Patient handheld device for use with a spinal cord stimulation system

• US 9,592,385 B2
• Filed: 07/28/2015
• Issued: 03/14/2017
• Est. Priority Date: 05/31/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Nuvectra Corporation
• Inventors: Kaula, Norbert, Iyassu, Yohannes
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US14/810,758
• Publication Number:
  US 20150328463A1
• Time in Patent Office: 595 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback

Abstract

A patient feedback device for use in an electrical stimulation system is calibrated. The electrical stimulation system includes an implantable pulse generator (IPG) implanted in a patient and a patient feedback device having a force sensor. Input from the patient is sensed using the patient feedback device. At a first time, an electrical stimulus is applied with the IPG. The force sensor is monitored at a plurality of time points. A level of force sensed by the force sensor at each of the plurality of time points is recorded. A time point at which a maximum force is applied is identified, or a time point at which a minimum force is applied is identified. The first time is compared to the time point at which a minimum force is applied or the time point at which a maximum force is applied, in order to determine a patient response time.

Claims

1. A method of calibrating a patient feedback device for use in an electrical stimulation system, comprising:

applying an electrical stimulus to a patient;

measuring, via a force sensor on a patient feedback device, a squeezing of the patient feedback device by the patient in response to the applied electrical stimulus; and

calculating a patient response time based on a time lag between when the electrical stimulus is applied to the patient and when the patient feedback device was squeezed by the patient in response to the applied electrical stimulus.

2. The method of claim 1, further comprising:

after the calculating of the patient response time, delivering a plurality of electrical stimuli to the patient;

detecting a plurality of patient engagements with the patient feedback device in response to the delivering of the plurality of the electric stimuli; and

determining, based on the calculated patient response time, which of the patient engagements correspond to which of the electrical stimuli, respectively.

3. The method of claim 1, wherein the applying of the electrical stimulus is performed via an implantable pulse generator implanted in the patient.

4. The method of claim 1, wherein the measuring comprises measuring a level of a squeezing force applied by the patient in response to the applied electrical stimulus.

5. The method of claim 4, wherein:

the measuring of the force comprises;

monitoring the force sensor at a plurality of time points;

recording a level of force sensed by the force sensor at each of the plurality of time points; and

identifying a first time point corresponding to a maximum force and second time point corresponding to a minimum force; and

the calculating comprises;

comparing the first and second time points with a time point when the electrical stimulus was applied.

6. The method of claim 5, wherein the calculating comprises calculating a first derivative of the levels of force sensed by the force sensor at each of the plurality of time points.

7. The method of claim 5, wherein the calculating comprises applying a high-pass filter to the levels of force sensed by the force sensor at each of the plurality of time points.

8. The method of claim 5, wherein the calculating comprises using a learning algorithm to identify probabilities of maxima and minima based on the patient'"'"'s use of the patient feedback device.

9. The method of claim 1, wherein the patient feedback device includes a motion sensor, and wherein the measuring comprises measuring a movement of the patient as a part of a physical action in response to the applied electrical stimulus.

10. The method of claim 1, wherein the patient feedback device includes an optical sensor, and wherein the measuring comprises measuring visual cues of the patient as a part of a physical action in response to the applied electrical stimulus.

11. A method of calibrating a patient feedback device for use in an electrical stimulation system, comprising:

delivering a first electrical stimulus to a patient via an implantable pulse generator;

detecting a first patient engagement with a patient feedback device in response to the first electrical stimulus;

calculating a patient response time based on a time lag between a first point in time when the first electrical stimulus is delivered and a second point in time when the first patient engagement is detected;

thereafter delivering a plurality of second electrical stimuli to the patient via the implantable pulse generator;

detecting a plurality of second patient engagements with the patient feedback device in response to the delivering of the plurality of the second electric stimuli; and

associating, based on the calculated patient response time, each of the second patient engagements with each of the second electrical stimuli, respectively.

12. The method of claim 11, wherein the patient feedback device includes a force sensor, and wherein the detecting comprises measuring forces applied to the patient feedback device in response to the first electrical stimulus.

13. The method of claim 12, wherein:

the measuring of the forces comprises;

monitoring the force sensor at a plurality of time points;

recording a level of force sensed by the force sensor at each of the plurality of time points; and

identifying a time point corresponding to a maximum force and a time point corresponding to a minimum force; and

the calculating comprises;

comparing the first point in time with the time points corresponding to the maximum force and the minimum force.

14. The method of claim 13, wherein the calculating comprises one of:

calculating a first derivative of the levels of force sensed by the force sensor at each of the plurality of time points;

applying a high-pass filter to the levels of force sensed by the force sensor at each of the plurality of time points;

or

using a learning algorithm to identify probabilities of maxima and minima based on the patient'"'"'s use of the patient feedback device.

15. The method of claim 11, wherein the patient feedback device includes a motion sensor, and wherein the detecting comprises measuring a movement of the patient in response to the first electrical stimulus.

16. The method of claim 11, wherein the patient feedback device includes an optical sensor, and wherein the detecting comprises measuring visual cues of the patient in response to the first electrical stimulus.

17. A method of calibrating a patient feedback device for use in an electrical stimulation system, the system including an implantable pulse generator (IPG) implanted in a patient and a patient feedback device having a force sensor, the method comprising:

sensing input from the patient using the patient feedback device;

at a first time, applying an electrical stimulus with the IPG;

monitoring the force sensor at a plurality of time points that include a second time point and a third time point;

recording a level of force sensed by the force sensor at each of the plurality of time points;

identifying at least one of;

the second time point at which a maximum force is applied and the third time point at which a minimum force is applied; and

comparing the first time to at least one of;

the second time point and the third time point to determine a patient response time.

18. The method of calibrating a patient feedback device of claim 17, wherein identifying at least one of the second time point and the third time point comprises calculating a first derivative of the levels of force sensed by the force sensor at each of the plurality of time points.

19. The method of calibrating a patient feedback device of claim 17, wherein identifying at least one of the second time point and the third time point comprises applying a high-pass filter to the levels of force sensed by the force sensor at each of the plurality of time points.

20. The method of calibrating a patient feedback device of claim 17, wherein identifying at least one of the second time point and the third time point comprises using a learning algorithm to identify probabilities of maxima and minima based on the patient'"'"'s use of the patient feedback device.