Abstract:
The present invention relates to a first conformable material having a three-dimensional shape and a first hypothermia and/or hyperthermia device. This invention is used as a pad for sleeping, lying down, or sitting, to maintain a desired temperature to the contacting surface of a body to the pad.

Description:
CLAIM OF PRIORITY  
       [0001]    The present invention claims priority to U.S. Provisional patent application No. 60/128,433, filed on Apr. 6, 1999. 
     
    
     
       FIELD OF INVENTION  
         [0002]    The present invention relates to a pad that provides hypo/hyperthermia properties to a person using the pad.  
         BACKGROUND OF THE INVENTION  
         [0003]    In U.S. Pat. No. 5,336,708, Chen discloses a gelatinous elastomer composite article. These articles, as disclosed by Chen, “include: GMG, MGM, MG 1 G 2 M, M 1 M 2 G 1 G 2 , M 2 M 1 G 1 G 2 , G 1 MG 1 G 2 , MG 1 G 2 , G 1 G 2 M, G 2 G 1 M, GM 1 M 2 G, G 1 M 1 G 2 M 2 M 1 , M 1 GM 2 GM 3 GM 4 , [sic] ect, where G=gel and M=material. The subscript 1, 2, 3, and 4 are different and are represented by n which is a positive number. The material (M) suitable for forming composite articles with the gelatinous elastomer compositions can include foam, plastic fabric, metal, concrete, wood, wire screen, refractory material, glass, synthetic resin, synthetic fibers, and the like. Sandwiches of gel/material . . . are ideal for use as shock absorbers, acoustical isolators, vibration dampers, vibration isolators and wrappers. For example the vibration isolators can be [sic] use under research microscopes, office equipment, tables, and the like to remove background vibrations.” U.S. Pat. No. 5,336,708, col. 3, lines 35-51. Chen further discloses, “generally the molten gelatinous elastomer composition will adhere sufficiently to certain plastics (e.g., acrylic, ethylene copolymers, nylon, polybutylene, polycarbonate, polystyrene, polyester, polyethylene, polypropylene, styrene copolymers, and the like) provided the temperature of the molten gelatinous elastomer composition is [sic] sufficient high to fuse or nearly fuse with the plastic. In order to obtain sufficient adhesion to glass, ceramics, or certain metals, sufficient temperature is also required (e.g., above 250° F. [121° C.]).” U.S. Pat. No. 5,336,708, col. 9, lines 8-18 (brackets added for consistency of temperature comparison).  
           [0004]    Elkins in U.S. Pat. No. 4,884,304 describes a bedding system with selective heating and cooling of a person. That system has, from top to bottom, in order: a top mattress cover, a gas envelope and a multiplicity of liquid flow channels. The multiplicity of liquid flow channels is accomplished by a conventional hypo/hyperthermia blanket. The details of this conventional blanket are set forth in this patent. A problem with this system occurs when a person is on the mattress cover. When the person is on that mattress cover, the person has two sides: (1) a “contacting side” that touches the mattress cover and (2) the “exposed side” that does not touch the mattress cover. The person disperses the gas-envelope and only certain portions of the contacting side contact the flow channels. As shown in FIG. 5 of that patent, the shoulders and other peripheral points of the contacting side of the person, such as arms, do not contact the flow channels. Thereby, that bedding system fails to transfer the desired temperature of the flow channels uniformly to all sections of the contacting side of the person.  
           [0005]    M. Figman in U.S. Pat. No. 3,266,064, and von der Heyde in U.S. Pat. No. 5,887,304 illustrate conventional convective medium mattress system which essentially has a lower “box spring” and a mattress made of rubber, foam, or conventional mattress materials that an individual or object lies thereon. In each embodiment, the lower box spring has a cavity that the medium enters and distributes throughout. The medium then escapes from the cavity through apertures of the mattress.  
           [0006]    A problem with these apertures  89  is that they kink  90  when an adult lies  22  thereon, as shown in FIG. 8. Please note that von der Heyde&#39;s system is designed for an infant, not an adult. And an infant is of such low weight that kinking is essentially nonexistent.  
           [0007]    When kinking occurs, the medium is prevented from contacting the body. And when the medium does not contact the body, the medium is unable to treat the hypothermia or hyperthermia portions of the patient that contact the mattress, or even cool or heat the portions of the patient that contact the mattress.  
           [0008]    The present invention solves this problem.  
         SUMMARY OF THE INVENTION  
         [0009]    The present invention relates to a first conformable material having a three-dimensional shape and a first hypothermia and/or hyperthermia device.  
       
    
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0010]    A preferred embodiment of the present invention is described in detail hereinafter with reference to the accompanying drawing, in which:  
         [0011]    [0011]FIG. 1 is a cross-sectional view of the present invention; and  
         [0012]    FIGS.  2 - 7  are alternative embodiments of FIG. 1.  
         [0013]    [0013]FIG. 8 is prior art of an adult patient on a conventional mattress system with apertures.  
         [0014]    [0014]FIG. 9 is the present invention of an adult patient on a gelatinous elastomeric material with apertures.  
         [0015]    [0015]FIG. 10 is an alternative embodiment of the present invention with a conventional blanket.  
         [0016]    [0016]FIG. 11 is an alternative embodiment of FIG. 10 with a convective blanket.  
         [0017]    [0017]FIG. 12 is an alternative embodiment of FIG. 7.  
         [0018]    [0018]FIG. 12 a  is an enlarged version of material  18  of FIG. 12.  
         [0019]    [0019]FIG. 13 is an alternative embodiment of FIG. 7. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0020]    [0020]FIG. 1 illustrates a pad  10  having a first sealable bag  12 , a first hypothermia and/or hyperthermia device  14 , and a pad cover  16 . The bag  12  contains at least a first conformable material  18 , and a thermally conductive medium  20 . The thermal conductive medium  20  is any liquid or viscous gel that transfers energy generated by the device  14  to a patient (not shown). Examples of this liquid include water, water-based solutions, oil-based solutions, oils, alcohols, mixtures thereof, and viscous gels.  
         [0021]    The conformable material  18  is any material having apertures that do not easily kink, preferably, a gelatinous elastomeric material. Examples of types of gelatinous materials, which are heat formable and heat reversible, are fully described in U.S. Pat. Nos. 4,369,284, 4,618,213, 5,262,468, 5,336,708, and 5,508,334, which are hereby incorporated by reference herein, and those made by Pittsburgh Plastic. The gelatinous materials manufactured by Pittsburgh Plastic are allegedly distinct from the patented types. This conformable material can be of any shape or design, so long as it has a three-dimensional shape that supports a patient or object on the pad  10 .  
         [0022]    The hypothermia and/or hyperthermia device  14  is any conventional hypo/hyperthermia blanket—an example of this blanket is the MUL-T-PAD® or the THERMACARE® blanket by Gaymar Industries, Inc. of Orchard Park, N.Y.—and its corresponding pump—the MEDI-THERM II® temperature regulator by Gaymar Industries, Inc. of Orchard Park, N.Y.—, an electric blanket, a cold compress, and a convective device. The convective device pumps or blows air or other gaseous medium (collectively “Air”) having a predetermined temperature. The Air obtains the desired temperature in a conventional Air temperature regulator (for example, an air conditioner, a heat pump, a ThermaCare® blower unit, or the MEDI-THERM II® temperature regulator) and then circulates through a mesh screen like the Air Queen by Teijin, Inc. or a nonwoven polymeric device having a plurality, of tubes with numerous apertures therein. The Air is then distributed throughout the entire pad  10 . In any embodiment of device  14 , the device  14  affects the temperature that a patient (not shown) or object (not shown) is exposed to, and, in some embodiments, the medium  20  that encompasses the conformable material  18 .  
         [0023]    The bag  12  is any sealable instrument that contains at least the thermally conductive medium  20  and conformable material  18  in place. Preferably, the bag  12  is plastic, and it can be sealed thermally, acoustically, by a zipper, zip locked, or even by Velcro®.  
         [0024]    The pad cover  16  is any conventional material used to cover a pad  10 . The pad cover  16  can encompass the entire pad  10 , the preferred embodiment as shown, or cover the pad  10  like a conventional mattress sheet. In either embodiment the pad cover  16  can be cloth, leather, plastic or conventional cover material. The materials of the pad cover  16  allow the patient or object, on the pad  10 , to feel the desired temperature of the pad  10  (Air or medium  20 ). The pad cover  16  can also allow moisture to pass through it. Thereby, it helps control the patient&#39;s temperature and prevents overcooling or overheating.  
         [0025]    Turning to FIG. 2, a patient  22  disperses a portion of the thermal conductive medium  20  in the bag  12  and contacts at least a portion of the conformable material  18  when the patient  22  lies on the pad  10 . The conformable material  18  provides support to the patient  22 , increases the effective surface contact of the pad  10  to the patient  22  to ensure greater desired thermal conductivity to the patient  22 , maintains the stability of the bag  12 , and reduces the pressure to the patient  22 . By maintaining the stability of the bag  12 , the conformable material  18  ensures the patient (or object)  22 , on the pad  10 , from directly contacting the hypothermia and/or hyperthermia device  14 . In other words, the patient  22  does not “bottom out” to or directly contact the device  14 .  
         [0026]    In a preferred embodiment, the conformable material  18  has apertures  24 . The apertures  24 , in this embodiment, go from the bottom to the top of the material  18  and ensure the thermal conductive medium  20  is between the patient  22  and the hypothermia and/or hyperthermia device  14 . However, in order to decrease, and essentially avoid, kinking—which is discussed above and, as a reminder, inhibits the medium  20  or the Air from contacting the patient—and which is common in many mattress materials, the preferred embodiment of the conformable material  18  is a gelantinous elastomer material. The gelantinous elastomer material has a structure design that admittedly bends and indents, as shown in FIG. 9, when a patient lies thereon, but does not kink. Thereby, the Air or medium can go through the apertures  24 .  
         [0027]    The hypothermia and/or hyperthermia device  14  heats or cools the thermal conductive material  20  and the patient  22  to a predetermined temperature. Since the thermal conductive material  20  contacts most, if not all, portions of the contacting side  23  of the patient  22 , the material  20  ensures a uniform, or nearly uniform application of the predetermined temperature to the contacting side  23 .  
         [0028]    Turning to FIG. 3, the pad  10  contains at least a second bag  12   a . The second bag  12   a  has at least a second conformable material  18   a  and a second thermal conductive material  20   a . The second thermal conductive material  20   a , the second bag  12   a , and the second conformable material  18   a  can be the same or different materials as the previously listed corresponding elements  12 ,  18 ,  20 .  
         [0029]    Turning to FIG. 4, an alternative embodiment of FIG. 3 is shown. A second hypothermia and/or hyperthermia device  14   a  is positioned under the second bag  12   a . The second hypothermia and/or hyperthermia device  14   a  can be set at the same or different temperature as the hypothermia and/or hyperthermia device  14 . Thereby, the first thermally conductive material  20  can apply one temperature to one portion of the contacting side  23   b  of the patient  22  and the second thermally conductive material  20   a  can apply the same or a different predetermined temperature to another portion contacting side  23   c.    
         [0030]    Turning to FIG. 5, an alternative embodiment of FIG. 4 is shown. A third conformable material  18   b  underlies the hypothermia and/or hyperthermia devices  14 ,  14   a . This material  18   b  offers further support to the patient  22 , maintains the stability of the bags  12 ,  12   a , and further reduces the pressure to the patient  22 . Obviously, this third material  18   b  can underlie, or alternatively be over (not shown), the hypothermia and/or hyperthermia device(s)  14 ,  14   a  of FIGS.  1 - 4 .  
         [0031]    Turning to FIG. 6, an alternative embodiment of FIG. 1 is shown. The hyperthermia and/or hypothermia device  14  is within the bag  12  under, or alternatively be over (not shown), the conformable material  18  and surrounded by the thermal conductive medium  20 . In this embodiment, the conventional inlet-outlet  77  of the device  14 , i.e., the pump hoses of the MEDI-THERM II® system, protrudes from the sealed bag  12 . Obviously this embodiment can be used in the other embodiments illustrated in FIGS. 3 and 4.  
         [0032]    [0032]FIG. 7 illustrates an alternative embodiment of FIG. 1, wherein the conformable material is not inserted in a bag  12  or surrounded by a medium  20 . In this embodiment, the hypothermia and/or hyperthermia device  14  is a convective unit and the Air goes through the apertures  24  of the gelatinous elastomer material  18 .  
         [0033]    [0033]FIGS. 12 and 12 a  illustrate an alternative embodiment of FIG. 7. Along with the apertures  24 , the conformable material  18  has a plurality of side apertures  24   a  interspaced between the upper wall  560  and a lower wall  562  of the material  18 . Side apertures  24   a  receive Air and then distribute the Air throughout the conformable material  18 .  
         [0034]    In one embodiment (like that shown in FIG. 7) the device  14  is positioned below the conformable material  18 . In yet another embodiment, as shown in FIG. 12, the device  14  is positioned at an end  563  of the conformable material  14 . Thereby the Air goes into the side apertures  24   a  and is distributed throughout the conformable material  18  and apertures  24 , to effect the patient&#39;s  22  temperature.  
         [0035]    Turning to FIG. 13, another embodiment of the present invention relates to the positioning of the hypothermia and/or hyperthermia device  14 . The device  14  can also be positioned above the conformable material  18 . The device  14  adjusts the temperature of the air within the pad  10 , and that air cools or heats or maintains the temperature of the patient  22 . The air also circulates through the pad  10  within the apertures  24  (and maybe  24   a ).  
         [0036]    Turning to FIGS. 10 and 11, the Air of FIG. 7 circulates under the cover  16 , and escapes from, preferably predetermined, a gap  345  in the cover. Extending from gap  345  is a tube  347 , flexible or not, that directs the Air under a conventional blanket  348 , as shown in FIG. 10, or into an aperture  349  of a convective blanket  350 , like the THERMACARE® blanket by Gaymar Industries, Inc., as shown in FIG. 11.  
         [0037]    Alternatively, the pad cover  16  has a material that transfers the temperature to the patient but influences the Air to a predetermined gap(s)  345  in the pad  10 . The predetermined gap(s)  345  can be located anywhere within the pad, i.e. at the bottom of the pad, a side of the pad as shown in FIGS. 10 and 11, if necessary, under the patient  22 , or under the blanket  348  directly.  
         [0038]    Turning to the method of the invention the preferred embodiment of the present invention is as an operating table pad and/or any other structure or object used in an operating room or hospital-like mattress system, such as bed systems or seat cushions. An operating technician inserts at least one pad  10 , having a hypothermia and/or hyperthermia device  14 , and a conformable material  18 , under a predetermined area of a patient  22 . The technician then adjusts the device  14  to a predetermined temperature, in some instances the device  14  can only obtain one temperature. In either case, the device  14  adjusts the pad  10  to the predetermined temperature. At any time before or after the device  14  is initially adjusted to the predetermined temperature, the patient  22  lies on the pad  10  and the contacting side  23  of the patient  22  will be or is exposed to the predetermined temperature.  
         [0039]    Although a particular preferred embodiment of the invention has been illustrated and described in detail for illustrative purposes, it will be recognized that variations or modifications of the disclosed apparatus, including the rearrangement of parts, lie within the scope of the invention defined by the claims.  
         [0040]    The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows: