Polyhydroxyalkanoate medical textiles and fibers

• US 10,111,738 B2
• Filed: 04/01/2014
• Issued: 10/30/2018
• 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 A
• Application Number:
  US14/242,599
• Publication Number:
  US 20150073444A1
• Time in Patent Office: 1,673 Days
• Field of Search: 606151
• 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 comprising oriented polymeric monofilament fibers, wherein the polymer consists of P4HB homopolymer and wherein the fibers are produced by a method comprising drying the polymer, extruding the polymer at a temperature between 100°

C. and 220°

C., allowing the polymer time to crystallize, and then drawing the polymer to stretch ratios from 6 to 11×

at a temperature above the polymer'"'"'s glass transition temperature.

2. The knitted mesh of claim 1 wherein the fibers have a tensile strength of 739 MPa.

3. The knitted mesh of claim 1 wherein the fibers have been heat set.

4. The knitted mesh of claim 1 wherein the mesh is a warp knit.

5. The knitted mesh of claim 1 wherein the diameter of the fibers is between 82 μ

m and 217 μ

m.

6. The knitted mesh of claim 1 wherein the elongation to break of the fibers is between 29% and 134%.

7. A medical device comprising the knitted mesh of claim 1.

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

9. The device of claim 7, selected from the group consisting of a tube, general surgical mesh, hernia mesh, 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.

10. A method of using the device of claim 7, the method comprising the steps of implanting the device in a patient for pelvic floor reconstruction, urethral suspension, hernia repair, 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, mastopexyor breast reconstruction, vascular grafts orfistulae, GI resection, tracheal reconstruction, intracardiac defect closure, support is disc herniation palliation, urinary bladder repair, and encephalocele ormeningomyelocele repair.

11. A medical device comprising the knitted mesh of claim 1.

12. The medical device of claim 11, selected from the group consisting of a tube, general surgical mesh, hernia mesh, 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.

13. A method of using the device of claim 11, the method comprising the steps of implanting the device in a patient for pelvic floor reconstruction, urethral suspension, hernia repair, 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, mastopexyor breast reconstruction, vascular grafts orfistulae, GI resection, tracheal reconstruction, intracardiac defect closure, support is disc herniation palliation, urinary bladder repair, and encephalocele ormeningomyelocele repair.