An implant for deployment in select locations or select tissue for regeneration of tissue is disclosed. The implant comprising collagen and or other bio-resorbable materials, where the implant may also be used for therapy delivery. Additionally, the implant may be “matched” to provide the implant with similar physical and/or chemical properties as the host tissue.

Devices and methods for treating defects in the tissue of a living being

An allogenic intervertebral implant for fusing vertebrae is disclosed. The implant is a piece of allogenic bone conforming in size and shape with a portion of an end plate of a vertebra. The implant has a wedge-shaped profile to restore disc height and the natural curvature of the spine. The top and bottom surfaces of the implant have a plurality of teeth to resist expulsion and provide initial stability. The implant according to the present invention provides initial stability need for fusion without stress shielding.

Intervertebral allograft spacer

Gamma irradiation from Cobalt 60 sources has been used to terminally sterilize bone allografts for many years. Gamma radiation adversely affects the mechanical and biological properties of bone allografts by degrading the collagen in bone matrix. Specifically, gamma rays split polypeptide chains. In wet specimens irradiation causes release of free radicals via radiolysis of water molecules that induces cross-linking reactions in collagen molecules. These effects are dose dependent and give rise to a dose-dependent decrease in mechanical properties of allograft bone when gamma dose is increased above 25 kGy for cortical bone or 60 kGy for cancellous bone. But at doses between 0 and 25 kGy (standard dose), a clear relationship between gamma dose and mechanical properties has yet to be established. In addition, the effects of gamma radiation on graft remodelling have not been intensively investigated. There is evidence that the activity of osteoclasts is reduced when they are cultured onto irradiated bone slices, that peroxidation of marrow fat increases apoptosis of osteoblasts; and that bacterial products remain after irradiation and induce inflammatory bone resorption following macrophage activation. These effects need considerably more investigation to establish their relevance to clinical outcomes. International consensus on an optimum dose of radiation has not been achieved due to a wide range of confounding variables and individual decisions by tissue banks. This has resulted in the application of doses ranging from 15 to 35 kGy. Here, we provide a critical review on the effects of gamma irradiation on the mechanical and biological properties of allograft bone.

Sterilization of allograft bone: effects of gamma irradiation on allograft biology and biomechanics

Almost 20 years after the invention of tissue engineering, autogenous bone grafting has remained the favored strategy for the treatment of bone defects. As an alternative, a vast variety of bone substitutes has been developed and is available for clinical use. The ongoing search for bone substitutes, however, reflects the limitations imposed to both autogenous and allogenous bone grafts as well as to bone substitute materials. The concept of tissue engineering holds great promise for the future treatment of osseous defects. Research in this interdisciplinary field is carried out to find a way of producing biologic substitutes as functional tissue replacement. For this, functionally active cells are applied on supporting scaffolds under controlled stimulation with growth factors. Scaffolds are temporary matrices for bone growth and provide a specific environment and architecture for tissue development. Ideally, scaffolds favor cellular attachment, growth and differentiation in vitro and in vivo. Especially ceramics and biodegradable polymers are widely used and have been tested in various animal studies. Yet, to allow for precise production of specific custom-made scaffolds, rapid prototyping (RP) techniques have recently drawn a lot of attention. Using these methods scaffolds with a predefined, well-controlled internal and external architecture mimicking the structure of natural bone can be generated. Although biocompatibility of the materials used in the process and the structural resolution that can be technically achieved so far limit the range of use, rapid manufacturing techniques do offer great opportunities to generate suitable scaffolds for bone tissue engineering in the near future.

Biomaterials as Scaffold for Bone Tissue Engineering

Background: Porous bovine bone mineral (PBBM) has been used in ridge preservation procedures following tooth extractions. The aim of this study was to investigate histochemically tissue sockets grafted with PBBM at 9 months post-extraction. By using different histochemical stainings, characteristics of the newly formed bone; i.e., lamellar/woven ratio at different socket depths, were investigated and the arrangement of bone around the grafted material, as well as the nature of the amorphous organic material found in all specimens, were examined. Methods: After extraction of 15 single-rooted maxillary teeth from 15 patients, socket sites were grafted with PBBM particles (250 to 1000 µ). Primary soft tissue closure of the grafted site was established using the rotated split palatal pedicle flap technique. At 9 months, a cylindrical tissue specimen, 2.5 mm in diameter, was trephined from each previously grafted site followed by placement of a screw-shaped implant. Horizontal tissue section cuts, 5 µ wide, we...

Porous bovine bone mineral in healing of human extraction sockets: 2. Histochemical observations at 9 months.

Sterilization of Partially Demineralized Bone Matrix: The Effects of Different Sterilization Techniques on Osteogenetic Properties

To minimize potential infection following the transplantation of allogeneic bone, extremely rigorous selection of donors and careful processing and storage of samples are required. Other major problems related to allogeneic transplants, such as reduced osteogenic properties and immunological reactions, led to the development of demineralized bone matrix (DBM). This osteoinductive bone extract is largely free of antigens and is easy to produce. However, to eliminate the potential risk of infection, DBM should be sterilized prior to implantation. The purpose of this study was to investigate the influence of different sterilization techniques on the osteoinductive properties of DBM. A series of 76 cortical defects (drill holes) 0.6 cm in diameter in the tibiae of 11 Merino sheep were filled with DBM in addition to autogeneic and allogeneic cancellous bone. Prior to implantation DBM was sterilized by autoclaving, gamma irradiation, or application of ethylene oxide or ethyl alcohol. A further 12 drill holes were left empty as controls. The formation of new bone was examined 3 and 6 weeks postoperatively, using histological, fluorescent-optical and microradiographical techniques. The amount of newly formed bone was also quantified. Apart from autoclaved DBM all matrix grafts showed excellent new bone formation following sterilization, by far exceeding the formation with allogeneic cancellous bone.

The effect of various sterilization procedures on the osteoinductive properties of demineralized bone matrix

The problems arising from the transplantation of autogenic and allogenic bone have significantly limited the use of these methods. Hence, there is an ever increasing demand for suitable transplant materials that could be readily available to orthopaedic surgeons throughout the country. Although the advantages of demineralized bone matrix over allogenic cancellous bone have been shown in numerous experimental studies, its broad clinical application has so far been limited. The purpose of this study was to investigate the osteogenic properties of partially demineralized bone matrix in clinically relevant and realistic conditions. Tibial defects 5 cm in length in 24 merino sheep were bridged by way of medullary nailing and filled with various preparations of bone matrix. Cortical bone displaying poor vascularization and rotation instability of the osteosynthesis ensured extremely difficult testing conditions for the transplant. Postoperatively, the extent of new bone formation was evaluated by means of regular X-ray examinations over a period of 12-20 weeks. In addition, histological, fluorescent-optical and microradiographic examinations of the final specimen were carried out. Good new bone formation regularly followed the transplantation of partially demineralized bone matrix with a particle size of 750 microns. Complete bridging of the defect was achieved when small amounts of bone marrow were added. The use of bone matrix with a smaller or larger particle size did not influence the rate of new bone formation perceptibly.

Bridging long tibial shaft defects by partially demineralized bone matrix

Die experimentelle Charakterisierung einer teildemineralisierten Knochenmatrix erfordert die morphometrische Quantifizierung (Wolf et al. 1991). Die teildemineralisierte Knochenmatrix, welche unterschiedlichen Sterilisationsverfahren entstammte, wurde in standardisiert angelegten Tibia-Bohrlochern am Schaf eingebracht. Das Ziel der Untersuchung war es, den transplantierten und den neugebildeten Knochen in Mikroradiographien mit Hilfe der Video-densitometrie zu analysieren und zu quantifizieren. Zudem sollte ein Vergleich der DKM mit einer Spongiosatransplantation durchgefuhrt werden.

Morphometrische Untersuchung von Mikroradiographien der Spongiosatransplantation im Vergleich zur teildemineralisierten Knochenmatrix

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Sterilization of Partially Demineralized Bone Matrix: The Effects of Different Sterilization Techniques on Osteogenetic Properties

The effect of various sterilization procedures on the osteoinductive properties of demineralized bone matrix

Bridging long tibial shaft defects by partially demineralized bone matrix

Morphometrische Untersuchung von Mikroradiographien der Spongiosatransplantation im Vergleich zur teildemineralisierten Knochenmatrix