Collagen implant material and method for augmenting soft tissue

• US 4,424,208 A
• Filed: 01/11/1982
• Issued: 01/03/1984
• Est. Priority Date: 01/11/1982
• Status: Expired due to Term

• Current Assignee: Cohesion Technologies Inc. (Angiotech Pharmaceuticals Incorporated)
• Original Assignee: Collagen Corp. (Abbvie Incorporated)
• Inventors: Wallace, Donald G., Wade, Susan B.
• Primary Examiner(s): Phillips, Delbert R.
• Assistant Examiner(s): Moezie, F. T.
• Application Number:
  US06/338,661
• Time in Patent Office: 722 Days
• Field of Search: 424/177, 260/112.5 R
• US Class Current: 514/17.2
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: C07K 14/78 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
• CPC Class Codes: Y10S 530/842 Skin; hair; nails; sebaceous glands; cerumen

Abstract

An injectable implant material for soft tissue augmentation comprising a dispersion of (a) particles of cross-linked atelopeptide collagen; and (b) reconstituted fibrous atelopeptide collagen in a (c) physiological aqueous carrier. Implants of this material have improved persistence relative to currently used collagen implant materials.

Claims

1. An injectable implant material for soft tissue augmentation comprising a dispersion of:

(a) particulate cross-linked atelopeptide collagen; and

(b) reconstituted fibrous atelopeptide collagen;

dispersed in

(c) an aqueous carrier wherein the total collagen in the dispersion is in the range of about 15 to about 80 mg/ml, the cross-linked collagen constitutes about 70% to 95% by weight of the total collagen in the dispersion and the fibrous collagen constitutes about 5% to about 30% by weight of the total collagen in the dispersion.

2. The implant material of claim 1 wherein said carrier has a substantially physiological pH and ionic strength.

3. The implant material of claim 1 wherein the particle size of the cross-linked collagen is in the range of about 50 to about 200 microns and the cross-linked collagen has a Young'"'"'s modulus of about 5,000 to about 50,000 dynes/cm².

4. The implant material of claim 3 wherein the cross-linked collagen is cross-linked with glutaraldehyde.

5. The implant material of claim 1 wherein the carrier has a substantially physiological pH and ionic strength;

the total collagen in the dispersion is in the range of 40 to 60 mg/ml;

the cross-linked collagen constitutes 75% to 85% by weight of the total collagen in the dispersion and the fibrous collagen constitutes 15% to 25% by weight of the total collagen in the dispersion; and

the cross-linked collagen has a particle size in the range of about 50 to about 200 microns and a Young'"'"'s modulus of about 5,000 to 50,000 dynes/cm².

6. The implant material of claim 1 or 5 wherein the dispersion includes

(d) a local anesthetic.

7. A method for augmenting soft tissue in a living mammal comprising injecting the material of claim 1 or 7 into the mammal at the augmentation site.