Resorbable implant materials

• US 6,312,474 B1
• Filed: 09/15/1999
• Issued: 11/06/2001
• Est. Priority Date: 09/15/1999
• Status: Expired due to Term

• Current Assignee: Synovis Life Technologies Incorporated (Baxter International Inc.)
• Original Assignee: Bio-Vascular, Inc. (Baxter International Inc.)
• Inventors: Desmith, Amy, Oray, B. Nicholas, Zhao, Qing Hong, Francis, Ralph T.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US09/396,279
• Time in Patent Office: 783 Days
• Field of Search: 623/23.72, 623/23.73, 623/23.74, 623/23.75, 623/23.76, 623/1.41
• US Class Current: 623/23.72
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/362 Skin, e.g. dermal papillae
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 31/043 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 31/044 Collagen

Abstract

A non-crosslinked, decellularized and purified mammalian tissue (e.g., bovine pericardium) having particular use as an implantable resorbable material. The material is treated by alkylating its primary amine groups in a manner sufficient to reduce the antigenicity of the tissue, permitting the treated tissue to be used in vivo and without crosslinking, and in turn, permitting it to be resorbable. The material can be used in surgical repair of soft tissue deficiencies for a certain period of time while the implant itself is gradually remodeled or absorbed by the host. Also provided are a method of preparing such a material, as well as a method of using such a material for surgical repair.

Claims

1. A resorbable, remodelable implant material comprising a sterile, non-crosslinked, decellularized and purified mammalian tissue having a major percentage of its available amine groups alkylated.

2. A material according to claim 1 wherein the tissue is selected from the group consisting of serous and fibro-serous membranes.

3. A material according to claim 2 wherein the tissue is selected from the group consisting of pericardium, peritoneum, fascia lata, dura mater, dermis and small intestinal submucosa.

4. A material according to claim 3 wherein the tissue comprises bovine pericardium.

5. A material according to claim 1 wherein the material has been alkylated by an alkylating agent selected from the group consisting of 1,2-epoxy-R compounds where R is an alkyl group up to 6 carbon atoms.

6. A material according to claim 5 wherein the alkylating agent is propylene oxide.

7. A material according to claim 5 wherein the alkylating agent is methyl glycidyl ether.

8. A material according to claim 1 wherein the material is provided in the form of flat or textured sheets or strips.

9. A material according to claim 1 wherein the material is adapted for use in a surgical application selected from the group consisting of duraplasty, thoracic, abdominal, urological, opthalmological, cardiac, and vascular surgery.

10. A process of preparing a resorbable, remodelable implant material according to claim 1, the method comprising the step of treating a biological tissue with an alkylating agent under conditions suitable to alkylate a major percentage of available amine groups in the tissue, and sterilizing the treated tissue for use in vivo.

11. A process according to claim 10 wherein the cleaned tissue is treated with a base prior to the alkylating step.

12. A process according to claim 10 wherein the alkylating agent is used at a pH of between about 9 and about 11.

13. A process according to claim 10 wherein the concentration of alkylating agent is between about 2% (v/v) and about 5% (v/v).

14. A process according to claim 10 wherein the tissue is exposed to the alkylating agent for at least 48 hours.