Bandage for wound or incision closure

Background of the Invention

0001Compositions and methods for wound or incision closure are known in the art. The use of sutures or staples to close a wound or incision represents the most common of these prior art techniques. The use of sutures or staples is an invasive technique which can be painful and frequently the use of an anesthetic is required. These processes often leave unsightly scars, both from the insertion holes and from varying tensions applied to the wound or surgical incision between the suturing points and intervening spaces. Moreover, these methods necessitate follow-up visits to a hospital or doctor's office for removal.

0002Although other compositions and methods for closing wounds or incisions are known in the art, these have not gained popular acceptance due to limitations in their design. There is a clear need for non-, or less invasive method for wound or incision closure which is practical and easy to use.

0003<patcit id="pcit0001" dnum="US5263970A"><text>US-A-5,263,970</text></patcit> discloses a surgical dressing for closing a wound including a pair of locating members, the locating members, in use, being placed on opposed sides of the wound. A manipulating means interconnects the locating members, the manipulating means and the locating members being a one piece article and the manipulating means being operable to draw the locating members towards each other the close the wound.

0004<patcit id="pcit0002" dnum="US2762371A"><text>US-A-2,762,371</text></patcit> discloses a twin bandage in which two substantially duplicate adhesive bandages are provided. Each has a centrally padded portion either medicated or non-medicated on opposite sides of which are the usual end portions, the latter being covered by customary removable crinoline or equivalent covering. One bandage has an opening at the center of its padded portion and the central padded portion of the other bandage is notched and restricted in width and the restricted portion is laced or threaded through the opening in the apertured first-named bandage to provide the adjustable uniting connection and also to provide the aforementioned four adhesive hold-down or anchoring ends which are used in progressive pairs in a manner to be more explicitly set forth.

0005<patcit id="pcit0003" dnum="US1299367A"><text>US-A-1,299,367</text></patcit> discloses an elasticated bandage which has knitted therein a geometrical pattern comprising two components which adopt recognizable configurations when the bandage is extended to corresponding predetermined degrees. The two components may be alternating large and small rectangles arranged with colinear short edges. When the bandage is stretched, the short sides of the rectangles become lengthened. In each case, a point is reached at which the short and long sides of the rectangle becomes square, and this indicates that a predetermined tension has been reached.

0006<patcit id="pcit0004" dnum="US5534010A"><text>US-A-5,534,010</text></patcit> disclosed a bandage having the features of the preamble of claim 1. The present invention is a bandage having the features of the characterizing portion of claim 1. Optional features are recited in the dependent claims.

0007The pulling elements tend to spread the pulling force provided by a person applying the bandage of the present invention across each of the elongated connectors to which it is attached.

0008The adhesives provided on the lower surface of the first and second flat flexible components are selected based on their compatibility with the skin; as well their ability to securely hold the bandage for a period of time sufficient for the wound to heal. A variety of such adhesives are known in the art. Prior to application, the adhesives may be protected from contamination and oxidation by one or more sheets of a protective film. The film is removed prior to application of the bandage thereby exposing the adhesive.

0009In embodiments of the present invention in which the first and second flat flexible components are thin and extremely flexible, the adhesive protecting film may be selected to provide a degree of stiffness which aids in application of the bandage. Multiple protective films may be provided to protect the adhesive on a single flat flexible component, thereby providing convenient locations to grip the top and protected bottom of the bandage with the fingers during application.

0010When the flat flexible components are applied, and a desired tension is reached effecting wound or incision closure, the elongated connectors are brought into contact with the flat flexible components and the adhesive fixes their positions relative to one another. It will be recognized that during manufacture, the adhesive may be applied to the upper surfaces of the flat flexible components, to the lower surfaces of the elongated connectors, or to both. A variety of pressure sensitive adhesives are appropriate for this application and the choice of which adhesive to employ is largely one of design choice and optimization. As was discussed above in connection with the adhesive on the lower surfaces of the flat flexible components, the adhesives are protected prior to application with a thin removable film.

0011The sizes of the various components are variable within parameters defined by functional considerations. For example, the length of the first and second flat flexible components (i.e., in a dimension generally parallel to the wound or incision), must be approximately the same length as the wound or incision to effect closure. To a large extent, the length of the first and second flat flexible components (which is determined based on the length of the wound or incision) determines the width of the first and second flat flexible components (i.e., the dimension perpendicular to the length of the first and second flat flexible components in the plane of application). In other words, the relationship of length to width must be selected such that sufficient adhesive may be applied to hold the bandage in place once applied to the skin. If the width of the bandage is.too small, relative to its length, the bandage will be insecure when applied and susceptible to premature and unintended separation from the skin. The determination of length to width ratios are empirical in nature and adhesive-dependent. Generally speaking, an acceptable length to width ratio may be from about 1:2 to about 8:1. These ratios are provided as examples, with no attempt being made to provide maximum or minimum ratios.

0012Another consideration which relates to the sizing of the elements of the bandage of the present invention is the spacing between the elongated connectors. It is important that there be sufficient space between adjacent elongated connectors to allow adjustment of the first and second flat flexible components relative to one another. More specifically, in application, one of the two flat flexible components is applied to the skin before the other flat flexible component. Following application, this flat flexible component is not easily removed and repositioned. Therefore, having sufficient spacing between the elongated connectors is important to facilitate fine adjustment of the unattached flat flexible component relative to the attached flat flexible component. There is no absolute minimum which can be stated with respect to spacing between elongated connectors. Preferred ranges are probably best stated as a percentage of the bandage length. For example, a spacing between adjacent elongated connectors of between about 5% to about 10% of the bandage length (as defined above) is an example of an appropriate range.

0013In preferred embodiments, the flat flexible components, elongated connectors, and pulling elements described in the preceding paragraph are produced from a substantially inelastic polymeric material. Alternatively, they may be produced from an elastic material which is reinforced with an inelastic structural component thereby rendering the device substantially inelastic. For example, such inelastic materials may include monofilament polymeric line or mesh. Reinforcement of the flat flexible components along the wound edge, and of the pulling elements, is preferably done using a material which is both rigid and inelastic (e.g., a rigid polymer is a preferred material for this purpose).

0014In preferred embodiments, the flat flexible elements, elongated connectors and pulling elements are produced from sheet stock (e.g., plastic sheet stock). Die cutting these elements from plastic sheet stock to provide monolithic components which are subsequently joined to produce a functional bandage is a particularly cost-effective approach. The sheet stock may be perforated to allow for the exchange of air with the skin beneath the bandage. The thickness of the sheet stock may vary depending upon application. In addition, as discussed above, portions may be reinforced with a rigid material as needed.

0015In preferred embodiments, the first and second pulling elements are removable following application of the bandage to the skin. This feature minimizes the bandage size following application to the patient. This decrease in the overall size of the bandage reduces the chance that a portion of the bandage may be caught, for example, on clothing or a pillow. Such an occurrence could tend to pull the bandage away from the skin thereby causing the wound or incision to open. Minimizing the overall size of the bandage following application also tends to provide for a more comfortable fit.

0016A preferred design which provides for the removal of the pulling elements includes in-line perforations or scoring along the first and second elongated connectors. By breaking the elongated connectors along these perforations, the first and second pulling elements are removed.

0017In the bandage of the present invention, the first and second elongated connectors are interleaved. The interleaving of the elongated connectors can be effected in a variety of ways which will be apparent to one of skill in the art. By way of example, at least one member of the pair of flat flexible components and elongated connectors may be die cut as a single unit, while die cutting the corresponding pulling element separately. The first and second elongated connectors may then be interleaved, followed by attachment of the individually die cut pulling element to the appropriate elongated connectors using, for example, an adhesive.

0018Another method for assembling an interleaved embodiment is most readily described by way of example. A first monolithic component comprising a pulling element, a pair of first elongated connectors and a first flat flexible component is provided. A second monolithic component comprising a pulling element, three second elongated connectors and a second flat flexible component is provided. The elongated connectors are spaced such that they would interleave, if mated, but for the fact that the middle second elongated connector (being fixed at each end) prohibits the mating of the two elements. In order to mate the two monolithic components it is necessary to cut this middle second elongated connector, mate the two monolithic components such that the elongated connectors interleave, then reattach the middle second elongated connector. Clearly this method of assembling applies also to embodiments having more than 5 total elongated connectors.

0019when applied to the skin and appropriately tensioned, one edge of the first flat flexible component and one edge of the second flat flexible component are position nearest to and substantially parallel to the wound or incision. These edges will be referred to herein as the wound edges. In preferred embodiments of the present invention, the wound edges are adapted to evert (or raise) skin edges to promote wound healing. It is known in the art that everting, raising or mounding of the skin edges at the wound or incision site prevents wound inversion. One way in which this may be accomplished is to provide a bend at the wound edge. The bend may angled or arcuate. The adhesive on the lower portion of the flat flexible components is also applied to the portion of the wound edge. When attached to the skin this eversion edge tends to lift the edges of the skin at the point of closure contact thereby promoting wound or incision healing.

0020As mentioned above, preferred embodiment of the present invention include die cut embodiments. In such embodiment, the elongated connectors may be viewed as strap-like in their dimensions. In preferred embodiments, a portion of the elongated connectors is cut away to increase the unobstructed surface area over the wound or incision. This tends to facilitate drainage of exudates and application of medication. This cut-away is best made in a die cut process.

0021In preferred embodiments, the bandage of the present invention is also adapted for wound closure alignment. Spacing between adjacent elongated connectors, as discussed above, is relevant to the issue of wound closure alignment. Additionally, preferred embodiments of the bandage of the present invention include wound closure alignment indicators. These alignment indicators are visual indicators which appear on the flat flexible components near the wound edge. Typically, they will appear as a line or an arrow generally perpendicular to the wound or incision. In closing a wound or incision, a clinician typically closes the wound manually with his/her fingers at the approximate mid-point, then makes a small mark or line perpendicular to the wound with a surgical pencil. These marks are used to align the device precisely with the wound alignment indicators on the bandage of the present invention.

0022The bandage of the present invention can be optionally adapted for transdermal drug delivery. As is known in the art, a drug is deliverable transdermally through the skin. For such an application, a drug-containing patch is secured to at least one of the flat flexible components in such a way that the drug can be delivered through the skin. Given the fact that there will be no adhesive contact between the skin and the flat flexible component in the area of the drug delivery patch, it may be necessary to increase the size of the flat flexible component to secure the bandage in such a transdermal drug delivery embodiment. Transdermal drug delivery is well known in the art and a review of the background is not necessary to enable one of skill in the art to make and use the present invention.

0023The bandage of the present invention may optionally include an elastic tension indicator element. The purpose of the tension indicator element is to provide a visual indication that a desired tension has been reached while applying the bandage. For example, materials are known in the art which change color when a predetermined tension is applied. Similarly, other graphic representations may be used for this purpose. For example, a rectangular graphic representation may be applied to an elastic tension indicator element. As this tension indicator is stretched, the graphic representation of the rectangle stretches. This element may be designed such that the desired tension is indicated when the original rectangular representation is stretched to the point where it closely approximates a geometric square.

0024It is desirable that this elastic tension indicator element be removable with the pulling elements following application of the bandage. At a minimum, the elastic tension indicator element should be positioned in the bandage such that when the bandage is applied, it is not possible for the elastic element to continue to stretch and release the desired tension previously established.

Brief Description of the Drawings

0025<ul id="ul0001" list-style="none" compact="compact"><li><figref idref="f0001">Fig. 1</figref> is a perspective view illustrating a bandage of the present invention in a non-tensioned state.</li><li><figref idref="f0002">Fig. 2</figref> is a perspective view illustrating a bandage of the present invention with tension applied.</li><li><figref idref="f0003">Fig. 3</figref> is a perspective view illustrating a bandage of the present invention with elongated connectors secured to flat flexible components and pulling elements removed.</li><li><figref idref="f0004">Fig. 4</figref> is a perspective view illustrating a bandage not according to the present invention in non-tensioned a wide-keyhole embodiment.</li><li><figref idref="f0005">Fig. 5</figref> is a perspective view of a protective cover for application over the bandage of the present invention.</li><li><figref idref="f0005">Fig. 6</figref> is a perspective view of the protective cover of <figref idref="f0005">Fig. 5</figref>, applied to protect a bandage of the present invention.</li></ul>

Detailed Description of Preferred Embodiments

0026A bandage of the present invention in a non-tensioned state is depicted in <figref idref="f0001">Fig. 1</figref>. Bandage (1) includes a first flat flexible component (5) and a second flat flexible component (25). Each of these components has an upper surface to which lead lines 5 and 25 are directed, and lower surfaces which are not visible in the drawing. The lower surfaces are coated with adhesive to facilitate attachment to the skin. A plurality of first elongated connectors (15) extend from the wound edge (20) of the first flat flexible component (5) in a first direction, and a plurality of second elongated connectors (35) extend from the wound edge (42) of the second flat flexible component in a second direction which is generally opposite to the first direction. A first pulling element (40) is joined to the first elongated connectors (15) and adapted for lateral translation of the first flat flexible component (5) toward a wound or incision. Similarly, a second pulling element (45) is joined to the second elongated connectors (35) and adapted for lateral translation of the second flat flexible component (25) toward the wound or incision. According to the invention, the means for attaching the first elongated connectors (15) to the second flat flexible component (25), and the second elongated connectors (35) to the first flat flexible component (5), comprise an adhesive. The adhesive is applied to the lower surfaces of the first and second elongated connectors (15 and 35). Perforations (17 and 37) in the elongated connectors facilitate removal of the pulling elements (40 and 45) from the elongated connectors (15 and 35) following application of the bandage.

0027Lower surfaces of the first and second flat flexible components are covered (at least partially) with adhesive to facilitate attachment to the patient's skin. Such adhesives facilitate attachment and allow easy removal of the bandage after the wound or incision has healed. Protective films (not shown), removable by hand, serve as means for protecting the adhesive on the first and second flexible flat components (5 and 35) prior to use of the bandage.

0028<figref idref="f0002">Fig. 2</figref> depicts the bandage of <figref idref="f0001">Fig. 1</figref> in a tensioned, but non-fixed state. More specifically, <figref idref="f0002">Fig. 2</figref> depicts first and second flat flexible components (5 and 25) attached to the skin with adhesive. Tension has been applied to pulling elements (40 and 45) thereby drawing wound edges (20 and 42) toward one another, thereby effecting wound closure. Elongated connectors (15 and 35) have not yet been fixed by adhesive to the flat flexible components (5 and 25) thereby completing application.

0029<figref idref="f0003">Fig. 3</figref> depicts the bandage of <figref idref="f0001">Fig. 1</figref> in the tension and fixed (i.e., applied) state. Pulling elements 40 and 45 as shown in <figref idref="f0001">Figs. 1</figref> and <figref idref="f0003">3</figref> have been removed along perorations 17 and 37. Elongated connectors 15 and 35 are attached to flat flexible components 5 and 25 by adhesive. Cut-outs (47 and 49) in elongated connectors (35 and 15) are positioned directly above the wound or incision to facilitate drainage of exudates and application of medication.

0030Referring to <figref idref="f0004">Fig. 4</figref>, a bandage of <figref idref="f0001">Fig. 1</figref> is shown in which only a single elongated connector (15) is attached to the first flat flexible component (5). This bandage is referred to herein as a wide key-hole bandage and is not according to the present invention.

0031Referring to <figref idref="f0005">Fig. 5</figref>, a clear, breathable protective cover (51) having an adhesive strip (53) along the perimeter may be applied to protect the area to which a bandage of the present invention has been applied. <figref idref="f0005">Fig. 6</figref> depicts the protective cover (51) applied to the skin over a bandage of the present invention.