An artificial heart valve

Abstract

The present invention provides an artificial heart valve, comprising: an annular stent, annular leaflets, an annular inner skirt and an annular outer skirt, wherein the annular stent is coaxially provided with a first rhombus layer, an intermediate rhombus layer and a second rhombus layer in sequence, wherein the first rhombus layer is provided with a fixing beam; the annular inner skirt is sutured and fixed inside the intermediate rhombus layer; the annular leaflets are inside the annular outer skirt, the first ends of the annular leaflets and the annular outer skirt are sutured and fixed to the first end of the second rhombus layer, the second end of the annular leaflets is provided with an anchoring block, the second end of the annular leaflets is turned toward the inside of the second rhombus layer, and the anchoring block is sutured and fixed to the fixing beam; the second end of the annular outer skirt is turned toward the outside of the second rhombus layer and sutured and fixed to the second end of the second rhombus layer. The embodiment of the present invention can reduce the contact between sutures and blood during the use of the artificial heart valve, and reduce the risk of thrombosis.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an artificial heart valve. Background Art

[0002] Heart valve disease or damage can easily lead to heart malfunction, which in turn affects a person's health and even life. Currently, heart valve disease is mainly solved by using artificial heart valves to replace human heart valves. In the related art, when artificial heart valves are used, the sutures are exposed, and blood comes into contact with the exposed sutures when passing through the artificial heart valves, which can easily increase the risk of thrombosis. Summary of the invention

[0003] The embodiment of the present invention provides an artificial heart valve to reduce the risk of causing thrombosis in the human body in the prior art.

[0004] To achieve the above-mentioned object, an embodiment of the present invention provides an artificial heart valve, comprising: an annular stent, an annular valve leaflet, an annular inner skirt and an annular outer skirt, wherein:

[0005] The annular support is coaxially provided with a first rhombus layer, a middle rhombus layer and a second rhombus layer in sequence, wherein the middle rhombus layer is located between the first rhombus layer and the second rhombus layer;

[0006] A fixing beam is provided on the side surface of the first rhombus layer in the axial direction;

[0007] The annular inner skirt is located on the inner side of the middle diamond-shaped layer, and the first end of the annular inner skirt is sewed and fixed to the first end of the middle diamond-shaped layer, and the second end of the annular inner skirt is sewed and fixed to the second end of the middle diamond-shaped layer;

[0008] The first end of the annular outer skirt is located on the inner side of the second diamond-shaped layer, and the first end of the annular outer skirt is sewed and fixed to the first end of the second diamond-shaped layer, and the second end of the annular outer skirt is turned to the outer side of the second diamond-shaped layer and is sewed and fixed to the second end of the second diamond-shaped layer;

[0009] The first end of the annular leaflet is located on the inner side of the annular outer skirt, the second end of the annular leaflet is provided with an anchor block located on the inner side of the annular leaflet, the first end of the annular leaflet is sutured and fixed to the second end of the middle diamond-shaped layer, the second end of the annular leaflet is flipped toward the inner side of the annular outer skirt, and the second end of the annular leaflet is sutured and fixed to the first diamond-shaped layer through the anchor block and the fixing beam.

[0010] The above technical solution has the following advantages or beneficial effects:

[0011] In the embodiment of the present invention, the first end of the annular valve leaflet is sutured and fixed to the second diamond-shaped layer and then flipped to the inside of the second diamond-shaped layer, thereby reducing the contact between the sutured and fixed position and the blood; an anchor block is arranged inside the second end of the annular valve leaflet, and after flipping, it is sutured to the fixing beam, so that the sutures are mainly distributed on the fixing beam and the anchor block, and the exposed sutures inside the annular valve leaflet are reduced. By reducing the contact between the sutures and the blood, the risk of thrombosis is reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for use in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative labor.

[0013] Figure 1 is a schematic structural diagram of an artificial heart valve provided by an embodiment of the present invention;

[0014] Figure 2 is a plan view of a ring-shaped stent for an artificial heart valve provided by an embodiment of the present invention;

[0015] Figure 3 is a schematic diagram of the position of an artificial heart valve provided by an embodiment of the present invention;

[0016] Figure 4 is a schematic diagram of an annular inner skirt of an artificial heart valve provided by an embodiment of the present invention;

[0017] Figure 5 It is a position diagram of the annular inner skirt of an artificial heart valve provided by an embodiment of the present invention;

[0018] Figure 6 It is a schematic diagram of the suturing of an annular leaflet, an annular inner skirt and an annular outer skirt of an artificial heart valve provided by an embodiment of the present invention;

[0019] Figure 7 It is a schematic structural diagram of an annular leaflet of an artificial heart valve provided by an embodiment of the present invention;

[0020] Figure 8 It is a schematic structural diagram of an anchor block of an artificial heart valve provided by an embodiment of the present invention;

[0021] Fig. 9 It is a structural schematic diagram of a fixing beam of an artificial heart valve provided by an embodiment of the present invention;

[0022] Fig.10 It is a schematic diagram of suturing the second end of an annular leaflet of an artificial heart valve provided by an embodiment of the present invention;

[0023] Fig.11 It is a schematic diagram of suturing an anchor block of an artificial heart valve provided by an embodiment of the present invention;

[0024] Fig.12 is a schematic structural diagram of another artificial heart valve provided by an embodiment of the present invention;

[0025] Fig.13 It is a schematic diagram of suturing a protective gasket of an artificial heart valve provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0026] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] like Figure 1 As shown, the present invention provides an artificial heart valve, characterized in that it includes: an annular stent 10, an annular valve leaf 11, an annular inner skirt 12 and an annular outer skirt 13, wherein:

[0028] The annular support 10 is coaxially provided with a first rhombus layer 101, a middle rhombus layer 102 and a second rhombus layer 103 in sequence, and the middle rhombus layer 102 is located between the first rhombus layer 101 and the second rhombus layer 103;

[0029] A fixing beam 1011 is provided on the side surface of the first rhombus layer 101 in the axial direction;

[0030] The annular inner skirt 12 is located inside the middle diamond-shaped layer 102, and the first end of the annular inner skirt 12 is sewed and fixed to the first end of the middle diamond-shaped layer 102, and the second end of the annular inner skirt 12 is sewed and fixed to the second end of the middle diamond-shaped layer 102;

[0031] The first end of the annular outer skirt 13 is located on the inner side of the second diamond-shaped layer 103, and the first end of the annular outer skirt 13 is sewed and fixed to the first end of the second diamond-shaped layer 103, and the second end of the annular outer skirt 13 is turned to the outer side of the second diamond-shaped layer 103 and sewed and fixed to the second end of the second diamond-shaped layer 103;

[0032] The first end of the annular leaflet 11 is located on the inner side of the annular outer skirt 13, and the second end of the annular leaflet 11 is provided with an anchor block 111 located on the inner side of the annular leaflet 11. The first end of the annular leaflet 11 is sutured and fixed to the second end of the middle rhombus layer 102, and the second end of the annular leaflet 11 is flipped toward the inner side of the annular outer skirt 13, and the second end of the annular leaflet 11 is sutured and fixed to the first rhombus layer 101 through the anchor block 111 and the fixing beam 1011.

[0033] In the above embodiment, by adjusting the suture positions of the annular leaflet 11, the annular inner skirt 12 and the annular outer skirt 13 with the annular stent 10, the contact between the suture and the blood flushing surface is reduced, thereby achieving the purpose of reducing the risk of thrombosis.

[0034] Specifically, the direction of blood flushing flows from the second end of the annular stent 10 to the first end, that is, the blood passes through the annular outer skirt 13 and the annular valve leaflet 11 in sequence, and then flushes the annular inner skirt 12 after passing through the annular valve leaflet 11. When the blood passes through the annular outer skirt 13, since the second end of the annular outer skirt 13 is turned toward the outside of the second diamond layer 103 and sutured and fixed at the second end of the second diamond layer 103, the suture at the second end of the annular outer skirt 13 does not contact the blood, thereby avoiding the formation of thrombus.

[0035] In addition, the first end of the annular leaflet 11, the first end of the annular outer skirt 13 and the first end of the second diamond-shaped layer 103 are sutured and fixed, and the second end of the annular leaflet 11 is flipped toward the inside of the second diamond-shaped layer 103, so that the sutured and fixed position forms a relatively closed area. When blood passes through the annular outer skirt 13 and the annular leaflet 11, it basically does not contact the sutured and fixed position, thereby reducing the risk of thrombosis.

[0036] In addition, the second end of the annular leaflet 11 is turned inside the second diamond-shaped layer 103 and then sutured and fixed to the first diamond-shaped layer 101 through the anchor block 111 and the fixing beam 1011. After turning, the inner anchor block 111 is turned outside and then sutured and fixed to the fixing beam 1011. At this time, the contact between the blood and the annular leaflet 11 will not be affected by the anchor block 111, and the sutured and fixed position of the anchor block 111 and the fixing beam 1011 does not contact the blood, thereby reducing the risk of thrombosis.

[0037] As an optional implementation, Figure 2 As shown, the first rhombus layer 101 , the middle rhombus layer 102 and the second rhombus layer 103 include rhombus cells, and the sides of the rhombus cells parallel to the axis of the annular support 10 are connected in pairs to form the first rhombus layer 101 , the middle rhombus layer 102 and the second rhombus layer 103 .

[0038] In the above embodiment, the first diamond layer 101, the middle diamond layer 102 and the second diamond layer 103 are configured to connect the sides of the diamond cells in pairs, which can increase the elasticity of the artificial heart valve while maintaining the strength on the blood flushing surface to maintain normal operation.

[0039] Specifically, during the process of installing the artificial heart valve in the human body, the artificial heart valve needs to be compressed first, and then released after being transported to the destination. When the diameter of the stent is compressed, the diamond-shaped cells are compressed and become slender along the axial direction, and can now enter the blood vessels for transportation. After release, as the diameter of the stent is restored, the diamond-shaped cell structure is restored, and the implantation of the artificial heart valve is completed. At this time, the artificial heart valve begins to work, and blood is flushed along the axial direction. At this time, the diamond-shaped cells are not easily compressed in the axial direction, so that the overall structure remains stable.

[0040] The angle of the rhombus cells along the axis is 90° to 170°, preferably 110° to 130°; and the number of the rhombus cells is 6-18 rows.

[0041] In addition, the rhombus cells of the middle rhombus layer 102 are arranged in 1 to 3 rows.

[0042] As an optional implementation, Figure 3 and Figure 4 As shown, the first end of the annular leaflet 11, the first end and the second end of the annular inner skirt 12, and the first end and the second end of the annular outer skirt 13 are all provided with serrations 112, and the number of serrations 112 matches the number of rhombus cells, and the shape of the serrations 112 matches the shape of the rhombus cells.

[0043] In the above embodiment, the first end of the annular leaflet 11, the first end and the second end of the annular inner skirt 12, and the first end and the second end of the annular outer skirt 13 are provided with serrations 112 adapted to the diamond-shaped cells, so that stability is increased during suturing and fixation, and material waste can be reduced.

[0044] As an optional embodiment, the diamond-shaped cells are provided with support beams, the serrations 112 at the first end of the annular inner skirt 12 and the support beams of the diamond-shaped cells at the first end of the middle diamond-shaped layer 102 are sutured and fixed, the serrations 112 at the second end of the annular inner skirt 12, the serrations 112 at the first end of the annular outer skirt 13, the serrations 112 at the first end of the annular leaflet 11 and the support beams of the diamond-shaped cells at the first end of the second diamond-shaped layer 103 are sutured and fixed, and the serrations 112 at the second end of the annular outer skirt 13 are sutured and fixed with the support beams of the diamond-shaped cells at the second end of the second diamond-shaped layer 103;

[0045] A suture line is provided at the position where the sawtooth 112 at the first end of the annular inner skirt 12 and the support beam of the rhombus cell of the middle rhombus layer 102 are sutured and fixed. The suture line passes through the sawtooth 112 at the first end of the annular inner skirt 12, and the suture line also goes around the support beam of the rhombus cell of the first end of the middle rhombus layer 102 for a certain number of turns.

[0046] The serrations 112 at the second end of the annular inner skirt 12, the serrations 112 at the first end of the annular outer skirt 13, the serrations 112 at the first end of the annular leaflet 11, and the stent beams of the rhombus cells at the second end of the middle rhombus layer 102 are sutured and fixed in the same manner as the serrations 112 at the first end of the annular inner skirt 12 and the stent beams of the rhombus cells of the middle rhombus layer 102;

[0047] The manner in which the serrations 112 at the second end of the annular outer skirt 13 are sewn and fixed to the support beams of the rhombus cells at the second end of the second rhombus layer 103 is consistent with the manner in which the serrations 112 at the first end of the annular inner skirt 12 are sewn and fixed to the support beams of the rhombus cells of the middle rhombus layer 102 .

[0048] In the above embodiment, the first end of the annular leaflet 11, the annular inner skirt 12 and the annular outer skirt 13 are sutured and fixed to the annular stent 10. The method of fixing the diamond-shaped cell stent and the annular leaflet 11, the annular inner skirt 12 and the annular outer skirt 13 by sutures can reduce the contact between the sutures and blood while ensuring the strength of the overall structure.

[0049] Specifically, Figure 5 and Figure 6 The first end of the annular inner skirt 12 is sewn and fixed to the middle diamond layer 102, and the suture passes through the first end of the annular inner skirt 12 and the support beam of the diamond cells of the middle diamond layer 102. Each support beam is sewn and fixed a number of times. After the sewing is completed, the first end of the annular inner skirt 12 and the middle diamond layer 102 are sewn and fixed.

[0050] In addition, the same method is used to sew and fix the serrations 112 at the second end of the annular inner skirt 12, the serrations 112 at the first end of the annular outer skirt 13, the serrations 112 at the first end of the annular leaflet 11, and the support beams of the rhombus cells at the second end of the intermediate rhombus layer 102, with the same number of sew and fixation turns. The serrations 112 at the second end of the annular outer skirt 13 and the support beams of the rhombus cells at the second end of the second rhombus layer 103 are also sewed and fixed with the same number of sew and fixation turns.

[0051] The number of stitching circles is 1 to 6.

[0052] As an optional implementation, Figure 7 and Figure 8As shown, the anchor block 111 includes a strip-shaped slice 1111, the strip-shaped slice 1111 is located at the second end of the annular leaflet 11, a protrusion 113 is provided on the inner side of the annular leaflet 11, the strip-shaped slice 1111 is sutured with the protrusion 113, and the strip-shaped slice 1111 is parallel to the axis of the annular stent 10;

[0053] The protrusion 113 and the fixing beam 1011 are fixed by sewing.

[0054] In the above embodiment, the use of the strip-shaped slice 1111 can effectively separate the anchor block 111 at the second end of the annular valve leaflet 11 and the blood flushing surface, reduce the contact between the suture and the blood, and thus reduce the formation of thrombus.

[0055] Specifically, the strip slice 1111 and the protrusion 113 are first sutured and fixed, and at this time, due to the effect of the strip slice 1111, the blood does not flow through the protrusion 113. Then the protrusion 113 and the fixing beam 1011 are sutured to complete the fixation. At this time, the blood is intercepted by the adjustment slice and does not pass through the suture in the protrusion 113, thus reducing the formation of thrombus.

[0056] As an optional implementation, Fig. 9 , Fig.10 As shown, the fixed beam 1011 is provided with a plurality of rows of tooth structures 10111;

[0057] A suture is provided at the fixed position of the protrusion 113 and the fixing beam 1011 . The suture passes through the protrusion 113 and also bypasses the teeth. The protrusion 113 and the fixing beam 1011 are connected and fixed by the suture.

[0058] In the above embodiment, by providing a multi-row tooth structure 10111, the anchor block 111 can be effectively fixed and the fixing strength can be improved.

[0059] Specifically, the suture passes through the protrusion 113 and then passes through the tooth structure 10111. The suture passes around the tooth structure 10111 for a fixed number of turns, such as Fig.11 In this way, the anchor block 111 can be kept in a fixed position by the tooth structure 10111, and will not change position due to the effect of blood flushing, thereby improving the fixing strength.

[0060] Among them, the tooth structure 10111 is set to 3 to 8 rows of teeth.

[0061] As an optional implementation, a plurality of fixing beams 1011 are provided on the first diamond-shaped layer 101 , and the number of the anchor blocks 111 matches the number of the fixing beams 1011 .

[0062] In the above embodiment, different numbers of fixing beams 1011 and anchoring blocks 111 are provided to meet the requirements for different numbers of leaflets.

[0063] Specifically, if an artificial heart valve with a mitral valve structure is needed, two fixing beams 1011 and two anchoring blocks 111 can be provided, and the artificial heart valve structure thus formed is a mitral valve structure.

[0064] Similarly, if a prosthetic heart valve with a tricuspid structure is needed, such as Figure 1 As shown, three fixing beams 1011 and three anchoring blocks 111 may be provided, and the artificial heart valve structure thus formed is a tricuspid valve structure.

[0065] As an optional embodiment, the material of the annular inner skirt 12 and the annular valve leaflet 11 is porcine pericardium or bovine pericardium, and the material of the annular outer skirt 13 is polyester fiber.

[0066] In the above embodiment, the material of the annular inner skirt 12 is porcine pericardium or polyester fiber, the material of the annular valve leaflet 11 is porcine pericardium or bovine pericardium, and the material of the annular outer skirt 13 is polyester fiber, which can better adapt to human body reactions and structural strength requirements.

[0067] As an optional implementation, Fig.12 and Fig.13 As shown, it also includes a protective gasket 14, which is located on the outside of the annular bracket 10, and is sewn and fixed to the fixing beam 1011 and the anchor block 111; the protective gasket 14 is a polyethylene terephthalate fabric.

[0068] In the above embodiment, by providing a protective gasket 14, the loss of the suture between the anchor block 111 and the fixing beam 1011 can be reduced and the fixing strength can be increased.

[0069] Specifically, during the use of the artificial heart valve, the annular leaflet 11 will be affected by blood flushing and continue to exert force on the fixing beam 1011. Adding a protective gasket 14 can disperse part of the force to the protective gasket 14, reduce the force on the fixing beam 1011, and thus play a protective effect and extend the service life.

[0070] In addition, when the protective gasket 14 is sutured and fixed to the fixing beam 1011, the suture passes through the anchor block 111, so that the anchor block 111 is fixed once again by the suture of the protective gasket 14, thereby improving the fixing strength. Fig.13 As shown, the suture passes through the protective gasket 14, passes through the fixing beam 1011, and then passes through the anchor block 111 for fixation. The fixing strength is improved by the two suture fixations.

[0071] It should be noted that, in this article, the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or device including the element.

[0072] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation modes, which are merely illustrative rather than restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are within the protection of the present invention.

Claims

1. An artificial heart valve, characterized in that: include: An annular stent, an annular valve leaf, an annular inner skirt and an annular outer skirt, wherein: The annular support is coaxially provided with a first rhombus layer, a middle rhombus layer and a second rhombus layer in sequence, wherein the middle rhombus layer is located between the first rhombus layer and the second rhombus layer; A fixing beam is provided on the side surface of the first rhombus layer in the axial direction; The annular inner skirt is located on the inner side of the middle diamond-shaped layer, and the first end of the annular inner skirt is sewed and fixed to the first end of the middle diamond-shaped layer, and the second end of the annular inner skirt is sewed and fixed to the second end of the middle diamond-shaped layer; The first end of the annular outer skirt is located on the inner side of the second diamond-shaped layer, and the first end of the annular outer skirt is sewed and fixed to the first end of the second diamond-shaped layer, and the second end of the annular outer skirt is turned to the outer side of the second diamond-shaped layer and is sewed and fixed to the second end of the second diamond-shaped layer; The first end of the annular leaflet is located on the inner side of the annular outer skirt, the second end of the annular leaflet is provided with an anchor block located on the inner side of the annular leaflet, the first end of the annular leaflet is sutured and fixed to the second end of the middle rhombus layer, the second end of the annular leaflet is turned toward the inner side of the annular outer skirt, and the second end of the annular leaflet is sutured and fixed to the first rhombus layer through the anchor block and the fixing beam; The first rhombus layer, the middle rhombus layer and the second rhombus layer include rhombus cells, and the sides of the rhombus cells parallel to the axis of the annular support are connected in pairs to form the first rhombus layer, the middle rhombus layer and the second rhombus layer; The first end of the annular leaflet, the first end and the second end of the annular inner skirt, and the first end and the second end of the annular outer skirt are all provided with saw teeth, and the number of the saw teeth matches the number of the rhombus cells, and the shape of the saw teeth matches the shape of the rhombus cells; The rhombus cells are provided with support beams, the serrations at the first end of the annular inner skirt and the support beams of the rhombus cells at the first end of the middle rhombus layer are sutured and fixed, the serrations at the second end of the annular inner skirt, the serrations at the first end of the annular outer skirt, the serrations at the first end of the annular leaflet and the support beams of the rhombus cells at the first end of the second rhombus layer are sutured and fixed, and the serrations at the second end of the annular outer skirt and the support beams of the rhombus cells at the second end of the second rhombus layer are sutured and fixed; A suture line is provided at the position where the sawtooth at the first end of the annular inner skirt and the support beam of the rhombus cells of the middle rhombus layer are sutured and fixed, and the suture line passes through the sawtooth at the first end of the annular inner skirt, and the suture line also goes around the support beam of the rhombus cells at the first end of the middle rhombus layer for a certain number of times; The anchor block comprises a strip-shaped slice, the strip-shaped slice is located at the second end of the annular leaflet, a protrusion is provided on the inner side of the annular leaflet, the strip-shaped slice is sutured with the protrusion, and the strip-shaped slice is parallel to the axis of the annular stent; The protrusion and the fixing beam are fixed by sewing.

2. The artificial heart valve according to claim 1, characterized in that: The serrations at the second end of the annular inner skirt, the serrations at the first end of the annular outer skirt, the serrations at the first end of the annular leaflet, and the stent beams of the rhombus cells at the second end of the middle rhombus layer are sutured and fixed in the same manner as the serrations at the first end of the annular inner skirt and the stent beams of the rhombus cells of the middle rhombus layer; The manner in which the serrations at the second end of the annular outer skirt are sewn and fixed to the support beams of the rhombus cells at the second end of the second rhombus layer is consistent with the manner in which the serrations at the first end of the annular inner skirt are sewn and fixed to the support beams of the rhombus cells of the middle rhombus layer.

3. The artificial heart valve according to claim 1, characterized in that: The fixed beam is provided with a multi-row tooth structure; A suture is provided at the fixed position of the protrusion and the fixing beam. The suture passes through the protrusion and also bypasses the teeth. The protrusion and the fixing beam are connected and fixed by the suture.

4. The artificial heart valve according to claim 3, characterized in that: A plurality of fixing beams are arranged on the first rhombus layer, and the number of the anchor blocks matches the number of the fixing beams.

5. The artificial heart valve according to claim 1, characterized in that: The material of the annular inner skirt is porcine pericardium or polyester fiber, the material of the annular valve leaflet is porcine pericardium or bovine pericardium, and the material of the annular outer skirt is polyester fiber.

6. The artificial heart valve according to claim 1, characterized in that: It also includes a protective gasket, which is located on the outside of the annular bracket and is fixed to the fixing beam and the anchor block by sewing; the protective gasket is a polyethylene terephthalate fabric.

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