CN210056341U

CN210056341U - Heart valve

Info

Publication number: CN210056341U
Application number: CN201821742229.2U
Authority: CN
Inventors: 姚斌
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Shenzhen Jianxin Medical Technology Co ltd
Priority date: 2018-10-25
Filing date: 2018-10-25
Publication date: 2020-02-14
Anticipated expiration: 2028-10-25

Abstract

The utility model relates to a heart valve, including support, connector, tether and fixer, the fixer includes fixed rope and gasket, fixed rope with gasket fixed connection, the one end of tether is passed through the connector with the leg joint, the other end of tether with on the fixer fixed rope is connected. Above-mentioned heart valve, the structure of fixer is simpler, the volume is smaller and more exquisite, ties through the fixed rope on the fixer and ties and can accomplish the fixed of tether on the fixer, and the operation is simpler in the in-service use.

Description

Heart valve

Technical Field

The utility model relates to the field of medical equipment, in particular to a heart valve.

Background

The human heart comprises four valves, namely an aortic valve, a mitral valve, a tricuspid valve and a pulmonary valve, and the four valves are all one-way valves, so that blood in a cardiac cycle is ensured not to flow in wrong directions. In the field of heart valves, heart valves are used to repair or reconstruct diseased heart valves.

Some known devices that exist to anchor medical devices, such as heart valves, can include securing one or more tethers extending from the medical device to body tissue. For example, the apical fixator disclosed in patent document CN201480050061 performs one needle-shaped puncture apical pull wire through a bulky mechanism, thereby playing a role in controlling the displacement of the tether. However, since the apex anchor itself is an implant, the need for as small a volume as possible reduces complications and rejection for the patient, and the mechanisms disclosed in the prior art are too numerous to cause rejection for the patient. And too complicated mechanism can cause the apex cordis fixer area big, and simultaneously will be big with human tissue area of contact, and the base is a stereoplasm object, so the apex department can produce the perk, and is not good enough with the laminating of tissue, and produce the condition such as blood leakage, friction tissue hemorrhage.

SUMMERY OF THE UTILITY MODEL

In view of the above, there is a need for a heart valve with a holder having a simple structure.

The heart valve is characterized by comprising a support, a connector, a tether and a fixer, wherein the fixer comprises a fixing rope and a gasket, the fixing rope is fixedly connected with the gasket, one end of the tether is connected with the support through the connector, and the other end of the tether is connected with the fixing rope on the fixer.

In one embodiment, the gasket is provided with a central hole for the tether to pass through, the central hole is positioned at the geometric center of the gasket, and the tether passes through the central hole and then is connected with the fixing rope.

In one embodiment, the gasket is further provided with at least two fixing holes, and one end of the fixing rope passes through one of the fixing holes from the surface of the gasket away from the bracket and extends out of the other fixing hole to be tied and fixed with the middle part of the tether.

In one embodiment, two of the fixing holes are disposed near the center of the gasket.

In one embodiment, the gasket includes a first wrapper sheet, a support sheet, and a second wrapper sheet, the support sheet being positioned between and fixedly connected to the first wrapper sheet and the second wrapper sheet.

In one embodiment, the first wrapping sheet, the support sheet and the second wrapping sheet are provided with corresponding center holes, the center hole is positioned at the geometric center of the support sheet, and the tether passes through the center hole and is connected with the fixing rope.

In one embodiment, the first wrapping sheet, the support sheet and the second wrapping sheet are provided with at least two fixing holes corresponding to each other one by one, and one end of the fixing rope passes through one of the fixing holes from the surface of the first wrapping sheet far away from the bracket, extends to the other fixing hole, and is knotted and fixed with the middle part of the fixing rope after passing through the other fixing hole.

In one embodiment, the first wrapping sheet, the supporting sheet and the second wrapping sheet are respectively provided with one-to-one corresponding stitching holes, and the gasket further comprises stitching threads which penetrate through the one-to-one corresponding stitching holes to fixedly connect the first wrapping sheet, the supporting sheet and the second wrapping sheet.

In one embodiment, the outer contour of each of the first and second wrapsheets is larger than that of the support sheet, so that the first and second wrapsheets completely cover the support sheet.

In one embodiment, the thickness of the gasket is 1mm to 10 mm.

Above-mentioned heart valve, the structure of fixer is simpler, the volume is smaller and more exquisite, ties through the fixed rope on the fixer and ties and can accomplish the fixed of tether on the fixer, and the operation is simpler in the in-service use.

Drawings

FIG. 1 is a schematic view of a heart valve according to a first embodiment of the present application;

FIG. 2 is a schematic structural view of the heart valve of FIG. 1 after implantation in the heart;

FIG. 3 is a schematic view of the heart valve retainer of FIG. 1;

FIG. 4 is a schematic structural view of a heart valve according to a second embodiment of the present application;

FIG. 5 is a schematic view of the fixation device of the heart valve of FIG. 4;

FIG. 6 is a cross-sectional view of the anchor of FIG. 5;

fig. 7 is an exploded view of the anchor of fig. 5.

Detailed Description

In order to make the above objects, features and advantages of the present invention more comprehensible, embodiments of the present invention are described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention can be embodied in many different forms other than those specifically described herein, and it will be apparent to those skilled in the art that similar modifications can be made without departing from the spirit and scope of the invention, and it is therefore not to be limited to the specific embodiments disclosed below.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1, in the present embodiment, the structure of the heart valve 10 is described by taking a mitral valve stent as an example, but in other embodiments, the heart valve 10 is not limited to the mitral valve stent shown in fig. 1, and may also be other types of artificial valve stents, such as a pulmonary valve stent and an aortic valve stent.

Referring to fig. 1 and 2, a heart valve 10 according to a first embodiment of the present application includes a stent 140, a connector 130, a tether 120, and a holder 110, wherein one end of the tether 120 is connected to the stent 140 via the connector 130, and the other end of the tether 120 is connected to the holder 110. In this embodiment, the connector 130 and the bracket 140 are both independent structures, and the connector 130 is fixedly connected with the bracket 140. Of course, in other embodiments, the connector 130 and the bracket 140 may be formed as a single piece.

The fixer 110 includes a pad 111 and a fixing string 112, and the fixing string 112 is fixedly connected to the pad 111. Referring to fig. 3, the pad 111 is provided with a central hole 1111 for the tether 120 to pass through the pad 110, and the tether 120 is fixedly connected to the fixing cord 112 after passing through the central hole 1111. Referring to fig. 2, after the heart valve 10 is implanted into the heart, the stent 140 is located at the mitral valve annulus of the heart, the stent 140 is connected to the tether 120 through the connector 130, the tether 120 is further connected to the holder 110 disposed outside the apex of the heart, when the heart is in diastole, the annular tissue of the heart can block the stent 140 to prevent the heart valve 10 from sliding into the ventricle, when the heart is in systole, the holder 110 can provide a supporting force outside the heart to prevent the heart valve 10 from moving towards the atrium, and can effectively prevent the heart valve 10 from shifting under the impact of blood flow after being released. Meanwhile, the fixator 110 and the tether 120 which are positioned outside the apex of the heart can close the access channel at the apex of the heart, thereby preventing blood leakage. During the implantation of the heart valve 10, the paravalvular leakage of the heart in which the heart valve 10 is implanted can be diagnosed through the ultrasonic doppler image, and if paravalvular leakage exists, the adhesion force of the stent 140 of the heart valve 10 and the mitral valve annulus in the heart can be improved by adjusting the tension of the tether 120 or the length of the tether 120 between the fixator 110 and the connector 130 during the knotting process of the tether 120 and the fixing rope 112 on the fixator 110, so as to achieve the purpose of reducing the paravalvular leakage.

The holder 110 of the heart valve 10 has a simple structure and a small volume, and the tether 120 can be fixed to the holder 110 by knotting the fixing string 112 of the holder 110 with the tether 120, so that the operation is simple in practical use.

Referring to fig. 3, in the present embodiment, the central hole 1111 is located at the geometric center of the pad 111 for allowing the tether 120 to pass through the pad 111, and the diameter of the central hole 1111 is not smaller than the diameter of the tether 120. The center hole 1111 located at the geometric center may enable the force point of the tether 120 to be located at the geometric center of the pad 111 after the tether is connected to the anchor 110 through the center hole 1111, which may prevent the pad 111 from shifting and rotating. In the present embodiment, the spacer 111 has a disc shape, and the central hole 111 is located at the center of the spacer 111. Furthermore, the pad 111 is further provided with at least two fixing holes 1112, the diameter of the fixing hole 1112 is not smaller than the diameter of the fixing rope 112, one end of the fixing rope 112 passes through one of the fixing holes 1112 from the surface of the pad 111 away from the bracket 140, extends to the other fixing hole 1112 and penetrates out, and is knotted at the middle part of the fixing rope 112 to form a knot 1121, so that the fixing rope 112 is fixedly connected with the pad 111, and a free end is left for fixing with the tether 120. Specifically, the two fixing holes 1112 are provided near the geometric center of the gasket 111, that is, the two fixing holes 1112 are provided near the center hole 1111. In the present embodiment, two fixing holes 1112 are symmetrically disposed on two sides of the central hole 1111. Referring also to fig. 2, after the tether 120 is inserted through the central hole 1111, the fixing cord 112 and the tether 120 are coupled to complete the coupling of the tether 120 to the anchor 110. The fixing strength of the tether 120 and the gasket 111 can be effectively improved through the connection mode, and the conditions of looseness, falling off and the like of the tether 120 after long-time use are avoided. It is understood that in other embodiments, the fixing string 112 may be fixedly connected to the pad 111 by other means, for example, the fixing string 112 is integrally formed with the pad 111.

It is understood that the number and the positions of the central hole 1111 and the fixing holes 1112 can be selected according to actual requirements in practical application. In one embodiment, only one fixing hole 1112 may be provided, and the fixing rope 112 is fixed to the pad 111 after passing through the central hole 1111 and the fixing hole 1112, respectively.

Preferably, the tether 120 and the fixing rope 112 are made of ultra-high molecular weight polyethylene or other biocompatible materials, so as to reduce the occurrence of rejection reactions and improve the safety of the patient.

Preferably, the gasket 111 is made of soft and biocompatible materials such as PE felt, PTFE cloth, and silicone, so as to reduce the probability of rejection, reduce the wear on the cardiac tissue, and improve the safety of the patient. It will be appreciated that the gasket 111 may alternatively be provided with a covering or coating of the above-mentioned materials on the gasket 111.

Further, the thickness of the spacer 111 should be 1mm to 10 mm. Preferably, the thickness of the pad 111 is 1.5mm to 4mm, which can reduce the abrasion to the heart tissue while ensuring a certain supporting strength of the pad 111.

Referring to fig. 4, a heart valve 20 according to a second embodiment of the present disclosure has substantially the same structure as the heart valve 10 according to the first embodiment, and mainly referring to fig. 5 to 7, the spacer 211 includes a first wrapping sheet 2116, a supporting sheet 2115 and a second wrapping sheet 2117, and the supporting sheet 2115 is located between the first wrapping sheet 2116 and the second wrapping sheet 2117 and fixedly connected to the first wrapping sheet 2116 and the second wrapping sheet 2117. The support piece 2115 is made of stainless steel, cobalt-chromium alloy, or other rigid materials. Further, the first wrapping sheet 2116, the support sheet 2115 and the second wrapping sheet 2117 are provided with one-to-one corresponding suture holes 2113. In this embodiment, the suture holes 2113 are circumferentially arranged on the first package 2116, the support piece 2115, and the second package 2117, respectively, and the suture holes 2113 of the first package 2116, the support piece 2115, and the second package 2117 are in one-to-one correspondence, and the suture holes 2113 in one-to-one correspondence are tightly connected by the suture thread 213, but may be connected in other manners. Further, the outer contours of the first and

second wrapping sheets

2116 and 2117 are larger than the outer contour of the support sheet 2115, so that the support sheet 2115 can be completely covered by the first and

second wrapping sheets

2116 and 2117, and abrasion to the heart tissue caused by contact between the support sheet 2115 and the heart tissue is avoided.

It will be appreciated that the arrangement of the suture holes 2113 is selected according to the requirements of the application. It will also be appreciated that in one embodiment, the support sheet 2115 may be provided without suture holes 2113, and the suture holes 2113 of the first and

second sheets

2116, 2117 may be provided outside the contour of the support sheet 2115, and the support sheet 2115 may be wrapped therein by suturing the suture holes 2113 together. It is also understood that in some embodiments, the support tab 2115 may be omitted when the strength of the support for the gasket 211 is not critical. It will also be appreciated that in some embodiments, the first packet 2116 may be omitted, with the second packet 2117 being used to contact cardiac tissue.

Further, the first wrapping plate 2116, the support plate 2115 and the second wrapping plate 2117 are all provided with corresponding center holes 2111, the center hole 2111 is located at the geometric center of the support plate 2115, and the tether 220 passes through the center hole 2111 and then is connected with the fixing tether 212. The first wrapping sheet 2116, the support sheet 2115 and the second wrapping sheet 2117 are all provided with at least two fixing holes 2112 corresponding to one another, one end of the fixing rope 212 penetrates through one of the fixing holes 2112 from the surface of the first wrapping sheet 2116 away from the bracket 240, extends out of the other fixing hole 2112 and is knotted with the middle part of the fixing rope 212 to form a knot 2121, so that the fixing rope 212 is fixedly connected with the pad 211, and a free end is reserved for fixing with the tether 220. In this embodiment, the supporting piece 2115 is made of a metal material, which can provide a good supporting effect, so that the pad 211 is not deformed during use, and the first and

second wrapping pieces

2116 and 2117 are made of a soft material with excellent biocompatibility as the pad 111 of embodiment 1, which can reduce abrasion to heart tissue when the pad 211 contacts with the heart tissue.

It will be appreciated that in other embodiments, after suturing the suture 213 through the suture hole 2113, a suitable length of suture 213 may be left, and the length of suture 213 may be tied to the tether 220 through the central hole 2111, which may also serve to secure the tether 220. Preferably, the suture line 213 is made of ultra-high molecular weight polyethylene or other biocompatible material.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only represent some embodiments of the present invention, and the description thereof is specific and detailed, but not to be construed as limiting the scope of the present invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.

Claims

1. The heart valve is characterized by comprising a support, a connector, a tether and a fixer, wherein the fixer comprises a fixing rope and a gasket, the fixing rope is fixedly connected with the gasket, one end of the tether is connected with the support through the connector, and the other end of the tether is connected with the fixing rope on the fixer.

2. The heart valve of claim 1, wherein the spacer has a central hole for the tether to pass through, the central hole being located at a geometric center of the spacer, and the tether passes through the central hole and is connected to the securing tether.

3. The heart valve of claim 1, wherein the gasket is further provided with at least two fixing holes, and one end of the fixing rope passes through one of the fixing holes from the surface of the gasket far away from the bracket and extends out of the other fixing hole to be knotted and fixed with the middle part of the fixing rope.

4. The heart valve of claim 3, wherein two of the fixation holes are disposed near a geometric center of the spacer.

5. The heart valve of claim 1, wherein the spacer comprises a first wrap, a support tab, and a second wrap, the support tab positioned between and fixedly connected to the first wrap and the second wrap.

6. The heart valve of claim 5, wherein the first, support and second wraps each have a corresponding central aperture located at a geometric center of the support, and wherein the tether passes through the central aperture and is connected to the tether.

7. The heart valve of claim 5, wherein the first wrapping sheet, the supporting sheet and the second wrapping sheet are provided with at least two fixing holes corresponding to each other one by one, and one end of the fixing rope passes through one of the fixing holes from the surface of the first wrapping sheet away from the stent and extends out of the other fixing hole to be fixed with the middle part of the fixing rope in a knotted manner.

8. The heart valve of claim 5, wherein the first, support, and second wraps each have a one-to-one correspondence of suture holes formed therein, the spacer further comprising sutures passing through the one-to-one correspondence of suture holes to fixedly connect the first, support, and second wraps.

9. The heart valve of claim 5, wherein the first and second wraps each have an outer contour that is larger than an outer contour of the support sheet such that the first and second wraps completely cover the support sheet.

10. A heart valve as claimed in any one of claims 1 to 9 wherein the spacer has a thickness of from 1mm to 10 mm.