WO2017035341A1 - Procédés et dispositifs pour gestion de la température corps de noyau - Google Patents

Procédés et dispositifs pour gestion de la température corps de noyau Download PDF

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Publication number
WO2017035341A1
WO2017035341A1 PCT/US2016/048669 US2016048669W WO2017035341A1 WO 2017035341 A1 WO2017035341 A1 WO 2017035341A1 US 2016048669 W US2016048669 W US 2016048669W WO 2017035341 A1 WO2017035341 A1 WO 2017035341A1
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WO
WIPO (PCT)
Prior art keywords
thermal
patient
glabrous
area
core body
Prior art date
Application number
PCT/US2016/048669
Other languages
English (en)
Inventor
David Brian Marquette
Adam Joseph Steinman
Original Assignee
Gentherm Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gentherm Inc. filed Critical Gentherm Inc.
Publication of WO2017035341A1 publication Critical patent/WO2017035341A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/002—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches with controlled internal environment
    • A41D13/005—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches with controlled internal environment with controlled temperature
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/12—Surgeons' or patients' gowns or dresses
    • A41D13/1236—Patients' garments
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/12—Surgeons' or patients' gowns or dresses
    • A41D13/1236—Patients' garments
    • A41D13/1281—Patients' garments with incorporated means for medical monitoring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0029—Arm or parts thereof
    • A61F2007/0034—Lower arm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0029—Arm or parts thereof
    • A61F2007/0036—Hand
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0039—Leg or parts thereof
    • A61F2007/0045—Foot
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0054—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A61F2007/0075—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating using a Peltier element, e.g. near the spot to be heated or cooled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0095—Heating or cooling appliances for medical or therapeutic treatment of the human body with a temperature indicator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A61F2007/0225—Compresses or poultices for effecting heating or cooling connected to the body or a part thereof
    • A61F2007/0233—Compresses or poultices for effecting heating or cooling connected to the body or a part thereof connected to or incorporated in clothing or garments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A61F2007/0225—Compresses or poultices for effecting heating or cooling connected to the body or a part thereof
    • A61F2007/0239—Compresses or poultices for effecting heating or cooling connected to the body or a part thereof using vacuum

Definitions

  • the present disclosure relates to thermophysiology, and more particularly to methods and devices for managing the core body temperature of patients based on applying targeted heating or cooling to glabrous skin areas.
  • Cooling of human or other mammalian skin can provide one or more benefits, particularly in situations or circumstances where a subject's skin and/or body temperature is elevated relative to normal, acceptable, comfortable and/or safe levels.
  • a person's skin and/or body temperature may be dangerously high because of fever and/or another medical condition (e.g., infection, allergy or other adverse reaction, disease, etc.).
  • a subject's temperature may be elevated due to exposure to heat or sun and/or other source of heat (e.g., workspace).
  • it may be desirable to heat a person's skin or other anatomical location either in lieu of or in addition to cooling, as desired or required.
  • heating can be used to treat hypothermia, chills and/or any other condition or ailment.
  • Anesthesia compromises patients' ability to thermoregulate to their normal core body temperature. Because anesthesia can cause the bodily temperature of patients to drop, medical practitioners may wish to control a patient's core temperature during and/or after a surgical procedure.
  • BAIR HUGGER In the context of surgical procedures, one device that has been used to control core temperature is the "BAIR HUGGER" from 3M.
  • the device which works like a forced-air heater, carries warmed air through a hose to a special blanket that is draped over a patient.
  • the BAIR HUGGER is often used to cover large bodily areas (e.g., a patient's entire torso or entire lower body), which can obstruct access to various bodily areas during a surgical procedure. Also, because of its size, the BAIR HUGGER can be impractical to use in many environments.
  • thermoregulatory structure facilitates direct heat transfer between the body core and the external environment.
  • thermoregulatory system which allow blood flow from the arteries to the veins, are called arteriovenous anastomoses (AVAs).
  • AVAs arteriovenous anastomoses
  • the AVAs enable a significant increase in blood flow beneath the skin in glabrous regions.
  • the function of these vascular structures has only recently been appreciated, and fine anatomy of unique vascular structures has only recently been characterized. Dilation and contraction of the AVAs are controlled by the body's thermoregulatory system.
  • the AVAs dilate to increase blood flow near the skin surface, thereby increasing heat loss to the environment.
  • the AVAs constrict, decreasing blood flow, allowing the body to conserve more of its metabolic heat.
  • the unique vascular structures enable these adjustments of blood flow to glabrous skin.
  • the unique vascular structures are composed of AVAs and a dense network of interwoven venous structures.
  • the AVAs are direct shunts between arteries and veins that bypass capillaries, and provide a low-resistance pathway for the movement of blood through the glabrous skin regions.
  • the receiving venous structures (retia venosa) are arranged in a plexus or large network of vessels that have a large surface-to- volume ratio and can contain a large volume of blood. Thus, the venous plexus acts as a radiator.
  • the AVAs are gated by smooth muscle.
  • vasomotor tone defines the condition in which the AVAs are open and blood is flowing freely through the venous plexuses.
  • Vasoconstriction defines the condition in which the AVAs are closed and blood is not flowing through the venous plexuses.
  • One example embodiment of a core body temperature adjustment system includes a thermal housing operable to transfer heat between the thermal housing and a glabrous area of a patient' s appendage, wherein the appendage is a hand or foot.
  • a garment sized to at least partially enclose the appendage includes a flap operable to removably secure a first side of the thermal housing against the glabrous area.
  • a control circuit is operable to control a temperature within the thermal housing.
  • the garment comprises an opening sized to expose the glabrous area
  • the flap is operable to removably secure the first side of the thermal housing against the glabrous area through the opening.
  • a pump is operable to apply negative pressure to the glabrous area through the opening.
  • a seal ring that surrounds a perimeter of the opening, and is operable to maintain the negative pressure.
  • a top layer at least partially covers a second side of the thermal housing that is opposite to the first side of the thermal housing, and spacing layer that is situated between the top layer and the glabrous area is operable to space the top layer away from the glabrous area when negative pressure is applied to the glabrous area through the opening.
  • the spacing layer is situated between the thermal housing and the glabrous area, and is also operable to space the thermal housing away from the glabrous area when negative pressure is applied to the glabrous area through the opening.
  • the spacing layer comprises a mesh with air pockets.
  • a spacing material is situated within the thermal housing, and a pump is operable to circulate a fluid through the spacing material within the thermal housing.
  • the pump is a peristaltic pump, a centrifugal pump, or a hand pump.
  • the glove includes a forearm sleeve sized to at least partially enclose a patient' s forearm, and the pump is situated on the forearm sleeve.
  • an additional second housing encloses the control circuit and a power supply, and is mounted to a second side of the thermal housing that is opposite to the first side of the thermal housing.
  • an electric heat source is situated within the thermal housing.
  • At least one sensor is situated within the garment, and the control circuit is operable to control the temperature within the thermal housing based on input received from the at least one sensor.
  • the at least one sensor includes a heat flux sensor, a temperature sensor, a blood flow sensor, or a combination thereof.
  • the thermal housing is one of a plurality of thermal housings, each of which is secured against a different glabrous area of the patient, and is operable to transfer heat between itself and its associated glabrous area.
  • Each of the thermal housings are operably connected to a shared resource, and the control circuit is operable to control a temperature within the plurality of the thermal housings by controlling the shared resource.
  • the shared resource includes either a shared power source that is electrically connected to the plurality of thermal housings or a shared fluid reservoir that is in fluid communication with the plurality of thermal housings.
  • the thermal housing is a first thermal housing
  • the glabrous area is a first glabrous area
  • the control circuit is a first control circuit.
  • a different, second thermal housing is secured against a different, second area of the patient, and is operable to transfer heat between itself and the second glabrous area.
  • a different, second control circuit that is operable to control a temperature within the second thermal housing.
  • the thermal housing comprise a first conduit, and the system includes a second conduit that connects to the first conduit to form a circulation loop.
  • a Peltier device has opposing first and second faces, and is operable, when a voltage is applied to the Peltier device, to provide heating to the first face and to provide cooling to the second face.
  • One of the first or second faces include one or more thermally conductive sleeves, each of which surrounds a portion of the second conduit, to provide a heating or cooling effect to its surrounded portion of the second conduit.
  • One example embodiment of a method of controlling the core body temperature of a patient includes situating a thermal housing on a glabrous area of the patient, situating at least one sensor near the patient, and applying heat from the thermal housing to the glabrous area to effectuate core temperature heating of the patient.
  • a temperature of the thermal housing is controlled based on data received from the at least one sensor.
  • a warming blanket is separately applied to a non-glabrous torso area of the patient to enable patient thermal comfort, wherein the warming blanket is not controlled based on the data received from the at least one sensor.
  • the non- glabrous torso area includes the patient' s chest.
  • the non-glabrous torso area includes the patient' s back.
  • Fig. 1 depicts target areas for core body temperature management with interface electronics.
  • FIG. 2 schematically depicts an example glove that includes a thermal transfer element for heating and/or cooling a patient' s hand.
  • FIG. 3 schematically depicts an example foot garment that includes a thermal transfer element for heating and/or cooling a patient's foot.
  • FIGs. 4-6 schematically depict additional foot garment embodiments.
  • Fig. 7 schematically depicts an example mask that includes a thermal transfer element for heating and/or cooling a patient' s face.
  • FIGS. 8A-B, 9, and 10 schematically illustrate other example mask features.
  • FIG. 11 schematically depicts a core body temperature adjustment system with a related fluid pumping configuration.
  • FIG. 12 schematically depicts an enlarged view of the pumping configuration of Fig. 8.
  • Fig. 13 schematically illustrates an example pumping configuration.
  • Fig. 14 schematically illustrates an arrangement for pumping fluid to heat or cool a patient' s hand.
  • Fig. 15 schematically illustrates an example peristaltic pump that may be used in the embodiment of Fig. 14.
  • FIG. 16 schematically illustrates another example arrangement for pumping fluid to heat or cool a patient' s hand
  • thermoelectric device configurations [0044] Figs. 17-18 schematically illustrate example thermoelectric device configurations.
  • Figs. 19-21 schematically illustrate embodiments in which a glove includes a flap for securing a thermal transfer element to a patient' s palm.
  • FIGs. 22-25 schematically illustrate additional example features for heating or cooling a patient' s palm.
  • Figs. 26-27 schematically illustrate embodiments in which a temperature distribution medium comprises a fluid, and a pump is configured to circulate the fluid.
  • Figs. 28-31 schematically illustrate embodiments in which negative pressure can be applied to a patient' s palm.
  • Figs. 32-33 schematically illustrate embodiments in which a thermoelectric device is mounted to a palm area of a glove.
  • Fig. 34 is a flowchart of an example method of controlling the core body temperature of a patient.
  • the present disclosure describes techniques for adjusting the core temperature of patients based on applying targeted heating or cooling to glabrous bodily areas at which arteriovenous anastomoses (AVAs) are located. Because these areas are natural heat exchange portals, applying heating and/or cooling to them can yield considerable efficiency improvements over the prior art. For example, some of the devices and techniques discussed herein can be implemented without limiting access to a patient's hands and/or fingers, as such access may be needed for common field medicine assessments, such as blood pressure monitoring.
  • AVAs arteriovenous anastomoses
  • the devices and techniques discussed herein are also effective if contact is only possible with only one limb or facial interface, as in the case of casualties with multiple traumas affecting one or more limbs. Still further, these devices and techniques can facilitate a greater variety of patient postures (e.g., upright, seated, or lying down) than was possible in the prior art. The devices and techniques discussed herein can be used to maintain patient warming at a level of performance seen in current standard of care systems, but with reduced package size, and reduced power consumption.
  • a heating and/or cooling loop is attached to a flexible fluid pack (containing, e.g., a gas, liquid, gel and/or conductive slurry) that can conform to the palm of the hand (or foot or face). Circulation within the loop facilitates heat transfer with a glabrous skin area.
  • Power can be provided onboard via batteries or from an external power source (e.g., an electrical outlet).
  • pumps, a control unit, and other related components can be part of the onboard pack or accessed through a remote connection (i.e., tube, wire, etc.).
  • a patient's core body temperature without applying heating or cooling directly to the patient' s core. This can be achieved by instead applying heat to one or more glabrous areas of the patient's body via thermal transfer elements.
  • Such core body temperature control can be useful for perioperative care (i.e., preoperative, intraoperative, and postoperative care).
  • heating and/or cooling is still provided to a patient's torso area (e.g., stomach or back) to provide comfort.
  • the various thermal transfer elements may be centrally controlled by a shared control circuit, or may have individual localized control circuits.
  • the localized control circuits are configured to communicate with each other using wireless signaling.
  • a system for core body temperature adjustment system may comprise a disposable portion, and a reusable portion.
  • the thermal transfer element comprises a circulation loop that circulates fluid on glabrous areas.
  • the circulation loop is detachable into first and second conduits, with one portion of the conduit being disposable, and the other portion being reusable.
  • Fig. 1 depicts target areas for core body temperature management with interface electronics for a core body temperature adjustment system 10.
  • the target areas of patient 12 are glabrous areas, and they include portions of the patient's hands 14, feet 16, and head 18.
  • the glabrous areas include a palm of the hands 14, a sole of the feet 16, and a cheek and/or forehead area of the head 18.
  • the system 10 includes a set of discrete, thermal transfer elements 24, each of which is mounted to a different glabrous area of a patient's body, and is configured to heat and/or cool its associated glabrous area (see Figs. 2-7).
  • Electronic control circuitry (shown as electronic control unit "ECU" 20 in Fig. 1) is operatively connected to the thermal transfer elements 24, and is configured to control a temperature of the thermal transfer elements 24.
  • each thermal transfer element 24 is detachable from its operative connection to its associated control circuitry via one or more detachable connectors (e.g., electrical or fluid connectors).
  • Each thermal transfer element 24 is part of a respective garment, such that the set of thermal transfer elements corresponds to a set of thermal garments.
  • the set of thermal garments may include at least two of the following:
  • a right hand glove configured to situate its thermal transfer element on a palm of patient's right hand 14A;
  • a left hand glove configured to situate its thermal transfer element on a palm of a patient's left hand 14B;
  • a right foot covering configured to situate its thermal transfer element on a sole of a patient's right foot 16A;
  • a left foot covering configured to situate its thermal transfer element on a sole of a patient's left foot 16B;
  • a mask configured to situate its thermal transfer element on a patient's forehead, cheek, or both.
  • Fig. 2 schematically depicts an example glove 22 sized to at least partially enclose a patient's hand 14.
  • the glove 22 includes a thermal transfer element (TTE) 24 for heating and/or cooling the patient's hand 14.
  • the TTE 24 is mounted to the glove 22, and includes detachable connectors 26.
  • the TTE 24 is embedded within the glove 22.
  • the TTE 24 is mounted to an interior or exterior of the glove 22.
  • the TTE 24 follows a winding (e.g., serpentine) path along the palm of the hand 14, which is a glabrous area.
  • the glove 22 also includes straps 25 for securing the glove to the hand 14 (e.g., using a snap, a hook and loop fastener, or some other fastener).
  • the TTE 24 is an electrical heat exchanger (e.g., for heating and/or cooling), and its associated connectors 26 are electrical connectors.
  • the TTE 24 includes a conduit through which a fluid can flow for heating and/or cooling the palm of a patient' s hand, and its associated connectors 26 facilitate a flow of fluid through the conduit.
  • the connectors 26 prevent fluid from flowing into and out of the conduit (e.g., water, air, a gel, etc.).
  • connector 26A can serve as a fluid inlet
  • connectors 26B can serve as a fluid outlet (or vice versa).
  • Fig. 3 schematically depicts an example foot garment 28A that includes a TTE 24 for heating and/or cooling a patient's foot 16.
  • the TTE 24 follows a winding path along a sole of the foot 16, which is a glabrous area.
  • the TTE 24 could comprise an electrical heat exchanger or a conduit, and includes connectors 26.
  • the foot garment comprises a sock that includes a heel opening 29A, and also includes a toe opening 29B that is sized for a plurality of the patient' s toes to extend through.
  • the foot garment could include a thong member that would be inserted between two toes to prevent the sock from sliding up the patient's leg.
  • a toeless foot garment is shown in Fig. 3 and various other figures, it is understood that a foot garment including toe coverings could be used instead.
  • Figs. 4-6 schematically illustrate some alternative embodiments of the foot garment.
  • the foot garments 28B-C include a slip-on shoe.
  • the TTE 24 winds along a heel area at the rear of the garment 28C and an upper foot area on the top of the garment 28C.
  • Fig. 6 depicts a sock foot garment 28D in which the TTE 24 also winds along a top and heel of a patient's foot 16.
  • Fig. 7 schematically depicts an example mask 30A that includes a TTE 24 for heating and/or cooling a patient's face.
  • the TTE 24 follows a winding path along a cheek of a patient, which is a glabrous area. In other embodiments, the TTE 24 may follow a path along the patient's forehead instead of, or in addition to, the cheek.
  • the mask 30A may be used in conjunction with a breathing mask 31 A.
  • the mask 30A includes a chinstrap 32 for placement on the patient's head 18.
  • Figs. 8A-B and 9-10 illustrate other example mask features.
  • the mask 30B has a TTE 24 that follows a winding path along a patient's forehead. Also, the mask 30B omits the chinstrap 32 of Fig. 7.
  • Fig. 9 illustrates a breathing mask 3 IB
  • Fig. 10 illustrates how a seal portion 36 of the breathing mask 3 IB may abut a patient's nose 35 along cross-section A-A of Fig. 9.
  • the ECU 20 is connected to a thermal element 33 and a power supply 34.
  • the thermal element 33 includes an electrical connection to an electrical heat exchanger TTE 24.
  • the thermal element includes a heating or cooling device for heating and/or cooling a fluid in a conduit TTE 24. In some embodiments, a combination of these may be used (e.g., use electrical heat exchanger TTE 24 for hands 14, but conduit TTE 24 for feet 16, or some other combination).
  • the power supply 34 includes at least one of the following: a rechargeable or non- rechargeable battery (e.g. a 12 volt battery), a connection to an AC or a DC power source (e.g., 120 VAC), or the like.
  • the ECU may optionally also be connected to one or more of the following: a fluid pump 38, a fan or blower (generically referred to as 40 herein), a communication circuit 42, and one or more sensors 44.
  • the ECU 20 is configured to control the temperature of the TTE 24 based on input received from the sensor(s).
  • sensors include a heat flux sensor, a temperature sensor, a blood flow sensor (e.g., a perfusion sensor), or a combination thereof.
  • a remote sensor is used, such as esophageal temperature sensor 45, which communicates wirelessly with ECU 20 via communication circuit 42 (the wireless communication is shown schematically as 46 in Fig. 1). Of course other temperature sensors could be used.
  • "local" temperature sensors are used that are either on, or in close proximity to a glabrous area (e.g., on a palm, or forearm, on a foot or lower leg, etc.). Such local temperature sensors could be an alternative to an esophageal temperature sensor 45, for example.
  • a pump 38 is included for circulating fluid within one or more of the TTEs 24, the pump may be a peristaltic pump, a centrifugal pump, a hand pump, or any other kind of pump.
  • An optional warming blanket 19 is also shown in Fig. 1 on a torso area of the patient 12.
  • the blanket 19 is not intended to achieve core body temperature adjustment, but rather is intended (if it is used at all) to give a pleasant warm sensation to a patient while that patient's body is being warmed (e.g., after a general anesthesia if the patient is cognitive).
  • the blanket 19 is controlled and powered by circuitry 21 that is separate from the ECU 20 and its related components, but may be similarly controlled (e.g., using a TTE 24 as discussed in the other embodiments). Although illustrated on a patient's chest (anterior torso area), the blanket 19 could be used in other locations, such as on the patient's back (posterior torso area).
  • Figs. 11-12 schematically depict a pumping configuration 46 for circulating fluid through the TTEs 24 in embodiments in which the TTEs 24 comprise conduits, with Fig. 11 depicting the configuration 46 in its system context, and Fig. 12 depicting the configuration 46 in an enlarged view.
  • the configuration includes a pump 38, supply manifold 50, a return manifold / reservoir 52, thermostat 54, bypass 56, and restriction 58.
  • these components may be situated within a housing 47.
  • FIG. 11 shows the housing 47 situated on a torso area of the patient 12, it is understood that the housing 47 could be situated away from the patient 12, and that warming blanket 19 could instead be situated on the torso area of the patient 12 (e.g., as shown in Fig. 1).
  • the thermostat 54 comprises a wax thermostatic element configured to selectively shutoff a flow of fluid to the supply manifold 50 based on a temperature (e.g., a temperature of the fluid being pumped and/or a patient temperature).
  • a temperature e.g., a temperature of the fluid being pumped and/or a patient temperature
  • the thermostat 54 can be configured to act as a valve.
  • the bypass 56 may be utilized, in some embodiments, to ensure that the pump 38 does not deadhead or cavitate when the valve of thermostat 54 is shut.
  • a single pump 38 does not have to be used for multiple TTEs 24 as shown in Fig. 11. Instead, individual pumps 38 could be used, and those pumps could optionally be situated in closer proximity to the glabrous areas being heated and/or cooled (e.g., on a forearm and/or on a leg).
  • Fig. 13 depicts a pumping configuration 46' that is the same as configuration 46, but includes less supply and return lines because pumping is only being performed for a single TTE 24.
  • Fig. 14 illustrates an arrangement for pumping fluid to heat and/or cool a patient' s hand, in which TTE 24 is a first conduit having a fluid inlet at connector 26 A, and a fluid outlet at connector 26B (of course these roles could be reversed, so connector 26A has a fluid outlet and connector 26B has a fluid inlet).
  • a second conduit 60 connects to the fluid inlet and fluid outlet of the first conduit (TTE 24) to form a circulation loop 61.
  • the second conduit 60 is secured to a forearm sleeve 68 (e.g., secured on or within the forearm sleeve 68).
  • a pump 38 is configured to circulate fluid in the circulation loop 61.
  • a thermal element 33 is configured to adjust a temperature of a fluid in the circulation loop 61, and ECU 20 is configured to control the pump 38 and is configured to control a temperature of the thermal element 33.
  • the thermal element 33 and ECU 20 are located within housing 64.
  • ECU 20 may be situated within the housing 64 (as shown in Fig. 14), or may be situated outside of the housing 64.
  • a majority of the circulation loop 61 has a generally uniform radius and circumference, but the circulation loop 61 also includes an enlarged portion 66 sized to be a fluid reservoir in the circulation loop 61.
  • a reservoir e.g., a bladder
  • the forearm sleeve 68 and glove 22 are detachable (e.g., along dotted line 70).
  • the glove 22 may be a disposable piece, while the forearm sleeve 68 is reusable.
  • Fig. 15 illustrates an example peristaltic fluid pump 38' that could be used in the embodiment of Fig. 14.
  • Fig. 16 illustrates another example arrangement for pumping fluid to heat or cool a patient's hand.
  • TTE 24 is a first conduit having a fluid inlet at connector 26A, and a fluid outlet at connector 26B (of course these roles could be reversed, so connector 26A has a fluid outlet and connector 26B has a fluid inlet).
  • forearm sleeve 68 includes a second conduit 60 that connects to the first conduit to form circulation loop 61.
  • a reservoir 66 and fluid pump 38 are also included.
  • thermoelectric device (TED) 72 acts as the thermal element 33.
  • the TED 72 is configured to heat or cool fluid in circulation loop 61.
  • the TED 72 may be a Peltier device, for example.
  • the TED 72 includes thermally conductive sleeves 74, each of which surrounds a portion of the second conduit 60, to provide a heating and/or cooling effect to the surrounded portions of the second conduit 60.
  • the TED 72 is a Peltier device having opposing first and second faces 73A-B (see Fig. 17), and is configured, when a voltage is applied to the Peltier device, to provide heating to the first face 73A and to provide cooling to the second face 73B (or vice versa).
  • the thermally conductive sleeves 74 are part of the first or second face of the Peltier device.
  • the ECU 20 and power supply 34 may be situated within housing 75, for example.
  • Figs. 17-18 illustrate example TED configurations that utilize a fan or blower (generically referred to as 40 herein).
  • a heat exchanger 76 e.g., a heat sink
  • a fan 40 is situated on top of the heat exchanger 76 for either drawing air into the air channels 81 from opposing ends of the channels 81, or for forcing air from above the heat exchanger 76 out of the opposing ends of the channels 81.
  • An axis of rotation Al of the fan 40 extends through the TED 72 in Fig. 17.
  • a blower 40 is used to blow air into the air channels formed by the fins 80.
  • An axis of rotation A2 of the blower 40 is offset from the TED 72 and does not extend through the TED 72 in Fig. 18.
  • Figs. 19-31 schematically illustrate embodiments in which a glove 22 includes a flap 90 for securing a thermal housing 92 to a patient' s palm (although the flap 90 is not shown in every one of these figures).
  • Reference numeral 92 is generically used herein to refer to a thermal housing that is situated against a glabrous area.
  • the thermal housing 92 encloses TTE 24 within a temperature distribution medium 93.
  • the temperature distribution medium 93 comprises a fluid (e.g., gas, water, a gel, or a slurry).
  • a spacing material is situated within the thermal housing 92, and the temperature distribution medium 93 flows through the spacing material.
  • spacing materials may include a mesh with air pockets (e.g., a three-dimensional spacer fabric from Miiller Textil).
  • the spacing material which will be discussed in more detail below, provides spacing between an item (e.g., a face of thermal housing 92) and a glabrous skin area.
  • the temperature distribution medium 93 includes a solid plate (e.g., a foil or plate).
  • a second housing 94 encloses ECU 20 and a power supply 34.
  • the ECU 20 is configured to control a temperature of the TTE 24 situated in a palm area of the glove 22.
  • the second housing 94 is mounted to a top face of the thermal housing 92.
  • the glove 22 includes a strap 90 for securing the glove 22 (e.g., using a snap, or a hook and loop fastener, or some other fastener).
  • the thermal housing 92 and second housing 94 form an assembly 96 that may be removably secured to a glabrous palm area through an opening 95 (see Fig. 20).
  • Flap 90 can be closed over the assembly 96 and fastened using its own straps 25, to place the assembly 96 directly against the glabrous palm area of the glove 22 through the opening 95.
  • a fabric membrane may be used that is situated between the thermal housing 92 and the glabrous palm area.
  • An adhesive layer may be used on a bottom side of the thermal housing 92 that is opposite to the second housing 94 to further secure the assembly 96 to the glove 22 or patient's palm.
  • Fig. 20 schematically illustrates the assembly 96 when separated from the glove 22.
  • Fig. 21 schematically illustrates how a sensor 44 may be utilized in conjunction with the embodiment of Fig. 19-20.
  • the thermal housing 92 includes an opening 97 that the sensor 44 can reside within when the thermal housing 92 is situated in the glove 22. If the sensor 44 is not directly connected to ECU 20 within the second housing 94, then sensor circuitry 98 may be used to obtain readings from the sensor 44, and communicate them to the ECU 20 (e.g., through wireless signal transmissions to communication circuit 42).
  • Fig. 22 illustrates another embodiment that uses an alternate thermal housing 92 with its sensor opening 97 in a different location.
  • ECU 20 could be mounted to the thermal housing 92, or could be separately mounted to the glove 22.
  • the sensor 44 in this embodiment could be a heat flux sensor, for example.
  • Fig. 23 schematically illustrates other example features for heating and/or cooling a patient's palm.
  • Fig. 23 illustrates another example path that the TTE 24 can follow within the thermal housing 92 (e.g., a spiral).
  • Fig. 23 illustrates how the ECU 20 and power supply 34 can be located in a wrist area, while the thermal housing 92 is located in a patient's palm.
  • Fig. 23 illustrates how the ECU 20 and power supply 34 can be located in a wrist area, while the thermal housing 92 is located in a patient's palm.
  • a sensor 44 e.g., a temperature sensor
  • the ECU 20 may control the TTE 24 based on sensor data from the sensor 44.
  • An elongated flap 90' may be used to secure the housings 92, 94 to the glove 22.
  • Figs. 24-25 provide alternate views of the thermal housing 92 and/or second housing 94.
  • Fig. 25 illustrates TTE 24 being on top of thermal housing 92, it is understood that the TTE 24 may alternatively be situated within the thermal housing 92.
  • Figs. 26-27 schematically illustrate embodiments in which the temperature distribution medium 93 comprises a fluid, and a fluid pump 38 is configured to circulate the fluid, which may favorably achieve a more uniform temperature within the temperature distribution medium 93.
  • Fig. 27 schematically illustrates an adhesive layer 100 that may be situated on a bottom of the housing 92, for securing the thermal housing 92 to the glove 22 or to the patient's palm.
  • An adhesive backing 102 may be peeled away to expose the adhesive layer 100.
  • Figs. 28-31 schematically illustrate examples of how negative pressure can be applied to a patient's palm to facilitate greater heat transfer with the palm.
  • a seal ring 110 surrounds a perimeter of an opening 95 in the glove 22.
  • a pump 38 is configured to apply negative pressure to an area between the flap 90 and a palm of a patient's hand, such that the seal ring 110 abuts the palm of the patient's hand, and the negative pressure is applied to the palm from a palm-facing side of the thermal housing 92.
  • a spacing material 114 e.g., a mesh with air pockets such as a reticulated fabric
  • the opening 95 facilitates direct skin contact from a thermal housing (e.g., a TTE 24 or a housing within which the TTE resides 24).
  • a thermal housing e.g., a TTE 24 or a housing within which the TTE resides 24.
  • an adhesive 116 is used along a perimeter of the housing 92 to provide a seal.
  • Figs. 32-33 schematically illustrate example embodiments in which a TED 72 and heat exchanger 76 similar to the ones shown in Fig. 17 are utilized, but instead of exchanging heat with a conduit that is on a forearm and that carries a fluid to a patient's palm, in these embodiments the TED 72 is situated on a patient's palm (via glove 22) and exchanges heat with the patient's palm without requiring use of a fluid conduit.
  • a fan 40 is situated on the TED 72 and facilitates heat transfer by the TED 72. In one example, airflow is drawn upwards away from the TED 72. Of course, the opposite configuration could be used instead, in which airflow is drawn downwards onto the TED 72.
  • Fig. 34 schematically illustrates a method 200 of controlling the core body temperature of a patient.
  • a TTE 24 is situated on glabrous area of the patient 12 (block 202). An example of this is shown in Fig. 1.
  • At least one sensor is situated near the patient (block 204) (see, e.g., Figs. 1 and 21-22). Heat from the TTE 24 is applied to the glabrous area to effectuate core temperature heating of the patient (block 206).
  • a temperature of the thermal housing is controlled based on data received from the at least one sensor (block 208).
  • a warming blanket is separately applied to a non- glabrous torso area of the patient 12 to enable patient thermal comfort, wherein the warming blanket is not controlled based on the data received from the at least one sensor (block 210).
  • the method 200 has been described with a single TTE 24, it is understood that the method could be performed using a plurality of TTEs 24 that are each on different glabrous areas of a patient and are controlled based on the same or different sensors.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Textile Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Physics & Mathematics (AREA)
  • Thermal Sciences (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)

Abstract

L'invention concerne un système d'ajustement de température corps de noyau qui comprend un boîtier thermique permettant de transférer la chaleur entre le boîtier thermique et une zone glabre d'un appendice du patient. L'appendice est une main ou un pied. Un vêtement est dimensionné pour entourer au moins partiellement l'appendice, et comprend un volet permettant de fixer de manière amovible un premier côté du boîtier thermique contre la zone glabre. Un circuit de commande permet de commander une température à l'intérieur du boîtier thermique.
PCT/US2016/048669 2015-08-25 2016-08-25 Procédés et dispositifs pour gestion de la température corps de noyau WO2017035341A1 (fr)

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WO2019118286A1 (fr) * 2017-12-13 2019-06-20 Fresenius Medical Care Holdings, Inc. Articles pour réchauffer et pour surveiller un patient pendant une dialyse
GB2580947A (en) * 2019-01-30 2020-08-05 Mdmi Ltd A heating device
EP3873577A4 (fr) * 2018-11-01 2022-08-10 Somnibliss, LLC Systèmes et procédés d'induction de sommeil par refroidissement de température de corps central
WO2023204796A1 (fr) * 2022-04-18 2023-10-26 C.R. Bard, Inc. Coussin chauffant/rafraîchissant thermoélectrique

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WO1998007397A1 (fr) * 1996-08-20 1998-02-26 Kolen Paul T Application de therapie thermique
US6268595B1 (en) * 2000-02-23 2001-07-31 Jon Haenel Circulation warmer
US20050103353A1 (en) * 2003-11-14 2005-05-19 Grahn Dennis A. Controlled heat transfer with mammalian bodies
EP1929980A1 (fr) * 2006-12-04 2008-06-11 Dynatherm Medical, Inc. Procédés et appareils de réglage de la circulation sanguine
US20100025009A1 (en) * 2007-07-31 2010-02-04 Klett James W Thermal management system
WO2014180975A1 (fr) * 2013-05-10 2014-11-13 Kirwan Laurence Méthode et système de conservation de la normothermie
US20140364777A1 (en) * 2013-06-07 2014-12-11 Mark Swyer Modifying humidity and convection to glabrous tissue to control metabolism
WO2015117063A1 (fr) * 2014-02-03 2015-08-06 The Board Of Trustees Of The Leland Stanford Junior University Procédés de transfert de chaleur transcutané, et dispositifs et systèmes pour utilisation dans ceux-ci

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WO1998007397A1 (fr) * 1996-08-20 1998-02-26 Kolen Paul T Application de therapie thermique
US6268595B1 (en) * 2000-02-23 2001-07-31 Jon Haenel Circulation warmer
US20050103353A1 (en) * 2003-11-14 2005-05-19 Grahn Dennis A. Controlled heat transfer with mammalian bodies
EP1929980A1 (fr) * 2006-12-04 2008-06-11 Dynatherm Medical, Inc. Procédés et appareils de réglage de la circulation sanguine
US20100025009A1 (en) * 2007-07-31 2010-02-04 Klett James W Thermal management system
WO2014180975A1 (fr) * 2013-05-10 2014-11-13 Kirwan Laurence Méthode et système de conservation de la normothermie
US20140364777A1 (en) * 2013-06-07 2014-12-11 Mark Swyer Modifying humidity and convection to glabrous tissue to control metabolism
WO2015117063A1 (fr) * 2014-02-03 2015-08-06 The Board Of Trustees Of The Leland Stanford Junior University Procédés de transfert de chaleur transcutané, et dispositifs et systèmes pour utilisation dans ceux-ci

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019118286A1 (fr) * 2017-12-13 2019-06-20 Fresenius Medical Care Holdings, Inc. Articles pour réchauffer et pour surveiller un patient pendant une dialyse
US11191881B2 (en) 2017-12-13 2021-12-07 Fresenius Medical Care Holdings, Inc. Articles for warming and monitoring patient during dialysis treatment
EP3873577A4 (fr) * 2018-11-01 2022-08-10 Somnibliss, LLC Systèmes et procédés d'induction de sommeil par refroidissement de température de corps central
GB2580947A (en) * 2019-01-30 2020-08-05 Mdmi Ltd A heating device
US20200268550A1 (en) * 2019-01-30 2020-08-27 Mdmi Ltd Heating device
EP3756630A1 (fr) * 2019-01-30 2020-12-30 MDMI Ltd Dispositif de chauffage
GB2580947B (en) * 2019-01-30 2021-11-10 Mdmi Ltd A heating device
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WO2023204796A1 (fr) * 2022-04-18 2023-10-26 C.R. Bard, Inc. Coussin chauffant/rafraîchissant thermoélectrique

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