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Self-adhesive hemostatic artificial dura mater repair patch and preparation method thereof

A self-adhesive, patch technology, applied in the field of neurosurgery materials, can solve the problems of increasing patient damage, insufficient elasticity and toughness, and insufficient safety, so as to reduce damage and patient pain, reduce surgical anesthesia time, and simplify repair. The effect of the process

Pending Publication Date: 2021-02-23
鹏拓生物科技杭州有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, most of the pressure-sensitive adhesives commonly used at present are for industrial purposes, and it is difficult to be absolutely non-toxic, harmless, and non-antigenic to the human body. Various body fluids and wounds are rich in blood, so the application of ordinary pressure-sensitive adhesives in dura mater bonding is correspondingly limited
Some artificial dura mater does not have a spongy structure and may not be sufficiently elastic
In the part of the dura mater defect, the pressure-sensitive adhesive will directly contact with the brain tissue and adhere to the brain tissue. or minor exposure, may cause brain tissue damage
[0010] Also in some special operations, such as the repair of cerebrospinal fluid leakage, resection of intracranial tumors through the transsphenoidal approach, open closure of cranial air cells or sinuses, repair of damaged venous sinuses, etc., can it be effectively repaired and closed at this time? It is related to the success of the operation, and even the life of the patient. There is a great need for a simple, convenient, self-adhesive patch material that can be applied in an environment with a lot of tissue fluid, but there is no suitable material in clinical practice.
It is often necessary to take the patient's autologous tissue as a repair material, which not only takes time and effort, but also increases the patient's damage, and because it must be used with medical adhesives at the same time, due to the poor effect of the adhesive, it also greatly increases the operating time. difficulty and danger
[0011] To sum up, the existing medical adhesives often have insufficient bonding strength, or insufficient elasticity and toughness, or insufficient safety.

Method used

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preparation example Construction

[0032] The preparation method of self-adhesive hemostatic artificial dura patch of the present invention comprises the following steps:

[0033] S1: Water-soluble chitosan and hyaluronic acid are mixed alone or in a certain proportion, dissolved in deionized water, and made into an aqueous solution with a concentration of 3%-10%;

[0034] S2: Coating the aqueous solution on the surface of the artificial dura mater substrate 1 with a thickness of 4mm-6mm, which can be applied on one side or both sides, to form an adhesive layer 2 with a thickness of 0.5mm-1mm;

[0035] S3: Freeze the artificial dura mater to dry the adhesive layer 2 on the surface to form a hard film structure. The thickness of the artificial dura mater will be reduced to 0.5mm-1mm as the Layer 2 is not sticky after drying, so there is no need to use release paper to isolate it; after disinfection, it will form a self-adhesive hemostatic artificial dura mater patch for future use.

[0036] When in use, the sel...

Embodiment 1

[0039] Production of self-adhesive hemostatic artificial dura mater patch: choose absorbable collagen sponge as the base material, dissolve water-soluble chitosan in deionized water to make a 7% solution, and brush it on the 4mm thick collagen sponge base material , the thickness of the glue layer is about 0.5mm, freeze-dried, and sterilized for later use.

[0040] Animal experiment: In the experimental group, 15 rats were taken, the top of the skull was opened, the dura mater was cut, and the dura mater was cut off to create a dural defect with a diameter of about 3 mm. For 15 rats, a self-adhesive hemostatic artificial dura mater patch with a side length of 6 mm was applied to the surface of the rat dura mater defect. After 5 minutes, observe under the operating microscope whether there is leakage of cerebrospinal fluid at the repaired dura mater defect, and record it. The rat scalp was sutured and housed. One week later, the skin incisions on the head of the rats were hea...

Embodiment 2

[0042] Production of self-adhesive hemostasis artificial dura mater patch: choose absorbable collagen sponge as the base material, dissolve hyaluronic acid in deionized water to make a 3% solution, brush on the 5mm thick collagen sponge base material, glue The thickness of the layer is about 1 mm, freeze-dried and sterilized for later use.

[0043] Animal experiment: In the experimental group, 15 rats were taken, the top of the skull was opened, the dura mater was cut, and the dura mater was cut off to create a dural defect with a diameter of about 3 mm. For 15 rats, a self-adhesive hemostatic artificial dura mater patch with a side length of 6 mm was applied to the surface of the rat dura mater defect. After 5 minutes, observe under the operating microscope whether there is leakage of cerebrospinal fluid at the repaired dura mater defect, and record it. The rat scalp was sutured and housed. One week later, the skin incisions on the head of the rats were healed well. Under ...

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Abstract

The invention relates to the technical field of materials for neurosurgery, in particular to a self-adhesive hemostatic artificial dura mater repair patch and a preparation method thereof. The repairpatch comprises an artificial dura mater substrate which is a porous sponge structure substrate, the surface of the substrate is coated with an adhesive layer, and the used adhesive is chitosan and / orhyaluronic acid. The preparation method comprises the following steps: separately or proportionally mixing the chitosan and hyaluronic acid, and dissolving the obtained mixture in deionized water toprepare an aqueous solution with a certain concentration; coating the surface of the artificial dura mater substrate with the aqueous solution to form the adhesive layer with a certain thickness; andfreezing the artificial dura mater to dry the adhesive layer on the surface to form the self-adhesive hemostatic artificial dura mater repair patch. The repair patch can simplify the dura mater repairprocess in an operation, reduce the requirements for the technology of doctors, improve the water tightness of dura mater repair, has a hemostatic function, shortens the operation time, reduces the application of anesthetic drugs and the pain of patients, and reduces the corresponding medical expenses.

Description

technical field [0001] The invention relates to the technical field of neurosurgery materials, in particular to a self-adhesive hemostatic artificial dura patch and a preparation method thereof. Background technique [0002] Neurosurgery generally requires suturing and anatomical reduction of the incised dura (spinal) membrane. In the absence of dura (spinal) membrane defects, surgical sutures are generally used at present. If there is a dural (spinal) membrane defect, autologous Fascia or artificial materials for repair. Artificial dura can be divided into two types: absorbable materials and non-absorbable polymer materials. [0003] Most neurosurgical procedures require dura anatomical suture reduction. The suture repair of the dura mater requires watertight suture (that is, after suturing the dura mater, inject water with a certain pressure, requiring no water leakage at the suture), regardless of whether artificial dura mater or other repair materials are used, the tec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/34A61L27/56A61L24/08A61L24/00
CPCA61L27/56A61L27/34A61L24/08A61L24/0036A61L2430/00A61L2400/06C08L5/08
Inventor 孟国路
Owner 鹏拓生物科技杭州有限公司
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