1. Field of the Invention
This invention relates generally to medical wound dressings, and particularly to wound dressings for covering intradermal chemotherapy and other treatment ports adapted for periodic reuse. More particularly, this invention relates to a flanged, rigid or semi-rigid, domed cover adapted to protect such ports or wounds from impact.
2. Description of Related Art
Chemotherapy and other ongoing treatment patients often have intradermal access ports installed to permit periodic injections of therapeutic treatment fluids. These can be very sensitive, and impacts upon them, even slight, can be very painful. Especially with physically active patients, or with access ports located in certain places on patients' bodies, the likelihood of an impact event is high. A need exists for a sterile protective cover which shields such intradermal treatment ports from most impacts.
Some wounds also can be very sensitive while healing. The typical gauze bandage, while effective for keeping such wounds sanitary and sterile, provides little or no impact resistance. A need exists for a protective cover for shielding wounds from impacts.
A light-weight, rigid or semi-rigid wound shield protects wounds and intradermal therapy ports from painful and potentially injurious impacts while the patient goes about his daily life between therapy sessions. The wound shield comprises a truncated-dome-shaped cover that forms a concave cavity above the wound or therapy port. A flange surrounding the cavity presses against the patient's skin to deflect and distribute the force of impacts. The flange may include an adhesive layer on its bottom side that renders the wound shield self-adhesive. Additionally, or alternately, the wound shield may be secured with medical tape or with a fitted, adhesive web disposed atop the flange and overlapping onto the surrounding skin. A peel-away membrane covers the adhesive layers. A tunnel through the flange may connect to the cavity to accommodate a therapy tube which remains in place while the shield is worn. In an alternate embodiment, a base coextensive with the flange adheres to the patient's skin and the wound shield removably couples to the base by its flange. The assembly comes in a sterile envelope or package.
The novel features believed characteristic of the present invention may be set forth in appended claims. The invention itself, however, as well as a preferred mode of use and further objects and advantages thereof, will best be understood by reference to the following detailed description of an illustrative embodiment when read in conjunction with the accompanying drawings, wherein:
Referring now to
Shield 10 comprises a dome 11 forming upwardly concave cavity 12 above site 2. Cavity 12 at its apex preferably rises at least one-half (½ in.) inch above the plane of site 2 and provides space into which may extend any therapy port couplings, bandages or other objects (not shown) associated therewith. Dome 11 thereby provides a protective roof over site 2 adapted to reduce or eliminate contact with site 2 by clothing, stray hands or unexpected impacts which may impinge upon site 2.
Surrounding and extending radially outward from dome 11, flange 13 integrates with dome 11 at its perimeter to provide a widened engagement surface for shield 10 to bear upon the skin of patient 1 in the vicinity surrounding site 2. For most applications, flange 13 preferably measures approximately one-half (½ in.) inch in width, but one having ordinary skill in the art will recognize that the width of flange 13 may vary for larger and smaller shields 10.
Further, preferably and for most applications, flange 13 is substantially flat, occupying a single plane. One having ordinary skill in the art will recognize, however, that for specific applications, such as on patient 1's leg or another more curved body site 2 (not shown), flange 13 may be curved along any major or minor axis to match more accurately the curvature of said other body site 2. For example,
In
Similarly, one having ordinary skill in the art will recognize that shields 10, 110, 210 may be any size necessary to cover site 2 sufficiently to protect the wound or therapy port (neither shown) therein. Preferably, shield 10, 110, 210 for most applications will be approximately five (5 in.) inches in diameter, including flange 13, 113, 213. Where larger or smaller domes 11, 111, 211 are needed for different applications, flange 13, 113, 213 preferably will remain approximately one-half (½ in.) inch wide surrounding the perimeter of dome 11, 111, 211.
NOTE: henceforth herein, all shapes of shields considered to be in conformity with the present invention will be referred to using reference numerals for the preferred embodiment of shield 10, including all corresponding components thereof bearing other reference numbers. Only where the particular shape of an alternate embodiment such as shields 110, 210 requires it will particular references to those embodiments or components thereof be used. One having ordinary skill in the art will recognize that such discussions apply equally to each of such alternate embodiments absent specific indication to the contrary.
As shown in
As depicted in
Tunnel 20 preferably is formed as a downwardly concave channel open at its bottom side flush with bottom 15 of flange 13. Tunnel 20 extends radially outward from cavity 12 to the perimeter of flange 13, thereby forming a gap in flange 13 wide enough for tubing 5 to fit through. Arch 21 formed by tunnel 20 necessarily extends above flange 13 to intersect dome 11 radially inward toward the center of shield 10 to the extent that curvature of dome 11 requires. Arch 21 integrates seamlessly with dome 11 at such intersection point to assure the integrity of cavity 12.
The shape of arch 21 and tunnel 20 may vary. For example, arch 21 may be a full semicircle having a radius equal to twice the outside diameter of tubing 5. This permits tubing 5 and the bottom of flange 13 to lie flush against the skin of patient 1 and keeps flange 13 fully engaged with said skin without tubing 5 depressing it appreciably. Such arrangement in some cases may be important for deterring discomfort to patient 1. One having ordinary skill in the art will recognize, however, that this arrangement leaves a peripheral gap on either side of tubing 5 between it and the widest part of arch 21 and tunnel 20. Such peripheral gap compromises the integrity of cavity 12, and if the sterile integrity of cavity 12 is to be maintained, must be sealed with medical tape by a nurse (not shown) or other user such as patient 1.
Alternately, arch 21 may have a radius substantially equal to the outside diameter of tubing 5, but be disposed above flange 13 by the same distance, the resulting vertical separation being closed by vertical tunnel walls (not shown) extending downward from arch 21 to intersect flange 13. This configuration greatly decreases, but does not eliminate, the peripheral gap between tube 5 and tunnel 20, thus still requiring taping, though perhaps not as much. The benefit of such arrangement is that tubing 5 and flange 13 remain flush with the skin of patient 1, maximizing closure of cavity 12 even without using medical tape.
As another alternate, tunnel 20 could be integral with or disposed above flange 13 (neither shown) while of appropriate diameter for tubing 5 to be inserted through tunnel 20 from within cavity 12 before flange 13 is engaged with patient 1's skin. Still further, tunnel 20 could comprise a short segment of tubing affixed to flange 13 and extending into cavity 12 to couple to therapy port couplings (not shown). Such a tunnel 20 further could have a nozzle (not shown) extending outward beyond the radius of flange 13 to provide a place to which tubing 5 may be coupled. One having ordinary skill in the art will recognize that all such configurations for tunnel 20 are considered to be within the spirit and scope of the present invention.
In any shape, size or tunnel 20 configuration, shield 10 must adhere to site 2 so that it doesn't slip off and therefore fail to provide the protection for which it is intended. This may be accomplished by simply taping shield 10 to site 2 using strips of any of a number of readily available medical tapes adapted to secure bandages to patient 1's skin. A plurality of said strips of tape (not shown) would be placed in chordal positions around the perimeter of flange 13 and overlapping onto the skin of patient 1 in the vicinity of site 2. The width and type of said tape so employed is not of particular specification, except that it preferably comprises a standard medical tape of appropriate size and adapted to adhere, but be readily removable from without causing injury, to the skin of patient 1.
Turning now also to
Another optional alternative to medical tape depicted in
Peel-away protective layer 37 disposed on the under side of bandage 30 keeps adhesive layers 17, 35 unexposed until such time as bandage 30 is needed. Protective layer 37 could take several forms. Where shield 10 is provided with no adhesive means 17, or where only flange adhesive 17 is provided thereon, bandage 30 could be provided separately as an optional alternative to medical tape. In such case, protective layer 37 preferably would be coextensive with and would line the bottom of bandage 30. Alternately, where shield 10 is provided with bandage 30 already installed (as in
Turning now also to
Turning now to
Cover 60 has been discussed above as having hinge 61 and second adhesive layer 65 for accomplishing the desired result of making site 2 repeatedly accessible without having to reinstall cover 60 each time. One having ordinary skill in the art will recognize that other means could be employed to make dome 11 temporarily removable, such as replacing second adhesive layer 65 with a hook-and-loop layer (commonly known as Velcro), with or without eliminating hinge 61, without departing from the spirit and scope of this embodiment of the present invention, and that all such temporary adherence means are considered to be within the spirit and scope of the present invention.
Shield 10 preferably is fabricated from a rigid or semi-rigid thermoplastic material readily moldable through conventional injection molding processes into the desired shapes described above. More preferably, shield 10 is fabricated from a medical grade polyester which itself is capable of being sterilized and does not emit or sluff off its own contaminants which might derogate from the integrity of cavity 12. Such material preferably is approximately forty-three thousandths (0.043″) inches in thickness. Still more preferably, shield 10 is transparent or translucent to provide visible feedback while positioning shield 10 over site 2, as described below. A suitable polyester for shield 10 comprises model Prime PETG 6763, or PETG 14471, both available from Primex Plastics Corporation of Richmond, Ind., USA. Adhesives 17, 35 preferably are made from hypoallergenic medical adhesives designed for sustained contact with human skin, commonly used on bandages and medical tape. Likewise, bandage 30 may be made of a flexible polyethylene plastic or woven fabric commonly employed to fabricate such self-adhesive bandages. A suitable product for bandage 30, including adhesive 35, is available as Product No. DM-6001 from DermaMed Coatings Company, LLC, of Tallmadge, Ohio, USA. A suitable primary adhesive 17 for flange 13 and base 63 is available as Product No. 9943 from 3M Medical Specialties Company of St. Paul, Minn., USA. A suitable secondary adhesive 63 for interface between flange 13 and the top of base 63 is available as Product No. 9833 from 3M Medical Specialties Company of St. Paul, Minn., USA. Peel-away layers 37, 18 also preferably are fabricated from flexible, polyethylene plastic and fabricated in two parts to overlap one part over the other to provide convenient means for a user to remove them when needed.
In operation, shield 10 of suitable size and shape for application to site 2 is selected and removed from package 50. Peel away layer 37 is removed and cavity 12 inverted above site 2 so that all portions of flange 13 are disposed substantially equidistant from the wound or therapy port at site 2. Where tubing 5 must be left in place, it is taped into position extending from site 2. Then, a suitable shield 20 having tunnel 20 through flange 13 is selected and tunnel 20 is oriented to straddle tubing 5. Shield 10 then is secured in place by pressing it onto patient 1's skin until adhesive 35 bonds sufficiently therewith to hold shield 10 in place. If desired, the user may supplement bandage 30 and flange adhesive 17 with strips of medical tape to assure that shield 10 remains in place even under physical impacts from sports activities.
Thus, shield 10 as described herein in its preferred and alternate embodiments provides a light-weight, rigid or semi-rigid cover for wounds and therapy ports for patient 1 to employ while going about his daily life. Shield 10 prevents or dramatically softens impacts on or around site 2 and gives patient 1 a less stressful and less painful experience while undergoing therapy for which the patient needs the therapy port, or simply while a significant wound is healing.
While the invention has been particularly shown and described with reference to preferred and alternate embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention. For example, though shield 10 is described above as being transparent, it could be preferable in some cases that it be opaque to conceal the therapy port and/or wound. Also, bandage 30 has been described herein as surrounding dome 11 without covering it. However, bandage 30 could instead cover dome 11 partially or entirely (neither shown) so that shield 10 better resembles a conventional, self-adhesive bandage having perhaps a more conventional and desirable aesthetic appearance and at least partly concealing shield 10 and the therapy port or wound beneath it. Still further, bandage 30 has been described herein as continuous around the perimeter of dome 11, but instead it could comprise strips of bandage material (not shown) adapted to be placed across flange 13 in selected locations around dome 11 without entirely covering flange 13.
Dome 11 also has been discussed herein as continuous and serving among other things to seal off wound site 2 from environmental contaminants. Dome 11 could, however, include one or more breathing holes to allow evaporation of perspiration and to allow fresh air to reach wound site 2.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US11/43730 | 7/12/2011 | WO | 00 | 1/4/2013 |
Number | Date | Country | |
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61363437 | Jul 2010 | US |