Polyhydroxyalkanoate medical textiles and fibers

• US 10,314,683 B2
• Filed: 07/21/2016
• Issued: 06/11/2019
• 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:
  US15/215,878
• Publication Number:
  US 20160324619A1
• Time in Patent Office: 1,055 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 monofilament or multifilament fiber comprising poly-4-hydroxybutyrate homopolymer wherein the multifilament fiber has a tenacity greater than 0.5 g/denier and wherein the monofilament fiber has a tensile strength greater than 126 MPa, wherein the fiber is prepared by a method comprising drying the homopolymer and extruding the polymer at a temperature between 100°

C. and 220°

C., and drawing the fiber, wherein the method comprises heating the homopolymer r at a temperature greater than 150°

C.

2. The multifilament fiber of claim 1 wherein the tenacity is greater than 3.5 g/denier.

3. The multifilament fiber of claim 1 wherein the tenacity is up to 4.1 g/denier.

4. The multifilament fiber of claim 1 wherein the fiber is prepared by a method comprising, allowing the homopolymer time to crystallize, and then drawing the polymer at a temperature above the homopolymer'"'"'s glass transition temperature.

5. A device comprising one or more monofilament or multifilament fibers comprising poly-4-hydroxybutyrate homopolymer wherein the multifilament fiber has a tenacity of greater than 0.5 g/denier and wherein the monofilament fiber has a tensile strength greater than 126 MPa, wherein the fibers are prepared by a method comprising drying the homopolymer and extruding the homopolymer at a temperature between 100°

C. and 220°

C., and drawing the fiber, wherein the method comprises heating the homopolymer at a temperature greater than 150°

C.

6. The device of claim 5 wherein the device is selected from the group consisting of a medical textile, tube, general surgical mesh, hernia mesh, breast reconstruction mesh, mastopexy mesh, monofilament suture, multifilament suture, pericardial patch, anti-adhesion patch, cardiovascular patch, guided tissue regeneration patch, tissue engineering scaffold, sling, multifilament suture, braid, ligament repair device, tendon repair device, meniscus repair device, cartilage repair device, rotator cuff repair device, nerve guide, stent, vascular graft, dura patch, retentive device for bone graft or cartilage, and devices for pelvic floor reconstruction, urethral suspension, myocardial regeneration, organ salvage, cardiac support, elevation of the small bowel during radiation of the colon in colorectal cancer patients, tracheal reconstruction, intracardiac defect closure, and urinary bladder repair.

7. The device of claim 6 wherein the device is a knitted mesh, woven mesh, or nonwoven mesh.

8. The device of claim 7 wherein the mesh is a warp knit.

9. The device of claim 7 wherein the breaking strength of the device is at least 10 psi and optionally, wherein the one or more fibers are oriented.

10. The device of claim 5, wherein the weight average molecular weight of the monofilament or multifilament fiber decreases:

(i) less than 80% after implantation for 6 months or (ii) less than 75% after implantation for 2 weeks.

11. The device of claim 5, wherein the monofilament or multifilament fiber has an elongation to break over 20%.

12. A method of making the medical device of claim 5 comprising melt extruding poly-4-hydroxybutyrate homopolymer r, allowing the extruded monofilament fiber or multifilament fiber time to crystallize, and orientating the monofilament fiber or multifilament fiber at a temperature above the polymer'"'"'s glass transition temperature wherein method comprises heating the homopolymer at a temperature greater than 150°

C.

13. The method of claim 12, wherein the extruded monofilament or multifilament fiber is cooled after melt extrusion to a temperature that is at or above the glass transition temperature of poly-4-hydroxybutyrate homopolymer.

14. The method of claim 12, wherein the poly-4-hydroxybutyrate homopolymer is dried, extruded at a temperature between 100°

C. and 220°

C., and the fiber is drawn to stretch ratios from 6 to 11×

.

15. A method of using the device of claim 5, 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 grafting, GI (gastro intestinal) resection, tracheal reconstruction, intracardiac defect closure, support in disc herniation palliation, urinary bladder repair, and encephalocele/meningomyelocele repair.