Combination therapy including peripheral nerve field stimulation

• US 10,300,273 B2
• Filed: 03/28/2016
• Issued: 05/28/2019
• Est. Priority Date: 06/09/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rooney, Ethan A., Wahlstrand, Carl D., King, Gary W., Cross, Jr., Thomas E., Heruth, Kenneth T., Wacnik, Paul W., Evanson, Jeffrey S.
• Primary Examiner(s): Marlen, Tammie K
• Application Number:
  US15/082,536
• Publication Number:
  US 20160279411A1
• Time in Patent Office: 1,156 Days
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• 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 1/36071 Pain
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings

Abstract

Delivery of peripheral nerve field stimulation (PNFS) in combination with one or more other therapies is described. The other therapy delivered in combination with PNFS may be, for example, a different type of neurostimulation, such as spinal cord stimulation (SCS), or a drug. PNFS and the other therapy may be delivered simultaneously, in an alternating fashion, according to a schedule, and/or selectively, e.g., in response to a request received from a patient or clinician. A combination therapy that includes PNFS may be able to more completely address complex or multifocal pain than would be possible through delivery of either PNFS or other therapies alone. Further, the combination of PNFS with one or more other therapies may reduce the likelihood that neural accommodation will impair the perceived effectiveness PNFS or the other therapies.

Claims

1. An implantable medical device system comprising:

at least one implantable medical device, wherein the at least one implantable medical device comprises a single implantable medical device configured to deliver a first electrical stimulation therapy to a patient via a first implantable element and deliver a second electrical stimulation therapy to the patient via a second implantable element in combination with delivery of the first electrical stimulation therapy or more than one implantable medical devices configured to collectively deliver the first electrical stimulation therapy to the patient via the first implantable element and deliver the second electrical stimulation therapy to the patient via the second implantable element in combination with delivery of the first electrical stimulation therapy; and

a processor configured to control the at least one implantable medical device to deliver, via the first implantable element, the first electrical stimulation therapy to the patient according to a duty cycle throughout a period of time such that the first electrical stimulation therapy delivery is cycled on and off more than once during the period of time, and control the at least one implantable medical device to deliver the second electrical stimulation therapy continuously and according to a selected frequency throughout the period of time, via the second implantable element, such that the first electrical stimulation therapy and the second electrical stimulation therapy are both delivered during a first portion of the period of time when the first electrical stimulation therapy is cycled on and the second electrical stimulation therapy is delivered but the first electrical stimulation therapy is not delivered during a second portion of the period of time when the first electrical stimulation therapy is cycled off, wherein one of the first electrical stimulation therapy and the second electrical stimulation therapy comprises peripheral nerve field stimulation therapy, and another of the first electrical stimulation therapy and the second electrical stimulation therapy comprises an electrical stimulation therapy configured to treat pain to the patient in combination with the peripheral nerve field stimulation.

2. The system of claim 1, wherein the processor is configured to control the delivery of the second electrical stimulation therapy to the patient based upon receipt of a request from a user.

3. The system of claim 1, wherein the first implantable element is configured to deliver the first electrical stimulation therapy to a first anatomical region and the second implantable element is configured to deliver the second electrical stimulation therapy to a second anatomical region.

4. The system of claim 3, wherein the first anatomical region comprises one of a spinal cord or a limb of the patient, and wherein the second anatomical region comprises another of the spinal cord or the limb of the patient.

5. The system of claim 1, wherein the processor is configured to control the at least one implantable medical device to deliver the first electrical stimulation therapy to be time-interleaved with the second electrical stimulation therapy.

6. The system of claim 1, wherein an amplitude of electrical stimulation pulses of the first electrical stimulation therapy is different from an amplitude of electrical stimulation pulses of the second electrical stimulation therapy.

7. The system of claim 1, wherein a frequency of electrical stimulation pulses of the first electrical stimulation therapy is different from a frequency of electrical stimulation pulses of the second electrical stimulation therapy.

8. The system of claim 1, further comprising a medical device programmer configured to communicate wirelessly with the at least one implantable medical device to program the at least one implantable medical device.

9. The system of claim 1, further comprising the first implantable element and the second implantable element.

10. The system of claim 1, wherein the more than one implantable medical devices includes a first implantable medical device configured to deliver the first electrical stimulation therapy to the patient via the first implantable element but not the second electrical stimulation therapy via the second implantable element, and a second implantable medical device configured to deliver the second electrical stimulation therapy to the patient via the second implantable element but not the first electrical stimulation therapy via the first implantable element.

11. The system of claim 1, wherein the at least one implantable medical device comprises the single implantable medical device configured to deliver the first electrical stimulation therapy to the patient via the first implantable element and deliver the second electrical stimulation therapy to the patient via the second implantable element in combination with delivery of the first electrical stimulation therapy.

12. The system of claim 1, wherein the first electrical stimulation therapy comprises a first plurality of electrical stimulation pulses and the second electrical stimulation therapy comprises a second plurality of electrical stimulation pulses, and wherein the processor is configured to control the at least one implantable medical device to deliver, via the first implantable element, the first plurality of electrical stimulation pulses during the first portion of time when the first therapy is cycled on, and control the at least one implantable medical device to deliver, via the second implantable element, a first set of electrical stimulation pulses of the second plurality of electrical stimulation pulses during the first portion of time and according to the selected frequency when the first plurality of electrical stimulation pulses are delivered and a second set of electrical stimulation pulses of the second plurality of electrical stimulation pulses during the second portion of time and according to the selected frequency when the first plurality of electrical stimulation pulses are not delivered.

13. The system of claim 10, wherein there is a time delay between respective pulses of the first plurality of electrical stimulation pulses and a time delay between respective pulses of the second plurality of electrical stimulation pulses.

14. The system of claim 1, wherein the second electrical stimulation therapy comprises a plurality of electrical stimulation pulses delivered at a selected pulse rate throughout the period of time.

15. The system of claim 14, wherein the plurality of electrical stimulation pulses are delivered at a constant pulse rate throughout the period of time.

16. The system of claim 1, wherein the second electrical stimulation therapy comprises an electrical stimulation signal delivered at a constant signal frequency throughout the period of time.

17. The system of claim 1, wherein the first implantable element comprises a first implantable electrical lead and the second implantable element comprises a second implantable electrical lead.