Abstract: Methods to produce thermoforms from P4HB homopolymer and blends thereof have been developed. These thermoforms are produced from films and sheets including P4HB, wherein the intrinsic viscosity of the P4HB is less than 3.5 dl/g, but greater than 0.35 dl/g, and the thermoforms are produced at a temperature equal to or greater than the softening point of P4HB, and more preferably at a temperature higher than the melting point of P4HB. A preferred embodiment includes a P4HB thermoform wherein a film or sheet including a P4HB polymer is thermoformed at a temperature between its melting point and 150° C. In a particularly preferred embodiment the thermoform is a laminate made from a P4HB film and a P4HB mesh.

Abstract: Absorbable implants for breast surgery that conform to the breast parenchyma and surrounding chest wall have been developed. These implants support newly lifted breast parenchyma, and/or a breast implant. The implants have mechanical properties sufficient to support a reconstructed breast, and allow the in-growth of tissue into the implant as it degrades. The implants have a strength retention profile allowing the support of the breast to be transitioned from the implant to regenerated host tissue, without significant loss of support. Three-dimensional implants for use in minimally invasive mastopexy/breast reconstruction procedures are also described, that confer shape to a patient's breast. These implants are self-reinforced, can be temporarily deformed, implanted in a suitably dissected tissue plane, and resume their preformed three-dimensional shape. The implants are preferably made from poly-4-hydroxybutyrate (P4HB) and copolymers thereof.

Abstract: Methods to produce thermoforms from P4HB homopolymer and blends thereof have been developed. These thermoforms are produced from films and sheets including P4HB, wherein the intrinsic viscosity of the P4HB is less than 3.5 dl/g, but greater than 0.35 dl/g, and the thermoforms are produced at a temperature equal to or greater than the softening point of P4HB, and more preferably at a temperature higher than the melting point of P4HB. A preferred embodiment includes a P4HB thermoform wherein a film or sheet including a P4HB polymer is thermoformed at a temperature between its melting point and 150° C. In a particularly preferred embodiment the thermoform is a laminate made from a P4HB film and a P4HB mesh.

Abstract: Compositions and materials for making soft suture anchors comprising materials that improve osteointegration have been developed. These compositions and materials comprise bioceramics, resorbable materials, and combinations thereof. A preferred embodiment comprises a soft suture anchor comprising a resorbable ceramic and a resorbable suture.

Abstract: Absorbable implants for breast surgery that conform to the breast parenchyma and surrounding chest wall have been developed. These implants support newly lifted breast parenchyma, and/or a breast implant. The implants have mechanical properties sufficient to support a reconstructed breast, and allow the ingrowth of tissue into the implant as it degrades. The implants have a strength retention profile allowing the support of the breast to be transitioned from the implant to regenerated host tissue, without significant loss of support. Three-dimensional implants for use in minimally invasive mastopexy/breast reconstruction procedures are also described, that confer shape to a patient's breast. These implants are self-reinforced, can be temporarily deformed, implanted in a suitably dissected tissue plane, and resume their preformed three-dimensional shape. The implants are preferably made from poly-4-hydroxybutyrate (P4HB) and copolymers thereof.

Abstract: Resorbable multifilament yarns and monofilament fibers including poly-4-hydroxybutyrate and copolymers thereof with high tenacity or high tensile strength have been developed. The yarns and fibers are produced by cold drawing the multifilament yarns and monofilament fibers before hot drawing the yarns and fibers under tension at temperatures above the melt temperature of the polymer or copolymer. These yarns and fibers have prolonged strength retention in vivo making them suitable for soft tissue repairs where high strength and strength retention is required. The multifilament yarns have tenacities higher than 8.1 grams per denier, and in vivo, retain at least 65% of their initial strength at 2 weeks. The monofilament fibers retain at least 50% of their initial strength at 4 weeks in vivo. The monofilament fibers have tensile strengths higher than 500 MPa. These yarns and fibers may be used to make various medical devices for various applications.

Abstract: Resorbable multifilament yarns and monofilament fibers including poly-4-hydroxybutyrate and copolymers thereof with high tenacity or high tensile strength have been developed. The yarns and fibers are produced by cold drawing the multifilament yarns and monofilament fibers before hot drawing the yarns and fibers under tension at temperatures above the melt temperature of the polymer or copolymer. These yarns and fibers have prolonged strength retention in vivo making them suitable for soft tissue repairs where high strength and strength retention is required. The multifilament yarns have tenacities higher than 8.1 grams per denier, and in vivo, retain at least 65% of their initial strength at 2 weeks. The monofilament fibers retain at least 50% of their initial strength at 4 weeks in vivo. The monofilament fibers have tensile strengths higher than 500 MPa. These yarns and fibers may be used to make various medical devices for various applications.

Abstract: Compositions of P4HB with high purity have been developed. The compositions are prepared by washing P4HB biomass prior to solvent extraction, and precipitating P4HB from solution. The same solvent is preferably used to wash the P4HB biomass, and as a non-solvent to precipitate the polymer from a P4HB solvent solution. The highly pure P4HB compositions are suitable for preparing implants. The implants may be used for the repair of soft and hard tissues.

Abstract: Absorbable implants for breast surgery that conform to the breast parenchyma and surrounding chest wall have been developed. These implants support newly lifted breast parenchyma, and/or a breast implant. The implants have mechanical properties sufficient to support a reconstructed breast, and allow the in-growth of tissue into the implant as it degrades. The implants have a strength retention profile allowing the support of the breast to be transitioned from the implant to regenerated host tissue, without significant loss of support. Three-dimensional implants for use in minimally invasive mastopexy/breast reconstruction procedures are also described, that confer shape to a patient's breast. These implants are self-reinforced, can be temporarily deformed, implanted in a suitably dissected tissue plane, and resume their preformed three-dimensional shape. The implants are preferably made from poly-4-hydroxybutyrate (P4HB) and copolymers thereof.

Abstract: Toughened compositions of PLA and PLA copolymers are disclosed, which also have low tensile modulus values and greater elongation to break. These toughened compositions are prepared by blending PLA and PLA copolymers with poly-4-hydroxybutyrate, and copolymers thereof. Blending of poly-4-hydroxybutyrate with PLA and its copolymers has been found to impart advantageous properties to the resulting blend. These compositions, and objects formed from these compositions, have improved toughness and lower stiffness than polylactic acid polymers or copolymers alone.

Abstract: Toughened compositions of PLA and PLA copolymers are disclosed, which also have low tensile modulus values and greater elongation to break. These toughened compositions are prepared by blending PLA and PLA copolymers with poly-4-hydroxybutyrate, and copolymers thereof. Blending of poly-4-hydroxybutyrate with PLA and its copolymers has been found to impart advantageous properties to the resulting blend. These compositions, and objects formed from these compositions, have improved toughness and lower stiffness than polylactic acid polymers or copolymers alone.

Abstract: Continuous processing methods are used for making absorbable polymeric non-wovens, with anisotropic properties, improved mechanical properties and without substantial loss of polymer molecular weight during processing. The method includes producing dry spun-non wovens from a polymer, and collecting the fibers using a rotating collector plate, preferably a rotating cylinder, to collect the non-woven instead of a fiberglass stationary collector plate. The non-wovens can be used for a variety of purposes including fabrication of medical devices.

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.

Abstract: Compositions of P4HB with high purity have been developed. The compositions are prepared by washing P4HB biomass prior to solvent extraction, and precipitating P4HB from solution. The same solvent is preferably used to wash the P4HB biomass, and as a non-solvent to precipitate the polymer from a P4HB solvent solution. The highly pure P4HB compositions are suitable for preparing implants. The implants may be used for the repair of soft and hard tissues.

Abstract: Methods to produce micro-fiber webs containing fibers of 4-hydroxybutyrate or copolymers thereof with average diameters from 0.01 to 100 ?m, have been developed. The micro-fiber webs are produced by centrifugal spinning. These methods allow the micro-fiber webs to be produced without substantial loss of the polymer weight average molecular weight. Webs containing micro-fibers of poly-4-hydroxybutyrate or copolymer thereof, are made by centrifugal spinning. The micro-fibers have average diameters ranging from 0.01 to 100 ?m and contain crimped fibers with a higher elongation at break fibers when compared to fibers derived by melt-blown extrusion, dry spinning and electrospinning. The fibers of the micro-fiber webs have a high degree of orientation. These micro-fiber webs can be used for a variety of purposes including fabrication of medical devices.

Abstract: Resorbable multifilament yarns and monofilament fibers including poly-4-hydroxybutyrate and copolymers thereof with high tenacity or high tensile strength have been developed. The yarns and fibers are produced by cold drawing the multifilament yarns and monofilament fibers before hot drawing the yarns and fibers under tension at temperatures above the melt temperature of the polymer or copolymer. These yarns and fibers have prolonged strength retention in vivo making them suitable for soft tissue repairs where high strength and strength retention is required. The multifilament yarns have tenacities higher than 8.1 grams per denier, and in vivo, retain at least 65% of their initial strength at 2 weeks. The monofilament fibers retain at least 50% of their initial strength at 4 weeks in vivo. The monofilament fibers have tensile strengths higher than 500 MPa. These yarns and fibers may be used to make various medical devices for various applications.

Abstract: Compositions of P4HB with high purity have been developed. The compositions are prepared by washing P4HB biomass prior to solvent extraction, and precipitating P4HB from solution. The same solvent is preferably used to wash the P4HB biomass, and as a non-solvent to precipitate the polymer from a P4HB solvent solution. The highly pure P4HB compositions are suitable for preparing implants. The implants may be used for the repair of soft and hard tissues.

Abstract: Compositions and methods of making and using of microparticle compositions that provide faster flow or improved injectability through smaller or small-diameter needles have been developed. Notably, the microparticle compositions can be successfully delivered or administered through smaller-diameter needles than other microparticle compositions prepared from biocompatible or biodegradable polymers including, for example, poly(lactide), poly(lactide-co-glycolide), polycaprolactone, or poly-3-hydroxybutyrate. The microparticle compositions can exhibit a higher solids loading for a given needle size and/or faster flow through needles than other microparticle compositions. Further, blending or mixing the polymer of the microparticle composition with other polymer formulations can enhance the injectability of the resulting formulation.

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.

Abstract: Biocompatible coatings and spin finishes that can be applied to polyhydroxyalkanoate (PHA) polymers, and medical devices made from PHA polymers, have been developed. The coatings impart good lubricity to PHA polymers, particularly to fibers and braids made from these materials, making the coatings ideal for use on medical devices such as PHA braided sutures. The spin finishes can be applied to PHA fibers to facilitate their manufacture, and also for their conversion to other products, including medical textiles. The spin finishes serve to protect multifilament fiber bundles, and keep them intact following extrusion, and also to impart lubricity to the fiber bundles and monofilament fibers so that they are not damaged in subsequent processing steps particularly in textile processing. The coating reduces tissue drag of, for example, braided sutures.