Bandage for wound or incision closure

DESCRIPTION

LINK TO CLOSURE

INJURY OR INCISIONS

Background of the invention

Compositions 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 that can be painful and often requires the use of an anesthetic. Often these processes leave deformed scars from both the insertion orifices and the varying tensions applied to the wound or surgical incision between suture points and the intervention spaces. In addition, these methods require follow-up visits to a hospital or doctor's office for their removal.

Although other compositions and methods for closing wounds or incisions are known in the art, they have not been popularly accepted due to limitations in their construction. There is a clear need for noninvasive or less invasive incision or wound closure methods that are practical and easy to use.

US-A-5 263 970 discloses a surgical wound closure adhesive which includes a pair of locating elements, the locating elements for use being placed on opposite sides of the wound. A manipulation means connects the locating elements, the manipulating means and locating elements forming an article in one piece and the manipulating means being employed to pull the locating elements against each other to close the wound.

US-A-2,762,371 discloses a double bandage, in which two essentially duplicate adhesive bandages are found. Each has a cushioned central area, both medicated and non-medicated, on opposite sides of which are the usual end portions, the latter being covered by the usual removable crinoline covers, or equivalent covers. One of the bandages has an opening in the center of its cushioned part, and the cushioned central part of the other bandage is cut and narrow in width, and the restricted part is tightened or traversed through the opening in the first one-piece opening bandage. in order to promote an adjustable bonding connection and also to constitute the four retention or fastening adhesive ends mentioned above which are used in progressive pairs, in a way that will be explained in more detail.

US-A-1 299 367 discloses an elastic bandage which has knitted a geometric pattern comprising two components which adopt recognizable configurations when the ligature is extended to corresponding predetermined degrees. The two components may be alternating large and small rectangles arranged with the collinear smaller sides. When the bandage is stretched, the shorter sides of the rectangles are elongated. In each case, a point is reached where the short and long sides of the rectangle become a square, and this indicates that a predetermined stress has been reached.

US-A-5,534,010 discloses a bandage that has the features of the preamble of claim 1. The present invention is a bandage that has the features of the characterizing part of claim 1. Option features are described in the dependent claims.

The pulling elements tend to distribute the fractional force exerted by a bandage person of the present invention across each of the elongate joining means to which it is attached.

The adhesives on the undersurface of the first and second smooth flexible members are chosen based on their skin compatibility as well as their ability to hold the bandage firmly 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 applying the bandages, thereby exposing the adhesives.

In embodiments of the present invention, wherein the first and second smooth flexible members are thin and extremely flexible, the adhesive protection film may be chosen to provide a degree of stiffness that assists in applying the bandage. Multiple protective films may be provided to protect the glue on a single smooth flexible component, thereby providing convenient points for finger-holding on the protected upper and lower portions of the bandage during application.

It is evident that when applied to

When the smooth flexible members are applied and a desired tension is achieved which closes the wound or incision, the elongate joint members are brought into contact with the smooth flexible members and the glue fixes the positions relative to one another. In manufacture, the glue may be superior to the smooth flexible components, to the lower surfaces of the elongate joining means, or both. For this application a number of pressure sensitive adhesives are suitable and the choice of concrete adhesive to be applied is primarily a matter of choice and design optimization. As already discussed above in connection with the glue on the lower surfaces of the smooth flexible components, the glues are protected prior to application with a removable thin film.

The dimensions of the various components are variable, within parameters defined by functional considerations. For example, the length of the first and second smooth flexible members (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 dimensions perpendicular to the length of the first and second smooth flexible components in the application plane). In other words, the length to width ratio must be chosen such that sufficient glue can be applied to hold the bandage in place once it is applied to the skin. If the width of the bandage is too small relative to its length, the bandage will be poorly secured when applied and susceptible to premature and unexpected skin separation. Determining the relationships between length and width is empirical in nature and depends on glue. In general terms, an acceptable length to width ratio may be from about 1: 2 to about 8: 1. These relationships are given by way of example and are not intended to establish maximum or minimum relations at all.

Another consideration that relates to the sizing of the bandage elements of the present invention is the spacing between the elongate joining means. It is important that there is sufficient space between adjacent elongate joining means to allow adjustment of the first and second smooth flexible members relative to one another. Specifically, in application, one of the two smooth flexible components is applied to the skin before the other smooth flexible component. Following application, this smooth flexible component is not easily removed and replaced. Therefore, having sufficient clearance between the elongate joining means is important to facilitate a fine adjustment of the unjoined smooth flexible member relative to the joined smooth flexible member. There is no absolute minimum value that can be set regarding the spacing between the elongate joining means. Probably the preferred ranges are best set as a percentage of the bandage length. For example, a spacing between adjacent elongate joining means between about 5% to about 10% of the bandage length (as defined above) is an example of an appropriate range.

In preferred embodiments, the smooth flexible members, elongate joining means and tensile members described in the preceding paragraph are produced from an essentially non-elastic polymeric material. Alternatively, they may be made from an elastic material that is reinforced with a non-elastic structural member, thereby rendering the device essentially non-elastic. For example, these non-elastic materials may include a polymeric coating or a monofilament mesh. Reinforcement of the smooth flexible components along the wound edge and the traction elements is preferably done using a material that is both rigid and non-elastic (for example, a rigid polymer is a preferred material for this purpose).

In preferred embodiments, flat flexible components, elongate joining means and tensile elements are produced from a film feedstock (e.g., a plastic film piece). Cutting these elements into wedges from the plastics film piece to provide unitary components which are subsequently joined to produce a functional bandage is a particularly cost-effective approach. The plastic film piece can be perforated to allow air to exchange with the skin beneath the bandage. The thickness of the plastic film piece may vary, depending on the application. In addition, as stated above, the parts may be reinforced with a rigid material if required.

In preferred embodiments, the first and second traction elements are removable following application of the bandage to the skin. This feature minimizes the size of the bandage after application to the patient. This decrease in the overall size of the bandage reduces the likelihood that a part of the bandage may be caught, for example, in clothing or a pillow. Such an occurrence could tend to remove the bandage from the skin, thereby causing the wound or incision to open. Minimizing the overall size of the bandage after application also tends to provide a more comfortable seating.

A preferred design, which provides for removal of the fraction elements, includes inline perforations or indentations along the first and second elongate joining means. By separating the elongate joining means along these perforations, the first and second fraction elements are removed.

In the bandage of the present invention the first and second elongate joining means are interleaved. The interleaving of the elongate joining means may be effected in a variety of ways, which are apparent to those skilled in the art. By way of example, at least one of the elements of the flat flexible component pair and the elongate joining means may be die cut as a unitary element, while separate die cutting of the corresponding traction element. The first and second elongate joining means may then be interleaved, followed by connecting the individually die-cut traction elements to the appropriate elongated joining means, for example using a glue.

Another process for assembling an interleaved embodiment is described more briefly as an example. A first one-piece component is produced, comprising a tensile element, a pair of first elongate joining means and a first smooth flexible member. A second one-piece component is produced, comprising a tensile element, three second elongate joining means and a smooth second flexible member. The elongate joining means are spaced apart so that they would be interspersed if they were paired, but because the second central elongated joining means (being fixed at each end) prevents the pairing of the two elements. In order to pair the two integral components, it is necessary to cut this second central elongate joining means, to pair the two integral components so that the elongated joining means are interspersed, then to reconnect the central elongated joining means. Of course, this mounting method also applies to construction variants having more than 5 elongated joining means in total.

When applied to the skin and conveniently tensioned, one of the edges of the first smooth flexible member and an edge of the second smooth flexible member are positioned in the vicinity of the wound or incision and are essentially parallel thereto. These lips will be referred to herein as wound lips. In preferred embodiments of the present invention, the wound edges are adapted to turn (or raise) the edges of the skin to promote wound healing. It is well known in the art that rolling, elevating or piling up the edges of the skin at the wound or incision site prevents the inversion of the wound. One way this can be achieved is to perform a bend at the edge of the wound. Folding can be performed at an angle or at a curve. The glue on the bottom of the smooth flexible components is also applied to the wound edge portion.

When attached to the skin, this twisting edge tends to elevate the edges of the skin at the closing contact point, thereby promoting wound healing or incision.

As mentioned above, the preferred embodiment of the present invention includes die cut variants. In this embodiment, the elongate joining means may be viewed as corridor-like in size. In preferred embodiments, a portion of the elongate joining means is cut-off to increase the unobstructed surface area of ​​the wound or incision. This tends to facilitate drainage of exudates and application of medication. This cutting removal is best accomplished by a die cutting process.

In preferred embodiments, the bandage of the present invention is also adapted for alignment of the wound closure. The spacing between adjacent elongate joining means as discussed above is relevant to the successful alignment of the wound closure. Additionally, preferred embodiments of the bandage of the present invention include indicators of wound closure alignment. These alignment indicators are visual indicators, which appear on smooth flexible components in the vicinity of the wound edge. Typically, they appear as a line or an arrow, usually perpendicular to the wound or incision. When closing a wound or incision, a clinician typically closes the wound manually with his or her fingers at approximately the center point, then makes a small mark or line perpendicular to the wound with a surgical pencil. These marks are used to precisely align the device with the wound alignment indicators on the bandage of the present invention.

The bandage of the present invention may optionally be adapted for transcutaneous administration of medicaments. As is known in the art, a drug may be administered transcutaneously through the skin. For an application of this nature, a medicament-containing dressing is attached to at least one of the smooth flexible components such that the medicament can be delivered through the skin. Because there is no glue contact between the skin and the smooth flexible member in the area of ​​the drug delivery patch, it may be necessary to increase the size of the smooth flexible member to hold the bandage in a constructive variant of transcutaneous delivery of the drug. medicine of this nature. Transcutaneous administration of medicaments is well known in the art and no background study is required to enable anyone skilled in the art to perform and use the present invention.

The bandage of the present invention may optionally include an elastic tension indicating element. The purpose of the elastic tension indicating element is to provide a visual indication that a desired tension has been reached by applying the bandage. For example, color-changing materials are known in the art when a predetermined stress 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 voltage indicator is extended, the graphical representation of the rectangle distends. This element may be designed in such a way that the desired voltage is indicated when the original rectangular representation has been extended to a point which is very close to a geometric square.

It is desirable that this elastic tension indicator element be removable with the traction element following the 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 extend and release the previously established desired tension.

Brief Description of Drawings

Fig. 1 is a ligature view of the present invention.

perspective illustrating one in a state not subject to

Fig. 2 is a perspective view illustrating a bandage of the present invention with tension applied.

Fig. 3 is a perspective view illustrating a bandage of the present invention with the elongate joining means attached to the smooth flexible members and the pulling elements removed.

Fig. 4 is a perspective view illustrating a bandage that is not in accordance with the present invention, in a large tensionless keyhole embodiment.

Fig. 5 is a perspective view of a protective covering for bandage application of the present invention.

Fig. 6 is a perspective view of the protective cover of FIG. 5 applied to protect a bandage of the present invention.

Detailed Description of Preferred Embodiments

The bandage of the present invention in an unstressed state is shown in FIG. 1. The bandage (1) includes a first smooth flexible member (5) and a second smooth flexible member (25). Each of these components has an upper surface, towards which the guide lines 5 and 25 are directed, and lower surfaces, which are not visible in the drawing. The lower surfaces are covered with glue to facilitate their attachment to the skin. A series of first elongate joining means (15) extend from the wound edge (20) of the first smooth flexible member (5) in a first direction, and a series of second elongated joining means (35) extend from the wound edge 42 of the second smooth flexible member in a second direction which is generally opposite the first direction. A first traction member (40) is attached to the first elongate joining means (15) and is adapted for lateral translation of the first smooth flexible member (5) towards a wound or incision. Similarly, a second traction member (45) is attached to the second elongate joining means (35) and is adapted for lateral translation of the second smooth flexible member (25) towards the wound or incision. According to the invention, the means for securing the first elongate joining means (15) to the second smooth flexible member (25) and the second elongated joining means (35) to the first smooth flexible member (5) comprise a glue. The glue is applied to the lower surfaces of the first and second elongate joining means (15 and 35). Perforations (17 and 37) in the elongate joining means facilitate removal of the traction members (40 and 45) from the elongated joining means (15 and 35) after application of the bandage.

The lower surfaces of the first and second smooth flexible components are (at least partially) covered with glue to facilitate attachment to the patient's skin. These adhesives facilitate attachment and allow easy removal of the bandage after the wound or incision has healed. Hand-peelable protective films (not shown) serve as glue protection means on the first and second smooth flexible members (5 and 35) prior to the use of the bandage.

Fig. 2 shows the bandage of fig. 1 in a stressed state but not fixed. More concretely, fig. 2 shows the first and second smooth flexible components (5 and 25) fixed to the skin without glue. Tension was applied to the fraction elements (40 and 45), thereby pulling the wound edges (20 and 42) against each other. The elongate joining means (15 and 35) have not yet been glued to the smooth flexible members (5 and 25), thus completing the application.

Fig. 3 shows the bandage of fig. 1 in the stressed and fixed (ie applied) state. Fraction elements 40 and 45 as shown in FIGS. 1 and 3 have been removed along the perforations 17 and 37. The elongate joining means 15 and 35 are bonded to the flexible flexible members 5 and 25 by means of glue. The indentations (47 and 49) in the elongate joining means (15 and 35) are located directly above the wound or incision to facilitate exudate drainage and medication application.

With reference to fig. 4, a bandage of FIG. 1, in which only a single elongate joining means (15) is fixed to the first smooth flexible member (5). This bandage is referred to herein as a wide key hole bandage and is not in accordance with the invention.

With reference to fig. 5, a transparent breathable protective cover may be provided with a glue strip (53) along its periphery to protect the area to which a bandage of the present invention has been applied. Fig. 6 shows the protective covering (51) applied to the skin over a bandage according to the present invention.

Lisbon, August 18th, 2009

CLAIMS