CN113907918B

CN113907918B - Valve clamping system

Info

Publication number: CN113907918B
Application number: CN202111163592.5A
Authority: CN
Inventors: 魏勇强; 刘美辰; 杨文广
Original assignee: Hangzhou Duanyou Medical Technology Co ltd
Current assignee: Hangzhou Duanyou Medical Technology Co ltd
Priority date: 2021-09-30
Filing date: 2021-09-30
Publication date: 2023-02-28
Anticipated expiration: 2041-09-30
Also published as: CN113907918A

Abstract

In the valve clamping system of the present invention, the valve clamping system comprises: a spacer; a joint assembly movably arranged relative to the spacing body along an axial direction of the spacing body; two repair assemblies symmetrically arranged along the radial direction of the spacing body; the repair kit comprises: the spacing arm comprises a capturing section and a supporting section which extend along the axial direction of the spacing body, and the spacing body, the capturing section and the supporting section are sequentially connected from the proximal end to the distal end; the spacing arm is an elastic piece; the distal end of the support section is connected to the joint assembly; a clamper arranged on the catching section; a compression ring is connected between the capturing section and the support section at a proximal end thereof, and is connected to the connector assembly at a distal end thereof. According to the configuration, the spacing arms can be changed into different forms under the combined action of the pressing ring and the connector assembly, and the position of the clamping device arranged on the capturing section is changed along with the change of the form of the spacing arms, so that the implantation of the clamping device, the capturing and clamping of the valve and the edge-to-edge repair of the valve are completed.

Description

Valve clamping system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a valve clamping system.

Background

The mitral valve and the tricuspid valve are two very important valves in the heart, and like the check valve, are important heart structures which enable the heart blood to pass through the left atrium to the left ventricle or the right atrium to the right ventricle without backflow, and the mitral valve backflow or the tricuspid valve backflow is a phenomenon that the blood flows back from the ventricle to the atrium due to the fact that the mitral valve or the tricuspid valve is not closed tightly, and the backflow phenomenon can cause the risk of heart failure of the patient, and seriously affects the daily life and work of the patient.

Mitral regurgitation or tricuspid regurgitation are the two most common conditions in valvular heart disease, and are relatively cumbersome and costly to treat, usually by open-chest surgery, but at a greater risk. Another mode of treatment for mitral valve regurgitation or tricuspid valve regurgitation is a minimally invasive catheter intervention operation, and the implantation instrument is implanted into the heart of a patient through a catheter conveying system to achieve the effect of repairing the mitral valve or the tricuspid valve leaflet from the edge to the edge, so that the inhibition of mitral valve regurgitation or tricuspid valve regurgitation is achieved, and the effect of treating the symptoms of mitral valve regurgitation or tricuspid valve regurgitation of the patient is achieved.

The existing mitral valve or tricuspid valve transcatheter implantation device is generally a mechanical clamping device or an elastic clamping device for clamping mitral valve or tricuspid valve leaflets to realize edge-to-edge repair operation, so that the inhibition of mitral regurgitation or tricuspid regurgitation is realized, and the treatment effect of mitral regurgitation or tricuspid regurgitation is achieved.

However, the existing mechanical clamping device is easy to cause large clamping stress, so that valve leaflets of the valve are torn, and the elastic clamping device realizes clamping and tightening by means of the clamping force of the elastic element, so that if the clamping force is not appropriate or the design of the clamp thorn is not reasonable or the elastic element is irreversibly plastically deformed in the working process, the final clamping effect can be influenced, and the final treatment effect of mitral regurgitation or tricuspid regurgitation after implantation can be influenced. Once the valve tears or fits loosely edge to edge, it can lead to a risk of mitral regurgitation or recurrence of tricuspid regurgitation. In addition, the mechanical clamping device is usually difficult to separate and capture the valve leaflets, while the existing elastic clamping device can separate and capture the valve leaflets, but the barb design of the clamp is not reasonable enough, so that the valve leaflets are often separated and captured insecurely, the phenomenon that the valve leaflets fall off after being captured is caused, secondary or multiple times of capturing and clamping are often required, and the difficulty and time of the operation are increased.

Disclosure of Invention

The invention aims to provide a valve clamping system to solve the problem that the clamping repair effect of the existing clamping device on a mitral valve or a tricuspid valve is not ideal.

To solve the above technical problem, the present invention provides a valve clamping system, comprising:

a spacer;

a joint assembly movably arranged relative to the spacer body along an axial direction of the spacer body;

two repair members symmetrically arranged in a radial direction of the spacer body; the repair assembly includes:

a 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 far end of the catching section and the near end of the supporting section are connected to form a spacing part, and the far end of the supporting section is connected to the joint component; the spacing arm is an elastic piece;

the clamping device is arranged on the catching section along the axial direction of the spacing body and is used for clamping a preset part;

and the near end of the pressing ring is connected with the spacing part, and the far end of the pressing ring is connected with the joint assembly.

Optionally, the valve clamping system further comprises a proximal joint connected to the proximal end of the spacer body;

the proximal joint has at least two first extensions projecting radially outward of the spacer body;

the proximal joint has at least two second extensions projecting radially outward of the spacer body, the second extensions having through-going receptacles.

Optionally, the valve clamping system further comprises a sealing gasket connected with the proximal connector, the sealing gasket having at least two third extensions extending radially outward of the spacer body, the third extensions having a first snap slot hole therethrough;

the center of the sealing gasket is provided with a second through slot hole;

the first slot hole and the second slot hole are in a cutting slit shape.

Optionally, the valve clamping system further comprises a support body located inside the spacer body and fixed near the distal end of the spacer body, the support body having a first guide hole penetrating along the axial direction of the spacer body;

first guide hole includes first hole section, second hole section and the third hole section that connects gradually by the direction of near-end to the distal end, the radial dimension of first hole section with the radial dimension of third hole section all is greater than the radial dimension of second hole section, just the radial dimension of first hole section reduces by the direction of near-end to the distal end gradually, the radial dimension of third hole section is by the direction crescent of near-end to the distal end.

Optionally, the connector assembly comprises a guide wire connector, a distal connector and a covering connector arranged from the proximal end to the distal end; the far end of the guide wire joint is fixedly clamped with the far end joint; the covering joint is fixed with the guide wire joint in a threaded mode.

Optionally, the guide wire joint is provided with a second guide hole, and the axial direction of the second guide hole is parallel to the axial direction of the spacer; the cover joint is provided with a fifth extending part protruding towards the support body, and the fifth extending part is used for being in threaded connection with the second guide hole.

Optionally, the guide wire connector has a sixth extension protruding away from the spacer, and the distal connector has a connector groove recessed in a proximal-to-distal direction, the connector groove fitting with the sixth extension.

Optionally, the distal end connector has a first connection groove, the first connection groove is recessed outward along the radial direction of the spacer, the distal end of the pressing ring has a second connection groove recessed inward along the radial direction of the spacer, and the first connection groove is adapted to the second connection groove; the near-end of clamping ring is equipped with two at least pressure holes that link up.

Optionally, the clamp comprises a clamp plate and a support plate; the supporting plate is arranged on the capturing section; one end of the clamping plate is elastically connected with the supporting plate, so that the clamping plate is applied with an elastic force towards the supporting plate;

the sandwich plate is provided with a through strip hole, and the long axis direction of the strip hole is parallel to the capturing section; the backup pad is including being horizontal portion and the perpendicular portion that T shape is connected, perpendicular portion is followed the major axis direction of rectangular hole extends in the scope in rectangular hole, horizontal portion is followed the minor axis direction of rectangular hole extends outside the scope in rectangular hole, just horizontal portion be used for with the plywood counterbalance leans on.

Optionally, be equipped with the barb structure on the plywood, the barb structure includes long thorn and short thorn, long thorn is including the fixed part, connecting portion and the pyramis that connect gradually, the fixed part connect in the plywood.

Optionally, the tapered portion is in the shape of a pyramid.

Optionally, the plywood is scalable along self extending direction.

Optionally, the sandwich panel includes a plurality of flexible section along the extending direction of self, flexible section is the wave form.

Optionally, the spacer is woven from a plurality of wires.

Optionally, the valve clamping system is covered by a cover membrane.

In conclusion, the invention can change different forms under the combined action of the pressing ring and the joint component by configuring the spacing arm, and the clamp is arranged on the catching section to change the position of the clamp along with the change of the form of the spacing arm, thereby completing the implantation of the clamp, the catching and clamping of the valve and the edge-to-edge repair of the valve.

Drawings

It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation to the scope of the invention. Wherein:

FIG. 1 is a schematic view of a valve clamping system with spacer arms in a first configuration according to an embodiment of the invention;

figures 2 and 3 are schematic views of a valve clamping system with spacer arms in a second configuration according to an embodiment of the invention;

FIGS. 4 and 5 are schematic views of a valve clamping system with spacer arms in a third configuration according to an embodiment of the invention;

FIG. 6 is a schematic view of the spacer arm and spacer body when the spacer arm is in a third configuration in accordance with an embodiment of the present invention;

FIG. 7 is an axial cross-sectional view of the valve clamping system along the spacer body with the spacer arms in the third configuration according to one embodiment of the invention;

FIG. 8 is a top view of the valve clamping system with spacer arms in a third configuration according to an embodiment of the invention;

FIG. 9 is a schematic view of a pressure ring according to an embodiment of the present invention;

FIG. 10 is a side view of FIG. 9;

figures 11, 12 and 13 are schematic views of a clip according to an embodiment of the present invention;

FIG. 14 is a schematic view of a barb configuration of a clip according to an embodiment of the invention;

FIG. 15 is a schematic view of a support according to an embodiment of the invention;

FIG. 16 isbase:Sub>A cross-sectional view taken along line A-A of FIG. 15;

FIG. 17 is a schematic view of a proximal fitting according to an embodiment of the present invention;

FIG. 18 is a schematic view of a gasket seal of an embodiment of the invention;

FIG. 19 is a schematic view of a distal joint of one embodiment of the present invention;

FIG. 20 is a schematic view of a guidewire junction according to an embodiment of the invention;

FIG. 21 is a schematic view of a covered joint according to an embodiment of the invention;

FIG. 22 is an assembly view of the pressure ring and distal tab of one embodiment of the present invention;

FIG. 23 is an exploded view of the delivery system and gasket and proximal fitting of one embodiment of the present invention;

FIG. 24 is an assembly view of a delivery system and valve clamping system according to one embodiment of the present invention.

In the drawings:

10-a spacer;

20-a distal joint; 21-a joint groove; 22-first connecting slot;

30-repairing the component; 31-spacer arms; 311-a capture segment; 312-a support section; 310-a spacer; 32-a clamp; 321-a sandwich plate; 3211-a long hole; 3212-control holes; 3213-telescoping section; 322-a support plate; 3221-transverse part; 3222-vertical section; 323-barb structure; 3231-needling; 3232-short thorn; 3233-fixed part; 3234-a connecting portion; 3235-taper; 33-a pressure ring; 331-punching; 332-a second connecting groove;

40-a proximal joint; 41-a first extension; 42-a second extension; 420-a jack;

50-a sealing gasket; 51-a third extension; 510-a first card slot; 52-second card slot hole;

60-a support; 61-a first guide hole; 611 — a first bore section; 612-a second bore section; 613-third hole section; 62-support holes;

70-a guide wire connector; 71-a fourth extension; 710-a second via; 72-a sixth extension; 73-grooves;

80-covering the joint; 81-a fifth extension;

90-a guide wire;

100-control wire;

110-a connector; 111-a first connecting tab; 1110-perforation; 112-second connecting piece.

Detailed Description

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is to be noted that the drawings are in simplified form and are not to scale, but are provided for the purpose of facilitating and clearly illustrating embodiments of the present invention. Further, the structures illustrated in the drawings are intended to be part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.

As used in this application, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally employed in a sense including "and/or," the terms "a" and "an" are generally employed in a sense including "at least one," the terms "at least two" are generally employed in a sense including "two or more," and the terms "first", "second" and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicit to the number of technical features indicated. Thus, features defined 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 the corresponding two parts, which include not only the end points, but also the terms "mounted", "connected" and "connected" should be understood broadly, e.g., as a fixed connection, as a detachable connection, or as an integral part; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or may be connected through the use of two elements or the interaction of two elements. Furthermore, as used in the present invention, the disposition of an element with another element generally only means that there is a connection, coupling, fit or driving relationship between the two elements, and the connection, coupling, fit or driving relationship between the two elements may be direct or indirect through intermediate elements, and cannot be understood as indicating or implying any spatial positional relationship between the two elements, i.e., an element may be in any orientation inside, outside, above, below or to one side of another element, unless the content clearly indicates otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

The invention provides a valve clamping system, which aims to solve the problem that the existing clamping device is not ideal in repairing effect on a mitral valve or a tricuspid valve.

The valve clamping system of the present embodiment will be described with reference to the drawings.

It is noted that "proximal" and "distal" are defined herein as: "proximal" generally refers to the end of the medical device that is near the operator during normal operation, while "distal" generally refers to the end of the medical device that first enters the patient during normal operation.

As shown in fig. 1-6, the present embodiment provides a valve coaptation system, comprising: the spacer body 10, the spacer body 10 is usually woven by metal wires into an ellipsoid-like shape, such as nickel-titanium alloy wires, and then the shape of the spacer body 10 is fixed by a heat setting process; a joint assembly movably arranged relative to the spacer body 10 in an axial direction of the spacer body 10; two repair members 30 are symmetrically arranged in a radial direction of the spacer body 10, that is, two repair members 30 are symmetrically arranged with respect to a diameter direction of the spacer body 10. Further, the repair assembly 30 includes: a spacer arm 31 including a capturing section 311 and a supporting section 312 extending along the axial direction of the spacer body 10, the capturing section 311 and the supporting section 312 being connected in sequence from the proximal end to the distal end, it being understood that, as illustrated in fig. 1, the capturing section 311 and the supporting section 312 extend along the axial direction of the spacer body 10 and are connected in sequence in fig. 1; the far end of the catching segment 311 and the near end of the supporting segment 312 are connected to form a spacing part 310, that is, the spacing part 310 is defined where the catching segment 311 and the supporting segment 312 are connected, and further, the spacing arm 31 is generally in a band shape or a plate shape, and the spacing arm 31 is an elastic member, that is, has elasticity, that is, is made of an elastic material, and can change its shape under the action of an external force, that is, change the presenting states of the catching segment 311 and the supporting segment 322, for example, the catching segment 311 and the supporting segment 322 can relatively present a folded state; the distal end of the support section 312 is connected to the connector assembly, it should be noted that the spacer arm 31 may also be formed by weaving a metal wire (such as nitinol wire), the connection between the spacer arm 31 and the distal connector 20 may be laser welding, and in addition, the spacer arm 31 may be formed integrally with the spacer body 10, or may be formed separately and then connected; a clamping device 32, disposed on the capturing section 311 along the axial direction of the spacer body 10, for clamping a predetermined portion, which is usually referred to as a mitral valve or a tricuspid valve, but can be other natural valves, such as an aortic valve or a pulmonary valve; a clamping ring 33 is connected at its proximal end to the spacer 310, the clamping ring 33 being connected at its distal end to the connector assembly, the clamping ring 33 being adapted to apply a force to the spacer arm 31. It should be noted that the press ring 33 and the clip 32 are typically formed by a nitinol laser cutting process followed by a heat setting process.

With the above configuration, the spacer arm 31 can be shifted between different configurations under the action of the pressing ring 33, following the movement of the distal joint 20 (proximal to distal movement, or distal to proximal movement), typically, between the first configuration and the second configuration, and between the second configuration and the third configuration, where the second configuration is understood to mean that the configurations between the first configuration and the third configuration are the second configuration. Referring to FIG. 1, the capture section 311 and the support section 312 are substantially co-linearly arranged and substantially close to a central axis of the spacer body 10 when the spacer arms 31 are in the first configuration, it should be understood that co-linear arrangement is understood to be broadly co-linear arrangement, i.e., substantially co-linear, and further understood that the spacer portion 310 is not bent, and that a projection of the spacer portion 310 radially inward of the spacer body 10 when the spacer arms 31 are in the first configuration is outside the range of the spacer body 10, and more specifically, the projection is on the central axis outside the spacer body 10, specifically, the axial position of the spacer portion 310 along the spacer body 10 is far from the distal end of the spacer body 10. The spacer arms 31 on both sides are shaped in a front view (shown in fig. 1) substantially like an ellipse. Referring to fig. 2 and 3, when the spacing arms 31 are in the second state, the spacing arms 31 are expanded outward along the radial direction of the spacer body 10, and the spacing portion 310 is far away from the far end of the spacer body 10 along the axial position of the spacer body 10, i.e., the projection of the spacing portion 310 on the central axis of the spacer body 10 along the radial direction of the spacer body 10 is outside the range of the spacer body 10. The spacer 31 is transformed from the first configuration to the second configuration, and is similar to the gradually outward expansion of the middle portion of the ellipsoid, which is equivalent to the spacer 310 of the present embodiment. In particular, referring to FIGS. 2 and 3, when the spacer arm 31 is in the second last minute configuration (herein referred to as the second vertical configuration for ease of description) as the joint assembly moves distally and proximally, the capture segment 311 is perpendicular to the central axis of the spacer body 10, and the spacer arms 31 of both prosthetic assemblies 30 are shaped like an isosceles triangle, it being understood that herein perpendicular to the central axes of the capture segment 311 and the spacer body 10 is to be understood as broadly perpendicular, such as where the capture segment 311 is at an angle in the range of [90 ° -5 °,90 ° +5 ° ] to the central axis of the spacer body 10, and the capture segment 311 is perpendicular to the central axis of the spacer body 10. As shown in fig. 4 and 5, when the spacing arm 31 is in the third configuration, the spacing arm 31 expands outward along the radial direction of the spacing body 10, the projection of the spacing portion 310 inward along the radial direction of the spacing body 10 is located on the spacing body 10, the axial position of the spacing portion 310 along the spacing body 10 is within the range of the spacing body 10, and the capturing section 311 and the supporting section 312 are folded and close to the spacing body 10, that is, the capturing section 311 and the supporting section 312 are urged by the pressing ring 33 to close to the spacing body 10. It should be noted that, in order to reduce the trauma of the valve clamping system to the human tissue, at least one layer of cover film is usually coated on the outer surface of the valve clamping system, the cover film is usually a medical polymer material film, and the valve clamping systems shown in fig. 1, 2, 3 and 5 are all coated with the cover film, which is shown as a filler in the figure.

As configured above, edge-to-edge repair of the mitral or tricuspid valve can be achieved by implanting the spacer arms 31 in the first configuration into the ventricle of the patient with the valve clamping system, then transforming the spacer arms 31 to the third configuration with the spacer 10 placed between the leaflets of the mitral or tricuspid valve, then transforming the spacer arms 31 to the second configuration (preferably the second perpendicular configuration), then capturing and clamping the leaflets by the clamps 32 on the capturing sections 311, and finally transforming the spacer arms 31 to the third configuration after the clamps 32 of both repair assemblies 30 clamp their respective leaflets. It should be noted that the leaflet is captured and clamped by the clamp 32 when the spacer arm 31 is in the second vertical configuration, and in practical applications, the configuration of the spacer arm 31 is generally between the second vertical configuration and the third configuration, which means that the leaflet is captured by the clamp 32 when the spacer arm 31 starts to enter the third configuration, 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 spatial shape to prevent the leaflet from tearing after being clamped and repaired. According to the invention, the form of the spacer arm 31 is changed under the combined action of the pressing ring 33 and the distal joint 20, and the clamp 32 is arranged on the capturing section 311, so that the position of the clamp is changed along with the change of the form of the spacer arm 31, thereby completing the implantation of the clamp 32, the capturing and clamping of the valve and the edge-to-edge repair of the valve, greatly improving the success rate of the implantation of the instrument, reducing the risk of the implantation failure of the instrument, ensuring that the implantation of the instrument is safer, more reliable and more stable, simultaneously reducing the operation difficulty and the operation time in the operation process, improving the safety and reliability in the operation process, reducing the risk caused by the instrument in the operation process, and effectively inhibiting the mitral regurgitation or tricuspid regurgitation of a patient. In addition, the spacer arms 31 in the third form are driven by the pressing ring 33 to close the spacer body 10, so that the repair form of the mitral valve or the tricuspid valve is better, the repair effect is improved, and the risk of mitral regurgitation or tricuspid regurgitation recurrence is reduced.

Typically, the physician controls the operation of the valve clamping system through an external delivery system, including, but not limited to, actuating the leaflet clamping system into the patient and into the patient's ventricle, controlling the transition of the spacer arms 31 between the three configurations, controlling the operation of the clamps 32, and controlling the delivery system to disengage from and withdraw from the valve clamping system after the valve clamping system has completed a repair of the mitral or tricuspid valve. Specifically, the delivery system includes a guide wire 90 and a control wire 100, the guide wire 90 being used to control movement of the connector assembly and delivery of the valve clamping system to the interior of the human body, and the control wire 100 being used to control the clamping or working state of the clamp 32.

Further, referring to fig. 1, 6 and 7, the valve clamping system includes a proximal connector 40, the proximal connector 40 is connected to the proximal end of the spacer body 10, the valve clamping system is used for connecting to an external delivery system through the proximal connector 40, and specifically, the delivery system is detachably connected to the proximal connector 40, so that the delivery system can be separated from the proximal connector 40, and thus, the valve clamping system can be separated from the valve clamping system. Generally, the delivery system includes a connector 110, whereby the connector 110 provides for a detachable connection to the proximal connector 40. The connector 110 enables the proximal joint 40 of the valve clamping system to be fixed to the delivery system, the guide wire 90 is arranged in the connector 110 in a penetrating mode, and the distal end of the guide wire 90 is fixed to the distal end of the valve clamping system, so that when the proximal joint 40 is fixed to the distal end of the delivery system, the delivery system pushes the guide wire 90 to move back and forth along the axial direction of the spacer body 10, and the valve clamping system is switched among the first form, the second form and the third form.

Further, referring to fig. 17, the proximal joint 40 has at least two first extensions 41 (fig. 15 shows two symmetrically arranged first extensions 41) protruding radially outward (i.e., away from the central axis of the spacer body 10) of the spacer body 10, and the first extensions 41 are used for snap-fit connection with a delivery system. Specifically, referring to fig. 23, the connecting member 110 has first connecting pieces 111 corresponding to the number and positions of the first extending portions 41, and the connecting pieces have through piece holes 1110, when assembling, the first connecting pieces 111 expand outward along the radial direction of the spacer 10, the expansion process of the first connecting pieces 111 is similar to that of petals, then the piece holes 1110 are inserted into the corresponding first extending portions 41, and the first connecting pieces 111 contract inward to realize the fastening connection between the first extending portions 41 and the piece holes 1110.

Furthermore, the proximal connector 40 has at least two second extensions 42 protruding outward in the radial direction of the spacer body 10, and the second extensions 42 have through-holes 420, and the through-holes 420 are used for inserting and connecting with the delivery system. Specifically, the connecting member 110 has second connecting pieces 112 corresponding to the number and positions of the first extending portions 41, and the second connecting pieces 112 are inserted into the insertion holes 420.

Referring to fig. 8 and 18, the valve clamping system further 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 of the spacer body 10, the third extensions 51 have a first slot 510 therethrough, and the first slot 510 is used for inserting connection with the delivery system. By providing the sealing gasket 50, blood can be prevented from entering the valve clamping system and the conveying system, and the operation risk is reduced. The sealing gasket 50 may be made of silica gel, i.e., a silica gel gasket. In addition, compared with the prior art, the first slot 510 of the sealing gasket 50 facilitates the separation of the delivery system from the valve clamping system, and specifically, the second connecting piece 112 of the connecting piece 110 is connected to the proximal connector 40 by being sequentially inserted into the first slot 510 and the insertion hole 420, and when the second connecting piece 11 is withdrawn from the proximal connector 40 and separated from the sealing gasket 50, the first slot 510 can reduce the friction between the second connecting piece 112 and the sealing gasket 50, thereby facilitating the withdrawal of the second connecting piece 112.

Further, the center of the sealing gasket 50 has a second slot 52 therethrough, and the second slot 52 is used for the guide wire 90 of the delivery system to pass through. The second slot 52 is not only beneficial to pushing or withdrawing the guide wire 90, but also beneficial to achieving the sealing function between the sealing gasket 50 and the guide wire 90, so as to prevent the guide wire 90 from bringing blood into the valve clamping system in the working process. Preferably, the first slot-locking hole 510 and the second slot-locking hole 52 are slit-shaped, and the shape makes the sealing gasket 50 at the first slot-locking hole 510 and the second slot-locking hole 52 completely fit to the outer surface of the insert, so as to further improve the sealing performance of the sealing gasket 50 compared with the hole-shaped structure.

Referring to fig. 7 and 15, the valve clamping system further includes a support 60, the support 60 is located inside the spacer 10 and fixed near the distal end of the spacer 10, the support 60 has a first guide hole 61 penetrating along the axial direction of the spacer 10, the first guide hole 61 is used for a guide wire 90 of an external delivery system to pass through, and generally, the guide wire 90 passes through the sealing gasket 50, the proximal joint 40, the spacer 10 and the support 60 in sequence. Regarding the specific fixing form of the support body 60, the support body 60 is provided with a support hole 62 therethrough for passing a suture thread therethrough to realize the suture connection between the support body 60 and the spacer 10.

Preferably, referring to fig. 16, the first guide hole 61 includes a first hole segment 611, a second hole segment 612 and a third hole segment 613 sequentially connected from a proximal end to a distal end, a radial dimension of the first hole segment 611 and a radial dimension of the third hole segment 613 are both greater than a radial dimension of the second hole segment 612, the radial dimension of the first hole segment 611 gradually decreases from the proximal end to the distal end, and the radial dimension of the third hole segment 613 gradually increases from the proximal end to the distal end. It should be noted that the radial dimension herein refers to the largest dimension of the first guide hole 61 in the radial direction thereof, and when the first guide hole 61 is a circular hole, the diameter thereof is referred to. Thus, the first hole section 611 corresponds to an inverted circular truncated cone hole, and the third hole section 613 corresponds to an upright circular truncated cone hole. In fact, after the valve clamping system is delivered to the ventricle, the valve clamping system needs to be diverted and delivered between the leaflets of the mitral valve or the tricuspid valve, the diversion of the valve clamping system is realized by controlling the guide wire 90 of the delivery system, and the embodiment can enable the guide wire 90 to have a larger degree of freedom in the first guide hole 61 by configuring the first guide hole 61 with the first hole section 611, the second hole section 612 and the third hole section 613, so that the guide effect on the valve clamping system can be better realized.

Referring to fig. 2 and 4, it should be noted that the connector assembly of the present embodiment includes a guide wire connector 70, a distal connector 20 and a covering connector 80 arranged from a proximal end to a distal end, the guide wire connector 70 and the distal connector 20 are fixed by snap-fitting, and the covering connector 80 and the guide wire connector 70 are fixed by screw thread.

Further, referring to fig. 20 and 21, the guide wire connector 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 covering adapter 80 has a fifth extension 81 protruding toward the support body 10, and the fifth extension 81 is used for being screwed with the second guide hole 710 so as to realize the screw thread fixation of the guide wire adapter 70 and the covering adapter 80. The second guiding hole 710 may be a through hole or a blind hole, and if the second guiding hole 710 is a blind hole, the proximal end of the second guiding hole 710 is closed. In addition, the guide wire 90 of the delivery system is fixed to the guide wire connector 70, such as the guide wire 90 is fixed to the proximal end of the second guide hole 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, the distal connector 20 has a connector slot 21 recessed in the proximal-to-distal direction, and the connector slot 21 is matched with the sixth extension 72. The sixth extension 72 engages in the connector slot 21 to achieve a snap-fit fixation of the distal connector 20 to the guide wire connector 70. Regarding the arrangement form of the second guiding hole 710, it may be that the guide wire connector 70 has a fourth extension 71 protruding toward the spacer 10, and a part of the second guiding hole 710 is in the fourth extension 71, and another part is in the sixth extension 72. In addition, the fourth extension 71 also serves to enter or exit the first guide hole 61 of the support body 60 following the movement of the joint assembly.

While the connection of the pressing ring 33 with the spacer arm 31 and the joint assembly is not limited in this embodiment, in an exemplary embodiment, referring to fig. 9 and 10, the pressing ring 33 is provided with at least two pressing holes 331 formed therethrough at the proximal end thereof, and the pressing holes 331 are used for cooperating with a suture to sew the pressing ring 33 with the spacer 310. In another exemplary embodiment, referring to fig. 9 and 19, the present embodiment is configured to connect the pressing ring 33 with the distal connector 20 of the connector assembly, the distal connector 20 has a first connecting slot 22, the first connecting slot 22 is recessed outward along the radial direction of the spacing body 10, the distal end of the pressing ring 33 has a second connecting slot 332 recessed inward along the radial direction of the spacing body 10, the first connecting slot 22 is matched with the second connecting slot 332, the connection between the pressing ring 33 and the distal connector 20 is realized by the matching of the first connecting slot 22 and the second connecting slot 332, and further referring to fig. 20 and 22, during the assembly process of the pressing ring 33 and the distal connector 20, the distal end of the pressing ring 33 passes through the groove 73 of the guide wire connector 70 and is finally fixed in the first connecting slot 22.

Referring to fig. 11, 12 and 13, the clamping device 32 includes a clamping plate 321 and a supporting plate 322; the supporting plate 322 is fixedly arranged on the capturing section 311, the supporting plate 322 is close to the attaching capturing section 311, and preferably, the supporting plate 322 is parallel to the capturing section 311; one end of the engaging plate 321 is elastically coupled to the supporting plate 322 such that the engaging plate 321 is applied with an elastic force toward the supporting plate 322. The position of the clip 32 is changed accordingly following the change in configuration of the spacer arm 31, the spacer arm 31 being in the second configuration, preferably the second perpendicular configuration, or the spacer arm 31 initially entering the third configuration, at which time the clip 32 is operated to capture and clip the leaflets. Specifically, the support plate 322 and the clip plate 321 are elastically connected to each other such that the clip plate 321 is applied with an elastic force toward the support plate 322, and the support plate 322 is fixed to the capturing section 311, so that an external force substantially toward the proximal direction is applied to the clip plate 321, such that the clip plate 321 and the support plate 322 are opened and substantially shaped like a ">", and thereby the leaflet is captured, and after the external force is removed, the clip plate 321 is restored by the elastic force and the leaflet is clamped between the clip plate 321 and the support plate 322. Understandably, the opening and closing degree of the plywood 321 and the supporting plate 322 can be controlled by controlling the magnitude of the external force, that is, the opening degree of ">". The external force is typically applied by the control wire 100 of the delivery system.

As a detail of a further embodiment, the clamping plate 321 has a through elongated hole 3211, 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, the vertical portion 3222 extends along a long axis direction of the elongated hole 3211 within a range of the elongated hole 3211, the horizontal portion 3221 extends along a short axis direction of the elongated hole 3211 outside a range of the elongated hole 3211, and the horizontal portion 3221 is configured to abut 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.

Preferably, be equipped with barb structure 323 on sandwich panel 321, barb structure 323 includes long thorn 3231 and short thorn 3232, and the length dimension of long thorn 3231 is greater than the length dimension of short thorn 3232, and long thorn 3231 is including the fixed part 3233, connecting portion 3234 and the toper portion 3235 that connect gradually, fixed part 3233 is connected in sandwich panel 321, and short thorn 3232 plays the firm effect of support to long thorn 3231, and long thorn 3231 punctures the valve leaflet through toper portion 3235. The long spine 3231 penetrates into the leaflet, which can improve the capturing of the leaflet by the clip 32 and the stability and reliability of the clipping. In practice, the length of the long spine 3231 can be extended within an allowable range to improve the penetration effect and the penetration depth.

Referring to fig. 14, the present embodiment is not limited to the specific form of the tapered portion 3235, including but not limited to a cone and a pyramid (such as the rectangular pyramid shown in fig. 14). Compared with the conical part of the barb structure in the prior art which is triangular on a plane, the conical part 3235 of the barb structure 323 is conical in a spatial three-dimensional manner, so that the barb 3231 of the barb structure can puncture the valve leaflet more easily, and the barb structure is uniformly stressed on the valve leaflet tissue in the circumferential direction, thereby reducing the damage to the valve leaflet and having better stabilizing effect.

In an exemplary embodiment, referring to fig. 13, the engaging plate 321 is retractable along its extending direction (along the extending direction of the catching segment 311), which means that the engaging plate 321 has elasticity or elasticity along its extending direction. Thus, when the plywood 321 is opened by the control wire 100 and the supporting plate 322, the plywood 321 will be elongated adaptively for the patients with large leaflet prolapse or large distance between the anterior leaflet and the posterior leaflet; when the clamping plate 321 cooperates with the supporting plate 322 to clamp the valve leaflets, the barb structures 323 pierce through the long barbs 3231 in the valve leaflets, and after the external force applied by the control wire 100 is removed, the clamping plate 321 can gradually elastically recover to pull the valve leaflets, so as to improve the clamping repair effect on the valve leaflets. In this embodiment, the arrangement manner of the clip plate 321 having elasticity or elasticity is not particularly limited, in an exemplary embodiment, please refer to fig. 13, the clip plate 321 is made of an elastic material, the clip plate 321 includes a plurality of telescopic segments 3213 along the extending direction thereof, the telescopic segments 3213 substantially exhibit a waveform (including but not limited to a smooth wavy line shape or a sawtooth waveform), and the telescopic segments 3213 are extended by applying an external force and restored by removing the external force.

Based on the valve clamping system, the present embodiment further provides a medical repair device, referring to fig. 24, the medical repair device includes: the valve clamping system as described above; a delivery system comprising a guide wire 90 and a control wire 100, the guide wire 90 passing through the spacer body 10 to connect with a connector component for driving the connector component to move along the axial direction of the spacer body 10; the control wire 100 is connected to the clip 32 and is used for controlling the clipping state of the clip 32, i.e. operating the clip 32 to capture and clip the valve leaflets, and operating the clip 32 to capture and clip the valve leaflets again when the clipping effect of the clip 32 is not ideal. The guide wire 90 is passed through the connector 110 of the delivery system, the sealing gasket 50 of the valve clamping system, the proximal connector 40, the spacer 10, the support 60 and finally connected to the guide wire connector 70.

In an exemplary embodiment, referring to fig. 1, 3 and 11, 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 plate 321. During the operation, the spacer arm 31 is in the second form, preferably the second vertical form, under the combined action of the guide wire 90, the joint assembly and the pressing ring 33, or the spacer arm 31 just starts to enter the third form, at this time, the control wire 100 is operated to control the clamping plate 321 and the support plate 322 to be in the open state so as to capture and clamp the valve leaflet, specifically, the clamping state of the valve leaflet by the clamp 32 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, and can simultaneously operate the corresponding clamps 32, or can independently operate the corresponding clamps 32, so as to implement the function of separately opening and capturing the two clamp plates 321, thereby meeting the surgical requirements of the operation requirements of the single clamp 32 that may appear in the surgical process.

It should be noted that the present embodiment is only focused on the embodiment of the delivery system controlling the valve clamping system, and the working principle and other structural components of the delivery system, as well as other auxiliary components in the medical repair device, will not be described herein, and can be learned by those skilled in the art according to the prior art.

Based on the above, the present embodiment provides a valve clamping system as described above applied to a mitral valve or a tricuspid valve. Specifically, the spacer arms 31 of the valve clamping system are in the third configuration, the mitral valve or the valve leaflet of the tricuspid valve is clamped by the clamp 32, and the guide wire 100 and the pressing ring 33 urge the spacer arms 31 to close the spacer 10.

In conclusion, the invention can change different forms under the combined action of the pressing ring and the connector component by configuring the spacing arm, and the clamping device is arranged on the catching section to change the position of the clamping device along with the change of the form of the spacing arm, thereby completing the implantation of the clamping device, the catching and clamping of the valve and the edge-to-edge repair of the valve, so that the success rate of the implantation of the valve clamping system can be improved, the risk of implantation failure is reduced, the system implantation is safer, more reliable and more stable, the operation difficulty and the operation time in the operation process are reduced, the safety and the reliability in the operation process are improved, the risk caused by instruments in the operation process is reduced, and the inhibition of mitral regurgitation or tricuspid regurgitation of a patient is facilitated.

The above description is only for describing the preferred embodiment of the present invention, and it is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art according to the above disclosure are within the protection scope of the present invention.

Claims

1. A valve clamping system, comprising:

a spacer;

a support body located inside the spacer body and fixed near a distal end of the spacer body, the support body having a first guide hole penetrating in an axial direction of the spacer body;

the near end of the pressing ring is connected with the spacing part, and the far end of the pressing ring is connected with the joint assembly;

the clamp comprises a clamp plate and a support plate; the supporting plate is arranged on the capturing section; one end of the clamping plate is elastically connected with the supporting plate, so that the clamping plate is applied with an elastic force towards the supporting plate; the plywood is telescopic along the extension direction of the plywood; the first guide hole comprises a first hole section, a second hole section and a third hole section which are sequentially connected from a near end to a far end, the radial size of the first hole section and the radial size of the third hole section are both larger than the radial size of the second hole section, the radial size of the first hole section is gradually reduced from the near end to the far end, and the radial size of the third hole section is gradually increased from the near end to the far end;

the extending direction of double-layered board along self includes the flexible section of a plurality of, flexible section is the wave form, just flexible section is exerted external force and is extended to and remove external force and recover.

2. The valve clamping system of claim 1, further comprising a proximal joint connected to a proximal end of the spacer body;

3. The valve clamping system of claim 2, further comprising a sealing gasket connected to the proximal fitting, the sealing gasket having at least two third extensions extending radially outward of the spacer body, the third extensions having first snap-in slots therethrough;

the center of the sealing gasket is provided with a second through slot hole;

the first slot hole and the second slot hole are in a cutting joint shape.

4. The valve clamping system of claim 1, wherein the connector assembly comprises a guide wire connector, a distal connector and a covering connector arranged in a proximal to distal direction; the far end of the guide wire joint is fixedly clamped with the far end joint; the covering joint and the guide wire joint are fixed in a threaded mode.

5. The valve clamping system of claim 4, wherein the guide wire joint has a second guide hole, an axial direction of the second guide hole being parallel to an axial direction of the spacer; the cover joint is provided with a fifth extending part protruding towards the support body, and the fifth extending part is used for being in threaded connection with the second guide hole.

6. The valve clamping system of claim 4, wherein the guide wire connector has a sixth extension that is convex away from the spacer body, and the distal connector has a connector slot that is concave in a proximal-to-distal direction, the connector slot mating with the sixth extension.

7. The valve clamping system of claim 4, wherein the distal tab has a first attachment slot that is recessed radially outward of the spacer body, and wherein the distal end of the compression ring has a second attachment slot that is recessed radially inward of the spacer body, the first attachment slot mating with the second attachment slot; the near-end of clamping ring is equipped with two at least pressure holes that link up.

8. The valve clamping system of claim 1, wherein said clamping plate has a through elongated hole with a long axis parallel to said capturing section; the backup pad is including being horizontal portion and the perpendicular portion that T shape is connected, perpendicular portion is followed the major axis direction of rectangular hole extends in the scope in rectangular hole, horizontal portion is followed the minor axis direction of rectangular hole extends outside the scope in rectangular hole, just horizontal portion be used for with the plywood counterbalance leans on.

9. The valve clamping system of claim 8, wherein the clamping plate is provided with a barb structure, the barb structure comprises a long barb and a short barb, the long barb comprises a fixing part, a connecting part and a cone part which are connected in sequence, and the fixing part is connected to the clamping plate.

10. The valve clamping system of claim 9, wherein the taper is in the shape of a pyramid.

11. The valve clamping system of claim 1, wherein the spacer is woven from a plurality of wires.

12. The valve clamping system of claim 1, wherein said valve clamping system is covered by a cover membrane.