip shown;
[0032] Figure 7 Schematic diagram of the structure of the valve clipper (two sliding components) according to an embodiment of the present invention Figure 2 ;
[0033] Figure 8 for Figure 7 A front view of the valve clip shown;
[0034] Figure 9 Schematic diagram of the structure of the valve clipper (two sliding components) according to an embodiment of the present invention Figure 3 ;
[0035] Figure 10 Schematic diagram of the structure of the locking mechanism (the bent spring piece is in the first working state) in the valve clipper (a sliding member) according to an embodiment of the present invention;
[0036] Figure 11 Schematic diagram of the structure of the locking mechanism (the bent spring piece is in the second working state) in the valve clipper (a sliding member) according to an embodiment of the present invention;
[0037] Figure 12 Schematic diagram of the structure of the bent spring piece in the valve clipper (two sliding components) according to an embodiment of the present invention in a first working condition;
[0038] Figure 13 Schematic diagram of the structure of the bent spring piece in the valve clipper (two sliding components) according to an embodiment of the present invention in the second working condition;
[0039] Figure 14 Schematic diagram of the structure of a valve repair system according to an embodiment of the present invention;
[0040] Figure 15 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.
[0041] The symbols in the accompanying drawings represent the following:
[0042] 1000, valve repair system;
[0043] 100. Valve clip;
[0044] 10. Locking mechanism; 11. Control member; 12. Bent spring; 1201. Locking hole; 121. Fixed section; 122. Movable section; 1221. Connecting hole; 1222. Avoidance hole;
[0045] 20. Clamping arm; 201. Avoidance groove; 202. Connecting ear;
[0046] 30. Sliding member; 31. First sliding rod; 32. Second sliding rod; 33. Sliding cylinder;
[0047] 40. Pivoting mechanism; 41. Base; 411. First base; 412. Second base; 42. Linkage arm;
[0048] 50. Center shaft; 51. Mounting seat; 52. Limit block;
[0049] 60. Capture components;
[0050] 710. Handle; 720. Sheath; 730. Bending mechanism; 740. Driving component. DETAILED DESCRIPTION
[0051] As described in the background art, taking mitral valve repair surgery as an example, the clamping arms of the valve clip need to be locked after clamping the valve, that is, to prevent the clamping arms from rotating and unfolding. In some existing valve clippers, the locking mechanism includes multiple components. Since the valve clipper is an implant with limited volume, the overall radial dimension of the valve clipper is generally 5mm-6mm after the clamping arms are closed, and the axial dimension is generally less than 16mm. Therefore, when multiple components are combined to achieve locking, the overall volume and mass of the valve clipper will be too large, affecting the surgical effect and increasing the burden on the patient's heart. If the size of other components, such as the clamping arms, is adjusted while the overall volume or mass remains unchanged, the clamping effect of the clamping arms will be affected. In response to the above problems, the present invention proposes a valve clamper and a valve repair system. A bent spring sheet is provided in the valve clamper. Since the bent spring sheet can produce elastic deformation, the different shapes of the bent spring sheet before and after deformation are utilized to change the matching relationship between the bent spring sheet and the sliding member, so that the bent spring sheet can prevent or allow the sliding member to slide. Since the clamping arm rotates according to the sliding of the sliding member, the bent spring sheet can prevent the clamping arm from rotating by preventing the sliding member from sliding, thereby achieving locking. Therefore, the locking mechanism is not only simple in structure but also occupies little space.
[0052] 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.
[0053] See also Figures 1 to 9 An embodiment of the present invention provides a valve clamp 100, which includes a locking mechanism 10, multiple clamp arms 20 and at least one sliding member 30. The sliding member 30 is connected to the clamp arm 20 through a pivot mechanism 40 so that the clamp arm 20 can rotate according to the axial sliding of the sliding member 30; the locking mechanism 10 includes a control member 11 and a bent spring 12. The control member 11 controls the bent spring 12 to switch between a first working condition and a second working condition. In the first working condition, the bent spring 12 abuts against at least one sliding member 30 to prevent the sliding member 30 from sliding. In the second working condition, the bent spring 12 allows the sliding member 30 to slide.
[0054] 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 reach a designated location via a minimally invasive portal and blood vessels, thereby achieving repair treatment for heart valves (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 volume of the valve clip 100 is strictly limited. In this embodiment, a bent spring 12 is provided, and its elastic deformation property is utilized to change the mating relationship between the bent spring 12 and the sliding member 30. In a first operating state, the bent spring 12 abuts against the sliding member 30, preventing it from sliding. In a second operating state, the abutment is released, allowing the sliding member 30 to slide. The operator can then manipulate the control member 12 to adjust the size of the valve clip 100. 11 manipulates the bent spring piece 12. Thus, the locking mechanism 10 in this embodiment is not only simple in structure and easy to assemble and operate, but also occupies a small space, which meets the requirement of limited volume of the valve clipper 100. Moreover, compared with the prior art, the overall weight is lighter, and the burden on the heart after implantation in the patient's body is less, which solves the problem of excessive volume and mass of the valve clipper 100. In addition, based on the small volume of the locking mechanism 10, the size of the clamping arm 20 of the valve clipper 100 can be increased accordingly, thereby further increasing the contact area with the valve, that is, increasing the clamping area, and further improving the clamping effect.
[0055] In the valve clipper 100 proposed in this embodiment, the sliding member 30 is capable of sliding axially, thereby driving the clamping arm 20 to rotate, expand, or close. The locking mechanism 10 prevents the sliding member 30 from sliding axially, thereby preventing the clamping arm 20 from rotating. The linkage between the sliding member 30 and the clamping arm 20 is described in detail below in connection with the overall structure and principle of the valve clipper 100. In this embodiment, the locking mechanism 10 includes a control member 11 and a bent spring 12. The operator uses the control member 11 to change at least one of the shape and position of the bent spring 12, causing the bent spring 12 to abut against the sliding member 30 in a first operating condition and to release the abutment against the sliding member 30 in a second operating condition. It should be noted that, in this embodiment, the control member 11 can only control the bending spring piece 12 to switch from the first working condition to the second working condition, and the bending spring piece 12 switches from the second working condition to the first working condition by restoring the deformation, or the control member 11 can only control the bending spring piece 12 to switch from the second working condition to the first working condition, and the bending spring piece 12 switches from the first working condition to the second working condition by restoring the deformation, or the control member 11 can actively control the bending spring piece 12 to switch between the first working condition and the second working condition, and this embodiment does not limit this. In addition, in this embodiment, release of abutment refers to the situation where the bending spring piece 12 and the sliding member 30 can slide relative to each other, including relative sliding when the bending spring piece 12 and the sliding member 30 are in contact and relative sliding after a gap is generated between the two.
[0056] Please continue reading Figures 1 to 9 , and refer to Figures 10 to 13 In this embodiment, the bent spring piece 12 is a sheet structure with a certain thickness. For example, it can be a spring piece in a bent state of rectangle, circle, ellipse or other shapes. With the vertical plane as the cross-section, the cross-sectional shape of the bent spring piece 12 can be set to V-shape, U-shape, S-shape, Z-shape, W-shape, etc. The specific shape of the bent spring piece 12 can be set according to actual needs, and this embodiment does not limit this. There are many ways for the bent spring piece 12 to prevent the sliding member 30 from sliding by abutting it. For example, any side edge of the bent spring piece 12 can abut against the outer wall of the sliding member 30 and apply a certain force to the sliding member 30, thereby preventing the sliding member 30 from sliding axially, and the bent spring piece 12 can release the lock by elastically deforming the above-mentioned edge away from the sliding member 30; or, a gap or hole is formed on the bent spring piece 12, and the sliding member 30 is clamped by the gap or hole, thereby preventing the sliding member 30 from sliding axially, and the bent spring piece 12 can release the lock by elastically deforming the shape of the gap or hole. This embodiment does not limit this.
[0057] Please continue reading Figures 10 to 13In some embodiments of the present invention, at least one locking hole 1201 is provided on the bent spring piece 12. For example, when the shape of the bent spring piece 12 is set to be U-shaped, one locking hole 1201 can be provided on the U-shaped bent spring piece 12; when the shape of the bent spring piece 12 is set to be Z-shaped, two locking holes with coincident axes can be provided on the Z-shaped bent spring piece 12; the number of locking holes is set according to the shape of the bent spring piece 12 and actual needs, and is not listed here one by one. The shape of the locking hole 1201 is set according to the shape of the sliding member 30. For example, when the sliding member 30 is set to be cylindrical or cylindrical, that is, when the cross-sectional shape of the sliding member 30 is circular, the locking hole 1201 can be set to be a circular through hole, and of course it can also be set to be a square through hole. Taking the locking hole 1201 as a circular through hole as an example, the diameter of the locking hole 1201 is larger than the diameter of the sliding member 30, thereby ensuring that the sliding member 30 can slide axially when the abutment is released.
[0058] Based on the above implementation, please continue to refer to Figures 1 to 9 , the sliding member 30 is inserted into the locking hole 1201. When the bent spring piece 12 is in the first working condition, the sliding member 30 abuts against the inner wall of the locking hole 1201. As a result, the sliding member 30 is subjected to the force exerted by the inner wall of the locking hole 1201 and cannot slide. There are many ways of abutting. For example, when the bent spring piece 12 is in the first working condition, the position where the locking hole 1201 is located can be horizontal, that is, the axis of the locking hole 1201 is parallel to the axis of the sliding member 30, and part of the inner wall of the locking hole 1201 abuts against the sliding member 30, applying radial force to the sliding member 30. On this basis, the operator can use the control member 11 to change the position of the bent spring piece 12 so that the inner wall of the locking hole 1201 leaves the sliding member 30, thereby releasing the lock; or, as shown in FIG. Figure 10 and Figure 12 As shown, the portion where the locking hole 1201 is located is in an inclined state, that is, an angle is formed between the axis of the locking hole 1201 and the axis of the sliding member 30, and part of the inner wall of the locking hole 1201 abuts against the sliding member 30, applying a force to the sliding member 30 at a certain angle to the radial direction. On this basis, the operator can use the control member 11 to change the shape of the bent spring piece 12 so that the inner wall of the locking hole 1201 no longer applies force to the sliding member 30, thereby releasing the lock.
[0059] In an optional embodiment, as Figure 1 and Figure 2 、 Figure 5 and Figure 6 As shown, when the valve clip 100 enters the patient's body, the initial state of the bent spring piece 12 can be the first working condition, at which time the sliding member 30 cannot slide; when the sliding member 30 is required to drive the clamp arm 20 to rotate, as shown in FIG. Figure 3 and Figure 4 、 Figure 7 and Figure 8 As shown, the operator can use the control member 11 to convert the bent spring piece 12 to the second working state, at which point the sliding member 30 can slide; when the clamping arm 20 successfully clamps the valve, the operator can remove the force applied to the bent spring piece 12 by the control member 11, causing the bent spring piece 12 to naturally return to its initial state, i.e., convert back to the first working state, and re-lock the sliding member 30. It can be understood that in this embodiment, the first working state of the bent spring piece 12 is used as the initial state, so that when finally locking, the locking can be completed based on the natural recovery of the elastic deformation of the bent spring piece 12, which facilitates the operator's operation and improves the reliability of the locking.
[0060] Please continue reading Figures 1 to 9 , 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 Figures 1 to 4 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. Figures 5 to 9 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.
[0061] For further information, please refer to Figures 1 to 9In some embodiments of the present invention, the valve clamp 100 further includes a central shaft 50, which is located in the middle of the valve clamp 100. The sliding member 30 is slidably arranged in the central shaft 50, and a plurality of clamp arms 20 are arranged around the periphery of the central shaft 50. One end of the clamp arm 20 is rotatably connected to the central shaft 50. 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 50. In this embodiment, the central shaft 50 is configured as a cylindrical structure with a cavity therein; the shape of the clamp arm 20 can be configured as a long strip, for example, The clamp arm 20 is in the shape of an arc plate, and the distal end of the clamp arm 20 is rotatably connected to the central shaft cylinder 50, and the inner arc surface of the clamp arm 20 faces the central shaft cylinder 50. When the number of clamp arms 20 is set to two, the two clamp arms 20 are symmetrically arranged on both sides of the central shaft cylinder 50. After the two clamp arms 20 are closed, they are in a hugging state, which is convenient for clamping the valve. An avoidance groove 201 is provided near the distal end of the clamp arm 20, and two connecting ears 202 are extended from the distal end of the clamp 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 cylinder 50 to be connected to the central shaft cylinder 50. For example, they can be rotatably connected by a rotating shaft.
[0062] Based on the above implementation, please continue to refer to Figures 1 to 9 The valve clipper 100 further includes a pivot mechanism 40 connected between the sliding member 30 and the clamp arm 20. The pivot mechanism 40 drives the clamp arm 20 to rotate about the connection with the central shaft cylinder 50 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 distally therewith and drives the clamp arm 20 rotatably connected therewith to rotate in a direction away from the central shaft cylinder 50, 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 proximally therewith and drives the clamp arm 20 rotatably connected therewith to rotate in a direction toward the central shaft cylinder 50, that is, drives the clamp arm 20 to close.
[0063] Please continue reading Figures 1 to 9In some embodiments of the present invention, 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 50, and the base 41 can be connected to the end of the sliding member 30. In other words, the base 41 is connected to the distal end of the sliding member 30, thereby expanding the range of movement of the base 41 and, in turn, the opening and closing range of the clamping arm 20. Furthermore, 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. Therefore, when the linkage arm 42 rotates, it can apply a pulling force or a pushing force to the clamping arm 20, thereby driving the clamping arm 20 to rotate and achieve expansion or closure.
[0064] On the basis of the above implementation mode, Figures 1 to 4 As shown, the bent spring piece 12 can be connected to the part of the sliding member 30 that extends out of the central shaft tube 50. The bent spring piece 12 includes a fixed section 121 and a movable section 122 connected thereto. When the bent spring piece 12 produces elastic deformation, the movable section 122 rotates relative to the fixed section 121, and the fixed section 121 can be connected to the central shaft tube 50, thereby providing movable support for the movable section 122. In this embodiment, the fixed section 121 can be directly connected to the central shaft tube 50 or indirectly connected. For example, a mounting seat 51 is provided near the far end of the central shaft tube 50. The mounting seat 51 can be provided on the outer wall of the central shaft tube 50 by welding or integral molding. The fixed section 121 of the bent spring piece 12 can be connected to the mounting seat 51. The connection method can be welding or plug-in combined with welding. It can be understood that due to the small size of the central shaft tube 50, the provision of the mounting seat 51 in this embodiment not only facilitates the connection between the bent spring piece 12 and the central shaft tube 50, that is, facilitates assembly, but also improves the reliability of the connection between the two.
[0065] On the basis of the above implementation method, continue to refer to Figures 1 to 9 , and refer to Figures 10 to 13The locking hole 1201 is provided on the movable section 122, and the locking hole 1201 abuts or releases the abutment with the sliding member 30 according to the rotation of the movable section 122. It should be noted that the relative positional relationship between the fixed section 121 and the movable section 122 can be set to be parallel or to form an angle according to the specific shape of the bent spring piece 12; the specific number of the fixed sections 121 and the movable sections 122 is also set according to the specific shape of the bent spring piece 12, for example, a U-shaped bent spring piece 12 may include a fixed section 121 and a movable section 122, and an S-shaped bent spring piece 12 may include a fixed section 121 and two movable sections 122 connected in sequence; the fixed section 121 and the movable section 122 may be set to an integrally formed structure, which is not only convenient for processing and manufacturing, but also can ensure the reliability of the bent spring piece 12.
[0066] Furthermore, the control member 11 is detachably connected to the movable section 122. The end of the control member 11 away from the bent spring piece 12 extends toward the proximal end for the operator to pull or push, thereby switching the bent spring piece 12 between the first working state and the second working state. For example, the bent spring piece 12 is set to a U shape. Figure 2 and Figure 10 、 Figure 6 and Figure 12 As shown, when the bent spring piece 12 is in the first working state, the movable section 122 is in an inclined state, and an angle is formed between the axis of the locking hole 1201 and the axis of the sliding member 30. When the operator pulls or pushes the control member 11, the bent spring piece 12 is transformed from the inclined state to the horizontal state, that is, the first working state is transformed into the second working state, as shown in FIG. Figure 4 and Figure 11 、 Figure 8 and Figure 13 As shown, when the bent spring piece 12 is in the second working state, the movable section 122 is horizontal or approximately horizontal. At this time, the axis of the locking hole 1201 tends to coincide with the axis of the sliding member 30, so the sliding member 30 can slide within the locking hole 1201. When the operator stops pulling or pushing the control member 11, the bent spring piece 12 can automatically return to the tilted state.
[0067] Based on the above implementation, please refer to Figure 10 and Figure 11The control member 11 is connected to the side of the movable segment 122 away from the fixed segment 121 to facilitate pulling or pushing. When the side of the movable segment 122 away from the fixed segment 121 is closer to the distal end than the side of the movable segment 122 connected to the fixed segment 121, the operator can pull the movable segment 122 toward the proximal end through the control member 11; when the side of the movable segment 122 connected to the fixed segment 121 is closer to the distal end than the side of the movable segment 122 away from the fixed segment 121, the operator can push the movable segment 122 toward the distal end through the control member 11. In an optional embodiment, the side of the movable segment 122 away from the fixed segment 121 is closer to the distal end than the side of the movable segment 122 connected to the fixed segment 121. On this basis, the control member 11 can be set to a metal wire or a non-metallic wire. The non-metallic wire can be a nylon wire or a suture thread, etc. The metal wire or non-metallic wire is used to provide tension. Thus, the operator can pull the movable segment 122 by pulling the control member 11 to rotate the movable segment 122, so that the bent spring piece 12 is converted from the first working condition to the second working condition, so that the inner wall of the locking hole 1201 no longer abuts against the sliding member 30, thereby releasing the lock.
[0068] For further information, please refer to Figure 10 and Figure 11 , the movable section 122 may be provided with a connecting hole 1221. Taking the control member 11 as an example of a suture, the suture passes through the connecting hole 1221 and is connected to the movable section 122. Furthermore, the number of connecting holes 1221 may be set to one or two. When there is one connecting hole 1221, the suture is passed through the proximal side of the connecting hole 1221, and then passes out from the distal side and extends toward the proximal end; when there are two connecting holes 1221, the suture can be passed through the proximal side of one of the connecting holes 1221, and then pass out from the distal side, and then pass through the distal side of the other connecting hole 1221, and then pass out from the proximal side and extend toward the proximal end. This method facilitates the withdrawal of the suture after the clamping is completed. Taking the bending spring piece 12 as an example of a U-shaped spring piece, when the bending spring piece 12 is in the first working condition, a first angle is formed between the fixed section 121 and the movable section 122. When the lock needs to be released, the operator can move along the following direction. Figure 10 or Figure 11 In the direction indicated by the arrow, the movable segment 122 is pulled by pulling the suture thread, so that the angle between the fixed segment 121 and the movable segment 122 becomes a second angle. It can be understood that the second angle is smaller than the first angle.
[0069] Based on the above embodiment, the valve clipper 100 includes one or more sliding members 30, which are axially slidably arranged in the central shaft tube 50. Each sliding member 30 can drive one or more clamping arms 20 to rotate. In this embodiment, the bent spring piece 12 in the locking mechanism 10 cooperates with one or more of the sliding members 30, and the cooperation method between the sliding member 30 and the bent spring piece 12 varies depending on the number of sliding members 30.
[0070] In an alternative embodiment, see Figures 1 to 4 , and refer to Figure 10 and Figure 11 In this embodiment, the number of sliding members 30 is set to one. For example, the sliding member 30 is set to a first sliding rod 31. The first sliding rod 31 is slidably set in the central shaft tube 50. The distal end of the first sliding rod 31 extends from the distal end of the central shaft tube 50. 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 refer to the above embodiments and are not repeated here. In this embodiment, the two pivoting mechanisms 40 are connected to the same base 41. The seat 41 is connected to the distal end of the first slide bar 31, the fixed section 121 of the bent spring piece 12 is connected to the central shaft tube 50, and the movable section 122 cooperates with the portion of the first slide bar 31 located between the base 41 and the central shaft tube 50. The bent spring piece 12 locks the first slide bar 31 in the first working condition, thereby preventing the two clamping arms 20 from rotating. The operator can pull the movable section 122 through the control component 11 to convert the bent spring piece 12 to the second working condition, allowing the first slide bar 31 to slide, thereby driving the two clamping arms 20 to unfold.
[0071] Furthermore, if Figure 2 and Figure 4 As shown, a limit block 52 can also be provided on the mounting seat 51. The limit block 52 can be provided on the side of the mounting seat 51 near the distal end by welding or integral molding. The side surface of the limit block 52 near the distal end can be set to a plane. Thus, when the operator uses the control member 11 to pull the movable section 122, the movable section 122 can rotate toward the proximal end until it contacts the distal end surface of the limit block 52. At this time, the movable section 122 is close to or in a horizontal state, and the lock on the first slide bar 31 is released, and it cannot continue to rotate under the stop of the limit block 52. That is to say, the setting of the limit block 52 in this embodiment can prevent the movable section 122 from rotating too much, which makes it easy for the operator to quickly unlock and improves the operating efficiency and accuracy.
[0072] In another optional embodiment, the number of sliding members 30 is set to multiple, and the multiple sliding members 30 are sequentially connected. In a first working state, the bent spring piece 12 abuts against the innermost sliding member 30 to lock the sliding member 30. In a second working state, the bent spring piece 12 allows all sliding members 30 to slide. Exemplarily, the multiple sliding members 30 include a sliding rod and at least one sliding cylinder 33 sleeved outside the sliding rod, and the bent spring piece 12 cooperates with the sliding rod.
[0073] See also Figures 5 to 9 , and refer to Figure 12 and Figure 13 Taking the case where the number of slide cylinders 33 is set to one as an example, the plurality of sliding members 30 include a second slide rod 32 and a slide cylinder 33. The slide cylinder 33 is slidably arranged in the central shaft cylinder 50, and the second slide rod 32 is slidably arranged in the slide cylinder 33. The distal end of the slide cylinder 33 extends from the distal end of the central shaft cylinder 50, and the distal end of the second slide rod 32 extends from the distal end of the slide cylinder 33. The valve clipper 100 includes two clamping arms 20 and two pivot mechanisms 40. Each pivot mechanism 40 includes a base 41 and a linkage arm 42. The specific structures of the clamping arms 20 and the base 41 and the linkage arm 42 are referred to in the previous embodiment and will not be repeated here. The two bases 41 are respectively a first base 411 and a second base 412. The first base 411 is connected to the slide cylinder 33, and the second base 412 is connected to the second slide rod 32. It can be understood that in this embodiment, the second base 412 is located on the side close to the distal end of the first base 411, and the fixed section 121 of the bent spring piece 12 is connected to the central shaft cylinder 50. The movable section 122 of the bent spring piece 12 locks the second slide rod 32 in the first working condition. At this time, the second slide rod 32 and the slide cylinder 33 cannot slide, thereby preventing the two clamping arms 20 from rotating. The operator can pull the movable section 122 through the control component 11 to convert the bent spring piece 12 to the second working condition. At this time, the second slide rod 32 and the slide cylinder 33 can slide, thereby driving the two clamping arms 20 to unfold respectively.
[0074] Furthermore, if Figure 12 and Figure 13 As shown, the bent spring piece 12 is also provided with an escape hole 1222, which is used for one or more pivoting mechanisms 40 to pass through. It can be understood that, in conjunction with reference to FIG. Figure 9 When multiple sliding members 30 are sequentially connected, in the state of the clamping arm 20 being closed, the movable section 122 of the bent spring 12 abuts against the innermost sliding member 30. Therefore, except for the base 41 connected to the innermost sliding member 30, the other bases 41 are all located on the proximal side of the movable section 122 and need to pass through the avoidance hole 1222 when sliding. Based on the above embodiment, taking the sliding member 30 including the second sliding rod 32 and the sliding cylinder 33 as an example, combined with Figure 6 and Figure 9As shown, the movable section 122 abuts against the second slide rod 32 in the first working condition. When the operator pulls the movable section 122 to release the lock through the control component 11, the second slide rod 32 and the slide cylinder 33 can both slide, and the first base 411 connected to the slide cylinder 33 slides axially through the avoidance hole 1222.
[0075] According to the above embodiment, the locking hole 1201 is provided on the bent spring piece 12. In this embodiment, the avoidance hole 1222 and the locking hole 1201 can be separated or connected, for example, they can be integrally cut and formed. For example, Figure 12 and Figure 13 As shown, the avoidance hole 1222 and the locking hole 1201 are integrally configured as a U-shaped through hole. Figure 5 As shown, the curved inner wall of the U-shaped through hole abuts against the side wall of the second slide bar 32 to lock it. When the lock is released, the first base 411 can slide through the U-shaped through hole along with the axial direction of the slide cylinder 33. In this embodiment, the avoidance hole 1222 and the locking hole 1201 are integrated to facilitate processing and avoid interference between the first base 411 and the bent spring 12.
[0076] Please continue reading Figures 1 to 9 In some embodiments of the present invention, the valve clipper 100 further includes a capture member 60, which is mounted between the central shaft 50 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 thread, such as a nylon thread, suture thread, or metal wire, connected to the capture member 60. The control thread 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. For example, 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 multiple springs, for example, two springs located on either side of the central shaft 50. The two springs can be configured as an integrally formed structure with a predetermined angle between them. A single control thread can be provided to simultaneously control both springs, or a plurality of control threads 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.
[0077] See also Figure 14, an embodiment of the second aspect of the present invention proposes a valve repair system, 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, and the control member 11 of the locking mechanism 10 in the valve clipper 100 can be connected to the hand The valve clip 100 is in the handle 710, so that the operator can operate the control member 11 through the handle 710; the connecting mechanism is connected to the distal end of the innermost sheath 720 and is detachably connected to the valve clip 100. Therefore, when the valve clip 100 is delivered to the set position, the valve clip 100 adjusts its position according to the bending and movement of the sheath 720. When the valve clip 100 clamps the valve and locks it, the connecting mechanism disengages from the valve clip 100, so that the valve clip 100 remains in the patient's body.
[0078] For further information, please refer to Figure 14 , and refer to Figure 15 In 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. For example, when there is one sliding member 30, there is also one driving member 740. 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. The proximal end of the driving member 740 is connected to the handle 710. Thus, 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.
[0079] Taking the sliding member 30 as a sliding rod as an example, in an optional embodiment, as Figure 15As shown, a blind hole is provided at one end of the sliding rod near the proximal end, and an internal thread is provided in the blind hole. The driving member 740 can be specifically provided as a metal wire, and an external thread matching the above-mentioned internal thread is provided on the outer wall of the driving member 740 near the distal end, so that the distal end of the driving member 740 is connected to the sliding rod; 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 through the handle 710. When the sliding member 30 needs to move axially, the operator can move the driving member 740 through the handle 710. When the delivery device needs to be disengaged from the valve clipper 100, the operator can rotate the driving member 740 through the handle 710 to release the internal thread and the external thread, and then withdraw the driving member 740.
[0080] On the basis of the above-mentioned embodiment, illustratively, the operation method of the valve repair system proposed in this embodiment is as follows: the operator operates the handle 710 to move the sheath assembly and the valve clip 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 11 to convert the bent spring piece 12 from the first working state to the second working state, and release the locking of the bent spring piece 12 on the sliding member 30; then use the handle 710 to push the driving member 740 to move the sliding member 30 connected thereto toward the distal end, so that the sliding member 30 is pivoted to the driving member 740. The clamping arm 20 connected to the rotating mechanism 40 is unfolded, and the position of the valve clamp 100 is adjusted to align with the part of the mitral valve to be clamped. Then, the handle 710 is used to pull the driving member 740 to move the sliding member 30 toward the proximal end, so that the clamping arm 20 closes and clamps the valve. The control member 11 is released to pull the bent spring piece 12, so that the bent spring piece 12 returns to the first working state and locks the sliding member 30. Finally, the driving member 740 and the sliding member 30 are disengaged, and the connecting mechanism and the valve clamp 100 are disengaged. The driving member 740 and the sheath assembly are withdrawn, so that the valve clamp 100 remains in the patient's body in a state of clamping the valve.
[0081] 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: Multiple clamping arms; A central shaft cylinder, wherein the plurality of clamping arms are arranged around the periphery of the central shaft cylinder; at least one sliding member, the sliding member being slidably disposed within the central shaft, 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; A locking mechanism includes a control member and a bent spring sheet, wherein the bent spring sheet is connected to the portion of the sliding member extending out of the central shaft tube, and the control member controls the bent spring sheet to switch between a first working condition and a second working condition. In the first working condition, the bent spring sheet abuts against at least one of the sliding members to prevent the sliding member from sliding, and in the second working condition, the bent spring sheet allows the sliding member to slide.
2. The valve clip according to claim 1, characterized in that: At least one locking hole is provided on the bent elastic sheet, and the sliding member is inserted into the locking hole. In the first working condition, the inner wall of the locking hole abuts against the side wall of the sliding member.
3. The valve clipper according to claim 2, characterized in that: In the first working condition, an angle is formed between the axis of the locking hole and the axis of the sliding member.
4. The valve clipper according to claim 2, characterized in that: The bent spring sheet includes a fixed section and a movable section connected to each other, an angle is formed between the fixed section and the movable section, the movable section can rotate relative to the fixed section, the locking hole is provided through the movable section, and the locking hole abuts or releases the abutment with the sliding member according to the rotation of the movable section.
5. The valve clipper according to claim 4, characterized in that: The fixing section is connected to the central shaft cylinder.
6. The valve clip according to claim 5, characterized in that: The outer wall of the central shaft is provided with a mounting seat, the fixed section is connected to the mounting seat, and a limiting block for stopping the movable section is extended from the mounting seat.
7. The valve clip according to claim 4, characterized in that: The control member is detachably connected to the movable section, and one end of the control member away from the bent elastic sheet extends toward the proximal end for an operator to pull or push, so that the bent elastic sheet is switched between the first working state and the second working state.
8. The valve clip according to claim 7, characterized in that: The control member is configured as a metal wire or a non-metal wire.
9. The valve clip according to claim 8, characterized in that: At least one connecting hole is provided on the movable section, and the control member is passed through the connecting hole to be connected with the bent elastic sheet.
10. The valve clip according to any one of claims 1 to 9, characterized in that: There are multiple sliding members, which are sleeved in sequence. The bent spring piece abuts against the innermost sliding member in the first working condition, and allows all sliding members to slide in the second working condition.
11. The valve clip according to claim 10, characterized in that: The bent spring sheet is provided with an avoidance hole, and the avoidance hole is used for allowing at least one of the pivoting mechanisms to pass through.
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 clamping system
CN113367844A