Conditional electrical stimulation

• US 10,076,661 B2
• Filed: 12/23/2016
• Issued: 09/18/2018
• Est. Priority Date: 03/27/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wei, Xuan K., Bonde, Eric H.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US15/390,168
• Publication Number:
  US 20170173327A1
• Time in Patent Office: 634 Days
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

In general, the disclosure describes techniques for providing conditional electrical stimulation to a patient for pelvic health. An implantable medical device (IMD) may adjust the delivery cycle of the electrical stimulation applied to a patient in response to receiving a delivery cycle parameter associated with one or more of the following: a time in a time schedule, a control device output from a control device, and physiological information from a physiological information sensing device. As an example, the IMD may monitor a status of one or more inputs of the IMD and adjust the delivery cycle of the electrical stimulation applied to the patient based on the status of the input(s).

Claims

1. A system comprising:

a therapy delivery circuit configured to apply a plurality of electrical stimulation pulse trains from an electrical stimulation device to a patient; and

one or more processors configured to;

cause the therapy delivery circuit to apply, according to a first delivery cycle, a first plurality of electrical stimulation pulse trains from an electrical stimulation device to a patient, wherein each electrical stimulation pulse train of the first plurality of electrical stimulation pulse trains comprises a series of pulses, wherein the first delivery cycle of the first plurality of electrical stimulation pulse trains is a first ratio of a first time duration during which the electrical stimulation pulse train of the first plurality of electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the first plurality of electrical stimulation pulse trains;

receive at least one of a user input or physiological information from a physiological information sensing device;

cause the therapy delivery circuit to apply, according to a second delivery cycle and in response to the at least one of the user input or the physiological information, a second plurality of electrical stimulation pulse trains from the electrical stimulation device to the patient, wherein each electrical stimulation pulse train of the second plurality of electrical stimulation pulse trains comprises a series of pulses, wherein the second delivery cycle of the second plurality of electrical stimulation pulse trains is a second ratio of a first time duration during which the electrical stimulation pulse train of the second plurality of electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the second plurality of electrical stimulation pulse trains and is different than the first delivery cycle; and

cause the therapy delivery circuit to automatically change, over at least three electrical stimulation pulse trains, the second delivery cycle to a third delivery cycle different than the second delivery cycle, wherein each electrical stimulation pulse train of the at least three electrical stimulation pulse trains comprises a plurality of pulses, and wherein the third delivery cycle is a third ratio of a first time duration during which a final electrical stimulation pulse train of the at least three electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the at least three electrical stimulation pulse trains.

2. The system of claim 1, wherein the one or more processors is configured to cause the therapy delivery circuit to automatically change, over at least three electrical stimulation pulse trains, the second delivery cycle to the third delivery cycle by at least:

causing the therapy delivery circuit to at least one of automatically increase, over the at least three electrical stimulation pulse trains, the delivery cycle of the electrical stimulation pulse train or automatically decrease, over the at least three electrical stimulation pulse trains, the delivery cycle of the electrical stimulation pulse train.

3. The system of claim 1, wherein the therapy delivery circuit is configured to apply the electrical stimulation pulse trains from the electrical stimulation device to at least one of a sacral nerve, a pudendal nerve, or a dorsal genital nerve of the patient to alleviate a pelvic floor disorder of the patient.

4. The system of claim 1, further comprising an implantable medical device, wherein the implantable medical device comprises the one or more processors and the therapy delivery circuit.

5. The system of claim 1, further comprising an implantable medical device and a programmer, wherein the implantable medical device comprises the therapy delivery circuit and the programmer comprises the one or more processors.

6. The system of claim 1, wherein the at least one of the user input or the physiological information comprises an indication of a voiding or defecation event.

7. The system of claim 1, wherein a pulse duty cycle is substantially unchanged between a first electrical stimulation pulse train of the at least three electrical stimulation pulse strains and a last electrical stimulation pulse train of the at least three electrical stimulation pulse trains.

8. The system of claim 1, further comprising an implantable medical lead configured to be coupled to the therapy delivery circuit.

9. A device comprising:

means for applying, according to a first delivery cycle, a first plurality of electrical stimulation pulse trains to a patient, wherein each electrical stimulation pulse train of the first plurality of electrical stimulation pulse trains comprises a series of pulses, wherein the first delivery cycle of the first plurality of electrical stimulation pulse trains is a first ratio of a first time duration during which the electrical stimulation pulse train of the first plurality of electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the first plurality of electrical stimulation pulse trains;

means for receiving at least one of a user input or physiological information from a physiological information sensing device;

means for applying, according to a second delivery cycle and in response to the at least one of the user input or the physiological information, a second plurality of electrical stimulation pulse trains to the patient, wherein each electrical stimulation pulse train of the second plurality of electrical stimulation pulse trains comprises a series of pulses, wherein the second delivery cycle of the second plurality of electrical stimulation pulse trains is a second ratio of a first time duration during which the electrical stimulation pulse train of the second plurality of electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the second plurality of electrical stimulation pulse trains and is different than the first delivery cycle; and

means for automatically changing, over at least three electrical stimulation pulse trains, the second delivery cycle to a third delivery cycle different than the second delivery cycle, wherein each electrical stimulation pulse train of the at least three electrical stimulation pulse trains comprises a plurality of pulses, and wherein the third delivery cycle is a third ratio of a first time duration during which a final electrical stimulation pulse train of the at least three electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the at least three electrical stimulation pulse trains.

10. The device of claim 9, wherein the means for automatically changing, over at least three electrical stimulation pulse trains, the second delivery cycle to the third delivery cycle comprises:

means for causing at least one of automatically increasing, over the at least three electrical stimulation pulse trains, the delivery cycle of the electrical stimulation pulse train or automatically decreasing, over the at least three electrical stimulation pulse trains, the delivery cycle of the electrical stimulation pulse train.

11. The device of claim 9, wherein the means for applying the first plurality of electrical stimulation pulse trains and the means for delivering the second plurality of electrical stimulation pulse trains are configured to apply the electrical stimulation pulse trains from the electrical stimulation device to at least one of a sacral nerve, a pudendal nerve, or a dorsal genital nerve of the patient to alleviate a pelvic floor disorder of the patient.

12. The device of claim 9, wherein the at least one of the user input or the physiological information comprises an indication of a voiding or defecation event.

13. The device of claim 9, wherein a pulse duty cycle is substantially unchanged between a first electrical stimulation pulse train of the at least three electrical stimulation pulse strains and a last electrical stimulation pulse train of the at least three electrical stimulation pulse trains.

14. The device of claim 9, further comprising an implantable medical lead configured to be coupled to the means for applying the first plurality of electrical stimulation pulse trains and the means for applying the second plurality of electrical stimulation pulse trains.

15. A method comprising:

applying, according to a first delivery cycle, a first plurality of electrical stimulation pulse trains from an electrical stimulation device to a patient, wherein each electrical stimulation pulse train of the first plurality of electrical stimulation pulse trains comprises a series of pulses, wherein the first delivery cycle of the first plurality of electrical stimulation pulse trains is a first ratio of a first time duration during which the electrical stimulation pulse train of the first plurality of electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the first plurality of electrical stimulation pulse trains;

receiving at least one of a user input or physiological information from a physiological information sensing device;

applying, according to a second delivery cycle and in response to the indication of the at least one of the user input or the physiological information, a second plurality of electrical stimulation pulse trains from the electrical stimulation device to the patient, wherein each electrical stimulation pulse train of the second plurality of electrical stimulation pulse trains comprises a series of pulses, wherein the second delivery cycle of the second plurality of electrical stimulation pulse trains is a second ratio of a first time duration during which the electrical stimulation pulse train of the second plurality of electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the second plurality of electrical stimulation pulse trains and is different than the first delivery cycle; and

automatically changing, over at least three electrical stimulation pulse trains, the second delivery cycle to a third delivery cycle different than the second delivery cycle, wherein each electrical stimulation pulse train of the at least three electrical stimulation pulse trains comprises a plurality of pulses, and wherein the third delivery cycle is a third ratio of a first time duration during which a final electrical stimulation pulse train of the at least three electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the at least three electrical stimulation pulse trains.

16. The method of claim 15, wherein automatically changing, over at least three electrical stimulation pulse trains, t the second delivery cycle to the third delivery cycle comprises:

at least one of automatically increasing, over the at least three electrical stimulation pulse trains, the delivery cycle of the electrical stimulation pulse train or automatically decreasing, over the at least three electrical stimulation pulse trains, the delivery cycle of the electrical stimulation pulse train.

17. The method of claim 15, wherein the electrical stimulation pulse trains from the electrical stimulation device are applied to at least one of a sacral nerve, a pudendal nerve, or a dorsal genital nerve of the patient to alleviate a pelvic floor disorder of the patient.

18. The method of claim 15, wherein:

applying the first plurality of electrical stimulation pulse trains from the electrical stimulation device to the patient comprises applying the first plurality of electrical stimulation pulse trains from the electrical stimulation device to the patient via an implantable medical lead; and

applying the second plurality of electrical stimulation pulse trains from the electrical stimulation device to the patient comprises applying the second plurality of electrical stimulation pulse trains from the electrical stimulation device to the patient via an implantable medical lead.

19. The method of claim 15, wherein the at least one of the user input or the physiological information comprises an indication of a voiding or defecation event.

20. The method of claim 15, wherein a pulse duty cycle is substantially unchanged between a first electrical stimulation pulse train of the at least three electrical stimulation pulse strains and a last electrical stimulation pulse train of the at least three electrical stimulation pulse trains.

23. The non-transitory computer readable medium of claim 20, wherein a pulse duty cycle is substantially unchanged between a first electrical stimulation pulse train of the at least three electrical stimulation pulse strains and a last electrical stimulation pulse train of the at least three electrical stimulation pulse trains.

21. A non-transitory computer readable medium comprising instructions that cause a one or more processors to:

cause a therapy delivery circuit to apply, according to a first delivery cycle, a first plurality of electrical stimulation pulse trains from an electrical stimulation device to a patient, wherein each electrical stimulation pulse train of the first plurality of electrical stimulation pulse trains comprises a series of pulses, wherein the first delivery cycle of the first plurality of electrical stimulation pulse trains is a first ratio of a first time duration during which the electrical stimulation pulse train of the first plurality of electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the first plurality of electrical stimulation pulse trains;

receive at least one of a user input or physiological information from a physiological information sensing device;

cause the therapy delivery circuit to apply, according to a second delivery cycle and in response to the at least one of the user input or the physiological information, a second plurality of electrical stimulation pulse trains from the electrical stimulation device to the patient, wherein each electrical stimulation pulse train of the second plurality of electrical stimulation pulse trains comprises a series of pulses, wherein the second delivery cycle of the second plurality of electrical stimulation pulse trains is a second ratio of a first time duration during which the electrical stimulation pulse train of the second plurality of electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the second plurality of electrical stimulation pulse trains and is different than the first delivery cycle; and

cause the therapy delivery circuit to automatically change, over at least three electrical stimulation pulse trains, the second delivery cycle to a third delivery cycle different than the second delivery cycle, wherein each electrical stimulation pulse train of the at least three electrical stimulation pulse trains comprises a plurality of pulses, and wherein the third delivery cycle is a third ratio of a first time duration during which a final electrical stimulation pulse train of the at least three electrical stimulation pulse trains is delivered to a second time duration between successive electrical stimulation pulse trains of the at least three electrical stimulation pulse trains.

22. The non-transitory computer readable medium of claim 21, wherein the instructions that cause the one or more processors to cause the therapy delivery circuit to automatically change, over at least three electrical stimulation pulse trains, the delivery cycle of the electrical stimulation pulse trains from the second delivery cycle to a third, different delivery cycle comprise instructions that cause the one or more processors to:

causing the therapy delivery circuit to at least one of automatically increasing, over the at least three electrical stimulation pulse trains, the delivery cycle of the electrical stimulation pulse train or automatically decreasing, over the at least three electrical stimulation pulse trains, the delivery cycle of the electrical stimulation pulse train.