CN212089843U - Artificial heart valve - Google Patents
Artificial heart valve Download PDFInfo
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- CN212089843U CN212089843U CN202020180295.6U CN202020180295U CN212089843U CN 212089843 U CN212089843 U CN 212089843U CN 202020180295 U CN202020180295 U CN 202020180295U CN 212089843 U CN212089843 U CN 212089843U
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Abstract
The utility model discloses a heart valve prosthesis, which comprises a bracket, a gasket, valve leaflets, a suture film and a suture line; the stent is of a multi-layer reticular structure, and comprises a blood flow inflow end and a blood flow outflow end and is used for propping and connecting the original heart valve; the gasket is arranged at the blood flow outflow end of the bracket; the valve leaflet is arranged inside the blood outflow end of the support and is used for replacing the original heart valve; the suture films are arranged on the inner side and the outer side of the blood flow inflow end of the stent and are used for preventing paravalvular leakage; the bracket is provided with a suture hole; the valve leaf penetrates through the stitching hole and is stitched with the gasket, and the support and the valve leaf are stitched by a stitching film through a stitching line to form a heart valve prosthesis structure. The utility model has strong radial supporting force, can reduce the symptom of regurgitation of the patient's blood, and is not easy to cause atrioventricular block; the higher suture holes reduce the height of the valve, reducing implant material; and can prevent the problem of perivalvular leakage after operation.
Description
Technical Field
The utility model relates to the technical field of medical equipment, in particular to an artificial heart valve.
Background
The aortic valve is a tri-leaflet valve located between the left ventricular outflow tract and the ascending aorta. The main function of the valve is to maintain an effective left ventricular ejection. The valve is affected in many pathological conditions and various abnormalities appear. Aortic valve disease is a disease that is more common in cardiology and cardiac surgeon clinical work, primarily due to its higher incidence in the elderly. Methods of treatment of severe aortic valve disease include valve surgical repair or replacement surgery. Standard surgical treatment strategies include aortic valve repair, valve protection techniques, and aortic valve replacement techniques.
Aortic valve disorders include aortic stenosis and aortic insufficiency, in most cases with both. Aortic stenosis accounts for the majority of aortic valve disease, as
The incidence is 1-2% in people older than 65 years of age and 4% in people older than 85 years of age.
The transfer of aortic valve diseases is inevitable at last, and a mechanical valve or a biological valve is placed through a sternotomy without surgical valve replacement. The procedure requires general anesthesia and cardiopulmonary bypass support, which can lead to dysfunction of the vital organs (heart, brain and kidney) in elderly patients. In addition, many patients are not suitable for open-chest surgery and are not treated because surgery has many complications and patient discomfort, and many patients often have a multi-organ disease.
The technical principle of Transcatheter Aortic Valve Replacement (TAVR) is to compress and load a stent sutured with a prosthetic valve into a delivery system, then deliver it along an access (e.g., artery) to the aortic valve and release it, compressing the diseased aortic valve adjacent to the prosthetic valve, which is then fixed at the aortic valve, replacing the diseased aortic valve.
Products in some current markets have insufficient radial supporting force and are difficult to fix; too large a length easily causes atrioventricular block; and perivalvular leakage after surgery.
SUMMERY OF THE UTILITY MODEL
The utility model aims at the defects of the prior art and provides a prosthetic heart valve which has stronger radial supporting force, can reduce the symptoms of regurgitation of blood of a patient and is not easy to cause atrioventricular block; and can prevent the problem of perivalvular leakage after operation.
In order to realize the above purpose, the utility model adopts the following technical scheme:
a heart valve prosthesis comprises a support, a gasket, valve leaflets, a suture film and a suture line; the stent is of a multi-layer reticular structure, and comprises a blood flow inflow end and a blood flow outflow end and is used for propping and connecting the original heart valve; the gasket is arranged at the blood flow outflow end of the bracket; the valve leaflet is arranged inside the blood outflow end of the support and is used for replacing the original heart valve; the suture films are arranged on the inner side and the outer side of the blood flow inflow end of the stent and are used for preventing paravalvular leakage; the bracket is provided with a suture hole; the valve leaf penetrates through the stitching hole and is stitched with the gasket, and the support and the valve leaf are stitched by a stitching film through a stitching line to form a heart valve prosthesis structure.
Further, each layer of the bracket is a polygonal net structure or a circular net structure, and the polygonal net structure comprises a hexagonal net structure; the bracket is made of a metal material or a high polymer material, and the metal material comprises stainless steel or an alloy containing cobalt and chromium; the support is formed by laser cutting and integrally forming or welding.
Further, the vertex angle of the mesh structure at the blood outflow end of the stent is 100-125 degrees in the unfolded state; the wall thickness of the stent blood flow outflow end is not less than that of the stent blood flow inflow end.
Further, the suture holes are rectangular suture holes; the rectangular suture holes are arranged in the middle of the first layer of the net structure of the support and are deviated to the blood outflow end of the support.
Further, the valve leaflets are three valve leaflets, wherein each valve leaflet is provided with a protruding part matched with the sewing hole; the bulge of each valve leaf is inserted into the suture hole, and each valve leaf is connected with the support through the suture line in sequence.
Further, the leaflet includes a smooth surface and a rough surface; when the leaflets are sutured, the roughened surface of the leaflets contacts the stent blood inflow end.
Further, the thickness of the valve leaf is 0.1-1 mm; the material of the valve leaf is biological material and/or high molecular material.
Further, the area of the gasket is larger than that of the sewing holes; the thickness of the gasket is 0.1mm-3 mm; the gasket is made of one or more of high polymer materials, biological materials, metal materials and elastic plastics; the gasket is arranged on the outer side of the bracket sewing hole; the pad is connected with the convex part of the valve leaf by sewing thread.
Furthermore, the surface of the gasket is provided with 0-12 holes; the gasket is made of one or more of high polymer materials, biological materials and metal materials.
Furthermore, no hole is formed in the surface of the gasket, and the gasket is made of one or more of a high polymer material and a biological material.
Further, the thickness of the sewing film is 0.01mm-1 mm; the material of the sewing membrane is one or more of PET, PTFE, ePTFE and TPU; the suture line is made of one or more of PET, PTFE and ePTFE; the suture comprises one or more of a multifilament suture and a monofilament core multifilament suture in total; the silk diameter range of the suture is 0.01mm-0.5 mm.
Further, the suture film is made by one or more of weaving, non-weaving and composite processes; the connection mode of the sewing film and the bracket comprises one or more methods of sewing with a sewing thread, ultrasonic welding and the combination of a welding point and a sewing point;
the sewing film and the bracket are completely attached to the wall or an outer pocket is formed outside the sewing film and the bracket; the sewing film and the bracket are adjusted through the welding point and the position of the sewing point;
the material of the sewing film has the following properties:
the water permeability is less than 2000ml/cm 2.min;
② the axial tensile strength is not lower than 5N;
the radial tensile strength is not lower than 5N;
and the breaking strength of the probe is not lower than 1N. Further, the artificial heart valve enters the heart by any one of puncturing a blood vessel, puncturing the heart through the blood vessel and puncturing the apex of the heart, and is implanted at the aortic valve through balloon expansion.
Compared with the prior art, the utility model has stronger radial supporting force, can reduce the symptom of regurgitation of the patient, and is not easy to cause atrioventricular block; the higher suture holes reduce the height of the valve, reducing implant material; and can prevent the problem of perivalvular leakage after operation.
Drawings
FIG. 1 is a block diagram of a prosthetic heart valve provided in accordance with one embodiment;
FIG. 2 is a structural view of a stent of a prosthetic heart valve according to one embodiment;
FIG. 3 is a structural view of a sewing membrane of a heart valve prosthesis provided in accordance with one embodiment;
FIG. 4 is a leaflet structure view of a prosthetic heart valve according to one embodiment;
wherein, 1, a bracket; 1-1, sewing holes; 2. a gasket; 3. a leaflet; 3-1. bulge of valve leaflet; 4. sewing the film; 5. a suture; 6. a blood flow inflow end; 7. a blood flow outflow end; 8. a second layer of a mesh structure; 9. a first mesh structure; a. any position of the suture hole; b. any position of the second mesh structure; c. the apex angle of the first layer of mesh structure.
Detailed Description
The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It is to be noted that the features in the following embodiments and examples may be combined with each other without conflict.
The utility model aims to provide a prosthetic heart valve aiming at the defects of the prior art.
Example one
The embodiment provides a heart valve prosthesis, as shown in fig. 1, comprising a stent 1, a gasket 2, a valve leaflet 3, a suture film 4 and a suture line 5; the stent 1 is of a multi-layer reticular structure, and the stent 1 comprises a blood flow inflow end 6 and a blood flow outflow end 7 which are used for propping and connecting the original heart valve; the gasket 2 is arranged at the blood outflow end 7 of the stent; the valve leaflet 3 is arranged inside the blood outflow end 7 of the bracket 1 and is used for replacing the original heart valve; the suturing film 4 is wrapped on the inner side and the outer side of the blood inflow end 6 of the stent and used for preventing perivalvular leakage; the bracket 1 is provided with a suture hole 1-1; the valve leaflet 3 is sewed with the gasket 2 through the sewing hole 1-1, and the bracket 1 and the valve leaflet 3 are sewed by the sewing film 4 through the sewing thread 5 to form the artificial heart valve structure.
In this embodiment, the leaflet 3 is connected to the spacer 2 through the suture hole 1-1. The valve leaf 3 and the gasket 2 are connected by sewing with a suture 5; the suturing film 4 is connected with the valve leaf 3 and the bracket 1 through the suture 5.
The structure of the stent 1 is a multi-layer mesh barrel-shaped structure, wherein the diameter of the stent 1 is 10mm-40mm, and preferably, the diameter of the stent 1 is 16mm-35 mm. The wall thickness of the stent 1 is 0.1mm to 1mm, and preferably, the wall thickness of the stent 1 is 0.15mm to 0.8 mm. In this embodiment, the wall thickness of the stent blood flow outflow end 7 is not smaller than the wall thickness of the stent blood flow inflow end 6.
The stent 1 is made of a metal material or a polymer material, and the stent 1 of the present embodiment is preferably made of stainless steel or an alloy containing cobalt and chromium. In particular, the MP35N/R30035 alloy is preferred. The approximate chemical composition of the alloy is shown in table 1 below, and the material properties are shown in table 2 below.
| Ni | 35％ |
| Co | 35％ |
| Cr | 25％ |
| Mo | 10％ |
TABLE 1
| Density of | 8.43g/cm3 |
| Melting Point | 1440℃ |
| Coefficient of expansion | 12.8μm/m℃(20-100℃) |
| Modulus of rigidity | 80.7kN/mm2 |
| Modulus of elasticity | 234kN/mm2 |
TABLE 2
In the present embodiment, the thickness of the middle stent of the stent 1 is 0.5mm, and the outer diameter of the stent 1 is 21 mm. The metal pipe of the bracket 1 is integrally formed or welded by laser cutting. The present embodiment is preferably integrally formed by laser cutting. Specifically, the redundant part of the pipe is cut off through laser cutting, a metal support is left, residues are removed through polishing, acid washing and other modes, and then heat treatment is carried out, so that the mechanical property of the material is improved. The bracket 1 is subjected to electrochemical polishing, so that the product has higher surface smoothness and better biocompatibility. The safety of the product use is improved.
In the present embodiment, each layer of the stent 1 has a polygonal or circular mesh structure, preferably a polygonal structure, and usually a quadrangular or hexagonal structure.
As shown in FIG. 2, in the present embodiment, the suture holes 1-1 are rectangular suture holes, and the rectangular suture holes 1-1 are disposed in the middle of the first layer mesh structure 9 of the stent 1 and are biased toward the blood outflow end 7 of the stent; in particular between two adjacent reticular structures at the blood outflow end 7 of the stent 1. The valve leaflet 3 passes through the suture hole 1-1 to be sutured with the bracket 1 to connect the suture hole 1-1 with a square hole, so that the valve leaflet 3 can be conveniently inserted and sutured with the bracket 1, is firmer than the traditional circular suture hole and is positioned at the upper midpoint of the bracket 1. Because the support 1 wraps the valve leaf 3 and the position of the suture hole 1-1 is higher, the height of the valve can be reduced, and the material of the implant is reduced.
In this embodiment, the stent 1 is specifically described as a two-layer mesh structure:
the second layer of net-shaped structure 8 is a hexagonal net-shaped structure with a convex lower side and a concave upper side, and the number of the net-shaped structures is 9; the first layer of reticular structure 9 is a quadrilateral reticular structure with the upper side and the lower side protruding outwards, 9 quadrilateral reticular structures are totally formed, wherein every 3 quadrilateral reticular structures are connected, two sides of the connected 3 quadrilateral reticular structures are respectively connected with 1 suture hole 1-1, and the support 1 is totally provided with 3 suture holes 1-1 which are respectively connected with the valve leaflets. And as shown in fig. 1-2, the position a of the suture hole 1-1 is connected to the position b in the second layer of the net-like structure 8.
In the present embodiment, the vertex angle c of the first layer of mesh structure 9 is 100-.
It should be noted that the mesh shape of the stent 1 is not limited to the number and the number of layers provided in the present embodiment, and is not limited to the structure provided in the present embodiment.
In the present embodiment, as shown in fig. 4, the leaflet 3 is cut by laser, the leaflet 3 has 3 pieces, and each 1 piece of leaflet 3 has a protrusion 3-1 matching with each 1 suture hole 1-1; the projections 3-1 of the leaflets are inserted into the suture holes 1-1 and are protruded outside the stent 1 to attach the leaflets 3 to the stent 1. The leaflets 3 of this embodiment are connected to the suture holes 1-1 by sutures 5, and each leaflet 3 is sequentially sutured to the stent 1.
The valve leaflet 3 is divided into a smooth surface and a rough surface according to the number of fibers; the thickness of the valve leaf 3 is 0.1-1 mm; the material of the leaflet 3 is a biological material or a polymer material, and in this embodiment, a biological material is selected. When the pericardium is closed, the rough surface of the leaflets faces the direction of inflow of blood flow and the smooth surface faces the direction of outflow of blood flow.
It should be noted that the leaflet is not limited to the type provided in the present embodiment, and can be selected according to actual situations.
In the embodiment, the area of the gasket 2 is larger than that of the suture hole 1-1, and the gasket 2 is arranged outside the suture hole of the bracket 1; the pad is connected with the convex part of the valve leaf by sewing thread; the thickness of the gasket 2 is 0.1mm-3mm, and the material of the gasket 2 is one or more of high polymer material, biological material, metal material and elastic plastic. The number of the spacers 2 is 3.
In this embodiment, the surface of the gasket 2 may be provided with 0 to 12 holes; the gasket is made of one or more of high polymer materials, biological materials and metal materials.
The surface of the gasket 2 can also be provided with no hole, and the gasket is made of one or more of high polymer materials and biological materials.
As shown in fig. 3, the suture membrane 4 is formed by cutting with laser or the like, the material of the suture membrane 4 is one or more of PET, PTFE, ePTFE and TPU, and the suture membrane 4 wraps the inner and outer regions of the blood inflow end 6 of the stent, but does not completely wrap the outer region, so as to avoid blocking the coronary artery when being implanted.
As shown in fig. 3, this embodiment shows the shapes of the two sewing films of fig. 3A and 3B, but it should be noted that the shapes of the sewing films are not limited to the shapes shown in this embodiment, and can be selected according to actual situations.
The sewing film 4 wraps partial areas inside and outside the stent 1. The sewing film cannot wrap all of the outer layer area of the stent. The thickness of the sewing film 4 is 0.01 to 1mm, preferably 0.02 to 0.3 mm. The thickness of this example is 0.05 mm. The sewing film 4 is sewn to the stent and/or the leaflet from the inside of the stent. The blood inflow end 6 sewed to the stent is turned out to the outside of the stent, so as to prevent paravalvular leakage.
The sewing film 4 is made by one or more of weaving, non-weaving and composite processes; the connection mode of the sewing film 4 and the bracket 1 comprises one or more methods of sewing by a sewing thread, ultrasonic welding and the combination of a welding point and a sewing point;
the sewing film 4 and the bracket 1 are completely attached to the wall or the sewing film 4 and the bracket 1 form an outer pocket; the sewing film 4 and the bracket 1 are adjusted through welding points and the positions of the sewing points;
in this example, the material properties of the sewing film 4 are as shown in table 3:
| performance of | Parameter(s) |
| Permeability to water | 670ml/cm2.min |
| Axial tensile strength | 23N |
| Radial tensile strength | 21N |
| Breaking strength of probe | 7N |
TABLE 3
The sewing film 4 is sewn with the leaflet 3 and the stent 1 by the sewing thread 5. The material of the sewing thread 5 is one or more of PET, PTFE and ePTFE. Suture 5 comprises one or more of a multifilament suture and a monofilament core multifilament suture in total; the silk diameter range of the suture 5 is 0.01mm-0.5 mm; preferably one or more of the specifications of 2-0, 3-0, 4-0, 5-0 and 6-0, and in the embodiment, 5-0 specification suture is adopted.
In this embodiment, when the prosthetic heart valve is used, the prosthetic heart valve is compressed on the balloon of the delivery system by a dedicated press-and-grip machine, and is delivered to the aortic valve by puncturing the blood vessel or puncturing the heart through the blood vessel or apex of the heart, and the balloon is expanded to expand the valve, so that the valve is fixed at the aortic valve and the diseased aortic valve is replaced.
Compared with the prior art, the embodiment has stronger radial supporting force, can reduce the symptom of blood reflux of the patient, and is not easy to cause atrioventricular block; the higher suture holes reduce the height of the valve, reducing implant material; and can prevent the problem of perivalvular leakage after operation.
The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications, additions and substitutions for the specific embodiments described herein may be made by those skilled in the art without departing from the spirit of the invention or exceeding the scope of the invention as defined in the accompanying claims.
Claims (13)
1. A heart valve prosthesis is characterized by comprising a bracket, a gasket, valve leaflets, a suture film and a suture line; the stent is of a multi-layer reticular structure, and comprises a blood flow inflow end and a blood flow outflow end and is used for propping and connecting the original heart valve; the gasket is arranged at the blood flow outflow end of the bracket; the valve leaflet is arranged inside the blood outflow end of the support and is used for replacing the original heart valve; the suture films are arranged on the inner side and the outer side of the blood flow inflow end of the stent and are used for preventing paravalvular leakage; the bracket is provided with a suture hole; the valve leaf penetrates through the stitching hole and is stitched with the gasket, and the support and the valve leaf are stitched by a stitching film through a stitching line to form a heart valve prosthesis structure.
2. The prosthetic heart valve of claim 1, wherein each layer of the stent is a polygonal mesh structure or a circular mesh structure, the polygonal mesh structure comprising a hexagonal mesh structure; the bracket is made of a metal material or a high polymer material, and the metal material comprises stainless steel or an alloy containing cobalt and chromium; the support is formed by laser cutting and integrally forming or welding.
3. The heart valve prosthesis of claim 2, wherein the apex angle of the stent blood flow outflow end mesh structure is 100-125 degrees in the deployed state; the wall thickness of the stent blood flow outflow end is not less than that of the stent blood flow inflow end.
4. A prosthetic heart valve according to claim 1, wherein the suture holes are rectangular suture holes; the rectangular suture holes are arranged in the middle of the first layer of the net structure of the support and are deviated to the blood outflow end of the support.
5. A prosthetic heart valve according to claim 4, wherein said leaflet is three leaflets, each leaflet having a protrusion adapted to fit into said suture hole; the bulge of each valve leaf is inserted into the suture hole, and each valve leaf is connected with the support through the suture line in sequence.
6. The prosthetic heart valve of claim 5, wherein the leaflet includes a smooth surface and a rough surface; when the leaflets are sutured, the roughened surface of the leaflets contacts the stent blood inflow end.
7. A prosthetic heart valve according to claim 6, wherein the leaflet has a thickness of 0.1-1 mm; the material of the valve leaf is biological material and/or high molecular material.
8. A prosthetic heart valve according to claim 5, wherein the area of the spacer is larger than the area of the suture holes; the thickness of the gasket is 0.1mm-3 mm; the gasket is made of one of a high polymer material, a biological material and a metal material; the gasket is arranged on the outer side of the bracket sewing hole; the pad is connected with the convex part of the valve leaf by sewing thread.
9. The heart valve prosthesis of claim 8, wherein the spacer surface is provided with holes, the number of the holes being 0-12; the gasket is made of one of a high polymer material, a biological material and a metal material.
10. The heart valve prosthesis of claim 8, wherein the surface of the spacer is not provided with holes, and the spacer is made of one of a polymer material and a biological material.
11. A prosthetic heart valve according to claim 1, wherein the sewing membrane has a thickness of 0.01mm to 1 mm; the sewing membrane is made of one of PET, PTFE, ePTFE and TPU; the suture line is made of one of PET, PTFE and ePTFE; the suture comprises one of a multifilament suture and a monofilament core multifilament suture; the silk diameter range of the suture is 0.01mm-0.5 mm.
12. The prosthetic heart valve of claim 1, wherein the sewing membrane comprises one or more of a woven, non-woven, composite process; the connection mode of the sewing film and the bracket comprises one or more methods of sewing with a sewing thread, ultrasonic welding and the combination of a welding point and a sewing point;
the sewing film and the bracket are completely attached to the wall or an outer pocket is formed outside the sewing film and the bracket; the sewing film and the bracket are adjusted through the welding point and the position of the sewing point;
the material of the sewing film has the following properties:
the water permeability is less than 2000ml/cm 2.min;
② the axial tensile strength is not lower than 5N;
the radial tensile strength is not lower than 5N;
and the breaking strength of the probe is not lower than 1N.
13. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve is inserted into the heart by any of puncturing the blood vessel, puncturing the heart through the blood vessel, puncturing the apex of the heart, and implanting the prosthetic heart valve by balloon expansion.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202020180295.6U CN212089843U (en) | 2020-02-18 | 2020-02-18 | Artificial heart valve |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202020180295.6U CN212089843U (en) | 2020-02-18 | 2020-02-18 | Artificial heart valve |
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| CN212089843U true CN212089843U (en) | 2020-12-08 |
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| CN202020180295.6U Active CN212089843U (en) | 2020-02-18 | 2020-02-18 | Artificial heart valve |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111184596A (en) * | 2020-02-18 | 2020-05-22 | 科凯(南通)生命科学有限公司 | Artificial heart valve |
| CN113730040A (en) * | 2021-10-09 | 2021-12-03 | 复旦大学附属儿科医院 | Application and sewing method of novel ePTFE stent valve |
| WO2022121872A1 (en) * | 2020-12-11 | 2022-06-16 | 山前(珠海)生物材料科技有限公司 | Heart valve stent, and heart valve prosthesis structure composed of same |
-
2020
- 2020-02-18 CN CN202020180295.6U patent/CN212089843U/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111184596A (en) * | 2020-02-18 | 2020-05-22 | 科凯(南通)生命科学有限公司 | Artificial heart valve |
| WO2022121872A1 (en) * | 2020-12-11 | 2022-06-16 | 山前(珠海)生物材料科技有限公司 | Heart valve stent, and heart valve prosthesis structure composed of same |
| CN113730040A (en) * | 2021-10-09 | 2021-12-03 | 复旦大学附属儿科医院 | Application and sewing method of novel ePTFE stent valve |
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Address after: No.10 Yongfu Road, shibeikeji City, Gangzha District, Nantong City, Jiangsu Province, 226000 Patentee after: KEKAI (NANTONG) LIFE SCIENCE Co.,Ltd. Address before: 2269, Liugang Road, Nantong City, Jiangsu Province Patentee before: KEKAI (NANTONG) LIFE SCIENCE Co.,Ltd. |
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Effective date of registration: 20230818 Address after: Room 405, Building 18, No. 2555 Xiupu Road, Pudong New Area, Shanghai, 201315 Patentee after: Ketong (Shanghai) Medical Devices Co.,Ltd. Address before: No.10 Yongfu Road, shibeikeji City, Gangzha District, Nantong City, Jiangsu Province, 226000 Patentee before: KEKAI (NANTONG) LIFE SCIENCE Co.,Ltd. |