Expandable artificial biological heart valve

Abstract

The invention discloses an expandable artificial biological heart valve and belongs to the technical field of medical instruments, the expandable artificial biological heart valve comprises a valve leaflet, a valve frame and a valve seat, the valve frame is of an annular structure, the valve frame is used for supporting the valve leaflet and fixed to the valve seat, the periphery of the valve frame is wrapped with polyester fabric, the valve leaflet is fixed to the valve frame through a suture line, and the valve leaflet is fixed to the valve seat through the suture line. The outer surface of the valve seat is sleeved with a suture ring, the suture ring is fixedly connected with the valve seat through a suture line, the outer surface of the suture ring is sleeved with a polyester fabric tube, and the valve seat has the elastic deformation capacity so as to adapt to size adjustment in the minimally invasive surgery. The valve seat not only can meet the requirement of minimally invasive surgery, but also meets the requirement of repeated valve implantation possibly needed by young valvular disease patients, the service life of the valve is remarkably prolonged, and the postoperative life quality of the patients is remarkably improved.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a dilatable artificial biological heart valve. Background Art

[0002] Artificial heart valves play an important role in modern medicine, especially in the treatment of congenital heart diseases, rheumatic heart diseases, and heart valve diseases. With the aggravation of population aging, the incidence of heart valve diseases has been increasing year by year.

[0003] Common heart valves on the market mainly include mechanical valves and biological valves. Although mechanical valves are durable, they are prone to thrombus formation and require long-term anticoagulant drugs; biological valves have good biocompatibility and a lower thrombus risk, but due to material limitations, their lifespan is short, and usually, open-chest surgery is required again within a certain period for replacement, bringing a greater physical burden and psychological pressure to patients. Moreover, for some young patients with valvular heart diseases, as the patient ages, the heart will dilate to a certain extent, which may lead to valve dysfunction or the need for reoperation for replacement. Summary of the Invention

[0004] In order to improve the problem of valve dysfunction as the patient ages, this application provides a dilatable artificial biological heart valve.

[0005] A dilatable artificial biological heart valve provided by this application adopts the following technical solution: A dilatable artificial biological heart valve includes valve leaflets, a valve frame, and a valve seat. The valve frame is a ring structure, which is used to support the valve leaflets and is fixed on the valve seat. The outer periphery of the valve frame is wrapped with a polyester cloth. The valve leaflets are fixed on the valve frame through sutures. A suture ring is sleeved on the outer surface of the valve seat, and the suture ring is fixedly connected to the valve seat through sutures. A polyester cloth tube is sleeved on the outer surface of the suture ring. The valve seat has the ability of elastic deformation to adapt to size adjustment during minimally invasive surgery.

[0006] By adopting the above technical solution, when the patient needs to replace the artificial biological heart valve after several years of use, due to the certain elastic deformation ability of the valve seat, the original valve seat can be enlarged by an interventional balloon in the form of minimally invasive surgery, and then a new heart valve can be implanted into the original valve seat. Due to the expansion of the original valve seat, a larger-sized heart valve can be accommodated for implantation, which not only meets the requirements of minimally invasive surgery but also satisfies the needs of young patients with valvular heart diseases for multiple valve implantations that may be required throughout their lives, significantly improving the service life of the valve and the postoperative quality of life of the patient.

[0007] Preferably, the valve seat is formed by braiding wire materials. The wire materials are made of nitinol or cobalt-chromium alloy. After braiding, the wire materials are arranged in a ring shape, and the inner ring surface and the outer ring surface of the wire materials are respectively covered with PET films.

[0008] By adopting the above technical solution, the valve seat is formed by braiding wire materials. The wire materials are made of nitinol or cobalt-chromium alloy. The wire materials have good biocompatibility with human tissues, are suitable for implantation into the human body, and have high elastic deformation ability. They can withstand large deformations without permanent deformation. When a patient needs to replace the artificial biological heart valve after several years of use, the original valve seat can be expanded by an interventional balloon through minimally invasive surgery. The wire materials deform and expand, and then a new heart valve is implanted into the original valve seat. Due to the expansion of the original valve seat, a larger-sized heart valve can be accommodated for implantation.

[0009] Preferably, the valve seat is a ring-shaped metal seat. A plurality of oval through holes are formed on the outer side surface of the valve seat. The plurality of oval through holes are arranged at equal intervals along the circumferential direction of the valve seat. A first notch is arranged on the lower side of the oval through holes.

[0010] By adopting the above technical solution, when the original valve seat is expanded by means such as a balloon, the lower side of the first notch at the oval through hole on the valve seat will be torn, and at this time, the lower side of the oval through hole is disconnected, and the valve seat remains connected through the upper side of the oval through hole, thereby completing the expansion of the original valve seat to facilitate the implantation of a new heart valve.

[0011] Preferably, the valve seat includes an inner layer, a middle layer and an outer layer. A plurality of first circular through holes are formed on the outer side surface of the inner layer. A plurality of second circular through holes are formed on the outer side surface of the middle layer. A plurality of third circular through holes are formed on the outer side surface of the outer layer. The first circular through holes, the second circular through holes and the third circular through holes are coaxially arranged. A second notch is arranged on the lower side of each of the second circular through holes. The middle layer is made of metal material, and the inner layer and the outer layer have elastic deformation ability.

[0012] By adopting the above technical solution, when the original valve seat needs to be expanded by means such as a balloon, the cobalt-chromium alloy of the middle layer is easily disconnected due to the second notch on the second circular through hole, and then the overall shape is changed by being carried by the inner layer and the outer layer with certain elasticity, thereby completing the expansion of the original valve seat to facilitate the implantation of a new heart valve.

[0013] Preferably, both the inner layer and the outer layer are made of PET material.

[0014] By adopting the above technical solution, the PET materials of the inner layer and the outer layer provide good elastic deformation ability, which can ensure the stability and long-term durability of the valve during use.

[0015] Preferably, the material of the middle layer is cobalt-chromium alloy.

[0016] By adopting the above technical solution, a cobalt-chromium alloy with relatively high hardness is used in the middle layer, which further enhances the mechanical strength of the valve and improves the wear resistance of the valve.

[0017] Preferably, the valve seat includes four connecting bars connected end to end in sequence. A plurality of the connecting bars are connected to form a ring. A connecting piece is fixed at one end of the connecting bar, and a moving through groove is formed at the other end of the connecting bar. The connecting piece is inserted into the moving through groove of the adjacent connecting bar, and the connecting piece can move a certain distance along the circumferential direction of the valve seat in the moving through groove.

[0018] By adopting the above technical solution, when it is necessary to use means such as a balloon to expand the original valve seat, the balloon enters the valve seat, the balloon expands and presses on a plurality of connecting bars, so that the connecting piece moves in the moving through groove, and then the ring formed by the plurality of connecting bars expands, thus completing the expansion of the original valve seat to facilitate the implantation of a new heart valve.

[0019] Preferably, the connecting piece is a rivet.

[0020] By adopting the above technical solution, the rivet connection method ensures the firm connection between the connecting bars, improves the overall stability of the valve seat, and reduces the risk of loosening or breaking of the valve seat during use.

[0021] Preferably, the valve seat includes a plurality of moving tubes. A plurality of the moving tubes are connected to form a ring. A press riveting sleeve is installed between two adjacent moving tubes. The press riveting sleeve is sleeved on the outer periphery of two adjacent moving tubes. The moving tube is press-fitted and connected with the press riveting sleeve, and the moving tube can move a certain distance in the press riveting sleeve.

[0022] By adopting the above technical solution, when it is necessary to use means such as a balloon to expand the original valve seat, the balloon enters the valve seat, the balloon expands and presses on a plurality of moving tubes, so that the moving tubes move in the press riveting sleeve, and then the ring formed by the plurality of moving tubes expands, thus completing the expansion of the original valve seat to facilitate the implantation of a new heart valve.

[0023] In summary, the present application includes at least one of the following beneficial technical effects: 1. When a patient needs to replace the artificial biological heart valve after several years of use, due to the certain elastic deformation ability of the valve seat, the original valve seat can be enlarged by means of an interventional balloon through minimally invasive surgery, and then a new heart valve can be implanted in the original valve seat. Due to the expansion of the original valve seat, larger-sized heart valves can be accommodated for implantation, which not only meets the requirements of minimally invasive surgery but also satisfies the needs of young patients with valvular heart disease for multiple valve implantations that may be required in their lifetime, significantly improving the service life of the valve and the postoperative quality of life of the patient. 2. The valve seat is formed by braiding wire materials. The wire materials are nitinol wires or cobalt-chromium alloys, which have good biocompatibility with human tissues, are suitable for implantation into the human body, and have high elastic deformation ability, and can withstand large deformations without permanent deformation. When the patient needs to replace the artificial biological heart valve after several years of use, the original valve seat can be expanded by using an interventional balloon through minimally invasive surgery. The wire materials deform and expand, and then a new heart valve is implanted into the original valve seat. Due to the expansion of the original valve seat, a larger-sized heart valve can be accommodated for implantation; 3. When means such as a balloon are needed to expand the original valve seat, the cobalt-chromium alloy in the middle layer is easily disconnected due to the notch two on the circular through hole two, and then the overall shape is changed under the drive of the inner layer and the outer layer with certain elasticity, so as to complete the expansion of the original valve seat for facilitating the implantation of a new heart valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is the overall structural schematic diagram of Embodiment 1 of the present application.

[0025] Figure 2 is the exploded view of the heart valve along its own axis in Embodiment 1 of the present application.

[0026] Figure 3 is the structural schematic diagram of the valve seat in Embodiment 1 of the present application.

[0027] Figure 4 is the structural schematic diagram of the valve seat in Embodiment 2 of the present application.

[0028] Figure 5 is the structural schematic diagram of the valve seat in Embodiment 3 of the present application.

[0029] Figure 6 is the exploded view of the valve seat along its own axis in Embodiment 3 of the present application.

[0030] Figure 7 is the structural schematic diagram of the valve seat in Embodiment 4 of the present application.

[0031] Figure 8 is the structural schematic diagram of the valve seat in Embodiment 5 of the present application.

[0032] Reference numerals: 1, valve frame; 11, polyester cloth; 2, valve leaf; 3, valve seat; 31, suture ring; 32, polyester cloth tube; 4, wire material; 41, PET film; 5, metal seat; 51, oval through hole; 52, notch one; 6, inner layer; 61, middle layer; 62, outer layer; 63, circular through hole one; 64, circular through hole two; 641, notch two; 65, circular through hole three; 7, connecting strip; 71, rivet; 72, moving through slot; 8, moving tube; 81, press riveting sleeve. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0033] The following will further elaborate on this application in conjunction with the attached drawings. Figure 1-8 A further detailed description of this application will be given below.

[0034] The embodiment of this application discloses an expandable artificial biological heart valve.

[0035] Embodiment 1 Referring to Figure 1 and Figure 2 The expandable artificial biological heart valve includes a valve frame 1, valve leaflets 2, and a valve seat 3. The valve frame 1 is a ring structure for supporting the valve leaflets 2 and fixing them on the valve seat 3. The outer periphery of the valve frame 1 is wrapped with a polyester cloth 11, and the valve leaflets 2 are fixed on the valve frame 1 through sutures. A suture ring 31 is sleeved on the outer surface of the valve seat 3. The material of the suture ring 31 is silicone, and the suture ring 31 is fixedly connected to the valve seat 3 through sutures. A polyester cloth tube 32 is sleeved on the outer surface of the suture ring 31.

[0036] Referring to Figure 3 The valve seat 3 is formed by braiding a wire material 4. The material of the wire material 4 is nitinol or cobalt-chromium alloy. After braiding, the wire material 4 is arranged in a ring shape, and PET films 41 are respectively covered on the inner ring surface and the outer ring surface of the wire material 4. The wire material 4 has good biocompatibility with human tissues, is suitable for implantation into the human body, and has a high elastic deformation ability, capable of withstanding large deformations without permanent deformation.

[0037] The implementation principle of Embodiment 1 of this application is as follows: When a patient needs to replace the artificial biological heart valve after several years of use, the original valve seat 3 can be enlarged by using an interventional balloon through minimally invasive surgery. The inner ring surface of the wire material 4 expands, and then a new heart valve is implanted into the original valve seat 3. Due to the expansion of the original valve seat 3, a larger-sized heart valve can be accommodated for implantation, which not only meets the requirements of minimally invasive surgery but also satisfies the need for multiple valve implantations that young valve disease patients may require throughout their lives, significantly improving the service life of the valve and the postoperative quality of life of the patient.

[0038] Embodiment 2 Referring to Figure 4 The difference between this embodiment and Embodiment 1 is that the valve seat 3 is a ring-shaped metal seat 5, and the material of the metal seat 5 is cobalt-chromium alloy. A plurality of oval through holes 51 are formed on the outer side surface of the valve seat 3. The plurality of oval through holes 51 are arranged at equal intervals along the circumferential direction of the valve seat 3, and a notch one 52 is arranged below the oval through holes 51.

[0039] The implementation principle of Embodiment 2 of this application is as follows: When the original valve seat 3 is expanded by means of a balloon or the like, the notch one 52 at the lower side of the oval through holes 51 on the valve seat 3 will be torn, and at this time, the lower side of the oval through holes 51 is disconnected, and the valve seat 3 remains connected through the upper side of the oval through holes 51, thus completing the expansion of the original valve seat 3 to facilitate the implantation of a new heart valve.

[0040] Example 3 Refer to Figure 5 and Figure 6 , the difference between this embodiment and Embodiment 1 is that the valve seat 3 includes an inner layer 6, an intermediate layer 61 and an outer layer 62. Both the inner layer 6 and the outer layer 62 are made of PET material, and the material of the intermediate layer 61 is cobalt-chromium alloy with relatively high hardness. A plurality of circular through holes one 63 are formed on the outer side surface of the inner layer 6, a plurality of circular through holes two 64 are formed on the outer side surface of the intermediate layer 61, and a plurality of circular through holes three 65 are formed on the outer side surface of the outer layer 62. The circular through holes one 63, the circular through holes two 64 and the circular through holes three 65 are coaxially arranged, and a notch two 641 is arranged below the circular through hole two 64.

[0041] The implementation principle of Embodiment 3 of this application is as follows: when it is necessary to use means such as a balloon to expand the original valve seat 3, due to the notch two 641 on the circular through hole two 64, the cobalt-chromium alloy of the intermediate layer 61 is easily broken, and then it is driven by the inner layer 6 and the outer layer 62 with certain elasticity to change the overall shape, so as to complete the expansion of the original valve seat 3 for facilitating the implantation of a new heart valve.

[0042] Example 4 Refer to Figure 7 , the difference between this embodiment and Embodiment 1 is that the valve seat 3 includes four connecting strips 7 connected end to end in sequence, and a ring is formed after a plurality of connecting strips 7 are connected. A rivet 71 is inserted and fixed at one end of the connecting strip 7, and a moving through groove 72 is formed at the other end of the connecting strip 7. The rivet 71 on the connecting strip 7 is inserted into the moving through groove 72 of the adjacent connecting strip 7, and the rivet 71 can move a certain distance along the circumferential direction of the valve seat 3 in the moving through groove 72.

[0043] The implementation principle of Embodiment 4 of this application is as follows: when it is necessary to use means such as a balloon to expand the original valve seat 3, the balloon enters the valve seat 3, the balloon expands and squeezes a plurality of connecting strips 7, so that the rivet 71 moves in the moving through groove 72, and then the ring formed by a plurality of connecting strips 7 expands, so as to complete the expansion of the original valve seat 3 for facilitating the implantation of a new heart valve.

[0044] Example 5 Refer to Figure 8 , the difference between this embodiment and Embodiment 1 is that the valve seat 3 includes four moving tubes 8, and a ring is formed after the four moving tubes 8 are connected. A press riveting sleeve 81 is installed between two adjacent moving tubes 8, the press riveting sleeve 81 is sleeved on the outer periphery of two adjacent moving tubes 8, and both the moving tube 8 and the press riveting sleeve are made of cobalt-chromium alloy material. The moving tube 8 and the press riveting sleeve 81 are press-fitted and connected, and the moving tube 8 can move a certain distance in the press riveting sleeve 81.

[0045] The implementation principle of Embodiment 5 of this application is as follows: When it is necessary to use means such as a balloon to expand the original valve seat 3, the balloon enters the valve seat 3, the balloon expands and squeezes several moving tubes 8, so that the moving tubes 8 move within the swaging sleeve 81, and then the ring formed by the several moving tubes 8 expands, thereby completing the expansion of the original valve seat 3 to facilitate the implantation of a new heart valve.

[0046] The above are all preferred embodiments of this application, and the protection scope of this application is not limited accordingly. Therefore, all equivalent changes made according to the structure, shape, and principle of this application shall be covered within the protection scope of this application.

Claims

1. An expandable artificial biological heart valve, characterized in that: It includes leaflets (2), a valve frame (1) and a valve seat (3). The valve frame (1) is of an annular structure. The valve frame (1) is used to support the leaflets (2) and is fixed on the valve seat (3). The outer periphery of the valve frame (1) is wrapped with a polyester cloth (11). The leaflets (2) are fixed on the valve frame (1) by suture lines. A suture ring (31) is sleeved on the outer surface of the valve seat (3). The suture ring (31) is fixedly connected to the valve seat (3) by suture lines. A polyester cloth tube (32) is sleeved on the outer surface of the suture ring (31). The valve seat (3) has the ability of elastic deformation to adapt to size adjustment during minimally invasive surgery.

2. The expandable artificial biological heart valve according to claim 1, characterized in that: The valve seat (3) is formed by braiding a wire material (4). The material of the wire material (4) is nitinol or cobalt-chromium alloy. After braiding, the wire material (4) is arranged in a ring shape. The inner ring surface and the outer ring surface of the wire material (4) are respectively covered with a PET film (41).

3. The expandable artificial biological heart valve according to claim 1, wherein: The valve seat (3) is a ring-shaped metal seat (5). A plurality of oval through holes (51) are formed on the outer side surface of the valve seat (3). The plurality of oval through holes (51) are arranged at equal intervals along the circumferential direction of the valve seat (3). A first notch (52) is arranged on the lower side of the oval through hole (51).

4. The expandable artificial biological heart valve according to claim 1, characterized in that: The valve seat (3) includes an inner layer (6), an intermediate layer (61) and an outer layer (62). A plurality of first circular through holes (63) are formed on the outer side surface of the inner layer (6). A plurality of second circular through holes (64) are formed on the outer side surface of the intermediate layer (61). A plurality of third circular through holes (65) are formed on the outer side surface of the outer layer (62). The first circular through holes (63), the second circular through holes (64) and the third circular through holes (65) are coaxially arranged. Second notches (641) are arranged on the lower sides of the second circular through holes (64). The intermediate layer (61) is made of a metal material. The inner layer (6) and the outer layer (62) have the ability of elastic deformation.

5. The expandable artificial biological heart valve according to claim 4, characterized in that: Both the inner layer (6) and the outer layer (62) are made of PET material.

6. The expandable artificial biological heart valve according to claim 4, characterized in that: The material of the intermediate layer (61) is cobalt-chromium alloy.

7. The expandable artificial biological heart valve according to claim 1, characterized in that: The valve seat (3) includes a plurality of connecting bars (7) connected end to end in sequence. After the plurality of connecting bars (7) are connected, they form a ring. A connecting member is fixed at one end of the connecting bar (7). A moving through slot (72) is formed at the other end of the connecting bar (7). The connecting member is inserted into the moving through slot (72) of the adjacent connecting bar (7). The connecting member can move a certain distance along the circumferential direction of the valve seat (3) in the moving through slot (72).

8. The expandable artificial biological heart valve according to claim 7, wherein: The connecting member is a rivet (71).

9. The expandable artificial biological heart valve according to claim 1, characterized in that: The valve seat (3) includes a plurality of moving tubes (8). After the plurality of moving tubes (8) are connected, they form a ring. A press riveting sleeve (81) is installed between two adjacent moving tubes (8). The press riveting sleeve (81) is sleeved on the outer periphery of two adjacent moving tubes (8). The moving tube (8) is press-fitted and connected with the press riveting sleeve (81). The moving tube (8) can move a certain distance in the press riveting sleeve (81).

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