CN219021751U - Valve clamping instrument and valve repair system - Google Patents

Valve clamping instrument and valve repair system Download PDF

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Publication number
CN219021751U
CN219021751U CN202222756949.7U CN202222756949U CN219021751U CN 219021751 U CN219021751 U CN 219021751U CN 202222756949 U CN202222756949 U CN 202222756949U CN 219021751 U CN219021751 U CN 219021751U
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China
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valve
spacer
elastic
proximal end
distal end
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CN202222756949.7U
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Chinese (zh)
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刘建明
刘祥
魏勇强
王思琪
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Jiangsu Zhenyi Medical Technology Co ltd
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Jiangsu Zhenyi Medical Technology Co ltd
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Abstract

The utility model provides a valve clamping apparatus and a valve repair system. After the edge-to-edge repair of the clamped valve is realized, the pushing shaft is separated from the joint assembly and exits from each limiting ring, the coupling piece moves outwards in the radial direction of the spacer body through the support part, so that the corresponding traction body is stretched, and then the elastic compression rings on two sides are driven to be further close to the spacer body under the action of the two coupling pieces, firstly, valve tissues in contact with the elastic compression rings can be further folded towards the center, secondly, the clamping device can be further folded towards the spacer body to drive the valve tissues clamped by the clamping device on two sides to be further folded towards the center, and therefore, after the edge-to-edge repair of the valve is realized through the valve clamping device, the closing folding force can be increased and the valve closing effect is improved through the design of the coupling piece.

Description

Valve clamping instrument and valve repair system
Technical Field
The utility model relates to the technical field of medical appliances, in particular to a valve clamping appliance and a valve repair system.
Background
The existing heart valve diseases are more and more aged, and domestic heart valve diseases are different from foreign complications and causes, and the conditions of patients suffering from heart valve diseases in different domestic areas are different, so that the complicated disease complications are faced, and the requirements on the instruments are also different. Currently, there are many patients with mitral valve disease among heart valve patients, the main condition is mitral regurgitation, followed by aortic stenosis and combined valve disease, and the patients with tricuspid regurgitation are also increasing. The heart valve plays a role in isolating an atrium from a ventricle, prevents blood in the ventricle from flowing back into the atrium, and can ensure that blood in all ventricles can enter an aorta or a pulmonary artery through an aortic valve or a pulmonary valve, so that the blood rich in oxygen and nutrient substances flows into the whole body through the aorta, and the blood collected by the upper and lower vena cava flows into the lung for oxygen exchange, so that the blood becomes arterial blood rich in oxygen. The heart valve is equivalent to a check valve, and if the valve is not tightly closed, serious reflux phenomenon can be caused, so that blood cannot completely enter the aorta or the pulmonary artery, heart failure of a patient is caused, normal life quality of the patient is affected, and serious patients are even life-threatening.
Mitral regurgitation can be performed by surgical procedures for the shaping of the leaflets or annuloplasty, but surgical procedures require chest opening, are quite risky, and are often not well suited for older individuals. Mitral regurgitation can also be inhibited by interventional procedures, which currently mainly involve both transcatheter edge-to-edge repair and transcatheter replacement, but transcatheter replacement procedures are less safe and less mature. The current transcatheter interventional operation mode adopting the edge-to-edge repair mode is mature, reliable and safe. However, the existing devices for the transcatheter edge-to-edge repair surgery are complex to operate, the connection between the device delivery system and the clamps is complex, the reliability is not very high, and most devices require 1.5 clamps to be implanted on average in one surgery due to the limitation of the capture range.
Current devices for treating mitral regurgitation or tricuspid regurgitation mainly include two types, a mechanical clamp and an elastic clamp. An elastic spacer is arranged in the middle of the elastic clamp, so that good elastic buffering can be realized, the stress on the valve leaflet during clamp capture is reduced, and the risk of tearing after the valve She Buzhuo is reduced. But the locking of the elastic clamp is performed by adopting the elastic restoring force of the elastic part, and the locking force is not reliable by adopting a mechanical structure to lock the mechanical clamp. The elastic clamp adopts the shape memory function of nickel-titanium alloy, and repairs the single orifice of the mitral valve into double orifices after capturing the valve, but due to the elastic structure, the valve is stretched outwards to a certain extent, so that edge regurgitation is increased, and the elastic clamp has a certain negative effect on treating mitral regurgitation.
Disclosure of Invention
The utility model aims to provide a valve clamping device and a valve repair system, which are used for solving the problem that after the clamping device clamps a valve to realize edge-to-edge repair, the valve edge is likely to flow back seriously due to insufficient closing and gathering force.
To solve the above technical problem, according to one aspect of the present utility model, there is provided a valve clamping apparatus for implanting in a predetermined area under the drive of a delivery apparatus, the delivery apparatus including a pushing shaft, the valve clamping apparatus comprising:
a spacer;
a joint assembly for axial movement of the spacer body under the drive of the push shaft;
at least two repair assemblies symmetrically disposed along a radial direction of the spacer, the repair assemblies comprising;
an elastic spacer arm comprising a capturing section and a supporting section extending along the axial direction of the spacer body, wherein the spacer body, the capturing section and the supporting section are sequentially connected from the proximal end to the distal end; the distal end of the capturing section is connected with the proximal end of the supporting section to form a spacing part, and the distal end of the supporting section is connected with the joint assembly;
the clamping device is arranged on the capturing section and is used for clamping a preset position;
The proximal end of the elastic compression ring is connected with the spacing part, and the distal end of the elastic compression ring is connected with the joint assembly;
the coupling piece comprises a bracket part and a limiting ring arranged on the bracket part, and the distal end of the bracket part is connected with the joint assembly; the coupling piece is configured such that the pushing shaft penetrates the limiting ring to restrict the radial position of the bracket part along the spacer, and the pushing shaft exits the limiting ring so that the bracket part deflects outwards around the distal end of the pushing shaft along the radial direction of the spacer;
the proximal end of the bracket part of any repairing component is connected with the supporting section of the elastic compression ring or the elastic spacing arm of at least one other repairing component through a traction body.
Optionally, the limiting rings are disposed on one side of the bracket portion along a radial inward direction of the spacer, and all the limiting rings are different in axial positions along the spacer.
Optionally, when the pushing shaft penetrates through the limiting ring, the proximal end of the bracket portion does not extend beyond the distal end of the bracket portion along the radial direction of the spacer.
Optionally, the material of the bracket part is memory shape alloy, and the memory shape of the bracket part is configured that the proximal end of the bracket part extends outwards beyond the distal end of the bracket part along the radial direction of the spacer.
Optionally, when the pushing shaft penetrates through all the limiting rings, all the limiting rings are coaxial.
Optionally, the connection location of the traction body on the support section of the corresponding elastic compression ring or elastic spacer arm is configured not to exceed the proximal end of the bracket portion in a distal-to-proximal direction.
Optionally, the traction body includes at least one traction wire, and the elastic compression ring or the support section of the elastic spacer arm is connected with the proximal end of the bracket portion through the traction wire.
Optionally, the elastic compression ring or the supporting section of the elastic spacer arm is connected with the proximal end of the bracket portion through at least two traction wires, and any traction wire corresponding to the repairing assembly and at least one traction wire corresponding to another repairing assembly are distributed in a central symmetry manner.
Optionally, the valve clamping apparatus further comprises a base, the coupling piece is fixed on the base, and the base is sleeved on the joint assembly.
Based on a second aspect of the present utility model, the present utility model further provides a valve repair system, which comprises a delivery device and a valve clamping device as described above, wherein the delivery device comprises a pushing shaft, and the pushing shaft is used for detachably connecting with the joint assembly after sequentially penetrating through the spacer body and each limiting ring.
The valve clamping apparatus has at least the following technical effects:
in the first aspect, different forms can be changed under the combined action of the elastic compression ring and the joint component by configuring the elastic spacing arm, and the position of the clamp is changed along with the change of the form of the elastic spacing arm when the clamp is arranged on the capturing section, so that implantation of the clamp, capturing and clamping of the valve and edge-to-edge repair of the valve are completed;
in the second aspect, after edge-to-edge repair of the clamped valve is achieved, the pushing shaft is separated from the joint assembly and exits from each limiting ring, the coupling piece moves outwards in the radial direction of the spacer body through the support portion to stretch the corresponding traction body, and then the supporting sections of the elastic pressing rings or the elastic spacer arms on two sides are driven to further approach the spacer body to be folded under the action of the two symmetrical coupling pieces, firstly, valve tissues contacted with the elastic pressing rings can be further folded towards the center under the action of the coupling piece, secondly, the clamping devices on the capturing section can be further folded towards the spacer body to drive the valve tissues clamped by the clamping devices on two sides to further be folded towards the center, and therefore, after the valve is clamped by the valve clamping device, the closing folding force of the valve can be increased, the closing effect of the valve is improved, the edge backflow of the operated valve is improved, and the success rate of the operation is improved.
It should be noted that, since the valve repair system includes the valve clamping apparatus, the valve repair system also has the technical effects brought by the valve clamping apparatus, and the description thereof will not be repeated.
Drawings
It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the utility model and do not constitute any limitation on the scope of the utility model. Wherein:
FIG. 1 is a schematic view of a valve clasping apparatus in accordance with an embodiment of the present utility model in a first configuration;
FIG. 2 is a schematic view of a valve clasping apparatus in accordance with an embodiment of the present utility model in a second configuration;
FIG. 3 is a schematic view of the attachment of a valve clasping instrument to a delivery instrument with the resilient spacer arms of an embodiment of the present utility model in a second configuration;
FIG. 4 is a schematic view of a valve clasping apparatus in accordance with an embodiment of the present utility model in a third configuration;
FIG. 5 is an elevation view of a valve clamping apparatus with the resilient spacer arms of an embodiment of the utility model in a third configuration;
FIG. 6 is a schematic view of a resilient spacer arm and spacer body in a third configuration of a resilient spacer arm according to an embodiment of the present utility model;
FIG. 7 is a schematic view of a coupling and resilient compression ring and joint assembly of an embodiment of the present utility model;
FIG. 8 is a schematic view of a coupling, an elastic compression ring and a joint assembly of the pushing shaft of the embodiment of the present utility model when the pushing shaft is threaded through the limit ring;
FIG. 9 is a schematic view of the coupling and resilient compression ring and joint assembly after the push shaft exits the stop collar in accordance with an embodiment of the present utility model;
FIG. 10 is a top view of the coupling and stop collar after the push shaft exits the stop collar in accordance with an embodiment of the present utility model;
FIG. 11 is a front view of the coupling after the push shaft exits the stop collar in accordance with an embodiment of the present utility model;
FIG. 12 is a top view of the coupling after the push shaft exits the stop collar in accordance with an embodiment of the present utility model;
FIG. 13 is a schematic view of an elastic compression ring according to an embodiment of the present utility model;
FIG. 14 is a side view of an elastomeric compression ring in accordance with an embodiment of the utility model;
FIG. 15 is a schematic view of a clutch according to an embodiment of the utility model;
FIG. 16 is another schematic view of a clutch according to an embodiment of the utility model;
FIG. 17 is a schematic view of a proximal joint according to an embodiment of the present utility model;
FIG. 18 is a schematic view of a gasket seal of an embodiment of the present utility model;
FIG. 19 is a schematic view of a distal joint according to an embodiment of the present utility model;
FIG. 20 is a schematic view of a guidewire adapter according to an embodiment of the utility model;
FIG. 21 is a schematic view of a cover joint according to an embodiment of the utility model;
FIG. 22 is an exploded view of a delivery instrument and gasket seal and proximal connector according to an embodiment of the present utility model;
fig. 23 is a schematic view of a delivery device according to an embodiment of the present utility model in connection with a valve clasping device.
In the accompanying drawings:
10-spacers;
20-distal joint; 21-a joint groove; 22-a first connecting groove;
30-repairing the component; 31-elastic spacer arms; 311-capturing section; 312-supporting segments; 310-spacers; 32-a clamp; 321-a sandwich panel; 3211-elongated holes; 3212-control aperture; 322-supporting plates; 3221-a transverse portion; 3222-a vertical section; 323-barb structure; 33-an elastic compression ring; 331-pressing holes; 34-a fixing piece; 340-a second connecting groove; 35-a coupling; 351-a bracket portion; 352-stop collar; 36-traction body; 360-pulling the wire;
40-proximal end fitting; 41-a first extension; 42-a second extension; 420-jack;
50-sealing gaskets; 51-a third extension; 510-a first card slot; 52-a second slot;
60-an annular base;
70-a guidewire connector; 71-fourth extension; 710-a second guide hole; 72-sixth extension; 73-grooves;
80-covering the joint; 81-fifth extension;
90-pushing shaft;
100-control wire;
110-a connector; 111-a first connection piece; 1110-plate holes; 112-second connecting piece.
Detailed Description
The utility model will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the utility model more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the utility model. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.
As used in this disclosure, the singular forms "a," "an," and "the" include plural referents, the term "or" are generally used in the sense of comprising "and/or" and the term "several" are generally used in the sense of comprising "at least one," the term "at least two" are generally used in the sense of comprising "two or more," and the term "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying any relative importance or number of features indicated. Thus, a feature defining "first," "second," "third," or "third" may explicitly or implicitly include one or at least two such features, with "one end" and "another end" and "proximal end" and "distal end" generally referring to the respective two portions, including not only the endpoints, but also the terms "mounted," "connected," "coupled," and "connected" are to be construed broadly, e.g., as being either a fixed connection, a removable connection, or as being integral therewith; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. Furthermore, as used in this disclosure, an element disposed on another element generally only refers to a connection, coupling, cooperation or transmission between two elements, and the connection, coupling, cooperation or transmission between two elements may be direct or indirect through intermediate elements, and should not be construed as indicating or implying any spatial positional relationship between the two elements, i.e., an element may be in any orientation, such as inside, outside, above, below, or on one side, of the other element unless the context clearly indicates otherwise. The specific meaning of the above terms in the present utility model can be understood by those of ordinary skill in the art according to the specific circumstances.
It should be noted that, the definition of "proximal" and "distal" in this document is: "proximal" generally refers to the end of the medical device that is closest to the operator during normal operation, and "distal" generally refers to the end of the medical device that first enters the patient during normal operation.
As shown in fig. 1 to 6, the present embodiment provides a valve clamping apparatus which is detachably connected to a delivery apparatus and is implantable in a predetermined area under the drive of the delivery apparatus, the delivery apparatus including a pushing shaft 90, and the implantation of the valve clamping apparatus being typically performed by the pushing shaft 90, wherein the predetermined area may be a ventricle of a patient. The valve clamping apparatus comprises a spacer body 10, a connector assembly, at least two prosthetic assemblies 30. The spacer 10 has a space shape, the spacer 10 is generally woven into an ellipsoidal shape by using a metal wire, for example, nickel-titanium alloy wires are woven in advance, and then the shape of the spacer 10 is fixed by a heat setting process, and the preparation method is not limited to the above method, but also can be: such as laser cutting, etc. The axial direction of the spacer 10 in this embodiment refers to the direction of the long axis of the spheroid-like shape, the push shaft 90 is generally connected to the joint assembly after passing through the spacer 10 in the axial direction of the spacer 10, and the push shaft 90 is generally collinear with the central axis of the spacer 10. The joint assembly is located at a distal position of the spacer 10 and is movably arranged with respect to the spacer 10 in an axial direction of the spacer 10, in particular, a push shaft 90 is connected to the joint assembly through the spacer 10, and the joint assembly is driven to move with respect to the spacer 10 by the advance or the withdrawal of the push shaft 90. At least two repair assemblies 30 are symmetrically arranged along the radial direction of the spacer 10, i.e. at least two repair assemblies 30 are arranged symmetrically with respect to the radial direction of the spacer 10, and it is also understood that two repair assemblies 30 are arranged on both sides of the same radial direction of the spacer 10. For example, only two repair assemblies are illustrated in the present embodiment as being symmetrically arranged about the radial direction of the spacer 10, but it is understood that the two repair assemblies in the illustration are for illustration only and not limiting the number of repair assemblies. Further, the repair assembly 30 includes an elastic spacer arm 31, a clamp 32, and an elastic compression ring 33. The elastic spacer arm 31 includes a catching section 311 and a supporting section 312 extending along the axial direction of the spacer body 10, and the spacer body 10, the catching section 311 and the supporting section 312 are sequentially connected from the proximal end to the distal end, it being understood that the catching section 311 and the supporting section 312 extend along the axial direction of the spacer body 10 and are sequentially connected as illustrated in fig. 1; the distal end of the capturing section 311 and the proximal end of the supporting section 312 are connected to form a spacer 310, that is, the connection between the capturing section 311 and the supporting section 312 is defined as the spacer 310, in addition, the elastic spacer arm 31 is generally in a belt shape or a plate shape, the elastic spacer arm 31 has elastic force, that is, is made of an elastic material, and can change its shape under the action of external force, that is, change the presenting states of the capturing section 311 and the supporting section 322, for example, the capturing section 311 and the supporting section 322 can relatively present a folded state; the distal end of the support section 312 may be connected to the connector assembly, and it should be noted that the elastic spacer arm 31 may be formed by braiding a metal wire (such as a nickel-titanium alloy wire), the elastic spacer arm 31 may be connected to the connector assembly by laser welding, and the elastic spacer arm 31 may be integrally formed with the spacer body 10 or may be formed separately and then connected thereto, including but not limited to the above-mentioned manufacturing method. The clip 32 is disposed on the capturing section 311 (as illustrated in fig. 1, the clip 32 may be disposed on a side of the capturing section 311 that is radially outward of the spacer), and the clip 32 is used to clip a predetermined portion, where the predetermined portion is generally referred to as a mitral valve or a tricuspid valve, but may be any other natural valve, such as an aortic valve or a pulmonary valve, as determined according to the actual application scenario. The proximal end of the elastic pressing ring 33 is connected to the spacer 310, the distal end of the elastic pressing ring 33 is connected to the joint assembly, and the elastic pressing ring 33 is used for applying a force to the elastic spacer arm 31 and changing the direction of the force along with the movement of the joint assembly, so as to correspondingly change the shape of the elastic spacer arm 31. The hollow area (see fig. 13) in the middle of the elastic pressing ring 33 can be penetrated by the clip 32, specifically, when the form of the elastic spacer 31 is changed, the clip 32 disposed on the elastic spacer can be penetrated in and out of the hollow area in the middle of the elastic pressing ring 33. It should be noted that, the elastic pressing ring 33 and the clamping device 32 may be formed by a nickel-titanium alloy laser cutting process and then a heat setting process.
The construction of the valve clasping apparatus as configured above allows the resilient spacer arms 31 to transition between different configurations following movement of the connector assembly (either in a proximal-to-distal direction or in a distal-to-proximal direction driven by the push shaft 90) under the force exerted by the resilient compression ring 33, typically between a first configuration and a second configuration, and between the second configuration and a third configuration, where the second configuration is understood to be the second configuration for both the first configuration and the third configuration, and one of the second configurations is the second vertical configuration. Referring to fig. 1, when the elastic spacer arm 31 is in the first configuration, the capturing section 311 and the supporting section 312 are arranged substantially co-linearly and are substantially close to the central axis of the spacer body 10, and it should be understood that the co-linear arrangement is understood to be a co-linear arrangement in a broad sense, that is, substantially co-linear, and further that the spacer portion 310 is not bent, and that, when the elastic spacer arm 31 is in the first configuration, a projection of the spacer portion 310 along a radial inward direction of the spacer body 10 is out of the range of the spacer body 10, precisely, a projection is located on the central axis outside the spacer body 10, specifically, an axial position of the spacer portion 310 along the spacer body 10 is far away from the distal end of the spacer body 10. The resilient spacer arms 31 on both sides are shaped in front view (shown in fig. 1). Referring to fig. 2 and 3, when the elastic spacer arm 31 is in the second configuration, the elastic spacer arm 31 expands radially outwardly of the spacer body 10, and the spacer portion 310 is located away from the distal end of the spacer body 10 along the axial direction of the spacer body 10, i.e., the projection of the spacer portion 310 on the central axis of the spacer body 10 along the radial direction of the spacer body 10 is out of the range of the spacer body 10. The resilient spacer arms 31 switch from the first configuration to the second configuration and the spacer portions 310 gradually expand outwardly. In particular, referring to fig. 2 and 3, when the elastic spacer arms 31 are in the second vertical configuration as the joint assembly moves along the distal end toward the proximal end, the capturing section 311 is perpendicular to the central axis of the spacer body 10, and the elastic spacer arms 31 of the two repairing assemblies 30 are shaped like isosceles triangles, that is, the two elastic spacer arms 31 are stably triangular under the supporting action of the corresponding two elastic pressing rings 32, it should be understood that the capturing section 311 and the central axis of the spacer body 10 are generally understood to be vertical, such as the capturing section 311 forms an angle with the central axis of the spacer body 10 in the range of [90 ° -5 °,90 ° +5 ° ], and the capturing section 311 is considered to be perpendicular to the central axis of the spacer body 10. As shown in fig. 4 and 5, when the elastic spacer arm 31 is in the third configuration, the elastic spacer arm 31 expands outwards along the radial direction of the spacer body 10, the projection of the spacer portion 310 inwards along the radial direction of 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 section 311 and the supporting section 312 are folded and close to each other and are folded to the spacer body 10, that is, the capturing section 311 and the supporting section 312 are driven by the elastic compression ring 33 to be folded towards the spacer body 10. It should be noted that, in order to reduce the trauma of the valve clamping device to the human tissue, at least one covering film is generally coated on the outer surface of the valve clamping device, where the covering film is generally a medical polymer material film, and the valve clamping devices shown in fig. 1, 2, 3 and 5 are coated with the covering film, and the covering film is shown as a filler in the drawings. It should be noted that, when the joint assembly moves so that the elastic pressing ring 33 drives the elastic spacer arms 31 to switch between the above three modes, the elastic pressing ring 33 is made of an elastic material, and a certain curvature deformation is usually generated by the elastic pressing ring 33, for example, as shown in fig. 1, 2, 3 and 5, and the elastic pressing ring 33 also has a certain curvature in a natural state (as shown in fig. 14).
With the above configuration, after the elastic spacer arm 31 in the first configuration is implanted into the ventricle of the patient along with the valve clamping apparatus, the elastic spacer arm 31 is converted into the third configuration and is placed between the leaflets of the mitral valve or tricuspid valve along with the spacer body 10, the elastic spacer arm 31 is converted into the second configuration (preferably, the second vertical configuration), and then the leaflets are captured and clamped by the clamp 32 on the capturing section 311 (the clamp 32 passes through the hollowed-out area in the middle of the elastic compression ring 33 to capture the clamping operation), and when the clamp 32 of the two repairing assemblies 30 are aligned with the corresponding valve She Gage, the edge-to-edge repairing of the mitral valve or tricuspid valve can be realized by finally converting the elastic spacer arm 31 into the third configuration. In practical applications, the elastic spacer arm 31 is generally in a form between the second vertical form and the third form, and it is understood that the elastic spacer arm 31 captures the leaflet when the elastic spacer arm 31 is just started to enter the third form, and the projection of the spacer 310 along the central axis of the spacer 10 is located at the distal end of the spacer 10. The spacer 10 has a space shape, reduces the gap between the spacer and the valve leaflet, and can avoid the situation that the valve leaflet is torn after being clamped and repaired. According to the utility model, the elastic spacer arms 31 are configured to change the shape under the combined action of the elastic compression ring 33 and the distal joint 20, and the clamp 32 is arranged on the capturing section 311 to change the position of the clamp along with the change of the shape of the elastic spacer arms 31, so that the implantation of the clamp 32, the capturing and clamping of a valve and the edge-to-edge repair of the valve are completed, the success rate of instrument implantation is greatly improved, the risk of instrument implantation failure is reduced, the instrument implantation is safer, more reliable and more stable, the operation difficulty and operation time in the operation process are reduced, the safety and reliability in the operation process are improved, the risk caused by the instrument in the operation process is reduced, and the mitral regurgitation or tricuspid regurgitation of a patient can be effectively inhibited. In addition, the elastic spacing arm 31 in the third form is driven by the elastic compression ring 33 to close to the spacing body 10, so that the clearance between the valve leaflet and the valve clamping apparatus is further reduced, the repair form of the mitral valve or tricuspid valve is better, the repair effect is improved, and the risk of mitral regurgitation or tricuspid valve regurgitation recurrence is reduced. It can be understood that, in the above three mode conversions of the elastic spacer arm 31 and after the clamping device 32 clamps the valve leaflet, the elastic pressing ring 33 plays a role of elastic support, and the elastic pressing ring 33 can also drive the valve tissue contacted with the elastic pressing ring to be folded toward the center to a certain extent, so as to promote the closing effect of the valve.
Further, referring to fig. 7, the prosthetic assembly 30 of the present utility model further comprises a coupling element 35, and the two prosthetic assemblies are radially symmetric about the spacer body 10 for a set 30, and then the corresponding two coupling elements 35 are also radially symmetric about the spacer body 10. The coupling 35 includes a support portion 351 and a stop collar 352 disposed on the support portion 351, for example, the stop collar 352 may be disposed on a side of the support portion 351 radially inward of the spacer 10, further, the support portion 351 may be plate-shaped or sheet-shaped, the plane of the stop collar 352 may be perpendicular to the support portion 351 (i.e., the axial direction of the stop collar 352 is parallel to the support portion 351), and in other embodiments, the axial direction of the stop collar 352 may be at an angle (e.g., 15 °,30 ° or the like) with respect to the support 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 resilient compression ring 33 or the support section 312 of the resilient spacer arm of at least one other repair assembly by a traction body 36. With respect to the coupling members 35, all of the corresponding stop rings 352 in the two coupling members 35 are different in axial position along the spacer 10. The coupling element 35 may deflect radially around the distal end of the coupling element 10, in particular the coupling element 35 may deflect inwardly around the distal end of the coupling element under the influence of an external force, which upon withdrawal of the external force will deflect outwardly around the distal end of the coupling element. Thus, the coupling 35 is configured such that the push shaft 90 passes through the stop collar 352 to constrain the stent section 351 from collapsing along the radial position of the spacer 10, and such that the push shaft 90 withdraws from the stop collar 352 causing the stent section 351 to deflect radially outwardly of the spacer 10 about its distal end.
Referring to fig. 7, and taking two symmetrically arranged repair modules as exemplified in fig. 1-6 as an example, specifically, proximal ends of respective support portions 351 of two repair modules 30 are respectively connected to each other's elastic pressing ring 33 through a traction body 36, that is, are not connected to the elastic pressing ring 33 and the support portion 351 belonging to one repair module 30, but the support portion 351 of the repair module 30 is connected to the elastic pressing ring 33 of the other repair module 30 through the traction body 36, for example, referring to fig. 9, the left support portion 351 is connected to the right elastic pressing ring 33 through the traction body 36, and the right support portion 351 is connected to the left elastic pressing ring 33 through the other traction body 36. The proximal ends of the bracket portions 351 of the two prosthetic components 30 are connected to each other via the traction body 36 to the support segment 312, respectively, in the same manner as the elastic pressing ring 33, and will not be described again. It should be noted that, the components of the bracket portions 351 of the two repair assemblies 30 that are connected to each other by the traction body 36 may not be the elastic compression ring 33 or the support segments 312, for example, referring to fig. 9, for example, the left bracket portion 351 may be connected to the right elastic compression ring by the traction body 36, and the right bracket portion 351 may be connected to the support segment 312 of the left elastic spacer arm by the other traction body 36.
In the expanded state, referring to fig. 8, during the implantation process of the valve clamping apparatus and the conversion process of the three forms, the pushing shaft 90 always passes through each limiting ring 352 and is fixed on the joint assembly, at this time, the coupling pieces 35 on two sides are drawn towards the middle (near to the axis of the spacer body 10) due to the pushing shaft 90 passing through each limiting ring 352, so that the radial position of the bracket portion 351 along the spacer body 10 is limited, and the bracket portion 351 is ensured not to deflect outwards due to the cooperation constraint of the pushing shaft 90 and the limiting rings 352. Referring to fig. 9-12, in conjunction with fig. 4, after the valve clasping apparatus has been used to perform the limbic repair by the valve clasping apparatus in the third configuration described above, the operator separates the push shaft 91 from the connector assembly and gradually withdraws the push shaft 90 from the patient's body, the push shaft 10 will withdraw from each stop ring 352 and the spacer body 10 in turn, thereby releasing the constraint of the push shaft 90 on the support portion 351 by the stop ring 352, the support portion 351 will automatically deflect outwardly around its distal end and along the radial direction of the spacer body 10, and deflect towards the return to the original state, thereby stretching the traction body 36, and the traction body 36 will apply a pulling force to the corresponding elastic compression ring 33 or support segment 312 of the elastic spacer arm, thereby pulling the corresponding elastic compression ring 33 or support segment 312 of the elastic spacer arm to retract further inwardly toward the spacer body 10.
After edge-to-edge repair of the clamped valve is achieved through the matching design of the coupling pieces 35 and the traction bodies 36, the pushing shaft 90 is separated from the joint assembly and exits from each limiting ring 352, the coupling pieces 35 move outwards along the radial direction of the spacer body 10 through the support portions 351 to stretch the corresponding traction bodies 36, and further the elastic compression rings 33 on two sides or the supporting sections 312 of the elastic spacer arms are driven to further approach the spacer body 10 under the action of the two coupling pieces 35 to be folded, firstly, valve tissues contacted with the elastic compression rings 353 can be further folded towards the center under the action of the coupling pieces 35, secondly, the clamp 32 on the capturing section can be further folded towards the spacer body 10 to drive the valve tissues clamped on two sides through the clamp 32 to be further folded towards the center, and after the valve clamp is clamped by the valve clamp device provided by the utility model to achieve edge-to-edge repair, the closing effect of the valve can be increased, the closing effect of the valve can be improved, and the surgical success rate of the valve can be improved.
In addition, the coupling 35 can be connected with the joint assembly in a welding or mechanical structure mode, the structure is simple, safety margin can be designed according to actual conditions, and the safety performance of the whole structure is improved. In an embodiment, referring to fig. 9 and 11, the valve clamping apparatus further includes a base 60, the base 60 may be, for example, annular, the coupling member 35 is fixed on the base 60, all the support portions 351 of the coupling member 35 are fixed on the base 60, that is, in two symmetrical repair assemblies, the two support portions 351 are located on two sides of the base 60 in the same diameter direction, and the base 60 is sleeved on the joint assembly, so as to realize connection between the support portions 351 and the joint assembly.
Further, referring to fig. 8, when the pushing shaft 90 is inserted through the stop collar 352, the proximal end of the bracket 351 does not protrude beyond the distal end of the bracket 351 radially outward of the spacer 10. That is, when the push shaft 90 is inserted through the stopper ring 352, the distance from the proximal end of the bracket portion 351 to the perpendicular line of the push shaft 90 is not greater than the distance from the distal end of the bracket portion 351 to the perpendicular line of the push shaft 90. For example, the distance from the proximal end of the bracket portion 351 to the perpendicular line of the pushing shaft 90 may be equal to the distance from the distal end of the bracket portion 351 to the perpendicular line of the pushing shaft 90 (in this case, it may be understood that the extending direction of the bracket portion 351 is parallel to the axial direction of the spacer 10), or the distance from the proximal end of the bracket portion 351 to the perpendicular line of the pushing shaft 90 may be smaller than the distance from the distal end of the bracket portion 351 to the perpendicular line of the pushing shaft 90 (in this case, it may be understood that the extending direction of the bracket portion 351 is angled with respect to the axial direction of the spacer 10, and the bracket portion 351 is inclined inward). In this way, when the pushing shaft 90 is removed, the bracket portion 351 may have a larger offset angle outwards, and apply a larger pulling force to the corresponding elastic pressing ring 33 or the supporting arm 312, so that the elastic pressing ring 33 or the supporting arm 312 can be further folded towards the center, and the closing effect of the valve clamping apparatus may be further improved.
Still further, referring to fig. 9 and 11, after the push shaft 90 is withdrawn from each stop collar 352, the bracket portion 351 will deflect radially outwardly about its distal end and along the spacer 10, with the proximal end of the bracket portion 351 radially outwardly beyond the distal end of the bracket portion 351 along the spacer 10, i.e., the distance from the proximal end of the bracket portion 351 to the perpendicular to the push shaft 90 is greater than the distance from the distal end of the bracket portion 351 to the perpendicular to the push shaft 90. Further, the material of the stent portion 351 may be, for example, a memory shape alloy (e.g., nickel-titanium alloy), and the memory shape (original shape) of the stent portion 351 is configured to deflect radially outwardly of the spacer 10 around its distal end so that the proximal end of the stent portion 351 extends radially outwardly of the distal end of the stent portion 351 along the spacer 10. The memory shape of the bracket portion 351 may be formed by a heat setting process using a memory shape alloy.
Preferably, when the pushing shaft 90 is inserted through all of the stop rings 352, all of the stop rings are coaxial. In this way, all the limiting rings 352 are ensured to be concentrically arranged as much as possible, so that the included angles between the bracket parts 351 at two sides and the pushing shaft 90 are basically consistent, and the overall stability of the structure is improved.
Further, the connection position of the traction body 36 on the support section 312 of the corresponding elastic pressing ring 33 or elastic spacer arm is configured not to exceed the proximal end of the corresponding bracket portion 351 in the distal-to-proximal direction. For example, referring to fig. 8 and 9, no matter the pushing shaft 90 is inserted into the stop collar 352 or withdrawn from the stop collar 352, the connection position of the traction body 36 on the elastic pressing ring 33 does not exceed the proximal end of the bracket portion 351 along the axial direction of the spacer 10, which is understood that the connection position of the traction body 36 on the elastic pressing ring 33 in fig. 8 and 9 does not exceed the top end of the bracket portion 351. As regards the connection position of the traction body 36 on the corresponding support segment 312, the person skilled in the art will further understand from the position of the traction body 36 on the corresponding elastic pressure ring 33 that will not be explained here.
Further, the traction body 36 comprises at least one traction wire 360, and the elastic compression ring 33 or the support section 312 of the elastic spacer arm is connected to the proximal end of the bracket portion 351 by means of the traction wire 360. Referring to fig. 10 for example, the traction body 36 includes at least two traction wires 360, and both sides of the elastic pressing ring 33 are connected to the proximal end of the bracket 351 through at least one of the traction wires 360. Specific connection modes, such as holes connected with the traction wires 360 are formed on the elastic compression ring 33 and the bracket portion 351.
Preferably, the elastic compression ring 33 or the supporting section 312 of the elastic spacer arm is connected to the proximal end of the bracket 351 by at least two traction wires 360, and the traction wires 360 corresponding to any one of the repair assemblies and the traction wires 360 corresponding to at least one other repair assembly are distributed in a central symmetry manner (specifically, may be distributed in a central symmetry manner about the central axis of the spacer 10). With continued reference to fig. 10, in the exemplary illustration of fig. 10, all the connecting positions of the traction wires 360 on the support portion 351 are the same (i.e. all are connected to the same point, or in the same hole), the traction body 36 corresponding to one elastic pressing ring 33 and the traction body 36 corresponding to the other elastic pressing ring 33 are distributed symmetrically in the center, in the traction bodies 36 corresponding to the left and right elastic pressing rings 33 in fig. 10, the connecting positions of the traction wires 360 on each support portion 351 and the connecting positions of the traction wires 360 on each elastic pressing ring 33 and the total six connecting positions are distributed symmetrically in the center around the pushing shaft 90, and the lengths of the traction wires 360 are the same, so that the support portions 351 on both sides are configured so as to symmetrically apply closing forces (symmetrically apply closing forces close to the spacers 10) to the elastic pressing rings 33 on both sides through the traction bodies 360 respectively, thereby improving the stability and the clamping force of the valve clamping device and realizing a better closing effect on the valve tissue of the device. As a further illustration, in fig. 10, of the two traction wires 360 corresponding to the left bracket portion 351, the connection positions of the two traction wires 360 on the left bracket portion 351 are the point a, and the connection positions of the two traction wires 30 on the right elastic pressing ring 33 are the point B and the point C, respectively; in fig. 10, in the two traction wires 360 corresponding to the right bracket portion 351, the connection positions of the two traction wires 360 on the right bracket portion 351 are all points D, and the connection positions of the two traction wires 30 on the left elastic pressing ring 33 are points E and F, respectively; wherein, the point A, the point B, the point C, the point D, the point E and the point F are distributed in central symmetry; wherein E-D-C and B-A-C are two traction wires respectively.
Based on the above-mentioned valve clamping apparatus, the present embodiment further provides a valve repair system, which includes a delivery apparatus and the above-mentioned valve clamping apparatus, as shown in fig. 23. The valve clamping apparatus of the present embodiment will be further described in connection with a delivery apparatus in a valve repair system.
Typically, the physician controls the operation of the valve clasping apparatus through the delivery apparatus, including but not limited to driving the valve clasping apparatus into the patient and into the heart chamber of the patient, controlling the switching of the resilient spacer arm 31 between the three configurations, controlling the operation of the clasper 32, and controlling the detachment of the delivery apparatus from the valve clasping apparatus and the withdrawal from the patient after the repair of the mitral valve or tricuspid valve is completed by the valve clasping apparatus. Specifically, the delivery device includes a pushing shaft 90, a control wire 100, and a connector 110, where the pushing shaft 90 is used to control movement of the connector assembly, pass through or withdraw from the stop collar 352, and deliver the valve clamping device to the inside of the human body, the control wire 100 is used to control the clamping state or working state of the clamping device 32, and the connector 110 is used to connect the delivery device and the valve clamping device.
Further, referring to fig. 1, 4 and 6, the valve clasping apparatus includes a proximal connector 40, the proximal connector 40 is connected to the proximal end of the spacer body 10, and the valve clasping apparatus is configured to connect to a delivery apparatus via the proximal connector 40. Specifically, the delivery device and the proximal connector 40 are detachably connected, so that the delivery device and the proximal connector 40 are conveniently separated, and separation from the valve clamping device is realized. Typically, delivery instrument connector 110 is removably attached to proximal hub 40. The connecting piece 110 makes the proximal joint 40 of the valve clamping apparatus fixed to the conveying apparatus, the pushing shaft 90 penetrates through the connecting piece 110, the distal end of the pushing shaft 90 is fixed to the distal end of the valve clamping apparatus, and when the proximal joint 40 is fixed to the distal end of the conveying apparatus, the pushing shaft 90 is pushed to move back and forth along the axial direction of the spacer body 10 by the conveying apparatus, so that the valve clamping apparatus is converted in the first, second and third forms. Also during delivery, the delivery instrument implants the valve clasper instrument (shown in fig. 1) in the patient with the resilient spacer arms 31 in the first configuration.
Still further, referring to fig. 17, the proximal joint 40 has at least two first extensions 41 (two symmetrically arranged first extensions 41 are shown in fig. 15) protruding radially outwardly of the spacer body 10 (i.e., in a direction away from the central axis of the spacer body 10), the first extensions 41 being adapted for snap-fit connection with a delivery device. Specifically, referring to fig. 22, the connecting piece 110 has first connecting pieces 111 corresponding to the number and positions of the first extending portions 41, the connecting pieces have through holes 1110, when assembled, the first connecting pieces 111 expand outwards along the radial direction of the spacer body 10, the expansion process of the plurality of first connecting pieces 111 is similar to the spreading of petals, then the holes 1110 are inserted into the corresponding first extending portions 41, and the first connecting pieces 111 shrink inwards again to realize the snap connection between the first extending portions 41 and the holes 1110. Still further, the proximal connector 40 has at least two second extensions 42 protruding radially outwardly of the spacer 10, the second extensions 42 having a through-going receptacle 420, the receptacle 420 being adapted for a snap-fit connection with the delivery device, the connector 110 having second connecting tabs 112 corresponding in number and location to the first extensions 41, the second connecting tabs 112 being snap-fit connected with the receptacle 420.
Referring to fig. 18 and 22, the valve clasping apparatus further includes a sealing gasket 50 coupled to the proximal hub 40, the sealing gasket 50 having at least two third extensions 51 extending radially outwardly of the spacer body 10, the third extensions 51 having first clip slots 510 therethrough, the first clip slots 510 for insertion coupling with the delivery apparatus. By providing the sealing gasket 50, blood is prevented from entering the valve clasping apparatus and the delivery apparatus, reducing the risk of surgery. The sealing gasket 50 may be made of silicone, i.e., a silicone gasket. In addition, compared with the prior art, the first slot 510 on the sealing gasket 50 is beneficial to separating the delivery device from the valve clamping device, specifically, the second connecting piece 112 of the connecting piece 110 is connected with the proximal connector 40 by sequentially inserting the first slot 510 and the jack 420, and when the second connecting piece 11 withdraws from the proximal connector 40 and is separated from the sealing gasket 50, the friction between the second connecting piece 112 and the sealing gasket 50 can be reduced by the arrangement of the first slot 510, so that the second connecting piece 112 can be withdrawn conveniently. Further, the sealing gasket 50 has a second slot 52 formed therethrough, and the second slot 52 is used for the pushing shaft 90 of the delivery device to pass through. The second clamping slot 52 is not only beneficial to pushing or withdrawing the pushing shaft 90, but also beneficial to realizing the sealing effect of the sealing gasket 50 and the pushing shaft 90, so that the pushing shaft 90 is prevented from bringing blood into the valve clamping device in the working process. Preferably, the first slot hole 510 and the second slot hole 52 are in a slit shape, and the shape enables the sealing gasket 50 at the first slot hole 510 and the second slot hole 52 to be completely attached to the outer surface of the insert, so that the sealing performance of the sealing gasket 50 is further improved compared with a hole-shaped structure.
Referring to fig. 2 and 4, the connector assembly of the present embodiment includes a guide wire connector 70, a distal connector 20 and a cover connector 80 arranged in a distal direction from a proximal end, wherein the guide wire connector 70 and the distal connector 20 are fastened and fixed, and the cover connector 80 is screwed and fixed with the guide wire connector 70. The coupling member 35 of this embodiment may be connected to the distal joint 20, for example, the annular base 60 is sleeved on the distal joint 20, and the bracket portion 351 of the coupling member 35 is connected to the annular base.
Further, referring to fig. 20 and 21, the guide wire joint 70 has a second guide hole 710, and the axial direction of the second guide hole 710 is parallel to the axial direction of the spacer 10; the cover joint 80 has a fifth extension 81 protruding toward the support body 10, and the fifth extension 81 is configured to be screwed with the second guide hole 710 so as to achieve the screw-fastening of the guide wire joint 70 and the cover joint 80. The second via 710 may be a through hole or a blind hole, and if the blind hole is formed, the proximal end of the second via 710 is closed. In addition, the push shaft 90 of the delivery device is secured to the guidewire hub 70, such as by the push shaft 90 being secured to the proximal end of the second guide opening 710.
Further, referring to fig. 19 and 20, the guide wire connector 70 has a sixth extension 72 protruding away from the spacer body 10, and the distal connector 20 has a connector groove 21 recessed in a proximal-to-distal direction, and the connector groove 21 is adapted to the sixth extension 72. The sixth extension 72 is engaged in the joint groove 21 to achieve the engagement fixation of the distal joint 20 and the guide wire joint 70. Regarding the arrangement form of the second guide hole 710, it may be that the wire joint 70 has a fourth extension 71 protruding toward the spacer 10, and one portion of the second guide hole 710 is in the fourth extension 71 and the other portion is in the sixth extension 72. In addition, the fourth extension 71 is also used to follow the movement of the joint assembly into or out of the first guide hole 61 of the support body 60.
In this embodiment, the connection manner of the elastic pressing ring 33 and the elastic spacer arm 31 and the joint assembly is not particularly limited, and in an exemplary embodiment, referring to fig. 13, at least two through pressing holes 331 are provided at the proximal end of the elastic pressing ring 33, and the pressing holes 331 are used for being matched with a suture thread to enable the elastic pressing ring 33 to be in suture connection with the spacer 310. In another exemplary embodiment, referring to fig. 9 and 19, the elastic pressing ring 33 is configured to be connected to the distal joint 20 in the joint assembly, the distal joint 20 has a first connecting groove 22, the first connecting groove 22 is recessed radially outwards of the spacer 10, the distal end of the elastic pressing ring 33 is connected to the fixing member 34, the fixing member 34 has a second connecting groove 340 recessed radially inwards of the spacer 10, the first connecting groove 22 is matched with the second connecting groove 340, the connection between the elastic pressing ring 33 and the distal joint 20 is achieved through the cooperation of the first connecting groove 22 and the second connecting groove 340, further referring to fig. 19 and 20, and during the assembly process of the elastic pressing ring 33 and the distal joint 20, the fixing member 34 at the distal end of the elastic pressing ring 33 passes through the groove 73 of the wire guide joint 70 and is finally fixed in the first connecting groove 22. The fixing member 34 may be integrally formed with the elastic pressing ring 33, or may be formed separately and then assembled together.
Referring to fig. 15 and 16, the clamp 32 includes a clamp plate 321 and a support plate 322; the supporting plate 322 is fixedly arranged on the capturing section 311, and the supporting plate 322 is close to the attaching capturing section 311, preferably the supporting plate 322 is parallel to the capturing section 311; one end of the clamping plate 321 is elastically coupled to the support plate 322 such that the clamping plate 321 is applied with an elastic force toward the support plate 322. It should be noted that the clip 32 passes through the hollow area in the middle of the elastic pressing ring 33, and specifically, the clip 321 is used to pass through the hollow area in the middle of the elastic pressing ring 33 under a force (as can be understood, the force is applied by the control wire 100) away from the supporting plate 322. The position of the gripper 32 changes accordingly with the change in form of the elastic spacer arm 31, and the elastic spacer arm 31 is in the second form, preferably the second vertical form, or the elastic spacer arm 31 is initially brought into the third form, at which time the gripper 32 is operated to catch and grip the leaflet. Specifically, the elastic connection between the support plate 322 and the support plate 321 makes the support plate 321 apply an elastic force towards the support plate 322, and the support plate 322 is fixed on the capturing section 311, so that an external force substantially away from the support plate 322 can be applied to the support plate 321, so that the support plate 322 and the support plate 321 are in an open shape, substantially in a ">" shape, thereby capturing the valve leaflet, and after the external force is removed, the support plate 321 is restored and the valve She Gage is between the support plate 322 and the support plate 321 under the action of the elastic force. It can be understood that the opening and closing degree of the clamping plate 321 and the supporting plate 322 can be controlled by controlling the magnitude of the external force, i.e., the opening degree of ">" can be controlled by the magnitude of the external force.
As a further implementation detail of the structure of the further clip 32, the clip 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 support plate 322 includes a transverse portion 3221 and a vertical portion 3222 connected in a T shape, the vertical portion 3222 extends within the range of the elongated hole 3211 along the long axis direction of the elongated hole 3211, the transverse portion 3221 extends outside the range of the elongated hole 3211 along the short axis direction of the elongated hole 3211, and the transverse portion 3221 is used for abutting against the clamping plate 321, so that the vertical portion 3222 is prevented from penetrating into the elongated hole 3211 under the action of elastic force, and one end of the vertical portion 3222, which is far from the transverse portion 3221, is elastically connected with the clamping plate 321.
Preferably, referring to fig. 15 and 16, the clutch plate 321 is provided with a barb structure 323. The barb structures 323 are pierced in the leaflet to improve the capture of the leaflet by the clip 32 and the stability and reliability of the clip.
Based on the above, the control wire 100 is connected to the clamp 32, and is used for controlling the clamping state of the clamp 32, that is, manipulating the clamp 32 to capture and clamp the valve leaflet, and manipulating the clamp 32 to capture and clamp the valve leaflet again when the clamping effect of the clamp 32 on the valve leaflet is not ideal, so that the connector 110 is detachably connected to the valve clamping apparatus through the proximal end connector 40. The push shaft 90 passes sequentially through the connector 110 of the delivery device, the sealing gasket 50 of the valve clasping device, the proximal hub 40, the spacer 10, and the respective stop collars 352, and is ultimately connected to the guidewire hub 70.
In one embodiment, referring to fig. 1, 3 and 15, the clamping plate 321 has a control hole 3212, the clamping plate 321 is connected to the control wires 100 through the control hole 3212, and two control wires 100 are respectively connected to the clamping plates 321 on two sides. In the surgical procedure, the elastic spacer arm 31 is in the second configuration, preferably the second vertical configuration, under the combined action of the pushing shaft 90, the joint assembly and the elastic pressing ring 33, or when the elastic spacer arm 31 is just started to enter the third configuration, the control wire 100 is manipulated to control the clamping plate 321 and the supporting plate 322 to be opened so as to capture and clamp the valve leaflet, specifically, the clamping state of the clamping device 32 on the valve leaflet is observed through an external ultrasonic imaging device, and if the clamping state does not achieve the ideal effect, the valve leaflet can be captured and clamped again under the action of the control wire 100. It should be noted that, the two control wires 100 do not interfere with each other, so that the respective corresponding clampers 32 can be operated simultaneously, or the respective corresponding clampers 32 can be operated separately, so as to realize the function of separately opening and capturing the two clamping plates 321, thereby meeting the operation requirement of the single clamping device 32 possibly occurring in the operation process.
The foregoing description is only illustrative of the preferred embodiments of the present utility model, and is not intended to limit the scope of the present utility model in any way, and any changes and modifications made by those skilled in the art in light of the foregoing disclosure will be deemed to fall within the scope and spirit of the present utility model.

Claims (10)

1. A valve clasping apparatus for implantation in a predetermined area under the drive of a delivery apparatus, said delivery apparatus comprising a pushing shaft, said valve clasping apparatus comprising:
a spacer;
a joint assembly for axial movement of the spacer body under the drive of the push shaft;
at least two repair assemblies disposed along radial symmetry of the spacer, the repair assemblies comprising:
an elastic spacer arm comprising a capturing section and a supporting section extending along the axial direction of the spacer body, wherein the spacer body, the capturing section and the supporting section are sequentially connected from the proximal end to the distal end; the distal end of the capturing section is connected with the proximal end of the supporting section to form a spacing part, and the distal end of the supporting section is connected with the joint assembly;
the clamping device is arranged on the capturing section and is used for clamping a preset position;
the proximal end of the elastic compression ring is connected with the spacing part, and the distal end of the elastic compression ring is connected with the joint assembly;
the coupling piece comprises a bracket part and a limiting ring arranged on the bracket part, and the distal end of the bracket part is connected with the joint assembly; the coupling piece is configured such that the pushing shaft penetrates the limiting ring to restrict the radial position of the bracket part along the spacer, and the pushing shaft exits the limiting ring so that the bracket part deflects outwards around the distal end of the pushing shaft along the radial direction of the spacer;
The proximal end of the bracket part of any repairing component is connected with the supporting section of the elastic compression ring or the elastic spacing arm of at least one other repairing component through a traction body.
2. The valve clasper apparatus of claim 1, wherein the stop collar is disposed on a radially inward side of the frame portion along the spacer body, and wherein all of the stop collars are differently positioned axially along the spacer body.
3. The valve clasper apparatus of claim 1 or 2, wherein the proximal end of the stent portion does not extend radially outward of the spacer beyond the distal end of the stent portion when the push shaft is threaded through the stop collar.
4. The valve clasper instrument of claim 3, wherein the material of the stent portion is a memory shape alloy, the memory shape of the stent portion configured such that the proximal end of the stent portion extends radially outward of the distal end of the stent portion along the spacer.
5. The valve clasper apparatus of claim 1 wherein all of the stop collars are coaxial when all of the stop collars are threaded by the push shaft.
6. The valve clasping apparatus of claim 1, wherein the connection location of the traction body on the corresponding elastic compression ring or support segment of the elastic spacer arm is configured not to extend beyond the proximal end of the stent portion in a distal-to-proximal direction.
7. The valve clasping apparatus of claim 1 or 6, wherein the traction body comprises at least one traction wire, and the elastic compression ring or the support section of the elastic spacer arm is connected to the proximal end of the stent portion by the traction wire.
8. The valve clasping apparatus of claim 7, wherein the support section of the elastic compression ring or the elastic spacer arm is connected to the proximal end of the stent portion by at least two of the traction wires, and the traction wires corresponding to any of the prosthetic components are centrally symmetrically distributed with the traction wires corresponding to at least one other of the prosthetic components.
9. The valve clasper instrument of claim 1, further comprising a base, wherein the coupling is secured to the base, and wherein the base is sleeved over the connector assembly.
10. A valve repair system comprising a delivery device and a valve clasper device according to any one of claims 1-9, the delivery device comprising a push shaft for detachably connecting to the connector assembly after sequentially threading the spacer and each of the stop collars.
CN202222756949.7U 2022-10-17 2022-10-17 Valve clamping instrument and valve repair system Active CN219021751U (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024082751A1 (en) * 2022-10-17 2024-04-25 江苏臻亿医疗科技有限公司 Valve clamp device and valve repair system

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024082751A1 (en) * 2022-10-17 2024-04-25 江苏臻亿医疗科技有限公司 Valve clamp device and valve repair system

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