WO2002085266A1 - Dispositif d'echange thermique a etancheite amelioree - Google Patents

Dispositif d'echange thermique a etancheite amelioree Download PDF

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Publication number
WO2002085266A1
WO2002085266A1 PCT/US2002/012399 US0212399W WO02085266A1 WO 2002085266 A1 WO2002085266 A1 WO 2002085266A1 US 0212399 W US0212399 W US 0212399W WO 02085266 A1 WO02085266 A1 WO 02085266A1
Authority
WO
WIPO (PCT)
Prior art keywords
seal
chamber
module
opening
mammal
Prior art date
Application number
PCT/US2002/012399
Other languages
English (en)
Other versions
WO2002085266A9 (fr
Inventor
David Frederick Lyons
Dennis A. Grahn
Bruce G. Macgregor
Todd Allen Pelman
Mark A. Zeh
Rudy Lucas Samuels
David William Licata
Original Assignee
Avacore Technologies, 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 Avacore Technologies, Inc. filed Critical Avacore Technologies, Inc.
Publication of WO2002085266A1 publication Critical patent/WO2002085266A1/fr
Publication of WO2002085266A9 publication Critical patent/WO2002085266A9/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
    • A61F7/02—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
    • 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
    • A61F7/02—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
    • 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
    • A61F7/03—Compresses or poultices for effecting heating or cooling thermophore, i.e. self-heating, e.g. using a chemical reaction

Definitions

  • This application relates to body temperature control and management, and more particularly to, a system for applying or removing thermal energy to or from a mammalian body, the system having an improved interface with the external environment.
  • BACKGROUND [0003] Regulating human or mammalian body temperature is desirable in many instances. For example, it may be desirable to raise the core body temperature to treat hypothermia arising, for example, from prolonged exposure to cold environments, trauma or post-operative conditions. Raising body temperature to induce hyperthermia is desirable as well. For example, various treatments for viral diseases and cancers call for elevated body temperatures. Another avenue for body temperature regulation is the lowering of body temperature to treat hyperthermia that may arise, for example, from fever, heat stroke, extreme environments, multiple sclerosis, exercise or exertion induced conditions.
  • Lowering body temperature to induce hypothermia is also desirable to minimize damage to the brain when a patient has suffered a stroke, for example, or to minimize damage to heart or brain tissue when a patient has undergone cardiac arrest. It may sometimes also be desirable to induce hypothermia during surgery to minimize tissue damage.
  • thermal regulation aims at raising, maintaining or lowering body temperature. Whether to induce certain therapies or to normalize body temperature, core body temperature control and management is valuable and potentially life-saving.
  • thermoregulatory responses that maintain the body at a near constant normothermic temperature include sweating and vasodilation to enhance heat loss, arterio venous shunting and vasoconstriction to enhance heat retention, and shivering to enhance increased production of body heat.
  • One important effector of the regulatory system is blood flow to specialized skin areas where heat from the deep body core can be dissipated to the environment.
  • thermoregulatory mechanisms provide a daunting defense when attempts are made to change the body temperature and there is a great interest in the development of methods in which the thermoregulatory system is manipulated so that energy can be transferred into or out of the core body without triggering an opposing thermoregulatory response.
  • Core body temperature control and management methods may involve various drugs and methods that are employed to control the thermoregulatory response so that energy may be added or removed as efficiently and safely as possible.
  • One temperature control and management method involves the application of a negative pressure to a portion of the body in order to induce vasodilatation for regulated heat transfer.
  • Devices for practicing temperature control and management methods that involve the application of a negative pressure include means for providing the negative pressure environment for a portion of the body as well as a heat exchange medium.
  • this means for providing a negative pressure environment includes a means for sealing a portion of the mammal's body in an enclosed environment in which negative pressure conditions can be produced.
  • Representative enclosing means include sleeves, boots/shoes, gloves, etc.
  • a negative pressure inducing means e.g., a vacuum
  • the devices also include a means for thermal communication with a heat exchange medium.
  • the interface of the negative pressure environment with the environment outside of the sealed enclosure must permit a portion of the mammal to be received and be substantially sealed within the enclosure while maintaining an adequate negative pressure within the environment.
  • a module for thermal exchange with a portion of a mammal includes a first chamber that defines a chamber opening and is adapted to receive the portion of the mammal.
  • the module includes an exchange surface in thermal communication with the first chamber.
  • a seal is connected to the first chamber at the chamber opening.
  • the seal includes a seal opening and a waist opening. The chamber opening and the seal opening are greater than the waist opening such that a ramped entry and exit is provided for the portion of the mammal.
  • a module for thermal exchange with a portion of a mammal includes a housing including a first chamber and an exchange surface.
  • the first chamber includes a chamber opening and is adapted to receive a portion of a mammal.
  • the exchange surface is in thermal communication with the first chamber.
  • a seal is connected to the first chamber at the chamber opening. The seal forms a variable opening adapted to substantially conform against the mammal to seal the portion of the mammal inside the first chamber.
  • the first chamber is adapted to receive a portion of a mammal and is adapted to provide a negative pressure environment.
  • the first chamber includes a chamber opening.
  • the exchange surface is in thermal communication with the first chamber.
  • a seal is connected to the first chamber at the chamber opening.
  • the seal has a longitudinal axis and comprises a flexible wall member that provides substantial contact sealing against at least a portion of the external surface of the mammal while accommodating motion of the portion of the mammal that is lateral to the longitudinal axis.
  • a module for thermal exchange with a portion of a mammal includes a housing including a first chamber and an exchange surface.
  • the first chamber includes a chamber opening.
  • the first chamber is adapted to receive a portion of a mammal and is adapted to provide a negative pressure environment.
  • the exchange surface is in thermal communication with the first chamber.
  • a seal is connected to the first chamber at the chamber opening.
  • the seal comprises a flexible sleeve including a waist portion.
  • the waist portion is adapted to engage at least a portion of the external surface of a portion of the mammal.
  • the sleeve is deflectable with movement of the portion of the mammal.
  • a module for thermal exchange with a portion of a mammal includes a housing including a first chamber and an exchange surface.
  • the first chamber is adapted to receive a portion of a mammal and is adapted to provide a negative pressure environment.
  • the first chamber includes a chamber opening.
  • the exchange surface is in thermal communication with the first chamber.
  • a seal is connected to the first chamber at the chamber opening.
  • the seal includes an elastic element to bias the seal against the portion of the mammal.
  • the first chamber is adapted to receive a portion of a mammal via the chamber opening.
  • the first chamber being adapted to receive a negative pressure via the port.
  • the exchange surface is in thermal communication with the first chamber.
  • a seal is connected to the first chamber at the chamber opening to seal the portion of the mammal inside the first chamber.
  • a module for thermal exchange with a portion of a mammal includes a housing having a first end and a second end.
  • the housing includes a chamber that is adapted to receive a portion of the mammal and a heat exchange cavity in thermal communication with the chamber.
  • a seal is connected to the housing at the second end.
  • the seal defines a chamber opening, a waist opening, and a seal opening.
  • the waist opening is located between the chamber opening and the seal opening.
  • the chamber opening is located proximate to the plate relative to the seal opening.
  • a seal frame is connected to the housing at the second end and supports the seal.
  • a module for thermal exchange with a portion of a mammal that includes a base having an exchange surface and a base perimeter.
  • the module further includes a cover connected to the base to form a chamber for receiving the portion of a mammal such that the portion of the mammal is in thermal communication with the exchange surface.
  • the chamber is adapted to receive a negative pressure environment relative to atmospheric pressure.
  • the cover has a cover perimeter.
  • the module includes a seal for contacting the portion of the mammal to substantially prevent leakage of air across the seal.
  • the method comprises the steps of providing a module having a chamber for receiving a portion of the mammal.
  • the module includes a seal that allows a variable leakage of air across the seal.
  • a vacuum pump that is coupled to the chamber to draw air from the chamber is also provided.
  • a control system that is coupled to the vacuum pump for regulating the air pressure within the chamber is also provided.
  • the method further includes the steps of selecting a pressure set-point and establishing an air pressure inside the chamber that is substantially equal to the pressure set-point.
  • the method includes the step of maintaining the pressure set-point within the chamber.
  • FIG. 1 is a fore perspective view of the thermal exchange module of the present invention
  • FIG. 2 is an aft perspective view of the thermal exchange module of the present invention
  • FIG. 3 is an exploded view of the thermal exchange module of the present invention.
  • FIG. 4 is a rear elevational view of the thermal exchange module of the present invention.
  • FIG. 5 is a cross-sectional view along line A-A of FIG. 4 of the thermal exchange module of the present invention.
  • FIG. 6 is a cross-sectional view along line B-B of FIG. 4 of the thermal exchange module of the present invention.
  • FIG. 7 is a perspective view of the thermal exchange module of the present invention.
  • FIG. 8 is a perspective view of the thermal exchange module with a detached seal cartridge of the present invention.
  • FIG. 9 is an exploded view of the thermal exchange module of the present invention.
  • FIG. 10 is a perspective view of the thermal exchange module of the present invention.
  • FIG. 11 is a perspective view of the thermal exchange module of the present invention.
  • FIG. 12 is a perspective view of the thermal exchange module and heat exchange element of the present invention.
  • FIG. 13 is a perspective view of the thermal exchange module of the present invention with a human hand inserted therein.
  • This invention relates generally to hardware configured for carrying out the methodologies in particular, those described in Provisional Patent Application entitled METHODS AND DEVICES FOR EXTRACTING THERMAL ENERGY FROM THE BODY CORE OF A MAMMAL filed on April 20, 2000, Provisional Patent Application entitled METHODS AND DEVICES FOR ENHANCING THE PHYSICAL ABILITY OF A MAMMAL filed on April 20, 2000, Provisional Patent Application entitled METHODS AND DEVICES FOR MANIPULATING THE THERMOREGULATORY STATUS OF A MAMMAL filed on June 9, 2000 and Provisional Patent Application entitled METHODS AND DEVICES FOR PREVENTION OF HYPOTHERMIA IN A MAMMAL DURING PROLONGED EXPOSURE TO EXTREME COLD, each to Dr.
  • FIGs. 1 and 2 provide fore and aft perspective views of a negative pressure thermal exchange module (100).
  • FIG. 3 provides an exploded view of the same.
  • the system components not shown in the figures include a thermal control or perfusion unit. Such a unit may be adapted to provide a stream of heat exchange media such as fluid at elevated temperatures, lowered temperatures or both.
  • thermal exchange methods include employing a temperature-controlled fluid, thermoelectric elements, desiccants, micro-refrigeration, and chemical reactions.
  • module (100) includes a housing (102) defining a negative pressure chamber (104), a heat-exchange element (106) and a soft, two-sided seal (108) supported by seal frame elements (110).
  • Housing (102) may be made from a cover (112) and a base (114).
  • Negative pressure chamber (104) is preferably provided between heat exchange element (106) and cover (112).
  • Chamber (104) is adapted to receive a portion of a mammal and to provide a negative pressure environment.
  • the chamber (104) is in thermal communication with the heat exchange element (106) that is in thermal communication with a working medium located in a heat exchange cavity (126).
  • the heat exchange cavity (126) is external to the module (100).
  • the embodiment shown is adapted to fit the hand of a human user.
  • Chamber (104) is preferably configured to fit a human hand of any size, however the invention is not so limited and any functional portion of a mammal may be employed.
  • the housing (102) may be configured to fit a human foot since the under surface of a foot may also be used effectively as a heat exchange surface.
  • Housing (102) may be constructed from multiple pieces, including an end cap (116) as shown, or it may be provided as a unitary structure.
  • Cap (1 16) is shown including a ports (118).
  • a first port may be utilized for connection to a vacuum source, while the second may be utilized for a vacuum gauge.
  • alternate port placement is also possible.
  • housing (102) is made of plastic. Most preferably, the material and design of at least a portion of module (100) are such that housing (102) may be produced by vacuum forming or molding techniques.
  • discrete cover (112) and base (114) portions may be mechanically secured to one another via fastening means such as through bolt holes (120), adhesive, or retention bands that help form a substantially airtight seal.
  • fastening means such as through bolt holes (120), adhesive, or retention bands that help form a substantially airtight seal.
  • a gasket or caulking may be employed to seal the periphery of housing (102).
  • housing (102) provide advantageous access to clean module (100) after use.
  • top and bottom portions of the module may be fused together, for instance, by ultrasonic welding, chemical bonding or otherwise.
  • housing (102) may be provided in a single piece.
  • a heat exchange surface (122) for delivering or accepting a thermal load from a user also defines a portion of chamber (104).
  • a user may directly contact heat exchange surface (122). Alternately, a user may wear a glove or sock or take other prophylactic measures.
  • Heat exchange surface (122) may be provided by a member separate from heat exchange member (106) such as by an intermediate layer of foil, metalized Mylar or another material.
  • Heat exchange element (106) is preferably made of aluminum, stainless steel or another high thermally conductive and non-corrosive material. It may be in communication with a thermal electric heating element such as a Peltier device, a desiccant cooling device or an endothermic or exothermic chemical reaction to provide a temperature variance. More preferably, however, heat exchange member (106) is in communication with at an inlet and an outlet (124) to accommodate a flow of perfusion liquid behind heat exchange surface (122). Chilled or heated water may be used to maintain the contact surface of the element at a desired temperature. Optimally, perfusion fluid is run through a series of switchbacks in cavity (126) between element (106) and base (1 14) to ensure adequate thermal contact with the heat exchange surface (122) and to maintain even heating or cooling by avoiding hot or cold spots.
  • a thermal electric heating element such as a Peltier device, a desiccant cooling device or an endothermic or exothermic chemical reaction to provide a temperature variance. More preferably, however, heat exchange member (106) is in communication with at an
  • a rear portion of housing (102) and heat exchange member (106) may be provided by plate (128). As depicted, this portion may include provision for inlet and outlet (124) to heat exchange cavity (126) and a chamber opening (130) to chamber (104).
  • a preferred manner of constructing seal (108) is disclosed in connection with plate (128).
  • FIG. 4 shows an end-on view of seal (108).
  • the seal (108) having a longitudinal axis (L) includes a chamber portion (129), a waist portion (135), and a seal portion (137) each defining a chamber opening (131), a waist opening (136), and a seal opening (138) respectively.
  • the chamber portion (129) of the seal (108) is connected to the housing (102) at the chamber opening (130).
  • at least portions of seal (108) are ovalized in form.
  • An elliptical shape may be preferred.
  • a circular shape may also be used.
  • a shape having a major axis (132) and a minor axis (134) will be preferred, at least for the waist opening (136) of seal (108).
  • An ovalized shape approximately corresponds to the shape of the wrist or forearm of a user.
  • seal webbing (140) will also be preferred at chamber opening (131) and seal opening (138). This will assist in providing clearance for hand entry and exit of module (100). It will also simplify the construction of seal webbing (140).
  • seal (108) Whether or not ovalized features are utilized for seal (108), it will be shaped roughly like an hourglass. Seal (108) will most closely resemble an hourglass if openings
  • profiles of seal (108) may be viewed as hyperbolic or parabolic. Further, simple radiused or semi-circular cross-sections may be utilized in producing seal (108). Further straightened sections may be used, especially, between the openings (131) and (138) and waist (136).
  • a seal with outside openings of a greater size than that of the inside opening is to be used in module (100).
  • the opening 131 and the seal opening 138 are greater relative to the waist opening 136.
  • This geometry provides for ramps or transition sections for appendage entry and exit. These features assist in stretching the seal interface or waist (136) sufficiently wide to pass a hand or foot both for insertion into and removal from module (100).
  • Material selection is important in providing such a seal. Clearly, the material must be able to stretch. Further, it should provide a substantial barrier to air flow.
  • the material (or materials) selected for webbing (140) preferably has a finish that does not grip onto a user so as to complicate entry and exit from module (100).
  • the urethane skin of the referenced material has a satin finish. This decreases friction with the skin and hair of a user.
  • the seal webbing material should also have sufficient strength to avoid being drawn too far into cavity (104) upon the application of vacuum.
  • the open construction of seal (108) will result in cavity-side webbing material exposed to partial vacuum within chamber (104) to be forced by ambient pressure inward.
  • This self-inflation phenomena observed for the chamber-side of the seal is of assistance in providing seal patency with a user.
  • an elasticity of the seal material is selected such that too much material does not bow inwardly when negative pressure is applied in the chamber.
  • a less elastic seal will not bow inwardly as much when compared to a seal that is more elastic.
  • the seal will bow inwardly to reduce at least the waist opening by an amount sufficient to contact the appendage without uncomfortably cinching the wrist. Therefore, the elastic seal permits sealing upon the application of a vacuum without the use of a "hard” seal such as an inflatable bladder cuff. Accordingly, with proper material choice, the side of seal (108) opposite chamber (104) provides not only a transition section for entry and exit, but also a stabilizing feature for seal position.
  • Seal (108) is preferably formed by a sleeve made by stitching two pieces of webbing material (140) together where they are shown broken apart in the exploded view of FIG. 3, although the invention is not so limited. By constructing the sleeve from two or more pieces, complex shapes can be easily produced. To secure the sleeve webbing (140) in place to form seal (108), it is folded over rings (142) at each end as variously depicted.
  • Such an anisotropic effect may be achieved in a number of ways. It may be accomplished by providing longitudinal reinforcement member(s) associated with the webbing. They may be incorporated through braiding techniques, by bonding/affixing stiffener(s) to the sleeve surface or by other means as would be apparent to one with skill in the art.
  • the seal (108) includes a relaxed position defined by the fact that no portion of the mammal is contact with the seal (108).
  • the waist opening (136) will expand under force of the moving portion of the mammal as it is being inserted.
  • the elastic material of the seal provides a waist opening (136) that varies in size with the insertion of the portion of the mammal and substantially conforms to seal against the portion of the mammal.
  • the waist opening (136) when in a relaxed position, may be sized smaller than the expected size of the portion of the mammal to pass therethrough, or alternatively, the waist opening
  • (136) may be miniscule.
  • the invention is not limited to a variable waist opening (136).
  • the seal opening (138) may likewise be variable as are portions between the waist opening
  • the seal (108) includes an elastic element to bias the seal (108) against the portion of the mammal.
  • the seal (108) forms a variable opening adapted to substantially conform against the mammal to contact or seal a portion of the mammal inside the chamber (104).
  • the seal (108) includes a flexible wall member that provides substantial contact sealing against at least a portion of the external surface of the mammal while accommodating motion of the portion of the mammal wherein the motion of the mammal is in a direction lateral to the longitudinal axis (L) of the seal (108). For example, when a hand is inserted into the seal (108), and if the middle finger first breaches the seal opening
  • the seal (138) it may do so with or without forcing expansion of the seal opening (138).
  • the middle finger for example, may breach the waist opening (136) and it may do so with or without forcing expansion of the waist opening (136).
  • the seal (108) will surely expand and circumferentially conform to seal against the hand. Any one portion or at least the waist portion (135) will engage at least a portion of the external boundary of the portion of the mammal.
  • the wrist will rest within the seal (108).
  • the seal (108) will preferably engage the entire boundary of the external surface of that portion of the wrist.
  • the seal (108) is no longer in a relaxed position, but in what may be called an active engaged position.
  • the seal (108) is designed to substantially accommodate movement of the portion of the mammal yet substantially prevent leakage of vacuum fluid from the chamber (104).
  • the seal (108) accommodates motion of the hand that is eccentric or lateral to the longitudinal axis (L).
  • the seal (108) is said to be laterally deflectable with motion of the portion of the mammal relative to the rest of the module (100).
  • a "soft" seal as described herein is characterized as providing an approximate or imperfect seal at a user/seal interface while accommodating substantial eccentricities of the portion of the mammal received. Such a seal may be more compliant in its interface with a user. Indeed, in response to user movement, such a seal may leak or pass some air at the user/seal interface as described above.
  • a regulator or another feedback mechanism/routine will cause a vacuum pump, generator, fan or any such other mechanism capable of drawing a vacuum to respond and evacuate such air as necessary to stabilize the pressure within the chamber, returning it to the desired level.
  • Active control of vacuum pressure in real-time or at predetermined intervals in conjunction with a "soft" seal provides a significant advantage over a "hard” seal system that relies on simply pulling a vacuum with the hopes of maintaining the same.
  • Vacuum regulation in the application of body temperature regulation is very important.
  • a negative pressure environment is generated within the module to distend the blood vessels of the appendage located inside the module. This distension dilates the blood vessels, which allows higher bloodflow rates, which is advantageous for delivery of energy from the appendage to the rest of the body or from the body to the appendage for dissipation into the module.
  • the distension of blood vessels pools more blood volume in the region that is in thermal communication with the module.
  • a set-point for the desired level of negative pressure within the chamber is selected.
  • This set-point level of negative pressure within the negative pressure chamber is then established and maintained by a control system.
  • the control system is in communication with a vacuum pump that is in communication with the negative pressure chamber for withdrawing air therefrom.
  • the control system monitors the pressure within the chamber and adjusts a valve to throttle it accordingly until the pressure within the chamber is re-established at the selected set-point.
  • the "soft" seal is designed such that leakage of air at the seal is possible in order to avoid a tourniquet effect at the wrist.
  • the negative pressure control system is adapted to maintain a negative pressure environment at the set-point pressure despite a great variability in leaks.
  • the variability of leaks arises, for example, when an appendage is displaced by varying distances from the longitudinal axis and by the time period of such displacements.
  • varying appendage geometries of different or same users may create a variability of leaks. Simply repositioning the appendage can create a very large, small, or no leak at all.
  • the allowability of leaks is inherent in the seal design of the present invention.
  • the negative pressure control system is adapted to maintain a functional negative pressure for optimum heat exchange with the appendage that involves maintaining a constant level of vacuum throughout a wide range of leaks having varying leak flow rates. For example, if there is a large leak, the vacuum regulator must draw air from the chamber at a very high flow rate in a short amount of time to re-establish the set-point pressure without over-drawing.
  • the control system monitors the leak flow rate and responds to the leak flow rate with an equivalent vacuum draw rate by throttling the valve accordingly.
  • supplemental forcing means may be provided to apply pressure around seal waist (134).
  • Mechanical means such as at least one of a strap, VelcroTM, belt or cinch may be used.
  • an inflatable cuff or bladder portions around the periphery of the seal may be employed.
  • the "soft" seal (108) is designed to have a waist opening (136) that is smaller than the seal opening (138) and chamber opening (131).
  • Expansion means to expand or pull the seal open for insertion of the appendage is connected to the seal.
  • the expansion means for example, include cordage, mechanical linkage and any other expansion means known to a person skilled in the art.
  • the expansion means includes stop means to keep the opening constant for tailored sealing with a particular user. For example, a user expands the seal using the expansion means until insertion of the hand is easy and comfortable and a seal is properly established without undue constriction. Then, the user can engage the stop means to prevent the seal from contracting back to its initial opening and creating an uncomfortable tourniquet effect.
  • stop means include any device or mechanical linkage that limits the travel of the expansion and contraction of the seal and those known to one skilled in the art.
  • Supplemental forcing or seal shaping means may also be used to produce a more complex "soft” seal than that described above. As with a “hard” seal approach, this would open design and fit possibilities. Forcing or seal shaping parameters may, again, be controlled manually or automatically. Except, in a complex "soft” seal, the control of pressure applied to waist (134) is gauged to provide a compliant feel or fit. Since the application of pressure on the seal interface with the user may be the only difference between a complex "soft" seal approach and a "hard” seal approach utilizing the dual-sided configuration, the same apparatus may be configured to function in either manner, for instance, by providing variable pressure control.
  • the seal (108) is adapted such that one end of the seal (108) is rotatable relative to the other end of the seal (108) to reduce the opening of the seal.
  • ring (142) carrying the chamber portion (129) is adapted to rotate relative (128) to ring (144).
  • Ring (144) may remain stationary or rotate by a lesser degree such that there is relative movement of the chamber portion (129) of the seal (108) with respect to the seal portion (137) of the seal (108).
  • ring (142) may remain stationary or rotate by a lesser degree such that there is relative movement of the chamber portion (129) with respect to the seal portion (137).
  • Rotation of one end of the seal (108) relative to the other end of the seal (108) constricts the seal (108) inwardly to reduce at least one of the openings (131), (136) and (138). Twisting the seal can finely control the degree to which the openings in the seal are reduced or expanded.
  • folds in the seal (108) may be created.
  • the seal (108) is inserted into a cylindrical sheath or sock (not shown).
  • the sheath encompasses the seal (108) and is substantially coaxial with respect to the seal
  • the sheath is made of similar material as the seal (108) or it can be made of any suitable material.
  • the sheath is supported by the seal frame or by a sheath frame.
  • the seal (108) is not rotatable.
  • the sheath is adapted such that one end of the sheath is rotatable relative to the other end of the sheath. When one end of the sheath rotates relative to the other end of the sheath, the sheath opening is reduced. Reduction of the sheath opening will gently push against the seal (108) to reduce the opening of the seal without generating folds in the seal (108). Folds are created in the twisted sheath and not in the seal (108).
  • the sheath is easily adapted into the frame elements of the device to provide a complex "soft" seal variation.
  • the module (200) includes a housing (202) and a seal cartridge (204).
  • the seal cartridge (204) is removably connected to the housing
  • the housing (202) includes a cover (206), a base (208), a plate (212), and a heat exchange element (210) having a heat exchange surface (222).
  • the cover (206) is connected to the base (208) and plate (212) to define a chamber (214) for receiving a portion of a mammal via a chamber opening (216) defined in the plate (212).
  • the cover (206) is made of transparent plastic material; however, the invention is not so limited and any suitable material, transparent or not, is within the scope of the present invention.
  • the base (208) includes a heat exchange cavity (218). Thermal exchange media (not shown) is received within the heat exchange cavity (218) via inlet and outlet ports (not shown) such that the media is communication with an element (not shown) that is external to the module (200) such as a thermal electric heating element such as a Peltier device, a desiccant cooling device or an endothermic or exothermic chemical reaction to provide a temperature variance. As shown, the base (208) includes pathways (220) in the form of switchbacks for the media to ensure adequate thermal contact with the heat exchange element (210) and to maintain even heating and cooling.
  • a thermal electric heating element such as a Peltier device, a desiccant cooling device or an endothermic or exothermic chemical reaction to provide a temperature variance.
  • the base (208) includes pathways (220) in the form of switchbacks for the media to ensure adequate thermal contact with the heat exchange element (210) and to maintain even heating and cooling.
  • the heat exchange element (210) is in thermal communication with the heat exchange surface (222) and in thermal communication with the media received in the pathways (220).
  • the heat exchange element (210) is in thermal communication with the heating and/or cooling element that is preferably external to the device.
  • the heat exchange element (210) is preferably made of aluminum or another highly conductive, non-corrosive material.
  • the heat exchange element (210) includes a surface (222) with which the mammalian appendage comes into contact.
  • the contact surface (222) in one variation, is separable from the heat exchange element (210).
  • One advantage of the separability of the heat exchange surface (222) from the heat exchange element (210) is to dispose of a used or soiled surface for the replacement of a new one.
  • a separable heat exchange surface (222) is to have the heat exchange element external to the module (200). Furthermore, the heat exchange element (210) is shown to be convex with respect to inside the chamber (214). Of course, the contact surface (222) substantially conforms to the curvature of the heat exchange element (210). Aside from its aesthetic appeal and ornamental quality, the curvature of the heat exchange element (214) provides for a naturally curved surface for an appendage such as a human hand to comfortably rest in a relaxed position on top of the surface (222).
  • the plate (212) is connected to the rear portion of the housing (202) such that its chamber opening (216) provides passage to the chamber (214).
  • the chamber opening (216) is suitably sized to receive a wide range of appendage sizes.
  • the plate (212) also includes additional ports.
  • a pressure port (224) is formed in the plate (212) for the attachment of a pressure gauge (226).
  • ports (228 for vacuum induction are also be formed in the plate (212) in one variation.
  • ports for receiving various fasteners (230) are also provided for fastening the seal cartridge (204).
  • the seal cartridge (204) includes a seal (232) and seal frame elements (234) supporting the seal (232) on both sides.
  • the seal (232) is the same seal as that described above with respect to figures 1 through 6.
  • the frame elements (234) include a first frame element (236) that is adapted for connecting with the plate (212).
  • the first frame element (236) is spaced apart with standoffs (238) from a second frame element (240).
  • the first frame element (236) includes a ring (242), a first retaining member (244) and a second retaining member (246).
  • the second frame element (240) includes a ring (248), a first retaining member (250) and a second retaining member (252).
  • one side of the seal (232) is folded over ring (242) and captured between the first and second retaining members (244), (246) of the first frame element (236).
  • the other end of the seal (232) is folded over ring (248) and likewise captured between the first and second retaining members (250), (252) of the second frame element (240).
  • Standoffs (238) or equivalent structure space the first and second frame elements (236), (240) apart to define the overall length of the seal (232).
  • the length of the standoffs (238) or seal (232) are varied as well as other parameters of the seal (232) that affect fit.
  • the seal cartridge (204) is removably connected to the housing (202) with fasteners (254).
  • Alternative fastening means are within the scope of the invention and are known to one skilled in the art.
  • the seal cartridge (204) can be rotatably connected or attached in a snap-fit engagement.
  • One advantage associated with the seal cartridge (204) is that different users can have personal seal cartridges (204) that are customized for differently sized appendages, yet operably attachable with one or more housings (202).
  • Personal seal cartridges (204) are also adjustable with respect to the individual requirements relating tolerance, ease, or speed of insertion. For example, an unconscious patient whose temperature is being regulated is not available to actively participate in positioning and insertion into the device.
  • the device is adapted for the insertion of a mammalian appendage such as a hand; however, the invention is not so limited and the device may be designed to accommodate an appropriate appendage.
  • a negative pressure thermal exchange module 300 that is shaped to accommodate a human foot.
  • the module (300) includes a housing (302) and a seal cartridge (304).
  • the seal cartridge (304) is configured as described above with respect to
  • FIGs. 7-9 or FIGs. 1-6 may be removably attached via fasteners (305) or other means.
  • the housing (302) includes a cover
  • the cover (306) is connected to the base (308) and plate (312) to define a chamber (314) for receiving the foot. Entry into the chamber (314) is provided in the top of the module instead of through an opening in the plate (312).
  • the heat exchange element (310) includes a convex heat exchange surface (316) when viewed from inside the chamber (314) to comfortably accommodate the natural curvature of the foot received therein. All components are similar to the corresponding components of the module described above as is readily apparent to one skilled in the art.
  • FIGs. 11-13 there is depicted another variation of a negative pressure thermal exchange module (400).
  • the module (400) includes a cover
  • the cover (402) pivotably connected to a base (404).
  • the cover (402) includes a first end (406) and a second end (408).
  • a perimeter (409) encompasses a surface (410).
  • the surface (410) is shaped to accommodate an appendage. As shown, the surface (410) is curved or concave.
  • the cover (402) includes an opening portion (412). As shown in FIG. 1 1, the opening portion (412) is formed in the perimeter (409).
  • the opening portion (412) is a curved portion that is adapted to receive at least a portion of a seal (413) and a portion of an appendage such as a wrist of a human hand (407) as shown in FIG. 13.
  • the seal (413) is a "hard” seal.
  • the seal (413) is a soft seal of the type described above.
  • the base (404) includes a first end (414) and a second end (416).
  • a perimeter (420) encompasses a chamber surface (418) that includes a heat exchange surface
  • the base perimeter (420) includes an opening portion (424). The opening portion
  • (424) is a curved portion that is adapted to receive at least a portion or second half of a seal
  • the seal (426) is a "hard” seal.
  • the seal (426) is a soft seal of the type described above.
  • the module (400) is preferably formed of molded plastic polycarbonate.
  • the heat exchange surface (422) is made of thermally conductive material such as metallic foil or a thin film of thermally conductive plastic.
  • the first end (406) of the cover (402) is connected to the first end (414) of the base (404) such that the cover (402) is hinged and is rotatable between at least a substantially open first position and at least a substantially closed second position.
  • FIG. 11 A substantially open position is depicted in FIG. 11 and a substantially closed position is depicted in FIGs. 12 and 13.
  • an appendage such as the wrist of a human (407) hand is rested on the seal (426) that is securely disposed within the opening portion (424) of the base (404).
  • the hand (407) comfortably rests and is in thermal communication with the heat exchange surface (422).
  • the cover (402) is then rotated about its first end (406) to a substantially closed position.
  • the perimeter (409) of the cover (402) substantially aligns with the perimeter (420) of the base
  • the perimeter (409) of the cover (402) is connected to the perimeter (420) of the base (404) with an adhesive layer (430), for example, located on either perimeter (409), (420).
  • a protective release layer (not shown) is removed to expose the adhesive layer (430) therebeneath so that the adhesive layer (430) can seal the cover
  • the cover (402) is attached to the base (404) in a snap-fit engagement or by employing a variety of fasteners
  • the module (400) is designed to be separable from a heat exchange element
  • the module For example, with the hand (407) positioned inside the chamber (428), the module
  • the heat exchange element (434) is in thermal communication with the heat exchange surface (422) and in thermal communication with the appendage (407) inside the chamber (428).
  • the heat exchange element (434) is made from aluminum, stainless steel, or other highly thermally conductive and non-corrosive material. It may be in communication with a thermal electric heating element such as a Peltier device, a desiccant cooling device or an endothermic or exothermic chemical reaction to provide a temperature variance.
  • the heat exchange surface (422) is shaped to conform to the general aspects of the appendage inserted within the chamber (428). Furthermore, the heat exchange element (434) is shaped to substantially conform to the heat exchange surface (422). In one variation, the heat exchange surface (422) is flexible and made from a material that is easily conformable to the appendage (407) such as metallic foil. As a vacuum is generated inside the chamber (428), a flexible heat exchange surface (422) is drawn in contact with the appendage (407). The module (400) is placed over the heat exchange element (434) such that the heat exchange element (434) is received outside of the heat exchange surface (422).
  • the heat exchange surface (422) is substantially concave with respect to the outside of the module (400) and the outer surface of the heat exchange element (434) is substantially convex such that when the module (400) is placed over the heat exchange element (434) it is substantially conformingly received within the outer concavity of the heat exchange surface (422).
  • the invention is not so limited and irrespective of the concavity of either the heat exchange surface (422) or the heat exchange element (434), the surface (422) and the element (434) have generally complementary shapes so as to place the surface (422) in closer thermal communication with the element (434).
  • the module (400) is adapted such that the heat exchange element (434) can be secured to the module (400).
  • the module (400) can be secured to the heat exchange element (434) in a snap-fit engagement or with fasteners.
  • the module (400) is easily separated from the thermal exchange element (434) making the module (400) easily portable with the patient as the patient is moved from bed to bed, for example, with separate heat exchange elements (434) awaiting the patient in different locations.
  • the variation of FIGs. 11-13, is a disposable version most suitable for the hospital environment where individual modules are desired for sanitary purposes.

Landscapes

  • 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

L'invention concerne un module d'échange thermique avec une partie corporelle d'un mammalien. On utilise le module avec des procédés avancés afférents à la régulation et à la gestion thermiques corporelles. Une partie corporelle d'un mammalien est placée dans une enveloppe étanche qui est en communication thermique avec un fluide d'échange thermique. L'enveloppe est conçue pour engendrer un environnement de pression négative et comporte une interface améliorée avec l'environnement externe.
PCT/US2002/012399 2001-04-19 2002-04-19 Dispositif d'echange thermique a etancheite amelioree WO2002085266A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US28506001P 2001-04-19 2001-04-19
US60/285,060 2001-04-19

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WO2002085266A9 WO2002085266A9 (fr) 2004-07-22

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FR2853225A1 (fr) * 2003-04-07 2004-10-08 Electro Vela Soc Dispositif chauffant embarquable sur un engin tel un fauteuil roulant electrique pour la protection contre le froid des mains d'un operateur installee dans ledit engin ou fauteuil roulant equipe d'un tel dispositif
WO2005030101A1 (fr) * 2003-09-24 2005-04-07 Dynatherm Medical, Inc. Procedes et appareil de regulation de la temperature interne du corps
US10183174B2 (en) 2015-06-22 2019-01-22 Quantum Dynamics, LLC Device for providing body temperature regulation and/or therapeutic light directed to vasculature
US10350134B2 (en) 2006-12-04 2019-07-16 Avacore Technologies, Inc. Methods and apparatus for adjusting blood circulation

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CA2478665C (fr) * 2002-03-29 2012-11-06 The Board Of Trustees Of The Leland Stanford Junior University Procedes et dispositifs de regulation de la temperature des patients
US7666213B2 (en) * 2002-07-11 2010-02-23 Life Recovery Systems Hd, Llc Apparatus for altering the body temperature of a patient
US6969399B2 (en) * 2002-07-11 2005-11-29 Life Recovery Systems Hd, Llc Apparatus for altering the body temperature of a patient
US7547320B2 (en) * 2002-07-11 2009-06-16 Life Recovery System Hd, Llc Apparatus for altering the body temperature of a patient
US8182521B2 (en) * 2003-09-24 2012-05-22 Dynatherm Medical Inc. Methods and apparatus for increasing blood circulation
US7377935B2 (en) 2004-09-24 2008-05-27 Life Recovery Systems Hd, Llc Apparatus for altering the body temperature of a patient
US9308148B2 (en) * 2006-12-04 2016-04-12 Thermatx, Inc. Methods and apparatus for adjusting blood circulation
US8182520B2 (en) 2006-12-07 2012-05-22 Life Recovery Systems Hd, Llc Apparatus for altering the body temperature of a patient
WO2008070853A2 (fr) * 2006-12-07 2008-06-12 Life Recovery Systems Hd, Llc Appareil permettant de modifier la température corporelle d'un patient et d'administrer une décompression au niveau du torse du patient
US20090048649A1 (en) * 2007-08-16 2009-02-19 Gaymar Industries, Inc. Heat transfer device: seal and thermal energy contact units
US20090177184A1 (en) * 2008-01-09 2009-07-09 Christensen Scott A Method and apparatus for improving venous access
CN102639087B (zh) * 2009-09-16 2017-01-18 德克萨斯大学体系董事会 改变哺乳动物身体的温度
KR20120123408A (ko) * 2010-01-08 2012-11-08 다이나썸 메디칼, 인코포레이티드 치료적 및 개입적 절차를 향상시키기 위한 부속기관 내의 혈관 접근을 향상시키기 위한 방법 및 장치
EP2633736B1 (fr) * 2011-01-03 2015-03-11 Bell Helicopter Textron Inc. Dispositif de fixation de forme conformée à dépression
WO2017070683A1 (fr) * 2015-10-22 2017-04-27 Marcio Marc Abreu Lit thérapeutique ou civière roulante pour le diagnostic et le traitement thermique d'un être humain

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US4003371A (en) * 1975-02-13 1977-01-18 Fischer Boguslav Low pressure hyperbaric chamber
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Publication number Priority date Publication date Assignee Title
FR2853225A1 (fr) * 2003-04-07 2004-10-08 Electro Vela Soc Dispositif chauffant embarquable sur un engin tel un fauteuil roulant electrique pour la protection contre le froid des mains d'un operateur installee dans ledit engin ou fauteuil roulant equipe d'un tel dispositif
WO2005030101A1 (fr) * 2003-09-24 2005-04-07 Dynatherm Medical, Inc. Procedes et appareil de regulation de la temperature interne du corps
US7160316B2 (en) 2003-09-24 2007-01-09 Dynatherm Medical, Inc. Methods and apparatus for adjusting body core temperature
US10350134B2 (en) 2006-12-04 2019-07-16 Avacore Technologies, Inc. Methods and apparatus for adjusting blood circulation
US11324656B2 (en) 2006-12-04 2022-05-10 Avacore Technologies, Inc. Methods and apparatus for adjusting blood circulation
US10183174B2 (en) 2015-06-22 2019-01-22 Quantum Dynamics, LLC Device for providing body temperature regulation and/or therapeutic light directed to vasculature

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WO2002085266A9 (fr) 2004-07-22
US20030024684A1 (en) 2003-02-06

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