Apparatus and method for invasive electrical stimulation of bone fractures

Claim 2

An invasive electric stimulation device, comprising, a cathode comprising a thin electrically conductive sheet having an exposed surface and an opposite surface, an insulation layer connected to said conductive sheet and covering said opposite surface to protect against the dissipation of charge therefrom, a plurality of elongated spaced-apart channel monitors electrically connected to and extended across said cathode conductive sheet toring the resistance between said cathode and an anode, said anode comprising a thin electrically conductive sheet having an exposed surface and an opposite surface, an insulation layer connected to said conductive sheet of the anode and covering said opposite surface thereof, an implantable power pac including a source of electric power having positive and negative terminals, and an insulating encasement surrounding said source of electric power, an insulated cathode lead electrically connected to and extended between said negative terminal of said source of electric power and said conductive sheet of the cathode, and an insulated anode lead electrically connected to and extended between said positive terminal of said source of electric power and said conductive sheet of the anode.

Claim 3

The device of claim 1 wherein said insulation layer of the cathode has a reinforcing grid included therein.

Claim 4

The device of claim 2 wherein said insulation layer is formed of silicon and said reinforcing grid comprises a nylon grid molded into the silicon insulation.

Claim 5

The device of claim 1 wherein said insulation layer includes a border extending beyond the edges of the cathode conductive sheet.

Claim 6

The device of claim 4 wherein said border includes a plurality of suture rip-out ports.

Claim 7

The device of claim 1 wherein said power pac further comprises an FM telemetry component, including a radio transmitter and electronic switching chip, electrically connected to the channel monitors of said cathode and to said source of electric power, said FM telemetry component being operative to transmit a signal indicative of the monitored resistance on a selected channel of said channel monitors.

Claim 8

The device of claim 6 wherein said power pac further comprises a frequency modulated current regulator, including an FM receiver and antenna, electrically interposed between said source of electric power and cathode and operative to adjust current flow from said source of electric power in response to receipt of FM control signals from a remote transmitter.

Claim 9

An invasive electric stimulation device, comprising, a cathode comprising a thin electrically conductive sheet having an exposed surface and an opposite surface, an insulation layer connected to said conductive sheet and covering said opposite surface to protect against the dissipation of charge therefrom, an anode comprising a thin electrically conductive sheet having an exposed surface and an opposite surface, an insulation layer connected to said conductive sheet of the anode and covering said opposite surface thereof, an implantable power pac including a source of electric power having positive and negative terminals, and an insulating encasement surrounding said source of electric power, an insulated cathode lead electrically connected to and extended between said negative terminal of said source of electric power and said conductive sheet of the cathode, an insulated anode lead electrically connected to and extended between said positive terminal of said source of electric power and said conductive sheet of the anode, a current regualtor electrically associated with said source of electric power, monitoring means electrically associated with said cathode, anode, power source and current regulator, for measuring electrical resistance between said cathode and anode as a measure of the thickness of the various layers of periosteum buildup, bone, soft tissue and cartilage in proximity of a fracture in response to electrical stimulation, and a computer assisted device associated with said power pac and monitoring means and operative to automatically cause said current regulator to adjust current flow from said source of electric power in response to predetermined measurements of electrical resistance by said monitoring means.

Claim 10

An invasive electric stimulation device, comprising, a cathode comprising a thin electrically conductive sheet having an exposed surface and an opposite surface, an insulation layer connected to said conductive sheet and covering said opposite surface to protect against the dissipation of charge therefrom, an anode comprising a thin electrically conductive sheet having an exposed surface and an opposite surface, an insulation layer connected to said conductive sheet of the anode and covering said opposite surface thereof, an implantable power pac including a source of electric power having positive and negative terminals, and an insulating encasement surrounding said source of electric power, an insulated cathode lead electrically connected to and extended between said negative terminal of said source of electric power and said conductive sheet of the cathode, an insulated anode lead electrically connected to and extended between said positive terminal of said source of electric power and said conductive sheet of the anode, a current regualtor electrically associated with said source of electric power, monitoring means electrically associated with said cathode, anode, power source and current regulator, for measuring electrical resistance between said cathode and anode as a measure of the thickness of the various layers of periosteum buildup, bone, soft tissue and cartilage in proximity of a fracture in response to electrical stimulation, and a computer assisted device associated with said power pac and monitoring means and operative to automatically cause said current regulator to adjust current flow from said source of electric power in response to predetermined measurements of electrical resistance by said monitoring means.

Claim 13

The method of claim 9 wherein said remotely monitoring step includes monitoring the thickness of said various layers at a plurality of spaced-apart positions on said cathode.

Claim 14

The method of claim 9 further comprising the steps of providing a computer assisted device electrically associated with said power pac and monitoring means, and said computer assisted device automatically increasing or decreasing the current flow across said cathode and anode in response to pre-programmed commands responsive to predetermined measurements monitored by said monitoring means.