Systems and methods for providing therapy using electrical stimulation to disrupt neuronal activity

• US 9,925,377 B2
• Filed: 09/22/2015
• Issued: 03/27/2018
• Est. Priority Date: 09/22/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Moffitt, Michael A., Carcieri, Stephen
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/861,415
• Publication Number:
  US 20160082253A1
• Time in Patent Office: 917 Days
• Field of Search: 607 2, 607 46
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

A transcutaneous electrical-stimulation system includes a transcutaneous control module including a processor. The transcutaneous control module provides electrical-stimulation signals to electrode sets electrically-coupled to the transcutaneous control module. A first electrode set is electrically-coupled to the transcutaneous control module and is placed along patient skin over a first stimulation location. The first electrode set generates a first effective electric field suitable for transcutaneous stimulation of patient tissue at the first stimulation location. A second electrode set is electrically-coupled to the transcutaneous control module and is placed along patient skin over a second stimulation location. The second electrode set generates a second effective electric field suitable for stimulating patient tissue at the second stimulation location. The second effective electric field is time-delayed from the first effective electric field such that the second effective electric field is out of phase with the first effective electric field.

Claims

1. A transcutaneous electrical stimulation system, comprising:

a transcutaneous control module comprising a processor, wherein the transcutaneous control module is configured and arranged to provide electrical stimulation signals to a plurality of electrode sets electrically-coupled to the transcutaneous control module and configured and arranged to remain external to a patient for transcutaneous electrical stimulation of patient tissue to treat patient pain;

a first electrode set electrically-coupled to the transcutaneous control module and configured and arranged for placement along patient skin over a first stimulation location, the first electrode set configured and arranged to communicate with the processor and to generate a first effective electric field suitable for transcutaneous stimulation of patient tissue at the first stimulation location using the electrical stimulation signals provided from the transcutaneous control module;

a second electrode set electrically-coupled to the transcutaneous control module and configured and arranged for placement along patient skin over a second stimulation location, the second electrode set configured and arranged to communicate with the processor and to generate a second effective electric field suitable for stimulating patient tissue at the second stimulation location using the electrical stimulation signals provided from the transcutaneous control module, wherein the second effective electric field is time-delayed from the first effective electric field such that the second effective electric field is out of phase with the first effective electric field; and

a sensor in communication with the processor, the sensor configured and arranged for monitoring patient theta band activity and detecting frequency shifts,

wherein the transcutaneous control module is further configured and arranged to provide the electrical stimulation signals to the first electrode set and the second electrode set in response to a first detected shift in frequency of the theta band activity.

2. The transcutaneous electrical stimulation system of claim 1, wherein the processor is configured and arranged for determining a time delay between the electrical stimulation signals to generate the first effective electric field and the electrical stimulation signals to generate the second effective electric field based on the first detected shift in frequency of the theta band activity.

3. The transcutaneous electrical stimulation system of claim 1, wherein the transcutaneous control module is configured and arranged to adjust at least one of amplitude, frequency, impedance, voltage, or pulse width of the electrical stimulation signals provided to the first electrode set and the second electrode set in response to a second detected shift in frequency of the theta band activity.

4. The transcutaneous electrical stimulation system of claim 1, wherein the transcutaneous control module is configured and arranged to terminate the electrical stimulation signals provided to the first electrode set and the second electrode set in response to a third detected shift in frequency of the theta band activity.

5. The transcutaneous electrical stimulation system of claim 1, further comprising a processing unit in communication with the processor, the processing unit configured and arranged for coordinating with the processor to facilitate positioning of the first electrode set and the second electrode set in a spinal cord of the patient.

6. The transcutaneous electrical stimulation system of claim 1, further comprising a processing unit in communication with the processor, the processing unit configured and arranged for coordinating with the processor to adjust at least one of amplitude, frequency, impedance, voltage, or pulse width of at least one of the first effective electric field or the second effective electric field.

7. The transcutaneous electrical stimulation system of claim 1, further comprising an actuator located external to the patient and in communication with the processor, the actuator configured and arranged for causing the transcutaneous control module to at least one of initiate providing the electrical stimulation signals to the at least one lead or terminate providing the electrical stimulation signals to the at least one lead.

8. The transcutaneous electrical stimulation system of claim 1, further comprising a programming unit in communication with the processor, the programming unit configured and arranged for at least one of adjusting a time-delay between the first effective electric field and the second effective electric field, or select between two or more different electrode sets of the plurality of electrode sets for providing the transcutaneous electrical stimulation of patient tissue.

9. A transcutaneous electrical stimulation system, comprising:

a transcutaneous control module comprising a processor, wherein the transcutaneous control module is configured and arranged to provide electrical stimulation signals to a plurality of electrode sets electrically-coupled to the transcutaneous control module and configured and arranged to remain external to a patient for transcutaneous stimulation of patient tissue to treat patient pain;

a first electrode set of the plurality of electrode sets electrically coupled to the transcutaneous control module and configured and arranged for placement along patient skin, the first electrode set configured and arranged to communicate with the processor and to generate a first effective electric field suitable for transcutaneously stimulating a first set of target neurons within patient tissue using the electrical stimulation signals provided from the transcutaneous control module; and

a second electrode set of the plurality of electrode sets electrically coupled to the transcutaneous control module and configured and arranged for placement along patient skin, the second electrode set configured and arranged to communicate with the processor and to generate a second effective electric field suitable for transcutaneously stimulating a second set of target neurons that is different from the first set of target neurons within patient tissue using the transcutaneous electrical stimulation signals provided from the transcutaneous control module, wherein the second effective electric field has an overlap in volume of at least 50% with the first effective electric field.

10. The transcutaneous electrical stimulation system of claim 9, wherein the second set of target neurons is a subset of the first set of target neurons.

11. The transcutaneous electrical stimulation system of claim 9, wherein the second set of target neurons is mutually exclusive of the first set of target neurons.

12. An electrical stimulation system, comprising:

a transcutaneous control module comprising a first processor, wherein the transcutaneous control module is configured and arranged to provide first electrical stimulation signals to a transcutaneous electrode set electrically-coupled to the transcutaneous control module for transcutaneous stimulation of patient tissue to treat patient pain;

a transcutaneous electrode set electrically-coupled to the transcutaneous control module and configured and arranged for placement along patient skin, the transcutaneous electrode set configured and arranged to communicate with the first processor and to generate a first effective electric field suitable for stimulating patient tissue at a first stimulation location using the first electrical stimulation signals provided from the transcutaneous control module;

an implantable control module configured and arranged for implantation in a body of the patient and comprising a second processor in communication with the first processor, wherein the implantable control module is configured and arranged to provide second electrical stimulation signals to at least one implantable electrode electrically-coupled to the implantable control module for stimulation of patient tissue to treat patient pain; and

at least one implantable electrode electrically-coupled to the implantable control module and configured and arranged to communicate with the second processor and to generate a second effective electric field suitable for stimulating patient tissue at a second stimulation location using the second electrical stimulation signals provided from the implantable control module, wherein the second effective electric field is coordinated with the first effective electric field.

13. The electrical stimulation system of claim 12, wherein the second effective electric field is time-delayed from the first effective electric field such that the second effective electric field is out of phase with the first effective electric field.

14. The electrical stimulation system of claim 12, further comprising a sensor in communication with at least one of the first processor or the second processor, the sensor configured and arranged for monitoring patient theta-band activity and detecting frequency shifts.

15. The electrical stimulation system of claim 12, wherein the second effective electric field has an overlap in volume of no more than 20% with the first effective electric field.

16. The electrical stimulation system of claim 12, wherein the first effective electric field is suitable for stimulating a first set of target neurons within patient tissue using the first electrical stimulation signals, wherein the second effective electric field is suitable for stimulating a second set of target neurons that is different from the first set of target neurons within patient tissue using the second electrical stimulation signals, and wherein the second effective electric field has an overlap in volume of at least 50% with the first effective electric field.

17. The electrical stimulation system of claim 16, wherein the second set of target neurons is a subset of the first set of target neurons.

18. The electrical stimulation system of claim 16, wherein the second set of target neurons is mutually exclusive of the first set of target neurons.