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Methods for repairing and regenerating human dura mater

A dura mater and bio-matrix technology, applied in the field of bio-matrix for dura mater regeneration, can solve the problems of low transmission of microorganisms, viruses and prions, and inability to provide resorbable replacement dura mater

Active Publication Date: 2006-09-13
BAXTER INT INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Seven of the 200 patients developed postoperative complications such as infection and cerebrospinal fluid (CSF) fistula, however, none were reported to be due to the graft itself
[0020] Known dural substitute materials, and related methods of using them, do not provide a liquid-impermeable, resorbable replacement dura that avoids encapsulation, dural scarring, or adhesion in the on brain tissue and also has a low risk of spreading microorganisms, viruses, and prions that may cause spongiform encephalitis or other diseases

Method used

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  • Methods for repairing and regenerating human dura mater
  • Methods for repairing and regenerating human dura mater
  • Methods for repairing and regenerating human dura mater

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0126] This example provides the results of experiments conducted with sheep to evaluate the suitability of equine collagen flakes as a dura mater substitute for repairing dura mater tissue and as a biomatrix for dura mater regeneration.

[0127] Experiments were performed in order to evaluate the properties of equine collagen flakes as a skull dura mater substitute, as studied in a sheep model. The equine collagen flakes comprise native equine collagen fibrils (5.6 mg / cm2) purified from minced equine Achilles tendon 2 ) and does not include cellular components.

[0128] The reference product used was preserved human cadaver dura mater (Tutoplast  Dura). Both products were attached in place using only fibrin glue (Tissucol Duo S Immuno, Baxter AG, Vienna, Austria).

[0129] The following items were studied:

[0130] Visual inspection of the integration of the two grafts;

[0131] Reactions of adjacent tissue structures (inflammation, adhesions, fibrosis, necrosis); and ...

Embodiment 2

[0257] Example 2 - Swellability of Equine Collagen Flakes

[0258] Studies concerning the swelling capacity of the equine collagen flakes were carried out as follows:

[0259] 1) First, the horse collagen sheet is cut into 1cm 2 square slices.

[0260] 2) Examine samples of these cut pieces under a conventional scanning microscope in order to determine the general morphological consistency and thickness of the material as a reference for the expansion process.

[0261] 3) These cut pieces were then put into plastic Petri dishes.

[0262] 4) Fluid uptake capacity and swelling capacity are then checked by serial titration with physiological saline solution, administered with an Eppendorf micropipette, using gradually increasing amounts of fluid from 10 μl / cm 2 Start up to a maximum of 150 μl / cm 2 (See Table 3).

[0263] Amount of Fluid Applied to Equine Collagen Flakes

time

10μl / cm 2

20μl / cm 2

30μl / cm 2

40μl / cm 2

50μl / cm 2

...

Embodiment 3

[0270] Example 3 - Increase in length of hydrated equine collagen flakes

[0271] 1.0cm 2 Seven dried equine collagen flakes of the size were placed in isotonic sodium chloride and hydrated for 1 hour. The average increase in length due to hydration of the dried equine collagen flakes was approximately 3.4%.

[0272] film number

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Abstract

A method of using a substantially non-porous equine collagen foil to repair and regenerate dura mater tissue of mammals when the dura mater tissue is damaged as a result of injury, tumors, surgery, and the like. The non-porous equine collagen foil comprises collagen fibrils which provides a replacement dura mater composition that is elastic, liquid-tight, and which has a high tensile strength. The non-porous equine collagen foil is furthermore resorbable and provides a biomatrix, wherein a neodura is rapidly formed which becomes indistinguishable from the autologous dura mater in a matter of weeks. The process for making the equine collagen foil reduces the likelihood of disease transmission.

Description

[0001] A portion of the disclosure of this patent document includes material that is subject to copyright protection. The copyright owner has no objection to the reproduction by anyone of the patent document or the patent disclosure as it appears in the patent file or records of the Patent and Trademark Office, but otherwise All other copyrights reserved. field of invention [0002] The present invention relates to the use of a substantially non-porous collagen sheet composition as a graft material to repair and / or regenerate dura mater tissue in mammals. More specifically, the present invention relates to the use of a collagen flake composition of non-human origin as a replacement dura mater material, and as a biomatrix for dura mater regeneration. Background of the invention [0003] The dura mater is a structure that plays an important role in the anatomy of the central nervous system, forming a membrane system that coats the entire central nervous system and protects th...

Claims

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Application Information

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IPC IPC(8): A61L27/24
Inventor J·奥达A·泽佩尔尼亚R·沙赫特勒A·W·施滕伯格
Owner BAXTER INT INC
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