JPH0115386Y2 - - Google Patents

Description

[Detailed Description of the Invention] <Industrial Application Field> The present invention relates to a scalp cooling cap, and particularly to a freely deformable scalp cooling cap that can be freely deformed while closely contacting the scalp. <Prior art and problems> Various cooling gels have already been developed under the names of cooling gels, cold preservation gels, cold heat transfer media, colloidal refrigerants, cold preservation tools, cold preservation compositions, and ice pillows that do not require ice. have been proposed, and some have been put into practical use. Among these cooling devices, some are specifically designed to keep the scalp cool, but because they all have a predetermined shape and size, they are difficult to fit tightly to the entire scalp, and cannot be deformed freely. The drawback was that it could not be applied to people. Furthermore, when simply cold water, ice water, viscous liquid, fluid soft gel, etc. are filled into a hollow bag in an attempt to keep the entire scalp cool, it is unavoidable that these fillers flow downward and become unevenly distributed. Even if an attempt is made to adjust the shape with a band or the like, it is obvious that it is difficult to maintain the desired shape. <Purpose of the invention> The object of the invention is to provide a scalp cooling cap that can fit, adhere to, and cover the entire scalp of various shapes and sizes, is deformable, and is easy to put on and take off. The present invention particularly provides a scalp cooling cap for preventing alopecia that occurs as a side effect of administration of anticancer drugs. <Means for Solving the Problems> According to the present invention, two of the flexible materials constituting a cap-shaped scalp cooling cap obtained by deaerating a hollow ball made of a flexible material. Inside the heavy cap wall, saponification degree is 98 mol% or more, average polymerization degree
Contains polyvinyl alcohol of 1000 or more, and
The concentration of the polyvinyl alcohol exceeds 8wt%,
After injecting an aqueous solution of 25wt% or less into a molding mold of any shape, it is cooled to a temperature of -10°C or less, solidified, and molded, and then thawed.
A plurality of small pieces of high water content rubber obtained by repeating the thawing operation to make the cumulative number of freezing times 1 to 8,
A freely deformable scalp cooling cap is provided which is characterized by a hermetically sealed enclosure. The present invention will be explained in more detail below. The polyvinyl alcohol used in the present invention has a saponification degree of 98 mol% or more, preferably 98.5 mol%.
The above is required. Even if polyvinyl alcohol with a saponification degree of 80 to 88 mol%, particularly 85 mol% or less, is used, only a soft gel is obtained, but no rubber-like elastic body is produced. Further, the degree of polymerization of polyvinyl alcohol is required to be 1000 or more. Otherwise, a gel with poor mechanical strength tends to be produced. Therefore, it is preferable to use polyvinyl alcohol with a degree of polymerization of about 1000 to 3300, such as a commercially available polyvinyl alcohol with a degree of polymerization of 1000 to 2600. In the present invention, first, an aqueous solution or suspension aqueous solution containing the aforementioned polyvinyl alcohol is prepared. The concentration of polyvinyl alcohol can be more than 8 wt% and 25 wt% or less, preferably 9 to 15 wt%. Although this concentration can be increased above 25wt%, the viscosity of the aqueous solution increases sharply, which tends to cause inconvenience in operation, and the water content is 75wt%.
It also tends to be inferior in terms of cold retention ability. Also, if this concentration is lowered below 8wt%,
It is too soft for cold storage, and the gel molded product tends to lose its shape and collapse. In order to use the scalp cooling cap obtained by the present invention without pre-cooling it to a low temperature below freezing point, for example, to about 0 to 10 degrees Celsius, it is sufficient to prepare the polyvinyl alcohol aqueous solution as described above. can be reached, but the scalp cooling cap is 0.
After pre-cooling to below 0°C, when ready for use, it is possible to further dissolve a water-soluble organic compound in the polyvinyl alcohol aqueous solution to lower the freezing hardening point of the gel to below 0°C, for example, from -15°C to -20°C. can. In such a case, a water-soluble organic compound as an antifreeze agent (freezing point depressant) is dissolved in the polyvinyl alcohol aqueous solution prior to gel formation. Water-soluble organic compounds include water-soluble monohydric alcohols such as methyl alcohol, ethyl alcohol, and isopropyl alcohol and their derivatives, ethylene glycol, propylene glycol,
Water-soluble polyhydric alcohols such as 3-propylene glycol, glycerin, 2-methyl-2,4-pentanediol, other water-soluble polyhydric alcohols such as acetone, dimethylsulfoxide, methylsulfonic acid, ethylsulfonic acid, dimethylamine, methylamine, formic acid, etc. Examples include organic compounds. In addition, monosaccharides (erythritol, arabinose, xylose, xylitol, glucose, glucitol (sorbitol, sorbitol), gluconic acid, glucuronic acid, glucaric acid, galacturonic acid, fructose, glucosamine), disaccharides (sucrose,
cellobiose, lactose), trisaccharides (raffinose), water-soluble polysaccharides (agarose, amylose,
Sodium alginate, glycogen, chondroitin, chondroitin sulfate, dextran, pectic acid, propylene glycol alginate, gum tragacanth, pullulan, sodium chondroitin sulfate). Among these water-soluble organic compounds, the advantages are that they are odorless and have extremely low volatility, that they can achieve the objective of lowering the freezing point with a relatively small amount of substitution, and that they contribute to the mechanical strength of the resulting gel. In consideration of this, ethylene glycol, propylene glycol, glycerin, D-sorbitol, etc. are preferable. The coexisting concentration of the water-soluble organic compounds mentioned above is:
The content is 5 to 40 wt%, preferably 10 to 35 wt%. When this coexisting concentration is lower than 10 wt%, it is difficult to lower the freezing/hardening point of the gel to -10°C or lower. Additionally, if the coexisting concentration is higher than 40wt%, the freezing point may be lowered unnecessarily, and freezing and
In some cases, this may actually increase the hardening point.
In either case, it unnecessarily increases the economic burden. By coexisting water-soluble organic compounds,
The curing temperature of the gel drops to -20°C or lower, and it does not harden in the ice chamber (-10 to -20°C) of a regular household refrigerator (freezer), maintaining flexibility and a feel similar to living tissue. I can do it. When preparing an aqueous solution containing both polyvinyl alcohol and a water-soluble organic compound as an antifreeze agent, as described above, in addition to adding, dissolving, or suspending polyvinyl alcohol and the water-soluble organic compound in water, A method in which polyvinyl alcohol is dissolved in water in advance and then mixed with the water-soluble organic compound (or its aqueous solution);
Alternatively, a method can be adopted in which a polyvinyl alcohol aqueous solution or polyvinyl alcohol powder is added, dissolved, or suspended in the water-soluble organic compound (or its aqueous solution). In either method, the final polyvinyl alcohol concentration is 8 wt.
% and below 25 wt%, and the concentration of the water-soluble organic compound is adjusted to 5 to 40 wt%. In the present invention, an aqueous solution or suspension aqueous solution containing the polyvinyl alcohol or a water-soluble organic compound therein is injected into a desired mold,
Cool and mold. In this case, the coolant may be, for example, salt-ice (23:77) (-21°C), calcium chloride-ice (30:77) (-21°C),
70) (-55°C), dry ice-methyl alcohol (-72°C), liquid nitrogen (-196°C), etc., to a temperature below -10°C. In addition, liquid helium can be used to cool down to -269°C, but it is uneconomical and has no advantage in gel quality, so in practice a Freon refrigerator is used.
For example, it is best to cool it to -20 to -80°C. There is no harm in cooling it by storing it in a home refrigerator (freezer) or icemaker (-10 to -20℃). Insufficient cooling is not preferred for the present invention because the resulting gel has poor mechanical strength. Therefore, in the present invention, polyvinyl alcohol or an aqueous solution containing a water-soluble organic compound therein is heated to -10°C or lower, preferably -20°C or lower. In the present invention, after the above-mentioned cooling treatment, a series of thawing operations are repeated to thaw the product, and the cumulative number of times of freezing is 1 to 8, thereby obtaining a high water content gel (rubber) that can be used in the present invention. . As the cumulative number of freezing times increases, the hardness of the obtained high water content rubber also improves, but after 8 cumulative freezing times, this effect almost disappears (Masao Nanbu, Polymer Processing,
32, 523 (1983)), the above-mentioned 1 to 8, preferably 2 to 6, are economical. In the present invention, the high water content gel obtained as described above is formed into small pieces. Polyvinyl alcohol or an aqueous solution containing a water-soluble organic compound is injected into a mold for forming small pieces, and multiple pieces of high water content gel are directly formed. You may also mold small pieces. In addition, if small pieces of high hydrous gel are not directly molded, the high hydrous gel obtained in an arbitrary shape can be cut into a plurality of small pieces. The shape of the small pieces of high water content gel is not particularly limited, and may be cubic, rectangular parallelepiped, cylindrical, etc.
It may have any shape such as a spherical shape, and its dimensions are not critical as long as it can be deformed by applying finger pressure from the outer surface when it is included in the cap wall as described later. The size is usually 2 mm to 3 cm on a side or in diameter.
It is preferable that <Example> An embodiment of the scalp cooling cap of the present invention will be described with reference to the accompanying drawings. In FIG. 1, a plurality of small pieces of high water content gel (high water content rubber) obtained as described above are placed in a hollow ball 2 (spherical or ellipsoidal) made of a flexible material. The amount of small pieces filled is preferably 0.3 kg or more from the viewpoint of the required cold storage capacity, but in consideration of the burden on the patient when wearing a cold cap, it is preferably 3 kg or less, 0.3 to 3 kg, particularly preferably 0.35 kg. By setting the weight to 2 kg, the purpose of preventing hair loss can be sufficiently achieved. As the flexible hollow ball 2 for storing this small piece, a hollow ball made of plastic film such as polyvinyl chloride, polyethylene, or polypropylene or a thin rubber ball is preferable from the viewpoint of feeling on the scalp and sealing property. Vinyl beach balls, balloons made of polypropylene/nylon laminated film, thin rubber balls made of candy rubber, etc. are most convenient, as well as rugby balls, American football balls, airships, and UFOs (flying saucers) made of the above-mentioned soft films. )
Model toys such as the above can also be used as long as they have the function of the spherical or oval hollow ball of the present invention. In order to store the small pieces 1 of the water-containing gel (water-containing rubber) into these hollow balls, a small piece inlet 3 can be provided on the wall surface of the hollow ball 2 if necessary, and in advance, when producing the hollow balls, A small piece inlet may also be provided. In the present invention, after a predetermined amount of water-containing rubber pieces are input through the input port 3, unnecessary air inside the hollow ball is released. That is, in order to obtain a depression on the wall of the ball for covering the head, it is necessary to evacuate the inside of the hollow ball. If a large amount of air remains due to insufficient degassing, the small pieces 1 tend to flow downward, which impedes uniform cooling of the entire scalp. Therefore, although the air release described above is extremely important, it is not necessary to completely eliminate all the air; it is sufficient to release most of the air by compressing the ball wall surface. After that, all the openings 3 on the wall of the ball are closed and sealed. In order to seal the opening, the opening can be heat-sealed, or the opening can be tied with a string, sealed with a seal, or adhered with an adhesive. FIG. 2 shows the scalp cooling cap 10 of the present invention obtained by degassing. In the illustrated example, the opening 3 is sealed with a sealing plug 4. Due to the above-mentioned air release and ball wall sealing measures, the hollow ball inevitably has a crescent shape (boat shape, boat shape).
The cold cap 10 of the present invention is obtained. As mentioned above, the high water content rubber filling amount is 0.3 to 3
However, setting the filling layer thickness to 3 cm or more means that the duration of cold storage is often extended unnecessarily and the patient is forced to bear extra weight, so the filling layer thickness is 0.6 kg. It is best to select the filling amount according to the size of the hollow ball so that the filling amount is ~2.5 cm, preferably 0.8 ~ 2 cm. An example of a preferred filling amount is for a hollow bowl with a diameter of 32 cm.
1.2-2Kg (filling layer thickness 0.8-2cm), 0.3-0.6Kg (filling layer thickness 0.8-2cm) in a hollow ball with a diameter of 16cm
etc. When wearing the ice pack 10 of the present invention, place the recessed part (inside) 5 of the ice pack on the head 6 and apply finger pressure from the outer surface of the ice pack to move a part of the filling layer as appropriate. The filling layer is arranged so that the entire area where hair exists is almost uniformly covered, and the extra part of the ice cap wall is pinched with the fingertips to fit the shape of each patient's head. The shape of the ice pack is finally adjusted so that the size of the ice pack is shortened appropriately, or a fold 7 is added to the excess portion exceeding the head circumference so that the ice cap fits tightly over the entire head area. In this invention, the cooling cap is designed to maintain close contact with the scalp after the patient puts it on, and to maintain this close contact even when the patient makes head movements such as shaking his head. Elastic band 8 around the hem
It is preferable to wrap and secure it with a band (band, flat fastener, elastic bandage) (see Figure 4). Regarding the dimensions of the hollow ball, consider the following points from the viewpoint of adhering and covering the entire scalp. That is, the head shapes of infants and children are close to spherical, and therefore, a hemispherical ice pack corresponding to the head circumference can cover almost the entire scalp. Furthermore, in order to keep eyebrows, nuchal region, side-whiskers, etc. cool, a cooler cap with a size that exceeds the head circumference is used, and an extra ball wall portion that exceeds the head circumference is used. After that, an elastic band 8 (plane fastener, magic belt) or an elastic bandage is wrapped around the hem of the ice-packed cap, and the ice-packed cap 10 is tightly fitted along the circumference of the head. In adults, the brain cranium (the part above the eyes) is not much different from that of children, but considering the long face and head height, it is especially desirable to wear a cold cap with a vertically long ball (ellipsoid). Using a spherical ball that exceeds the enclosing dimensions, pinch or fold the excess wall of the ball (Figure 3), and as described above, wrap the elastic band 8 (belt) around the hem of the ice pack to reduce the diameter of the ball. It can also be shortened and shaped into a vertically long (vase-shaped) shape. Therefore, the dimensions of the hollow ball are preferably spherical with a diameter of 15 to 32 cm, or a shorter axis of less than 12 to 32 cm and a longer axis of 15 to 32 cm, from the viewpoint of covering the entire hair.
Especially for infants (head circumference 33.5-51cm) with a diameter of 15-24cm.
Spherical shape, or short axis less than 12-24cm, major axis 15-24cm
For children (head circumference 50-52cm), a spherical shape with a diameter of 17-25cm, or an oval-spherical shape with a minor axis of less than 14-25cm and a major axis of 17-25cm, and for adults, a diameter of 19-25cm.
32cm spherical, or short axis 17~32cm, diameter 19~
A 32 cm oval spherical shape is preferred. In either case, these can cover not only the top of the head, but also the occiput, temporal region, eyebrows, etc., as well as the sideburn and sideburns.
-whiskers), nuchal region can also be covered. <Effects of the invention> In the present invention, the entire scalp can be covered with a filler made of small pieces of highly water-containing rubber 1, and by applying finger pressure and moving the filler appropriately, it can be formed into any shape according to the head shape of each patient. It is easy to deform, and moreover, the desired shape is maintained as it is after the finger pressure is released. The scalp cooling cap of the present invention is suitable for preventing hair loss caused by administering anticancer drugs to cancer patients, and is particularly suitable for Adriamycin, which is frequently used as an antibiotic, or 14-hydroxy daunorubicin (doxorubicin).
It has great utility in preventing and inhibiting severe hair loss as a side effect of drugs such as daunorubicin and doxorubicin. The usual method of using the ice pack of this invention is to store it in the refrigerator (3 to 10℃) overnight, then wear it as described above before injecting adriamycin, and then apply the filling layer to the entire hair area, and then put it on as described above. , inject adriamycin. For example, if the thickness of the filling layer is 13 mm, the scalp temperature will be maintained at 25 degrees Celsius or less for 30 minutes after installation.
Similarly, the scalp temperature is maintained below 30°C for 60 min, but usually the scalp temperature is kept below 30°C for 15 min after injection.
By cooling to 25-30°C, the purpose of preventing hair loss is fully achieved. The injection time for Adriamycin is usually approx.
Although the administration time is within 5 minutes, some hospitals require 1 to 2 hours for intravenous administration. For the latter case, it is possible to extend the duration of cold retention by increasing the thickness of the filling layer of the cooling cap of the present invention to 2.5 to 3.5 cm, but the burden on the patient due to the filling (weight) can be taken into consideration. As mentioned above, the filling layer thickness is set to 0.8~
It is best to use a pre-chilled ice cap and replace it every 30 to 60 minutes during the infusion period. Adriamycin dosage is 30-50mg
m ^-2 (dose per 1 m ² of body surface area), but higher doses, for example 60 to 80 mg m ^-2 (per kg of body weight, adults: 1.6 to 2.3 mg, 13 to 19 years old: 1.6 to 2.5 mg,
In some cases, 7-12 years old: 2-3.5 mg; 0-6 years old: 2.5-11 mg). When administering such a large amount, some people recommend that the scalp be deeply cooled (J.
G.Dean, SESalmon etal., N.Eng.J.Med.,
301, 253 (1977)). In order to meet this demand, high water content rubber obtained by the above-mentioned treatment method that uses a water-soluble organic compound in combination is filled to a thickness of 2 to 3 cm.
What's more, you can store this ice pack in the freezer (ice maker, -20℃).
The method is to pre-cool the product and then put it on.
Scalp temperature can be maintained below 20℃ for 50min.

[Brief explanation of drawings]

Figure 1 is a partially cutaway perspective view showing a small piece of high water content gel placed inside a hollow ball to make the scalp cooling cap of the present invention, and Figure 2 is a scalp cooling cap of the present invention obtained by degassing. A sectional view showing the cap, FIG. 3 is a schematic view showing the scalp cooling cap being worn, and FIG. 4 is a schematic view showing the flat fastener being wrapped. In the figure, 1 is a small piece of high water content gel, 2 is a hollow ball, 3 is a small piece inlet, and 10 is a scalp cooling cap.

Claims (1)

[Claims for Utility Model Registration] 1. Within the double cap wall of the flexible material constituting a cap-shaped scalp cooling cap obtained by deaerating a hollow ball made of a flexible material,
Contains polyvinyl alcohol with a saponification degree of 98 mol% or more and an average polymerization degree of 1000 or more, and the concentration of the polyvinyl alcohol exceeds 8 wt% and 25 wt%
After injecting the following aqueous solution into a mold for any shape, it is cooled to a temperature below -10℃, solidified, and molded, and then thawed. A series of freezing and thawing operations is repeated to cumulatively freeze the solution. A plurality of small pieces of high water content rubber obtained by making the number of times 1 to 8,
A freely deformable scalp cooling cap characterized by a hermetically sealed structure. 2. The freely deformable scalp cooling cap according to claim 1, wherein the aqueous solution contains a water-soluble organic compound at a concentration of 5 to 40 wt%.