Protective Covering for Body Lesions

This invention relates generally to a protective covering for a body lesion, and more particularly, to a protective covering for a lesion during bathing and showering by the wearer. Whereas there is a constant stream of new developments related to medical cures, disease detection and protection, magnetic resonance imaging, gene splicing, etc., some of the more prosaic and basic problems that have haunted medical practice through its annals, go unattended and without advancement to keep pace with other events.

When a person has a body lesion, whether that lesion is in the process of healing or that lesion is intended to be a permanent or semi-permanent part of the anatomy so as to substitute for a bodily function or to assist in medical treatments or procedures, a problem is created when the patient must be bathed by emersion in a tub or by taking a shower. Also, people having lesions may wish to exercise by swimming, whether for therapy or general conditioning. To this day, some of the finest, modern medical facilities in the world, when facing the problem of bathing or showering, offer a film of thin plastic, which is more commonly used in the kitchen to wrap leftover food, as a protective sheathing to be wrapped to cover a lesion in the hope that water will not reach the affected area.

A wound that is covered with padding and gauzes, perhaps containing medication, can be adversely affected by contact with water, scabs may dissolve and impede the process of healing, and the danger of infection is increased at the wound site. Another approach to protecting a lesion during bathing or showering, is to cover the lesion with a bandage that is taped around the edges and to completely cover the lesion. However, it is known that removing adhesive bandages from close proximity to a wound often aggravates the skin near the lesion causing sensitivity, swelling, hazards of infection, and loss of skin where the adhesive is removed. Thus, such bandaging techniques have disadvantage when bathing and have not been widely used in recent years.

A similar problem arises with regard to adhesive bandages when using these adhesives to hold pads, and the like, in place to provide protection for the lesion and also frequently to apply medication or provide drainage means.

For these reasons, treatment devices include a frame or base having a central opening. The base includes an adhesive surface and is positioned so that the opening surrounds the body lesion when the base is attached to the body surface (skin). Wound dressing materials are then placed over the lesion by passing them through the opening in the base. These dressing materials are attached to the base and may be removed and changed without the need for removing the base from the skin surface. Thus, the problem of wound and skin irritation that results from repetitive addition and removal of adhesive tape to the skin, is avoided.

U.S. Pat. No. 5,106,362, issued Apr. 21, 1992, to Gilman discloses a dressing for a wound including a vent which provides controlled leakage of fluid from the wound along a path through an opening in a base sheet or frame of the device, which is attached to the skin using an adhesive. In this device, the frame need not be removed each time the dressing is changed. The device is primarily intended to control the outflow of fluid oozing from a wound and prevention of bacterial infection of the wound is also a problem which is considered.

U.S. Pat. No. 4,865,026, issued Sep. 12, 1989, is a sealing/wound closure device which includes an annular ring that is attached to the skin with an adhesive. A closure device for drawing the edges of a wound together operates through the central opening of the ring or frame that is attached to the skin. A removable cover is placed over the closure device. This cover may be removed such that medications may be changed, etc. without disturbing the adhesive connection between the frame and skin.

U.S. Pat. No. 5,086,763, issued Feb. 11, 1992, to Hathman provides a protective reclosable wound dressing. The dressing is disposable and the device has a hinged flap arrangement whereby it is easy to gain access to the wound without disturbing a protective crust of blood and serum that forms over a wound. In addition, it is easy to apply medication without removing the bandage which is attached by adhesive to the skin surrounding the wound. Ready access to the lesion is provided through the hinged opening mechanism. The device may be repeatedly opened for inspection or for application of medication and thereafter be reclosed, without losing the integrity of the seal on the body or on the hinged flap.

U.S. Pat. No. 4,909,243, issued Mar. 20, 1990, is for a wound dressing system that also includes a frame with a central opening that is permanently attached to the skin. A pad of a desired wound dressing material is placed over the frame with the dressing material opposite the wound. The pad is held to the frame by an adhesive having less holding power than the adhesive which keeps the frame on the skin.

A patent to Spangler, U.S. Pat. No. 4,399,816, issued Aug. 23, 1983, is similar to U.S. Pat. No. 4,909,243. In Spangler, the pad is placed in the central opening of a frame and is covered by a hinged cover that is permanently attached at one edge to the frame. Thus, the cover can be raised and lowered so that there is access to the wound and any padding that is placed thereon.

Each of the patents addresses the problems that arise from frequent removal of adhesive material from the skin in the immediate vicinity of a wound. However, none of the patents addresses the problem of bathing or showering or discloses a covering for the wound that not only protects the wound during such activity but avoids the aforementioned irritation associated with frequent removal of adhesive bandages, and the like, from the wound vicinity.

What is needed, is a protective covering for body lesions that is simple to use and effective in preventing contamination of a wound or lesion, and its dressing or medication, by exposure to water during bathing, showering, therapeutic baths, exercise, and the like.

Accordingly, it is an object of the invention to provide an improved protective covering for body lesions that prevents access to the wound by liquids during baths and showers, and the like.

Another object of the invention is to provide an improved protective covering for body lesions that addresses the problem associated with frequent addition and removal of adhesive material to the skin adjacent a wound.

Yet another object of the invention is to provide an improved protective covering for body lesions that can be used in conjunction with prior art devices that hold medications and dressings in place over a wound.

Still another object of the invention is to provide an improved protective covering for body lesions that is simple to use, protects a lesion from exposure to liquids, and is readily adaptable and non-interferring with regard to other treatments, examinations, or use of a lesion on the body surface.

Still another object of the invention is to provide an improved protective covering for body lesions wherein the cover can be added and removed without excessive pressures or pulling on the body surface, and an extremely effective water seal is made by the cover.

A protective covering for a lesion in accordance with the invention comprises a frame for adhering to the skin of a patient and for surrounding a lesion. The frame has a central opening and a generally L-shaped cross section including a wall, and a base that surrounds the lesion and attaches to the patient's skin with an adhesive. One end of the wall extends perpendicularly from the base, extending around the central opening. The free end of the wall includes a peripheral recess wherein a rim of a cover is received.

The cover aligns with the opening and the rim extends fully around the cover so that when the frame base is attached to the patient's skin surrounding a lesion, and the rim of the cover is sealingly received in the recess of the wall, a sealed space is provided enclosing the lesion to protect it from water.

The cover may be put on and taken off the frame many times while the adhesive connection between the frame and skin remains intact.

Tabs on the frame allow for tugging the frame in opposition to locally applied forces as the cover rim is pressed into the recess of the frame.

The invention accordingly comprises the features of construction, combinations of elements and arrangements of parts which will be exemplified in the constructions hereinafter set forth, and the scope of the invention will be indicated in the claims.

For a fuller understanding of the invention, reference is had to the following description taken in connection with the accompanying drawings, in which:

FIG. 1 is a front perspective view of a main element or frame of a protective covering for body lesions in accordance with the invention;

FIG. 2 is a cover used in conjunction with the element of FIG. 1 in accordance with the invention;

FIG. 3 is a sectional view of a protective covering for body lesions in accordance with the invention showing an assembly of the elements of FIGS. 1 and 2;

FIG. 4 is an enlarged portion of the frame of FIG. 1;

FIG. 5a is an enlarged view taken along the line 5a--5a of FIG. 1, and FIG. 5b is an enlarged view taken along the line 5b--5b of FIG. 2;

FIGS. 6a and 6b are views similar to FIGS. 5a, b of an alternative embodiment in accordance with the invention;

FIG. 7 is a partial sectional view of another alternative embodiment of a protective covering, in accordance with the invention;

FIG. 8 is a view similar to FIG. 1 of yet another alternative embodiment of a protective cover for body lesions in accordance with the invention;

FIG. 9 is a view similar to FIG. 3 of the embodiment of FIG. 8; and

FIG. 10 is a front elevational view, in section, of an alternative embodiment of a protective covering, in accordance with the invention.

With reference to FIGS. 1-6b, a protective covering 8 for body lesions in accordance with the invention includes a frame 10 having a generally planar rectangular base 12 with a rectangular opening 16 defined in the base. A wall 14 rises from the base 12 at the periphery of the opening 16. The base 12 and vertical wall 14 are formed integrally of a flexible plastic material, for example, polyethylene, polyurethane, and polypropylene, and a surface 18 (FIG. 5a) of the base 12 has a thin adhesive layer 20 whereby the frame may be attached to the skin 22 of a person and surround a lesion 24 of the skin. Such skin adhesives are known in the art.

The free edge 26 of the wall 14 has a recess or socket 28 formed therein extending toward the base 12. The entire frame 10 is flexible and this flexibility is enhanced by V-shaped notches 30 cut into the walls of the socket 28, that is, cut into the vertical wall 14. FIG. 1 and FIG. 4 illustrate such notches 30 cut into two opposite parallel segments of the wall 14; notches 30 can also be provided on the other wall segments. The notches help to assure that the frame 10 readily bends to match the user's body contours and a water tight seal is made by the adhesive 20 with the skin 22 around the entire periphery of the frame 10, in use. The frame 10, with or without the notches 30, assures the desired complete sealing contact, and the frame can be made in many sizes and in shapes other than rectangular; e.g., round, oval, as suits the location and type of lesion which is to be protected.

A cover 32 for use with the frame 10 includes a rectangular panel 34 similar in size and in shape to the opening 16 in the frame 10. The panel 34 is of transparent plastic as illustrated, but is not so limited. At the periphery of the cover, a rectangular rim 36 extends generally at a right angle to the panel 34. The rim 36 has a perimeter and cross-section 38 that is contoured to fit sealingly within the recess or socket 28 of the frame 10 when the cover 32 is seated in position on the frame 10 (FIG. 3). In the sealed condition, a water-tight connection 40 is made between the frame 10 and cover 32 that extends around the entire periphery of the frame and cover. When the cover is sealed, a watertight enclosure is made over the skin 22 and lesion 24 as a result of the complete adhesive seal 20, the sealed joint 40 between the mated rim 36 and socket 28, and the watertight integrity of the cover wherein the panel 34 is made integral with the rim 36.

Such a sealed connection as illustrated in FIGS. 3 and 5a, b, is well known in the art and is readily made from available plastic materials such as polyethylene, polyurethane, and polypropylene.

In FIGS. 5a, b, the tightness of the joint 40 is enhanced by an O-ring type element 42 that is made as an integral part of the cover 32. The O-ring type element 42 has greater resiliency than the plastic in the other portions of the protective covering 10.

Fabrication of plastic elements having portions of different resiliency is also well known in the art, for example, as described in U.S. Pat. No. 3,950,483, issued Apr. 13, 1976, by the inventor here, and incorporated herein by reference.

A peripheral groove 44 formed in the socket 28 receives the O-ring type element 42 when the connection is made between the frame 10 and cover 32. This added feature provides additional protection against moisture seepage through the joint 40 and also increases the resistance to unintended separation of the cover from the frame 10.

FIGS. 6a, b show an alternative embodiment of a joint 40' wherein a knob 46 is formed at the free end of the cover 32' and the socket 28' is contoured to receive the knob 46. The knob 46 may be of the same flexibility as the remainder of the frame 32' or may be more resilient.

FIG. 3 is a cross-section through a protective covering 8 for a body lesion in accordance with the invention illustrating the frame 10 attached by adhesive 20 to the skin 22 of a person. The frame 10 surrounds a lesion 24 of the skin 22. The cover 32 is illustrated sealingly connected to the frame 10 in a construction of the joint 40 corresponding to FIGS. 5a, b. A clearance 48 is left between the skin 22 and the inner surface 50 of the panel 34.

In manufacture, protective coverings 8 can be made not only with different peripheral outlines but also with different amounts of clearance 48. Thus, the device, when properly selected, can be used over lesions that are covered with other bandages, pads, medications, etc.

As illustrated in FIG. 7, the protective covering 8' in accordance with the invention, can be placed over and surround a conventional dressing 50 of another type that is applied to the lesion. (For the sake of an example in FIG. 7, a dressing similar to FIG. 3 in U.S. Pat. No. 5,106,362, issued Apr. 21, 1992, has been illustrated. In all embodiments, the same reference numerals as in the earlier figures are used for similar parts. Conventional use can be made of the dressing 50 when the cover 32 is not attached.

In using a protective covering 8' in accordance with the invention, the frame 10 is adhered to the skin 22 of the person, using the adhesive 20 to make a complete seal. As stated, the frame 10 is positioned to surround the other device 50 that has a border 52 adhered to the skin 22 of the user. As illustrated in FIG. 7, the border 52 of the patent device 50 is integral with the frame 10, although the frame 10 may be entirely separate from the device 50.

In using a covering 8, 8', after the frame 10 is in place on the skin, the cover 32 can be pressed into place by mating the rim 36 in the socket 28 of the frame 10 whenever a hazard arises that the lesion may become wet. Such a hazard occurs at times of bathing, showering, swimming, etc.

After the hazard that may cause wetting of the wound has ended, it is only necessary to separate the cover 32 from the frame 10 until the next need arises. The adhesive 20 and the frame 10 remain in position on the skin 22 for extended periods of time, and for many cycles of use of the protective covering 8 for body lesions in accordance with the invention.

A problem may arise when the protective covering is used over lesions where pressing the cover 32 in place causes discomfort and pain. In order to alleviate this discomfort, in an alternative embodiment in accordance with the invention (FIG. 8), a frame 10', which is substantially similar to the frame 10 of FIG. 1, is provided. Tabs 52 extend from the outer lip or surface 54 of the vertical wall 14 and extend away from the base 12. The tabs 52 are flexible and lack rigidity. These tabs 52 are formed or made integral with the vertical wall 14 and are spaced around the periphery of the opening 16. When a person is applying the cover 32 to the frame 10', he or she grasps the tab 52 adjacent to the immediate area where the rim 36 is being applied to the frame 10', and a slight outward pulling with constant force, as indicated by the arrow 56, is applied to the tab 52. The pulling force on the tab 52 is not such that would stress the adhesive connection 20 to the skin 22 but is a counter-force to the local force of pressing insertion of the rim 36 of the cover 32 at that area. As the rim is inserted at different portions of the periphery of the opening 16, the nearest tab 52 (or tabs) is pulled gently with the constant force. The force applied to the tabs 52 counteracts the force applied by the cover at the point of connection, and relieves the pressure on the skin 22 itself. Thus, discomfort, if any, in applying the cover to the frame can be substantially relieved or eliminated.

Such tabs may be used on other devices of a similar nature that are adhered on the skin of a person in the vicinity of a lesion and have a moving part, whether for protection or for application of medication, etc.

Additionally, adjacent tabs 52, in an alternative embodiment, may be joined together at their ends so as to form a loop, as indicated with broken lines 58 in FIG. 9, which a person can more easily grip so as to apply the outward force in the direction 56, as needed. Additionally, the spacing of the tabs 52 around the opening 16 can be different in different applications and the tabs may be closely placed to substantially curtain the periphery, if not the entire periphery of the opening. As stated, the tabs, or the curtain formed to serve a similar function, are of extremely low rigidity and thus, although permanent on the frame 10', do not cause an interference that might otherwise be an obstacle to other devices and procedures related to the lesion.

A tab or tabs may also be part of the cover 32 so that these tabs (not shown) may be pulled in removing the cover 32 from the frame 10 after bathing, showering, etc. Such tabs on the cover 32 would be positioned so as not to interfere with the tabs 52 on the frame.

FIG. 10 illustrates a frame 10" including a base 12' with an adhesive coating 20 around its perimeter for attachment to the skin of a patient. The central opening 16 of the base 12' is surrounded by a wall 14' that is separated from the base by a web 60. The web 60 is resilient so that the wall 14' may be moved in any direction as illustrated by the crossed two-headed arrows 62. The web 60 is sealed to the base 12' around the entire periphery of the opening 16 and is joined sealingly to the wall 14' so that when a cover 32 is mated with the wall 14' by connection, as described above, in the recess socket 28, an enlarged enclosure about a lesion may be provided.

The web 60 may be completely without rigidity such that the wall 14' can be placed anywhere in relation to the base 12' within the physical limits of the web 60. On the other hand, the web may have a degree of resilience with memory in the nature of bellows that tend to keep the wall 14' separated from the base 12' but still allow movement of one relative to the other.

In FIG. 10, the opening in the wall 14' is smaller than the opening in the base 12. Alternatively, the opening in the wall portion may be larger (not shown) than the opening in the base portion.

By having the resilient web 60 between the wall 14' and the base 12', forces applied to the wall 14', for example, when attaching the cover 32, are not transmitted to the wearer's skin in the area of the lesion as in the case of the embodiment of FIG. 1. In actual use, any snagging of the cover 32 does not immediately stress the adhesive 20 or transmit forces to the skin.

Also, when applying the cover 32, the wall 14' can be held between the fingers while the rim 36 is pressed into the recess or socket 28. Thus, no force is transmitted to the skin. In removing the cover 32, the wall 14' can be held between the fingers while the cover 32 is pried off the wall 14'.

In every embodiment, the elements are impervious to water, at least in the direction from the outside of the device toward the patient's skin. However, it should be understood that for all of the embodiments described above, the constructions need not be made leak-tight. The cover 32 may be permeable to gases, such as air, and may include, for example, a grid or pattern of openings, or combinations of such features. The joint between the cover and frame need not be leak-tight.

Such a covering would be used as a lesion protector although one not especially suited for water immersion. The cover may hold in place bandages, dressings, medications, and the like, against the lesion during treatment and healing. These items may be attached to the cover, and may be used and then discarded along with the cover, while the frame remains attached to the skin.

It will thus be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained, and since certain changes may be made in the constructions set forth above without departing from the spirit and scope of the invention, it is intended that all matters contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.