U.S. patent application number 10/884837 was filed with the patent office on 2004-12-02 for method and apparatus for closing wounds without sutures.
Invention is credited to Weiser, Leslie Philipp.
Application Number | 20040243040 10/884837 |
Document ID | / |
Family ID | 33131335 |
Filed Date | 2004-12-02 |
United States Patent
Application |
20040243040 |
Kind Code |
A1 |
Weiser, Leslie Philipp |
December 2, 2004 |
Method and apparatus for closing wounds without sutures
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.
Inventors: |
Weiser, Leslie Philipp;
(Wellesley, MA) |
Correspondence
Address: |
Leslie Philipp Weiser
45 Oakland Street
Wellesley
MA
02481
US
|
Family ID: |
33131335 |
Appl. No.: |
10/884837 |
Filed: |
July 2, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10884837 |
Jul 2, 2004 |
|
|
|
10412967 |
Apr 14, 2003 |
|
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Current U.S.
Class: |
602/41 |
Current CPC
Class: |
A61B 50/30 20160201;
A61B 17/0466 20130101; A61B 2017/086 20130101; A61B 17/085
20130101 |
Class at
Publication: |
602/041 |
International
Class: |
A61F 013/00; A61F
015/00 |
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 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 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: 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; 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 1/4 of the distance between adjacent guidelines.
Description
RELATED APPLICATIONS
[0001] This application is a continuation in part application of
pending application Ser. No. 10/412967, filed Apr. 14, 2003 and
claims priority therefrom.
FIELD OF THE INVENTION
[0002] The disclosure of this application relates to a method and
device for closing wounds or incisions without the use of invasive
surgical procedures.
BACKGROUND
[0003] 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.
[0004] 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.
[0005] Beginning early in the 20.sup.th century, 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] A simple one-piece closure is historically represented by
the STERI-STRIP.RTM. 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).
[0016] 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.
[0017] 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
[0018] 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.
[0019] 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.
[0020] 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.
[0021] 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
[0022] The invention will be described in more detail below with
reference to the attached drawing in which:
[0023] FIG. 1 is a perspective view of a closure device of this
invention from the bottom with a first embodiment of protective
tapes exploded.
[0024] FIG. 2 is a perspective view of a closure device of this
invention from the top, with a second embodiment of protective
tapes exploded;
[0025] FIG. 3 is a perspective view of a closure device of this
invention from the top, with a third embodiment of protective tapes
exploded;
[0026] FIG. 4 is a perspective view of a closure device of this
invention from the top, with a forth embodiment of protective tapes
exploded;
[0027] 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.
[0028] FIG. 6 is a perspective view of a closure device of this
invention from the top, with some of the bridging links
engaged;
[0029] FIG. 7 is a perspective view of a closure device of this
invention from the top, in the completely engaged condition;
[0030] FIG. 8 is a perspective view of an alternate embodiment of
the closure device of this invention from the top;
[0031] 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;
[0032] 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;
[0033] 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;
[0034] 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;
[0035] 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;
[0036] FIG. 14 is a perspective view of the embodiment of FIGS. 9
and 10 with the engaging adhesive on the base strip only;
[0037] FIG. 15 is a top plan view of the closure of this
application;
[0038] FIGS. 16a-16d are top plan views showing the sequence of
aligning steps;
[0039] FIG. 17 is a top plan view of the closure in use;
[0040] FIG. 18 is a perspective, exploded, schematic view of the
protective shield of this application;
[0041] FIG. 19 is a perspective, assembled view of the protective
shield of this application; and
[0042] FIG. 20 is an end, schematic view of the protective shield
of this application.
DETAILED DESCRIPTION OF THE INVENTION
[0043] 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.
[0044] As shown in FIGS. 1-8, an elongated 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.
[0045] In an alternative embodiment, as shown in FIGS. 11 and 13,
an additional adhesive coated section 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).
[0046] In another alternative embodiment, as shown in FIG. 12 and
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.
[0047] The 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.
[0048] In the packaged or stored position, as shown in FIGS. 1 and
2, the bridging 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.
[0049] As shown in FIG. 6, a small amount of adhesive 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.
[0050] Folding the bridging links 5 provides an uncluttered
operating edge with which to properly align base strip 1 with the
wound lip 7.
[0051] In order to package the closure device of this invention
protective tapes, such as 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.
[0052] To facilitate positioning of the closure device, protective
tape covering the bottom surface 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.
[0053] In the stored position, the 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.
[0054] In an alternative embodiment, as shown in FIG. 2, the
protective tape 14a 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 14a up to the fold line 20, the limited edge
adhesive 19a may be exposed to accomplish the same purpose as
indicated above.
[0055] In another alternative embodiment, as shown in FIG. 3, edge
adhesive 19c is defined by limiting the width of tape 14c to leave
the edge adhesive 19c 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.
[0056] To complete the packaging of the closure device of this
invention, a tear away outer package, constructed of 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.
[0057] A typical wound 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 1a and 1b 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.
[0058] The inner edges 6a and 6b of each length of the base strips
1a and 1b are positioned adjacent the lip 7 of the wound 8. Base
strips 1a and 1b are adjusted to insure that the bridging links 5a
on one side of the wound 8 are displaced from the bridging links 5b
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 1a and 1b are secured to the skin in place adjacent to
the wound. Protective tape 16 may then be removed to expose
adhesive sections 9.
[0059] As shown in FIGS. 5 and 6, to close the gap 22 of wound 8,
the bridging links 5a and 5b 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 5a and 5b from opposing sides of the wound, the base strips
1a and 1b 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 6a and
6b of the lengths 1a and 1b, 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 5a and 5b to the upper
surface 12 of the opposite length of base strip 1 across the wound
8. The bridging links 5a and 5b 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.
[0060] In this manner a simple closure is constructed which is
easier to manufacture and use than the multiple component devices
of the prior art.
[0061] 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
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.
[0062] To facilitate use of the strips in short units, the bridging
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.
[0063] In the improvement of this application another embodiment of
the 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.
[0064] As indicated above, approximately equal lengths L of 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.
[0065] As shown in FIG. 15, the 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.
[0066] The alignment process is shown in the sequence of drawings
of FIGS. 16a-16d. 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.
[0067] As in the prior embodiments, and as shown in FIG. 18, the
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.
[0068] Protective shield 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.
[0069] To maximize the removal effect of the 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.
[0070] The folds of 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.
[0071] 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.
* * * * *