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Spinal dura mater sealing hydrogel and preparation method and application thereof

A hydrogel sealing and mixture technology, applied in the field of medical devices, can solve the problems of nerve tissue degeneration, cytotoxicity, etc.

Inactive Publication Date: 2020-02-18
金路平
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, residual glutaraldehyde in Bioglue can cause cytotoxicity and even neurological tissue degeneration

Method used

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  • Spinal dura mater sealing hydrogel and preparation method and application thereof
  • Spinal dura mater sealing hydrogel and preparation method and application thereof
  • Spinal dura mater sealing hydrogel and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The preparation method of the sealing hydrogel for preventing cerebrospinal fluid leakage of the present invention is as follows:

[0049] 0.2 g of human serum albumin (20%, w / v) was weighed and dissolved in 1 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.

[0050] Weigh 0.2 g of 4-arm polyethylene glycol succinimide glutarate (4-arm-PEG-SG, molecular weight 20,000 Da), dissolve it in 1 mL of phosphate buffer (10 mM, pH= 7.4), vortex to dissolve into a transparent liquid mixture.

[0051] The human serum albumin solution and the 4-arm-PEG-SG solution were respectively filled into the double-drug mixer, sprayed and then cross-linked to form a hydrogel sealant. The gelling time after mixing is 3 seconds, the swelling degree of t...

Embodiment 2

[0053] 0.2 g of human serum albumin and 0.0135 g of hyperbranched polyethyleneimine were weighed and dissolved in 1 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.

[0054] Weigh 0.2 g of 4-arm polyethylene glycol succinimide glutarate (4-arm-PEG-SG, molecular weight 20,000 Da), dissolve it in 1 mL of phosphate buffer (10 mM, pH= 7.4), vortex to dissolve into a transparent liquid mixture.

[0055] The human serum albumin solution and the 4-arm-PEG-SG solution were respectively filled into the double-drug mixer, sprayed and then cross-linked to form a hydrogel sealant. The gelling time after mixing is 2 seconds, the swelling degree of the prepared serum albumin gel is 126%, the bursting strength reaches 26.8kPa, and the degradation time...

Embodiment 3

[0057]0.2 g of human serum albumin and 0.0135 g of hyperbranched polyethyleneimine were weighed and dissolved in 1 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 to pump air for 30 minutes to quickly eliminate the bubbles in the solution.

[0058] Weigh 0.2 g of 4-arm polyethylene glycol ether tetrasuccinimide sebacate (4-arm-PEG-SSeb, molecular weight 12000D), dissolve it in 1 ml of phosphate buffer (10 mM, pH=6.0), vortex to dissolve into a transparent liquid mixture.

[0059] Plasma-derived human serum albumin solution and 4-arm-PEG-SSeb solution were respectively filled into a double-drug mixer, sprayed and then cross-linked to form serum albumin gel. The gelling time after mixing is 18 seconds, the swelling degree of the prepared serum albumin gel is 108%, the bursting strength reaches 34.2kPa...

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Abstract

The invention discloses a biodegradable hydrogel sealing agent. The colloid-forming time of the hydrogel is smaller than 20 seconds, the degree of swelling is 50-200%, the bursting strength is not less than 10kPa, and the in vitro degradation time is smaller than 90 days. The preparation raw materials of the hydrogel sealing agent comprise a first component namely albumin, containing nucleophilicfunctional groups, and a second compound of a hydrophilic polymer containing a plurality of electrophilic functional groups, wherein the two components are mixed physically through a dual medicine mixing machine, and in site covalent cross-linking is performed to form the hydrogel. The physical properties and the degradability of the hydrogel can be adjusted through changing the first component orthe second component, so that the biodegradable hydrogel sealing agent can be used for sealing wounded parts of different tissue parts in bodies, such as spinal dura mater damage parts.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to a hydrogel sealing agent and its preparation method and application. Background technique [0002] Cerebrospinal fluid is a colorless and transparent liquid that exists in the ventricle and subarachnoid space, surrounding and supporting the entire brain and spinal cord. Cerebrospinal fluid contains various concentrations of inorganic ions, glucose, trace proteins and a small amount of lymphocytes, with a pH of 7.4, which buffers, protects, transports metabolites and regulates intracranial pressure on the central nervous system. [0003] Cerebrospinal fluid leakage (cerebrospinal fluid, CSF) is one of the common complications of spinal surgery. The literature reports that the incidence of cerebrospinal fluid leakage after spinal surgery is about 2.31% to 9.37%. If not handled properly, dural pseudocyst can form, causing nerve root damage. In severe cases, infection can occur, caus...

Claims

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Application Information

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IPC IPC(8): A61L24/04A61L24/00A61L31/04A61L31/14A61L31/16
CPCA61L24/043A61L24/0042A61L24/0031A61L24/0015A61L31/041A61L31/148A61L31/145A61L31/16A61L2400/04A61L2300/412C08L89/00C08L79/02C08L71/02
Inventor 金路平
Owner 金路平
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