SYSTEMS AND METHODS FOR NEUROMODULATION FOR TREATMENT OF PAIN AND OTHER DISORDERS ASSOCIATED WITH NERVE CONDUCTION
Methods and apparatus are provided for selective destruction or temporary disruption of nerves and/or conduction pathways in a mammalian body for the treatment of pain and other disorders. Apparatus comprises catheters having electrodes for targeting and affecting nerve tissue at a cellular level to reversible and irreversible nerve poration and incapacitation.
1 . Apparatus for selective denervation of target tissue, comprising:
an electrode support having one or more electrodes disposed thereon, wherein said electrode(s) are adapted to transmit an electrical pulse and/or series of electrical pulses; and
a pulse generator operatively connected to the catheter, wherein the electrodes and generator are configured to deliver cellular poration energy in the range from 10 V/cm to 10 6 V/cm to disrupt membranes of target cells to disrupt pain conduction pathways.
2 . The apparatus of claim 1 , wherein the support comprises a catheter which is adapted to be positioned percutaneously in an artery at a location adjacent to a region of the spine in a human patient selected from the group consisting of the cervical, thoracic, sacral and lumbar regions.
3 . The apparatus of claim 1 , wherein the support comprises a catheter which is adapted to be positioned percutaneously at a region of the peripheral nerves in a human patient.
4 . The apparatus of claim 1 , wherein the support comprises a catheter which is adapted to be implantable within the body and a pulse generator adapted to be located outside the human body.
5 . The apparatus of claim 1 , wherein the support and pulse generator are implantable within the human body.
6 . The apparatus of claim 1 , wherein the support comprises a patch and the one or more electrodes are configured on the patch to be applied to the skin.
7 . The apparatus of claim 6 , wherein the one or more electrodes comprise one or more micro needles.
8 . The apparatus of claim 1 , wherein the pulse generator and electrodes are adapted to deliver poration energy at from 10 V/cm to 10 4 V/cm for durations from 10 μsec to 100 msec to achieve reversible poration.
9 . The apparatus of claim 1 , wherein the pulse generator and electrodes are adapted to deliver poration energy at from 100 V/cm to 10 6 V/cm for durations from 10 μsec to 100 msec to achieve irreversible poration.
10 . A method for selective denervation of targeted tissue of a patient, said method comprising delivering energy to target cells of said target tissue under conditions selected to permeabilize the cell membrane to disrupt a pain conduction pathway provided by the cell.
11 . A method as in claim 10 , wherein the target cells are nerve cells.
12 . A method as in claim 11 , wherein the nerve cells are selected from the group consisting of nerves of the spine, peripheral nerves, nerves of the head and neck, and the brain stem.
13 . A method as in claim 12 , wherein the nerve cells are in the spine.
14 . A method as in claim 13 , wherein the target spinal nerve cells are in the region of the sacral plexus.
15 . A method as in claim 13 , wherein the target spinal nerve cells comprise those in the stellate ganglion in the region of C6.
16 . A method as in claim 12 , wherein the target spinal nerve cells are in the area of T6.
17 . A method as in claim 11 , wherein the nerve cells are immediately adjacent to an artery.
18 . A method as in claim 17 , wherein said energy is delivered from a catheter positioned in the artery.
19 . A method as in claim 10 , wherein the energy is electric delivered in the range from 10 V/cm to 10 6 V/cm for a period in the range from 10 μsec to 100 msec.
20 . A method as in claim 10 , wherein the energy is delivered under conditions which provide a reversible poration.
21 . A method as in claim 20 , wherein the energy is electrical in the range from 10 V/cm to 10 4 V/cm.
22 . A method as in claim 10 , wherein the energy id delivered under conditions which provide an irreversible poration.
23 . A method as in claim 22 , wherein the energy is electrical in the range from 100 V/cm to 10 6 V/cm.
24 . A method as in claim 10 , wherein the energy comprises ultrasonic energy.
25 . A method as in claim 10 , further comprising delivering a nerve blocking agent under conditions to act together with the energy to block the pain conduction pathway.
26 . A method as in claim 25 , wherein the nerve blocking agent is delivered simultaneously with the energy delivery.
27 . A method as in claim 10 , wherein the energy is delivered with a catheter.
28 . A method as in claim 27 , wherein the catheter is implanted.
29 . A method as in claim 27 , wherein the catheter is percutaneously positioned in an artery.
30 . A method as in claim 10 , wherein the energy is delivered transcutaneously from a surface of the patient's skin.