Patent Document

CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This utility application claims the benefit under Title 35 United States Code §119(e) of U.S. Provisional Patent Application No. 61/276,899, which was filed on Sep. 17, 2009, and which is hereby incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present disclosure relates generally to a method and apparatus for treating patients afflicted with Lymphedema. More particularly, it relates to a multiple chamber sleeve to be positioned on a body extremity to be treated wherein the chambers are sequentially inflated and maintained so until all chambers are inflated and then all the chambers are simultaneously deflated to move edema fluids and stimulate the lymphatic system. 
       BACKGROUND OF THE INVENTION 
       [0003]    Lymphedema, also known as “Lymphoedema” or “lymphatic obstruction”, is an accumulation of lymphatic fluid in the interstitial tissue that causes swelling, most often in the arm(s) and/or leg(s) and occasionally in other parts of the body due to compromised lymphatic system. The lymphatic system collects and filters the interstitial fluid of the body. Primary Lymphedema can develop when lymphatic vessels are missing or impaired. It may be present at birth, develop at the onset of puberty (praecox), or not become apparent for many years into adulthood (tarda). Secondary Lymphedema occurs when lymph vessels are damaged or lymph nodes removed during surgery and/or radiation therapy for cancer treatment. Lymphedema affects both men and women. In women, it is most prevalent in the upper limbs after breast cancer surgery and lymph node dissection, occurring in the arm on the side of the body in which the surgery is performed. It may also occur in the lower limbs or groin after surgery for colon, ovarian or uterine cancer in which removal of lymph nodes is desirable. In men, lower-limb Primary Lymphedema is most common, occurring in one or both legs. Surgery and/or treatment for prostate, colon and testicular cancers may result in Secondary Lymphedema, particularly where lymph nodes have been removed or damaged. 
         [0004]    Lymphedema may also be associated with accidents or certain disease or problems that may inhibit the lymphatic system from functioning properly. In tropical areas, a common cause of Secondary Lymphedema is filariasis, a parasitic infection. Some cases of lower-limb lymphedema have been associated with the use of Tamoxifen, due to the blood clots and deep vein thrombosis (DVT) that can be caused by this medication. Lymphedema differs from edema resulting from venous insufficiency, which is not lymph-edema. However, untreated venous insufficiency can progress into a combined venous/lymphatic disorder which is treated in the same way as lymphedema. 
         [0005]    Lymphedema carries the constant risk of developing an uncontrolled infection in the affected limb(s). When the impairment becomes so great that the lymphatic fluid exceeds the lymphatic transport capacity, an abnormal amount of protein-rich fluid collects in the tissues of the affected area. Left untreated, this stagnant, protein-rich fluid not only causes tissue channels to increase in size and number, but also reduces oxygen availability in the transport system, interferes with wound healing, and provides a culture medium for bacteria that can result in lymphangitis (infection). Symptoms may include severe fatigue, a heavy swollen limb or localized fluid accumulation in other body areas, deformity (“elephantiasis”), discoloration of the skin overlying the lymphedema, recurrent episodes of cellulitis, and in severe cases, skin ulcers and infections. In certain exceptionally-severe cases, prolonged, untreated lymphedema can lead to a form of cancer known as Lymphangiosarcoma. Because the lymphatic fluids are basically stagnant, toxins and pathogens can build up after an injury and overwhelm the local defense system without completely activating an immune response. Lymphedema may also result in psychological distress. The normal, daily-living lifestyle can become severely limited. A treatment for lymphedema is called Complete Decongestive Therapy which may include manual lymphatic drainage, compression therapy, short stretch compression bandaging, therapeutic exercise, and skin care. 
       DESCRIPTION OF RELATED ART 
       [0006]    Manual massage coupled with compression therapy (CT) and/or Interferential therapy (IFT) has been shown to be highly effective in lymphedema treatment. In compression therapy, an elastic sleeve is wrapped around the affected limb and compression to the limb is applied by pneumatically inflating/deflating the sleeve with a pump. Various device combinations configured as a sleeve and pump (called compression pump—CP), currently exist in the marketplace for use in compression therapy. A schematic representation of one such sleeve is shown in  FIG. 1 . The sleeve is divided into multiple chambers (segments). These chambers are inflated/deflated to move the lymphatic fluid from the extremity (hand or foot) of the limb (arm or leg) towards the torso. Some sleeves create uniform pressure in a chamber while others create pressure points depending upon their individual construction. A block diagram of a currently available pump is shown in  FIG. 2   a . When power is applied, an air pump is actuated to provide pressurized air. The pressurized air from the pump goes through a mechanical pressure regulator, which is set to regulate and adjust the pressure of the air to a value that is desired in the sleeve. The regulated pressurized air is directed through a multi-port mechanical valve. An electric motor rotates the mechanical valve and sequentially directs the pressurized air though each port of the valve for a set period of time. Each port of the valve is connected to a tube that directs the air to each chamber of the sleeve. The number of ports in the mechanical valve and thus the number of tubes are same as the number of chambers in a sleeve. The pressure in a chamber is directly proportional to the pressure set by the regulator and the time the valve is opened into a given chamber. After all the connected chambers in a sleeve are inflated, the mechanical valve opens a port that deflates all the connected chambers in a sleeve simultaneously. Then the inflation cycle begins again. 
         [0007]    Another existing device in the marketplace is shown in the block diagram of  FIG. 2   b . In this device, an electronic controller controls an electric motor that rotates a multiport mechanical valve. In this device, a mechanical pressure regulator is eliminated and an electronic pressure sensor monitors the pressure of the air provided by the pump. By adjusting the motor speed and/or the time a valve is kept open, a desired pressure in the chamber can be achieved. The pressure in the chambers is set by a rotary knob with a dial. Another rotary knob with a dial allows setting a time pause between inflation of the individual chambers. Yet still another existing device in the marketplace is shown in the block diagram of  FIG. 2   c . In this device, the electric motor—multiport mechanical rotary valve combination is replaced by a pair of valves—one for inflation and one for deflation for each chamber of the sleeve or a modification thereof. The knobs are replaced by a keypad while the dial is replaced by an LCD display. Examples of prior art methods and devices described above can be found, for example, in U.S. Pat. No. 6,436,064 to Kloecker, U.S. Pat. No. 6,852,089 to Kloecker, U.S. Pat. No. 6,966,884 to Waldridge, U.S. Pat. No. 6,179,796 to Waldridge, U.S. Pat. No. 6,645,165 to Waldridge and U.S. Pat. No. 6,315,745 to Kloecker. 
         [0008]    An inspection of such patents reveals that they have a number of drawbacks and limitations. The inventors of the invention described herein have developed a unique inferential therapy (IFT) which uses multiple electrodes positioned in the sleeve which makes electrical contact with the body extremity when the sleeve is mounted on the extremity. These electrodes are attached to an electronic controller which allows a controlled pulsed faradic current corresponding to about 15-30 millivolts to pass through the limb (body extremity) for a certain period of time. The effect of IFT is to enhance the effectiveness of the lymphedema treatment provided by the compression therapy. Thus, IFT may be applied either alone or in combination with CT. The inventors have also developed a technique for the use of the biological impedance of the extremity under treatment as a measure of the effectiveness of the lymphedema treatment. The biological impedance of the extremity under treatment will change as lymphatic fluid is urged out of the extremity. None of the devices of the prior art offer integrated CT and IFT therapies and the monitoring and use of biological impedance as a treatment parameter. Moreover, regardless of the device(s) used, none of the existing devices have a provision to quantitatively assess the effectiveness of the therapy (CT and/or IFT) and adjustment of CT variables such as pressure in the sleeve chambers, a pause between inflation of adjacent chambers and termination of treatment upon attainment of a preset biological impedance and adjustment of IFT parameters such as pulse amplitude, pulse duration and pulse frequency, among others. The existing devices usually have controls that are used by the patient to set and/or modify the treatment parameters which may be dangerous since patients generally do not have the knowledge to set these parameters correctly. Incorrectly set parameters may either cause damage to the extremity under treatment or result in an ineffective treatment session. Usually no log is kept of the CT and/or IFT parameters, as well as the biological impedance, used in the therapy session and the corresponding quantitative improvement in lymphedema. Therefore, there is no way to determine if the treatment parameters were set correctly. Therefore, the inventors have developed a method and apparatus that overcomes the prior mentioned shortcomings. The apparatus described herein is compact, easy to use and offers greater flexibility and programmability according to the needs of the patient to aid in the successful treatment of lymphedema. 
       SUMMARY OF THE INVENTION 
       [0009]    The present invention is directed to an improved method and apparatus for treating a body extremity of a patient, typically but not limited to an arm or leg, to relieve the swelling and discomfort due to lymphedema and other causes. The apparatus comprises a sleeve with a plurality of individually inflatable chambers sequentially arranged along the length of the sleeve between its proximal end and its distal end. A pneumatic pump supplies regulated pressurized air to inflate the chambers in the sleeve through independently controlled solenoid valves. Uniquely, each chamber is maintained inflated as pressurized air is supplied sequentially to the chambers until the last chamber is inflated. Subsequent to monitoring selected parameters such as biological impedance; the number of inflation cycle repetitions and the total elapsed time, and depending upon their respective value, either all the chambers, with the exception of the initial one, are deflated and the inflation cycle is repeated or the therapy session is terminated wherein all the chambers are deflated. A programmable electronic controller can turn the pump on and off and the valves to be open or closed in a prescribed fashion to execute a preset therapy protocol. Moreover, in those instances where the use of pressure gradients is the therapy of choice, the controller (processor) can command inflating the chambers to different pressures such as monotonically increasing or monotonically decreasing and variations thereof, along the length of the sleeve. In sum, the apparatus is thus capable of performing the following functions: (1) adjustable/automatic gradient sequential compression therapy (CT); (2) interferential therapy (IFT); (3) quantitative assessment of the impact of CT &amp; IFT on the lymphedema condition; (4) evaluating biological impedance and (5) recording/logging the CT and IFT parameters and their correlation to the quantitative change in the lymphedema condition. The apparatus is small and versatile enough to be incorporated into chairs for home or office use and for the airline industry and hospitals. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    Non-limiting and non-exhaustive embodiments are described with reference to the following figures, wherein like reference numerals refer to like parts throughout the various views unless otherwise specified. 
           [0011]      FIG. 1  is a schematic drawing of a sleeve of the prior art; 
           [0012]      FIGS. 2(   a - c ) are block diagrams of lymphedema treatment apparatus of the prior art; 
           [0013]      FIG. 3   a  is a cross-sectional view of an elastic material used for the multi-chamber compression sleeve of the present invention; 
           [0014]      FIG. 3   b  is a cross-sectional view of an embodiment of the multi-chamber compression sleeve of the present invention; 
           [0015]      FIG. 3   c  is a front schematic view of the compression sleeve of  FIG. 3   b;    
           [0016]      FIG. 3   d  is a rear schematic view of the compression sleeve of  FIG. 3   b;    
           [0017]      FIG. 4   a  is front view of an alternate embodiment of the compression sleeve of the present invention; 
           [0018]      FIG. 4   b  is a cross-sectional view of a compression sleeve of the present invention wrapped around an extremity of patient; 
           [0019]      FIGS. 5(   a - b ) are cross-sectional views of air conduits (lumens) of the present invention; 
           [0020]      FIG. 6   a  is an overall block diagram of the lymphedema control system of the present invention; 
           [0021]      FIG. 6   b  is an overall block diagram of the electronic controller of the control system of  FIG. 6   a;    
           [0022]      FIG. 6   c  is a schematic diagram of the pneumatic manifold arrangement of the present invention; 
           [0023]      FIG. 7   a  is a front schematic view of an alternate embodiment of the present invention utilizing a respective EPM in pneumatic communication with each individual compression sleeve chamber; 
           [0024]      FIG. 7   b  is a block diagram of a remote control unit used in conjunction with the present invention; 
           [0025]      FIG. 7   c  is an overall block diagram of an EPM as used in conjunction with an example eight chamber compression sleeve; 
           [0026]      FIGS. 8(   a - e ) is a detailed flow chart describing the functional steps defining the overall operation of the lymphedema control system of the present invention; and 
           [0027]      FIG. 9  is a time pressure graphical representation of the inflation/deflation cycle for the chambers of the compression sleeve. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0028]    Various embodiments are described more fully below with reference to the accompanying drawings, which form a part hereof, and which show specific example embodiments for practicing various embodiments. However, other embodiments may be implemented in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete. 
         [0029]    Referring now to  FIGS. 3   a - 3   c  there is shown an example embodiment of a sleeve  16  adapted and configured for use on an arm of a patient. It is to be understood that although the description refers to an arm, the concepts and inventive attributes of the invention also apply for other body extremities, such as a patient&#39;s leg, except that the “sleeve” would be configured in shape to accommodate the extremity of interest. The sleeve  16  is configured in a multi bladder or chamber arrangement and is formed of a material having an outer layer  1  preferably made of a two ply elastic material comprising an outer ply  2  preferably made of a woven urethane fabric embedded with loops  3  similar to those found in a Velcro type material and an inner ply  4  formed of an elastic and non-gas permeable urethane sheet. The outer ply  2  and inner ply  4  are laminated together while under exposure to heat and pressure. The sleeve  16  also includes an inner layer  5  which is made from an elastic non-gas permeable material such as urethane. The two layers are suitably cut so that they can wrap around the arm when in use. Elastic sheets  6  are positioned within the sleeve  16  to establish a plurality of sealed chambers  9 . The sheets  6  are sealed from edge to edge (shown as  7 ) between the outer and inner layers to create multiple circumferential closed chambers. The two layers are sealed together at the sleeve periphery  8 . This structure creates multiple chambers  9  in the sleeve that are hermetically sealed and can be independently inflated. A suitable fitting  10 , such as barbed end, is also sealed to the outer layer of each chamber so that there is a passage or channel  11  to introduce air into the chamber. Flaps  12  are positioned at the edge of the sleeve  16  and Velcro sheets  13 , with “hooks”, are attached to the inner layer of the flaps. When the sleeve is positioned around the arm in a wraparound fashion, the Velcro hooks on the flaps engage the outer layer which has corresponding Velcro type loops for securing the sleeve  16  on the patients arm. The Velcro type anchoring capability permits one sleeve size to fit snugly around a multitude of different sized arms. The sleeve  16  may also be held in place by adjustable straps or a fastener such as a zipper disposed along the length of the sleeve. The inner layer  5  is configured to come in contact with the patient&#39;s skin when the sleeve  16  is wrapped around the arm and includes electrically conductive electrodes  14  for IFT and biological impedance analysis. The electrodes  14  may be created by silk screening electrically conductive ink (such as Ag or Au) on the surface of the inner layer  5  that comes in contact with the patient&#39;s skin or by attachment of an electrically conductive foil having an adhesive surface that will adhere to the inner layer. A suitable connector  15  in proximity to the flap edge is attached to the outer layer  1  of sleeve  16  to provide for making an electrical connection with the electrodes  14 . 
         [0030]    Regarding certain lymphedema conditions, it may be desirable to create pressure points  17  on the arm with circumferential and longitudinal channels  18  for fluid flow and to allow “breathing” of the patient&#39;s skin  19 .  FIGS. 4   a - 4   b  show a sleeve  22  which is a modification of the sleeve  16  for such purposes. Sleeve  22  includes an elastic sheet  20  (called an electrode flap) which is attached to the upper edge of the sleeve  22  and includes embedded electrodes  14 . The electrode flap  20  is placed on the patient&#39;s arm longitudinally so that the electrodes  14  come into electrical contact with the patient&#39;s skin. An “eggcrate” foam sheet  21  is wrapped around the patient&#39;s arm securing the electrode flap  20  to the arm. Sleeve  22  encases the eggcrate foam sheet  21  and is wrapped around the patient&#39;s arm and then is secured in place. Preferably, eggcrate foam sheet  21  is covered with a suitable cloth to prevent shedding of the foam during sleeve use. 
         [0031]    Multi-lumen tubing  63 , as shown in cross section in  FIGS. 5   a - 5   b , connects the fittings  10  attached to the sleeve  16  and ultimately to the pump  40  ( FIG. 6   c ) for inflation or deflation of the chambers  9 . The multi-lumen tubing cross section may be either circular or planar with hollow spaces or crevices  23  located between the lumens  24 . The electrical wiring  25  that connects the electrodes  14  to the biological impedance analysis and IFT circuitry  38  may be routed through the crevices  23  as an efficient packaging and routing technique. The lumens  24  effectively act as a sheath for the electrical wiring  25  and thereby providing an enhanced safety feature. Moreover, routing the electrical wiring  25  as described provides several other advantages such as protecting the wiring  25  from kinking &amp; nicking during apparatus use and storage because the multi-lumen planar or circular cross-section offers more overall stiffness compared to individual tubes. A further advantage realized is enhanced ease of use since there is no clutter since a single multi-lumen tubing carries both the air and electrical wiring. 
         [0032]    The operation of the sleeves ( 16  and  22 ) is controlled by lymphedema control system (LCS)  28 . An example embodiment of the lymphedema control system  28  is shown in the block diagram of  FIG. 6   a . The LCS  28  comprises two main components (modules), an electronic controller (EC)  26  and pneumatic manifold  27 . An example block diagram of the electronic controller  26  is shown in  FIG. 6   b . A main component of electronic controller (EC)  26  is a processor  29 . The processor  29  may be an ASIC configured to carry out a preselected lymphedema treatment protocol and issue commands to the various components such as for example, to the pump  40  and the valves  43 - 52  in carrying out an inflation/deflation cycle or a general purpose computer programmed to carry out the algorithm shown in  FIGS. 8   a - 8   e . The overall apparatus is powered by a low voltage DC power supply (less than 48V)  30 . This has several advantages such as protecting patient&#39;s safety against electrical shock. The apparatus may also be powered by a battery such as a car or airplane battery or an electrical chair making the apparatus very portable thus giving enhanced mobility to patients. Universal AC to DC converters such as used in laptop computers may also be used thus removing the problem of AC power supply incompatibility in different countries. 
         [0033]    EC  26  has an on-board battery backed real time clock (RTC)  31 , memory  32 , secure digital card (SDC)  33 , an audio processor  34  with a buzzer/speaker, a keypad  35 , a display  36  and wired and wireless communication  37 , biological impedance measurement and IFT circuitry  38  and input/output (I/O) circuitry  39 . RTC  31  keeps track of time as well as the current day and date. RTC  31  is also used to log the frequency, duration and time/day of the lymphedema treatment and to set an alarm to remind the patient that a lymphedema treatment is due. Multiple alarms may be set in a 24 hour period. RTC  31  also provides a reminder for the equipment service schedule times and total use time. The flash memory  32  is used to store patient information (name, ID No., etc), the patient treatment profile/protocol (such as pressure profile of the various chambers, inflation sequence of the chambers, dwell time between each chamber—the time interval before starting to inflate the next chamber, rate of inflation of the chambers, number of cycles a sleeve is pressurized/inflated and depressurized/deflated for different sleeves used for an arm or leg, etc. SDC  33  may be used to transfer data from the apparatus to a physician without the necessity of having to take the apparatus to the physician&#39;s office. The SDC  33  may be programmed by a physician to create a new treatment protocol as the lymphedema treatment progresses. EC  26  also includes the capability to store multiple treatment protocol for a patient such as one treatment protocol for the morning and a different treatment protocol for the evening. 
         [0034]    Audio processor  34  provides audible information regarding the current lymphedema treatment, alarm triggers and conditions and instructions about the use of the apparatus. A keypad  35  integrated into the apparatus permits entry of various commands such as starting and stopping the lymphedema treatment, accessing the status of the apparatus and the lymphedema treatment and adjusting the audio volume, as mere examples. However, keypad  35  does not permit modification of the treatment protocol variables. A display  36  attached to the device displays visual information about the lymphedema treatment status, treatment parameters, alarm conditions, etc. EC  26  also has wired and wireless communication interfaces (such as RS232, RS485, USB, LIN) to enable communication with an additional computer or PDA. A graphical user interface (GUI) (not shown) which is only accessible by service technicians permits reading, setting and modifying various hardware related parameters of the LCS  28  such as the number of chambers in the sleeve to be used, pressure sensors calibration, parameters related to the servo control of the pressure in chambers. Another GUI, only accessible to a physician and lymphedema therapy specialists permits adding, deleting and changing the treatment protocols. The wireless interface (such as Zigbee or proprietary protocols) allows the use of a handheld remote control which can initiate all the commands available using of the keypad. This makes the apparatus very easy to use since the apparatus does not have to be within physical reach of the patient. A hand held remote can also undertake the same functions as keypad  35 , display  36  and audio processing  34 . EC  26  includes circuitry  39  to turn all the valves and pump on and off as desired as well as circuitry ( 39 ) to monitor pressure transducers that measure pressure in each chamber. EC  26  further includes circuitry  38  that provides for application of low voltage AC/DC, pulsed and non-pulsed prescribed electrical signals to the electrodes  14  embedded into the sleeve  16  that come in contact with the skin of the patient. A suitable conductive gel may be applied to the skin of the patient before the sleeve is attached so as to provide good electrical contact between electrodes  14  and the patient&#39;s skin. The gel provides for enhanced interferential therapy applied to the extremity to which the sleeve  16  is wrapped around. The EC  26  provides performance of quantitative biological impedance measurements to monitor the effectiveness of compression and interferential therapies and assessment of the lymphedema condition. 
         [0035]    A block diagram of a pneumatic manifold  27  is shown in  FIG. 6   c . The output port  63  of a pneumatic pump  40  is attached to a manifold duct  67 . The input port  64  of the pump  40  is pneumatically connected to a particulate filter  41  and a muffler  42 . The particulate filter  41  is configured to prevent any particulate matter from entering the manifold  27  and the muffler  42  is configured to minimize any noise generated by the air flow to the manifold  27 . A two port, normally closed solenoid valve, identified as inflation/deflation (I/D) valve  43  is positioned between the pump  40  through duct  67  and the first chamber (CHN  1 ) of the sleeve  16  or sleeve  22  as the case may be. In a similar arrangement, I/D valves  44 - 50  are positioned between the pump  40  through duct  67  and sleeve chambers CHN  2 - 8 , respectively. Although an eight chamber sleeve has been described herein, it is to be understood that the number of channels, greater than one, is a design choice and may be altered depending upon use considerations. As discussed and shown in  FIG. 6   c , one port of I/D valve  43  is pneumatically connected to duct  67  in the manifold and the other port of I/D valve  43  is connected to duct  68  in the manifold which is pneumatically connected to CHN  1  of sleeve  16 . In a similar arrangement, I/D valves  44 - 50  are connected to ducts  69 - 75  respectively which in turn are pneumatically connected to sleeve CHN&#39;s  2 - 8 , respectively. The I/D valve of each sleeve chamber  9  permits inflation/deflation of the respective sleeve chamber. A temperature compensated pressure transducer  54  is pneumatically connected to duct  68 . Duct  68  in turn, is connected to CHN  1  of sleeve  16  through a multiport connector  62  and multi-lumen tubing  63 . Pressure transducer  54  permits monitoring of the pressure inside chamber  1  (CHN  1 ) so that EC  26  may cause the respective chamber pressure to be maintained at its prescribed value during a treatment protocol. In a similar arrangement pressure transducers  55 - 61  are connected to ducts  69 - 75  respectively for monitoring the pressure in CHN&#39;s  2 - 8 , respectively. Also in a similar arrangement ducts  69 - 75  are connected, through multiport connector  62  to multi-lumen tubing  63  which connects to CHN&#39;s  2 - 8 , respectively. A two port, normally closed purge valve  51  is also pneumatically connected to manifold  27 . The purge valve  51  has a valve orifice, through which air flows, that has a cross-sectional area about 5 times larger than the cross-sectional area of the orifice of I/D valve  43 . Accordingly, the purge valve  51  is capable of providing rapid discharge of air in the manifold  27  to the ambient environment. As noted, one port of the purge valve  51  is pneumatically connected to the duct  67  of manifold  27  while the other port of the purge valve discharges into the ambient environment  76 . Under the control of EC  26 , the purge valve  51  provides for rapid and complete deflation of the sleeve chambers. A two port, normally closed tuning valve  52 , is also pneumatically connected to the manifold  27 . The cross-sectional area of the tuning valve orifice is about 5 times smaller than the cross-sectional area of the orifice of I/D valve  43 . The tuning valve  52  provides for removal of small amounts of air from the sleeve chamber/s to adjust the air pressure in the chamber/s to a prescribed value. The tuning valve  52 , due to its small orifice, provides for better control of the amount of air removed from the sleeve chamber/s compared to purge valve  51 . A mechanical over-pressure relief valve  53  is pneumatically connected the manifold  27 . The input port  65  of the over-pressure relief valve  53  is pneumatically connected to duct  67  and the output port  66  of the over-pressure relief valve  53  discharges into the ambient environment  76 . The over-pressure relief valve  53  provides for a fail-safe operation in cases of malfunction of the pneumatic system. 
         [0036]    Another example embodiment of the LCS  28  is shown in  FIG. 7   a . The embodiment shown in  FIG. 7   a  comprises two main components (modules), namely, remote unit  77  and electro-pneumatic module  78  (EPM). An example electrical block diagram of the remote unit  77  is shown in  FIG. 7   b . The heart of the remote unit  77  is a processor (CPU)  79  powered by a battery  80 . It also has an on-board battery backed real time clock (RTC)  81 , memory  82 , an audio processor  83  with audio processing capability using a buzzer and speaker, a keypad  84 , a display  85  and a wired &amp; wireless communication module  86  to interface with a computer and the EPM&#39;s. When communicating with a computer, remote unit  77  acts as a “slave” to the computer (master) and when communicating with EPM modules, the remote unit  77  acts as a master. A block diagram of the EPM  78  is shown in  FIG. 7   c . The heart of an EPM is an integrated miniature air pump  87  and a two-port normally closed purge valve  88  driven by elastomers called electroactive polymers (EPAM). EPAM is currently available from Artificial Muscle Corporation of Redwood City, Calif. Also included in this embodiment is a mechanical over-pressure relief valve  89  assembly connected to each sleeve chamber. The pump output port  91 , an input port of the purge valve  88  and input port  93  of the over-pressure relief valve  89  are pneumatically connected directly to a sleeve chamber. Input port  92  of the air pump  87 , an output port of the purge valve  88  and an output port  94  of the over pressure relief valve  89  discharge into the ambient environment  76 . A pressure transducer  90  installed between a sleeve chamber and air pump  87  measures the pressure in a respective sleeve chamber. The pump  87  and the purge valve  88  are under the control of a local CPU (processor) and its associated circuitry assembly  95 . Biological impedance measurement and IFT circuitry  96  are also located on this assembly and are controlled by the local CPU. Wired and wireless communication interface  97  located on the assembly provides for communication between the remote unit  77  and an EPM  78 . An external power source  98  provides power to all the electronics, valves and pumps of an EPM. 
         [0037]    In this embodiment, I/D valves are not required because each sleeve chamber is pressurized individually by its own EPM pump instead of sharing a common pump. Each sleeve chamber has its own deflation/pressure adjustment valve rather than sharing common purge and tuning valves. This arrangement permits inflation or deflation of any chamber concurrently with other chambers. For example, while one sleeve chamber is being inflated, another sleeve chamber may be deflating to adjust its pressure concurrently or two chambers may be inflating concurrently independently of each other. Each sleeve chamber has its own EPM installed on the sleeve. All EPM&#39;s are under the direct control of the remote unit  77  which performs the same functions as the LCS  28  of the earlier described embodiment, except the sleeve control functions are performed by EPMs. Any EPM can perform biological impedance measurement and IFT functions depending on which EPM is connected to the electrodes  14 . Each EPM has its own ID number (set by switches or programmed into the CPU) which is same as the respective sleeve chamber number. This allows the remote unit  77  to communicate with each EPM directly. 
         [0038]    Electroactive Polymer Artificial Muscle (EPAM) has significant differences from not only conventional electromagnetic actuators but from other technologies like piezo-electric crystals and shape memory alloys. A significant advantage that EPAM has over electromagnetic actuators is its energy density, that is, more energy created for the mass of the actuator itself. Compared to shape memory alloy and piezo electric technology, EPAM&#39;s have a significant direct displacement advantage. While shape memory alloy and piezo-electric technology might achieve a 1% direct displacement, EPAM actuators can reach 20% or more displacement levels over long life cycles. Compared to conventional electromagnetic motors, EPAM&#39;s have a significant advantage in power density. EPAM&#39;s will provide the same level of power as an electromagnetic motor device but with a much smaller and lower weight form factor, much like the human muscle. The EPAM basic architecture is made up of a film of an elastomer dielectric material that is coated on both sides with another expandable film of a conducting electrode. When voltage is applied to the two electrodes, a Maxwell pressure is created on the elastic dielectric polymer layer. The elastic dielectric polymer acts as an incompressible fluid which means that as the electrode pressure (voltage) causes the elastomer dielectric film to become thinner, the dielectric film expands in planar directions and thus provides mechanical actuation and motion. Advantageously, EPAM&#39;s can be patterned to pinpoint actuation in multiple locations. 
         [0039]    Before commencing CT and/or IFT, a quantitative measurement of the biological impedance of the extremity afflicted with lymphedema is performed using a bio-impedance (biological impedance) analysis (BIA) methodology. BIA is based on two important concepts namely: a human body contains water and conductive electrolytes (collectively “fluids”) and the electrical impedance of a body part such as an extremity (limb) is related to the length and cross-sectional area of the extremity, as well the frequency of the electrical current applied to the extremity. For the most part, body fluids conduct the electrical current that passes through a limb. Fluids are present both inside a human body cell, called intracellular fluid and outside the human body cells, called extracellular fluid. At low frequency, electrical current passes through the extracellular fluid and does not penetrate the cell membrane. At high frequency, however, electrical current passes through both the intracellular and extracellular fluids. By using a fixed strength electrical current, the bio-impedance of a limb can be measured which is inversely proportional to the amount of fluid in the limb. Accordingly, as the fluid in the limb decreases, the bio-impedance will increase. Bio-impedance analysis may be performed by any of one of three methods. Single frequency analysis is generally performed at about 50 kHz. At this frequency, the electrical current passes through both the intracellular and extracellular fluids. Based on this measurement total body water can be calculated. However, since the current passes through both the intracellular and extracellular fluids, it is not possible to determine the intracellular fluid alone. The results are based on predictive algorithms derived from healthy subjects. In multi-frequency bio-impedance analysis, the impedance is measured at no greater than seven different frequencies. Empirical linear regression analysis is then used to derive the impedance values. In bio-impedance spectroscopy, impedance is measured at 256 different frequencies and mathematical modeling is used to calculate the impedance values. 
         [0040]    A data entry listing for an example treatment protocol (profile) having either compression therapy or interferential therapy parameters or both loaded into the memory of the EC  26  is shown in Appendix A. Multiple protocol&#39;s may be stored in the memory of the EC  26  for rapid access and use. For the present discussion, the input data for the sleeve chambers will refer to chamber one (CHN 1 ) of the sleeve with the understanding that the other chambers of the sleeve have similar data entries. A thorough description of the execution of a lymphedema protocol with reliance on a similar entered data listing will be described below with reference to  FIGS. 8   a - 8   e . The compression therapy (CT) parameters include pressure set point for all the chambers ( 101 ), sequence of inflation of the chambers ( 102 ), dwell (pause) time ( 103 ) for each chamber (the time interval after inflating a chamber to a pressure set point before starting inflation/deflation of the next chamber(s), sequence end delay ( 105 ) (time interval after inflating all the chambers and start of the deflation cycle), sleeve deflation period after the end of inflation cycle ( 115 ), “end of treatment” parameters ( 104 ) which includes the number of inflation/deflation cycles to occur for the treatment, a fixed amount of time for the treatment, attainment of a prescribed percentage of the original measured biological impedance, attainment of a fixed value of impedance value or a combination of the above parameters. The lymphedema treatment is terminated when any of the “End of Treatment” parameters are met. Any sleeve chamber can be set to stay inflated ( 106 ) throughout the treatment. This is especially true for the chamber at the proximal end of the sleeve when wrapped around a body extremity such as a hand or foot. Since a foot, for example, is at the distal end of a patient&#39;s leg, lymph fluid can only go out from and away from the foot along the patient&#39;s leg towards the groin, where the distal end of the sleeve is located and thus there is no need to deflate the sleeve chamber at its proximal end to permit the lymphatic fluid from entering the patient&#39;s foot. The product of a chamber pressure set point and corresponding dwell time is generally maintained at a constant value for all the chambers so that approximately same amount of lymphatic fluid moves along in the treated limb from chamber to chamber during inflation. These programmable parameters also provide the versatility of programming monotonically decreasing, monotonically increasing or constant pressure gradients in the sleeve. The IFT parameters include the amplitude of applied voltage (AC/DC) ( 107 ), pulse duration ( 108 ), pulse rate ( 109 ) and “end of treatment” parameters which are same as for the CT. The treatment protocol also contains treatment related parameters such as protocol number ( 111 ), protocol name (arm, leg, etc.)( 110 ) and patient related parameters such as name ( 112 ), social security number (SSN) ( 113 ), etc. Sleeve related parameters include the number of chambers ( 114 ). 
         [0041]    Referring now to  FIGS. 8   a - 8   e , there is shown an example flow diagram of a program, preferably cast in firmware that controls the operation of LCS  28 . Upon application of power to the LCS  28  (system power switch on), the CPU and the Support Circuitry  29  the EC  26  is reset, all the I/D valves  43 - 51  are set to closed position, and the pump  40  is in off condition. LCS  28  goes into a standby mode  121  which is shown on the display  36  as well as an audio message “power on” is announced. In the Standby Mode  121 , the treatment protocols may be loaded, erased, modified or an established treatment protocol can be set to a default treatment protocol for a particular limb positioned on sleeve  16 . The default treatment protocol is executed when the Treatment Start button is pressed either from the remote control  99  or keypad  35 . During the standby mode  121 , the purge cycle  122  can be initiated from the keypad  35  (all the I/D valves  43 - 52  are opened) thus removing any air from the sleeve which facilitates mounting the sleeve on the extremity to be treated. When a Start command is pressed from the keypad  35 , an autozero cycle  123  is started. The display  36  displays the notation “Starting Treatment” and the audio processor  34  announces “Start of Treatment”. In the auto zero cycle  123 , all I/D valves  43 - 52  are opened so as to deflate all the sleeve chambers thus equalizing the pressure inside and outside sleeve  16 . The pressure transducers  54 - 61  continuously monitor (measure) the pressure inside each of the sleeve chamber(s)  9 . When the measurements of all the pressure transducers  54 - 61  (after analog to digital ND conversion) becomes stable and meet programmed criteria, the pressure inside and outside the sleeve  16  is indicated as becoming equal. At this time, all the pressure transducer ( 54 - 61 ) measurements are equivalent to measuring “zero” pressure. These values are stored in memory  32  and used to measure the correct pressure inside the sleeve chambers. This procedure compensates for any zero drift of the pressure transducers due to aging and temperature and electronic component drift. After completion of the auto zero mode  123 , all I/D valves  43 - 52  are closed. If a pressure transducer stability criteria is not met, the apparatus goes into an alarm mode  125  and lymphedema treatment is aborted. 
         [0042]    Upon completion of the auto zero mode  123 , a lymphedema treatment cycle commences and depending upon the selected extremity, at  126  for an arm or at  127  for a leg with CT and IFT also starting according to the current active protocol. For CT, inflation cycle  128  commences and assuming that sleeve chamber  1  (CHN 1 ) is pressurized first (as defined in Appendix A), the I/D valve  43  is opened and the pneumatic pump  40  is started to provide pressurized air to CHN 1 . The pressure transducer  54  located between the I/D valve  43  and the corresponding CHN 1  of the sleeve monitors the chamber pressure. In one embodiment, the pressure transducer  54  is located close to I/D valve  43  and there is a measureable pressure drop between the pressure transducer  54  and the sleeve CHN 1  due to the resistance, caused by friction, to the air flow through manifold duct  68  and the multi-lumen tubing  63 . It is to be noted, that the longer the tubing  63 , the higher the pressure loss. Initially the pressure inside CHN 1  is zero. Therefore, the pressure reading from the pressure transducer  54  at the very beginning of the inflation cycle is equal to the pressure drop through the tubing  63  for CHN 1  for the given flow capacity of the pump  40 . This dynamic pressure drop is measured for all the chambers (channels) ( 1 - 8 ) during the first inflation cycle of all the chambers and stored in memory  32 . This dynamic pressure drop parameter is used as an input parameter to a commonly available proportional integral derivative algorithm (PID) stored and performed in EC  26  to compensate for any error in pressure measurement in order to achieve the programmed pressure in the sleeve chambers, in the least amount of time without either over or under shooting the programmed pressure value. This automatic compensation of the dynamic pressure drop through the tubing  63  for each sleeve chamber alleviates the need to manually set these values and results in maintaining accurate pressure values in the sleeve chambers. Alternatively, pressure transducers ( 54 - 61 ) may be mounted very close or on the respective sleeve chambers. In such case, the pressure drop between a pressure transducer and the respective sleeve chamber is negligible, if any, but requires that the electrical conductors must be provided between the pressure transducers on the sleeve ( 16 ,  22 ) to the EC  26 . 
         [0043]    As has been previously described, sleeve ( 16 ,  22 ) may be formed of flexible elastomeric material. Accordingly, when a sleeve chamber is pressurized to its programmed value (set point), the chamber applies a force to the adjacent chamber. This force causes the volume of the adjacent chamber to decrease slightly, especially if the adjacent chamber is pressurized, resulting in pressure increase above its set point. There is also a pressure drop in the adjacent chamber due to cooling of the hot air that was caused by adiabatic heating of the air during the pressurization process. These two factors may cancel each other or there may be some plus or minus pressure change depending upon such factors as the size and design of the sleeve and the amount of adiabatic heating occurring during the pressurization process. During a delay interval (pause time  103 ) and after a sleeve chamber is pressurized, the EC  26  causes adjustment of the pressure of the adjacent chamber(s) to their respective set points (either by deflating the chamber(s) or by pumping more air in the chamber(s). However, simultaneous inflation and deflation of the chambers can not be done. The difference in the set point and the actual pressure in a chamber determines the priority of pressure adjustment during the dwell time  103 , where the higher the difference, the higher the priority for pressure adjustment for the respective chamber. This continuous pressure control/adjustment of the chambers provides the capability of a monotonically decreasing, monotonically increasing or a constant pressure gradient along the length of the sleeve as defined by treatment protocol. At the conclusion of inflation cycle  128 , a purge cycle  129  commences wherein all chambers but CHN 1  are deflated. Subsequent to the completion of deflation of the desired chambers, the treatment termination criteria is checked. If any one of the treatment termination criteria has not been met, inflation cycle  128  is repeated. If any one of the treatment termination criteria has been met, purge cycle  130  commences wherein all of the chambers including CHN 1  are deflated. At the end of purge cycle  130 , EC  26  commands that the LCS  28  goes into standby mode  121 . 
         [0044]    At block  124 , the IFT and biological impedance measurement cycle commences. The first biological impedance measurement value is stored in memory  32  and used as a reference and the IFT cycle  131  commences. The IFT cycle  131  is undertaken with the preselected electrical pulse parameters for IFT such as amplitude, duration and frequency such pulse signals being applied to the sleeve electrodes  14 . The measured biological impedance values are then compared and displayed and when the treatment termination criteria is met, IFT is stopped and the device goes into standby mode. If IFT is being undertaken in conjunction with CT, any alarm in CT will also terminate IFT.  FIG. 9  shows the pressure-time profile in the chambers of the sleeve during compression therapy treatment cycle. 
         [0045]    A time pressure graphical representation of the inflation and deflation cycle for the eight chambers of the sleeve ( 16 ,  22 ) is shown in  FIG. 9 . At To, the initial starting time for the compression therapy, all of the sleeve chambers are completely deflated. At such time, EC  26  commands that inflation of chamber one (CHN 1 ) commences. At T 1 , the pressure in CHN 1  reaches its prescribed value (set point) and inflation of CHN 1 , ceases. A pause or delay interval then is commanded from between T 1  to T 2  where no further inflation activity is undertaken. At T 2 , inflation of CHN 2  commences while CHN 1  is maintained at its prescribed pressure set point. Once the pressure in CHN 2  reaches its prescribed value, inflation of CHN 2  ceases. Any variation of the pressure in CHN 1 , as shown at T 3 , resulting from the inflation of CHN 2  is compensated by EC  26  so as to maintain CHN 1  at its prescribed pressure set point. Subsequent to the delay interval between T 3  and T 4 , inflation of CHN 3  commences until the pressure in CHN 3  reaches its prescribed value, while the pressures in CHN 1  and CHN 2  are maintained at their respective prescribed values. The above process continues in a like manner, including checking the chambers for any changes in their pressure vale due to pressurization of adjacent chambers, until all the chambers are inflated which terminates at time T 6 . At T 6 , the treatment termination criteria are examined and if none of the criteria are satisfied all chambers, except CHN 1 , are deflated between T 6  and T 7 . The entire process, commencing with inflation of CHN 2 , is repeated. Upon completion of the entire repeated process, the termination criteria is again examined (at T 9 ) and if any one of the criteria is satisfied, all the chambers, including CHN 1  are deflated at T 10 , and the lymphedema treatment session is terminated. 
         [0046]    At end of a lymphedema treatment session, all the operational parameters are logged into memory  32  so that the effectiveness of the therapies can be ascertained. Depending on the embodiment, certain acts, events, or functions of any of the methods described herein can be performed in a different sequence, may be added, merged, or elimnated (e.g., not all described acts or events are necessary for the practice of the method). Moreover, in certain embodiments, acts or events may be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors, rather than sequentially. The various illustrative logical blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, firmware or combinations thereof. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall apparatus. The described functionality may be implemented in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope and intent of the disclosure. The various illustrative logical blocks, modules, and circuits described in connection with the embodiments disclosed herein may be implemented or performed with a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein without departing from the spirit of the invention. A general purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. 
         [0047]    The lyphedema treatment method or algorithm described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a software module executed by a processor, or in a combination thereof without departing from the spirit of the invention. A software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art. An exemplary storage medium is coupled to the processor such the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor. The processor and the storage medium may reside in an ASIC. The ASIC may reside in a user terminal. In the alternative, the processor and the storage medium may reside as discrete components in a user terminal. With regard to the use of a processor, the flow chart or algorithm disclosed at least in  FIGS. 8   a - 8   e  provides more than adequate information for one skilled in the art to program such processor to perform the lymphedema treatment method disclosed herein. 
         [0048]    While the above detailed description has shown, described, and pointed out novel features as applied to various embodiments, it will be understood that various omissions, substitutions, and changes in the form and details of the device or process illustrated may be made without departing from the spirit of the disclosure. As will be recognized, certain embodiments of the inventions described herein may be embodied within a form that does not provide all of the features and benefits set forth herein, as some features may be used or practiced separately from others. The scope of the inventions is indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope. 
         [0000]    
       
         
               
             
               
               
               
             
           
               
                   
               
               
                 APPENDIX A 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 KILL_PROFILE! 
                   
               
               
                   
                 PATIENT_FIRST=Emily 
                 112 
               
               
                   
                 PATIENT_LAST=Iker 
                 112 
               
               
                   
                 PATIENT_MID=Milka 
                 112 
               
               
                   
                 PATIENT_REF=123-45-6789 
                 113 
               
               
                   
                 CFG_PROFILE=0 
                 111 
               
               
                   
                 PROFILE_NAME=LEG 
                 110 
               
               
                   
                 STEP_ADDR[0]=0+8 
                 102 + 106 
               
               
                   
                 STEP_PRESS[0]=43 
                 101 
               
               
                   
                 STEP_END_DLY[0]=18 
                 103 
               
               
                   
                 STEP_ADDR[1]=1 
                   
               
               
                   
                 STEP_PRESS[1]=44 
                   
               
               
                   
                 STEP_END_DLY[1]=19 
                   
               
               
                   
                 STEP_ADDR[2]=2 
                   
               
               
                   
                 STEP_PRESS[2]=45 
                   
               
               
                   
                 STEP_END_DLY[2]=20 
                   
               
               
                   
                 STEP_ADDR[3]=3 
                   
               
               
                   
                 STEP_PRESS[3]=46 
                   
               
               
                   
                 STEP_END_DLY[3]=21 
                   
               
               
                   
                 STEP_ADDR[4]=4 
                   
               
               
                   
                 STEP_PRESS[4]=47 
                   
               
               
                   
                 STEP_END_DLY[4]=22 
                   
               
               
                   
                 STEP_ADDR[5]=5 
                   
               
               
                   
                 STEP_PRESS[5]=48 
                   
               
               
                   
                 STEP_END_DLY[5]=23 
                   
               
               
                   
                 STEP_ADDR[6]=6 
                   
               
               
                   
                 STEP_PRESS[6]=49 
                   
               
               
                   
                 STEP_END_DLY[6]=24 
                   
               
               
                   
                 STEP_ADDR[7]=7 
                   
               
               
                   
                 STEP_PRESS[7]=50 
                   
               
               
                   
                 STEP_END_DLY[7]=25 
                   
               
               
                   
                 CUFF_PURGE_DLY=30 
                   
               
               
                   
                 SEQ_NUM_CYC=10 
                   
               
               
                   
                 SEQ_END_DLY=2 
                   
               
               
                   
                 CUFF_NUM_STEPS=8 
                   
               
               
                   
                 CFG_PROFILE=1 
                   
               
               
                   
                 PROFILE_NAME=ARM 
                   
               
               
                   
                 STEP_ADDR[0]=0 
                   
               
               
                   
                 STEP_PRESS[0]=40 
                   
               
               
                   
                 STEP_END_DLY[0]=12 
                   
               
               
                   
                 STEP_ADDR[1]=1 
                   
               
               
                   
                 STEP_PRESS[1]=39 
                   
               
               
                   
                 STEP_END_DLY[1]=12 
                   
               
               
                   
                 STEP_ADDR[2]=2 
                   
               
               
                   
                 STEP_PRESS[2]=38 
                   
               
               
                   
                 STEP_END_DLY[2]=18 
                   
               
               
                   
                 STEP_ADDR[3]=3 
                   
               
               
                   
                 STEP_PRESS[3]=37 
                   
               
               
                   
                 STEP_END_DLY[3]=18 
                   
               
               
                   
                 STEP_ADDR[4]=4 
                   
               
               
                   
                 STEP_PRESS[4]=36 
                   
               
               
                   
                 STEP_END_DLY[4]=19 
                   
               
               
                   
                 STEP_ADDR[5]=5 
                   
               
               
                   
                 STEP_PRESS[5]=35 
                   
               
               
                   
                 STEP_END_DLY[5]=19 
                   
               
               
                   
                 STEP_ADDR[6]=6 
                   
               
               
                   
                 STEP_PRESS[6]=34 
                   
               
               
                   
                 STEP_END_DLY[6]=20 
                   
               
               
                   
                 STEP_ADDR[7]=7 
                   
               
               
                   
                 STEP_PRESS[7]=33 
                   
               
               
                   
                 STEP_END_DLY[7]=20 
                   
               
               
                   
                 CUFF_PURGE_DLY=30 
                 115 
               
               
                   
                 SEQ_NUM_CYC=10 
                 104 
               
               
                   
                 SEQ_END_DLY=2 
                 105 
               
               
                   
                 CUFF_NUM_STEPS=8 
                 114 
               
               
                   
                 IFT_AMPLITUDE=30 
                 107 
               
               
                   
                 PULSE_DURATION=5 
                 108 
               
               
                   
                 PULSE_FREQUENCY=11 
                 109 
               
               
                   
                 PROFILE_VALID=1

Technology Category: 1