Patent Publication Number: US-2013253383-A1

Title: Gradient sequential thermal compression therapy apparatus and system

Description:
CONTINUITY DATA 
     This application is a continuation-in-part of, claims priority to and the benefit of, U.S. Ser. No. 13/890,090 filed May 8, 2013 and entitled “Thermal Compression Therapy Apparatus and System.” The &#39;090 application is a continuation of, claims priority to and the benefit of, U.S. Ser. No. 12/501,258 filed Jul. 10, 2009 and entitled “SYSTEM AND METHOD FOR THERMAL COMPRESSION THERAPY.” The &#39;258 application claims priority to and the benefit of U.S. Provisional Application Ser. Nos. 61/134,676 and 61/134,677, filed on Jul. 10, 2008. All of which are incorporated herein in their entirety. 
    
    
     FIELD 
     The disclosure relates to a medical device and therapy system. More particularly, the disclosure includes an apparatus, method and system for providing sequential gradient pressure and/or compression therapy with combined heating or cooling for use, for example, in reducing edema, pain, preventing deep vein thrombosis (DVT) and/or lymphedema. 
     BACKGROUND 
     Various medical devices have been developed to deliver warming therapy and cooling therapy to patients recovering from injuries or surgeries. Additionally, it is known to provide a pressurized massage therapy (sometimes referred to as external pneumatic compression (“EPC”)) to these patients. Typical recipients of these therapies are patients recovering from orthopedic surgeries or injuries to various areas of the anatomy, particularly legs, knee and shoulder joints. Cooling therapy, heating therapy, and compression therapy can also be combined with a motion therapy in which a patient&#39;s joint is carefully and slowly moved through its natural motion so as to maintain flexibility in the joint. The above-described therapies have proven useful in, for example, speeding recovery and avoiding deleterious impacts of deep vein thrombosis. 
     Nevertheless, existing systems and methods continue to suffer from various shortcomings and are in need of improvement. One such shortcoming relates to the high cost associated with the core portion of the thermal compression therapy apparatus. The core portion, that portion of the apparatus that is wrapped around an area of the patient&#39;s body (e.g., a knee joint) is generally an expensive item. It comprises various tubings and channels that distribute the fluids through the core, so that they will surround the area to be treated. However, the core necessarily comes into contact with the patient. Thus, the core can easily become contaminated with blood and other discharges and fluids emitted by the recovering patient. Also, good hygiene practices also call for the sterilization of each core after a treatment if the core is to be reused. However, given the somewhat delicate nature of the materials and structures contained within the core, a sterilization process is not effective. Given the cost of the core, throwing each core away after a single use is an expensive option. Thus, a need exists to find a way to easily reuse cores so that a single core can be used multiple times before it needs to be discarded. 
     Further, the core structure itself suffers from various limitations in the present design and is in need of improvement. As previously described, a patient&#39;s joint (e.g., the knee joint) can be gradually flexed during a treatment. This movement of the joint necessarily flexes the core that is wrapped around the joint. During such therapies, there is a tendency within the core to fold and obstruct portions of the core that is repeatedly being bent. The cores can then suffer from malfunction or poor performance (even distribution of fluids) as various tubings are obstructed. There exists a need to overcome this shortcoming in current core designs. 
     An additional need for improvement relates to the heating and cooling therapy applied to the patient. In current methods, there is no direct way to determine the skin temperature of the patient in that area where the patient is receiving therapy. The skin is typically covered by the core. However, that is an important item of data to assure that the patient&#39;s body is not being overheated (burned) or overly chilled (frost bitten). Elderly patients or patients with severe trauma may suffer from an inability to sense temperature extremes; thus it falls upon the attending technician, nurse, or other professional to maintain a proper temperature. While the temperature exiting from the control machine can sometimes be programmed there is needed a way to confirm that the temperature at the patient also corresponds to that temperature. Hence, it would be desired to provide a core that enables a quick, easy, and reliable detection and confirmation of the patient&#39;s skin temperature where covered by the core. 
     SUMMARY 
     The present disclosure relates to a method, apparatus and system for compression and thermal therapy that addresses, among other things, the aforementioned deficiencies in prior systems. A method, apparatus and system for sequential gradient compression and thermal therapy is presented. According to various embodiments, the method, system and/or apparatus described herein provides for multiple uses and an improved function, both with relation to fluid distribution and with respect to temperature detection. Further, the thermal compression therapy described herein may be adapted for use with present controllers and pneumatic devices. An improved therapy core configured to provide robust and strong performance, while at the same time, providing cost advantages over presently known systems and methods is described herein. 
     According to various embodiments, a combined heating, cooling, and sequential calibrated gradient and/or targeted compression therapy system is provided. The system may be configured for automated use with a controller. The therapy system may also be particularly designed for easy use with multiple patients. The therapy system comprises a reusable core through which a separate sequential gradient compression apparatus and a heating/cooling apparatus are positioned. The core may be placed in a disposable outer cover. The disposable cover is typically the outer portion of the system that would come into contact with a patient&#39;s body. Thus, the outer cover can comprise an impermeable layer such that blood and other bodily fluids cannot pass through the cover and contact the core. In various embodiments, the outer cover comprises an opening such that the core can be easily passed through the opening and into an interior volume of the cover, and the interior volume of the cover is designed to closely hold the core in a desired position. The outer cover, which comes into contact with the patient, can comprise a temperature nodule attached to a surface for monitoring the temperature of the patient&#39;s skin. At any suitable time, such as in response to a treatment session being completed, the core can be removed (and later reused), and the outer cover may be disposed. 
     According to various embodiments, an improved therapeutic system for providing a combination of compression therapy and cold and heat therapy is disclosed. The system comprises a core having a plurality of separate channels for providing cold and heat and compression therapy; a cover for receiving the core; and a skin sensitive temperature node attached to the core cover. The therapy system can further be configured such that the cover defines an interior volume and an exterior region. The cover comprises an opening such that the core can be positioned within the interior volume of the cover by passing through the opening. Further, the cover can comprise a closure system, such as hook and loop attachment system (Velcro® type fastener) disposed proximate to the opening and configured to permit the opening to be opened and closed. According to various embodiments, the temperature node measures skin temperature as by way of a thermometer or thermocouple. In various embodiments, a thermometer having a visual indicator such as a color coded thermometer is used. 
     Other independent features and advantages of the gradient thermal compression therapy apparatus and system will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of described herein. 
    
    
     
       DETAILED DESCRIPTION OF THE FIGURES 
       With reference to the following description, appended claims, and accompanying drawings, below is a summary of the drawing figures, wherein like numerals denote like elements and wherein: 
         FIG. 1  is overhead plan view of a gradient thermal compression therapy unit adapted for use with a patient&#39;s appendage, showing a cover and a core configured for receipt by the cover in accordance with various embodiments; 
         FIG. 2  is an overhead plan view of the cover of  FIG. 1 , illustrating a closing means in accordance with various embodiments; 
         FIG. 3  is an overhead plan view of the cover of  FIG. 1 , illustrating straps and receiving areas in accordance with various embodiments; 
         FIG. 4  is a front perspective view of a control unit in accordance with various embodiments; 
         FIG. 5  is a rear perspective view of the control unit of  FIG. 4  in accordance with various embodiments; 
         FIG. 6  is a partial cut away side perspective view of the control unit of  FIG. 4 , illustrating a reservoir and a power supply, in accordance with various embodiments; 
         FIG. 7  is a side perspective view of a gradient thermal compression therapy system in use on a patient&#39;s thigh, in accordance with various embodiments; 
         FIG. 8  is a diagrammatical view of the a gradient thermal compression therapy system, illustrating various types of thermal compression units, in accordance with various embodiments; 
         FIG. 9  is a side perspective view of a gradient thermal compression therapy system in use on a leg of a patient, in accordance with various embodiments; and 
         FIG. 10  is a side perspective view of a gradient thermal compression therapy system depicted on a leg of a patient, in accordance with various embodiments. 
     
    
    
     DETAILED DESCRIPTION 
     The detailed description of exemplary embodiments herein makes reference to the accompanying drawings, which show exemplary embodiments by way of illustration and their best mode. While these exemplary embodiments are described in sufficient detail to enable those skilled in the art to practice the inventions, it should be understood that other embodiments may be realized and that logical, chemical and mechanical changes may be made without departing from the spirit and scope of the inventions. Thus, the detailed description herein is presented for purposes of illustration only and not of limitation. 
     For example, the steps recited in any of the method or process descriptions may be executed in any order and are not necessarily limited to the order presented. Furthermore, any reference to singular includes plural embodiments, and any reference to more than one component or step may include a singular embodiment or step. Thus, for example, reference to “a core” can include two or more such cores unless the context indicates otherwise. Also, any reference to attached, fixed, connected or the like may include permanent, removable, temporary, partial, full and/or any other possible attachment option. Additionally, any reference to without contact (or similar phrases) may also include reduced contact or minimal contact. 
     Ranges can be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. 
     Referring now to  FIG. 1 , in accordance with various embodiments, a combined sequential gradient thermal compression therapy unit  100  or system is presented. The gradient thermal compression unit  100  comprises a core  110  and cover  120 . While the core  110  and cover  120  are shown in an exploded arrangement in  FIG. 1 , in usage, the core  110  can be assembled with the cover  120  as explained further herein. The core  110  comprises at least one first channel  130  and at least one second channel  140 . The channels  130 ,  140  can be connected by tubing  150 . Generally, the cover  120  defines an interior volume  160  for receiving the core  110  and an exterior region  122 . In various embodiments, the exterior region  122  of the cover  120  comprises an impermeable surface which is generally the surface of the cover  120  that comes into contact with a patient. 
     As would be understood by a person skilled in the art, liquid tubing  150  and gas (or air) tubing  150  can be connected to a supply machine or control unit  200  that supplies fluid such as a liquid and/or gas materials to the core  110  via the tubing  150 . A In the case of liquid tubing  150 , a fluid can be heated or chilled to a desired temperature. In various embodiments, the fluid comprises distilled water, and can also comprise distilled water and alcohol. This fluid is then directed through liquid tubing  150  (typically having both an inlet  350  and an outlet  355  tubing  150 ) so as to circulate the fluid through the channels  130 ,  140  and thereby to provide heating or chilling therapy to a patient. The channels  130 ,  140  may comprise a series of baffles or other flow directing structures to distribute the fluid to the desired zones or sections of the core  110 . In various embodiments, a wide distribution of fluid is provided to avoid significant temperature gradients between one section and area of the core  110  to another. In addition, gas tubing  150  can receive a gas fluid (such as air) also directed from the supply machine or control unit  200 . A separate network of channels  130  may distribute gas through the core  110 . The pressure of the gas can be controlled and varied so as to provide a rhythmic pulsing of pressure around the patient&#39;s body  310  where the core  110  is positioned. Thus, for example, in the treatment of a knee, the rhythmic cycling of gas pressure increases and decreases the air pressure in the core  110  around the knee to assist with circulation among other desired benefits. Thus, it will be appreciated that the gas network of channels  130  can be separate from the liquid network of channels  130  in the core  110  so that each material provides its function; the liquid provides temperature therapy and the gas provides a pressure/compression % lymphedema treatment and/or therapy. In concert with this treatment, the patient&#39;s body  310 , such as a knee, can also be receiving a motion therapy, such as rhythmically straightening and flexing the knee joint. Thus, thermal compression units may be configured so as not to interfere with any possible flexion therapy. Additionally, while the embodiments described above include providing pressure using compressed gas, it is also contemplated that other substances and/or techniques may be used to provide the desired compression. 
     In accordance with various embodiments and with continued reference to  FIG. 1 , a core  110  configured to provide sequential gradient pressure is provided. In this way, the core  110  may comprise additional chambers/zones  405 ,  410 ,  415 ,  420  which may be individually pressure controlled. Thus, zones  405 ,  410 ,  415 ,  420  may be pressure sealed relative to each other. In accordance with various embodiments, liquid for thermal treatment may travel from zone to zone as those chambers are separate from the liquid delivery chamber. Each zone  405 ,  410 ,  415 ,  420  may comprise its own fluid and/or air input (and associated liquid output) such that the thermal properties and compression/pressure of each zone may be individually controlled by control unit  200 . 
     Core  110  may comprise any number of chambers/zones. For instance, 4 zones may be desirable. In other applications, such as for a larger extremity, 8 zones may be desirable. Contiguous zones may physically overlap to reduce the likelihood of localized fluid retention and/or tissue swelling at zone connection locations. Thus, the overlapping zones may form and/or approximate a multi-chambered pneumatic sleeve with overlapping cells to gently move fluid and simulate the natural movement of the body. The pressure in each zone may be individually controlled by the control unit  200 . The pressure in each zone may be controlled by the control unit  200  relative to the pressure of the other zones of core  110 . For example, the pressure in the core  110  may increase progressing distal to proximate the patient&#39;s core. Stated another way, for example in a gradient thermal compression therapy unit  100  applied to the leg of a patient, at a given time the pressure applied at the foot/ankle of the pressure may be greater than the pressure applied to the thigh. This may encourage fluid to travel to the trunk of the patient for processing and expelling. This may also reduce undesirable pooling of fluid. 
     This sequential gradient pressure may be applied in concert with thermal therapy and/or additional compression therapy such as the deep vein thrombosis (DVT) treatments/therapy described herein. For instance, zones may be combined to provide targeted compression as desired. For example, targeted compression may be used with one or more DVT compression devices  101 ,  102 . In various embodiments, the functionality of DVT compression devices  101 ,  102  may be built into the single core  110 . In this way, for instance, compression may be delivered to a first portion of an extremity of a patient via a first zone  420 , such as a foot, and in compression not being delivered to a first portion of an extremity of a patient such as a foot compression may be delivered to a second portion of an extremity of a patient such as a thigh via a second zone  405 . In this way, the first and second zones of the gradient thermal compression unit  100  may not be contiguous. Stated another way, there may be other zones, such as a third zone  415 , of the gradient thermal compression unit  100  between the first zone  420  and second zone  405 . The control unit  200  may adapted to automatically cycle through the following scheme: provide a pulse of compressed gas to a first zone  420  of the thermal therapy pad to achieve first desired pressure, provide a pulse of compressed gas to a third zone  415  of the thermal therapy pad to achieve second desired pressure; and provide a pulse of compressed gas to a second zone  405  of the thermal therapy pad to achieve third desired pressure. This cycle may imitate the natural flow of lymph from the distal end of a patient limb toward a trunk the patient. As used herein, a pulse may include one or more pulses. Moreover, a pulse may include any method or device for providing compressed gas to a zone. 
     Also, according to various embodiments, zones may be combined to produce regions of compression. For example, a first and second zone may be combined to produce a first pressure region, then according to programming and/or a timing scheme, a second zone and third zone may be combined to produce a second pressure region. These pressure regions may travel up and/or down the device  100 , such as distally to proximate in the direction of the trunk of the patient. 
     In accordance with various embodiments and with brief reference to  FIGS. 7 , and  9 , each zone  405 ,  410 ,  415 ,  420  may be fed directly by an individual fluid tube  407 ,  412 ,  418 ,  422  coupled to control unit  200 . Thus, the control unit  200  in communication with the processor may control the pressure in each zone  405 ,  410 ,  415 ,  420 . 
     In accordance with various embodiments and with renewed reference to  FIG. 1 , a single fluid delivery tube, such as tubing  150  coupled to a compressed air supply may deliver air to core  110 . This compressed air may then be delivered to each zone  405 ,  410 ,  415 ,  420  via internal/external valves  430 ,  435 ,  440 ,  445  and/or hoses/channels coupled to each zone. For instance, dashed paths  450 ,  455 ,  460  depict exemplary paths of these channels. These valves may be pressure sensitive such that they open in response to a threshold of pressure being met. It is contemplated that valves located on or proximate to core  110  and/or zones  405 ,  410 ,  415 ,  420  may be in communication with control unit  200  for selective air delivery and removal such as via a single air hose  150 . 
     In accordance with various embodiments and with reference to  FIG. 1 , a single fluid delivery tube, such as tubing  150  coupled to a compressed air supply may deliver air to core  110 . This compressed air may then be delivered to each zone  405 ,  410 ,  415 ,  420  via internal/external valves and/or an internal hose  150  of decreasing or increasing bore diameter. This diameter may restrict or increase the flow of air into each zone  405 ,  410 ,  415 ,  420 . 
     According to various embodiments, the gradient thermal compression therapy unit  100  may be an E0652 device and/or compatible with an E0652 device. 
     Referring now to  FIGS. 1 ,  2 , and  3 , in accordance with various embodiments of the gradient thermal compression unit  100 , the apparatus comprises a temperature module  170 . In this embodiment, the temperature module  170  is a temperature sensitive structure and/or device. Temperature module  170  can, for example, may comprise a thermometer, a thermocouple connected to a read out (typically positioned on the control unit  200 ), and/or a visual color-coded read out attached to a temperature sensitive structure. In various embodiments, the temperature module  170  comprises both a temperature sensitive section and a display section wherein the display provides a user readable indication enabling an attending technician or professional to quickly and easily determine temperature. 
     In accordance with various embodiments, the temperature module  170  may be disposed on and/or coupled to the gradient thermal compression unit  100  such that a temperature-sensitive portion of the temperature module  170  is positioned proximate to the skin of a patient when the gradient thermal compression unit  100  is disposed on the patient for therapy. Thus, in various embodiments, the temperature-sensitive portion of temperature module  170  can also be positioned on the exterior surface of the cover  120  that is designed to be in contact with the patient&#39;s skin. However, as can be appreciated, a read-out section can be placed on exterior surface of the cover  120  because it is typically the surface that is visible for observation by an attendant. In various embodiments, temperature module  170  read-out section may be disposed on and/or coupled to the exterior of the core  110  and viewable via at least partially transparent window/covering of cover  120 . Wires or leads or wireless communication devices may be used to connect any portion of the temperature module  170  to other devices or support structures such as a power source, a digital read out, control systems, memories, programming, alarm systems etc. The temperature of liquid deliver to the gradient thermal compression unit  100  may be automatically adjusted in response to a measurement temperature module  170 . For instance, the temperature of liquid being deliver to the core  110  may be increased and/or decreased in response to a threshold being met or exceeded. This may continue until a measured temperature returns to acceptable levels. The present system  100  may be coupled to a telemedicine system for monitoring of a patient by a remote practitioner. The control system  200  may also be coupled to a telemedicine system for remote monitoring and/or adjusting by a remote practitioner. According to various embodiments, the system  100  can record the temperature of the patient&#39;s skin at various intervals. 
     One advantage of an apparatus having a temperature module  170  relates to the temperature module  170  providing an accurate temperature reading on the patient&#39;s skin that generally lies under the cover  120  and overall apparatus. If a temperature in a heat therapy rises too high, there is a danger of burning the patient. Conversely, if the temperature falls too low, there is a danger of frostbite. Even when these two extremes do not occur, it is desirable to determine what the temperature of the patient&#39;s skin is as opposed to just the temperature of the fluids within the core  110  as it is the actual skin temperature that is important in judging the effectiveness of a therapy. 
     Referring again to the Figures and with reference to  FIG. 1 , in accordance with various embodiments, the gradient thermal compression unit  100  may comprise a tubing cover section  124 . The tubing-cover section  124  can be a unitary portion of the cover  120 , for example and not meant to be limiting. A portion of the cover  120  can be designed to extend from the main body of the cover  120  to provide protection to the liquid tubing  150  and/or the gas tubing  150 . In operation, when the core  110  is disposed within the interior volume  160  of the cover  120 , the liquid tubing  150  and/or gas tubing  150  can extend from the interior volume  160  through one or more aperture within the cover  120  that is designed to allow the tubings  150  to extend to the exterior region  122  of the cover  120 . In this way, the liquid tubing  150  and/or gas tubing  150  can make connections with supply tubings  150  that originate in the control unit  200 . The tubing-cover section  124  of the cover  120  can provide an extension of material that covers and protects and/or shroud the tubings  150  from damage or contact with skin surfaces. In various embodiments, the tubing-cover section  124  of the cover  120  can comprise padding or protective material to cushion and protect the liquid tubing  150 , the gas tubing  150 , and/or other connecting tubings  150 . 
     It is noted that the gradient thermal compression unit  100  can take any desired shape to conform to specified portions of the patient&#39;s anatomy. According to various embodiments, as can be seen in the figures, the illustrated shape has proven useful for treatment of the human thigh, see  FIG. 7 . In usage, the upper section  116  can wrap around an area generally proximate the core  110  of the body  310  while the lower section  114  can be applied to an area generally distal the core  110  of the body  310 . As can be appreciated, the gradient thermal compression unit  100  can be shaped to contour almost any extremity, including, but not limited to feet, ankles, legs, arms, calf, thigh, forearm, upper arm, shoulder, hands, wrists, and the like. The gradient thermal compression unit  100  can also be configured to affix to the extremity in such a way as to permit contraction and flexion or it can be configured to restrict movement altogether. 
     In various embodiments, and with reference to  FIG. 8 , a diagrammatical view of the gradient thermal compression therapy system  100 , illustrating various types of thermal compression units in accordance with an exemplary embodiment is depicted. Compression units  101 ,  102  may be integral to the gradient thermal compression therapy system  100  or they may be stand-alone separate elements. Compression units  101 ,  102  may be worn in addition to the core  110 . 
     In various embodiments, and with reference to  FIG. 9 , a full leg the gradient thermal compression unit  100  embodiment is depicted. As previously states, there may be any number of zones; however,  FIG. 9  depicts 5 zones  406 ,  411 ,  416 ,  421 ,  426 . Each zone may be individually pressure controlled by individual fluid delivery hoses  407 ,  412 ,  418 ,  422 , and  428 . These may deliver compressed air to zones  406 ,  411 ,  416 ,  421 ,  426  respectively. There may also be hoses  150  for delivering and receiving fluid to the entire gradient thermal compression unit  100 . For instance, to deliver and receive thermally conditioned liquid. In this embodiment, the gradient thermal compression unit  100  may imitate the natural flow of lymph from the distal end of a patient limb toward a trunk the patient via a sequential contiguous zone increase of pressure in each zone. Additionally, the control unit  200  may instruct two noncontiguous zones such as Zone  426  and zone  411  and/or  406  to apply DVT therapy as disclosed herein. In this way, zone  411  may be configured to act in the manner of DVT compression device  101  described herein. 
     In various embodiments, and with reference to  FIG. 10 , an alternative control unit  200  is depicted configured for sequential gradient compression and thermal therapy. This embodiment depicts additional zones as compared with the embodiment of  FIG. 9 . 
     In various embodiments the gradient thermal compression unit  100  comprises a bridge support  180  as a separate structure or comprised in either the core  110  or the cover  120 . The bridge support  180  is generally positioned proximate to the area of a middle section of the core  110 . As can be appreciate, folding of the core  110  can cause pinching of the channels  130 ,  140 , which, in turn, may cause the flow of gas or fluid to be impeded. Thus, the presence of a bridge support  180  can prevent this from occurring. Additionally, the repetitive flexing of the patient&#39;s joint can tend to induce a fold in the flexible plastic material of the channels  130 ,  140  this fold or bend can then lead to obstruction within the channels  130 ,  140  just as might happen when a drinking straw is folded in half. The bridge support  180  provides a flexible but firm reinforcing material that helps prevent and/or reduce the likelihood of channels  130 ,  140  from being pinched or closed. Bridge support  180  tends to inhibit an obstructing fold from forming in channels  130 ,  140  by providing a supportive structure. 
     Referring again to  FIGS. 1 ,  2 , and  3  the cover  120  is described in further detail. In various embodiments, the cover  120  is constructed of a low cost material such that cover  120  can be used as a replaceable, one time use item. The cover  120  is generally configured to closely receive the core  110 . Thus, the cover  120  can be a shield against contamination of the core  110  by blood or other human discharge. The cover  120  may comprise an impermeable surface, for example, that can be constructed of a material that prevents this kind of contamination of the core  110 . However, the cover  120  allows the function of the core  110  to continue unimpeded by easily transmitting heating, cooling, and pressure. Thus, after a usage has taken place, the technician or nurse can throw away the cover  120  and then reuse the core  110  in a subsequent treatment. 
     With reference to  FIG. 3  according to various embodiments, the cover  120  is shown having fastening straps  190  and receiving areas  192  attached to both the upper section  116  and the lower section  114 . In various embodiments, the fastening straps  190  and receiving areas  192  can comprise a reciprocal hook and loop attachment means (e.g., VELCRO® fabric). Thus, the cover  120  can be wrapped around a portion of the patient&#39;s body  310 , and then the fastening straps  190  and receiving areas  192  can be brought into contact. In this manner the cover  120  can be securely attached to the patient. The cover  120  can also be secured in this manner when the core  110  is disposed within the cover  120 . The cover  120  and/or core  110  may also be securably wrapped around an appendage of the patient and secured by a zipper closure. 
     As has been previously mentioned, the core  110  can be assembled with the cover  120  by passing the core  110  through the opening  126  of the cover  120  and into the interior volume  160  of the cover  120 . The opening  126  can comprise a closure means  128  for securing the opening  126  in a closed position to securely hold the core  110  within interior volume  160 . In various embodiments, the closure means  128  comprises a hook and loop reciprocal attachment fabric such as VELCRO® fabric; however, other embodiments may use other known kinds of fasteners such as zippers, buttons, clips and the like. 
     In various embodiments, a control unit  200  is presented that is adapted to provide the thermally controlled fluid and compressed gas for multiple therapeutic modalities. The control unit  200  for providing these selective features can be enclosed within a single chassis design capable of providing the described modalities. In various embodiments, the control unit  200  may comprise a separate temperature control unit  200  and a pressure control unit  200 , or it can comprise a single control unit  200  housing both modalities. This selective versatility provides financial and manufacturing incentives in that the simple design selectively can provide an industrial, medical, or electro-optic version that produces only thermally controlled liquid, such as co-liquid for cooling industrial equipment, in a configuration adaptable for other applications. 
     In accordance with various embodiments, thermal therapy can be afforded to a patient to reduce swelling and edema while, in conjunction with the DVT prophylaxis, preventing blood from pooling in lower body  310  extremities. In accordance with various embodiments thermal therapy can be afforded to a patient to reduce swelling and edema while, in conjunction with the DVT prophylaxis, preventing blood from pooling in lower body  310  extremities. This is particularly important after surgery when anesthesia has been involved. It is well known that anesthetics often tend to reduce the wall strength of veins and, if not otherwise treated, appropriate venous pumping cannot be afforded allowing for blood pooling in clots. 
     In accordance with various embodiments, the control unit  200  can be provided for thermal and compression therapy. The control unit  200  can be adapted to be coupled to thermal and compression elements to be applied to a patient. In this embodiments, the control unit  200  can comprise a filter  210  for filtering the compressed gas. In various embodiments, the filter  210  may be removable. In various embodiments, the filter  210  can comprise a gas-filtering substance, such as woven netting, that can be attached by VELCRO fasteners or the like outwardly of a perforated metal grate to allow for the low-pressure drawing of gas there through. This would allow cooling of components inside the control unit  200 . In various embodiments, the control unit  200  can comprise one or more fans to force gas across one or more heat transfer assemblies (HTA). 
     In accordance with various embodiments, a HTA can be disposed beneath a fluid reservoir  230 . The reservoir  230  can be configured to store liquid to be pumped into the first channel  130  via a fluid connector. In various embodiments, the fluid connector can be configured to be coupled to one or more cores  110 . As can be appreciated, in various embodiments, a dual-fan arrangement can be used. The fans can, for instance, be positioned to push and/or pull gas into the interior of the control unit  200  to distribution about the electronic components so that the gas flow is both quiet and at a rate allowing initial electronic cooling and then being available to be pushed into sections of the control unit  200  where most heat dissipation is needed. 
     In accordance with various embodiments, a power supply  220  can be disposed internally within the control unit  200 , or it can be external thereto. In various embodiments, the power supply  220  can be a 500 Watt power supply  220 . In various embodiments, additional power supplies  220  can also be used to power various components. For example, in addition to a 500 Watt power supply  220 , a 65 Watt power supply  220  can be used for components requiring less power. In various embodiments, the power supplies  220  are adapted to receive a plurality of inputs so the control unit  200  can be used in a plurality of countries without requiring substantial reconfiguration. 
     A fluid pump, for example, can also be comprised within and/or coupled to the control unit  200  for collecting fluid from a reservoir  230  that has been thermally controlled by the HTA. Thermal electric cooing devices (TEC) can also be used. In various embodiments, the TECs a positioned between a heat sink and a thermal transfer plate in a manner to provide the requisite thermal control of the fluid within the reservoir  230 . 
     In accordance with various embodiments, the control unit  200  for providing these selective features can be enclosed within a single chassis design capable of providing the described modalities. This selective versatility provides financial and manufacturing incentives in that the simple design selectively can provide an industrial, medical, or electro-optic version that produces only thermally controlled liquid, such as co-liquid for cooling industrial equipment, in a configuration adaptable for other applications. In various embodiments, the size of the reservoir  230  has been reduced relative to a number of earlier models of thermoelectric cooler (TEC) systems such that only around 175 Watts can be needed compared to 205 Watts for typical earlier systems. As such, the control unit  200  can be configurable with TEC assemblies maximizing efficiency. With regard to a medical modality, thermal therapy can be afforded to a patient to reduce swelling and edema while, in conjunction with the DVT prophylaxis, preventing blood from pooling in lower body  310  extremities. This is particularly important after surgery when anesthesia has been involved. It is well known that anesthetics often tend to reduce the wall strength of veins and, if not otherwise treated, appropriate venous pumping may not be afforded allowing for blood pooling in clots. 
     In accordance with various embodiments, a plurality of gas connectors and fluid connectors can be used to provide thermally conditioned heat-transfer fluid to a plurality of gradient thermal therapy units  100  and to provide pressurized gas to a plurality of compression therapy devices and DVT compression devices  101 ,  102 . In various embodiments, fluid connectors are provided in to facilitate circulation of fluid in a closed loop in an outward bound and an inward bound flow of fluid to and from the fluid reservoir  230  for thermal control. In various embodiments, a single compression therapy device can be coupled to a plurality of gas connectors and the control unit  200  can be programmed accordingly to provide compressed gas in a sequenced manner to a plurality of cores  110  in the compression therapy device. For example, a first core  110  can be inflated, followed by the inflation of a second core  110 , which is then followed by the inflation of a third core  110 , and so on. The first core  110  can be deflated before or after the second core  112  is inflated, or the first core  110  can remain inflated until all the cores  110  are inflated. 
     In accordance with various embodiments, the system  100  comprises a coupler  300  configured to selectively connect the first channel  130  to the liquid source and the second channel  140  to the compressed gas source. In various embodiments, the coupler  300  comprises a body defining a first interior pathway  320  and a second interior pathway  330 . Each pathway has an inlet  350  and an outlet  355 . The inlet  350  for the first interior pathway  320  can be configured to selectively couple with the first channel  130 , the outlet  355  of the first interior pathway  320  can be configured to selectively couple with the liquid source, the inlet  360  of the second interior pathway  330  can be configured to selectively couple with the second channel  140 , and the outlet  365  of the second interior pathway  330  can be configured to selectively couple with the compressed gas source. 
     In accordance with various embodiments, the body of the coupler  300  further defines a third interior pathway  340  having an inlet  370  and an outlet  375 . In various embodiments, the inlet  350  of the first interior pathway  320  can be configured to selectively couple with a first port  132  of the first channel  130  and the inlet  370  of the third interior pathway  330  can be configured to selectively couple with a second port  134  of the first channel  130 . Additionally, the outlet  375  of the third interior pathway  340  can be configured to selectively couple with the liquid source. 
     As one skilled in the art will appreciate, some or all of the inlets can comprise a male or female quick disconnect coupling. Likewise, the respective outlets can comprise a complimentary quick disconnect coupling. In one exemplary embodiment, the inlets for the first interior pathway  320  and the third interior pathway  330  comprise a female quick disconnect coupling, and the outlets for the first interior pathway  320  comprise a male quick disconnect coupling. Similarly, inlet  350  for the second interior pathway  330  comprises a male quick disconnect coupling, and the outlet  355  for the second interior pathway  330  comprises a female quick disconnect coupling. 
     In accordance with various embodiments, the cores  110  are pressurized in accordance with the medical modality described herein and the parameters are set by the programming within the control boards of the control unit  200 . Additionally, an RS232 connector for data communication with the control unit  200  may be provided. Other connections can be used such as, for example, a USB connection, or a wireless connection. 
     In accordance with various embodiments, the control unit  200  can be used to initiate and control different sequencing patterns, times, and pressures, depending on the type of treatment desired. In various embodiments a plurality of parameters may be specified by a user, such as, for example, the inflated pressure, the deflated pressure, the rate of inflation, the inflation-hold time, and the cycle time. For example, in one treatment modality, the control unit  200  can provide compressed gas to inflate a DVT compression device  100 ,  101 ,  102  for 3-20 seconds when the DVT compression device  100  is disposed on a calf. Thus, the control unit  200  can be configured to provide a series of timed pulses of compressed gas. The time period of the pulse can be more or less depending on the part of the body  310  being treated. For example, a pulse width of around 0.3 seconds can be desirable for a foot. Similarly, the inflation times may vary depending on whether DVT compression devices ( 101 ,  102 ) located on both right and left extremities are being inflated simultaneously or whether the inflation is being alternated between the devices  101 ,  102 . For example, an inflation period of 18 seconds may be desirable for simultaneous inflation whereas an inflation period of 8 seconds may be desirable when the inflation is being alternated. Similarly, when DVT compression devices  101 ,  102  are disposed around a patient&#39;s right and left feet, in some situations it may be desirable to have a wide pulse width on the order of 9 seconds whereas in other situations it may be desirable to have a narrow pulse width on the order of 0.3 seconds. In addition, it may be desirable to vary the cycle times in between DVT pulses. For example, a cycle time of 20 seconds in between DVT pulses may be desirable. Similarly, it may be desirable to completely deflate the DVT compression devices  100 ,  101 ,  102  in between inflations while in other embodiments; it may be desirable to keep the DVT compression devices  100 ,  101 ,  102  partially inflated. As can be seen from the above examples, it would be desirable to have a programmable control unit  200  that can be adapted to provide DVT compression at user-specified parameters. 
     In accordance with various embodiments, a method for providing a combined DVT and compression therapy to a patient is disclosed. The method comprises the steps of providing a control unit  200  configured to condition heat transfer fluid and to selectively provide a compressed gas; providing a thermal compression device that is mountable to a select portion of the patient; and programming the control unit  200  to supply heat transfer fluid to the gradient thermal compression unit  100  within a first predetermined temperature range and to supply compressed gas to the thermal compression device within a first predetermined pressure range. In various embodiments, the gradient thermal compression unit  100  is in operative communication with the control unit  200 . 
     As described in the various treatment modalities herein, the control unit  200  can be programmed to supply the heat transfer fluid and the compressed gas to the gradient thermal compression unit  100  in various manners. In fact, the control unit  200  can supply more than one gradient thermal compression unit  100 . In various embodiments, the heat transfer fluid and the compressed gas are supplied to the gradient thermal compression unit  100  sequentially. In various embodiments, the sequential supply of the heat transfer fluid and the compressed gas is repeated for a predetermined number of treatment applications. In various embodiments, the supply of the heat transfer fluid at least partially overlaps in time sequence with the supply of the compressed gas. As need for the therapy regimen, the heat transfer fluid and the compressed gas can also be supplied to the gradient thermal compression unit  100  substantially simultaneously. The gradient thermal compression unit  100  can be adapted to the patient in multiple modalities regulated by the control unit  200 . 
     As described herein, the control unit  200  can provide thermal conditioning of the heat transfer fluid to both cool and heat the thermal transfer fluid, depending on the therapy desired. In various embodiments, the heat transfer fluid is conditioned to a temperature of between about 37° F. and about 105° F. In a similar manner, the control unit  200  can provide compressed gas at pressures necessary for the particular therapy desired. In various embodiments, the control unit  200  can provide compressed gas to the gradient thermal compression unit  100  at a pressure at or below about 120 mm Hg. In various other exemplary embodiments, the control unit  200  can provide compressed gas at pressure at or below 100 mm Hg, at or below 80 mm Hg, at or below 60 mm Hg, at or below 40 mm Hg, or at or below 35 mm Hg. In various embodiments, the control unit  200  can provide compressed gas at a pressure of about 25 mm Hg. 
     In accordance with various embodiments, the control unit  200  can be programmed to instruct the gradient thermal compression unit  100  to movement of the pressure in the zones to stimulate the flow of the excess lymph out of the affected limb as if were flowing following the movements of the muscles. In response to the lymphatic system being prepared, such as by simple lymph drainage, self-massage and/or automated massage via aspects of gradient thermal compression unit  100  such as compression and pressure, this fluid will flow into the lymphatic vessels and eventually be returned to the bloodstream. The controller  200  may be configured according to a treatment plan. For instance, gradient thermal compression unit  100  may be configured to perform light massage to intense therapy with levels of granularity in between as desired. Not all zones may be utilized during a treatment session if desired. 
     In accordance with various embodiments, gradient thermal compression unit  100  may be configured for unilateral and/or bilateral use. The cycle times may be any suitable sequential gradient cycle time, such as about a 10 second, 15 second, 20 second, 25 second, time zone inflate time and about a 10 second, 5 second, 3 second zone deflate time. The pressure range of the gradient thermal compression unit  100  may be any suitable therapy range. For instance, it may be between about 0-120 mmHg. 
     In accordance with various embodiments, the control unit  200  can be programmed to supply the heat transfer fluid to the gradient thermal compression unit  100  for a predetermined heating time, depending upon the therapy desired. In various embodiments, the predetermined heating time is between about 5 minutes and about 25 minutes. In various embodiments, the control unit  200  can be programmed to supply the compressed gas to the gradient thermal compression unit  100  for a predetermined compression time. As can be appreciated, the method can also comprise varying the temperature of heat transfer fluid supplied to the gradient thermal compression unit  100  and/or varying the pressure of compressed gas provided to the gradient thermal compression unit  100 . In various embodiments, the method can comprise supplying compressed gas to the gradient thermal compression unit  100  until it reaches a predetermined pressure and, then, allowing the gradient thermal compression unit  100  to deflate and repeating, as necessary. In various embodiments, the predetermined pressure is 35 mm Hg. 
     In accordance with various embodiments, the method described herein can comprise using the gradient thermal compression unit  100  on one or more body  310  parts of the patient. For example, and not meant to be limiting, the method can comprise using the gradient thermal compression unit  100  on a knee of the patient, a calf of a patient, a foot of a patient, and the like. 
     As described herein, the method can also comprise using a plurality of gradient thermal compression units  100 , as needed and/or desired for therapy. As such, the control unit  200  can be programmed to supply heat transfer fluid to the second gradient thermal compression unit  100  within a second predetermined temperature range and to supply compressed gas to the second thermal compression device within a second predetermined pressure range. In various embodiments, the first predetermined temperature range can be substantially the same as the second predetermined temperature range. In various embodiments, the first predetermined pressure range can be substantially the same as the second predetermined pressure range. As one can appreciate, the pressures and temperatures of the first and second thermal compression devices  100 ,  101 ,  102  can also be varied. 
     In accordance with various embodiments, the gradient thermal compression unit  100  for a DVT and compression therapy system  100  comprises a control unit  200  comprising a processing system  100  as described herein. Specifically, the processing system  100  of the control unit  200  can comprise a memory, configured for storing a software program, a first predetermined temperature range, a first predetermined pressure range, and at least one application protocol, and a processor, coupled to the memory. 
     In accordance with various embodiments, the processor can be configured for executing the software program, selectively directing the supply of a heat transfer fluid at a temperature selected from the first predetermined temperature range, selectively directing the supply of a compressed gas at a pressure selected from the first predetermined pressure range; and selectively directing the supply of the heat transfer fluid and the compressed gas in accordance with an application protocol selected from the at least one application protocol. In various embodiments, the processor can be configured for directing the steps of the methods described herein. 
     In the detailed description herein, references to “various embodiments”, “one embodiment”, “an embodiment”, “in one aspect”, “an example embodiment”, etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. After reading the description, it will be apparent to one skilled in the relevant art(s) how to implement the disclosure in alternative embodiments. 
     Benefits, other advantages, and solutions to problems have been described herein with regard to specific embodiments. However, the benefits, advantages, solutions to problems, and any elements that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as critical, required, or essential features or elements of the inventions. The scope of the inventions is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” Moreover, where a phrase similar to “at least one of A, B, or C” is used in the claims, it is intended that the phrase be interpreted to mean that A alone may be present in an embodiment, B alone may be present in an embodiment, C alone may be present in an embodiment, or that any combination of the elements A, B and C may be present in a single embodiment; for example, A and B, A and C, B and C, or A and B and C. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. As used herein, the term adjacent may mean in close proximity to, but does not necessarily require contact. No claim element herein is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless the element is expressly recited using the phrase “means for.” As used herein, the terms “comprises”, “comprising”, or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.