A rapidly adjustable valve clip device and method of operation

Abstract

The application provides a fast-adjusting valve clamp device and an operating method. The valve clamp device has a direct drive assembly and a threaded locking assembly. One end of a threaded rod is detachably connected with a movable base through a buckle, and the other end is connected with a threaded drive member and a threaded disengaging rod. The threaded disengaging rod and the threaded rod are both hollow sleeves. A driving straight rod is sequentially arranged in the threaded disengaging rod and the threaded rod. The driving straight rod is detachably connected with the movable base. A fixed base is connected with the threaded rod through a second connecting thread. The buckle connected with the movable base and the threaded rod is connected and separated under the operation of the direct drive assembly.

Description

Technical Field

[0001] This application generally relates to valve clip devices and related operating methods and systems that help seal natural heart valves and prevent or reduce regurgitation therein. Background Technology

[0002] Mitral / tricuspid regurgitation is one of the most common valvular diseases today. The main causes include mitral / tricuspid annular dilatation, chordae tendineae insufficiency, mitral / tricuspid myxomatosis, leaflet prolapse, rheumatic valvular heart disease, and ischemic lesions. Open-heart mitral / tricuspid valve repair and artificial valve replacement are the most effective treatments for mitral / tricuspid regurgitation. However, because the surgery requires cardiopulmonary bypass, it is quite invasive and carries a high risk of complications and mortality, especially for elderly patients and those with multiple comorbidities.

[0003] In existing technologies, mitral / tricuspid valve clamping is the most reliable treatment for mitral / tricuspid regurgitation. The mitral valve clamp is inserted via atrial septal puncture to deliver an implantable clamp near the mitral valve, clamping and fixing the free edges of the anterior and posterior leaflets to ensure good leaflet apposition at end-systole and reduce regurgitation. For example, Chinese patent application CN116035766A discloses a valve repair device that uses a valve clamp to ensure good leaflet apposition at end-systole and reduce regurgitation. However, this valve clamp uses a spring-loaded hose and release wire to drive a threaded locking rod. Since interventional procedures typically use the inferior vena cava or jugular vein for entry, which is far from the heart, the lower clamp arm 202 is contracted and clamped by rotating the threaded locking rod 302 until it fixes the valve. Because the lower clamp arm 202 is deployed by rotating the threaded locking rod 302... The valves contract, so the threaded locking rod 202 and the fixation seat need to be connected by a relatively long thread. However, since the valves open and close continuously with the heartbeat, the window of opportunity for medical staff to operate is short. On the one hand, the long thread connection is not conducive to grasping the timing of the operation, requiring a high level of skill, and the operation process is also long. On the other hand, when it is necessary to open the lower clamp arm 202 to a greater angle, the thread length needs to be even longer. If the thread length is too long, the clamp device will be too long. After the instrument is closed, the threaded part will extend beyond the instrument, affecting blood flow and heart tissue. Another Chinese patent, CN116077234A, describes a valve repair device that moves the mounting base 105 by moving the connecting tube 202 along its axis, thereby expanding and contracting the lower clamping arm 102. Rotating the connecting tube 202 causes the locking element 107 and the connecting base 104 to engage threadedly, locking the lower clamping arm 102. However, due to the elasticity of the upper clamping arm and the valve, the connecting tube 202 needs to be moved and rotated simultaneously to maintain the clamping force on the valve and achieve threaded engagement. This increases the difficulty of the surgical procedure. Furthermore, the locking element 107 and the connecting base 104 have a thread-locking problem, requiring multiple applications of force and rotation of the connecting tube 202, further increasing the difficulty. The operation is difficult, and repeated operation can easily lead to a decrease in the clamping force of the clamping arm, increasing the risk of the clamping arm capturing the valve. Chinese patent CN114176839A discloses a valve repair device, in which the sliding component 30 is operated by a handle to control the contraction of the clamping arm 20 to clamp the valve. Then, a locking strip 13 is inserted into the locking buckle 12 to lock the sliding component 30. This locking structure is complex. During the locking process, point limiting locking is used, that is, the sliding component 30 slides to a certain position and the rolling body limits the locking strip to lock the sliding component. Since this position is limited by manufacturing deviation and static friction between the rolling body and the locking strip, long-term valve closing movement causes the locking strip to dislodge or slide out of the rolling body, reducing the valve clamping effect. Summary of the Invention

[0004] To address the shortcomings of existing valve repair devices, this application provides a rapidly adjustable valve clip device and its operation method. The device is easy to operate, reduces its length, further lowers the risk of clip dislodgement, and prevents the clip from affecting blood flow and cardiac tissue. It can be applied to the treatment of mitral / tricuspid regurgitation.

[0005] This application provides a rapidly adjustable valve clip device, including a fixed base and a movable base. Clamping arms are hinged to the fixed base, and two clamping arms are rotatably connected to the fixed base via a first hinge shaft. An upper clip is positioned above the clamping arms. The clamping arms and the upper clip cooperate to clamp and fix the valve. The upper clip is a spring clip, typically made of shape memory metal alloy. An upper clip pull wire can hold the upper clip on both sides near the fixed base. When the tension of the upper clip pull wire is released, the upper clip presses against the clamping arms under its own elastic force, i.e., the upper clip rotates in a direction away from the fixed base. The upper clip is connected to the far end of the fixed base. The clamping arms are hinged to the far end of the fixed base via the first hinge shaft. One end of a rotating arm is hinged to the movable base via a third hinge shaft, and the other end is hinged to the clamping arms via a second hinge shaft, preferably at the middle or end of the clamping arm.

[0006] The valve clamping device is characterized by further comprising a direct drive assembly and a threaded locking assembly. The threaded locking assembly includes a threaded rod, a threaded drive element, and a threaded release rod sleeved inside the fixed base. One end of the threaded rod is detachably connected to the movable base via a snap fastener, and the other end engages with the threaded drive element and the threaded release rod. Both the threaded release rod and the threaded rod are hollow sleeves. The direct drive assembly includes a drive rod, which passes sequentially through the threaded release rod and the threaded rod. The end of the drive rod is rotatably and detachably connected to the movable base. The fixed base and the threaded rod are engaged via a second connecting thread. The snap fastener connecting the movable base and the threaded rod engages and disengages under the operation of the direct drive assembly. The threaded locking assembly achieves angle locking of the clamping arm after valve clamping and fixing. When a thrust is applied to the drive rod of the direct drive assembly, the movable base separates from the threaded rod, and the valve is then... The efficiency of the operator pushing the drive rod is much higher than that of rotating the threaded rod. Therefore, the movable base can quickly move away from the fixed base, and the clamping arm can be quickly unfolded under the action of the rotating arm. When the clamping arm is in the unfolded state, a pulling force is applied to the drive rod, so that the movable base quickly engages with the threaded rod through a snap-fit. After the snap-fit ​​is engaged, the threaded rod can rotate relative to the movable base without axial movement. As the movable base approaches the fixed base, the clamping arm quickly completes the clamping and fixing of the valve object. Then, by operating the threaded locking assembly, the threaded drive is rotated. Usually, before rotating the threaded rod, the threaded rod has a certain length of thread protruding from the fixed base. Rotating the threaded rod in the first direction of rotation, under the action of the second connecting thread, the threaded rod moves towards the proximal end, thereby driving the movable base to move towards the fixed base, increasing the clamping force of the clamping arm on the valve, and completing the fixing of the valve. During the valve clamping process, the clamping arm rotates rapidly to expand or contract by sliding the driving rod, which reduces the difficulty of interventional surgery, improves surgical efficiency, and reduces the thread length of the connection between the movable base and the threaded rod in the existing technology. The clamping force of the clamping arm on the valve is increased by rotating the threaded rod, and the valve is locked after fixation. The self-locking characteristic of the thread improves the safety of locking.

[0007] In a preferred embodiment, the end of the drive rod is rotatably and detachably connected to the movable base. This detachable connection allows the drive rod to apply tension or thrust to the movable base, thereby moving the movable base proximally or distally. This detachable connection can be a conventional technology such as a rotary snap-fit, where the end of the drive rod is snapped onto the movable base by rotating it; or it can be connected by a first connecting thread, such as a screw or internal thread at the end, with a corresponding internal thread or screw on the movable base, where the end of the drive rod is threaded onto the movable base by rotating it. After the valve clamping and fixing is completed, the drive rod is rotated in the opposite direction to release it.

[0008] In a preferred embodiment, the threaded drive component is a hollow sleeve, and the threaded release rod passes through the threaded drive component. The threaded release rod and the threaded rod are fixed by a third connecting thread. Under the action of the third connecting thread, the threaded release rod biases the threaded drive component against the threaded rod, so that the threaded drive component does not rotate relative to the threaded rod. For example, the mating end faces of the threaded drive component and the threaded rod can be provided with bosses, grooves, serrations, etc., to transmit the torque of the threaded drive component to the threaded rod, driving the threaded rod to rotate.

[0009] In a preferred embodiment, the threaded release bar has a shoulder, and the threaded drive has a radially inwardly extending convex ring. The shoulder acts on the convex ring to bias the threaded drive onto the threaded bar.

[0010] Preferably, the third thread has a rotation direction opposite to the second thread, so that when the threaded release rod disengages, it rotates independently in the same direction as the first rotation direction. This causes the movable base to tend to move proximally during the disengagement or release of the threaded release rod, further increasing the clamping force of the clamping arm and upper clamp on the valve and improving the clamping and fixation effect on the heart valve. The threaded drive, threaded release rod, and drive rod are all connected to the control handle, with the proximal end defined as the direction of the control handle, and the distal end defined as the direction opposite to the control handle.

[0011] In a preferred embodiment, the rotating arm has an arc-shaped structure, which can be a single-arch structure, preferably a double-arch structure, thus forming an M-shaped rotating arm or a multi-arch structure. Utilizing this arc-shaped structure, when the clamping arm is brought to a retracted state (i.e., close to the fixed base) by rotating the threaded rod, and the clamping arm cooperates with the upper clamping plate to clamp the valve, the movable base moves proximally, and the rotating arm approaches the fixed base. The prestress of the threaded connection generates an elastically deformable thrust on the clamping arm, thereby ensuring a tight fit between the clamping arm and the upper clamping arm, increasing the clamping and fixing effect on the valve.

[0012] Preferably, to ensure safety after implantation, the threaded rod and movable base are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy with high hardness.

[0013] In a preferred embodiment, the movable base includes a connector and a base. The connector and the base can be integrally formed or detachably connected by a snap-fit. The proximal end of the connector is provided with a first flange, and the distal end of the threaded rod is provided with a second flange. The snap-fit ​​connection between the threaded rod and the movable base is achieved by the cooperation and limiting of the first flange and the second flange.

[0014] In a preferred embodiment, the proximal end of the connector is provided with an axially extending portion, and the fixed base has a groove corresponding to the extending portion. The threaded rod is snapped into the movable base, and the extending portion extends into the groove. The groove is used to radially limit the extending portion. When the first flange slides out axially from the second flange, the first flange will undergo radial deformation, causing the extending portion to open radially. At this time, the inner wall of the groove acts on the extending portion, reducing the radial deformation of the extending portion and the first flange, thereby reducing the risk of the first flange accidentally dislodging. When the operator uses the drive rod to push the movable base to move, the first flange can still be dislodged, separating the movable base from the threaded rod.

[0015] This invention also relates to a method of using the aforementioned valve clip device. After moving the clip device to a designated position, typically the lower part of the valve, a control handle is first used to control the movement of a drive rod, pushing the movable base away from the threaded rod, causing the clamping arm to open. After capturing the valve, the drive rod is pulled, causing the movable base to move upwards until the movable base and the threaded rod engage through a snap-fit. Then, the threaded drive member and the threaded release rod are rotated in a first direction of rotation to complete valve clamping, fixing, and locking. The threaded release rod is then rotated separately in the first direction of rotation to release it. This operation utilizes the upward movement tendency of the movable base during the release of the threaded release rod, further increasing the clamping force of the clamping arm and the upper clip on the valve, thus improving the clamping and fixing effect on the heart valve.

[0016] In a preferred embodiment, the drive rod is rotated before or after the step of disengaging the threaded release rod to complete the disengagement of the drive rod.

[0017] In other embodiments, a valve clip device includes a fixed base and a movable base. Clamping arms are hinged to the fixed base, and two clamping arms are rotatably connected to the fixed base via a first hinge axis. An upper clip is positioned above the clamping arms. The valve is clamped and fixed through the cooperation of the clamping arms and the upper clip. The upper clip is a spring clip, typically made of shape memory metal alloy. An upper clip pull wire can hold the upper clip on both sides near the fixed base. When the tension of the upper clip pull wire is released, the upper clip presses against the clamping arms (not shown) under its own elastic force, i.e., the upper clip rotates in a direction away from the fixed base. The upper clip is connected to the far end of the fixed base. The clamping arms are hinged to the far end of the fixed base via the first hinge axis. One end of a rotating arm is hinged to the movable base via a third hinge axis, and the other end is hinged to the clamping arms via a second hinge axis. Preferably, the second hinge axis is hinged to the middle or end of the clamping arm.

[0018] The valve clip device is characterized by comprising a direct drive assembly and a threaded locking assembly. The threaded locking assembly includes a threaded rod, a movable nut, and a threaded drive component. The movable base includes a base. One end of the threaded rod is rotatably connected to the base. For example, a flange is provided at the connection end of the threaded rod and the base. The flange engages to allow the threaded rod to rotate relative to the base 32 without axial movement. The threaded drive component, sleeved inside the fixed base, can rotate relative to the fixed base 1. The direct drive assembly includes a drive rod disposed inside the threaded drive component. The drive rod can slide relative to the threaded drive component. A movable nut is sleeved on the outer periphery of the middle part of the threaded rod. The other end of the threaded rod engages with the threaded drive component and the drive rod. The angle of the clamping arm can be quickly adjusted by the direct drive assembly, and the angle of the clamping arm can be locked after the valve clamping and fixing is completed by the threaded locking assembly.

[0019] The fixed base includes a receiving groove with a snap-fit ​​device. The snap-fit ​​device confines the movable nut within the receiving groove, thereby preventing the movable nut from moving axially. The receiving groove has a cross-sectional area that restricts the rotation of the movable nut. For example, the receiving groove can have the same or different cross-sectional area as the movable nut, such as hexagonal, elliptical, toothed, square, or oblong. Any cross-sectional area of ​​the receiving groove that prevents the movable nut from rotating can be used in the prior art.

[0020] The operator can slide the drive rod relative to the threaded drive component. When a pushing force is applied to the drive rod, the drive rod generates a pushing force on the threaded rod to overcome the frictional force of the locking device on the movable nut, causing the movable nut to move to the distal end and disengage from the receiving groove. Since the efficiency of the operator pushing the drive rod is much higher than the efficiency of rotating the threaded rod, the movable base can quickly move away from the fixed base, and the clamping arm can be quickly unfolded under the action of the rotating arm. When the clamping arm is in the unfolded state, a pulling force is applied to the drive rod, and this pulling force acts on the threaded rod. The lever causes the movable base to move proximally, and the movable nut moves into the receiving groove and is engaged. As the movable base approaches the fixed base, the clamping arm quickly clamps and fixes the valve. Then, by operating the threaded drive, typically with a thread protruding a certain length from the movable nut, the threaded rod is rotated in a first direction. Because the movable nut is limited by the fixed base, the threaded rod moves proximally under the action of the thread, thereby driving the movable base to move closer to the fixed base, increasing the clamping force of the clamping arm on the valve, and completing the valve fixation. During the valve clamping process, the sliding of the drive rod causes the clamping arm to rotate rapidly for expansion or contraction, improving surgical efficiency, reducing the thread length of the connection between the movable base and the threaded rod in existing technologies, increasing the clamping force of the clamping arm on the valve through the rotation of the threaded rod, and completing the locking after valve fixation, reducing the operational difficulty of interventional surgery.

[0021] In a preferred embodiment, the end of the drive rod and the threaded rod are rotatably detachably connected. Through this detachable connection, the drive rod can apply a pulling or pushing force to the movable base via the threaded rod, thereby driving the movable base to move towards the proximal or distal end. This detachable connection can be a prior art such as a rotary snap-fit, where the end of the drive rod is snapped onto the movable base by rotating it; or as shown in the figure, it can be engaged by a first connecting thread, such as a screw or internal thread provided at the end, with a corresponding internal thread or screw provided on the movable base, where the end of the drive rod is threaded onto the movable base 3 by rotating it; after the valve clamping and fixing is completed, the drive rod is rotated in the opposite direction to release and disengage the drive rod.

[0022] In a preferred embodiment, the threaded drive component is a hollow sleeve, and the drive rod passes through the threaded drive component. The threaded drive component is connected to the threaded rod in a non-rotating connection manner. For example, the mating end faces of the threaded drive component and the threaded rod can be provided with bosses, grooves, serrations, etc., to transmit the torque of the threaded drive component to the threaded rod, thereby driving the threaded rod to rotate.

[0023] Preferably, the first connecting thread has a helix direction opposite to that of the movable nut, so that when the drive rod disengages from the threaded rod 2, it rotates independently in the same direction as the first helix direction. This causes the friction generated by the first connecting thread 31 during the disengagement or release of the drive rod to cause the threaded rod 2 to continue rotating around the first helix direction. During this process, the rotation angle of the threaded rod 2 is small, and the movable base 3 tends to move proximally, further increasing the clamping force of the clamping arm 11 and the upper clamp on the valve, and improving the clamping and fixing effect on the heart valve. The threaded drive and the drive rod are both connected to the control handle, with the proximal end defined as the direction of the control handle, and the distal end defined as the direction opposite to that of the control handle.

[0024] In a preferred embodiment, the rotating arm has an arc-shaped structure, which can be a single-arch structure, preferably a double-arch structure, thus forming an M-shaped rotating arm or a multi-arch structure. Utilizing this arc-shaped structure, when the clamping arm is brought to a retracted state (i.e., close to the fixed base) by rotating the threaded rod, and the clamping arm cooperates with the upper clamping plate to clamp the valve, the movable base moves proximally, and the rotating arm approaches the fixed base. The prestress of the threaded connection generates an elastically deformable thrust on the clamping arm, thereby ensuring a tight fit between the clamping arm and the upper clamping arm, increasing the clamping and fixing effect on the valve.

[0025] In a preferred embodiment, the outer periphery of the movable nut is composed of two planes and two arc surfaces. Each plane includes a slope that begins to incline from the distal end, such that the distance between the two planes is maximized at the distal end. This slope facilitates guiding the movable nut into the receiving groove, and the locking device engages with the distal end of the movable nut to axially limit its movement.

[0026] In a preferred embodiment, the outer periphery of the receiving groove is provided with at least two notches, which divide the outer periphery of the receiving groove into at least two parts. When the movable nut is subjected to tension or thrust to enter or slide out of the receiving groove, at least two parts of the receiving groove undergo elastic deformation and open outward. When the movable nut is accommodated in the receiving groove, the receiving groove returns to its original state, and the movable nut is axially limited by the snap-fit ​​device.

[0027] In a preferred embodiment, the engaging device is a flange, which is located at the distal end of the receiving groove and is integrally formed with or separate from the receiving groove. The flange protrudes radially inward from the receiving groove and engages with the distal end of the movable nut to limit its movement. Preferably, the flange has at least one guide surface, which is an inclined surface, to guide the movable nut to slide into or out of the receiving groove.

[0028] This application also relates to a method of operating a valve clip device, which includes a valve clip device comprising a direct drive assembly, a threaded locking assembly, a clamping arm, and a threaded rod. First, the angle of the clamping arm is quickly adjusted by sliding the direct drive assembly. Then, the angle of the clamping arm is locked by rotating the threaded rod in a first direction using the threaded locking assembly.

[0029] As can be seen from the above technical solutions, the rapidly adjustable valve clip device and the method of using the valve clip device of this application achieve rapid rotation of the clamping arm by driving the sliding of the straight rod, which improves surgical efficiency, reduces the mating thread length of the movable base and the threaded rod connection in the prior art, increases the clamping force of the clamping arm on the valve by rotating the threaded rod, and avoids the technical problem of tooth misalignment when the thread is engaged because the corresponding second connecting thread or moving nut is always engaged with the threaded rod, and completes the locking after valve fixation, reducing the operation difficulty of interventional surgery and improving the safety of locking. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the valve clip device for rapid adjustment in Embodiment 1 of the present invention;

[0031] Figure 2 This is a schematic diagram showing the removal of the drive rod, threaded release rod, and threaded drive component from the valve clip device of the present invention;

[0032] Figure 3 This is a schematic diagram of the snap-fit ​​mechanism of the present invention;

[0033] Figure 4 This is a schematic diagram of the unfolded valve clip device of the present invention;

[0034] Figure 5 This is a schematic diagram of the movable base structure with an extension in this invention;

[0035] Figure 6 This is a schematic diagram showing the fit between the extension and the groove in this invention;

[0036] Figure 7 This is a split schematic diagram of the extension and groove in this invention;

[0037] Figure 8 This is a schematic diagram of the valve clip device in Embodiment 2 of the present invention;

[0038] Figure 9 This is a schematic diagram of the unfolded valve clip device in Example 2;

[0039] Figure 10 This is a schematic diagram of the fixed base in Example 2;

[0040] Figure 11This is a sectional view of the fixed base;

[0041] Figure 12 This is a schematic diagram of the movable nut.

[0042] Figure 13 This is a cross-sectional view of the movable nut;

[0043] Figure 14 This is a schematic diagram of the cross-sectional structure of the receiving groove.

[0044] Explanation of reference numerals in the attached figures:

[0045] 1-Fixed base, 11-Clamping arm, 12-Rotating arm, 13-Upper clamping piece, 14-Groove, 15-Accommodating groove, 151-Notch, 152-Flange, 2-Threaded rod, 21-Second connecting thread, 22-Third connecting thread, 23-Second flange, 24-Second guide surface, 3-Modible base, 31-First connecting thread, 32-Base, 33-Connector, 331-First flange, 332-First guide surface, 333-Slit, 334-Extension, 4-Threaded drive, 5-Threaded release rod, 6-Drive rod, 7-Moving nut, 71-Flat surface, 72-Arc surface. Detailed Implementation

[0046] To make the objectives, technical solutions, and advantages of the present invention clearer, the present invention will be further described in detail below with reference to specific embodiments and accompanying drawings.

[0047] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit this disclosure. The terms “comprising,” “including,” etc., as used herein indicate the presence of the stated features, steps, operations, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, or components.

[0048] All terms used herein (including technical and scientific terms) have the meanings commonly understood by those skilled in the art, unless otherwise defined. It should be noted that the terms used herein are to be interpreted in a manner consistent with the context of this specification, and not in an idealized or overly rigid way.

[0049] Certain embodiments of this disclosure will be described more fully below with reference to the accompanying drawings, some of which, but not all, will be shown. In fact, various embodiments of this disclosure may be implemented in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided to enable this disclosure to meet applicable legal requirements.

[0050] To address the shortcomings of existing valve repair devices, this application provides a valve clip device and a method for using the valve clip device, which can be applied to the treatment of mitral / tricuspid regurgitation. An embodiment of this application provides a valve clip device with a drive rod 6 for interventional treatment of the heart, see [link to related document]. Figure 1 The schematic diagram of the valve clip device includes a fixed base 1 and a movable base 3. The proximal end of the fixed base 1 is connected to a multi-lumen tube connector. Clamping arms 11 are hinged to the fixed base 1. The two clamping arms 11 are rotatably connected to the fixed base 1 through a first hinge shaft. An upper clip 13 is provided above the clamping arms 11. The clamping arms 11 and the upper clip 13 cooperate to clamp and fix the valve. The upper clip 13 is a spring clip, usually made of shape memory metal alloy. The upper clip 13 can be held on both sides near the fixed base 1 by the upper clip pull wire. When the tension of the upper clip pull wire is released, the upper clip 13 is pressed against the clamping arms 11 under the action of its own elastic force, that is, the upper clip 13 rotates around the direction away from the fixed base 1.

[0051] The upper clamping plate 13 is connected to the distal end of the fixed base 1, the clamping arm 11 is hinged to the distal end of the fixed base 1 via a first hinge axis, one end of the rotating arm 12 is hinged to the movable base 3 via a third hinge axis, and the other end is hinged to the clamping arm 11 via a second hinge axis; see also Figure 2 A schematic diagram of the valve clip device removing the drive rod, threaded release rod, and threaded drive component is shown. In Embodiment 1, the valve clip device further includes a direct drive assembly and a threaded locking assembly. The threaded locking assembly includes a threaded rod 2, a threaded drive component 4, and a threaded release rod 5 sleeved inside the fixed base 1. One end of the threaded rod 2 is detachably connected to the movable base 3 via a snap fastener, and the other end engages with the threaded drive component 3 and the threaded release rod 5. Both the threaded release rod 5 and the threaded rod 4 are hollow sleeves. The direct drive assembly includes a drive rod 6. The drive rod 6 passes sequentially through the threaded release rod 5 and the threaded rod 2 and can slide relative to the threaded release rod 5 and the threaded rod 2. The end of the drive rod 6 is rotatably and detachably connected to the movable base 3. The fixed base 1 and the threaded rod 2 are engaged by the second connecting thread 21. The latches connecting the movable base 3 and the threaded rod 2 are engaged and disengaged under the operation of the direct drive assembly to quickly adjust the angle of the clamping arm. The angle of the clamping arm is locked after the valve clamping and fixing is completed by the threaded locking assembly.

[0052] When a thrust is applied to the drive rod 6 of the direct drive assembly, the movable base 3 separates from the threaded rod 2. Since the efficiency of the operator pushing the drive rod 6 is much higher than the efficiency of rotating the threaded rod 2, the movable base 3 can quickly move away from the fixed base 1, and the clamping arm 11 can be quickly unfolded under the action of the rotating arm 12. See [link to relevant documentation]. Figure 4 As shown in the diagram; when the clamping arm 11 is in the extended state, a pulling force is applied to the drive rod 6, causing the movable base 3 to quickly engage with the threaded rod 2 through a snap-fit. After the snap-fit ​​is engaged, the threaded rod 2 can rotate relative to the movable base 3 without axial movement. As the movable base 3 approaches the fixed base 1, the clamping arm 11 quickly completes the clamping and fixing of the valve object. Then, by operating the threaded drive 4, the threaded rod 2 is rotated in the first direction. Under the action of the second connecting thread 21, the threaded rod 2 moves towards the proximal end, thereby driving the movable base 3 to move towards the fixed base 1, increasing the clamping force of the clamping arm 11 on the valve, and achieving angle locking of the clamping arm after completing the valve clamping and fixing, thus completing the valve fixing. During the valve clamping process, the clamping arm 11 is rapidly rotated to expand or contract by sliding the driving rod 6, which improves surgical efficiency, reduces the mating thread length of the movable base 3 and threaded rod 2 in the prior art, increases the clamping force of the clamping arm 11 on the valve by rotating the threaded rod 2, and completes the locking after the valve is fixed, reducing the difficulty of interventional surgery.

[0053] In a preferred embodiment, the end of the drive rod 6 is rotatably and detachably connected to the movable base 3. Through this detachable connection, the drive rod 6 can apply a pulling or pushing force to the movable base 3, thereby driving the movable base 3 to move towards the proximal or distal end. This detachable connection can be a conventional technology such as a rotary snap-fit, where the end of the drive rod 6 is snapped onto the movable base 3 by rotating it; or it can be engaged through a first connecting thread 31, such as a screw or internal thread provided at the end, with a corresponding internal thread or screw provided on the movable base 3, where the end of the drive rod 6 is threadedly connected to the movable base 3 by rotating it. After the valve clamping and fixing is completed, the drive rod 6 is rotated in the opposite direction to release and disengage it.

[0054] In a preferred embodiment, the threaded drive component 4 is a hollow sleeve, and the threaded release rod 5 passes through the threaded drive component 4. The threaded release rod 5 and the threaded rod 2 are fixed by a third connecting thread 22. Under the action of the third connecting thread 22, the threaded release rod 5 biases the threaded drive component 4 against the threaded rod 2, so that the threaded drive component 4 does not rotate relative to the threaded rod 2. For example, the mating end faces of the threaded drive component 4 and the threaded rod 2 can be provided with bosses, grooves, serrations, etc., to transmit the torque of the threaded drive component 4 to the threaded rod 2, driving the threaded rod 2 to rotate.

[0055] In a preferred embodiment, the threaded release rod 5 has a shoulder, and the threaded drive member 4 has a radially inwardly extending convex ring. The shoulder acts on the convex ring to bias the threaded release rod 5 onto the threaded rod 2.

[0056] Preferably, the third connecting thread 22 has a rotation direction opposite to the second connecting thread 21, so that when the threaded release rod 5 disengages from the threaded rod 2, it rotates independently in the same direction as the first rotation direction. This causes the movable base 3 to tend to move proximally during the disengagement or release of the threaded release rod 5, further increasing the clamping force of the clamping arm 11 and the upper clamping plate 13 on the valve, and improving the clamping and fixing effect on the heart valve. The threaded drive 4, the threaded release rod 5, and the drive rod 6 are all connected to the control handle, with the proximal end defined as the direction of the control handle, and the distal end defined as the direction opposite to the control handle.

[0057] In a preferred embodiment, the rotating arm 12 has an arc-shaped structure, which can be a single arch structure, preferably a double arch structure, thus forming an M-shaped rotating arm 12, or a multi-arch structure. Using this arc-shaped structure, when the threaded rod 2 is rotated to bring the clamping arm 11 to a retracted state (i.e., the clamping arm 11 is close to the fixed base 1), and the clamping arm 11 cooperates with the upper clamping plate 13 to clamp the valve, the movable base 3 moves proximally, and the rotating arm 12 approaches the fixed base 1. The prestress of the threaded connection generates an elastically deformable thrust on the clamping arm 11 in the rotating arm 12, thereby ensuring the clamping arm 11 is tightly attached to the upper clamping arm and increasing the clamping and fixing effect on the valve.

[0058] Preferably, to ensure safety after implantation, the threaded rod 2 and the movable base 3 are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy with high hardness.

[0059] In a preferred embodiment, the movable base 3 includes a connector 33 and a base 32. The connector 33 and the base 32 can be integrally formed or detachably connected by a snap-fit ​​engagement. See [link to previous embodiment]. Figure 2 and Figure 3 The structural diagram shows that the connector 33 has a first flange 331 at its proximal end and a second flange 23 at its distal end. The threaded rod 2 is connected to the movable base 3 by the engagement and limiting of the first flange 331 and the second flange 23. Preferably, the first flange 331 has at least one first guide surface 332, and the second flange 23 has at least one second guide surface 24. The inclined surfaces of the first guide surface 332 and the second guide surface 24 are used to align and guide the first flange 331 and the second flange 23. Preferably, the first flange 331 has an annular shape and at least two symmetrically arranged slits 333. These slits 333 divide the first flange 331 into at least two parts. When the first flange 331 moves relative to the second flange 23, it undergoes elastic deformation, achieving rapid snap-fit.

[0060] In a preferred embodiment, the proximal end of the connector 33 is provided with an axially extending portion 334, and the fixing base 1 has a groove 14 corresponding to the extending portion 334. (See also...) Figure 5-7 The structural diagram shows that the threaded rod 2 is connected to the movable base 3 by a snap-fit ​​connection. The extension 334 extends into the groove 14, which is used to radially limit the extension 334. When the first flange 331 slides out axially from the second flange 23, the first flange 331 will undergo radial deformation, causing the extension 334 to open radially. At this time, the inner wall of the groove 14 acts on the extension 334, reducing the radial deformation of the extension 334 and the first flange 331, thereby reducing the risk of the first flange 331 accidentally coming off. When the operator uses the drive rod 6 to push the movable base 3 to move, the first flange 331 can still be dislodged, separating the movable base 3 from the threaded rod 2.

[0061] This invention also relates to a method of using the aforementioned valve clip device. After moving the clip device to a designated position, typically the lower part of the valve, the control handle is first used to control the movement of the drive rod 6, pushing the movable base 3 away from the threaded rod 2, causing the clamping arm 11 to open. After capturing the valve, the drive rod 6 is pulled, causing the movable base 3 to move upwards until the movable base 3 and the threaded rod 2 are engaged by a snap-fit. Then, the threaded drive member 4 and the threaded release rod 5 are rotated in a first direction of rotation to complete the valve clamping, fixing, and locking. The threaded release rod 5 is then rotated individually in the first direction of rotation to release it. This operation utilizes the upward movement tendency of the movable base 3 during the release of the threaded release rod 5, further increasing the clamping force of the clamping arm 11 and the upper clip 13 on the valve, thus improving the clamping and fixing effect on the heart valve.

[0062] In a preferred embodiment, before or after the step of completing the release of the threaded release rod 5, the drive rod 6 is rotated to complete the release of the drive rod 6.

[0063] In Embodiment 2, this application improves the direct drive system and the threaded locking assembly, see [link to Embodiment 2]. Figure 8As shown in the figure, this embodiment provides a rapidly adjustable valve clip device for interventional treatment of the heart, including a fixed base 1 and a movable base 3. Clamping arms 11 are hinged to the fixed base 1, and the two clamping arms 11 are rotatably connected to the fixed base 1 via a first hinge shaft. An upper clip is disposed above the clamping arms 11. The valve is clamped and fixed through the cooperation of the clamping arms 11 and the upper clip. The upper clip is a spring clip, typically made of thermoplastic material. The upper clip can be held on both sides near the fixed base 1 by an upper clip pull wire. When the upper clamping cable is pulled, the upper clamping plate is pressed against the clamping arm 11 (not shown) under the action of its own elastic force, that is, the upper clamping plate rotates around the direction away from the fixed base 1; the upper clamping plate is connected to the far end of the fixed base 1, the clamping arm 11 is hinged to the far end of the fixed base 1 through the first hinge axis, one end of the rotating arm 12 is hinged to the movable base 3 through the third hinge axis, and the other end is hinged to the clamping arm 11 through the second hinge axis. Preferably, the second hinge axis is hinged to the middle or end position of the clamping arm 11.

[0064] The valve clip device includes a direct drive assembly and a threaded locking assembly. The threaded locking assembly includes a threaded rod 2, a movable nut 7, and a threaded drive component 4. The movable base 3 includes a base 32. One end of the threaded rod 2 is rotatably connected to the base 32. For example, a flange is provided at the connection end of the threaded rod 2 and the base 32. The flange engages to allow the threaded rod 2 to rotate relative to the base 32 without axial movement. The threaded drive component 4, sleeved inside the fixed base 1, can rotate relative to the fixed base 1. The direct drive assembly includes a drive rod 6 disposed inside the threaded drive component 4. The drive rod 6 can slide relative to the threaded drive component 4. The movable nut 7 is sleeved on the outer periphery of the middle part of the threaded rod 2. The other end of the threaded rod 2 engages with the threaded drive component and the drive rod. The angle of the clamping arm can be quickly adjusted by the direct drive assembly, and the angle of the clamping arm can be locked by the threaded locking assembly.

[0065] See Figure 10 As shown, the fixed base 1 includes a receiving groove 15, which has a snap-fit ​​device. The snap-fit ​​device confines the movable nut within the receiving groove 15, thereby preventing the movable nut from moving axially. The receiving groove 15 has a cross-sectional area that restricts the rotation of the movable nut. For example, the receiving groove 15 can have the same or different cross-sectional area as the movable nut, such as hexagonal, elliptical, toothed, square, or oblong. Any cross-sectional area of ​​the receiving groove 15 that prevents the movable nut from rotating can be used in the prior art.

[0066] The operator can slide the drive rod relative to the threaded drive component. When a thrust is applied to the drive rod, the drive rod generates a thrust on the threaded rod 2, overcoming the frictional force of the locking device on the movable nut, causing the movable nut to move to the distal end. The movable nut disengages from the receiving groove 15. Since the efficiency of the operator pushing the drive rod is much higher than the efficiency of rotating the threaded rod 2, the movable base 3 can quickly move away from the fixed base 1. Under the action of the rotating arm 12, the clamping arm 11 is quickly unfolded. (See also...) Figure 9 As shown in the diagram; when the clamping arm 11 is in the extended state, a pulling force is applied to the drive rod, which acts on the threaded rod 2, causing the movable base 3 to move towards the proximal end. The movable nut moves into the receiving groove 15 and is engaged. As the movable base 3 approaches the fixed base 1, the clamping arm 11 quickly completes the clamping and fixing of the valve object. Then, by operating the threaded drive component, the threaded rod 2, which typically has a certain length of thread protruding from the movable nut, is rotated in the first direction of rotation. Since the movable nut is limited by the fixed base 1, the threaded rod 2 moves towards the proximal end under the action of the thread, thereby driving the movable base 3 to move towards the fixed base 1, increasing the clamping force of the clamping arm 11 on the valve, and completing the fixing of the valve. During the valve clamping process, the clamping arm 11 is rapidly rotated to expand or contract by sliding the driving rod, which improves surgical efficiency, reduces the mating thread length of the movable base 3 and the threaded rod 2 in the prior art, increases the clamping force of the clamping arm 11 on the valve by rotating the threaded rod 2, and completes the locking after the valve is fixed, reducing the difficulty of interventional surgery.

[0067] In a preferred embodiment, the end of the drive rod is rotatably detachably connected to the threaded rod 2. This detachable connection allows the drive rod to apply tension or thrust to the movable base 3 via the threaded rod 2, thereby moving the movable base 3 towards the proximal or distal end. This detachable connection can be a conventional technique such as a rotary latch, where the end of the drive rod is latched to the movable base 3 by rotating it; or... Figure 9 The valve is connected by the first connecting thread 31. If a screw or internal thread is provided at the end, a corresponding internal thread or screw is provided on the movable base 3. The end of the drive rod is threaded to the movable base 3 by rotating the drive rod. After the valve clamping and fixing is completed, the drive rod is rotated in the opposite direction to release the drive rod.

[0068] In a preferred embodiment, the threaded drive component is a hollow sleeve, and the drive rod passes through the threaded drive component. The threaded drive component is connected to the threaded rod 2 in a non-rotating connection manner. For example, the mating end faces of the threaded drive component and the threaded rod 2 can be provided with bosses, grooves, serrations, etc., to transmit the torque of the threaded drive component to the threaded rod 2, thereby driving the threaded rod 2 to rotate.

[0069] Preferably, the first connecting thread 31 has a helix direction opposite to that of the movable nut, so that when the drive rod disengages from the threaded rod 2, it rotates independently in the same direction as the first helix direction. This causes the friction generated by the first connecting thread 31 during the disengagement or release of the drive rod to cause the threaded rod 2 to continue rotating around the first helix direction. During this process, the rotation angle of the threaded rod 2 is small, and the movable base 3 tends to move proximally, further increasing the clamping force of the clamping arm 11 and the upper clamp on the valve, and improving the clamping and fixing effect on the heart valve. The threaded drive and the drive rod are both connected to the control handle, with the proximal end defined as the direction of the control handle, and the distal end defined as the direction opposite to that of the control handle.

[0070] In a preferred embodiment, the rotating arm 12 has an arc-shaped structure, which can be a single arch structure, preferably a double arch structure, thus forming an M-shaped rotating arm 12, or a multi-arch structure. Using this arc-shaped structure, when the threaded rod 2 is rotated to bring the clamping arm 11 to a retracted state (i.e., the clamping arm 11 is close to the fixed base 1), and the clamping arm 11 cooperates with the upper clamping plate to clamp the valve, the movable base 3 moves proximally, and the rotating arm 12 approaches the fixed base 1. The prestress of the threaded connection generates an elastically deformable thrust on the clamping arm 11 in the rotating arm 12, thereby ensuring the clamping arm 11 is tightly attached to the upper clamping arm and increasing the clamping and fixing effect on the valve.

[0071] In a preferred embodiment, the outer periphery of the movable nut is formed by two planes 71 and two arc surfaces 72, see [reference]. Figure 11-12 As shown, the plane 71 includes an inclined surface that slopes from one end to the far end, such that the distance between the two planes 71 is maximized at the far end. This inclined surface facilitates guiding the movable nut to slide into the receiving groove 15, and the locking device engages with the far end of the movable nut to achieve axial positioning of the movable nut.

[0072] In a preferred embodiment, the outer periphery of the receiving groove 15 is provided with at least two notches 151, see [reference]. Figure 11 In the cross-sectional view, the notch 151 divides the outer periphery of the receiving groove 15 into at least two parts. When the movable nut is subjected to tension or thrust and enters or slides out of the receiving groove 15, at least two parts of the receiving groove 15 undergo elastic deformation and open outward. When the movable nut is accommodated in the receiving groove 15, the receiving groove 15 returns to its original state and the axial position of the movable nut is limited by the snap-fit ​​device.

[0073] In a preferred embodiment, the snap-fit ​​device is a flange 152, see [link to previous embodiment]. Figure 14The structural diagram shows that the flange 152 is located at the distal end of the receiving groove 15, and is integrally formed with or separately from the receiving groove 15. The flange 152 protrudes radially inward from the receiving groove 15, and the flange 152 cooperates with the distal end of the movable nut to limit its movement. Preferably, the flange has at least one guide surface, which is an inclined surface, to guide the movable nut to slide into or out of the receiving groove 15.

[0074] This application also relates to a method of operating a valve clip device, which includes a valve clip device comprising a direct drive assembly, a threaded locking assembly, a clamping arm, and a threaded rod. First, the angle of the clamping arm is quickly adjusted by sliding the direct drive assembly. Then, the angle of the clamping arm is locked by rotating the threaded rod in a first direction using the threaded locking assembly.

[0075] As can be seen from the above technical solutions, the valve clip device with driving rod 6 and the method of using the valve clip device of this application achieve rapid rotation of the clamping arm 11 by sliding the driving rod 6, which improves surgical efficiency, reduces the mating thread length of the movable base 3 and the threaded rod 2 in the prior art, increases the clamping force of the clamping arm 11 on the valve by rotating the threaded rod 2, and avoids the technical problem of tooth misalignment when the thread is engaged because the corresponding second connecting thread 21 or the movable nut is always engaged with the threaded rod, and completes the locking after valve fixation, reducing the operation difficulty of interventional surgery.

Claims

1. A rapidly adjustable valve clip device, comprising a fixed base and a movable base, wherein a clamping arm is hingedly connected to the fixed base, two clamping arms are rotatably connected to the fixed base via a first hinge shaft, and an upper clip is disposed above the clamping arm, wherein the valve is clamped and fixed by the cooperation of the clamping arm and the upper clip; the upper clip is connected to the distal end of the fixed base, the clamping arm is hinged to the distal end of the fixed base via the first hinge shaft, one end of the rotating arm is hinged to the movable base via a third hinge shaft, and the other end is hinged to the clamping arm via a second hinge shaft; Its features are, The valve clip device also includes a direct drive assembly and a threaded locking assembly. The threaded locking assembly includes a threaded rod, a threaded drive element, and a threaded release rod sleeved inside the fixed base. One end of the threaded rod is detachably connected to the movable base via a snap fastener, and the other end engages with the threaded drive element and the threaded release rod. Both the threaded release rod and the threaded rod are hollow sleeves. The direct drive assembly includes a drive rod that passes sequentially through the threaded release rod and the threaded rod. The end of the drive rod is rotatably and detachably connected to the movable base. The fixed base and the threaded rod are engaged via a second connecting thread. The snap fasteners connecting the movable base and the threaded rod engage and disengage under the sliding operation of the direct drive assembly to achieve rapid adjustment of the clamping arm angle. The angle of the clamping arm is locked by rotating the threaded rod in a first rotational direction using the threaded locking assembly. The threaded drive component is a hollow sleeve, and the threaded release rod passes through the threaded drive component. The threaded release rod and the threaded rod are fixed by a third connecting thread. Under the action of the third connecting thread, the threaded release rod biases the threaded drive component against the threaded rod. The third connecting thread has the opposite direction of rotation to the second connecting thread, so that when the threaded release rod is released from the threaded rod, it rotates independently in the same direction as the first direction of rotation. The movable base includes a connector and a base. The connector has a first flange at its proximal end and a second flange at its distal end. The threaded rod is connected to the movable base by the engagement of the first flange and the second flange.

2. The valve clip device according to claim 1, characterized in that, The threaded release rod has a shoulder, and the threaded drive has a radially inwardly extending convex ring. The shoulder acts on the convex ring to bias the threaded drive onto the threaded rod.

3. The valve clip device according to claim 1, characterized in that, The rotating arm has an arc-shaped structure.

4. The valve clip device according to claim 1, characterized in that, The connector has an axial extension at its proximal end, and the fixed base has a groove corresponding to the extension. The threaded rod is snapped into the movable base, and the extension extends into the groove. The groove is used to radially limit the extension.

5. A valve clip device, comprising a fixed base and a movable base, wherein a clamping arm is hingedly connected to the fixed base, characterized in that, The valve clip device includes a direct drive assembly and a threaded locking assembly. The threaded locking assembly includes a threaded rod, a movable nut, and a threaded drive component. The movable base includes a base. One end of the threaded rod is rotatably connected to the base. The threaded drive component, sleeved inside the fixed base, can be controlled to rotate relative to the fixed base. The direct drive assembly includes a drive rod disposed inside the threaded drive component. The drive rod is selectively slidable relative to the threaded drive component. A movable nut is sleeved on the outer periphery of the middle portion of the threaded rod. The movable nut selectively engages with the fixed base. When the movable nut is at its distal end, it is separated from the fixed base; when it is at its proximal end, it is engaged with the fixed base. The other end of the threaded rod engages with the threaded drive component and the drive rod. The angle of the clamping arm can be quickly adjusted by sliding the direct drive assembly. The angle of the clamping arm is locked by rotating the threaded rod in a first direction using the threaded locking assembly. The fixed base includes a receiving groove, and the receiving groove has a snap-fit ​​device, which limits the movable nut to be located within the receiving groove. The receiving groove has a cross-sectional area that restricts the rotation of the movable nut; The threaded drive component is a hollow sleeve, and the drive rod passes through the threaded drive component. The threaded drive component is operated to drive the threaded rod to rotate. The end of the drive rod is connected to the threaded rod by a first connecting thread. The first connecting thread has a direction of rotation opposite to that of the moving nut, so that when the drive rod disengages from the threaded rod, it rotates independently in the same direction as the first direction of rotation, thus separating the drive rod from the threaded rod.

6. The valve clip device according to claim 5, characterized in that, The receiving groove has the same or different cross-sectional area as the movable nut.

7. The valve clip device according to claim 5, characterized in that, The end of the drive rod is rotatably and detachably connected to the threaded rod, so that after the valve clamping and fixing is completed, the drive rod can be rotated in the opposite direction to release the drive rod.

8. The valve clip device according to claim 5, characterized in that, The outer periphery of the movable nut is composed of two planes and two arc surfaces. The planes include a section of inclined plane that slopes from the far end, such that the distance between the two planes is maximized at the far end.

9. The valve clip device according to claim 5, characterized in that, The outer periphery of the receiving groove is provided with at least two notches.

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