Neuro-stimulation and ablation system

• US 20070219547A1
• Filed: 12/21/2006
• Published: 09/20/2007
• Est. Priority Date: 12/27/2005
• Status: Active Grant

• Current Assignee: Neuropoint Medical, Inc.
• Original Assignee: Oscor Inc
• Inventors: Osypka, Thomas
• Granted Patent: US 7,949,402 B2
• Time in Patent Office: Days
• US Class Current: 606/31
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe

Abstract

The invention provides a system for treating chronic pain including a lead configured and adapted to be percutaneously implanted into an epidural space of a spinal cord, a stimulation generator that delivers electrical stimulation to the spinal cord through the lead to precisely locate the treatment area, and an ablation generator that delivers ablation energy to the treatment area through the same lead to inhibit the chronic pain. The invention also provides a method for treating chronic pain, including providing a lead, inserting the lead percutaneously into the epidural space, locating the treatment area by probing the epidural space while the lead sends electrical stimulation signals, and then ablating the treatment area.

Claims

1. A system for treating chronic pain comprising:

a. a lead configured and adapted to be percutaneously implanted into an epidural space defined within a spinal canal;

b. a stimulation generator that may selectively be connected electrically to the lead, the stimulation generator being operative to deliver electrical stimulation to a spinal cord through an electrode in order to determine a treatment location; and

c. an ablation generator that may selectively be connected electrically to the lead, the ablation generator being operative to deliver ablation energy to the treatment location to ablate spinal cord tissue.

2. The system recited in claim 1, further comprising a switch operative to allow a user to switch the system from a stimulation mode in which only the stimulation generator is electrically connected to the lead, to an ablation mode in which only the ablation generator is electrically connected to the lead.

3. The system recited in claim 1, wherein the ablation generator delivers ablation energy in a temperature controlled manner.

4. The system recited in claim 3, wherein the system further comprises a temperature sensor operably coupled to the ablation generator, the temperature sensor being operative to facilitate temperature controlled delivery of ablation energy to the treatment location by providing temperature feedback to the ablation generator.

5. The system recited in claim 4, wherein the temperature sensor is located within the lead.

6. The system recited in claim 5, wherein the temperature sensor is a thermocouple located within the electrode.

7. The system recited in claim 6, wherein the lead includes a plurality of electrodes, each electrode having a thermocouple embedded therein.

8. The system recited in claim 1, wherein the lead includes a plurality of electrodes.

9. The system recited in claim 1, further comprising a processor operably coupled to the stimulation and ablation generators, wherein the processor is adapted and configured to control output levels of stimulation and ablation energy delivered to a patient'"'"'s spinal cord tissue.

10. The system of claim 9, further comprising a machine readable program containing instructions for controlling the processor to control the stimulation and ablation generators, wherein the program comprises:

a. means for instructing the processor to control output levels of stimulation and ablation energy delivered to the patient'"'"'s spinal cord tissue, based on predetermined parameters.

11. The system recited in claim 1, wherein the lead includes:

a. an elongated lead body having opposed proximal and distal end portions, wherein the distal end portion is adapted for movement between a first state in which the distal end portion has a generally linear configuration and a second state in which the distal end portion has an undulating configuration;

b. at least one electrode operatively associated with the distal end portion of the lead body;

c. connector means operatively associated with the proximal end portion of the lead body for connecting to the stimulation generator and the ablation generator; and

d. conductor means extending through the lead body for conducting signals between the at least one electrode and the connector means, wherein the generally linear configuration of the distal end portion in the first state facilitates insertion of the lead into the epidural space and the undulating configuration of the distal end portion in the second sate allows for the distal end portion of the lead body to exert an outward force on structures of the spinal canal once situated within the epidural space to affix the lead within the spinal canal.

12. A method for treating chronic pain comprising:

a. providing an implantable lead having an electrode configured to deliver electrical stimulation and ablation energy to a treatment location of a spinal cord of a patient;

b. inserting the lead percutaneously into an epidural space of the spinal cord of the patient;

c. locating the treatment location on the spinal cord by;

i. sending electrical stimulation through the lead to the electrode; and

ii. probing with the lead in the epidural space until the electrode reaches the treatment location on the patient'"'"'s spinal cord where the patient experiences a physiological reaction from the electrical stimulation indicative of the electrode contacting the treatment location; and

d. delivering ablation energy to the electrode to ablate nerve tissue proximate the treatment location.

13. The method recited in claim 12, wherein the step of delivering ablation energy includes controlling ablation temperature by receiving feedback from a temperature sensor.

14. The method recited in claim 12, wherein the lead has a plurality of electrodes, and wherein the locating step includes cycling through the plurality of electrodes with stimulation signals.

15. The method recited in claim 12, further comprising the step of switching the lead from a stimulation mode, in which electrical stimulation is sent from a stimulation generator to the electrode, to an ablation mode, in which ablation energy is sent from an ablation generator to the electrode.

16. The method recited in claim 15, further comprising the step of controlling the output levels for the stimulation and ablation generators using a processor.

17. A spinal cord stimulation system for treating chronic pain comprising:

a. a lead configured and adapted to be implanted adjacent a treatment location of a spinal cord;

b. a stimulator for sending current controlled impulses to the treatment location by way of the lead;

c. an ablation generator for sending temperature controlled energy to the treatment location by way of the lead;

d. a processor configured to control output levels of the stimulator and ablation generator; and

e. a switch for allowing a user to alternate between sending stimulator and ablation energy to the treatment location.

18. A spinal cord stimulation system as recited in claim 17, wherein the ablation generator has a temperature sensor embedded proximate a distal end of the lead for measuring temperature during ablation.

19. A spinal cord stimulation system as recited in claim 17, wherein the lead includes a plurality of electrodes.

20. A spinal cord stimulation system as recited in claim 19, wherein each electrode includes an embedded temperature sensor.