Abstract: The present disclosure is directed to an organogel drug depot for use in a non-sterile environment and application to a non-sterile open wound site. The present disclosure is also directed to an organogel drug depot for use in delivering an active agent to a surgical site, such as an implant site, for instance an orthopedic implant site. In a further embodiment, there is disclosed a system for preparing an organogel drug depot including an organogel matrix comprising an organogelator and a biocompatible organic solvent, an active agent comprising solid particles, a container including at least one wall having an outer surface and defining a volume capable of containing the organogel matrix and active agent solid particles, and a heating component configured to contact the outer surface and supply an amount of heat to the container.

Abstract: Provided herein are compositions for treating biofilm-derived infections include a cis-monounsaturated fatty acid solubilized in a solvent with a concentration in the range of about 100 ppm (parts per million) to about 1000 ppm, where the composition is configured to produce a bactericidal effect measured as a log reduction of colony forming units (CFU) of a bacteria of at least 1.0 when the composition is applied to a biofilm formed from the bacteria. Also provided are methods for treating the site of a biofilm-derived infection comprising applying a composition as disclosed herein to the site.

Abstract: A device, having a housing; a power source configured to supply electrical power to a conductive percutaneous implant in a circuit including the conductive percutaneous implant and tissue of a patient adjacent to the conductive percutaneous implant; an electrical sensor configured to generate a signal indicative of at least one electrical parameter of the circuit; and at least one data processing system having one or more processors configured to receive the signal and analyze the signal to determine at least one of a presence or change of infection of the tissue, and pass a control signal to the power source to vary the electrical power responsive to determining at least one of the presence or change of infection of the tissue.

Abstract: A device, having a housing; a power source configured to supply electrical power to a conductive percutaneous implant in a circuit including the conductive percutaneous implant and tissue of a patient adjacent to the conductive percutaneous implant; an electrical sensor configured to generate a signal indicative of at least one electrical parameter of the circuit; and at least one data processing system having one or more processors configured to receive the signal and analyze the signal to determine at least one of a presence or change of infection of the tissue, and pass a control signal to the power source to vary the electrical power responsive to determining at least one of the presence or change of infection of the tissue.

Abstract: The present application discloses embodiments related to an implant and a method of forming an implant configured to treat a fractured bone. The implant can include a body having a proximal end, a distal end, and an outer surface extending from the proximal end to the distal end, wherein the body defines a central axis extending from the proximal end to the distal end; and a high tensile strand positioned adjacent the body such that at least a portion of the strand extends at least partially along the outer surface of the body in a direction substantially parallel with the central axis, and wherein the strand is loaded with an active agent.

Abstract: Provided are orthopedic implants and systems and kits containing orthopedic implants that include biodegradable polymer thin films containing an antimicrobial agent, wherein the implants produce an effective zone of inhibition around a periphery of the surface of the implant and do not produce a loss of release torque between interlocking implant components.

Abstract: The present disclosure is directed to temporary antimicrobial-eluting cement spacer implants, and assemblies, kits, and methods for forming the same. Particularly preferred disclosures are to modular spacers, assemblies, and kits, as well as methods of manufacturing the same, where the modular nature of the spacer permits the selection of specific desired length spacers, as well as specific selection of antimicrobial compounds and dosages, along with the components and processes for forming the same.

Abstract: Provided herein are compositions for treating biofilm-derived infections include a cis-monounsaturated fatty acid solubilized in a solvent with a concentration in the range of about 100 ppm (parts per million) to about 1000 ppm, where the composition is configured to produce a bactericidal effect measured as a log reduction of colony forming units (CFU) of a bacteria of at least 1.0 when the composition is applied to a biofilm formed from the bacteria. Also provided are methods for treating the site of a biofilm-derived infection comprising applying a composition as disclosed herein to the site.

Abstract: The present invention is directed to a method of reducing the risk of infection following surgery utilizing the drug eluting surgical screw disclosed herein to secure an implant in an animal following surgery. The drug eluting screw includes a drug eluting component that can elute a therapeutic agent locally at the surface of the implant reducing the risk of infection.

Abstract: The present disclosure is directed to systems, method of manufacture, and packaging configurations for an antimicrobial orthopedic implant having an antimicrobial coating on the outer surface of the implant including a vaporizable antimicrobial agent in a surface area concentration on the outer surface sufficient to prevent bacterial growth on the orthopedic implant, and can additionally provide a clinically effective zone of inhibition around the orthopedic implant. In certain embodiments, a container, a reservoir of the vaporizable antimicrobial agent, and the orthopedic implant are configured to remain thermally stable in a temperature range up to 200C.

Abstract: A device, having a housing; a power source configured to supply electrical power to a conductive percutaneous implant in a circuit including the conductive percutaneous implant and tissue of a patient adjacent to the conductive percutaneous implant; an electrical sensor configured to generate a signal indicative of at least one electrical parameter of the circuit; and at least one data processing system having one or more processors configured to receive the signal and analyze the signal to determine at least one of a presence or change of infection of the tissue, and pass a control signal to the power source to vary the electrical power responsive to determining at least one of the presence or change of infection of the tissue.

Abstract: A drug-impregnated sleeve for encasing a medical implant is provided. In one embodiment, the sleeve may include a body made of a biologically-compatible material that defines an internal cavity configured to receive the medical implant. In one embodiment, the biologically-compatible material is bioresorbable. The body may include a plurality of apertures, such as perforations or holes, extending from the cavity through the body. The sleeve may further include a first end, a second end, and a drug impregnated into the resorbable sheet. In one possible embodiment, the first end of the sleeve may be open for receiving the medical implant therethrough and the second end may be closed. The implant may be encased in the sleeve and implanted into a patient from which the drug is dispensed in vivo over time to tissue surrounding the implantation site. In one embodiment, the body is made from at least one sheet of a biologically-compatible material.

Abstract: A drug-impregnated sleeve for encasing a medical implant is provided. In one embodiment, the sleeve may include a body made of a biologically-compatible material that defines an internal cavity configured to receive the medical implant. In one embodiment, the biologically-compatible material is bioresorbable. The body may include a plurality of apertures, such as perforations or holes, extending from the cavity through the body. The sleeve may further include a first end, a second end, and a drug impregnated into the resorbable sheet. In one possible embodiment, the first end of the sleeve may be open for receiving the medical implant therethrough and the second end may be closed. The implant may be encased in the sleeve and implanted into a patient from which the drug is dispensed in vivo over time to tissue surrounding the implantation site. In one embodiment, the body is made from at least one sheet of a biologically-compatible material.

Abstract: The present disclosure is directed to an organogel drug depot for use in delivering an active agent to a surgical site, such as an implant site, for instance an orthopedic implant site. The present disclosure is also directed to an organogel drug depot for use in a non-sterile environment and application to a non-sterile open wound site. In a further embodiment, there is disclosed a system for preparing an organogel drug depot including an organogel matrix comprising an organogelator and a biocompatible organic solvent, an active agent comprising solid particles, a container including at least one wall having an outer surface and defining a volume capable of containing the organogel matrix and active agent solid particles, and a heating component configured to contact the outer surface and supply an amount of heat to the container.

Abstract: A flexible body comprises a polymer film having a first surface and an opposing second surface. The polymer film has a plurality of apertures extending from the first surface to the second surface and a plurality of raised lips protruding from the first surface such that each of the plurality of apertures is surrounded by one of the plurality of raised lips. A method of producing a polymer film comprises placing a polymer solution into a one sided mold having a plurality of protrusions extending from a bottom of the mold wherein the polymer solution is characterized by a viscosity that inhibits the unaided flow of the polymer throughout the mold; urging the polymer solution around each of the plurality of protrusions; and solidifying the polymer solution.

Abstract: Provided are porous, biocompatible implant bodies and materials. These materials suitably comprise a population of randomly arranged and entangled thermoplastic constituents, with at least some of the constituents being bonded to one another. The implant bodies are capable of being manipulated at room temperature from a first shape to a second shape, and of maintaining the second shape at about internal body temperature. Also provided are related methods of fabricating such implants and installing the implants into a subject.

Abstract: A flexible body comprises a polymer film having a first surface and an opposing second surface. The polymer film has a plurality of apertures extending from the first surface to the second surface and a plurality of raised lips protruding from the first surface such that each of the plurality of apertures is surrounded by one of the plurality of raised lips. A method of producing a polymer film comprises placing a polymer solution into a one sided mold having a plurality of protrusions extending from a bottom of the mold wherein the polymer solution is characterized by a viscosity that inhibits the unaided flow of the polymer throughout the mold; urging the polymer solution around each of the plurality of protrusions; and solidifying the polymer solution.

Abstract: Embodiments of the present disclosure are directed to perforated polymer films and methods of making the same. In some embodiments, the films are for use with implantable medical devices. In one embodiment there is a flexible body including a polymer film having a first surface and an opposing second surface, the film having a plurality of apertures extending from the first surface to the second surface and a plurality of raised lips protruding from the first surface such that each of the plurality of apertures is surrounded by a one of the plurality of raised lips. In one embodiment, the film comprises a single layer, and in another embodiment, the film can comprise a plurality of layers. In certain embodiments, the film can comprise an adhesive layer. In another embodiment, one or more of the layers may be a drug containing layer and/or a rate controlling layer for drug release.

Abstract: The present application discloses embodiments related to an implant and a method of forming an implant configured to treat a fractured bone. The implant can include a body having a proximal end, a distal end, and an outer surface extending from the proximal end to the distal end, wherein the body defines a central axis extending from the proximal end to the distal end; and a high tensile strand positioned adjacent the body such that at least a portion of the strand extends at least partially along the outer surface of the body in a direction substantially parallel with the central axis, and wherein the strand is loaded with an active agent.

Abstract: Embodiments of the present disclosure are directed to perforated polymer films and methods of making the same. In some embodiments, the films are for use with implantable medical devices. In one embodiment there is a flexible body including a polymer film having a first surface and an opposing second surface, the film having a plurality of apertures extending from the first surface to the second surface and a plurality of raised lips protruding from the first surface such that each of the plurality of apertures is surrounded by a one of the plurality of raised lips. In one embodiment, the film comprises a single layer, and in another embodiment, the film can comprise a plurality of layers. In certain embodiments, the film can comprise an adhesive layer. In another embodiment, one or more of the layers may be a drug containing layer and/or a rate controlling layer for drug release.