Systems and methods for providing therapy to a patient using intermittent electrical stimulation

• US 9,901,737 B2
• Filed: 09/22/2015
• Issued: 02/27/2018
• 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:
  US14/861,471
• Publication Number:
  US 20160082254A1
• Time in Patent Office: 889 Days
• Field of Search: 607 46, 607 57
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/378 Electrical supply
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A method for providing therapy to a patient using intermittent electrical stimulation includes advancing a plurality of electrodes disposed along a distal portion of a lead to a target stimulation location within a patient. A proximal portion of the lead is coupled to an electrical stimulator disposed external to the patient. Patient tissue at the target stimulation location is stimulated for a first duration of time that is no greater than one day using the plurality of electrodes. The stimulation provides efficacious treatment to the patient for a second duration of time that is at least twice as long as the first duration of time. Stimulation is ceased after completion of the first duration of time. The lead is removed from the patient after ceasing stimulation and prior to an end of the second duration of time.

Claims

1. A method for providing therapy to a patient using intermittent electrical stimulation, the method comprising:

a) advancing a plurality of electrodes disposed along a distal portion of a lead to a target stimulation location within a patient;

b) coupling a proximal portion of the lead to an electrical stimulator disposed external to the patient;

c) stimulating patient tissue at the target stimulation location for a first duration of time that is no greater than one day using the plurality of electrodes, the stimulation providing efficacious treatment to the patient for a second duration of time that is at least twice as long as the first duration of time, wherein the presence of the efficacious treatment is determined based, at least in part, on an observed reduction of patient pain as evaluated using a pain measurement scale;

d) ceasing stimulation after completion of the first duration of time; and

e) removing the lead from the patient after ceasing stimulation and prior to an end of the second duration of time.

2. The method of claim 1, wherein the second duration of time is at least five times longer than the first duration of time.

3. The method of claim 1, wherein the second duration of time is at least ten times longer than the first duration of time.

4. The method of claim 1, further comprising repeating steps a) through e) after completion of a third duration of time that is no less than one month from removing the lead from the patient.

5. The method of claim 4, wherein the second duration of time is less than the third duration of time.

6. The method of claim 4, wherein the second duration of time is greater than the third duration of time.

8. The method of claim 1, wherein advancing a plurality of electrodes disposed along a distal portion of a lead to a target stimulation location within a patient comprises advancing a plurality of electrodes disposed along a distal portion of a percutaneous lead to a target stimulation location within a patient.

9. The method of claim 1, wherein advancing a plurality of electrodes disposed along a distal portion of a lead to a target stimulation location within a patient comprises advancing a plurality of electrodes to a target stimulation location within an epidural space of a patient.

7. A method for providing therapy to a patient using intermittent electrical stimulation, the method comprising:

a) advancing a plurality of electrodes disposed along a distal portion of a lead to a target stimulation location within a patient;

b) coupling a proximal portion of the lead to an electrical stimulator disposed external to the patient;

c) stimulating patient tissue at the target stimulation location for a first duration of time that is no greater than one day using the plurality of electrodes, the stimulation providing efficacious treatment to the patient for a second duration of time that is at least twice as long as the first duration of time, wherein the presence of the efficacious treatment is determined based, at least in part, on an observed frequency shift in the patient'"'"'s theta wave activity;

d) ceasing stimulation after completion of the first duration of time; and

e) removing the lead from the patient after ceasing stimulation and prior to an end of the second duration of time.

10. A method for providing therapy to a patient using intermittent electrical stimulation, the method comprising:

stimulating patient tissue using an electrical stimulation system comprising a lead having a proximal portion and an opposing distal portion, a plurality of electrodes disposed along the distal portion of the lead, and an implantable control module coupled to the proximal portion of the lead, the control module comprising a processor coupled to the plurality of electrodes, and a rechargeable power source coupled to the processor, the power source configured and arranged for storing energy and supplying the stored energy to the processor for stimulating patient tissue via the plurality of electrodes, wherein the power source is configured and arranged to supply the processor with energy for no more than three hours of electrical stimulation before being depleted when fully charged, wherein the patient tissue is stimulated until the stored energy in the power source is depleted; and

recharging the implanted power source subsequent to depletion of the stored energy in the power source using a power-source recharger that is external to the patient.

11. The method of claim 10, further comprising implanting the electrical stimulation system into the patient prior to stimulating patient tissue.

12. The method of claim 10, wherein the power source does not comprise a battery.

13. The method of claim 10, wherein the power source comprises at least one capacitor.

14. The method of claim 10, wherein recharging the implanted power source subsequent to depletion of the stored energy in the power source comprises recharging the implanted power source after a duration of time that is longer than a duration of time in which the energy stored in the power supply is depleted during electrical stimulation when fully charged.

15. The method of claim 10, wherein recharging the implanted power source subsequent to depletion of the stored energy in the power source comprises recharging the implanted power source for no more than fifteen minutes.

16. The method of claim 10, wherein recharging the implanted power source subsequent to depletion of the stored energy in the power source comprises recharging the implanted power source for no more than ten minutes.

17. The method of claim 10, wherein the power source is configured and arranged to supply the processor with energy for no more than two hours of electrical stimulation before being depleted when fully charged.

18. The method of claim 10, wherein the power source is configured and arranged to supply the processor with energy for no more than one hour of electrical stimulation before being depleted when fully charged.

19. The method of claim 10, wherein implanting an electrical stimulation system into the patient comprises implanting an electrical stimulation system into the patient for a period of time that is no less than one year.