Leaflet clipping system
Patent Information
- Application Number
- CN202520369532.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-03-04
- Publication Date
- 2026-10-30
- Estimated Expiration
- 2035-03-04
AI Technical Summary
例如,由于实现锁定的驱动轴与锁定件表面较为光滑,摩擦力较小,使得锁定力不足,且持续摩擦会导致元件磨损,使得锁定机构出现滑移或锁定失效
[0009]本实用新型的实施方式相对于相关技术而言,设置至少部分容纳于所述基座的所述容纳通孔中的所述弹性锁定件,近端部分可移动容纳于所述容纳通孔中的耦合件,所述弹性锁定件位于所述耦合件垂直于轴线方向的外侧,且所述弹性锁定件可以与所述耦合件锁定以阻止底座沿第一方向移动,解锁丝用于牵拉弹性锁定件并使所述弹性锁定件至少在垂直于轴线方向发生变形以与耦合件解锁,以使所述底座可沿第一方向移动。由于在本实施例中,所述弹性锁定件位于所述耦合件垂直于轴线方向的外侧,可以设置较大的形变空间,因此当弹性锁定件与耦合件相互锁定时,可以保持提供较为稳定的耦合力;当弹性锁定件与耦合件解锁时,解锁丝直接作用于弹性锁定件,弹性锁定件在垂直于轴线方向发生形变以与所述耦合件解锁。如此,能够提高瓣叶夹合系统的使用可靠性。
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Figure CN224911370U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, and in particular to a leaflet clamping system. Background Technology
[0002] The main pathophysiological change in mitral regurgitation is mitral regurgitation. During left ventricular systole, blood flows from the left ventricle into the aorta and the less resistant left atrium. The regurgitated volume flowing into the left atrium can reach more than 50% of the left ventricular output, thus increasing the load on the left atrium and the left ventricular diastolic load. Transcatheter mitral valve repair is a minimally invasive surgical procedure for treating mitral regurgitation. This system can be briefly summarized as a mitral valve clamping device and a delivery device. After the delivery device delivers the mitral valve clamping device to the vicinity of the mitral valve, it clamps the anterior and posterior leaflets of the mitral valve, then releases the clamping device and withdraws the delivery device.
[0003] Generally, a mitral valve clamping device includes clamping arms and clamping blades, both of which can swing around the axis of the device. The relative swinging between the clamping arms and clamping blades clamps the edges of the mitral valve leaflets, reducing mitral regurgitation. A locking mechanism is required to lock and unlock the swinging of the clamping arms during this process.
[0004] Currently, the locking mechanism of existing mitral valve clamping devices often relies on the friction between the drive shaft and the locking element. For example, US Patent US20060020275A1 discloses a locking mechanism in which the locking element passes through the drive shaft and is angled relative to it. A spring applies an elastic force to the locking key, generating friction between the locking element and the drive shaft to prevent movement. However, this existing technology has several drawbacks. For instance, because the surfaces of the drive shaft and the locking element are relatively smooth, the friction is low, resulting in insufficient locking force. Furthermore, continuous friction can lead to component wear, causing slippage or locking failure. Another example is that because the locking element is angled and requires room to move for unlocking, the spring's deformation space, especially in the axial direction, is small. This results in a weak force exerted by the spring on the locking element, making it prone to misoperation and locking mechanism failure during locking. Furthermore, due to the limited deformation space of the spring, the magnitude of the external force driving the locking element to rotate is restricted. Too little force will result in poor separation between the locking element and the drive shaft, causing scraping; while too much force will damage the spring and even the drive wire of the drive spring. Therefore, the operator's learning time is relatively long. For example, unlocking the locking element and drive shaft by controlling the swing of the locking element through a wiring harness to overcome the spring's force requires precise assembly of the wiring harness, spring, and locking element. This prevents the wiring harness from failing to drive the locking element to swing, or the locking element from slipping relative to the spring during swing, thus failing to overcome the spring's force. These issues can easily lead to locking mechanism failure. Failure of the locking mechanism can cause the mitral valve clamp to open prematurely during delivery, accidentally open during leaflet clamping, or the valve clamp to dislodge after implantation, leading to surgical failure or even seriously endangering the patient's life and health.
[0005] Therefore, there is an urgent need in the art for a leaflet clamping system that can solve at least one of the above problems. Utility Model Content
[0006] The purpose of this invention is to provide a leaflet clamping system that can improve the locking force of the prosthesis clamping device and prevent the prosthesis from being prematurely released during transport due to locking failure.
[0007] To solve the above-mentioned technical problems, this utility model provides a leaflet clamping system, comprising:
[0008] A leaflet clamping device and a conveying device; the leaflet clamping device includes: a base having an axially arranged receiving through hole; a clamping arm including a connecting end and a clamping end, the connecting end being rotatably connected to the base, and the clamping end being a free end; an actuation assembly including a base, the proximal end of which is movably received in the receiving through hole, the base also being drively connected to the clamping arm; and a locking assembly including an elastic locking member disposed in the receiving through hole and a coupling member disposed at the proximal end of the base, the elastic locking member being located on the outer side of the coupling member perpendicular to the axial direction. Furthermore, when the elastic locking member and the coupling member are configured such that when the elastic locking member and the coupling member are locked, the base is prevented from moving along a first direction to maintain the posture of the clamping arm, the first direction being either a distal direction along the base axis or a proximal direction along the base axis; the conveying device includes: an unlocking wire, which is removably inserted through the elastic locking member for pulling the elastic locking member and causing the elastic locking member to deform at least in a direction perpendicular to the axis to unlock from the coupling member, thereby allowing the base to move along the first direction so that the clamping arm can rotate.
[0009] Compared with related technologies, this utility model provides an elastic locking member at least partially accommodated in the accommodating through-hole of the base, and a coupling member movably accommodated in the accommodating through-hole at its proximal end. The elastic locking member is located outside the coupling member in the direction perpendicular to the axis, and the elastic locking member can lock with the coupling member to prevent the base from moving in a first direction. An unlocking wire is used to pull the elastic locking member and cause it to deform at least in the direction perpendicular to the axis to unlock it from the coupling member, so that the base can move in the first direction. Because the elastic locking member is located outside the coupling member in the direction perpendicular to the axis in this embodiment, a larger deformation space can be provided. Therefore, when the elastic locking member and the coupling member are locked together, a relatively stable coupling force can be maintained. When the elastic locking member and the coupling member are unlocked, the unlocking wire acts directly on the elastic locking member, causing the elastic locking member to deform in the direction perpendicular to the axis to unlock it from the coupling member. This improves the reliability of the leaflet clamping system. Attached Figure Description
[0010] One or more embodiments are illustrated by way of example with reference numerals in the accompanying drawings. These illustrations do not constitute a limitation on the embodiments. Elements with the same reference numerals in the drawings are denoted as similar elements. Unless otherwise stated, the figures in the drawings are not to be limited by scale.
[0011] Figure 1 This is a schematic diagram of the cooperation between the leaflet clamping device and the conveying device in one embodiment of the present invention;
[0012] Figure 2This is a schematic diagram of the structure of the leaflet clamping device in one embodiment of the present invention;
[0013] Figure 3 yes Figure 2 A cross-sectional schematic diagram of the device shown;
[0014] Figure 4 This is a cross-sectional schematic diagram of the leaflet clamping device in one embodiment of the present invention when it is locked.
[0015] Figure 5 This is a schematic diagram of the locking mechanism of the leaflet clamping device in one embodiment of the present invention;
[0016] Figure 6 This is a schematic diagram of the structure of the leaf clamping device of the present invention, in which the elastic locking member and the capturing member are integrally formed;
[0017] Figure 7 This is a schematic diagram of the elastic locking component and base of the leaflet clamping device in one embodiment of the present invention;
[0018] Figure 8 This is a schematic diagram showing the arrangement of the unlocking wires in a leaf clamping device according to one embodiment of the present invention;
[0019] Figure 9 This is a cross-sectional schematic diagram showing the arrangement of the first and second unlocking wires of the leaflet clamping device in one embodiment of the present invention.
[0020] Figure 10 This is a schematic diagram of a single-sided unlocking wire controlling an elastic locking member and a capturing member in a leaf clamping device according to one embodiment of the present invention;
[0021] Figure 11 This is a schematic diagram of the structure of the elastic locking component of the leaflet clamping device in another embodiment of the present invention;
[0022] Figure 12 yes Figure 11 A cross-sectional schematic diagram of the elastic locking element shown;
[0023] Figure 13 This is a schematic diagram of the engagement of the capturing member and the elastic locking member of the leaflet clamping device in another embodiment of the present invention;
[0024] Figure 14 yes Figure 13 A cross-sectional view of the shown fitting diagram;
[0025] Figure 15 This is a schematic diagram of the structure of a leaf clamping device according to another embodiment of the present invention. Detailed Implementation
[0026] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the various embodiments of this utility model will be described in detail below with reference to the accompanying drawings. However, those skilled in the art will understand that many technical details have been presented in the various embodiments of this utility model to enable readers to better understand this application. However, the technical solutions claimed in this application can be implemented even without these technical details and various changes and modifications based on the following embodiments.
[0027] In this embodiment of the invention, the terms "upper," "lower," "left," "right," "front," "rear," "top," "bottom," "inner," "outer," "middle," "vertical," "horizontal," "lateral," and "longitudinal" indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. These terms are primarily for the purpose of better describing this invention and its embodiments, and are not intended to limit the indicated devices, elements, or components to having a specific orientation, or to be constructed and operated in a specific orientation.
[0028] Furthermore, in addition to indicating direction or positional relationship, some of the aforementioned terms may also have other meanings. For example, the term "above" may also be used in some cases to indicate a certain dependency or connection relationship. Those skilled in the art can understand the specific meaning of these terms in this utility model according to the specific circumstances.
[0029] Furthermore, the terms "installation," "setting," "equipped with," "opening," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral structure; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium, or an internal connection between two devices, components, or parts. Those skilled in the art can understand the specific meaning of these terms in this utility model based on the specific circumstances.
[0030] Furthermore, the terms "first," "second," etc., are primarily used to distinguish different devices, elements, or components (which may be the same or different in specific type and construction), and are not intended to indicate or imply the relative importance or quantity of the indicated devices, elements, or components. Unless otherwise stated, "a plurality of" means two or more.
[0031] It should be noted that in this application, "proximal" and "proximal" are relative positional concepts. Generally speaking, the end closer to the patient and farther from the operator is the distal end / distal side, and the end closer to the operator and farther from the patient is the proximal end / proximal side. For the delivery device, during use, the end closer to the target position is the distal end, and the end closer to the operating end is the proximal end. Furthermore, "parallel" and "perpendicular" should not be narrowly interpreted as 0° or 90°, but rather as a reasonable angular range that includes 0° or 90° and has a certain degree of fluctuation, provided that the technical effect is achieved.
[0032] This utility model provides a leaflet clamping system, including: a leaflet clamping device and a conveying device. The leaflet clamping device includes: a base having an axially arranged receiving through hole; a clamping arm including a connecting end and a clamping end, the connecting end being rotatably connected to the base, and the clamping end being a free end; an actuation assembly including a base, the proximal end of which is movably accommodated in the receiving through hole, and the base being drively connected to the clamping arm; and a locking assembly including an elastic locking member disposed in the receiving through hole and a coupling member disposed in the proximal end of the base. The elastic locking member is located outside the coupling member in a direction perpendicular to the axis, and the elastic locking member and the coupling member are configured such that when the elastic locking member is locked with the coupling member, the base is prevented from moving in a first direction to maintain the posture of the clamping arm; the conveying device includes: an unlocking wire, which is removably inserted through the elastic locking member for pulling the elastic locking member and causing the elastic locking member to deform at least in a direction perpendicular to the axis to unlock it from the coupling member, thereby allowing the base to move in the first direction so that the clamping arm can rotate. The first direction is a distal direction along the base axis and a proximal direction along the base axis.
[0033] The leaflet clamping system provided by this utility model includes an elastic locking member at least partially accommodated in the accommodating through hole of the base, and a coupling member movably accommodated in the accommodating through hole. The elastic locking member is located on the outer side of the coupling member in the direction perpendicular to the axis, and the elastic locking member can lock with the coupling member to prevent axial movement of the base. An unlocking wire is used to pull the elastic locking member and deform it at least in the direction perpendicular to the axis to unlock it from the coupling member. Because the elastic locking member is located on the outer side of the coupling member in the direction perpendicular to the axis in this embodiment, a larger deformation space can be provided. Therefore, when the elastic locking member and the coupling member are locked together, a relatively stable coupling force can be maintained. When the elastic locking member is unlocked from the coupling member, the unlocking wire acts directly on the elastic locking member, causing the elastic locking member to deform at least in the direction perpendicular to the axis to unlock it from the coupling member. This improves the reliability of the leaflet clamping system.
[0034] The following is a detailed description of the implementation details of the leaflet clamping system of this utility model. The following content is only for the convenience of understanding and is not necessary for implementing this solution.
[0035] Please see Figures 1 to 15 The leaflet clamping system in one embodiment of this utility model includes: a leaflet clamping device and a conveying device. The leaflet clamping device includes: a base 100 having an axially arranged receiving through hole 110; a clamping arm 200 including a connecting end 210 and a clamping end 220, the connecting end 210 being rotatably connected to the base 100, and the clamping end 220 being a free end; and an actuation assembly 300 including a base 310, the proximal end of which is movably accommodated in the receiving through hole 110, the base 310 being drively connected to the clamping arm 200, and the clamping arm 200 being conveyed when the base 310 moves axially. Arm 200 is driven to rotate around base 100; locking assembly 400 includes a resilient locking member 410 disposed in the receiving through hole 110 and a coupling member 420 disposed near the proximal end of base 310, the resilient locking member 410 being located outside the coupling member 420 in a direction perpendicular to the axis, and the resilient locking member 410 and the coupling member 420 being configured such that when the resilient locking member 410 is locked with the coupling member 420, the base 310 is prevented from moving along a first direction P1 to maintain the posture of clamping arm 200. The conveying device includes an unlocking wire 600, which is removably passed through the resilient locking member 410 for pulling the resilient locking member 410 and causing the resilient locking member 410 to deform at least in a direction perpendicular to the axis to unlock with the coupling member 420, thereby allowing the base 310 to move along the first direction P1 so that the clamping arm 200 can rotate. In this embodiment, the first direction P1 is the distal direction along the base axis. Obviously, in other embodiments, the first direction P1 can also be the proximal direction along the base axis.
[0036] In this embodiment, when the elastic locking member 410 and the coupling member 420 are locked together, the risk of the locking assembly 400 failing due to external axial force is reduced. When the elastic locking member 410 and the coupling member 420 need to be unlocked, the unlocking wire 600 acts directly on the elastic locking member 410, causing the elastic locking member 410 to deform in a direction perpendicular to the axis to unlock it from the coupling member 420. This improves the reliability of the leaflet clamping system.
[0037] In some embodiments, the leaf clamping device can be configured to prevent the base 310 from moving along the first direction P1, i.e., axially away from the base 100, when the elastic locking member 410 and the coupling member 420 are locked together, and at the same time prevent the base 310 from moving along the second direction P2, which is opposite to the first direction P1, i.e., axially close to the base 100.
[0038] In this embodiment, the elastic locking member 410 includes a coupling portion, which is a first protrusion. The first protrusion is a protrusion structure including a first abutment surface. The coupling member 420 has a plurality of second protrusions, which are protrusion structures including second abutment surfaces. The first abutment surface is used to abut against the second abutment surface so that when the elastic locking member 410 and the coupling member 420 are locked, the base 310 cannot move along the first direction P1. More specifically, the first abutment surface of the first protrusion can abut against the second abutment surface of the second protrusion adjacent to the first direction P1, and the first abutment surface and the second abutment surface are configured such that when the first abutment surface abuts against the second abutment surface, the force exerted by the first abutment surface on the second abutment surface is balanced with the external force received by the second abutment surface. Obviously, the external force received by the second abutment surface here refers to the force exerted by the non-first abutment surface on the second abutment surface. The external force on the second contact surface is, for example, the operating force applied to the second contact surface by the operator through the conveying device via the base 310, or the force applied to the second contact surface by the leaflet through the clamping arm 200 and the base 310.
[0039] Furthermore, the first protrusion also includes a third abutment surface, and the second protrusion also includes a fourth abutment surface. The third abutment surface is used to abut against the fourth abutment surface so that when the elastic locking member 410 is locked with the coupling member 420, the base 310 cannot move along the second direction P2. More specifically, the third abutment surface of the first protrusion can abut against the fourth abutment surface of the second protrusion adjacent to the second direction P2, and the third and fourth abutment surfaces are configured such that when the third abutment surface abuts against the fourth abutment surface, the force exerted by the third abutment surface on the fourth abutment surface is balanced with the external force on the fourth abutment surface. Here, the external force on the fourth abutment surface is similar to the external force on the second abutment surface. In one example, the first protrusion is a protrusion structure having a first abutment surface and a third abutment surface. For example, the first protrusion is a protrusion structure with a triangular, trapezoidal, rectangular, or square cross-section. In one example, the second protrusion is a protrusion structure having a second abutment surface and a fourth abutment surface. For example, the second protrusion is a protrusion structure with a triangular, trapezoidal, rectangular, or square cross-section. In a preferred embodiment, both the first and second protrusions are protrusion structures with a rectangular cross-section.
[0040] Exemplarily, when a leaflet clamping device for treating mitral regurgitation is delivered via catheter through a vein to the left atrium, the clamping arm 200 needs to be brought together towards the base 100 to achieve a minimum cross-sectional area for easy delivery, and the elastic locking member 410 and the coupling member 420 are locked together to prevent accidental rotation of the clamping arm 200. When the leaflet clamping device is passed through the mitral valve, the elastic locking member 410 and the coupling member 420 need to be unlocked, and the clamping arm 200 is rotated and unfolded by axial movement of the drive base 310 to determine whether the leaflet clamping device is at the appropriate angle relative to the mitral valve. After passing through the mitral valve and retracting the leaflet clamping device so that the leaflets fall into the space between the clamping arm 200 and the base 100, the clamping arm 200 is brought together and rotated towards the base 100 by axial movement of the drive base 310. After the clamping arm 200 rotates a certain angle, the elastic locking member 410 and the coupling member 420 lock together. Then, the state of the leaflet clamping device is determined, such as whether the anterior and posterior mitral leaflets have disengaged from the space between the clamping arm 200 and the base 100, and whether the anterior and posterior mitral leaflets are in a suitable posture within the space between the clamping arm 200 and the base 100. After confirmation, the elastic locking member 410 and the coupling member 420 are unlocked, and the clamping arm 200 continues to close. After the clamping arm 200 fully clamps the leaflets, the elastic locking member 410 and the coupling member 420 are locked together again. Here, the first direction P1 is along the axis towards the proximal end, and the second direction P2 is along the axis towards the distal end. During locking, the first abutment surface of the first protrusion facing the proximal end abuts against the second abutment surface of the second protrusion on its proximal side facing the distal end, and the third abutment surface of the first protrusion facing the distal end abuts against the fourth abutment surface of the second protrusion on its distal side facing the proximal end. Thus, the base 310 cannot move towards the far end or towards the near end.
[0041] In other embodiments, the leaflet clamping device can be configured such that, when the elastic locking member 410 and the coupling member 420 are locked together, the base 310 is prevented from moving in a first direction P1, for example, axially away from the base 100, but the base 310 is allowed to move in a second direction P2, for example, axially closer to the base 100, so that the clamping arm 200 can rotate in one direction. The first direction P1 and the second direction P2 are opposite.
[0042] like Figure 5-6As shown, in this embodiment, the elastic locking member 410 includes a coupling portion 414, which is a third protrusion. The third protrusion is a protrusion structure including a fifth abutment surface and a first sliding surface. The coupling member 420 has a plurality of fourth protrusions, which are protrusion structures including a sixth abutment surface and a second sliding surface. The fifth abutment surface is used to abut against the sixth abutment surface, and the first sliding surface is used to slide against the second sliding surface, so that when the elastic locking member 410 and the coupling member 420 are locked, the base 310 is allowed to move along the second direction P2 and is prevented from moving along the first direction P1. More specifically, the fifth abutment surface of the third protrusion is adjacent to the sixth abutment surface of the fourth protrusion located on its second direction P2 (proximal end in this embodiment). The fifth and sixth abutment surfaces are configured such that when the base 310 moves along the first direction P1, the fifth abutment surface abuts against the sixth abutment surface, and the force exerted by the fifth abutment surface on the sixth abutment surface is balanced by the external force on the sixth abutment surface. Here, the external force on the sixth abutment surface is similar to the external force on the second abutment surface. On the other hand, the first sliding surface of the third protrusion is adjacent to the second sliding surface of the fourth protrusion located on its first direction P1 (distal end in this embodiment). Furthermore, the first and second sliding surfaces are configured such that when the base 310 moves along the second direction P2, the force exerted by the first sliding surface on the second sliding surface is less than the external force on the second sliding surface. Here, the external force on the second sliding surface is similar to the external force on the second abutment surface, referring to the force exerted on the second sliding surface by a non-first sliding surface, such as the operating force exerted by the operator through the base 310. Thus, when the base 310 moves toward the first direction P1, the third abutment surface of the third protrusion abuts against the fourth abutment surface of the fourth protrusion adjacent to the first direction P1. When the base 310 moves toward the second direction P2, the first sliding surface of the third protrusion can move relative to the second sliding surface of the fourth protrusion adjacent to the second direction P2, causing the elastic locking member 410 to deform. After the third and fourth protrusions separate, the elastic locking member 410 returns to its original shape, and the first sliding surface of the third protrusion becomes adjacent to the second sliding surface of the next fourth protrusion.
[0043] In one example, the third protrusion is a protrusion structure with a triangular or trapezoidal cross-section. In another example, the fourth protrusion is a protrusion structure with a triangular or trapezoidal cross-section. Exemplarily, the third protrusion is a protrusion structure with a right-angled trapezoidal cross-section, and is set on the elastic locking member 410 via its hypotenuse. The surface corresponding to the shorter base serves as the third abutment surface, and the surface corresponding to the longer base serves as the first sliding surface. The shorter base is set at an acute angle to the second direction P2 on the elastic locking member 410 (i.e., greater than 0° and less than 90°). The angle between the shorter base of the right-angled trapezoidal protrusion structure and the second direction P2 is not specifically limited and can be any angle in the range of 10° to 60° or any angle in the range of 30° to 45°. Correspondingly, the fourth protrusion is a protrusion structure with an obtuse-angled triangle cross-section, and the obtuse-angled side (the surface on which it is located serves as the second sliding surface) is set at an obtuse angle to the second direction P2. One of the other two sides is located on the surface of the fourth abutment surface, and the other side is located on the connecting part 312 described below. Thus, the coupling element 420 forms a structure similar to a unidirectional rack.
[0044] Please see also Figure 2-5 In some embodiments, the actuation assembly 300 further includes a connecting rod 320, one end of which is rotatably connected to the base 310 and the other end of which is rotatably connected to the clamping arm 200, so that the base 310 is kinetically connected to the clamping arm 200.
[0045] In some embodiments, the actuation component 300 is configured to drive the clamping arm 200 to rotate and move toward the base 100 via the link 320 when the base 310 moves along the second direction P2, thereby reducing the space between the clamping arm 200 and the base 100; and to drive the clamping arm 200 to rotate and move away from the base 100 via the link 320 when the base 310 moves along the first direction P1, thereby increasing the space between the clamping arm 200 and the base 100. Exemplarily, after the leaflet falls into the space between the clamping arm 200 and the base 100, the clamping arm 200 is retracted and rotated toward the base 100 by driving the base 310 to move along the second direction P2. After the clamping arm 200 rotates to a certain angle, the elastic locking member 410 and the coupling member 420 lock together. Then, the state of the leaflet clamping device is determined, such as whether the anterior and posterior leaflets of the mitral valve have disengaged from the space between the clamping arm 200 and the base 100, and whether the anterior and posterior leaflets of the mitral valve are in a suitable posture in the space between the clamping arm 200 and the base 100. Then, the driving base 310 is moved along the second direction P2 to continue driving the clamping arm 200 to close, without needing to unlock the elastic locking member 410 and the coupling member 420. Then, the driving base 310 is moved along the second direction P2.
[0046] See also Figure 2-5In some embodiments, the base 310 includes a connecting portion 312 located at the proximal end and a main body portion 311 located at the distal end. The connecting portion 312 is movably accommodated in a receiving through-hole 110 of the base 100, and the coupling member 420 is disposed on the outer surface of the connecting portion 312. The main body portion 311 is located at the distal end of the base 100, and the connecting rod 320 is rotatably connected to the main body portion 311. In this embodiment, the distal surface of the main body portion 311 can be curved and arched towards the distal end, which facilitates the delivery of the leaflet clamping device inside the human body.
[0047] In one example, the base 310 is T-shaped, meaning the connecting portion 312 is arranged along the axial direction of the base 100, and the main body 311 is arranged perpendicular to the axis of the base 100. The connecting rod 320 is rotatably connected to the end of the main body 311. The other end of the connecting rod 320 is rotatably connected between the connecting end 210 and the clamping end 220 of the clamping arm 200 on the same side, and is located near the connecting end 210. The connecting end 210 of the clamping arm 200 is rotatably connected to the base 100. Thus, the actuation assembly 300, the clamping arm 200, and the base 100 form a four-bar linkage similar to a crank-slider; when the base 310 moves proximally relative to the base 100, the clamping arm 200 rotates and moves closer to the base 100, and vice versa.
[0048] Furthermore, the conveying device also includes a drive wire extending from the proximal end to the distal end of the conveying device and detachably connected to the proximal end of the connecting portion 312, for example, by a threaded connection. Driven by the axial movement of the drive wire, the base 310 moves axially.
[0049] In one example, the coupling member 420 extends from the proximal end of the connecting portion 312 to the distal end of the connecting portion 312. In another example, the coupling member 420 is located at the proximal end of the connecting portion 312. For example, the axial length of the coupling member 420 is 30% to 80% of the axial length of the connecting portion 312. Thus, locking functionality is no longer provided for stages where locking is not required, reducing manufacturing difficulty and costs.
[0050] In an alternative embodiment, the actuation assembly 300 is configured to drive the clamping arm 200 to rotate and move away from the base 100 via the link 320 when the base 310 moves along the second direction P2, thereby increasing the space between the clamping arm 200 and the base 100; and to drive the clamping arm 200 to rotate and move towards the base 100 via the link 320 when the base 310 moves along the first direction P1, thereby decreasing the space between the clamping arm 200 and the base 100. Specifically, as Figure 15As shown, the difference from the above embodiment is that the clamping arm 200 further includes an extension end, which is located on both sides of the connecting end 210 along with the clamping end 220. The other end of the connecting rod 320 is rotatably connected to the extension end of the clamping arm 200 on the other side. That is, the clamping arm 200 on the other side is rotatably connected to the base 100 and continues to extend to one side of the connecting rod 320, and is rotatably connected to the connecting rod 320.
[0051] Continue to refer to Figure 5-7 ,as well as Figure 11-14 In some embodiments, the elastic locking member 410 further includes a fixing part 413 and a retaining part 411. The fixing part 413 is used to fix the elastic locking member 410 inside the receiving through hole 110. The coupling part 414 is disposed on the retaining part 411. The retaining part 411 is used to keep the coupling part 414 locked to the coupling member 420 in a free state, and can undergo a deformation perpendicular to the axial direction under the action of the unlocking wire 600 to separate the coupling part 414 from the coupling member 420, thereby unlocking the elastic locking member 410 from the coupling member 420.
[0052] In one example, the fixing part 413 is located at the distal end of the resilient locking member 410 and is fixed to the inner wall of the receiving through hole 110. The fixing part 413 can be fixedly connected to the base 100 by conventional means, such as by adhesive bonding, welding, riveting, screw fixing, etc.
[0053] In another example, the fixing portion 413 is U-shaped to accommodate the wall portion of the base 100. That is, the fixing portion 413 extends distally from the inner wall of the receiving through hole 110, and then extends proximally from the outer side of the base 100 after extending beyond the base 100. Preferably, the space between the U-shaped fixing portions 413 for accommodating the wall portion is slightly smaller than the thickness of the wall portion, so that the fixing portion 413 has a tighter contact with the inner wall of the receiving through hole 110 and the outer side of the base 100. Preferably, a positioning portion 120 is provided on the outer side of the distal end of the base 100, and correspondingly, a positioning hole 413a is provided on the fixing portion 413 of the resilient locking member 410, and the positioning portion 120 and the positioning hole 413a are matched. The accommodation of the wall portion of the base 100 in the fixing portion 413 and the positioning portion 120 in the positioning hole 413a provides a fixing effect between the base 100 and the resilient locking member 410. For example, the positioning part 120 is a protrusion, and the cross-sectional shape of the protrusion can be square, circular, elliptical or other shapes; the cross-sectional shape and size of the positioning hole 413a are consistent with the cross-sectional shape and size of the protrusion, and the U-shaped fixing part 413 is squeezed into the wall of the base 100, and after the protrusion of the fixing part 413 is located in the positioning hole 413a, the elastic locking member 410 cannot move relative to the base 100.
[0054] Continue to refer to Figure 5-7 In some embodiments, the retaining portion 411 is elastic, so that when the retaining portion 411 is not subjected to external force (i.e., in a free state), it locks the coupling portion 414 to the coupling member 420, and deforms in a direction perpendicular to the axis under external force, so that the coupling portion 414 separates from the coupling member 420. In one example, the retaining portion 411 is arc-shaped, and the coupling portion 414 is disposed on the side of the retaining portion 411 near the coupling member 420. Preferably, the elastic locking member 410 further includes an extension extending from the retaining portion 411 toward the proximal end, one end of the arc-shaped retaining portion 411 is connected to the fixing portion 413, and the other end can be connected to the extension. The provision of the extension makes it easier for the retaining portion 411 to deform. When the retaining portion 411 is in a free state, the extension can be tightly attached to the inner wall of the receiving through hole 110. Figure 3 As shown), it can also be provided with a certain distance from the inner wall of the receiving through hole 110. Figure 7 As shown, this further increases the deformation space. When the arc-shaped retaining portion 411 is subjected to an external force, it can produce deformation perpendicular to the axial direction. Furthermore, the retaining portion 411 is made of a biocompatible material with good elasticity, such as a nickel-titanium alloy. In other embodiments, the retaining portion 411 can also adopt other easily deformable shapes, such as folded shapes (e.g., M-shapes), spiral shapes, circular structures, etc.
[0055] Continue to refer to Figure 8-9 In some embodiments, the unlocking wire 600 extends from the proximal end of the conveying device to the distal end of the base 100, enters the receiving through hole 110, and is at least partially located on the side of the holding portion 411 near the coupling member 420. After exiting the receiving through hole 110, it extends towards the proximal end of the conveying device. Thus, when the two ends of the unlocking wire 600 are pulled from the proximal end of the conveying device, the unlocking wire 600 located on the side of the holding portion 411 near the coupling member 420 will exert a force on the holding portion 411, causing the holding portion 411 to deform in a direction perpendicular to the axis.
[0056] In one example, the sidewall of the base 100 is provided with at least two first threading holes 111 spaced apart along the axial direction, and the first threading holes 111 communicate with the receiving through hole 110. At least one first threading hole 111 is located at the proximal end of the holding part 411, and one first threading hole 111 is located at the distal end of the holding part 411. For example, on one sidewall of the base 100, a first threading hole 111 communicating with the receiving through hole 110 is provided at the proximal end of the holding part 411, and on the same sidewall, a first threading hole 111 communicating with the receiving through hole 110 is provided at the distal end of the holding part 411. Preferably, the first threading holes 111 are provided on the positioning part 120. The elastic locking member 410 is provided with at least two second threading holes 412 spaced apart along the axial direction, wherein the two second threading holes 412 are respectively connected to the first threading holes 111. For example, the second threading hole 412 located near the end of the holding portion 411 communicates with the first threading hole 111 located near the end of the holding portion 411, and the second threading hole 412 located at the distal end of the holding portion 411 communicates with the first threading hole 111 located at the distal end of the holding portion 411. The unlocking wire 600 passes through the first threading hole 111 located near the end of the holding portion 411, and the second threading hole 412 located near the end of the holding portion 411, and then enters the side of the holding portion 411 near the coupling member 420, and then passes through multiple second threading holes 412 (if any) in sequence, and finally exits from the second threading hole 412 located at the distal end of the holding portion 411 and the first threading hole 111 located at the distal end of the holding portion 411 to the outside of the base 100, and then extends towards the proximal end of the conveying device. In this way, by pulling the unlocking wire 600, the elastic locking member 410 can be deformed in a direction perpendicular to the axial direction, thereby unlocking the elastic locking member 410 and the coupling member 420. In this embodiment, the second threading hole 412 is located at the proximal or distal end of the outer side of the holding portion 411, that is, one second threading hole 412 is located in the extension portion and the other second threading hole 412 is located in the fixing portion. In other embodiments, the second threading hole 412 is located at the proximal or distal end of the holding portion 411.
[0057] like Figure 8-9As shown, the sidewall of the base 100 is provided with two first threading holes 111 spaced apart along the axial direction, respectively located at the proximal and distal ends of the base 100. The elastic locking member 410 is provided with four second threading holes 412 spaced apart along the axial direction. One of the four second threading holes 412 is located in the extension of the elastic locking member 410 and communicates with the first threading hole 111 located at the proximal end of the base 100; two are located in the holding part 411; and the other is located in the fixing part and communicates with the first threading hole 111 located at the distal end of the base 100. That is, two second threading holes 412 are located outside the holding part 411 and are located at the proximal and distal ends of the holding part 411, respectively; two second threading holes 412 are located on the holding part 411 and are located at the proximal and distal ends of the holding part 411, respectively. Preferably, the coupling part 414 is disposed between the two second threading holes 412 disposed in the retaining part 411; more preferably, it is disposed at the edge of one of the second threading holes 412. The unlocking wire 600 passes through the first threading hole 111 located near the end of the retaining part 411 and enters the receiving through hole 110. After passing through the second threading hole 412 near the end, it is located on the side of the retaining part 411 near the coupling member 420. Then, it passes through the second threading hole 412 located in the retaining part 411 and enters the side of the retaining part 411 away from the coupling member 420 to avoid interfering with the contact between the coupling part 414 and the coupling member. After passing through the other second threading hole 412 located in the retaining part 411, the unlocking wire 600 continues to be located on the side of the retaining part 411 near the coupling member 420. After continuing to pass through the second threading hole 412 and the first threading hole 111 located at the far end of the retaining part 411, it exits the base 100 and extends proximally.
[0058] Understandably, when there are two elastic locking members 410, the other elastic locking member 410 can be symmetrically arranged with the aforementioned elastic locking member 410 about the axis of the base 100. In this case, there are two coupling members 420, symmetrically arranged on opposite sides of the proximal end of the base 310 about the axis of the base 100. Furthermore, the same first threading hole 111 can be provided on the other sidewall of the base 100 opposite to the sidewall with the first threading hole 111, and the second threading hole 412 on the second elastic locking member 410 can also be set with reference to the second threading hole 412 of the aforementioned elastic locking member 410, which can prevent the two unlocking wires 600 from interfering with each other. In some examples, the two first threading holes 111 at the proximal end of the holding part 411 can be axially corresponding or offset to a certain extent in the axial direction. Simultaneously, the two first threading holes 111 at the distal end of the holding part 411 can also be axially corresponding or offset to a certain extent in the axial direction.
[0059] The operator can pull either end of the unlocking wire 600, or both ends of the unlocking wire 600 simultaneously, to deform the holding part 411, specifically deforming it away from the connecting part 312. This causes the coupling part 414 to move away from the connecting part 312, thereby allowing the connecting part 312 to move and enabling the clamping arm 200 to be driven. It should be noted that when pulling either end of the unlocking wire 600, it is preferable to fix the other end to prevent the unlocking wire 600 from being pulled out of the leaf clamping device during pulling.
[0060] Continue to refer to Figure 5-7 as well as Figure 13-14 In some embodiments, the leaflet clamping device further includes a capturing member 230, which includes a fixed end 234 and a free end 231. The fixed end 234 is fixedly connected to the base 100, and the free end 231 can swing relative to the base 100. By setting the capturing member 230 so that it cooperates with the clamping arm 200, the leaflet 500 can be clamped more conveniently and securely.
[0061] In one example, the fixed end 234 is fixedly connected to the fixed portion 413 of the elastic locking member 410, so that the capturing member 230 is fixedly connected to the base 100. Preferably, the two are integrally formed.
[0062] In another example, there are two capture elements 230, symmetrically arranged along the axial direction of the base 100. The fixed ends 234 of the two capture elements 230 are fixedly connected to each other to form a capture element assembly. Each capture element 230 in the assembly cooperates with a clamping arm 200 to clamp a leaf 500. Thus, the capture element assembly is Ω-shaped and sleeved and fixed to the outside of the fixing part 413. Furthermore, the fixing end 234 is provided with a fourth threading hole 235, which communicates with the first threading hole 111 at the distal end of the holding part 411. After the unlocking wire 600 passes through the first threading hole 111 at the distal end of the holding part 411, that is, after exiting the base 100, it passes through the fourth threading hole 235 and extends towards the proximal end of the conveying device.
[0063] In some examples, the capturing member 230 further includes a bent portion 238 located between the fixed end 234 and the free end 231. The bent portion 238 connects the fixed end 234 and the free end 231, which have different extension directions, and provides elastic force for the free end 231 to return to its original shape after swinging and deflecting. Furthermore, the bent portion 238 is also provided with a fifth threading hole 236. The elastic performance of the bent portion 238 can be adjusted by the shape and size of the fifth threading hole 236, and the fifth threading hole 236 can also provide a channel for the unlocking wire 600, which extends from the distal end of the base 100 to the proximal end of the conveying device. The first threading hole 111, located near the end of the holding portion 411, is positioned away from the bent portion 238, thus preventing the capturing member 230 from interfering with the unlocking wire 600 entering the base 100.
[0064] In other embodiments, the unlocking wire 600 extends from the first wire hole 111 at the distal end of the holding part 411, that is, after exiting the base 100, and continues to be movably connected to the capturing member 230, and then extends towards the proximal end. In this way, the operator can control the elastic locking member 410 and the swinging of the capturing member 230 by means of the unlocking wire 600.
[0065] Furthermore, there are two capturing members 230, which are symmetrically arranged about the axis of the base 100. The unlocking wire 600 includes a first unlocking wire 610 and a second unlocking wire 620. The first unlocking wire 610 extends from the proximal end of one side of the conveying device to the base 100, enters the receiving through hole 110, and is at least partially located on the side of one of the holding portions 411 near one of the coupling members 420. After leaving the receiving through hole 110, it is movably connected to one of the capturing members 230 and then extends towards the proximal end of the conveying device. The second unlocking wire 620 extends from the proximal end of the other symmetrical side of the conveying device to the base 100, enters the receiving through hole 110, and is at least partially located on the side of another holding portion 411 near another coupling member 420. After leaving the receiving through hole 110, it is movably connected to the other capturing member 230 and then extends towards the proximal end of the conveying device.
[0066] In one example, after passing through the first threading hole 111 at the distal end of the holding part 411, i.e., through the base 100, the unlocking wire 600 interlocks with the capturing member 230 or an accessory disposed on the capturing member 230 to control the swing of the capturing member 230. This example does not impose any particular limitation on the specific implementation method.
[0067] For example, such as Figure 8-10As shown, the accessory is a connecting ring 232, which is disposed at the free end, for example, by binding or knotting. After the unlocking wire 600 passes through the fourth through hole 237, it passes through the connecting ring 232 and then extends towards the proximal end of the conveying device.
[0068] For example, the capturing member 230 has multiple third wire-threading holes 233 spaced apart along its extension direction. After the unlocking wire 600 exits from the base 100, it passes through the multiple third wire-threading holes 233 in sequence and then extends towards the proximal end. It can be understood that the connecting ring 232 and the third wire-threading holes 233 can be used together, that is, the capturing member 230 is provided with both the connecting ring 232 and the third wire-threading holes 233.
[0069] The movable connection between the unlocking wire 600 and the capturing member 230 can also refer to the connection method shown in the drawings and corresponding description in Chinese Patent Document CN115501001A. These connection methods are incorporated into this application as a part of this application. Obviously, here the unlocking wire 600 can pass through the base 100, through the fifth wire hole 236, and then interlock with the capturing member 230 or the accessories on the capturing member 230.
[0070] Under normal circumstances, in order to control the state of the free end 231, a control wire is separately provided on the free end 231 to drive the free end 231 to swing relative to the base 100. In this case, the operator not only needs to unlock the device using the unlocking wire 600, but also needs to manipulate the control wire to control the free end 231, which increases the operator's workload and the difficulty of operation. However, with the technical setting of this embodiment, the unlocking wire 600 can also serve as a control wire to control the free end 231, simplifying the structure of the leaflet clamping device, reducing the number of parts that the operator needs to operate, and reducing the difficulty of operating the leaflet clamping device.
[0071] In this invention, the base 100, the capturing member 230, the elastic locking member 410, the clamping arm 200, the base 310, and the connecting rod are made of biocompatible materials, such as pure titanium, titanium alloy, or cobalt-chromium alloy. The holding part 411 and the unlocking wire 600 can be made of a metal material with good elasticity, such as a nickel-titanium alloy.
[0072] Please see again Figure 1 , Figure 5 and Figure 8The conveying device further includes a conveying handle, a sheath 700, a drive wire, and an unlocking wire 600; the proximal ends of the unlocking wire 600, the drive wire, and the sheath 700 are all located on the conveying handle; the distal end of the drive wire passes through the sheath 700 and is detachably connected to the proximal end of the base 310 of the leaflet clamping device to drive the clamping arm 200 to rotate; the unlocking wire 600 extends from the proximal end to the distal end, passes through the elastic locking member 410, and then extends toward the conveying handle; the sheath 700 is detachably connected to the base 100.
[0073] Specifically, the proximal end of the connecting portion 312 is provided with a threaded section 422 for threaded connection with the drive wire. The operator can control the drive wire through the delivery handle, thereby driving the base 310 to move towards the proximal end or towards the distal end. The sheath 700 is detachably connected to the base 100 for delivering the leaflet clamping device to the target position and separating from the base 100 after the leaflet clamping device clamps the leaflet 500 to withdraw the human body. Both the first unlocking wire 610 and the second unlocking wire 620 extend from the delivery handle at the proximal end of the system, pass through the sheath 700, pass through the elastic locking member 410, and then extend through the sheath 700 to the delivery handle. Preferably, after passing through the elastic locking member 410, the first unlocking wire 610 and the second unlocking wire 620 are movably connected to the capturing member 230, and then extend through the sheath 700 to the delivery handle. This allows the operator to control the unlocking of the leaf clamping device and the control of the capture member 230 via the first unlocking wire 610 and the second unlocking wire 620.
[0074] When the leaflet clamping device is transported into the human body via the delivery device, the drive wire needs to be moved proximally so that the two clamping arms 200 are fully closed, and the clamping arms 200 press the capturing member 230 towards the base 100, minimizing the overall profile of the leaflet clamping device for easy transport within the human body. At this time, the first unlocking wire 610 and the second unlocking wire 620 need to be released so that the elastic locking member 410 and the coupling member 420 are locked, i.e., the connecting part 312 is locked.
[0075] When it is necessary to deploy the leaflet clamping device to clamp the leaflet 500, the first unlocking wire 610 and the second unlocking wire 620 are pulled, causing the elastic locking member 410 and the coupling member 420 to unlock. The drive wire then moves the connecting portion 312 toward the distal end (e.g., Figure 3The main body 311 moves towards the far end (as shown in P2), thereby driving the two connecting rods 320 to swing the two clamping arms 200 towards the far end, causing the two clamping arms 200 to open. At the same time, due to the pulling of the first unlocking wire 610 and the second unlocking wire 620, the free ends 231 of the two capturing members 230 swing towards the near end. At this time, the free ends 231 of the two capturing members 230 and the two clamping arms 200 move away from each other in a corresponding manner, so as to increase the clamping space formed between the capturing members 230 and the clamping arms 200.
[0076] When the leaflet 500 needs to be clamped after entering the clamping space, the connecting part 312 moves towards the proximal end via the drive wire. The main body 311 drives the two connecting rods 320 to swing the two clamping arms 200 towards the proximal end. Then, the first unlocking wire 610 and the second unlocking wire 620 are released, locking the elastic locking member 410 and the coupling member 420, i.e., locking the connecting part 312. At the same time, the two capturing members 230 return to their original shape under their own elastic force. In this way, the clamping arms 200, in conjunction with the capturing members 230, clamp the leaflet 500.
[0077] Furthermore, when the capture member 230 is finely adjusted, the corresponding unlocking wire on that side can be pulled. Since multiple elastic locking members 410 lock the coupling member 420, when one unlocking wire unlocks the elastic locking member 410 on that side of the coupling member 420 due to the need to adjust the capture member 230, the connection part 312 will not be unlocked, and the clamping arm 200 will not swing undesirably.
[0078] Optionally, the leaflet 500 in this embodiment may be a native leaflet of the mitral valve, a native leaflet of the tricuspid valve, or other native leaflets. This utility model does not specifically limit this.
[0079] The above provides a detailed description of the leaflet clamping system provided by the embodiments of this utility model. Specific examples have been used to illustrate the principle and implementation of this utility model. The above description of the embodiments is only for the purpose of helping to understand the idea of this utility model. There may be changes in the specific implementation and application scope. Therefore, the content of this specification should not be construed as a limitation of this utility model.
Claims
1. A leaflet clamping system, characterized in that, include: Leaflet clamping device and conveying device; The leaflet clamping device includes: The base has an axially arranged receiving through hole; The clamping arm includes a connecting end and a clamping end, the connecting end being rotatably connected to the base, and the clamping end being a free end; An actuation assembly includes a base, the proximal end of which is movably received in the receiving through-hole, and the base is also kinetically connected to the clamping arm; The locking assembly includes an elastic locking member disposed in a receiving through hole and a coupling member disposed near the proximal end of the base. The elastic locking member is located outside the coupling member in a direction perpendicular to the axial direction, and the elastic locking member and the coupling member are configured such that when the elastic locking member is locked with the coupling member, the base is prevented from moving in a first direction to maintain the posture of the clamping arm. The first direction is either a distal direction along the base axis or a proximal direction along the base axis. The conveying device includes: An unlocking wire, removably threaded through the elastic locking member, is used to pull the elastic locking member and cause it to deform at least in a direction perpendicular to the axis to unlock it from the coupling member, thereby allowing the base to move along a first direction so that the clamping arm can rotate.
2. The leaflet clamping system according to claim 1, characterized in that, The elastic locking member includes a coupling portion, which is a first protrusion. The first protrusion includes a first abutting surface. The coupling member has a plurality of second protrusions, each of which includes a second abutting surface. The first abutting surface is used to abut against the second abutting surface so that when the elastic locking member is locked with the coupling member, the base is prevented from moving along the first direction.
3. The leaflet clamping system according to claim 2, characterized in that, The first protrusion further includes a third abutting surface, and the second protrusion further includes a fourth abutting surface. The third abutting surface is used to abut against the fourth abutting surface so that when the elastic locking member is locked with the coupling member, the base is prevented from moving in a second direction, which is the opposite direction to the first direction.
4. The leaflet clamping system according to claim 1, characterized in that, The elastic locking member includes a coupling portion, which is a third protrusion. The third protrusion includes a fifth abutment surface and a first sliding surface. The coupling member has a plurality of fourth protrusions, each of which includes a sixth abutment surface and a second sliding surface. The fifth abutment surface is used to abut against the sixth abutment surface, and the first sliding surface is used to slide relative to the second sliding surface. When the elastic locking member and the coupling member are locked, the base is allowed to move in a second direction and is prevented from moving in the first direction.
5. The leaflet clamping system according to claim 4, characterized in that, The fifth abutment surface of the third protrusion is adjacent to the sixth abutment surface of the fourth protrusion located on one side of the second direction and adjacent to it, and the fifth abutment surface and the sixth abutment surface are configured such that when the base moves along the first direction, the fifth abutment surface abuts against the sixth abutment surface, and the force exerted by the fifth abutment surface on the sixth abutment surface is balanced with the external force received by the sixth abutment surface; The first sliding surface of the third protrusion is adjacent to the second sliding surface of the fourth protrusion located on one side of it along the first direction, and the first sliding surface and the second sliding surface are configured such that when the base moves along the second direction, the force exerted by the first sliding surface on the second sliding surface is less than the external force on the second sliding surface.
6. The leaflet clamping system according to claim 1, characterized in that, The actuation assembly further includes a connecting rod, one end of which is rotatably connected to the base, and the other end of which is rotatably connected to the clamping arm, so that the base is kinetically connected to the clamping arm.
7. The leaflet clamping system according to claim 6, characterized in that, The clamping arm includes a connecting end and a clamping end. The connecting end is rotatably connected to the base, and the clamping end is a free end. The base includes a connecting portion at a proximal end and a main body portion at a distal end. The connecting portion is movably accommodated in the receiving through hole of the base. The main body portion is located at the distal end of the base. One end of the connecting rod is rotatably connected to the end of the main body portion, and the other end of the connecting rod is rotatably connected between the connecting end and the clamping end of the clamping arm on the same side; or... The clamping arm includes an extension end, a connecting end, and a clamping end. The connecting end is rotatably connected to the base, and the clamping end is a free end. The extension end and the clamping end are located on opposite sides of the connecting end. The base includes a connecting portion located at a proximal end and a main body portion located at a distal end. The connecting portion is movably accommodated in the accommodating through hole of the base. The main body portion is located at the distal end of the base. One end of the connecting rod is rotatably connected to the end of the main body portion, and the other end of the connecting rod is rotatably connected to the extension end of the clamping arm on the other side.
8. The leaflet clamping system according to any one of claims 2 to 5, characterized in that, The elastic locking member further includes a fixing part and a retaining part. The fixing part is used to fix the elastic locking member in the receiving through hole. The coupling part is disposed in the retaining part. The retaining part is used to keep the coupling part locked to the coupling member in a free state, and can undergo a deformation perpendicular to the axial direction under the action of the unlocking wire to separate the coupling part from the coupling member, thereby unlocking the elastic locking member from the coupling member.
9. The leaflet clamping system according to claim 8, characterized in that, The unlocking wire extends from the proximal end of the conveying device to the distal end of the base, enters the receiving through hole and is at least partially located on the side of the holding part near the coupling member, and extends proximal to the proximal end of the conveying device after passing through the receiving through hole.
10. The leaflet clamping system according to claim 9, characterized in that, The base has at least two first threading holes spaced apart along the axial direction and respectively connected to the receiving through hole. The elastic locking member has at least two second threading holes spaced apart along the axial direction and respectively connected to the first threading holes. At least one first threading hole and at least one second threading hole are located at the proximal end of the holding part, and at least one first threading hole and at least one second threading hole are located at the distal end of the holding part. The unlocking wire passes through the first wire-threading hole located near the end of the holding part and enters the receiving through hole. After passing through the second wire-threading hole located near the end of the holding part, it enters the side of the holding part near the coupling member. Finally, it exits from the second wire-threading hole and the first wire-threading hole located at the far end of the holding part to the outside of the base, and then extends towards the near end of the conveying device.
11. The leaflet clamping system according to claim 10, characterized in that, The base has two first threading holes spaced apart along the axial direction and connected to the receiving through hole respectively. The elastic locking member has four second threading holes spaced apart along the axial direction, and two second threading holes are connected to the first threading holes respectively. One of the first threading holes and two of the second threading holes are located at the proximal end of the holding part, while the other first threading hole and the other two second threading holes are located at the distal end of the holding part. The unlocking wire passes through the first wire-threading hole located near the end of the holding part and enters the receiving through hole. After passing through the second wire-threading hole located near the end of the holding part, it enters the side of the holding part near the coupling member. Then, it enters the side of the holding part away from the coupling member through another second wire-threading hole. Then, it enters the side of the holding part near the coupling member through yet another second wire-threading hole. Finally, it exits from the second wire-threading hole and the first wire-threading hole located at the far end of the holding part to the outside of the base and then extends towards the near end of the conveying device.
12. The leaflet clamping system according to claim 10, characterized in that, The elastic locking member further includes an extension extending from the retaining portion toward the proximal end. One end of the retaining portion is connected to the fixing portion, and the other end is connected to the extension. A second threading hole located at the proximal end of the retaining portion is located in the extension. The retaining portion is in a free state. The extension is in close contact with the inner wall of the receiving through hole, or the extension is spaced apart from the inner wall of the receiving through hole.
13. The leaflet clamping system according to claim 10, characterized in that, The fixing part extends distally from the inner wall of the receiving through hole, and after extending beyond the base, extends proximally from the outer side of the base. A positioning part is provided on the outer side of the distal end of the base. A positioning hole is provided on the fixing part. The wall of the base is accommodated in the fixing part, and the positioning part is accommodated in the positioning hole, so that the elastic locking member is fixed to the base. The first threading hole located at the distal end of the holding part is provided in the positioning part.
14. The leaflet clamping system according to claim 10, characterized in that, The leaflet clamping device further includes a capturing element, which comprises a fixed end and a free end. The fixed end is fixedly connected to the base, and the free end is oscillating relative to the base. After the unlocking wire passes through the first wire hole located at the distal end of the holding part, it continues to be movably connected to the capturing member so that the unlocking wire controls the swing of the capturing member.
15. The leaflet clamping system according to claim 14, characterized in that, After passing through the first threading hole at the distal end of the holding part, the unlocking wire interpenetrates with the capturing member or an accessory disposed on the capturing member.
16. The leaflet clamping system according to claim 14, characterized in that, The capturing element also includes a curved portion located between the fixed end and the free end, the curved portion being used to provide elastic force for the free end to return to its original shape after swinging and deflecting, the curved portion also having a fifth threading hole, the fifth threading hole being used to adjust the elastic properties of the curved portion and to provide a channel for the unlocking wire that extends from the distal end of the base to the proximal end of the conveying device.
17. The leaflet clamping system according to claim 14, characterized in that, The fixed end is fixedly connected to the fixed part of the elastic locking member so that the capturing member is fixedly connected to the base.
18. The leaflet clamping system according to claim 14, characterized in that, There are two capture elements, which are symmetrically arranged along the axial direction of the base. The fixed ends of the two capture elements are fixedly connected to each other to form an Ω-shaped capture element group, which is sleeved and fixed on the outside of the fixed part. The fixed end is provided with a fourth wire threading hole. After the unlocking wire passes out from the base, it passes through the fourth wire threading hole and then extends to the proximal end of the conveying device.
19. The leaflet clamping system according to claim 14, characterized in that, There are two coupling elements, which are symmetrically arranged on opposite sides of the near end of the base about the axis of the base; there are two elastic locking elements, which are symmetrically arranged in the receiving through hole about the axis of the base; there are two capturing elements, which are symmetrically arranged about the axis of the base. The unlocking wire includes a first unlocking wire and a second unlocking wire. The first unlocking wire extends from the proximal end of one side of the conveying device to the base. After entering the receiving through hole, it is at least partially located on the side of one of the holding portions near one of the coupling members. After leaving the receiving through hole, it is movably connected to one of the capturing members and then extends towards the proximal end of the conveying device. The second unlocking wire extends from the proximal end of the other symmetrical side of the conveying device to the base. After entering the receiving through hole, it is at least partially located on the side of another holding portion near another of the coupling members. After leaving the receiving through hole, it is movably connected to another of the capturing members and then extends towards the proximal end of the conveying device.
20. The leaflet clamping system according to claim 1, characterized in that, The conveying device further includes a conveying handle, a sheath, and a drive wire; the proximal end of the unlocking wire, the proximal end of the drive wire, and the proximal end of the sheath are all connected to the conveying handle; the distal end of the drive wire passes through the sheath and is detachably connected to the proximal end of the base of the leaf clamping device to drive the clamping arm to rotate; the unlocking wire extends from the proximal end to the distal end, passes through the elastic locking member, and then extends toward the conveying handle; the sheath is detachably connected to the base.
Citation Information
Patent Citations
Prosthesis system
CN115501001A
Locking mechanisms for fixation devices and methods of engaging tissue
US20060020275A1