CN212261612U

CN212261612U - Artificial heart valve's implantation device

Info

Publication number: CN212261612U
Application number: CN202021191038.9U
Authority: CN
Inventors: 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Ketong Shanghai Medical Devices Co ltd
Priority date: 2020-06-24
Filing date: 2020-06-24
Publication date: 2021-01-01
Anticipated expiration: 2030-06-24

Abstract

The utility model discloses an implantation device of a prosthetic heart valve, which comprises a valve bracket, a prosthetic valve and an implantation device; the valve support comprises a support structure, and the support structure is used for supporting and jointing the original heart valve; the outer surface of the bottom of the support structure is connected with a fixing structure, and the fixing structure is used for being connected with an implantation device so that the implantation device can convey the valve support to a target position; the artificial valve is arranged inside the support structure and used for replacing the original heart valve. The utility model implants the artificial valve sewed on the valve support and the valve support into the damaged part of the atrioventricular valve through the implantation device to replace the damaged diseased valve to work normally.

Description

Artificial heart valve's implantation device

Technical Field

The utility model relates to the technical field of medical equipment, concretely relates to prosthetic heart valve's implantation device.

Background

Valves are membranous structures that can be opened and closed inside the organs of humans or some animals. Each individual has four valves in the heart. Namely, the aortic valve, which joins the left ventricle and the aorta, the pulmonary valve, which joins the right ventricle and the pulmonary artery, the mitral valve, which joins the left atrium and the left ventricle, and the tricuspid valve, which joins the right atrium and the right ventricle. They all act as one-way valves, allowing blood to flow only from one direction to the other, but not back.

The clinical common valvular diseases are the pathological changes of the mitral valve and the active valve. The aortic valve thickening with junction fusion is rheumatic, and the annular thickening or calcification is senile lesion. Congenital bilobal malformations see only two aortic valves. Valve prolapse is seen with a lengthy valve, with the mitral valve in systole prolapsing to the left atrium and the aortic valve in diastole prolapsing to the left ventricular outflow tract.

The mitral chordae tendineae may also be shown to shorten and thicken. Judging the nature of valvular disease from the morphological characteristics of the lesion, wherein if the anterior leaflet of the mitral valve is thickened, the valve is in a round bulge shape when in diastole, and the valve accords with rheumatic lesion; thickening or calcification of the posterior leaflet ring of the mitral valve is senile degenerative disease. The aortic valve thickening with junction fusion is rheumatic, and the annular thickening or calcification is senile lesion. Congenital bilobal malformations see only two aortic valves. Valve prolapse is seen with a lengthy valve, with the mitral valve in systole prolapsing to the left atrium and the aortic valve in diastole prolapsing to the left ventricular outflow tract.

The anchoring systems developed so far for atrioventricular prostheses are based on various ideas, among which are hooks that grab the mitral annulus or anchors that grab the anterior and/or posterior leaflets or the mitral triangle. Other solutions include a neochordae anchoring the prosthesis to the outer surface of the apex of the left ventricle. For the sake of simplicity, two different approaches have been identified: invasive anchoring and anatomic anchoring.

The invasive method looks for anchoring groove hooks that exit the stent and penetrate the heart tissue at the level of the ring or subcyclic layer. This idea is to mimic surgical sutures to hold the valve in place. The main advantage of this approach is that the prostheses can have a low ventricular profile because they do not need to be anchored using a mitral valve device or capturing the mitral valve leaflets, thus reducing the risk of creating left ventricular infarct zones, and can therefore be deployed from the left ventricle (retrograde) or from the apex of the left atrium (antegrade). However, there are three major disadvantages to using this approach; (i) it is well known that the left atrium is associated with thromboembolic events, especially in patients with mitral valve disease and atrial fibrillation, and it sounds logical that large atrial protrusions of this type of valve may increase the risk of such complications; (ii) low-profile ventricular valves are often associated with a high risk of paravalvular leakage due to the limited attachment area between the valve stent and the annulus/ventricular tissue; (iii) the tissue penetration of the hooks promotes secondary infection (endocarditis) due to the presence of chronic inflammation caused by tissue penetration of the hooks.

Most of traditional artificial heart valves adopt three-leaflet valves, when the three-leaflet valves are selected, the sizes, the thicknesses, the hardness, the fiber orientations and the like of the three-leaflet valves need to be highly matched, and the selection cost is high and the selection difficulty is high.

Therefore, the utility model provides a novel artificial heart valve implanting device.

SUMMERY OF THE UTILITY MODEL

The utility model aims to overcome the defects of the prior art and provides an implantation device of a prosthetic heart valve.

In order to realize the above purpose, the utility model adopts the following technical scheme:

an implantation device of a prosthetic heart valve comprises a valve bracket, a prosthetic valve and an implantation device; the valve support comprises a support structure, and the support structure is used for supporting and jointing the original heart valve; the outer surface of the bottom of the support structure is connected with a fixing structure, and the fixing structure is used for being connected with an implantation device so that the implantation device can convey the valve support to a target position; the artificial valve is arranged inside the support structure and used for replacing the original heart valve.

Further, the support structure is formed by one or more of weaving of a memory material, cutting of the memory material, cutting of laser and laser welding; the stent structure comprises a stent main body and a joint component arranged at the top of the stent main body, wherein the stent main body is of a net structure, and the shape of the joint component is matched with that of the original heart valve.

Furthermore, the fixing structure comprises a plurality of elastic buckles, and the elastic buckles are uniformly distributed on the outer surface of the bottom of the bracket main body; the fixed structure has smooth appearance.

Further, the diameter of the joint component is larger than that of the top of the bracket main body.

Further, the artificial valve is a single-lobe valve, and the angle between the valve leaflets and the valve in the single-lobe valve is 110-160 degrees; the single-leaf valve adopts a full biological membrane.

Further, the connection of the prosthetic valve to the stent structure may include one or more of suturing, articulating, and mechanical clamping.

Furthermore, the implantation device comprises an implantation rod, an outer sleeve and a guide mechanism, wherein the guide mechanism is sleeved in the implantation rod, and the implantation rod is sleeved in the outer sleeve.

Furthermore, implant pole one end and be equipped with the locking piece, fixed knot constructs to be equipped with and implants the locking piece assorted slotted hole of pole to make locking piece and slotted hole are connected, the mode of connecting includes one or more in riveting, the buckle.

Further, the implantation device further comprises a rope, the rope is arranged between the implantation rod and the outer sleeve, and the rope is connected with the locking block.

Furthermore, one end of the outer sleeve is provided with an elastic head, and the diameter of the through hole of the elastic head is larger than or equal to the outer diameter of the guide mechanism.

Compared with the prior art, the beneficial effects of the utility model are that:

1. the utility model implants the artificial valve and the valve bracket sewed on the valve bracket into the damaged part of the atrioventricular valve through the implantation device to replace the damaged diseased valve to work normally;

2. the utility model adopts the single-leaf valve made of the whole biological membrane, which can effectively prevent the blood from flowing back and can also prevent the leakage around the valve;

3. the fixing structure of the utility model can not only be fixed with the native valve, but also be clamped with the implantation rod, so that the valve support has simple structure and can be stably fixed at the native heart valve;

4. the utility model adopts the jointing component which is in the shape of a petal which is similar to the shape of the valve leaf of the original heart valve which is folded and loosened, and the petal-shaped structure needs to keep certain tension in the heart environment, so that the valve support can be more attached to the original heart valve;

5. the utility model discloses a rope separates locking block and fixed knot to prevent directly through withdrawing the implant and drive the produced elasticity of locking block and fixed knot structure separation and cause secondary damage to former valve.

Drawings

FIG. 1 is a block diagram of an implantation device for a prosthetic heart valve according to an embodiment;

FIG. 2 is a schematic structural diagram of a valve stent provided by an embodiment;

FIG. 3 is a schematic structural diagram of a prosthetic valve provided by an embodiment;

FIG. 4 is a schematic structural view of the prosthetic valve provided in the embodiment, which is disposed in a valve holder;

FIG. 5 is a schematic structural diagram of an implantation device provided by an embodiment;

FIG. 6 is a schematic view of an initially installed implant device provided by an embodiment;

FIG. 7 is a schematic view of the placement of the implant device at a damaged valve provided by the example;

FIG. 8 is a schematic view of a release valve stent provided in accordance with an embodiment;

FIG. 9 is a schematic illustration of a locking block separated from a securing structure provided by an embodiment;

wherein, 10, the valve support; 110. an engaging member; 120. a fixed structure; 130. a stent body; 140. a network structure; 20. a prosthetic valve; 201. a valve body; 202. a leaflet; 30. an implant device; 310. implanting a rod; 320. an outer sleeve; 330. a guide mechanism; 340. a rope; 350. a locking block; 360. an elastic head; a. a damaged valve.

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It is to be noted that the features in the following embodiments and examples may be combined with each other without conflict.

The present embodiment provides an implantation device of a prosthetic heart valve, as shown in fig. 1, including a valve holder 10, a prosthetic valve 20, an implantation device 30; the valve stent 10 comprises a stent structure, and the stent structure is used for propping and jointing the original heart valve; the bottom outer surface of the stent structure is connected with a fixing structure 120, and the fixing structure 120 is used for connecting with the implant device 30 so that the implant device 30 can deliver the valve stent 10 to a target position; a prosthetic valve 20 is disposed within the interior of the stent structure for replacing the native heart valve.

As shown in fig. 2, which is a schematic structural diagram of the valve stent 10, the valve stent 10 is formed by heat setting one or more of nitinol, titanium alloy and organic polymer, and the valve stent 10 includes a stent structure and a fixing structure 120, wherein the stent structure includes a stent main body 130 and a joint member 110;

the stent main body 130 is in a net structure 140, and after being shaped, the stent main body is expanded to keep an inverted truncated cone shape, the shape of the stent main body is similar to the structure of the original heart valve, and the artificial valve is also conveniently connected in the stent main body.

The engaging members 110 are arranged on the top of the stent body 130, and the diameter of the engaging members 110 is larger than that of the top of the stent body 130, specifically, the minimum diameter of the engaging members 110 after being fully expanded is larger than the maximum diameter of the fully expanded opening of the stent body 130, so as to prevent the valve stent 10 from falling off; the shape of the coaptation member 110 is matched with the shape of the original heart valve, the coaptation member 110 is in a petal shape, which is similar to the closed and loose shape of the valve leaves of the original heart valve, the petal-shaped structure needs to keep a certain tension in the heart environment, and the valve stent 10 can be more fit with the original heart valve.

The fixing structure 120 includes a plurality of elastic buckles, the elastic buckles are evenly distributed on the outer surface of the bottom of the support main body 130, one end of each elastic buckle is connected with the bottom of the support main body 130, the other end of each elastic buckle is suspended and separated from the support main body 130 by a certain gap, preferably, the size of the gap is the same as the thickness of the original heart valve, and the gap of each elastic buckle is clamped at the bottom of the original heart valve to prevent the valve support 10 from popping out. The fixation structure 120 is provided with a slot that mates with the implant device 30, such that the implant device 30 is attached to the slot and delivers the valve stent 10 to the target site.

As shown in fig. 3, which is a schematic structural diagram of the artificial valve 20, the artificial valve 20 is made of a whole biological film, and includes a valve main body 201 and valve leaflets 202, and an angle between the valve leaflets 201 and the valve leaflets 202 is 110 ° to 160 °; the valve leaflet 202 is preferably a single-lobe valve which has a simple structure, can effectively prevent blood from flowing backwards, and can also prevent paravalvular leakage. Typically, the prosthetic valve is attached to the interior surface of the valve stent 10, which attachment may be mechanical clamping, suturing, articulating, or the like.

As shown in fig. 4, which is a structural diagram of the prosthetic valve 20 disposed in the valve holder 10, the prosthetic valve 20 is attached to the holder main body 130 and the joint member 110 by mechanical clamping or sewing or hinging, and when the attachment is completed, the prosthetic valve 20 and the valve holder 10 can contract and relax simultaneously.

Fig. 5 is a schematic structural view of the implantation device 30, which includes an implantation rod 310, an outer sleeve 320, a guiding mechanism 330, and a rope 340, wherein the guiding mechanism 330 is sleeved in the implantation rod 310, the implantation rod 310 is sleeved in the outer sleeve 320, and the implantation rod 310 can be inserted into the outer sleeve 320 to move freely; the cable 340 is disposed between the implant rod 310 and the outer sleeve 320.

The implantation rod 310 is provided with a locking block 350 at one end, the locking block 350 is used for connecting with the fixing structure 120 of the valve stent 10, so that the valve stent 10 can be stably fixed on the implantation rod 310, wherein the connecting mode comprises one or more of riveting and buckling; the locking block 350 is also bolted to the cable 340, and after the implantation device delivers the valve stent to the target site, the cable 340 is pulled by an external force to disengage the locking block 350 from the fixation structure 120.

One end of the outer sleeve 320 is provided with an elastic head 360, the elastic head 360 is in a round table shape (similar to a pen point), the diameter of the through hole of the elastic head 360 is larger than or equal to the outer diameter of the guide mechanism 330, and the elastic head is made of soft material (such as rubber and the like), so that the diameter of the through hole can be increased; particularly, after the valve stent reaches the target position, the valve stent is released out of the elastic head part after the outer sleeve pipe is withdrawn, and the valve stent can be extruded out of the elastic head part in the releasing process due to the elasticity of the elastic head part.

The guiding mechanism 330 is connected with the implanted rod 310, and the material of the guiding mechanism is flexible. The guide is initially curved in shape and is intended to pass through the aortic arch (since it is curved) without causing damage to the heart, and when the procedure is completed, the guide becomes straight when the device is withdrawn, with the aim of providing a solution for withdrawal from the body. It should be noted that the guiding mechanism is the prior art, and this embodiment is not described in detail.

In this embodiment, the implantation method of the artificial heart valve is specifically as follows:

in the initial installation, as shown in fig. 6, the prosthetic valve 20 is attached to the inside of the valve holder 10 by mechanical clamping or suturing or hinge, then the rope 340 is bolted to the locking block 350 on one side of the implantation rod 310, the bolted locking block 350 is locked in the locking slot of the fixing structure 120, then the guiding mechanism 330 is sleeved in the implantation rod 310, the implantation rod 310 is sleeved in the outer sleeve 320, and at this time, the rope 340 is disposed between the implantation rod 310 and the outer sleeve 320, and the valve holder 10 is in the contracted state.

During implantation, as shown in fig. 7, the entire implant system is guided to the location to be implanted, which may be the mitral valve or the aortic valve, by the guiding mechanism 330; the elastic head 360 of the outer sleeve 330 is now placed at the damaged valve a; then slowly recovering the outer casing 330, releasing the valve stent 10 out of the elastic head 360, i.e. exposing the valve stent 10 to the damaged valve a; because the engagement members 110 of the valve stent 10 have elasticity, the engagement members 110 of the valve stent 10 are expanded to the inner wall of the heart in a petaloid shape (as shown in fig. 8); then, the locking block 350 is separated from the fixing structure 120 by pulling the rope 340 (as shown in fig. 9), the outer casing 320 and the implantation rod 310 are continuously and slowly recovered, so that the whole valve stent 10 is released, the whole valve stent 10 is fully expanded (including the closing member 110 and the stent main body 130) to the inner wall of the heart, the fixing structure 120 arranged at the bottom of the stent main body 130 is clamped at the bottom of the original heart valve, and finally the implantation device 30 is removed from the body, so as to complete the implantation of the valve stent.

The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications, additions and substitutions for the specific embodiments described herein may be made by those skilled in the art without departing from the spirit of the invention or exceeding the scope of the invention as defined in the accompanying claims.

Claims

1. An implantation device of a prosthetic heart valve is characterized by comprising a valve bracket, a prosthetic valve and an implantation device; the valve support comprises a support structure, and the support structure is used for supporting and jointing the original heart valve; the outer surface of the bottom of the support structure is connected with a fixing structure, and the fixing structure is used for being connected with an implantation device so that the implantation device can convey the valve support to a target position; the artificial valve is arranged inside the support structure and used for replacing the original heart valve.

2. The prosthetic heart valve implant device of claim 1, wherein the stent structure is formed using one or more of memory material weaving, memory material cutting, laser welding; the stent structure comprises a stent main body and a joint component arranged at the top of the stent main body, wherein the stent main body is of a net structure, and the shape of the joint component is matched with that of the original heart valve.

3. The device for implanting the prosthetic heart valve as claimed in claim 2, wherein the fixing structure comprises a plurality of elastic buckles, and the plurality of elastic buckles are uniformly distributed on the outer surface of the bottom of the stent body; the fixed structure has smooth appearance.

4. The device of claim 2, wherein the engagement member has a diameter greater than a diameter of the top of the stent body.

5. The device for implanting the artificial heart valve as claimed in claim 1, wherein the artificial valve is a single-leaflet valve, and the angle between the leaflet and the valve in the single-leaflet valve is 110-160 °; the single-leaf valve adopts a full biological membrane.

6. An implantation device of a prosthetic heart valve as claimed in claim 5, wherein the means of attachment of the prosthetic valve to the stent structure comprises one or more of suturing, articulating, mechanical clamping.

7. The device for implanting the artificial heart valve as claimed in claim 1, wherein the device comprises an implanting rod, an outer casing and a guiding mechanism, the guiding mechanism is sleeved in the implanting rod, and the implanting rod is sleeved in the outer casing.

8. The device as claimed in claim 7, wherein the implantation rod has a locking block at one end, and the fixing structure has a slot matching with the locking block of the implantation rod, so that the locking block is connected with the slot by one or more of riveting and snapping.

9. The prosthetic heart valve implant device of claim 8, further comprising a tether disposed between the implant rod and the outer sleeve, the tether coupled to the locking block.

10. The device for implanting the prosthetic heart valve as claimed in claim 7, wherein an end of the outer sleeve is provided with an elastic head, and a diameter of a through hole of the elastic head is larger than or equal to an outer diameter of the guiding mechanism.