Patent Publication Number: US-2010121287-A1

Title: Wound care system

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     This application is a continuation application of U.S. application Ser. No. 11/602,653 filed on Nov. 21, 2006, entitled “Wound Care System” which claims priority from U.S. Provisional Patent Application Ser. No. 60/738,690 filed on Nov. 21, 2005, entitled “Pioneer Hyperbaric Closed Suction Wound Drainage System,” both of which are hereby incorporated by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates generally to wound care treatment and systems for treating wounds. More specifically, the present invention relates to a system designed for alternating applications of vacuum and hyperbaric wound treatments to a wound site. 
     The patient care industry is continually searching to provide better services, reduce costs, and improve the equipment used to provide the best possible care to the patients. One such way to advance patient care is to improve the treatment of chronic and acute wounds and various types of therapies to treat these wounds. One of two types of treatments is often used to treat chronic and acute wounds: negative pressure therapy or hyperbaric oxygen therapy. 
     Negative pressure therapy is the controlled application of sub-atmospheric pressure to a wound using a therapy unit, such as a vacuum or suction device, to expose a wound to negative pressure to help promote wound healing. The wound is typically covered to facilitate this negative pressure and suction at the wound area. Various types of resilient, open cell foam surface dressings are typically sealed within an adhesive drape to provide the sub-atmospheric pressure at the wound site. The exudates drained from the wound site are normally directed to a canister that stores the fluids and/or infectious material until properly disposed. The negative pressure wound therapy has been typically prescribed for chronic and acute wound types such as diabetic wounds, pressure ulcers, abdominal wounds, trauma wounds, various burns, flaps and grafts. One of the limitations of negative pressure therapy is that it may be less effective on patients with vascular disorders, such as diabetes, particularly because negative pressure therapy creates a hypoxic environment at the wound. Current research indicates that wound healing is impaired when the oxygen level is 30 millimeters of mercury (mmHg) or less. 
     Hyperbaric oxygen therapy is the controlled application of greater-than-atmospheric pressures of oxygen to a wound. Oxygen is typically required for all new cell growth, and chronic or nonhealing wounds tend to exhibit low oxygen tensions, or tend to be ischemic. A wound can become dormant if the amount of wound tissue that is poorly oxygenated reaches a critical mass. In this state, the body may no longer recognize the need to heal that area, which exacerbates the lack of oxygen in that wound and thus substantially prevents healing of the wound by the body. Oxygen therapy is particularly useful for patients with poor circulation. In addition to helping kill bacteria, oxygen applied to an open wound at a hyperbaric level is dissolved into the wound and absorbed by the surface wound tissue. The cells of the wound tissue that absorb the oxygen will begin metabolic activity in response to the increased oxygen tension. Once the oxygen source is removed, the previously active cells request more oxygen from the body. The body responds by beginning to form new blood cells, and thus, starting the healing process. 
     Typically, hyperbaric oxygen therapy is performed by placing the patient into a hyperbaric chamber that encompasses the full body of the patient or an entire extremity, such as a leg or an arm. Such chambers are problematic due to their lack of portability, the difficulty in sterilization of the chambers between patients, and the potential adverse effects of breathing oxygen at hyperbaric pressure. It would be preferable if the hyperbaric oxygen treatment were localized at the wound rather than applied to the patient&#39;s entire body or extremity. 
     While both negative pressure and hyperbaric oxygen therapies are each believed to be effective when administered as separate wound care treatments, many patients may benefit from a treatment plan incorporating both negative pressure and hyperbaric oxygen therapies. Because existing hyperbaric oxygen treatment is typically performed in a hyperbaric chamber, switching between negative pressure therapy and hyperbaric oxygen therapy is a long process. Before entering a hyperbaric oxygen chamber, a patient would first have to be disconnected from the negative therapy device and the negative pressure therapy dressing—which typically includes packing materials, a drain, tubing, and sealing material—would have to be removed. Then, following hyperbaric oxygen treatment, a new negative pressure dressing would have to be applied. These procedures are wasteful and time-consuming, making it difficult, if not impossible, to alternate between negative pressure therapy and hyperbaric oxygen therapy every few minutes or less. 
     It would be preferable if an apparatus were capable of localized alternating administration of negative pressure and hyperbaric oxygen therapies to treat a single wound without requiring a change of dressing. 
     BRIEF SUMMARY OF THE INVENTION 
     Disclosed is an apparatus for the treatment of a wound on a patient. The apparatus includes a drain line configured for attachment to a negative pressure source and for removing exudate from the wound; a supply line configured for attachment to a fluid source and for supplying fluid to the wound; and a controller. The controller is configured to cause negative pressure therapy to be administered to the wound via the drain line. The controller is further configured to cause hyperbaric fluid therapy to be administered to the wound via the supply line. 
     The controller is further configured to cause hyperbaric fluid therapy to be administered to the wound at an absolute pressure of at least approximately 1.5 atmospheres via the supply line. 
     Also disclosed is a wound treatment apparatus that includes a drain line configured for attachment to a negative pressure source and for removing exudate from the wound. The apparatus further includes a supply line configured for attachment to a fluid source and for supplying fluid to the wound and a controller. The controller is configured to cause negative pressure therapy to be administered to the wound for a first time period via the drain line, and cause hyperbaric fluid therapy to be administered to the wound for a second time period via the supply line, wherein the first time period is approximately two to three times as long as the second time period. 
     Also disclosed is a portable wound treatment apparatus. The portable wound treatment apparatus includes a negative pressure source configured for operative engagement with a wound dressing via a drain line and a fluid source configured for operative engagement with a wound dressing via a supply line. The apparatus also includes a controller that is configured to cause negative pressure therapy to be administered to the wound, and also to cause hyperbaric fluid therapy to be administered to the wound at an absolute pressure of at least approximately 1.5 atmospheres. The apparatus further includes a housing configured to house the negative pressure source, the fluid source and the controller. 
     Further disclosed is a portable wound treatment apparatus including a negative pressure source configured for operative engagement with a wound dressing via a drain line. The apparatus also includes a fluid source configured for operative engagement with a wound dressing via a supply line, a controller and a housing configured to house the negative pressure source, the fluid source and the controller. The controller is configured to cause negative pressure therapy to be administered for a to the wound first time period, and cause hyperbaric fluid therapy to be administered to the wound for a second time period, wherein the first time period is approximately two to three times as long as the second time period. 
     Also disclosed is a wound treatment apparatus comprising including a drain line configured for attachment to a negative pressure source and for removing exudate from the wound and a supply line configured for attachment to a fluid source and for supplying fluid to the wound. The apparatus further includes a controller that is configured to cause negative pressure therapy to be administered to the wound via the drain line, and to cause hyperbaric fluid therapy to be administered to the wound at via the supply line. The controller is further configured to control the administration of negative pressure therapy and hyperbaric fluid therapy such that the administration of negative pressure therapy and hyperbaric fluid therapy is cyclical and the hyperbaric fluid therapy is administered to the wound for no more than 30 minutes during each cycle. 
     Also disclosed is a method for treating a wound. The method includes applying to the wound a dressing that engages a supply line and a drain line; connecting the supply line to a fluid source; connecting the drain line to a negative pressure source; administering negative pressure therapy to the wound via the supply line; and administering hyperbaric fluid therapy to the wound at an absolute pressure of at least 1.5 atmospheres via the supply line. 
     Further disclosed is another method for treating a wound. The method includes applying to the wound a dressing that engages a supply line and a drain line; connecting the supply line to a fluid source; connecting the drain line to a negative pressure source; administering negative pressure therapy to the wound via the drain line for a first time period; and administering hyperbaric fluid therapy to the wound via the supply line for a second time period. The first time period is approximately two to three times as long as the second time period. 
     Also disclosed is a method for treating a wound comprising: applying to the wound a dressing that engages a supply line and a drain line; connecting the supply line to a fluid source; connecting the drain line to a negative pressure source; administering negative pressure therapy to the wound via the drain line for a first time period; following the administration of negative pressure therapy, administering hyperbaric fluid therapy to the wound via the supply line for no more than 30 minutes; and following the administration of hyperbaric fluid therapy, administering negative pressure therapy to the wound via the drain line. 
     The negative pressure therapy and hyperbaric fluid therapy may be administered intermittently. 
     The fluid source may be configured to supply a constant flow of fluid such that the administration of negative pressure therapy is accomplished by activating the negative pressure source and the administration of hyperbaric fluid therapy is accomplished by deactivating the negative pressure source. 
     The administration of negative pressure therapy may also be accomplished by activating the negative pressure source and reducing the flow of fluid from the fluid source. Similarly, the administration of hyperbaric fluid therapy may be accomplished by deactivating the negative pressure source and increasing the flow of fluid from the hyperbaric fluid source. 
     The administration of negative pressure therapy and hyperbaric fluid therapy may also be adjusted in response to information received from a sensor, such as a diffusion sensor, that measures tissue conditions at the wound. 
     In addition, the disclosed apparatus may also include either mechanical or electronic pressure regulation to ensure that the pressures applied to the wound site do not exceed a desired level. 
     Also disclosed is a method for preparing a wound dressing. The method includes inserting packing material into the wound; inserting open ends of a supply line and a drain line into the wound; molding a pliable adhesive around the perimeter of the wound such that the adhesive separates the supply line from the skin surrounding the wound and such that the adhesive separates the drain line from the skin surrounding the wound; molding another piece of pliable adhesive over the supply line and the drain line; and placing sealing material over the wound, the packing material, the supply line, the drain line and the adhesive such that the sealing material adheres to both the adhesive and the skin surrounding the adhesive. 
     It is therefore a general object of the present invention to provide an improved apparatus for the treatment of wounds. 
     Another object of the present invention is to provide an apparatus that provides both negative pressure therapy and hyperbaric fluid therapy to a wound site. 
     These and further features of the present invention will be apparent with reference to the following description and attached drawings. In the description and drawings, particular embodiments of the invention have been disclosed in detail as being indicative of some of the ways in which the principles of the invention may be employed, but it is understood that the invention is not limited correspondingly in scope. Rather, the invention includes all changes, modifications and equivalents coming within the spirit and terms of the claims appended hereto. 
     Features that are described and/or illustrated with respect to one embodiment may be used in the same way or in a similar way in one or more other embodiments and/or in combination with or instead of the features of the other embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         FIG. 1  is a schematic view of an apparatus made in accordance with the current disclosure; 
         FIG. 2  is a schematic illustration of an example wound dressing and surrounding elements made in accordance with the current disclosure; 
         FIG. 3  is a schematic illustration of a hospital bed embodiment of apparatus made in accordance with the current disclosure; 
         FIG. 4  is an embodiment of a portable apparatus made in accordance with the current disclosure positioned on a wound; 
         FIG. 5  is an alternate embodiment of an apparatus made in accordance with the current disclosure positioned on a wound; 
         FIG. 6  is a side view of a wound being treated by an apparatus made in accordance with the current disclosure and using an embodiment of a drain made in accordance with the current disclosure; 
         FIG. 7  is top view of a wound being treated using the drain of  FIG. 6 ; 
         FIG. 8  is a view of the drain of  FIGS. 6 and 7 ; 
         FIG. 9  is an embodiment of the supply and drain lines made in accordance with the current disclosure; 
         FIGS. 10A-F  illustrate the preparation of a wound dressing made in accordance with the current disclosure; and 
         FIG. 11  is a flow chart illustrating a method performed in accordance with the current disclosure. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The invention relates to a novel therapeutic method and apparatus capable of administering both negative pressure therapy and hyperbaric fluid therapy for wound healing. Preferably, negative pressure therapy and hyperbaric fluid therapy, such as hyperbaric oxygen, are intermittently applied to the wound area to remove exudate from the wound and to infuse oxygen into the wound. It is believed that the controlled application of these therapies can greatly increase wound healing success, both clinically and aesthetically, and minimize wound healing time 
     The apparatus includes a drain line that attaches to a negative pressure source and is used to remove exudate from the wound. The apparatus also includes a supply line that attaches to a fluid source, such as an oxygen source, and is used to supply fluid to the wound under positive pressure. The system further includes a controller that controls the administration of negative pressure therapy via the drain line and the administration of hyperbaric fluid therapy via the supply line. The apparatus is thus capable of alternating between negative pressure therapy and hyperbaric fluid therapy in an automated manner without requiring clinician assistance and without necessitating a wound dressing change. Moreover, the apparatus can also be made portable because it provides localized therapy without requiring a chamber encompassing a patient&#39;s entire body or extremity. 
     Monitoring of the therapy results, such as monitoring of oxygen levels at the wound site or monitoring of exudate removal, allows the wound treatment therapy to be tailored to each individual to maximize the therapeutic effect while minimizing therapy duration. 
     Referring generally now to  FIG. 1 , a wound treatment apparatus  10  according to the present invention is illustrated schematically. The apparatus  10  includes a drain line  18  that is attached to a negative pressure source  14 . The drain line  18  is preferably positioned to remove exudates from the wound  12 . The apparatus  10  also includes a supply line  20  that is attached to a fluid source  16 . The supply line  20  is preferably positioned to supply fluid to the wound  12 . A controller  22  functions to control the therapy administered by the wound treatment apparatus  10  to the wound  12 . 
     As will be understood by those skilled in the art, the controller  22  may be implemented as a control system or even as a control circuit, such as one or more of the following: programmable circuit, integrated circuit, memory and I/O circuits, an application specific integrated circuit, microcontroller, complex programmable logic device, field programmable gate arrays, other programmable circuits, or the like. 
     The controller  22  can cause the wound treatment apparatus  10  to administer negative pressure therapy to the wound  12  via the drain line  18 . The controller  22  can also cause the wound treatment apparatus  10  to administer hyperbaric fluid therapy to wound  12  via the supply line  20 . Preferably, hyperbaric fluid therapy is administered to the wound  12  at an absolute pressure of at least approximately 1.5 atmospheres. 
     In operation, negative pressure therapy and hyperbaric oxygen therapy may each be administered intermittently. In other words, negative pressure therapy and hyperbaric fluid therapy may be administered in alternating treatments where the wound treatment apparatus  10  cycles between negative pressure therapy and hyperbaric fluid therapy or, only one type of treatment (i.e. negative pressure therapy or hyperbaric fluid therapy) may be administered in an intermittent manner such that the wound treatment apparatus  10  cycles between administering treatment to the wound  12  and not administering treatment to the wound  12 . 
     For example, controller  22  may be configured to cause negative pressure therapy to be administered to the wound  12  via the drain line  18  for a first time period and hyperbaric fluid therapy to be administered to the wound  12  via the supply line  20  for a second time period. In one presently preferred embodiment, the first time period during which negative pressure therapy is administered is approximately two to three times as long as the second time period during which hyperbaric fluid therapy is administered. The controller  22  may be further configured to cause hyperbaric fluid therapy to be administered immediately following the cessation of the administration of negative pressure therapy and to cause negative pressure therapy to be administered immediately following the cessation of the administration of hyperbaric fluid therapy. 
     The administration of negative pressure therapy and hyperbaric fluid therapy may be controlled using a variety of methods. For example, the fluid source  16  may be configured to supply a constant flow of fluid. The controller  22  may be configured to cause the administration of negative pressure therapy by activating the negative pressure source  14 , which would create a negative pressure environment at the wound  12  even though the wound  12  would continue to be exposed to fluid from the fluid source  16 . The controller  22  may be further configured to cause the administration of hyperbaric fluid therapy by deactivating the negative pressure source  14 , thereby causing the wound  12  to be exposed only to the fluid from the fluid source  16  and causing pressures at the wound  12  to build to hyperbaric levels determined by, among other factors, the flow rate of the fluid. 
     Another mechanism for controlling the administration of negative pressure therapy and hyperbaric fluid therapy is to use the controller  22  to control both the negative pressure source  14  and the fluid source  16 . Thus, the controller  22  may be configured to cause the administration of negative pressure therapy by activating the negative pressure source  14  and either reducing the flow from or deactivating the fluid source  16 . Similarly, the controller  22  may be further configured to cause the administration of hyperbaric fluid therapy by deactivating the negative pressure source  14  and increasing the flow of fluid from the fluid source  16 . 
     Alternatively, the controller  22  may include two controllers, one for each device. The controller that controls the fluid source  16  may be configured to detect the state of the negative pressure source  14  or the state of the environment surrounding the wound  12 . Upon determining an end of a negative pressure therapy cycle, the controller controlling the fluid source  16  could cause the administration of hyperbaric fluid therapy by activating or increasing the fluid flow from the fluid source  16 . Conversely, the controller that controls the negative pressure source  14  could be configured to detect the state of the fluid source  16  or the state of the environment surrounding the wound  12 . Upon determining an end of a hyperbaric fluid therapy cycle, the controller controlling the negative pressure source  14  could cause the administration of negative pressure therapy by activating the negative pressure source  14 . 
     While each of the negative pressure therapy and the hyperbaric fluid therapy could potentially be administered to the wound  12  for hours before alternating to the other therapy, it is presently preferred that the controller  22  cause negative pressure therapy to be administered to the wound  12  for relatively short periods of time. For example, negative pressure therapy may be administered for approximately 20 seconds to approximately 180 seconds before moving on to hyperbaric fluid therapy or to non-therapy in the event that the apparatus is set to intermittently apply only negative pressure therapy. Similarly, the controller  22  may cause hyperbaric fluid therapy to be administered to the wound  12  for approximately 10 seconds to approximately 60 seconds before moving on to negative pressure therapy or to non-therapy in the event that the apparatus is set to intermittently apply only hyperbaric pressure therapy. 
     Moreover, the negative pressure therapy and the hyperbaric fluid therapy may be administered in a cyclical manner. For each cycle consisting of negative pressure therapy administration and hyperbaric fluid therapy administration, the administration of hyperbaric fluid therapy may be limited to no more than 30 minutes. In other words, following the administration of negative pressure therapy for a first time period, hyperbaric fluid therapy is administered for no more than 30 minutes, after which the negative pressure therapy is administered again for some time period, which may be the same as the first time period. Hyperbaric fluid therapy would then preferably be administered again for no more than 30 minutes, after which negative pressure therapy would be administered again. 
     In addition, the controller  22  may also be capable of selectively causing the cessation of negative pressure therapy without causing the cessation of the hyperbaric fluid therapy. Similarly, the controller  22  is preferably configured to be capable of selectively causing the cessation of hyperbaric fluid therapy without causing the cessation of the negative pressure therapy. 
     As will be understood by those of skill in the art, the administration of negative pressure therapy generally involves exposing the wound  12  to pressures of less than 1 atmosphere. The pressures employed during negative pressure therapy may include absolute pressures ranging from approximately 0 mmHg to approximately 300 mmHg. Preferably, the absolute pressure ranges from approximately 60 mmHg to approximately 160 mmHg during the administration of negative pressure therapy. 
     As will also be understood by those of skill in the art, the administration of hyperbaric fluid therapy involves exposing the wound  12  to a fluid at greater than atmospheric pressures. Preferably, the wound  12  is subjected to an absolute pressure ranging from approximately 1.5 atmospheres to approximately 3 atmospheres during the administration of hyperbaric fluid therapy. 
     The negative pressure source  14  can be any suitable suction device such as a vacuum, a manual, mechanical, or electrical pump, a hospital room suction line, or any other device exhibiting vacuum or suction capabilities. The fluid source  16  can be a suitable fluid supply device and preferably is an oxygen source or a humidified oxygen source, such as an oxygen concentrator, oxygen canister, or oxygen supplied from a hospital room oxygen line. For example, the fluid source  16  may administer oxygen or humidified oxygen at approximately 0.1 liters per minute to approximately 3 liters per minute. Preferably, the fluid source  16  administers oxygen or humidified oxygen at approximately 1 liter per minute to approximately 2 liters per minute. 
     Also, the negative pressure source  14  and the fluid source  16  may be powered by a single power source, such as a wall plug or a rechargeable battery, and may share a power supply, such as power supply  23 . Further, the negative pressure source  14  and the fluid source  16  may both reside in a single portable casing that houses the negative pressure source  14  and the fluid source  16  as one unit. 
     The drain line  18  may be surgical tubing, oxygen tubing or any other suitable type of line for removing exudate from a wound site. The supply line  20  may be surgical tubing, oxygen tubing or any other suitable type of line for carrying fluid, such as oxygen, to a wound site. In addition, part of the drain line  18  and part of the supply line  20  may be formed by a multi-lumen tube. 
     To perform localized administration of negative pressure therapy and hyperbaric fluid therapy, the drain line  18  and supply line  20  preferably engage a wound dressing.  FIG. 2  is a schematic illustration of an example wound dressing and surrounding elements made in accordance with the current disclosure. As shown in  FIG. 2 , the dressing includes packing material  42  above the wound  12  and a drain  24  atop the packing material  42 . The packing material may be, for example, gauze, foam dressing/packing, sponges, or the like. Preferably, the packing material is anti-microbial gauze saturated with saline. 
     The drain device  24  may be included as part of the drain line  18  or attached to the end of the drain line  18  opposite the negative pressure source  14 . Suitable drain devices include Jackson-Pratt silicon drain, flat drain, round channel drain, fluted drain, drain tube, Kremlin drain, or other drains capable of removing exudates from within or on top of the wound  12 . An example of a drain  24  is illustrated in  FIGS. 6-8 . 
     Atop the drain  24  is more packing material  42 . The dressing further has a gasket  41  made from pliable adhesive material molded around the surrounding edge of the wound  12 . The drain line  18  and the supply line  20  are atop the gasket  41 . Optionally, additional gasket  41  material is included atop the drain line  18  and supply line  20  for engaging the drain line  18  and the supply line  20 . The gasket  41  material may be, for example, an Eakin Cohesive Seal. 
     Sealing material  40  surrounds the wound  12 , the drain  24 , the packing material  42  and the gasket  41 . The sealing material  40  can adhere to the gasket  41  and the skin surrounding the wound  12 . Preferably, the dressing is capable of maintaining adherence during administration of hyperbaric fluid therapy at pressures of at least 3 atmospheres. The sealing material  40  preferably has adhesive properties to withstand the pressure induced by the supply of hyperbaric fluid from the fluid source  16  and the negative pressures drawn by the negative pressure source  14 . 
     It will be understood by those skilled in the art that various types of dressings may be used. For example, the drain  24  may be positioned above the packing material  42  or below the packing material  42 , as opposed to sandwiched between packing material  42  as shown. Also, the drain  42  and sealing material  40  may be incorporated as one device. In addition, the dressing may also include a protective mesh separating the packing material  42  from the wound  12 . 
     Turning next to  FIG. 3 , a schematic illustration of a hospital bed embodiment of apparatus made in accordance with the current disclosure is provided. Because of the presence of both a negative pressure supply  14  and a fluid supply  16  in many hospital rooms, it may be desirable to incorporate the controller  22  into a hospital bed  25 , which may include the bed frame and/or the mattress. Thus, the controller  22  in a hospital bed  25  is preferably used to administer negative pressure therapy and hyperbaric pressure therapy on a wound  12  using a hospital room suction line as the negative pressure source  14  and the hospital room oxygen line as the fluid source  16 . To control the pressures at the wound, the apparatus further includes valves  27   a  and  27   b  that are and located on the drain line  18  and supply line  20  and controlled in an automated manner by the controller  22 . The apparatus may further include sensors to provide the controller  22  with information used by the controller  22  in controlling the valves  27  and  27   b.    
     Turning next to  FIG. 4 , a portable wound treatment apparatus  10  made in accordance with the current disclosure and positioned on a wound  12  is illustrated schematically. Like  FIGS. 1 and 3 ,  FIG. 4  includes a negative pressure source  14 , a fluid source  16 , a controller  22 , drain line  18  and supply line  20 . Attached to the drain line  18  is a drain  24  placed in the wound  12 . A dressing including packing material  42  and a sealing material  40  is placed over the wound  12  and adhered to the skin  11 . 
     To make the apparatus of  FIG. 3  portable, the negative pressure source  14 , the controller  22  and the fluid source  16  are positioned in a housing  36  to house the negative pressure source  14  and the fluid source  16  as a single unit. The housing  36  may also house the collection device  26  and a humidification device, such as the humidification device  38  of  FIG. 5 . The humidification device  38  may be connected to the supply line  20  to add moisture to fluid being supplied to the wound  12 . In addition, it may be desirable to include a power source  39 , such as a rechargeable battery, within the housing  36 . The power source  39  may run both negative pressure source  14  and the fluid source  16 . The casing  36  may further include a handle  37  used to transport the apparatus  10  and/or suspend the apparatus  10  on a medical support such as an IV stand. 
     The drain  24 , in conjunction with the drain line  18  under operation of the negative pressure source  14 , may operate to transport exudates from the wound  12  to a collection device  26  connected to the drain line  18 . The exudates can be stored in the collection device  26  until properly disposed of. 
     Turning next to  FIG. 5 , another embodiment of a wound treatment apparatus  10  made in accordance with the current disclosure and positioned on a wound is illustrated schematically. Like  FIGS. 1 ,  3  and  4 ,  FIG. 5  includes a negative pressure source  14 , a fluid source  16 , a controller  22 , a drain line  18  and a supply line  20 . Attached to the drain line  18  is a drain  24  placed in the wound  12 . A dressing including packing material  42  and a sealing material  40  is placed over the wound  12  and adhered to the skin  11 . Following placement, the sealing material  40  may create a fluidic chamber around the wound  12 . 
     The apparatus of  FIG. 5  also includes a collection device  26  connected to the drain line  18  for storing exudates from the wound  12  until properly disposed of. As shown, the drain line  18  includes a drain line connection end  19  and the collection device  26  includes a drain line portal  15  shaped to accept the drain line connection end  19 . Preferably, the drain line portal  15  is shaped to accept only the drain line connection end  19  so as to avoid unintentionally connecting the supply line  20  to the drain collection device  26 . The collection device  26  may also include a collection device sensor  28  engaging the collection device  26  and connected to the controller  22  to indicate the level to which the collection device  26  is filled with exudates. The controller  22  may be configured to stop the administration of negative pressure therapy upon receiving information from the collection device sensor indicating that the collection device is full. In one embodiment, the collection device sensor  28  may notify the controller  22  and a warning can be issued to the user and/or the apparatus  10  can be shut down. 
     The supply line  20  supplies fluid to the wound site. Preferably, fluid supply  16  has a supply line portal  17  that is shaped to accept only a supply line connection end  21  so as to avoid unintentionally connecting the drain line  18  to the fluid source  16 . The wound treatment apparatus  10  may also include a pressure regulator to help prevent excessive pressurization of the wound site. The pressure regulator may be, for example, a pressure sensor  44 , which can be positioned to determine the pressure at the wound site. For example, the pressure sensor  44  may be positioned at the wound site or anywhere along the pathway between the fluid source  16  and the wound  12  or anywhere along the pathway between the negative pressure source  14  and the wound  12 . The pressure sensor  44  may be any type of device capable of providing information to either a user or the controller  22  about the pressure at the wound site. The pressure sensor  44  may be operatively connected to the controller  22  and the controller  22  may be configured to adjust the negative pressure therapy or the hyperbaric fluid therapy in response to information received from the pressure sensor  44 . 
     The pressure regulator may also be a mechanical pressure regulator  30  positioned along the supply line  20  between the wound  12  and fluid supply  16 . The mechanical pressure regulator  30  may be used in conjunction with the pressure sensor  44 . The mechanical pressure regulator  30  is preferably configured to actuate when the pressure in the supply line  20  at the pressure regulator  30  exceeds a set threshold. The actuation of the mechanical pressure regulator  30  causes a reduction of the supply line  20  pressure. For example, the mechanical pressure regulator  30  may include a release valve that opens when the pressure within the supply line  20  exceeds a certain threshold. 
     One embodiment of the mechanical pressure regulator  30  is illustrated in  FIG. 9 . As shown, the mechanical pressure regulator  30  is a Y valve. One side of the Y valve has a wound connection line  34  that is operatively connected to the wound  12 . The opposite side of the Y valve has two pathways. One of the pathways has a release valve  33  for venting excess fluid. The other pathway has a fluid source connection line  32  for connecting the mechanical pressure regulator  30  to the fluid source  16 . The mechanical pressure regulator  30  is preferably configured to actuate when the pressure at the mechanical pressure regulator  30  exceeds a set threshold. Actuation of the mechanical pressure regulator  30  causes the release valve  33  to open. The set threshold may be determined by the desired pressure to be applied to the wound  12  during hyperbaric fluid therapy. The actuation of the mechanical pressure regulator  30  then causes a reduction of the supply line  20  pressure as fluid is vented out of the system. 
     In addition, the mechanical pressure regulator  30  may be configured to maintain a reduced pressure within the supply line  20  following the actuation of the mechanical pressure regulator  30 . While the venting of fluid may cause a reduction in the supply line  20  pressure, the system may equalize if the flow rate of the fluid through the supply line  20  remains constant and the release valve  33  remains open. Thus, the mechanical pressure regulator  30  causes the pressure in the supply line  20  to be maintained at a reduced level. 
     Also as shown in  FIG. 9 , the Y valve  50  may connect the drain line  18  and the supply line  20  into a single-lumen tube for engaging the dressing. The Y valve  50  includes a drain connection line  54  and supply connection line  56 . The supply line  20  and drain line  18  are merged together by the Y valve  50  and the merged supply line  20  and drain line  18  are engageable with the wound  12  via the wound connection  52 . 
     Also as shown in  FIG. 5 , the wound treatment apparatus may also include humidification device  38  operatively connected the supply line  20 . The humidification device  38  may be configured to humidify the fluid from the fluid source  16  before the fluid is administered to the wound  12 . For example, when the fluid source  16  supplies oxygen, the humidification device  38  may function to humidify the oxygen so that humidified oxygen is supplied to the wound  12 . In addition, the humidification device  38  may be configured to heat the fluid in the supply line  20 , thereby causing an increase in the temperature at the wound  12 . Accordingly, the humidification device  38  may comprise a heating element  46  that is operatively connected to the controller  22 . Alternatively, a heating element  46  may be a component of the apparatus  10  that is separate from the humidification device  38 . In operation, the controller  22  may be configured to cause the heating element  46  to maintain a temperature at the wound  12  above approximately 98 degrees Fahrenheit and below the combustion temperature of the fluid administered during hyperbaric fluid therapy. Also, the heating element  46  may be configured to control the temperature at the wound independent of the controller  22 . 
     The humidification device  38  may also act as a drug delivery device. For example, the humidification device  38  may function to introduce at least one non-oxygen drug into the supply line  20 . The non-oxygen drug may be introduced into the humidification device  38  in powder form and may be supplied by the humidification device  38  to the supply line  20  in powder form via gas. The non-oxygen drug may also be supplied in vapor form via humidified gas. Alternatively, a separate drug delivery device may be attached to the supply line  20  to deliver non-oxygen drugs to the wound  12 . 
     Also as shown in  FIG. 5 , the wound treatment apparatus may further include a diffusion sensor  45  to measure diffusion of fluid, such as oxygen, into the wound  12 . The diffusion sensor  45  may be, for example, a transcutaneous oxygen sensor. The diffusion sensor  45  is preferably operably connected to the controller  22  and the controller  22  is preferably configured to adjust at least one of the negative pressure therapy or the hyperbaric fluid therapy in response to information received from the diffusion sensor  45 . For example, in response to information received from the diffusion sensor  45  indicating that the fluid diffusion rate is below a desired level, the controller  22  may be configured to cause an increase in at least one of the fluid flow rate or the pressure at the wound  12  during hyperbaric fluid therapy. 
     The controller  22  may also or alternatively be configured to cause an increase in the duration of the administration of hyperbaric fluid therapy relative to the negative pressure therapy in response to information received from the diffusion sensor  45 . Similarly, the controller  22  may be configured to cause a decrease in the duration of the administration of negative pressure therapy relative to the hyperbaric fluid therapy in response to information received from the diffusion sensor  45  indicating that the fluid diffusion rate is below a desired level. 
     In another embodiment the supply line  20  has a supply line connection end  21  while the fluid source  16  includes a supply line portal  17 . The supply line portal  17  is shaped to accept the supply line connection end  21 . The drain line  18  includes a drain line connection end  19  while the collection device  26  includes a drain line portal  15  shaped to accept the drain line connection end  19 . The supply line portal  17  is shaped such that it will only accept the supply line connection end  21  while the drain line portal  15  is shaped to only accept the drain line connection end  19 . This configuration assists in the safe connection of the negative pressure source  14  and fluid source  16  to the proper lines  18  and  20 . 
     The apparatus  10  can include various disposable elements and still maintain the inventive nature disclosed herein. For example, the drain line  18  and supply line  20  as well as the collection device  26 , or the container that collects the exudants, the sealing material  40 , packing material  42  and other elements that are in or near the wound  12  can be made to be disposable and discarded between uses of the remainder of the apparatus  10  to facilitate sterilization and reduce the potential contamination of subsequent patients by infectious diseases. 
     Assembly of the apparatus  10  and engagement of the apparatus  10  to a wound  12  can be accomplished as follows. The packing material  42  can be positioned in and around the wound to take up empty space thereby. A drain device  24  can be positioned in and around the wound  12  and connected to the drain line  18 . The drain line connection end  19  can be attached to the negative pressure source  14  in the drain line portal  15 . The drain line  18  can alternately go through a separate collection device  26  that will collect the exudates from the wound  12 . The supply line  20  can also be positioned in or near the wound  12  while the supply line connection end  21  can be inserted into the supply line portal  17  of the fluid source  16 . Alternatively the supply line  20  can be connected to a humidification device  38  that will add moisture to the oxygen as it flows to the wound  12 . 
     Turning next to  FIGS. 10A-F  and  11 , the preparation of one embodiment of a wound dressing made in accordance with the current disclosure is illustrated schematically and in flow chart form. As shown in  FIG. 10A  and process block  1102 , packing material  42  is inserted into the wound  12 . The packing material  42  preferably comprises anti-microbial gauze saturated with saline. Prior to inserting the packing material  42 , it may be desirable to insert a protective mesh into the wound  12 . Open ends of the supply line  20  and drain line  18  are then inserted into the wound  12  atop the packing material  42 . This is illustrated in  FIG. 10A  and process block  1104 . As shown, the process of inserting open ends of the supply line  20  and drain line  18  may involve inserting into the wound  12  a drain  24  connected to the supply line  20  and drain line  18 . A multi-lumen tube may form the supply line  20  and the drain line  18 . Preferably, additional packing material  42  is inserted atop the drain  24  as shown in  FIG. 10B . An example of a drain  24  is illustrated in  FIGS. 6-8 . 
     As shown in  FIG. 10C  and process block  1106 , a pliable adhesive gasket  41  is molded around the perimeter of the wound  12 . Preferably, the gasket  41  separates supply line  20  and drain line  18  from the patient&#39;s skin surrounding the wound  12 . The supply line  20  and the drain line  18  are thus engaged with adhesive gasket  41 . Preferably, as shown in  FIG. 10C  and process block  1108 , another piece of a pliable adhesive gasket  41  is then molded over the supply line  20  and the drain line  18  to strengthen the engagement. The pliable adhesive gasket  41  may be made from a cohesive seal. 
     As shown in  FIG. 10D  and process block  1110 , sealing material  40  is then placed over the wound  12 , the packing material  42 , the supply line  20 , the drain line  18  and the adhesive gasket  41  such that the sealing material  40  adheres to both the adhesive gasket  41  and the skin surrounding the adhesive.  FIGS. 10E and 10F  show the dressing during hyperbaric pressure therapy and negative pressure therapy, respectively. 
     Although the invention has been shown and described with respect to certain embodiments, it is obvious that equivalents and modifications will occur to others skilled in the art upon the reading and understanding of the specification. The present invention includes all such equivalents and modifications, and is limited only by the scope of the following claims.