CN211155935U - Degradable plugging device - Google Patents
Degradable plugging device Download PDFInfo
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- CN211155935U CN211155935U CN201921282181.6U CN201921282181U CN211155935U CN 211155935 U CN211155935 U CN 211155935U CN 201921282181 U CN201921282181 U CN 201921282181U CN 211155935 U CN211155935 U CN 211155935U
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- degradable
- disc surface
- occluder
- polylactic acid
- lower disc
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00597—Implements comprising a membrane
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00601—Implements entirely comprised between the two sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
The utility model discloses a degradable plugging device. The degradable occluder is an integral net-shaped structure woven by degradable filaments, and the structure of the degradable occluder comprises an upper disc surface, a lower disc surface and a waist part connecting the upper disc surface and the lower disc surface; the upper disc surface, the waist part and the lower disc surface are sewed with a plurality of layers of degradable flow-resisting films through degradable stitches; and in the conveying process of the degradable plugging device, the sintering tail end is connected with a pushing device. The utility model discloses after implanting the human body, can degrade completely gradually, degradation product is discharged along with human metabolism is external, avoids nickel titanium occluder to stop the problem of a series of complications that arouse in vivo for a long time.
Description
Technical Field
The utility model relates to a degradable plugging device for the treatment of congenital heart disease, which belongs to the field of medical equipment.
Background
The occluder is a medical apparatus mainly used for treating congenital heart disease, and mainly comprises an atrial septal defect occluder, a ventricular septal defect occluder, an arterial duct patent occluder, a left atrial appendage occluder and the like. At present, the occluder on domestic market generally consists of a nickel-titanium alloy stent and a choke membrane group, wherein the nickel-titanium alloy stent is formed by weaving nickel-titanium wires into a net and performing heat treatment and shaping in a mold. The flow-resistant film is generally a non-degradable polyester material.
After the occluder is implanted into a body, the occluder mainly plays a role of a bridge and promotes the endothelialization of surrounding tissues on the surface of the occluder, thereby realizing the occlusion of defects. However, after the endothelialization is completed, the mission of the occluder is completed, the occluder is continuously left in the body, and the risk of causing a series of complications including allergy and arrhythmia caused by nickel ion precipitation is caused, so that the nickel-titanium alloy stent and the flow blocking membrane need to be replaced by degradable high polymer materials, and a degradable occluder is developed.
SUMMERY OF THE UTILITY MODEL
The utility model discloses the problem that will solve is: the degradable occluder can be gradually degraded after the surface of the occluder is completely endothelialized, and degradation products are discharged along with metabolism of a human body, so that hidden dangers caused by long-term retention of the metal occluder in the body are avoided.
In order to solve the technical problem, the utility model provides a technical scheme is: a degradable plugging device is an integral reticular structure woven by degradable filaments, and the structure of the degradable plugging device comprises an upper disc surface, a lower disc surface and a waist part connecting the upper disc surface and the lower disc surface, and is characterized in that a closing opening of the reticular structure is positioned on the bottom surface of the lower disc surface, and the degradable filaments at the closing opening are melted to form a fusion tail end; the upper disc surface, the waist part and the lower disc surface are sewed with a plurality of layers of degradable flow-resisting films through degradable stitches; in the conveying process of the degradable plugging device, the sintering tail end is connected with a pushing device; two free ends of the safety rope penetrate from any two positions on the upper disc surface to the lower disc surface and penetrate out from the lower disc surface after penetrating through the waist.
Preferably, the top surface of the upper disc surface is a plane or a raised arc surface or a combination structure of the plane and the raised arc surface.
Preferably, the maximum diameter of the upper disc surface is larger than the minimum diameter of the waist; the maximum diameter of the lower disc surface is larger than or equal to the minimum diameter of the waist.
Preferably, the fusion tail end is concave to the inner part of the lower disc surface or protrudes from the bottom of the lower disc surface.
Preferably, the degradable filaments are amorphous polylactic acid, levorotatory polylactic acid, dextrorotatory polylactic acid, polydioxanone, polycaprolactone, polyglycolic acid PGA or polylactic acid-glycolic acid copolymer.
Preferably, the degradable obstructing film or the degradable suture is made of one or a mixture of more than two of polydioxanone, polycaprolactone, polyglycolic acid, polylactic acid-glycolic acid copolymer or amorphous polylactic acid, levorotatory polylactic acid and dextrorotatory polylactic acid; the degradable flow-resistant film is in the structure of spunlace non-woven fabric, needle-punched non-woven fabric, spun-bonded non-woven fabric, heat-seal non-woven fabric, wet non-woven fabric or electrostatic spinning fiber film; the number of layers of the degradable flow-blocking film is 2-6.
Preferably, the contact surface of the sintering tail end and the pushing device is provided with grains so as to increase the surface roughness of the sintering tail end, increase the friction force between the sintering tail end and the pushing device and further ensure the conveying safety.
More preferably, the texture is a thread, a wave or a fish scale.
Preferably, the material of the safety rope is amorphous polylactic acid PD LL A, levorotatory polylactic acid P LL A, dextrorotatory polylactic acid PD L A, polydioxanone PDO, polycaprolactone PC L, polyglycolic acid PGA, polylactic acid-glycolic acid copolymer P L GA, dacron PET, chinlon PA or polytetrafluoroethylene PTFE.
Compared with the prior art, the utility model discloses there is following beneficial effect:
the degradable occluder is completely made of degradable materials, and can be gradually and completely degraded after being implanted into a human body, and degradation products are discharged out of the body along with metabolism of the human body, so that the problem of a series of complications caused by long-term stay of the nickel-titanium occluder in the body is solved. In addition, the upper disc surface of the degradable plugging device is a flat plane, so that the degradable plugging device is more favorable for the climbing of endothelial cells, accelerates the endothelialization of the surface of the plugging device and achieves a good plugging effect. The fusion tail end of the lower disc surface of the degradable plugging device is formed by melting degradable filaments, the surface of the fusion tail end is provided with rough grains, and the fusion tail end can be well connected with a conveying device.
Drawings
Fig. 1 is a front view of the degradable occluder provided in example 1;
FIG. 2 is a top view of FIG. 1;
fig. 3 is a front view of the degradable occluder provided in example 2;
FIG. 4 is a top view of FIG. 3;
fig. 5 is a front view of the degradable occluder provided in example 3;
FIG. 6 is a top view of FIG. 5;
fig. 7 is a front view of the degradable occluder provided in example 4;
FIG. 8 is a top view of FIG. 7;
FIG. 9 is a front view of the tubular net woven by degradable filaments in examples 1 to 4;
FIG. 10 is a side view of FIG. 9;
fig. 11 is a front view of the degradable occluder provided in example 5;
FIG. 12 is a top view of FIG. 11;
fig. 13 is a front view of the degradable occluder provided in example 6;
FIG. 14 is a top view of FIG. 13;
fig. 15 is a front view of the degradable occluder provided in example 7;
FIG. 16 is a top view of FIG. 16;
fig. 17 is a front view of the degradable occluder provided in example 8;
fig. 18 is a top view of fig. 17.
FIG. 19 is a front view of a tubular mesh woven from degradable filaments provided in examples 5-8;
fig. 20 is a side view of fig. 19.
Detailed Description
In order to make the present invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings.
The preparation method of the degradable occluders provided in examples 1-8 comprises the following steps: a tubular net woven by degradable filaments (the tubular net woven by the degradable filaments in examples 1 to 4 is shown in fig. 9 and 10, and the tubular net woven by the degradable filaments in examples 5 to 8 is shown in fig. 19 and 20) is reduced by the degradable filaments at one end or woven into a flat net structure with an open tubular net at the other end; one end of the opening is wound and fixed by a copper wire, the fixed length is 1-5 mm, a heating device is started, only the degradable wires at the winding part of the copper wire are continuously heated, the heating temperature is 110-250 ℃, the heating time is 1-15 s, until the degradable wires in the copper wire are molten, and meanwhile, the degradable wires outside the winding part of the copper wire are not damaged; removing the copper wire to form a sintering tail end 6, wherein the sintering tail end 6 is provided with grains; putting the shaping die into a tubular net with a sintering tail end 6, and carrying out heat treatment shaping, wherein the shaping temperature is 50-100 ℃, and the shaping time is 10-100 min; removing the mould to obtain a degradable occluder bracket; filling the degradable flow-blocking film 2 into the degradable plugging device bracket to form an upper disc surface 3, a lower disc surface 5 and a waist part 4, and fixing the degradable flow-blocking film 2 by degradable sutures.
The corresponding relationship between the setting temperature and the setting time in the heat treatment setting process and the diameter of the used degradable filaments is shown in table 1.
TABLE 1
| Degradable filament diameter (mm) | Setting temperature (. degree. C.) | Setting time (min) |
| 0.250-0.339 | 40-100 | 50-100 |
| 0.200-0.249 | 40-100 | 50-100 |
| 0.150-0.199 | 40-100 | 10-80 |
| 0.095-0.149 | 40-100 | 10-80 |
Example 1
As shown in fig. 1 and 2, the degradable occluder provided in this embodiment is an integral mesh structure woven by degradable filaments 1, and the structure includes an upper disc surface 3, a lower disc surface 5 and a waist portion 4 connecting the upper disc surface and the lower disc surface, and is characterized in that a closing opening of the mesh structure is located on the bottom surface of the lower disc surface 5, and the melting tail end 6 is formed by melting the degradable filaments at the position; the upper disc surface 3, the waist 4 and the lower disc surface 5 are sewed with a plurality of layers of degradable flow-resisting films 2 through degradable stitches; in the conveying process of the degradable occluder, the fusion tail end 6 is connected with a pushing device, so that the degradable occluder can be conveyed to the defect position. Two free ends of the safety rope penetrate from any two positions on the upper disc surface 3 from top to bottom, penetrate through the waist part 4 and penetrate out of the lower disc surface 5.
The top surface of the upper disc surface 3 is a plane; the maximum diameters of the upper disc surface 3 and the lower disc surface 5 are the same and are both larger than the minimum diameter of the waist part 4. The fusion tail end 6 is concave inside the lower disc surface 5.
The degradable filaments are amorphous polylactic acid, levorotatory polylactic acid, dextrorotatory polylactic acid, polydioxanone, polycaprolactone, polyglycolic acid PGA or polylactic acid-glycolic acid copolymer.
The degradable flow-resistant film 2 or the degradable suture is made of any one or more than two blends of poly (p-dioxanone), polycaprolactone, polyglycolic acid, polylactic acid-glycolic acid copolymer or amorphous polylactic acid, levorotatory polylactic acid and dextrorotatory polylactic acid; the degradable flow-resistant film 2 is made of spunlace non-woven fabrics, needle-punched non-woven fabrics, spun-bonded non-woven fabrics, heat-seal non-woven fabrics, wet non-woven fabrics or electrostatic spinning fiber films; the number of layers of the degradable flow-resistant film 2 is 2-6.
And the contact surface of the sintering tail end 6 and the pushing device is provided with threads.
The material of the safety rope is amorphous polylactic acid PD LL A, levorotatory polylactic acid P LL A, dextrorotatory polylactic acid PD L A, polydioxanone PDO, polycaprolactone PC L, polyglycolic acid PGA, polylactic acid-glycolic acid copolymer P L GA, dacron PET, chinlon PA or polytetrafluoroethylene PTFE.
Example 2
The difference between the embodiment and the embodiment 1 is that the top surface of the upper disc surface 3 is a convex arc surface; the maximum diameter of the upper disc surface 3 is less than or equal to the minimum diameter of the lower disc surface 5, and both diameters are greater than the minimum diameter of the waist part 4. The fusion tail end 6 protrudes from the bottom of the lower disc surface 5.
Example 3
The difference between the embodiment and the embodiment 1 is that the top surface of the upper disc surface 3 is in a circular truncated cone shape with a plane top surface, and the periphery of the upper disc surface 3 extends downwards to surround the waist part 4; the maximum diameter of the upper disc surface 3 is larger than the minimum diameter of the lower disc surface 5, and both are larger than the minimum diameter of the waist part 4. The fusion tail end 6 protrudes from the bottom of the lower disc surface 5, and the periphery of the lower disc surface 5 also extends downwards.
Example 4
This embodiment is different from embodiment 1 in that the maximum diameter of the upper disc surface 3 is larger than the lower disc surface 5, and the diameter of the lower disc surface 5 is the same as the diameter of the waist portion 4, i.e., the lower portion is cylindrical.
Example 5
The present embodiment is different from embodiment 1 in that the above disc surface 3 has a different net shape due to a different weaving rule of the tubular net.
Example 6
The difference between this embodiment and embodiment 2 is that the above disc surface 3 has a different net shape due to the different weaving rules of the tubular net.
Example 7
The difference between this embodiment and embodiment 3 is that the above disc surface 3 has a different net shape due to the different weaving rules of the tubular net.
Example 8
The present embodiment is different from embodiment 4 in that the above disc surface 3 is different in mesh shape because the tubular mesh is different in weaving rule.
Claims (9)
1. A degradable plugging device is an integral reticular structure woven by degradable filaments (1), and the structure of the degradable plugging device comprises an upper disc surface (3), a lower disc surface (5) and a waist part (4) connecting the upper disc surface and the lower disc surface, and is characterized in that a closing opening of the reticular structure is positioned at the bottom surface of the lower disc surface (5), and the degradable filaments at the closing opening are melted to form a fusion tail end (6); the upper disc surface (3), the waist part (4) and the lower disc surface (5) are sewed with a plurality of layers of degradable flow-resisting films (2) through degradable stitches; in the conveying process of the degradable plugging device, the sintering tail end (6) is connected with a pushing device; two free ends of the safety rope penetrate from any two positions on the upper disc surface (3) from top to bottom, penetrate through the waist part (4) and penetrate out of the lower disc surface (5).
2. The degradable occluder of claim 1, wherein the top surface of the upper disk surface (3) is a plane surface or a convex circular arc surface or a combination of the two.
3. The degradable occluder of claim 1, wherein the maximum diameter of the upper disk face (3) is larger than the minimum diameter of the waist (4); the maximum diameter of the lower disc surface (5) is larger than or equal to the minimum diameter of the waist (4).
4. The degradable occluder of claim 1, wherein said fusion-bonded tail end (6) is recessed within the lower disk surface (5) or protrudes from the bottom of the lower disk surface (5).
5. The degradable occluder of claim 1, wherein said degradable filaments are amorphous polylactic acid, poly-L-lactic acid, poly-D-lactic acid, polydioxanone, polycaprolactone, polyglycolic acid PGA or polylactic acid-glycolic acid copolymer.
6. The degradable occluder of claim 1, wherein the degradable barrier membrane (2) or the degradable suture is made of polydioxanone, polycaprolactone, polyglycolic acid, polylactic acid-glycolic acid copolymer or amorphous polylactic acid, polylactic acid-lactic acid, or a blend of two or more of them; the degradable flow-resistant film (2) is in the structure of spunlace non-woven fabric, needle-punched non-woven fabric, spun-bonded non-woven fabric, heat-seal non-woven fabric, wet non-woven fabric or electrostatic spinning fiber film; the number of layers of the degradable flow-resistant film (2) is 2-6.
7. The degradable occluder of claim 1, wherein the contact surface of the fusion tail end (6) and the pushing device is textured.
8. The degradable occluder of claim 7, wherein said thread is a thread and said thread is a thread, a wave or a fish scale.
9. The degradable occluder of claim 1, wherein the safety line is made of amorphous polylactic acid PD LL A, L-polylactic acid P LL A, D-polylactic acid PD L A, polydioxanone PDO, polycaprolactone PC L, polyglycolic acid PGA, polylactic acid-glycolic acid copolymer P L GA, polyester PET, polyamide PA or polytetrafluoroethylene PTFE.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2019107054486 | 2019-08-01 | ||
| CN201910705448 | 2019-08-01 |
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| CN211155935U true CN211155935U (en) | 2020-08-04 |
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| CN201910721466.3A Pending CN110432935A (en) | 2019-08-01 | 2019-08-06 | Degradable plugging device and preparation method thereof |
| CN201921282181.6U Active CN211155935U (en) | 2019-08-01 | 2019-08-06 | Degradable plugging device |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110432935A (en) * | 2019-08-01 | 2019-11-12 | 上海形状记忆合金材料有限公司 | Degradable plugging device and preparation method thereof |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111110288A (en) * | 2020-01-14 | 2020-05-08 | 赵天力 | Ventricular septal defect occluder and preparation method thereof |
| CN113208685A (en) * | 2020-02-05 | 2021-08-06 | 江苏暖阳医疗器械有限公司 | Degradable braided body system for embolizing aneurysm |
| CN112773418B (en) * | 2020-12-31 | 2021-10-01 | 上海锦葵医疗器械股份有限公司 | Degradable heart foramen ovale closure device and manufacturing method thereof |
| CN112773419B (en) * | 2020-12-31 | 2022-01-07 | 上海锦葵医疗器械股份有限公司 | Heart patent foramen ovale plugging device with flat two end surfaces and manufacturing method thereof |
| CN112932589B (en) * | 2021-02-01 | 2022-06-28 | 上海锦葵医疗器械股份有限公司 | Patent heart artery duct plugging device with two smooth end surfaces and manufacturing method thereof |
| CN112932562B (en) * | 2021-02-01 | 2022-06-28 | 上海锦葵医疗器械股份有限公司 | Heart atrial septal defect occluder with flat two end surfaces and manufacturing method thereof |
| CN112932567A (en) * | 2021-03-15 | 2021-06-11 | 上海捍宇医疗科技股份有限公司 | Plugging device |
| WO2022252463A1 (en) * | 2021-06-03 | 2022-12-08 | 上海形状记忆合金材料有限公司 | Implantable instrument having vertical double-concave structure |
| CN114587472B (en) * | 2022-02-25 | 2024-05-28 | 上海形状记忆合金材料有限公司 | Plugging device |
| CN114559642B (en) * | 2022-02-28 | 2023-07-21 | 上海形状记忆合金材料有限公司 | Method and device for preparing closing end of plugging device |
| CN116439879A (en) * | 2023-06-13 | 2023-07-18 | 杭州锐健马斯汀医疗器材有限公司 | Medical implantation sheath and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110464403B (en) * | 2015-09-07 | 2021-08-31 | 先健科技(深圳)有限公司 | Absorbable plugging device |
| CN205126332U (en) * | 2015-10-09 | 2016-04-06 | 青岛科技大学 | Damaged plugging device of degradable heart |
| CN205322380U (en) * | 2015-12-31 | 2016-06-22 | 上海锦葵医疗器械有限公司 | Degradable heart ventricular septal defect plugging device |
| CN205322379U (en) * | 2015-12-31 | 2016-06-22 | 上海锦葵医疗器械有限公司 | Degradable heart atrial septal defect plugging device |
| CN207785224U (en) * | 2015-12-31 | 2018-08-31 | 上海锦葵医疗器械有限公司 | Degradable heart occluder for left auricle |
| CN207996221U (en) * | 2015-12-31 | 2018-10-23 | 上海锦葵医疗器械有限公司 | Degradable heart arter patent ductus plugging device |
| CN107970493B (en) * | 2016-10-25 | 2021-08-17 | 先健科技(深圳)有限公司 | Absorbable plugging device |
| CN108451570A (en) * | 2018-02-23 | 2018-08-28 | 上海形状记忆合金材料有限公司 | Assist molding device and method in Wholly-degradable plugging device body |
| CN108888302B (en) * | 2018-07-03 | 2021-07-16 | 哈尔滨工业大学 | Degradable drug-loaded occluder and method for forming, unfolding and folding occluder |
| CN110432935A (en) * | 2019-08-01 | 2019-11-12 | 上海形状记忆合金材料有限公司 | Degradable plugging device and preparation method thereof |
-
2019
- 2019-08-06 CN CN201910721466.3A patent/CN110432935A/en active Pending
- 2019-08-06 CN CN201921282181.6U patent/CN211155935U/en active Active
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110432935A (en) * | 2019-08-01 | 2019-11-12 | 上海形状记忆合金材料有限公司 | Degradable plugging device and preparation method thereof |
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| CN110432935A (en) | 2019-11-12 |
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