Method and apparatus for pain management using objective pain measure

• US 10,750,994 B2
• Filed: 08/28/2017
• Issued: 08/25/2020
• Est. Priority Date: 09/27/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Annoni, Elizabeth M., Clark, Bryan Allen, Thakur, Pramodsingh Hirasingh, Gu, Jianwen, Kleinedler, James John, Srivastava, Kyle Harish, Ternes, David J., Perschbacher, David L., Esteller, Rosana
• Primary Examiner(s): Dietrich, Joseph M
• Application Number:
  US15/688,676
• Publication Number:
  US 20180085055A1
• Time in Patent Office: 1,093 Days
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2505/09 Rehabilitation or training
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/4824 Touch or pain perception evaluation A61B5/4821 takes precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: G16H 20/70 relating to mental therapies, e.g. psychological therapy or autogenous training
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

An example of a system for managing pain may include a pain monitoring circuit, a pain relief device, and a control circuit. The pain monitoring circuit may include a parameter analyzer and a pain score generator. The parameter analyzer may be configured to receive and analyze at least two parameters selected from a physiological parameter indicative of a physiological function or state of a patient, a functional parameter indicative of a physical activity or state of the patient, or a patient parameter including subjective information provided by the patient. The pain score generator may be configured to compute a composite pain score using an outcome of the analysis. The composite pain score may indicate a degree of the pain. The pain relief device may be configured to deliver a pain-relief therapy. The control circuit may be configured to control the delivery of the pain-relief therapy using the composite pain score.

Claims

1. A system for managing pain of a patient, comprising:

a pain monitoring circuit including;

a parameter analyzer configured to receive at least two parameters, to generate weighting factors, to produce a signal metric using the at least two parameters each weighted by applying a weighting factor of the weighting factors, and to adjust the weighting factors by automatic adaptation to the patient over time, the at least two parameters selected from a physiological parameter indicative of a physiological function or state of the patient, a functional parameter indicative of a physical activity or state of the patient, and a patient parameter including subjective information provided by the patient; and

a pain score generator configured to compute a composite pain score using the signal metric, the composite pain score being a quantitative measure of the pain;

a pain relief device configured to deliver one or more pain-relief therapies; and

a control circuit configured to control the delivery of the one or more pain-relief therapies using the composite pain score and therapy parameters.

2. The system of claim 1, wherein the pain monitoring circuit further comprises:

one or more physiological signal sensors configured to sense one or more physiological signals from the patient;

a physiological signal sensing circuit configured to process the one or more physiological signals;

a physiological parameter generator configured to generate the physiological parameter using the processed one or more physiological signals;

one or more functional signal sensors to sense one or more functional signals from the patient;

a functional signal sensing circuit configured to process the one or more functional signals; and

a functional parameter generator configured to generate the functional parameter using the processed one or more functional signals.

3. The system of claim 2, wherein the one or more physiological signal sensors comprises a sensor configured to sense a physiological signal indicative of change in sympathetic activity, and the physiological parameter generator is configured to generate a physiological parameter being a measure of the change in sympathetic activity.

4. The system of claim 2, wherein the one or more physiological signal sensors comprises a sensor configured to sense a physiological signal indicative of a neural activity, and the physiological parameter generator is configured to generate a physiological parameter being a measure of the neural activity.

5. The system of claim 2, wherein the one or more functional signal sensors comprises a sensor configured to sense a function signal indicative of a measure of movement or posture, and the functional parameter generator is configured to generate a functional parameter quantitatively indicative of the measure of movement or posture.

6. The system of claim 2, comprising an implantable medical device and an external device configured to be communicatively coupled to the implantable medical device, the implantable medical device including the pain monitoring circuit, the pain relief device, and the control circuit, and the control circuit comprises an implant control circuit, the external device including:

a patient information input device configured to receive patient information related to pain, the patient information input device including a patent input device configured to receive a parameter representative of intensity of the pain specified by the patient;

a patient information processing circuit configured to process the patient information; and

a patient parameter generator configured to generate the patient parameter using the processed patient information.

7. The system of claim 6, wherein the external device is configured to receive the composite pain score, to produce a notification using the composite pain score, to determine one or more recipients of the notification using the composite pain score, and to control delivery of the notification to each of the one or more recipients.

8. The system of claim 7, wherein the external device is configured to produce external commands for adjusting the therapy parameters using the composite pain score and the patient information and transmit the external commands to the implantable medical device, and the implant control circuit is configured to adjust the therapy parameters using the external commands.

9. The system of claim 1, wherein the parameter analyzer is further configured to allow the weighting factors to be adjusted manually.

10. A method for managing pain of a patient, comprising:

receiving at least two parameters selected from a physiological parameter indicative of a physiological function or state of the patient, a functional parameter indicative of a physical activity or state of the patient, and a patient parameter related to the pain automatically using a processor, the patient parameter including subjective information provided by the patient;

generating weighting factors;

generating a signal metric using the at least two parameters each weighted by applying a weighting factor of the weighting factors;

computing a composite pain score using the processor based on the signal metric, the composite pain score being a quantitative measure of the pain;

delivering one or more pain-relief therapies using a pain relief therapy device;

controlling the delivery of the one or more pain-relief therapies from the pain relief therapy device automatically using the processor based on the composite pain score and therapy parameters; and

adjusting the weighting factors by automatic adaptation to the patient over time.

11. The method of claim 10, further comprising:

sensing one or more physiological signals from the patient using one or more physiological signal sensors;

generating the physiological parameter based the one or more physiological signals using the processor;

sensing one or more functional signals from the patient using one or more functional signal sensors;

generating the functional parameter based the one or more functional signals using the processor; and

receiving a parameter representative of intensity of the pain from the patient.

12. The method of claim 11, wherein generating the physiological parameter comprises generating a measure of the change in sympathetic activity.

13. The method of claim 11, wherein generating the physiological parameter comprises generating a measure of a neural activity.

14. The method of claim 11, wherein generating the functional parameter comprises generating a functional parameter quantitatively indicative of a measure of movement or posture.

15. The method of claim 10, further comprising:

producing a notification using the composite pain score;

determining one or more recipients of the notification using the composite pain score and one or more specified thresholds; and

delivering the notification to each of the one or more recipients.

16. The method of claim 10, wherein delivering the one or more pain-relief therapies using the pain relief therapy device comprises delivering one or more of a neuromodulation therapy including electrical stimulation or a drug therapy from an implantable medical device.

17. The method of claim 16, further comprising adjusting the therapy parameters using the composite pain score and a patient command entered by the patient using an external device communicatively coupled to the implantable medical device.

18. The method of claim 10, further comprising adjusting the weighting factors dynamically based on at least one of conditions or activities of the patient.

19. The method of claim 10, further comprising performing an automatic adjustment of the weighting factors initiated by the patient.

20. A non-transitory computer-readable storage medium including instructions, which when executed by a system, cause the system to perform a method for managing pain of a patient, the method comprising:

receiving at least two parameters selected from a physiological parameter indicative of a physiological function or state of the patient, a functional parameter indicative of a physical activity or state of the patient, and a patient parameter related to the pain automatically using a processor, the patient parameter including subjective information provided by the patient;

generating weighting factors;

generating a signal metric using the at least two parameters each weighted by applying a weighting factor of the weighting factors;

computing a composite pain score using the processor based on the signal metric, the composite pain score being a quantitative measure of the pain;

delivering one or more pain-relief therapies using a pain relief therapy device;

controlling the delivery of the one or more pain-relief therapies from the pain relief therapy device automatically using the processor based on the composite pain score and therapy parameters and

adjusting the weighting factors by automatic adaptation to the patient over time.