CN219042819U

CN219042819U - Stentless prosthetic valve

Info

Publication number: CN219042819U
Application number: CN202222048303.3U
Authority: CN
Inventors: 于存涛; 赵锐
Original assignee: Fuwai Hospital of CAMS and PUMC
Current assignee: Fuwai Hospital of CAMS and PUMC
Priority date: 2022-08-04
Filing date: 2022-08-04
Publication date: 2023-05-19
Anticipated expiration: 2032-08-04

Abstract

The embodiment of the application discloses a prosthetic valve without a bracket, which comprises: an aortic annular part, a Dou Bu and a vascular part which are communicated sequentially from bottom to top; the Dou Bu is in a ampullate structure, the sinus is formed by encircling three petal structures, and the petal structures comprise inner side surfaces and radially protruding outer side surfaces; the inner side surfaces of the three valve body structures are respectively connected and fixed with dry artificial valve leaves, and blood flow channels are formed by enclosing the three dry artificial valve leaves. The opening and closing of the three artificial valve leaves are close to the normal state of the human body, and the three artificial valve leaves can be freely opened and closed, so that the activity degree of the three artificial valve leaves is improved, and the service life of the artificial valve is prolonged; when the three artificial valve leaflets are opened, a larger opening area can be provided, the pressure difference at two sides of the artificial valve is reduced, the artificial valve is more fit with the hemodynamics of a human body, the service life of the artificial valve is prolonged, and the life quality of a patient is improved.

Description

Stentless prosthetic valve

Technical Field

The present application relates to the technical field of medical devices, and more particularly, to a stentless prosthetic valve.

Background

Heart valve disease is the most common heart disease, and aortic valve replacement with artificial blood vessels (Bentall surgery) is an effective treatment when an ascending aortic aneurysm is accompanied by an aortic valve insufficiency. The existing artificial blood vessel with aortic valve mainly has mechanical valve or biological valve, and the mechanical valve has longer service life, but needs lifelong anticoagulation, thus obviously reducing the life quality of patients. The biological valve is mainly a porcine aortic valve or bovine pericardial valve treated by glutaraldehyde, is transported and stored to be soaked in glutaraldehyde, cannot be prefabricated with an artificial blood vessel, needs to be sutured in operation, and increases operation time.

The biological valve used at present comprises a bracket, the use of the bracket occupies the opening area when the biological valve is opened, the pressure difference at two sides of the artificial valve is increased, and the situation that the valve is not matched with a human body is easy to occur.

Accordingly, to overcome the deficiencies of the prior art, it is desirable to provide a stentless prosthetic valve.

Disclosure of Invention

The present utility model aims to provide a stentless prosthetic valve which solves at least one of the above-mentioned technical problems.

In order to achieve at least one of the above purposes, the present application adopts the following technical solutions:

the present application provides a stentless prosthetic valve comprising:

an aortic annular part, a Dou Bu and a vascular part which are communicated sequentially from bottom to top;

the Dou Bu is in a ampullate structure, the sinus is formed by encircling three petal structures, and the petal structures comprise inner side surfaces and radially protruding outer side surfaces;

the inner side surfaces of the three valve body structures are respectively connected and fixed with dry artificial valve leaves, and blood flow channels are formed by enclosing the three dry artificial valve leaves.

Optionally, the artificial leaflet includes: valve and leaflet combination;

the artificial valve leaflet is fixedly connected with the inner side wall of the sinus through the valve leaflet combination part.

Optionally, the valve portion is half-moon shaped in shape.

Optionally, the leaflet combination section is secured to the inner sidewall of the sinus section by an adhesive or suture connection.

Optionally, the artificial valve leaflet is a dried porcine aortic valve, a dried bovine pericardium or a polyurethane polymer artificial synthetic material.

Optionally, the vessel part is a straight tube type structure.

Optionally, the aortic annulus is of a straight barrel configuration.

Optionally, the aortic annular part Dou Bu and the vascular part are made of polyurethane polymer materials.

Optionally, the polyurethane polymer material is polyurethane.

The beneficial effects of this application are as follows:

aiming at the problems existing in the prior art, the application provides a bracket-free artificial valve, wherein the sinus part formed by surrounding three valve body structures is highly similar to the structure of a human body, and the opening and closing of three artificial valve leaves can be close to the normal state of the human body, so that the service life of the artificial valve leaves is prolonged, and the later secondary operation is avoided; the three artificial valve leaflets can be freely opened and closed, and the three artificial valve leaflets are similar to the natural anatomical form of a human body, so that the activity of the artificial valve leaflets is improved; in addition, the artificial valve leaflet realizes a bracket-free structure, and when three artificial valve leaflets are opened, a larger opening area can be provided, so that the pressure difference at two sides of the artificial valve leaflet is reduced, and the artificial valve leaflet is more suitable for the hemodynamics of a human body. The dry preserved artificial valve leaflet can be prefabricated with the artificial blood vessel, thereby reducing the time for suturing the artificial valve leaflet and the artificial blood vessel in the operation. The artificial valve without the bracket can replace the root structure of the human aorta, can be suitable for aortic valve diseases combined with the expansion of the ascending aorta or the aneurysm of the ascending aorta, reduces operation difficulty and operation time in operation, fits normal blood flow of the human body, prolongs the service life of artificial valve leaves, and improves the life quality of patients.

Drawings

The following describes the embodiments of the present utility model in further detail with reference to the drawings.

Fig. 1 shows a schematic overall external structural view of a stentless prosthetic valve in one embodiment of the present application.

Fig. 2 shows a schematic overall structure of a stentless prosthetic valve in one embodiment of the present application.

Fig. 3 shows a schematic structural view of the sinus portion of a stentless prosthetic valve in connection with a prosthetic leaflet in one embodiment of the present application.

Detailed Description

In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of one or more embodiments. It may be evident, however, that such embodiment(s) may be practiced without these specific details.

In the description of the present application, it should be noted that the azimuth or positional relationship indicated by the terms "upper", "lower", etc. are based on the azimuth or positional relationship shown in the drawings, and are merely for convenience of description of the present application and simplification of the description, and are not indicative or implying that the apparatus or element in question must have a specific azimuth, be configured and operated in a specific azimuth, and thus should not be construed as limiting the present application. Unless specifically stated or limited otherwise, the terms "mounted," "connected," and "coupled" 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 terms in this application will be understood by those of ordinary skill in the art as the case may be.

It should also be noted that in the description of the present application, relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.

To address the problems of the prior art, one embodiment of the present application provides a stentless prosthetic valve comprising: an aortic annular part 1, a sinus part 2 and a blood vessel part 4 which are communicated in sequence from bottom to top; wherein, the joint of the sinus part 2 and the blood vessel part 4 is a sinus canal junction part 3; the aortic annular part 1, the sinus part 2 and the sinus canal junction 3 form a structure similar to the vascular structure of the root of the human aorta; the aortic annulus 1 has a size of 2cm to 5cm and the vessel 4 has a size of 5cm to 15cm; the sinus part 2 is in a ampullate structure, the sinus part 2 is formed by enclosing three valve body structures, and the valve body structures comprise inner side surfaces and radially protruding outer side surfaces; the inner side surfaces of the three valve body structures are respectively connected and fixed with dry artificial valve leaves 5, and blood flow channels 6 are formed by enclosing the three dry artificial valve leaves 5; when the three valve portions 51 are opened, blood flows from the aortic annular portion 1 into the blood vessel portion 4 through the blood flow channel 6. The artificial valve 5 can be preserved by drying during preservation, and the dried and preserved artificial valve 5 can be combined with the aortic annular part 1, the sinus part 2 and the blood vessel part 4 to form an integrated structure.

In the above embodiment of the present application, the sinus part 2 formed by enclosing the three valve structures is highly similar to the structure of the human body, so that the opening and closing of the three artificial valve leaves 5 can be close to the normal state of the human body, thereby prolonging the service life of the artificial valve leaves 5 and avoiding the secondary operation in the later period; the three artificial valve leaves 5 can be freely opened and closed, and the shape of the artificial valve leaves is similar to the natural anatomical shape of a human body, so that the activity of the artificial valve leaves 5 is improved; in addition, the artificial valve leaflet realizes a bracket-free structure, and when the three artificial valve leaflets 5 are opened, a larger opening area can be provided, so that the pressure difference at two sides of the artificial valve leaflets 5 is reduced, and the artificial valve leaflet is more suitable for the hemodynamics of a human body. The dry preserved artificial valve leaflet can be prefabricated with the artificial blood vessel, thereby reducing the time for suturing the artificial valve leaflet and the artificial blood vessel in the operation. The artificial valve without the bracket can replace the root structure of the human aorta, can be suitable for aortic valve diseases of the expansion of the ascending aorta or the aneurysm of the ascending aorta, reduces operation difficulty and operation time in operation, fits normal blood flow of the human body, prolongs the service life of the artificial valve 5 and improves the life quality of patients.

In a specific embodiment, the artificial leaflet 5 comprises: valve portion 51 and leaflet combination portion; the artificial valve leaflet 5 is fixedly connected with the inner side wall of the sinus part 2 through the valve leaflet combination part; in this way, the artificial valve leaflet 5 is connected with the sinus portion 2 to form a whole, so that the artificial valve leaflet 5 can not separate from the sinus portion 2 when opening and closing, and can realize free opening and closing; specifically, the leaflet combination part and the inner side wall of the sinus part 2 are fixedly connected through an adhesive or a suture; of course, the present utility model is not limited to the adhesive or the suture without affecting the effect of the present utility model.

In one embodiment, the valve portion 51 is semi-lunar in shape. The valve portion 51 in the shape of a half moon matches the shape of the aortic valve leaflet of the human body.

In a specific embodiment, the artificial valve 5 may be a dried aortic valve of a pig, a dried bovine pericardium or a polyurethane polymer artificial synthetic material; of course, other polymer artificial materials are also possible; in the operation, individual tailoring and customization are carried out according to the aortic valve structure of a patient or an Ozaki valve measurement and manufacturing technology is applied, and the dried and stored porcine aortic valve or the dried bovine pericardium or the high polymer artificial material is sewn into the artificial valve leaflet 5.

In an embodiment, the aortic annular portion, dou Bu and the vascular portion may be made of polyurethane polymer materials; of course, other synthetic materials are also possible, without limitation. The polyurethane polymer material can provide good morphology, mechanical elasticity (can stretch in the horizontal direction and stretch in the radial direction), structural stability, histocompatibility and biosafety for the sinus part 2, and better fits the hemodynamics of the human body in the natural state, and the artificial valve leaflet 5 is protected from being impacted and damaged from morphology. The polyurethane polymer material is polyurethane, particularly polyester polyurethane, and is not limited to the polyester polyurethane under the condition of not affecting the using effect of the polyurethane polymer material.

In one embodiment, the vessel portion 4 has a straight-tube structure and is connected to the ascending aorta of the human body. The sinus ostium 3 and vessel 4 are also formed in a straight tubular configuration. The aortic annular part 1 is of a straight cylinder type structure and is connected with a heart of a human body.

The preparation method of the stentless artificial valve provided by the application comprises the following steps:

importing the aortic root imaging data of a healthy person into Freeform software for repair modeling, if the surface of the model is rough, smoothing by using the Freeform software, and then exporting a 3D printing model file; and finally, importing the 3D model file into printer software to print out the 3D model. Applying 3D printing technique 1:1, restoring the sinus part 2 without the branch vessel part 4 to form a hollow or solid model;

and cleaning and drying the 3D printing die, spraying a release agent on the surface, and drying at 30-60 ℃ for 1-2 hours. Coating a casting solution used for the inner membrane layer on a 3D printing die by using a pulling method or a spraying method to obtain a loose porous polyurethane polymer inner membrane, namely forming the inner membrane layer; the middle layer is formed into a polyester layer by adopting a diamond grid-shaped weaving process; coating a casting solution used for the outer layer on a 3D printing die which is sequentially sleeved with an inner film layer and an intermediate layer by using casting, spraying and other methods to form the outer layer; after the outer layer is prepared, the pipeline is taken down from the 3D printing die and cleaned, and then the artificial vascular pipeline is obtained; cutting the same material into artificial valve leaves 5 with three half-moon structures, wherein the same material can be porcine aortic valve, bovine pericardium or polyurethane polymer artificial synthetic material; finally, the circular arc edge of the artificial valve leaflet 5 is connected in the prepared ampullate sinus portion 2 blood vessel by using an adhesive or a suture.

The material of the 3D printing mold can be one of polylactic acid, photosensitive resin, ABS resin, nylon carbon fiber, stainless steel, silicone rubber, polypropylene and paraffin.

It should be understood that the foregoing examples of the present utility model are provided merely for clearly illustrating the present utility model and are not intended to limit the embodiments of the present utility model, and that various other changes and modifications may be made therein by one skilled in the art without departing from the spirit and scope of the present utility model as defined by the appended claims.

Claims

1. A stentless prosthetic valve, comprising:

2. The stentless prosthetic valve of claim 1, wherein the valve is a valve,

the prosthetic valve includes: valve and leaflet combination;

the artificial valve is fixedly connected with the inner side wall of the sinus through the valve leaflet combination part.

3. The stentless prosthetic valve of claim 2, wherein the valve is configured to,

the valve part is in a half-moon shape.

4. The stentless prosthetic valve of claim 2, wherein the valve is configured to,

the leaflet combination section is secured to the inner sidewall of the sinus section by an adhesive or suture connection.

5. The stentless prosthetic valve of claim 1, wherein the valve is a valve,

the artificial valve leaflet is made of dry porcine aortic valve, dry bovine pericardium or polyurethane polymer artificial synthetic material.

6. The stentless prosthetic valve of claim 1, wherein the valve is a valve,

the blood vessel part is of a straight cylinder type structure.

7. The stentless prosthetic valve of claim 1, wherein the valve is a valve,

the aortic annular part is of a straight cylinder type structure.

8. The stentless prosthetic valve of claim 1, wherein the valve is a valve,

the aortic annular part, the Dou Bu and the vascular part are made of polyurethane polymer materials.

9. The stentless prosthetic valve of claim 8, wherein the valve further comprises a valve element,

the polyurethane polymer material is polyurethane.