Resorbable implant materials

• US 6,652,594 B2
• Filed: 03/14/2002
• Issued: 11/25/2003
• Est. Priority Date: 09/15/1999
• Status: Expired due to Term

• Current Assignee: Synovis Life Technologies Incorporated (Baxter International Inc.)
• Original Assignee: Synovis Life Technologies Incorporated (Baxter International Inc.)
• Inventors: Oray, B. Nicholas, Zhao, Qing Hong, Francis, Ralph T., DeSmith, Amy
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US10/099,425
• Publication Number:
  US 20020138152A1
• Time in Patent Office: 621 Days
• Field of Search: 623/23.72, 623/23.73, 623/23.74, 623/23.75, 623/23.76, 623/13.17, 623/14.13, 623/15.11, 623/15.12
• 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 surgical method comprising the steps of:

providing 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; and

implanting the implant material within the body, the material being adapted for use in a surgical application selected from the group consisting of duraplasty, thoracic, abdominal, urological, opthalmological, cardiac, and vascular surgery.

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

3. A surgical method 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 surgical method according to claim 3 wherein the tissue comprises bovine pericardium.

5. A surgical method 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 surgical method according to claim 5 wherein the alkylating agent is propylene oxide.

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

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

9. A surgical method according to claim 1 wherein the step of providing a resorbable, remodelable implant material includes the steps of providing a biological tissue, treating the 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.

10. A surgical method according to claim 9 wherein the biological tissue is treated with a base prior to the alkylating step.

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

12. A surgical method according to claim 9 wherein the concentration of alkylating agent is between about 2% (v/v) and about 5% (v/v).

13. A surgical method according to claim 9 wherein the tissue is exposed to the alkylating agent for at least 48 hours.

14. A surgical method according to claim 1 wherein the step of implanting comprises implanting the material using a suture material.

15. A surgical method according to claim 14 wherein the step of implanting comprises implanting the material using a glue.

16. A surgical method according to claim 14 wherein the suture material is absorbable.

17. A surgical method according to claim 14 wherein the suture material is non-absorbable.

18. A surgical method according to claim 1 wherein the step of implanting comprises implanting the material and leaving the material in the body so that it is gradually remodeled or absorbed.

19. A surgical method according to claim 1 wherein the step of providing an implant material comprises providing implant materials prepared and packaged in various sizes.

20. A surgical method according to claim 1 wherein the step of providing an implant material comprises providing the implant material in a packaged form.

21. A surgical method according to claim 20 wherein the packaged form comprises an implant material packaged in a dehydrated condition.

22. A surgical method according to claim 21 further comprising the step of rehydrating the implant material packaged in a dehydrated condition prior to surgery.

23. A surgical method according to claim 1 wherein the step of providing an implant material comprises providing the implant material having a configuration and dimension adapted for use with a particular type of surgery.

24. A surgical method comprising the steps of:

providing a resorbable, remodelable implant material comprising a sterile, non-crosslinked, decellularized and purified bovine pericardium tissue having a major percentage of its available amine groups 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; and

implanting the implant material within the body, the material being adapted for use in a surgical application selected from the group consisting of duraplasty, thoracic, abdominal, urological, opthalmological, cardiac, and vascular surgery.