Systems and methods for closed-loop pain management

• US 10,610,688 B2
• Filed: 09/21/2017
• Issued: 04/07/2020
• 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: Thakur, Pramodsingh Hirasingh, Gu, Jianwen, Clark, Bryan Allen, Ternes, David J., Perschbacher, David L., Kleinedler, James John, Annoni, Elizabeth M.
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US15/711,578
• Publication Number:
  US 20180085584A1
• Time in Patent Office: 929 Days
• Field of Search: 607 46
• 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 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

Systems and methods for managing pain in patient are described. A system may include sensors configured to sense physiological or functional signals, and a pain analyzer to generate signal metrics from the physiological or functional signals. The pain analyzer also generates weight factors corresponding to the signal metrics. The weight factors may indicate the signal metrics reliability in representing an intensity of the pain. The pain analyzer generates a pain score using a plurality of signal metrics and a plurality of weight factors. The pain score may be output to a user or a process. The system may additionally include an electrostimulator to generate and deliver closed-loop pain therapy according to the pain score.

Claims

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

two or more sensors configured to respectively sense two or more signals from the patient, the signals including a physiological or functional signal from the patient;

a pain analyzer coupled to the two or more sensors, the pain analyzer configured to;

generate a plurality of signal metrics from the sensed two or more signals and a plurality of weight factors corresponding to the plurality of signal metrics, the weight factors indicating the corresponding signal metrics reliability in representing an intensity of the pain; and

generate a pain score using a combination of the plurality of signal metrics each weighted by the corresponding weight factor; and

an output unit configured to output the pain score to a user or a process.

2. The system of claim 1, further comprising:

an electrostimulator configured to generate electrostimulation energy to treat pain; and

a controller coupled to the pain analyzer and the electrostimulator, the controller configured to control the electrostimulator to deliver a pain therapy, including controlling the electrostimulation energy generated by the electrostimulator according to the pain score.

3. The system of claim 1, wherein the electrostimulator is configured to deliver spinal cord stimulation (SCS) via one or more electrodes positioned at a target site on or near a spinal cord of the patient.

4. The system of claim 1, wherein:

the physiological signal is selected from the group of signals consisting of;

a heart rate signal;

a heart rate variability signal;

a heart sounds signal;

a thoracic impedance signal;

a respiration signal; and

one or more biochemical signals; and

the functional signal is selected from the group of signals consisting of;

a posture;

a gait;

a balance indicator; and

a physical activity.

5. The system of claim 1, wherein the pain analyzer includes a weight generator configured to:

compute correlations between a plurality of quantified pain scales and measurements of the plurality of signal metrics corresponding to the plurality of quantified pain scales; and

determine or adjust the weight factors to be proportional to the correlations.

6. The system of claim 5, including a memory configured to store the plurality of quantified pain scales including quantification of one or more historical pain episodes;

and

wherein the weight generator is configured to determine the correlations between (1) the quantification of the one or more historical pain episodes and (2) the plurality of signal metrics measured during the one or more historical pain episodes.

7. The system of claim 5, including a user interface configured to receive user input of the plurality of quantified pain scales when the electrostimulator delivers programmed electrostimulation energy to induce one or more pain episodes;

and

wherein the weight generator is configured to determine the correlations between (1) the user input of the plurality of quantified pain scales and (2) the plurality of signal metrics measured during the one or more induced pain episodes.

8. The system of claim 5, wherein the pain analyzer is configured to determine or adjust the respective weight factors further based on patient demographic information.

9. The system of claim 5, wherein the pain analyzer is configured to:

determine, for the plurality of signal metrics, respective signal sensitivity to pain; and

determine or adjust the respective weight factors further using the signal sensitivity to pain,

wherein the signal sensitivity to pain includes a rate of change of the signal metrics over time during a pain episode.

10. The system of claim 9, wherein the pain analyzer is configured to generate the pain score using a combination of comparisons between the plurality of the signal metrics and respective threshold values, wherein the threshold values are proportional to the signal sensitivity to pain.

11. The system of claim 5, wherein the pain analyzer is configured to:

generate a projection vector using (1) a first covariance matrix of first plurality of signal metrics generated from the physiological or functional signals sensed during a historical or induced pain episode with a first pain scale and (2) a second covariance matrix of second plurality of the signal metric generated from the physiological or functional signals sensed during a historical or induced pain episode with a second pain scale; and

generate the pain score including a projection of the sensed plurality of the signal metrics along a direction of the projection vector.

12. The system of claim 1, wherein the pain analyzer is configured to differentiate chronic pain from acute pain based on an abruptness of signal metric change over a specified time period.

13. The system of claim 1, including an implantable neuromodulator device (IND) and an external system communicatively coupled to the IND, wherein:

the IND includes at least a portion of the pain analyzer, the electrostimulator, and sensor circuits coupled to the two or more sensors; and

the external system includes the weight generator and a programmer configured to program the electrostimulator including programming the pain therapy according to the pain score.

14. A method for managing pain in a patient using an implantable neuromodulator device (IND), the method comprising:

sensing two or more signals from the patient via two or more sensors, the signals including physiological or functional signals;

generating a plurality of signal metrics from the sensed two or more signals;

generating a plurality of weight factors corresponding to the plurality of signal metrics, the weight factors indicating the corresponding signal metrics'"'"' reliability in representing an intensity of the pain;

generating a pain score using a combination of the plurality of signal metrics each weighted by the corresponding weight factor; and

delivering a pain therapy via the IND, the pain therapy including electrostimulation energy determined according to the pain score.

15. The method of claim 14, wherein the pain therapy includes spinal cord stimulation (SCS) of a target site on or near a spinal cord of the patient.

16. The method of claim 14, wherein the determination of the electrostimulation energy includes increasing the electrostimulation energy in response to the pain score exceeding a threshold, or decreasing the electrostimulation energy in response to the pain score falling below a threshold.

17. The method of claim 14, wherein generating a plurality of weight factors includes:

computing correlations between a plurality of quantified pain scales and measurements of the plurality of signal metrics corresponding to the plurality of quantified pain scales; and

determining or adjusting the weight factors to be proportional to the correlations.

18. The method system of claim 14, further comprising generating a projection vector using (1) a first covariance matrix of first plurality of signal metrics generated from the physiological or functional signals sensed during a historical or induced pain episode with a first pain scale and (2) a second covariance matrix of second plurality of the signal metric generated from the physiological or functional signals sensed during a historical or induced pain episode with a second pain scale;

wherein generating the pain score includes computing a projection of the sensed plurality of the signal metrics along a direction of the projection vector.

19. At least one non-transitory machine-readable medium including instructions that, when executed by a machine, cause the machine to:

receive two or more signals sensed from a patient, the signals including physiological or functional signals;

generate a plurality of signal metrics from the received two or more signals;

generate a plurality of weight factors corresponding to the plurality of signal metrics, the weight factors indicating the corresponding signal metrics'"'"' reliability in representing an intensity of the pain;

generate a pain score using a combination of the plurality of signal metrics each weighted by the corresponding weight factor; and

deliver a pain therapy via an implantable neuromodulator device, the pain therapy including electrostimulation energy determined according to the pain score.

20. The at least one non-transitory machine-readable medium of claim 19, wherein the instructions, when performed by the machine, cause the machine to:

increase the electrostimulation energy in response to the pain score exceeding a threshold;

or

decrease the electrostimulation energy in response to the pain score falling below a threshold.