Valve clip applicator and valve repair system
By using the design of connecting the sliding member in the central shaft cylinder to the clamp arm in the valve clamp, independent clamping and precise operation of the valve clamping device are achieved, solving the problem of poor clamping effect in the prior art and improving surgical efficiency.
Patent Information
- Application Number
- CN202111499544.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-12-09
- Publication Date
- 2025-07-22
- Estimated Expiration
- 2041-12-09
AI Technical Summary
When existing valve clamping devices clamp the heart valve, it is difficult to accurately clamp two leaflets at the same time, resulting in poor clamping effect and cumbersome operation.
A valve clamp is designed, and a plurality of sliding members in the central shaft cylinder are connected to the clamp arm through a pivot mechanism, allowing each clamp arm to slide and rotate independently, achieving separate closure, reducing volume and improving operating accuracy.
It improves the accuracy and simplicity of valve clamping, reduces the difficulty of surgery, and ensures the clamping effect.
Smart Images

Figure CN114176837B_ABST
Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a valve clip and a valve repair system. Background Art
[0002] The heart valve refers to the valve between the atrium and the ventricle or between the ventricle and the artery. The atrioventricular valves include the mitral valve and the tricuspid valve. The mitral valve is composed of two valve leaflets attached to the periphery of the left atrioventricular orifice, which are connected to the papillary muscles by chordae tendineae and can prevent the blood in the left ventricle from flowing back into the left atrium. Mitral regurgitation is caused by organic or functional changes in the mitral valve leaflets and their related structures, resulting in poor anastomosis of the anterior and posterior mitral valve leaflets. When mitral regurgitation occurs, the blood flow will flow backward 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 such diseases. However, surgery has the disadvantages of large trauma, obvious postoperative pain, slow recovery, and high risk. In recent years, the interventional treatment of heart valve disease has developed rapidly due to its advantages of small trauma, relatively high safety, and good efficacy. Among them, the valve repair method developed based on the principle of surgical edge-to-edge suture technology has been recognized for its high safety, simple technical principle, and high feasibility.
[0004] However, in the related art, most valve clips are designed to capture the front and rear valve leaflets and then simultaneously close the two clamping arms to clamp the two valve leaflets. Due to the different sizes and relative positions of the two valve leaflets of different surgical individuals, when the two clamping arms are closed simultaneously, it is impossible to ensure that the two valve leaflets are clamped at the same time. Therefore, such a valve clip has the risk of only clamping one valve leaflet and being misaligned or separated from the other valve leaflet, resulting in poor clamping effect, requiring multiple re-clamping, complicated operation, and affecting the surgical effect. Summary of the Invention
[0005] The object of the present invention is to at least solve the problem of poor clamping effect of the valve clip. This object is achieved by the following technical solutions:
[0006] The first aspect of the present invention provides a valve clip, which includes:
[0007] A central shaft cylinder;
[0008] A plurality of clamping arms, which are arranged around the periphery of the central shaft cylinder. One end of each clamping arm is rotatably connected to the central shaft cylinder, and the clamping arms are configured to expand or close according to rotation.
[0009] A plurality of sliding members are axially slidably arranged within the central shaft tube. The plurality of sliding members are sleeved in sequence, and each sliding member is connected to at least one of the clamping arms through a pivoting mechanism, so that the clamping arms rotate according to the sliding of the sliding members.
[0010] The valve clip applicator provided by the embodiment of the present invention has the following advantages:
[0011] In the embodiment of the present invention, a plurality of sliding members are arranged within the central shaft tube. The limited installation space within the central shaft tube is fully utilized in the form of sequential sleeving, which is beneficial to reducing the volume of the valve clip applicator; each sliding member can slide independently without mutual influence; each sliding member can drive at least one clamping arm connected thereto to move, so that the clamping arm closes independently to clamp the valve, avoiding inaccurate clamping caused by simultaneous clamping of multiple clamping arms. At the same time, the independent closing of the clamping arm reduces the difficulty of surgical operation, thereby improving the valve clamping effect.
[0012] In addition, the valve clip applicator provided by the embodiment of the present invention may further have the following technical features:
[0013] In some embodiments of the present invention, one end of the pivoting mechanism is fixedly connected to the sliding member, and the other end of the pivoting mechanism is rotatably connected to the clamping arm.
[0014] In some embodiments of the present invention, the pivoting mechanism includes a base and a linkage arm. The base is fixedly connected to the sliding member, one end of the linkage arm is connected to the base, and the other end of the linkage arm is rotatably connected to the clamping arm.
[0015] In some embodiments of the present invention, the linkage arm is rotatably connected to the base.
[0016] In some embodiments of the present invention, the sliding member extends out from the distal end of the central shaft tube, and the base is connected to the end of the sliding member extending out from the central shaft tube.
[0017] In some embodiments of the present invention, the plurality of sliding members include a slide bar and at least one slide cylinder. The at least one slide cylinder is slidably arranged within the central shaft tube and extends out from the distal end of the central shaft tube. The slide bar is slidably arranged within the innermost slide cylinder and extends out from the distal end of the slide cylinder.
[0018] In some embodiments of the present invention, the valve clip applicator further includes a locking mechanism. The locking mechanism is connected to at least one of the sliding member, the pivoting mechanism, and the clamping arm, and the locking mechanism can at least restrict the opening of the clamping arm after closing.
[0019] In some embodiments of the present invention, the valve clip also includes a capturing member, which is installed between the central shaft cylinder and the clip arm, and barbs are provided on one side of the capturing member facing the clip arm to capture the valve.
[0020] A second aspect of the present invention provides a valve repair system, which includes a delivery device and the valve clip according to any of the above embodiments. The delivery device is detachably connected to the valve clip to deliver the valve clip to a set position.
[0021] The valve repair system provided by the embodiments of the present invention has the same advantages as the valve clip provided by any of the above embodiments, and will not be elaborated here.
[0022] In some embodiments of the present invention, the delivery device includes a plurality of driving members, and each driving member is connected to one of the sliding members to drive the sliding member to slide. Description of the Drawings
[0023] The following briefly introduces the drawings in the embodiments. Those skilled in the art can also obtain other drawings based on these drawings without creative efforts.
[0024] Figure 1 Structural schematic of the valve clip in the embodiment of the present invention Figure 1 ;
[0025] Figure 2 is Figure 1 the front view of the shown valve clip;
[0026] Figure 3 Structural schematic of the valve clip in the embodiment of the present invention Figure 2 ;
[0027] Figure 4 is Figure 3 the front view of the shown valve clip;
[0028] Figure 5 Structural schematic of the valve clip in the embodiment of the present invention Figure 3 ;
[0029] Figure 6 Structural schematic of the valve repair system in the embodiment of the present invention;
[0030] Figure 7 Cross-sectional schematic of the cooperation between the driving member and the sliding member in the valve repair system in the embodiment of the present invention.
[0031] The reference signs in the drawings are as follows:
[0032] 1000, valve repair system;
[0033] 100. Valve clip applicator;
[0034] 10. Central shaft cylinder; 11. Mounting base;
[0035] 20. Clip arm; 201. Avoidance groove; 202. Connecting ear; 21. First clip arm; 22. Second clip arm;
[0036] 30. Sliding member; 31. Slide bar; 32. Slide cylinder;
[0037] 40. Pivoting mechanism; 41. Base; 411. First base; 412. Second base; 42. Linkage arm; 421. First linkage arm; 422. Second linkage arm;
[0038] 51. Locking spring piece; 511. Locking hole;
[0039] 60. Capturing member;
[0040] 710. Handle; 720. Sheath tube; 730. Bending adjustment mechanism; 741. First driving member; 742. Second driving member. Detailed implementation manner
[0041] As described in the background art, taking mitral valve repair surgery as an example, the valve clip applicator closes both clip arms simultaneously to clip the valve. However, the inventor found during the experiment that since the valve is always in motion during the surgical operation, closing both clip arms simultaneously to clip the valve leaflets requires high operating requirements for the surgeon and high precision requirements for the specific position of the clip arms. It is very difficult to ensure accurate simultaneous clamping of the two valve leaflets, and it is extremely easy to occur that one clip arm is clamped in place while the other clip arm is misaligned with the valve leaflet. In this case, not only do the two clip arms need to be opened and reclamped, but repeated clamping multiple times is likely to damage the valve leaflets and affect the surgical effect. To address the above problems, the present invention proposes a valve clip applicator and a valve repair system. By arranging a plurality of sliding members sleeved in sequence in the central shaft cylinder of the valve clip applicator, different sliding members are used to slide to drive different clip arms to rotate, enabling the clip arms to be closed separately. Taking mitral valve repair surgery as an example, when the surgeon uses the valve clip applicator proposed by the present invention to clip the valve leaflets, one clip arm can be closed first to clip one valve leaflet, and then the angle or position of the valve clip applicator relative to the other valve leaflet can be finely adjusted according to the conditions of different surgical individuals. After getting as close as possible to and aligning with the other valve leaflet, clamping can be performed. Thus, not only is the operation difficulty reduced, but also rapid and accurate clamping can be achieved, thereby improving the clamping effect.
[0042] Next, in combination with the accompanying drawings in the embodiments of the present invention, the terms used herein are only for the purpose of describing specific example embodiments and should not be construed as limiting the present invention. For example, the terms "comprising" and "having" not only indicate the presence of the stated features but also do not exclude the presence of other features; the terms "first" and "second" do not imply order or sequence; the terms "inner", "outer", "above", and "below" are only for facilitating the description of the relationship of one feature shown in the accompanying drawings relative to another feature and do not indicate that it 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 centers of the distal end and the proximal end of the medical device in the natural state.
[0043] Please refer to Figures 1 to 5 , an embodiment of the first aspect of the present invention provides a valve clip 100, which includes a central shaft tube 10, a plurality of clip arms 20, and a plurality of sliding members 30. The plurality of clip arms 20 are wound around the periphery of the central shaft tube 10. One end of each clip arm 20 is rotatably connected to the central shaft tube 10, and the clip arms 20 are configured to expand or close according to rotation; the plurality of sliding members 30 are slidably arranged along the axial direction in the central shaft tube 10, and the plurality of sliding members 30 are sleeved in sequence. Each sliding member 30 is connected to at least one clip arm 20 through a pivoting mechanism 40, so that the clip arms 20 rotate according to the sliding of the sliding members 30.
[0044] The valve clip 100 proposed in this embodiment can be used as an edge-to-edge repair implant in the field of interventional treatment of heart diseases. The valve clip 100 proposed in this embodiment can reach the designated position through a minimally invasive transcutaneous entrance and blood vessels, and realize the repair treatment of heart valves (including but not limited to mitral valve, tricuspid valve, aortic valve, pulmonary valve). It can be understood that since the valve clip 100 needs to be implanted inside the patient's heart, especially in the way of being introduced through a minimally invasive transcutaneous entrance and blood vessels, the volume of the valve clip 100 is strictly limited. In this embodiment, by arranging the plurality of sliding members 30 in a sleeved manner in the central shaft tube 10, it meets the requirement of the limited volume of the valve clip 100, not only makes full use of the limited installation space in the central shaft tube 10, but also ensures that each sliding member 30 can slide independently and without mutual influence. On this basis, in this embodiment, the plurality of sliding members 30 are used to drive the clip arms 20 to rotate respectively, so that the clip arms 20 can independently close to clamp the valve, which is convenient for the surgical operator to fine-tune the angle or position of the valve clip 100 after clamping one side of the valve leaf, realize the accurate clamping of the remaining side of the valve, avoid the problems of large operation difficulty and inaccurate clamping in the existing simultaneous clamping of multiple clip arms 20, reduce the surgical operation difficulty, and solve the problem of poor clamping effect of the valve clip 100.
[0045] AsFigure 1 and Figure 3 As shown in Figure 3 , in the valve clip 100 proposed in this embodiment, the central shaft tube 10 is located in the middle of the valve clip 100. Understandably, there is a cavity inside the central shaft tube 10, and the central shaft tube 10 is used to provide an installation space for the sliding member 30 so that the sliding member 30 can slide therein; one end of the clamping arm 20 is rotatably connected to the central shaft tube 10. When the sliding sliding member 30 is linked with the clamping arm 20, the clamping arm 20 can rotate around the connection with the central shaft tube 10. In this embodiment, the central shaft tube 10 is set as a cylindrical structure. Exemplarily, it can be set as a cylindrical structure, or can be set as a square tube structure, or can also be set as a cylindrical structure of other shapes according to actual needs.
[0046] The valve clip 100 proposed in this embodiment includes a plurality of clamping arms 20, and the clamping arms 20 are used to clamp the valve. It should be noted that the number of clamping arms 20 in this embodiment can be set to two, or can be set to more than two. Exemplarily, if the valve clip 100 is applied to mitral valve repair treatment, the number of clamping arms 20 can be correspondingly set to two. If the valve clip 100 is applied to tricuspid valve repair treatment, the number of clamping arms 20 can be correspondingly set to three. This embodiment does not make a specific limitation on the number of clamping arms 20 and can be set according to actual needs. On the basis of the above implementation manner, the plurality of clamping arms 20 are arranged around the central shaft tube 10, and can be arranged at equal intervals or at unequal intervals. Exemplarily, when the number of clamping arms 20 is set to two, the two clamping arms 20 can be symmetrically arranged with respect to the central shaft tube 10.
[0047] In this embodiment, the shape of the clamping arm 20 can be set as a long strip plate shape. For example, it can be set as a flat plate shape or an arc plate shape. The structures of the two clamping arms 20 can be the same or different; one end of each clamping arm 20 is rotatably connected to the central shaft tube 10. Exemplarily, as shown in Figure 1 and Figure 3 , taking the clamping arm 20 set as an arc plate shape as an example, the distal end of the clamping arm 20 is rotatably connected to the central shaft tube 10, and the inner arc surface of the clamping arm 20 faces the central shaft tube 10. When the number of clamping arms 20 is set to two, the two clamping arms 20 are symmetrically arranged on both sides of the central shaft tube 10, and the two clamping arms 20 are in a clasped state after closing, so as to facilitate clamping the valve. Further, as shown in Figure 3 , a relief groove 201 is provided at a position of the clamping arm 20 near the distal end, and two connecting ears 202 are provided protruding from the distal end of the clamping arm 20. The two connecting ears 202 are respectively located on both sides of the relief groove 201 and extend to the other opposite sides of the outer wall of the central shaft tube 10, so as to be rotatably connected to the central shaft tube 10. Exemplarily, it can be rotatably connected through a rotating shaft. The rotating shaft is installed on the central shaft tube 10 and passes through the connecting holes provided on the connecting ears 202, so that the clamping arm 20 can rotate around the rotating shaft. Figure 1 and Figure 3 As shown in Figure 1 and Figure 3 , taking the clamping arm 20 set as an arc plate shape as an example, the distal end of the clamping arm 20 is rotatably connected to the central shaft tube 10, and the inner arc surface of the clamping arm 20 faces the central shaft tube 10. When the number of clamping arms 20 is set to two, the two clamping arms 20 are symmetrically arranged on both sides of the central shaft tube 10, and the two clamping arms 20 are in a clasped state after closing, so as to facilitate clamping the valve. Further, as shown in Figure 3 , a relief groove 201 is provided at a position of the clamping arm 20 near the distal end, and two connecting ears 202 are provided protruding from the distal end of the clamping arm 20. The two connecting ears 202 are respectively located on both sides of the relief groove 201 and extend to the other opposite sides of the outer wall of the central shaft tube 10, so as to be rotatably connected to the central shaft tube 10. Exemplarily, it can be rotatably connected through a rotating shaft. The rotating shaft is installed on the central shaft tube 10 and passes through the connecting holes provided on the connecting ears 202, so that the clamping arm 20 can rotate around the rotating shaft. Figure 3 As shown in Figure 3 , a relief groove 201 is provided at a position of the clamping arm 20 near the distal end, and two connecting ears 202 are provided protruding from the distal end of the clamping arm 20. The two connecting ears 202 are respectively located on both sides of the relief groove 201 and extend to the other opposite sides of the outer wall of the central shaft tube 10, so as to be rotatably connected to the central shaft tube 10. Exemplarily, it can be rotatably connected through a rotating shaft. The rotating shaft is installed on the central shaft tube 10 and passes through the connecting holes provided on the connecting ears 202, so that the clamping arm 20 can rotate around the rotating shaft.
[0048] Please continue to refer to Figures 1 to 5 , taking the number of clamping arms 20 as two, and the two clamping arms 20 being the first clamping arm 21 and the second clamping arm 22 respectively as an example for description. The connecting ears 202 on the same side of the first clamping arm 21 and the second clamping arm 22 can cooperate with the same rotating shaft. On this basis, the two connecting ears 202 of the first clamping arm 21 can be located outside or inside the two connecting ears 202 of the second clamping arm 22 at the same time, or one connecting ear 202 of the first clamping arm 21 is located outside the connecting ear 202 on the same side of the second clamping arm 22, and the other connecting ear 202 of the first clamping arm 21 is located inside the connecting ear 202 on the same side of the second clamping arm 22, so as to ensure the reliability of the connection between the first clamping arm 21 and the second clamping arm 22 and the central shaft cylinder 10. This embodiment does not make specific limitations on this.
[0049] In the valve clamp 100 proposed in this embodiment, the sliding member 30 is used to drive the clamping arm 20 to rotate by sliding. In this embodiment, the number of sliding members 30 can be set to two, or can be set to more than two. Each sliding member 30 can be linked with one clamping arm 20, or can be linked with multiple clamping arms 20. It can be understood that when one sliding member 30 is connected to multiple clamping arms 20, this sliding member 30 can drive the connected multiple clamping arms 20 to rotate and open and close simultaneously. Exemplarily, the number of sliding members 30 is set to two, and the number of clamping arms 20 is set to three. Thus, one sliding member 30 is connected to one clamping arm 20, and the other sliding member 30 is connected to two clamping arms 20; when the number of sliding members 30 is equal to the number of clamping arms 20, each sliding member 30 is connected to one clamping arm 20.
[0050] Please continue to refer to Figures 1 to 5 On the basis of the above embodiment, when the number of clamping arms 20 is set to two, the number of sliding members 30 can also be set to two accordingly. On this basis, the two sliding members 30 are both arranged in the central shaft cylinder 10. Taking the two sliding members 30 as the first sliding member 30 and the second sliding member 30 respectively for description, the first sliding member 30 is sleeved outside the second sliding member 30, and the first sliding member 30 is located between the central shaft cylinder 10 and the second sliding member 30. In this embodiment, the fitting methods between the central shaft cylinder 10 and the first sliding member 30, and between the first sliding member 30 and the second sliding member 30 are both set as clearance fits, so as to facilitate the sliding of the first sliding member 30 and the second sliding member 30 relative to the central shaft cylinder 10.
[0051] On the basis of the above embodiment, as Figure 5As shown, each sliding member 30 is connected to the clamping arm 20 through a pivoting mechanism 40. That is to say, at least part of the sliding member 30 is exposed outside the central shaft cylinder 10, so that the pivoting mechanism 40 can be connected to the exposed part. In an alternative embodiment, a plurality of windows may be provided on the cylinder wall of the central shaft cylinder 10. The windows have a certain length in the axial direction. Thus, one end of the pivoting mechanism 40 can extend into the window and be connected to the sliding member 30. When the sliding member 30 slides, the pivoting mechanism 40 moves within the range defined by the window, thereby driving the clamping arm 20 to rotate. In another alternative embodiment, as Figure 2 and Figure 4 shown, the distal end of the central shaft cylinder 10 has an opening communicating with the internal cavity. The sliding member 30 extends out from the opening. That is to say, the sliding member 30 extends out from the distal end of the central shaft cylinder 10. On this basis, one end of the pivoting mechanism 40 is connected to the part where the sliding member 30 extends out. When the sliding member 30 slides, the pivoting mechanism 40 moves accordingly, thereby driving the clamping arm 20 to rotate.
[0052] Based on the above embodiments, the pivoting mechanism 40 is respectively connected to the sliding member 30 and the clamping arm 20. According to the sliding of the sliding member 30, the clamping arm 20 is driven to rotate around the connection with the central shaft cylinder 10. The structure of the pivoting mechanism 40 will be specifically described below. Please continue to refer to Figures 1 to 5 , in some embodiments of the present invention, one end of the pivoting mechanism 40 is fixedly connected to the sliding member 30, and the other end is rotatably connected to the clamping arm 20. It can be understood that when the sliding member 30 slides axially towards the distal end, the pivoting mechanism 40 moves towards the distal end accordingly, and drives the clamping arm 20 rotatably connected thereto to rotate away from the central shaft cylinder 10, that is, drives the clamping arm 20 to unfold; when the sliding member 30 slides axially towards the proximal end, the pivoting mechanism 40 moves towards the proximal end accordingly, and drives the clamping arm 20 rotatably connected thereto to rotate towards the central shaft cylinder 10, that is, drives the clamping arm 20 to close.
[0053] In 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. The fixed connection method can be that the base 41 and the sliding member 30 are integrally formed, or it can be a welded connection. This embodiment does not make specific limitations on this. The position where the base 41 is connected to the sliding member 30 can be set according to the structures of the sliding member 30 and the central shaft cylinder 10. Exemplarily, in some embodiments of the present invention, the sliding member 30 extends from the distal end of the central shaft cylinder 10, and the base 41 can be connected to the part of the sliding member 30 that extends from the central shaft cylinder 10. Further, the base 41 is connected to the end of the sliding member 30, that is to say, the base 41 is connected to the distal end of the sliding member 30. Thus, the movement range of the base 41 is the same as the movement range of the distal end of the sliding member 30, thereby expanding the movement range of the base 41, and further expanding the opening and closing range of the clamping arm 20. On this basis, one end of the linkage arm 42 is connected to the base 41, and the other end of the linkage arm 42 is rotatably connected to the clamping arm 20. Thus, when the base 41 slides axially along with the sliding member 30, the linkage arm 42 rotates between the base 41 and the clamping arm 20, and further drives the clamping arm 20 to rotate. In this embodiment, there are various connection methods between the linkage arm 42 and the base 41, which can be set as a rotational connection or an elastic connection. The specific connection method can be set according to actual needs.
[0054] In an alternative embodiment, the linkage arm 42 and the base 41 can be set as an integral elastic structure, such as a shape memory alloy part, or the linkage arm 42 and the base 41 are connected by elastic components such as elastic sheets and torsion springs. It can be understood that when the base 41 moves axially, the elastic component connected between the base 41 and the linkage arm 42 will undergo elastic deformation, enabling the linkage arm 42 to rotate within a certain range, and further driving the clamping arm 20 to rotate. In another alternative embodiment, the linkage arm 42 is rotatably connected to the base 41. Exemplarily, the linkage arm 42 and the base 41 can be hinged by components such as hinges, or connected by a rotating shaft.
[0055] Such as Figure 3 and Figure 5As shown, one side of the base 41 away from the sliding member 30 is rotatably connected to the linkage arm 42 through a rotating shaft. Specifically, a first connection hole may be penetrated through the base 41. Two connection parts are provided at one end of the linkage arm 42 close to the base 41. The connection parts may be specifically provided as connecting rods or connecting plates. A second connection hole is penetrated through the connection parts. The two connection parts are respectively located on both sides of the base 41, and the rotating shaft is penetrated through the first connection hole and the second connection hole, so that the linkage arm 42 and the base 41 are rotatably connected; alternatively, a rotating shaft is welded or integrally provided on the base 41, and a connection hole is penetrated through the connection part. The connection hole is matched with the rotating shaft and can rotate around the rotating shaft. Such a method is not only convenient for assembly, but also ensures the reliability of the connection between the base 41 and the linkage arm 42.
[0056] As Figure 3 and Figure 5 shown, one end of the linkage arm 42 away from the base 41 is rotatably connected to the clamping arm 20. According to the above embodiment, the distal end of the clamping arm 20 is rotatably connected to the central shaft cylinder 10. In this embodiment, the linkage arm 42 is connected to the middle part of the clamping arm 20. Thus, when the linkage arm 42 rotates, it can apply a pulling force or a pushing force to the clamping arm 20, and then drive the clamping arm 20 to rotate to realize opening or closing. The way of rotatably connecting the linkage arm 42 and the clamping arm 20 can be through a rotating shaft connection or through a hinge joint. According to the above embodiment, an avoidance groove 201 is provided at a position of the clamping arm 20 close to the distal end. Mounting holes may be provided on the groove wall of the avoidance groove 201. One end of the linkage arm 42 away from the base 41 may be provided with a mounting shaft. This end extends into the avoidance groove 201 and the mounting shaft is matched with the mounting hole, so as to realize the rotational connection between the linkage arm 42 and the clamping arm 20.
[0057] In this embodiment, multiple sliding members 30 are sleeved in sequence, which can reduce the overall volume of the valve clamp 100 by saving the installation space and facilitate its implantation at the valve. Please refer to Figures 2 to 5 , in some embodiments of the present invention, the multiple sliding members 30 include a sliding rod 31 and at least one sliding cylinder 32. At least one sliding cylinder 32 is slidably arranged in the central shaft cylinder 10 and extends out from the distal end of the central shaft cylinder 10. The sliding rod 31 is slidably arranged in the innermost sliding cylinder 32 and extends out from the distal end of the sliding cylinder 32. The sliding rod 31 and the sliding cylinder 32 are respectively connected to at least one clamping arm 20 through a pivoting mechanism 40, so as to drive at least one clamping arm 20 to rotate to realize opening and closing. It should be noted that in this embodiment, the inner side refers to the side close to the central shaft cylinder 10.
[0058] Exemplarily, when the number of the clamping arms 20 and the sliding members 30 are both set to two, the two sliding members 30 include a sliding rod 31 and a sliding cylinder 32. The sliding rod 31 and the sliding cylinder 32 are both arranged inside the central shaft cylinder 10, and the sliding cylinder 32 is sleeved outside the sliding rod 31. The sliding rod 31 and the sliding cylinder 32 are respectively connected to a clamping arm 20 through a pivoting mechanism 40. According to the above embodiment, the pivoting mechanism 40 includes a base 41 and a linkage arm 42, as Figure 3 and Figure 4 shown, the sliding cylinder 32 is connected to the first clamping arm 21 through a first pivoting mechanism. The first pivoting mechanism includes a first base 411 and a first linkage arm 421. The sliding rod 31 is connected to the second clamping arm 22 through a second pivoting mechanism. The second pivoting mechanism includes a second base 412 and a second linkage arm 422. On this basis, the distal end of the sliding cylinder 32 extends out from the distal end of the central shaft cylinder 10. The first base 411 is fixedly connected to the distal end of the sliding cylinder 32. The distal end of the first linkage arm 421 is rotationally connected to the first base 411 through a rotating shaft. The proximal end of the first linkage arm 421 is rotationally connected to the first clamping arm 21 through a rotating shaft. The distal end of the first clamping arm 21 is rotationally connected to the central shaft cylinder 10 through a rotating shaft; the distal end of the sliding rod 31 extends out from the distal end of the sliding cylinder 32. The second base 412 is fixedly connected to the distal end of the sliding rod 31. The distal end of the second linkage arm 422 is rotationally connected to the second base 412 through a rotating shaft. The proximal end of the second linkage arm 422 is rotationally connected to the second clamping arm 22 through a rotating shaft. The distal end of the second clamping arm 22 is rotationally connected to the central shaft cylinder 10 through a rotating shaft. Among them, the first base 411 is located between the second base 412 and the central shaft cylinder 10. It can be understood that when there are multiple sliding members 30, the base 41 of the pivoting mechanism 40 connected to the sliding rod 31 is located on the outermost side of all the bases 41. In this embodiment, the outside refers to the side away from the central shaft cylinder 10, so as to ensure that all the sliding members 30 can slide towards the proximal end independently, thereby driving the corresponding clamping arms 20 to close.
[0059] Further, please refer to Figures 1 to 5 , in some embodiments of the present invention, the valve clip 100 further includes a locking mechanism. In this embodiment, the locking mechanism is connected to one or more of the sliding member 30, the pivoting mechanism 40, and the clamping arm 20, and the locking mechanism can at least limit the clamping arm 20 from rotating and unfolding after closing. It can be understood that in this embodiment, the locking mechanism can be set to only limit the clamping arm 20 from rotating and unfolding after closing, or can be set to both limit the clamping arm 20 from unfolding and limit the clamping arm 20 from closing. That is to say, the locking mechanism can limit the rotation of the clamping arm 20 under the set working conditions. Exemplarily, the locking mechanism is used to limit the clamping arm 20 from unfolding after the clamping arm 20 is closed, so that the valve clip 100 remains in the patient's body in the state of clamping the valve.
[0060] In an alternative embodiment, the locking mechanism can be installed on the central shaft cylinder 10 and connected to the sliding member 30, so as to restrict the rotation of the clamping arm 20 by restricting the sliding of the sliding member 30. Exemplarily, please continue to refer to Figures 1 to 5 , the locking mechanism includes a control line (not shown in the figure) and a locking spring piece 51. A locking hole 511 is provided on the locking spring piece 51. The sliding member 30 passes through the locking hole 511 and can abut against the inner wall of the locking hole 511. The locking spring piece 51 is connected to the control line and can generate elastic deformation under the pulling of the control line. Thus, the locking spring piece 51 remains in an inclined state when not stressed, so as to abut against and clamp the sliding member 30. The control line pulls the locking spring piece 51 to rotate to a horizontal state to release the abutment. In addition, a mounting seat 11 is provided at a position of the central shaft cylinder 10 close to the distal end. One end of the locking spring piece 51 is connected to the mounting seat 11. It can be understood that due to the small size of the central shaft cylinder 10, the setting of the mounting seat 11 in this embodiment facilitates the connection between the locking spring piece 51 and the central shaft cylinder 10 and improves the reliability of the connection between the two.
[0061] It can be understood that one or more locking mechanisms can be provided in this embodiment. On the basis of the multiple sliding members 30 sleeved in sequence in the above embodiment, the locking mechanism can cooperate with the innermost sliding member 30 to prevent all sliding members 30 from sliding. In another alternative embodiment, the locking mechanism can be connected to the pivoting mechanism 40 or the clamping arm 20, and the rotation of the clamping arm 20 is restricted by restricting the rotation of the pivoting mechanism 40. For example, the locking mechanism can include a control line and a locking coil, and the control line is used to pull the locking coil to lock the linkage arm 42 or the clamping arm 20 of the pivoting mechanism 40, so as to restrict the rotation of the clamping arm 20. The structure of the locking mechanism in this embodiment is not specifically limited and can be set according to actual situations.
[0062] Furthermore, as Figures 1 to 5As shown, in some embodiments of the present invention, the valve clip 100 further includes a capture member 60. The capture member 60 is installed between the central shaft cylinder 10 and the clip arm 20. Barbs are provided on the side of the capture member 60 facing the clip arm 20 to capture the valve. Correspondingly, the valve clip 100 further includes a control wire connected to the capture member 60, such as a suture, a nylon wire or a wire. The control wire is used to drive the capture member 60 to rotate. Thus, during the process of the valve clip 100 clamping the valve, the valve can be captured by the capture member 60 first, and then clamped by the clip arm 20. Exemplarily, the capture member 60 can be set as a capture spring piece formed by processing a shape memory alloy such as a nickel-titanium alloy material. The capture spring piece includes a plurality of bullet pieces, for example, two bullet pieces located on both sides of the central shaft cylinder 10 respectively. The two bullet pieces can be set as an integrally formed structure, and there is a set angle between them. One control wire can be provided to control the two bullet pieces simultaneously, or multiple control wires can be provided, and each control wire is connected to and controls one bullet piece. In this embodiment, by providing barbs on the capture member 60, it is convenient for the capture member 60 to capture the valve when contacting the valve, improving the accuracy of subsequent clamping by the clip arm 20.
[0063] Please refer to Figure 6 , an embodiment of the second aspect of the present invention provides a valve repair system 1000. The valve repair system 1000 includes a delivery device and the valve clip 100 according to any of the above embodiments. The delivery device is detachably connected to the valve clip 100 to deliver the valve clip 100 to a set position. In this embodiment, the delivery device includes a handle 710, a sheath assembly and a connection mechanism. The sheath assembly includes a bending adjustment mechanism 730 and a plurality of sheaths 720 sleeved in sequence. The handle 710 is connected to the sheath assembly and can control some or all of the sheaths 720 in the sheath assembly to reach a set position in the patient's body. The bending adjustment mechanism 730 can control some or all of the sheaths 720 in the sheath assembly to bend at the set position. The control member of the locking mechanism in the valve clip 100 can be connected to the handle 710, so as to facilitate the operator to operate the control member through the handle 710; the connection mechanism is connected to the distal end of the innermost sheath 720 and is detachably connected to the valve clip 100. Thus, 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. After the valve clip 100 clamps the valve and locks, the connection mechanism is dissociated from the valve clip 100, leaving the valve clip 100 in the patient's body.
[0064] Further, please refer to Figure 7, in some embodiments of the present invention, the conveying device includes a plurality of driving members, each driving member is connected to a sliding member 30 to drive the sliding member 30 to slide. In this embodiment, the number of driving members is set according to the number of sliding members 30. Exemplarily, when the number of sliding members 30 is set to two, the number of driving members is also set to two, and the two driving members do not affect each other. According to the above embodiment, a channel is provided in the innermost sheath 720 of the sheath assembly. The driving member is inserted into the channel. The distal end of the driving member extends out from the distal end of the sheath 720 and cooperates with the sliding member 30 of the valve clip 100. Thus, the operator can pull or push the driving member to realize the pulling or pushing of the sliding member 30, so that the sliding member 30 slides axially.
[0065] Taking the case where there are two sliding members 30 as an example, as Figure 7 shown, the two sliding members 30 include a slide bar 31 and a slide cylinder 32. In an alternative embodiment, a blind hole is provided at one end of the slide bar 31 close to the conveying device, and a first internal thread is provided in the blind hole. The first driving member 741 cooperating with the slide bar 31 can be set as a metal wire. The outer wall of the first driving member 741 near the distal end is provided with a first external thread cooperating with the first internal thread. Thus, the distal end of the first driving member 741 is connected to the slide bar 31; a second internal thread is provided on the inner wall of the slide cylinder 32 close to the conveying device. The second driving member 742 cooperating with the slide cylinder 32 can be set as a metal tube, such as a shape memory alloy tube that can be bent. The outer wall of the second driving member 742 is provided with a second external thread cooperating with the second internal thread. Thus, the distal end of the second driving member 742 is connected to the slide cylinder 32. The proximal ends of the first driving member 741 and the second driving member 742 can be connected to the handle 710. The operator can control the movement and rotation of the first driving member 741 and the second driving member 742 through the handle 710. It can be understood that when the slide bar 31 needs to move axially, the operator can move the first driving member 741 through the handle 710. When the slide cylinder 32 needs to move axially, the operator can move the second driving member 742 through the handle 710. When the conveying device needs to be disengaged from the valve clip 100, the operator can rotate the first driving member 741 and the second driving member 742 in sequence through the handle 710, and withdraw the first driving member 741 and the second driving member 742 after releasing the thread fit.
[0066] On the basis of the above embodiments, by way of example, taking the two sliding members 30 in the valve clip 100 including a slide bar 31 and a slide cylinder 32 as an example, the operation method of the valve repair system 1000 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 to the set position of the mitral valve through a minimally invasive body surface entry and blood vessel according to the set steps. After unlocking the locking mechanism, first use the handle 710 to push the first driving member 741 and the second driving member 742 to move the slide bar 31 and the slide cylinder 32 distally, so that the two clamping arms 20 are respectively deployed; after adjusting the position of the valve clip 100 to align it with the part of the mitral valve to be clamped, use one bullet piece of the capturing member 60 to first capture the valve on one side of the clamping arm 20 connected to the slide cylinder 32, and use the handle 710 to pull the second driving member 742 to move the slide cylinder 32 proximally, so that the clamping arm 20 connected to the slide cylinder 32 closes and clamps the valve on this side. Then use the other bullet piece of the capturing member 60 to capture the valve on one side of the clamping arm 20 connected to the slide bar 31, and use the handle 710 to pull the first driving member 741 to move the slide bar 31 proximally, so that the clamping arm 20 connected to the slide bar 31 closes and clamps the valve on this side. Finally, use the locking mechanism to lock, disconnect the first driving member 741 from the slide bar 31, disconnect the second driving member 742 from the slide cylinder 32, disconnect the connecting mechanism from the valve clip 100, withdraw the first driving member 741, the second driving member 742 and the sheath assembly, and leave the valve clip 100 in the patient's body in a state of clamping the valve.
[0067] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention should be covered by the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.
Claims
1. A valve clip, characterized in that, Comprising: A central shaft cylinder; A plurality of clamping arms, which are wound around the periphery of the central shaft cylinder. One end of each clamping arm is rotatably connected to the central shaft cylinder, and the clamping arms are configured to expand or close according to rotation; A plurality of sliding members, the plurality of sliding members including slide rods and at least one sliding cylinder. The at least one sliding cylinder is slidably disposed within the central shaft cylinder and extends from the distal end of the central shaft cylinder. The slide rods are slidably disposed within the innermost sliding cylinder and extend from the distal end of the sliding cylinder. The plurality of sliding members are slidably disposed axially within the central shaft cylinder, and the plurality of sliding members are sleeved in sequence. Each sliding member is connected to at least one of the clamping arms through a pivoting mechanism, so that the clamping arms rotate according to the sliding of the sliding members.
2. The valve clip according to claim 1, characterized in that, One end of the pivoting mechanism is fixedly connected to the sliding member, and the other end of the pivoting mechanism is rotatably connected to the clamping arm.
3. The valve clip according to claim 2, wherein The pivoting mechanism includes a base and a linkage arm. The base is fixedly connected to the sliding member. One end of the linkage arm is connected to the base, and the other end of the linkage arm is rotatably connected to the clamping arm.
4. The valve clip according to claim 3, wherein The linkage arm is rotatably connected to the base.
5. The valve clip applicator according to claim 3, wherein The plurality of sliding members extend from the distal end of the central shaft cylinder, and the base is connected to the end of the sliding member that extends from the central shaft cylinder.
6. The valve clip applicator according to any one of claims 1 to 5, characterized in that, The valve clip also includes a capturing member, which is installed between the central shaft cylinder and the clamping arms. Barbs are provided on the side of the capturing member facing the clamping arms to capture the valve.
7. The valve clip according to any one of claims 1 to 5, characterized in that The valve clip also includes a locking mechanism, which is connected to at least one of the sliding member, the pivoting mechanism and the clamping arm. The locking mechanism can at least restrict the opening of the clamping arms after closing.
8. A valve repair system, characterized in that, The valve repair system includes: A valve clip, which is the valve clip according to any one of claims 1 to 7; A delivery device, which is detachably connected to the valve clip to deliver the valve clip to a set position.
9. The valve repair system according to claim 8, characterized in that, The delivery device includes a plurality of driving members, and each driving member is connected to one of the sliding members to drive the sliding member to slide.
Citation Information
Patent Citations
Controllable valve clamping system
CN113648107A