CN111772883B

CN111772883B - Mitral valve repair system

Info

Publication number: CN111772883B
Application number: CN202010860093.0A
Authority: CN
Inventors: 徐靖; 王耀鹏
Original assignee: Shijiazhuang Dizhong Medical Device Technology Co ltd
Current assignee: Shijiazhuang Dizhong Medical Device Technology Co ltd
Priority date: 2020-08-24
Filing date: 2020-08-24
Publication date: 2024-08-20
Anticipated expiration: 2040-08-24
Also published as: CN111772883A

Abstract

The invention provides a mitral valve repair system, and relates to the technical field of medical appliances. The mitral valve repair system comprises a delivery sheath, a guide tube, a puncture member and a support member; the support piece is arranged at the outlet end of the conveying sheath pipe; the guide tube is arranged in the conveying sheath tube, and the puncture member is movably arranged in the guide tube; the guide tube is used for guiding the puncture member to the outlet end of the delivery sheath tube and abutting the support member, and the puncture member is used for connecting the anterior leaflet and the posterior leaflet of the mitral valve. Compared with the conventional clamping repair method, the mitral valve repair system provided by the invention has the advantages that the puncture piece is utilized to realize the connection repair of the anterior leaflet and the posterior leaflet of the mitral valve, so that the closure stability of the mitral valve and the long-acting use property of the mitral valve repair system are greatly improved. In addition, the puncture member can be designed to be small and light, is convenient to operate, reduces interference to the heart, and improves the operation safety.

Description

Mitral valve repair system

Technical Field

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

Background

The mitral valve is a valve between the left atrium and the left ventricle, and when the mitral valve is not completely closed, blood can regurgitate back to the left atrium, i.e. mitral regurgitation occurs, which causes a series of pathological changes and clinical symptoms of the heart, which in severe cases can lead to heart failure.

Surgery for treating the above-mentioned diseases is diverse. Wherein, according to the operation method, different classifications include surgical open chest operation and minimally invasive intervention operation, and according to the valve treatment mode, different classifications include mitral valve repair operation and valve replacement operation. Clinically, for elderly patients with history of thoracotomy, poor cardiac function, combined multi-organ dysfunction, and mild mitral regurgitation, interventional repair procedures, i.e., transcatheter mitral valve pinching, are commonly employed.

Transcatheter mitral valve clamping typically uses a clamping device to clamp and secure the partially closed mitral valve. The clamping device utilizes two sets of parallel clamping plates or clips that can be closely attached to each other to clamp a smooth valve. However, in the follow-up observation of the patient, the clamping device has the defects of insufficient stability and poor long-acting performance.

Disclosure of Invention

The object of the present invention is to provide a mitral valve repair system that helps to solve the above mentioned technical problems.

The invention is realized in the following way:

A mitral valve repair system comprising a delivery sheath, a guide tube, a penetrating member, and a support member; the support piece is arranged at the outlet end of the conveying sheath pipe; the guide tube is arranged in the conveying sheath tube, and the puncture element is movably arranged in the guide tube; the guide tube is used for guiding the puncture member to the outlet end of the delivery sheath tube and abutting the support member, and the puncture member is used for connecting the anterior leaflet and the posterior leaflet of the mitral valve.

In use, the mitral valve repair system described above is first pushed through the delivery sheath to the surgical site with the valve of the mitral valve between the support and the outlet of the guide tube. The penetrating member is then rotated or pushed along the guide tube and through the valve of the mitral valve to effect the penetrating fixation of the mitral valve. The support and guide tube are then withdrawn from the delivery sheath. Finally, the delivery sheath is withdrawn.

It should be noted that, the conventional thickness of human mitral valve is 1-2 mm, and the puncture member should be designed according to this data, so as to meet the requirement that the mitral valve can be repaired and locked after passing through the anterior leaflet and the posterior leaflet of the mitral valve.

Further, the puncture element comprises a puncture spring and a pushing steel cable; the tail end of the puncture spring is pointed, and the starting end of the puncture spring is detachably arranged on the pushing steel cable. The technical effects are as follows: firstly, the appearance structure of the puncture spring is spiral, which is favorable for fixing after puncture and prevents the puncture spring from falling off from the valve. Secondly, the appearance structure of puncture spring is spiral, does benefit to and carries out rotatory propelling movement control to it, passes the valve fast. Again, the push wire cable has a certain stiffness and is easy to bend, so that the puncture spring can be pushed to move forward along the bent guide tube. Finally, the pushing steel cable has large torque and is easy to rotate.

Further, the puncture spring is made of cobalt-based alloy material. The technical effects are as follows: cobalt-based alloys are alloys formed by adding other alloying elements based on cobalt. Non-magnetic cobalt alloys have high strength and excellent corrosion resistance, and have been demonstrated to be compatible and reliable for medical implants in long-term use. Wherein, the puncture spring is preferably made of cobalt-chromium alloy.

Further, the curvature of the guide tube can be adjusted. The technical effects are as follows: the curvature of the guide tube is adjusted so that the outlet end of the guide tube is directed towards the support. The middle mitral valve can be pierced when the piercing member pierces from the guide tube and abuts the support member.

Further, the support comprises a push tube; the curvature of the pushing tube can be adjusted. The technical effects are as follows: the pushing tube is beneficial to adjusting the curvature and changing the pushing direction in the pushing process, and the center of the cylindrical port is used for accommodating the puncture spring and the edge of the port is used for limiting the mitral valve, so that the puncture and fixation effects of the puncture spring are improved.

Further, the device also comprises a guide piece movably arranged in the conveying sheath tube; the guide piece comprises a pushing rod and a top block which are connected with each other; the pushing rod is used for pushing the ejector block to the outlet end of the conveying sheath tube. The technical effects are as follows: the guide member is capable of being advanced from the delivery sheath until it is at the forward end of the guide tube and support member, with which it is used to guide the delivery sheath in the vessel in the correct direction.

Further, the pushing rod is in a shuttle shape, and one tip end of the pushing block is connected with the pushing rod. The technical effects are as follows: the front end of the shuttle-shaped ejector block is small in size, so that the resistance is small when the ejector block is pushed forward in a blood vessel, and the damage to the wall of the blood vessel is not easy to happen. The rear end of the shuttle-shaped top block is smaller in size, and the inner wall of the blood vessel is not easily damaged in the process of withdrawing the top block and the whole guide piece. Preferably, the maximum diameter of the top piece is equal to the outer diameter of the delivery sheath.

Further, a first traction rope is arranged on the conveying sheath tube; the first haulage rope is arranged in the side wall of the conveying sheath pipe, and the extending direction of the first haulage rope is parallel to the axis of the conveying sheath pipe. The technical effects are as follows: the first haulage rope is used for changing the bending direction of the delivery sheath, and when the first haulage rope is pulled, the delivery sheath can deflect towards one direction.

Further, a second traction rope is arranged on the conveying sheath tube; the second haulage rope is arranged in the side wall of the conveying sheath pipe, and the axes of the first haulage rope, the second haulage rope and the conveying sheath pipe are positioned in the same plane. The technical effects are as follows: the second traction rope is also used for changing the bending direction of the conveying sheath pipe, and the first traction rope and the second traction rope can be pulled to enable the conveying sheath pipe to deflect in opposite directions, so that the operation efficiency is improved. And, mitral valve repair system's suitability is stronger.

Further, a third traction rope is arranged on the conveying sheath tube; the third traction rope is arranged in the side wall of the conveying sheath pipe, and the extending direction of the third traction rope is parallel to the axis of the conveying sheath pipe; the axis of the third traction rope and the axis of the conveying sheath tube are set to be located on a first plane, the first traction rope and the second traction rope are set to be located on a second plane, and the first plane and the second plane are perpendicular to each other. The technical effects are as follows: the third traction rope is also used for changing the bending direction of the conveying sheath tube. At this time, the first traction rope, the second traction rope, and the third traction rope are pulled out, respectively, so that the delivery sheath can be deflected to the left, right, and lower sides.

Further, the guiding tube and the pushing tube are similar to the conveying sheath tube, and one, two or three traction ropes are arranged to realize self directional deflection.

The beneficial effects of the invention are as follows:

Compared with the conventional clamping repair method, the mitral valve repair system provided by the invention has the advantages that the puncture piece is utilized to realize the connection repair of the anterior leaflet and the posterior leaflet of the mitral valve, so that the closure stability of the mitral valve and the long-acting use property of the mitral valve repair system are greatly improved. In addition, the puncture member can be designed to be small and light, is convenient to operate, reduces interference to the heart, and improves the operation safety.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic diagram of a mitral valve repair system according to a first embodiment of the present invention;

FIG. 2 is a schematic diagram of a mitral valve repair system according to a second embodiment of the present invention;

FIG. 3 is a schematic diagram of a mitral valve repair system according to a third embodiment of the present invention;

FIG. 4 is a schematic diagram of a mitral valve repair system according to a fourth embodiment of the present invention;

FIG. 5 is a schematic view of a puncture spring in a mitral valve repair system according to a fourth embodiment of the present invention;

FIG. 6 is a schematic view of a delivery sheath in a mitral valve repair system according to a fifth embodiment of the present invention;

FIG. 7 is a schematic view of a delivery sheath in a mitral valve repair system according to a sixth embodiment of the present invention;

FIG. 8 is a schematic view of a delivery sheath in a mitral valve repair system according to a seventh embodiment of the present invention;

FIG. 9 is a cross-sectional view taken along line A-A of FIG. 8;

Fig. 10 is a schematic diagram illustrating operation of the mitral valve repair system provided by the present invention during a surgical procedure.

In the figure: 100-delivery sheath; 101-a first traction rope; 102-a second traction rope; 103-a third traction rope; 200-guiding tube; 300-piercing member; 301-piercing a spring; 302-pushing a wire rope; 400-support; 401-pushing the tube; 500-guides; 600-valve.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. It will be apparent that the described embodiments are some, but not all, embodiments of the invention. The components of the embodiments of the present invention, as generally described and illustrated in the figures, can be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.

In the description of the present invention, it should be noted that, directions or positional relationships indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., are directions or positional relationships based on those shown in the drawings, or are directions or positional relationships conventionally put in use of the inventive product, are merely for convenience of describing the present invention and simplifying the description, and are not indicative or implying that the apparatus or element to be referred to must have a specific direction, be constructed and operated in a specific direction, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used merely to distinguish between descriptions and should not be construed as indicating or implying relative importance.

Furthermore, the terms "horizontal," "vertical," "overhang," and the like do not denote a requirement that the component be absolutely horizontal or overhang, but rather may be slightly inclined. As "horizontal" merely means that its direction is more horizontal than "vertical", and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

In the description of the present invention, it should also be noted that, unless explicitly specified and limited otherwise, the terms "disposed," "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

Some embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following embodiments and features of the embodiments may be combined with each other without conflict.

First embodiment:

Fig. 1 is a schematic structural diagram of a mitral valve repair system according to a first embodiment of the present invention. Referring to fig. 1, the present embodiment provides a mitral valve repair system comprising a delivery sheath 100, a guide tube 200, a puncture 300, and a support 400.

Wherein the support 400 is provided at the outlet end of the delivery sheath 100; the guide tube 200 is arranged in the delivery sheath 100, and the puncture member 300 is movably arranged in the guide tube 200; the guide tube 200 is used to guide the penetrating member 300 to the outlet end of the delivery sheath 100 and against the support 400, and the penetrating member 300 is used to connect the anterior leaflet and the posterior leaflet of the mitral valve.

The puncture element 300 may be movably disposed in the guide tube 200 or may be detachably mounted at the distal end of the guide tube 200 to be separated from the guide tube 200 after the puncture.

The support 400 may be a rigid bar structure, or may be a rod or tube capable of bending and deflecting. To facilitate piercing fixation of piercing member 300, rod-shaped support member 400 may be provided with a recess or counterbore at the distal end.

Among them, the diameter of the delivery sheath 100 is preferably set to 20F to 26F according to the actual size of the human body.

The operation principle and operation method of the mitral valve repair system of the present embodiment are as follows:

First, the support 400 and guide tube 200 are pushed through the delivery sheath 100 to the surgical site with the valve 600 of the mitral valve between the support 400 and the outlet of the guide tube 200. Next, the penetrating member 300 is rotated or pushed along the guide tube 200 and passed through the valve 600 of the mitral valve, thereby achieving the penetrating fixation of the valve 600 of the mitral valve. The support 400 and guide tube 200 are then withdrawn from the delivery sheath 100. Finally, the delivery sheath 100 is withdrawn.

Second embodiment:

Fig. 2 is a schematic structural diagram of a mitral valve repair system according to a second embodiment of the present invention. Referring to fig. 2, the present embodiment provides a mitral valve repair system, which is substantially the same as the mitral valve repair system of the first embodiment, and differs therefrom in that a puncture member 300 in the mitral valve repair system of the present embodiment includes a puncture spring 301 and a push wire cable 302; the tail end of the puncture spring 301 is pointed, and the starting end of the puncture spring 301 is detachably arranged on the pushing steel cable 302.

Further, as shown in fig. 2, the puncture spring 301 is made of a cobalt-based alloy material.

Further, as shown in fig. 2, the curvature of the guide tube 200 can be adjusted.

Among them, the outer diameter of the puncture spring 301 is preferably set to 2.5 mm to 3.5 mm, and the length is preferably set to 4 mm to 8mm.

Third embodiment:

Fig. 3 is a schematic structural diagram of a mitral valve repair system according to a third embodiment of the present invention. Referring to fig. 3, the present embodiment provides a mitral valve repair system which is substantially the same as the mitral valve repair system of the first embodiment or the second embodiment, and differs in that the support 400 in the mitral valve repair system of the present embodiment includes a pushing tube 401; the curvature of the ejector barrel 401 can be adjusted.

Fourth embodiment:

FIG. 4 is a schematic diagram of a mitral valve repair system according to a fourth embodiment of the present invention; fig. 5 is a schematic structural view of a puncture spring 301 in a mitral valve repair system according to a fourth embodiment of the present invention. Referring to fig. 4 and 5, the present embodiment provides a mitral valve repair system, which is substantially the same as any one of the first to third embodiments, and differs from the first embodiment in that the mitral valve repair system further comprises a guide 500 movably disposed in the delivery sheath 100; the guide 500 includes a push rod and a top block connected to each other; the push rod is used to push the pusher block to the outlet end of the delivery sheath 100.

Wherein, as shown in fig. 4, the top block is in a shuttle shape, and one tip of the top block is connected with the pushing rod.

Fifth embodiment:

fig. 6 is a schematic structural view of a delivery sheath 100 in a mitral valve repair system according to a fifth embodiment of the present invention. Referring to fig. 6, the present embodiment provides a mitral valve repair system, which is substantially the same as any one of the first to fourth embodiments, and differs from the first embodiment in that a first traction rope 101 is disposed on a delivery sheath 100 in the mitral valve repair system; the first drawing rope 101 is built in the side wall of the delivery sheath 100, and the extending direction of the first drawing rope 101 is parallel to the axis of the delivery sheath 100.

Sixth embodiment:

Fig. 7 is a schematic structural diagram of a delivery sheath 100 in a mitral valve repair system according to a sixth embodiment of the present invention. Referring to fig. 7, the present embodiment provides a mitral valve repair system, which is substantially the same as the mitral valve repair system of the fifth embodiment, and differs from the fifth embodiment in that a second traction rope 102 is further provided on a delivery sheath 100 in the mitral valve repair system; the second haulage cable 102 is built into the side wall of the delivery sheath 100, and the axes of the first haulage cable 101, the second haulage cable 102 and the delivery sheath 100 are located in the same plane.

Seventh embodiment:

FIG. 8 is a schematic view of a delivery sheath 100 in a mitral valve repair system according to a seventh embodiment of the present invention; fig. 9 is a cross-sectional view taken along A-A in fig. 8. Referring to fig. 8 and 9, the present embodiment provides a mitral valve repair system, which is substantially the same as the mitral valve repair system of the sixth embodiment, and is different in that a third traction rope 103 is further provided on a delivery sheath 100 in the mitral valve repair system of the present embodiment; the third haulage rope 103 is built in the side wall of the delivery sheath 100, and the extending direction of the third haulage rope 103 is parallel to the axis of the delivery sheath 100; the third traction rope 103 and the axis of the delivery sheath 100 are set to be positioned on a first plane, the first traction rope 101 and the second traction rope 102 are set to be positioned on a second plane, and the first plane and the second plane are mutually perpendicular.

It should be noted that, the guide tube 200 and the pushing tube 401 may be configured similar to the delivery sheath tube 100, and one, two or three haulage ropes may be provided to implement the direction deflection.

In addition, the first traction rope 101, the second traction rope 102 and the third traction rope 103 each include two sections extending forward and backward in the delivery sheath 100, and the front ends are connected to each other without fixing one end of the traction rope in the delivery sheath 100.

Fig. 10 is a schematic diagram illustrating operation of the mitral valve repair system provided by the present invention during a surgical procedure. In summary, the overall surgical procedure of the mitral valve repair system provided by the present invention includes:

Step 1, firstly, the guide catheter 200 and the superhard guide wire are conveyed to the right atrium through a femoral artery access, after the atrial septum is punctured, the guide catheter 200 and the superhard guide wire are conveyed to the left ventricle part from the left atrium, and then the guide catheter 200 is withdrawn.

Step 2, the pushing tube 401, the guide tube 200 (comprising the puncture spring 301 and the pushing steel cable 302) and the guide piece 500 are placed in the conveying sheath 100 and conveyed into the left ventricle through the superhard guide wire.

Step3, pushing the guide 500 to the front end of the delivery sheath 100, and pushing the pushing tube 401 and the guide tube 200 (including the puncture spring 301 and the pushing wire 302) to a specified position, so that the valve 600 of the mitral valve is located between the pushing tube 401 and the outlet of the guide tube 200. At this point the mitral valve is pierced by piercing spring 301, where the anterior and posterior mitral valve leaflets are joined, thereby forming a double orifice inflow channel.

Step 4, the pushing steel cable 302, the guide tube 200 and the pushing tube 401 at the tail end of the puncture spring 301 are retracted, and finally the guide piece 500 and the delivery sheath tube 100 are withdrawn.

Step 5, if mitral regurgitation is serious, the doctor needs to increase the number of placement of the puncture springs 301, and repeat the operations of step 2, step 3 and step 4.

The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A mitral valve repair system, comprising a delivery sheath (100), a guide tube (200), a piercing member (300), and a support member (400);

The support (400) is arranged at the outlet end of the delivery sheath (100); the guide tube (200) is arranged in the conveying sheath tube (100), and the puncture piece (300) is movably arranged in the guide tube (200);

The guide tube (200) is used for guiding the puncture element (300) to the outlet end of the delivery sheath tube (100) and abutting the support (400), and the puncture element (300) is used for connecting the anterior leaflet and the posterior leaflet of the mitral valve;

the puncture member (300) comprises a puncture spring (301) and a push wire cable (302); the tail end of the puncture spring (301) is pointed, and the starting end of the puncture spring (301) is detachably arranged on the pushing steel cable (302);

-the curvature of the guide tube (200) is adjustable; the support (400) comprises a push tube (401); the curvature of the pushing tube (401) can be adjusted;

the guide piece (500) is movably arranged in the conveying sheath tube (100); the guide (500) comprises a pushing rod and a pushing block which are connected with each other, wherein the pushing rod is used for pushing the pushing block to the outlet end of the conveying sheath tube (100);

The conveying sheath tube (100) is provided with a first traction rope (101), a second traction rope (102) and a third traction rope (103); the first traction rope (101), the second traction rope (102) and the third traction rope (103) are all arranged in the side wall of the conveying sheath tube (100); the extending direction of the first traction rope (101) is parallel to the axis of the conveying sheath tube (100), and the axes of the first traction rope (101), the second traction rope (102) and the conveying sheath tube (100) are positioned in the same plane; the extending direction of the third traction rope (103) is parallel to the axis of the conveying sheath tube (100); setting the axes of the third traction rope (103) and the conveying sheath tube (100) to be positioned on a first plane, and setting the first traction rope (101) and the second traction rope (102) to be positioned on a second plane, wherein the first plane and the second plane are mutually perpendicular.

2. The mitral valve repair system of claim 1, wherein the puncture spring (301) is made of a cobalt-based alloy material.

3. The mitral valve repair system of claim 1, wherein the top piece is shuttle-like with one of the tips of the top piece coupled to the push rod.