# US 10,307,288 B2 · Methods and apparatus for optimizing therapeutic temperature control

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- Number: US 10,307,288 B2
- Document ID: US10307288B2
- Status: Granted
- Kind: B2
- Application number: 15/307,690
- Filed: 2015-04-29
- Published: 2017-02-23
- Granted: 2019-06-04
- Earliest claimed: 2014-04-29
- Assignees: The Regents of the University of Michigan
- Applicants: Hasan Alam; Kevin Ward; Kyle Gunnerson; Kayvan Najarian
- Inventors: Kevin Ward; Kyle Gunnerson; Kayvan Najarian
- Web page: https://patentgrep.com/patent/US10307288B2

## CPC

- A61F 7/12: Devices for heating or cooling internal body cavities
- A61B 3/113: for determining or recording eye movement
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/14551: {for measuring blood gases}
- A61B 5/383: Somatosensory stimuli, e.g. electric stimulation
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/6852: {Catheters}
- A61B 5/7267: {involving training the classification device}
- A61F 7/02: Compresses or poultices for effecting heating or cooling
- A61F 7/08: Warming pads, pans or mats; Hot-water bottles
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/02405: {Determining heart rate variability}
- A61B 5/0533: Measuring galvanic skin response
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/412: {Detecting or monitoring sepsis}
- A61B 2505/01: Emergency care
- A61F 2007/0093: {programmed}
- A61F 2007/0094: {using a remote control}
- A61F 2007/0096: {with a thermometer}
- A61F 2007/126: {for invasive application, e.g. for introducing into blood vessels}
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Vascular pressures and oximetry are optimized through administration of fluids and other support prior to manipulating temperature in a therapeutic hypothermia procedure. Temperature and active hemodynamic management are utilized, through measurement and adjustment of temperature and hemodynamic parameters through the use of an internal cooling device, such as endovascular catheter, and/or an external temperature-altering device, to ensure that temperature management is optimized, and hemodynamics and tissue resuscitation are optimized prior to and during temperature manipulation.

## Claims

### Claim 1

A system for performing therapeutic hypothermia, comprising:
a controller;
one or more sensors and devices for at least one of measuring or adjusting hemodynamic parameters;
at least one of a group of an external pulse oximeter or an indwelling arterial catheter capable of continuous blood gas measurements;
an endovascular catheter providing oximetric values, wherein said one or more sensors and devices, and said endovascular catheter, are operatively controlled by said controller; and
said external pulse oximeter or said indwelling arterial catheter providing oxygen saturation data combinable with the oximetric values from the endovascular catheter to determine an oxygen extraction ratio (OER), the controller being operable to control the endovascular catheter to regulate temperature control based on the determined OER.

### Claim 2 (depends on 1)

The system of claim 1 wherein one or more of said one or more sensors and devices and said endovascular catheter are connected with said controller by wireless communication.

### Claim 3 (depends on 1)

The system of claim 1, wherein said controller comprises one of a group of a stable multi-input multi-output (MIMO) fuzzy neural model controller, an optimal controller, an H-Infinity (robust) controller, a linear adaptive controller, a neural (non-fuzzy) controller, a PID controller, and a model-based controller.

### Claim 4 (depends on 1)

The system of claim 1, wherein said controller is configured to receive and process one or more of: desired values of hemodynamic and physiological parameters for a patient; actual values of hemodynamic and physiological parameters for said patient; error signals; and heuristic knowledge.

### Claim 5 (depends on 1)

The system of claim 1, wherein said system further comprises an update law unit.

### Claim 6 (depends on 1)

The system of claim 1, further comprising external means for cooling or warming said patient.

### Claim 7 (depends on 6)

The system of claim 6, wherein said external means includes heating or cooling pads as alternative to or adjuncts to endovascular temperature methods.

### Claim 8 (depends on 1)

The system of claim 1, wherein said one or more sensors and devices include an intravenous infusion system.

### Claim 9 (depends on 8)

The system of claim 8, wherein said intravenous infusion system is a medication or fluid delivery intravenous infusion system.

### Claim 10 (depends on 1)

The system of claim 1, further comprising an external temperature-altering device including at least one of a cooling surface, a cooling blanket, a cooling pad, a cooling pillow, a cooling wrap, a cooling garment, an evaporative cooling method, a heating surface, a heating blanket, a heating pad, a heating pillow, a heating wrap, or a heating garment.

### Claim 11 (depends on 1)

The system of claim 1, wherein the one or more sensors and devices for at least one of measuring or adjusting hemodynamic parameters includes sensors of at least one of a group including neural activity, consciousness, circadian physiology, and attentiveness.

### Claim 12

A method of performing therapeutic temperature management, comprising:
measuring and adjusting hemodynamic parameters in a patient;
determining an oxygen extraction ratio (OER) using oximetry values from an endovascular catheter and arterial saturation data provided by one of an external pulse oximeter or an indwelling arterial catheter capable of continuous blood gas measurement; and
adjusting temperature in said patient using at least one of an internal temperature-altering device or external temperature-altering device, based on the OER.

### Claim 13 (depends on 12)

The method of claim 12, wherein the internal temperature-altering device includes an endovascular catheter.

### Claim 14 (depends on 12)

The method of claim 12, wherein the external temperature-altering device includes at least one of a cooling surface, a skin cooling pad, a cooling blanket, a cooling pad, a cooling pillow, a cooling wrap, a cooling garment, an evaporative cooling method, a heating surface, a skin heating pad, a heating blanket, a heating pad, a heating pillow, a heating wrap, or a heating garment.

### Claim 15 (depends on 12)

The method of claim 12, wherein said measuring and adjusting includes measuring one or more of vascular pressure and oximetric measurements.

### Claim 16 (depends on 15)

The method of claim 15 wherein said measuring and adjusting includes measuring one or more of central venous hemoglobin saturation, central venous pressure, oxygen extraction ratio, pulse oximetry, transcutaneous CO2 end-tidal CO2 skin temperature flux, galvanic skin response, transcutaneous PO2 variations of Heart Rate Variability, cardiac output, stroke volume variation, pulse volume variation, central venous pressure, tissue hemoglobin oxygen saturation, cerebral hemoglobin oxygen saturation, EEG, transcranial Doppler, somatosensory evoked potential, breathing rate, auditory evoked potentials, actigraphy, and eye movement.

### Claim 17 (depends on 15)

The method of claim 15 wherein the measured and adjusted variables are correlated to a state of precision and optimized physiologic endpoints including at least one of a group comprising metabolism, cardiovascular function, and at least one neurologic state.

### Claim 18 (depends on 12)

The method of claim 12 further comprising the step of controlling one or more of a skin heating pad or a skin cooling pad.

### Claim 19 (depends on 12)

The method of claim 12 wherein said measuring and adjusting includes measuring and adjusting one or more of central venous hemoglobin saturation, central venous pressure, oxygen extraction ratio, pulse oximetry, transcutaneous CO2 end-tidal CO2 skin temperature flux, galvanic skin response, transcutaneous PO2 variations of Heart Rate Variability, cardiac output, stroke volume variation, pulse volume variation, central venous pressure, tissue hemoglobin oxygen saturation, cerebral hemoglobin oxygen saturation, EEG, and transcranial Doppler.