Systems and methods for post-operative outcome monitoring

• US 10,445,466 B2
• Filed: 11/18/2015
• Issued: 10/15/2019
• Est. Priority Date: 11/18/2015
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Schulhauser, Randal, Brown, Richard L., Justis, Jeff R., Morrison, Matthew M., Cherry, Jeff M.
• Primary Examiner(s): Chng, Joy
• Assistant Examiner(s): Barr, Evangeline
• Application Number:
  US14/945,167
• Publication Number:
  US 20170140121A1
• Time in Patent Office: 1,427 Days
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 30/20 for handling medical images, e.g. DICOM, HL7 or PACS
• 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

A system including a range of motion module, a quality of sleep module, an overall module, and a control module. The range of motion module, subsequent to performing a procedure on a patient, determines a first range of motion score of the patient based on a signal generated by a sensor. The quality of sleep module, subsequent to performing the procedure on the patient, determines a first quality of sleep score or a first pain score based on the signal generated by the sensor. The overall module determines a combined score based on (i) the first range of motion score, and (ii) the first sleep score or the first pain score. The control module (i) determines whether an outcome of the procedure is positive based on the combined score, and (ii) stores the determined outcome and the combined score in a memory.

Claims

1. A spinal kinematics system for measuring objective parameters used to determine whether an outcome of a procedure is positive based on vertebral motion analysis of a patient, the system comprising:

at least one imaging sensor configured to image and measure vertebral displacement by measuring the displacement of one or more vertebra of the patient relative to one or more predetermined reference points;

at least one motion sensor configured detect motion using accelerometers to detect motion of the patient; and

a monitoring device that includes;

a wireless interface adapter in communication with and receives information from the at least one imaging sensor and the at least one motion sensor, and a control circuit having a processor and a memory and is configured to process information received from the at least one imaging sensor and the at least one motion sensor;

wherein the control circuit is further configured to determine, post-operation for the patient;

an activity score, based on the vertebral displacement measured by the at least one imaging sensor and the motion detected by the at least one motion sensor, that measures a rest-activity cycle of the patient for a predetermined activity period;

a quality of sleep score, based on information generated by the at least one motion sensor, that measures a number of sleep interruptions during a predetermined sleep period;

a cumulative activity score by summing weighted daily averages of a plurality of activity scores across a plurality of predetermined activity periods;

a cumulative quality of sleep score by summing weighted daily averages of a plurality of quality of sleep scores across a plurality of predetermined sleep periods;

a combined score by summing the cumulative activity score and the cumulative quality of sleep score; and

whether the outcome of the procedure is positive by comparing the combined score to a second combined score, the second combined score being determined for the patient prior to performing the procedure.

2. The system according to claim 1, further comprising:

at least one parametric sensor configured to measure one or more first parameters associated with the patient, wherein the quality of sleep score is further based on information generated by the at least one parametric sensor.

3. The system according to claim 2, wherein the one or more first parameters are selected from a list consisting of voltages, frequencies, current levels, durations, amplitudes, temperatures, impedances, resistances, and wavelengths.

4. The system according to claim 2, wherein the activity score is further based on one or more second parameters generated by the monitoring device using one or more of the first parameters generated by the at least one parametric sensor.

5. The system according to claim 4, wherein the one or more second parameters are selected from a list consisting of durations, oxygen levels, temperatures, impedances, pH levels, accelerations, amplitudes, heart rates, blood pressures, electro-cardiogram (ECG) parameters, respiratory parameters, body activity values, heart sounds, blood gas pH, red blood cell counts, white blood cell counts, and electro-encephologram (EEG) parameters.

6. The system according to claim 1, wherein the at least one motion sensor is a three-axis motion sensor or nine-axis motion sensor.

7. The system according to claim 1, wherein the activity score is further determined by measuring a size of a radius of an arc formed by a curvature of a spine of the patient.

8. The system according to claim 1, wherein the activity score and the quality of sleep score are determined based on a scale of 0 to 10.

9. The system according to claim 1, wherein the control circuit further comprises a posture circuit which analyses information generated by the at least one imaging sensor and the at least one motion sensor, wherein the control circuit is further configured to determine:

a posture state of the patient, using the posture circuit, based on information generated by the at least one imaging sensor and the at least one motion sensor;

a motion score based on information generated by the at least one motion sensor; and

a pain score based on the number of sleep interruptions,

wherein the activity score of the patient is further determined based on the posture state of the patient, and the activity score; and

the quality of sleep score of the patient is further determined based on the posture state of the patient, and the pain score.

10. The system according to claim 9, wherein the control circuit further comprises a prone circuit which analyses information generated by the at least one imaging sensor and the at least one motion sensor, and wherein the control circuit is further configured to determine:

whether the patient is in a prone state using the prone circuit;

the quality of sleep score if the patient is in the prone state; and

the activity score if the patient is not in the prone state.

11. A method for measuring, post-operation for a patient, objective parameters used to determine whether an outcome of a procedure is positive based on vertebral motion analysis of the patient for use in a spinal kinematics system, the method comprising:

measuring, using at least one imaging sensor, vertebral displacement by measuring the displacement of one or more vertebra of the patient relative to one or more predetermined reference points;

detecting, using at least one motion sensor, motion of the patient, the at least one motion sensor comprising an accelerometer;

calculating, based on the measured vertebral displacement and the detected motion, an activity score that measures a rest-activity cycle of the patient for a predetermined activity period;

calculating, based on the detected motion, a quality of sleep score that measures a number of sleep interruptions during a predetermined sleep period;

determining a cumulative activity score based on weighted daily averages of a plurality of activity scores across a plurality of predetermined activity periods;

determining a cumulative quality of sleep score based on weighted daily averages of a plurality of quality of sleep scores across a plurality of predetermined sleep periods;

determining a combined score by calculating the sum of the cumulative activity score and the cumulative quality of sleep score; and

determining whether the outcome of the procedure is positive by comparing the combined score to a second combined score, the second combined score being determined for the patient prior to performing the procedure.

12. The method according to claim 11, further comprising measuring, using at least one parametric sensor, one or more first parameters associated with the patient, wherein the quality of sleep score is further based on the one or more first parameters.

13. The method according to claim 12, wherein the first parameters are selected from a list consisting of voltages, frequencies, current levels, durations, amplitudes, temperatures, impedances, resistances, and wavelengths.

14. The method according to claim 12, further comprising generating, based on the one or more first parameters, one or more second parameters, wherein the activity score is further based on the one or more second parameters.

15. The method according to claim 14, wherein the second parameters are selected from a list consisting of durations, oxygen levels, temperatures, impedances, pH levels, accelerations, amplitudes, heart rates, blood pressures, electro-cardiogram (ECG) parameters, respiratory parameters, body activity values, heart sounds, blood gas pH, red blood cell counts, white blood cell counts, and electro-encephologram (EEG) parameters.

16. The method according to claim 11, wherein the at least one motion sensor is a three-axis motion sensor or nine-axis motion sensor.

17. The method according to claim 11, further comprising measuring a spinal curvature of the patient based on a size of a radius of an arc formed by a curvature of a spine, wherein the activity score is determined using the spinal curvature.

18. The method according to claim 11, wherein the control circuit further comprises a posture circuit which analyses information generated by the at least one imaging sensor and the at least one motion sensor, the method further comprising:

determining, using the posture circuit, a posture state of the patient based on information generated by the at least one imaging sensor and the at least one motion sensor;

determining a motion score based the motion detected by the at least one motion sensor; and

determining a pain score based on the number of sleep interruptions,

further determining the activity score based on the posture state of the patient, and the activity score; and

further determining the quality of sleep score of the patient based on the posture state of the patient, and the pain score.

19. The method according to claim 18, wherein the control circuit further comprises a prone circuit which analyses information generated by the at least one imaging sensor and the at least one motion sensor, the method further comprising:

determining whether the patient is in a prone state using the prone circuit;

determining the quality of sleep score if the patient is in the prone state; and

determining the activity score if the patient is not in the prone state.

20. The method according to claim 19, further comprising predicting an outcome of a second procedure based on the determined outcome and the combined score.