Abstract:
A wound treatment system including a treatment chamber, a source of an aqueous antibiotic, a source of an oxygen-enriched gas, and a control system adapted to alternately surround a human limb with antibiotic mist and the oxygen enriched gas, which can be used to heal lesions such as foot ulcers. A method of treating lesions such as foot ulcers is also disclosed, that includes bathing the lesion in antibiotic mist and contacting it with oxygen gas.

Description:
RELATED APPLICATION 
       [0001]    This claims priority from U.S. Provisional Patent Application Ser. No. 60/555,568, filed Mar. 22, 2004, the entirety of which is incorporated herein by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    The present disclosure relates in general to wound treatment systems. More particularly, the present disclosure relates to a wound treatment apparatus and system for treatment of surface wounds. 
       BACKGROUND 
       [0003]    Medical professionals and healthcare providers such as nurses and doctors routinely treat patients having surface wounds of varying size, shape and severity caused by skin ulcerations due to diabetes, venous stasis, post surgical infections, gangrenous lesions, decubitus ulcers, amputations, skin grafts, burns, and frostbite. Variations in wound type and other patient indications dictate variations in desired medications for treatment, such as antibiotics, growth factors, enzymes, hormones, protocols, such as delivery rates for medication and temperature control. 
         [0004]    One particular area of concern involves foot or limb wounds in diabetic patients. It is known that foot wounds in diabetic patients represent a significant public health problem throughout the world. Diabetes is a large and growing problem in the United States and worldwide, costing an estimated $45 billion dollars to the U.S. health care system. Patients afflicted with diabetes often have elevated glucose and lipid levels due to inconsistent use of insulin, which can result in a damaged circulatory system and high cholesterol levels. Often, these conditions are accompanied by deteriorating sensation in the nerves of the foot. As a result, diabetics experience a high number of non-healing foot ulcers. 
         [0005]    It is estimated that each year up to three million leg ulcers occur in patients in the U.S., including venous stasis ulcers, diabetic ulcers, ischemic leg ulcers, and pressure ulcers. The national cost of chronic wounds is estimated at $6 billion. Diabetic ulcers often progress to infections, osteomyelitis and gangrene, subsequently resulting in toe amputations, leg amputations, and death. In 1995, approximately 70,000 such amputations were performed at a cost of $23,000 per toe and $40,000 per limb. Many of these patients progress to multiple toe amputations and contralateral limb amputations. In addition, the patients are also at a greatly increased risk of heart disease and kidney failure from arteriosclerosis which attacks the entire circulatory system. 
         [0006]    The conventional methods of treatment for non-healing diabetic ulcers include wound dressings of various types, antibiotics, wound healing growth factors, skin grafting including tissue engineered grafts, use of wheelchairs and crutches to remove mechanical pressure, and finally amputation. In the case of ischemic ulcers, surgical revascularization procedures via autografts and allografts and surgical laser revascularization have been applied with short term success, but with disappointing long term success due to reclogging of the grafts. In the treatment of patients with venous stasis ulcers and severe venous disease, antibiotics and thrombolytic anticoagulant and anti-aggregation drugs are often indicated. The failure to heal and the frequent recurrence of these ulcers points to the lack of success of these conventional methods. Accordingly, the medical community has a critical need for a low cost, portable, non-invasive method of treating diabetic, venous, ischemic and pressure ulcers to reduce mortality and morbidity and reduce the excessive costs to the health care system. 
         [0007]    Most problematic of all is that treatment of diabetic foot ulcers has been focused on amputation and not on limb salvage, as many of the wounds have not been properly treated. Improper treatment can be attributed to lack of an easy and inexpensive treatment system and method and severe inconvenience to the patient in using current methods. There is a need to prevent amputation by healing such wounds, particularly at an early stage. 
         [0008]    Furthermore, amputation for conditions such as foot ulcers and frostbite becomes less avoidable the longer the condition is either left untreated or is unsuccessfully treated. Therefore, it is crucial to apply an effective treatment regimen as soon as possible. Unfortunately, foot wounds in patients with, for example, diabetes develop because of a process called neuropathy. Diabetes causes loss of sensation such that skin injury and complete breakdown (ulcer) can develop with no or minimal pain. These wounds tend not to heal because of ongoing mechanical trauma not felt at all by the patient as painful. Therefore, by the time the patient discovers the wound, the wound has often progressed so that the patient&#39;s treatment options have become severely limited. 
         [0009]    In many cases, such wounds can only be healed by protecting them from mechanical trauma. Small plantar ulcers in diabetic patients area usually seen by primary care practitioners and endocrinologists. The present method for healing plantar ulcers is a total contact cast for the foot, which provides complete mechanical protection. This method is not ideally suited for either of these practice settings, because it requires skilled and specialized care in application, along with frequent follow up. Most patients perceive the cast to be an inconvenience at the early stages of such a wound, while perceiving that such a wound is not a serious matter. The alternative to the cast is to ask the patient to be non-weight bearing through the use of a wheelchair, crutches, or a walker, which provide complete mechanical protection only with complete patient compliance. This alternative rarely proves to be effective in healing wounds within a reasonable time period. 
         [0010]    What is needed is a treatment that primary care physicians and their staff can employ to treat ulcers and other wounds that does not require extended physician time and that is effective even at later stages of wound progression. Also, what is needed is a treatment that allows patients to be able to continue their active lives without the need to wear casts, or be confined to wheelchairs and crutches. 
       SUMMARY 
       [0011]    In one embodiment, a wound treatment apparatus includes a treatment vessel having a treatment chamber and an opening to the treatment chamber that are sized to receive a human limb. A removable and substantially gas impermeable liner lines the chamber of the vessel and forms a treatment zone around the patient&#39;s limb. A cuff is removably coupled to the opening of the vessel and is sized to sealingly engage a human limb when the limb is inserted through the opening. A mixture tank holds a humidifying agent and is in fluid communication with the chamber of the vessel. A first array of light emitting diodes is coupled to the chamber and emits ultraviolet light into the chamber. A speaker is attached to the vessel and delivers low frequency sound waves to the chamber. A second array of light emitting diodes is coupled to the chamber and emits pulsed light into the chamber. 
         [0012]    A wound treatment system includes a vessel that is sized to receive a human limb. The vessel includes a chamber with an opening leading into the chamber. A removable liner lines the chamber of the vessel and forms a treatment zone. A humidifier in fluid communication with the treatment zone humidifies a solution of water and antibacterial agent. An oxygen source is in fluid communication with the treatment zone. A speaker is coupled to the vessel and emits low frequency sound waves to the chamber. A first array of light emitting diodes that emits ultraviolet light is coupled to the vessel near the opening of the treatment chamber. A second array of light emitting diodes that emits pulsed light into the chamber is coupled to the chamber. The system also includes a control panel. 
         [0013]    A wound treatment method for treating a wounded limb is also described. The method includes cleaning the wound. The method also includes disinfecting the limb by passing the limb through a ring of ultraviolet light emitting diodes that emit ultraviolet light on the limb as the limb passes through the ring. The limb is placed into a vessel having a chamber that is lined, with a substantially gas impermeable liner by passing the limb through a cuff that sealingly surrounds a portion of the limb, thus forming a substantially gas impermeable treatment zone around a portion of the limb distal the cuff. The limb is heated by introducing warm water into the chamber, which causes the inner liner to collapse around the patient&#39;s limb. The warm water is emptied out of the chamber, and a temperature controlled mist of topical hyperbaric oxygen, water and an antibacterial solution is introduced into the treatment zone. The limb is massaged by activating a speaker coupled to the vessel that transmits low frequency sound waves to the treatment zone. The limb is heated and kept warm by activating an array of light emitting diodes coupled to the vessel that emits pulsed light onto the limb. 
     
    
     
       DESCRIPTION OF DRAWINGS 
         [0014]    These and other features and advantages will be apparent from the following more particular description thereof, presented in conjunction with the following drawings, wherein: 
           [0015]      FIG. 1  is a three-dimensional view of a wound treatment system. 
           [0016]      FIG. 2  is a is an illustration of a control panel of a wound treatment system. 
           [0017]      FIG. 3A  is another three-dimensional view of the wound treatment system depicted in  FIG. 1 . 
           [0018]      FIG. 3B  is a three dimensional view of the wound treatment system depicted in  FIG. 1  with patient being treated. 
           [0019]      FIG. 4A  is a three dimensional view of a lid assembly of a wound treatment system. 
           [0020]      FIG. 4B  is a three dimensional view of a treatment vessel of a wound treatment system. 
           [0021]      FIG. 5  is a side exploded view of a treatment vessel of a wound treatment system. 
           [0022]      FIG. 6A  is a front transparency view of the treatment vessel depicted in  FIG. 5 . 
           [0023]      FIG. 6B  is a top view of the wound treatment tank depicted in  FIG. 5 . 
           [0024]      FIG. 7A  is a front transparency view of a wound treatment chamber. 
           [0025]      FIG. 7B  is a bottom view of the wound treatment chamber depicted in  FIG. 7B . 
           [0026]      FIG. 8A  is a rear view of a wound treatment system with a rear panel removed. 
           [0027]      FIG. 8B  is another rear view of the wound treatment system depicted in  FIG. 8B  further depicting a humidifier. 
           [0028]      FIG. 9A  is a front transparency view of a water reservoir used in a wound treatment system. 
           [0029]      FIG. 9B  is a side transparency view of the water reservoir depicted in  FIG. 9A . 
       
    
    
     DETAILED DESCRIPTION 
       [0030]    The apparatus, systems, and methods described herein provide hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, per determination by the healthcare providers that use the described apparatus, systems, and methods, they can also provide mild heat, gentle massage, infrared and ultraviolet light therapy, moisture therapy, and application of antibacterial agents. These features are intended to promote the rate of healing and suppression of bacterial growth. 
         [0031]    Turning to  FIG. 1 , a wound treatment system  10  is shown, which generally includes a topical oxygen chamber for limbs and is intended to surround a patient&#39;s limb and apply humidified water, antibacterial agent, and oxygen topically at a pressure slightly greater than atmospheric pressure. The wound treatment system  10  includes a rectangular, rigid plastic carriage  15  having a treatment vessel  800  forming a chamber  810  (shown in  FIG. 5 ) that is sized to accommodate a patient&#39;s limb, particularly a patient&#39;s foot and a portion of the leg up to the knee. A padded leg rest  18  supports the patient&#39;s leg during treatment sessions. The system also includes a control panel  30 , a cart  40  housing a first reservoir  600  for water, an adiabatic humidifier  400  that holds a solution of water and antibacterial agent, a water pump  500  (all shown in  FIGS. 8A and 8B ), and a control box (beneath the control panel) that houses the circuit boards that control the system  10 . A mist control valve unit  50  is attached to a back panel of the cart  40 . A hose  70  connects the mist control valve unit  50  to the vessel  20 , and one or more hoses  71  connect the humidifier  400  to the mist control valve unit  50 . 
         [0032]    Covering the vessel  800  is a lid assembly  60  (shown in  FIGS. 1 and 4A ) that includes a first lower lid  61  that is hinged to the vessel  800  at the proximal end  64  of the vessel  800  opposite the end abutting the back panel of the cart  40 . The lower lid  61  includes a circular opening  161  that provides access to a chamber  810  formed inside the vessel. 
         [0033]    The lid assembly  60 , as shown in  FIGS. 1 and 4A , also includes a second upper lid that is formed by two opposing covers  62  and  63 . Cover  62  covers the distal side  64  of the vessel  800  and cover  63  covers the proximal side  65  of the vessel  800 . The covers  62  and  63  are completely removable from the top of the vessel  800 . The distal side of cover  63  forms a half circular indentation that is matched by a half circular indentation in the proximal side of cover  62  so that when the distal side of cover  63  and the proximal side of cover  62  join, a round opening  169  is formed when the covers  62  and  63  are secured over lid  61 . Each cover  62  and  63  has a raised half circular wall  67  and  68  projecting vertically from its top surface around its corresponding half circular indentation. When the covers are joined as shown in  FIG. 1 , the walls  67  and  68  join to form a cylinder  69 . The round opening  169  formed when the half circular indentations are joined is concentric with the circular opening  161  of the lower lid  61  so that a patient&#39;s limb can project down through the cylinder  69 , through opening  169  formed by the covers  62  and  63 , through opening  161  of the lower lid  61 , and into the chamber  830  of the vessel  20 . 
         [0034]    An oxygen inlet port  77  on the cover  62  (or alternatively cover  63 ) receives a hose  78  connected to an oxygen source, such as an oxygen tank or a central oxygen source in a hospital. The inlet port  77  can include a fitting (not shown) to sealingly secure the hose  78  to the cover  62 . The cover  62  includes a vapor inlet port  72  that receives the hose  70 . The vapor inlet port  72  can include a fitting  73  to sealingly secure the hose  70  to the vapor inlet port  72 . Either of the covers  62  or  63  can also include a temperature sensor  92 , a humidity sensor  94 , and a pressure sensor  96 , each of which are in fluid communication with a treatment zone formed by a treatment bag  100  sealed to the lid  61  of the vessel ( FIG. 4B ). The cart  40  includes wheels  41  at each corner to mobilize the system  10 . 
         [0035]    As shown in  FIG. 2 , the control panel  30  includes a display with various knobs and switches that controls the operation of the wound treatment system  10 . The panel includes controls  130  that control the humidifier, controls  140  that control an array of ultraviolet light emitting diodes (LEDs)  310  (see  FIGS. 4A and 4B ) controls  150  that control an array or board of infrared light  880  (see  FIGS. 4B ,  6 A, and  7 A) and an audio transducer or speaker  870  (see  FIGS. 5 ,  6 A,  7 A, and  7 B), controls  160  that control a water pump  500  (see  FIG. 8A ), and controls  170  that control the master power for the system  10 . 
         [0036]    The humidifier functions of the system are controlled by controls  130 , which include at least some of the following: an on/off switch  131  that turns on the humidifier function; a button  132  that can be used to manually activate or open the mist control valve unit  50  and that illuminates when the mist control valve unit  50  is open and allowing the flow of therapeutic mist into the chamber  830 ; a button  133  that opens an electronic oxygen flow valve in the tubing  78  connected to the oxygen source and illuminates when the oxygen flow valve is open and allowing oxygen flow into the chamber  810 ; an auto/manual switch  134  that sets the humidifier function to either manual operation or auto operation; a mist timer knob  135  that is used to set the amount of time for mist flow into the chamber  810 ; and an oxygen timer knob  136  that sets the amount of time for oxygen flow into the chamber  810 . 
         [0037]    The UV functions of the system is controlled by controls  140 , which include at least some of the following: an on/off switch  141  that turns on the UV function; a foot in button  142  that illuminates when the patient inserts his foot through the opening  169 —the collar  300  can have a sensor  360  that senses the foot and sends a signal back to the control box to activate the UV LEDS; a UV on button  143  that can be depressed to manually activate the UV LEDS  310  and that illuminates when the UV LEDS  310  are activated; an auto/manual switch  144  that sets the UV function to either manual operation or auto operation; and an UV timer knob  145  that sets the amount of time that the UV LEDS will remain on once they are activated. 
         [0038]    The IR/Audio functions of the system is controlled by controls  150 , which include at least some of the following: an on/off switch  151  that turns on the IR/Audio function; an IR button  152  that can be used to manually activate the IR LEDS and that illuminates when the IR LEDS and speaker are operating; an Audio, button  153  that can be used to manually activate the speaker or audio transducer and that illuminates when the speaker is operating; an auto/manual switch  154  that sets the IR/Audio function to either manual operation or auto operation; and a timer knob  155  that sets the amount of time that the IR LEDS and speaker will remain on once they are activated. 
         [0039]    The pump control functions of the system is controlled by controls  160 , which include at least some of the following: an an/off switch  161  that turns on the pump control function; a drain button  162  that can be used to manually operate the timing of drainage of the chamber  810  and that illuminates when the chamber  810  is draining; a fill button  163  that can be used to manually operate the timing of filling the chamber  810  with warm water and that illuminates when the chamber is filling with water; and an auto/manual switch  164  that sets the pump control function to either manual operation or auto operation. 
         [0040]    The master control buttons  170  include at least some of the following: a master control switch  171  that turns the system on and off; a start button  171  that is used to start the operation of the system and that illuminates when the system is operating; and a stop button  172  that can be depressed to prematurely stop the operation of the system. 
         [0041]    In one embodiment, the control panel  30  also includes a thermostat (not shown) that is electrically coupled to a submergible water heater  680  (see  FIG. 9A ) that is located in the water reservoir tank  600 . The thermostat can be used to control the temperature of the water that is pumped from the water reservoir tank  600  into the chamber  810 . 
         [0042]    In operation, the system  10  works by switching the master power switch  170  to the on position, which turns the system on and puts the system in ready mode. The healthcare provider then decides which of the functions will be used in the specific regimen for the particular patient. Depending on the patient and the ailment, the regimen may provide for operation of all of the functions, or just some of the functions. For example, a regimen may call for warming the limb with injection of warm water into the chamber and then treating the wound with the antibiotic mist, but may not require infrared treatment and low frequency sound vibrations. Thus, all of the on/off switches would be switched to the one position except for the IR/Audio control switch  151 , which would remain in the off position. When operating under normal conditions, all of the functions can be turned on by switching all of the on/off switches to the on position. This sets all of the functions to ready mode. The mist timer knob  135  and oxygen timer knob  136  can then be set to operate for the appropriate amount of time. According to one embodiment, the mist can be set at about fifteen minutes, while the oxygen is set at about five minutes. The UV timer knob  145  is set to operate for an appropriate amount of time. According to one embodiment, the UV timer is set to operate for less than 5 seconds, less than 4 seconds, less than 3 seconds, less than 2 seconds, or less than 1 second. The IR/Audio timer can be set to operate for a period of time coinciding with the warm water bath of the limb, which is when the chamber is filled with warm water, which warms the limb. This period can last from about one minute to about ten minutes or more. All of the auto/manual switches can be set to auto for a predetermined and default regimen. Next the healthcare provider depresses the start button  171 , which begins the regimen. 
         [0043]    According to one embodiment, when all of the functions are in operation and auto modes, and the start button  171  is depressed, the system operates as follows. First the system waits for the sensor  360  to detect the insertion of a limb of a patient P, as shown in  FIG. 3B ) into the chamber  810 . After the wound in the limb is cleaned, the limb is inserted through the opening  169  of the covers  62  and  63  and the opening  161  of the lid  61 . The sensor  360  detects the limb as it passes through the opening  161  and activates the UV function, which activates the ring of UV LEDs  310  located concentrically around the opening  161 . The UV LEDS  310  briefly stimulate the limb (about one to five seconds) as it passes through the opening of the chamber  810  and then the UV LEDs  310  deactivate. The UV on button  143  illuminates while the UV LEDs are on. 
         [0044]    Next, a cuff  90  is placed around the limb and the lids  62  and  63  closed around the cuff  90  so that the half circular walls  67  and  68  form a substantial seal around the cuff. The cuff will be discussed in more detail later. The limb is placed in a bag or liner  100  that is substantially impermeable to gas. The top opening of the bag  100  is sealed to the bottom surface of the lid  61  and forms an airtight seal with the bottom surface of the lid  61 . Thus, when the limb is surrounded by the cuff  90 , which is surrounded by the half circular walls  67  and  68 , the portion of the limb distal the cuff is inside the bag in a substantially sealed treatment zone. 
         [0045]    Once the limb is secured as described, the pump  500  is activated and pumps warm water from the water reservoir  600  to the chamber  810  of the vessel  800  through a hose  510  that is connected to an outlet port  660  in the reservoir  600  on one end and the pump  500  on the other end. Another hose  520  carries the water from the pump  500  to a water pipe protruding from the vessel  20  that is connected to an opening in the chamber  810 . The water pump  500  shuts off automatically after a predetermined amount of water is drained from the reservoir  600 . The warm water entering the chamber  810  causes the bag  100  to collapse around the limb and creates a warm southing sensation on the limb. The warm water bath remains in the chamber  810  for a predetermined amount of time, generally between about one minute and ten minutes or more. The array of IR LEDs  880  in the chamber  810  is activated and transmits a pulsed (or steady) IR light during the warm water bath. The IR LEDS further warm the limb increasing circulation. 
         [0046]    Also contemporaneous with the activation with the IR LEDs  880 , the audio transducer or speaker  870  is activated and generates a low frequency sound wave that surrounds the limb. This creates a massaging effect, stimulates the skin and further enhances circulation. The water pump  500  is then activated in reverse and the warm water is pumped out of the chamber  810  and back into the reservoir  600 . The IR LEDs  880  and the audio transducer  870  are turned off. 
         [0047]    An adiabatically-humidified, temperature-controlled vapor of water and a topical antibacterial, antiseptic or antibiotic agent is released from the humidifier  400  by mist control valve unit  50 . The vapor travels through the tube  70  and, enters the treatment zone through a port  72  in the lid  62 , which is substantially sealed to the tube  70 . The vapor hydrates the wound and provides antibacterial effects. This vapor treatment can last between about two minutes and about thirty minutes, depending on the timer  135  set by the healthcare provider. In one embodiment, vapor treatment lasts about fifteen minutes. Then the mist control valve unit  50  is activated to close the valve between the humidifier  400  and the tube  70 . 
         [0048]    At this time, the oxygen release valve is opened and oxygen flows from the oxygen source, which can either be an oxygen tank as shown or a wall mounted oxygen unit connected to a central oxygen source, such as in a hospital setting (not shown). The oxygen flows through the tube  78  into an oxygen inlet port  77  on the surface of the lid  62 . The oxygen displaces the vapor and oxygenates the wound. Oxygenation can last between about one minute and about fifteen minutes. In one embodiment, oxygenation lasts about five minutes. The process between vapor treatment and oxygenation can be repeated several times. In one embodiment, vapor treatment and oxygenation are repeated three times for a total of four rounds of treatment lasting approximately eighty minutes. The patient&#39;s oxygen level can be monitored during treatment using an oximeter connected to the patients finger or other body part. The oximeter can be electrically connected to the control circuits in the control box of the system  10 , and a display can warn the user to stop treatment or introduction of oxygen if the patient&#39;s blood oxygen level is too low or too high according to a predetermined level, such as below 80% saturation for an extended period of time. An extended period of time can be two or more minutes. 
         [0049]      FIG. 3A  shows the wound treatment system  10  with the control panel  30  lid removed and the lid  61  opened. Underneath the lid of the control panel reside the various electronics and circuitry of the system  10 . A 12V power supply  220  can be used to power the system. A sweep function generator  210  is used to generate a low frequency waveform for the audio function. The sweep function generator  210  can generate an adjustable frequency of between about 1 Hz and about 1000 Hz. It can generate various types of waveforms, such as sweeping waveforms and ramping waveforms within that range of frequencies. The sweep function generator  210  produces a sin wave signal that is transmitted to the audio amplifier  230 , which can be a 12V amplifier. The amplifier  230  amplifies, the signal to about 50 W and transmits the amplified signal to the speaker or audio transducer  870  connected to the vessel  800 . The sweep function generator  220  can be preset to a default frequency and waveform. In one embodiment, it can be preset to generate a 60 Hz signal, which can be manually altered to produce a signal at other frequencies between the range of about 1 Hz and about 1000 Hz. An assembly control cable  240  connects the control box (not shown) with the electronic components of the system. The control box (not shown), which is housed underneath the control panel lid  30 , houses all of the circuit boards required to operate the system  10 . 
         [0050]    In one embodiment, as shown in  FIGS. 3A and 4B , on the bottom surface  61 B of the lid  61  is a circular collar  300  that forms a perimeter around the opening  161  on the bottom surface  61 B of the lid  61 . An array of UV LEDs  310  is mounted on the inner surface of the collar forming a ring. The UV LEDs  310  each point toward the center of the opening  161 . There can be as few as four LEDS and as many as one hundred twenty or more LEDs in the array of UV LEDs  310 . The array of UV LEDs  310  can deliver 330 W of UVA at about 320 nm to about 400 nm. Alternatively, or in addition to, the array of UV LEDs  310  can deliver 330 W of UVB at about 290 nm to about 320 nm. Alternatively, or in addition to, the array of UV LEDs  310  can deliver 330 W of UVC at about 100 nm to about 200 nm. In one embodiment, there are ninety UV LEDs delivering 330 W of UVA at about 374 nm to about 392 nm, delivering a total of about 324 mW or 324 W. The collar  300  also includes a motion sensor  360  to detect when a limb has been inserted through the collar and the ring of UV LEDs  310 . The motion sensor is connected to the control box through a wire  312  that is threaded through a hole in the collar and then a hole in the bottom of the carriage  15  and up through the bottom of the cart  40 . The wire  312  is eventually bundled in the cable  240  and carries an electrical signal to the circuitry in the control box. The array of UV LEDs  310  receives its electrical signals from the control box through a wire  311  that is also threaded through the hole in the collar and then a hole in the bottom of the carriage  15  and up through the bottom of the cart  40  and eventually bundled in the cable  240 . 
         [0051]    The lid  61  is raised by lifting the distal side of the lid while the proximal side pivots along its hinges. Chains or wires  85  are connected at one of their ends to the bottom surface  61 B of the lid  61  and at their other ends to the back panel of the cart with hooks or other securement means. The lid  61  falls back and is supported by the chains  85 . The bottom surface  61 B of the lid  61  includes a gasket  184  around its square or rectangular perimeter that seals the bottom surface  61 B of the lid  61  to the vessel  800  when the lid  61  is closed. 
         [0052]    As shown in  FIG. 4A , the lid  61  can have a substantially circular crown  350  projecting vertically from its upper surface  340 . This crown is in lieu of the collar  300  shown in  FIGS. 3A and 4B . The array of UV LEDs  310  is coupled to the inside surface of the crown  350 , as is the motion detector  360 . The upper lid is formed by covers  62  and  63 . Each of the covers  62  and  63  can form a corresponding half washer shaped raised portion  62  and  63 . Projecting vertically from the center of each raised portion  62  and  63  is a half circular wall  67  and  68 . When the covers  62  and  63  are placed over the lid, the washer shaped raised portions  62  and  63  join to form a raised washer shaped portion that fits over the circular crown  350  to form a substantial seal between the outer wall of the crown  350  and the inner wall of the washer shaped raised portion. The outer wall of the crown  350  can include a gasket (not shown) to reinforce the seal. The half circular walls  67  and  68  also join to form a cylinder with an opening  169  in the center that is concentric with and open to the opening  161  of the lid  61 . 
         [0053]    An oxygen inlet port  77  on the washer shaped raised portion  62  (or alternatively on washer shaped raised portion  63 ) receives a hose (not shown) connected to an oxygen source, such as an oxygen tank or a central oxygen source in a hospital. The oxygen inlet port  77  can include a fitting (not shown) to sealingly secure the hose to the cover raised portion  62 . The raised portion  62  includes a vapor inlet port  72  that receives the hose  70  (shown in  FIG. 1 ). The vapor inlet port  72  can include a fitting  73  (shown in  FIG. 1 ) to sealingly secure the hose  70  to the vapor inlet port  72 . 
         [0054]    There are only two components of the wound treatment system  10  that make physical contact with the patient&#39;s skin: a liner or bag  100  (as shown in  FIGS. 3A and 4B ) into which the patient&#39;s limb is placed; and a foam cuff  90  (as shown in  FIGS. 3B and 4A ), which is placed around the patient&#39;s limb. 
         [0055]    The liner  100  forms a treatment zone around the wound and makes contact with the open wound. Therefore, it is preferable that the liner  100  be biocompatible and sterile. The liner  100  can be discarded or sterilized after each use and/or replaced with a new or sterilized liner  100 . 
         [0056]    The material from which the liner  100  is made can be any strong substantially gas impermeable material. Extruded flexible plastic film material, such as polyethylene (hdpe, ldpe, lldpe, polyprolene, etc,), polyurethane ether or ester open cell foam (e.g., United States Plastics Corp. Stock No. 47154), polyethylene terephthalate, polyvinyl chloride, or ethylene/polyvinyl copolymer sheet stock, and vapor proof treated fabric, such as nylon, are suitable. The material can be puncture resistant and transparent. The flexible sheet material can have a variety of shapes. It can be a single layer, such as a bag to surround a limb, or have multiple layers. The bag or liner  100  may also be co or tri axially oriented. 
         [0057]    The term “substantially gas impermeable”, as used herein with respect to the sheet material, means gas impermeable to the extent needed to prevent excessive gas escape from the treatment zone through the sheet material. Total gas impermeability seldom is needed, particularly for continuous flow treatment devices. However, generally high impermeability is desirable for static treatment devices. 
         [0058]    The perimeter of the opening of the liner  100  can have an adhesive strip with a removable backing. The backing can be removed and the perimeter of the lining can be substantially sealed against the crown  350  (or the collar  300 ), thus forming a sealed connection between the perimeter of the opening of the liner  100  and the lid  61 . Alternatively, the liner  100  can be taped to the crown  350  (or the collar  300 ) to form a substantial seal between the lid  61  and the liner  100 . 
         [0059]    In one embodiment, the liner  100  includes a pressure release valve  105  built into it. The design of the pressure release valve  105  is not critical. Many different types are suitable. For example, the valve  105  can be a ball valve or a baffle valve such as a flap or butterfly baffle valve. Other valves are equally suitable, so long as they are capable of accurately setting the maximum release pressure and are inexpensive and so discardable. If desired the adjustable valve  105  can be calibrated to show the pressure setting. In one embodiment, the maximum release pressure can be set at 22 mm of mercury so that the pressure inside the liner  100  never surpasses that amount of pressure. The valve body can be made of any rigid plastic, although metals such as stainless steel can be used also. The spring can be steel or plastic. Very inexpensive completely plastic valves can be used as well.\ 
         [0060]    The pressure release valves  105  integrated with the liner  100  are inexpensive yet reliably accurate, within the preferred accuracy ranges. If desired, they can be removed from a used liner  100  and reused on new liners. Using a valve that is in communication with the treatment zone and not with the gas supply eliminates the need for a separate pressure control mechanism between the chamber  810  and the oxygen source. The chamber  810  can be connected directly to a gas or oxygen tank or a hospital gas supply line. 
         [0061]    With any of the embodiments described herein, a foam cuff  90 , as shown in  FIG. 3B , is placed around the patient&#39;s limb and inserted concentrically with the cylinder formed by the half circular walls  67  and  68 . The foam cuff  90  can be disjoined so that it can be opened and placed around a limb. The foam cuff  90  can be made of a biocompatible open cell material that is compressible and resilient and forms a substantial seal or baffle between the patient&#39;s limb and the cylinder formed by the walls  67  and  68 . The open cell configuration prevents rapid fluid leakage through the cuff, but does allow for some fluid leakage at pressures approaching 22 mm of mercury, thus acting as a baffle. The pressure inside the treatment zone should not reach 22 mm of mercury, and the fluid leakage through the foam cuff  90  as the pressure inside the treatment zone increases will prevent pressures from building up beyond that level. Thus, with the use of an open cell material in the foam cuff  90 , a pressure release valve  105  in the liner  100  may not be necessary. The foam cuff  90  can also include a backing on its outer non-skin contacting surface that can be peeled away, exposing a sticky surface that sticks to the cylinder. The foam cuff  90  can be made of a polyurethane ester or a natural material. 
         [0062]      FIGS. 5-7B  show the vessel  800  in which the patient&#39;s wound is treated. The vessel  800  sits inside of the rigid plastic carriage  15  shown in  FIG. 1 . As shown in  FIGS. 5 and 6A , the vessel  800  is formed by inserting chamber  810  into tank  830 . The outer dimensions of the chamber  810  are slightly smaller than the inner dimensions of the tank  830  so that the chamber  810  is nested securely within the tank  830 . The only dimension of the tank  830  that is substantially different from the chamber  810  is that the tank  830  is several inches deeper than the chamber  810 . This provides for extra room at the bottom of the tank  830  for the audio transducer or speaker  870  connected to the bottom of the chamber  810 , so that when the chamber  810  is placed in the tank  830 , the top edges  812  and  832  of the chamber  810  and tank  830  are substantially coplanar as shown in  FIG. 6A . 
         [0063]    The tank  830  is made of a molded plastic or metal that is rigid and durable. As shown in  FIGS. 6A and 6B , the tank  830  has a foam platform  835  forming an inner bottom surface of the tank  830 . The foam platform  835  has a circular pipe hole  836  cut into it that receives the audio transducer or speaker  870 . The foam platform  835  has a second pipe hole  837  cut into it that is matched up with a hole  838  cut in the bottom of the tank  830  to form an outlet port for the water pipe  818  projecting vertically downward from the bottom surface of the chamber  810 . Bolts  833  projecting vertically downward from the bottom of the tank  830  are used to guide and connect the tank  830  to the carriage  15 . 
         [0064]    Turning to  FIGS. 7A and 7B , chamber  810  is shown in more detail. The chamber  810  includes a sealing member  813  that surrounds the chamber just beneath its edge  812 . The sealing member  813  forms a substantially fluid-tight seal between the chamber  810  and the tank  830 . Inside the chamber  810  is an IR board  880  with an array of IR LEDs. The board  880  has bolts  881  on its corners that are used to bolt the board  880  to the bottom of the chamber  810 . PCB wiring  881  is coupled to the IR board  880  and exits from the chamber  810  through hole  882  drilled into the bottom of the chamber  810 . The hole  882  can be drilled at a location beneath the IR board  880  and can be about ¼ inch. Silicone, hot glue, and/or other sealing materials can be used to form a fluid tight seal between the wiring  881  and the hole  882  to seal the chamber  810 , hardware, and wires from leaks. The wiring  881  is lead through the pipe hole  837  in the tank  830  and connects with a connection to the control box. 
         [0065]    The IR board  880  includes IR LEDs arranged in a pattern on a square or rectangular board. The IR LEDs can emit energy at infrared frequencies of between about 700 nm and 50,000 nm. The IR board  880  can be controlled by the control panel to adjust the frequency. In one embodiment, the IR LEDs deliver about 2000 mW of infrared light at about 810 nm. In one embodiment, the IR board  880  can also generate about 1.2 W of Red light at about 660 nm for a combined total light output of 1911 mW. For example, the IR board  880  can be a Thor DDII IR Lamp System. 
         [0066]    Turning to  FIG. 7A , a hole is drilled through the bottom of the chamber  810 , and the water pipe  818  is inserted through the hole, projecting vertically downward through the hole and out the bottom of the chamber  810 . A tub seal pipe coupling  819  is used to form a fluid tight seal between the pipe  818  and the hole through which it is inserted through the chamber  810 . The water pipe  818  is open at both ends to allow water to flow in and out of the chamber  810  when the chamber  810  is connected to the reservoir  600  through a water hose. 
         [0067]    As shown in  FIGS. 7A and 7B , coupled to the outside of the chamber at the bottom of the chamber  810  is an audio transducer or speaker  870 . The speaker  870  is bolted to the bottom of the chamber  810 . Transducer wires  876  are connected to the speaker  870  and, like the IR wiring, are threaded through the pipe hole  837  in the tank  830  to form a connection with the control box. As shown in  FIGS. 5 and 6A , a rigid plastic or metal collar  890  with a hole  892  is placed around the speaker  870  to protect the speaker  870 . The speaker  870  emits energy at a low frequency sound wave, of between about 1 Hz and about 1000 Hz. In one embodiment, the speaker emits energy at about 60 Hz. This causes a therapeutic vibration on the chamber  830  and a massaging effect on the patient&#39;s limb. 
         [0068]    In one embodiment the foam platform  835  is a premolded piece that is inserted into the bottom of the tank  810 , and the chamber  810  is placed on top of the foam  835 . In another embodiment, a hardening foam gel is poured into the bottom of the tank  810  to a predetermined depth, and the chamber  810  with speaker  870  and collar  890  are quickly placed into the tank  810 . The foam gel hardens around the pipe  838  and wires  881  and  876 , the collar  890 , and the bottom of the chamber  810 . The tank  830  is ultimately bolted to the rigid plastic carriage  15 . 
         [0069]    Now turning to  FIGS. 8A and 8B , the components of the wound treatment system  10  that are housed in the cart  40  are shown. Both  FIGS. 8A and 8B  are front views of the cart  40  looking at the cart  40  from the direction of viewing the control panel  30 .  FIG. 8A  shows the components with the humidifier  400  removed so that the water pump  500  is visible.  FIG. 8B  shows the components with the humidifier  400  in its normal position blocking a view of the pump  500 , which sits behind the humidifier  400 . 
         [0070]    As shown in  FIG. 8A , a warm water reservoir  600  rests on a shelf  43  at the bottom of the cart  40 . A first hose  510  is connected to the water pump  500  through fitting  512 . The other end of the hose  510  is secured to a hose fitting  630  (shown in  FIG. 9B ) laterally projecting from the reservoir  600  so that the hose is in fluid communication with the inside of the reservoir  600 . A second hose  520  is connected to the water pump  500  through fitting  522 . The other end of hose  520  is connected to the water pipe  818  projecting vertically from the bottom of the vessel  800  so that the hose  520  is in fluid communication with the inside of the chamber  810 . Cables  510  electrically couple the water pump to the control box. The reservoir  600  has a rigid lid  610  that can, be removed to expose the inside of the reservoir and fill it with water. 
         [0071]    Turning to  FIGS. 9A and 9B , the reservoir  600  is shown in more detail. The reservoir  600  includes two float twitches  640  and  650 . An upper float switch  640  is used to determine when the reservoir  600  is full and a lower float switch  650  is used to determine when the reservoir  600  is empty. Switch  640  has a lead  642  that is electrically connected to terminal block  660  with wire  645 . Switch  650  has a lead  652  that is electrically connected to terminal block  660  with wire  655 . Terminal block  660  is electrically connected to the pump with wires  670 . The spacing between the switches  640  and  650  determines the amount of water that will be pumped into the chamber  830  when the system  10  is activated and the pump function is operating. The switches  640  and  650  are arranged so that the optimal amount of water is pumped into the chamber  830 . If too much water is pumped into the chamber, the lid  61  can dislodge causing the chamber  830  to leak. If there isn&#39;t enough water, the patient&#39;s limb will not be warmed enough. In one embodiment, about five gallons of water is pumped from the reservoir  600  to the chamber  830 . When the pump function is activated, the pump begins to pump water  500  out of the reservoir  600  through fitting  660 . When the water level reaches the lower switch  650  and the floating arm  653  of the switch  650  begins to dip fall, an electrical signal is transmitted to the pump  500  through wires  670 , and the pump  500  automatically shuts off. When the drain function is activated, the pump  500  begins to pump in reverse, draining the water from the chamber  830  and back into the reservoir  600 . When the water in the reservoir reaches the upper switch  650  and the floating arm  643  of the switch  640  begins to rise, an electrical signal is transmitted to the pump  500  through wires  670 , and the pump automatically turns off. 
         [0072]    In one embodiment, the water is kept at an optimal temperature with a portable heating unit  680  that is adjustable between a range of about 70° F. and about 90° F. In another embodiment, a more sophisticated heating unit is used (not shown) that is electrically coupled to the control box and can be controlled with a thermostat in the control panel  30 . 
         [0073]    Turning back to  FIG. 8B , the humidifier unit  400  sits atop the lid  610  of the reservoir  600 . The humidifier has a removable lid  410  that can be removed to fill the reservoir of the humidifier  400  with water and an antibacterial agent, such as ionic silver, hydrogen peroxide, bacitracin, betadine, or isopropyl alcohol. In one embodiment, adiabatically humidified 1% hydrogen peroxide/silver solution is used, but other FDA approved topical antibacterial, antibiotic, antiseptics and antimicrobial solutions and agents, such as those described above, may also be used. 
         [0074]    The humidifier  400  has a misting unit that constantly produces mist as long as the humidifier function on the control panel  30  is activated. The misting unit can be an adiabatic temperature controlled humidifier or ultrasonic nebulizer. The humidifier  400  can generate room temperature mist or heated mist. It can include a built-in heater (not shown) with an on/off switch and an indicator light that shows that the heater is on and at operating temperature. Warm mist temperature in the bag  100  can reach between about 77° F. and about 82° F. as measured with a temperature gauge in the lid assembly. The humidity in the bag  100  can reach about 89% to about 91% as measured by a humidity gauge. The humidifier has a transducer that generates ultrasonic energy at about 40 kHz to create an adiabatic/humid mist that creates a cloud. Ultrasonic energy from the misting unit is not transmitted to the limb, which is about two feet away from the misting unit. When the valve control unit  50  is opened, the mist travels from the humidifier  400  into the exit tube  410  and out through the exit port  420  where it enters the valve control unit  50 . From there the mist travels through the tube  70  and into the treatment zone formed by the bag  100  surrounding the patient&#39;s limb. 
         [0075]    Other embodiments are within the scope of the following claims.