Abstract:
An oxygenation and temperature thermal therapy and oxygenation treatment pad with a plurality of air chambers is disclosed for treatment of skin wound tissues. The air chambers are filled and released by a valve assembly that may be separate from or integrated within the blanket. The thermal therapy and oxygenation treatment pad includes a fluid bladder for delivering hot and/or cold therapy to a patient in conjunction with oxygenation. The temperature therapy blanket may also include an air bladder for providing compression. Oxygenation is provided subsequent to initial heating in order to promote oxygen absorption by the wound tissues prior to the cooling thereof which facilitates pulling oxygen into the wound tissues. This Abstract is provided to comply with rules requiring an Abstract that allows a searcher or other reader to quickly ascertain subject matter of the technical disclosure. This Abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.  37  CFR  1.72 (b).

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a Continuation of U.S. patent application Ser. No. 11/801,662, now U.S. Pat. No. 8,100,956, filed May 9, 2007. U.S. patent application Ser. No. 11/801,662 claims priority from, and incorporates the entire disclosure of, U.S. Provisional Patent Application No. 60/798,982 filed May 9, 2006 and U.S. Provisional Patent Application No. 60/852,803 filed Oct. 19, 2006. 
     The present application is a Continuation-In-Part of U.S. patent application Ser. No. 12/730,060, filed Mar. 23, 2010. U.S. patent application Ser. No. 12/730,060 is a division of U.S. patent application Ser. No. 10/894,369, filed Jul. 19, 2004, now abandoned. U.S. patent application Ser. No. 10/894,369 claims priority from, and incorporates by reference the entire disclosure of, U.S. Provisional Patent Application No. 60/550,658, filed Mar. 5, 2004, U.S. Provisional Patent Application No. 60/588,453, filed Jul. 16, 2004, and U.S. Provisional Patent Application No. 60/488,709, filed Jul. 18, 2003. This application is also related to, and hereby incorporates by reference, commonly assigned U.S. Pat. Nos. 5,097,829 and 5,989,285. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Technical Field 
     The present invention relates to a thermally augmented oxygenation system for wound care and method, and more particularly, but not by way of limitation, to a programmable system adapted for oxygenation of a wound area in conjunction with high thermal contrast modalities, specifically adapted to facilitate the healing process. 
     2. Description of the Related Art 
     An important aspect of planned patient treatment is wound care. Medical facilities are constantly in need of advanced technology for the cleaning and treatment of skin wounds. The larger the skin wound, the more serious the issues are of wound closure and infection prevention. The rapidity of the migration over the wound of epithelial and subcutaneous tissue adjacent the wound is thus critical. Devices have been developed and/or technically described which address certain aspects of such wound healing. For example, U.S. Pat. No. 6,695,823 B1 describes a wound therapy device that facilitates wound closure. A vacuum pump is taught for collecting fluids from the wound. WO 93/09727 discloses a solution for wound drainage by utilizing negative pressure over the wound to promote the above references migration of epithelial and subcutaneous tissue over the wound. 
     Another aspect of wound care is the use of oxygen. The use of oxygen for the treatment of skin wounds has been determined to be very beneficial in certain medical instances. The advantages are multitudinous and include rapidity in healing. For this reason, systems have been designed for supplying high concentration of oxygen to wound sites to facilitate the healing process. For example, U.S. Pat. No. 5,578,022 teaches an oxygen producing bandage and method. One of the benefits cited in U.S. Pat. No. 5,578,022 is the ability to modulate a supply of concentrated hyperbaric oxygen to skin wounds. Although oxygen is beneficial in direct application of predetermined dosages to skin wounds, too much oxygen can be problematic. Oxygen applied to a wound site can induce the growth of blood vessels for stimulating the growth of new skin. Too much oxygen, however, can lead to toxic effects and the cessation of healing of the wound. It would be an advantage, therefore, to maximize the effectiveness of oxygen applied to a wound area by enhancing the absorption rate of oxygen into the skin and tissue fluids. By enhancing the absorption rate of the oxygen in the wound, less exposure time and concomitantly fewer toxic side effects to the endothelial cells surrounding the wound, such as devasculation, occurs. It would be a further advantage, therefore, to utilize existing medical treatment modalities directed toward other aspects of patient therapy to augment oxygenation for wound care. 
     It has been accepted for many years by medical care providers that patient thermal therapy can be very advantageous for certain injuries and/or post operative recovery. For this reason, thermal therapy has been advanced and many reliable and efficient systems exist today which provide localized thermal therapy to patients in both pre and post surgical environments. 
     Addressing first thermal therapy systems, several devices have been engineered to deliver temperature controlled fluids through pads or convective thermal blankets to achieve the above purpose. Typically, these devices have a heating or a cooling element, a source for the fluid, a pump for forcing the fluid through the pad or blanket, and a thermal interface between the patient and the temperature controlled fluid. U.S. Pat. No. 4,884,304 to Elkins is, for example, directed to a mattress cover device which contains liquid flow channels which provide the selective heating or cooling by conduction. 
     Devices have also been developed for simply providing heat or cooling to a person in bed. Electric blankets containing electric heating elements have been used, for example, to provide heat to people in bed. Likewise, cooling blankets, such as the blanket disclosed in U.S. Pat. No. 4,660,388 to Greene, have also been proposed. Greene discloses a cooling cover having an inflatable pad with plenum chambers at opposite ends thereof. Cool air is generated in a separate unit and directed to the pad and out to a number of apertures on the underside of the pad and against the body of the person using the cover. 
     A disposable heating or cooling blanket is disclosed in U.S. Pat. No. 5,125,238 to Ragan et al., which has three layers of flexible sheeting. Two of the layers form an air chamber while a third layer includes a comfortable layer for contact with the patient. Conditioned air is directed toward the covered person through a multiplicity of orifices in the bottom layers of the blanket. 
     A temperature controlled blanket and bedding assembly is also disclosed in U.S. Pat. No. 5,989,285 to DeVilbiss et al., assigned to the assignee of the present invention. The disclosure of DeVilbiss discloses a temperature controlled blanket and temperature control bedding system having the provision of both recirculating temperature controlled fluid and temperature controlled gas to enhance performance for convectively heating or cooling a patient. Counter-flow or co-flow heat exchanging principles between the temperature controlled liquid and the temperature controlled gas achieve temperature uniformity across different sections of the blanket and the bedding system. Drapes and the temperature controlled bedding system provided temperature controlled envelope around a person using the bedding system. In one embodiment of the bedding system, the air portion of the bedding system is provided for use with a patient that supplies the fluid portion of the overall bedding system. In another embodiment of the bedding system, the fluid portion of the bedding system is provided for use with a patient bed which supplies the air portion of the overall bedding system. 
     U.S. Pat. No. 5,097,829 to Quisenberry describes an improved temperature controlled fluid circulating system for automatically cooling a temperature controlled fluid in a thermal blanket with a thermoelectric cooling device having a cold side and a hot side when powered by electricity. The temperature controlled fluid is cooled by the cold side of the cooling device and pumped through, to, and from the blanket through first and second conduits. 
     Finally, co-pending U.S. patent application Ser. No. 10/894,369 teaches a sequential compression blanket for use with heating or cooling therapy. In this particular embodiment, the utilization of thermal therapy with sequential compression in a programmable format which further has the option of the introduction of oxygenation through a perforated membrane disposed between the patient and the thermal therapy pad is taught. These advances in the medical industry have been recognized as advantageous to both the medical care providers as well as the patients. The precise manner of oxygenation application is, however, still in need of improvement. 
     The present invention provides improvements in wound care by providing multiple wound healing approaches such as negative pressure over the wound as well as oxygenation in conjunction with thermal therapy. By combining an oxygenation modality that is utilized in conjunction with thermal therapy and/or sequential compression in association therewith, the benefits of both negative wound pressure and oxygenation treatments can be enhanced. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention relates to a method of and apparatus for oxygenation and thermal therapy for wound care. In one aspect, an embodiment of the present invention comprises a compression blanket for use with heating or cooling therapy having an oxygenation region disposed therebeneath providing limited contact to the underlying skin area which may comprise a wound. In this manner, the wound area may receive localized oxygenation and thermal therapy treatment modality. 
     In another aspect, one embodiment of the invention includes an oxygenation and compression therapy blanket comprising a plurality of gas, such as air, chambers for receiving a gas to cause compression, a valve assembly internal to the compression therapy blanket for delivering gas to each of a plurality of air chambers (which in one embodiment is in a predetermined pattern), an inlet port for delivering air from a control unit to the valve assemblies, and a plurality of connections for delivering gas from the valve assembly to the plurality of gas/air chambers as well as oxygenation gas. The plurality of gas/air chambers may comprise four to seven chambers and an electrical signal connection may be provided for transmitting data related to the predetermined pattern to the valve assembly. One embodiment includes the predetermined pattern comprising sequential inflation of the plurality of chambers to produce series of compression movements peripherally toward a given area of a patient, while another embodiment includes inflating two of the plurality of gas/air chambers simultaneously. The oxygenation is provided via a separate oxygenation gas line which is adapted for filling a localized area on a patient&#39;s skin in conjunction with hot and cold therapy. 
     In yet another aspect, the above described compression therapy blanket further comprises a heat transfer fluid bladder for providing temperature therapy to a portion of a patient to be used in conjunction with oxygenation. The bladder includes a fluid inlet port for delivering heat transfer fluid from the control unit to the heat transfer fluid bladder and a fluid outlet port for delivering heat transfer fluid from the heat transfer fluid bladder to the control unit. The heat transfer fluid bladder delivers thermal treatment to a patient in the form of heat or cold or alternating heat and cold in conjunction with the oxygenation treatment. 
     Yet a further aspect includes one embodiment of the invention comprising a system for passing heat transfer fluid between a control unit and a blanket in conjunction with oxygenation. The system comprises a reservoir for housing heat transfer fluid for utilization by the system, a flow network in flow communication with the reservoir and including a junction having at least three branches, wherein a first branch receives heat transfer fluid from the reservoir, a second branch receives the heat transfer fluid returning from the blanket, and a third branch for delivering the heat transfer fluid to the blanket, and a pump for creating a low pressure site at the third branch, wherein the low pressure site causes the heat transfer fluid from the second branch to be pulled into the third branch. In one embodiment of the invention, the three-point junction is generally configured as an inverted Y from a fluid flow standpoint. In this particular embodiment, the oxygenation gas would be delivered in a separate line. 
     In yet another aspect, one embodiment of the invention includes a system for wound cleaning and drainage by negative pressure and then oxygenation of the cleaned and drained wound site in conjunction with thermal therapy comprising a thermal therapy blanket and system for providing heat transfer fluid thereto. The thermal therapy blanket includes at least one spacing member facilitating a separation of a lower surface of the blanket relative to a skin area of the patient for facilitating the receipt of oxygenation gas therein for the treatment of a wound area therebeneath, which wound area is also thermally exposed to the blanket for first heating and opening pores of the skin to expose capillaries and saturate and facilitate the saturation of the skin area with oxygen prior to the cooling thereof which helps close the area and pull oxygen into the underlying tissue. Additionally, one aspect of the invention includes a method of cleaning dead tissue from, and subsequent oxygenation of a wound area in conjunction with thermal therapy wherein thermal therapy-oxygenation treatment pads are held in place by an adhesive border and securing means while oxygenation gasses are fed thereto. In one embodiment, a 93% concentration of oxygen gas is provided at a one to two atmospheric pressure for treatment of the wound site. In one embodiment of the invention, the wound site is warmed through a fluid path on a back side of the treatment pad to five degrees to six degrees above the body temperature to open the pores and expose the capillaries and saturate the area with oxygen for approximately fifteen to thirty minutes. 
     In another embodiment, the above-described method includes continuing oxygenation at one to two atmospheres while lowering the treatment pad fluid to thirty degrees to forty degrees below body temperature to help close the wound area and pull oxygen into the tissues for a period of time on the order between thirty to forth-five minutes. In another embodiment, the process is repeated periodically with the wound being cleaned of dead tissue by negative pressure, or the like, before each treatment. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A more complete understanding of the method and apparatus of the present invention may be obtained by reference to the following Detailed Description when taken in conjunction with the accompanying Drawings wherein: 
         FIG. 1  is an illustration of the oxygenation and thermal therapy system according to an embodiment of the present invention showing both an oxygenation and thermal therapy treatment pad and a second wound evacuation treatment pad; 
         FIG. 2  is a block diagram according to an embodiment of the present invention; 
         FIG. 3  is a flow diagram listing a process according to an embodiment of the present invention; 
         FIG. 4  is a diagram, schematically illustrating in a side elevational cross sectional view a thermal therapy and oxygenation treatment pad according to an embodiment of the present invention; 
         FIG. 5  is a diagram, schematically illustrating in a side elevational cross sectional view a thermal therapy and oxygenation treatment pad according to an alternate embodiment of the present invention wherein compression may be provided; 
         FIG. 6  is a diagrammatic (photographic) illustration of a thermal therapy and oxygenation treatment pad according to an embodiment of the present invention; and 
         FIG. 7  is a diagrammatic illustration of a wound evacuation pad according to an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring first  FIG. 1 , there is shown an illustrations of one embodiment of an oxygenation and thermal therapy system  10  in accordance with the principles of the present invention. The system  10  comprises a control unit  12 , a thermal therapy and oxygenation treatment pad  14  and a plurality of tubular members  16  (to be defined below) connecting the control unit  12  to the thermal therapy and oxygenation treatment pad  14 . The system  10  further includes a wound evacuation unit  28  and a wound evacuation pad  58  (shown in  FIG. 7 ). The wound evacuation unit  28  is connected to the control unit  12  while the wound evacuation pad  58  is connected to the wound evacuation unit  28 . A system for providing both oxygenation therapy in conjunction with certain aspects of thermal therapy and fully describing the thermal operation and sequence compression aspects of one embodiment of the present invention is set forth and shown in parent U.S. patent application Ser. No. 10/894,369 which is incorporated herein in its entirety by reference. For that reason, thermal detail relative to the interaction between the control unit  12  and the thermal therapy and oxygenation treatment pad  14  relative to the thermal fluid flow and pressurization for sequenced compression therapy is not further defined herein. What is defined, is the added aspect of the creation of a localized oxygenation chamber defined by a space disposed beneath an underneath side of the thermal blanket and above the patient&#39;s skin. With such a system, oxygen rich gas may be concentrated in an area immediately beneath the thermal therapy and oxygenation treatment pad  14  and substantially contained therebeneath to aid wound healing. The space between the patient&#39;s skin and the underneath side of the thermal therapy and oxygenation treatment pad may be defined by attachment edges and other spacer elements which separate the underneath side of the thermal therapy and oxygenation treatment pad  14  from the user&#39;s skin or wound site. In this manner, a localized treatment chamber for oxygenation treatment is defined and thermally controlled for maximum efficiency in oxygenation treatment as described below. 
     Still referring to  FIG. 1 , the use of the thermal therapy and oxygenation treatment pad  14  to the wound site of the patient may be, in one embodiment, subsequent to the cleaning of the wound area of dead tissue by the wound evacuation pad  58  and the utilization of an adhesive border (in one embodiment) to secure the thermal therapy and oxygenation treatment pad  14  thereover. In one embodiment, Velcro cross straps may be utilized. A 93% concentration of oxygen has been suggested to be advantageous when applied to a wound site as described herein with one or two atmospheres of pressure. In accordance with one aspect of the present invention, an oxygen supply/or an oxygen generator may be utilized within the control unit  12  or may be separate therefrom. In  FIG. 1 , an oxygen supply and/or generator concentrator  20  is shown in association with the control unit  12  by dotted line  22  and an oxygenation gas line  24  shown extending between the control unit  12  and the thermal therapy and oxygenation treatment pad  14  as a diagrammatic illustration of one embodiment of the principles of the present invention. 
     Referring now to  FIG. 2 , there is a block diagram illustrating the flow of oxygenation gas as a transfer fluid according to an embodiment of the present invention. As set forth in the block diagram, a controlled unit display  30  is provided in conjunction with an analog/digital processing unit  32 . The process is referred to herein as “oxytherm” which is the term currently being utilized by the Applicant of the present invention through its assignee in preparation for commercial disclosure of certain ones of the methods, systems and principles of the present invention. 
     Still referring to  FIG. 2 , sensors  34  are utilized in conjunction with the digital process unit  32  for control of heat transfer fluids to the thermal therapy and oxygenation treatment pad  14  as well as the oxygen delivery thereto. The oxygen generator concentrator  20  is connected to a power supply  36 , which power supply  36 , also powers the analog/digital process unit  32 . The oxygen generated from the concentrator  20  is then pumped through compression pump  38  before delivery to the thermal therapy and oxygenation treatment pad  14 . It should be noted that an oxygen supply may also be used. 
     Referring still to  FIG. 2 , a water alcohol reservoir  40  is shown in fluid flow communication with fluid pump  42  and TEC computer cooler  44 . The TEC computer cooler  44  is controlled by the digital process unit  32  and a TEC supply  46  is likewise shown. Adjacent the TEC supply  46  is illustrated a diagrammatical schematic of a treatment chamber  50  defined beneath the thermal therapy and oxygenation treatment pad  14  wherein the treatment chamber  50  is thermally exposed to the thermal fluid by the fluid path therein illustrated. The adhesive attachment edges  119  therein shown likewise define the treatment chamber space  50  between the thermal therapy and oxygenation treatment pad  14  and the wound site to allow for the flow of the oxygenation gas therein. 
     Referring still to  FIG. 2 , there is shown a vacuum pump  54  powered by the power supply  36 . A collection chamber  56  is connected to the vacuum pump  54  and to a wound evacuation pad  58 . The wound evacuation pad  58  is used prior to the thermal therapy and oxygenation treatment pad  14 , in one embodiment of the present invention, for cleaning the wound area in preparation for oxygenation in conjunction with thermal therapy in accordance with the present invention. 
     Referring now to  FIG. 3 , there is shown a flow diagram listing a process  100  according to an embodiment of the present invention wherein the wound area is first cleaned of dead tissue and the thermal therapy and oxygenation treatment pad  14  applied in step  102 . The thermal therapy and oxygenation treatment pad  14  is held in position by an adhesive border and, in one embodiment, elastic Velcro cross straps. In step  104 , a oxygenation gas comprising on the order of 93% concentration of oxygen gas is delivered to the wound site with one to two atmospheric pressures. The numbers are set forth and shown for purposes of reference in that additional studies may be underway relative to the efficacy of other oxygenation concentrations as well as pressures in accordance with the principles of the present invention. The present description is presented as an illustration of the best mode and understanding of the present invention as Applicant is currently aware. Consistent therewith, however, is the concept of, and teachings for, thermal treatment of the wound site in conjunction with the oxygenation and/or cleaning and draining as set forth herein. In accordance therewith, the site is thus warmed through the fluid path herein shown on the back side of the thermal therapy and oxygenation treatment pad  14  up to 5 to 6 degrees above the body temperature of the patient in step  106 . This warming allows the pore of the patient&#39;s skin to open and expose capillaries therein. The capillaries of the skin are then saturated with oxygen. In one period of time herein described, a period of 15 to 30 minutes is recommended. Oxygenation is continued at one to two atmospheres and the thermal therapy and oxygenation treatment pad fluid is lowered to 30 to 40 degrees below body temperatures to help close the pores of the area and pull oxygen into the underlying tissue in step  108 . This step then proceeds for approximately for 30 to 45 minutes in the current embodiment of the present invention. The process is then repeated periodically with the would site cleaned of dead tissue before each treatment in step  110 . 
       FIG. 4  is a side elevational, cross sectional view of one embodiment of the thermal therapy and oxygenation treatment pad  14  of the present invention. In this embodiment, the thermal therapy and oxygenation treatment pad  14  is constructed within a single bladder configuration  114  where thermal fluid flow may be provided. The tubes  16  are coupled to the treatment pad  14 , which is fabricated with a circuitous flow path therein for thermal fluid flow. This path may be tubular in form, or simply a path within pad  14  defined by flow channels. What is shown is a path  117  within thermal therapy and oxygenation treatment pad  14 . The path  117  is shown with tubular ends  117 A, for example, in order to illustrate that thermal fluid flows therein for thermal treatment of the underlying wound area. Again, the path  117  may not be of tubular form and may have a variety of shapes and fabrication techniques well know in the art of thermal pads. 
     Still referring to  FIG. 4 , a chamber  50  is defined thereby and is separated from the patient&#39;s skin by adhesive strips  119  having a thickness (by way of example only) on the order of ⅛ inch. The thermal therapy and oxygenation treatment pad  14  (not drawn to scale) exposes the wound to heat and then cold via path  117  while oxygen is injected into chamber  50 . The injection of oxygen in conjunction with the aforesaid heating and cooling via path  117  helps treat the wound and any stasis zones therein where tissue swelling has restricted the flow of blood to the wound tissues. It is well known that without sufficient blood flow the epithelial and subcutaneous tissues referenced above receive less oxygen and are less able to migrate over the wound to promote healing. By utilizing the methods and apparatus of the present invention, oxygenation is enhanced and the problems associated with such conditions mitigated. 
       FIG. 5  illustrates an alternative embodiment of the thermal therapy and oxygenation treatment pad of  FIG. 4 . A dual bladder configuration  214  is thus provided where air may be applied to bladder  207  atop the thermal flow tubes  117 , also represented by the “tubular” ends  117 A shown for purposes of example only. In this manner, select compression therapy may be afforded in conjunction with the thermal and oxygenation treatment. In that regard, air inlet tube  201  is illustrated in connection to bladder  207 . Both  FIGS. 4 and 5  show oxygen tube  24  for feeding oxygen to chamber  50 , with tube  203  allowing thermal fluid into conduits  117  with tube  205  allowing thermal fluid return to control unit  12  of  FIG. 1 . 
     Referring now to  FIG. 6 , there is shown a labeled photographic representation of the thermal therapy and oxygenation treatment pad of  FIGS. 1 and 4 . The tubular connections  16  for thermal fluid flow and the tube  24  for oxygen flow is clearly seen. The adhesive border  119  is likewise shown, as further outlined for clarity in the photograph of the prototype shown herein. 
     Referring now to  FIG. 7 , there is shown a diagrammatic illustration of a wound evacuation treatment pad  58 . The wound evacuation treatment pad  58  also contains an array of removal ports  57  that may be used to remove any undesirable fluid from the wound area. The wound evacuation treatment pad  58  further contains a non-tissue adhesive surface  80 . An adhesive circumference  82  is defined around the periphery of the wound evacuation treatment pad  58  by pads  119  described above to allow for a seal to be formed around the wound area. A similar adhesive may also be used with the treatment pad  14 . The seal, in conjunction with the removal ports  57 , allows for a negative pressure to form over the wound area, which facilitates the removal of the undesirable tissues from the wound area. The device also includes a control unit  12 , which contains a vacuum pump (not shown). The vacuum pump is connected to the wound evacuation treatment pad  58  via a vacuum line  55 . A collection chamber  56  is positioned inline between the vacuum pump and the wound evacuation treatment pad  58  to intercept and store any undesirable fluids or the like that are removed from the wound area as a result of applying a negative pressure to the wound area with the vacuum pump. This aspect of one embodiment of the invention is also set forth and shown in U.S. Provisional Patent Application Ser. No. 60/852,803, referenced above, to which priority is claimed. 
     The previous Detailed Description is of embodiment(s) of the invention. The scope of the invention should not necessarily be limited by this Description. The scope of the invention is instead defined by the following claims and the equivalents thereof.