Systems and methods to place one or more leads in tissue to electrically stimulate nerves of passage to treat pain
Systems and methods are provided for applying electrical stimulation to a body by an electrode spaced from a target nerve of passage. It has been discovered that pain felt, or perceived to be felt, in a given region of the body can be treated by stimulating muscle close to a “nerve of passage” in a region that is superior (i.e., cranial or upstream toward the spinal column) to the region where pain is felt, such as in a case of post-amputation residual limb pain, or purportedly felt in the case of post-amputation phantom limb pain.
1 . A stimulation system comprising:
a lead comprising at least two non-insulated portions, wherein the at least two non-insulated portion are spaced apart from one another with an insulated portion positioned between them and wherein one of the at least two non-insulated portions is configured to be positioned at a therapeutically effective distance from a neural fiber bundle within tissue, wherein the neural fiber bundle comprises more than one type of nerve fiber, and wherein the lead comprises an insulated coiled lead body with an open core and the insulated portion is a coiled body with an open core; and
an electrical stimulation device operatively coupled with the lead, the electrical stimulation device configured to deliver electrical stimulation to the neural fiber bundle.
2 . The stimulation system of claim 1 , wherein the one of the at least two non-insulated portions is an electrode through which the electrical stimulation is delivered.
3 . The stimulation system of claim 2 , wherein the electrical stimulation device is fixed to the lead.
4 . The stimulation system of claim 2 , further comprising a surface electrode operatively coupled with the electrical stimulation device.
5 . The stimulation system of claim 4 , wherein the surface electrode serves as an anode.
6 . The stimulation system of claim 4 , wherein the surface electrode serves as a cathode.
7 . The stimulation system of claim 1 , wherein the coiled lead comprises one or more coiled metal wires and is insulated and coated with a material stabilizing the lead.
8 . The stimulation system of claim 7 , wherein the insulation comprises a biocompatible film.
9 . The stimulation system of claim 7 , wherein the insulation comprises a biocompatible polymer film.
10 . The stimulation system of claim 2 , wherein the electrical stimulation delivered by the electrical stimulation device is configured to be scaled to account for variations in a geometry of the electrode.
11 . The stimulation system of claim 2 , wherein the electrical stimulation device is configured to account for variations in current density resulting from variations in a geometry of the electrode.
12 . The stimulation system of claim 2 , wherein the electrode comprises a spherical, raised, and depressed characteristics and contours that are undulating.
13 . The stimulation system of claim 2 , wherein the electrode comprises hemispherical, raised, and depressed characteristics and contours that are undulating.
14 . The stimulation system of claim 2 , wherein the electrode comprises elevated and recessed characteristics and contours that are continuous and undulating.
15 . The stimulation system of claim 2 , wherein electrode comprises a contact configuration that is intermittent.
16 . The stimulation system of claim 2 , wherein the electrode is spherical.
17 . The stimulation system of claim 2 , wherein the lead is configured to withstand mechanical forces and resist migration during a home trial.
18 . The stimulation system of claim 17 , wherein the home trial lasts for two weeks.