EP0079346A4

EP0079346A4 - Temperature regulator for human scalp.

Info

Publication number: EP0079346A4
Application number: EP19820901489
Authority: EP
Inventors: Peter Bowen Jones
Original assignee: Individual
Current assignee: Individual
Priority date: 1981-05-25
Filing date: 1982-05-25
Publication date: 1985-02-28
Also published as: AU8412082A; EP0079346A1; WO1982004184A1; JPS58500790A

Abstract

A method and apparatus for preventing hair loss in patients undergoing chemo-therapy treatment. The method involves positioning a cap (1) on patient's head and circulating throughout cavity (5) a cold liquid to reduce and maintain the patient's scalp temperature at between 0<o>C and 5<o>C for a period of between 40 and 120 minutes. The cap (1) being formed of a flexible impervious material and having an inner lining (2) and outer lining (3) sealed together at their peripheries thereby forming a cavity (5) having inlets (10)-(14) and outlets (21)-(26) to permit the cold liquid to circulate.

Description

mPΕRX∑mE ΗBGULASOR POR HUMAN SCALP The present invention relates to a method and apparatus for preventing hair loss, in patients undergoing chemo-therapy treatment, with scalp hypothermia..

-4f In the treatment of cancer patients by cherao-therapy 5 the use of the drug doxorubicin hydrochloride is known to cause alopecia, i.e. hair loss, in patients. The psychological impact of this drug-induced side effect in some instances leads patients to refuse chemo-therapy and in other instances results in acute depression in patients 10 undergoing chemo-therapy treatment.

Several methods are presently in use to alleviate the drug-induced alopecia with scalp hypothermia, ranging from simply covering the patients¹ head in bags of crushed ice held in place by means of bandages, to caps containing 15 packs of ice or chemical coolants. All of these known methods suffer from some disadvantages inter alia: they have poor temperature distribution, they are cumbersome in use, they have limited effective cooling life, they provide less than 100% effective scalp cover; with the result that 20 no known method is completely satisfactory.

The present invention seeks to ameliorate these disadvantages or at the very least to provide a choice of preventive measures.

Two advantages are understood to accrue from scalp 25 hypothermia: firstly the vasoconstriction induced by temperature fall should act to reduce the drug quantities ^'reaching the hair follicles, and secondly cellular uptake of the drug should be reduced (like many other drugs, doxorubicin hydrochloride requires temperature-dependant

-B0 metabollic processes for cellular uptake) . _/_ According to the present invention there is provided a method and apparatus for preventing hair loss in patients undergoing chemo-therapy treatment.

The method aspect of the present invention provides a ³5 method of preventing hair-loss in patients undergoing chemo-therapy treatment with scalp hypothermia which comprises positioning a cap formed of flexible impervious material on the head of a patient so as to cover the patient's hair, said cap being formed of an inner and an outer lining sealed together around their peripheries and thereby forming a cavity within said cap, said cavity being provided with at least two inlets and two outlets so spaced from each other as to permit fluid admitted to said cavity to circulate there throughout and circulating a fluid through said cavity to maintain the patient's scalp temperature to between 0°C and 5°C for a period of between 40 and 120 minutes.

The apparatus aspect of the present invention provides an apparatus comprising a cap formed of flexible impervious material, said cap being formed of an inner and an outer lining sealed together around their peripheries and thereby forming a cavity within said cap, said cavity being provided with at least two inlets and two outlets so spaced from each other as to permit fluid admitted to said cavity to circulate there throughout and having a vent tube connected to one outlet to permit the evacuation -of air from said cavity and to prevent a syphoning effect occurring in the outlet.

In one preferred embodiment of the invention, the cavity is filled with an externally temperature regulated fluid admitted to the cavity via five inlet ports and, after circulating throughout the said cavity, the said ^'fluid is removed via 10 outlet ports to a water/ice reservoir where it is cooled and returned to the cap by means of a known pump. The circulating fluid reduces the temperature for as long as scalp hypothermia is required. The cap device of the present invention effectively restricts the flow of blood to the hair follicles through constricting the blood vessels by reducing the temperature thereof and by applying pressure thereto by means of the fluid-filled cap.

-βURfcAϋ- It -has been found that the duration of scalp hypothermia is critical to ensure that no drugs reach or are taken up by the hair follicles. Preferably the temperature of the scalp should be reduced ten minutes 5 prior to beginning chemo-therapy treatment and scalp hypothermia maintained for preferably 90 minutes. These times are presently used; however, it is to be understood that the present invention encompasses such variations in time of use and temperature of fluid used as may be 10 required through the use of drugs other than doxorubicin hydrochloride in chemo-therapy treatment.

For patients that are elderly or weak the preferred embodiment of the present invention is adapted to be suspended from a hook above the patients' head to relieve 15 the weight of the fluid-filled cap.

The invention will now be further described with reference to the preferred embodiment and to the . accompanying drawing, in which: Figure 1 is a schematic view of the cap in position on^' a patient^'. The cap' 20 identified generally by the reference (1) is formed of an inner lining (2) and an outer lining (3) formed of any suitable impervious material, for example flexible rubber. The peripheries of the linings are sealed together as indicated at (4) , thereby forming a cavity (5) within the 25 cap.

The cap as illustrated is provided with a number of inlets and outlets to the cavity (5) . These inlets comprise tubes (6) , (7) , (8) and (9) connected to ports (10) , (11) and (12) located in the forehead region and , 30 right temple region of cap. There are two further ports _ (13) and (14) (not shown) in the left temple region of the cap which mirror ports (11) and (12) respectively.

These outlets comprise tubes (15) , (16) , (17) , (18) , (19) and (20) connected to ports (21) and (22) and (23) , 35 (24) , (25) and (26) located in the upper front region, the crown region and the lower rear region of the cap respectively. There are four additional tubes and four additional ports (not shown) which are mirrored by outlet tubes (17)-(20) and outlet ports (23)-(26) respectively.

It has been discovered that the dimensions of outlet port (21) are important as they directly affect the pressure of the fluid inside the cap. The pressure gradient between the cap and the water/ice reservoir alters whenever the cap is worn at different heights by different patients. In order to minimise these changes in pressure, it is important to ensure that the internal diameter of port (21) marked (B) in the drawing is large enough to remove at least one half of the fluid circulating within the cavity at any given time.

The height of port (21) marked (A) in the drawing, directly affects the internal pressure of the fluid within the cavity. Increasing the dimension (A) increases the internal pressure and decreasing the dimension A correspondingly decreases the internal pressure. Preferred dimensions of (A) are 3.5cm^*and of B are 1cm..

Also shown in the drawing is a vent tube (27 with stopper (28) . This vent tube, without stopper, acts ^' initially to evacuate air from the said cavity whilst the cavity is filling with fluid via said inlets and later acts to permit air to enter outlet tube 15 thereby overcoming any syphoning effect caused by the fluid exiting from outlet port (21) .

The said inlet tubes converge and join a common single inlet pipe (29) which is connected to an immersible pump immersed in the water/ice reservoir. The immersible pump and the water/ice reservoir are known and are not shown in the drawing for reason of clarity. The said outlet tubes also converge and join a common single outlet pipe (30) which discharges into said water/ice reservoir.

The left side of the cap is identical to the right side and for clarity only the right-hand side has now been discussed. An optional feature of the invention is an attachment means (31) arid strap (32) by which the cap can be suspended from a hook above the patient to thereby alleviate the ft weight of the cap when it is filled with fluid. This 5 attachment means is particularly advantageous when the patient is elderly or weak.

The apparatus and method of the present invention has been used on actual patients undergoing chemo-therapy treatment as set out in the following examples: 10 Example 1:

Female aged 62. Hair medium length of approximately 125 mm. Previously undergone two chemo-therapy treatments with total loss of hair on both occasions. Cap of present invention positioned on head 10 minutes prior to beginning 15 chemo-therapy treatment (with same chemical mixture) . Temperature of fluid maintained at 1. °C. Scalp hypothermia continued for total time of 60 minutes. On follow up of patient - no detectable hair loss. Example 2: 20 Female aged 53. Hair condition medium sparse 400mm length. Previously undergone chemo-therapy treatment with accompanying total loss of hair on that previous occasion. Method of invention as for Example 1 except total time of treatment 70 minutes. (Same chemical mixture as with 25 previous chemo-therapy treatment.)

On follow up of patient - no detectable hair loss. Example 3:

Female aged 62. Hair thick and curly. Previously experienced total hair loss with same chemical mixture. 3 Method of invention as for Example 1 except total time of _f 4 treatment 80 minutes. On follow up of patient - no detectable hair loss.

'BϋKtATT

Claims

The claims

1. A method of preventing hair loss in patients undergoing chemo-therapy treatment with scalp hypothermia which comprises positioning a cap formed of flexible impervious material on the head of a patient so as to cover the patient's hair, said cap being formed of an inner and an outer lining sealed together around their peripheries and thereby forming a cavity within said cap, said cavity being provided with at least two inlets and two outlets so spaced from each other as to permit fluid admitted to said cavity to circulate there throughout and circulating a fluid through said cavity to maintain the patient's scalp temperature to between 0°C and 5°C for a period of between 40 and 120 minutes.

2. A method as claimed in claim 1 wherein said treatment is continued for a period of 60 to 90 minutes.

3. A method as claimed in claims 1 or 2 wherein said fluid is a water/ice mixture.

4. A cap used for scalp hypothermia said cap being formed of flexible impervious material, said cap being formed of an inner and an outer lining sealed together around their peripheries and thereby forming a cavity within said cap, said cavity being provided with at least two inlets and two outlets so spaced from each other as to permit fluid admitted to said cavity to circulate there throughout and having a vent tube connected to one outlet to permit the evacuation of air from said cavity and to prevent a syphoning effect occurring in the outlet.

5. A cap as claimed in claim 4 wherein the front outlet port is larger than the rear outlet ports said front outlet port being of diameter 1cm and height 3.5cm and capable of removing at least one half of the volume of fluid circulating within said cavity at any given time.

6. A cap as claimed in claims 4 and 5 wherein said inlets are connected to a common source of supply and said outlets are connected to a common discharge member. 7. A cap as claimed in claim 6 wherein the cap is provided with 5 inlets and 10 outlets.

8. A cap substantially as described with reference to the

A accompanying drawing.

9. A method of preventing hair loss in patients undergoing chemo-therapy substantially as hereinbefore described with reference to the accompanying drawing.

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