Abstract: Compositions of P4HB (poly-4-hydroxybutyrate) and copolymers thereof, have been developed for pultrusion, as well as processes to produce profiles from these compositions by pultrusion. These pultrusion processes provide profiles without causing structural damage to the surface of the profile. The profiles may be used in medical applications. These compositions include P4HB, and copolymers thereof, having intrinsic viscosities less than 3.2 dl/g but greater than 0.8 dl/g. The profile may be formed using conditions such as: pull rate of 0.1 to 100 mm/min, die temperature of up to 95° C., rod stock temperature up to 95° C., draw ratio of up to 100×, pulling force of greater than 10 MPa, and clamping pressure at least 10% higher than the pulling force. Preferably, the profile is formed by pulling the rod stock through a series of dies placed at intervals with the hole sizes decreasing in diameter by 0.1 to 10 mm.

Abstract: Oriented resorbable implants made from poly-4-hydroxybutyrate (P4HB) and copolymers thereof, have been developed that contain one or more antimicrobial agents to prevent colonization of the implants, and reduce or prevent the occurrence of infection following implantation in a patient. These oriented implants are particularly suitable for use in procedures where prolonged strength retention is necessary and there is a risk of infection. Coverings and receptacles made from poly-4-hydroxybutyrate and copolymers thereof, containing antimicrobial agents, have also been developed for use with implantable devices to prevent colonization of these devices, and to reduce or prevent the occurrence of infection following implantation of these devices in a patient. These coverings and receptacles may be used to hold, or partially or fully cover, devices such as pacemakers and neurostimulators.

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: A system has a compressor (22, 412). A heat rejection heat exchanger (30) is coupled to the compressor to receive refrigerant compressed by the compressor. The system has a heat absorption heat exchanger (64). The system includes a separator (170) comprising a vessel having an interior. The separator has an inlet, a first outlet, and a second outlet. An inlet conduit may extend from the inlet and may have the conduit outlet positioned to discharge an inlet flow into the vessel interior to cause the inlet flow to hit a wall before passing to a liquid refrigerant accumulation in the vessel.

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: 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: Resorbable three-dimensional implants that can be temporarily deformed, implanted by minimally invasive means, and resume their original shape in vivo, have been developed. These implants are particularly suitable for use in minimally invasive procedures for tissue reinforcement, repair of hernias, and applications where it is desirable for the implant to contour in vivo to an anatomical shape, such as the inguinofemoral region. In the preferred embodiment, the implants are made from meshes of poly-4-hydroxybutyrate monofilament that have reinforced outlying borders that allow the meshes to form three-dimensional shapes that can be temporarily deformed. These implants can resume three-dimensional shapes after being temporarily deformed that contour to the host's tissue or an anatomical shape, for example, in the repair of a hernia, and particularly a hernia in the inguinofemoral region.

Abstract: Compositions of P4HB and processes to injection mold these compositions have been developed. These compositions are prepared from P4HB polymers and blends having intrinsic viscosities less than 3.2 dl/g but greater than 0.8 dl/g, moisture contents of less than 0.5% by weight, and more preferably less than 0.05% by weight, and using a polymer melt temperature during molding of at least 150° C. A preferred embodiment comprises a P4HB molding with an intrinsic viscosity of less than 3.2 dl/g that degrades rapidly in vivo.

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: 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: Methods to produce laminates including layers of constructs made from P4HB and copolymers thereof have been developed. These laminates may be used as medical implants, or further processed to make medical implants. The laminates are produced at a temperature equal to or greater than the softening points of the P4HB or copolymers thereof. The layers may include oriented forms of the constructs. Orientation can be preserved during lamination so that the laminate is also oriented, when the laminates are formed at temperatures less than the de-orientation temperatures of the layers. The laminate layers may include, for example, films, textiles, including woven, knitted, braided and non-woven textiles, foams, thermoforms, and fibers. The laminates preferably include one or more oriented P4HB films.

Abstract: A gatekeeper device delegates an ability to access a resource to an access device by transmitting metadata, which includes access information for accessing the resource. The access device uses the metadata to retrieve the associated resource from a resource server. By transmitting the metadata in lieu of the resource, flexible use of the resources is implemented while enabling compliance with various restriction schemes. The system may condition the delegation or transfer of resource access on one or more factors, such as proximity between the gatekeeper device and the access devices. Using information about an access device, the resource server may optimize the resources for the receiving access device.

Abstract: A generic address resolution system facilitates communications among multiple network applications with heterogeneous addressing mechanisms, thereby allowing the network applications to interoperate with each other and/or with modules for providing enhanced functionalities. The address resolution system includes a resource mapping module that modularizes the components needed for address resolution and abstracts content from the underlying address types and content used by the network applications. The address resolution system includes a context engine that analyzes the addressing data to be resolved, selects one or more appropriate destination network applications based on contextual rules, and creates the application mapping template for the end-end routing of the communications among the network 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 of P4HB (poly-4-hydroxybutyrate) and copolymers thereof, have been developed for pultrusion, as well as processes to produce profiles from these compositions by pultrusion. These pultrusion processes provide profiles without causing structural damage to the surface of the profile. The profiles may be used in medical applications. These compositions include P4HB, and copolymers thereof, having intrinsic viscosities less than 3.2 dl/g but greater than 0.8 dl/g. The profile may be formed using conditions such as: pull rate of 0.1 to 100 mm/min, die temperature of up to 95° C., rod stock temperature up to 95° C., draw ratio of up to 100×, pulling force of greater than 10 MPa, and clamping pressure at least 10% higher than the pulling force. Preferably, the profile is formed by pulling the rod stock through a series of dies placed at intervals with the hole sizes decreasing in diameter by 0.1 to 10 mm.

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: Absorbable stents and absorbable stent coatings have been developed with improved properties. These devices preferably comprise biocompatible copolymers or homopolymers of 4-hydroxybutyrate, and optionally polylactic acid and other absorbable polymers and additives. Compositions of these materials can be used to make absorbable stents that provide advantageous radial strengths, resistance to recoil and creep, can be plastically expanded on a balloon catheter, and can be deployed rapidly in vivo. Stent coatings derived from these materials provide biocompatible, uniform coatings that are ductile, and can be expanded without the coating cracking and/or delaminating and can be used as a coating matrix for drug incorporation.

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: 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: Methods to produce substantially closed cell foams with densities less than 0.75 g/cm3, and more preferably less than 0.5 g/cm3, without substantial loss of the polymer's weight average molecular weight, have been developed. The closed cells foams have an open cell content of generally less than 50%, and more preferably an open cell content of less than 20%, and the cells have a maximum diameter of less than 5 mm. The foam may include poly-4-hydroxybutyrate or a copolymer thereof. Preferably, the foam is derived by heating a foam polymer formula to a temperature above the melt temperature of the polymer to form a melt polymer system, adding a blowing agent to produce a foamable melt, extruding the foamable melt through a die to a lower pressure to cause foaming, cooling of the foam, and solidification of the foam. These foam structures can be used for fabrication of medical products.