WO1997006839A1 - Appareil de traitement hyperthermique pour le corps entier - Google Patents

Appareil de traitement hyperthermique pour le corps entier Download PDF

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Publication number
WO1997006839A1
WO1997006839A1 PCT/DE1996/001555 DE9601555W WO9706839A1 WO 1997006839 A1 WO1997006839 A1 WO 1997006839A1 DE 9601555 W DE9601555 W DE 9601555W WO 9706839 A1 WO9706839 A1 WO 9706839A1
Authority
WO
WIPO (PCT)
Prior art keywords
control
temperature
blood
catheter
kidney
Prior art date
Application number
PCT/DE1996/001555
Other languages
German (de)
English (en)
Inventor
Panagiotis Tsolkas
Rudolf Launee
Original Assignee
Panagiotis Tsolkas
Rudolf Launee
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 Panagiotis Tsolkas, Rudolf Launee filed Critical Panagiotis Tsolkas
Publication of WO1997006839A1 publication Critical patent/WO1997006839A1/fr

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
    • 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
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/166—Heating
    • 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
    • A61M2205/366—General characteristics of the apparatus related to heating or cooling by liquid heat exchangers

Definitions

  • WBH whole body hyperthermia
  • ESH extraco ⁇ oreal systemic heating.
  • the temperature is controlled by measuring probes.
  • Applications are mainly cancer and infectious diseases (HIV infection / AIDS, hepatitis B and C).
  • Willnow had used an artificial kidney as the heat exchanger (U. Willnow et al., DMW (Dtsch.med.Wschr. 114 (1989) 208-213): The temperature control is carried out as with Alonso.
  • a hyperthermia device using ESH describes the US (- 5354277: The blood is led out of the body via catheters and heated to 42 ° C.
  • a dialysis machine is also used as the heat exchanger Dialysis fluid is 48 ° C. The temperature is controlled using a tubular heat exchanger and a heated mattress.
  • a temperature control zone is presented in the patents US 4479798 and DE 2822167. The temperature is kept constant at 41.5 ° C and must not rise above 42.5 ° C. The temperature control zone can also be attached as a skin implant. - Roller pumps for blood transport are proposed in US 4692138.
  • a device for performing an extracorporeal hyperthermia treatment is shown in DE 3817603.
  • the blood is then heated up to 47 ° C and cooled again before being returned to the body.
  • the temperature is controlled via two switching thermostats, to which temperature sensors are attached.
  • hyperthermia devices that heat and regulate by means of infrared or microwave radiation. They are mainly used for brain tumor therapies or for local hyperthermia (DE 4020714). Hyperthermia devices without extracorporeal heating, the energy supply using an electric field (US 5251645), electromagnetic waves (US 5231997), high-frequency circuits (DE 3526531 and DE 3306391) or ultrasound (US 5230334) are known. Control circuits have not previously been described in connection with extracorporeal hyperthermia treatment.
  • the invention has for its object to develop a hyperthermia device that enables improved temperature control via measuring probes.
  • the object is achieved by an arrangement according to which there are several measuring probes in the blood circulation and a cascade control consisting of several successive ones Trigger control loops, the decisive control variable being the venous temperature at the inlet of the catheter.
  • the arrangement according to the invention consists in the combination of known and new or newly composed elements. It represents a new combination of known elements based on an artificial kidney (hemodialyzer); essential components of dialysis technology are also used.
  • Figure 1 shows schematically the structure used. A distinction is made between a blood circulation and a heating circuit. The heat exchanger is the dialyzer. The hose system of the heating circuit is connected to the water side of the kidney. This - a closed - system is filled with electrolyte solution. A pump transports the solution past the heater and back. Temperature sensors are installed in front of and behind the heater.
  • the blood circulation works by inserting a double-barreled catheter into the large draining jugular vein (internal vena jugular, right or left, but also vena subclavia or vena femoralis, right or left). It is known from dialysis treatment that these catheters, with a correspondingly sterile dressing, can remain for several weeks to months, so that a series of treatments via the same catheter is possible.
  • the inlet of the blood is at the tip of the catheter, the outlet above the tip through holes made on the side of the catheter.
  • the blood is pumped out of the body, through the heat exchanger and back into the body via a roller pump (blood flow 350 ml / min).
  • the patient is secured against air embolism by a bladder trap and an air trap (ultrasound).
  • a temperature probe at the blood outlet of the heat exchanger, as well as at the inlet and outlet of the catheter.
  • the probe at the inlet detects the temperature of the blood with which it is pumped into the body. This temperature can be selected, up to a maximum of 42.2 ° C.
  • the decisive control variable is the venous temperature at the inlet of the catheter. With the help of a protective device, it can also cause an emergency shutdown of the heater: at 42.3 ° C, the heater switches off with an alarm tone after 20 seconds, at 42.6 ° C the heater is immediately switched off with an alarm tone.
  • the probe at the outlet shows the actual temperature of the body, which rises slowly. If a target temperature of 42 ° C is specified, this is achieved in 70 to 80 minutes with simple sedation of the patient, in 40 to 50 minutes with intubation anesthesia (ITN).
  • ITN intubation anesthesia
  • the time difference between sedation and ITN until the target temperature is reached results from the fact that when the patient is sedated, the room temperature can only be increased to 39 ° C, while in ITN the breathing air is sufficiently preheated.
  • the treatment time is 2 hours.
  • Chemotherapy drugs can be administered throughout the treatment period. The loss of water and electrolyte is continuously compensated for, the loss of energy due to glucose.
  • standard systems from dialysis treatment can be used without changes, such as: single-use pump tubing arterial and venous, single-use dialyzer as a heat exchanger, single-use pump tubing for substitution solutions and standard substitution solutions from dialysis treatment.
  • the heating circuit can be disinfected with water after treatment (hydrogen peroxide, sodium hypochlorite).
  • the device according to the invention for whole body hypertherapy treatment consists of an arrangement - based on an artificial kidney - with a hemodialyzer as a heat exchanger with blood pumps, heater and circulating pump, from temperature measuring probes before and after the heater, a cascade control of the blood temperature, a control part of the temperature probe at the catheter inlet and a control unit for cascading blood temperature control from a temperature control with the temperature at the catheter inlet as a reference variable (FIG. 1).
  • the heating circuit consists of a closed hose system connected to the water side of the kidney, which is filled with electrolyte solution.
  • the blood circulation of the system is formed by a double-barreled catheter and the blood is pumped out of the body by roller pumps and pumped back into the body after passing through the heat exchanger.
  • the blood is admitted at the tip of the catheter and the outlet above the tip through holes made on the side of the catheter.
  • the probe at the inlet detects the blood temperature.
  • the probe at the outlet shows the actual temperature of the body rising during the treatment and the probe at the inlet shows the blood temperature generated in the heating system.
  • the decisive control variable is the venous temperature at the catheter inlet.
  • a protective device which may become necessary and which acts as an emergency shutdown is also regulated via it.
  • the cascade control of the blood temperature consists of several successive control loops: a heating control, a kidney output control and a venous temperature control ( Figure 2).
  • the heating control receives its setpoint from the kidney output control (reproduction of the water temperature in the dialyzer) and the kidney output control receives its soli value from the venous temperature control. This evaluates the venous temperature as a controlled variable, with the control loops being determined by the control deviation and the manipulated variable.
  • the venous temperature control receives its setpoint from the outside, whereby the individual control loops calculate their respective manipulated variables from the control deviation, the setpoints directly and other physical variables that influence the controlled system.
  • the manipulated variables (control parameters and control methods) of the kidney outlet and venous temperature control can also be calculated by a higher-level adaptive control or by automatically controlled and evaluated tests before the treatment.
  • the device according to the invention is used for the treatment of cancer or infectious diseases (HIV infections / AIDS, hepatitis B and C).
  • Th temperature heating output Thr should set temperature heating
  • Tn is designed to target kidney exit temperature
  • Tv should target venous temperature
  • a four-way tap either leads the water circuit to external connections or closes it to form a ring
  • a water pump fills / empties the water circuit, e.g. for sterilization or creates a circulation - a heater heats the water in the water circuit (control variable)
  • a dialyzer serves as a heat exchanger between the water and blood circulation
  • a blood pump (peristaltic pump) creates a blood circulation - a temperature sensor Tv (venous temperature) provides a measured value for the venous temperature control (controlled variable)
  • a temperature sensor Tn (kidney outlet temperature) provides a measured value for the kidney outlet control
  • a hose clamp prevents blood circulation when air is detected
  • a temperature sensor Ta (arterial temperature) provides a measured value for information to the treating personnel
  • the decisive variable is the venous temperature, which is the temperature of the blood that is returned to the patient. It is ultimately influenced by the heater (temperature increase) and by heat radiation in the individual components of the arrangement (temperature decrease).
  • the closed water circuit supplies thermal energy to the dialyzer (heat exchanger). This releases heat energy to the blood circulating in the bloodstream. Considerable dead times can be expected in these processes, which make the regulation of the venous temperature very difficult.
  • the control consists of three successive control loops (a cascade control; partly a mixture of control and regulation).
  • the innermost control loop is the heating control.
  • the setpoint comes from the higher-level kidney output control; It is regulated to a value that reflects the temperature of the water in the dialyzer as well as possible (e.g. (Th + Tr)).
  • the manipulated variable is made up of a P and a D component, calculated from the control deviation, and a further component, calculated from the setpoint specification Tn so n and other process parameters, such as circulation speed in the water and blood circulation.
  • Tn setpoint specification
  • the latter serves to prevent strong control vibrations due to the inertia of the system.
  • the control algorithm uses two parameter sets, depending on whether the control deviation is above a certain threshold (heating phase) or whether it is below (fine control).
  • Y P * x + D * x '+ f (process) (manipulated variable)
  • the manipulated variable is composed again of a P and a D component, calculated from the control deviation, and a further component, calculated from the setpoint specification Tv S0 u and other process parameters, as mentioned above. The latter is particularly important here, since a long and non-constant dead time makes regulation with the required control quality impossible.
  • the control algorithm also uses two parameter sets here, depending on whether the control deviation is above a certain threshold (heating phase) or whether it is below (fine control).
  • the process-dependent terms used in the kidney outlet and vein temperature control for calculating the manipulated variable can also be determined by a further superordinate control. The dependencies can be calculated either by longer observation of the control behavior (adaptive control) or by automatically controlled and evaluated tests before the treatments. Furthermore, an emergency shutdown is implemented, which brings about the fastest possible cooling at temperatures dangerous for the patient (see above).

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Emergency Medicine (AREA)
  • External Artificial Organs (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)

Abstract

Le fonctionnement de cet appareil de traitement hyperthermique, destiné au corps entier, est constitué d'un rein artificiel qui sert d'échangeur de chaleur, de sondes de mesures de la température montées en amont et en aval des éléments chauffants et d'un appareil de régulation en cascade de la température du sang qui utilise la température à l'admission du cathéter comme valeur de commande. L'appareil est utile pour traiter des maladies cancéreuses et infectieuses, telles que le SIDA/VIH ou l'hépatite B et C.
PCT/DE1996/001555 1995-08-17 1996-08-16 Appareil de traitement hyperthermique pour le corps entier WO1997006839A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19531935A DE19531935A1 (de) 1995-08-17 1995-08-17 Gerät zur Ganzkörperhyperthermie-Behandlung
DE19531935.4 1995-08-17

Publications (1)

Publication Number Publication Date
WO1997006839A1 true WO1997006839A1 (fr) 1997-02-27

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Application Number Title Priority Date Filing Date
PCT/DE1996/001555 WO1997006839A1 (fr) 1995-08-17 1996-08-16 Appareil de traitement hyperthermique pour le corps entier

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DE (1) DE19531935A1 (fr)
WO (1) WO1997006839A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6629946B2 (en) 1999-01-12 2003-10-07 Jean-Louis Fressinet Continuous renal replacement therapy heat loss compensation
US6951219B2 (en) * 2000-01-14 2005-10-04 First Circle Medical, Inc. Treatment of hepatitis C using hyperthermia

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US6338727B1 (en) 1998-08-13 2002-01-15 Alsius Corporation Indwelling heat exchange catheter and method of using same
US7892269B2 (en) 2005-04-18 2011-02-22 Zoll Circulation, Inc. External heat exchange pad for patient
US7951182B2 (en) 2005-07-14 2011-05-31 Zoll Circulation, Inc. System and method for leak detection in external cooling pad
US8475509B2 (en) 2007-08-09 2013-07-02 Zoll Circulation, Inc. Devices and methods for using endovascular cooling to treat septic shock and other disorders
DE102011016508A1 (de) 2011-04-08 2012-10-11 Sorin Group Deutschland Gmbh Temperiervorrichtung für den Einsatz in fluidbasierten Hyper-/Hypothermie-Systemen
US9283110B2 (en) 2011-09-20 2016-03-15 Zoll Circulation, Inc. Patient temperature control catheter with outer sleeve cooled by inner sleeve
US10045881B2 (en) 2011-09-28 2018-08-14 Zoll Circulation, Inc. Patient temperature control catheter with helical heat exchange paths
US8888832B2 (en) 2011-09-28 2014-11-18 Zoll Circulation, Inc. System and method for doubled use of patient temperature control catheter
US9314370B2 (en) 2011-09-28 2016-04-19 Zoll Circulation, Inc. Self-centering patient temperature control catheter
US9259348B2 (en) 2011-09-28 2016-02-16 Zoll Circulation, Inc. Transatrial patient temperature control catheter
EP2698177B1 (fr) 2012-08-13 2015-01-14 Sorin Group Deutschland GmbH Procédé pour commander un état de désinfection d'un dispositif de commande de température et dispositif de contrôle de température pour la régulation de la température du corps humain pendant une circulation extra-corporelle
EP2698176B1 (fr) * 2012-08-13 2017-03-15 Sorin Group Deutschland GmbH Procédé et appareil de désinfection d'un dispositif de régulation de température pour la régulation de la température du corps humain pendant la circulation extra-corporelle
US9801756B2 (en) 2012-09-28 2017-10-31 Zoll Circulation, Inc. Intravascular heat exchange catheter and system with RFID coupling
US9433528B2 (en) 2012-09-28 2016-09-06 Zoll Circulation, Inc. Intravascular heat exchange catheter with rib cage-like coolant path
US9241827B2 (en) 2012-09-28 2016-01-26 Zoll Circulation, Inc. Intravascular heat exchange catheter with multiple spaced apart discrete coolant loops
US9717625B2 (en) 2012-09-28 2017-08-01 Zoll Circulation, Inc. Intravascular heat exchange catheter with non-round coiled coolant path
US9474644B2 (en) 2014-02-07 2016-10-25 Zoll Circulation, Inc. Heat exchange system for patient temperature control with multiple coolant chambers for multiple heat exchange modalities
US10500088B2 (en) 2014-02-14 2019-12-10 Zoll Circulation, Inc. Patient heat exchange system with two and only two fluid loops
US11033424B2 (en) 2014-02-14 2021-06-15 Zoll Circulation, Inc. Fluid cassette with tensioned polymeric membranes for patient heat exchange system
US10792185B2 (en) 2014-02-14 2020-10-06 Zoll Circulation, Inc. Fluid cassette with polymeric membranes and integral inlet and outlet tubes for patient heat exchange system
US9784263B2 (en) 2014-11-06 2017-10-10 Zoll Circulation, Inc. Heat exchange system for patient temperature control with easy loading high performance peristaltic pump
US11359620B2 (en) 2015-04-01 2022-06-14 Zoll Circulation, Inc. Heat exchange system for patient temperature control with easy loading high performance peristaltic pump
US11213423B2 (en) 2015-03-31 2022-01-04 Zoll Circulation, Inc. Proximal mounting of temperature sensor in intravascular temperature management catheter
US10537465B2 (en) 2015-03-31 2020-01-21 Zoll Circulation, Inc. Cold plate design in heat exchanger for intravascular temperature management catheter and/or heat exchange pad
US10022265B2 (en) 2015-04-01 2018-07-17 Zoll Circulation, Inc. Working fluid cassette with hinged plenum or enclosure for interfacing heat exchanger with intravascular temperature management catheter
DE102015014453A1 (de) 2015-11-05 2017-05-11 Technische Hochschule Nürnberg Georg Simon Ohm Vorrichtung für eine Hyperthermiebehandlung von Körpern, Körperteilen oder Körperregionen
US11116657B2 (en) 2017-02-02 2021-09-14 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control
US11337851B2 (en) 2017-02-02 2022-05-24 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control
US11185440B2 (en) 2017-02-02 2021-11-30 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control
US20240148952A1 (en) * 2021-03-08 2024-05-09 C. R. Bard, Inc. Systems and Methods for Hyperthermic Cancer Treatment

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Publication number Priority date Publication date Assignee Title
DE1566651A1 (de) * 1967-03-21 1970-08-06 Sp Kb Poluprovodnikovykh Pribo Einrichtung zur AEnderung und Einhaltung der Koerpertemperatur
DE3425379A1 (de) * 1984-07-10 1986-01-16 Johnson Service Co., Milwaukee, Wis. Verfahren zur regelung einer waermeuebergabestation
US4894164A (en) * 1986-10-30 1990-01-16 Fresenius Ag Apparatus for treating blood in an extracorporeal circuit
DE3817603A1 (de) * 1988-05-24 1989-11-30 Michael Stieglitz Extrakorporale-hyperthermie-geraet
CH678886A5 (en) * 1990-09-19 1991-11-15 Sulzer Ag Central heating system regulator - with separate control of primary circuit temp. and flow vol. through heat exchanger

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6629946B2 (en) 1999-01-12 2003-10-07 Jean-Louis Fressinet Continuous renal replacement therapy heat loss compensation
US6951219B2 (en) * 2000-01-14 2005-10-04 First Circle Medical, Inc. Treatment of hepatitis C using hyperthermia

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