Patent Document

This application is a divisional of U.S. patent application Ser. No. 08/636,614 filed on Apr. 23, 1996, now U.S. Pat. No. 6,248,125. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates generally to thermal therapy devices and relates more specifically to hot and cold packs for providing thermal therapy to the perineal area of a patient. 
     2. Brief Description of the Prior Art 
     Various forms of thermal therapy have been used in the past to provide either heating or cooling to specific parts of a patient&#39;s body. For example, heat has been used in the past to increase blood flow and speed the healing process to an injured area. Similarly, cooling has been used to prevent and reduce swelling and pain. In the past, hot or cold packs have been used in a variety of applications. One application of particular interest is in providing thermal therapy to postpartum patients in the perineal and rectal areas. This therapy has been provided in a variety of ways. For example, cool therapy has been provided by placing crushed ice in a latex exam glove, closing the cuff of the glove and placing it on the perineal area. Obvious problems with using an exam glove and ice to provide cool therapy include: (1) leakage, (2) uncontrolled temperature, (3) nursing time, (4) latex allergies, (5) lack of conformity to shape of the perineal area, AND (6) uncontrolled duration of temperature. One advantage of this type of device, however, is that it is relatively inexpensive and relatively readily available. 
     However, due to the many disadvantages listed above, another type of device which has been developed is a combination perineal pad and cold pack in which the cold pack is located either inside or on top of the perineal pad. When the cold pack is located inside the perineal pad, the amount of cooling available to the patient is reduced due to the insulative qualities of the absorbent material. In instances in which the cold pack is fixedly attached to the top of the perineal pad, cooling is readily available, but the cold pack may not be located in the most useful location on the pad. Also, the pad may not be of the most appropriate size or absorbency for the particular patient&#39;s needs. Also, the combination of a cold pack and perineal pad can be more expensive than desired in today&#39;s cost-conscious health care environment. 
     Similar advantages and disadvantages exist with regard to methods and devices for providing heat therapy to the perineal and rectal areas of a patient. Two commonly used methods to provide heat therapy are: (1) moistening a towel or other absorbent device with hot water and applying it to a patient, or (2) moistening a towel or other absorbent device and then heating it in a microwave oven before applying it to a patient. Obvious disadvantages of each of these methods include potential for burning due to overheating, not achieving therapeutic heat, and presence of moisture when moisture may be contra indicated. 
     Therefore, a need existed to provide a device which is relatively inexpensive, easy for hospitals to use, and flexible to meet the individual needs of a particular patient. The subject invention meets all of the needs described above. 
     SUMMARY OF THE INVENTION 
     A device is provided for applying thermal therapy to the perineal or rectal area of a patient. The device includes an elongated pack to provide either heat or cold therapy. The pack has an outer shell means for placement against a patient&#39;s perineal and/or rectal area. In the preferred embodiment, the outer shell means is formed from a pliant, non-woven, fluid-impervious material. The elongated pack also includes a sealed inner space that is enclosed within the outer shell. In the preferred embodiment, the sealed space has a first compartment containing a first chemical and a second compartment containing a second chemical. In the preferred embodiment, the first and second compartments are adjacent to one another and are separated by a rupturable wall. When the wall is ruptured, the contents of the two compartments are allowed to mix to create a thermal reaction which produces a temperature in a therapeutic range. In other embodiments, the sealed inner space may be filled with a gel or other material which may be mechanically heated or cooled to a therapeutic temperature range. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a partially broken away perspective view of the preferred embodiment of the subject invention; 
     FIG. 2 is a side view of the preferred embodiment illustrated in FIG. 1 along sectional lines  2 — 2 ; 
     FIG. 3 is an end view of the preferred embodiment of FIG. 1; 
     FIG. 4 is a side view of another embodiment of the invention in which a rupturable wall extends between two sheets of fluid-impervious material; 
     FIG. 5 is a side view of yet another embodiment of the invention in which a rupturable wall is attached to one sheet of fluid-impervious material; 
     FIG. 6 is another embodiment of the subject invention in which a bubble is located inside a pouch formed of a single sheet of material and sealed about three edges; 
     FIG. 7 is another embodiment of the invention in which multiple devices are connected to one another yet are detachable; 
     FIG. 8 illustrates another embodiment of the invention in which attachment devices are provided for placement; and 
     FIG. 9 illustrates another embodiment of the invention in which a reusable pouch is used with a single-use disposable outer envelope. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to FIG. 1, the subject invention is a device  10  for applying thermal therapy to the perineal or rectal area of a patient. The device  10  includes an elongated pack  12  for producing a thermal treatment. In the preferred embodiment, the thermal treatment is produced through a chemical reaction of two chemical compounds which, when mixed, produce either an endothermic or exothermic reaction. 
     In the preferred embodiment, the pack  12  includes an outer shell means  14  for placement against a patient&#39;s perineal or rectal area. The outer shell  14  is formed of a pliant, non-woven, fluid-impervious material. Examples of such materials include co-extruded poly back non-wovens, polyester and rayon blends and spun bond. The preferred material is co-extruded poly backed non-woven. It is desirable to use a fluid-impervious material because it allows the maximum amount of thermal therapy to be available to a patient. If the outer shell  14  is a fluid-absorbent material, the fluid absorbed in the material will tend to act as an insulator against the cold or heat therapy and will reduce the effectiveness of the device  10 . It is also desirable to use a pliant material to maximize the comfort of the device  10 , since it is being placed against sensitive tissue. Therefore, it is highly desirable for the outer shell  14  not to include rough edges. In the preferred embodiment, the outer shell  14  is formed from a co-extruded sheet of material  16  having a single seal  18 . Also, in the preferred embodiment, seal  18  is placed away from the patient&#39;s tissue so that a uniform surface  20  is in contact with the patient. 
     In the preferred embodiment, a sealed inner space  22  is provided within the outer shell  14 . In another embodiment, the sealed inner space  22  is formed from a separate pouch  24 . In yet another embodiment, the outer shell  14  can form a pouch  26  that forms both the outer shell  14  and inner space  22 . 
     In the preferred embodiment, the sealed inner space  22  is formed of a pouch  24  made of a laminated rollstock, polyester/low-density polyethylene (LDPE). Other materials which may be used to form the pouch  24  include biaxially oriented nylon laminated to linear low density polyethylene (LLDPE) and straight polyethylene. The inner space  22  includes a first compartment  28  which contains a first chemical  30 . The inner space  22  also includes a second compartment  32  containing a second chemical  34 . A rupturable wall  36  is also provided between the first and second compartments  28 ,  32 . When the rupturable wall  36  is ruptured, the first and second chemicals  30 ,  34  are allowed to mix to cause either an endothermic or exothermic reaction to occur. When heat therapy is desired, the first chemical  30  may be taken from the group consisting of sodium acetate and sodium thiosulfate, and the second chemical  34  may be taken from the group consisting of borax and aluminum oxide so that when the first and second chemicals  30 ,  34  are exposed, an exothermic chain reaction occurs. 
     Similarly, when cold therapy is desired, the first chemical  30  may be taken from the group consisting of ammonium nitrate and urea, and the second chemical  34  may be taken from the group consisting of water and additives so that when the first and second chemicals  30 ,  34  are mixed, an endothermic reaction occurs. 
     In the preferred embodiment, the elongated pack  12  is generally rectangular and of a length designed to contact at least one of the perineal and rectal areas. In another embodiment, the pack  12  may be long enough to cover both areas. 
     In one embodiment, the first compartment  28  is formed of a rupturable sealed bubble  38 . The bubble  38  is located entirely within the sealed pouch  24 . The second compartment  32  is formed from an area  42  remaining between the sealed bubble  38  and the inner wall  40  of the pouch  24 . Accordingly, the bubble  38  contains the first chemical  30 , and area  42  contains the second chemical  34 . For example, bubble  38  may contain water  44 , and area  42  may contain ammonium nitrate  46 . When the bubble  38  is ruptured, the ammonium nitrate  46  and water  44  mix to produce an endothermic reaction, resulting in cooling. 
     As illustrated in FIG. 4, in another embodiment of the invention, the outer shell  14  of the device  10  is formed from first and second sheets of a fluid-impervious material  48 ,  50 . The first and second sheets  48 ,  50  are sealed to one another around the edges to form a sealed inner space  22 . A third rupturable sheet  52  is located between the first and second sheets  48 ,  50 . The third sheet  52  is sealed to at least one of the first and second sheets  48 ,  50  around the edges of the third sheet  52  so that a first compartment  28  is formed by an area  54  between the first and third sheets  48 ,  52  and a second compartment  32  is formed in the area  56  between the second and third sheets  50 ,  52 . 
     Another embodiment of the invention is illustrated in FIG.  5 . As can be seen in this figure, the device  10  is formed from two sheets of material. A first sheet  58  is used to form an outer shell  60 . A second sheet of material  62  is a rupturable material. The second sheet  62  is sealed about its edges to the first sheet  58  to form a first compartment  64 . The first sheet  58  is then folded over the second sheet  62  and sealed about its edges to form a second compartment  66 . First and second chemicals  68 ,  70  are inserted in the first and second compartments  64 ,  66  respectively. 
     In a particularly preferred embodiment illustrated in FIG. 6, the first compartment  72  is formed from a bubble  74  made of laminated film made of polyester/LDPE and is filled with water  76 . The second compartment  78  is formed from a second single sheet  80  of polyester/LDPE. The second sheet  80  is folded to surround and encase the bubble  74 . The second sheet  80  is sealed along its opposite folded edges  82 ,  84  to form an envelope type pouch  86  which forms the second compartment  78 . The second compartment  78  is then filled with ammonium nitrate  88 . The remaining edges  90 ,  92  between the opposite folded edges  82 ,  84  are then sealed to seal the second compartment  78 . In the preferred embodiment, the bubble  74  has a perforated area  94  which weakens the bubble  74  and allows it to rupture prior to any rupturing of the second sheet  80 . Thus, when pressure is applied to the device  10 , the perforated area  94  will rupture first to allow the water  76  and ammonium nitrate  88  to mix, thereby producing the desired endothermic reaction. In other similar embodiments, other chemicals may be used as described above to produce an exothermic reaction. 
     In another embodiment of the invention as illustrated in FIG. 7, multiple thermal packs  96 ,  98 ,  100  are connected to one another and can be detached from one another as desired. In the preferred embodiment, each pack  96 ,  98 ,  100  is generally rectangular in shape and has opposed first and second narrow ends  102 ,  104 . A first end  102  of one pack  96  is attached to a second end  104  of an adjacent pack  98 . In the preferred embodiment, a perforation  106  exists between the first and second ends  102 ,  104  to make the packs separable from one another. 
     In yet another embodiment illustrated in FIG. 8, each device  10  may include one or more tabs  108  which can be used to attach the device  10  to a holding mechanism such as a sanitary pad belt or other device (not illustrated). Another attachment means  110  may be provided. The attachment means  110  may be an adhesive strip  112  or other securing mechanism. 
     Finally, in another embodiment of the invention/illustrated in FIG. 9, a reusable pouch  114  containing a gel or other material  116  can be used in conjunction with a single use disposable pouch  118 . The gel  116  may be heated or cooled as desired and then placed inside of the disposable pouch  118 . In this way, the possibility of cross-contamination through multiple uses of the same pouch  114  can be reduced by having a new surface  120  in contact with the patient for each use. 
     While the invention has been described in detail and with reference to specific embodiments thereof, it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention.

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