Shapeable pack for cold therapy

Details Shapeable pack for cold therapy Shapeable pack for cold therapy

2001-09-18

2003-08-26

Dvorak, Linda C. M. (Department: 3739)

Surgery: light, thermal, and electrical application

Light, thermal, and electrical application

Thermal applicators

C607S108000

Reexamination Certificate

active

06610084

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to compositions for use in the preparation of contouring, reusable glycerine-free cold packs that provide cold therapy shapeable to a curved contour of the body, and that have an improved ability to slow down temperature change while maintaining pliancy over a range of temperatures applicable to cold therapy.
BACKGROUND OF THE INVENTION
The use of cold as a therapeutic treatment is as old as the practice of medicine, dating back to Hippocrates. Cold therapy helps reduce or prevent the swelling and pain that accompany musculoskeletal injuries. It can also be used to treat or prevent heat exhaustion, or for general cooling of the body. Cold's therapeutic effects are the result of a reduction in the local metabolic activity of underlying tissues, the slowing of nerve conduction and, by its direct effect on muscle spindle activity, the reduction of muscle spasm.
Ice bags, gel packs, chemical cold packs, immersion and ice massage are the most common methods for delivering cold therapy. Each has advantages and disadvantages:
the cooling effect of ice bags lasts long, but they do not contour to the body's curves for maximum application;
cold gel packs can be frozen and refrozen, but require greater caution because they cool the skin fast; and, like ice bags, they do not contour to the body's curves for maximum application;
chemical cold bags are a good first-aid approach for field or wilderness, but do not produce a great degree of cold;
immersion of the foot, hand, or elbow in icy water provides complete and concentrated cold exposure, but does not lend itself to other body areas because too much of the uninjured area is exposed to the cold;
and ice massage is easy to apply and focus, but the cold tends not to penetrate deeply or last as long.
An ideal cold therapy product would, therefore, produce an effective but safe degree of cold over an extended period of time; be very flexible for maximum application to as many areas of the body as possible; and be reusable.
In addressing the demand for cold therapy products, the modern health care industry has significantly focused on gel technology. However, because the technology typically produces a gel that is a semi-solid, single mass, cold gel packs are limited in their ability to conform easily to the injured part of the body for maximum application. The industry has attempted to mitigate this limitation through innovations in packaging that enhances body fit.
A non-industry approach to contouring cold therapy is the common practice of applying a frozen pack of vegetables—usually a pack of frozen peas—to an injured area of the body as a treatment for swelling and pain. Frozen peas, particularly, are mobile and mold into the shape of the body area treated. However, their use is limited because they cannot be frozen and unfrozen repeatedly.
The need for cold packs that address the disadvantages of limited flexibility and application, fast cooling, and limited effectiveness over an extended period of time, as well as the advantage of repeated use, remains current. A variety of approaches have been taken in an attempt to meet this need.
U.S. Pat. No. 5,129,391 to Brodsky, et al, which is incorporated herein in its entirety by reference, discloses a reusable thermal pack that, while frozen, is pliable and contours when placed against injured areas. The pack comprises uniquely shaped packaging, held in place by straps and/or fasteners, and a specially formulated gel that has a greater capacity for cold. The gel is an insoluble, colloidal, homogeneous emulsion that requires several chemicals and other specialized material. In its simplest formulation, it is made of a minimum of one light metal and a plurality of glass beads dispersed in a cellulose material. The process for preparing the gel requires many steps and includes the need for heating and controlled mixing mechanisms. The packaging is varied and complicated. For the gel to contour as effectively as possible, it must be in packs that are specially configured according to the area of the body to be treated. The teaching also discloses steps that must be taken to ensure that the gel does not accumulate in one location within packs of the invention.
U.S. Pat. No. 5,190,033 to Johnson, which is incorporated herein in its entirety by reference, teaches a reusable, cold/hot therapeutic pack that conforms to the natural contours of the body. The pack contains a plurality of thin-walled, hollow capsules containing a temperature storing substance, such as water or gel. The teaching indicates capsules manufactured of non-toxic plastic in a variety of shapes, preferably spherical in shape and one half inch or less in size. The teaching discloses that the ability to conform to the natural contours of the body is delimited by the manner of packaging. The manufacture of different sizes and shapes for application to different parts of the body is required. Because the capsules may be affected by gravity in some applications, special packaging incorporating compartments must be used in these instances. Packs of the invention also require mechanisms for the management of air in order to conform to the body part and provide maximum therapeutic benefit. In addition, manufacturing packs of the invention requires mechanisms for filling the capsules and sealing the filled capsules.
U.S. Pat. No. 5,409,500 to Dyrek, which is incorporated herein in its entirety by reference, teaches a therapeutic cold pack designed to accommodate anatomical surfaces of different sizes, shapes and locations. The pack comprises a plurality of cooling gel compartments, a distribution of predeterminedly anchored straps, and a plurality of mating fasteners on the body of the overlay and at free ends of the straps. The teaching indicates that the delivery of cold therapy to the area of the body being treated is primarily dependent upon the configuration of the pack and, only incidentally, upon the cold providing medium—the cold gel. The design and manufacture of a series of cold packs is required to accommodate not just the areas of the body that contour, but all body areas as well. It is also disclosed that the composition of the cold gel is such that it remains pliant only within temperatures around 0° C., that is, the freezing point of water—again, reinforcing the need for complex, anatomical site-specific design to ensure the cold pack of the invention's claim of versatility, accommodation and effectiveness.
U.S. Pat. No. 6,051,159 to Jie, which is incorporated herein in its entirety by reference, discloses a filling material for cold packs appropriate for laboratory, medical, industrial or home use. The filling is made of varying compositions of water, salt, glycerine and polyacrylamide that are processed in the same manner by dissolving the salt in water and mixing the solution obtained with the glycerine and polyacrylamide until a colloid forms. The resulting filling can then be packaged in a variety of ways according to the intended use. The varying compositions provide a filling material that remains flexible at temperatures no lower than −7° C. There is teaching that indicates that packs of the invention may become too hardened for a particular use and, thus, require softening by kneading with the hands. In addition, the filling alone does not provide maximum flexibility, but requires special packaging.
U.S. Pat. No. 6,099,555 to Sabin, which is incorporated herein in its entirety by reference, discloses a cold pack that utilizes an activatable gelling agent to increase cold persistence, better distribute cold, and more completely utilize its ingredients. To produce cold, the cold pack depends upon the negative heat of solution of a material from one zone dissolving in a liquid from another zone. There is teaching derivable from
FIG. 1
of the referenced patent indicating that even though the gelling cold pack may be superior to one that is non-gelling, it still shares a property of cold produced by this method: a constant and significant increas

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