Polyhydroxyalkanoate medical textiles and fibers

• US 8,034,270 B2
• Filed: 04/30/2004
• Issued: 10/11/2011
• Est. Priority Date: 05/08/2003
• Status: Active Grant

• Current Assignee: Tepha Incorporated (Becton, Dickinson & Co)
• Original Assignee: Tepha Incorporated (Becton, Dickinson & Co)
• Inventors: Rizk, Said, Martin, David P., Williams, Simon F., Ahuja, Ajay
• Primary Examiner(s): Tentoni; Leo B
• Application Number:
  US10/835,926
• Publication Number:
  US 20040234576A1
• Time in Patent Office: 2,720 Days
• Field of Search: 264/103, 264/210.7, 264/210.8, 264/211.14
• US Class Current: 264/103
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: B29C 48/022 characterised by the choice of material
• CPC Class Codes: B29C 48/05 Filamentary, e.g. strands
• CPC Class Codes: B29C 71/0072 for changing orientation
• CPC Class Codes: B29K 2067/00 Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: D01D 5/088 Cooling filaments, threads or the like, leaving the spinnerettes
• CPC Class Codes: D01D 5/098 with simultaneous stretching
• CPC Class Codes: D01D 5/16 using rollers, or like mechanical devices, e.g. snubbing pins
• CPC Class Codes: D01F 6/62 from polyesters
• CPC Class Codes: D01F 6/625 derived from hydroxy-carboxylic acids, e.g. lactones
• CPC Class Codes: D01F 6/84 from copolyesters
• CPC Class Codes: D02G 3/02 Yarns or threads characterised by the material or by the materials from which they are made
• CPC Class Codes: Y10T 428/1362 Textile, fabric, cloth, or pile containing [e.g., web, net, woven, knitted, mesh, nonwoven, matted, etc.]
• CPC Class Codes: Y10T 428/1369 Fiber or fibers wound around each other or into a self-sustaining shape [e.g., yarn, braid, fibers shaped around a core, etc.]
• CPC Class Codes: Y10T 428/249922 : Embodying intertwined or helical component[s]
• CPC Class Codes: Y10T 442/10 : Scrim [e.g., open net or mesh, gauze, loose or open weave or knit, etc.]
• CPC Class Codes: Y10T 442/183 : Synthetic polymeric fiber
• CPC Class Codes: Y10T 442/184 : Nonwoven scrim
• CPC Class Codes: Y10T 442/2525 : Coating or impregnation functions biologically [e.g., insect repellent, antiseptic, insecticide, bactericide, etc.]

Abstract

Absorbable polyester fibers, braids, and surgical meshes with prolonged strength retention have been developed. These devices are preferably derived from biocompatible copolymers or homopolymers of 4-hydroxybutyrate. These devices provide a wider range of in vivo strength retention properties than are currently available, and could offer additional benefits such as anti-adhesion properties, reduced risks of infection or other post-operative problems resulting from absorption and eventual elimination of the device, and competitive cost. The devices may also be particularly suitable for use in pediatric populations where their absorption should not hinder growth, and provide in all patient populations wound healing with long-term mechanical stability. The devices may additionally be combined with autologous, allogenic and/or xenogenic tissues to provide implants with improved mechanical, biological and handling properties.

Claims

1. A method for producing fiber comprising a poly-4-hydroxybutyrate polymer or copolymer wherein the fiber has a tensile strength of greater than 126 MPa, comprising

quenching the fiber following extrusion at a temperature that is greater than the glass transition temperature of the polymer,

orienting the fiber at a temperature above the polymer'"'"'s glass transition temperature by spinning, allowing the polymer time to crystallize, and then drawing the polymer or copolymer to yield a fiber with a tensile strength greater than 126 MPa.

7. The method of claim 1 wherein the weight average molecular weight of the fiber decreases less than 80% after implantation for 6 months.

8. The method of claim 7 wherein the weight average molecular weight of the fiber decreases less than 75% after implantation for 2 weeks.

9. The method of claim 7 wherein the tensile strength of the fiber decreases less than 80% after implantation for 6 months.

10. The method of claim 7 wherein the tensile strength of the fiber decreases less than 75% after implantation for 2 weeks.

11. The method of claim 1 wherein the elongation to break is over 20%.

12. The method of claim 1 wherein the polymer is a copolymer of 4-hydroxybutyrate and one or more co-monomers.

13. The method of claim 12 wherein the co-monomer is glycolate.

14. The method of claim 12 wherein the co-monomer is 3-hydroxybutyrate.

15. The method of claim 12 wherein the fiber is a monofilament, multifilament, or braided structure.

2. A method for producing a multifilament yarn fiber comprising providing multiple fibers, at least one fiber comprising a poly-4-hydroxybutyrate polymer or copolymer made by a process comprising

quenching the fiber following extrusion at a temperature that is greater than the glass transition temperature of the polymer,

orienting the fiber at a temperature above the polymer'"'"'s glass transition temperature by spinning, allowing the polymer time to crystallize, and then drawing the polymer or copolymer to yield a fiber having a tensile strength of greater than 126 MPa wherein the yarn is spun and drawn to yield a yarn with a tenacity of greater than 0.5 g/denier.

3. The method of claim 2 wherein the yarn has a tenacity greater than 1 g/denier.

4. The method of claim 2 wherein the yarn has a tenacity greater than 3 g/denier.

5. The method of claim 2 wherein the yarn has a tensile strength of greater than 126 MPa.

6. The method of claim 2 further comprising making a medical textile from the yarn.

16. The method of claim 6 wherein the medical textile is combined with harvested autologous tissue, allogenic tissue, and/or xenogenic tissue.

17. The method of claim 16 wherein the medical textile reinforces, supports, strengthens, or stiffens the autologous, allogenic, and/or xenogenic tissues.

18. The method of claim 16 wherein the harvested autologous tissue, allogenic tissue, and/or xenogenic tissues include vascular grafts, heart valves, pericardium, skin, intestine (including small intestine submucosa), muscle, ligament and tendon, cartilage and meniscus, nerves, dura, fascia, and organs.

19. The method of claim 6 wherein the medical textile is selected from the group consisting of a tube, general surgical mesh, hernia mesh, pericardial mesh, anti-adhesion patch, cardiovascular graft, guided tissue regeneration patch, sling, monofilament suture, monofilament suture, braid, ligament or tendon repair device, meniscus repair device, cartilage repair device, nerve guide, stent, vascular graft, and dural patch.

20. The method of claim 19 where the medical textile is used for hernia repair, mastopexy/breast reconstruction, rotator cuff repair, vascular grafting/fistulae, tissue flaps, pericardial patching in intracardiac repair, tissue heart valve implants, bowel interposition, and dura patching.