CN111839809A - Tubular repairing part for organ repair and preparation method thereof - Google Patents
Tubular repairing part for organ repair and preparation method thereof Download PDFInfo
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- CN111839809A CN111839809A CN201910323326.0A CN201910323326A CN111839809A CN 111839809 A CN111839809 A CN 111839809A CN 201910323326 A CN201910323326 A CN 201910323326A CN 111839809 A CN111839809 A CN 111839809A
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- tubular
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y10/00—Processes of additive manufacturing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Manufacturing & Machinery (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Chemical & Material Sciences (AREA)
- Materials Engineering (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
The present invention provides a tubular repair for organ repair comprising: a tube body formed of a degradable support adhesive layer having mechanical strength sufficient to maintain the shape of the tube body, the tube body being coated with biocompatible layers on inner and outer surfaces thereof. The invention also provides a method for preparing a tubular repair for organ repair. The tubular repair part can meet the mechanical property required by the repair part when being implanted into a human body for organ repair, can be degraded in the human body, and avoids the influence of non-degradable materials on the metabolism and reconstruction of organs and the problem of scar caused by the non-degradable materials.
Description
Technical Field
The invention relates to a tubular repairing part for organ repair and a preparation method thereof.
Background
The existence of various tubular organs in the human body, such as blood vessels, nerves, trachea, esophagus, urethra, urinary catheter, nasolacrimal duct, etc., and the segmental defects of such organs caused by trauma or disease (e.g., tumor resection) have created a need for repair of such defects. At present, the mature repair materials for blood vessels, nerves and tracheas are clinically used, and other organs are mainly repaired in a mode of autologous tissue transplantation reconstruction or direct drawing and suturing of the end parts, so that the organ structure can be obviously changed. Although materials for repairing blood vessels, nerves, trachea and the like are mature, the repairing materials are mostly non-biodegradable materials such as silica gel, expanded polytetrafluoroethylene, knitted terylene and the like, and the materials exist in repaired tubular organs for a long time to influence the metabolism and reconstruction of the organs, particularly the reconstruction activity of the blood vessels in the aspects of diameter, curvature, branching and the like. In addition, non-degradable materials generally cause scarring problems of varying degrees, especially at the anastomotic site, which can lead to re-occlusion. The above problems are improved by coating techniques, but some remaining problems remain.
At present, degradable tubular repair materials are still in research stage, wherein the better effect comprises acellular matrixes, flaky acellular matrixes, electrostatic spinning tubules and the like made of natural tubular animal organs. The tubular acellular matrix is the material with the best application effect in the current research, but due to the limitation of material obtaining, the tubular organs of different animal individuals have large difference, uniform quality is difficult to realize, and the tubular acellular matrix is not suitable for industrialization. The sheet acellular matrix has obviously improved uniformity compared with a tubular acellular matrix and is suitable for industrialization, but the sheet acellular matrix is not tubular in shape, so that the sheet acellular matrix needs to be wrapped, fixed and sutured to form a tubular shape when in use, and the sheet acellular matrix has the problems of rupture, fistula anastomosis, incapability of maintaining opening and the like. The electrostatic spinning tubule has good shape controllability and uniformity, but the components beneficial to cell growth are difficult to simultaneously meet the requirements of mechanical properties, and are not widely applied.
Furthermore, there are C-roll tubular members in the prior art. Fig. 1 shows a schematic cross-sectional view of such a C-roll tubular member. As can be seen from the figure, the C-roll tubular member cannot be formed by one-time rolling, and the biocompatible layer does not completely cover the inner and outer surfaces of the tube body, and thus it can be seen that the manufacturing method of the C-roll tubular member is poor in operability.
Therefore, there is a need in the art for a degradable tubular repair that can be formed in one roll and has certain mechanical properties.
Disclosure of Invention
In one aspect, provided herein is a tubular repair for organ repair comprising: a tube body formed of a degradable support adhesive layer having mechanical strength sufficient to maintain the shape of the tube body, the tube body being coated with biocompatible layers on inner and outer surfaces thereof. The tubular repair may be a cylinder or a cone.
In some embodiments of the invention, the biocompatible layer coating the inner and outer surfaces of the tube body extends beyond the support adhesive layer in the direction of the tube axis to form an annular groove in which the tissue to be repaired is embedded. The depth of the annular groove may be 1mm to 5 mm.
In some embodiments of the invention, the biocompatible layer is made of an acellular matrix-like material and/or a biocompatible material. The acellular matrix material comprises: fibrin, elastin, laminin, fibronectin, or combinations thereof; the biocompatible material includes: collagen, gelatin, cellulose, chitin, chitosan, alginate, agarose, or combinations thereof. The term "acellular matrix-like material" as used herein refers to a material in which after an allogeneic tissue is subjected to an acellular process, antigenic components capable of causing an immune rejection reaction are removed, while the three-dimensional structure of the extracellular matrix and some growth factors important for cell differentiation are completely retained. The term "biocompatible material" as used herein refers to a class of materials that are capable of withstanding the action of the host system while remaining relatively stable, and are not rejected or destroyed (i.e., biocompatible and bioacceptable) in the organism.
In some embodiments of the invention, the degradable support adhesion layer is made of polycaprolactone PCL, polylactic acid PLA, polylactic glycolic acid PLGA, polyglycolic acid PGA, or a combination thereof.
In some embodiments of the invention, the biocompatible layer and the supporting adhesive layer are formed by casting, or lyophilization, or electrospray, or electrospinning, or 3D printing. The "casting method" as used herein includes coating a solution obtained by melting a material on a releasable support, drying by heating in a drying tunnel, thereby melt-plasticizing the solution to form a film layer, and releasing the film layer from the release surface of the support after cooling to form a flat sheet. As used herein, "lyophilization" includes the formation of a planar sheet by applying a solution of a material to a mold, followed by lyophilization and removal from the mold. "electrospray" as used herein includes spraying a material as a planar sheet by melting the material. As used herein, "electrospinning" includes forming a material from a solution into fibers, which are woven into a planar sheet. As used herein, "3D printing" includes direct printing with a 3D plotter using CAD data, filling the material into a high temperature printer head of the 3D biopgrapher and melting, printing the melted material as a planar sheet.
In another aspect, provided herein is a method of preparing a tubular repair for organ repair comprising:
i. providing a biocompatible layer having a first size and a degradable supporting adhesive layer having a second size, and placing the biocompatible layer having the first size and the degradable supporting adhesive layer having the second size in a non-aligned manner in a stack;
rolling the non-aligned layered biocompatible layer and degradable support adhesive layer to obtain a tubular repair, wherein the degradable support adhesive layer forms a tubular body of the tubular repair and the biocompatible layer covers the inner and outer surfaces of the tubular body, and the degradable support adhesive layer provides mechanical strength sufficient to maintain the shape of the tubular body. The rolled tubular repair may be cylindrical or conical.
In some embodiments of the present invention, in the rolled tubular prosthesis, the biocompatible layer coating the inner and outer surfaces of the tubular body exceeds the support adhesion layer in the tubular axis direction to form an annular groove in which the tissue to be repaired is embedded.
In some embodiments of the invention, the rolling is performed around a spool.
In some embodiments of the invention, each side of the biocompatible layer having the first size and the degradable supportive adhesive layer having the second size are positioned in a non-aligned layered arrangement with each side of the biocompatible layer having the first size extending beyond each side of the degradable supportive adhesive layer having the second size. In some embodiments of the present invention, the length of the biocompatible layer having the first dimension in the rolling direction is at least twice as long as the length of the degradable support adhesive layer having the second dimension in the rolling direction, and in one embodiment, the length of the biocompatible layer having the first dimension in the rolling direction is 2.5 times or 3 times as long as the length of the degradable support adhesive layer having the second dimension in the rolling direction. The width of the biocompatible layer having the first size in the direction perpendicular to the rolling direction is 2 to 10mm greater than the width of the degradable support adhesive layer having the second size in the direction perpendicular to the rolling direction.
In some embodiments of the invention, the method further comprises heating and/or solvent wetting the rolled tubular repair to adhere the support adhesive layer to the biocompatible layer encasing the support adhesive layer.
The tubular repair part for organ repair comprises a degradable support adhesion layer forming a pipe body of the tubular repair part and a biocompatible layer wrapping the inner surface and the outer surface of the pipe body, wherein the degradable support adhesion layer and the biocompatible layer are arranged in a non-aligned stacking mode and are rolled, so that the rolled tubular repair part can meet the mechanical property required by a repair part when being implanted into a body for organ repair, can be degraded in the body, and avoids the influence of non-degradable materials on the metabolism and reconstruction of the organ and the scar problem caused by the non-degradable materials.
Drawings
FIG. 1 is a schematic cross-sectional view of a prior art C-coil.
Figure 2 is a schematic cross-sectional view of a tubular repair according to an embodiment of the present invention.
Detailed Description
The various aspects of the present invention will be described in detail with reference to specific examples, which are provided for illustration only and are not intended to limit the scope and spirit of the present invention.
Example 1
Fig. 2 shows an exemplary tubular repair member for organ repair according to the present invention, which comprises a tubular body formed of a degradable support adhesive layer, wherein the inner and outer surfaces of the tubular body are coated with a biocompatible layer, and the biocompatible layer coated on the inner and outer surfaces of the tubular body exceeds the support adhesive layer in the tubular axial direction to form an annular groove into which a tissue to be repaired is inserted, and the depth of the annular groove is about 2 mm. The depth of the annular groove may be adjusted according to the extent that the width of the biocompatible layer in the tube axis direction is greater than the width of the support adhesion layer in the perpendicular direction to the tube axis, for example, the width of the biocompatible layer in the tube axis direction may be 6mm greater than the width of the support adhesion layer in the perpendicular direction to the tube axis, and the depth of the annular groove may be about 3 mm.
The tubular repair for organ repair in this example was prepared by a method comprising the steps of:
(1) providing a rectangular biocompatible layer having a first size and a rectangular degradable support adhesive layer having a second size according to the size of a site to be repaired, and stacking the biocompatible layer and the support adhesive layer in a non-aligned manner such that each side of the biocompatible layer having the first size is positioned beyond each side of the degradable support adhesive layer having the second size in the non-aligned stacking, the biocompatible layer having a first minor size has a length (in a rolling direction) 2.5 times as long as a length (in a rolling direction) of the degradable support adhesive layer having the second size, and the biocompatible layer having the first size has a width (in a direction perpendicular to the rolling direction) 4mm greater than a width (in a direction perpendicular to the rolling direction) of the degradable support adhesive layer having the second size, both long side sides of the rectangular biocompatible layer having the first size are 2mm beyond both long side sides of the rectangular degradable support adhesive layer having the second size, and the short side of the rectangular biocompatible layer having the first size as a roll start side is about 0.1mm to 1mm beyond the short side of the rectangular degradable support adhesive layer having the second size as a roll start side;
(2) The biocompatible layer and the support adhesive layer which are non-aligned and stacked are rolled around a reel as the innermost layer contacting the reel, thereby obtaining a tubular repair member in which a tubular body of the tubular repair member is formed by the degradable support adhesive layer and the inner and outer surfaces of the tubular body are coated by the biocompatible layer.
After the rolling is completed, the tubular repair is heated to 55 to 65 ℃, thereby adhering the support adhesive layer to the biocompatible layer covering the support adhesive layer.
In the tubular repair member of the present embodiment, the biocompatible layer is made of fibrin by a 3D printing method, and the supporting adhesion layer 2 is made of Polycaprolactone (PCL) by an electrospray method.
The tubular repairing part prepared by the embodiment can be used for repairing blood vessels, is composed of a degradable support adhesion layer capable of being formed into a pipe body and a biocompatible layer covering the inner surface and the outer surface of the pipe body, has certain support property, meets the requirement on the mechanical property of a part to be repaired when being implanted into a body for repairing, and avoids the problems of rupture, anastomotic fistula, incapability of maintaining opening and the like when being wrapped, fixed and sutured into a pipe shape when being used for repairing organs. In addition, the tubular repair part can be degraded in a human body integrally, so that the influence of non-degradable materials on the metabolism and reconstruction of organs and the problem of scar caused by the non-degradable materials are avoided.
In other alternative embodiments, according to the size requirement of the repair site, the fan-shaped biocompatible layer with the first size and the fan-shaped degradable support adhesive layer with the second size may be provided, and the biocompatible layer and the support adhesive layer may be stacked in a non-aligned manner, wherein each side edge of the biocompatible layer with the first size exceeds each side edge of the degradable support adhesive layer with the second size, and the rolling is performed by the method described in the above embodiments to obtain the non-equal-diameter hollow conical tubular repair member with two end cross sections having unequal diameters, which may be used in the case that the repair site is non-equal-diameter.
The present invention has been described in detail with reference to the specific embodiments, which are exemplary only, and are not intended to limit the scope of the present invention, and those skilled in the art may make various modifications, changes, or alterations to the present invention without departing from the spirit and scope of the present invention. Therefore, various equivalent changes made in accordance with the present invention are also within the scope of the present invention.
Claims (20)
1. A tubular repair for organ repair comprising:
A tube body formed of a degradable support adhesive layer having mechanical strength sufficient to maintain the shape of the tube body, the tube body being coated with biocompatible layers on inner and outer surfaces thereof.
2. The tubular repair of claim 1, wherein the biocompatible layer coating the inner and outer surfaces of the tubular body extends beyond the support adhesion layer in the direction of the tubular axis to form an annular recess into which the tissue to be repaired is inserted.
3. The tubular repair of claim 2, wherein the annular recess has a depth of 1mm to 5 mm.
4. The tubular repair of claim 1, wherein the tubular repair is cylindrical or conical.
5. The tubular repair of claim 1, wherein the biocompatible layer is made of an acellular matrix-like material and/or a biocompatible material.
6. The tubular repair of claim 5, wherein the acellular matrix-like material comprises: fibrin, elastin, laminin, fibronectin, or combinations thereof; the biocompatible material includes: collagen, gelatin, cellulose, chitin, chitosan, alginate, agarose, or combinations thereof.
7. The tubular repair of claim 1, wherein the degradable support adhesion layer is made of polycaprolactone PCL, polylactic acid PLA, polylactic glycolic acid PLGA, polyglycolic acid PGA, or a combination thereof.
8. The tubular repair of claim 1, wherein the biocompatible layer and the support adhesion layer are formed by casting, or lyophilization, or electrospray, or electrospinning, or 3D printing.
9. A method of preparing a tubular repair for organ repair comprising:
i. providing a biocompatible layer having a first size and a degradable supporting adhesive layer having a second size, and placing the biocompatible layer having the first size and the degradable supporting adhesive layer having the second size in a non-aligned manner in a stack;
rolling the non-aligned stacked biocompatible layer and degradable support adhesive layer to obtain a tubular repair, wherein the degradable support adhesive layer forms a tubular body of the tubular repair and the biocompatible layer covers the inner and outer surfaces of the tubular body.
10. The method of claim 9, wherein the rolled tubular repair is a cylinder or a cone.
11. The method of claim 9, wherein in the rolled tubular repair, the biocompatible layer coated on the inner and outer surfaces of the tubular body exceeds the support adhesion layer in the tubular axial direction to form an annular groove in which the tissue to be repaired is embedded.
12. The method of claim 9, wherein said rolling is performed about a spool.
13. The method of claim 9, wherein the degradable support adhesive layer provides mechanical strength sufficient to maintain the shape of the tubular body.
14. The method of claim 9, wherein each side of the biocompatible layer having the first size exceeds each side of the degradable support adhesive layer having the second size in a non-aligned stacked arrangement of the biocompatible layer having the first size and the degradable support adhesive layer having the second size.
15. The method of claim 9, wherein the length of the biocompatible layer having the first dimension in the rolling direction is at least twice the length of the degradable support adhesive layer having the second dimension in the rolling direction.
16. The method of claim 9, wherein the width of the biocompatible layer having the first size in the direction perpendicular to the direction in which rolling is performed is 2mm to 10mm greater than the width of the degradable support adhesive layer having the second size in the direction perpendicular to the direction in which rolling is performed.
17. The method of claim 9, wherein the method further comprises: heating and/or solvent wetting the rolled tubular repair to adhere the support adhesive layer to the biocompatible layer encasing the support adhesive layer.
18. The method of claim 9, wherein the biocompatible layer is made of an acellular matrix-like material and/or a biocompatible material.
19. The method of claim 18, wherein the acellular matrix-based material comprises: fibrin, elastin, laminin, fibronectin, or combinations thereof; the biocompatible material includes: collagen, gelatin, cellulose, chitin, chitosan, alginate, agarose, or combinations thereof.
20. The method of claim 9, wherein the degradable support adhesion layer is made of polycaprolactone PCL, polylactic acid PLA, polylactic glycolic acid PLGA, polyglycolic acid PGA, or a combination thereof.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910323326.0A CN111839809B (en) | 2019-04-22 | 2019-04-22 | Tubular repair part for organ repair and preparation method thereof |
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| CN201910323326.0A CN111839809B (en) | 2019-04-22 | 2019-04-22 | Tubular repair part for organ repair and preparation method thereof |
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| CN111839809B CN111839809B (en) | 2022-12-27 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112843334A (en) * | 2021-01-13 | 2021-05-28 | 东华大学 | Bionic trachea constructed by three-dimensional printing composite aerogel and preparation method thereof |
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| WO2002047557A1 (en) * | 2000-12-15 | 2002-06-20 | The University Of Nottingham | Nerve regeneration |
| US20070010831A1 (en) * | 2002-08-01 | 2007-01-11 | Romero-Ortega Mario I | Biomimetic biosynthetic nerve implant |
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| CN112843334B (en) * | 2021-01-13 | 2022-07-08 | 东华大学 | Bionic trachea constructed by three-dimensional printing composite aerogel and preparation method thereof |
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| CN111839809B (en) | 2022-12-27 |
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