CN106901866A - Compound dural patch for preventing adhesion and preparation method thereof - Google Patents

Compound dural patch for preventing adhesion and preparation method thereof Download PDF

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Publication number
CN106901866A
CN106901866A CN201510974426.1A CN201510974426A CN106901866A CN 106901866 A CN106901866 A CN 106901866A CN 201510974426 A CN201510974426 A CN 201510974426A CN 106901866 A CN106901866 A CN 106901866A
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CN
China
Prior art keywords
compound
preventing adhesion
preparation
dural patch
functional layer
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Pending
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CN201510974426.1A
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Chinese (zh)
Inventor
刘超
万隆
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SHANGHAI DIVINE MEDICAL TECHNOLOGY Co Ltd
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SHANGHAI DIVINE MEDICAL TECHNOLOGY Co Ltd
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Priority to CN201510974426.1A priority Critical patent/CN106901866A/en
Publication of CN106901866A publication Critical patent/CN106901866A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The present invention relates to a kind of compound dural patch for preventing adhesion and preparation method thereof, including antiblocking layers and functional layer, wherein, described antiblocking layers are the cerebripetal one layer of dense film in face, described functional layer is the cerebripetal one layer of nano fibrous membrane of the back of the body, and described antiblocking layers are compound by crosslinking method with described functional layer.Present invention also offers its preparation method.Compound dural patch for preventing adhesion of the invention and preparation method thereof, cerebripetal one layer of face is designed for dense film, and surface is smooth, can more be prevented adhesion with respect to other spinning or establishment class product, effectively prevents cerebrospinal fluid seepage;Cerebripetal one layer is carried on the back for nanofiber functional layer, is favorably adhered to cell, promote cell growth, accelerate endocranium reparation;And dense film is compound with the crosslinking of nanofiber functional layer, its preventing adhesiving effect more preferably, can more prevent the problem of seepage, very with practical value.

Description

Compound dural patch for preventing adhesion and preparation method thereof
Technical field
The present invention relates to field of medical materials, more particularly to a kind of compound dural patch for preventing adhesion and preparation method thereof.
Background technology
Dura defect is one of neurosurgery common disease, lies in wound, tumour, cranial vascular disease, other nervous system diseases more Disease etc. is needed caused by operation of opening cranium.Dura defect need to be repaired in time in case cerebrospinal fluid seepage and extraneous compressing, can otherwise draw The complication, entail dangers to human life when serious such as hair intracranial infection, brain adhesion, hypohydropses.
Current duramater reparation class material mainly has nonabsorable material, the major class of absorbable material two.Nonabsorable material, implantation After can forever retain in vivo, as foreign matter, local organization inflammation and infection can be caused after inserting.Absorbable material then can be by Absorption of human body, the more sticking patch class absorbable material of current clinical practice is animal derived material and medical macromolecular materials, animal Property material in source cannot completely avoid the antigen of immunological rejection, residual from causing different degrees of inflammatory reaction, cause fibre modification and Brain adhesion, easily produces stimulation to brain tissue.
Now, medical high polymer class material, by its excellent biocompatibility and the security of degraded, increasing application In product technology in dura defect neoplasty but current, also there is many defects, such as a certain proportion of cerebrospinal fluid oozes Leakage, cerebripetal one layer of face is not yet in effect prevents adhesion.In existing patent, though the selection for passing through different materials, possesses certain anti- Adhesion function, but it prevents adhesion and the effect of anti-cerebrospinal fluid seepage is extremely limited.
So, a kind of compound dural patch for preventing adhesion and preparation method thereof is that very have practical value.
The content of the invention
The invention aims to provide a kind of compound dural patch for preventing adhesion and preparation method thereof.
To achieve these goals, one aspect of the present invention provides a kind of compound dural patch for preventing adhesion, it is characterised in that Including antiblocking layers and functional layer, wherein, described antiblocking layers are the cerebripetal one layer of dense film in face, and described functional layer is Cerebripetal one layer of nano fibrous membrane is carried on the back, described antiblocking layers are compound by crosslinking method with described functional layer.
It is preferred that described antiblocking layers thickness is 0.01~0.1mm.
It is preferred that described functional layer thickness is 0.1~0.5mm.
It is preferred that the nanofiber diameter of the described nano fibrous membrane of composition is 100nm~500nm, aperture is 50nm~200nm.
Another aspect of the present invention provides a kind of preparation method of the above-mentioned compound dural patch for preventing adhesion, it is characterised in that bag Include following steps:
Step (1):Using medical macromolecular materials under solution or molten condition film forming, obtain dense film;
Step (2):Separately take medical macromolecular materials to be dissolved in solvent, obtain electrostatic spinning raw material solution, electrostatic spinning obtains nanometer Tunica fibrosa, composite membrane is compounded to form after described dense film and described nano fibrous membrane cross-linking reaction;
Step (3):By described composite membrane using hot-forming after the treatment of two-way heat stretching process, cut by drying, obtained Described compound dural patch.
It is preferred that described medical macromolecular materials be PLA, polyvinyl alcohol, polyethylene glycol, polycaprolactone, polyurethane, One or more blending or copolymerization in shitosan, cellulose, silk-fibroin, hyaluronic acid are formed.
It is preferred that described solvent is acetone, tetrahydrofuran, dimethyl sulfoxide (DMSO), dichloromethane, chloroform, hexafluoro isopropyl One or more mixture in alcohol, Isosorbide-5-Nitrae dioxane.
It is preferred that in step (3), the parameter of two-way heat stretching process is:40~100 DEG C of temperature, extensibility is 10%~60%.
It is preferred that in step (3), hot-forming parameter is:40~100 DEG C of temperature, 0.1~10Mpa of pressure.
It is preferred that using curtain coating or blow molding process film forming in step (1).
Compound dural patch for preventing adhesion of the invention and preparation method thereof, cerebripetal one layer of face is designed for dense film, surface It is smooth, can more be prevented adhesion with respect to other spinning or establishment class product, effectively prevent cerebrospinal fluid seepage;Cerebripetal one layer is carried on the back to receive Rice fiber functional layer, favorably adheres to cell, promotes cell growth, accelerates endocranium reparation;And dense film and nanofiber work( Ergosphere crosslinking is compound, and its preventing adhesiving effect more preferably, can more prevent the problem of seepage.And in its processing technology, composite patch is created The two-way heat stretching process of use of new property, by the PROCESS FOR TREATMENT, sticking patch is more soft, and layers of nanofibers is more fluffy, is more beneficial for Cell attached;By the hot-pressing processing under certain temperature and pressure, effectively prevent the fibre shedding of layers of nanofibers, sticking patch outward appearance is more Neatly, more security.Its preparation method is simple, very with practical value.
Brief description of the drawings
Fig. 1 is the structure chart of compound dural patch prevented adhesion in the embodiment of the present invention 1.
Specific embodiment
In order to be more clearly understood that technology contents of the invention, specific implementation method of the invention is described further below.
Embodiment 1
Fig. 1 is the structure of dural patch in the present embodiment, as shown in figure 1, the dural patch is by functional layer 1 and antiblocking layers 2 Composition.Functional layer 1 is nano fibrous membrane, and antiblocking layers 2 are dense film.
(1) dense film is prepared:Selection polyethylene glycol modified polylactide, polyethylene glycol ratio 20%, as copolymerized macromolecule raw material, Weight average molecular weight 200,000, is dissolved in ethyl acetate, and ultrasonic vibration, by filtering, is proportionally added into reeded polytetrafluoroethylene (PTFE) On plate, casting film-forming is put into vacuum drying chamber, is vacuum dried 24h, the soft dense film of 0.03mm thickness is obtained, also It is antiblocking layers 2.
(2) composite construction is prepared:Prepare electrostatic spinning raw material solution:Selection shitosan, PLA ratio 50:50, it is dissolved in hexafluoro In isopropanol, ultrasonic vibration, filtering are stand-by.
Above-mentioned solution is added in device for spinning infusing device, regulation injection pump rate 10ml/h;High pressure generator voltage 20KV, Reception device negative pressure 5KV, starts electrostatic spinning, the functional layer 1 being made up of nanofiber is obtained, by functional layer 1 and antiblocking layers 2 crosslinkings, are obtained with antiblocking layers 2 as substrate, and the thickness of functional layer 1 is the crosslinking composite construction of 0.2mm.Wherein nanofiber Average diameter 200nm, average pore size 150nm.
By above-mentioned composite construction, it is fixed on the fixture of constant temperature stretching device, temperature 50 C, extensibility 30% carries out hot-stretch, It is subsequently placed in hot-forming, temperature 45 C under minute surface hot-pressing roller;
Compound film sheet after shaping is the dural patch of the standby function that prevents adhesion of fixture by dry, cutting, sterilizing.
Embodiment 2
(1) dense film is prepared:Selection caprolactone modification PLA, caprolactone ratio 15%, as copolymerized macromolecule raw material, weight Average molecular weight 200,000, heats Blown Film, and the soft dense film of 0.02mm thickness is obtained.
(2) composite construction is prepared:Prepare electrostatic spinning raw material solution:Selection PLA, PEG6000 ratios 70:30 are dissolved in trichlorine In methane, ultrasonic vibration, filtering are stand-by.
Above-mentioned solution is added in device for spinning infusing device, regulation injection pump rate 10ml/h;High pressure generator voltage 22KV, Reception device negative pressure 5KV, starts electrostatic spinning, and functional layer is obtained, and functional layer and antiblocking layers are crosslinked, and is obtained to prevent adhesion Layer is substrate, and functional layer thickness is the crosslinking composite construction of 0.2mm.Wherein nanofiber average diameter 200nm, average pore size 150nm。
Above-mentioned composite construction is fixed on the fixture of constant temperature stretching device, 80 DEG C of temperature, extensibility 20% carries out hot-stretch, It is subsequently placed in hot-forming, 100 DEG C of temperature under minute surface hot-pressing roller;
Compound film sheet after shaping is the dural patch of the standby function that prevents adhesion of fixture by dry, cutting, sterilizing.
Embodiment 3
Rabbit animal experiment is carried out with dural patch obtained in embodiment 1,2
Then selection healthy rabbits, artificial manufacturing department point dura defect under general anesthesia state is implanted into dural patch and implements repairing, Suture is fixed.It is postoperative that routine feeding and routine observation are implemented to animal.Postoperative 6 months, tissue specimen is extracted by standard requirement, Prepare case section.Material obvious degradation, has very small amount to remain, and collagenous fibres increase, and interface has slight cyst wall to be formed;Art December, cutting tissue sample, remain without material afterwards, and endocranium healing is good, and rarely seen suture vestige, brain tissue is normal, invariably Good reaction.
Compound dural patch for preventing adhesion of the invention and preparation method thereof, cerebripetal one layer of face is designed for dense film, surface It is smooth, can more be prevented adhesion with respect to other spinning or establishment class product, effectively prevent cerebrospinal fluid seepage;Cerebripetal one layer is carried on the back to receive Rice fiber functional layer, favorably adheres to cell, promotes cell growth, accelerates endocranium reparation;And dense film and nanofiber work( Ergosphere crosslinking is compound, and its preventing adhesiving effect more preferably, can more prevent the problem of seepage.And in processing technology, composite patch is innovated Property the two-way heat stretching process of use, by the PROCESS FOR TREATMENT, sticking patch is more soft, and layers of nanofibers is more fluffy, is more beneficial for thin Born of the same parents attached;By the hot-pressing processing under certain temperature and pressure, effectively prevent the fibre shedding of layers of nanofibers, sticking patch outward appearance is more whole It is clean, more security.Its preparation method is simple, very with practical value.
In this description, the present invention is described with reference to its specific embodiment.But it is clear that can still make various Modification and conversion are without departing from the spirit and scope of the present invention.Therefore, specification is regarded in an illustrative, rather than a restrictive.

Claims (10)

1. a kind of compound dural patch for preventing adhesion, it is characterised in that including antiblocking layers and functional layer, wherein, it is described Antiblocking layers are the cerebripetal one layer of dense film in face, and described functional layer is the cerebripetal one layer of nano fibrous membrane of the back of the body, and described is anti- Adhering layer is compound by crosslinking method with described functional layer.
2. the compound dural patch for preventing adhesion according to claim 1, it is characterised in that described antiblocking layers thickness It is 0.01~0.1mm.
3. the compound dural patch for preventing adhesion according to claim 1, it is characterised in that described functional layer thickness is 0.1~0.5mm.
4. the compound dural patch for preventing adhesion according to claim 1, it is characterised in that the described nanofiber of composition The nanofiber diameter of film is 100nm~500nm, and aperture is 50nm~200nm.
5. a kind of preparation method of the compound dural patch for preventing adhesion according to claim 1, it is characterised in that including Following steps:
Step (1):Using medical macromolecular materials under solution or molten condition film forming, obtain dense film;
Step (2):Separately take medical macromolecular materials to be dissolved in solvent, obtain electrostatic spinning raw material solution, electrostatic spinning obtains nanometer Tunica fibrosa, composite membrane is compounded to form after described dense film and described nano fibrous membrane cross-linking reaction;
Step (3):By described composite membrane using hot-forming after the treatment of two-way heat stretching process, cut by drying, obtained Described compound dural patch.
6. the preparation method of the compound dural patch for preventing adhesion according to claim 5, it is characterised in that wherein, institute The medical macromolecular materials stated be PLA, polyvinyl alcohol, polyethylene glycol, polycaprolactone, polyurethane, shitosan, cellulose, One or more blending or copolymerization in silk-fibroin, hyaluronic acid are formed.
7. the preparation method of the compound dural patch for preventing adhesion according to claim 5, it is characterised in that wherein, institute The solvent stated is acetone, tetrahydrofuran, dimethyl sulfoxide (DMSO), dichloromethane, chloroform, hexafluoroisopropanol, Isosorbide-5-Nitrae dioxy six One or more mixture in ring.
8. the preparation method of the compound dural patch for preventing adhesion according to claim 5, it is characterised in that step (3) In, the parameter of two-way heat stretching process is:40~100 DEG C of temperature, extensibility is 10%~60%.
9. the preparation method of the compound dural patch for preventing adhesion according to claim 5, it is characterised in that step (3) In, hot-forming parameter is:40~100 DEG C of temperature, 0.1~10Mpa of pressure.
10. the preparation method of the compound dural patch for preventing adhesion according to claim 5, it is characterised in that step (1) It is middle to use curtain coating or blow molding process film forming.
CN201510974426.1A 2015-12-22 2015-12-22 Compound dural patch for preventing adhesion and preparation method thereof Pending CN106901866A (en)

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Cited By (7)

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Publication number Priority date Publication date Assignee Title
CN108852484A (en) * 2018-03-23 2018-11-23 山东省千佛山医院 Bone window protective device and preparation method after a kind of 3D printing skull decompressive craniectomy
CN109984857A (en) * 2019-04-10 2019-07-09 华中科技大学同济医学院附属协和医院 Establishment method and application of a precise animal model of peritoneal adhesion
CN110755173A (en) * 2018-07-27 2020-02-07 陕西佰傲再生医学有限公司 Antibacterial anti-seepage dura mater repairing piece and preparation method thereof
CN111420123A (en) * 2020-03-16 2020-07-17 江西光至金辉医疗制品有限公司 Degradable anti-adhesion double-layer dura mater patch and preparation method thereof
CN113713186A (en) * 2021-09-24 2021-11-30 孟国路 Surgical anti-adhesion sealing sheet
CN114887119A (en) * 2022-05-09 2022-08-12 浙江大学医学院附属第一医院 High-molecular artificial dura mater with anti-infection capacity and preparation method thereof
CN119818723A (en) * 2025-01-07 2025-04-15 西安蝾螈生物技术有限公司 Degradable anti-adhesion artificial synthetic dura mater patch and preparation method thereof

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CN104888273A (en) * 2015-05-14 2015-09-09 四川大学 Double-layer composite cerebral dura mater, and preparation method thereof
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108852484A (en) * 2018-03-23 2018-11-23 山东省千佛山医院 Bone window protective device and preparation method after a kind of 3D printing skull decompressive craniectomy
CN108852484B (en) * 2018-03-23 2021-07-09 山东省千佛山医院 A 3D printed cranial bone window protection device and preparation method after decompressive craniectomy
CN110755173A (en) * 2018-07-27 2020-02-07 陕西佰傲再生医学有限公司 Antibacterial anti-seepage dura mater repairing piece and preparation method thereof
CN109984857A (en) * 2019-04-10 2019-07-09 华中科技大学同济医学院附属协和医院 Establishment method and application of a precise animal model of peritoneal adhesion
CN109984857B (en) * 2019-04-10 2021-09-24 华中科技大学同济医学院附属协和医院 Establishment method and application of a precise animal model of peritoneal adhesion
CN111420123A (en) * 2020-03-16 2020-07-17 江西光至金辉医疗制品有限公司 Degradable anti-adhesion double-layer dura mater patch and preparation method thereof
CN113713186A (en) * 2021-09-24 2021-11-30 孟国路 Surgical anti-adhesion sealing sheet
CN114887119A (en) * 2022-05-09 2022-08-12 浙江大学医学院附属第一医院 High-molecular artificial dura mater with anti-infection capacity and preparation method thereof
CN119818723A (en) * 2025-01-07 2025-04-15 西安蝾螈生物技术有限公司 Degradable anti-adhesion artificial synthetic dura mater patch and preparation method thereof

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Application publication date: 20170630