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AssigneeThe Trustees of the University of Pennsylvania
InventorCarl T. Brighton
Estimating the term…
Methods and devices are described for the regulation of Transforming Growth actor (TGF)-β1, β2, and/or β3 protein gene expression in bone cells and other tissues via the capacitive coupling or inductive coupling of specific and selective electric fields to the bone cells or other tissues, where the specific and selective electric fields are generated by application of specific and selective electric and electromagnetic signals to electrodes or one or more coils or other field generating device disposed with respect to the bone cells or other tissues so as to facilitate the treatment of diseased or injured bone and other tissues. By gene expression is meant the up-regulation or down-regulation of the process whereby specific portions (genes) of the human genome (DNA) are transcribed into mRNA and subsequently translated into protein. Methods and devices are provided for the targeted treatment of injured or diseased bone and other tissue that include generating specific and selective electric and electromagnetic signals that generate fields in the target tissue optimized for increase of TGF-β1, β2, and/or β3 protein gene expression and exposing bone and other tissue to the fields generated by specific and selective signals so as to regulate TGF-β1, β2, and/or β3 protein gene expression in such tissue. The resulting methods and devices are useful for the targeted treatment of bone fractures, fractures at risk, delayed unions, nonunion of fractures, bone defects, spine fusions, osteonecrosis or avascular necrosis, as an adjunct to other therapies in the treatment of one or all of the above, in the treatment of osteoporosis, and in other conditions in which TGF-β1, β2, and/or β3 protein may be implicated.
A method of up-regulating the gene expression of Transforming Growth Factor (TGF)-β1, β2, and/or β3 protein in targeted tissue, comprising the steps of:
A method for treating a bone fracture, fracture at risk, delayed union, nonunion, bone defect, spine fusion, osteonecrosis, osteoporosis, and/or other conditions in which Transforming Growth Factor (TGF)-β1, β2, and/or β3 protein has been implicated in a patient, comprising the steps of:
A device for the treatment of a bone fracture, fracture at risk, delayed union, nonunion, bone defect, spine fusion, osteonecrosis, osteoporosis, and/or other conditions in which Transforming Growth Factor (TGF)-β1, β2, and/or β3 protein has been implicated in a patient, comprising a signal source that generates at least one specific and selective signal having a frequency from 30 kHz to 120 kHz and a field generating device connected to the signal source so as to receive said at least one specific and selective signal and that is operatively disposed with respect to targeted tissue, said field generating device upon receipt of said at least one specific and selective signal causing the generation of an electric field having an amplitude of about 0.2 to 80 mV/cm in the targeted tissue that is specific and selective for up-regulating the gene expression of TGF-β1, β2, and/or β3 protein in said targeted tissue as measured by mRNA, said signal source controlling and varying the duration of time of application of said at least one specific and selective signal for a duration of time from approximately ½ hour to 24 hours per 24 hour period and controlling and varying the duty cycle of said at least one specific and selective signal applied to said field generating device from approximately 10% to 100% so as to selectively up-regulate gene expression of TGF-β1, β2, and/or β3 protein in said targeted tissue as a result of application of said specific and selective electric field thereto.
A method of determining a specific and selective electric signal that when applied to a field generating device causes the generation of an electric field in targeted tissue that up-regulates Transforming Growth Factor (TGF)-β1, β2, and/or β3 protein in the targeted tissue, comprising the steps of staffing with a staffing electric signal with a signal shape and frequency that when applied to said field generating device generates an electric field that is known or thought to affect cellular production of TGF-β1, β2, and/or β3 protein, selectively varying a duration of application of said staffing signal until a duration that provides a most significant increase in production of TGF-β1, β2, and/or β3 protein is found, selectively varying an amplitude of the staffing signal until an amplitude that provides a most significant increase in production of TGF-β1, β2, and/or β3 protein is found, selectively varying a duty cycle of the staffing signal until a duty cycle that provides a most significant increase in production of TGF-β1, β2, and/or β3 protein is found, and selectively varying an on-off interval of the duty cycle of the signal until an on-off interval that provides a most significant increase in production of TGF-β1, β2, and/or β3 protein is found.
Dependencies are inferred from the claim text.