Abstract:
A thermal therapy device for applying temperature controlled therapy to a therapy site on a mammalian body, comprising: a therapy pad for applying a selected therapy temperature to the therapy site; a recirculating fluid loop comprising a fluid channel defined by the therapy pad; a pump for circulating fluid through the recirculating fluid loop; a thermal reservoir; a heat exchanger coupling the thermal reservoir with the recirculating fluid loop; and a control mechanism coupled to the heat exchanger for enabling adjustable control of therapy temperature. The heat exchanger selectively mixes fluid recirculating in the fluid loop with fluid from the thermal reservoir in an adjustable mixing ratio to achieve the selected therapy temperature at the therapy site.

Description:
This is a continuation-in-part of U.S. application Ser. No. 08/450,641, filed May 25, 1995, now U.S. Pat. No. 5,865,841. 
    
    
     BACKGROUND OF THE INVENTION 
     This invention relates to devices and methods for applying thermal therapy to living tissue. 
     Thermal therapy involves the application of heat or cold to tissue to heal and rehabilitate injuries, such as, bruises, sprains, or other trauma to bone, muscle, ligaments, tendons, and skin. Cold therapy can be used to reduce swelling, reduce pain and promote healing of injured tissue. Heat therapy can be used to loosen joint tissue, such as, ligaments and tendons, to increase range of motion, e.g., before strenuous activity. Thermal therapy can be used after surgery to reduce pain and swelling and promote healing. Thermal therapy can also be used as part of an orthopedic therapy program, a sports medicine program, and to heal and rehabilitate animals, such as, thoroughbred race horses. 
     Common thermal therapy methods, e.g., application of an ice bag or a hot water bottle, are difficult to hold in place, are statically applied, cause uneven cooling or heating across the treatment site, and do not allow the cooling or heating temperature to be readily controlled. 
     A number of devices have been proposed for applying cold therapy to living tissue, with or without pressure. One device that has been developed for cooling a human knee includes a large cooler that contains chilled water which is circulated through a tube and into a cooling pad. The cooling pad is applied to a desired therapy site and held in place by a strap. The cooling rate is adjusted by increasing or decreasing the flow resistance through the tube leading to the cooling pad. Miller U.S. Pat. No. 2,531,074 describes a device which includes a flexible, multi-chamber thermal pad into which heated or cooled water is alternately injected at high and low pressures to provide temperature-controlled message therapy. Chessey U.S. Pat. No. 2,726,658 describes a system in which a coolant is pumped directly from a thermostatically-controlled refrigeration system into a cooling pad. Grossan U.S. Pat. No. 3,993,053 describes a massaging pad that includes a set of elastic tubing coils through which temperature controlled fluid is pulsed at high and low pressures to achieve a massaging effect. Copeland U.S. Pat. No. 4,149,529 describes a system that delivers heated or cooled liquid into a dry appliance for performing temperature and intermittent compression treatment; the system also provides a thermal therapy bath treatment. 
     SUMMARY OF THE INVENTION 
     In one aspect, the invention features a thermal therapy device for applying temperature controlled therapy to a therapy site on a mammalian body, comprising: a therapy pad for applying a selected therapy temperature to the therapy site; a recirculating fluid loop comprising a fluid channel defined by the therapy pad; a pump for circulating fluid through the recirculating fluid loop; a thermal reservoir; a heat exchanger coupling the thermal reservoir with the recirculating fluid loop; and a control mechanism coupled to the heat exchanger for enabling adjustable control of therapy temperature. 
     In another aspect, the invention features a thermal therapy device for applying temperature-controlled therapy to a therapy site on a mammalian body, comprising: a therapy pad for applying a selected therapy temperature to the therapy site; a recirculating fluid loop comprising a fluid channel defined by the therapy pad; a thermal reservoir; and a heat exchanger coupling the thermal reservoir with the recirculating fluid loop, the heat exchanger being constructed and arranged to selectively mix fluid recirculating in the fluid loop with fluid from the thermal reservoir in an adjustable mixing ratio to achieve the selected therapy temperature at the therapy site. 
     Embodiments of the invention may include one or more of the following features. The heat exchanger preferably comprises means for delivering a predetermined volume of fluid from the thermal reservoir into the recirculating fluid loop. The therapy pad preferably includes a flexible surface, and the control mechanism is preferably coupled to the pump for enabling adjustable control of fluid pressure in the therapy pad. The control mechanism is preferably adapted to vary pressure of recirculating fluid within the therapy pad in a manner to apply tactile stimulation to a therapy site by increasing and decreasing fluid pressure in the therapy pad. The control mechanism preferably comprises an alarm adapted to actuate whenever the thermal reservoir lacks thermal capacity to maintain a predetermined therapy temperature. 
     In some embodiments, the recirculating fluid loop comprises a first temperature sensor for monitoring therapy temperature. In these embodiments, the control mechanism preferably comprises control electronics for the heat exchanger. The control electronics are preferably coupled to the first temperature sensor, user-operated controls and a display for manual selection and visual confirmation of therapy temperature. The control electronics also preferably comprise an associated operating program and means for programming, storing and retrieving a therapy temperature-time profile for implementing therapy temperature control. The control electronics further preferably comprise means for determining a time-varying therapy temperature specified in the therapy temperature-time profile in real time for implementing therapy temperature control. The electronics may comprise means for comparing time-varying therapy temperature applied at the therapy site to a temperature specified in the therapy temperature-time profile in real time for implementing closed-loop therapy temperature control. The control electronics may also comprise an alarm for warning a user when the thermal reservoir lacks thermal capacity to maintain therapy temperature. The alarm preferably comprises a second temperature sensor connected to the control electronics for monitoring temperature in the recirculating fluid loop of fluid exiting the therapy pad, the first temperature sensor monitoring temperature in the recirculating fluid loop of fluid entering the therapy pad, the control electronics monitoring the first temperature sensor and the second temperature sensor and producing a signal when temperatures detected by the first temperature sensor and the second temperature sensor indicate that the thermal reservoir has insufficient thermal capacity to maintain a selected therapy temperature within a preset tolerance value. 
     The heat exchanger preferably comprises a second thermal reservoir. The heat exchanger also preferably comprises a valve for selectively mixing fluid from the first thermal reservoir with fluid from the second thermal reservoir according to a prescribed mixing ratio and for introducing mixed fluid to the pump for circulation in the recirculating fluid loop. In some embodiments, the control mechanism comprises a knob for manually adjusting the valve to achieve the prescribed mixing ratio. 
     In some embodiments, the second thermal reservoir comprises an air/water separator. In other embodiments, the heat exchanger comprises a second pump for delivering fluid from the first thermal reservoir to the second reservoir, and further comprises an overflow fluid path for returning excess fluid in the second thermal reservoir to the first thermal reservoir. The control mechanism preferably selectively adjusts the second pump to achieve a prescribed fluid temperature in the second thermal reservoir. 
     There is a need for a cost-effective thermal therapy device for applying cold or heat therapy to a human or mammalian body that is small enough to be easily transported and used in a wide variety of locations, adaptable to many different mammalian body forms and potential therapy sites, capable of providing controlled temperature therapy at a preset temperature or by a preprogrammed temperature profile, capable of monitoring the therapy temperature directly at the therapy site, and capable of providing tactile stimulation to the therapy site to alleviate the problems of static thermal therapy and enhance the beneficial effects of thermal therapy. The present invention fulfills these needs, and further provides related advantages. 
     Other features and advantages of the invention will become apparent from the following description of presently preferred embodiments, and from the claims. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a diagrammatic view of a thermal therapy device of the invention for applying thermal therapy to the knee of a person. 
     FIG. 2 is a perspective view, partially broken away, of a reservoir housing for a thermal therapy device of the invention. 
     FIG. 2A is a schematic diagram of the thermal therapy device of FIG. 1, including a thermal reservoir, a heat exchanger, and a treatment pad. 
     FIG. 3 is a diagrammatic view of insulated fluid supply and return lines a thermal therapy device of the invention. 
     FIG. 4 is a diagrammatic view of a thermal therapy treatment pad for a device of the invention. 
     FIGS. 5 and 5A are cross-sectional views of the treatment pad of FIG. 4 shown in inflated condition and deflated condition, respectively. 
     FIG. 6 is a therapy temperature time profile programmed into a therapy device controller. 
     FIG. 7 is a schematic diagram of an alternative thermal therapy device. 
     FIG. 8 is a schematic diagram of another alternative thermal therapy device. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring to FIG. 1, a thermal therapy device 10 applies temperature-controlled thermal therapy to the knee 12 of a person 14. Thermal therapy device 10 includes a portable reservoir 16 that is connected to a thermal therapy treatment pad 18 by a thermally insulated supply and return assembly 20. As described in detail below, thermal therapy device 10 uniformly heats or cools the person&#39;s knee according to a predetermined temperature schedule, and can be programmed to stimulate the patient&#39;s knee by controllably varying the inflation pressure inside treatment pad 18. A wrap 21, which is made of, e.g., neoprene rubber, is shaped to snugly hold treatment pad 18 in place at the therapy site, while allowing the treatment pad to expand and contract during tactile stimulation of the person&#39;s knee. Wrap 21 is held in place by VELCRO®, i.e. hook-and-loop type, fasteners that allow the wrap to be selectively adjusted to fit firmly, evenly and comfortably in place at the therapy site. 
     Referring to FIG. 2, in one embodiment, portable reservoir 16 includes a protective outer case 22 and an inner, leak-proof thermal reservoir 24. Reservoir 24 is thermally insulated by a thermal lining 26, which fills the space between the outer walls of reservoir 24 and the inner wall of outer case 22. A thermally insulated lid 28 opens to provide access to reservoir 24. Lid 28 includes a seal (not shown) sized and constructed to form a fluid-tight seal between lid 28 and the top opening of reservoir 24 when the lid is closed, to prevent fluid from leaking during use. 
     A fluid control system 30 is contained within the housing, in a compartment space provided between the thermal reservoir and the outer casing. A heat exchanger 31, within the fluid control system, includes a pump 32, a single pole, double-throw priming valve 34, and an air/water separator 36. (In some embodiments, a solenoid valve may replace the single pole, double-throw priming valve.) Pump 32 includes an input 40 and an output 42, and is powered by a motor 38. Pump input 40 is connected to the output of priming valve 34, and pump output 42 is connected to a quick-disconnect outlet 44, through which fluid flows from the pump to the treatment pad. An input 46 of priming valve 34 is connected to thermal reservoir 24, and an input 48 of the priming valve is connected to an output of air/water separator 36. An overflow tube 50 provides a fluid path between the air/water separator and thermal reservoir 24. Air/water separator 36 receives fluid from the treatment pad through tubing 51 from a quick-disconnect inlet 52. The temperature of the fluid that is supplied to the treatment pad is monitored by thermistors 54 placed in the fluid paths of the supply and return lines of supply and return assembly 20. 
     Reservoir 24 accommodates crushed ice, ice cubes and pre-formed freezable cold sources, such as, those commonly used in portable coolers. The reservoir is easily recharged with additional ice if needed during use, without requiring the person to remove the pad from the therapy site. For heat therapy, hot water can be introduced into the reservoir, or the reservoir fluid can be controllably heated using an immersion heater. 
     The temperature of the fluid supplied to the treatment pad is controlled by a microprocessor-based controller 56 (control electronics). Based on the therapy temperature measured by thermistors 54, controller 56 produces an audible alarm signal when the cold or heat source in the reservoir is exhausted and the desired therapy temperature cannot be maintained within preset tolerances; an alarm also sounds if the unit detects a restricted flow in the circulation system. Controller 56 incorporates a non-volatile electronic memory for storing, recalling and implementing one or more preprogrammed or user-defined therapy temperature time profiles. Input keys 58 are used to program the desired temperature profile into controller memory. The monitored temperature is shown on a digital display 60. Display 60 may also indicate the amount of therapy time remaining. Electrical power is supplied to fluid control system 30 from a conventional wall outlet, through power connector 62, to switching power electronics 64. 
     As shown in FIG. 2A, heat exchanger 31 controls the temperature of treatment pad 18 by mixing a controlled amount of fluid from thermal reservoir 24 with recirculated fluid returning from the treatment pad through air/water separator 36. By using the real-time temperature information generated by thermistors 54, controller 56 adjusts valve 34 to control the proportion of reservoir fluid that mixes with the recirculation fluid received from the pad to achieve the prescribed treatment pad temperature. For example, if the fluid injected to the treatment pad through quick-disconnect outlet 44 is at the prescribed temperature, controller 56 will adjust valve 34 so that no fluid is received from reservoir 24; in other words, pump 32, treatment pad 18, and air/water separator 36 form a closed-loop system (the fluid may flow in either direction). If the output fluid temperature drops, however, controller 56 will adjust valve 34 so that fluid from reservoir 24 mixes with recirculated water from air/water separator 36 in the proportion selected to achieve the desired output fluid temperature. Because the fluid volume in the fluid flow path defined by the pump, the treatment pad, and the air/water separator is substantially fixed, some recirculated fluid will be displaced and flow into reservoir 24 via overflow tube 50 to complete the heat exchange process. 
     To ensure uniform temperature distribution at the therapy site (or sites), a high flow rate is used to reduce the temperature gradient that develops across the treatment pad as a result of heat transfer at the treatment site. In some embodiments, the thermal therapy device includes multiple treatment pads coupled in series, which can be used, e.g., in the treatment of post bilateral surgery therapy. High flow rates are generally needed in these multi-pad embodiments to reduce the temperature differential between the upstream and downstream treatment pads. The flow rate can also be selected based on the anticipated heat load at the treatment site. 
     Referring to FIG. 3, insulated supply and return assembly 20 includes a flexible fluid supply line 66 that connects to quick-disconnect outlet 44 via a mating quick-disconnect connector 68, and a flexible fluid return line 70 that connects to quick-disconnect return inlet 52. In the embodiment shown in FIG. 3, the supply and return line assembly 20 is attached to the treatment pad via quick-disconnect connectors 74, 76. The flexible supply and return lines 66, 70 are encased in thermal insulation 78 (e.g., polyurethane foam) that reduces ambient heat loads, makes the entire line assembly fluid tight, durable and flexible, and is more comfortable for the user to handle. The length of the supply and return line assembly is selected based at least in part on the size of the user and on the anticipated thermal therapy treatment. 
     Various treatment pad shapes and sizes are contemplated depending on the selected treatment site (e.g., ankle, knee, elbow), with the object being to sufficiently cover the treatment site to achieve optimal therapy results. In the embodiment shown in FIG. 4, a treatment pad 80 is formed of two layers of flexible polymeric material 82 that are heat-welded or otherwise sealed together at the outer edge 84 of the pad. In this embodiment, supply and return lines 86, 88 are permanently attached to treatment pad 80 by a leak proof seal 90. Pad 80 also includes one or more internal seams 92 (or internal walls), which uniformly direct the flow of cooling fluid through the pad; the internal seams also control the expansion and contraction of the pad. 
     Referring to FIGS. 5 and 5A, treatment pad 80 is constructed to allow the pad to expand (FIG. 5) and to contract (FIG. 5A) in response to varying fluid pressures applied by the heat exchanger, and to ensure a uniform distribution of circulating fluid within the pad. To achieve tactile stimulation, pump 32 is turned off and on at preprogrammed intervals to periodically allow the pressure in the treatment pad to be cycled between low and high values. Such a periodic pressure variation in the treatment pad provides tactile stimulation at the therapy site while achieving the desired therapy temperature. Controller 56 (FIG. 2) can be programmed to simultaneously provide the desired temperature profile and the desired tactile stimulation. 
     Although a constant therapy temperature time profile may be programmed into controller 56, it is preferable to vary the temperature during treatment to avoid discomfort and permit long term thermal therapy without causing tissue damage. As shown in FIG. 6, a preferred cold therapy temperature time profile calls for a reduction in the applied therapy temperature from room temperature to a predetermined minimum temperature (e.g., 45° F.) during an initial treatment stage; during an intermediate stage the minimum therapy temperature is maintained for a fixed period (e.g., nine minutes); and during a final treatment stage the temperature is increased at regular intervals (e.g., every five minutes) until the treatment temperature is at about 65° F. The applied therapy temperature is maintained at 65° F. for the duration of the prescribed treatment period. 
     Other embodiments are within the scope of the claims. 
     For example, in one embodiment, the thermal therapy device uses two pumps, instead of the combination of a single pump and a single pole, double-throw valve, to achieve bi-directional flow, closed-loop temperature control and increased tactile stimulation. Such a dual-pump device implements closed-loop temperature control using analog control electronics in the form of a solid state thermostat with the therapy site temperature selected with a mechanically operated device, such as a potentiometer in conjunction with a temperature read-out device. Increased tactile stimulation for a dual-pump device could be achieved by engaging both pumps simultaneously, imposing momentary higher pressure on the pad with no net fluid flow. 
     Automatic Closed-Loop Heat Exchanger 
     Referring to FIG. 7, a thermal therapy device 100 includes a primary reservoir 102 that is coupled to a secondary reservoir 104 by an active flow path 106 and by an overflow path 108; the primary and secondary reservoirs are separated by a thermal barrier 110. Active flow path 106 includes a dedicated constant pressure circulation pump 112. The temperature of the fluid in the secondary reservoir is monitored using a thermal sensor 114. A controller 116 adjusts the pump rate to maintain the temperature in the secondary reservoir at a desired temperature by controlling the fluid flow from the primary reservoir. Any excess fluid in the secondary reservoir is returned to the primary reservoir through overflow fluid path 108, completing the heat exchange circuit. A high speed circulation pump 118 controllably injects fluid from secondary reservoir 104 into a thermal therapy treatment pad 120. 
     The closed-loop electronic control allows the temperature of the secondary reservoir fluid to be maintained at a desired set-point value within about ±0.3° F. in a desired temperature range (e.g., 45° F. to 65° F., with the temperature of the primary reservoir fluid at about 35° F.) for practical thermal loads. When the secondary reservoir fluid temperature corresponds to the programmed temperature, the controller adjusts the pump speed so that the thermal transfer from the primary reservoir makes up for the thermal transfer at the treatment site through the treatment pad, which is represented by the difference in temperature between fluid 122 injected into the pad and fluid 124 returning from the pad. When the temperature profile programmed into controller 116 indicates that the therapy temperature is to be changed, the controller increases or decreases the speed of pump 112, depending on whether the applied temperature is to be increased or decreased. Because the fluid from the secondary reservoir is injected into the treatment pad at a high rate, the thermal load at the treatment site does not substantially affect the temperature of the fluid through the treatment pad and, consequently, the temperature differential across the treatment pad is maintained within about 2-3° F. of the programmed set-point value. 
     Reservoir 102 accommodates crushed ice, ice cubes and pre-formed freezable cold sources, such as, those commonly used in portable coolers. The reservoir is easily recharged with additional ice if needed during use, without requiring the person to remove the pad from the therapy site. For heat therapy, hot water can be introduced into the reservoir, or the reservoir fluid can be controllably heated using an immersion heater. Because ice water is used for the primary thermal reservoir, the thermal therapy device is highly cost-effective. 
     Manual Open-Loop Heat Exchanger 
     Referring to FIG. 8, a thermal therapy device 130 includes a primary thermal reservoir 132 and a secondary thermal reservoir 134. As in the embodiments described above, primary thermal reservoir 132 can accommodate a mixture of water and crushed ice or other cold source, or heated fluid. The mixing ratio of primary reservoir fluid 133 and recirculation fluid 135 from the secondary reservoir is adjusted by a manually-controlled valve 136. A high speed circulation pump 138 controls the flow of fluid into a thermal therapy treatment pad 140. Any excess fluid in the secondary reservoir is returned to the primary reservoir through overflow path 142, which completes the heat exchange circuit. 
     By adjusting valve 136 a user can empirically control the temperature of the secondary in an open-loop fashion. The water is mixed within the pump creating a near constant temperature within the circulation loop and the secondary reservoir. Preferably, valve 136 includes markings that indicate the correspondence between valve position and treatment temperature. For example, in one embodiment, valve 136 includes a marking that corresponds to a mixing ratio needed to provide a temperature of 45° F., which the user may apply to the treatment site for the initial period of treatment (e.g., ten to fifteen minutes). Valve 136 also includes a second marking that corresponds to a mixing ratio needed to provide a temperature of 65° F., which the user may apply to the treatment site indefinitely. 
     Still other embodiments are within the scope of the claims.