WO2008063365A2 - Temperature management system with assist mode for use with heart-lung machine - Google Patents

Temperature management system with assist mode for use with heart-lung machine Download PDF

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Publication number
WO2008063365A2
WO2008063365A2 PCT/US2007/022975 US2007022975W WO2008063365A2 WO 2008063365 A2 WO2008063365 A2 WO 2008063365A2 US 2007022975 W US2007022975 W US 2007022975W WO 2008063365 A2 WO2008063365 A2 WO 2008063365A2
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WO
WIPO (PCT)
Prior art keywords
temperature
patient
hlm
catheter
heart
Prior art date
Application number
PCT/US2007/022975
Other languages
French (fr)
Other versions
WO2008063365A3 (en
Inventor
Kenneth A. Collins
Original Assignee
Alsius Corporation
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 Alsius Corporation filed Critical Alsius Corporation
Publication of WO2008063365A2 publication Critical patent/WO2008063365A2/en
Publication of WO2008063365A3 publication Critical patent/WO2008063365A3/en

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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
    • A61F7/12—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
    • 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
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
    • 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
    • A61F7/12—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
    • A61M2205/36—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
    • A61M2205/366—General characteristics of the apparatus related to heating or cooling by liquid heat exchangers

Definitions

  • the present invention relates generally to patient temperature control systems.
  • the above-mentioned advantages in regulating temperature can be realized by cooling or heating the patient's entire body.
  • the present invention understands that since many patients already are intubated with central venous catheters for other clinically approved purposes anyway such as drug delivery and blood monitoring, providing a central venous catheter that can also cool or heat the blood requires no additional surgical procedures for those patients.
  • HLM heart-lung machine
  • a method includes engaging a heat exchange element with a patient.
  • the heat exchange element is coupled to a primary control system for controlling patient temperature.
  • the method also includes engaging a component such as a heart lung machine (HLM) with the patient for, e.g., cardiac bypass surgery, with the component also controlling patient temperature.
  • HLM heart lung machine
  • the primary control system is used to assist the component in establishing a target patient temperature. Then, at or about target temperature being reached, temperature control functions of the primary control system are suspended so that only the component controls patient temperature.
  • the heat exchange element can include an intravascular catheter and/or a pad applied externally to a patient's skin.
  • a system for exchanging heat with primary coolant flowing through a patient-engageable heat exchange element includes a processor executing logic including receiving a target temperature signal, and resetting a low temperature alarm setpoint based on the target temperature signal.
  • a method in still another aspect, includes engaging a heart-lung machine (HLM) with a patient and engaging a heat exchange element that is not part of the HLM with the patient. The method further includes using both the HLM and heat exchange element to approach a target patient temperature. The method also includes at or about the target temperature, suspending temperature control of the heat exchange element and controlling patient temperature using only the HLM.
  • HLM heart-lung machine
  • Figure 1 is a schematic diagram showing two heat exchange modalities for use of one or both as "primary" temperature control systems that may be used to assist another component, such as a HLM, in controlling patient temperature; and
  • Figure 2 is a flow chart of the present logic.
  • a system is shown, generally designated 10, that may include a heat exchange catheter 12 that is in fluid communication with a catheter temperature control system 14 that includes a processor 15 executing logic described in one or more of the patents referenced herein and also described further below in reference to Figure 2.
  • the system 10 can be used to induce therapeutic hypothermia in a patient 16 using a catheter in which coolant such as but not limited to saline circulates in a closed loop, such that no coolant enters the body.
  • coolant such as but not limited to saline circulates in a closed loop, such that no coolant enters the body.
  • the system 10 may include one or more pads 18 that are positioned against the external skin of the patient 16 (only one pad 18 shown for clarity).
  • the pad 18 may be, without limitation, any one of the pads disclosed in the external pad patents.
  • the temperature of the pad 18 can be controlled by a pad controller 20 with processor 22 in accordance with principles set forth in the external pad patents to exchange heat with the patient 16, including to induce therapeutic mild or moderate hypothermia in the patient in response to the patient presenting with, e.g., cardiac arrest, myocardial infarction, stroke, high intracranial pressure, traumatic brain injury, or other malady the effects of which can be ameliorated by hypothermia.
  • the control systems 14, 20 may be implemented by a single system having one or more processors for executing temperature control algorithms in accordance with the referenced patents.
  • One or both of the primary control systems 14, 20 may be used during, e.g., a surgical procedure such as cardiac bypass surgery that might employ a component such as Uj ⁇ t not limited to a heart-lung machine (HLM) 24 with component processor 26 that happens to control blood temperature extracorporeal ⁇ , in addition to other functions it might perform such as blood oxygenation. During some of these procedures it might happen to be desirable to cool the patient to temperatures (e.g., fifteen degrees Centigrade) far lower than those normally used for therapeutic hypothermia (e.g., mild hypothermia temperatures). As recognized herein, one or both of the primary control systems 14, 20 can be used to assist the HLM 24 in lowering patient temperature. It should be understood that while for simplicity the discussion below relates to using only the primary control system 14 with catheter 12 to assist the HLM 24, one or both of the primary control systems 14, 20 can be used to assist the HLM 24.
  • HLM heart-lung machine
  • a user manipulates controls on the primary system 14 to cause the system 14 to enter the assist mode, in which target temperature is set at block 30.
  • target temperature in procedures that might require very low patient temperatures
  • the low temperature alarm of the system 14 normally set around thirty two degrees C or so, is reset at block 32 to be "C" degrees (e.g., two) below the target temperature set at block 30. Consistent with the reset of the low temperature alarm setpoint, a warning can be displayed on the system 14 at block 34 to the effect that patient health can be compromised at such low temperatures.

Abstract

A system uses both a heart-lung machine (HLM) (24) and a catheter (12) and/or pad (18) to reach a target temperature for, e.g., cardiac bypass surgery. At or about the target temperature, temperature control of the catheter/pad is suspended and patient temperature controlled using only the HLM.

Description

TEMPERATURE MANAGEMENT SYSTEM WITH ASSIST MODE FOR USE WITH HEART-LUNG MACHINE
I. FIELD OF THE INVENTION
The present invention relates generally to patient temperature control systems.
II. BACKGROUND OF THE INVENTION
It has been discovered that the medical outcome for a patient suffering from severe brain trauma or from ischemia caused by stroke or heart attack or cardiac arrest is improved if the patient is cooled below normal body temperature (37°C). Furthermore, it is also accepted that for such patients, it is important to prevent hyperthermia (fever) even if it is decided not to induce hypothermia. Moreover, in certain applications such as post- CABG surgery, it might be desirable to rewarm a hypothermic patient.
As recognized by the present invention, the above-mentioned advantages in regulating temperature can be realized by cooling or heating the patient's entire body. Moreover, the present invention understands that since many patients already are intubated with central venous catheters for other clinically approved purposes anyway such as drug delivery and blood monitoring, providing a central venous catheter that can also cool or heat the blood requires no additional surgical procedures for those patients. The following U.S. patents, all of which are incorporated herein by reference, disclose various intravascular catheters/systems/methods: 6,749,625, 6,786,916, 6,581 ,403, 6,454,792, 6,436,130, 6,146,411, 6,109,783, 6,419,643, 6,416,533, 6,409,747, 6,405,080, *■ 393,320, 6,368,304, 6,338,727, 6,299,599, 6,290,717, 6,287,326, 6,165,207, 6,149,670, 6,146,411 , 6,126,684, 6,306,161, 6,264,679, 6,231,594, 6,149,676, 6,149,673, 6,1 10,168, 5,989,238, 5,879,329, 5,837,003, 6,383,210, 6,379,378, 6,364,899, 6,325,818, 6,312,452, 6,261 ,312, 6,254,626, 6,251 , 130, 6,251 , 129, 6,245,095, 6,238,428, 6,235,048, 6,231 ,595, 6,224,624, 6,149,677, 6,096,068, 6,042,559, and U.S. patent application serial no. 10/355,776. Less optimally, surface cooling can be used. U.S. Patent Nos. 6,827,728, 6,818,012, 6,802,855, 6,799,063, 6,764,391 , 6,692,518, 6,669,715, 6,660,027, 6,648,905, 6,645,232, 6,620,187, 6,461 , 379, 6,375,674, 6,197,045, and 6,188,930 (collectively, "the external pad patents"), all of which are incorporated herein by reference, disclose such surface cooling systems. In both intravascular catheters and external pad systems, coolant such as a gas or saline is circulated through the heat exchange element.
Regardless of the particular heat exchange element that is engaged with the patient, as understood herein it may be advantageous to use such a system during surgical procedures to control patient temperature. As further understood herein, some procedures may employ another component such as a heart-lung machine (HLM) that can also function to control patient temperature. The present invention understands that during such procedures, a primary temperature control system such as those disclosed in the above patents can be used to assist the other component, e.g., the HLM, in reducing patient temperature to a very low level. However, as further recognized herein it is important to avoid the control processor of one system from "fighting" the control processor of the other system during such assist procedures. SUMMARY OF THE INVENTION
A method includes engaging a heat exchange element with a patient. The heat exchange element is coupled to a primary control system for controlling patient temperature. The method also includes engaging a component such as a heart lung machine (HLM) with the patient for, e.g., cardiac bypass surgery, with the component also controlling patient temperature. The primary control system is used to assist the component in establishing a target patient temperature. Then, at or about target temperature being reached, temperature control functions of the primary control system are suspended so that only the component controls patient temperature.
The heat exchange element can include an intravascular catheter and/or a pad applied externally to a patient's skin.
In another aspect, a system for exchanging heat with primary coolant flowing through a patient-engageable heat exchange element includes a processor executing logic including receiving a target temperature signal, and resetting a low temperature alarm setpoint based on the target temperature signal.
In still another aspect, a method includes engaging a heart-lung machine (HLM) with a patient and engaging a heat exchange element that is not part of the HLM with the patient. The method further includes using both the HLM and heat exchange element to approach a target patient temperature. The method also includes at or about the target temperature, suspending temperature control of the heat exchange element and controlling patient temperature using only the HLM. The details of the present invention, both as to its structure and operation, can best be understood in reference to the accompanying drawings, in which like reference numerals refer to like parts, and in which:
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a schematic diagram showing two heat exchange modalities for use of one or both as "primary" temperature control systems that may be used to assist another component, such as a HLM, in controlling patient temperature; and
Figure 2 is a flow chart of the present logic.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring initially to Figure 1 , a system is shown, generally designated 10, that may include a heat exchange catheter 12 that is in fluid communication with a catheter temperature control system 14 that includes a processor 15 executing logic described in one or more of the patents referenced herein and also described further below in reference to Figure 2.
In accordance with present principles, the system 10 can be used to induce therapeutic hypothermia in a patient 16 using a catheter in which coolant such as but not limited to saline circulates in a closed loop, such that no coolant enters the body. While certain preferred catheters are disclosed below, it is to be understood that other catheters can be used in accordance with present principles, including, without limitation, any of tV"2 catheters disclosed in the following U.S. patents, all incorporated herein by reference: USPN 5,486,208, 5,837,003, 6,110,168, 6,149,673, 6,149,676, 6,231,594, 6,264,679, 6,306,161 , 6,235,048, 6,238,428, 6,245,095, 6,251,129, 6,251,130, 6,254,626, 6,261 ,312, 6,312,452, 6,325,818, 6,409,747, 6,368,304, 6,338,727, 6,299,599, 6,287,326, 6, 126,684. The catheter 12 may be placed in the venous system, e.g. , in the superior or inferior vena cava. Examples of non-limiting control systems 14 are shown in USPN 6,786,916, 6,581 ,403, 6,454,792, 6,436,130, 6,146,41 1, and 6,109,783, incorporated herein by reference.
Instead of or in addition to the catheter 12, the system 10 may include one or more pads 18 that are positioned against the external skin of the patient 16 (only one pad 18 shown for clarity). The pad 18 may be, without limitation, any one of the pads disclosed in the external pad patents. The temperature of the pad 18 can be controlled by a pad controller 20 with processor 22 in accordance with principles set forth in the external pad patents to exchange heat with the patient 16, including to induce therapeutic mild or moderate hypothermia in the patient in response to the patient presenting with, e.g., cardiac arrest, myocardial infarction, stroke, high intracranial pressure, traumatic brain injury, or other malady the effects of which can be ameliorated by hypothermia. The control systems 14, 20 may be implemented by a single system having one or more processors for executing temperature control algorithms in accordance with the referenced patents.
One or both of the primary control systems 14, 20 may be used during, e.g., a surgical procedure such as cardiac bypass surgery that might employ a component such as Uj\t not limited to a heart-lung machine (HLM) 24 with component processor 26 that happens to control blood temperature extracorporeal^, in addition to other functions it might perform such as blood oxygenation. During some of these procedures it might happen to be desirable to cool the patient to temperatures (e.g., fifteen degrees Centigrade) far lower than those normally used for therapeutic hypothermia (e.g., mild hypothermia temperatures). As recognized herein, one or both of the primary control systems 14, 20 can be used to assist the HLM 24 in lowering patient temperature. It should be understood that while for simplicity the discussion below relates to using only the primary control system 14 with catheter 12 to assist the HLM 24, one or both of the primary control systems 14, 20 can be used to assist the HLM 24.
Now referring to Figure 2, at block 28 a user manipulates controls on the primary system 14 to cause the system 14 to enter the assist mode, in which target temperature is set at block 30. Because target temperature in procedures that might require very low patient temperatures, the low temperature alarm of the system 14, normally set around thirty two degrees C or so, is reset at block 32 to be "C" degrees (e.g., two) below the target temperature set at block 30. Consistent with the reset of the low temperature alarm setpoint, a warning can be displayed on the system 14 at block 34 to the effect that patient health can be compromised at such low temperatures. Once target temperature is substantially reached, to avoid the primary control system processor 22 counteracting the temperature control efforts of the HLM processor 26, at block 36 the temperature control functions of the primary system processor 22 are suspended, so that only the HLM 24 controls patient temperature once target temperature is reached. While the particular TEMPERATURE MANAGEMENT SYSTEM WITH ASSIST MODE FOR USE WITH HEART-LUNG MACHINE is herein shown and described in detail, it is to be understood that the subject matter which is encompassed by the present invention is limited only by the claims.

Claims

WHAT IS CLAIMED IS:
1. A system for exchanging heat with primary coolant flowing through a patient-engageable heat exchange element, comprising: a processor (15/22/26) executing logic comprising: receiving a target temperature signal; and resetting a low temperature alarm setpoint based on the target temperature signal.
2. The system of Claim 1 , wherein the logic further comprises: establishing primary coolant temperature to approach target temperature; and at or about target temperature, suspending control of coolant temperature.
3. A system, comprising: at least one heart-lung machine (HLM) (24); at least one intravascular temperature control catheter (12) and in addition to the catheter ( 12) or in lieu thereof, at least one external pad ( 18) for warming or cooling a patient, wherein at or about a target temperature, temperature control of the catheter/pad is suspended and patient temperature control is effected using only the HLM.
PCT/US2007/022975 2006-11-13 2007-10-30 Temperature management system with assist mode for use with heart-lung machine WO2008063365A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/598,352 US7867266B2 (en) 2006-11-13 2006-11-13 Temperature management system with assist mode for use with heart-lung machine
US11/598,352 2006-11-13

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WO2008063365A2 true WO2008063365A2 (en) 2008-05-29
WO2008063365A3 WO2008063365A3 (en) 2008-09-25

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