Abstract: Implantable medical devices and methods are provided that have one or more statins disposed therein. The medical devices may be implanted at near or in a bone defect to enhance bone growth. In some embodiments, the medical device provided allows for sustain release of the statin and facilitates bone formation and repair of the fracture site.

Abstract: The present invention is directed to an implantable drug depot useful for reducing, preventing or treating post-operative pain in a patient in need of such treatment, the implantable drug depot comprising a therapeutically effective amount of clonidine or pharmaceutically acceptable salt thereof and a polymer; wherein the depot is implantable at a site beneath the skin to reduce, prevent or treat post-operative pain, and the depot is capable of releasing (i) about 5% to about 45% of the clonidine or pharmaceutically acceptable salt thereof relative to a total amount of the clonidine or pharmaceutically acceptable salt thereof loaded in the drug depot over a first period of up to 48 hours and (ii) about 55% to about 95% of the clonidine or pharmaceutically acceptable salt thereof relative to a total amount of the clonidine or pharmaceutically acceptable salt thereof loaded in the drug depot over a subsequent period of at least 3 days.

Abstract: Effective treatments of pain for extended periods of time are provided. Through the administration of an effective amount of clonidine and a gamma-aminobutyric acid compound at or near a target site, one can relieve pain caused by diverse sources, including but not limited to spinal disc herniation (i.e. sciatica), spondilothesis, stenosis, discogenic back pain and joint pain, as well as pain that is incidental to surgery. When appropriate formulations are provided within biodegradable polymers, this relief can be continued for at least three days. In some embodiments, the relief can be for at least twenty-five days, at least fifty days, at least one hundred days, at least one hundred and thirty-five days or at least one hundred and eighty days.

Abstract: A spinal implant is provided. The spinal implant comprises a body configured for implantation between two adjacent vertebrae, and comprises a retaining member movable between a first position where the retaining member is in an unexpanded configuration and a second position where the retaining member is in an expanded configuration. The retaining member comprises a tissue contacting surface configured to engage a lamina of at least one of the adjacent vertebrae.

Abstract: Osteoinductive and osteoconductive compositions for bone graft which utilize less allograft tissue, and methods for their production, are provided. The compositions and methods contain a combination of fibers of demineralized bone matrix from allograft bone and fibers of non-allograft bone material. The fibers of non-allograft bone material comprise non-fibrous demineralized bone matrix particles embedded within or disposed on the fibers of non-allograft bone material. The non-allograft fibers of the composition contain a bone void filler of collagen and one or more ceramics embedded with demineralized bone matrix particles. In some embodiments, the composition also contains a bioactive agent.

Abstract: Effective treatments of pain and/or inflammation for extended periods of time are provided. Through the administration of an effective amount of sulindac or a pharmaceutically acceptable salt thereof at or near a target site, one can relieve pain and/or inflammation caused by diverse sources, including but not limited to spinal disc herniation (i.e. sciatica), spondilothesis, stenosis, discongenic back pain and joint pain, as well as pain that is incidental to surgery. When appropriate formulations are provided within biodegradable polymers, this relief can be continued for at least three days, at least twenty-five days. In some embodiments, the relief can be for at least fifty days, at least one hundred days, at least one hundred and thirty-five days or at least one hundred and eighty days.

Abstract: An expandable implant device for implantation at a surgical site is provided. The implant device is made of cortical bone and includes a top and bottom piece, both pieces configured to couple with each other. The top piece has superior and inferior surfaces, and at least a tapered leading end configured to distract open an intervertebral disc space so that the top piece can be slidably inserted over the bottom piece until a desired overlap is achieved. A composite interbody bone implant device is also provided including a body skeleton having a non-bone composition, such as a polymer, formed into a shape and including one or more cavities which can be filled with other material, for example, allograft material. A method of placing an expandable device into a disc space is also provided.

Abstract: Bone implant compositions are provided that include a body made of cortical bone extending along an axis between a first end and a second end. The body includes an outer surface configured to engage host bone of a patient and at least one recess extending transverse to the axis into the outer surface of the body configured for disposal of an insert. At least one insert made of demineralized bone is disposed in the at least one recess.

Abstract: Effective treatments of pain and/or inflammation are provided. Through the administration of an effective amount of at least analgesic and/or at least one anti-inflammatory agent at or near a target site, one can reduce, prevent or treat inflammation and pain.

Abstract: Flowable compositions and methods are provided for delivering a therapeutic agent at or near a target tissue site beneath the skin of a patient, the flowable composition comprising (i) a solvent and (ii) an effective amount of the therapeutic agent, the flowable composition being capable of hardening to form a drug depot at a physiological temperature or as solvent contacts bodily fluid at or near the target tissue site, wherein the drug depot is capable of releasing the therapeutic agent over a period of at least one day and the target tissue site comprises at least one muscle, ligament, tendon, cartilage, spinal disc, spinal foraminal space near the spinal nerve root, facet or synovial joint, or spinal canal.

Abstract: Compositions and methods for augmenting bone formation by administering isolated human mesenchymal stem cells (hMSCs) within a matrix provided. By adding calcium and/or phosphate ions to the matrix, one may foster greater bone regeneration.

Abstract: Effective treatments of pain and inflammation are provided. Through the administration of an effective amount of fluocinolone at or near a target site, one can reduce, prevent or treat inflammation and pain and autoimmune disorders. In various embodiments, fluocinolone formulations may be provided within biodegradable polymers to reduce, prevent or treat sciatic pain and/or inflammation. In various embodiments, prevent transplant rejection for at least twenty-five days. In some embodiments, the pain relief can be for at least fifty days, at least one hundred days, at least one hundred and thirty-five days or at least one hundred and eighty days.

Abstract: A delivery system comprising a biodegradable single or multi compartment covering is provided. The covering can be a mesh bag including a pre-attached detachable holding member surrounding the opening of at least one compartment and a pre-attached removable filling member configured to fit within the opening of the at least one compartment. The opening of the bag can include a closing member. The pre-attached detachable holding member can be a collar including finger grips and is used to hold the bag in one position while filling it. In some embodiments, the pre-attached detachable filling member can be a funnel for loading the mesh bag with bone graft material. Once the covering is filled, the holding member and filling member can be removed and the covering is closed with a closing member such as a drawstring. A method of treatment utilizing the delivery system is also provided.

Abstract: Ablation devices comprising a probe or needle useful for destroying nerve and soft tissue via a minimally invasive procedure to alleviate pain are provided. The probe comprises at least two prongs spaced apart and parallel to each other. The at least two prongs each having an interior surface and an exterior surface and an internal passage disposed in the interior surface of the at least two prongs. A filament is disposed in the internal passage of the at least two prongs that has an opening configured to release a pressurized material into the interior surface of the at least two prongs so as to cool the exterior surface of the at least two prongs to a temperature configured for ablating nerve and/or soft tissue. Methods for ablating nerve and/or soft tissue utilizing the ablation devices are also provided.

Abstract: Improved medical devices and methods are provided that are implantable at or near a target tissue site beneath the skin of a patient, the medical device comprises an adhesive sheet having a region configured to receive a drug depot, the drug depot disposed within the region of the adhesive sheet and the drug depot having at least one surface configured to release a therapeutically effective amount of the drug over a period of at least one day, wherein the adhesive sheet limits movement of the medical device at or near the target tissue site. In some embodiments, the medical device provided can include an effective amount of at least one analgesic and/or at least one anti-inflammatory agent at or near a target site, and can reduce, prevent or treat inflammation and/or pain, particularly postoperative pain or orthopedic degenerative pathology pain.

Abstract: A bone graft implant device for treating a tissue site is provided, the device including an implant body including a demineralized allograft bone material portion, and at least one engagement member protruding from the implant body including a mineralized allograft bone material portion. The engagement member may be integrally formed with the implant body, or alternatively, the implant body may include an aperture and the engagement member may be insertable therein. At least one of the amount of demineralization or area of the demineralized allograft bone material portion is adjustable to impart a desired flexibility to the implant body.

Abstract: Described is an implantable medical material comprising a malleable, cohesive, shape-retaining putty including mineral particles, insoluble collagen fibers and soluble collagen. The medical material can be used in conjunction with biologically active factors such as osteogenic proteins to treat bone or other tissue defects in patients.

Abstract: The present invention is directed to an implantable drug depot useful for reducing, preventing or treating post-operative pain in a patient in need of such treatment, the implantable drug depot comprising a therapeutically effective amount of clonidine or pharmaceutically acceptable salt thereof and a polymer; wherein the depot is implantable at a site beneath the skin to reduce, prevent or treat post-operative pain, and the depot is capable of releasing (i) about 5% to about 45% of the clonidine or pharmaceutically acceptable salt thereof relative to a total amount of the clonidine or pharmaceutically acceptable salt thereof loaded in the drug depot over a first period of up to 48 hours and (ii) about 55% to about 95% of the clonidine or pharmaceutically acceptable salt thereof relative to a total amount of the clonidine or pharmaceutically acceptable salt thereof loaded in the drug depot over a subsequent period of at least 3 days.

Abstract: Improved medical devices and methods are provided that are implantable at or near a target tissue site beneath the skin of a patient, the medical device comprising an adhesive sheet having a region configured to receive a solid or semi-solid drug depot, the drug depot disposed within the region of the adhesive sheet, the drug depot having at least one surface configured to release a therapeutically effective amount of the drug over a period of at least one day, wherein the adhesive sheet limits movement of the medical device at or near the target tissue site. In some embodiments, the medical device provided can include an effective amount of at least one analgesic and/or at least one anti-inflammatory agent at or near a target site, and can reduce, prevent or treat inflammation and/or pain, such as postoperative pain or orthopedic degenerative pathology pain.

Abstract: A biodegradable drug implant for reducing, preventing or treating pain and/or inflammation in a patient is provided. The biodegradable drug implant comprises dexamethasone and a polylactic acid polyglycolic acid (PLGA) copolymer matrix, wherein the dexamethasone comprises from about 50% to about 80% by weight of the drug implant. Methods of treating pain in a patient are also provided.