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WO2014096499A1 - Dispositif d'induction d'hypothermie thérapeutique - Google Patents

Dispositif d'induction d'hypothermie thérapeutique Download PDF

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Publication number
WO2014096499A1
WO2014096499A1 PCT/ES2013/070907 ES2013070907W WO2014096499A1 WO 2014096499 A1 WO2014096499 A1 WO 2014096499A1 ES 2013070907 W ES2013070907 W ES 2013070907W WO 2014096499 A1 WO2014096499 A1 WO 2014096499A1
Authority
WO
WIPO (PCT)
Prior art keywords
blood
patient
temperature
refrigerator
pump
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.)
Ceased
Application number
PCT/ES2013/070907
Other languages
English (en)
Spanish (es)
Inventor
Juan Antonio NUÑO MORALES
Alberto GÓMEZ BAREA
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.)
Universidad de Sevilla
Servicio Andaluz de Salud
Original Assignee
Universidad de Sevilla
Servicio Andaluz de Salud
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 Universidad de Sevilla, Servicio Andaluz de Salud filed Critical Universidad de Sevilla
Publication of WO2014096499A1 publication Critical patent/WO2014096499A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/369—Temperature treatment
    • 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
    • A61F7/0085—Devices for generating hot or cold treatment fluids
    • 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
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M19/00—Local anaesthesia; Hypothermia
    • 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
    • A61F2007/0059—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit
    • A61F2007/0063—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit for 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
    • A61F2007/0059—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit
    • A61F2007/0069—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit with return means
    • 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
    • A61F2007/0076—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 remote from 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
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A61F2007/126—Devices for heating or cooling internal body cavities for invasive application, e.g. for introducing into blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3606—General characteristics of the apparatus related to heating or cooling cooled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3673—General characteristics of the apparatus related to heating or cooling thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors

Definitions

  • the invention is framed within the field of medicine, and more particularly within the field of devices used to induce hypothermia in a patient.
  • the object of the invention is a novel device for inducing hypothermia in a patient that involves performing an extracorporeal cooling of the patient's blood flow and the corresponding overheating.
  • Induced or therapeutic hypothermia that is, causing the reduction of the central body temperature below 35 ° C, is a therapy that is frequently used to mitigate various types of neurological lesions.
  • tissue oxygen which exerts a protection of the vital organs (brain, heart, kidney), decreasing the heart rate, increasing coronary irrigation and improving myocardial perfusion, as well as decreasing inflammatory mediators that would worsen even more the forecast.
  • the devices currently used to cause hypothermia are fundamentally of two types:
  • This system is based on the use of thermal blankets cooled by means of an internal fluid circulation system connected to a cooling machine that allows to program the desired temperature of the water circuit. These thermal blankets are used to wrap the patient's chest, thus reducing the body's temperature.
  • the present invention describes a device for inducing therapeutic hypothermia in a patient that solves the problems described thanks to the fact that it comprises a blood pump combined with a Peltier-type thermoelectric cooler that allows extracting out and modifying a patient's blood temperature in a controlled manner, Dynamic and programmed. That is, instead of indirectly cooling the blood of the patient, as is the case in devices currently known, the device draws blood from the patient's body, modifies its temperature using the Peltier-type refrigerator, and the reintroduces into the patient's body at a different temperature.
  • means connected to the refrigerator and the pump are used that allow at least part of the patient's blood flow to be extracted, passed through said refrigerator and pump, and reintroduced into the body.
  • hypothermia induction cycle in a patient comprises a cooling stage and subsequently a controlled reheating stage of blood temperature.
  • a Peltier-type refrigerator is based on the so-called Peltier-Seebeck property, which is that when an electric current is passed through two metals or semiconductors connected by two Peltier junctions, a temperature difference between these junctions is induced.
  • the Peltier effect allows a temperature difference to be obtained from the application of an electrical voltage. Applying this effect properly, it is possible to design a refrigerator without moving parts or thermodynamic cycles, but mainly formed by metal plates that, depending on the applied voltage, are cooled to exchange heat with a fluid that is passed near its surface. Alternatively, by inverting the applied voltage it is possible to heat the plates, which allows to increase the temperature of the fluid.
  • a Peltier type refrigerator therefore, is a device that serves to modify the temperature of a fluid, in this case blood, only from the application of electric current, without the need to use cooling fluids or thermodynamic cycles.
  • the device of the invention is small in size and only requires a connection to the electricity network and optionally a battery to disconnect it from the network if necessary, which greatly facilitates its use and transport.
  • the cooling / heating is carried out directly on the patient's blood, so that it is easy to accurately measure the temperature of the blood flow that returns to the patient to maintain a better control of its temperature bodily.
  • the device of the invention preferably further comprises two inlet blood temperature sensors and two outlet blood temperature sensors connected to a control means capable of controlling the operation of the refrigerator.
  • the control means can act at least on the voltage that reaches the Peltier refrigerator, so that its cooling / heating capacity can be increased / decreased depending on the blood temperature that is desired at any time.
  • the control means can use any control strategy suitable for this process, although preferably it is used
  • PID integral proportional control
  • the device of the invention can be provided isolated or combined with another machine commonly used in the medical field.
  • another machine commonly used in the medical field.
  • Fig. 1 shows a scheme of a device for inducing therapeutic hypothermia according to a preferred embodiment of the invention.
  • Fig. 2 shows a diagram of a patient with whom the device of Fig. 1 is being used
  • Fig. 1 shows a diagram of the device (1) according to the present invention where the different parts that compose it are appreciated.
  • the device (1) has a blood pump (2) connected to a Peltier type thermoelectric cooler (3).
  • An input catheter (7) receives blood from the patient, for example from the subclavian or femoral, and leads in this example to the pump inlet (2), while an outlet catheter (8) conducts blood from the refrigerator outlet (3) and returns it to the patient at a modified temperature .
  • the inlet catheter (7) has a temperature sensor (4) connected that measures the inlet temperature (Te) of the blood to the device (1) and the outlet catheter (8) has a temperature sensor (5) that measure the outlet temperature (Ts) of the blood to the device (1).
  • the device (1) would have two input sensors (4) and two output sensors (5) to minimize failures due to failures.
  • the sensors (4, 5) of the inlet (Te) and outlet (Ts) temperature are connected with a control means (6), which in turn acts according to the information received and a program desired on the refrigerator (3) and the blood pump (2).
  • the feeding of the pump (2) and the refrigerator (3) is carried out in this example by means of a plug (9) connected to the mains.
  • the device (1) can include batteries (not shown) for feeding the pump (2) and the refrigerator (3) that would allow it to be unplugged from the network to facilitate travel through the hospital.
  • the device (1) of the invention is designed to control the entire induction process of therapeutic hypothermia, whereby in a first phase there is a cooling of the blood flow through the device. That is, the outlet temperature (Ts) is lower than the inlet temperature (Te). The cooling is carried out for a certain time until the desired temperature is reached, which is maintained for as long as necessary. Subsequently, once the patient's medical conditions advise to end hypothermia, slowly begin to return to the normal temperature of the patient, so in this phase the outlet temperature (Ts) is higher than the inlet temperature (Te ).
  • control means (6) which implements a feedback scheme of a derivative integral proportional type that allows to establish in a dynamic and controlled way the outlet temperature (Ts) of the blood flow according to the needs in every moment.
  • the control means (6) can have programming means that allow selecting the final temperature and the cooling / heating rate of the patient's blood flow.
  • the user only has to adjust the programming of the device (1) according to the application particular, and the controller itself (6) is responsible for managing the operation of the refrigerator (3) to follow the desired program.
  • Fig. 2 shows a device (1) as described during its use for the induction of therapeutic hypothermia to a patient and overheating.
  • the size of the device (1) of the invention is much smaller than that of the devices known at present, so it is easy to transport and connect, very useful since these patients usually require tests such as angiography, CT, NMR, etc.
  • the device (1) of the invention has the advantage that the catheters (7, 8) of input / output are conventional catheters.
  • the catheter used in said previous devices must have very special properties, since it must have a section with excellent thermal transfer properties that allow heat exchange between the cooling fluid and the blood flow. These requirements make its use very difficult, since it is essential to use very expensive catheters designed specifically for this use.

Landscapes

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

Abstract

La présente invention concerne un dispositif d'induction d'hypothermie thérapeutique qui comprend une pompe pour le sang associée à un dispositif de réfrigération thermoélectrique du type Peltier qui permettent de modifier de manière extracorporelle la température du sang d'un patient. Le dispositif comporte des moyens couplés à la pompe et au dispositif de réfrigération pour extraire au moins une partie du flux sanguin du patient, le faire passer dans la pompe et le dispositif de réfrigération, et le renvoyer dans le corps du patient.
PCT/ES2013/070907 2012-12-20 2013-12-20 Dispositif d'induction d'hypothermie thérapeutique Ceased WO2014096499A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESP201231985 2012-12-20
ES201231985A ES2478695B1 (es) 2012-12-20 2012-12-20 Dispositivo para inducir hipotermia terapéutica

Publications (1)

Publication Number Publication Date
WO2014096499A1 true WO2014096499A1 (fr) 2014-06-26

Family

ID=50977651

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES2013/070907 Ceased WO2014096499A1 (fr) 2012-12-20 2013-12-20 Dispositif d'induction d'hypothermie thérapeutique

Country Status (2)

Country Link
ES (1) ES2478695B1 (fr)
WO (1) WO2014096499A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102015014452A1 (de) 2015-11-05 2017-05-11 Technische Hochschule Nürnberg Georg Simon Ohm Vorrichtung für eine Hypothermiebehandlung von Körpern, Körperteilen oder Körperregionen
WO2023141717A1 (fr) * 2022-01-28 2023-08-03 Fusion Pharmaceuticals Inc. Polythérapie à base de produits radiopharmaceutiques ciblant ntsr1 et d'inhibiteurs de réponse aux dommages à l'adn

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000093449A (ja) * 1998-09-24 2000-04-04 Nikkiso Co Ltd 加温冷却自在型ｃｈｄｆ装置
US6413233B1 (en) * 1995-08-18 2002-07-02 Biothermics, Inc. Perfusion hyperthermia treatment system and method
WO2003020403A1 (fr) * 2001-09-04 2003-03-13 Gradipore Limited Extraction de constituants metaboliques du sang
WO2006063080A1 (fr) * 2004-12-09 2006-06-15 Smart Medical Technologies, Llc Systèmes et procédés d'ajustement de température à l'aide de fluides corporels en tant que milieu thermique
WO2012013925A2 (fr) * 2010-07-27 2012-02-02 University Of Strathclyde Dispositif de perfusion intégré

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6413233B1 (en) * 1995-08-18 2002-07-02 Biothermics, Inc. Perfusion hyperthermia treatment system and method
JP2000093449A (ja) * 1998-09-24 2000-04-04 Nikkiso Co Ltd 加温冷却自在型ｃｈｄｆ装置
WO2003020403A1 (fr) * 2001-09-04 2003-03-13 Gradipore Limited Extraction de constituants metaboliques du sang
WO2006063080A1 (fr) * 2004-12-09 2006-06-15 Smart Medical Technologies, Llc Systèmes et procédés d'ajustement de température à l'aide de fluides corporels en tant que milieu thermique
WO2012013925A2 (fr) * 2010-07-27 2012-02-02 University Of Strathclyde Dispositif de perfusion intégré

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Week 200027, Derwent World Patents Index; AN 2000-311404 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102015014452A1 (de) 2015-11-05 2017-05-11 Technische Hochschule Nürnberg Georg Simon Ohm Vorrichtung für eine Hypothermiebehandlung von Körpern, Körperteilen oder Körperregionen
WO2023141717A1 (fr) * 2022-01-28 2023-08-03 Fusion Pharmaceuticals Inc. Polythérapie à base de produits radiopharmaceutiques ciblant ntsr1 et d'inhibiteurs de réponse aux dommages à l'adn

Also Published As

Publication number Publication date
ES2478695A1 (es) 2014-07-22
ES2478695B1 (es) 2015-04-28

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