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EP1301153A2 - Dispositif medical non-infractif de refroidissement des carotides pour hypothermie cerebrale - Google Patents

Dispositif medical non-infractif de refroidissement des carotides pour hypothermie cerebrale

Info

Publication number
EP1301153A2
EP1301153A2 EP01954667A EP01954667A EP1301153A2 EP 1301153 A2 EP1301153 A2 EP 1301153A2 EP 01954667 A EP01954667 A EP 01954667A EP 01954667 A EP01954667 A EP 01954667A EP 1301153 A2 EP1301153 A2 EP 1301153A2
Authority
EP
European Patent Office
Prior art keywords
carotid
patient
cooling
cooler
medical device
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP01954667A
Other languages
German (de)
English (en)
Inventor
Michael E. Leckrone
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Inc
Original Assignee
Medtronic 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 Medtronic Inc filed Critical Medtronic Inc
Publication of EP1301153A2 publication Critical patent/EP1301153A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12Devices for heating or cooling internal body cavities
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001Body part
    • A61F2007/0002Head or parts thereof
    • A61F2007/0009Throat or neck
    • A61F2007/001Throat only
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0054Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
    • A61F2007/0056Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water for cooling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A61F2007/0075Heating 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

Definitions

  • This disclosure relates to a medical device and more specifically to a non-invasive medical device used to lower human brain temperature.
  • Non-invasive medical devices are used to treat medical conditions without the need for invasive procedures such as insertion of a catheter into a blood vessel.
  • Non-invasive medical devices are particularly suitable for the early responders to a medical condition such as emergency medical technicians and persons having limited training.
  • the early application of a medical device designed to reduce injury to a patient can greatly enhance restoration of an individual to a more healthful condition and a fuller life.
  • One type of non-invasive medical device designed to reduce injury is a brain cooler hypothermic medical device.
  • Cooling the brain can significantly reduce brain injury caused by lack of blood flow to the brain (ischemic) or lack of oxygen to the brain (anoxic).
  • Ischemic and anoxic brain injury can be caused by conditions such as strokes, cardiac arrest, transient ischemia attacks (TIA), brain injury, toxic poisoning, respiratory arrest, suffocation, electrocution, edema, and head trauma.
  • ischemic or anoxic conditions reversible brain damage can start as early as four minutes after the condition has begun and irreversible brain damage can start as early as six minutes after the condition has begun.
  • Lowering brain temperature, hypothermia slows brain metabolic activity to slow or reduce brain injury.
  • Early hypothermia of the brain in the initial critical minutes after injury can significantly reduce further injury compared with hypothermia of the brain performed once the patient reaches a facility such as a hospital.
  • Previous topical brain cooling medical devices do not efficiently target heat removal from the patient's carotid arteries and can require application of an encircling collar to the patient.
  • the cooling source is typically applied to the entire collar, and the collar is not shaped to apply the cooling source to the close proximity of the patient's carotid arteries. Additionally, the collar may be difficult to apply and risk further injury to patient's with neck and head.
  • Previous endotracheal brain cooling medical devices also do not efficiently target heat removal from the patient's carotid arteries.
  • the cooling source is placed in the patient's oral cavity which is a considerable distance from the patient's carotid arteries.
  • the non-invasive carotid cooler brain hypothermia medical device applies cooling efficiently to carotid arteries to rapid cool the brain to decrease brain injury.
  • at least one cooling element is configured to remove heat from an area substantially proximate the patient's carotid arteries.
  • the cooling element is carried on a patient side of a topical carotid cooler.
  • the topical carotid cooler is configured for placement on a patient's neck proximate the patient's carotid arteries and is coupled to a cooling source.
  • the cooling element is carried on an endotracheal carotid cooler.
  • methods for creating brain hypothermia with a non- invasive carotid cooler are provided.
  • FIG. 1 shows an environment view of a patient anatomy
  • FIG. 2 shows another environment view of the patient anatomy
  • FIG. 3 shows a topical carotid cooler applied to a patient embodiment
  • FIG.4 shows a brain hypothermia system embodiment
  • FIG. 5 shows a flow diagram of a method for brain hypothermia embodiment
  • FIG. 6 shows an endotracheal carotid cooler applied to a patient embodiment
  • FIG. 7 shows a cross-section view of both a topical carotid cooler and an endotracheal carotid cooler applied to a patient embodiment
  • FIG. 8 shows front view of both a topical carotid cooler and an endotracheal carotid cooler applied to a patient embodiment.
  • FIGS. 1 and 2 show environmental views of a patient; FIG. 3 shows a topical carotid cooler applied to a patient embodiment; and, FIG. 4 shows a brain hypothermia system embodiment.
  • One embodiment of the medical device for non-invasive brain hypothermia comprises a topical carotid cooler, a cooling source, and a cooling element.
  • This medical device embodiment can also include a cooling controller, a patient thermometer, a carotid flow sensor, a temperature sensor.
  • the topical carotid cooler is configured for application on a patient's neck proximate the patient's carotid arteries.
  • the topical carotid cooler has a patient side that is placed against the patient's neck when the topical carotid cooler is positioned on the patient.
  • the cooling source is coupled to the topical carotid cooler and can be a wide variety of cooling sources capable of cooling in the range from about 37° Celsius (98.6° Fahrenheit) to about 0° Celsius (32° Fahrenheit).
  • the cooling source can include technologies such as a Peltier device, a cryogenic fluid, ice, salinated ice, cold water, active refrigerant systems, Joule-Thompson cryostat, and the like.
  • the cooling source delivers cooling to the cooling element.
  • the cooling element is at least one cooling element carried on the topical carotid cooler patient side.
  • the cooling element is coupled to the cooling source, and the cooling element is configured to remove heat largely from an area substantially proximate the patient's carotid arteries.
  • the cooling element is positionable over both patient carotid arteries.
  • the cooling element can be at least a first cooling element positionable over one carotid artery and a second cooling element positionable over the other carotid artery. When a first and second cooling element are used, the cooling elements can be positionable laterally to a patient's trachea.
  • the temperature of the cooling element is regulated by the cooling controller.
  • the cooling controller is coupled to the cooling source for regulating the amount of cooling delivered by the cooling element.
  • the cooling controller regulates the cooling source, so the temperature of the cooling element cools blood flowing through the carotid arteries to rapidly reduce brain core temperature down to no lower than about 30.0°
  • the cooling controller regulates the cooling source so the temperature of the cooling element is not lower than about minus 2.0° Celsius (35.6° F).
  • the cooling controller is also configured to accept a variety of sensory inputs such as patient temperature, cooling element surface temperature, carotid blood flow, and the like.
  • the cooling controller can use these sensor inputs in its cooling control algorithm to regulate brain temperature to a predetermined value and otherwise regulate cooling.
  • the cooling controller can also use sensor inputs to alert the medical device operator of conditions such as inadequate carotid blood flow.
  • the cooling controller can also include communication capabilities to access telephone, radio, and internet networks as desired. For a patient temperature input to the cooling controller, patient temperature can be measured with a patient therometer.
  • the patient thermometer is coupleable to patient for measuring patient temperature.
  • the thermometer is can be any type of thermometer that measures a patient's temperature that can be correlated to brain temperature such as an infrared thermometer positionable in a patient's ear, bimetallic thermometers, thermistors, resistive temperature devices (RTDs), and the like.
  • An ear thermometer which measures tympanic membrane temperature can be configured similar to a stereo headphone set for ease of application to the patient.
  • the thermometer is coupled to the cooling controller to provide an input of patient temperature correlateable to patient brain temperature.
  • Another sensor that the cooling controller can use for adjusting cooling or identifying conditions to the operator is a carotid flow sensor.
  • the carotid flow sensor is carried on the topical carotid cooler patient side to determine if there is adequate carotid arterial blood flow to the brain.
  • Patient carotid blood flow to the brain is a critical parameter that should be monitored to avoid conditions that could adversely affect blood flow.
  • the carotid flow sensor can use a wide variety of sensors technologies capable of sensing carotid arterial flow such as Doppler ultrasound,
  • the carotid flow sensor is coupled to the cooling controller to provide an input of patient carotid blood flow.
  • Another sensor that the cooling controller can use for adjusting cooling or identifying conditions to the operator is a temperature sensor.
  • the temperature sensor is carried on the cooling element in a manner to measure cooling element surface temperature.
  • the temperature sensor provides a cooling element temperature input to a cooling controller.
  • the cooling controller will typically regulate the cooling element to prevent cooling below -2.2° Celsius (28° F) because these temperatures can induce tissue damage due to freezing also known as frostbite.
  • the temperature sensor can be coupled to the cooling controller to assist in regulating cooling.
  • the topical carotid cooler can be used to perform a method for non-invasive brain hypothermia.
  • FIG. 5 shows a flow diagram of a method for non-invasive brain hypothermia embodiment.
  • the medical device embodiment can be used to perform a method of creating brain hypothermia which may be beneficial in cases of stoke, cardiac arrest, transient ischemia attack (TIA), brain injury, toxic poisoning, respiratory arrest, suffocation, edema, head trauma, and the like.
  • the method begins by applying a topical carotid cooler topically to a patient's neck.
  • the topical carotid cooler is operationally positionable on a patient neck without the requirement of circumscribing the patient's neck.
  • the topical carotid cooler After application of the topical carotid cooler, the topical carotid cooler is positioned so that the cooling element is in close proximity to the patient's carotid arteries. Cooling the topical carotid cooler also cools blood flowing through carotid arteries to the patient's brain. Cooling blood destined for the patient's brain in turn cools the patient's brain. The cooled brain reduces tissue metabolism in the brain. By reducing tissue metabolism in the brain, the rate of irreversible brain damage caused by toxic metabolic byproducts can also be reduced.
  • Toxic metabolic byproducts including neurochemical such as glutamate, are produced by brain tissue from conditions such as stoke, cardiac arrest, transient ischemia attack (TIA), brain injury, toxic poisoning, respiratory arrest, suffocation, edema, head trauma, and the like. Additionally, the cooled brain reduces inflammation and swelling (edema) that often occurs with head trauma.
  • Other embodiments of the carotid cooler include an endotracheal carotid cooler.
  • FIG. 6 shows an endotracheal carotid cooler embodiment applied to a patient
  • FIG. 7 shows a cross-section view of both a topical carotid cooler and an endotracheal carotid cooler applied to a patient
  • FIG. 8 shows a front view of both a topical carotid cooler and an endotracheal carotid cooler applied to a patient.
  • the endotracheal carotid cooler embodiment of the medical device for non-invasive brain hypothermia comprises an endotracheal carotid cooler, a cooling source, and a cooling element.
  • This medical device embodiment can also include a cooling controller, a patient thermometer, a carotid flow sensor, a temperature sensor, and a positioning balloon.
  • the elements that are common between the previously described topical carotid cooler embodiment and the endotracheal carotid cooler embodiment are generally further described to the extent the common elements differ.
  • the endotracheal carotid cooler is configured for placement in a patient's trachea.
  • the endotracheal carotid cooler forms an air passage having an inner surface, an outer surface, a distal end, and a proximal end.
  • the cooling source is coupled to the endotracheal carotid cooler and serves as a means for removing heat from an area substantially proximate the patient's carotid arteries.
  • At least one conduit extending from the proximal end of the endotracheal carotid cooler couples the cooling source to the cooling element.
  • the cooling element is at least one cooling element and can be more than one cooling element carried on the endotracheal carotid cooler near the distal end.
  • the cooling element is positionable distal to a patient's oral cavity to cool blood flowing through the patient's carotid arteries.
  • the cooling source is regulated by a cooling controller.
  • the cooling controller is coupled to the cooling source for regulating the amount of cooling delivered by the cooling source.
  • the cooling controller is configurable to couple to both the topical carotid cooler embodiment and the endotracheal cooler embodiment to regulate the cooling source either independently or in conjunction with one another.
  • the carotid flow sensor carried on the endotracheal carotid cooler determines if there is adequate carotid arterial blood flow.
  • the carotid flow sensor can be used as an input for adjusting the positioning balloon to ensure adequate blood flow. Once the medical device operator becomes aware that the carotid flow rate is inadequate, the medical device operator can change the position of the topical carotid cooler and endotracheal carotid cooler as necessary to achieve adequate carotid arterial blood flow.
  • the endotracheal carotid cooler can also include a positioning balloon to assist in positioning the cooling element proximate the patient' s carotid arteries.
  • the positioning balloon urges the cooling element toward the patient's carotid arteries upon inflation of the positioning balloon.
  • the positioning balloon will typically have an inflation conduit extending out of the endotracheal tube proximal end.
  • the positioning balloon can be inflated manually by the medical device operator or automatically by the cooling controller. When inflated manually, the medical device operator typically measures the inflation pressure by tactile feel or with an instrument such as a pressure gauge.
  • the cooling controller When inflated automatically, the cooling controller inflates the positioning balloon to a predetermined inflation pressure or an inflation pressure dependent upon a sensed parameter such as the force the endotracheal carotid cooler is exerting near the patient's carotid arteries, or the sensed patient carotid blood flow.
  • the endotracheal carotid cooler can be used to perform a method for non-invasive brain hypothermia.
  • FIG. 5 shows a flow diagram of a method for non-invasive brain hypothermia embodiment.
  • the medical device embodiment can be use to perform a method of creating brain hypothermia.
  • the method begins by inserting the endotracheal carotid cool into the patient's trachea.
  • the endotracheal carotid cooler is positioned distal to the patient's oral cavity at this time. After positioning of the endotracheal carotid cooler such that the cooling element is urged proximate to the patent's carotid arteries, the endotracheal carotid cooler is cooled. Cooling the endotracheal carotid cooler also cools blood flowing through carotid arteries to the patient's brain.
  • Cooling blood destined for the patient's brain cools the patient's brain.
  • the cooled brain reduces tissue metabolism in the brain. By reducing tissue metabolism in the brain, the rate of irreversible brain damage caused by toxic metabolic byproducts is also reduced.
  • Toxic metabolic byproducts including neurochemical such as glutamate, are produced by brain tissue from conditions such as stoke, cardiac arrest, transient ischemia attack (TIA), brain injury, toxic poisoning, respiratory arrest, suffocation, edema, head trauma, and the like. Also the cooled patient's brain also appears to reduce inflammation and swelling that often occurs with head trauma.
  • a non-invasive brain hypothermia medical device to rapid cool the brain to decrease brain injury.
  • One skilled in the art will appreciate that the present invention can be practiced with embodiments other than those disclosed.
  • the disclosed embodiments are presented for purposes of illustration and not limitation, and the present invention is limited only by the claims that follow.

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

Abstract

Cette invention concerne un dispositif médical à refroidisseur de carotides avec un élément de refroidissement conçu pour évacuer une grande partie de la chaleur présente dans une région relativement proche des artères carotides et, par la même, abaisser rapidement la température du cerveau et réduire les lésions cérébrales. Ce refroidisseur de carotides peut se présenter sous forme d'un refroidisseur à application topique et d'un refroidisseur endotrachéal, à utiliser ensemble ou séparément. Le refroidisseur topique est fait pour être appliqué sur le cou du patient à proximité des artères carotides et est relié à une source de froid. Il comporte un côté patient qui porte au moins un élément de refroidissement couplé à la source de froid. Le refroidisseur endotrachéal se place dans la trachée du patient avec l'élément de refroidissement près de l'extrémité distale. L'élément de refroidissement peut être positionné à l'écart de la cavité buccale de manière à refroidir le sang qui traverse les artères carotides. L'invention concerne également une méthode permettant de créer une hypothermie du cerveau au moyen du refroidisseur de carotides.
EP01954667A 2000-07-13 2001-07-13 Dispositif medical non-infractif de refroidissement des carotides pour hypothermie cerebrale Withdrawn EP1301153A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US61552500A 2000-07-13 2000-07-13
US615525 2000-07-13
PCT/US2001/022036 WO2002005736A2 (fr) 2000-07-13 2001-07-13 Dispositif medical non-infractif de refroidissement des carotides pour hypothermie cerebrale

Publications (1)

Publication Number Publication Date
EP1301153A2 true EP1301153A2 (fr) 2003-04-16

Family

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Application Number Title Priority Date Filing Date
EP01954667A Withdrawn EP1301153A2 (fr) 2000-07-13 2001-07-13 Dispositif medical non-infractif de refroidissement des carotides pour hypothermie cerebrale

Country Status (4)

Country Link
EP (1) EP1301153A2 (fr)
AU (1) AU2001276895A1 (fr)
CA (1) CA2415878A1 (fr)
WO (1) WO2002005736A2 (fr)

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Also Published As

Publication number Publication date
CA2415878A1 (fr) 2002-01-24
WO2002005736A2 (fr) 2002-01-24
WO2002005736A3 (fr) 2002-05-02
AU2001276895A1 (en) 2002-01-30

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