WO2012028730A1

WO2012028730A1 - Device for thermal treatment of the scalp

Info

Publication number: WO2012028730A1
Application number: PCT/EP2011/065233
Authority: WO
Inventors: Olivier Zuercher; Richard Voellmy
Original assignee: Thermather Sarl
Priority date: 2010-09-02
Filing date: 2011-09-02
Publication date: 2012-03-08

Abstract

The subject invention relates to a device for thermal treatment of the scalp of a subject at a desired treatment temperature, comprising (1) a treatment station comprising a water inlet, a water outlet and means for heating or cooling the scalp of a subject by forced convection using water that directly contacts the scalp, (2) a treatment reservoir for holding a volume of water that is greater than that required to operate the treatment station, the treatment reservoir having a water inlet and a water outlet fluidly connected with the treatment station, (3) means for supplying to the treatment reservoir said volume of water having the desired treatment temperature and for maintaining this temperature in the treatment reservoir during the thermal treatment, and (4) means for supplying the treatment station with water from the treatment reservoir and for establishing a circulation of water between the treatment station and the treatment reservoir. The invention further relates to uses of the devices of the invention in thermal treatments of the scalp of a subject.

Description

Device for thermal treatment of the scalp

Field of the Invention

The subject invention relates to devices that are useful for administering in a uniform and reproducible fashion a thermal treatment to the scalp of a subject. Typically, the treatment consists of exposing the scalp of a subject to an appropriate, moderate heat dose for preventing chemotherapy-induced hair loss or inducing a feeling of well-being. Alternatively, devices of the invention are used for the reproducible cooling of the scalp of a subject. Background of the Invention

Certain groups of cytotoxic drug substances used in chemotherapy of cancers cause severe hair loss. Although this hair loss is largely reversible, its occurrence is, possibly, the most feared side effect of chemotherapy. The groups of cytotoxic substances that result in severe hair loss include some of the most frequently used drug classes in chemotherapy, i.e., alkylating agents such as cyclophosphamide, anthracyclines such as doxorubicin, taxanes and topoisomerase inhibitors such etoposide. Decades ago it was recognized that reduction of the blood flow in the scalp and scalp metabolism during such chemotherapy can have a hair-saving effect. While chemotherapists also resorted to applying icepacks to the scalp of patients to limit chemotherapy-induced hair loss, a number of devices were conceived that were intended to facilitate scalp cooling during chemotherapeutic interventions. U.S. Patent No. 4,425,916 discloses a cap capable of covering a large portion of the scalp of a wearer, which cap includes multiple "cap structures" or "panels", each containing at least one compartment for receiving a liquid capable of being cooled and thereafter maintaining a low temperature for a considerable length of time. U.S. Patent No. 4,382,446 discloses another headpiece for heating or cooling the scalp of a subject comprising a headband to be wrapped around the head and an affixed crown portion for covering the top of the head, headband and crown portion incorporating sealed bags filled with "heat exchanging medium". A related headpiece is described in U.S. Patent No. 4,765,338. Another headpiece essentially consisting of an assembly of a multitude of pockets into which gel units can be placed is disclosed in U.S. Patent No. 5,480,418. A helmet-like structure that provides for a closed air space between the scalp of a subject and the helmet and comprising a thermoelectric element for cooling or heating said air space is provided in U.S. Patent No. 5,603,728. Several patents describe somewhat related heating devices designed for uses unrelated to prevention of hair loss. For example, U.S. Patent No. 4,459,471 proposes a cap said to be useful for hair conditioning. This cap is capable of heating hair on top of the head by means of an electrical heating coil integrated in the cap. U.S. Patent No. 6,500,201 describes a cap containing a heating section, which heating section consists of an internal, waterproof layer sheet and an outer air-permeable sheet. A composition comprising a compound that generates heat when exposed to air is introduced in spaces between the two sheets. With the exception of the device of U.S. Patent No. 5,603,728, the various devices cool or heat the scalp in an indirect fashion: the cooling or heating medium is not in contact with the scalp. Because of the different length, quality and density of scalp hair (and variable quantities of air trapped therein) in different regions of the scalp as well as between different human subjects, these devices are incapable administering a reproducible thermal treatment to the scalp of a subject. The device of U.S. Patent No. 5,603,728 uses still warm or cold air for heating or cooling, respectively. Much as with the other devices, the hair layer of subjects represents an insulation of varying importance, precluding reproducible thermal treatment of the scalp.

A novel method for preventing chemotherapy-induced hair loss has been disclosed in U.S.

Patent No. 7,405,080 (EP1427383). In an embodiment of this method the scalp of a cancer patient who is to undergo a chemotherapy treatment is subjected to controlled heating so that hair follicles in the scalp receive an effective dose of mild heat. Heat dose is defined both by temperature and time of exposure. Useful temperature and time ranges for exposure of hair follicles are about 39 to 45°C and about 15 to 120 minutes, respectively. This thermal treatment of the scalp, which is administered preferably several hours prior to chemotherapy treatment, induces over-expression of heat shock proteins in the hair follicles. The resulting elevated levels of heat shock proteins have a generalized cytoprotective effect, preventing or dramatically mitigating damage to the hair follicles inflicted by their subsequent exposure to cytotoxic agents. Extrapolating from animal model experiments, there will be a relatively narrow range of heat doses that will produce optimal hair- protecting effects in human subjects. To practice this thermal treatment approach, a device is required that is capable of reproducibly exposing the scalp to a precisely maintained temperature for a defined time. Heat transfer from heating medium to the scalp needs to be effective for achieving heating of the hair follicles that are situated below the scalp surface and for overcoming heat losses to the blood circulation in the live layers of the scalp. Finally, effective, uniform and reproducible heating must be administered to patients with different head size, hair length and hair density. The inventors realized that none of the prior art devices or adaptations thereof would be capable of satisfying the latter requirements.

The inventors developed devices whose peripheral element is a treatment station into which the back of the head of a patient is inserted up to the hairline. The scalp of the patient is heated or cooled, as the case may be, by forced convection using water which directly contacts the patient's scalp in the course of its rapid circulation through the treatment station. The primary function of the remaining aspects of the devices is to provide adequate volumes of water having the desired treatment temperature for circulation through the treatment station and to accurately maintain treatment temperature during treatment. Effective, uniform and reproducible heating such as is provided by devices of the invention will also be important in the wellness area. Poor reproducibility, poor temperature control and lack of uniform administration of heat will diminish the acceptance of wellness-type thermal treatments of the scalp. Furthermore, standardization of cooling that can be achieved by the devices of the invention is expected to enhance the efficacy and reproducibility of the age-old scalp cooling method for the prevention of chemotherapy-induced hair loss.

Summary of the invention

The subject invention relates to a device for thermal treatment of the scalp of a subject at a desired treatment temperature. The device comprises a treatment station comprising a water inlet, a water outlet and means for heating or cooling the scalp of a subject by forced convection using water that directly contacts the scalp. In some embodiments, the treatment station is a head bath that when filled with water to its working level, which is typically a level close to or at the rim of the bath, is sufficiently large for a subject to insert its head so that its hairline is submersed and the back of the head does not touch the bottom of the bath, leaving sufficient space for effective water circulation around the scalp. The head bath contains at least one water inlet and at least one water outlet and is capable of being maintained in a filled state during treatment, in the course which water is rapidly circulated through the bath. This is most conveniently achieved by having the circulating water exit the bath over the top of the bath or through an outlet located near the rim. However, the outlet or outlets may be located elsewhere than near the rim of the bath, provided that an associated mechanism controls the rate of water exit such that the bath remains in a filled state. The water inlet or inlets may be positioned anywhere in the head bath; in particular embodiments a singular water inlet is placed at or near the lowest point of the head bath. The inlet or inlets can contain impinging jets that are pointing towards the head of the subject for improved convection or for a gentle head massage or, alternatively, jets that eject water in a peripheral direction to generate a current around the head of a subject installed in the bath. The inlet or inlets can also contain a vortex/twisting element(s) to create more uniform convective conditions. While the head of a subject installed in the filled head bath is partially supported by its own buoyancy, the head bath optionally contains a permanently or removably affixed head support to increase the comfort of the subject. Although such head support may take different forms, a simple head support may be a wide mesh net made from water-resistant material that is suspended from the rim or positions close to the rim. An example of a head support of this kind is shown in Fig. 4. In other embodiments, the treatment station is configured such that the subject can remain in a seated position during treatment and enjoy some freedom of movement. This will be particularly important when the thermal treatment is a cooling treatment administered to prevent chemotherapy-induced hair loss. In such treatments, the subject's scalp may need to be cooled during a period of several hours. A treatment station for treatment of a subject in a seated position comprises (a) a rigid container structure comprising at least one water inlet, at least one water outlet and an opening near the bottom wide enough to allow for insertion of the head of the subject up to its hairline, the opening being reversibly sealable around the head of the subject, and (b) a sieve shaped to follow the curvature of the subject's scalp at a suitable distance from the scalp and fastened to the interior side of the container structure near the edges of the opening thereby creating spaces on either side of the sieve that are liquid-connected through the perforations of the sieve, the perforations serving as impinging jets capable of directing water to essentially all points of the scalp, whereby the water inlet communicates with the space formed between the rigid enclosing structure and the sieve and the water outlet communicates with the space formed between the sieve and the head of the subject. A suitable distance between the sieve and the scalp of the subject can be between about 1 cm and 25 cm, more preferably between about 2 cm and 5 cm. The weight of the treatment station may be supported by the subject. Alternatively, it may be suspended from a supporting structure to reduce the weight to be carried by the subject. The treatment station can be produced in several different sizes to accommodate different head sizes of subjects. In another embodiment, a treatment station for treatment of a subject in a seated position comprises (a) a rigid container structure comprising at least one water inlet, at least one water outlet and an opening near the bottom through which opening the head of the subject is inserted up to its hairline, the opening being reversibly closed around the head of the subject by stretchable, flexible material that bridges the gap between opening and head of the subject thereby preventing water leakage from the station, and (b) a support shaped to follow the curvature of the subject's scalp at a suitable distance from the scalp and fastened to points on the interior side of the container structure, the support carrying a multitude of impinging jets that are capable of distributing incoming water to essentially all points of the scalp, the impinging jets being fluidly connected with the one or more water inlets. The latter treatment station can be designed to be used in one of two different modes. In one mode, the one or more water outlets are near the bottom of the station, and the closing of the device around the subject's head is configured to facilitate water drainage through the one or more water outlets. In this mode, the water exiting the jets travels through air before contacting the scalp. In the other mode, the one or more water outlets may still be near the bottom of the station, but, preferably, will be placed higher up on the side wall of the container structure, most preferably above the nozzles of the jets. Alternatively or in addition, the one or more water outlets are controlled by regulatable valves. During operation, water is allowed to accumulate in the container to a level at which the nozzles of the jets are submerged. Hence, the jets will operate underwater for most of the treatment duration. This mode of operation will be quieter and more comfortable for the subject than the other mode. A suitable distance between support and scalp is a distance at which the nozzles of the jets are separated from the scalp by between about 1 cm and 25 cm, more preferably between about 2 cm and 5 cm. The single jets or arrays of jets ("showerheads") may be associated with a mechanism that allows for their axial displacement when mounted on the support. The treatment station advantageously is suspended from a supporting structure to reduce or remove the weight to be carried by the subject.

The device further comprises a treatment reservoir that holds a volume of water that is larger than the volume required for operating the treatment station with a subject installed therein. The treatment reservoir comprises a water inlet and a water outlet which are fluidly connected with an outlet and an inlet, respectively, of the treatment station. The device further includes means for supplying the treatment station with water from the treatment reservoir and for establishing a circulation of water between the treatment station and the treatment reservoir. In a convenient arrangement of components, the treatment station is positioned slightly higher than the treatment reservoir. The treatment station is supplied with water from the treatment reservoir and a rapid circulation of water through the treatment station is thereafter established by a pump that is mounted in the fluid connection that links treatment reservoir and an inlet of the treatment station. Water exits the treatment station through an outlet and is returned through a connecting fluid line to the treatment reservoir. The device of the invention further includes means for providing water of the desired treatment temperature to the treatment reservoir and of maintaining this water temperature during treatment. Such means can comprise one or more heating or refrigeration elements (or heat exchangers) mounted in the treatment station, in the treatment reservoir or in a fluid connection between the treatment reservoir and the treatment station and one or more temperature sensors for measuring water temperature in the device and enabling regulation of the heating or refrigeration elements. This regulation can be automated by means of a logic controller that integrates measurements from the one or more temperature sensors for controlling the one or more heating or cooling elements so that the desired treatment temperature is reached and maintained for the duration of the thermal treatment. Water can be supplied to the treatment reservoir from a water line of the building in which the device is located. In a different embodiment, means for providing water of the desired treatment temperature to the treatment reservoir and of maintaining this water temperature during treatment comprises a combination of valves communicating on the one hand with cold and hot water lines of the building in which the device is installed and on the other hand with an inlet of the treatment reservoir, the valves capable of mixing the cold and hot water of the building in any proportion and regulating the flow of the so mixed water. Further included is at least one temperature sensor that is mounted in the treatment station, in the treatment reservoir or in a fluid line connecting treatment station and treatment reservoir. Information from the temperature sensor can be used to regulate the combination of valves so that water of the desired treatment temperature is delivered to the treatment reservoir. In a particular embodiment, a second temperature sensor is mounted close to the combination of valves, i.e., in the fluid line connecting the combination of valves and the treatment reservoir. Having such an additional temperature sensor close to the combination of valves can facilitate their proper regulation, although the temperature sensor located in the treatment reservoir or elsewhere in the water circuit that connects treatment station and treatment reservoir remains the primary reference for regulation. During a thermal treatment, which may last for hours, water in the treatment circuit will cool down in the case of a hot treatment or heat up in the case of a cold treatment. Treatment temperature is maintained by delivery through the combination of valves of either hot water in the case of a hot treatment or cold water in the case of a cold treatment from the building's water supply. Consequently, water volume in the treatment reservoir will increase during the thermal treatment. To remove excess water, i.e., to maintain a constant volume in the treatment reservoir or to prevent its overfilling, the treatment reservoir can comprise a further outlet through which excess water can be removed in a controlled fashion. Such an outlet can be an opening near the top of the reservoir or an outlet near the bottom of the reservoir, evacuation of water through the outlet being controlled by a valve. Alternatively, the treatment reservoir may be sufficiently large so that removal of excess water during treatment is unnecessary. While the device may be operated manually, it will preferably include a logic controller that utilizes signals from the one or more temperature sensors for operating the combination of valves so that the treatment reservoir is first supplied with a volume of water of the desired treatment temperature sufficient for supplying the treatment station with the head of the subject installed therein and establishing a water circulation through the treatment station and thereafter hotter or colder water is added to the treatment reservoir to maintain treatment temperature during treatment. If the outlet for removing excess water is located near the bottom of the treatment reservoir, an automatically controlled device may further comprise a water level sensor that is installed in the treatment reservoir, and the logic controller will integrate signals from the level sensor to regulate flow through the valve securing the outlet so as to prevent overfilling of the treatment reservoir or keeping the water level constant.

Particular embodiments incorporate the concept of using two reservoirs, a treatment reservoir fluidly linked to the treatment station and an auxiliary water reservoir holding water that is either hotter (in the case of a hot treatment) or colder (in the case of a cold treatment) than the desired treatment temperature. Addition of water from the auxiliary reservoir to the treatment reservoir permits temperature maintenance in the treatment reservoir over the treatment duration and, additionally, allows for ramping up or down temperature in the treatment reservoir as desired. In a first such embodiment, the device of the invention that is useful for thermal treatment of the scalp of a subject at a desired treatment temperature comprises a treatment station comprising a water inlet, a water outlet and means for heating or cooling the scalp of a subject by forced convection using water that directly contacts the scalp. The device further comprises a treatment reservoir for holding a volume of water that is greater than that needed to operate the treatment station when the subject is installed therein, the treatment reservoir being fluidly connected with the treatment station through a water inlet and a water outlet of the reservoir and further fluidly connected through a water inlet and a water outlet of the reservoir with an auxiliary water reservoir. It is noted that the latter water inlet and/or water outlet may be the same or different from the water inlet and water outlet which are part of the water circuit connecting treatment reservoir and treatment station. A further element of the device is an auxiliary water reservoir for holding a volume of water of a temperature that is either higher, in the case of use of the device for a hot treatment, or lower, in the case of use of the device for a cold treatment, than the desired treatment temperature, the auxiliary water reservoir being fluidly connected with the treatment reservoir through a water inlet and a water outlet in the auxiliary reservoir. A combination of valves communicates on the one hand with the cold and hot water lines of the building in which the device is installed and on the other hand with either one or both an inlet of the auxiliary water reservoir and an inlet of the treatment reservoir, whereby the combination of valves is capable of mixing the cold and hot water in any proportion and regulating the flow of the so mixed water. The device further comprises pumping means as required for supplying the treatment station and establishing a continuous water circulation through treatment station and treatment reservoir, and for moving water between the treatment reservoir and the auxiliary water reservoir as well as one or more other valves if and as required for controlling flow through water outlets. The specific number of pumps and valves required will depend on the relative positions of treatment station and reservoirs. For example, if treatment reservoir and auxiliary water reservoir are mounted side-by-side, no valves will be required for securing an outlet of one bath that is fluidly connected with the inlet of the other bath. However, two pumps will be needed for moving water between the reservoirs. If the auxiliary water reservoir is mounted above the treatment reservoir, a valve will be needed to secure the outlet of the auxiliary water bath that is fluidly connected with an inlet of the treatment reservoir and a single pump will be required for moving water from the treatment reservoir to the auxiliary water reservoir. The device also includes one or more temperature sensors, of which at least one is mounted either in the treatment reservoir, the treatment station or a fluid connection between treatment station and treatment reservoir. A water level sensor is mounted in each reservoir that is communicating with the combination of valves. Finally, the device comprises a logic controller that utilizes measurements from the one or more temperature sensors and the one or more water level sensors for operating the combination of valves, pumping means and other valves as required to provide water of the desired treatment temperature to the treatment reservoir and hotter water, in the case of use of the device for a hot treatment, or colder water, in the case of use of the device for a cold treatment, to the auxiliary water reservoir and, thereafter, for maintaining the desired treatment temperature in the treatment reservoir by addition of water from the auxiliary water reservoir to the treatment reservoir as well as, if this needs to be actively controlled, for returning water from the treatment reservoir to the auxiliary water reservoir. To allow the subject to be treated to adapt to a hot or cold treatment temperature, the logic controller can also be instructed to operate the combination of valves so as to provide warm water of a temperature from about 30 to 40°C to the treatment reservoir and water that is above or below the desired treatment temperature to the auxiliary water bath and thereafter to cause a controlled ramp-up (in the case of a hot treatment) or ramp-down (in case of a cold treatment) to the desired treatment temperature in the treatment reservoir by addition of water from the auxiliary reservoir.

In a related particular embodiment of the device of the invention, excess water in the treatment reservoir resulting from addition of water from the auxiliary water reservoir that is made to compensate temperature deviations from the desired treatment temperature is not returned to the auxiliary water reservoir, but is discarded. As a consequence, the water volume in the auxiliary water reservoir decreases during treatment. Lost volume is made up by addition of water from the building's water supply. The variant device differs from the previously described device in that the treatment reservoir only optionally contains an outlet that is fluidly linked with an inlet of the auxiliary water reservoir, the combination of valves provides water to the auxiliary water reservoir alone or, optionally, to both the auxiliary water reservoir and the treatment reservoir, and the logic controller also integrates measurements from the one or more level sensors to operate the combination of valves so that water of the appropriate temperature (i.e., hotter than treatment temperature in the case of a hot treatment or colder than treatment temperature in the case of a cold treatment) is added to the auxiliary reservoir in order to maintain volume or prevent a water shortage and, if this needs to be actively controlled, to cause water to be discarded from the treatment reservoir in order to maintain volume or prevent overfilling (instead of being returned to the auxiliary reservoir as in the previously described device).

As discussed for the preceding embodiment, to allow the subject to be treated to adapt to a hot or cold treatment temperature, the logic controller can also be instructed to operate the combination of valves so as to provide warm water of a temperature from about 30 to 40°C to the treatment reservoir and water that is above or below the desired treatment temperature to the auxiliary water bath and thereafter to cause a controlled ramp-up (in the case of a hot treatment) or ramp-down (in case of a cold treatment) to the desired treatment temperature in the treatment reservoir by addition of water from the auxiliary reservoir.

The devices of the above two particular embodiments are intended for environments in which appropriately hot and cold waters are available. To illustrate this requirement, the desired treatment temperature for a hot treatment can be between about 35 and 48°C. In order to maintain treatment temperature in treatment reservoir and treatment station, hot water of a somewhat higher temperature needs to be available for supplying the auxiliary water bath. An analogous requirement for availability of sufficiently cold water applies in the case of use of the devices for cold treatments. If an appropriate hot or cold water supply is not available, the device needs to be capable of actively heating or cooling water. Devices containing active heating or cooling components are considered to be within the scope of the invention. Hence, devices can further comprise a heating or cooling element mounted on the auxiliary water reservoir for further heating or cooling of the water in the reservoir. The auxiliary water reservoir can also be heated or cooled by a separate heating or cooling component. Such component comprises a heating reservoir for holding water or oil onto which heating reservoir a heating element is mounted that is capable of heating the liquid contained in the reservoir or a cooling reservoir for holding water or a refrigerant onto which cooling reservoir a cooling element is mounted that is capable of cooling the liquid contained in the reservoir, a heat exchanger that is in fluid communication on the one hand with the heating or cooling reservoir and on the other hand with the auxiliary water reservoir, and pumping means for establishing a circulation of liquid between the heating or cooling reservoir and the heat exchanger, and between the heat exchanger and the auxiliary water reservoir, whereby the logic controller also operates the heating or cooling element and the pumping means so as to achieve and maintain a desired water temperature in the auxiliary water reservoir. In the case an electrical heating or cooling element is used, the liquid in the heating or cooling reservoir can be distilled or de-ionized water, which is essentially non-conducting.

For ease of operation, the devices of the invention can be fitted with additional outlets for evacuating treatment station and the one or more reservoirs. Furthermore, the devices can integrate means for disinfection or cleaning. Minimally, such means include a reservoir for disinfectant or cleaning agent, a fluid connection with the remainder of the device (e.g., a reservoir, treatment station or fluid connection) and a dosing pump or a valve for controlling agent delivery.

The devices of the invention are capable of administering a precise thermal dose to the scalp of a subject in a uniform and reproducible fashion. Uniformity of application of a thermal treatment to all parts of the scalp of a subject is provided by the use of a treatment station, wherein the scalp of a subject is directly exposed to the heating/cooling medium, i.e., water, and the generation of favorable convective conditions through rapid circulation of the heating/cooling medium through the treatment station, typically at a rate between about 5 liters/minute and about 300 liters/minute, preferably from about 20 liters/minute to about 120 liters/minute. Treatment temperature is maintained accurately. The maximally tolerated deviation from the desired treatment temperature is less than +/- 0.5°C, and more preferably less than about +/- 0.2°C.

The invention also encompasses the use of any of the afore-mentioned devices for a hot treatment of the scalp of a subject, whereby the desired treatment temperature is between about 35°C and 48°C, or for a cold treatment of the scalp of a subject, whereby the desired treatment temperature is below about 20°C and, more preferably, below about 15°C. Such treatments are administered for any desired period, typically ranging from about 5 minutes to about 6 hours. To prevent undesired exposure during a thermal treatment, in particular in a device featuring a head bath as the treatment station, the subject can wear a face frame mask that protects front, ears and neck from exposure to the heating or cooling medium.

Brief description of the drawings

Fig.l Examples of different head bath (treatment station) configurations. 102: head bath; 405: valve; e: water inlet; s: water outlet. Water entry can be perpendicular to the external surface of the head bath or in a tangential direction. Furthermore, water entry can be in a horizontal direction, upwards or downwards. A vortex-inducing element can be inserted in a water inlet. The point of water entry into the head bath can be anywhere, including at the lowest point of the bath or on or close to the rim. Single or multiple water inlets can be used. Water inlets can contain nozzles to direct the incoming water. For example, nozzles can be used to direct water jets to the head of a subject to improve convection and/or to effect a gently scalp massage. Similarly, a water outlet can be placed anywhere on the bath, preferably at the lowest point, and most preferably near or on the rim of the bath. Single or multiple water outlets can be used. Concept A: water inlet with or without vortex-generating element is at or near the lowest point of the head bath, water outlet is on top in the form of an overflow. Typically, water is transported to the inlet by a pump. Water evacuation occurs when the pump is deactivated. Concept B: Water inlet is at or near the top; water outlet is on top in the form of an overflow. A further outlet at the lowest point of the bath, controlled by valve 405, serves water evacuation of bath 102. Concept C: multiple water inlets are distributed over the (interior) surface of bath 102, and a single water outlet is at the lowest point. Inlets can comprise jets to direct the incoming water (e.g., to improve convection or to achieve a scalp massage). Water level in the bath can be maintained by means of a floater-controlled valve (not shown). Evacuation can be achieved through a further, separate outlet controlled by a valve or through a bypass upstream from the floater-controlled valve, water exit through the bypass being regulated by a further valve. Concept D: water inlet(s) is near or at the top; water outlet is on the lowest point. Water level in the bath is regulated by means of a siphon. Water evacuation occurs by means of a bypass that is controlled by valve 405. Concept E & F: similar to concept C, except that a single water inlet is on top of bath 102 (concept E) or any other position on the bath (concept F). Concept G: similar to concept B, except that multiple water inlets are distributed over the (interior) surface of bath 102. Water evacuation occurs when the one or more pumps used for transporting water to the inlets are deactivated.

Fig.2 Examples of devices for scalp heating or cooling. It is understood that devices for scalp heating shown in panels A-H and M can be converted to devices for scalp cooling by exchanging heating elements for cooling/refrigeration elements. A. Treatment reservoir 101 is supplied with water from a cold water line of a building (f). Water supply is controlled by valve 401 (that responds to signals from level sensor 501). Pump 201 drives water circulation between treatment reservoir and head bath 102. Heating element 601 heats the water in the treatment reservoir to the desired temperature. Heating is controlled by temperature sensor 301. B. Similar device in which a heating element (602) is placed in the fluid connection of treatment reservoir and head bath. C. Similar device in which a heating element (602) is placed in the head bath. D. Similar device, but water in the treatment reservoir is heated by heat pump 604. E - H. Devices similar to that in A, wherein treatment reservoir and head bath are connected by sufficiently long, non-conducting fluid connections to achieve effective electrical separation between head bath and a powerful electrical heating element (601) that is either directly affixed to the treatment reservoir (E & F) or mounted more remotely and connected to the treatment reservoir via heat pump 604 (G & H). A low voltage heating element 603 can be mounted in the head bath (F & H) or in the fluid connection of head bath and treatment reservoir (E & G) for fine regulation of water temperature and temperature maintenance during treatment, respectively. I. Water from a building's water lines flows through head bath 102 and is thereafter discarded (e). Water from hot (c) and cold (f) supply lines is mixed in the appropriate proportion by three-way valve 402 to provide water of the desired temperature to the head bath. Water flow is controlled by valve 401. Water mixing is controlled by temperature sensors 302 and 303. J & K. Treatment reservoir 101 is supplied with water from hot (c) and cold (f) water lines of a building. The waters are mixed in the appropriate proportion by three-way valve 402 to provide water of the desired temperature to treatment reservoir 101. Water flow is controlled by valve 401. Water mixing is controlled by temperature sensor 302, and temperature in the treatment reservoir by temperature sensor 301. Pump 201 drives water circulation between treatment reservoir and head bath 102. Temperature maintenance and, if desired, temperature ramp- up or ramp-down are achieved by addition of hot or cold water, respectively, to the treatment reservoir. Water level is managed in J by means of an overflow (e) and in K by an outlet at the bottom of the reservoir (e). Water evacuation is controlled by a valve in the evacuation line that is actuated in response to signals from level sensor 501. L. Device identical to that in I, except for the addition of heat exchanger 605. Operation of the heat exchanger serves to minimize the use of building hot water. M. Device similar to that in A, except that treatment reservoir 101 is supplied with water from hot (c) and cold (f) water lines of a building. The waters are mixed in the appropriate proportion by three-way valve 402 to provide water of the desired temperature to treatment reservoir 101. Water flow is controlled by valve 401. Water mixing is controlled by temperature sensor 302. The heating element is used when the hot water supply is inadequate. It is noted that, in case of employment of a powerful heating element, treatment reservoir and head bath may be connected by sufficiently long, non-conducting fluid connections to achieve effective electrical separation between head bath and the electrical heating element (not indicated in the drawing). Fig.3 Hydraulic scheme for the first example device including an external heating component (heating tower). The numbered or lettered components are described in Table I.

Fig.4 Head bath with inserted head support, which is removably affixed at the rim.

Fig.5 Outside view of first example device and external heating tower.

Fig.6 Front view of the first example device, open. Numbers and letters identify components described in Table I.

Fig.7 Back view of the first example device, open. Numbers identify components described in Table I.

Fig.8 Section view of the first example device. Numbers and letters identify components described in Table I.

Fig.9 View of the heating tower, open. Numbers and letters identify components described in Table I.

Fig.10 Hydraulic scheme for the second example device. The numbered or lettered components are described in Table II.

Example treatment stations for treatment of a subject in a seated position. Fig.11 Helmet -like system comprises an outer shell into which is inserted sieve element 107, which separates the system into two compartments liquid-connected only by the perforations in the sieve. Water enters (e) and fills the outer compartment. Water is then pressed through sieve 107, whose perforations serve as jets. The system is reversibly closed around the hairline of the subject by stretchable, flexible material, (s) Water exit. Optional suspension (901) to remove weight from the bearer.

Fig.12 Rigid container structure comprising at least one water inlet (e), at least one water outlet (s) and an opening near the bottom through which opening the head of the subject is inserted up to its hairline, the opening being reversibly closed around the head of the subject by stretchable, flexible material that bridges the gap between opening and head of the subject. A multitude of impinging jets (108) that are fluidly connected to the water inlet are mounted on a support shaped to follow the curvature of the subject's scalp at a suitable distance from the scalp. Spent water is drained (s). Fig.13 Device similar to that shown in Fig. 12, except that it is configured to allow for a water build-up to a level at which scalp and jets are submerged. Water flow through outlet (s) is regulated to allow for the water build-up. The devices of Figs. 12 & 13 are suspended from a supporting structure (not shown).

Fig.14 Bundle of impinging jets and associated mechanism for axial displacement (108).

Detailed description

Definitions:

"Convection" refers to heat transfer that will occur between a surface and a moving fluid when they are at different temperature. One speaks of "forced convection" when the fluid movement is caused by external means such as by a fan, pump or atmospheric winds. In contrast, in free convection the flow is induced by buoyancy forces which arise from density differences caused by temperature variations in the fluid. An "impinging jet" describes a single fluid jet or an array of such jets, impinging more or less normally (perpendicularly) on a surface. This achieves enhanced convective effects.

The term "water" as used herein refers to fresh water such as drinking water. Less preferably, the term also encompasses water supplemented with minerals and the like as well as to water having reduced salt concentrations as a result of de-ionizing treatment, distillation and the like.

The term "subject" relates to a healthy human person or to a human person afflicted by an illness or disorder such as cancer.

The present invention relates to a device for thermal treatment of the scalp of a subject. The term "thermal treatment" is intended to include any exposure to medium, here water, of a temperature that is greater as, equal to or lower than the typical surface temperature of the scalp of a subject. Such thermal treatment includes exposure to a cold temperature, possibly a temperature approaching freezing level, intended to reproducibly restrict blood circulation and hair cell metabolism for preventing chemotherapy-induced hair loss or to achieve other medical or wellness- type benefits. It also includes exposures to temperatures in the range of normal body temperature or warmer for any purpose including the induction of a feeling of wellbeing. Hot treatment means exposure to a temperature that is comparable with or greater than scalp surface temperature, whereas a cold treatment refers to an exposure to a temperature that is lower than scalp surface temperature.

A device of the invention capable of administering reproducibly and uniformly an appropriate thermal dose to the scalp of a subject comprises a treatment station incorporates a water inlet, a water outlet and means for heating or cooling the scalp of a subject by forced convection using water that directly contacts the scalp. Different types of treatment stations can be employed in the devices of the present invention. One such treatment station comprises a rigid container structure comprising a water inlet (one or more), a water outlet (one or more) and an opening near the bottom wide enough to allow for insertion of the head of the subject up to its hairline, the opening being sealable around the head of the subject in a reversible fashion (Fig.11). The system further comprises a sieve shaped to follow the curvature of the subject's scalp at a suitable distance from the scalp and fastened to the interior side of the container structure near the edges of the opening thereby creating spaces on either side of the sieve that are liquid-connected through the perforations of the sieve. The perforations serve as impinging jets capable of directing water to essentially all points of the scalp. The water inlet communicates with the space formed between the enclosing container structure and the sieve, and the water outlet communicates with the space formed between the sieve and the head of the subject (Fig.11). During operation water circulates through the system, whereby the space between the enclosing container structure and the sieve serves as an intermediate reservoir from which water is pressed through the sieve, the water being accelerated in the process. After impact with the scalp water leaves the station through the outlet.

Another type of treatment station comprises a rigid container structure comprising a water inlet (one or more), a water outlet (one or more) and an opening near the bottom through which opening the head of the subject is inserted up to its hairline, the opening being closed reversibly around the head of the subject by stretchable, flexible material that bridges the gap between opening and head of the subject (Figs.12 & 13). The system further comprises a support shaped to follow the curvature of the subject's scalp at a suitable distance from the scalp, which support is fastened to points on the interior side of the container structure. The support carries a multitude of impinging jets or bundles of impinging jets (Fig.14) that are capable of distributing incoming water to essentially all points of the scalp. During operation, incoming water distributes through fluid connections to the different jets or bundles of jets. After impact with the scalp of the subject installed in the station, the water exits through the outlet. In a particular embodiment of the treatment station, water flow through the outlet is regulated, e.g., by a regulatable valve controlled by input from a level sensor or a siphon, so that water builds up to a level at which the jets are submerged. This elevated water level is thereafter maintained for the duration of a thermal treatment.

A further type of treatment station, which is used as the example treatment station in the ensuing detailed discussion, comprises a head bath. This head bath has a sufficiently large interior volume for insertion of the back of the head of the subject so that when the bath is filled with water to its working level (i.e., the maximal level reachable based on the design of the head bath or by regulation) the hairline of the subject is submerged, and the back of the head does not contact the bottom of the head bath, leaving sufficient space for effective water circulation around the back of the head. The bath may have various forms, but a regular bowl shape is preferred.

The head bath contains at least one inlet for water. This inlet may be placed anywhere on the head bath. Preferably, the inlet is in a lower portion of the bath and, most preferably, is at or near the lowest point in the bath. The inlet may, optionally, be fitted with a vortex/swirling element for generating in the bath convective conditions that are as uniform as possible. In other embodiments, the one or more inlets can also be mounted near the top or on the side of the bath. In this case, the inlets preferably contain nozzles that are mounted at an angle so as to generate a circular flow in the bath. In other embodiments, the inlet or inlets can contain jets that are directed towards the inserted head of a subject. The head bath further contains at least one water outlet. This outlet may be placed anywhere on the head bath. Preferably, it is a return installed close to the rim of the bath, e.g, consisting of one or more openings in the bath near the rim. Alternatively, the water may leave over the rim of the bath. Regardless of the form of the one or more outlets, the bath needs to integrate means for collecting the out-flowing water. Such means may consist of draining channels and/or pipes. The bath can also consist of more than one layer of material, and spaces between layers can form part of the water inlet or the draining system. Examples of head baths with different configurations of inlets and outlets are presented schematically in Fig.l . When the head bath is filled with water, the head of a subject that is installed in the head bath is partially supported by its own buoyancy. To enhance comfort, an additional support is preferably provided. Such support can be integrated in the head bath, or it can be provided separately and installed in the bath prior to use. The support can also be integrated in a face frame mask covering temperature-sensitive areas such as front, ears and neck of the subject's head, which mask can be worn by a subject during treatment. A convenient support that can be integrated in or added to the head bath or provided separately, e.g., as part of a frame mask, consists of a wide mesh net made from a water- resistant material. Such support can be permanently or removably attached to positions on or near the rim. An example head support is shown in Fig.4.

The device further comprises a treatment reservoir for holding a volume of water sufficient for filling the head bath with a subject installed therein and for allowing establishment of a rapid circular flow of water between the reservoir and the filled head bath. The treatment reservoir comprises at least one water inlet and one water outlet. Inlet and outlet are fluidly connected with the outlet and inlet, respectively, of the head bath. The device also includes pumping means for transporting water from the treatment reservoir to the head bath and/or from the head bath to the treatment reservoir. Such pumping means can consist of one or more electrical pumps installed in a fluid connection between head bath and treatment reservoir. The achievement of an adequately rapid flow of water through the head bath is an important aspect of the device of the invention. Such rapid flow is important for continuously replacing water on the surface of the scalp so that optimal convective conditions are maintained and water temperature remains uniform over the entire surface of the scalp of a subject. A rapid flow also furthers the elimination of residual air trapped in a subject's hair. Typically, the flow rate of water through the head bath is from about 5 liters/minute to about 300 liters/minute, preferably from about 20 liters/minute to about 120 liters/minute. Optionally, a filter can be mounted downstream from the head bath for removing hair or skin particles originating from the subject being treated.

Also part of the device is means for providing an adequate volume (i.e., the volume needed in the treatment reservoir for filling the head bath and supporting circulation) of water of the desired temperature for an intended thermal treatment and for maintaining this temperature for the duration of the treatment. The desired treatment temperature may be any temperature between about 1°C and about 48°C. The upper limit temperature is the temperature at which exposure can produce skin burns (Moritz, A.R. and Henriques, F.C. 1947. Am. J. Pathol. 23: 695-720). For a hot treatment intended as a treatment for the prevention of chemotherapy-induced hair loss or as a wellness-type treatment, the desired temperature will be between about 35°C and about 48°C, and preferably between about 40°C and about 46°C. For scalp cooling intended, e.g., for reducing blood flow and cell metabolism in the scalp, the desired temperature will be below about 20°C and, more preferably, below about 15°C. The desired water temperature can be attained by any means, including electrical or chemical heating or cooling, gas firing, oil firing, heat pump or jet effect. Alternatively, it may be prepared by mixing hot and cold water from a building's water supply lines. Water can be heated or cooled within the device, i.e., in the treatment reservoir, the head bath or the fluid lines linking head bath and treatment reservoir, or more remotely, whereby a correspondence is established between the heating or cooling location and the treatment reservoir. For example, an electrical heating element can be installed in the treatment reservoir, anywhere in the fluid connection between treatment reservoir and head bath, or in the head bath. Electrical separation between the subject and a powerful electrical heating element used for rapidly heating the necessary volume of water may be desirable. Such electrical separation can be achieved, e.g., by installing the electrical heating element in the treatment reservoir and separating the treatment reservoir from the head bath by means of electrically non-conducting water lines of a sufficient length to exclude any possibility of electrical shock to the subject in the case of an accidental electrical discharge from the heating element (resistance in the order of 1.7 x 10⁸ Ohm). The length of the non-conducting water lines required for producing effective electrical separation will depend on the conductivity of the water used. To avoid any possible instability of regulation due to the long fluid connections, low voltage auxiliary heating elements can be installed in the head bath or in the water line near the inlet of the head bath for temperature maintenance. Different versions of the device are exemplified schematically in Fig.2 A-H.

An alternative embodiment of a device of the invention comprises a head bath as described above, a combination of valves communicating on the one hand with the hot and cold water lines of the building in which the device is installed and on the other hand with an inlet of the head bath. An outlet of the head bath is used for discharging water (see, e.g., Fig.2 I). The functions of the combination of valves are to mix hot and cold water from the building' s water lines to achieve the desired treatment temperature and to regulate the flow of so mixed water to the head bath (providing an on/off function in the simplest case). A temperature sensor mounted preferably in the head bath indicates whether the desired treatment temperature has been attained. In an automated version of this device, the valves are electrically actuated or driven, and the temperature sensor provides the signal that operates the valves such that water of the desired temperature is delivered to the head bath. This type of device is less preferred than devices including a treatment reservoir for ecological reasons: at a flow rate of 30 1/min, a one -hour thermal treatment would consume 1 '800 1 of fresh water. In a more particular embodiment, a device of the invention comprises a head bath, a treatment reservoir and pumping means for establishing a rapid circulation of water between head bath and treatment reservoir, all as described before. In addition, the device comprises a combination of valves that on the one hand is in fluid communication with the cold and hot water lines of the water supply of the building in which the device is situated and on the other hand is fluidly connected with an inlet of the treatment reservoir. The combination of valves is capable of mixing building hot and cold water in any proportion and of regulating the flow of the mixed water. The system further includes at least one temperature sensor that is preferably mounted in the treatment reservoir, the head bath or a fluid connection between head bath and treatment reservoir. More preferred is the use of at least two temperature sensors, of which one is mounted as described and the other is installed closely downstream from the combination of valves, in the fluid line connecting valves and treatment reservoir. The single or multiple temperature sensors serve to support regulation by an operator or support automated actuation of the combination of valves such that the treatment reservoir is filled with water of the desired temperature for the ensuing thermal treatment, which water is circulated through the head bath for treatment. When the water temperature in the system deviates from the specified treatment temperature at any time during treatment, the temperature sensor(s) activates the combination of valves so that either hot water (in case of a hot treatment) or cold water (in case of a cold treatment) is added to the treatment reservoir, resulting in a correction of the water temperature in treatment reservoir and head bath. The treatment reservoir comprises an outlet for evacuation of excess water. This outlet can be in the form of a simple overflow (Fig.2 J). The outlet can also be installed at a lower position in the treatment reservoir, the outlet being secured by a valve (Fig.2 K). The latter valve can be triggered manually. Control of the water level in the treatment reservoir can also be automated. A level sensor mounted on the treatment reservoir will provide input for guiding water evacuation. Alternatively, the treatment reservoir may be sufficiently large so that water evacuation may not be required during the course of a treatment.

The above systems (Fig.2 J & K) can also be operated so that a subject is gradually exposed to the intended treatment temperature. For example, prior to a hot treatment the combination of valves is operated in such a way that a volume of warm water is released that is sufficient for filling the treatment reservoir with the volume needed for filling the head bath and for establishing a circulation to and from the head bath. The warm water arriving in the treatment reservoir should have a temperature of between about 30 and 40°C and, more preferably, between about 35 and 40°C. The warm water is then circulated between the treatment reservoir and the head bath. A subject can insert the back of his/her head into the head bath either prior to or subsequent to the filling of the head bath. The settings of the combination of valves are then changed to allow for the addition of hot water to the treatment reservoir. The hot water being taken from the building' s water supply preferably has a temperature of between 50 and 60°C, and more preferably between about 55 and 60°C. Hot water is added continuously or intermittently to the treatment reservoir to slowly elevate the temperature in the treatment reservoir and, consequently the head bath, over a period of between about 1 and 5 minutes and, preferably, between about 2 and 4 minutes to the desired treatment temperature of between about 35 and 48°C and, more preferably, between about 40 and 46°C. In parallel, excess water is evacuated from the treatment bath. Alternatively, the treatment reservoir may be sufficiently large so that water evacuation may not be required during the course of a treatment. This controlled ramp-up of temperature in the head bath allows the subject undergoing a hot treatment to acclimatize to the treatment temperature. The temperature of the water in the treatment bath is thereafter maintained at the desired level for the duration of the thermal treatment, which can be from a few minutes to several hours. Temperature maintenance is achieved by addition of hot water as needed (and, if required, removal of excess water from the treatment reservoir). Alternatively or in addition, temperature maintenance may be achieved by means of a heating element, e.g., an electrical heating element, mounted in the treatment reservoir, fluid lines or head bath. In the case the building's hot water is less than about 50°C, more powerful auxiliary heating may be required to reach treatment water temperature in the treatment reservoir within a useful time period. For example solutions, see Fig.2K and the subsequently described embodiments. Increased comfort in cold treatments of the scalp can be achieved analogously: the initial setting of the combination of valves will be such that water of a temperature between about 30 and about 40°C, preferably between about 30°C and 35°C, is delivered to the treatment reservoir. The setting will then be changed so that only cold water is delivered to the treatment reservoir for a ramp-down to a temperature of below about 20°C, more typically below about 15°C. Temperature maintenance can be achieved by continuous or intermittent addition to the treatment reservoir of cold water. Alternatively or in addition, a cooling element may be utilized that is mounted in or is in functional communication with the treatment reservoir. As discussed before, in an automated version of this device, valves are electrically actuated or driven, and a temperature sensor(s) provides the signal for adjusting and correcting the settings of the valves and, if present, for actuating the heating or cooling element to achieve temperature ramp-up or ramp-down and temperature maintenance. Optionally, a level sensor provides the signal for needed water evacuation from the treatment reservoir.

While the afore -described devices of the invention (as well as those described below) are intended to provide to a subject a well-dosed and uniform thermal treatment of its scalp either for the prevention of hair loss caused by chemotherapy or for general wellness purposes, the functionality of these devices can be expanded readily. For example, a thermal treatment device can be transformed by the addition of a small number of elements into a device that may assist a hairdresser and is capable of administering a hair wash and/or conditioning treatment to a subject in combination with a thermal wellness treatment. A hydraulic scheme illustrating components of such a modified device and their relationships is shown in Fig. 10. The operation of the device is explained in the example section, and components are identified in Table II.

In the above -described embodiments of the devices of the invention, deviations in water temperature in the treatment reservoir are corrected by direct addition of water from the building's water supply. For example, if in the course of a thermal treatment a temperature sensor in the treatment reservoir measures a temperature that is below the intended treatment temperature, hot water will be added that is directly taken from the building's hot water supply. Depending on season and recent water use, water taken from the building's hot water supply may initially be cold because of its passage through cold pipes. Hence, addition to the treatment reservoir of water from the building's hot water line may result in a momentary reduction of water temperature in the treatment reservoir. The subsequent embodiments avoid confounding effects of this kind by inclusion of an auxiliary water reservoir, used either as a hot water reservoir or as a cold water reservoir.

In a particular embodiment, the device of the invention intended for hot treatments comprises a head bath, a treatment reservoir and pumping means for filling the head bath and establishing a rapid circulation of water between head bath and treatment reservoir, all as described before. In addition, the device comprises an auxiliary water reservoir. Furthermore, a combination of valves is incorporated in the device for supplying the treatment and auxiliary water reservoirs with water having the desired treatment temperature and hot water, respectively. The combination of valves on the one hand is in fluid communication with the cold and hot water lines of the water supply of the building in which the device is situated and on the other hand is fluidly connected with the auxiliary water reservoir. The auxiliary water reservoir is also fluidly connected with the treatment reservoir. In this particular embodiment, treatment reservoir and auxiliary water reservoir are mounted side by side. The two reservoirs can also be on different levels (which will require the use of additional valves for securing outlets of the higher positioned reservoir). The device further comprises pumping means for moving water from the auxiliary water reservoir to the treatment reservoir and vice-versa. Typically, the device comprises at least two temperature sensors, of which one is mounted closely downstream from the combination of valves, in the line connecting valves and auxiliary water reservoir. The second, dominant sensor measures temperature in the treatment reservoir, the head bath or a fluid line connecting treatment reservoir and head bath.

Prior to a hot treatment, the combination of valves is operated in such a way that a volume of water having approximately the desired treatment temperature is released that is sufficient for filling the treatment reservoir. The water is delivered to the treatment reservoir via the auxiliary water reservoir. Once delivered in the treatment reservoir, the water is circulated through the head bath. The setting of the valves is then changed and the auxiliary water reservoir is filled to its working level with hot water. If, at any time at the beginning of or during a thermal treatment, temperature in the treatment reservoir is below the desired treatment temperature, hot water is added from the auxiliary water reservoir to correct the deficiency. Excess water in the treatment reservoir is returned to the hot water reservoir.

The device is also capable of providing for a gradual ramp-up of temperature in the treatment reservoir to help a subject adapt to the treatment temperature. Prior to a hot treatment, the combination of valves is operated in such a way that a volume of warm water is released that is sufficient for filling the treatment reservoir to its working level. The warm water is delivered to the treatment reservoir via the auxiliary water reservoir. The warm water arriving in the treatment reservoir should have a temperature of between about 30 and 40°C and, more preferably, between about 35 and 40°C. The warm water is then circulated between the treatment reservoir and the head bath. A subject can introduce the back of his/her head in the head bath either prior to or subsequent to the filling of the head bath. The setting of the valves is then changed to allow for the addition of hot water to the auxiliary water reservoir. Once the auxiliary water reservoir is filled to its working level, hot water from the auxiliary water reservoir is added to the treatment reservoir over a period of about one to five minutes and, more preferably, about two to four minutes to bring the temperature in the treatment reservoir and, consequently the head bath, to the desired treatment temperature of between about 35 and 48°C and, more preferably, between about 40 and 46°C. Excess water is transferred from the treatment bath to the auxiliary water bath as needed. The temperature of the water in the treatment bath is thereafter maintained at the desired level for the duration of the thermal treatment. Temperature maintenance is achieved by addition of water from the auxiliary water reservoir as needed (and return of water from treatment reservoir to auxiliary water reservoir as needed). It is noted that while the device can be operated manually to achieve the desired temperature ramp-up and subsequent temperature maintenance, the device preferably is automated, employing a logic controller for actuating pumps in response to signals from temperature sensors and a water level sensor mounted in the treatment reservoir. An entire treatment cycle can be automated by further subjecting the combination of valves to the control of the logic controller.

In an alternative embodiment of the latter device of the invention, addition of hot water to the treatment reservoir during temperature ramp-up and maintenance of treatment temperature during the course of a thermal treatment is not compensated by the return of water from the treatment reservoir to the auxiliary water reservoir. Instead, the water volume in the treatment reservoir (and head bath) is regulated by evacuation of water to waste. The volume of water in the auxiliary water reservoir can be kept constant or maintained at a working level by addition of hot water from the building's hot water supply. In this embodiment of the device, it is no longer important that the originally charged amount of hot water suffices for bringing up temperature in the treatment reservoir to the desired treatment temperature as well as for maintaining this temperature for the treatment duration. Hence, the auxiliary water reservoir can be considerably smaller than that in the previously described device.

For the proper operation of a device comprising an auxiliary water reservoir as described before, hot water of a temperature that significantly exceeds the desired treatment temperature needs to be available in the building in which the device is located. With treatment temperature being possibly as high as 48°C, the hot water supply of the building should be hotter than about 50°C and, preferably, hotter than about 55°C. Although this may generally be the case in medical establishments, it is not certain that hot water of this temperature will be available at all times of the day. Furthermore, a thermal treatment using a device of the invention may not only be carried out in medical establishments, but also in other facilities, e.g., in a commercial or private building. In such a building, hot water temperature may occasionally or even frequently be below 50°C. To accommodate such environments, a device of the invention can further comprise an active heating component. Such heating component can comprise a heating element (e.g., an electrical heating element, gas firing, oil firing or heat pump) that is capable of further heating the water in the auxiliary water reservoir. A temperature sensor mounted in the auxiliary water reservoir for measuring actual temperature and control means for activating and deactivating the heating element as needed to achieve a desired water temperature of at least about 50°C and, more preferably, of at least about 55°C in the auxiliary water reservoir are also part of the heating component. It is noted that when an electrical heating element is used, it may be desirable to maintain electrical separation between the auxiliary water reservoir containing the heating element and the treatment reservoir. Electrical separation can be achieved by the use of sufficiently long non-conducting waterlines for separating auxiliary water reservoir and treatment reservoir.

Alternatively, the active heating component can comprise a heating reservoir holding an adequate volume of water and a heating element, typically an electrical heating element, capable of heating the water in the reservoir. Heated water from the heating reservoir is added the auxiliary water reservoir, which addition is compensated by the return of water from the auxiliary water reservoir. Pumping means for achieving water transport between heating reservoir and auxiliary water reservoir are also included. The system further comprises temperature sensors for measuring water temperature in the heating and auxiliary water reservoirs and control means for operating heating element and pumping means. In another embodiment of the heating component, the heated liquid of the heating reservoir is circulated through one side of a heat exchanger. Consequently, the heating component further includes a heat exchanger, fluid lines connecting heating reservoir and heat exchanger to form a closed circuit, and pumping means for propelling the heated liquid through the circuit. A further water circuit fluidly connects the other side of the heat exchanger and the auxiliary water reservoir, the circuit comprising pumping means for driving water circulation. Control means for managing temperatures in the heating and auxiliary water reservoirs and for operating the two liquid circuits are also part of the heating component. It is noted that in this embodiment, which makes use of a heat exchanger, the liquid of the heating reservoir is not mixed with other waters in the device. Hence, the liquid in the heating reservoir does not need to be water, but can be another liquid such as an oil. Electrical separation between heating reservoir and auxiliary water reservoir can be achieved by means of non-conducting fluid lines of adequate length. In addition or alternatively, in the case of a heating component in which there is no water exchange between heating and auxiliary water reservoirs, effective electrical separation can also be produced by the use of pure water, e.g., distilled or de -ionized water, or oil for filling the heating reservoir.

The above-described devices for hot treatment incorporating an auxiliary water reservoir and, optionally, an active heating component can also be configured for scalp cooling uses. The auxiliary water bath is used to hold cold water and the heating component is substituted by an active cooling component comprising a cooling element. The cooling element may be used for cooling the water in the auxiliary water reservoir or for cooling fluid in a separate cooling reservoir. In embodiments in which there is no exchange of liquids between auxiliary water reservoir and cooling reservoir, the liquid in the cooling reservoir can be a refrigerant.

As illustrated in the further embodiments described below, the devices of the invention can comprise means for evacuation of water from head bath and reservoir(s). In particular embodiments, these means can consist of water outlets at or near the lowest point of the head bath or a reservoir, which water outlets are controlled by valves. The devices can further incorporate means for cleaning and disinfection, including arrangements for self-cleaning and self -disinfection.

In further particular embodiments of the invention, of which a version is described in more detail in Figs.3-9 and in the example section, the device of the invention intended for hot treatments comprises a bowl-shaped head bath that has a sufficiently large interior volume for insertion of the back of the head of a subject so that when the bath is filled with water to its working level the hairline of the subject is submerged and the back of the head does not contact the bottom of the head bath, leaving sufficient space for effective water circulation around the back of the head. The head bath comprises a water inlet at or near the lowest point. The head bath further comprises a return in the form of one or more openings in the bath near the rim, and draining channels and pipes to collect the out-flowing water. A further outlet is present near the lowest point of the head bath, enabling evacuation of the bath. To this outlet is connected a water evacuation line that integrates a valve for controlling evacuation from the head bath. The head bath may further contain a removably mounted head support that can, e.g., be a wide mesh net made from a water-resistant material mounted at points on or closely below the rim of the bath. It may also contain points for attaching a face frame mask that can incorporate such head support. The device further comprises a treatment reservoir that is positioned lower than the head bath and holds a volume of water that is greater than that needed to fill the head bath with a subject installed therein. Affixed to the treatment reservoir is at least one temperature sensor and, if the device is intended for automated operation, at least one level sensor. The treatment reservoir has a least two water inlets and two water outlets. The first inlet and first outlet are fluidly connected with the head bath, whereby the inlet is linked to the outlet/drain of the head bath and the outlet is connected with the inlet of the head bath. An electrical pump is providing for a rapid circulation of water through treatment reservoir and head bath. The second inlet is fluidly connected with an auxiliary water reservoir, whereas the second outlet feeds into the water evacuation line and is secured by a valve.

Further included in the device is an auxiliary water reservoir that holds an appropriate volume of water, which preferably is comparable to or larger than the volume held by the treatment reservoir. The auxiliary water reservoir is mounted approximately level with the treatment reservoir. Like the treatment reservoir, the auxiliary water reservoir is donned with at least one temperature sensor and, if the device is intended for automated operation, at least one level sensor, and has at least two fluid inlets and two outlets. The first outlet fluidly communicates with the second inlet of the treatment reservoir. An electrical pump enables water transfer to the treatment reservoir. The first inlet is communicating with the building's water supply lines. The second inlet and the second outlet are connected, via sufficiently long non-conducting fluid lines to achieve electrical separation, to one side of a heat exchanger, forming a closed water circuit between auxiliary water reservoir and heat exchanger. The second outlet is also connected through a bifurcation secured by a valve with the water evacuation line. Water flow in this circuit is driven by means of an electrical pump.

A combination of valves connects the cold and hot water supply lines of the building in which the device is installed with the first inlet of the auxiliary water reservoir of the device. This valve assembly mixes hot and cold water to provide warm water destined for the treatment reservoir or delivers hot water destined for the auxiliary water reservoir. The valve assembly is operated by reference to a temperature sensor that is mounted immediately downstream of the valves. The device further comprises a heating component, which comprises a heating reservoir, an electrical heating element, a heat exchanger, an electrical pump and connecting fluid lines. The heating reservoir holds an appropriate volume of water or oil, preferably a volume comparable or smaller than that held by the auxiliary water bath. The electrical heating element is mounted thereon such that it is capable of heating the liquid in the heating reservoir. The heating reservoir has at least one inlet and one outlet, both of which are in fluid connection with the second side of the heat exchanger. The closed fluid circuit includes an electrical pump for supporting circulation between heating reservoir and heat exchanger. A temperature sensor is affixed to the heating reservoir and serves as a reference for controlling liquid temperature. While the device can be operated manually, it is advantageous to automate some or all operations to save on operator effort. Hence, most valves typically are electrically actuated or motor-driven, and the device includes a logic controller as a control means. The device, optionally, also includes a cleaning and/or a disinfection component. Both of these components include a storage reservoir for cleaning agent or disinfectant, respectively, and a dosing pump for adding cleaning agent or disinfectant, respectively, into the auxiliary water reservoir.

To administer a hot treatment to the scalp of a subject, the device will carry out, or will be prompted to carry out, the following functional sequence: (1) The electrical heating element is engaged and the heating water circuit becomes operational. (2) The combination of valves connecting the cold and hot water supply lines of the building and the auxiliary water reservoir is set to provide warm water as specified, e.g., water having a temperature of about 37°C. An appropriate volume of warm water destined for the treatment reservoir is released and flows into the auxiliary water reservoir. If the temperature of the water as measured in the auxiliary water reservoir is as specified, the water is pumped into the treatment reservoir. If it is too hot, the auxiliary water reservoir is emptied and the entire sequence reinitiated. If it is too cold, the heating water circuit is set in motion, and the water is heated to the specified temperature by passage through the heat exchanger and, once this temperature is reached, is transferred to the treatment reservoir. (3) The combination of valves connecting the cold and hot water supply lines of the building and the auxiliary water reservoir is set to provide water from only the hot water supply line. An appropriate volume of hot water is released into the auxiliary water reservoir, which is thereby filled to its working level. If the water temperature in the auxiliary water reservoir is above the specified minimum, e.g., about 55°C, the device is ready to carry out a thermal treatment, and the subject is installed. If temperature is lower, the heating water circuit is operated to heat the water to a temperature at or above the latter minimum. (4) The subject to be treated is installed and the treatment water circuit is set in motion, resulting in the filling of the head bath and subsequent rapid circulation of warm water through bath and treatment reservoir. Over a specified period, e.g., about 1-5 minutes, water from the auxiliary water reservoir is added to the treatment reservoir to slowly elevate the temperature in the latter reservoir and in the head bath to the specified treatment temperature, e.g., 43°C. Excess water is evacuated from the treatment reservoir and is discarded. Water losses in the auxiliary water reservoir are compensated by addition of hot water from the building's hot water line. The controlled, slow rise in head bath temperature allows the subject to adapt to the treatment temperature. (5) Water temperature is maintained in the treatment reservoir for the duration of the thermal treatment. This achieved by addition of hot water from the auxiliary water reservoir to compensate heat losses (and evacuation of water from the treatment reservoir as needed). Water losses in the auxiliary water reservoir are compensated as before. (6) At the end of the treatment, the head bath, treatment reservoir and auxiliary water reservoir are evacuated and the subject is disengaged. The subsequent optional steps primarily are to clean and disinfect the parts of the device that directly or indirectly came into contact with the subject undergoing treatment. (7) The auxiliary water reservoir is filled with fresh water (of a desired temperature) to which an appropriate volume of cleaning agent is admixed. This water is then allowed to circulate through auxiliary water reservoir, treatment reservoir and head bath for a specified time. Thereafter, the head bath and the treatment and auxiliary water reservoirs are evacuated. The same cycle is repeated (once or multiple times) without added cleaning agent for rinsing the device. (8) The auxiliary water reservoir is filled again with fresh water (having a temperature adapted to the particular disinfectant used) to which an appropriate volume of a disinfectant, e.g., chlorine ("eau de javel"), is admixed. This water is then allowed to circulate through auxiliary water reservoir, treatment reservoir and head bath for the time needed to achieve disinfection. Thereafter, the head bath and the two reservoirs are emptied. The same cycle is run again, typically several times, without added disinfectant for rinsing the device.

When administering a thermal (hot or cold) treatment for the purpose of protecting hair follicles of the scalp from the noxious effect of cytotoxic agents, thereby preventing or reducing hair loss in a subject, it will be desirable to direct the thermal treatment strictly to the scalp of the subject. Unnecessary exposure of the front, the ears and the neck of the subject can be avoided by means of a face frame mask that is worn by the subject during the thermal treatment and that covers the latter regions. It is noted that the face frame mask does not need to be watertight. Insulation from hot or cold water in the treatment bath is achieved by significantly reducing water exchange between the inside and the outside of the mask (wetsuit principle). The face frame mask may also integrate a head support.

It is noted that the term "desired treatment temperature" can refer to a specific temperature that will be kept constant throughout a treatment. Also encompassed are fractionated thermal schemes. For example, a first part of a treatment is administered at a first temperature and a second or subsequent part is administered at a higher or lower temperature. Fractionated thermal schemes are more likely to find use in wellness-type treatments than in medically motivated thermal treatments, e.g., treatments to prevent chemotherapy-induced hair loss. The term "desired treatment temperature" is meant to encompass any controlled temperature course.

All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise indicated. No language in the specification should be construed as indicating any element is essential to the practice of the invention unless as much is explicitly stated. The description herein of any aspect or embodiment of the invention using terms such as reference to an element or elements is intended to provide support for a similar aspect or embodiment of the invention using the terms "consists of ," "consists essentially of or "substantially comprises" for that particular element or elements, unless otherwise stated or clearly contradicted by context (e.g. , a composition described herein as comprising a particular element should be understood as also describing a composition consisting of that element, unless otherwise stated or clearly contradicted by context). This invention includes all modifications and equivalents of the subject matter recited in the aspects or claims presented herein to the maximum extent permitted by applicable law. The description herein of any aspect or embodiment of the invention using the term "means" is intended to provide support for use of the term "device", "apparatus", "mechanism", "system" or "configuration" in place of "means" with reference to the particular element or elements, unless otherwise stated or clearly contradicted by context

All publications referred to herein shall be considered as having been incorporated in their entirety. The invention is further elaborated by the following examples. The examples are provided for purposes of illustration to a person skilled in the art and are not intended to be limiting the scope of the invention as described in the claims. Thus, the invention should not be construed as being limited to the examples provided, but should be construed to encompass any and all variations that become evident as a result of the teaching provided herein.

Example Section

Example 1

The example device below is described with reference to the hydraulic scheme of Fig. 3 and the views of Figs. 4-9. The numbered and letter components are identified in Table I.

Table I: Components of the example device

No. Description

101 Heating reservoir

102 Auxiliary water reservoir

103 Treatment reservoir

104 Chlorine reservoir

105 Detergent reservoir

106 Head bath 201-205 Diaphragm bilge pumps

206 & 207 Digital dosing pumps

302 & 303 Nonreturn valves

401 Motorized 3 -way valve

402-409 Solenoid valves

501 & 502 Strainers

601 Electrical heating element

701-705 Temperature sensors PtlOO

801 Capacitance level sensor

802 & 803 Analog ultrasound level sensors

804 & 805 Digital level sensors

806-809 Capacitance level sensors

1001 Building hot & cold water

a Movable support for subject web panel

b Subject web panel

c Frame of the device

d Operator' s web panel

e Emergency stop

f Button for engaging the heating component

g Light

h Button for turning off the heating component

k Key and lock power

m Electrical box

n Plate heat exchanger

P 3 -way valve

q Electrical box of the heating component

A bowl-shaped head bath made from stainless steel (106) is mounted on top of the chest-shaped device. The device is supplemented with a treatment table (Linak AG, Thalwil, Switzerland) on which a subject to be treated rests with its face up. The table is brought in immediate proximity of the device so that the subject is capable of inserting the back of its head into the head bath. The head bath has horizontal slots just below the rim, the slots being placed all around the circumference. These slots serve as water outlets. Out-flowing water collects in a draining area external to the bath, which area is connected with treatment reservoir 103 by means of PVC tubing . (All tubing present in the device is made from PVC). A strainer (501) serves to retain hair and skin particles. The head bath has a useable volume of about 15 liters. Affixed to the rim of the head bath are several hooks that support a head support (Fig.4). A water inlet is positioned at the lowest point of the head bath, and an outlet for evacuation of the bath is placed next to the inlet. The inlet contains an inserted vortex/swirling element for generating convective conditions in the bath that are as nearly uniform as possible. A pipe serving as a waste water line is affixed to the outlet. A low-voltage solenoid valve (409) is mounted just below the outlet.

A treatment reservoir (103) is designed for a useable volume of about 20 liters. (All reservoirs are made from PVC-C, except for the disinfectant and cleaning fluid reservoirs that are in PVC.) Affixed to this reservoir are two PtlOO temperature sensors (703, 704) for measuring water temperature, an analog ultrasound level sensor for measuring relative water levels (803) and two capacitance level sensors (808, 809), of which one is for detection of excessive water levels and the other for indicating complete evacuation. The reservoir has two water inlets and two water outlets. The first outlet is fluidly connected to the inlet of the head bath (106). The first inlet receives the return water from the head bath. A low-voltage, diaphragm bilge pump (205) drives water circulation between treatment reservoir and head bath (at a flow rate of about 20 liters/minute). A bypass located on the reservoir-proximal side of pump 205 serves evacuation and is connected with the waste water line. Evacuation is controlled by low-voltage solenoid valve 408. The second outlet is also linked to the waste water line, interrupted by low-voltage solenoid valve 407. The second inlet receives water from auxiliary water reservoir 102.

Auxiliary water reservoir 102 has a useable volume of about 30 liters and contains affixed to it PtlOO temperature sensor 702, an analog ultrasound level sensor for measuring relative water levels (802) and two capacitance level sensors (806, 807), of which one is for detection of excessive water levels and the other for indicating complete evacuation. Reservoir 102 contains three water inlets and two water outlets. The first outlet is connected to the second inlet of reservoir 103, the outlet secured by low-voltage solenoid valve 403, and water transport mediated by low-voltage, diaphragm bilge pump 203. The first inlet is fluidly connected to the building water supply 1001. Second inlet and second outlet (through a bypass located just downstream of the outlet) are integrated in a hot water circuit linking auxiliary water reservoir 102 and a plate heat exchanger n (located in a separate heating tower). The circuit is driven by low-voltage, diaphragm bilge pump 202. A strainer (502) is mounted upstream from pump 202. The second outlet is also connected to the waste line, secured by low-voltage solenoid valve 404. It is noted that water evacuation (to a higher-located drain) is driven by low-voltage, diaphragm bilge pump 204 and controlled by low- voltage solenoid valve 406. A bypass in the waste line secured by solenoid valve 405 allows for optional return of water from the treatment circuit to the auxiliary water reservoir.

A combination of a low-voltage, motorized three-way valve (401) and low-voltage solenoid valve 402 regulates temperature and flow of water imported from the building's cold and/or hot water supply lines, which water is routed to the first inlet of reservoir 102. PtlOO temperature sensor 701 measures the temperature of incoming fresh water and is capable of controlling the setting of valve 401. Disinfectant (chlorine) reservoir 104 contains a digital level sensor (805) for detecting low fluid level. Introduction of an appropriate quantity of disinfectant into the fresh water line is mediated by low voltage digital dosing pump 206. Backflow of water into reservoir 104 is prevented by non-return valve 302. Cleaning fluid reservoir 105 contains a digital level sensor (804) for detecting low fluid level. Introduction of an appropriate volume of cleaning product into the fresh water line is mediated by low voltage digital dosing pump 207. Backflow of water into reservoir 105 is prevented by non-return valve 303.

Auxiliary water heating is provided by a heating tower, which is physically separated from the remainder of the device. The core of the heating tower is an electrical heating element, Lauda Proline (220V/3,5kW) (601), which is thermostat-controlled and contains an integrated level sensor (705, 801). Heating element 601 heats reservoir 101, which is filled with 20 1 of pure water. A closed water circuit, driven by low-voltage, diaphragm bilge pump 201, links reservoir 101 and the plate heat exchanger. The distal side of the heat exchanger is fluidly linked with reservoir 102 by tubes of about 5 meters in length.

Operation of the device is fully automated. The programmable logic controller used is Saia Burgess PCD2.M5540. A proportional-integral-derivative controller (PID controller) manages three-way valve 401, whereas proportional regulators (P) control all other elements. Programming is in code FUPLA, SAIA's proprietary equivalent of Labview.

Low voltage, diaphragm bilge pumps (Flojet Quad II 4125-314) were from Techma Sari

(Renens, Switzerland), low voltage solenoid valves from Georg Fischer AG (Schaffhausen, Switzerland), the three-way valve (VXP45.25-6.3+SSB61) from Siemens AG (Renens, Switzerland) and digital dosing pumps including associated level sensors and non-return valves from Grundfos Pumpen AG (Faellanden, Switzerland). All other level sensors and PtlOO temperature sensors were from Baumer Bourdon-Haenni GmbH (Stuttgart, Germany). The electrical heating element was obtained from Lauda (Lauda- Koenigshofen, Germany).

The performance of the above-described device was tested in pre -clinical and clinical experiments and was found to function as intended. In the clinical experiment, 15 subjects were subjected to 30-minute hot treatments at temperatures between 37 and 46°C. Temperature of the water in the head bath was maintained accurately within +/- 0.1°C of the specified treatment temperature for the entire treatment duration.

Example 2

The example device below is described with reference to the hydraulic scheme of Fig. 10. The numbered and letter components are identified in Table II. Table II: Components of the example device

For sources of components, see example 1. A regulated two-way valve (component 410) can be obtained from Siemens AG (Renens, Switzerland) (VVP47.15-2.5 + SSP61).

A bowl-shaped head bath made from stainless steel (102) is mounted on top of the chest-shaped device. The device is supplemented with a treatment table on which a subject to be treated rests with its face up. The table is brought in immediate proximity of the device so that the subject is capable of inserting the back of its head into the head bath. The head bath has horizontal slots just below the rim, the slots being placed all around the circumference. These slots serve as water outlets. Out-flowing water collects in a draining area external to the bath, which area is connected with treatment reservoir 101 by means of PVC tubing. (All tubing present in the device is made from PVC). A strainer (501) serves to retain hair and skin particles. Affixed to the rim of the head bath are several hooks to which is attached a head support of the kind shown in Fig. 4. A first water inlet is positioned at the lowest point of the head bath, the inlet containing an inserted vortex/swirling element for generating convective conditions in the bath that are as nearly uniform as possible. An outlet for evacuation of the bath is placed next to the latter inlet. A pipe serving as a waste water line is affixed to the latter outlet. A low-voltage solenoid valve (405) is mounted just below the outlet. Several additional inlets are present in various positions on the head bath, which inlets are fitted with nozzles that are oriented such that they direct jets of water to various sectors of the subject's scalp.

A treatment reservoir (101) is designed for a useable volume that is larger than that needed to fill the head bath with the head of a subject installed therein. Affixed to this reservoir are a PtlOO temperature sensor (702) for measuring water temperature and an analog ultrasound level sensor for measuring relative water levels (801). The reservoir has three water inlets and two water outlets. The first outlet is fluidly connected to the inlet of the head bath (102) and is secured by low-voltage solenoid valve 404. The first inlet receives the return water from the head bath. A low-voltage, diaphragm bilge pump (201) drives water circulation between treatment reservoir and head bath (at a flow rate of about 20 liters/minute). The second outlet feeds a waste water line that is interrupted by low-voltage solenoid valve 403. The second inlet receives water from the fresh water supply lines of the building in which the device is located. The third inlet serves as a conduit for products (e.g., shampoo).

A combination of a low-voltage, motorized three-way valve (401) and low-voltage solenoid valve 409 regulates temperature and flow of water imported from the building's cold and/or hot water supply lines, which water is routed to either one or both of the set of nozzles in the head bath and the second inlet of treatment reservoir 101. Water flow to the head bath and the treatment reservoir is controlled by low-voltage solenoid valve 402 and regulated, low voltage, two-way valve 410. (It is noted that if valve 409 is closed, one of valves 402 and 410 is open.) PtlOO temperature sensor 701 measures the temperature of incoming fresh water and is capable of controlling the setting of valve 401.

Reservoirs 103-105 contain products such as shampoos and/or conditioners or a system self-cleaning product. A product is delivered into treatment reservoir 101 by low-voltage digital dosing pump 202. The choice of product to be delivered is made by closing and opening, respectively, of low-voltage solenoid valves 406-408. Backflow of water into product reservoirs is prevented by non-return valve 301.

Operation of the device is fully automated. The programmable logic controller used is Saia Burgess PCD2.M5540. Proportional-integral-derivative controllers (PID controllers) manage three-way valve 401 and 410, whereas proportional regulators (P) control all other elements. Programming is in code FUPLA, SAIA's proprietary equivalent of Labview.

The device can be programmed to carry out the following example sequence of operations (after subject is installed): (1) Warm water is delivered to both the treatment reservoir that is thereby filled to its operating level and the nozzles of the head bath to wet and rinse the subject's hair. Water delivered to the head bath is evacuated immediately. (2) An appropriate volume of a selected product is added to the treatment reservoir, and the product-containing water is circulated through the head bath to treat, e.g., shampoo, the hair of the subject. (3) All water is evacuated from head bath and treatment reservoir. (4) Fresh warm water is delivered to the nozzles of the head bath to rinse the subject's hair and scalp as well as to the treatment reservoir for rinsing the reservoir. The treatment reservoir may be filled with fresh water and emptied once or several times. During this step valve 405 remains open to immediately evacuate spent water from the head bath. (5) The treatment reservoir is filled again with fresh warm water, and water circulation through the head bath is reinitiated. (6) Water temperature in the treatment reservoir is slowly ramped up to the desired wellness treatment temperature by addition of water from the building's hot water line. Excess water is evacuated from the treatment reservoir. (7) Treatment temperature is maintained during treatment by further addition of fresh hot water as needed. Hot water addition is controlled by reference to measurements by temperature sensor 702. Excess water is evacuated from the treatment reservoir. (8) After the subject is disengaged and all waters are evacuated from head bath and reservoir, a device cleaning and rinse cycle may be carried out.All headings and sub-headings are used herein for convenience only and should not be construed as limiting the invention in any way. Any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. Unless otherwise stated, all exact values provided herein are representative of corresponding approximate values (e. g., all exact exemplary values provided with respect to a particular factor or measurement can be considered to also provide a corresponding approximate measurement, modified by "about," where appropriate).

Claims

1. A device for thermal treatment of the scalp of a subject at a desired treatment temperature, comprising

(a) a treatment station comprising a water inlet, a water outlet and means for heating or cooling the scalp of a subject by forced convection using water that directly contacts the scalp, (b) a treatment reservoir for holding a volume of water that is greater than that required to operate the treatment station, the treatment reservoir having a water inlet and a water outlet fluidly connected with the treatment station,

(c) means for supplying to the treatment reservoir said volume of water having the desired treatment temperature and for maintaining this temperature in the treatment reservoir during the thermal treatment, and

(d) means for supplying the treatment station with water from the treatment reservoir and for establishing a circulation of water between the treatment station and the treatment reservoir.

2. The device of claim 1 wherein the treatment station comprises (a) a rigid container structure comprising a water inlet, a water outlet and an opening near the bottom wide enough to allow for insertion of the head of the subject up to its hairline, the opening being reversibly sealable around the head of the subject, and (b) a sieve shaped to follow the curvature of the subject's head at a suitable distance from the subject's scalp and fastened to the interior side of the container structure near the edges of the opening thereby creating spaces on either side of the sieve that are liquid- connected through the perforations of the sieve, the perforations serving as impinging jets capable of directing water to essentially all points of the scalp, whereby the water inlet communicates with the space formed between the rigid container structure and the sieve and the water outlet communicates with the space formed between the sieve and the head of the subject.

3. The device of claim 1 wherein the treatment station comprises (a) a rigid container structure comprising a water inlet, a water outlet and an opening near the bottom through which opening the head of the subject is inserted up to its hairline, the opening being reversibly closed around the head of the subject by stretchable, flexible material that bridges the gap between opening and head of the subject, and (b) a support shaped to follow the curvature of the subject's head at a suitable distance from the subject's scalp and fastened to points on the interior side of the container structure, the support carrying a multitude of impinging jets that are capable of distributing incoming water to essentially all points of the scalp, the impinging jets being fluidly connected with the water inlet.

4. The device of claim 1 wherein the treatment station is a head bath comprising a water inlet, a water outlet and means for keeping the head bath in a filled state during a treatment, the head bath dimensioned to permit insertion of the back of the subject's head so that it is immersed up to its hairline but does not touch the bottom of the head bath when it is in a filled state, the head bath optionally containing permanently or removably affixed support means for supporting the head of the subject immersed in the filled bath.

5. A device according to any of the above claims, wherein means for supplying to the treatment reservoir said volume of water having the desired treatment temperature and for maintaining this temperature for the duration of the thermal treatment comprises one or more temperature sensors and one or more heating or refrigeration elements mounted in the treatment station, the treatment reservoir or a fluid connection between the treatment reservoir and the treatment station.

6. The device of claim 5 further comprising a logic controller that utilizes measurements from the one or more temperature sensors for controlling the one or more heating or cooling elements so that the desired treatment temperature is reached and maintained for the duration of the thermal treatment.

7. A device according to claims 1-6, wherein the treatment reservoir comprises an optional means for removing excess water from the reservoir in a controlled fashion and wherein means for supplying to the treatment reservoir said volume of water having a desired treatment temperature and for maintaining this temperature in the treatment reservoir during the thermal treatment comprises one or more temperature sensors for measuring water temperature in the device and a combination of valves communicating on the one hand with cold and hot water lines of the building in which the device is installed and on the other hand with an inlet of the treatment reservoir, the valves capable of mixing the cold and hot water of the building in any proportion and regulating the flow of the so mixed water, whereby at least one temperature sensor is mounted in the treatment station, the treatment reservoir or a fluid line connecting treatment station and treatment reservoir.

8. The device of claim 7, wherein means for supplying to the treatment reservoir said volume of water having a desired treatment temperature and for maintaining this temperature in the treatment reservoir during the thermal treatment further comprises a logic controller that utilizes signals from the one or more temperature sensors for operating the combination of valves so that the treatment reservoir is first supplied with a volume of water of the desired treatment temperature sufficient for supplying the treatment station with the head of the subject installed therein and establishing a water circulation through the treatment station and thereafter quantities of hotter or colder water are added to the treatment reservoir to maintain treatment temperature during treatment.

9. The device of claims 7 or 8 whereby the optional means for removing excess water is an opening located near the top of the reservoir or an outlet near the bottom of the reservoir, evacuation of water through the outlet being controlled by a valve.

10. The device of claim 8 having an outlet for evacuation of excess water controlled by a valve located near the bottom of the treatment reservoir, further comprising a water level sensor mounted in the treatment reservoir, whereby the logic controller integrates signals from the level sensor to operate the valve controlling the evacuation of excess water from the treatment reservoir, thereby maintaining a constant water volume in the reservoir or preventing overfilling of the reservoir.

11. A device for thermal treatment of the scalp of a subject at a desired treatment temperature, the device comprising

(a) a treatment station comprising a water inlet, a water outlet and means for heating or cooling the scalp of a subject by forced convection using water that directly contacts the scalp,

(b) a treatment reservoir for holding a volume of water that is greater than that needed to operate the treatment station when the subject is installed therein, the treatment reservoir being fluidly connected with the treatment station through a water inlet and a water outlet of the reservoir and further fluidly connected through a water inlet and a water outlet of the reservoir with an auxiliary water reservoir,

(c) an auxiliary water reservoir for holding a volume of water of a temperature that is either higher or lower than the desired treatment temperature, the auxiliary water reservoir being fluidly connected with the treatment reservoir through a water inlet and a water outlet in the auxiliary reservoir,

(d) a combination of valves communicating on the one hand with cold and hot water lines of the building in which the device is installed and on the other hand with either one or both an inlet of the auxiliary water reservoir and an inlet of the treatment reservoir, the valves capable of mixing the cold and hot water in any proportion and regulating the flow of the so mixed water,

(e) pumping means as required for supplying the treatment station and establishing a continuous water circulation through treatment station and treatment reservoir and for moving water between the treatment reservoir and the auxiliary water reservoir,

(f) one more other valves as required for controlling flow through water outlets, (g) one or more temperature sensors, of which at least one is mounted in the treatment reservoir, the treatment station or a fluid connection between treatment station and treatment reservoir,

(h) one or more water level sensors mounted at least in each reservoir that is communicating with the combination of valves, and

(i) a logic controller that utilizes measurements from the one or more temperature sensors and the one or more water level sensors for operating the combination of valves and pumping means and other valves as required to provide water of the desired treatment temperature to the treatment reservoir and hotter or colder water to the auxiliary water reservoir and, thereafter, for maintaining the desired treatment temperature in the treatment reservoir by addition of water from the auxiliary water reservoir to the treatment reservoir and returning equivalent volumes of water from the treatment reservoir to the auxiliary water reservoir.

12. A device for thermal treatment of the scalp of a subject at a desired treatment temperature, the device comprising

(b) a treatment reservoir for holding a volume of water that is greater than that needed to operate the treatment station when the subject is installed therein, the treatment reservoir being fluidly connected with the treatment station through a water inlet and a water outlet of the reservoir, and further fluidly connected through a water inlet and, optionally, a water outlet of the reservoir with an auxiliary water reservoir, whereby excess water from the treatment reservoir is discarded through a water outlet of said reservoir,

(c) an auxiliary water reservoir for holding a volume of water of a temperature that is either higher or lower than the desired treatment temperature, the auxiliary water reservoir being fluidly connected with the treatment reservoir through a water outlet and, optionally, also a water inlet in the auxiliary reservoir,

(d) a combination of valves communicating on the one hand with cold and hot water lines of the building in which the device is installed and on the other hand with a water inlet of the auxiliary water reservoir or, optionally, both a water inlet of the auxiliary water reservoir and a water inlet of the treatment reservoir, the valves capable of mixing the cold and hot water in any proportion and regulating the flow of the so mixed water,

(j) pumping means as required for supplying the treatment station and establishing a continuous water circulation through treatment station and treatment reservoir and for moving water from the auxiliary water reservoir to the treatment reservoir and, optionally, from the treatment reservoir to the auxiliary water reservoir, (k) one more other valves as required for controlling flow through water outlets,

(e) one or more temperature sensors, of which at least one is mounted in the treatment reservoir, the treatment station or a fluid connection between treatment station and treatment reservoir,

(f) one or more water level sensors mounted at least in each reservoir that is communicating with the combination of valves, and

(g) a logic controller that utilizes measurements from the one or more temperature sensors and the two or more water level sensors for operating the combination of valves and pumping means and other valves as required to provide water of the desired treatment temperature to the treatment reservoir and hotter or colder water to the auxiliary water reservoir and, thereafter, for maintaining the desired treatment temperature in the treatment reservoir by addition of water from the auxiliary water reservoir to the treatment reservoir, keeping constant the water level in the treatment reservoir or preventing its overfilling by evacuation of excess water and maintaining the water level in the auxiliary water reservoir by addition of water of a temperature that is higher or lower than treatment temperature through operation of the combination of valves.

13. The device of claim 11 or 12, whereby the logic controller operates the combination of valves to provide warm water of a temperature from about 30 to 40°C to the treatment reservoir and water that is above or below the desired treatment temperature to the auxiliary water bath and thereafter causes a controlled ramp-up or ramp-down to treatment temperature in the treatment reservoir by addition of water from the auxiliary reservoir, allowing the subject to adapt to the treatment temperature.

14. The device of claims 11-13, further comprising a heating or cooling element mounted on the auxiliary water reservoir for further heating or cooling of the water in the reservoir.

15. The device of claims 11-13, further comprising a heating or cooling component comprising

(a) a heating reservoir for holding water or oil onto which heating reservoir a heating element is mounted that is capable of heating the liquid contained in the reservoir or a cooling reservoir for holding water or a refrigerant onto which cooling reservoir a cooling element is mounted that is capable of cooling the liquid contained in the reservoir,

(b) a heat exchanger that is in fluid communication on the one hand with the heating or cooling reservoir and on the other hand with the auxiliary water reservoir, and (c) pumping means for establishing a circulation of liquid between the heating or cooling reservoir and the heat exchanger, and between the heat exchanger and the auxiliary water reservoir,

whereby the logic controller operates the heating or cooling element and the pumping means to achieve and maintain a desired water temperature in the auxiliary water reservoir.

16. The device of any of the preceding claims further comprising means for evacuating head bath and the one or more reservoirs, and, optionally, means for disinfecting or cleaning the device.

17. Use of the device of any of claims 1-16 for a hot treatment of the scalp of a subject, whereby the desired treatment temperature is between about 35°C and 48°C.

18. Use of the device of any of claims 1-16 for a cold treatment of the scalp of a subject, whereby the desired treatment temperature is below about 20°C and, more preferably, below about 15°C.