摘要:
A demineralized bone matrix (DBM) or other matrix composition is provided that has been stabilized by lowering the pH of the composition, reducing the water content, adding water substitutes, and/or increasing the amount of deuterated water present in the composition in order to reduce the activity of endogenous degrading enzymes such as proteases. A hydrated form of a stabilized DBM composition may be stable up to a year at room temperature at acidic pH. The acidified DBM compositions may be further stabilized by the addition of a stabilizing agent such as deuterated water, water substitutes, polymers, protease inhibitors, glycerol or hydrogels.
摘要:
The present invention provides methods of improving the osteogenic and/or chondrogenic activity of a bone matrix, e.g., a dermineralized bone matrix (DBM), by exposing the bone matrix to one or more treatments or conditions. In preferred embodiments the bone matrix is derived from human bone. The treatment or condition may alter the structure of the bone matrix and/or cleave one or more specific proteins. Cleavage may generate peptides or protein fragments that have osteoinductive, osteogenic, or chondrogenic activity. Preferred treatments include collagenase and various other proteases. The invention further provides improved bone and cartilage matrix compositions that have been prepared according to the inventive methods and methods of treatment using the compositions. The invention further provides methods of preparing, testing, and using the improved bone matrix compositions. Ona assay comprises exposing relatively undifferentiated mesenchymal cells to a bone matrix composition and measuring expression of a marker characteristic of osteoblast or chondrocyte lineage(s). Increased expression of the marker relative to the level of the marker in cells that have been exposed to a control matrix (e.g., an inactivated or untreated matrix) indicates that the treatment or condition increased the osteogenic and/or chondrogenic activity of the bone matrix. Suitable cells include C2C12 cells. A suitable marker is alkaline phosphatase. The inventive methods increase the osteogenic and/or chondrogenic activity of human DBM when tested using this assay system.
摘要:
An implant including a substantially cohesive aggregate comprising bone-derived particles. Cohesiveness is maintained by a member of mechanical interlocking, engagement of adjacent bone-derived particles with one another through engagement with a binding agent, thermal bonding, chemical bonding, or a matrix material in which the bone-derived particles are retained. The aggregate is shaped as a one-dimensional or two-dimensional body.
摘要:
An osteoinductive/osteoconductive composition prepared from a quantity of demineralized fibrous bone elements possessing an average surface area to volume ratio of about 100:1 to about 20:1, a quantity of mostly shaped regular non-fibrous bone elements possessing an average surface area to volume ratio of about 10:1 or less and a sufficient quantity of biocompatible fluid carrier sufficient to provide the composition as a deformable mass is provided herein. Also provided is a method of using the composition to repair a bone defect site.
摘要:
An osteogenic osteoimplant in the form of a flexible sheet comprising a coherent mass of bone-derived particles, the osteoimplant having a void volume not greater than about 32 % and a method of making an osteogenic osteoimplant having not greater than about 32 % void volume, the method comprising: providing a coherent mass of bone-derived particles; and, mechanically shaping the coherent mass of bone-derived particles to form an osteogenic osteoimplant in the form of a flexible sheet.
摘要:
A pressure flow system and method for its use are provided for contacting the interior of a fluid permeable, e.g., porous, workpiece. The system includes a fluid pressure chamber having an inlet port and an opening formed in one of the chamber walls. An adjustable seal capable of providing a fluid-tight seal about the exterior of a workpiece having a non-uniform surface is positioned within the opening. Fluid under pressure is supplied to the pressure chamber to force fluid to flow through the internal matrix of the workpiece. In a preferred embodiment, the workpiece is a bone or a section thereof, and the fluid is forced to flow from the endosteal portion of bone to the periosteal portion of bone through the vasculature and porous structure of the bone to remove blood, bone marrow and/or other non-bone constituent(s) from the bone. Alternatively, the fluid can be chosen to decontaminate and/or demineralize the bone, to stain the bone to improve visualization of the bone microvasculature or to impregnate with pharmacological agents (antibiotics, bone growth factors, etc.) so that bone can act as a delivery system.
摘要:
A method for dehydrating a monolithic bone intended for implantation is provided. The method serves to conserve at least one of the biomechanical properties of the bone during the dehydration of the bone and its subsequent packaging. Also provided is a monolithic bone for implantation and a method of using the bone for the repair of damaged bone.
摘要:
A C-shaped or ring shaped implant formed of cortical bone has its C-shaped or inner channel filled with a bone promoting material which is preferably demineralized bone fibers formed as a flexible wet sheet or may be cancellous bone, pressed bone fibers formed from demineralized cortical bone chips soaked in acid, or a flex material formed of demineralized bone growth promoting bone fibers. The discrete bone filler element may be secured by a bonding agent, pins or screws, metal, polymer or bone material. The bone filler material is preferably bonded by filling a section of a long bone medullary cavity with wet bone fibers and then drying the fibers to bond them to the outer bone.
摘要:
An intervertebral spacer (400) formed of dense cancellous human or animal bone is provided. In one preferred embodiment, the intervertebral spacer (400) includes at least one bore (414) which is dimensioned to receive a plug (412) formed from cortical bone tissue. The cortical bone plug (412) provides increased mechanical strength to the intervertebral spacer (400). Instrumentation for gauging the size of an intervertebral receiving bed and for grasping and inserting an intervertebral spacer or implant into an intervertebral receiving bed are also provided. These instruments include a spacer trial or set of spacer trials for determining the appropriate size spacer required for a particular surgical procedure, a spacer introducer for grasping and positioning a spacer at least partially within a receiving bed formed in the intervertebral space, and a bone tamp for driving a spacer into the receiving bed. Any one or all these instruments may be provided in a kit for inserting an implant into the intervertebral space. The kit may also include one or more intervertebral spacers or implants.