Patient temperature response control system and method

• US 9,763,823 B2
• Filed: 09/24/2015
• Issued: 09/19/2017
• Est. Priority Date: 11/16/2007
• Status: Active Grant

• Current Assignee: Medivance Incorporated (Becton, Dickinson & Co)
• Original Assignee: Medivance Incorporated (Becton, Dickinson & Co)
• Inventors: Voorhees, Marc, Carson, Gary A., Gruszecki, Gary
• Primary Examiner(s): Hoekstra, Jeffrey G
• Assistant Examiner(s): ABOUELELA, MAY A
• Application Number:
  US14/864,532
• Publication Number:
  US 20160008166A1
• Time in Patent Office: 726 Days
• Field of Search: 600300, 600301, 600587, 600595
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1101 Detecting tremor
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 5/68335 including release sheets or liners
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 7/0097 Blankets with active heating or cooling sources warming mats A61F7/08
• CPC Class Codes: A61F 7/02 Compresses or poultices for effecting heating or cooling

Abstract

A system and method are provided that employ a monitoring device to monitor at least one patient physiological response to a change in temperature of the patient (e.g. pursuant to induced hypothermia therapy), wherein a monitoring signal is provided by the monitoring device. In turn, an output (e.g. a visual and/or auditory output) may be provided to a user indicative of at least one measure of patient response to the change in temperature. Alternatively or additionally, a processor may be provided to process the monitoring signal and provide an output employable by medical personnel to control a patient shivering response to the patient temperature change. Such information may comprise information regarding one or more anti-shivering medicament(s), e.g. corresponding dosage and/or frequency information for use by medical personnel in the administration of the anti-shivering medicament. In one approach, a motion sensor may be selectively attached to a patient'"'"'s chin to provide a wireless monitoring signal to a transceiver. In turn, the transceiver may provide the monitoring signal to the processor on an ongoing basis to output information useful in the administration of an anti-shivering medicament, including updated information that takes into account a patient'"'"'s response to a prior administration of one or more medicaments in conjunction with the subsequent administration of an anti-shivering medicament.

Claims

1. A system for use in a patient cooling therapy procedure, comprising:

a monitoring device comprising a three-axis accelerometer for monitoring patient shivering and for providing a monitoring signal responsive thereto, wherein the monitoring device is selectively interconnectable to and disconnectable from a patient, wherein the monitoring device is maintainable in fixed relation to a patient upon interconnection, and wherein said monitoring signal is indicative of acceleration in three dimensions as a function of time and comprises a stream of sequential data sets;

a control unit configurable to cool and circulate a fluid through at least one contact pad for thermal exchange with a patient;

at least one processor programmed to;

control automatically a temperature of the circulated fluid so as to adjust a temperature of a patient during at least a portion of a patient cooling therapy procedure; and

,

process said monitoring signal utilizing frequency domain processing to provide an output control signal indicative of a magnitude of patient shivering, wherein in said process said at least one processor is programmed to process a plurality of frames of said sequential data sets on an ongoing basis to determine spectral data corresponding with each different one of said plurality of frames of said sequential data sets, wherein each frame of said plurality of frames of said sequential data sets comprises a plurality of said sequential data sets, wherein sequential ones of said plurality of said frames of said sequential data sets are partially overlapping and partially non-overlapping, and wherein for said plurality of frames of said sequential data sets the at least one processor is programmed to collect and analyze spectral data sets corresponding with each different one of a plurality of different, predetermined frequency bands to detect said magnitude of patient shivering; and

,

a user interface to graphically display, on an ongoing basis as a function of time during a patient cooling therapy procedure, each of the following;

a predetermined patient temperature adjustment rate plot indicating a desired patient temperature to be reached as a function of time;

a measured patient temperature plot indicating a measured patient temperature as a function of time; and

,

patient motion data, responsive to said output control signal, indicating a magnitude of patient shivering, as a function of time, wherein said patient motion data is displayed in relation to a predetermined magnitude scale having a plurality of predetermined levels of patient motion indicative of increasing degrees of patient shivering.

2. A system as recited in claim 1, wherein said user interface graphically displays, on an ongoing basis as a function of time during a patient cooling therapy procedure, a measured circulated fluid temperature plot indicating a measured temperature of said circulated fluid as a function of time.

3. A system as recited in claim 2, wherein said user interface provides a screen that includes:

a graphic display portion that graphically displays said predetermined patient temperature adjustment rate plot, said measured patient temperature plot, and said measured circulated fluid temperature plot in a first region of the graphic display portion, relative to a temperature scale and time scale.

4. A system as recited in claim 3, wherein said graphic display portion graphically displays said patient motion data in a second region of the graphic display portion, relative to said time scale.

5. A system as recited in claim 1, wherein said at least one processor is programmed to:

control automatically a temperature of the circulated fluid so as to cool and warm a patient in different treatment phases in accordance with a predetermined and controllable protocol.

6. A system as recited in claim 1, wherein each of said sequential data sets comprises data corresponding with a measured magnitude related to acceleration in each of said three dimensions.

7. A system as recited in claim 6, wherein for each frame of said plurality of frames said at least one processor is programmed to:

de-interleave said frame to obtain three data portions corresponding with each of said three dimensions;

window said three data portions; and

,

transform the three windowed data portions to obtain three corresponding frequency domain data portions.

8. A system as recited in claim 7, wherein for each frame of said plurality of frames said at least one processor is programmed to:

utilize the three corresponding frequency domain data portions to obtain said corresponding spectral output.

9. A system as recited in claim 8, wherein for each frame of said plurality of frames the at least one processor is programmed to:

analyze the spectral data sets corresponding with each of said plurality of different, predetermined frequency bands to determine a mean square energy value, a peak energy value and a crest factor; and

,

compare the mean square energy values, peak energy values, and crest factor values for each of the plurality of different, predetermined frequency bands to one another or with previously determined, corresponding values to detect a degree of motion corresponding with patient shivering.

10. A system as recited in claim 1, wherein said plurality of different, predetermined frequency bands includes at least a predetermined first frequency band and a different, predetermined second frequency band, wherein only one of said predetermined first frequency band and said predetermined second frequency band includes a frequency of 9.5 Hz.

11. A system as recited in claim 1, wherein said plurality of different, predetermined frequency bands includes at least three non-overlapping frequency bands, only one of which includes a frequency of 9.5 Hz.

12. A system as recited in claim 1, further comprising:

at least one of a battery and a wireless energy conversion device, interconnected to said monitoring device for direct co-movement therewith, for powering said monitoring device free from hardwire interconnection with a power source.

13. A system as recited in claim 12, wherein said at least one of a battery and a wireless energy conversion device being one of directly connected to said monitoring device and interconnected to a common support member together with said monitoring device for co-movement therewith.

14. A system as recited in claim 12, further comprising:

a transmitter for transmission of a wireless signal corresponding with said monitoring signal, wherein said transmitter comprises an antenna and is interconnected to said monitoring device for co-movement therewith.

15. A system as recited in claim 1, wherein said processor is operable to employ said monitoring signal to generate an input for use in controlling the temperature of the circulated fluid.

16. A system for use in a patient cooling therapy procedure, comprising:

a monitoring device comprising a three-axis accelerometer for monitoring patient shivering and for providing a monitoring signal responsive thereto, wherein the monitoring device is selectively interconnectable to and disconnectable from a patient, wherein the monitoring device is maintainable in fixed relation to a patient upon interconnection, and wherein said monitoring signal is indicative of acceleration in three dimensions as a function of time and comprises a stream of sequential data sets;

a control unit configurable to cool and circulate a fluid through at least one contact pad for thermal exchange with a patient;

at least one processor programmed to;

control automatically a temperature of the circulated fluid so as to adjust a temperature of a patient during at least a portion of a patient cooling therapy procedure;

process said monitoring signal utilizing frequency domain processing to provide an output control signal indicative of a magnitude of patient shivering, wherein in said process said at least one processor is programmed to process a plurality of frames of said sequential data sets on an ongoing basis to determine spectral data corresponding with each different one of said plurality of frames of said sequential data sets, wherein each frame of said plurality of frames of said sequential data sets comprises a plurality of said sequential data sets, wherein sequential ones of said plurality of said frames of said sequential data sets are partially overlapping and partially non-overlapping, and wherein for said plurality of frames of said sequential data sets the at least one processor is programmed to collect and analyze spectral data sets corresponding with each different one of a plurality of different, predetermined frequency bands to detect said magnitude of patient shivering; and

,

a user interface to graphically display, on an ongoing basis, patient motion data, responsive to said output control signal, and indicative of a magnitude of patient shivering, wherein said patient motion data is displayed in relation to a predetermined magnitude scale having a plurality of predetermined levels of patient motion indicative of increasing degrees of patient shivering.

17. A system as recited in claim 16, wherein said user interface displays said patient motion data as a function of time.

18. A system as recited in claim 16, wherein each of said sequential data sets comprises data corresponding with a measured magnitude related to acceleration in each of said three dimensions.

19. A system as recited in claim 18, wherein for each frame of said plurality of frames said at least one processor is programmed to:

de-interleave said frame to obtain three data portions corresponding with each of said three dimensions;

window said three data portions; and

,

transform the three windowed data portions to obtain three corresponding frequency domain data portions.

20. A system as recited in claim 19, wherein for each frame of said plurality of frames said at least one processor is programmed to:

utilize the three corresponding frequency domain data portions to obtain a corresponding spectral output.

21. A system as recited in claim 16, wherein said plurality of different, predetermined frequency bands includes at least a predetermined first frequency band and a different, predetermined second frequency band, wherein only one of said predetermined first frequency band and said predetermined second frequency band includes a frequency of 9.5 Hz.

22. A system as recited in claim 16, wherein said plurality of different, predetermined frequency bands includes at least three non-overlapping frequency bands, only one of which includes a frequency of 9.5 Hz.

23. A system as recited in claim 16, wherein for each frame of said plurality of frames the at least one processor is programmed to:

analyze the spectral data sets corresponding with each of said plurality of different, predetermined frequency bands to determine a mean square energy value, a peak energy value and a crest factor; and

,

compare the mean square energy values, peak energy values, and crest factor values for each of the plurality of different, predetermined frequency bands to one another or with previously determined, corresponding values to detect a degree of motion corresponding with patient shivering.