SYSTEMS AND METHODS FOR SPINAL CORD STIMULATION TRIAL

• US 20170232255A1
• Filed: 02/29/2016
• Published: 08/17/2017
• Est. Priority Date: 02/12/2016
• Status: Abandoned Application

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kent, Alexander, Nabutovsky, Yelena, Rosenberg, Stuart, Bornzin, Gene A.
• Application Number:
  US15/056,595
• Publication Number:
  US 20170232255A1
• Time in Patent Office: Days
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/37241 providing test stimulations

Abstract

The present disclosure provides a spinal cord stimulation (SCS) trial system. The SCS trial system includes at least one rigid needle lead including a biocompatible conductor extending from a proximal end to a distal end, and insulation surrounding at least a portion of the biocompatible conductor, wherein the at least one rigid needle lead is configured to pierce the skin of a patient and be percutaneously implanted in the patient such that the distal end is proximate to at least one of a dorsal column, a dorsal root, dorsal root ganglia, and a peripheral nerve of the patient. The system further includes an external pulse generator (EPG) coupled to the at least one rigid needle lead and configured to apply electrical stimulation to the patient via the at least one rigid needle lead.

Claims

1. A spinal cord stimulation (SCS) trial system comprising:

at least one rigid needle lead comprising;

a biocompatible conductor extending from a proximal end to a distal end; and

insulation surrounding at least a portion of the biocompatible conductor, wherein the at least one rigid needle lead is configured to pierce the skin of a patient and be percutaneously implanted in the patient such that the distal end is proximate to at least one of a dorsal column, a dorsal root, dorsal root ganglia, and a peripheral nerve of the patient; and

an external pulse generator (EPG) coupled to the at least one rigid needle lead and configured to apply electrical stimulation to the patient via the at least one rigid needle lead.

2. The SCS trial system of claim 1, wherein the distal end comprises a straight tip.

3. The SCS trial system of claim 1, wherein the distal end comprises a curved tip.

4. The SCS trial system of claim 1, wherein the distal end comprises a spiral tip.

5. The SCS trial system of claim 1, further comprising a button connector attached to the proximal end of the at least one rigid needle lead, the EPG coupled to the button connector.

6. The SCS trial system of claim 5, further comprising a water-proof patch configured to adhere to skin of the patient and cover the button connector.

7. The SCS trial system of claim 1, wherein the at least one rigid needle lead further comprises a cannula surrounding the biocompatible conductor and insulation, the cannula configured to facilitate implantation of the at least one rigid needle lead.

8. The SCS trial system of claim 1, wherein the distal end comprises a tip made of at least one:

a shape memory material configured to change shape in response to a change in temperature and a superelastic material configured to recover an undeformed shape without a change in temperature.

9. The SCS trial system of claim 1, further comprising a microdriver system configured to orient and advance the at least one rigid needle lead during implantation, the microdriver system comprising:

a base;

an arm coupled to the base and configured to be translated relative to the base; and

a mounting plate coupled to the arm and configured to be translated relative to the arm, the mounting plate comprising a thumb screw attachment configured to attach the at least one rigid needle lead to the mounting plate.

10. A method for implanting a spinal cord stimulation (SCS) trial system in a patient, the method comprising:

percutaneously implanting at least one rigid needle lead by piercing the skin of the patient, the at least one rigid needle lead including a biocompatible conductor extending from a proximal end to a distal end, and insulation surrounding at least a portion of the biocompatible conductor, the at least one rigid needle lead percutaneously implanted such that the distal end is proximate to at least one of a dorsal column, a dorsal root, dorsal root ganglia, and a peripheral nerve of the patient;

electrically coupling an external pulse generator (EPG) to the at least one rigid needle lead; and

applying electrical stimulation to the patient via the at least one rigid needle lead.

11. The SCS method of claim 10, wherein percutaneously implanting at least one rigid needle lead comprises percutaneously implanting at least one rigid needle lead having a distal end that includes a straight tip, and wherein piercing the skin of the patient comprises piercing the skin of the patient using the straight tip of the rigid needle lead.

12. The SCS method of claim 10, wherein percutaneously implanting at least one rigid needle lead comprises percutaneously implanting at least one rigid needle lead having a distal end that includes a curved tip.

13. The SCS method of claim 10, wherein percutaneously implanting at least one rigid needle lead comprises percutaneously implanting at least one rigid needle lead having a distal end that includes a spiral tip.

14. The SCS method of claim 10, wherein electrically coupling an EPG to the at least one rigid needle lead comprises:

crimping the proximal end of the at least one rigid needle lead;

attaching a button connector to the crimped proximal end; and

electrically coupling the EPG to the button connector.

15. The SCS method of claim 14, further comprising covering the button connector with a water-proof patch.

16. The SCS method of claim 10, wherein percutaneously implanting at least one rigid needle lead comprises percutaneously implanting at least one rigid needle lead using a cannula that surrounds the biocompatible conductor and insulation.

17. The SCS method of claim 10, further comprising determining a location of the at least one rigid needle lead within the patient using at least one of test stimulation, impedance measurements, photoelectric sensor measurements, and neural activity measurements.

18. A microdriver system for use in orienting and percutaneously implanting at least one rigid needle lead in a patient, the microdriver system comprising:

a base configured to be positioned on skin of the patient;

an arm coupled to the base and configured to be translated relative to the base; and

a mounting plate coupled to the arm and configured to be translated relative to the arm, the mounting plate further configured to attach to the at least one rigid needle lead.

19. The microdriver system of claim 18, wherein the mounting plate comprises a thumb screw attachment configured to attach the at least one rigid needle lead to the mounting plate.

20. The microdriver system of claim 18, wherein the base includes at least one track, the arm configured to be translated relative to the base by sliding along the at least one track.