Timing therapy evaluation trials

Patent metadata

Field	Value
Publication number	US-10493281-B2
Application number	US-42592209-A
Country	US
Kind code	B2
Filing date	Apr 17, 2009
Priority date	Apr 18, 2008
Publication date	Dec 3, 2019
Grant date	Dec 3, 2019

Abstract

A characteristic of a washout period following the delivery of therapy to a patient according to a therapy program may be determined based on a physiological parameter of the patient. A washout period includes the period of time during which a carryover effect from the therapy delivery dissipates. Monitoring a washout period may be useful for timing the delivery of therapy according to different therapy programs during a therapy evaluation period. For example, at least one physiological signal of the patient may be monitored to automatically determine when a washout period has ended, e.g., when stimulation and carryover effects of therapy delivery according to a first therapy program have substantially dissipated, in order to determine when therapy delivery according to a second therapy program can be initiated.

First claim

The invention claimed is:

1. A method comprising:
monitoring a signal indicative of a physiological parameter of a patient during and after a first period during which therapy according to a first therapy program is delivered to the patient;
determining, with a processor, a characteristic of a washout period based on the signal monitored after the first period, wherein the washout period follows the first period, and wherein a carryover effect from the delivery of the therapy according to the first therapy program substantially dissipates during the washout period;
determining, with the processor and based on the characteristic of the washout period, a time at which to deliver therapy to the patient according to a second therapy program; and
automatically initiating the delivery of therapy to the patient according to the second therapy program at the time determined based on the characteristic of the washout period.

2. The method of claim 1 , wherein the signal indicative of the physiological parameter comprises a first signal indicative of a first physiological parameter of the patient, the method further comprising monitoring a second signal indicative of a second physiological parameter of the patient during and after the first period, wherein determining the characteristic of the washout period comprises determining the characteristic of the washout period based on the first and second signals monitored after the first period.

3. The method of claim 1 , wherein the characteristic of the washout period indicates an end of the washout period, and wherein the time determined based on the characteristic of the washout period is at the end of the washout period or after the end of the washout period.

4. The method of claim 1 , wherein determining the characteristic of the washout period based on the signal monitored after the first period comprises detecting a change in the signal from a baseline state of the signal during a second period following the first period.

5. The method of claim 4 , wherein determining the characteristic of the washout period based on the signal comprises determining when the signal returns to the baseline state during the second period, and wherein determining the time based on the characteristic of the washout period comprises determining the time at which the signal returned to the baseline state during the second period.

6. The method of claim 4 , wherein determining the characteristic of the washout period based on the signal comprises determining when the signal returns to the baseline state during the second period, the method further comprising, after determining when the signal returns to the baseline state during the second period, determining whether a minimum waiting period has expired following the first period, wherein determining the time based on the characteristic of the washout period comprises determining the time as the later of a first time at which the signal returned to the baseline state during the second period or a second time at which the minimum waiting period has expired.

7. The method of claim 6 , further comprising applying a stimulus to decrease a duration of the washout period.

8. The method of claim 4 , wherein the signal indicative of the physiological parameter comprises a first signal indicative of a first physiological parameter of the patient, the change in the first signal from a baseline state comprises a first change in the first signal from a first baseline state of the first signal, the method further comprising monitoring a second signal indicative of a second physiological parameter of the patient, wherein determining the characteristic of the washout period based on the signal comprises detecting the first change in the first signal from the first baseline state during the second period, and detecting a second change in the second signal from a second baseline state of the second signal during the second period.

9. The method of claim 8 , wherein determining the characteristic of the washout period based on the signal comprises determining when the first signal returns to the first baseline state during the second period and when the second signal returns to the second baseline state during the second period, and wherein determining the time based on the characteristic of the washout period comprises determining the time at which the first signal returned to the first baseline state and the second signal returned to the second baseline state during the second period.

10. The method of claim 8 , wherein determining the characteristic of the washout period based on the signal comprises determining when the first signal returns to the first baseline state during the second period or when the second signal returns to the second baseline state during the second period, and wherein determining the time based on the characteristic of the washout period comprises determining the time at which either the first signal returned to the first baseline state or the second signal returned to the second baseline state during the second period.

11. The method of claim 1 , wherein determining the characteristic of the washout period based on the signal comprises determining when the signal returns to a first state during a second period immediately following the first period.

12. The method of claim 11 , further comprising determining the first state prior to delivery of the therapy according to the first therapy program.

13. The method of claim 11 , wherein the carryover effect comprises a first carryover effect, the signal comprises a first signal, the characteristic comprises a first characteristic, the washout period comprises a first washout period, and the time comprises a first time, the method further comprising:
monitoring a second signal indicative of the physiological parameter of the patient during and after a third period during which therapy according to the second therapy program is delivered to the patient;
determining a second characteristic of a second washout period based on the second signal monitored after the third period, wherein the second washout period follows the third period, and wherein a second carryover effect from the delivery of therapy according to the second program substantially dissipates during the second washout period;
determining, based on the second characteristic of the second washout period, a second time at which to deliver therapy to the patient according to a third therapy program; and
automatically initiating delivery of therapy to the patient according to the third therapy program at the second time determined based on the second characteristic of the second washout period.

14. The method of claim 13 , wherein determining the second characteristic of the second washout period based on the second signal comprises determining when the second signal returns to the first state during a fourth period immediately following the third period.

15. The method of claim 13 , further comprising determining a second state of the second signal prior to the delivery of therapy according to the second therapy program, wherein determining the second characteristic of the second washout period comprises determining when the second signal returns to the second state during a fourth period immediately following the third period.

16. The method of claim 1 , wherein the therapy comprises at least one of electrical stimulation therapy or therapeutic agent delivery therapy.

17. The method of claim 1 , wherein the characteristic of the washout period comprises an amplitude of the signal, a power level in a freq

Assignees

• Giftakis Jonathon E
• Rise Mark T
• Stypulkowski Paul H
• Denison Timothy J
• Medtronic Inc

Inventors

• Giftakis Jonathon E
• Rise Mark T
• Stypulkowski Paul H
• Denison Timothy J

Classifications

• A61N1/36135 Primary

  using physiological parameters · CPC title

• A61N1/37211

  Means for communicating with stimulators · CPC title

• A61N1/37247

  User interfaces, e.g. input or presentation means · CPC title

• A61N1/36082

  Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease · CPC title

• A61N1/0534

  Electrodes for deep brain stimulation · CPC title