WO2006126059A1

WO2006126059A1 - Cooling device

Info

Publication number: WO2006126059A1
Application number: PCT/IB2006/001341
Authority: WO
Inventors: John Kern; Yvonne Olofsson; Lars Kjaerulff
Original assignee: Fiomed Aps
Priority date: 2005-05-24
Filing date: 2006-05-23
Publication date: 2006-11-30

Abstract

A system for cooling the hands, in particular the apical parts thereof , of a patient undergoing chemotherapy comprising: - a glove adapted to the patient's fingers, said glove being provided with flow passages for a cooling fluid, - a cooling unit and a pump for supplying the glove with cooling fluid at a predetermined temperature, and - tubes for transporting the cooling fluid from the cooling unit to the glove wherein the flow passages are connected in serial or parallel and extend along the fingers of the glove.

Description

Cooling Device

SUMMARY OF THE INVENTION

The present invention relates to coaling gloves and moccasins to be worn on a human hand and foot, respectively, and more specifically to cooling gloves and moccasins comprising a flowing liquid for cooling the gloves and moccasins to a temperature around 0-5⁰C in order to reduce undesired effects from chemotherapy, e.g. loss of naiis and painful skin reactions.

A well-known problem associated with chemotherapy treatment is loss of hair. The side effects of chemotherapy depend on the type of chemotherapy and the amount given. Anticipating and managing side effects can help to minimize them and provide the best possible experience for the person receiving chemotherapy. Many patients who undergo chemotherapy are also surprised to learn that their nails become brittle or discolored, crack easily, or even fall off. The only parts of the human body which continue to grow after adulthood is reached are the hair and nails. In other words, if it needs trimming, there is a risk that it will be affected by chemotherapy. If a nail is lost, it can take 6 months or longer for it to grow back. These nail changes are especially common with chemotherapy such as Taxotere (Docetaxel or paclitaxel) and 5-FU (Fluorouracil).

The reason that nails are affected is identical to the reason that hair is affected. Cancerous tumors are made up of rapidly dividing cells, which are targetted by chemotherapy. However, rapidly dividing cells are also crucial to the formation of hair and nails, and chemotherapy cannot distinguish these "good" celts from the cancerous ones. While normal cells are able to repair themselves and grow back, cancer cells will die. The result can be damaged or weakened nails during the time of treatment. Following treatment, the patient's nail beds will return to normal and re-grow healthy nails.

By cooling the relevant parts of the body these undesired effects may be partly or fully eliminated. With respect to hair loss, it has been observed that cooling of the scalp, and therewith the roots of the hair, to a temperature of from -8 to 5⁰C will reduce the ability of the roots to take-up the chemotherapeutic drug and thus increase the chances of the roots surviving the treatment to a corresponding extent. According to known techniques, this cooling treatment will preferably be continued for one to five hours. Similarly, it has been shown that by cooling the fingers and the toes, the corresponding problems may be alleviated.

While continuously cooled head coverings have been widely used in connection with loss of hair, the above mentioned nail problems have so far primarily been coped with by immersing the hands or feet into a cooling medium, wherein the skin is in direct contact with a liquid kept at a temperature between -10 and 5^DC.

WO 98/16176 discloses an apparatus for regulating the temperature of the scatp of a person undergoing chemotherapy. The apparatus comprises a head covering that includes a plurality of flow passages that extend from the edge of the head covering up towards the crown of said covering.

US patent No 5,950,234 discloses a cooling pack in the form of a container encapsulating a cooling substance for preventing loss of hair during chemotherapy treatment. The cooling pack may be formed in a bowl shape to cover the scalp portion of the users head.

US patent No 4,765,338 discloses a reusable heat exchanging head piece employable with cancer therapy patients in order to cool the scalp zone of the head for preventing hair loss during chemotherapy treatment.

US patent No 4,753,242 discloses a skull helmet, which in use, is worn on the head of a patient and receives circulatory cooling fluid to cool the patient's scalp. The helmet is particularly useful when a patient undergoes chemotherapy.

Other parts of the human body, including the oral cavity, may also need to be cooled during chemotherapeutic treatment. In this respect, US patent No 5,509,801 discloses an oral therapeutic apparatus comprising an oral device formed to be insertable within a patient's mouth and receiving a circulated cooling medium.

So far, the prior art does not teach nor does it envisage how the problems of loss of e.g. nails may be circumvented in a practicable and simple way. The traditional method of immersing the hands or feet into a cooling medium such as water is inappropriate since the patient is immobile and cannot use in particular the hands for other purposes, e.g. reading, writing or eating. Moreover, the skin being in direct contact with the liquid may swell or otherwise be influenced by the liquid. Additionally the temperature is difficult to control.

US patent No 6,315,696 discloses a therapeutic device for use in the treatment and/or rehabilitation of injuries to bodily extremities, such as the hands or feet. In the device, a capsule or chamber is provided which is at least partially filled with a Newtonian or non-Newtonian liquid. An area approximating the shape of the extremity, such as a hand, is formed and made an integral part of the capsule such that the extremity may be inserted to move freely within the liquid physically coming into contact with the liquid.

WO 99/47011 discloses a thermal glove fitted to a human hand having integrated with a body of the glove a thermal gel-filled pack. The gel pack includes a sealed bladder constructed of a flexible, durable material resistant to heat and rupture. The bladder encloses a thermal gel adapted for repeated heating and cooling for comfort, prosthetic and/or injury preventive use for technical workers, such as computer users and laboratory workers.

The prior art does not describe gloves or moccasins adapted for cooling the fingers and toes, respectively, during chemotherapy treatment. The devices disclosed in US patent No 6,315,696 and WO 99/47011 do not make use of any temperature- regulating means during the treatment period. The devices do not include flow passages causing the cooling fluid to flow in the regions adjacent to the nails, and thus the body temperature would inevitably increase the temperature of the cooling liquid giving rise to less efficient cooling. It should be noted that the most efficient treatment is achieved at temperatures between 0 and 5⁰C; at lower temperatures freeze-injuries will appear, and at higher temperatures the treatment is inefficient.

US patent No 5,871,526 discloses a light-weight portable temperature control unit integrating a variety of face and body pads that will conform to the various contours of the face and body to aid in the therapeutic treatment of sports injuries and other forms of trauma. The patent does not envisage a system which would be able to cool all fingers or all toes sufficiently well for being suitable in connection with chemotherapy. Importantly, it fails to constantly and uniformly cool all of the fingers and toes simultaneously. Hence, the known methods and apparatus for cooling extremities would either not maintain the skin at a constant desired temperature for the duration of extended treatments or otherwise not be suitable for cooling the entire region, i.e. all fingers or all toes.

Thus, in view of the inadequacies of the known methods and apparatus, there has been a need for a therapeutic apparatus, and a method of using the device, for effectively cooling selected regions of the extremities to reduce absorption of chemotherapy agents and the subsequent loss of nails, throughout extended periods with chemotherapy treatment. Such a device would reduce or eliminate the problem which has not been overcome by the known methods and apparatus and which has reduced the effectiveness of previous chemotherapy treatments. Furthermore, there has been a need for a device that remains comfortable to the patient throughout the length of any treatment which device may be worn without significantly affecting the patient's ability to use his fingers for purposes such as reading, writing or eating.

It is therefore an objective of the present invention to provide a cooling system suitable for constantly keeping the temperature immediately above the skin at temperatures around 0 to 5^βC. It is also an object of the invention to provide a cooling system which enables the patients to walk around and freely move the fingers for purposes such as reading, writing or eating.

To achieve the objects of the invention, as embodied and broadly described herein, the present invention comprises an apparatus for reducing the undesired side-effects on extremities of a patient being subjected to a chemotherapy treatment, which comprises a hand or foot therapeutic device having an inner contour that conforms to the patient's hand or foot and contacts the patient's fingers or toes. The device contains a cooling medium, which is preferably circulated therethrough by a supply source, which maintains the cooling medium at the desired temperature to prevent warming of the device for the duration of the chemotherapy treatment.

The inventors have found that in order to have a perfect cooling effect on the skin, the flow of the circulating cooling liquid around the areas of the patient to be cooled must be guided, Hence the flow passages are provided with baffles or the tike giving rise to optimum heat-exchange. Thus, in one aspect of the present invention there is provided an apparatus for regulating the temperature of a human hand, in particular the apical parts thereof, comprising a glove that includes a plurality of flow passages and a cooling fluid which flows through the passages from an inlet and which are connected through an outlet to a circulating system, wherein the flow passages are provided with baffles or the like and a regulating device is provided for regulating the temperature and/or the flow of the fluid flowing through the respective flow passages.

Accordingly the present invention is directed to a system for cooling the hands, in particular the apical parts thereof, of a patient undergoing chemotherapy comprising:

-a glove adapted to the patient's fingers, said glove being provided with flow passages for a cooling fluid,

-a cooling unit and a pump for supplying the glove with cooling fluid at a predetermined temperature, and -tubes for transporting the cooling fluid from the cooling unit to the glove wherein the flow passages are connected in serial or parallel, and which extend along the fingers of the glove.

In one embodiment of the invention, the flow passages are connected in serial. This offers a very simple design since the supply of cooling fluid to the glove may be accomplished by virtue of a single tube connected to one end of the glove. The flow passages may be provided with baffles in order to establish a guided flow around the fingers (see e.g. Figure 1). Such baffles have in some cases proven to be decisive for optimum cooling around the fingers, since they may prevent dead volumes, air bubbles and other undesired fluid dynamics.

One aspect of the present invention is that the cooling unit and the glove are connected so as to form a circulating system for the cooling fluid. Such a simple design may have several advantages including low manufacturing cost and facilitates the disconnection of the glove from the cooling unit, However, such a system may also suffer from the fact that the temperature of the cooling fluid increases when it travels from one end of the glove to the other end. In order to minimize such undesired effects the cooling unit of the system may be adapted for regulating the temperature and/or the flow of the fluid flowing through the flow passages. With respect to the material of the cooling glove, several natural and synthetic polymers are suitable provided that the material exhibits a sufficient degree of elasticity and chemical inertness. Preferred materials include natural rubber and silicone rubber.

As mentioned, above the system may be made so that the cooling fluid circulates between the glove and the cooling unit. In order to facilitate patient movement, the system may be provided with two sets of quick disconnects, one being coupled by tubes to the cooling unit and the other being coupled to the pump for return of the fluid. In this way the patient may easily and rapidly disintegrate from the cooling unit.

In order to provide optimum treatment of the affected skin area, the system utilizes water as the cooling fluid kept at a temperature between 0 and 5⁰C₁ more preferably between 2 and 4^βC, and most preferably between 2.5 and 3.5°C.

In another aspect of the present invention, there is provided an apparatus for regulating the temperature of a human foot, in particular the apical parts thereof, comprising a moccasin or shoe that includes a plurality of flow passages and a cooling fluid which flows through the passages from an inlet and which are connected through an outlet to a circulating system, wherein the flow passages are provided with baffles or the like and a regulating device is provided for regulating the temperature and/or the flow of the fluid flowing through the respective flow passages.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 shows a cooling glove according to a preferred embodiment of the invention.

Figure 2 shows a cooling moccasin according to a preferred embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Figure 1 shows a cooling glove 1 according to a preferred embodiment of the invention. The glove is made of an elastic material so that it will fit to the fingers of the patient and remain in place without being dislodged from the patient should he/she change the position of his/her body during treatment. The glove may also be supplemented with a strap for instance, if so desired.

The material from which the glove is made will also be capable of enclosing a cooling fluid intended for circulation between walls embodied in the glove, in the manner described in more detail hereinafter, without the fluid leaking from the glove.

In the case of the illustrated embodiment, the glove is produced from a rubber fabric. It will be understood, however, that this fabric Is only an example of possible materials that can be used and does not constitute a limitation of the scope of the invention. Different types of elastic, impervious materials or coated and therefore densely net- formed material structures can also be used with advantage.

The glove includes an inner fabric 2 which lies proximal to the patient's fingers, and externally of the fabric an outer fabric 3, The fabrics define therebetween a space 4 through which cooling fluid shall flow. The fabrics are joined together at their bottom regions around the edge 5 of the glove and along walls 6 defining passages through which the cooling fluid may flow. The walls 6 extend from said edge towards the apices/tips 7 of the glove.

The glove thereby defines sections 8 for separately cooling the patient's fingers. At the bottom of each section there is provided an inlet 9 and an outlet 10 for flow connection of the sections and for flow connection of the glove to a cooling unit (not shown). Alternatively, the inlet and outlet of each section may be individually connected to the cooling unit, whereby the sections are connected in parallel. This may have the advantage that each finger is cooled with cooling fluid having a uniform temperature; this may be necessary where the cooling fluid has to be kept at a very low temperature, where serially connected sections are, in some instances, not cooled to the same degree.

Arranged in the interior of each section chamber 4 a temperature sensor may be provided, which monitors the current local temperature. In one embodiment, the sensor may be electric and the temperature reading delivered via a cable. This cable may be drawn out of the section through the inlet or the outlet and passed out of the section through the inlet or the outlet and passed out through the conductor wall at an appropriate position. The sensor will preferably lie in abutment with the inner fabric wail 2.

The temperature sensor may alternatively be mounted in the interior of the glove, which simplifies the delivery of the information from the temperature sensor and slightly enhances monitoring precision. In one embodiment, the sensor may be mounted on or in the inner fabric wall 2, for instance in immediate contact with the head, inwardly of respective sections.

Monitoring of the local temperatures in each section enables the temperature and/or the rate of the flow of the coolant delivered to respective sections to be regulated or controlled so that ail sections will obtain precisely that cooling effect which is required.

This regulation can be effected manually after manually reading the temperatures, or automatically with the aid of an electronic monitoring and regulating means.

With the aid of a simple apparatus, a desired set point value, e.g. +3⁰C can be compared in a computer with current information from the temperature sensors in the respective sections, said computer functioning to initiate adjustment of the cooling effect in each section in relation to the difference.

With the object of lessening the discomfort of the patient still further, such an apparatus may include a program for regulated cooling. The glove may be at room temperature when placed on the patient's fingers and the patient given the choice of lowering the temperature rapidly or slowly.

With the intention of preventing power losses, and therewith a reduction in the requisite fluid volume in each section, the glove may be provided externally with an outer insulating guard. This guard may, for instance, include a heat-radiation reflecting and/or a porous insulating material. Particularly preferred in this respect is an outer covering that comprises several layers which include separate air-filled cavities or channels that function to counteract conduction, radiation and convection of heat.

In an alternative embodiment, a cooling unit may be used for each section (in parallel), so that flow rate and temperature can be regulated individually for each section. In another alternative embodiment, there is used a single cooling unit with which there is used a common temperature for the cooling fluid supplied to the sections. The cooling effect can then be regulated, by throttling the flow of the fluid.

The joints can be produced by any means suitable in respect of the material chosen. In the case of rubber, the joints may be vulcanized or glued. In the case of thermoplastics, the joints may be glued or welded, e.g. high-frequency welds, etc.

The materials will preferably be elastic so as to fit the patient's fingers. Moldabiiity assists in ensuring that the inner wall of the inner fabric of the sections will lie against the whole of the fingers so no part of the fingers go untreated.

The cooling fluid used may be any fluid known to the skilled person, in this particular technical field any fluid suitable for the temperature intervals and cooling units concerned. Water is the preferred cooling fluid because it has desirable heat transfer properties; however, other cooling mediums such as solutions of water and alcohol may optionally be used. Preferably, the cooling medium is maintained at a temperature of approximately 0⁰C to approximately 5^ΛC.

Figure 2 shows a cooling moccasin according to a preferred embodiment of the invention, with the moccasin applied to a patient's foot for the purpose of cooling the patient's toes. The concept and materials used herein identical to those described above for the cooling glove.

The cooling glove and/or moccasins may be connected to a portable temperature control system (cooling unit). The basic components of a portable temperature control system according to the present invention are means, usually a pump, for circulating the cooling fluid through the temperature control system, and means for cooling the fluid.

Moreover, the system may comprise an electronic programmable temperature controller for minute adjustments of the temperature of the fluid flowing through the system such that the control system can be programmed to provide cooling cycles in any sequence for variable periods of time, a power supply for powering the temperature control system, a keypad connected to the electronic programmable temperature controller for programming the cooling and heating variable periods of time. The temperature control system may also include a liquid crystal display screen for communicating with the machine's operator, and liquid electronic displays. The system preferably comprises a dual output system wherein there is a fixed voltage output for the pump and a programmable voltage for regulating the temperature. Alternatively, the power supply may be a single output DC system and the pump operated from the AC line source.

This invention preferably utilizes an arrangement of the thermoelectric elements to effect a lightweight portable cooler. These thermoelectric elements or couplers heat or cool depending on the direction of the current flow through the elements (Peltier effect). The cooler is precisely temperature controlled and can be coupled through quick disconnects to the glove or moccasin of the present invention.

The programmable temperature controller includes a microprocessor capable of controlling the temperature of the circulating fluid within ±0.5°C of the preset temperature. The microprocessor of the programmable temperature controller can be programmed to automatically provide heating and cooling cycles in any desired sequence and duration of time.

The power supply of the temperature control unit preferably comprises an international front end power supply having a direct current voltage converter adaptable with an international input power supply functional on either 40 to 60 cycles and 90 to 270 volts AC or operational on battery power. Alternatively, the power supply may be an AC power supply, or the temperature control unit may have more than one power supply.

Claims

1. A system for cooling the hands, in particular the apical parts thereof, of a patient undergoing chemotherapy comprising: - a glove adapted to the patient's fingers, said glove being provided with flow passages for a cooling fluid,

- a cooling unit and a pump for supplying the glove with cooling fluid at a predetermined temperature, and

- tubes for transporting the cooling fluid from the cooling unit to the glove wherein the flow passages are connected in serial or parallel and extend along the fingers of the glove.

2. A system according to claim 1 , wherein the flow passages are connected in serial.

3. A system according to claims 1 or 2, wherein one or more flow passages are provided with baffles.

4. A system according to any one of claims 1 to 3, wherein the cooling unit and the glove are connected so as to form a circulating system for the cooling fluid.

5. A system according to any one of claims 1 to 4, wherein the cooling unit is adapted for regulating the temperature and/or the flow of the fluid flowing through the flow passages.

6. A system according to any one of the preceding claims, wherein the glove is made from a naturally occurring material, including natural rubber.

7. A system according to any one of claims 1 to 5, wherein the glove Is made from a chemically inert material.

8. A system according to claim 7, wherein the glove is made from silicone rubber.

9. A system according to any one of the preceding claims, wherein the glove is connected in the system with two sets of quick disconnects, one being coupled by tubes to the cooling unit and the other being coupled to the pump for return of the fluid.

10. A system according to any one of the preceding claims, wherein said system further comprises water a cooling fluid kept at a temperature between 0 to 5⁰C.

11. A system according to claim 10, wherein the cooling fluid is kept at temperature between 2 to 4°C.

12. A system in accordance with any one of claims 1 to 11, wherein the glove is replaced by a moccasin, said system being adapted for cooling the feet of a patient undergoing chemotherapy.