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Biphasic Collagen Membrane or Capsule for Guided Tissue Regeneration

a collagen membrane and capsule technology, applied in the direction of prosthesis, peptides/protein ingredients, peptides, etc., can solve the problems of small amount of porosity disproportionally reducing mechanical properties, growth factors or particulate matrices at a targeted location, and does not contain or retain cells, etc., to achieve strong/stiffer collagen membrane, weak collagen structure, and increase strength

Inactive Publication Date: 2012-06-07
OSSEOUS TECH OF AMERICA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0009]Tissue regeneration is a race between competing tissues. Whichever tissue fills the space first, will dominate. Fibrovascular tissues proliferate faster than bone tissue. Consequently, fibrovascular tissue can preferentially fill in a defect where bone is desired, resulting in scar tissue. The present inventors have discovered that a membrane of collagen according to the invention can block the fibrovascular tissue, giving more time for bone formation to occur. Therefore, by using biocompatible, resorbable membranes according to the present invention as barriers to tissue regeneration, bone surgeons can exclude fibrovascular (i.e., scar tissue) from bone defects.
[0022]In the process for producing the membranes of the invention, the a molded collagen suspension is placed in a freezer and then a vacuum is applied. Under vacuum, the water within the collagen moves directly from the solid phase to the gas phase. Consequently, there is no shrinking or change to the dimensions. This makes a highly porous, but relatively weak collagen structure. A key step in the production process according to the invention is then to lightly wet the porous collagen with water which collapses the porosity. The material is then air dried. This makes a much stronger / stiffer collagen membrane. Air drying also crosslinks some of the collagen molecules to further increase the strength and decrease the resorption rate.

Problems solved by technology

Highly porous collagen permits essential ingrowth but does not contain or retain cells, growth factors or particulate matrices at a targeted location.
Third, they serve as a biocompatible structural material for containing biomaterials at a desired location and / or in a desired configuration.
However, porosity generally decreases strength, typically non-linearly such that a small amount of porosity disproportionally decreases mechanical properties.
Consequently, fibrovascular tissue can preferentially fill in a defect where bone is desired, resulting in scar tissue.

Method used

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  • Biphasic Collagen Membrane or Capsule for Guided Tissue Regeneration
  • Biphasic Collagen Membrane or Capsule for Guided Tissue Regeneration

Examples

Experimental program
Comparison scheme
Effect test

example 1

Casting

[0031]The first step is casting the basic capsule. A 10-60 mg / ml suspension of purified collagen in 5-25% alcohol / water is formed. A particularly preferred suspension contains 15 mg of collagen per ml of a 10% solution of ethanol in water. The collagen fibers preferably have a native fibrous structure and a length of from 0.2 to 3 mm, particularly preferably about 1.5 mm. After removing air bubbles from the suspension, a fixed amount of the suspension is poured into a mold comprised of mating male and female mold members which form a mold cavity between them. The mold cavity is completely filled with the collagen suspension, and the main frame of the mold is tightly attached to the elastic surface of bottom plate. A plurality of pins are then strategically extended through the female mold into the male mold. These pins serve as spacers for making the transmembrane, unidirectional holes in the membrane. Sufficient number of pins are placed to provide adequate neovascular ingro...

example 2

Penetration

[0034]The first step is casting the basic capsule. A 10-60 mg / ml suspension of purified collagen in 5-25% alcohol / water is formed. A particularly preferred suspension contains 15 mg of collagen per ml of a 10% solution of ethanol in water. The collagen fibers preferably have a native fibrous structure and a length of from 0.2 to 3 mm, particularly preferably about 1.5 mm. After removing air bubbles from the suspension, a fixed amount of the suspension is poured into a mold comprised of mating male and female mold members which form a mold cavity between them. The mold cavity is completely filled with the collagen suspension, and the main frame of the mold is tightly attached to the elastic surface of bottom plate.

[0035]The filled mold was then placed in −70° C. freezer. After solidification of the collagen matrix, the pins were removed from the molds. Then one of the two vertical plates holding the frozen collagen was removed. The other vertical plate was also removed wit...

example 3

Selective Rehydration / drying

[0038]The first step is casting the basic capsule. A 10-60 mg / ml suspension of purified collagen in 5-25% alcohol / water is formed. A particularly preferred suspension contains 15 mg of collagen per ml of a 10% solution of ethanol in water. The collagen fibers preferably have a native fibrous structure and a length of from 0.2 to 3 mm, particularly preferably about 1.5 mm. After removing air bubbles from the suspension, a fixed amount of the suspension is poured into a mold comprised of mating male and female mold members which form a mold cavity between them. The mold cavity is completely filled with the collagen suspension, and the main frame of the mold is tightly attached to the elastic surface of bottom plate.

[0039]The filled mold was then placed in −70° C. freezer. After solidification of the collagen matrix, the pins were removed from the molds. Then one of the two vertical plates holding the frozen collagen was removed. The other vertical plate was...

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Abstract

A biocompatible, resorbable biphasic collagen membrane having a first area of relatively higher tensile strength and stiffness and lower porosity and a second area of relatively lower tensile strength and stiffness and higher porosity, and a method of manufacturing the such a membrane.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a biphasic collagen membrane for guided tissue regeneration in a human or other mammal.BACKGROUND OF THE INVENTION[0002]Collagen has been used as an implantable biomaterial for more than 50 years. The collagen used for biomedical implants is either derived from animals (e.g., cows, pigs, horses) and humans, or it is manufactured in vitro using recombinant engineering. It is known to be biocompatible and is resorbed and remodeled like natural tissues, via cellular and enzymatic processes.[0003]Conventional collagen implants typically have been made of highly porous, reconstituted bovine (i.e., cow) collagen. These collagen implants are commercially sold to surgeons as rectilinear sheets with uniform thicknesses and porosity. Their low density and high porosity make these collagen membranes supple and conformable. Unfortunately they therefore have inadequate tensile strength and stiffness, particularly after wetting with sal...

Claims

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Application Information

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IPC IPC(8): B32B1/08B32B7/02B29C35/16C07K14/78
CPCA61L31/044A61L31/146A61L31/148Y10T428/24942C07K14/78Y10T428/1397Y10T428/1352A61L27/24Y10T428/1348Y10T428/1376Y10T428/1372Y10T428/139A61L27/3633A61L31/12A61L27/36A61L27/56B32B5/06A61L27/60A61L27/58B32B5/14B32B1/08B32B5/18B32B1/00
Inventor CHEUNG, DAVIDKNOX, WILLIAMMALMQUIST, JAYSHORS, EDWINSMILER, DENNIS
Owner OSSEOUS TECH OF AMERICA