CN113331998B

CN113331998B - Artificial heart valve

Info

Publication number: CN113331998B
Application number: CN202110630550.1A
Authority: CN
Inventors: 李传保
Original assignee: Qilu Hospital of Shandong University
Current assignee: Qilu Hospital of Shandong University
Priority date: 2021-06-07
Filing date: 2021-06-07
Publication date: 2024-04-26
Anticipated expiration: 2041-06-07
Also published as: CN113331998A

Abstract

The invention relates to the field of medical appliances, in particular to a prosthetic heart valve, and more particularly relates to a Tesla valve type prosthetic heart valve. The valve can realize unidirectional passing effect on the basis of not using a movable part, namely, the valve effect of unidirectional passing of fluid and reverse flow stop is achieved, and the service life of the artificial heart valve is prolonged. The valve material is made of super-lubricating material or a super-lubricating material coating is designed on the surface of a new valve, so that thrombus is avoided. The artificial heart valve has the characteristics of comprehensive structure and materials, long service life and better high safety coefficient.

Description

Artificial heart valve

Technical Field

The invention relates to the field of medical appliances, in particular to a prosthetic heart valve, and more particularly relates to a Tesla valve type prosthetic heart valve.

Background

The disclosure of this background section is only intended to increase the understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art already known to those of ordinary skill in the art.

The prosthetic heart valve (HEART VALVE Prothesis) is an artificial organ implantable in the heart to replace heart valves (aortic valve, tricuspid valve, mitral valve), which allows unidirectional blood flow, and functions as a natural heart valve. Prosthetic valves fall into two broad categories depending on the materials used: one is a mechanical flap made entirely of man-made material; the other is a so-called biological valve which is made entirely or partially of biological tissue. The basic structure of the mechanical valve or the biological valve comprises a metal valve frame, a blocking body and a sewing ring. The metal valve frame is generally made of stainless steel, titanium, cobalt-nickel alloy or other superhard metals; the sewing ring is a part for sewing the artificial valve to the heart valve ring of the human body and is sewn by knitting materials, and polypropylene, terylene, polytetrafluoroethylene and carbon fibers which are also useful in recent years are used. Biological valves are typically made from porcine aortic valves and bovine pericardial valves.

At present, the clinical artificial heart mechanical valve has better durability but is easy to form thrombus, and patients need to be anticoagulated for life after operation; patients with biological valves do not need to take anticoagulants, but have a short service life due to calcification problems of biological valves.

In addition, the inventor researches and discovers that the existing artificial heart mechanical valve has the problem that thrombus is easy to form, and the mechanical valve has the problem of fatigue damage due to the movement of a mechanical structural part, so that the service life is influenced.

Disclosure of Invention

In order to solve the problems of easy thrombus formation and easy fatigue damage of mechanical valves in the prior art, the invention provides a prosthetic heart valve, in particular to a Tesla valve type prosthetic heart valve by utilizing the fluid mechanics principle and through structural design. The valve has no movable parts, so the valve has long service life. The valve material is made of super-lubricating material or is coated on the surface of a new valve, so that the valve does not need anticoagulant, and one or more ends of the valve are provided with rotary expansion fixing structures connected with the heart for fixing connection in use.

Specifically, the invention is realized by the following technical scheme:

The invention provides a prosthetic heart valve, which comprises a central shaft and a hollow revolving body, wherein the hollow revolving body is sleeved on the periphery of the central shaft and is coaxial with the central shaft, a cavity between the central shaft and the hollow revolving body is a revolving cavity, a guide ring is arranged in the revolving cavity, and a Tesla valve is formed by the longitudinal section of a cavity structure formed by the central shaft, the guide ring and the hollow revolving body along the axial direction.

In a second aspect of the invention, a rotary tesla valve is provided, including a prosthetic heart valve.

One or more of the technical schemes of the invention has the following beneficial effects:

1) The Tesla valve type artificial heart valve can realize the unidirectional passing effect on the basis of not using a movable piece, namely, the unidirectional passing of fluid is realized, the reverse flow is stopped, and the service life of the artificial heart valve is prolonged. The valve material is made of super-lubricating material or a super-lubricating material coating is designed on the surface of a new valve, so that thrombus is avoided. The artificial heart valve has the characteristics of comprehensive structure and materials, long service life and better high safety coefficient.

2) The artificial heart valve can be provided with a plurality of hollow revolution bodies and guide rings according to the requirement to form a plurality of revolution cavities, so that the blood flux is increased.

3) According to the actual use requirement, the number of the hollow revolution body and the guide rings can be adjusted, so that the length and the radial size of the whole artificial heart valve are adjusted, and different use requirements are met.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention. Embodiments of the present invention are described in detail below with reference to the attached drawing figures, wherein:

FIG. 1 is a schematic view of a 3/4 longitudinal cross-sectional configuration of a prosthetic heart valve according to embodiment 1 of the present invention;

FIG. 2 is a cross-sectional view of a prosthetic heart valve as disclosed in example 2 of the present invention;

FIG. 3 is a cross-sectional view of a prosthetic heart valve as disclosed in example 3 of the present invention;

wherein: 1. the central shaft, 2, the first hollow revolution body, 3, the first revolution cavity, 4, the first guide ring, 5, the second hollow revolution body, 6, the second revolution cavity, 7, the second guide ring, 8, the support piece, 9, the stiff end.

Detailed Description

The invention will be further illustrated with reference to specific examples. It is to be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. The experimental procedures, which do not address the specific conditions in the examples below, are generally carried out under conventional conditions or under conditions recommended by the manufacturer.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments in accordance with the present disclosure. As used herein, the singular is also intended to include the plural unless the context clearly indicates otherwise, and furthermore, it is to be understood that the terms "comprises" and/or "comprising" when used in this specification are taken to specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof.

It should be understood that the terms "upper," "lower," "horizontal," and the like indicate an orientation or a positional relationship based on that shown in the drawings, and are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the apparatus or element in question must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention.

In order to solve the problems of easy thrombus formation and easy fatigue damage of mechanical valves in the prior art, the invention provides a prosthetic heart valve, in particular to a Tesla valve type prosthetic heart valve by utilizing the fluid mechanics principle and through structural design. The valve has no movable parts, so the valve has long service life. The valve material is super-lubricating material or super-lubricating material coating is designed on the surface of the new valve, so that the valve does not need anticoagulant, and one or more ends of the valve are provided with rotary expansion fixing structures connected with the heart for fixing connection in use.

Specifically, the invention is realized by the following technical scheme:

In a first aspect of the invention, there is provided a prosthetic heart valve comprising: the hollow revolving body is sleeved on the periphery of the central shaft and is coaxial with the central shaft, a cavity between the central shaft and the hollow revolving body is a revolving cavity, a guide ring is arranged in the revolving cavity, and a longitudinal section of a cavity structure formed by the central shaft, the guide ring and the hollow revolving body along the axial direction forms a Tesla valve.

Although the prior art discloses some tesla valve structures, most of the valve structures are two-dimensional structures, fluid control can only be completed from a certain plane, and the valve structure is large in size and single in function.

The inventor seriously researches the existing artificial heart valve, and finds that the existing artificial heart valve is easy to fatigue and damage and easy to generate thrombus, so that the Tesla valve type artificial heart valve is provided, the contribution of the Tesla valve type artificial heart valve is not only to reduce the size of the valve, but also to adjust the structure of the whole valve, expand the structure of the traditional two-dimensional valve into a three-dimensional structure, fully utilize the space on the limited circular blood flow channel section, and increase the blood flow. Meanwhile, the channel structure of the Tesla valve in the artificial heart valve is reasonably designed, so that the Tesla valve can meet the requirements of different blood fluxes and different sizes.

In one or more specific embodiments, the number of the hollow revolution bodies is 1 or more, the diameters of the hollow revolution bodies are different, and the hollow revolution bodies are sequentially sleeved on the periphery of the central shaft according to the order from the smaller diameter to the larger diameter. Such a design may provide a prosthetic heart valve with one or more mutually independent swivel lumens that may help increase blood flow.

Preferably, the cavity between the central shaft and the hollow revolution body and the cavity between the adjacent hollow revolution bodies are revolution cavities, guide rings are arranged in the revolution cavities, and the longitudinal sections of the cavity formed by the central shaft, the hollow revolution bodies and the guide rings between the central shaft and the hollow revolution bodies and the cavity formed by the adjacent hollow revolution bodies and the guide rings between the adjacent hollow revolution bodies form a Tesla valve along the axial direction.

The traditional Tesla valve is designed into a rotary structure in combination with the actual use scene of the artificial heart valve, and the Tesla valve channel is designed in a rotary way, so that the requirement of unidirectional blood flow is met, a movable structure is not used, fatigue damage of the device is avoided, and the effect of realizing larger blood flow in a smaller space can be realized.

Taking 1 hollow revolution body as an example, the artificial heart valve sequentially comprises a central shaft, a revolution cavity, a guide ring and the hollow revolution body from inside to outside.

Taking 2 hollow revolution bodies as an example, the artificial heart valve sequentially comprises a central shaft, a first revolution cavity, a first guide ring, a first hollow revolution body, a second revolution cavity, a second guide ring and a second hollow revolution body from inside to outside.

In one or more embodiments of the present invention, a plurality of guide rings are arranged in parallel in the same rotation cavity, and the guide rings are coaxial with the central shaft, so that the rotation cavity can be divided into a plurality of diversion channels by design, and the more the diversion channels, the better the unidirectional circulation effect.

Preferably, the diameters of the guide rings in the same rotary cavity are the same, so that the periodical change of the size and shape of the cavity in each independent Tesla valve channel can be ensured, and the uniform flow of blood is facilitated.

If the diameters of the guide rings in the same rotary cavity are different, the formed Tesla valve channel has no periodical change in size and shape, and the smooth flow of blood is not facilitated.

In one or more embodiments of the invention, the deflector ring is fixed to the central shaft or hollow rotator by a support. The guide ring is not contacted with the hollow revolution body and the central shaft, so as to form a blood channel, and the supporting piece is a rib plate or a supporting rod.

However, if a generally plate-like fixation is used, there is a risk of blocking the blood flow, so in one or more embodiments of the invention, the support is an axial rib, the planar direction of which coincides with the direction of the cavity or blood flow, which serves both to fix the support and to avoid blood blocking.

The diameter of the hollow revolution body changes periodically along the axial direction, and the diameter of the hollow revolution body positioned outside the guide ring is the largest. The diameter of the hollow revolving body periodically changes along the axial direction to show a concave-convex structure, so that the hollow revolving body can be better fixed with the heart during assembly or use, and displacement is avoided.

Preferably, the axial direction of the hollow revolving body is periodically changed in the shape of water drops, and the diameter of the hollow revolving body, which is close to the inner guide ring, is large. The shape of the water drop is an asymmetric structure along the axial direction, one end of the water drop is small in diameter, and the other end of the water drop is large in diameter. The lower end of one water drop is connected with the upper end of the next water drop by taking the small diameter as the upper end and taking the large diameter as the lower end. The diameter size of the hollow revolving body slowly increases from the upper end of one water drop to the lower end, and the size of the hollow revolving body rapidly decreases from the lower end to the upper end of the next water drop, so that a step-like structure appears and is a fixed end. The hollow revolution body has large diameter change, and the step-like shape is helpful for fixing on the heart.

In yet another embodiment, the hollow body of revolution has a thinner wall near the inner guide ring than the wall far from the inner guide ring, which allows the size of the revolution cavity to be larger without affecting the overall prosthetic heart valve size, which helps to increase blood flow.

Preferably, the position with larger diameter of the hollow revolving body is provided with a stitching hole, and as the position with larger diameter of the hollow revolving body is the position with larger shape and size of the water drop or the size suddenly changed region, the geometric shape fixing effect is good, and the stitching hole is used for assisting, so that better fixing is realized.

In a further embodiment, the fixed end of the artificial heart valve connected with the heart is a rotary expansion structure, and suture holes are designed on the rotary expansion structure, and in the embodiment, the shape fixation and the suture fixation are matched with each other, so that the artificial heart valve is connected and fixed with the heart.

In one or more embodiments of the present invention, the radial dimension of the hollow revolution body is greater than the central axis, and the axial dimension is the same as the central axis, so that the hollow revolution body or bodies can be ensured to be sleeved on the periphery of the central axis in turn, and one or more revolution cavities are formed.

Preferably, the diameters of the guide rings in the adjacent rotary cavities are different, and the diameters of the guide rings in the adjacent rotary cavities are different because the sizes of the adjacent hollow rotary bodies are different, so that the connectivity of the rotary cavities and the connectivity of the Tesla valves are ensured.

In one or more embodiments of the invention, the guide rings in the adjacent rotary cavities are arranged in a staggered manner, so that the dislocation prevention not only does not affect the structures of the independent rotary cavities and the Tesla valve, but also reduces the overall size of the artificial heart valve on the premise of ensuring connectivity.

In one or more embodiments of the invention, the prosthetic heart valve material is selected from the group consisting of a super-lubricious material or a super-lubricious material coating, preferably a polytetrafluoroethylene super-lubricious coating material, is designed on the surface of each structure of the prosthetic heart valve.

Preferably, the prosthetic heart valve axis is straight or curved or the prosthetic heart valve material is bendable. If rigid materials are used for the prosthetic heart valve, the rigid prosthetic heart valve is susceptible to damage to the heart or to the connection to the heart during heart beating or cyclic deformation. In the embodiment, the artificial heart valve is bendable, and can deform along with the movement of the heart on the premise of not affecting blood circulation, so that surrounding organs or tissues are prevented from being damaged. In addition, because the rotary type expansion structure and the suture hole positioned on the rotary type expansion structure are arranged, the artificial heart valve can be effectively prevented from shifting, and the use safety and stability are ensured.

The artificial heart valve is straight or curved along the axial direction, so that different use requirements can be met.

The invention will now be described in further detail with reference to the following specific examples, which should be construed as illustrative rather than limiting.

Example 1

As shown in fig. 1, a schematic diagram of a 3/4 longitudinal section structure of a prosthetic heart valve disclosed in this embodiment is shown, the prosthetic heart valve sequentially comprises a central shaft 1, a first rotary cavity 3, a first guide ring 4, a first hollow rotary body 2, a second rotary cavity 6, a second guide ring 7, a second hollow rotary body 5, wherein the diameter of the first hollow rotary body 2 is smaller than that of the second hollow rotary body 5, the first hollow rotary body 2 and the second hollow rotary body 5 are sequentially sleeved on the periphery of the central shaft 1, and the first hollow rotary body 2 and the second hollow rotary body 5 are coaxial with the central shaft 1. The cavity between the central shaft 1 and the first hollow revolving body 2 is a first revolving cavity 3, a first guide ring 4 is arranged in the first revolving cavity 3, and a longitudinal section of a cavity structure formed by the central shaft 1, the first guide ring 4 and the first hollow revolving body 2 along the axial direction forms a primary Tesla valve. The first rotary cavity 3 is internally provided with 3 first guide rings 4, the 3 first guide rings 4 are parallel to each other and coaxial with the central shaft 1, and the first guide rings 4 are fixed on the central shaft 1 and the first hollow rotary body 2 through supporting pieces 8.

The cavity between the second hollow revolving body 5 and the first hollow revolving body 2 is a second revolving cavity 6, a second guide ring 7 is arranged in the second revolving cavity 6, and a second tesla valve is formed by the longitudinal section of a cavity structure formed by the first hollow revolving body 2, the second guide ring 7 and the second hollow revolving body 5 along the axial direction. And 3 second guide rings 7 are arranged in the second rotary cavity 6, the 3 second guide rings 7 are parallel to each other and coaxial with the central shaft 1, and the second guide rings 7 are fixed on the first hollow rotary body 2 and the second hollow rotary body 5 through supporting pieces.

The first-stage Tesla valve is positioned outside the second-stage Tesla valve, and the first-stage Tesla valve and the second-stage Tesla valve are coaxial. The first guide ring 4 and the second guide ring 7 are arranged in a staggered manner and are not at the same height, so that the design can reduce the overall size on the premise of ensuring the blood flux. The second hollow revolution solid 5 and the first hollow revolution solid 2 have different diameters and the same shape, and the parts with larger diameters in the second hollow revolution solid 5 and the first hollow revolution solid 2 are not positioned on the same height.

The second hollow revolving body 5 axially changes in a periodical water drop shape, the diameter of the second hollow revolving body 5 close to the inner side second guide ring 7 is large, the wall of the second hollow revolving body 5 close to the inner side second guide ring 7 is thinner than the wall of the second hollow revolving body 5 far from the inner side second guide ring 7, and a sewing hole is formed in the position with the larger diameter of the second hollow revolving body 5.

The second hollow revolution body 5 is formed by connecting a plurality of water drops end to end. The shape of the water drop is an asymmetric structure along the axial direction, one end of the water drop is small in diameter, and the other end of the water drop is large in diameter. The lower end of one water drop is connected with the upper end of the next water drop by taking the small diameter as the upper end and taking the large diameter as the lower end. The diameter of the second hollow revolving body 5 slowly increases from the upper end to the lower end of one water drop, the size of the second hollow revolving body 5 rapidly decreases from the lower end to the upper end of the next water drop, a step-like structure appears, and the second hollow revolving body is a fixed end 9 for fixing with heart tissues.

In fig. 1, taking the first rotary cavity 3 as an example, if blood moves from bottom to top, when flowing through the first guide ring 4, the blood is divided into two parts, one part flows into a channel close to the central shaft 1, the other part flows into a channel far away from the central shaft 1, after flowing through the first guide ring 4, the two parts have the same direction, and after being collected, the blood continues to move forwards, so that forward flow is realized.

The first hollow revolving body 2 is formed by connecting a plurality of water drop shapes end to end, and the lower diameter of each water drop shape structure is large, and the upper diameter is small, so that a revolving expansion structure is formed. If the blood moves from top to bottom, it is split into two parts when flowing through the first deflector ring 4, one part flowing into the channel near the central axis 1 and one part flowing into the channel far from the central axis 1. The radius of the blood movement of the lower part is large, so that after the two parts flow through the first guide ring 4, the blood flowing through the channel far away from the central shaft 1 has a trend of upward movement, while the blood flowing through the channel near the central shaft 1 has a trend of downward movement, the energy loss of the two blood flows, the movement speed or the blood quantity of the blood moving downwards decreases, and the blood cannot move downwards by analogy, so that the effect of inhibiting the reverse movement of the blood is achieved.

Example 2

As shown in fig. 2, a cross-sectional view of a prosthetic heart valve according to the present embodiment is different from embodiment 1 in that only one layer of the first hollow revolution body 2 is designed outside the central shaft 1 in order to adapt to the passing diameter, and thus the prosthetic heart valve can be applied to applications in a small-diameter space.

Example 3

As shown in fig. 3, a cross-sectional view of a prosthetic heart valve according to the present embodiment is different from embodiment 1 in that the second hollow revolution body 5 and the first hollow revolution body 2 are provided with 6 water drop shapes along the axial direction, and are provided with 6 guide rings, respectively, so that a more efficient unidirectional control effect can be achieved.

The surface of each structure of the artificial heart valve is designed with polytetrafluoroethylene super-lubrication coating material.

The foregoing description is only a preferred embodiment of the present invention, and the present invention is not limited thereto, but it is to be understood that modifications and equivalents of some of the technical features described in the foregoing embodiments may be made by those skilled in the art, although the present invention has been described in detail with reference to the foregoing embodiments. 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 prosthetic heart valve, comprising: the hollow revolving body is sleeved on the periphery of the central shaft and is coaxial with the central shaft, a cavity between the central shaft and the hollow revolving body is a revolving cavity, a guide ring is arranged in the revolving cavity, and a longitudinal section of a cavity structure formed by the central shaft, the guide ring and the hollow revolving body along the axial direction forms a Tesla valve;

the hollow revolving body axially changes in a periodical water drop shape, the diameter of the lower part of each water drop shape structure is large, and the diameter of the upper part is small, so that a revolving expansion structure is formed;

The artificial heart valve material is selected from super-lubricating materials or super-lubricating material coatings are designed on the surfaces of all structures of the artificial heart valve.

2. The heart valve prosthesis of claim 1, wherein the number of hollow revolution bodies is plural, the diameters of the hollow revolution bodies are different, and the hollow revolution bodies are sequentially sleeved on the periphery of the central shaft in the order from the smaller diameter to the larger diameter.

3. The artificial heart valve according to claim 2, wherein the cavity between the central shaft and the hollow revolution body and between the adjacent hollow revolution bodies is a revolution cavity, a guide ring is arranged in the revolution cavity, and a Tesla valve is formed by the longitudinal section of the cavity formed by the central shaft, the hollow revolution body and the guide ring between the central shaft and the hollow revolution body, and the longitudinal section of the cavity formed by the adjacent hollow revolution body and the guide ring between the adjacent hollow revolution bodies along the axial direction.

4. The prosthetic heart valve of claim 1, wherein a plurality of deflector rings are disposed in parallel within the same swivel chamber, the deflector rings being coaxial with the central axis.

5. The prosthetic heart valve of claim 4, wherein the plurality of deflector rings are of the same diameter in the same swivel lumen.

6. The prosthetic heart valve of claim 1, wherein the deflector ring is secured to a central shaft or hollow rotator by a support.

7. The prosthetic heart valve of claim 6, wherein the support member is a rib or a support rod.

8. The prosthetic heart valve of claim 1, wherein the hollow body of revolution has a diameter that varies periodically in an axial direction, the diameter of the hollow body of revolution being greatest outside of the deflector ring.

9. The prosthetic heart valve of claim 8, the hollow body of revolution being large in diameter proximate the inner deflector ring.

10. The prosthetic heart valve of claim 8, the hollow body of revolution having a thinner wall proximate the inner deflector ring than a wall distal the inner deflector ring.

11. The prosthetic heart valve of claim 8, wherein the larger diameter hollow body is provided with suture holes.

12. The prosthetic heart valve of claim 8, wherein the fixed end of the prosthetic heart valve connected to the heart is a rotary expanded structure with suture holes.

13. The prosthetic heart valve of claim 1, wherein the hollow body of revolution has a radial dimension greater than the central axis and an axial dimension equal to the central axis.

14. The prosthetic heart valve of claim 13, wherein the diameter of the deflector rings in adjacent rotating chambers varies.

15. The prosthetic heart valve of claim 1, wherein the deflector rings in adjacent rotating chambers are offset.

16. The prosthetic heart valve of claim 1, wherein each structural surface of the prosthetic heart valve is a polytetrafluoroethylene super-lubricious coating material.

17. The prosthetic heart valve of claim 16, the prosthetic heart valve axis being straight or curved or the prosthetic heart valve material being bendable.

18. A rotary tesla valve comprising the prosthetic heart valve of any one of claims 1 to 17.