US20040243040A1

US20040243040A1 - Method and apparatus for closing wounds without sutures

Info

Publication number: US20040243040A1
Application number: US10/884,837
Authority: US
Inventors: Leslie Weiser
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-04-14
Filing date: 2004-07-02
Publication date: 2004-12-02
Also published as: WO2006014323A1; CA2499866C; US20040204740A1; US8764792B2; CA2499866A1; US20080228220A1

Abstract

An elongated flexible base strip is constructed with a bottom surface coated with an adhesive material. The base strip is constructed with bridging links that are spaced along the inner edge of the base strip and extend outward therefrom. Adhesive sections above and below the strip are exposed and a shield is provided to protect the exposed adhesive sections from above and below the base strip. The base strip, is cut to a first length and aligned with the wound with the bridging links extending over the wound. The base strip is marked with guide lines used to avoid interference between opposing bridging links. The guidelines are positioned in the gap between bridging links and located so that when the guidelines of opposite base strips are aligned the bridging links do not interfere with each other. A matching portion of base strip is cut to a second length and aligned with the wound with the bridging links opposing. The opposing links are drawn together to close the wound. Adhesive on the links holds the links to the opposite base strip.

Description

RELATED APPLICATIONS

This application is a continuation in part application of pending application Ser. No. 10/412967, filed Apr. 14, 2003 and claims priority therefrom.[0001]

FIELD OF THE INVENTION

The disclosure of this application relates to a method and device for closing wounds or incisions without the use of invasive surgical procedures.

BACKGROUND

The most common methods for closing wounds caused by lacerations or surgical incisions are suturing and stapling. Both of these procedures are skin invasive, which can traumatize and compromise the integrity of the wound. They increase the possibility of infection, expose the surgeon, as well as the patient to blood bourn disease, leave behind scar tracks and require a follow-up visit for suture or staple removal.

As is well known, a cut that invades deeply into the tissue of the skin generally requires a mechanism for drawing the sides of a wound together to promote healing and to reduce the formation of scar tissue. Surgeons have become skilled in the various techniques of suturing to minimize the resulting blemish that occurs during the healing process. These methods have always generated issues of sterilization and the very nature of suturing requires a threshold of dexterity that escapes many care providers. This is particularly true in emergency situations, which call for immediate treatment to secure the wound for transport or until such time as proper surgery is available. Suturing even by a skilled surgeon, punctures and stresses skin tissue causing scaring. It is well recognized that a sutureless wound closure would be a great benefit in many situations.

Beginning early in the 20 ^thcentury, attempts were made to provide non-invasive closures. An early example of this is described in U.S. Pat. No. 1,074,413 (1913), which teaches the use of a pair of strips of fabric having adhesive backing. The strips of fabric are applied in parallel on either side of the wound and are constructed with threads extending transversely to bridge the wound. A compressive force is applied across the wound by tying opposing ends of the transverse threads of adjacent strips. In order to maintain the threads in an orderly fashion prior to use, another strip of fabric is attached to the distal ends of the threads to secure the thread ends in parallel for packaging and applying the closure. In one embodiment the threads are woven into both of the strips and then cut after placement of the strips on either side of the wound.

Another early device is described in U.S. Pat. No. 1,230,444 (1917). This is a woven fabric adhesive element having a gap intermittently formed in the length of the strip. The gap is formed in the weaving process by omitting weft strands (parallel to the length of the strip) in the gap and reducing the number of warp threads (transverse to the length of the strip) in the gap. A limited number of warp threads, therefore, bridge the gap. An advantage of this device is that it may be constructed in continuous lengths and packaged in a roll for convenient storage. A disadvantage is that the ability to apply a cross-wound force would be limited.

A more sophisticated approach is described in the reference Flynn, U.S. Pat. No. 2,196,296 (1940), in which a closure is designed for the express purpose of eliminating suturing. This device illustrates an early step in a trend towards interlocking multiple element devices. Dual adhesive strips are connected to a base adhesive element and to each other by threads woven through eyelets in the base element. The base element is applied to one side of the wound edge and one of the adhesive strips is applied to the other side. A cross wound force can be applied and held by drawing the threads through the eyes and pulling the remaining pair of adhesive strips away from the wound and attaching them to the skin beyond the associated counter part. The construction and assembly of this device is necessarily complex. It employs dual adhesive strips, i.e., the base strip and one of the adhesive strips applied in parallel on either side of the wound, but uses a third adhesive strip to generate and maintain the wound closing force.

U.S. Pat. No. 4,423,731 (1984) describes a suture-less wound closure which is similar to that shown in the above cited '413 patent. In this patent the distal ends of the bridging threads of one adhesive strip are interconnected by another pulling strip, allowing the bridging threads to be manipulated in concert. This configuration requires that the bridging threads or filaments of each of the adhesive strips be interlaced to enable the pulling strips to be pulled across the wound and secured. Dual adhesive strips are constructed with bridging filaments interlaced and attached to a pulling strip also having adhesive. The adhesive strips are applied on either side of the wound and are drawn together by grasping the pulling strips and thereby drawing the edges of the wound together. The closure is secured by adhering the pulling strip to the skin on the outer side of the opposing adhesive strip. Opposing forces can be applied simultaneously to each of the adhesive strips at the wound edge to close the wound.

The suture-less closure of U.S. Pat. No. 5,263,970 (1993) operates similarly to the closure of the '731 patent. It is however, formed of a single adhesive element which is placed over the wound. Centrally located over the wound opening, there are constructed dual sets of separated elongated extensions. The distal ends of each set of extensions are attached by a laterally extending tab portion. By manipulating the tabs, each set of extensions may be independently manipulated to allow the wound edges to be pulled together or otherwise advantageously moved. The closure is secured by adhering the tabs to adhesive pads on the exposed surface of the adhesive element.

An interlocked assembly of adhesive pads are assembled in the system of U.S. Pat. No. 5,534,010 (1996) to be operated in a manner similar to the '731 patent discussed above. First and second pads are adapted for application to the skin on either side of the wound. A third and fourth pad are adapted to adhere to the upper side of the first and second pads respectively. The third pad is attached by bridging filaments to the first pad and may be applied to the upper side of the second pad and the fourth pad is attached by bridging filaments to the second pad and may be applied to the upper side of the first pad.

In the bandage of U.S. Pat. No. 6,329,564 (2001), a two component interlocked system is devised which operates similarly to the system of the '010 patent. First and second adhesive strips are constructed with elongated connectors extending transverse to bridge the wound. The connectors are in turn interconnected by a pulling element. The adhesive strips, connectors, and pulling elements are interlaced so the connectors of one adhesive strip extend over the outer surface of the opposing adhesive strip. Similarly to the assembly discussed above opposing forces maybe applied to draw each of the adhesive strips toward each other and thereby close the wound.

All of the above bandage configurations, in particular the interlocked dual element style, appear to be difficult to manufacture and to use. The manipulation of a loose assembly of multiple parts in an emergency and possibly life-threatening situation is a challenging undertaking. It is a purpose of this invention to provide a suture-less wound closure, which is more easily manufactured and packaged. It is another purpose of this invention to provide a wound closure, which is easy to unpackage and apply.

The prior art cited above is consistent in several respects namely, that two adhesive strips need to be provided for application to either side of the wound and that a mechanism is needed to apply forces to each of the adhesive strips to draw them together to close the wound. The prior art seems to solve this need by proposing multiple interlaced parts.

It is a purpose of this invention to construct a suture-less wound closing device in one piece that can be used on both sides of a wound without the need for interlacing the parts during manufacturing. It is a purpose of this invention to provide a single element wound closure that does not require suturing, stapling or gluing.

A simple one-piece closure is historically represented by the STERI-STRIP® adhesive strip available from 3M Corporation or butterfly shaped adhesive strips both of which are used to bridge the wound. These configurations may be used singly, in pairs, or multiple units to apply a closing force to the wound. A more complex version of such wound closures is shown in U.S. patent application, Pub. No. 2002/0099315, which was published Jul. 25, 2002. A substantially more complex version of this type of closure is described in U.S. Pat. No. 6,293,281 (2001).

A purpose of this invention is to simplify, improve upon, and facilitate the customization capability of these various adhesive strip, wound closure devices and methods. A purpose is to provide a simplified elemental device capable of applying a series of adhesive bandage strips that can be used to close wounds and can be adapted to a variety of wound shapes and sizes. It is a further purpose of this invention to provide a closure that does not require any particular dexterity, skill, or knowledge and is reasonable in cost so that it can be used by anyone, even the lay person.

In the course of describing this invention below, the bottom of the closing device of this invention will refer to the surface that is intended to engage the skin and the upper side or top will refer to the side of a component that is facing away from the skin after application. Directions will be indicated according to the position of the wound being treated, for example, transverse shall refer to directions across the wound. The inner edge of the closing device shall refer to the side, which is intended to be adjacent to the wound lip, and the outer edge shall refer to the side of the device that is intended to be away from the wound.

SUMMARY OF THE INVENTION

The main element of this invention comprises an elongated flexible base strip having its bottom surface coated with an adhesive material suitable for adherence to skin. The base strip is constructed with bridging links, which are spaced along the inner edge of the base strip and extend outward therefrom. The inner edge of the base strip, from which the links extend, is intended to be aligned with a lip of the wound being treated. Each of the bridging links has an adhesive coated section displaced from the inner edge. In the packaged or stored position, prior to engagement, the bridging links are folded over the upper surface of the adhesive strip about a hinge that is at the joint of the bridging link to the base strip. The base strip may be of an extended length so that it might be customized to size and shape of the wound.

In order to package the closure device of this invention, protective tapes may be positioned over exposed adhesive material to preserve the adhesive characteristics and avoid undesirable sticking to packaging materials, surgical gloves, and other non-designated areas surrounding the wound. To facilitate positioning of the closure device, the protective tape covering the bottom surface may be constructed to expose a region of the adhesive, which is immediately adjacent to the inner edge. This inner edge region of adhesive permits the practitioner to apply the base strip without fully engaging the entire adhesive area. The inner edge of the base strip may then be adjusted into alignment with the edge of the wound. After alignment with the wound, the remaining protective tape is removed and the entire base strip is secured adjacent to the wound.

In the stored position the adhesive sections of the bridging links will be exposed on the top surface of the links. A protective tape is applied to cover these adhesive sections.

In operation the wound will be examined and two substantially equal lengths of the base strip will be cut, torn, or separated from the packaged closure device. In many instances, the contour of the wound will need to be manipulated to form a substantially straight lip to facilitate alignment of the inner edge of the base strip. The inner edge of each length of the base strip is positioned on opposite sides of the wound. The base strip is adjusted to insure that the bridging links on one side of the wound are displaced from the bridging links on the other. To close the wound the bridging links are manually pivoted about a hinge from their stored position and pulled transverse to the wound lip to close the wound. The closing force is maintained by engaging the adhesive section of the bridging links to the upper surface of the opposite length of the base strip across the wound.

DESCRIPTION OF THE DRAWING

The invention will be described in more detail below with reference to the attached drawing in which: [0022]
FIG. 1 is a perspective view of a closure device of this invention from the bottom with a first embodiment of protective tapes exploded. [0023]
FIG. 2 is a perspective view of a closure device of this invention from the top, with a second embodiment of protective tapes exploded; [0024]
FIG. 3 is a perspective view of a closure device of this invention from the top, with a third embodiment of protective tapes exploded; [0025]
FIG. 4 is a perspective view of a closure device of this invention from the top, with a forth embodiment of protective tapes exploded; [0026]
FIG. 5 is a perspective view of a closure device of this invention from the top, with aligned lengths of base strips applied to a wound. [0027]
FIG. 6 is a perspective view of a closure device of this invention from the top, with some of the bridging links engaged; [0028]
FIG. 7 is a perspective view of a closure device of this invention from the top, in the completely engaged condition; [0029]
FIG. 8 is a perspective view of an alternate embodiment of the closure device of this invention from the top; [0030]
FIG. 9 is a perspective view of an alternate embodiment of the closure device of this invention from the top with aligned lengths of the base strip applied to the wound; [0031]
FIG. 10 is a perspective view of an alternate embodiment of the closure device of this invention from the top in a fully engaged condition; [0032]
FIG. 11 is a perspective view of an alternate embodiment of the invention with the engaging adhesive section resident on both the base strip and the bridging links; [0033]
FIG. 12 is a perspective view of an alternate embodiment of the invention with the adhesive section for engaging the bridging links only resident on the base strip; [0034]
FIG. 13 is a perspective view of the embodiment of FIGS. 9 and 10 with the engaging adhesive resident on both the base strip and the bridging links; [0035]
FIG. 14 is a perspective view of the embodiment of FIGS. 9 and 10 with the engaging adhesive on the base strip only; [0036]
FIG. 15 is a top plan view of the closure of this application; [0037]
FIGS. 16[0038] a-16 d are top plan views showing the sequence of aligning steps;
FIG. 17 is a top plan view of the closure in use; [0039]
FIG. 18 is a perspective, exploded, schematic view of the protective shield of this application; [0040]
FIG. 19 is a perspective, assembled view of the protective shield of this application; and [0041]
FIG. 20 is an end, schematic view of the protective shield of this application.[0042]

DETAILED DESCRIPTION OF THE INVENTION

The invention of this application involves a single component wound closure that is easy to manufacture and simple to use. It is useable to reliably close a wide variety of wound openings, large and small. It is designed for ease of use in any environment, whether it's a field emergency or an in hospital surgical procedure. It employs the basic concept of providing a single component surgical strip which can be used on both sides of the wound and avoids the difficulties of complex interlaced multiple component bandages. [0043]
As shown in FIGS. 1-8, an elongated [0044] flexible base strip 1 forms the main element of this invention and is constructed having its bottom surface 2 coated with an adhesive material 3 suitable for adherence to skin 4 (FIG. 5). As shown in FIG. 2, base strip 1 is constructed with multiple bridging links 5 that extend generally transverse to the base strip 1. The links 5 are spaced along the inner edge 6 of the base strip 1 and extend outward therefrom. The inner edge 6 of the base strip 1, from which the links 5 extend, is intended to be aligned with a lip 7 of the wound 8 being treated, as shown in FIG. 5. Each of the bridging links 5 has an adhesive coated section 9, on its bottom (engaging) surface 18, displaced from the inner edge 6.
In an alternative embodiment, as shown in FIGS. 11 and 13, an additional adhesive coated section [0045] 30 (130 in FIG. 13) is coated on both the top surface 12 of the base strip 1 (112 in FIG. 13) and the engaging surface 18 (118 in FIG. 13) of the bridging links 5 (105 in FIG. 13).
In another alternative embodiment, as shown in FIG. 12 and [0046] 14, the adhesive coated section 9 is absent from bridging links 5 and an adhesive section 30 (130 in FIG. 14) is applied to top surface 12 (112 in FIG. 14) of base strip 1. Adhesive sections 30 (130) receive the engaging surface 18 (118 in FIG. 14) of each bridging link 5 (105) and hold the links 5 (105) securely in their bridging position.
The [0047] base strip 1 and its associated bridging links 5 may be constructed by stamping from a single elongated piece of plastic sheet stock. Alternatively molding or extruding processes may be advantageously used. In some circumstances, it may be advantageous to stiffen the bridging links to facilitate handling. The bridging links may be made more rigid by laying up a second or third layer of plastic sheet material or by otherwise thickening the plastic material in the area of the bridging links 5, as shown in FIG. 2.
In the packaged or stored position, as shown in FIGS. 1 and 2, the bridging [0048] links 5 are folded over the upper surface 12 of the adhesive base strip 1 about a hinge 10 that is at the joint of the bridging links and base strip 1. Hinge 10 may be a hinge region formed to provide increased flexibility where bridging links 5 are joined to the base strip. As shown no adhesive is applied to the hinge region.
As shown in FIG. 6, a small amount of adhesive [0049] 11 can be used on the upper surface 12 of the base strip 1 to engage each of the folded bridging links 5 and releasably hold them in a stored position, see FIGS. 1-4. The base strip 1 may be of an extended length so that it might be cut, torn, or otherwise separated to the desired size, depending on the wound. It could also be packaged in a rolled configuration 13 as shown in FIGS. 3 and 4 and separated as needed.
Folding the bridging links [0050] 5 provides an uncluttered operating edge with which to properly align base strip 1 with the wound lip 7.
In order to package the closure device of this invention protective tapes, such as [0051] 14, 15, and 16 shown in FIG. 1, may be positioned over exposed adhesive materials 3 and 9. Protective tapes 14, 15 and 16 act to preserve the adhesive characteristics while helping to avoid undesirable, sticking to packaging materials and other areas surrounding the wound.
To facilitate positioning of the closure device, protective tape covering the bottom surface [0052] 3 may be constructed in two parts, a main part 14 and an edge part 15. The edge part 15 of the protective tape is aligned with the inner edge 6 of the base strip 1 and is of limited width. This allows the initial exposure of a limited edge adhesive surface 19. This in turn allows the base strip 1 to be aligned with the wound 8 and adjusted prior to adhering the entire base strip 1 adjacent to the wound 8.
In the stored position, the [0053] adhesive sections 9 of the bridging links 5 will be exposed as shown in FIGS. 1-4. A protective tape 16 is applied to cover the adhesive sections 9. To assist the user in applying the closure, each of the tape elements may be color coded or otherwise identified to indicate the order of removal. For example: in the removal of the parts 14 and 15 of the bottom protective tape, and the top protective tape 16, different colors or transparency tints may be used. Alternatively, the parts may be numbered or otherwise labeled to indicate the order of removal.
In an alternative embodiment, as shown in FIG. 2, the [0054] protective tape 14 a is formed in one piece having a fold or perforated line 20 constructed a distance outward from the inner edge 6 and extending the length of the edge 6. By partially removing the tape 14 a up to the fold line 20, the limited edge adhesive 19 a may be exposed to accomplish the same purpose as indicated above.
In another alternative embodiment, as shown in FIG. 3, edge adhesive [0055] 19 c is defined by limiting the width of tape 14 c to leave the edge adhesive 19 c exposed. The edge adhesive is covered in this embodiment only by the exterior packaging sheet 21. In the further alternative embodiment of this invention, as shown in FIG. 4, the protective tapes 14 and 15 are eliminated and the exterior packaging sheet 21 provides the necessary protection from exposure.
To complete the packaging of the closure device of this invention, a tear away outer package, constructed of [0056] appropriate sheet material 21 is used to provide an overall sterile wrap for the closure, as is well known. In some situations wrap 21 can be used to protect exposed adhesive sections, if no protective tapes are used. An overall wrap 21 surrounds the closure device and is edge sealed to maintain sterile conditions. When packaged in an extended length such as a roll, a variety of lengths of base strip 1 may be precut and contained in sealed segments of wrap 21 or means may be provided to create an edge seal at the cut edge of a packaged closure which is of continuous length.
A typical wound [0057] 8 caused by a laceration or surgical incision is shown in FIG. 5 having a lip 7 at the edge of the gap 22. Before the closure of this invention is applied, the wound 8 is examined to determine the length L of wound 8. The base strip is then cut to a length L+ which is slightly longer than wound 8. Two approximately equal lengths 1 a and 1 b of the base strip 1 are cut, torn or otherwise separated from the packaged closure device, as for example roll 13. After removing the outer wrap 21, edge protective tape 15 is removed to expose adhesive edge 19. In many instances the wound lip 7 will be curvilinear or otherwise of irregular shape because of natural skin tension or the nature of the injury. This may require manipulation of the skin surrounding the wound to bring the lip 7 into a substantially straight form to accommodate the straight edge 6 of base strip 1.
The inner edges [0058] 6 a and 6 b of each length of the base strips 1 a and 1 b are positioned adjacent the lip 7 of the wound 8. Base strips 1 a and 1 b are adjusted to insure that the bridging links 5 a on one side of the wound 8 are displaced from the bridging links 5 b on the other side, as shown by arrows x and y in FIG. 5. At this point the remaining part 14 of protective tape is removed and the base strips 1 a and 1 b are secured to the skin in place adjacent to the wound. Protective tape 16 may then be removed to expose adhesive sections 9.
As shown in FIGS. 5 and 6, to close the gap [0059] 22 of wound 8, the bridging links 5 a and 5 b are manually pivoted from their stored position and pulled transverse to the wound lip 7. By simultaneously exerting a force F on pairs of adjacent bridging links 5 a and 5 b from opposing sides of the wound, the base strips 1 a and 1 b and the wound lip 7 will be drawn together to close gap 22, as shown in FIG. 6. The space G between the inner edges 6 a and 6 b of the lengths 1 a and 1 b, shown in FIGS. 5 and 6, is reduced during this process. It is advantageous to adjust the position of the operating edges 6 so that a small separation G′ remains after the wound is closed. This will leave room for the emission of exudates from the wound, while also providing access for the delivery of medication. The closing force is maintained by engaging the adhesive section 9 of the bridging links 5 a and 5 b to the upper surface 12 of the opposite length of base strip 1 across the wound 8. The bridging links 5 a and 5 b are thus applied until the wound is closed and secure, as shown in FIG. 7. To provide an uncluttered overall wound dressing, the excess portions of bridging links 5 may be trimmed by cutting or tearing along perforations 31 which may be constructed in each link.
In this manner a simple closure is constructed which is easier to manufacture and use than the multiple component devices of the prior art. [0060]
To facilitate the closure of small wounds or partial areas of larger wounds, the adhesive strip may, in the alternative, be constructed as shown in FIGS. 8-10. In this embodiment the components are arranged generally as described before. An elongated [0061] adhesive base strip 101 is formed having multiple bridging links 105. The bottom 102 is coated with an adhesive material. Adhesive sections 109 are applied to the top surface 118 of bridging link 105. The base strip 101 may be sealed in sterile packages of various lengths, in rolled configurations 113, or other appropriate means.
To facilitate use of the strips in short units, the bridging [0062] links 105 are spaced differently. The base strip 101 is divided, by markings and/or perforated lines 140, into operational units 141 and 142. The units 141 and 142 are marked off over the entire length of base strip 101. A pair 143 of links 105 are positioned together with a normal spacing 144 within the first unit 141. The pair 143 is centered within the unit 141. A single link 105 is then positioned in the center of the adjacent unit 142. This arrangement is alternated over the length of the base strip 101. To use this alternative embodiment, the base strip 101 is cut or separated to obtain one operational unit 141, having a pair 143 of bridging links 105, and one operational unit 142, having a single bridging link 105. Operational units 141 and 142 are placed on opposite sides of wound 108, as shown in FIG. 9. By aligning the units 141 and 142, the bridging links 105 can be applied without interference, as shown in the secured closure in FIG. 9.
In the improvement of this application another embodiment of the [0063] wound closure 200 of this invention is constructed to assist in the application of base strips 201 on either side of the wound. Closure 200 is shown in FIGS. 15-17 and is constructed substantially similar to the embodiments of FIGS. 1-8. Base strip 201 is constructed with bridging links 205, extending outward from inner edge 206. Bridging links 205 are connected by a hinge portion 210 to the inner edge 206 of base strip 201.
As indicated above, approximately equal lengths L of [0064] base strip 201 are cut from an elongated strip or roll 13, as shown in FIG. 4, the length L being commensurate with the size of the wound. In order to assist in the cutting of the base strip 201, the base strip 201 is constructed with guidelines 250, as shown in FIGS. 15-17. These guidelines are printed, impressed or perforated on or in the base strip 201 at predetermined intervals on the base strip 201. In the embodiment shown in FIGS. 15-17, a guideline 250 is placed between each of the bridging links 205.
As shown in FIG. 15, the [0065] guidelines 250 are positioned a distance x, from the center line CL of a bridging link 205. Distance x is selected to be slightly greater than the maximum width of the bridging link 205, but shorter than the distance y of the center line CL to the midpoint MP of the gap between adjacent bridging links 205. The base strip 201 is cut along a guideline 250 that results in a pair of base strips 201 for placement on either side of the wound. The guidelines are designed to also provide an alignment guide during positioning of the opposing lengths of base strip 205. It is advantageous to set the distance x, such that the over all distance between guidelines can be 4 times x. In this way, the bridging links 205 will align with the midpoint MP of the distance between bridging links.
The alignment process is shown in the sequence of drawings of FIGS. 16[0066] a-16 d. A length of base strip 201 is divided into two approximately equal lengths A and B, along a guideline 250, as shown in FIG. 16b. The base strip lengths A and B are repositioned on opposite sides of a wound 251 with the opposite guidelines 250A and 250B in alignment as shown in FIG. 17. Further aligned positioning of the lengths A and B will avoid any possible interference among opposing bridging links. By positioning the guidelines to provide ample clearance, the closure 200 may be conveniently applied by visual alignment in any circumstance. By separating adjacent lengths of base strip along a guideline 250 and aligning the opposite guidelines 250A and 250B interference is avoided.
As in the prior embodiments, and as shown in FIG. 18, the [0067] closure 200 is coated with an adhesive on several surfaces. A section 203 of bottom surface 202 of the base strip 201 is coated with the primary adhesive suitable for adherence to the skin. In addition, an adhesive layer is applied to a section 230 of the engaging surface 218 of bridging links 205 as shown in FIG. 18. To protect the adhesive qualities of these adhesive layers and to prevent premature adherence to skin or packaging, shield 260 is constructed to releasably cover the exposed adhesive sections 203, 230 in conjunction with protective tape 215. Protective tape 215 is constructed to cover a limited section 219 of the adhesive on bottom surface 202, referred to as edge adhesive 219. Edge adhesive 219 is the section of the base strip 201 that is applied close to the wound edge and initial exposure of edge adhesive 219, allows the placement of the closure 200 next to wound edge 251 while permitting adjustment of the position without full engagement of the closure.
Protective shield [0068] 260 is shown in FIGS. 18-20 and is formed of a plastic film, consisting of a main part 261 and grip part 262. Main part 261 is folded at 266 to permit engagement both from above and below closure 200. Main part 261 includes a flap 263 folded underneath, as shown in FIG. 18, to engage exposed adhesive section 30 on surface 218. A second flap 264 is similarly folded back over main part 261 and is positioned on the shield to cover the remainder of the adhesive section 203 not covered by the protective tape 215. As shown in FIG. 20, protective tape 215, overlaps the edge 269 of main part 262. To assist in removing the protective shield 260 and tape 215, tape 215 may be colored one color, while grip part 262 is colored another, for example red and blue respectively so that these elements may be easily visibly defined. The flap 264 may also be colored, for example white to make its position readily visible. In addition the colored elements will facilitate the education of the user in the application of closure 200. The parts of the protective assembly comprised of shield 260 and tape 215 that interface with adhesive may be treated with a release agent, such as silicon, to further protect the adhesive and facilitate removal of the protective assembly.
To maximize the removal effect of the [0069] force 265 on the protective shield, grip part 262 is constructed of a more dense material to increase rigidity relative to shield 260. Grip part 262 is connected to the lower section 267 of main part 261, generally along a line transverse to the longitudinal axis of the main part 261. The line of connection is positioned on the lower section 267, as shown best in FIG. 20, at a point M at least mid way or closer to the edge 269 of section 267 which is closer to wound edge 206 of the closure 200.
The folds of [0070] flaps 263 and 264 are constructed to generate a peeling of the shield 261 from the respective adhesive sections when a pulling force, in the direction of arrow 265, is applied to grip part 262. By incorporating the folded flap configuration, the removal force is applied to the leading edge of the adhesive/shield interface, which results in a smooth and consistent removal. In operation protective tape 215 is removed first and the closure is placed next to the wound and properly aligned with the wound edge 251. Next, the grip part 262 is held and pulled away from the closure to release the remaining operative adhesive sections 230 and 203.
It should be understood that the foregoing description is only illustrative of the invention. Various alternatives and modifications can be devised by those skilled in the art without departing from the invention. Accordingly, the present invention is intended to embrace all such alternatives, modifications and variances, which fall within the scope of the appended claims. [0071]

Claims

I claim:

1. A device for closing a wound comprising:

an elongated flexible base strip having a bottom surface coated with an adhesive material;

a plurality of bridging links connected to an inner edge of the base strip in spaced relation, said bridging links extending outward from said inner edge, said bridging links folded over a top surface of said base strip in a storage position and having a layer of adhesive material applied to the top surface of said bridging links in the storage position;

wherein said base strip, is of a sufficient length to allow the division of said base strip into at least a first length and a second length, wherein each of said first and second lengths is adaptable for alignment on opposite sides of the wound with said bridging links extending over the wound in opposing directions, and further wherein said opposing links may be drawn together and secured to the opposite base strip to close and secure the wound;

a protective assembly for releasably covering said bottom adhesive layer and said top adhesive layer positioned above and below said wound closure device in the storage position, said protective assembly comprising:

a main part folded into upper and lower sections to engage the closure from above and below respectively;

a first flap integral with the upper section and folded to overlap said upper section of said main part from below;

a second flap integral with the lower section and folded to overlap said lower section of said main part from above;

a grip flap connected to said lower section of said main part from below in a position to provide a means by which a user can grip the protective assembly and exert a removal force thereon; and

wherein said first flap is positioned to releasably engage the top adhesive layer and said second flap is positioned to releasably engage said bottom adhesive layer.

2. A protective assembly for releasably covering upper and lower adhesive layers positioned above and below a wound closure, said protective assembly comprising:

a first flap integral with the upper section of the main part and folded to overlap said upper section from below;

a second flap integral with the lower section of the main part and folded to overlap said lower section from above;

a grip flap connected to said lower section of the main part from below in a position to provide a means by which a user can grip the protective assembly and exert a removal force thereon; and

wherein said first flap is positioned to releasably engage the upper adhesive layer and said second flap is positioned to releasably engage said lower adhesive layer.

3. A protective assembly, according to claim 2, wherein the grip flap is connected to said lower section along a line positioned at a midpoint of said lower section or closer to an edge of said closure intended to be placed adjacent a wound.

4. A protective assembly, according to claim 2, wherein the grip flap is constructed of more rigid material relative to the main part.

5. A device for closing a wound comprising:

a plurality of bridging links connected to an inner edge of the base strip in spaced relation, said bridging links extending outward from said inner edge;

wherein said base strip, is of a sufficient length to allow the division of said base strip into at least a first length and a second length, wherein each of said first and second lengths is adaptable for alignment on opposite sides of the wound with said bridging links extending over the wound in opposing directions, and further wherein said opposing links may be drawn together and secured to the opposite base strip to close and secure the wound; and

guidelines constructed on the base strip in a predetermined position at which the base strip is to be divided into first and second lengths and by which said bridging links can be aligned on opposite sides of the wound without interference, when said guidelines on said first and second lengths are aligned.

6. A device for closing a wound, according to claim 5, wherein said guidelines are printed, impressed, or perforated into said base strip.

7. A device for closing a wound, according to claim 5, wherein said guidelines are placed between each of the bridging links.

8. A device for closing a wound, according to claim 5, wherein the predetermined position is located a distance from a centerline of a bridging link greater than the width of said bridging link and less than one half the distance between centerlines of adjacent bridging links.

9. A device for closing a wound, according to claim 7, wherein position is located a distance from a centerline of a bridging link that equals ¼ of the distance between adjacent guidelines.