WOUND CLOSURE MATERIAL

• US 20100076489A1
• Filed: 03/31/2009
• Published: 03/25/2010
• Est. Priority Date: 03/06/2007
• Status: Abandoned Application

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Ostapoff, Roland, Stevenson, Richard, Stopek, Joshua, Nentwick, Brian, Elachchabi, Amin
• Application Number:
  US12/415,374
• Publication Number:
  US 20100076489A1
• Time in Patent Office: Days
• US Class Current: 514/1.100
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/44 Radioisotopes, radionuclides
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Articles are provided having no orientation or a multi-directional orientation. Such articles may be in the form of films, ribbons, sheets, and/or tapes and may be utilized as buttresses with a surgical stapling apparatus or as reinforcing means for suture lines. The articles may be produced with a polymeric material having an agent, such as a chemotherapeutic agent or a radiotherapeutic agent, incorporated therein or applied as a coating thereon.

Claims

1. A method comprising:

obtaining a polymeric material selected from the group consisting of glycolic acid, lactic acid, glycolide, lactide, dioxanone, trimethylene carbonate, caprolactone, and combinations thereof;

forming the polymeric material into an article that does not possess orientation in a single direction;

contacting the polymeric material with at least one agent selected from the group consisting of paclitaxel, DHA-paclitaxel, doxetaxel, abraxane, 5-fluorouracil, mitoxantrone, daunorubicin, doxorubicin, cisplatin, carboplatin, methotrexate, bevacizumab, antibody and prodrug conjugates of these, HER-2/neu peptides, proteins, and related vaccines, iodine 125, palladium 103, iridium 192, cesium 131, gold 198, yttrium 90, phosphorus 32, and combinations thereof; and

recovering the article.

2. The method of claim 1, wherein the polymeric material comprises a copolymer including glycolide in amounts from about 60% to about 75% by weight of the copolymer and trimethylene carbonate in amounts from about 25% to about 40% by weight of the copolymer.

3. The method of claim 1, wherein the polymeric material comprises a copolymer including glycolide in amounts from about 55% to about 65% by weight of the copolymer, dioxanone in amounts from about 10% to about 18% by weight of the copolymer, and trimethylene carbonate in amounts from about 17% to about 35% by weight of the copolymer.

4. The method of claim 1, wherein the polymeric material comprises a copolymer including caprolactone in amounts from about 14% to about 20% by weight of the copolymer, lactide in amounts from about 4% to about 10% by weight of the copolymer, trimethylene carbonate in amounts from about 4% to about 10% by weight of the copolymer, and glycolide in amounts from about 60% to about 78% by weight of the copolymer.

5. The method of claim 1, wherein forming the polymeric material into an article comprises forming an article selected from the group consisting of ribbons, tapes, sheets, and films.

6. The method of claim 1, wherein forming the polymeric material into an article that does not possess orientation in a single direction results in an article possessing no orientation.

7. The method of claim 1, wherein forming the polymeric material into an article that does not possess orientation in a single direction results in an article possessing multi-directional orientation.

8. The method of claim 1, wherein forming the polymeric material into an article that does not possess orientation in a single direction occurs by a process selected from the group consisting of compression rollers, contoured rollers, heat pressing, blown film methods, and combinations thereof.

9. The method of claim 1, wherein forming the polymeric material into an article that does not possess orientation in a single direction occurs by subjecting the polymeric material to a temperature of from about 95°

C. to about 230°

C. and a pressure of from about 1 psi to about 2500 psi, for a period of time from about 5 seconds to about 10 minutes.

10. The method of claim 1, wherein forming the polymeric material into an article that does not possess orientation in a single direction occurs by introducing the polymeric material into a barrel heated to a temperature of from about 290°

F. to about 355°

F., extruding the polymeric material through a die having a diameter of from about 1 inch to about 1.5 inches to produce a tubular film, expanding the tubular film to a diameter of from about 2 inches to about 4 inches, and flattening the tubular film to produce a film having a thickness from about 0.001 inches to about 0.014 inches.

11. The method of claim 1, further comprising forming a texture on at least one surface of the article.

12. The method of claim 1, wherein the article possesses a thickness of from about 0.0005 inches to about 0.014 inches.

13. The method of claim 1, wherein the article possesses a thickness of from about 0.002 inches to about 0.005 inches.

14. The method of claim 1, wherein the agent is blended with the polymeric material.

15. The method of claim 1, wherein the agent comprises a coating on at least a portion of the polymeric material.

16. A surgical stapler buttress comprising the article produced by the method of claim 1.

17. A reinforcement means for a suture line comprising the article produced by the method of claim 1.

18. A surgical stapling apparatus comprising:

a staple cartridge containing at least one staple;

an anvil having a staple forming surface; and

a buttress positioned adjacent the anvil or the cartridge, the buttress comprising an article produced by the method of claim 1.

19. A method of sealing a wound comprising:

enclosing tissue between a cartridge and an anvil of a surgical stapling apparatus, one of the cartridge or anvil having a buttress positioned adjacent thereto, wherein the buttress comprises an article produced by the method of claim 1; and

ejecting staples from said cartridge to secure the buttress to the tissue.