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Collagen implant material and method of preparing it

Assignee: Collagen Aesthetics Inc
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Filing: 1986-03-20
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Granted: —
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Expires: 2006-03-20
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Abstract

Abstract An injectable collagen material composed of reconstituted, mechanically sheared atelopeptide collagen fibers. The material is prepared by passing reconstituted collagen fibers repeatedly through a rigid mesh screen, until a substantial raduction in fiber size and size-heterogeneity is achieved. The mechanically sheared fibers may be further crosslinked to improve implant characteristics.

Inventors

  • 👤 Hoc M. Nguyen
  • 👤 George H. Chu

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 10:19
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/14; A61L27/22; A61L27/24; C; C07; C07K; C07K14/00; C07K14/435; C07K14/78; A61F; A61F2310/00; A61F2310/00005; A61F2310/00365; A61K; A61K38/00; Y; Y10; Y10S; Y10S128/00; Y10S128/08

Claims Analysis

Total Claims: 34
Claim 1
Independent Claim 12 words
An injectable collagen material composed of reconstituted, mechanically sheared atelopeptide collagen fibers.
Claim 2
Dependent Claim 12 words
An injectable collagen material composed of reconstituted, mechanically sheared atelopeptide collagen fibers.
Claim 3
Dependent Claim 18 words
The material of claim 1, wherein the nominal size of the fibers is less than about 200 microns.
Claim 4
Dependent Claim 20 words
The material of claim 2, wherein the fibers are in the size range of between about 50 and 150 microns.
Claim 5
Dependent Claim 48 words
The material of claim 1, which has a viscosity, measured at shear rates varying from 10 -6 -2 -1 to 10 sec , at 20 °C and at a protein concentration of about 65 mg/ml, about 20-30% less than that of unsheared material measured under the same conditions.
Claim 6
Dependent Claim 19 words
The material of claim 1, resulting from crosslinking the mechanically sheared fibers under conditions which produce predominantly intrafibrillar crosslinks.
Claim 7
Dependent Claim 48 words
The material of claim 5 which, at a concentration of about 35 mg/ml, has a viscosity, measured at shear rates ranging from 10 -6 to 10 -2 sec -1 , at 20°C, about 40 - 60% lower than that of unsheared crosslinked material measured under the same conditions.
Claim 8
Dependent Claim 35 words
The material of claim 1, wherein the fibers are mechanically sheared by repeated passage through a wire mesh screen under conditions which produce a more than two-fold reduction in the size of the largest fibers.
Claim 9
Dependent Claim 20 words
An injectable collagen material composed of reconstituted, non-crosslinked, mechanically sheared atelopeptide collagen fibers having fiber sizes between about 50-150 microns.
Claim 10
Dependent Claim 20 words
An injectable collagen material composed of reconstituted, non-crosslinked, mechanically sheared atelopeptide collagen fibers having fiber sizes between about 50-150 microns.
Claim 11
Dependent Claim 21 words
The material of claim 8, contained in a substantially isotonic medium, pH 6-8. at a concentration of between about 20-80 mg/ml.
Claim 12
Dependent Claim 20 words
An injectable collagen material composed of reconstituted, crosslinked, mechanically sheared atelopeptide collagen fibers having fiber sizes between about 50-200 microns.
Claim 13
Dependent Claim 20 words
An injectable collagen material composed of reconstituted, crosslinked, mechanically sheared atelopeptide collagen fibers having fiber sizes between about 50-200 microns.
Claim 14
Dependent Claim 21 words
The material of claim 10, contained in a substantially isotonic medium, pH 6-8, at a concentration of between about 15-70 mg/ml.
Claim 15
Dependent Claim 12 words
The material of claim 10, wherein the fibers contain substantially intrafibrillar crosslinks.
Claim 16
Independent Claim 30 words
A method of preparing a collagen implant material comprising: providing reconstituted atelopeptide collagen fibers; and shearing the fibers mechanically until a substantial reduction in fiber size and size-heterogeneity is achieved.
Claim 17
Independent Claim 30 words
A method of preparing a collagen implant material comprising: providing reconstituted atelopeptide collagen fibers; and shearing the fibers mechanically until a substantial reduction in fiber size and size-heterogeneity is achieved.
Claim 18
Dependent Claim 34 words
The method of claim 13 wherein said providing includes reconstituting a suspension of atelopeptide collagen fibers in a hypotonic medium, pH 6-8. for about 1-8 hours at a temperature between about 10° and 25°C.
Claim 19
Dependent Claim 21 words
The method of claim 13, wherein said shearing includes passing the reconstituted fibers multiple times through a selected-size rigid mesh screen.
Claim 20
Dependent Claim 19 words
The method of claim 15, wherein the screen has a mesh size between about 20 0 - 300 microns.
Claim 21
Dependent Claim 16 words
The method of claim 16, wherein the screen is a 60 mesh (250 micron) wire screen.
Claim 22
Dependent Claim 22 words
The method of claim 16, wherein the fibers are passed through the mesh at a flow rate of between about 5-7 liters/min.
Claim 23
Dependent Claim 19 words
The method of claim 16, wherein the fibers are passed through the mesh between about 50 and 200 times.
Claim 24
Dependent Claim 23 words
The method of claim 15, wherein said passing is effective to reduce the size of the fibers to less than about 200 microns.
Claim 25
Dependent Claim 23 words
The method of claim 20, wherein said passing is effective to reduce the size of the fibers to less than about 150 microns.
Claim 26
Dependent Claim 16 words
The method of claim 13, which further includes incubating the sheared fibers an additional 6-24 hours.
Claim 27
Dependent Claim 50 words
The method of claim 22, wherein said shearing is effective to reduce the viscosity of the sheared, incubated material, measured at a protein concentration of about 65 mg/ml, at shear rates varying from 10 to 10 -2 sec -1 , at 20°C, about 20-30% with respect to unsheared, incubated material.
Claim 28
Dependent Claim 29 words
The method of claim 22, which further includes concentrating the sheared, incubated fibers by centrifugation, and resuspending the fibers in a medium suitable for injecting into a human patient.
Claim 29
Dependent Claim 26 words
The method of claim 24, wherein the fibers are resuspended in a substantially isotonic medium, pH 6-8, at a protein concentration of between about 40-80 mg/ml.
Claim 30
Dependent Claim 16 words
The method of claim 13, which further includes reacting the sheared fibers with a crosslinking agent.
Claim 31
Dependent Claim 44 words
The method of claim 26, wherein the fibers are reacted with a crosslinking agent at a fiber concentration of between about 0.1 and 10 mg/ml, and at a concentration of crosslinking agent of between about 0.001-0.1 percent, and the resulting crosslinks are substantially intrafibrillar.
Claim 32
Dependent Claim 52 words
The method of claim 27, wherein said shearing is effective to reduce the viscosity of the sheared, crosslinked material, measured at a protein concentration of about 35 mg/ml, at shear rates varying from 10 -6 to 10 -2 sec -1 , and at 20°C, about 40-60% with respect to unsheared, crosslinked material.
Claim 33
Dependent Claim 29 words
The method of claim 27, which further includes concentrating the sheared, crosslinked fibers by centrifugation and resuspending the fibers in a medium suitable for injecting into a human patient.
Claim 34
Dependent Claim 26 words
' The method of claim 29, wherein the fibers are resuspended in a substantially isotonic medium, pH 6-8, at a protein concentration of between 15-70 mg/ml.

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