The present invention relates to cold packs.
Reusable cold packs are known, however, these are not used in many clinical situations because they require freezing and because of sterility concerns and the need to reduce the spread of disease.
Certain kinds of disposable cold packs are also known, however, these suffer from drawbacks including poor manufacturability, design complexity, and high unit cost.
In addition, certain materials used in disposable cold packs, such as ammonium nitrate, may be controlled or regulated and therefore difficult to obtain and potentially hazardous to store in quantities suitable for mass production of disposable cold packs.
Therefore, the prior art suffers for lack of a disposable cold pack that is readily manufacturable in large quantities and convenient and safe to use in various clinical situations.
The present invention relates to disposable cold packs for cold therapy and methods of manufacturing same. Such disposable cold packs can include a mixture of urea and ammonium chloride.
According to one aspect of the present invention, a method of manufacturing a disposable cold pack for cold therapy includes heat-sealing plastic sheet to form a water-tight envelope having an open top and loading a predetermined amount of urea into the envelope through the open top. The method further includes, separate from the loading of the urea, loading a predetermined amount of ammonium chloride into the envelope through the open top. The method further includes loading a water-tight frangible container into the envelope through the open top. The water-tight frangible container contains a predetermined amount of water. The relative proportions of the predetermined amount of urea, the predetermined amount of ammonium chloride, and the predetermined amount of water are selected to provide a target cooling effect to a portion of a body to which cooling is applied. The method further includes heat-sealing the open top of the envelope to form a water-tight outer pack.
According to another aspect of the present invention, a disposable cold pack for providing cold therapy to a portion of a body includes an outer pack formed of a water-tight sealed envelope. The outer pack has an outer surface configured for placement on skin or clothing covering the portion of the body. The cold pack further includes a mixture of urea and ammonium chloride contained inside the outer pack. The cold pack further includes a water-tight frangible container disposed inside the outer pack. The water-tight frangible container contains water, and is configured to release the water into the inside of the outer pack in response to an external force applied to the outer pack. The relative proportions of the urea, the ammonium chloride, and the water are selected to provide a target cooling effect to the portion of the body.
According to another aspect of the present invention, a disposable cold pack for providing cold therapy to a portion of a body includes an outer pack formed of a water-tight sealed envelope formed of at least one layer of plastic sheet that is heat-sealed at one or more heat-sealed seams. The plastic sheet has a fibre texture at an outer surface of the outer pack to configure the outer pack for placement in direct contact with skin of the portion of the body. The cold pack further includes a mixture of urea and ammonium chloride contained inside the outer pack. The mixture does not contain a substantial amount of ammonium nitrate. The cold pack further includes a water-tight frangible container disposed inside the outer pack. The water-tight frangible container includes a heat-sealed plastic bag containing water, and is configured to rupture and release the water into the inside of the outer pack in response to an external force applied to the outer pack. The relative proportions of the urea, the ammonium chloride, and the water are selected to provide a target cooling effect to the portion of the body. The relative proportions are between about 32-38% urea, between about 7-16.5% ammonium chloride, and between about 45.5-61% water, by weight.
The drawings illustrate, by way of example only, embodiments of the present invention.
a-f are schematic diagrams of a method of manufacturing the cold pack
g-h are schematic diagrams of steps for attaching the strap to the cold pack of
The reaction of urea and water does not achieve temperatures cold enough for many therapeutic applications. Hence, according to the invention, ammonium chloride is included with the urea to reduce the temperature further. This provides the benefit of temperatures comparable to those that can be attained when using ammonium nitrate, but without the need to use ammonium nitrate and be limited by its distinct disadvantages.
The cold pack 10 includes an outer pack 12 formed of a water-tight sealed envelope 14. The envelope 14 may be formed of at least one layer of plastic sheet, which can be heat-sealed at one or more seams 16 that define the outer perimeter of the envelope 14. In the embodiment depicted, all four edges of the rectangular envelope 14 have heat-sealed seams 16. In other embodiments, three edges of the rectangular envelope 14 have heat-sealed seams 16, with the fourth edge being formed by a fold of a single sheet of plastic.
The plastic sheet may be of any suitable polymer, such as polyethylene, polyester, polypropylene, nylon, polyvinyl chloride, and combinations of these materials, such as laminates of multiple layers of these materials, as well laminates of such materials further including paper. The plastic sheet material may be selected to be free of latex and other allergenic materials.
The plastic sheet can have a fibre texture at an outer surface 18 of the outer pack 12 to configure the outer pack 12 for placement in direct contact with skin of the portion of the body. The fibre texture provides an amount of thermal insulation to disperse the cooling effect of the cold pack 10 and prevent the skin for becoming too cold. The fibre texture can reduce or eliminate the need to use a wrap or towel around the cold pack, and therefore reduce the time it takes to apply the cold pack, which can be important in emergency situations. The cold pack 10 can be used against clothes as well, and the fibre texture does not limit potential modes of application of the cold pack 10.
The plastic sheet can have the fibre texture on one side 20 and bare plastic on the other side 22. The envelope 14 is formed with the fibre texture on the outside surface 18 and the bare plastic on opposite, inside surfaces, at 22, which undergo the heat-sealing.
The fibre texture can be formed by filaments or fibers that are integral to the plastic sheet and made of the same material as the plastic sheet. Alternatively, the fibre texture can be formed separate from the plastic sheet, such as a fabric weave, paper, or similar, that is then joined to the plastic sheet, by adhesive, heat-sealing, etc.
With reference to
Also disposed inside the outer pack 12 is a water-tight frangible container 26, which can include a heat-sealed plastic bag, and glass ampoule, or the like. The frangible container 26 contains water 28 and is configured to rupture and release the water 28 into the inside of the outer pack 12 in response to an external force applied to the outer pack 12. When the water is released and mixes with the mixture 24 of urea and ammonium chloride, an endothermic reaction takes place, thereby fulfilling the function of the disposable cold pack 10.
In some embodiments, the water-tight frangible container 26 is a plastic bag that is shaped and sized to rupture when the outer pack 12 is folded over itself about substantially any folding axis. To achieve this, the water-tight frangible container 26 can be rectangular in shape and sized to cover about more than half of the area within the outer pack 12, as measured parallel to the plastic sheet forming the envelope 14 of the outer pack 12.
It is advantageous that both urea and ammonium chloride are highly soluble in water and non-toxic. The relative proportions of urea, ammonium chloride, and water can be selected to tailor the cooling effect for the specific application of the cold pack and the material used for the outer pack, so that sufficient, but not too much, cooling is provided. Further, the relative proportions of urea, ammonium chloride, and water can be selected to take into account the expected initial starting temperature of the cold pack, just prior to activation.
The relative proportions of the urea, the ammonium chloride, and the water can be selected to provide a target cooling effect to the portion of the body to which the cold pack 10 is applied. The relative proportions can be between about 32-38% urea, between about 7-16.5% ammonium chloride, and between about 45.5-61% water, by weight.
In some embodiments, the relative proportions are between about 32-36% urea, between about 12.5-16.5% ammonium chloride, and between about 47.5-55.5% water, by weight. These proportions are suitable for general use of the cold pack, particularly when the fibre texture is provided to the outside surface 18.
In some embodiments, the outer pack 12 is sized and shaped to fit a female perineum, and the relative proportions are between about 34-38% urea, between about 7-11% ammonium chloride, and between about 51-59% water, by weight. Such proportions are suitable when the fibre texture is provided to the outside surface 18. Furthermore, such proportions can prevent the cold pack from becoming too cool and causing cold injury during postpartum application, while simultaneously reducing or eliminating the need to wrap the cold pack in a towel or other temperature buffer.
The cold pack 30 includes a strap 32 having a fixed end 34 heat-bonded between overlapping portions of the plastic sheet, which form the envelope 14, at one of the heat-sealed seams 35. The strap 32 can be made of a material such as gauze, can be permeable to air, and can have some elastic stretch. The strap 32 has a length selected to wrap around the portion of the body and over the outer pack 12, so as to secure the cold pack 30 to the area of the body in need of cooling. The strap 32 includes a fastener 36 at a free end 38 opposite the fixed end 34. The fastener 36 is configured to engage the material of the strap 32. The fastener 36 can include a hook side of a hook-and-loop fastener (e.g., Velcroâ„¢).
Further embodiments and implementation details of thermotherapeutic pads can be found in US patent application publication 2012/0004713, which is included herein by reference.
a-4f illustrate a method of manufacturing a disposable cold pack, such as the cold pack 10 discussed above. Like reference numerals designate like elements, and the description for the cold pack 10 can be referenced. The method is schematically illustrated, and equipment such as a rotary band sealer, an impulse sealer, a vertical form fill sealing machine, a horizontal form fill sealing machine, and similar may be used to carry out one, several, or all of the steps described.
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In this embodiment, the ammonium chloride is loaded separately from the loading of the urea. This allows the process to be flexible, in contrast to batch mixing, so as to allow different proportions of ammonium chloride and urea to be mixed, as needed. The order in which the urea and the ammonium chloride are loaded can be varied, and it may be easier, or provide for faster manufacture, to load the water-tight frangible container 26 after loading the urea and the ammonium chloride.
In other embodiments, the ammonium chloride and urea are loaded from separate hoppers into a mixing apparatus before being loaded together into the envelope 14. A cup filler or similar apparatus may be used to achieve this.
The relative proportions of the predetermined amount of urea, the predetermined amount of ammonium chloride, and the predetermined amount of water in the water-tight frangible container 26 are selected to provide a target cooling effect. Example proportions are discussed elsewhere herein.
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g-4h illustrate steps of a method of manufacturing a disposable cold pack having a strap, such as the cold pack 30 discussed above. Like reference numerals designate like elements, and the description for the cold packs 10, 30 can be referenced.
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The heat-sealed seam 35 can be a single seam, such that the heat-sealing action of the step in
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The cold pack 60 is made with an envelope 62 cut from plastic sheet stock to provide for an outer pack 64 with a size and shape selected to fit a female perineum. With reference to
It can be seen from the above, that the present invention provides a disposable cold pack that is readily manufacturable in large quantities and convenient and safe to use in various clinical situations.
While the foregoing provides certain non-limiting example embodiments, it should be understood that combinations, subsets, and variations of the foregoing are contemplated. The monopoly sought is defined by the claims.