Abstract:
A wound treatment apparatus is provided which includes a bandage that absorbs energy in the infrared (IR) range of the electromagnetic spectrum, a heater that generates heat, and an attachment apparatus for retaining the heater over or on the bandage. The bandage and heater together have a low profile so as to be convenient for a patient and are flexible so as to conform to the shape of a wound and to contours of the skin near the wound. The bandage is provided with an adhesive pattern for maintaining moisture at the wound site. The heater may maintain a normothermic condition at the wound treatment area. A controller may be provided for cycling the temperature of the heater in order to maintain the normothermic condition.

Description:
CROSS-REFERENCES TO RELATED PATENT AND COPENDING APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 09/055,725, filed Apr. 6, 1998. 
     This application contains material related to U.S. patent application Ser. No. 08/843,072 filed on Apr. 11, 1997 entitled “FLEXIBLE NON-CONTACT WOUND TREATMENT DEVICE WITH A SINGLE JOINT” and to the following commonly assigned pending U.S. Patent Applications: 
     Ser. No. 07/900,656, filed Jun. 19, 1992, for “THERMAL BODY TREATMENT APPARATUS AND METHOD”; 
     Ser. No. 08/342,741, filed Nov. 21, 1994, for WOUND TREATMENT DEVICE”; 
     Ser. No. 08/356,325, filed Feb. 21, 1995, for “WOUND COVERING”; 
     Ser. No. 08/785,794, filed Jan. 21,1997, for “NORMOTHERMIC HEATER WOUND COVERING”; 
     Ser. No. 08/786,713, filed Jan. 21, 1997, for “NORMOTHERMIC TISSUE HEATING WOUND COVERING”; 
     Ser. No. 08/786,714, filed Jan. 21, 1997, for “NEAR HYPOTHERMIC HEATER WOUND COVERING”; and 
     Ser. No. 08/838,618, filed Apr. 11, 1997, for “FLEXIBLE NON-CONTACT WOUND TREATMENT DEVICE”. 
     This application also contains material related to the following commonly assigned U.S. Patent Applications, which were concurrently filed with this application: 
     Ser. No. 09/056,191, filed Apr. 6, 1998 for “WOUND TREATMENT APPARATUS WITH A HEATER, A HEAT CONDUCTIVE BANDAGE, AND A HEAT-SPREADING MEANS ACTING BETWEEN THE HEATER AND BANDAGE”; 
     Ser. No. 09/056,063, filed Apr. 6, 1998 for “WOUND TREATMENT APPARATUS INCLUDING A HEATER AND AN IR-TRANSPARENT OR IR-TRANSMISSIVE BANDAGE”; 
     Ser. No. 09/055,597, filed Apr. 6, 1998 for “WOUND TREATMENT APPARATUS WITH IR TRANSPARENT OR IR TRANSMISSIVE WOUND COVER”; and 
     Ser. No. 09/055,605, filed Apr. 6, 1998 for “WOUND TREATMENT APPARATUS FOR NORMOTHERMIC TREATMENT OF WOUNDS”. 
    
    
     STATEMENT OF REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not Applicable 
     REFERENCE TO A MICROFICHE APPENDIX 
     Not Applicable 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to a wound treatment apparatus with a bandage that is essentially absorptive in the infrared range of the electromagnetic spectrum and a heater that emits energy in the IR range. The bandage and heater are connected or joined by an attachment means that holds the heater in position on or over the bandage. 
     2. Description of the Related Art 
     Wounds, in general, are breaks in the integrity of the skin of a patient. A first type of wound may result from mechanical trauma that produces a cut, tear, or an abrasion. There are many instruments of causality for such wounds, including knives, glass, gravel, or a scalpel. A second type of wound may be caused by a combination of heat and pressure wherein the heat alone is insufficient to cause an outright burn. Such wounds include pressure sores, decubitus ulcers, or bed sores, and reflect an injury that is chronic in nature. A wound may also be vascular in origin. In this third type of wound, blood flow through a region may be altered sufficiently to cause secondary weakening of tissues which are eventually disrupted, thus forming a wound. In the case of arterial causes, the primary difficulty is getting oxygenated blood to the affected area. For venous causes, the primary difficulty is fluid congestion in the affected area which backs up, decreasing the flow of oxygenated blood. Because these wounds manifest underlying chronic disease processes. such as atherosclerotic vascular disease, congestive heart failure, and diabetes, these vascular injuries also are chronic in nature, forming wounds with ulcerated bases. 
     Heat therapy has been used to treat wounds since the days of Hippocrates, with varying results. Up to now, heat therapy for wounds has involved the application of heat under conditions that make the tissues of a wound hyperthermic. Hyperthermia impedes wound healing and may actually damage the wound tissues. 
     The “normal” range of temperature for the human body is 37° C.±1° C. (36° C.-38° C.). This range is referred to as “normothermic”. Humans exhibit a thermoregulatory response to core temperature changes as little as ±0.1° C., wherein “icore” as used herein refers to interior portions of the body. This extremely tight temperature control is necessary because virtually all cellular functions, chemical reactions and enzymatic reactions are optimum at normothermia. 
     Surface tissue varies in temperature according to where on the body it is located. The skin of the torso is usually hypothermic, while the skin of the legs is always hypothermic. The normal skin temperature of the distal leg is approximately 32° C., which is considered to be “moderately hypothermic”. The skin temperature of the distal leg of a patient with vascular insufficiency may be as low as 25° C., which is “severely hypothermic”. The hypothermic condition of wounds and ulcers inhibits healing. Severely hypothermic skin or wound tissue is in a state that may be termed “suspended animation”. In suspended animation, tissue is living, but cellular functions necessary for cell division and collagen deposition are slowed or even stopped. Further, the immune system is inhibited, allowing wounds to become heavily colonized with bacteria. The local application of heat to hypothermic skin will cause some degree of vasodilatation, resulting in an increase in local blood flow. Increased blood flow increases the subcutaneous oxygen tension (PsqO 2 ) which, in turn, increases both collagen deposition and immune function. 
     Many references report that the immune system is inhibited by hypothermia and activated by mild hyperthermia (fever). Persp Biol Med:439-474, Spring 1980, reports that local body temperature is a critical factor determining host susceptibility, the location of lesions and contracting infectious diseases. New Eng J Med 305:808-814, 1981, reports that animals exposed to cold environments are more susceptible to infectious diseases, whereas exposure to high ambient temperatures often produces a beneficial result. Wound Rep Reg 2:48-56, 1994 and Acta Anaesth Scand 38:201-205, 1994, report that infections caused by a standard inoculum of  e. coli  or  s. aureus  were significantly more severe in hypothermic guinea pigs than in normothermic control animals. New Eng J Med 334:1209-1215, 1996, reports that hypothermic colorectal surgical patients had three times more wound infections (19% vs. 6%) than those who were kept normothermic during surgery with a Bair Hugger® patient warming system described in commonly assigned U.S. Pat. Nos. 5,324,320, 5,300,102 and 5,350,417. Further, six weeks of warming therapy with the Bair Hugger® patient warming system has successfully healed chronic progressive ulcers which heretofore have been resistant to standard therapies. 
     Currently available medical apparatuses that apply heat to wounds include infrared lights, warm water pads, warm water bottles, whirlpools and Sitz baths. All types of lesions, such as surgical, chronic, traumatic, donor sites, infected wounds and burns, have been treated with these warming modalities. Particularly difficult has been the application of heat to open wounds such as ulcers. Treatment of a wound with infrared light requires that the wound be positioned under the light during therapy, necessitating patient immobility. Further, the infrared heat causes wounds to dry, thereby slowing the healing process. Warm water pads and bottles and electrical heating pads are cumbersome, reduce patient mobility, and are usually applied to the extremities and held in place with inconvenient wraps such as straps, hook-and-eye material or tabs. Whirlpools and Sitz baths reduce mobility and limit the duration of warming therapy due to skin maceration by the water. None of these modalities is capable of prolonged heat treatment of a wound. 
     SUMMARY OF THE INVENTION 
     There is a need for a wound treatment apparatus to treat a wound with heat for a prolonged period of time, while promoting patient convenience and mobility. Preferably, the treatment would produce a substantially normothermic condition at the wound. It is also important that the wound treatment apparatus be flexible and have a low profile for convenience of the patient. Such a wound treatment apparatus should efficiently transfer heat to a treatment site, be convenient to operate without adversely impacting the patient, and be capable of maintaining a moist wound environment. 
     Preferably, the operation of the wound treatment apparatus is referred to a “wound treatment area” (or “treatment area”) that may include the wound, unwounded skin adjacent the wound (the periwound), or both. 
     The invention is a wound treatment apparatus that includes three parts. First is a wound bandage that absorbs energy in the infrared (IR) range of the electro-magnetic spectrum. The second part is a heater that is disposed on or over the bandage. The heater emits a significant amount of its energy in the IR range. The third part of the invention is an attachment means to hold the heater in position over the bandage. 
     Other objects and advantages of the invention will become apparent upon reading the following description taken together with the accompanying drawings. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is an isometric view of a first embodiment of the wound treatment apparatus being applied to a wound on a person&#39;s body; 
     FIG. 2 is an isometric view of the wound treatment apparatus applied to the wound on the person&#39;s body; and 
     FIG. 3 is an exploded isometric view of the wound treatment apparatus; 
     FIG. 4 is a cross-sectional view of the wound treatment apparatus applied to the wound on the person&#39;s body; 
     FIG. 5 is a plan view of a second surface of a wound treatment apparatus bandage; 
     FIG. 6A is a planar illustration of an electrical resistance element embedded in a flexible layer for uniform heating; 
     FIG. 6B is a view taken along plane VIB of VIB FIG. 6A; 
     FIG. 7A is a planar view of an electrical resistance element embedded in a flexible layer for heating a portion of a treatment area; 
     FIG. 7B is a view taken along plane VIIB—VIIB of FIG. 7A; 
     FIG. 8A is a planar view of an electrical resistance element embedded in a flexible layer for uniform heating of a central portion of a treatment area; and 
     FIG. 8B is a view taken along plane VIIIB—VIIIB of FIG.  8 A. 
     FIG. 9A is a side sectional view of the wound treatment apparatus applied to a wound, with areas of non contact between heater and bandage. 
     FIGS. 9B and 9C are magnified view of a detail in FIG. 9A enclosed in a circle. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring now to the figures, wherein like reference numerals designate like or similar parts throughout the several views there are shown various embodiments of a wound treatment apparatus according to this invention. 
     As shown in FIGS. 1-5, the wound treatment apparatus  100  includes a bandage  102  fabricated to absorb energy in the IR range. The bandage  102  has first (lower) and second (upper) surfaces  104  and  106 . A heater  108  generates thermal energy and emits a significant amount of this energy in the IR range. The heater  108  includes first (lower) and second (upper) surfaces  110  and  112 . An attachment means holds the heater  108  in position over the bandage  102  in such a manner as to transfer heat from the heater  108  through the bandage  102 . The attachment means may maintain the second surface  106  of the bandage  102  and the first surface  110  of the heater  108  in full or partial contact or out of contact. In FIGS. 2 and 4, the wound treatment apparatus  100  is shown in place covering a wound  116  of a person&#39;s body  118 . Immediately adjacent the wound is a periwound area  120  which is typically a peripheral band of tissue around the wound area with less trauma than the tissue of the wound area. The wound treatment apparatus  100  is capable of treating a wound treatment area that includes the wound and/or the periwound area, as desired. 
     In the wound treatment apparatus  100 , the heater  108  includes means for generating heat that may be electrically operated. For example, the means may take the form of an electrical resistance element  124  embedded in or laminated to a planar member of flexible material  126 , such as polyethylene, silicon, rubber or flexible cloth. In this regard, the heater  108  would form a “black body” that radiates heat in the form of energy in the IR range. In the preferred embodiment, the heater  108  is substantially planar, as shown in FIGS. 1 and 3, and yet flexible in order that it might conform, with the bandage  102 , to the wound  116 , as shown in FIG. 4, and to the person&#39;s body, as shown in FIGS. 2 and 4. 
     As illustrated in FIGS. 1 and 2, the electrical resistance element  124  is connected to first and second electrical conductors  128  and  130 , which are connected to an electrical power source  132 , via a controller  134 . The purpose of the controller  134  is to control electrical power provided to the electrical resistance element  124 . In this regard, the operation of the heater  108  may be cycled by the controller to maintain the tissue in the wound treatment area at a normothermic or a near normothermic temperature. As shown in FIGS. 1 and 2, the electrical resistance element  124  may extend back and forth in the flexible planar member  126  with a desired spacing to promote uniform heating of the heater  108 . 
     As shown in FIG. 5, the first surface  104  of the bandage  102  is provided with a pattern of adhesive  136  adjacent its periphery. The adhesive pattern  136  may completely encompass the wound and the periwound areas so as to trap the natural moisture of the body which. in turn. maintains a moist environment across the wound treatment area for wound therapy purposes. Accordingly, the pattern of adhesive  136  has inner and outer boundaries  138  and  140  wherein, in the preferred embodiment, the outer boundary  140  coincides with the outer perimeter of the bandage  102 . It should be understood that the bandage  102 , the heater  108 , and the pattern of adhesive  136  may take various shapes, such as the square shown in the drawings, or a rectangle, circle or ellipse, or any other regular or irregular shape, depending upon various shapes of wound treatment areas. 
     The bandage  102  is a flexible, planar member that is fabricated from a material or with a structure (or both) that absorbs energy in the IR range. The bandage  102  may be made using materials and structures that fall generally into two categories: 1.) water-containing materials; and, 2.) opaque, or painted, materials. 
     Water is highly absorptive of IR energy. Some of the water containing materials that may be used to fabricate the bandage  102  include: hydrogels, hydrocolloids, hydrated gauze, hydrated foam materials and hydrated alginates. An optional thin layer of IR-translucent polymeric film may be applied to the second surface  106  of the bandage  102  when the bandage is made from any of these materials. The thin layer of film will contain the moisture within the bandage  102  and protect the bandage  102  from the environment. 
     Alternately, the bandage  102  may be fabricated with films of certain polymeric materials. Any of these films may be used as an IR-absorbent layer which may or may not be used in combination with a hydrated layer that comprises the water-containing materials set forth above. Polymeric films absorb IR-energy depending on: 1.) the thickness of the film (greater that 5 mil thick is more absorptive than thinner films), 2.) opacity (opaque is more absorptive than transparent), 3.) a color applied to at least one surface of film (a colored surface of flat white or flat black is preferred). An IR film that includes one or more of these characteristics is preferable. 
     Since human body tissue comprises a large amount of water, the IR energy generated by the heater  108  and absorbed by the bandage  102  will be absorbed by the tissue in and near the wound treatment area, thereby warming the tissue. Manifestly, the structure of the wound treatment apparatus  100  as thus far described maintains a closed, moist, heated environment at and over the wound treatment area to promote fast healing of wounded tissue. 
     FIGS. 6-8 illustrate various embodiments of electrical resistance elements for the heater  108 . In the heater  108   a  shown in FIG. 6A, an electrical resistance element  124   a  winds back and forth within the flexible planar member  126 , similar to what is shown in FIG.  1 . The spacing between the windings of the electrical resistance element  124   a  may be sized so as to ensure substantially uniform heating of the heater  108   a . FIG. 6B shows the electrical resistance element embedded or laminated in the flexible planar member  126 . In FIG. 7A, the electrical resistance element  124   b  takes a path along a peripheral zone of the flexible planar member  126 , so that the periphery of the heater  108   b  is uniformly heated to a temperature greater than a central portion of the heater. Again, these electrical resistance elements  124   b  are shown embedded or laminated in the flexible planar member  126  in FIG.  7 B. In FIG. 8A, the electrical resistance element  124   c  takes a spiral path out and back within a central region of the heater  108   c  so as to uniformly heat the central region of the heater to a higher temperature than regions outbound therefrom. The heater  108   a  is adapted for applying heat to both the wound and periwound area  116  and  120  in FIG. 4, the heater  108   b  is adapted for applying heat primarily to the periwound area  120  and the heater  108   c  is adapted for applying heat primarily to the wound  116 . 
     Although the means in the heater  108  for generating heat is disclosed and described above as being electrically-actuated, this is not intended to limit the heater  108  solely to electrical operation. In fact, other heat generating means that would be suitable for the heater  108  include, without limitation. chemical heaters, water pad heaters, and phase-change salt heaters. Chemical heaters and phase-change salt heaters would preferably be formed into a relatively thin pad and sealed in a pouch made of polymeric film. A water pad heater can be fabricated by thermo-forming two sheets of polymeric film into fluid channels and sealing the sheets at their peripheries. Warm water is then circulated through the pad from an external source of hot water. 
     Many surfaces of the body have convexities and concavities in close proximity to one another. See for example the profile of the person&#39;s body  118  in the vicinity of the wound  116  in FIG.  4 . The ability of the bandage  102  to absorb energy in the IR region, is important because of the difficulty in achieving a continuous, uniform thermal contact for conductive heat transfer between the second surface  106  of the bandage  102  and the first surface  110  of the heater  108 , even when the heater  108  is fabricated to be moderately flexible and substantially planar. Even a highly flexible planar heater will tend to rest on top of the convexities and not touch the bottom of the concavities. For example, consider the profile of an ulcer on the skin. Consider further that base of the ulcer is sharply recessed. In this case, the base of the ulcer may not even be contacted by the first surface  104  of the bandage  102 . 
     The invention contemplates that the first surface  110  of the heater  108  may be in full, or partial contact with the second surface  106  of the bandage  102 . For example, in FIG. 9A, there is less than full contact between the surfaces  110  and  106 . In the areas where the first surface  110  and the second surface  106  are in contact, heat will be transferred by conduction between the first surface  110  and the second surface  106 . However, it may be very difficult to conform even the most flexible, substantially planar configuration of the heater  108  to the contours of the human body, and further to the contours of any particular wound such as the wound  116 . Therefore, in many cases, areas of non-contact between the heater  108  and the second surface  106  will exist, creating air spaces  160 ,  161 , and  162  which act as pockets of thermal insulation. 
     In prior art heater/bandage combinations such as that shown in FIG. 9B only inefficient convective heat transfer occurs in air spaces  161  and  162  because the bandage  202  is not transparent in the IR region. The regions of contact (supporting conductive heat transfer)  210  and the regions of non-contact (supporting convective heat transfer)  212  may have large and unpredictable differences in temperature and heat transfer, resulting in substantial non-uniformities in distribution of the heat across the prior art bandages  202 . The result is that, with prior art heater/bandage combinations, heating of the wound treatment area may be uneven, and ineffective in treating a wound. 
     As FIG. 9C shows, with the bandage  102  being fabricated so as to absorb energy in the IR range, and with the heater  108  acting as a radiating black body, a significant component of heat is transferred to the bandage  102  by radiation. Therefore, in the regions  212  where the first surface  110  of the heater  108  does not contact the second surface  106  of the bandage  102 , significant amounts of heat will be transferred by radiation. The invention therefore overcomes the inherent unevenness of heat transfer to the wound treatment area in the prior art heater/bandage lead combinations where heat transfer from heater to bandage is by conduction and convection only. In this invention, heat transfer between the heater  108  and the bandage  102  is by conduction, convection, and radiation. This provides more efficient, and more uniform, heat transfer from the heater  108  to the bandage  102 . This creates a more uniform distribution of heat in, and across, the bandage  102 , providing a more even and predictable distribution of heat across the tissue in and near the wound treatment area. 
     This invention further improves on the prior art modes of heating a wound with IR energy as, for example, where wounds are exposed to the output of high temperature heat lamps. In these case, the heat lamps shine on open, exposed wound treatment areas, causing drying of wound tissue, which inhibits and delays healing. This invention interposes an IR absorptive bandage layer between the IR heat source and the wound which seals about the wound, retaining moisture at the wound and preventing its drying. 
     The third component of this invention is an attachment means to hold the heater  108  in position on, or over, the bandage  102 . Such means may include, for example, a pattern of adhesive that acts between the first surface  110  of the heater  108  and the second surface  106  of the bandage  102 . The pattern may have, for example, the shape and composition of the pattern illustrated in FIG.  5 . This pattern of adhesive may be on the second surface  106  of the bandage  102  or on the first surface  110  film of two of the heater  108 . Alternatively, it may comprise a separate film of two sided adhesive between the surfaces  106  and  110 . Other attachment means contemplated for use in this invention include, without limitation, hook-and-eye material, a pocket formed on the first surface  106  of the bandage  102 , tabs, tapes, straps, clamps, and so forth. The function of the attachment means is to hold the heater  108  in close proximity to the bandage  102 . The function may result in full or partial contact between the first surface  110  of the heater  108  and the second surface  106  of the bandage  102 , or may even result in the heater  108  being held slightly off of the second surface  106 , out of direct contact with the bandage  102 . 
     Clearly, other embodiments and modifications of this invention will occur readily to those of ordinary skill in the art in view of these teachings. Therefore, this invention is to be limited only by the following claims, which include all such embodiments and modifications when viewed in conjunction with the above specification and accompanying drawings.