Patent Description:
It is now common to apply cold and compression to a traumatized area of a human body to facilitate healing and prevent unwanted consequences of the trauma. In fact, the acronym RICE (Rest, Ice, Compression and Elevation) is now used by many.

Typically thermally-controlled therapy involves cold packing with ice bags or the like to provide deep core cooling of a body part. Therapy often involves conventional therapy wraps with a fluid bladder for circulating a cooled heat exchange medium. Elastic wraps are often applied over the therapy wrap to provide compression.

More recently therapy wraps including a pair of compliant bladders to contain fluids have been disclosed. The therapy wrap typically has a compliant bladder for containing a circulating heat exchange liquid alone or in combination with a compressive bladder which overlays the compliant bladder for pressing the bladder against the body part to be subjected to heat exchange. In general, the body heat exchanging component(s) of such an apparatus include a pair of layers defining a flexible fluid bladder through which a liquid is circulated. The structure embodying both the liquid bladder and compressive bladder component is often referred to as a "wrap. " The liquid fed to the wrap is maintained at a desired temperature by passing the liquid through a heat exchanging medium such as an ice bath or a refrigeration unit. One such system is disclosed, for example, in <CIT>.

In some cases, heat treatment in conjunction with cryotherapy can provide benefits to the patient when provided in a rapidly alternating manner called rapid contrast therapy. Historically, this was done by alternating immersion in hot and cold water baths. However, use of hot and cold water baths is cumbersome and inconvenient to apply. Therefore, it would be desirable to provide a system and method for conveniently delivering rapid contrast therapy, cold therapy alone, heat therapy alone, and/or compression therapy. <CIT> and <CIT> are also considered to be relevant prior art for the present invention.

The present invention provides a system for providing rapid contrast therapy as defined in independent claim <NUM>. The system includes a cold reservoir configured to hold a cold liquid, the cold reservoir including a first liquid level sensor to measure a level of the cold liquid; a cold therapy supply valve in fluid communication with the cold reservoir, the cold therapy supply valve directing a flow of the cold liquid to a therapy device; a hot reservoir configured to hold a hot liquid, the hot reservoir including a second liquid level sensor to measure a level of the hot liquid; a hot therapy supply valve in fluid communication with the hot reservoir, the hot therapy supply valve directing a flow of the hot liquid to the therapy device; and a return valve directing return flow from the therapy device to at least one of the hot and cold reservoirs; and a controller directing operation of the cold and hot therapy supply valves to control the flow of the cold liquid and the hot liquid to the therapy device, the controller directing operation of the return valve to control the return liquid flowing from the therapy device to at least one of the cold and hot reservoirs. The controller directs the return flow to either the cold reservoir or the hot reservoir depending on the measured liquid level in each of the cold and hot reservoirs such that the measured liquid level in the cold and hot reservoirs does not exceed a corresponding maximum liquid level or fall below a corresponding minimum liquid level.

In some embodiments, the system further includes a first temperature sensor to measure a temperature of the cold liquid; a second temperature sensor to measure a temperature of the hot liquid; and a return temperature sensor for measuring a temperature of the return flow from the therapy device.

In some embodiments, the first temperature sensor is provided in cold liquid recirculation manifold and the second temperature sensor is provided in the hot liquid recirculation manifold.

In some embodiments, the first temperature sensor is provided in the cold liquid reservoir and the second temperature sensor is provided in the hot liquid reservoir.

In some embodiments, the controller directs return flow from the therapy device to at least one of the cold and hot reservoirs after determining that the measured liquid level within each of the cold and hot reservoirs is within a target liquid level range, wherein the controller directs the return flow to either the cold reservoir or the hot reservoir depending on the temperature of the return flow such that the return flow is directed to the reservoir containing the liquid having a closest temperature with the temperature of the return flow. The target liquid level range in each of the cold and hot reservoirs is greater than a corresponding minimum liquid level and less than a corresponding maximum liquid level.

In some embodiments, the controller directs return flow from the therapy device to at least one of the cold and hot reservoirs after determining that the measured liquid level within each of the cold and hot reservoirs is within a target liquid level range, wherein the controller directs the return flow to the hot reservoir when the temperature of the return flow is greater than an average of the temperatures of cold and hot liquids.

In some embodiments, the controller directs return flow from the therapy device to at least one of the cold and hot reservoirs after determining that the measured liquid level within each of the cold and hot reservoirs is within a target liquid level range, wherein the controller directs the return flow to the hot reservoir when the temperature of the return flow is greater than an average of the temperatures of cold and hot liquids by more than a predetermined offset amount.

In some embodiments, the predetermined offset amount is <NUM>°F (-<NUM>).

In some embodiments, the controller directs return flow from the therapy device to at least one of the cold and hot reservoirs after determining that the measured liquid level within each of the cold and hot reservoirs is within a target liquid level range, wherein controller directs return flow to the hot reservoir when the temperature of the return flow is equal to or greater than the temperature of the hot liquid in the hot reservoir.

In some embodiments, the controller directs return flow from the therapy device to at least one of the cold and hot reservoirs after determining that the measured liquid level within each of the cold and hot reservoirs is within a target liquid level range, wherein controller directs the return flow to the hot reservoir when the temperature of the return flow is greater than the temperature of the cold liquid in the cold reservoir.

In some embodiments, the controller directs return flow from the therapy device to at least one of the cold and hot reservoirs after determining that the measured liquid level within each of the cold and hot reservoirs is within a target liquid level range, wherein the controller directs the return flow to the hot reservoir when the temperature of the return flow is greater than a maximum cold reservoir return temperature.

In some embodiments, the maximum cold reservoir return temperature corresponds to the temperature of the cold liquid in the cold reservoir (measured in °F) (°C) plus an offset amount,.

In some embodiments, the wherein the offset amount is <NUM> °F (-<NUM>).

In some embodiments, the system further includes one or more conduits extending between the cold reservoir and the hot reservoir, the conduit providing fluid communication therebetween; and one or more cross-tank valves for controlling flow through the conduit; wherein the controller directs operation of the one or more cross-tank valves to control flow between the cold and hot reservoirs, wherein the controller directs operation of the one or more cross-tank valves in response to the measured liquid level in each of the cold and hot reservoirs such that the liquid level in either the cold and hot reservoirs does not exceed a maximum liquid level or fall below a minimum liquid level.

In some embodiments, the one or more cross-tank valves of the conduit is biased in a closed position.

In some embodiments, the system further includes a pump for moving liquid through the conduit.

In some embodiments, the conduit is connected to a recirculation pump for moving fluid through the conduit between the cold and hot reservoirs.

In some embodiments, the minimum liquid level of the cold and hot reservoirs is <NUM>% of a full operating liquid level of the corresponding cold and hot reservoir.

In some embodiments, the minimum liquid level of the cold and hot reservoirs is <NUM>% of a full operating liquid level of the corresponding cold and hot reservoirs.

In some embodiments, the minimum liquid level of the cold and hot reservoirs is <NUM>". In some embodiments, the full operating liquid level of the cold and hot reservoir ranges between <NUM>-<NUM>".

In some embodiments, the minimum liquid level is <NUM>". In some embodiments, the full operating liquid level of the cold and hot reservoir ranges between <NUM>-<NUM>".

In some embodiments, the controller directs flow through the conduit from the hot reservoir to the cold reservoir when the first liquid level sensor measures a liquid level below the minimum liquid level for the cold reservoir, wherein the controller directs flow through the conduit from the cold reservoir to the hot reservoir when the second liquid level sensor measures a liquid level below the minimum liquid level for the hot reservoir.

In some embodiments, the controller directs flow through the conduit from the cold reservoir to the hot reservoir when the first liquid level sensor measures a liquid level above the maximum liquid level for the cold reservoir, wherein controller directs flow through the conduit from the hot reservoir to the cold reservoir when the second liquid level sensor measures a liquid level above the maximum liquid level for the hot reservoir.

In some embodiments, during operation at least one of the cold and hot liquids is provided to a therapy device and the return flow is received from the therapy device and directed to the cold or hot reservoirs, wherein, during operation the controller directs operation of the cross-tank valve to open fluid communication between the reservoirs for a first time period.

In some embodiments, the controller directs cycled operation of the cross-tank valve to open and close fluid communication between the reservoirs, such that during each open-close cycle the cross-tank valve is open for the first time period and closed for a second time period until the difference between the measured liquid levels in the cold and hot reservoirs is within a predetermined deviation amount.

In some embodiments, the first time period is <NUM> seconds and the second time period is <NUM> seconds.

In some embodiments, the minimum liquid level of the cold and hot reservoirs corresponds to a liquid level where the cold and hot reservoirs indicate a critically low operating condition.

In some embodiments, the predetermined deviation amount is <NUM>/<NUM>" ± <NUM>/<NUM>".

In some embodiments, the system is not operating when at least one of the cold and hot liquids have not been provided to the therapy device for a predetermined off period, wherein, when the system is not operating, the controller directs operation of the cross-tank valve to open fluid communication between the reservoirs for a first time period.

In some embodiments, the predetermined off period that the therapy system is not operating is less than or equal to <NUM> seconds.

In some embodiments, the predetermined off period that the therapy system is not operating is at least <NUM> second.

In some embodiments, the predetermined off period that the therapy system is not operating is at least <NUM> seconds.

In some embodiments, the controller directs operation of the cross-tank valve to open fluid communication between the reservoirs until the difference between the measured liquid levels in the cold and hot reservoirs is within a predetermined deviation amount.

In some embodiments, the return valve comprises a cold reservoir return valve and a hot reservoir return valve, wherein the cold reservoir return valve directs return flow from the therapy device to the cold reservoir, wherein the hot reservoir return valve directs return flow from the therapy device to the hot reservoir.

In some embodiments, the system further includes at least one of the cold therapy supply valve, the hot therapy supply valve, the return valve and the cross-tank valve can be adjusted by the controller to vary at least one of a flow rate, volume, flow pressure, and temperature of the flow of liquid therethrough.

In some embodiments, the return temperature sensor is provided upstream of the return valve such that the return temperature sensor is between an output of the therapy device and the return valve.

In some embodiments, the therapy device comprises a therapy wrap configured for wrapping to a portion of an animate body for delivering treatment.

In some embodiments, the cold reservoir includes a cold reservoir fill port and the hot reservoir includes a hot reservoir fill port, wherein the cold and hot reservoir fill ports are housed in a receptacle that is configured to accommodate fluid overflow from the cold reservoir and the hot reservoir by allowing the cold liquid to overflow from the cold reservoir and into the hot reservoir or the hot liquid to overflow from the hot reservoir and into the cold reservoir.

In some embodiments, the system further includes a first pump configured to pump cold liquid from the cold reservoir to the therapy device; and a second pump configured to pump hot liquid from the hot reservoir to the therapy device.

In some embodiments, the system further includes a chiller configured to cool the cold liquid, and a third pump (recirculating pump) configured to pump the cold liquid from the cold reservoir to the chiller.

In some embodiments, the third pump (recirculating pump) is configured to pump cold liquid to the hot reservoir.

In some embodiments, the third pump is located upstream of the first pump.

In some embodiments, the cold therapy supply valve is located downstream from the first pump.

In some embodiments, the system further includes a heater configured to heat the hot liquid; and a fourth pump (recirculating pump) configured to pump the hot liquid from the hot reservoir to the heater.

In some embodiments, the heater is disposed in the hot reservoir.

In some embodiments, the system further includes a heater baffle disposed proximate the heater, wherein the heater baffle is configured to induce convection of the hot liquid around the heater.

In some embodiments, the fourth pump (recirculating pump) is configured to pump hot liquid to the cold reservoir.

In some embodiments, the fourth pump is located upstream of the second pump.

In some embodiments, the hot therapy supply valve is located downstream from the second pump.

In some embodiments, the system further includes a first pressure sensor located on the bottom of the cold reservoir, and a second pressure sensor located on the bottom of the hot reservoir.

In some embodiments, the system further includes a heating element disposed in the cold reservoir.

In some embodiments, the system further includes an overflow conduit extending from an upper portion of the cold reservoir to an upper portion of the hot reservoir, wherein the overflow conduit provides fluid communication between the cold reservoir and the hot reservoir.

In some embodiments, the system further includes a compressor configured to pressurize the therapy device.

In some embodiments, the system further includes a user interface configured to allow a user to set one or more parameters of the rapid contrast therapy; and wherein the controller operates at least one of a chiller, a heater, the first pump, and the second pump based on the parameters selected by the user using the user interface.

Also described but not claimed is a method for providing rapid contrast therapy using a rapid contrast therapy device. The method includes applying a therapy wrap to a patient; connecting a therapy wrap connector to a treatment device connector, the therapy device connector providing fluid communication between the therapy wrap and a cold therapy supply line, a hot therapy supply line and a pressurized gas supply line; measuring a liquid level of a cold and hot liquid within a cold and hot liquid reservoir provided in the therapy device; confirming a measured liquid level within each of the cold and hot reservoirs is within a target liquid level range; providing at least one of a temperature therapy and a pressure therapy to the patient via the therapy wrap by directing at least one of a cold liquid, a hot liquid and a pressurized gas through therapy wrap via a corresponding cold therapy supply valve, hot therapy supply valve and gas therapy supply valve; controlling via a return valve a return flow of the liquid from the therapy wrap to at least one of the cold and hot reservoirs to minimize the unnecessary thermal pollution of hot water from entering the cold tank or cold water from entering the hot tank upon return from the therapy wrap.

In some methods the return flow is directed to either the cold reservoir or the hot reservoir depending on the temperature of the return flow such that the return flow is directed to the reservoir containing the liquid having a closest temperature with the temperature of the return flow.

In some methods, the return flow is directed to the hot reservoir when the temperature of the return flow is greater than an average of the temperatures of cold and hot liquids.

In some methods, the return flow is directed to the hot reservoir when the temperature of the return flow is greater than an average of the temperatures of cold and hot liquids by more than a predetermined offset amount.

In some methods, the predetermined offset amount is <NUM>°F (-<NUM>).

In some methods, the return flow is directed to the hot reservoir when the temperature of the return flow is equal to or greater than the temperature of the hot liquid in the hot reservoir.

In some methods, the return flow is directed to the hot reservoir when the temperature of the return flow is greater than the temperature of the cold liquid in the cold reservoir.

In some methods, the return flow is directed to the hot reservoir when the temperature of the return flow is greater than a maximum cold reservoir return temperature.

In some methods, the maximum cold reservoir return temperature corresponds to the temperature of the cold liquid in the cold reservoir (measured in °F) (°C) plus an offset amount,.

In some methods, the offset amount is <NUM> °F.

In some methods, the measured liquid level within either of the cold and hot reservoirs is not within a target liquid level range the return flow is directed to either the cold reservoir or the hot reservoir depending on the measured liquid level in each of the cold and hot reservoirs such that the measured liquid level in the cold and hot reservoirs does not exceed the corresponding maximum liquid level or fall below the corresponding minimum liquid level.

In some methods, the return flow is directed to the cold reservoir when the first liquid level sensor measures a liquid level below the minimum liquid level for the cold reservoir, and wherein the return flow is directed to the hot reservoir when the second liquid level sensor measures a liquid level below the minimum liquid level for the hot reservoir.

In some methods, the return flow is directed to the hot reservoir when the first liquid level sensor measures a liquid level above a maximum liquid level for the cold reservoir, and wherein return flow is directed to the cold reservoir when the second liquid level sensor measures a liquid level above the maximum liquid level for the hot reservoir.

In some methods, the method further includes directing a cross-tank flow of the cold and hot liquids between the cold and hot reservoirs via a conduit operated by a cross-tank valve, where the cross-tank flow is directed in response to the measured liquid levels in each of the cold and hot reservoirs such that the liquid level in either the cold and hot reservoirs does not exceed a maximum liquid level or fall below a minimum liquid level.

In some methods, the method further includes directing flow through the conduit from the hot reservoir to the cold reservoir when the first liquid level sensor measures a liquid level below the minimum liquid level for the cold reservoir.

In some methods, the method further includes directing flow through the conduit from the cold reservoir to the hot reservoir when the second liquid level sensor measures a liquid level below the minimum liquid level for the hot reservoir.

In some methods, the method further includes directing flow through the conduit from the cold reservoir to the hot reservoir when the first liquid level sensor measures a liquid level above the maximum liquid level for the cold reservoir.

In some methods, the method further includes directing flow through the conduit from the hot reservoir to the cold reservoir when the second liquid level sensor measures a liquid level above the maximum liquid level for the hot reservoir.

In some methods, during operation of the therapy device at least one of the cold and hot liquids is provided to the therapy wrap and the return flow is received from the therapy wrap and directed to the cold or hot reservoirs, wherein during operation of the therapy device, directing operation of the cross-tank valve to open fluid communication between the reservoirs for a first time period.

In some methods, the method further includes directing cycled operation of the cross-tank valve to open and close fluid communication between the reservoirs, such that during each open-close cycle the cross-tank valve is open for the first time period and closed for a second time period until the difference between the measured liquid levels in the cold and hot reservoirs is within a predetermined deviation amount.

In some methods, the minimum liquid level of the of the cold and hot reservoirs corresponds to a liquid level where the cold and hot reservoirs indicate a critically low operating condition.

In some methods, the therapy device is not operating when at least one of the cold and hot liquids have not been provided to the therapy wrap for a predetermined off period, when the therapy device is not operating, directing operation of the cross-tank valve to open fluid communication between the reservoirs for a first time period.

<FIG> and illustrate a system <NUM> for providing cold, heat/hot/warm (hereafter referred to as "hot"), and/or rapid contrast therapy, which involves rapidly alternating between cold therapy and hot therapy. The system can circulate cold or warm fluid, such as water, through a hose, into a therapy wrap, and then back to the fluid reservoirs of the system. The system can utilize a vapor compression system or other chiller technology to cool the cold water reservoir, and immersion heaters can be used to heat the hot water reservoir. The system can have two or more ports, in order to serve two or more patients simultaneously. Two or more air pumps can be utilized (one for each port) in order to provide pneumatic compression along with the thermal therapy. In other embodiments, the system may have a single port and single air pump to treat just a single patient.

In some embodiments, the system <NUM> can have a user interface <NUM> on an upper front facing panel. The user interface <NUM> can be a touch display. An on/off power button <NUM> can be provided. The on/off power button can be located on, in or near the user interface <NUM>. The upper front facing panel can also have a reservoir fill cover <NUM> that can be opened to provide access to fill ports. Handles <NUM> can also be provided to allow the user to move the system, which can have a base with <NUM> locking casters <NUM>. A removable or openable front cover <NUM> can provide access to the internal components of the system. Air vents <NUM>, a hose holster <NUM>, and a connector hose <NUM> can be located on one or both the sides of the system.

The rear of the system can have a fan <NUM>, additional air vents <NUM>, drain ports <NUM>, a USB port <NUM> and/or network port, an additional on/off power switch <NUM>, a power cord inlet <NUM>, and equipotential ground pins <NUM>.

COOLING: water can be supplied and returned to the cold reservoir as controlled by the flow control valves associated with the port. Since there is only one cold reservoir in some embodiments, the cold reservoir temperature control may be common to both ports, or all ports for embodiments with more than <NUM> ports, and the temperature may be adjustable from the user interface, such as the home screen which can be the default display screen. Each port can have individual settings for treatment parameters, including treatment temperatures and duration and air pressure, which allow the system to deliver customized treatment to each wrap connected to the system.

HEATING: water can be supplied and returned to the hot reservoir as controlled by the flow control valves associated with the port. Since there may be only one hot reservoir in some embodiments, the hot reservoir temperature control may be common to both ports, or all ports for embodiments with more than <NUM> ports, and its temperature may be adjustable from the user interface, such as the home screen which can be the default display screen. Each port can have individual settings for treatment parameters, including treatment temperatures and duration and air pressure, which allow the system to deliver customized treatment to each wrap connected to the system.

CONTRAST: water supplied to the wraps can alternate between the hot and cold reservoirs based on the separate and customizable hot duration and temperature and cold duration and temperature settings. A typical treatment is alternating <NUM> hot and <NUM> cold. In some embodiments, durations of less than one min on either hot or cold therapy to prevent the wraps from being half filled with warm/hot water and half filled with cold water. Air pressure can also be adjustable separately for the hot and cold treatments. For example the pressure could be set to high (i.e., 75mmHg) during cold and med low (i.e., <NUM> mmHg) during hot. In some embodiments, the pressure applied during cold treatment can be higher during cold treatment than hot treatment to work alongside with vasoconstriction during cold treatment. Heat causes vasodilation, and blood rushes in - so air pressure may be counterproductive with heat therapy, which means using a lower pressure during heat treatment may be beneficial. In some embodiments, treatment duration selections may be limited to whole cycle values to end in a certain mode. For example, a hot and cold cycle may be limited to minute increments, and a combined hot and cold cycle duration may be limited to a set value or upper limit. For example, the single combined hot cold cycle may not exceed <NUM> minutes in some embodiments, meaning if the hot treatment is <NUM> minutes, then the cold treatment is <NUM> minute. In some embodiments, a hot cold cycle may be limited to <NUM> to <NUM> minutes, or <NUM> to <NUM> minutes, or <NUM> to <NUM> minutes. In some embodiments, the total treatment is configured to end with cold treatment or hot treatment by configuring the treatment times and number of cycles.

COMPRESSION ONLY: water is not pumped through the wraps but air or another gas can be pumped into the wrap. Treatment duration, air pressure, and optionally the pressure curve profile (the ramping up, maintenance, and release of pressure over time) will be adjustable.

COMPRESSION WITH THERMAL THERAPY: The thermal therapies described herein can be combined with the compression therapy.

<FIG> illustrates an embodiment of a user interface <NUM> that can serve as a control panel. The user interface <NUM> can be a touch screen with graphical icons that represent the different treatment modalities and can include adjustable parameter settings, such as hot and cold temperature settings for example. For example, the control panel can use a <NUM>" touchscreen TFT set in a traditional domed membrane switch. Most of the controls can be on the TFT display. A few buttons like power, STOP, home, etc. can be on the membrane switch. In some embodiments, a capacitive touch screen can be used.

In various embodiments, in the cooling mode the pressure of gas furnished by the control unit is between about <NUM> psig and about <NUM> psig, preferably between about <NUM> psig and about <NUM> psig, and more preferably about <NUM> to about <NUM> psig. In various embodiments, the control unit maintains a compressive force of between about <NUM> psig and about <NUM> psig. In various embodiments, the control unit maintains a compressive force of between about <NUM> psig and about <NUM> psig. In various embodiments, the pressure of gas furnished by the control unit is user selectable in increments of <NUM> Hg from <NUM> to about <NUM>.

In various embodiments, the pressure of gas furnished by the control unit is based on the patient's response. For example, if the patient is wearing the wrap during exercise, the pressure may vary based on how strenuous the exercise is. If the patient is having trouble breathing, the control unit may decrease the compressive force around the lungs. The pressure profile map may be set to adjust based on a predetermined routine. In various embodiments, the pressure profile map includes <NUM> minutes of slowly increasing pressure followed by <NUM> minutes of decreasing pressure. In various embodiments, the pressure profile map includes <NUM> seconds of increasing pressure followed by <NUM> seconds of decreasing pressure. In various embodiments, the pressure fluctuates at random. In various embodiments, the pressure profile map includes <NUM> minutes of compression followed by <NUM> minute with no compression.

The strength and frequency of the pulses may be modified depending on the application. In various embodiments, the control unit delivers pulses of compression for massaging therapy.

In various embodiments the wrap can be used with a rigid or semi-rigid support such as a brace. In various embodiments, the control unit can apply and maintain a low pressure or no pressure when the control unit detects a brace in use with the wrap. In various embodiments, the control unit can apply and maintain higher pressures when the control unit detects a brace not in use with the wrap. In some embodiments, a low pressure is less than <NUM> psig, <NUM> psig, <NUM> psig, <NUM> psig, <NUM> psig, <NUM> psig, or <NUM> psig. In some embodiments, a high pressure is greater than <NUM> psig, <NUM> psig, <NUM> psig, <NUM> psig, <NUM> psig, <NUM> psig, or <NUM> psig.

In heating mode, the same pressures will be available as for the cold settings.

<FIG> illustrates various pressure curve profiles: high (about <NUM> mmHg), medium high (about <NUM> mmHg), medium low (about <NUM> mmHg), and low (about <NUM> mmHg). The ramp time can be about <NUM> minutes to achieve the target pressure for high, medium high, and medium low, while the ramp time for low can be about <NUM> minute. The ramp times and target temperatures for the different settings can be adjustable, or can be predetermined and fixed.

In some embodiments, the default pressures for the cooling and heating modes is different. In other embodiments, the default pressures for the cooling and heating modes is the same.

In contrast therapy mode, the therapy profile can specify the cold duration and temperature and compression, the hot duration and temperature and compression, and the duration of treatment or number of cycles to be run.

In some embodiments, the system allows named preset therapy sessions to be configured and saved by the user that can be later selected directly by name and/or a unique icon.

Further details regarding wraps, fluid bladders, air bladders, and their operation and manufacture are described in <CIT>; <CIT> and <CIT>, <CIT>.

<FIG> illustrate an embodiment of a therapy wrap. The therapy wrap <NUM> is configured for wrapping to a portion of an animate body for delivering treatment. The body may include, but is not limited to, a mammalian body such as a human or an equine animal. The exemplary therapy wrap is in the form of a sleeve for connecting various components of heat transfer device <NUM> to the patient's body. The sleeve is similar in many respects to the sleeve disclosed by <CIT> and cover disclosed by <CIT>.

Exemplary therapy wrap <NUM> includes an opening <NUM> for directing heat transfer device <NUM> into a pouch or cavity in the sleeve interior. A portion of sleeve may be pulled back to reveal the pouch and facilitate positioning of the heat transfer device in the pouch as shown in <FIG>. Any suitable fastening means can be used to close the opening such as, but not limited to, a zipper.

The pouches may be selectively positioned in predetermined locations on therapy wrap <NUM>. In other words, the pouches may be fixed into a position on the wrap based on parameters defined before use of the wrap. Such parameters may include user preferences or application demands. In various embodiments, the sleeve is configured to position a bladder in one of a plurality of predefined locations. The predefined locations may be determined by user preferences. In various embodiments, the predefined locations correspond to key areas for core cooling of the body.

Therapy wrap <NUM> may have a variety of shapes and sizes for applying to different portions of the body or different body anatomies. The sleeve may be shaped and configured for application to a mammal, and in various embodiments, a human. In various embodiments, the sleeve is shaped for applying to and covering all or part of a torso, a thoracic region, a cranial region, a throat region, a limb, and a combination of the same. Various aspects of the therapy wrap, in particular the sleeve, shape and design may be similar to the devices disclosed by <CIT> and <CIT>.

In general, "heat transfer device" refers to the body heat exchanging component(s). In various embodiments, the heat transfer device includes layers of material defining a flexible fluid bladder through which a liquid is circulated and a gas bladder in which a pressurized gas is injected. Exemplary heat transfer device <NUM> is in the form of a conventional multi-bladder assembly for positioning adjacent a treatment site of a body. In various aspects, the multi-bladder assembly is manufactured and configured using known techniques. A commonly used thermal bladder assembly uses both a compliant fluid bladder <NUM> for circulating heat transfer fluid and a gas pressure bladder <NUM> which overlays the fluid bladder (best seen in <FIG>). The gas pressure bladder is adapted to inhibit edema and/or for pressing the fluid bladder against the body part to be subjected to heat exchange.

More specifically, outer gas pressure bladder <NUM> is adapted to receive a first fluid such as a gas (e.g., air) that can be regulated to provide the desired amount of inflation of the bladder or pressure therein. This inflation or pressure affects the compressive force applied to the animate body during use. Inner fluid bladder <NUM> is adapted to receive a fluid, such as a coolant which can be in the form of a cold liquid, to transfer heat away from the animate body part. Alternatively, the fluid supplied to the inner bladder can have a temperature higher than the animate body part to heat the body part.

The hose and connector to attach the therapy wrap to the system can use a <NUM>-port connector with a fluid inlet, a fluid outlet, and a gas port.

In some embodiments, the temperature of the hot reservoir can be adjustable from about <NUM> to <NUM> degF, and the temperature of the cold reservoir can be adjustable from about <NUM> to <NUM> degF. The temperature ranges can be determined by safety considerations (i.e., avoiding tissue damage) and freeze prevention of fluid in cold reservoir. In some embodiments, the range limits can be adjusted by the user. For example the upper range for the hot reservoir can be lowered by the user to, for example, <NUM> or 115F, and/or the lower range for the cold reservoir can be increased to <NUM> or <NUM> or 50F. In some embodiments, the user adjustable range is limited to adjustments made within a predetermined range so that the user cannot exceed a predetermined hot temperature limit or fall below a predetermined cold temperature limit.

In some embodiments, distilled water is provided and/or recommended for use to reduce scaling. In the event distilled water is not used, descaling agents such as phosphoric acid, acetic acid, or citric acid can be flushed through the system. Instructions for descaling the system can be provided.

In some embodiments, addition of an antimicrobial and or scale inhibiter may also be recommended.

In some embodiments, the system is drained when not in use and drained/refilled periodically. As shown in <FIG>, to facilitate draining and refilling, the system <NUM> can have easily accessible drain ports <NUM> and fill ports <NUM>. The fill ports <NUM> can be located on the front facing portion of system near the user interface for increased access, which allows the user to easily add more fluid to the system if needed, even during treatment. A removable or openable cover <NUM> can cover the fill ports <NUM>.

To make a reasonably sized system, the ratio of thermal mass to heat transfer suggests deviating from the traditional refrigeration temperature control methods.

<FIG> are schematic diagrams that illustrate various embodiments of the system. As shown in <FIG>, in some embodiments with an AC system, a hot gas bypass <NUM> can be used and temperature can be controlled with an isolation valve <NUM> upstream of the thermal expansion valve <NUM>. As shown in <FIG>, if a variable speed DC compressor <NUM> is used the power may be lowered to allow use of a heater <NUM> in the cold tank <NUM>. <FIG> illustrates a schematic of the cold tank portion, and <FIG> illustrates a schematic of the hot tank portion. <FIG> and <FIG> illustrate pumps <NUM>, <NUM>, <NUM>, <NUM> that can be used to pump fluid too the chiller <NUM>, the heater <NUM>, and between the cold tank <NUM> and the hot tank <NUM>. For example, recirculation pump <NUM> can be used to direct flow from the cold tank <NUM> to the hot tank <NUM>, and recirculation pump <NUM> can be used to direct flow from the hot tank <NUM> to the cold tank <NUM>. The pumps in combination with a system of valves can be used to control the fluid flow in the system.

In order to make the cooling and heating systems more efficient, it will be advantageous to delay switching of return water for a period of time after switching from hot to cold or from cold to hot, i.e., when switching from hot to cold, there will be about <NUM>-<NUM> or some other volume of hot water still in the hoses and wraps. If return water switched at the same time as the supply water, a large volume of hot water would be pumped into the cold water tank. The inverse would be true when switching from cold back to hot. Return water switching could be delayed until the return water reached a predetermined temperature or time, which can be measured using a temperature sensor, such as a thermistor. Switching between reservoirs can be achieved using solenoid valves that can be opened and closed based on measurements from the temperature sensor. For example:.

When water supply is switched during contrast therapy, the tanks will often be at different levels. There should be a method of protecting the system from overflow of one tank or another, and also a system to prevent one tank from running low on fluid.

A small equalization tube <NUM> may be a solution as shown in <FIG> and <FIG>. This equalization tube <NUM> would allow the tanks to equalize. The length and diameter of the tube could be sized to prevent fast equalization (which would dump hot water into the cold tank or vice versa). For example, the length and diameter of the tube can be sized to allow up to about <NUM>%, <NUM>%, or <NUM>% of the tank volume in fluid to pass through per minute. The equalization tube <NUM> can be located on the upper portion of each tank, such as the upper <NUM>/<NUM>, <NUM>/<NUM>, <NUM>/<NUM>, <NUM>/<NUM>, or <NUM>/<NUM>.

A reversible pump between the reservoirs is another possible solution. This would have the advantage of being able to stop or start equalization at any time, and in any direction. Further advantage would be that hot water could be added to the cold tank, or vice versa, in order to more rapidly reach a desired tank temperature (i.e., when changing tank temperatures) or to prevent overshoot, etc..

Another solution can be for overflow to be passed back and forth between the tanks at the filling ports shown in <FIG>. The filling ports can be housed in a receptacle that can accommodate fluid overflow from the reservoirs. As one reservoir overflows through its filling port, the receptacle is filled and the overflow fluid flows into the filling port of the other reservoir.

If the liquid levels in the tanks are equilibrated or balanced during therapy, either hot water is added to the cold tank or cold water is added to the hot tank, which reduces the temperature gradient between the hot and cold tanks. This change in tank temperatures during therapy may not be desirable. Therefore, in some embodiments, tank fluid level management, particularly the liquid leveling steps as described herein, can be generally performed outside of therapy, such as after therapy is completed. However, when the liquid level in a tank is critically low, a liquid leveling procedure can be used even during therapy to return the tank levels to noncritical levels. This liquid leveling procedure can be implemented, for example, through control of the pumps described herein in connection with <FIG> and <FIG>, for example.

It would be advantageous to make filling the system easy and intuitive. Since there will be two tanks, it may be advantageous to only have one fill port, and not have to fill each reservoir individually. In other embodiments, each reservoir can have its own fill port, as shown in <FIG>. Directing the water into both the hot tank and cold tank equally may be a challenge. If the fill line is above the level of each reservoir, then both reservoirs would equalize at that point. However, that does not leave room for additional head height in either tank during use, and the two tanks would mix freely, thus making temperature control of each tank more difficult and inefficient. In some embodiments, an indicator on the user interface can indicate the fill level of the reservoirs and/or can indicate when a reservoir is fully filled. The tanks can have a fluid level sensor to determine the amount of fluid in the tank.

Therefore, an embodiment of a reservoir that addresses these concerns is shown in <FIG> and <FIG>. The system comprises a Cold Reservoir <NUM>, a Hot Reservoir <NUM> and a Fill Port <NUM>. Water may be poured into the Fill Port <NUM> using a pitcher, hose, gallon jug, etc. Ease of filling may be aided by use of a wide, funnel or tapered shape to the fill port <NUM>. The fill port <NUM> may be sealed by a Fill Cap assembly <NUM>. The fill cap assembly <NUM> may include a Knob 9004A a strainer 9004B and a Tank Seal 9004C. The Tank Seal 9004C may be configured to provide an opening between the reservoirs and the ambient environment in one position (open position), and to seal the opening between the reservoirs and the ambient environment in another position (closed position). In the open position, there may be a conduit that connects the Hot and Cold Reservoirs. This allows for water to equalize between the hot and cold reservoirs once an adequate fill level is attained (between the Upper Fill Level <NUM> and Lower Fill Level <NUM>. When the Tank Seal 9004C is in the Closed Position, the conduit between the Hot and Cold reservoirs may be closed off, in order to prevent exchange of fluid as fluid levels 9008A-B and 9009A-B change independently within the system. Vents <NUM>, <NUM> in the Reservoirs <NUM>, 9001allow for the air pressure within the tanks to be nearly atmospheric.

Cold Water Outlet <NUM> and Hot Water Outlet <NUM> may be located at the bottom surface of the reservoir, or may be at a level just above the reservoir bottom to prevent sediment from entering the fluidics lines. Cold Water Inlet <NUM> and Hot Water Inlet <NUM> would desirably be configured such to encourage mixing within the reservoir. Proper mixing, or forced convection around the Heater <NUM>, is particularly important to efficiently heat the water tank, and reduce surface temperature on the heater, which in turn reduces the likelihood of scaling developing on the Heater <NUM>. For this reason, it may be desirable to include a Heater Baffle <NUM> near the heater increase water velocity around the heater surface. The Heater Baffle <NUM> may be designed such to provide a torturous water path to further reduce the boundary layer at the surface of the heater. A similar approach may be used if a Heater is used in the Cold Reservoir as well.

A sensor (preferably a Pressure Sensor) may be used in order to sense the water level in the tank. The Pressure Sensor <NUM>, <NUM> would be best placed near the bottom of the tank to most accurately measure Head Pressure within the tank. Reservoir Vents <NUM>, <NUM> would allow for accurate pressure measurement.

Water level may be equalized or adjusted via a Tank Level Facilitator <NUM> located adjacent to the reservoirs. The Tank Level Facilitator <NUM> may be passive, and could comprise of a simple orifice, or long length of tubing sized to provide a desired flowrate between the two reservoirs base simply on water level difference. The Tank Level Facilitator <NUM> may also be an active device that pumps fluid from the Hot Reservoir <NUM> to the Cold Reservoir <NUM> or vice versa. This may be desirable if a significant water level imbalance is sensed, or to adjust the temperature in one of the tanks rapidly. In addition to or in lieu of the tank head Pressure Sensors <NUM>, <NUM>, alternative liquid level sensors or switches may be employed in order to provide a means of identifying whether the tank is above or below a certain point. This may be valuable as a redundant indicator, or to ensure that water was always above the heater element.

An overflow prevention means may be to add an Overflow Conduit <NUM> between the two Reservoirs. This may provide for a more rapid exchange of excess water to the opposite tank than could be done with a passive version of the Tank Level Facilitator <NUM>.

Furthermore, Overflow Drains <NUM>, <NUM> may be utilized in order to route excess water to outside the device, (in an overflow tank, or onto the ground). Additional sensors could be added to the Overflow Drains <NUM>, <NUM> to sense this condition, or a means to detect moisture in the overflow tank could be added.

Parameters for using the system are shown in <FIG>.

Various screens displayed by the touch screen interface are shown in <FIG>. The system can include a controller and/or processor and memory for storing instructions and programming to implement the user interfaces described herein as well as controlling the system as described herein. The various components, such as the pumps, the sensors, the compressors, the heat exchangers, the heaters, and the valves, can be controlled by the processor and/or send information to the processor.

Hot and Cold Tank reservoir temperatures may deviate if tank level during therapy, as water fills the heat exchangers and then returns to either the hot tank or cold tank. Particularly during contrast therapy, water is returning to either the hot tank or cold tank. In the current embodiment, water is returned to the tank in which the temperature is closest to avoid unnecessary thermal pollution of excessively hot water entering the cold tank, or excessively cold water from entering the hot tank.

Over extended therapy times, or with larger heat exchanger volumes, this may lead to a condition where one of the tanks fills up and the other one gets too empty. This problem may be solved by keeping the tanks equalized during therapy by, for instance, pumping water from the higher tank to the lower tank. Or, connecting the tanks with a small diameter tube to allow tanks to equalize over time. This has the disadvantage of brining the emptier tank away from its set temperature, due to the other tank water entering the tank. For instance, if hot water is pumped into the cold tank to increase the tank level, the hot water will increase the temperature in the cold tank. It is not desirable to have therapy temperatures vary excessively away from the set point in this manner.

Increasing the tank size helps eliminate this condition because if the tank is sufficiently large, there is no worry of getting too full or too empty. However, the larger the tank volume, the longer it takes for reservoir temperatures to reach set point. So excessively large tanks may provide more stable temperature over time and provide plenty of room for large heat exchangers to be used without the tanks getting too full or too empty, but it may take an unacceptable amount of time for the system to reach desired set point. For instance, with <NUM> liter tanks, when turning the system on in the morning with the reservoir water at room temperature, it may take <NUM> minutes to reach set point. When with <NUM> liter tanks, it may only take <NUM> minutes to reach set point which is more desirable for the customer.

To keep the tanks closest to set point, an algorithm has been developed to optimize water temperature during therapy while keeping tank volumes small enough to allow for acceptable cool down and heat up times.

During therapy, the tanks will not be equalized in order to prevent unnecessary cross tank thermal pollution. However, if the water levels get too low or too full (overflow), preventative steps may be taken: for instance, at a predetermined level, the water returning from the heat exchanger(s) may be diverted to the lower tank instead of the tank of the closest temperature. This is more beneficial than sending water from the opposite tank, as the return water will be closer to the lower tank temperature than the opposite tank. As a further preventative measure, if the tank level gets critically low, cross tank flow may be initiated.

Similarly, if one tank gets too full, it will begin overflowing into the other tank. This causes thermal pollution in a similar manner as cross tank flow.

For instance, the water return valves may perform in the following manner:.

And the tank to tank valves may perform in the following manner:.

Once therapies end, there will be a tank equalization period where tanks will equalize, at which point the tank with the lower level will get water added from the tank of the higher level. This will thermally pollute one of the tanks, and some time would be required for the tank to get back to set point.

Adding a delay mechanism between the end of therapy and the tank equalization period may be desired in case the user wants to use the system right away while the tanks are near their set temperature. The delay could be a fixed period of time (i.e. <NUM> seconds), or could take the form of a "do not equalize" button.

A graph of the thermal performance is shown in <FIG> and is presented as an example of tank temperatures before and after the enhanced algorithm. The therapy in the example below is a Rapid Contrast Therapy with a straight knee wrap on each port (port <NUM> and port <NUM>) with <NUM> minutes on cold, followed by <NUM> minutes on hot therapy, alternating back and forth for a total of <NUM> minutes. Two versions of software (containing the algorithms) are presented. <NUM> is the improved algorithm that does not equalize the tanks during therapy. <NUM> keeps tanks equalized during therapy to within a certain limit.

Claim 1:
A system (<NUM>) for providing rapid contrast therapy, the system comprising:
a cold reservoir (<NUM>) configured to hold a cold liquid, the cold reservoir including a first liquid level sensor to measure a level of the cold liquid;
a cold therapy supply valve in fluid communication with the cold reservoir, the cold therapy supply valve directing a flow of the cold liquid to a therapy device;
a hot reservoir (<NUM>) configured to hold a hot liquid, the hot reservoir including a second liquid level sensor to measure a level of the hot liquid;
a hot therapy supply valve in fluid communication with the hot reservoir, the hot therapy supply valve directing a flow of the hot liquid to the therapy device; and
a return valve directing return flow from the therapy device to at least one of the hot and cold reservoirs; and
a controller directing operation of the cold and hot therapy supply valves to control the flow of the cold liquid and the hot liquid to the therapy device, the controller directing operation of the return valve to control the return liquid flowing from the therapy device to at least one of the cold and hot reservoirs,
characterized in that
the controller directs the return flow to either the cold reservoir or the hot reservoir depending on the measured liquid level in each of the cold and hot reservoirs such that the measured liquid level in the cold and hot reservoirs does not exceed a corresponding maximum liquid level or fall below a corresponding minimum liquid level.