Biomaterials for preventing post-surgical adhesions comprised of hyaluronic acid derivatives

• US 7,504,386 B2
• Filed: 03/29/2004
• Issued: 03/17/2009
• Est. Priority Date: 08/29/1995
• Status: Expired due to Fees

• Current Assignee: Anika Therapeutics Incorporated
• Original Assignee: Fidia Advanced Biopolymers S.R.L. (Anika Therapeutics Incorporated)
• Inventors: Pressato, Daniele, Callegaro, Lanfranco, Pavesio, Alessandra
• Primary Examiner(s): Maier; Leigh C
• Application Number:
  US10/812,587
• Publication Number:
  US 20040192643A1
• Time in Patent Office: 1,814 Days
• Field of Search: 514/54
• US Class Current: 514/54
• CPC Class Codes: A61L 31/042 Polysaccharides
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

New biomaterials essentially constituted by esterified derivatives of hyaluronic acid or by cross-linked derivatives of hyaluronic acid for use in the surgical sector, particularly for use in the prevention of post-surgical adhesions.

Claims

1. A method for preventing surgical adhesions of tissue which comprises applying to tissue involved in surgery a biomaterial comprised of at least one auto-crosslinked derivative of an hyaluronic acid with an average molecular weight of 150,000 to 730,000 Daltons, wherein 4.5 to 5% of the carboxyl group of hyaluronic acid are cross-linked to the hydroxyl group of the same or different hyaluronic acid molecule, wherein said biomaterial comprising the cross-linked derivative has a viscosity of at least 200 Pa*sec⁻

1.

3. The method according to claim 1, wherein said viscosity is at least 250 Pa*sec⁻

1.

4. The method according to claim 1 or 2, wherein said biomaterial further comprises a non-biodegradable synthetic polymer.

5. The method according to claim 4, wherein said synthetic polymer is at least one member selected from the group consisting of polypropylene, polyethylene, polyester and polytetrafluoroethylene.

6. The method according to claim 1 or 2, wherein said biomaterial is in the form of a gel, a membrane, a mesh or a woven or non-woven tissue.

7. The method according to claim 1 or 2, wherein said biomaterial further comprises a biologically active agent.

8. The method of claim 7 wherein said biologically active agent is selected from the group consisting of steroidal and non-steroidal antiinflammatories, fibrinolytics, hemostatics, antithrombotics, growth factors, antitumorals, antibacterials, antivirals and antifungals.

9. The method of claim 1 wherein the viscosity of said cross-linked derivative is at least 350 Pa* Sec⁻

1.

10. The method of claim 1 wherein the viscosity of said cross-linked derivative is at least 300 Pa* Sec⁻

1.

11. The method of claim 1 wherein said surgery is selected from the group consisting of abdominal, laparoscopic, laparotomic, intestinal, gynecologic, abdominalpelvic, peritoneal, urogenital, orthopedic, spinal/dura mater, tendon/nerve, including carpal tunnel, cardiovascular, thoracic, ophtalmic, oncologic, plastic, esthetic, ENT, paranasal sinuses, and transplantation.

12. The method of claim 1, wherein the viscosity of said cross-linked derivative is at least 400 Pa*Sec⁻

1.

13. The method of claim 1 or 2, wherein said auto-crosslinked derivative of an hyaluronic acid has an average molecular weight of 150,000 to 450,000 Daltons.

15. The method according to claim 1, wherein said cross-linked derivative has a viscosity of 200 Pa*sec⁻

1 to 450 Pa*sec<sup>−

1</sup>.

2. A method for preventing surgical adhesions of tissue which comprises applying to tissue involved in surgery a biomaterial comprised of at least one auto-crosslinked derivative of an hyaluronic acid with an average molecular weight of 150,000 to 730,000 Daltons, wherein 4.5 to 5% of the carboxyl group of hyaluronic acid are cross-linked to the hydroxyl group of the same or different hyaluronic acid molecule.

14. The method of claim 2, wherein said surgery is selected from the group consisting of abdominal, laparoscopic , laparotomic, intestinal, gynecologic, abdominalpelvic, peritoneal, urogenital, orthopedic, spinal/dura mater, tendon/nerve, including carpal tunnel, cardiovascular, thoracic, ophtalmic, oncologic, plastic, esthetic, ENT, paranasal sinuses, and transplantation.