Systems and methods for pre-operative procedure determination and outcome predicting

• US 10,665,337 B2
• Filed: 05/13/2019
• Issued: 05/26/2020
• 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., Morrison, Matthew M., Kinzie, Patrick W., VanRaaphorst, Jeffrey R., Byrne, Emily C.
• Primary Examiner(s): Hein, Devin C
• Application Number:
  US16/410,488
• Publication Number:
  US 20190304585A1
• Time in Patent Office: 379 Days
• Field of Search: None
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• 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 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A system including a range of motion, quality of sleep, overall, and control modules. The range of motion module, prior to a procedure being performed on a patient, determines a first range of motion score of the patient based on a first signal generated by a sensor. The quality of sleep module, prior to the procedure being performed on the patient, determines a first quality of sleep score or a first pain score based on the first signal. The overall module determines a combined score based on the first range of motion score and the first quality of sleep score or the first pain score. The control module compares the combined score to a predetermined threshold and predicts an outcome of the procedure based on the comparison. The control module, based on the combined score, determines whether to perform the procedure, adjust the procedure or refrain from performing the procedure.

Claims

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

at least one imaging sensor configured to image and measure vertebral displacement;

at least one motion sensor configured to detect motion of a patient; and

a monitoring device that comprises;

a wireless interface adapter in communication with and which 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;

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

a combined baseline score calculated using at least the cumulative activity score; and

whether the procedure is recommended by comparing the combined baseline score to one or more predetermined cut-points, wherein a higher baseline score indicates the procedure is likely to be successful.

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

3. 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.

4. 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 control circuit determines a quality of sleep score, based on information generated by the at least one motion sensor and by the at least one parametric sensor, that measures a number of sleep interruptions during a predetermined sleep period generated,

wherein the control circuit determines 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, and

wherein the control circuit determines the combined baseline score by calculating the sum of the cumulative activity score and the cumulative quality of sleep score.

5. The system according to claim 4, wherein the activity score and the quality of sleep score are determined based on a scale of 0 to 10.

6. The system according to claim 4 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.

7. The system according to claim 4 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.

8. The system according to claim 7 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.

9. The system according to claim 4, 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 (i) the posture state of the patient, and (ii) the activity score; and

the quality of sleep score of the patient is further determined based on (i) the posture state of the patient, and (ii) 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 objective parameters used to determine a predicted outcome of a procedure based on vertebral motion analysis of a patient for use in a spinal kinematics system, the method comprising:

measuring, using at least one imaging sensor, vertebral displacement;

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

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;

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 combined baseline score calculated using at least the cumulative activity score; and

determining whether the procedure is recommended by comparing the combined baseline score to one or more predetermined cut-points, wherein a higher baseline score indicates the procedure is likely to be successful.

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

13. 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.

14. The method according to claim 11, wherein the activity score and the quality of sleep score are determined based on a scale of 0 to 10.

15. The method according to claim 11, further comprising:

measuring, using at least one parametric sensor, one or more first parameters associated with the patient;

calculating, based on the detected motion and one or more of the first parameters, a quality of sleep score that measures a number of sleep interruptions during a predetermined sleep period;

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; and

determining the combined baseline score by calculating the sum of the cumulative activity score and the cumulative quality of sleep score.

16. The method according to claim 15 wherein the first parameters are selected from a list consisting of voltages, frequencies, current levels, durations, amplitudes, temperatures, impedances, resistances, and wavelengths.

17. The method according to claim 15 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.

18. The method according to claim 17 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.

19. The method according to claim 15 further comprising:

determining, using a posture circuit which analyses information generated by the at least one imaging sensor and the at least one motion sensor, 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 (i) the posture state of the patient, and (ii) the activity score; and

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

20. The method according to claim 19 further comprising:

determining whether the patient is in a prone state using a prone circuit which analyses information generated by the at least one imaging sensor and the at least one motion sensor;

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.