Polyhydroxyalkanoate medical textiles and fibers

• US 10,136,982 B2
• Filed: 05/13/2014
• Issued: 11/27/2018
• Est. Priority Date: 05/08/2003
• Status: Active Grant

• Current Assignee: Tepha Incorporated (Becton, Dickinson & Co)
• Original Assignee: Tepha Incorporated (Becton, Dickinson & Co)
• Inventors: Martin, David P., Rizk, Said, Ahuja, Ajay, Williams, Simon F.
• Primary Examiner(s): Tatesure, Vincent
• Application Number:
  US14/276,693
• Publication Number:
  US 20140248331A1
• Time in Patent Office: 1,659 Days
• Field of Search: 606151, 424 937, 424443, 442 50
• 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 knitted mesh, woven mesh, nonwoven mesh or braid comprising a poly-hydroxybutyrate homopolymer multifilament yarn, wherein the multifilament yarn has a tenacity of greater than 0.5 g/denier and is produced by a method comprising melt extrusion, allowing the extrudate dwell time to crystallize and drawing the resulting fiber.

2. The knitted mesh, woven mesh, nonwoven mesh or braid of claim 1 wherein the yarn has been oriented.

3. The knitted mesh, woven mesh, nonwoven mesh or braid of claim 1 further comprising a monofilament of poly-4-hydroxybutyrate polymer.

4. The knitted mesh, woven mesh, nonwoven mesh or braid of claim 1 wherein the elongation to break of the multifilament yarn is between 30% and 114%.

5. The knitted mesh, woven mesh, nonwoven mesh or braid of claim 1 wherein the multifilament yarn is produced by a method that comprises spinning the multifilament at a temperature that is greater than the glass transition temperature of the polymer, optionally, wherein the method comprises heating at a temperature greater than 150°

C., and stretching the multifilament at a temperature above the polymer'"'"'s glass transition temperature while allowing the polymer time to crystallize.

6. A medical device comprising the knitted mesh, woven mesh, nonwoven mesh, or braid of claim 1.

7. The medical device of claim 6 wherein the knitted mesh, woven mesh, nonwoven mesh or braid is combined with harvested autologous, allogeneic and/or xenogeneic tissue.

8. The devices of claim 6, where the device is selected from the group consisting of a tube, general surgical mesh, hernia mesh, suture, pericardial patch, anti-adhesion patch, cardiovascular patch, guided tissue regeneration patch, sling, braid, ligament or tendon repair device, meniscus repair device, cartilage repair device, nerve guide, stent, vascular graft, dural patch, organ salvage device, intracardiac defect closure device, mastopexy/breast reconstruction device, tracheal reconstruction device, and bladder repair device.

9. A method of using the device of claim 8, the method comprising the steps of implanting the device in a patient for pelvic floor reconstruction, urethral suspension, hernia repair, suturing, pericardial repair, cardiovascular patching, cardiac support, myocardial regeneration, organ salvage, elevation of the small bowel during radiation of the colon in colorectal cancer patients, bone, cartilage, and meniscus grafting procedures, guided tissue regeneration, vascular grafting, dural substitution, nerve repair, prevention of adhesions, ligament and tendon repair, mastopexy/breast reconstruction, vascular grafts/fistulae, GI (gastro intestinal) resection, tracheal reconstruction, intracardiac defect closure, support is disc herniation palliation, urinary bladder repair, and encephalocele/meningomyelocele repair.

10. The knitted mesh, woven mesh, nonwoven mesh or braid comprising a multifilament yarn of claim 1 wherein the multifilament yarn has a tenacity between 0.5 g/denier and 4.1 g/denier.

11. The knitted mesh, woven mesh, nonwoven mesh or braid comprising a multifilament yarn of claim 1 wherein the multifilament yarn has a tenacity between 3.1 g/denier and 4.1 g/denier.