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Celebral dura mater sealing hydrogel and a preparation method and application thereof

A gel and mixture technology, applied in the field of albumin-encapsulated gel and its preparation, can solve the problems of brain tissue compression, low bursting strength, and difficulty in observation, and achieve the effect of improving reaction speed and mechanical properties

Inactive Publication Date: 2018-01-05
HANGZHOU YAHUI BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Since the sealing agent gel is mostly colorless and transparent (such as Baxter’s Coseal Surgical Vascular Sealing Agent), it is difficult to observe with the naked eye after spraying on the tissue wound, so it is not easy to identify the position of gel spraying and the thickness of the formed gel
For dura mater sealants, if the thickness of the gel is too large, it may cause pressure on the brain tissue. If the thickness of the gel spray is too small, the bursting strength after sealing may be low, and the purpose of closing the wound cannot be achieved.

Method used

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  • Celebral dura mater sealing hydrogel and a preparation method and application thereof
  • Celebral dura mater sealing hydrogel and a preparation method and application thereof
  • Celebral dura mater sealing hydrogel and a preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0051] Cerebrospinal fluid leaks are a common complication after head and spine surgery. Because the nerves near the cranium and spine are sensitive to compression from tissue inflammation or swelling from surgically implanted materials such as artificial dura mater, hydrogels with low swelling properties are required to minimize tissue compression . The preparation method of the sealing hydrogel for preventing cerebrospinal fluid leakage of the present invention is as follows:

[0052] Weigh 2.5 g of human serum albumin (25%, w / v) and dissolve it in 10 mL of phosphate buffer (10 mM, pH=9.2) prepared from deionized water. Stir intermittently at 37°C for 1 hour to dissolve the protein. After the protein is completely dissolved and becomes a transparent liquid, use a vacuum pump for 30 minutes to quickly eliminate the bubbles in the solution.

[0053] Weigh 2 g of 4-arm polyethylene glycol succinimide glutarate (4-arm-PEG-SG, molecular weight 10,000 Da) and 5 mg of FD&C blue #...

Embodiment 2

[0056] Weigh 2 g of human serum albumin (20%, w / v) and dissolve it in 10 mL of phosphate buffer (10 mM, pH=9.2) prepared from deionized water. Stir intermittently at 37°C for 1 hour to dissolve the protein. After the protein is completely dissolved and becomes a transparent liquid, use a vacuum pump for 30 minutes to quickly eliminate the bubbles in the solution.

[0057] Weigh 2 g of 4-arm polyethylene glycol succinimide glutarate (4-arm-PEG-SG, molecular weight 20,000 Da) and 10 mg of FD&C blue #2 visualization reagent, dissolve in 10 mL of phosphoric acid prepared by deionized water Salt buffer solution (10mM, pH=7.4), vortex to dissolve it into a transparent mixture liquid.

[0058] Fill human serum albumin solution with 4-arm-PEG-SG and FD&C blue #2 visualization reagent mixture solution into two-component syringes, spray and cross-link to form albumin-sealing gel. The gelation time after mixing was 2 seconds, the swelling degree of the prepared serum albumin gel was 138...

Embodiment 3

[0060] Weigh 2.5 g (25%, w / v) of plasma-derived human serum albumin and dissolve it in 10 ml of borate buffer (10 mM, pH 9.0) prepared with deionized water. Stir intermittently at 37°C for 1 hour to dissolve the protein. After the protein is completely dissolved and becomes a transparent liquid, use a vacuum pump for 30 minutes to quickly eliminate the bubbles in the solution.

[0061] Weigh 2 g of 4-arm polyethylene glycol ether tetrasuccinimide sebacate (4-arm-PEG-SSeb, molecular weight 12000D) and 15 mg of methylene blue visualization reagent, dissolve in 10 ml of phosphate buffer prepared by deionized water solution (10mM, pH=6.0), vortex to dissolve it into a transparent mixture liquid.

[0062] Plasma-derived human serum albumin solution, 4-arm-PEG-SSeb and methylene blue visualization reagent mixture solution were respectively filled into two-component syringes, sprayed and cross-linked to form serum albumin gel. The gelling time after mixing was 18 seconds, the swelli...

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Abstract

The invention discloses a biodegradable albumin hydrogel. According to the hydrogel, the gelling time is smaller than 20 seconds, the swelling degree is 50-200%, the burst strength is not lower than 10 kPa, and the degradation time in vitro is smaller than 30 days. Raw materials for preparation of the hydrogel comprise a first component albumin containing a nucleophilic functional group, a hydrophilic polymer containing multiple electrophilic functional groups and a second component of visual reagent mixture, and the two components are physically mixed through a double-component syringe and then undergo covalent crosslinking to form the hydrogel. The physical performance and biodegradable performance of the hydrogel can be regulated through a change of the second component, the naked-eye visibility of the hydrogel is good, and the hydrogel can be applicable to wound closure of different tissue parts in vivo, for example, closure of a celebral dura mater incision.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to an albumin sealing gel, a preparation method and application thereof. Background technique [0002] As a biocompatible material, hydrogel is a kind of three-dimensional network structure polymer with hydrophilic groups. Due to the physical cross-linking and chemical cross-linking between polymer chains, hydrogel can be swelled by water but Insoluble in water and maintains a certain shape. In medicine, hydrogels can be used for wound dressing, anti-adhesion after surgery, hemostasis during surgery, tissue filling, and prevention of interstitial fluid leakage or gas leakage, etc. [0003] According to the formation principle, hydrogels can be divided into two categories: chemically cross-linked hydrogels and physically cross-linked hydrogels. Physical crosslinking can be divided into thermosensitive hydrogels and molecular self-assembled hydrogels. Physical hydrogels are combined ...

Claims

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Application Information

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IPC IPC(8): A61L24/04A61L24/06A61L24/10A61L31/04A61L31/06A61L31/14
Inventor 汪伟李丹祝文斌朱家喜林高品
Owner HANGZHOU YAHUI BIOTECH CO LTD
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