Valve clamping device and valve repair system
By designing a valve clamping device, the coupling of the elastic spacer arm and the elastic pressing ring can be achieved to achieve clamping of the valve and edge-to-edge repair, which solves the problems of complex operation of the instrument and insufficient closure force in the prior art, and improves the success rate and safety of the surgery.
Patent Information
- Application Number
- CN202211267999.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-10-17
- Publication Date
- 2025-08-05
- Estimated Expiration
- 2042-10-17
AI Technical Summary
The existing transcatheter edge-to-edge repair surgical instruments are complex in operation, and the clamping device is insufficient in closure and retraction force, resulting in severe valve edge regurgitation.
A valve clamping device is designed, including a spacer, a joint assembly, an elastic spacer arm, a clamper and an elastic press ring. By driving the spacer to move through the push shaft, the elastic spacer arm changes its shape under the joint action of the elastic press ring and the joint assembly, realizing the clamping of the valve and edge repair of the edge, and increasing the closing and closing force.
It improves the success rate and safety of the surgery, reduces valve edge regurgitation, simplifies operation difficulty and surgical time, and enhances the reliability and stability of the instrument.
Smart Images

Figure CN117918999B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular to a valve clamping device and a valve repair system. Background Art
[0002] The problem of existing heart valve disease is increasing with the aging population. Furthermore, the complications and causes of heart valve disease in China differ from those in other countries. The conditions of patients with heart valve disease in different regions of China also vary. Therefore, facing complex complications, the requirements for medical devices also vary. Currently, mitral valve disease is the most common complication among heart valve disease patients, with mitral regurgitation being the main symptom, followed by aortic stenosis and combined valvular disease. Meanwhile, the number of patients with tricuspid regurgitation is also increasing. Heart valves act as a barrier between the atria and ventricles, preventing blood in the ventricles from flowing back into the atria. They ensure that all blood in the ventricles can enter the aorta or pulmonary artery through the aortic valve or pulmonary valve, allowing oxygen- and nutrient-rich blood to flow through the aorta to the entire body. Blood collected in the superior and inferior vena cava is then sent to the lungs for oxygen exchange, becoming oxygen-rich arterial blood. The heart valve is equivalent to a check valve. If the valve is not closed tightly, it will cause severe reflux, resulting in the blood not being able to enter the aorta or pulmonary artery, causing heart failure in patients, affecting their normal quality of life, and even life-threatening in severe cases.
[0003] Mitral regurgitation can be treated through surgical leaflet or annulus repair, but surgery requires thoracotomy and carries significant risks, making it less suitable for older patients. Mitral regurgitation can also be suppressed through interventional surgery, which currently includes two main methods: transcatheter edge-to-edge repair and transcatheter replacement. However, transcatheter replacement surgery is less safe and less mature. Currently, transcatheter interventional surgery using edge-to-edge repair is more mature, reliable, and safe. However, the existing transcatheter edge-to-edge repair instruments are more complex to operate, the connection between the instrument delivery system and the clip is more complex, and the reliability is not very high. In addition, due to the limited capture range of most instruments, an average of 1.5 clips need to be implanted in one operation.
[0004] Currently, there are two main devices for treating mitral regurgitation or tricuspid regurgitation: mechanical clips and elastic clips. The elastic clip has an elastic spacer in the middle, which can achieve good elastic buffering, reduce the stress on the leaflets when the clip is captured, and reduce the risk of tearing after the leaflets are captured. However, the elastic clip is locked by the elastic recovery force of the elastic parts, and the locking force is not as reliable as the mechanical structure of the mechanical clip. The elastic clip uses the shape memory effect of nickel-titanium alloy to repair the single-hole mitral valve into a double-hole after capturing the valve. However, due to its elastic structure, it will open to a certain extent when the valve is pulled out, causing increased edge regurgitation, which has a certain negative effect on the treatment of mitral regurgitation. Summary of the Invention
[0005] The purpose of the present invention is to provide a valve clamping device and a valve repair system to solve the problem that after the clamping device in the prior art clamps the valve to achieve edge-to-edge repair, it may easily cause severe valve edge regurgitation due to insufficient closing and contraction force.
[0006] To solve the above technical problems, according to one aspect of the present invention, a valve clipping device is provided, which is used to be implanted in a predetermined area under the drive of a delivery device, wherein the delivery device includes a push shaft, and the valve clipping device includes:
[0007] spacer;
[0008] a joint assembly, configured to move along the axial direction of the spacer under the drive of the pushing shaft;
[0009] at least two repair components symmetrically arranged along the radial direction of the spacer, the repair components comprising:
[0010] an elastic spacer arm, comprising a capture segment and a support segment extending axially along the spacer body, wherein the spacer body, the capture segment, and the support segment are sequentially connected from the proximal end to the distal end; the distal end of the capture segment and the proximal end of the support segment are connected to form a spacer portion, and the distal end of the support segment is connected to the connector assembly;
[0011] a clamper, which is provided on the capturing section and is used to clamp a predetermined portion;
[0012] an elastic pressure ring, a proximal end of which is connected to the spacer, and a distal end of which is connected to the joint assembly;
[0013] A coupling member comprising a bracket portion and a limiting ring provided on the bracket portion, wherein the distal end of the bracket portion is connected to the joint assembly; the coupling member is configured such that the push shaft passes through the limiting ring to constrain the radial position of the bracket portion along the spacer, and the push shaft exits the limiting ring to allow the bracket portion to deflect radially outward about its distal end along the spacer;
[0014] Wherein, the proximal end of the bracket portion of any of the repair components is connected to the supporting section of the elastic pressure ring or elastic spacer arm of at least one other repair component through a traction body.
[0015] Optionally, the limiting ring is provided on a radially inward side of the bracket portion along the spacer, and all the limiting rings are at different axial positions along the spacer.
[0016] Optionally, when the pushing shaft passes through the limiting ring, the proximal end of the bracket portion does not extend outwardly along the radial direction of the spacer beyond the distal end of the bracket portion.
[0017] Optionally, the material of the stent portion is a memory shape alloy, and the memory shape of the stent portion is configured so that the proximal end of the stent portion extends outwardly beyond the distal end of the stent portion along the radial direction of the spacer.
[0018] Optionally, when the pushing shaft passes through all the limiting rings, all the limiting rings are coaxial.
[0019] Optionally, the connection position of the traction body on the corresponding supporting segment of the elastic pressure ring or the elastic spacer arm is configured not to exceed the proximal end of the bracket part along the direction from the distal end to the proximal end.
[0020] Optionally, the traction body includes at least one traction wire, and the supporting segment of the elastic pressure ring or the elastic spacer arm is connected to the proximal end of the bracket part through the traction wire.
[0021] Optionally, the supporting segment of the elastic pressure ring or the elastic spacer arm is connected to the proximal end of the bracket portion through at least two of the traction wires, and the traction wire corresponding to any of the repair components is centrally symmetrically distributed with the traction wire corresponding to at least one other repair component.
[0022] Optionally, the valve clamping instrument further includes a base, the coupling member is fixed on the base, and the base is sleeved on the connector assembly.
[0023] Based on the second aspect of the present invention, the present invention also provides a valve repair system, which includes a delivery device and the valve clamping device as described above, the delivery device includes a push shaft, and the push shaft is used to sequentially pass through the spacer and each of the limiting rings and then be detachably connected to the connector assembly.
[0024] The valve clipping device described above has at least the following technical effects:
[0025] First, the elastic spacer arm is configured to change into different shapes under the combined action of the elastic pressure ring and the connector assembly, and the clipper is arranged on the capture segment so that its position changes as the shape of the elastic spacer arm changes, thereby completing the clipper implantation, valve capture and clamping, and edge-to-edge repair of the valve.
[0026] Secondly, after the clamped valve is repaired edge to edge, the push shaft is separated from the joint assembly and each limiting ring is withdrawn. The coupling part moves radially outward along the spacer through the bracket part to stretch the corresponding traction body, and then under the action of the two symmetrical coupling parts, the elastic pressure rings on both sides or the support sections of the elastic spacer arms are driven to further move closer to the spacer. On the one hand, under the action of the coupling part, the valve tissue in contact with the elastic pressure ring can be further retracted toward the center. On the other hand, the clamp on the capture section can be further moved closer to the spacer to drive the valve tissue on both sides clamped by the clamp to be further retracted toward the center. In this way, after the valve is clamped by the valve clamping instrument of the present invention to achieve edge to edge repair, the design of the coupling part can increase the closing and retraction force, improve the valve closing effect, improve the postoperative valve edge reflux, and improve the success rate of the operation.
[0027] It should be noted that, since the valve repair system includes the valve clamping device, the valve repair system also has the technical effects brought by the valve clamping device, which will not be repeated here. BRIEF DESCRIPTION OF THE DRAWINGS
[0028] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.
[0029] Figure 1 is a schematic diagram of a valve clipping device according to an embodiment of the present invention when the elastic spacer arm is in a first state;
[0030] Figure 2 is a schematic diagram of a valve clipping device according to an embodiment of the present invention when the elastic spacer arm is in a second state;
[0031] Figure 3 is a schematic diagram of the connection between the valve clipping device and the delivery device when the elastic spacer arm according to an embodiment of the present invention is in the second state;
[0032] Figure 4 is a schematic diagram of the valve clipping device according to an embodiment of the present invention when the elastic spacer arm is in the third state;
[0033] Figure 5 is a front view of the valve clipping device according to an embodiment of the present invention, when the elastic spacer arm is in the third configuration;
[0034] Figure 6is a schematic diagram of the elastic spacer arm and the spacer body when the elastic spacer arm is in the third state according to an embodiment of the present invention;
[0035] Figure 7 Schematic diagram of a coupling member, an elastic pressure ring, and a joint assembly according to an embodiment of the present invention;
[0036] Figure 8 Schematic diagram of a coupling member, an elastic pressure ring, and a joint assembly when a push shaft passes through a limit ring according to an embodiment of the present invention;
[0037] Figure 9 Schematic diagram of the coupling member, elastic pressure ring and joint assembly after the push shaft exits the limit ring according to an embodiment of the present invention;
[0038] Figure 10 3. This is a top view of the coupling member and the limiting ring after the push shaft exits the limiting ring according to an embodiment of the present invention;
[0039] Figure 11 This is a front view of the coupling member after the push shaft exits the limit ring according to an embodiment of the present invention;
[0040] Figure 12 3. This is a top view of the coupling member after the push shaft exits the limit ring according to an embodiment of the present invention;
[0041] Figure 13 is a schematic diagram of an elastic pressure ring according to an embodiment of the present invention;
[0042] Figure 14 is a side view of an elastic pressure ring according to an embodiment of the present invention;
[0043] Figure 15 is a schematic diagram of a clamp according to an embodiment of the present invention;
[0044] Figure 16 is another schematic diagram of a clamp according to an embodiment of the present invention;
[0045] Figure 17 is a schematic diagram of a proximal connector according to an embodiment of the present invention;
[0046] Figure 18 is a schematic diagram of a sealing gasket according to an embodiment of the present invention;
[0047] Figure 19 is a schematic diagram of a distal connector according to an embodiment of the present invention;
[0048] Figure 20 is a schematic diagram of a guidewire connector according to an embodiment of the present invention;
[0049] Figure 21 is a schematic diagram of a covering joint according to an embodiment of the present invention;
[0050] Figure 22is an exploded view of the delivery device, the sealing gasket, and the proximal connector according to an embodiment of the present invention;
[0051] Figure 23 Schematic diagram of the connection between the delivery device and the valve clamping device according to an embodiment of the present invention.
[0052] In the attached figure:
[0053] 10-spacer;
[0054] 20- distal connector; 21- connector slot; 22- first connecting slot;
[0055] 30 - Repair assembly; 31 - Elastic spacer arm; 311 - Capturing section; 312 - Support section; 310 - Spacer; 32 - Clamp; 321 - Clamping plate; 3211 - Long hole; 3212 - Control hole; 322 - Support plate; 3221 - Horizontal section; 3222 - Vertical section; 323 - Barb structure; 33 - Elastic pressure ring; 331 - Pressure hole; 34 - Fixing member; 340 - Second connecting groove; 35 - Coupling member; 351 - Bracket; 352 - Limiting ring; 36 - Traction body; 360 - Traction wire;
[0056] 40-proximal connector; 41-first extension; 42-second extension; 420-jack;
[0057] 50 - sealing gasket; 51 - third extension portion; 510 - first slot hole; 52 - second slot hole;
[0058] 60-ring base;
[0059] 70 - guidewire connector; 71 - fourth extension; 710 - second guide hole; 72 - sixth extension; 73 - groove;
[0060] 80-covering joint; 81-fifth extension;
[0061] 90-push shaft;
[0062] 100-control wire;
[0063] 110 - connecting piece; 111 - first connecting piece; 1110 - sheet hole; 112 - second connecting piece. DETAILED DESCRIPTION
[0064] To make the objects, advantages, and features of the present invention more clearly apparent, the present invention is further described below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale. They are only used to conveniently and clearly assist in illustrating the purposes of the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, different drawings may need to illustrate different focuses and sometimes use different scales.
[0065] As used in the present invention, the singular forms "a", "an", and "the" include plural referents, the term "or" is generally used to include "and / or", the term "several" is generally used to include "at least one", and the term "at least two" is generally used to include "two or more". In addition, the terms "first", "second", and "third" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features specified as "first", "second", and "third" may explicitly or implicitly include one or at least two of the features, "one end" and "the other end" and "proximal end" and "distal end" generally refer to two corresponding parts, which not only include endpoints, and the terms "mounted", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be a communication between two elements or an interaction relationship between two elements. In addition, as used in the present invention, "one element is disposed on another element" generally only indicates that there is a connection, coupling, cooperation, or transmission relationship between the two elements, and the connection, coupling, cooperation, or transmission between the two elements may be direct or indirect through an intermediate element. It should not be understood as indicating or implying a spatial positional relationship between the two elements. That is, one element can be in any orientation, such as inside, outside, above, below, or to one side of another element, unless the content clearly indicates otherwise. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.
[0066] It should be noted that the definitions of "proximal" and "distal" in this article are: "proximal" usually refers to the end of the medical device that is close to the operator during normal operation, while "distal" usually refers to the end of the medical device that first enters the patient's body during normal operation.
[0067] like Figures 1 to 6As shown, this embodiment provides a valve clipping device that is detachably connected to a delivery device and can be implanted into a predetermined area under the drive of the delivery device. The delivery device includes a push shaft 90, which is typically used to complete the implantation of the valve clipping device. The predetermined area can be a patient's ventricle. The valve clipping device includes a spacer 10, a connector assembly, and at least two repair components 30. The spacer 10 has a spatial form and is typically woven into an ellipsoidal shape from metal wire. For example, it can be pre-woven from nickel-titanium alloy wire and then fixed in shape through a heat-setting process. The preparation method is not limited to the above method and can also be, for example, laser cutting. In this embodiment, the axial direction of the spacer 10 refers to the long axis of the ellipsoidal shape. The push shaft 90 typically passes through the spacer 10 along the axial direction and is connected to the connector assembly. The push shaft 90 is typically collinear with the central axis of the spacer 10. The connector assembly is located at the distal end of the spacer 10 and is movably arranged relative to the spacer 10 along the axial direction of the spacer 10. Specifically, a push shaft 90 passes through the spacer 10 and is connected to the connector assembly. The push shaft 90 is advanced or retracted to drive the connector assembly to move relative to the spacer 10. At least two repair assemblies 30 are arranged symmetrically along the radial direction of the spacer 10. That is, at least two repair assemblies 30 are arranged symmetrically about the diameter of the spacer 10 as a group. It can also be understood that two repair assemblies 30 are located on both sides of the same diameter of the spacer 10 as a group. For example, the illustrations of this embodiment only illustrate two repair assemblies arranged radially symmetrically about the spacer 10. However, it is understood that the two repair assemblies in the illustrations are for illustrative purposes only and do not limit the number of repair assemblies. Furthermore, the repair assembly 30 includes an elastic spacer arm 31, a clamp 32, and an elastic pressure ring 33. The elastic spacer arm 31 includes a capture segment 311 and a support segment 312 extending along the axial direction of the spacer 10. The spacer 10, the capture segment 311 and the support segment 312 are sequentially connected from the proximal end to the distal end. It should be understood that the elastic spacer arm 31 includes a capture segment 311 and a support segment 312 extending along the axial direction of the spacer 10. Figure 1 To explain, Figure 1The middle capture segment 311 and the support segment 312 extend along the axial direction of the spacer 10 and are connected in sequence; the distal end of the capture segment 311 and the proximal end of the support segment 312 are connected to form a spacer portion 310, that is, the connection between the capture segment 311 and the support segment 312 is defined as the spacer portion 310. In addition, the elastic spacer arm 31 is usually strip-shaped or plate-shaped. The elastic spacer arm 31 has elastic force, that is, it is made of elastic material and can change its own shape under the action of external force, that is, change the presentation state of the capture segment 311 and the support segment 322, such as the capture segment 311 and the support segment 322 can be relatively folded; the distal end of the support segment 312 is connected to the joint assembly. It should be noted that the elastic spacer arm 31 can also be woven by metal wire (such as nickel-titanium alloy wire), and the connection method between the elastic spacer arm 31 and the joint assembly can be laser welding. In addition, the elastic spacer arm 31 can be formed integrally with the spacer 10, or it can be formed separately and then connected, including but not limited to the above-mentioned manufacturing method. The clamp 32 is provided on the capture section 311 (with Figure 1 For example, the clamp 32 can usually be set on the radially outward side of the capture section 311 along the spacer. The clamp 32 is used to clamp a predetermined part. The predetermined part here usually refers to the leaflet of the mitral valve or tricuspid valve. Of course, it can also be other natural valves, such as the aortic valve or the pulmonary valve, which is determined according to the actual application scenario. The proximal end of the elastic pressure ring 33 is connected to the spacer 310, and the distal end of the elastic pressure ring 33 is connected to the joint assembly. The elastic pressure ring 33 is used to apply a force to the elastic spacer arm 31, and change the direction of the force as the joint assembly moves, thereby changing the shape of the elastic spacer arm 31 accordingly. The hollow area in the middle of the elastic pressure ring 33 (see Figure 13 ) allows the clamp 32 to pass through. Specifically, when the elastic spacer arm 31 changes its shape, the clamp 32 mounted thereon can pass in and out of the hollow area in the middle of the elastic pressure ring 33. It should be noted that the elastic pressure ring 33 and the clamp 32 can be formed using a nickel-titanium alloy laser cutting process followed by a heat setting process.
[0068] The structure of the valve clipping device configured as above can make the elastic spacer arm 31 follow the movement of the connector assembly (driven by the push shaft 90 to move from the proximal end to the distal end, or from the distal end to the proximal end) under the force applied by the elastic pressure ring 33 and switch between different forms, generally between the first form and the second form, and between the second form and the third form. The second form here should be understood as the form between the first form and the third form is the second form, and one of the second forms is the second vertical form. Please refer to Figure 1When the elastic spacer arm 31 is in the first form, the capture section 311 and the support section 312 are roughly collinearly arranged and roughly close to the central axis of the spacer 10. It should be understood that the collinear arrangement here should be understood as a broad collinear arrangement, that is, basically collinear. It can be further understood that the spacer 310 is not bent. When the elastic spacer arm 31 is in the first form, the radial inward projection of the spacer 310 along the spacer 10 is outside the range of the spacer 10. To be precise, the projection is located on the central axis outside the spacer 10, specifically referring to the axial position of the spacer 310 along the spacer 10 away from the far end of the spacer 10. Front view of the shape formed by the elastic spacer arms 31 on both sides ( Figure 1 See Figure 2 and Figure 3 When the elastic spacer arm 31 is in the second state, the elastic spacer arm 31 expands outward in the radial direction of the spacer 10, and the spacer portion 310 is located away from the distal end of the spacer 10 in the axial direction of the spacer 10, that is, the projection of the spacer portion 310 in the radial direction of the spacer 10 on the central axis of the spacer 10 is outside the range of the spacer 10. When the elastic spacer arm 31 is transformed from the first state to the second state, the spacer portion 310 gradually expands outward. In particular, please refer to Figure 2 and Figure 3 When the elastic spacer arm 31 is in the second vertical form as the joint assembly moves from the distal end to the proximal end, the capture segment 311 is perpendicular to the central axis of the spacer 10. The shape formed by the elastic spacer arms 31 of the two repair assemblies 30 is similar to an isosceles triangle, that is, the two elastic spacer arms 31 are supported by the corresponding two elastic pressure rings 32 to form a stable triangle. It should be understood that the capture segment 311 and the central axis of the spacer 10 are perpendicular to each other in a broad sense. For example, the angle between the capture segment 311 and the central axis of the spacer 10 is in the range of [90°-5°, 90°+5°], which can be regarded as the capture segment 311 being perpendicular to the central axis of the spacer 10. Figure 4 and Figure 5 As shown, when the elastic spacer arm 31 is in the third form, the elastic spacer arm 31 expands radially outward along the spacer body 10, the radially inward projection of the spacer portion 310 along the spacer body 10 is located on the spacer body 10, the axial position of the spacer portion 310 along the spacer body 10 is within the range of the spacer body 10, and the capturing segment 311 and the supporting segment 312 are folded and close to the spacer body 10, that is, the capturing segment 311 and the supporting segment 312 are driven by the elastic pressure ring 33 to move closer to the spacer body 10. It should be noted that in order to reduce the trauma of the valve clamping device to human tissue, the outer surface of the valve clamping device is usually covered with at least one layer of covering film, which is usually a medical polymer material film. Figure 1 、 Figure 2 、 Figure 3 and Figure 5 The valve clipping devices shown are all covered with a covering film, which is shown as a filler in the figure. It should be noted that when the joint assembly moves so that the elastic pressure ring 33 drives the elastic spacer arm 31 to transform between the three forms mentioned above, the elastic pressure ring 33 is made of elastic material and usually produces a certain degree of bending deformation, for example Figure 1 、 Figure 2 、 Figure 3 and Figure 5 As shown, the elastic pressure ring 33 also has a certain curvature in the natural state ( Figure 14 shown).
[0069] As configured above, the elastic spacer arm 31 in the first form is implanted into the patient's ventricle along with the valve clamping device, and then the elastic spacer arm 31 is converted to the third form and placed between the leaflets of the mitral valve or tricuspid valve along with the spacer 10. The elastic spacer arm 31 is then converted to the second form (preferably the second vertical form) and the leaflets are captured and clamped by the clamp 32 on the capture section 311 (in this process, the clamp 32 passes through the hollow area in the middle of the elastic pressure ring 33 to perform the capture and clamping work). When the clamps 32 of the two repair components 30 have clamped their corresponding leaflets, the elastic spacer arm 31 is finally converted to the third form to achieve edge-to-edge repair of the mitral valve or tricuspid valve. It should be noted that when the elastic spacer arm 31 is in the second vertical configuration, the clipper 32 captures and clamps the leaflets. In actual applications, the elastic spacer arm 31 is typically positioned between the second vertical configuration and the third configuration. This can be understood as the clipper 32 capturing the leaflets when the elastic spacer arm 31 begins to enter the third configuration. At this time, the projection of the spacer portion 310 along the central axis of the spacer 10 is located at the distal end of the spacer 10. The spacer 10 has a spatial configuration that minimizes the gap between the spacer and the leaflets, thereby preventing tearing of the leaflets after clipping and repair. The present invention configures an elastic spacer arm 31 to change shape under the combined action of an elastic pressure ring 33 and a distal connector 20, and arranges a clamp 32 on the capture section 311 to change its position as the elastic spacer arm 31 changes shape, thereby completing the implantation of the clamp 32, capturing and clamping the valve, and performing edge-to-edge repair of the valve. This greatly improves the success rate of device implantation, reduces the risk of device implantation failure, and makes device implantation safer, more reliable, and more stable. It also reduces the difficulty and time of the surgical procedure, improves the safety and reliability of the procedure, and reduces the risks associated with the device during the procedure, effectively suppressing the patient's mitral or tricuspid regurgitation. In addition, the elastic spacer arm 31 in the third shape is driven by the elastic pressure ring 33 to close to the spacer body 10, further reducing the gap between the leaflets and the valve clamping device, thereby improving the repair shape of the mitral or tricuspid valve, enhancing the repair effect, and reducing the risk of recurrence of mitral or tricuspid regurgitation. It can be understood that in the three form transformations of the above-mentioned elastic spacer arm 31, and after the clamp 32 clamps the leaflet, the elastic pressure ring 33 plays the role of elastic support, and the elastic pressure ring 33 can also drive the valve tissue in contact with it to converge toward the center to a certain extent, thereby improving the closing effect of the valve.
[0070] Furthermore, referring to FIG7 , the repair assembly 30 of the present invention also includes a coupling member 35. If two repair assemblies are grouped together and are radially symmetrical about the spacer 10, then the corresponding two coupling members 35 are also radially symmetrical about the spacer 10. The coupling member 35 includes a bracket portion 351 and a retaining ring 352 disposed on the bracket portion 351. For example, the retaining ring 352 may be disposed on the radially inward side of the bracket portion 351 along the spacer 10. Furthermore, the bracket portion 351 may be plate-shaped or sheet-shaped, and the plane on which the retaining ring 352 lies may be perpendicular to the bracket portion 351 (i.e., the axial direction of the retaining ring 352 is parallel to the bracket portion 351). In other embodiments, the axial direction of the retaining ring 352 may be at an angle (e.g., 15°, 30°, etc.) to the bracket portion 351. The distal end of the bracket portion 351 is connected to the connector assembly, and the proximal end of the bracket portion 351 of any repair assembly is connected to the elastic pressure ring 33 of at least one other repair assembly or the support segment 312 of the elastic spacer arm via a traction body 36. Regarding the coupling members 35, all corresponding retaining rings 352 in the two coupling members 35 are positioned at different axial positions along the spacer 10. The coupling members 35 can deflect radially along the spacer 10 around their distal ends. Specifically, the coupling members 35 can deflect inwardly around their distal ends under the action of an external force, and deflect outwardly around their distal ends when the external force is removed. Therefore, the coupling members 35 are configured such that the push shaft 90 passes through the retaining rings 352 to constrain the bracket portion 351 from retracting radially along the spacer 10, and the push shaft 90 exits the retaining rings 352, allowing the bracket portion 351 to deflect radially outwardly along the spacer 10 around its distal ends.
[0071] See Figure 7 , and Figures 1-6 The two symmetrically arranged repair components are used as an example for explanation. Specifically, the proximal ends of the bracket parts 351 of the two repair components 30 are connected to the elastic pressure ring 33 of the other party through a traction body 36. That is, the elastic pressure ring 33 and the bracket part 351 belonging to the same repair component 30 are not connected, but the bracket part 351 in the repair component 30 is connected to the elastic pressure ring 33 in the other repair component 30 through the traction body 36. For example, see Figure 9 , the bracket part 351 on the left is connected to the elastic pressure ring 33 on the right through a traction body 36, while the bracket part 351 on the right is connected to the elastic pressure ring 33 on the left through another traction body 36. The proximal ends of the bracket parts 351 of the two repair components 30 are connected to the supporting segments 312 of each other through the traction body 36, in the same way as the above-mentioned connection of the elastic pressure ring 33, which will not be described in detail here. It should be noted that the components of the bracket parts 351 of the two repair components 30 that are connected to each other through the traction body 36 may not be the elastic pressure ring 33 or the supporting segments 312. For example, in conjunction with Figure 9For example, the bracket portion 351 on the left side may be connected to the elastic pressure ring on the right side through a traction body 36, and the bracket portion 351 on the right side may be connected to the supporting section 312 of the elastic spacer arm on the left side through another traction body 36.
[0072] For details, see Figure 8 During the implantation process of the valve clipping device and the conversion process between the three forms, the push shaft 90 always passes through each limiting ring 352 and is fixed to the connector assembly. At this time, as the push shaft 90 passes through each limiting ring 352, it will pull the coupling members 35 on both sides toward the center (close to the axis of the spacer 10), thereby limiting the radial position of the stent portion 351 along the spacer 10, ensuring that the stent portion 351 will not deflect outward due to the cooperative constraint of the push shaft 90 and the limiting ring 352. Figures 9 to 12 , and refer to Figure 4 After the valve clipping device has clamped the valve to achieve edge-to-edge repair through the third form mentioned above, the operator will separate the push shaft 91 from the connector assembly and gradually withdraw the push shaft 90 from the patient's body. The push shaft 10 will exit each limit ring 352 and the spacer 10 in turn, thereby releasing the constraint of the push shaft 90 on the bracket part 351 through the limit ring 352. The bracket part 351 will automatically deflect outward around its own distal end and along the radial direction of the spacer 10, and deflect towards the trend of restoring its original state, thereby stretching the traction body 36. The traction body 36 will apply a pulling force to the corresponding elastic pressure ring 33 or the support section 312 of the elastic spacer arm, thereby pulling the corresponding elastic pressure ring 33 or the support section 312 of the elastic spacer arm inward and further retracting toward the spacer 10.
[0073] The coupling member 35 and the traction body 36 are designed to cooperate with each other. After the valve is clamped to achieve edge-to-edge repair, the pushing shaft 90 is separated from the joint assembly and each limiting ring 352 is withdrawn. The coupling member 35 is offset outward along the radial direction of the spacer 10 through the bracket portion 351, thereby stretching the corresponding traction body 36. Then, under the action of the two coupling members 35, the elastic pressure ring 33 on both sides or the support section 312 of the elastic spacer arm are driven to move further closer to the spacer 10. On the one hand, under the action of the coupling member 35, the valve tissue in contact with the elastic pressure ring 353 can be further retracted toward the center. On the other hand, the clamp 32 on the capture section can be further moved closer to the spacer 10 to drive the valve tissue clamped by the clamp 32 on both sides to be further retracted toward the center. In this way, after the valve is clamped to achieve edge-to-edge repair by the valve clamping instrument of the present invention, the design of the coupling member 35 and the traction body 36 can increase the closing and retraction force, improve the valve closing effect, improve the postoperative valve edge regurgitation, and improve the success rate of the operation.
[0074] In addition, the coupling member 35 can be connected to the joint assembly by welding or mechanical structure, which has a simple structure and can be designed with a safety margin according to actual conditions to improve the safety performance of the overall structure. Figure 9 and Figure 11 The valve clamping device also includes a base 60, which can be ring-shaped, for example. The coupling member 35 is fixed on the base 60, and the bracket portion 351 of all the coupling members 35 is fixed on the base 60, that is, in the two symmetrical repair components, the two bracket portions 351 are located on both sides of the same diameter direction of the base 60, and the base 60 is sleeved on the joint component to realize the connection between the bracket portion 351 and the joint component.
[0075] Further, see Figure 8 When the push shaft 90 passes through the limiting ring 352, the proximal end of the bracket portion 351 does not extend radially outward from the distal end of the bracket portion 351 along the spacer 10. That is, when the push shaft 90 passes through the limiting ring 352, the perpendicular distance between the proximal end of the bracket portion 351 and the push shaft 90 is no greater than the perpendicular distance between the distal end of the bracket portion 351 and the push shaft 90. For example, the perpendicular distance between the proximal end of the bracket portion 351 and the push shaft 90 may be equal to the perpendicular distance between the distal end of the bracket portion 351 and the push shaft 90 (in this case, it can be understood that the extension direction of the bracket portion 351 is parallel to the axial direction of the spacer 10), or the perpendicular distance between the proximal end of the bracket portion 351 and the push shaft 90 may be less than the perpendicular distance between the distal end of the bracket portion 351 and the push shaft 90 (in this case, it can be understood that the extension direction of the bracket portion 351 is at an angle to the axial direction of the spacer 10, and the bracket portion 351 is tilted inward). In this way, when the push shaft 90 is removed, the bracket part 351 can have a larger outward offset angle, applying a larger pulling force to the corresponding elastic pressure ring 33 or support arm 312, so that the elastic pressure ring 33 or support arm 312 can be further retracted toward the center, and the closing effect of the valve clamping device can be further improved.
[0076] Further, see Figure 9 and Figure 11When the push shaft 90 exits each retaining ring 352, the bracket portion 351 deflects outwardly around its own distal end and radially along the spacer 10, with the proximal end of the bracket portion 351 extending radially outward beyond the distal end of the bracket portion 351 along the spacer 10. In other words, the perpendicular distance between the proximal end of the bracket portion 351 and the push shaft 90 is greater than the perpendicular distance between the distal end of the bracket portion 351 and the push shaft 90. Furthermore, the bracket portion 351 can be made of, for example, a shape-memory alloy (e.g., nickel-titanium alloy). The memory shape (original shape) of the bracket portion 351 is configured to deflect outwardly around its own distal end radially along the spacer 10, so that the proximal end of the bracket portion 351 extends radially outward beyond the distal end of the bracket portion 351 along the spacer 10. The memory shape of the bracket portion 351 can be formed using a shape-memory alloy using a heat setting process.
[0077] Preferably, when the push shaft 90 passes through all the limiting rings 352, all the limiting rings are coaxial. In this way, all the limiting rings 352 are arranged concentrically as much as possible, so that the angles formed by the bracket parts 351 on both sides and the push shaft 90 are basically consistent, thereby improving the overall stability of the structure.
[0078] Furthermore, the connection position of the traction body 36 on the corresponding elastic pressure ring 33 or the support section 312 of the elastic spacer arm is configured to not exceed the proximal end of the corresponding bracket portion 351 along the direction from distal to proximal. For example, refer to Figure 8 and Figure 9 Regardless of whether the push shaft 90 is inserted into the limiting ring 352 or withdrawn from the limiting ring 352, the connection position of the traction body 36 on the elastic pressure ring 33 will not exceed the proximal end of the bracket portion 351 along the axial direction of the spacer 10. Figure 8 and Figure 9 The connection position of the traction body 36 on the elastic pressure ring 33 does not extend upward beyond the top of the bracket portion 351. As for the connection position of the traction body 36 on the corresponding support segment 312, those skilled in the art can further understand it based on the position of the traction body 36 on the corresponding elastic pressure ring 33, and will not be further explained here.
[0079] Furthermore, the traction body 36 includes at least one traction wire 360, and the elastic pressure ring 33 or the support section 312 of the elastic spacer arm is connected to the proximal end of the bracket portion 351 through the traction wire 360. Figure 10 For example, the traction body 36 includes at least two traction wires 360, and both sides of the elastic pressure ring 33 are connected to the proximal end of the bracket portion 351 through at least one of the traction wires 360. Specifically, the elastic pressure ring 33 and the bracket portion 351 are provided with holes for connecting with the traction wires 360.
[0080] Preferably, the elastic pressure ring 33 or the support segment 312 of the elastic spacer arm is connected to the proximal end of the bracket portion 351 through at least two traction wires 360, and the traction wire 360 corresponding to any one of the repair components is centrally symmetrically distributed with the traction wire 360 corresponding to at least one other repair component (specifically, it can be centrally symmetrically distributed about the central axis of the spacer 10). Figure 10 For example, all the traction wires 360 in the traction body 36 are connected to the same position on the bracket portion 351 (i.e., they are all connected to the same point or the same hole), and the traction body 36 corresponding to one of the elastic pressure rings 33 and the traction body 36 corresponding to the other elastic pressure ring 33 are centrally symmetrically distributed. Figure 10 In the traction bodies 36 corresponding to the left and right elastic pressure rings 33, there are six connection positions on each bracket part 351 and the traction wire 360, and on each elastic pressure ring 33 and the traction wire 360. These six connection positions are symmetrically distributed with the push shaft 90 as the center, and the lengths of the traction wires 360 are the same. Such a configuration facilitates the bracket parts 351 on both sides to symmetrically apply closing forces (symmetrically apply the retraction force close to the spacer 10) to the elastic pressure rings 33 on both sides through their corresponding traction bodies 360, thereby improving the stability and clamping force of the valve clamping device and achieving a better closing effect of the device on the valve tissue. As a further explanation, Figure 10 The two traction wires 360 corresponding to the left bracket part 351 are connected at point A on the left bracket part 351 , and the connection positions of the two traction wires 360 on the right elastic pressure ring 33 are points B and C respectively. Figure 10 Among the two traction wires 360 corresponding to the middle right bracket part 351, the connection positions of the two traction wires 360 on the right bracket part 351 are both point D, and the connection positions of the two traction wires 30 on the left elastic pressure ring 33 are points E and F respectively; among them, point A, point B, point C, point D, point E and F are distributed symmetrically around the center; among them, EDC and BAC are two traction wires respectively.
[0081] Based on the above-mentioned valve clipping device, this embodiment further provides a valve repair system, which includes a delivery device and the above-mentioned valve clipping device. Figure 23 The valve clipping device of this embodiment will be further described below in conjunction with the delivery device in the valve repair system.
[0082] Typically, the doctor uses the delivery device to control the working state of the valve clipping device, including but not limited to driving the valve clipping device to be implanted into the patient's body and enter the patient's ventricle, controlling the elastic spacer arm 31 to switch between three forms, controlling the working state of the clip 32, and controlling the delivery device to separate from the valve clipping device and withdraw it from the patient's body after the valve clipping device completes the repair of the mitral valve or tricuspid valve. Specifically, the delivery device includes a push shaft 90, a control wire 100, and a connector 110. The push shaft 90 is used to control the movement of the connector assembly, pass through or withdraw the limit ring 352, and deliver the valve clipping device into the human body. The control wire 100 is used to control the clamping state or working state of the clip 32. The connector 110 realizes the connection between the delivery device and the valve clipping device.
[0083] For further information, see Figure 1 、 Figure 4 and Figure 6 , the valve clamping device includes a proximal connector 40, which is connected to the proximal end of the spacer 10, and the valve clamping device is used to connect to the delivery device through the proximal connector 40. Specifically, the delivery device and the proximal connector 40 are detachably connected, which facilitates the separation of the delivery device from the proximal connector 40, thereby achieving separation from the valve clamping device. Usually, the delivery device connector 110 is detachably connected to the proximal connector 40. The connector 110 fixes the proximal connector 40 of the valve clamping device to the delivery device, and the push shaft 90 is passed through the connector 110. The distal end of the push shaft 90 is fixed to the distal end of the valve clamping device. Then, when the proximal connector 40 is fixed to the distal end of the delivery device, the delivery device pushes the push shaft 90 to move forward and backward along the axial direction of the spacer 10, thereby achieving the conversion of the valve clamping device among the first form, the second form and the third form. Moreover, during the delivery process, the delivery device moves the valve clamping device ( Figure 1 ) is implanted into the patient's body.
[0084] For further information, see Figure 17 The proximal joint 40 has at least two first extensions 41 ( Figure 15 Two symmetrically arranged first extensions 41 are shown, and the first extensions 41 are used to engage with the delivery device. Figure 22The connector 110 has first connecting pieces 111 corresponding in number and position to the first extensions 41. The connecting pieces have through-holes 1110. During assembly, the first connecting pieces 111 expand radially outward along the spacer 10. The expansion process of the multiple first connecting pieces 111 is similar to the blooming of petals. The holes 1110 are then inserted into the corresponding first extensions 41. The first connecting pieces 111 then retract inward to achieve a snap-fit connection between the first extensions 41 and the holes 1110. Furthermore, the proximal connector 40 has at least two second extensions 42 protruding radially outward from the spacer 10. The second extensions 42 have through-holes 420. The holes 420 are used for plugging and connecting with the delivery device. The connector 110 has second connecting pieces 112 corresponding in number and position to the first extensions 41. The second connecting pieces 112 are plugged and connected with the holes 420.
[0085] See also Figure 18 and Figure 22 The valve clamping device also includes a sealing gasket 50 connected to the proximal connector 40. The sealing gasket 50 has at least two third extensions 51 extending radially outward from the spacer 10. The third extensions 51 have a through-hole 510 for interfacing with the delivery device. The sealing gasket 50 prevents blood from entering the valve clamping device and the delivery device, reducing surgical risks. The sealing gasket 50 can be made of silicone. In addition, compared to the prior art, the first slot hole 510 on the sealing gasket 50 facilitates separation of the delivery device from the valve clamping device. Specifically, the second connecting piece 112 of the connector 110 is connected to the proximal connector 40 by sequentially inserting the first slot hole 510 and the insertion hole 420. When the second connecting piece 112 is withdrawn from the proximal connector 40 and detached from the sealing gasket 50, the provision of the first slot hole 510 can reduce friction between the second connecting piece 112 and the sealing gasket 50, facilitating the withdrawal of the second connecting piece 112. Furthermore, the center of the sealing gasket 50 has a through second slot hole 52 for the delivery device's push shaft 90 to pass through. The provision of the second slot hole 52 not only facilitates the pushing or retracting of the push shaft 90, but also facilitates the sealing effect between the sealing gasket 50 and the push shaft 90, preventing the push shaft 90 from introducing blood into the valve clamping device during operation. Preferably, the first slot hole 510 and the second slot hole 52 are slit-shaped, which allows the sealing gasket 50 at the first slot hole 510 and the second slot hole 52 to completely fit the outer surface of the insert, further improving the sealing performance of the sealing gasket 50 compared to a hole-shaped structure.
[0086] See also Figure 2 and Figure 4The connector assembly of this embodiment includes a guidewire connector 70, a distal connector 20, and a cover connector 80 arranged from proximal to distal. The guidewire connector 70 is fixedly engaged with the distal connector 20, and the cover connector 80 is threadedly fixed to the guidewire connector 70. The coupling member 35 of this embodiment can be connected to the distal connector 20. For example, the annular base 60 is sleeved on the distal connector 20, and the bracket portion 351 of the coupling member 35 is connected to the annular base.
[0087] For further information, see Figure 20 and Figure 21 The guidewire connector 70 has a second guide hole 710, the axial direction of which is parallel to the axial direction of the spacer 10. The cover connector 80 has a fifth extension 81 protruding toward the support body 10. The fifth extension 81 is configured to threadably engage with the second guide hole 710, thereby threadably securing the guidewire connector 70 to the cover connector 80. The second guide hole 710 can be a through hole or a blind hole. If it is a blind hole, the proximal end of the second guide hole 710 is closed. In addition, the delivery device's push shaft 90 is fixed to the guidewire connector 70, for example, at the proximal end of the second guide hole 710.
[0088] For further information, see Figure 19 and Figure 20 The guidewire connector 70 has a sixth extension 72 that protrudes away from the spacer 10, and the distal connector 20 has a connector groove 21 that is recessed from the proximal end to the distal end, and the connector groove 21 is adapted to the sixth extension 72. The sixth extension 72 is engaged with the connector groove 21, thereby achieving the engagement and fixation of the distal connector 20 and the guidewire connector 70. Regarding the arrangement of the second guide hole 710, the guidewire connector 70 may have a fourth extension 71 that protrudes toward the spacer 10, with a portion of the second guide hole 710 in the fourth extension 71 and another portion in the sixth extension 72. In addition, the fourth extension 71 is also used to follow the movement of the connector assembly and enter or exit the first guide hole 61 of the support body 60.
[0089] The present embodiment does not impose any specific restrictions on the connection method between the elastic pressure ring 33, the elastic spacer arm 31 and the joint assembly. In an exemplary embodiment, please refer to Figure 13 The proximal end of the elastic pressure ring 33 is provided with at least two through-holes 331, and the pressure holes 331 are used to cooperate with a suture thread to suture the elastic pressure ring 33 and the spacer 310. In another exemplary embodiment, please refer to Figure 9 and Figure 19In this embodiment, an elastic pressure ring 33 is configured to be connected to the distal connector 20 in the connector assembly. The distal connector 20 has a first connecting groove 22, which is recessed radially outward along the spacer 10. The distal end of the elastic pressure ring 33 is connected to a fixing member 34, which has a second connecting groove 340 recessed radially inward along the spacer 10. The first connecting groove 22 is adapted to the second connecting groove 340. The connection between the elastic pressure ring 33 and the distal connector 20 is achieved through the cooperation of the first connecting groove 22 and the second connecting groove 340. For further information, please refer to Figure 19 and Figure 20 During the assembly process of the elastic pressure ring 33 and the distal connector 20, the fixing member 34 at the distal end of the elastic pressure ring 33 passes through the groove 73 of the guide wire connector 70 and is finally fixed in the first connecting groove 22. The fixing member 34 can be integrally formed with the elastic pressure ring 33, or can be separately formed and then assembled together.
[0090] See also Figure 15 and Figure 16 The clamp 32 includes a clamping plate 321 and a support plate 322. The support plate 322 is fixed to the capture segment 311, adjacent to the capture segment 311, and preferably parallel to the capture segment 311. One end of the clamping plate 321 is elastically connected to the support plate 322, so that the clamping plate 321 is subjected to an elastic force toward the support plate 322. It should be noted that the clamp 32 passes through the hollow area in the middle of the elastic pressure ring 33. Specifically, the clamping plate 321 is designed to pass through the hollow area in the middle of the elastic pressure ring 33 under a force acting away from the support plate 322 (understandably, the force here is applied by the control wire 100). The position of the clamp 32 changes accordingly with the change in the shape of the elastic spacer arm 31. When the elastic spacer arm 31 is in the second shape, preferably the second vertical shape, or when the elastic spacer arm 31 begins to enter the third shape, the clamp 32 is operated to capture and clamp the leaflet. Specifically, the support plate 322 and the clamping plate 321 are elastically connected so that the clamping plate 321 is subjected to an elastic force toward the support plate 322. The support plate 322 is fixed to the capture section 311. In this way, an external force substantially away from the support plate 322 can be applied to the clamping plate 321, causing the clamping plate 321 and the support plate 322 to open, substantially forming a “>” shape, thereby capturing the leaflets. After the external force is removed, the clamping plate 321 recovers under the action of the elastic force and clamps the leaflets between the clamping plate 321 and the support plate 322. It is understandable that the degree of opening and closing of the clamping plate 321 and the support plate 322 can be controlled by controlling the magnitude of the external force, that is, the degree of opening of the “>” can be controlled by the magnitude of the external force.
[0091] As further implementation details of the clamp 32 structure, the clamping plate 321 has a through elongated hole 3211 (for example, a rectangular hole), and the long axis direction of the elongated hole 3211 is parallel to the capturing section 311; the supporting plate 322 includes a horizontal portion 3221 and a vertical portion 3222 connected in a T-shape, and the vertical portion 3222 extends within the range of the elongated hole 3211 along the long axis direction of the elongated hole 3211, and the horizontal portion 3221 extends outside the range of the elongated hole 3211 along the short axis direction of the elongated hole 3211, and the horizontal portion 3221 is used to abut against the clamping plate 321, so as to prevent the vertical portion 3222 from penetrating into the elongated hole 3211 under the action of elastic force, and the end of the vertical portion 3222 away from the horizontal portion 3221 is elastically connected to the clamping plate 321.
[0092] Preferably, see Figure 15 and Figure 16 The clamping plate 321 is provided with a barb structure 323. The barb structure 323 punctures the leaflet, which can improve the capture of the leaflet by the clamp 32 and the stability and reliability of the clamping.
[0093] As can be seen from the above description, the control wire 100 is connected to the clipper 32 and is used to control the clamping state of the clipper 32, namely, to manipulate the clipper 32 to capture and clamp the valve leaflets, and to manipulate the clipper 32 to recapture and clamp the valve leaflets when the clipper 32 clamping effect on the valve leaflets is unsatisfactory. The connector 110 is detachably connected to the valve clipping device via the proximal connector 40. The push shaft 90 sequentially passes through the connector 110 of the delivery device, the sealing gasket 50, the proximal connector 40, the spacer 10, and each of the retaining rings 352 of the valve clipping device, and is ultimately connected to the guidewire connector 70.
[0094] In one embodiment, see Figure 1 、 Figure 3 as well as Figure 15The clamping plate 321 has a control hole 3212, through which the clamping plate 321 is connected to the control wire 100. Two control wires 100 are connected to the clamping plates 321 on either side. During the operation, the elastic spacer arm 31 is in the second position, preferably the second vertical position, under the combined action of the push shaft 90, the connector assembly, and the elastic pressure ring 33. Or when the elastic spacer arm 31 begins to enter the third position, the control wire 100 is manipulated to control the clamping plate 321 and the support plate 322 to open, thereby capturing and clamping the leaflets. Specifically, the clamping state of the leaflets by the clamp 32 is observed using external ultrasound imaging equipment. If the clamping state does not achieve the desired effect, the control wire 100 can be used to recapture and clamp the leaflets. It should be noted that the two control wires 100 do not interfere with each other, and their corresponding clamps 32 can be manipulated simultaneously, or their corresponding clamps 32 can be manipulated individually to achieve the function of opening and capturing the two clamping plates 321 separately, thereby meeting the surgical requirements of operating a single clamp 32 that may arise during the operation.
[0095] The above description is only a description of the preferred embodiment of the present invention and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the scope of protection of the technical solution of the present invention.
Claims
1. A valve clipping device for implanting into a predetermined area under the drive of a delivery device, wherein the delivery device comprises a push shaft, characterized in that: The valve clipping device comprises: spacer; a joint assembly, configured to move along the axial direction of the spacer under the drive of the pushing shaft; At least two repair components are symmetrically arranged along the radial direction of the spacer, and the repair components include: an elastic spacer arm, comprising a capture segment and a support segment extending axially along the spacer body, wherein the spacer body, the capture segment, and the support segment are sequentially connected from the proximal end to the distal end; the distal end of the capture segment and the proximal end of the support segment are connected to form a spacer portion, and the distal end of the support segment is connected to the connector assembly; a clamper, which is provided on the capturing section and is used to clamp a predetermined portion; an elastic pressure ring, a proximal end of which is connected to the spacer, and a distal end of which is connected to the joint assembly; A coupling member comprising a bracket portion and a limiting ring provided on the bracket portion, wherein the distal end of the bracket portion is connected to the joint assembly; the coupling member is configured such that the push shaft passes through the limiting ring to constrain the radial position of the bracket portion along the spacer, and the push shaft exits the limiting ring to allow the bracket portion to deflect radially outward about its distal end along the spacer; Wherein, the proximal end of the stent portion of any of the repair components is connected to the supporting section of the elastic pressure ring or elastic spacer arm of at least one other repair component through a traction body; The limiting ring is provided on a radially inward side of the bracket portion along the spacer, and all the limiting rings are at different axial positions along the spacer; When the pushing shaft passes through all the limiting rings, all the limiting rings are coaxial.
2. The valve clipping device according to claim 1, characterized in that: When the pushing shaft passes through the limiting ring, the proximal end of the bracket portion does not extend beyond the distal end of the bracket portion in the radial direction of the spacer.
3. The valve clipping device according to claim 2, characterized in that: The material of the stent portion is a memory shape alloy, and the memory shape of the stent portion is configured such that the proximal end of the stent portion extends outwardly beyond the distal end of the stent portion along the radial direction of the spacer.
4. The valve clipping device according to claim 1, characterized in that: The connection position of the traction body on the corresponding supporting section of the elastic pressure ring or the elastic spacer arm is configured not to exceed the proximal end of the bracket part along the direction from the distal end to the proximal end.
5. The valve clipping device according to claim 1 or 4, characterized in that: The traction body includes at least one traction wire, and the supporting section of the elastic pressure ring or the elastic spacer arm is connected to the proximal end of the bracket part through the traction wire.
6. The valve clipping device according to claim 5, characterized in that: The supporting section of the elastic pressure ring or the elastic spacer arm is connected to the proximal end of the bracket part through at least two of the traction wires, and the traction wire corresponding to any of the repair components and the traction wire corresponding to at least one other repair component are distributed in a centrally symmetrical manner.
7. The valve clipping device according to claim 1, characterized in that: The valve clamping instrument further includes a base, the coupling member is fixed on the base, and the base is sleeved on the connector assembly.
8. A valve repair system, characterized in that: It comprises a delivery device and a valve clamping device as described in any one of claims 1 to 7, wherein the pushing shaft of the delivery device is used to sequentially pass through the spacer and each of the limiting rings and then be detachably connected to the connector assembly.
Citation Information
Patent Citations
Valve clamping instrument and valve repair system
CN219021751U