WO1999043279A1 - Thin film wound dressing and method for making same - Google Patents

Thin film wound dressing and method for making same Download PDF

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Publication number
WO1999043279A1
WO1999043279A1 PCT/US1999/002845 US9902845W WO9943279A1 WO 1999043279 A1 WO1999043279 A1 WO 1999043279A1 US 9902845 W US9902845 W US 9902845W WO 9943279 A1 WO9943279 A1 WO 9943279A1
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WO
WIPO (PCT)
Prior art keywords
film sheet
wound dressing
sheet
thin film
set forth
Prior art date
Application number
PCT/US1999/002845
Other languages
French (fr)
Inventor
Robert W. Sessions
Rainer Schmeichel
Original Assignee
Ferris Mfg. Corp.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ferris Mfg. Corp. filed Critical Ferris Mfg. Corp.
Priority to CA002321491A priority Critical patent/CA2321491C/en
Priority to EP99906866A priority patent/EP1058526A4/en
Priority to AU26683/99A priority patent/AU729366C/en
Publication of WO1999043279A1 publication Critical patent/WO1999043279A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive plasters or dressings
    • A61F13/023Adhesive plasters or dressings wound covering film layers without a fluid handling layer

Definitions

  • the present invention relates to wound dressings and methods for
  • Wound dressings consisting of a urethane film having adhesive on one
  • urethane film permits the dressing to conform to virtually any contour of the
  • the stretching forces may even cause abscesses or other skin
  • non-stretching backing sheet to the urethane film using adhesive.
  • the wound is maintaining the sterility of the dressing during the application
  • Another object of the invention is to provide a tab system that allows
  • a related object is to provide a wound dressing having a tab
  • One object of the invention is to provide a wound dressing having a tab
  • Yet another object of the invention is the coding of the tabs to indicate
  • Still another object of the present invention is to provide a wound
  • stretchable wound dressing which can be manufactured by overlying a series
  • the present invention provides a non-recording non-recording non-recording medium
  • stretchable wound dressing consisting of a thin film of material such as
  • polyurethane which is less than about 1.0 mil thick, more preferably about
  • wound dressing has a non-stretchable cover sheet, such as MYLAR ® , onto
  • the urethane film has an adhesive side and first and second releasable
  • the adhesive side of the first releasable end receives a first gripping
  • cover sheet and first gripping tab are in adjacent contact with each other but
  • a second gripping tab may be attached to the other side of the urethane
  • the adhesive side of the second releasable end receives an intermediate
  • a carrier sheet is attached to the urethane film surrounding the pad.
  • the second gripping tab may be peeled away from the other side of the
  • releasable ends may then be removed, leaving the wound dressing in proper
  • An object of the invention is to provide a method of manufacturing
  • the thin urethane films are less than about 1.0 thick and in a
  • FIGURE 1 is a top view of a wound dressing in accordance with the
  • FIG. 2 is a cross-sectional view of the wound dressing taken along line
  • FIG. 3 is a partially exploded view of the wound dressing shown in
  • FIGS. 4-6 are sequential views showing the application of the wound
  • FIG. 4 shows the carrier sheet being peeled
  • FIG. 5 shows the adhesive side of the urethane film placed in adjacent
  • FIG. 6 shows the ends of the urethane film being pulled away from the
  • FIGS. 7-11 are sequential schematic views showing one embodiment
  • FIG. 7 is a diagram of a method for manufacturing the wound dressing. Specifically, FIG. 7
  • FIG. 1 shows a tri-layered sheet consisting of a cover sheet, a thin urethane film, and
  • FIG. 8 shows the urethane film after removal of a portion of the left
  • FIG. 9 shows the absorbent pad attached to the adhesive side of the
  • FIG. 10 shows the first gripping tab attached to the adhesive side of the
  • FIG. 11 shows the carrier sheet being positioned into contact with the
  • FIGS. 1-3 a wound
  • wound dressing 10 is provided in accordance with the present invention.
  • dressing 10 consists of a substantially tri-layered sheet combination 12, the
  • the top layer of the wound dressing 10 is a non-stretchable but flexible
  • cover sheet 16 which is sufficiently flexible so it does not interfere with the
  • cover sheet 16 may be comprised, for example, of MYLAR ® polyester film,
  • the bottom layer of the wound dressing 10 consists of a carrier sheet
  • the carrier sheet 18 is preferably made of plastic, but in
  • carrier sheet 18 has a release side 20 which has means for facilitating release 8
  • the urethane film 14 is formed from the carrier sheet 18. In one embodiment, the
  • release means comprises a silicon release coating on the release side 20, but
  • sheet 16 carries a thin urethane film 14 which is preferably less than about 1.0
  • mil thick more preferably about 0.75 mil thick and, most preferably, less than
  • the thin urethane film 14 has a greater moisture vapor
  • MVTR transmission rate
  • the thin film 14 also conforms more
  • urethane conventional thick urethane films.
  • the thin film is referred to as a "urethane"
  • suitable material for the film sheet may be urethane film (medical grade).
  • the urethane film 14 is preferably formed or cast directly on the urethane film 14
  • thin urethane film 14 may be used in subsequent manufacturing steps
  • cover sheet 16 and urethane film 14 may be removed simply
  • the urethane film 14 consists of a middle
  • film 14 has an adhesive side 28 to which an appropriate conventional adhesive
  • the illustrated pad 30 has a generally rectangular shape centrally disposed in
  • cover sheet 16/urethane film 14 to be releasably attached to the carrier
  • the absorbent material 30 may be gauze, sponge or other inert
  • absorbent material which is suitable for absorbing moisture from the wound 10
  • absorbent material 30 may be clear or opaque to conceal the wound area.
  • hydrophilic absorbent materials which may be suitable are polystyrene foam, polystyrene foam, and polystyrene foam.
  • the absorbent material 30 may contain
  • the medication may be an antibiotic, a healing promoting agent,
  • an anti-inflammatory agent a transdermal diffusable pharmaceutical, a
  • Anticipated antibiotics include typical
  • anti-bacterial agents and anti-fungal agents are the penicillins,
  • griseofulvin pimaricin, cony statin, amphotericin B; and for viruses rifamycin,
  • nucleic acid analogs arabinosylthymine, 5-iodo-5'amino-2'-5' dideoxycridine,
  • arabinosyl adenine arabinosyl cytosine, acycloguanosine, ribavirin, 11
  • growth promoting hormones among them epidermal growth factor and
  • urogastrone Among the anti-inflammatory agents are the corticosteroids.
  • transdermal diffusable pharmaceuticals are nitroglycerin, and
  • anti-coagulants are heparin, citric acid, protamine
  • clotting agents are thrombolytic enzymes such as streptokinase and urokinase.
  • releasable ends 24, 26 are capable of receiving and carrying first tab 32 and an
  • cover sheet 16 and the carrier sheet covers substantially all of the left
  • Means is provided for removing the left and right releasable ends 24,
  • the left releasable end 24 is perforated along
  • line 24a is slightly stronger than the scored line 26a so that scored line 26a
  • a second gripping tab or strip 36 may be bonded at one end of the
  • the cover sheet 16 are inboard of the first tab 32 so that first tab 32 may be
  • FIGS. 4-6 schematically show the application of a wound dressing 10
  • the first tab 32 is gripped and
  • tacky is interposed between the adhesive side 28 of the urethane film 14 and
  • the user may then grip the first tab 32 and, if
  • film 14 permits the wound dressing 10 to be placed adjacent the patent's skin
  • the cover sheet 16 is sufficiently flexible so as not 14
  • cover sheet 16 also ensures the even
  • the second tab 36 can be pulled to separate the
  • the cover sheet 16 is in adjacent contact with the urethane film 14.
  • the user may pull the left releasable end 24 (and 15
  • the first tab 32 may bear
  • second tab 36 may contain an indicia indicating it is the second tab 36 in the
  • Two hands are particularly valuable for self-application to the hand or arm.
  • holding the first tab 32 may then apply the wound dressing 10 and remove the 16
  • the present invention also meets a long-felt need for a thin film wound
  • This wound dressing 10 can be easily
  • cover sheet 16 and tabs 32, 34 provide support for the wound
  • the wound dressing 10 can be applied with one hand.
  • the tabs may be
  • FIGS. 7-11 schematically show a method for manufacturing the wound
  • the wound dressing may be manufactured using rolls
  • a web of sandwiched thin urethane film 14 may be
  • the cover sheet 16 is preferably made
  • film and cover sheet be attached to each other without adhesives.
  • an adhesive may be used to attach the urethane film
  • An adhesive may be applied to the
  • the sandwiched urethane film 14 is typically formed
  • the triple-layered web 112 may subsequently be processed to separate
  • FIG. 8 portions of some of the layers as generally shown in FIG. 8. More
  • the intermediate liner and the urethane film are cut and removed
  • layered web 112 is subsequently scored and/or perforated at release lines 24a
  • layered web 112 is subsequently processed to receive the absorbent pad 30,
  • Pre-sized absorbent material 30 may be inserted into the predetermined
  • a web of the first tab 32 may be pressed into adjacent contact with the
  • portion of the first tab 32 (as shown in the figures) is positioned so that it is
  • the left portion of the first tab 32 is
  • releasable end 24 is disposed between the cover sheet 16 and the first tab 32
  • a web of the bottom carrier sheet 18 may be supplied so that the
  • release side 20 is brought into contact with adhesive side 28 of the urethane
  • the carrier sheet 18 is releasably attached to the portions of the adhesive side
  • sheet 18 is substantially inboard of the first tab 32.
  • the second tab 36 may be attached to the top side of the cover sheet
  • the second tab 36 have an adhesive side 28 which is
  • the size ranges of wound dressings 10 can vary from 0.20 x 1.0 inch to
  • wound dressing 10 18 x 18 inches.
  • Preferred sizes of wound dressing 10 are 1 " x 3", 2" x 3", 3"

Abstract

A non-stretching wound dressing (10) is provided for use with a patient. The wound dressing includes a cover sheet (16) having top, and bottom sides, a thin film sheet (34) formed on the bottom side of the cover sheet, the film sheet having first, and second ends (24, 26), an adhesive side (23), and a carrier sheet (18) in adjacent contact with the adhesive side of the thin film sheet. The dressing also includes a first gripping tab (32) attached to one end of the thin film sheet, disposed between the film sheet, and the carrier sheet for separating the carrier sheet from the film sheet with the cover sheet remaining affixed to the film sheet. A second gripping tab (36) is attached to the top side of the cover sheet, and at one end of the cover sheet so that pulling on the second gripping tab releases the cover sheet from the film sheet with the film sheet remaining in place on the patient.

Description

THIN FILM WOUND DRESSING AND METHOD FOR MAKING SAME
FIELD OF THE INVENTION
The present invention relates to wound dressings and methods for
making such wound dressings and, in particular, to a thin film wound dressing
which can be applied to a patient without stretching, and a method for the
continuous production of a large number of such wound dressings.
BACKGROUND OF THE INVENTION
Wound dressings, consisting of a urethane film having adhesive on one
side for carrying an absorbent pad and adhering to a patient's skin
surrounding an open wound, are known in the art. The flexible nature of the
urethane film permits the dressing to conform to virtually any contour of the
patient's skin at the location where the dressing is applied. The flexibility and
thinness of the urethane film, however, present the problem of applying the
wound dressing to the patient without stretching the urethane film. Stretching
of the dressing prior to or during application to a patient may momentarily
expand the stretchable urethane film and, even though the dressing may
appear smooth when applied to the patient, it will very quickly contract after
the stretching forces are relieved, thereby causing discomfort to the patient
and irritation to the area surrounding the wound. On weak or damaged skin,
as in the elderly, the stretching forces may even cause abscesses or other skin
damage. 2
One proposed solution to the stretching problem has been to use
heavier or thicker urethane films. Unfortunately, heavier urethane films are
undesirable as a wound dressing due to decreased flexibility and less gas
permeability. Many conventional urethane films are about 1.0 mil or more
thick. Although thinner urethane films will achieve greater gas permeability,
moisture vapor transmission rates and increased flexibility and comfort, use of
such thin films has been unsuccessful because they are relatively fragile and
consequently difficult to work with during manufacture and assembly of the
wound dressing.
Another proposed solution to this problem is to attach a flexible but
non-stretching backing sheet to the urethane film using adhesive. The backing
sheet remains in contact with the urethane film while the dressing is being
applied to the patient, thereby eliminating stretching during application of the
dressing. After the wound dressing has been attached to the patient, the
backing sheet is subsequently peeled from the urethane film. Unfortunately,
methods using adhesive to attach the urethane film to conventional backing
sheets have been unable to handle the fragile and thin urethane films.
Another problem encountered when applying the polyurethane film to
the wound is maintaining the sterility of the dressing during the application
process. Previous products such as a polyurethane film wound dressings
Ensure-IT (Deseret Medical, Inc.) and POLYSKIN® transparent dressing
(Kendall Company, Boston, Massachusetts) required contact between fingers 3
and the adhesive surface of the polyurethane film during application. It will
be appreciated that such contact is undesirable as it may potentially
contaminate the urethane film.
OBJECTS AND SUMMARY OF THE INVENTION
In view of the foregoing, it is an object of the present invention to
provide a wound dressing which provides ease of application while
maintaining sterility of the urethane film and the absorbent pad.
Another object of the invention is to provide a tab system that allows
support of the non-stretchable wound dressing following removal of the
carrier sheet. A related object is to provide a wound dressing having a tab
system that allows manipulation of the wound dressing without contaminating
contact between the sterile urethane film and the user's fingers.
One object of the invention is to provide a wound dressing having a tab
system that permits application of the wound dressing with one hand.
Yet another object of the invention is the coding of the tabs to indicate
the sequential order of utilization of the tabs.
Still another object of the present invention is to provide a wound
dressing having a unique thin urethane film which enhances healing and
maximizes gas permeability with the patient's skin. A more specific object is
to provide a thin urethane film having a thickness of about 1.0 mil or less. 4
It is an object of the present invention to provide a thin film, non-
stretchable wound dressing which can be manufactured by overlying a series
of continuous strips.
In accordance with these objects, the present invention provides a non-
stretchable wound dressing consisting of a thin film of material such as
polyurethane which is less than about 1.0 mil thick, more preferably about
0.75 mils thick, and most preferably less than about 0.75 mil thick. The
wound dressing has a non-stretchable cover sheet, such as MYLAR®, onto
which the urethane film is cast.
The urethane film has an adhesive side and first and second releasable
ends. The adhesive side of the first releasable end receives a first gripping
tab, which extends outboard of the left releasable end of the cover sheet. The
cover sheet and first gripping tab are in adjacent contact with each other but
are not adhesively attached so that they may be freely separated from each
other. A second gripping tab may be attached to the other side of the urethane
film. The adhesive side of the second releasable end receives an intermediate
liner. An absorbent pad is centrally positioned on the urethane film. Finally,
a carrier sheet is attached to the urethane film surrounding the pad. thereby
covering and protecting the sterility of the pad.
In order to apply the wound dressing, the user pulls the first gripping
tab which lifts the combination urethane film/cover sheet from the release
surface of the carrier sheet, thereby exposing the adhesive side of the urethane 5
film. Holding the first tab and, if necessary, the intermediate liner end to
prevent the user's fingers from contacting the urethane film or absorbent pad,
the user places this layered sheet combination over the wound. The cover
sheet prevents the urethane sheet from stretching while permitting the
urethane film to contact and conform to the contours of the patient's skin.
After the combination urethane film/cover sheet has been placed over the
wound, the second gripping tab may be peeled away from the other side of the
urethane film without stretching or wrinkling thereof. The first and second
releasable ends may then be removed, leaving the wound dressing in proper
contact with the patient's skin.
An object of the invention is to provide a method of manufacturing
wound coverings incorporating thin urethane films. In a preferred
embodiment, the thin urethane films are less than about 1.0 thick and in a
more preferred embodiment, about 0.75 mils thick.
DESCRIPTION OF THE DRAWINGS
FIGURE 1 is a top view of a wound dressing in accordance with the
present invention.
FIG. 2 is a cross-sectional view of the wound dressing taken along line
2-2 in FIG. 1.
FIG. 3 is a partially exploded view of the wound dressing shown in
FIG. 2. 6
FIGS. 4-6 are sequential views showing the application of the wound
dressing to a wound. Specifically, FIG. 4 shows the carrier sheet being peeled
away from the layered wound dressing and cover sheet.
FIG. 5 shows the adhesive side of the urethane film placed in adjacent
contact with the patient's skin and the cover sheet being peeled away from the
urethane film.
FIG. 6 shows the ends of the urethane film being pulled away from the
finished wound dressing.
FIGS. 7-11 are sequential schematic views showing one embodiment
of a method for manufacturing the wound dressing. Specifically, FIG. 7
shows a tri-layered sheet consisting of a cover sheet, a thin urethane film, and
an intermediate liner.
FIG. 8 shows the urethane film after removal of a portion of the left
urethane end and a portion of the intermediate liner, and formation of the
urethane first and second releasable ends.
FIG. 9 shows the absorbent pad attached to the adhesive side of the
urethane film.
FIG. 10 shows the first gripping tab attached to the adhesive side of the
first releasable end of the urethane film.
FIG. 11 shows the carrier sheet being positioned into contact with the
adhesive side of the urethane film, and the second tab attached to the cover
sheet. 7
While the invention will be described and disclosed in connection with
certain preferred embodiments and procedures, it is not intended to limit the
invention to those specific embodiments. Rather, it is intended to cover all
such alternative embodiments and modifications as fall within the spirit and
scope of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to the figures, and particularly to FIGS. 1-3, a wound
dressing 10 is provided in accordance with the present invention. The wound
dressing 10 consists of a substantially tri-layered sheet combination 12, the
combination generally consisting of a middle urethane film 14 sandwiched
between an upper cover sheet 16 and a bottom carrier sheet 18 which extend
along substantially the entire length of the wound dressing 10.
The top layer of the wound dressing 10 is a non-stretchable but flexible
cover sheet 16, which is sufficiently flexible so it does not interfere with the
ability of the urethane film 14 to conform to the contour of the patient P. The
cover sheet 16 may be comprised, for example, of MYLAR® polyester film,
but other materials will be known to those skilled in the art.
The bottom layer of the wound dressing 10 consists of a carrier sheet
or bottom liner 18. The carrier sheet 18 is preferably made of plastic, but in
other embodiments may be made of relatively heavy paper. The bottom
carrier sheet 18 has a release side 20 which has means for facilitating release 8
of the urethane film 14 from the carrier sheet 18. In one embodiment, the
release means comprises a silicon release coating on the release side 20, but
other release means and treatments will be known in the art.
In accordance with certain objects of the present invention, the cover
sheet 16 carries a thin urethane film 14 which is preferably less than about 1.0
mil thick, more preferably about 0.75 mil thick and, most preferably, less than
about 0.75 mil thick. The thin urethane film 14 has a greater moisture vapor
transmission rate (MVTR) than conventional relatively thick urethane films
used in wound dressings of the type described herein. It will, of course, be
appreciated that maximizing the MVTR enhances breathability of the wound
dressing 10 and wound healing. The thin film 14 also conforms more
effectively to the contour of a patient's skin and, once applied to the skin,
more effectively flexes in response to movement of the patient's skin than
conventional thick urethane films. The thin film is referred to as a "urethane"
film, but other suitable materials are known in the art. In one embodiment, a
suitable material for the film sheet may be urethane film (medical grade).
In order to handle the relatively fragile thin urethane film 14 during
manufacture, the urethane film 14 is preferably formed or cast directly on the
cover sheet 16. Once cast on the cover sheet 16, the unitary cover sheet 16
and thin urethane film 14 may be used in subsequent manufacturing steps
without stretching, tearing or otherwise destroying the thin urethane 14.
Moreover, unlike many prior wound dressings, it is not necessary to separate 9
the urethane film 14 from a conventional backing sheet or subsequently use
adhesive to attach the cover sheet 16 and urethane film 14 together. When it
is necessary, the cover sheet 16 and urethane film 14 may be removed simply
by pulling the two layers apart, thereby overcoming the attractive forces
which normally keep the two layers together.
As best shown in FIG. 8, the urethane film 14 consists of a middle
portion 22 and two releasable ends which will be generally referenced as first
or left releasable end 24 and second or right releasable end 26. The urethane
film 14 has an adhesive side 28 to which an appropriate conventional adhesive
is applied. As best shown in FIGS. 1 and 10, the middle portion 22 is thus
capable of receiving and carrying an absorbent pad 30 which is centrally
disposed on the wound dressing 10. Referring to FIG. 1, it will be seen that
the illustrated pad 30 has a generally rectangular shape centrally disposed in
the middle of the middle portion 22. It will be appreciated that the outer
periphery of the middle portion 22 remains uncovered so that the adhesive
side 28 may engage the bottom carrier sheet 18, permitting the combination of
the cover sheet 16/urethane film 14 to be releasably attached to the carrier
sheet 18 as best shown in FIGS. 1-2.
Although the absorbent material 30 shown in the figures is rectangular,
it may have any desirable shape including a square, circle, diamond, ellipse or
the like. The absorbent material 30 may be gauze, sponge or other inert
absorbent material which is suitable for absorbing moisture from the wound 10
area. The presence of an absorbent material or a hydrophilic absorbent
material patch not only serves as an absorbent, it also serves as an insulating
material that holds the body's warmth at the wound site. This increased
warmth due to the patch facilitates a more rapid healing of the wound. The
absorbent material 30 may be clear or opaque to conceal the wound area.
Among the hydrophilic absorbent materials which may be suitable are poly
(D-Glucosamine) from Bentech Laboratories and ARASORB™ 720
superabsorbent polymer from Arakawa Chemical Inc., Chicago, Illinois, and
WATERLOCK™ A-222; A- 100, D-212, D-242, G400 and WATERLOCK B,
C and H from Grain Processing Corporation.
In other embodiments, the absorbent material 30 may contain
medication. The medication may be an antibiotic, a healing promoting agent,
an anti-inflammatory agent, a transdermal diffusable pharmaceutical, a
coagulant or an anti-coagulant. Anticipated antibiotics include typical
bacteriostatic and bactericidal agents, anti-fungal and anti-viral agents.
Among the anti-bacterial agents and anti-fungal agents are the penicillins,
streptomycins, sulfuramides, cephalosporins, kanamycins, gentaminicin,
tobramycin, neomycin, paromomycin, chloramphenicol, tetracyclines,
lincomycin, novobiocin, nalidixic acid, rifamycins, polymyxin B,
griseofulvin, pimaricin, cony statin, amphotericin B; and for viruses rifamycin,
nucleic acid analogs, arabinosylthymine, 5-iodo-5'amino-2'-5' dideoxycridine,
arabinosyl adenine, arabinosyl cytosine, acycloguanosine, ribavirin, 11
phosphono acetic acid, and idoxuridine. Among healing promoting agents are
growth promoting hormones, among them epidermal growth factor and
urogastrone. Among the anti-inflammatory agents are the corticosteroids.
Among the transdermal diffusable pharmaceuticals are nitroglycerin, and
other cardiac and blood pressure affecting agents. Among the coagulants are
the blood clotting factors and activators of the intrinsic or extrinsic clotting
pathways. Among the anti-coagulants are heparin, citric acid, protamine
sulfate. and other inhibitors of blood clotting. Also useful as anti-blood
clotting agents are thrombolytic enzymes such as streptokinase and urokinase.
Referring again to FIGS. 2-3, the adhesive side 23 of the left and right
releasable ends 24, 26 are capable of receiving and carrying first tab 32 and an
intermediate liner 34, respectively. The intermediate liner 34, disposed
between the cover sheet 16 and the carrier sheet 18, covers substantially all of
the right releasable end 26 so that the adhesive side 28 of the right releasable
end 34 does not adhere to the carrier sheet 18. The first tab 32, which extends
outboard of the left end of the cover sheet 16, is similarly disposed between
the cover sheet 16 and the carrier sheet and covers substantially all of the left
releasable end 24 so that the adhesive side 28 of the left end 24 does not
adhere to the carrier sheet 18. The faces of the first tab 32 and the
intermediate liner 34 in adjacent contact with the carrier sheet 18 do not carry
an adhesive so that they do not adhere to the release side 20 of the carrier
sheet 18. 12
Means is provided for removing the left and right releasable ends 24,
26 of the urethane film 14 after the wound dressing 10 is applied to a wound.
In the illustrated embodiment, the left releasable end 24 is perforated along
the first or left release line 24a and the right releasable end 26 is scored along
the second or right release line 26a. Thus, the release lines 24a, 26a are
substantially weaker than the remaining urethane film 14 and will tear away
from the middle portion 22 of the urethane film 14. Generally, the perforated
line 24a is slightly stronger than the scored line 26a so that scored line 26a
will be removed first when the two releasable ends 24, 26 are simultaneously
pulled with equal force. Of course, other methods may be used to permit
removal of the two releasable ends 24, 26, including, for example,_scoring or
perforating both release lines.
A second gripping tab or strip 36 may be bonded at one end of the
cover sheet 16 by any suitable adhesive. Referring to FIGS. 1-2, it will be
seen that, in the illustrated embodiment, the second tab 36 and the left end of
the cover sheet 16 are inboard of the first tab 32 so that first tab 32 may be
more easily grasped by a user to separate the combination of the upper cover
sheet 16/urethane film 14 from the bottom carrier sheet 18.
FIGS. 4-6 schematically show the application of a wound dressing 10
made in accordance with the present invention to a wound on a patient P.
Referring first to FIG. 2, it will be appreciated that the first tab 32 is
positioned outboard of the second tab 36 so that the user may more easily 13
grab the first tab 32 without grabbing the second tab 36. In order to apply the
wound dressing 10 to a wound on a patient P, the first tab 32 is gripped and
pulled to facilitate separation of the layered upper urethane film 14/cover
sheet 16 from the bottom carrier sheet 18. The first tab 32, which is not
tacky, is interposed between the adhesive side 28 of the urethane film 14 and
the release surface 20 on the carrier sheet 18 to promote the initial separation
of the urethane film 14 from the carrier sheet 18. In response to the
combination of the release surface 20 and the non-tacky first tab 32, pulling
on the first tab 32 causes release of the urethane adhesive side 28 from the
release surface 20, with the cover sheet 16 still adhering to the opposite side
of the urethane film 14. The user may then grip the first tab 32 and, if
necessary, the intermediate liner 34 to place the remaining combination of the
urethane film 14/cover sheet 16 over the wound of a patient P as generally
shown in FIG. 5. Once the adhesive side 28 of the middle portion 22 of the
urethane film 14 contacts the skin, the adhesive side 28 sticks to the patient's
skin. The user's fingers therefore need never come into contact with the
adhesive layer 28 which will be placed against the patient's skin, thereby
maintaining sterility of the wound dressing 10.
Moreover, the presence of the cover sheet 16 adjacent the thin urethane
film 14 permits the wound dressing 10 to be placed adjacent the patent's skin
and wound without stretching, wrinkling, or tearing the thin and relatively
fragile urethane film 14. The cover sheet 16 is sufficiently flexible so as not 14
to interfere with the ability of the urethane film 14 to conform to the contour
of the patient P. The presence of cover sheet 16 also ensures the even
application of the wound dressing 10 to the patient P surface by promoting
evenly distributed tension between the cover sheet 16 and the urethane film
14, despite the tension created in response to manipulation of the first tab 32.
This even release ensures that the urethane film 14 will not be distorted by
excessive stresses exerted on any one region of the urethane film 14. It will
thus be appreciated that the user must first release non-tacky tab 32 to
overcome the attractive forces between the film 14 and the cover sheet 16.
Once in place, the adhesion of the urethane film 14 to the patient's skin
is greater than the adhesion between the urethane film 14 and the cover sheet
16. Thus, as shown in FIG. 5, the second tab 36 can be pulled to separate the
cover sheet 16 from the urethane film 14, thereby removing the cover sheet 16
and leaving the thin urethane film 14 adhering to the patient P. In order to
promote the initial separation of the cover sheet 16 from the urethane film 14,
it will be seen upon reference to FIG. 3, for example, that the non-tacky first
tab 32 is adjacent to the non-tacky cover sheet 16. In contrast, the right end of
the cover sheet 16 is in adjacent contact with the urethane film 14.
In the illustrated embodiment, the first tab 32 and the intermediate liner
34 are interposed between the adhesive side 28 of the urethane film 14 and the
patient's skin to prevent the releasable end tabs 24, 26 from adhering to the
patient's skin. Accordingly, the user may pull the left releasable end 24 (and 15
first tab 32) and right releasable end 26 (and intermediate liner 34) away from
the wound dressing 10 wherein the release means at the release lines 24a, 26a
facilitates removal of releasable ends 24, 26 without disturbing the wound
dressing 10 or the wound.
It should now be appreciated that the present invention, in accordance
with certain objects of the invention, leaves a finished wound dressing 10
comprising a thin urethane film 14 and absorbent pad 30 on the wound area
without stress areas or microbial contamination of the wound area.
In accordance with certain objects of the present invention, the tabs 32,
36 may bear an indicia indicating the order of use. The first tab 32 may bear
an indicia indicating it is the first tab 32 in the two tab system. Similarly, the
second tab 36 may contain an indicia indicating it is the second tab 36 in the
two tab system. Indicia useful for marking on the two tab system that allow
the error free application of the wound dressing 10 include color codes such
as a blue first tab, a red second tab and a white intermediate liner, or numeric
or alphanumeric references such as 1, 2, 3; I, II, III; A, B, C; Tab 1, Tab 2,
Tab 3; First, Second, Third; Pull First, Pull Second, Pull Third; and the like.
In accordance with other objects of the present invention, this two tab system
allows the application of the wound dressing 10 using only one hand,
particularly valuable for self-application to the hand or arm. Two hands are
used to remove the carrier sheet 18, by holding the first tab 32. The hand
holding the first tab 32 may then apply the wound dressing 10 and remove the 16
flexible cover sheet 16 by pulling on the second tab 36. Finally, the ends 24,
26 of the urethane film 14 may be removed by separating along the release
lines 24a. 26a.
The present invention also meets a long-felt need for a thin film wound
dressing 10 which increases gas permeability which is necessary for increased
healing rates and also patient comfort. This wound dressing 10 can be easily
and safely applied to any type of wound or to an intravenous site. The
transparent construction of the cover sheet 16 and urethane film 14 allow
visual observation of the wound site during application and while on the
patient P. The cover sheet 16 and tabs 32, 34 provide support for the wound
dressing 10 until after application wherein the cover sheet 16 can then be
removed easily using the two tab application system without distorting or
stretching the film sheet affixed to the patient surface or skin. If necessary,
the wound dressing 10 can be applied with one hand. The tabs may be
optionally marked with indicia indicating the order of utilization, thereby
permitting error free application on the first attempt even by the
inexperienced.
FIGS. 7-11 schematically show a method for manufacturing the wound
dressing 10. Generally, the wound dressing may be manufactured using rolls
or webs of material and assembling such webs in successive layers to form
the wound dressing 10. The various components are applied over each other
in connected layers. 17
Referring to FIG. 7, a web of sandwiched thin urethane film 14 may be
made by forming or casting a urethane film 14, having the desired thickness,
on a cover sheet 16 in a conventional manner. The thin urethane film 14
preferably has a thickness of less than about 1.0 mil, more preferably about
0.75 mil, and most preferably less than about 0.75 mil. It will, of course, be
appreciated that, in other embodiments, the thickness of the urethane film 14
may be greater than about 1.0 mil. The cover sheet 16 is preferably made
from a plastic material, but other conventional materials, such as paper, may
be used. The formation process creates sufficient attractive forces to permit
the urethane film and cover sheet to remain in adjacent contact during
subsequent manufacturing steps while permitting a user to manipulate the film
and to peel the film from the cover sheet. It is preferable that the urethane
film and cover sheet be attached to each other without adhesives. However,
in other embodiments, an adhesive may be used to attach the urethane film
and cover sheet in which case, a preformed urethane film must be brought into
adjacent contact with the cover sheet. An adhesive may be applied to the
adhesive side 28 of the urethane film 14 so that an intermediate liner 34 may
be attached to and cover the urethane film 14 for mechanical protection of the
membrane 14 and to protect against contamination during subsequent storage
and processing steps. The sandwiched urethane film 14 is typically formed
into rolls or webs 112. 18
The triple-layered web 112 may subsequently be processed to separate
portions of some of the layers as generally shown in FIG. 8. More
specifically, the intermediate liner and the urethane film are cut and removed
from the left end of the web 112 to form the releasable end 24. The tri-
layered web 112 is subsequently scored and/or perforated at release lines 24a
and 26a to form the left and right releasable ends 24, 26 and to properly size
the middle portion 22 of the wound dressing 10. Referring to FIGS. 8-9, it
will be seen that the remaining portion of the intermediate liner 34 now covers
only the right releasable end 26 of the urethane film 14. The trimmed tri-
layered web 112 is subsequently processed to receive the absorbent pad 30,
the first tab 32 and the carrier sheet 18, as schematically shown in FIGS. 9-10.
Pre-sized absorbent material 30 may be inserted into the predetermined
position on the urethane film 14. Specifically, the cut absorbent pad 30 are
inserted at a predetermined and typically centered position relative to the
release lines 24a, 26a defining the wound dressing 10. The adhesive side 28
of the urethane film 14 securely engages and holds the absorbent pad 30.
A web of the first tab 32 may be pressed into adjacent contact with the
left releasable end 24 of the urethane film 14. More specifically, the right
portion of the first tab 32 (as shown in the figures) is positioned so that it is
substantially adjacent to or slightly outboard of the release line 24a. It is
undesirable for the first tab 32 to be positioned on or inboard of the release
line 24a because it will interfere with the separation of the left releasable end 19
24 from the wound dressing 10. The left portion of the first tab 32 is
positioned outboard of the cover sheet 16. It will be appreciated that the left
releasable end 24 is disposed between the cover sheet 16 and the first tab 32,
but there is nothing between the cover sheet 16 and the left portion of the first
tab 32.
A web of the bottom carrier sheet 18 may be supplied so that the
release side 20 is brought into contact with adhesive side 28 of the urethane
film 14 as schematically shown in FIG. 11. It should now be appreciated that
the carrier sheet 18 is releasably attached to the portions of the adhesive side
28 which are not covered by the absorbent pad 30, thereby securing the carrier
sheet 18 and the urethane film 14 together. Referring to FIG. 11, it will be
seen that the right portion of the carrier sheet 18 liner is slightly inboard of the
right releasable end 26 of the cover sheet 16. The left portion of the carrier
sheet 18 is substantially inboard of the first tab 32.
The second tab 36 may be attached to the top side of the cover sheet
16. It is preferable that the second tab 36 have an adhesive side 28 which is
attached to the left end 24 of the cover sheet 16 as generally shown in FIG.
11, although other methods may apply the adhesive to the upper side of the
cover sheet.
The size ranges of wound dressings 10 can vary from 0.20 x 1.0 inch to
18 x 18 inches. Preferred sizes of wound dressing 10 are 1 " x 3", 2" x 3", 3"
x 4", 4" x 5", 6" x 8", 10" x 12", 12" x 18". 20
Although modifications and changes may be suggested by those skilled
in the art, it is the intention of the inventor to embody within the patent
warranted hereon all changes and modifications as reasonably and properly
come within the scope of his contribution to the art.

Claims

21We claim as our invention:
1. A non-stretching wound dressing for use with a patient
comprising:
a cover sheet having top and bottom sides,
a thin film sheet formed on the bottom side of the cover sheet, the film
sheet having first and second ends and an adhesive side,
a carrier sheet in adjacent contact with the adhesive side of the thin
film sheet,
a first gripping tab separate from and directly attached to one end of the
thin film sheet and disposed between the film sheet and the carrier sheet
for separating the carrier sheet from the film sheet with the cover sheet
remaining affixed to the film sheet, and
a second gripping tab separate from and directly attached to the top
side of the cover sheet and at one end of the cover sheet so that pulling on the
second gripping tab releases the cover sheet from the film sheet with the film
sheet remaining in place on the patient.
2. The wound dressing as set forth in claim 1 wherein the thin film
sheet has a thickness of about 1.0 mil.
3. The wound dressing as set forth in claim 1 wherein the thin film
sheet has a thickness of less than about 1.0 mil. 22
4. The wound dressing as set forth in claim 3 wherein the thin film
sheet has a thickness of about 0.75 mil.
5. The wound dressing as set forth in claim 4 wherein the thin film
sheet has a thickness of less than about 0.75 mil.
6. The wound dressing as set forth in claim 1 comprising an
intermediate liner separate from and directly attached to the adhesive side of
the film sheet and disposed between the film sheet and the carrier sheet to
promote removal of the film sheet and the carrier sheet, and to permit the
wound dressing to be held by the first gripping tab and intermediate liner
without contacting the thin film sheet.
7. The wound dressing as set forth in claim 6 wherein the second
end of the film sheet comprises a releasable end so that the intermediate liner
may be removed after the film sheet has been attached to the patient.
8. The wound dressing as set forth in claim 7 wherein the
releasable end is formed by perforations.
9. The wound dressing as set forth in claim 7 wherein the
releasable end is formed by scoring.
10. The wound dressing as set forth in claim 1 wherein the first end
of the film sheet comprises a releasable end so that the first gripping tab may
be removed after the film sheet has been attached to the patient.
11. The wound dressing as set forth in claim 10 wherein the
releasable end is formed by perforations. 23
12. The wound dressing as set forth in claim 10 wherein the
releasable end is formed by scoring.
13. The wound dressing as set forth in claim 1 wherein the thin film
sheet is polyurethane.
14. The wound dressing as set forth in claim 1 comprising an
absorbent material in adjacent contact with the adhesive side of the film sheet.
15. The wound dressing as set forth in claim 14 wherein the
absorbent material comprises a medication.
16. A method of use of the wound dressing set forth in claim 1
comprising removing the carrier sheet from the wound dressing,
applying the wound dressing to the patient such that the thin film sheet
binds to the patient,
removing the cover sheet from the thin film sheet using the first
gripping tab thereby leaving the thin film sheet on the patient, and
removing the first gripping tab.
17. A method for making a wound dressing comprising:
forming a thin film sheet on a cover sheet wherein the thin film sheet
has an first side and first and second ends,
adding an adhesive layer to a first side of the film sheet,
adding a first gripping tab to the first end of the thin film sheet, and
adding a carrier sheet to the adhesive side of the thin film sheet. 24
18. The method as set forth in claim 17 comprising adding an
intermediate liner to the second end of the thin film sheet between the thin
film sheet and the carrier sheet.
19. The wound dressing as set forth in claim 17 wherein the thin
film sheet has a thickness of about 1.0 mil.
20. The method as set forth in claim 17 wherein the thin film sheet
has a thickness of less than about 1.0 mil.
21. The wound dressing as set forth in claim 20 wherein the thin
film sheet has a thickness of about 0.75 mil.
22. The wound dressing as set forth in claim 21 wherein the thin
film sheet has a thickness of less than about 0.75 mil.
PCT/US1999/002845 1998-02-27 1999-02-10 Thin film wound dressing and method for making same WO1999043279A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CA002321491A CA2321491C (en) 1998-02-27 1999-02-10 Thin film wound dressing and method for making same
EP99906866A EP1058526A4 (en) 1998-02-27 1999-02-10 Thin film wound dressing and method for making same
AU26683/99A AU729366C (en) 1998-02-27 1999-02-10 Thin film wound dressing and method for making same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/032,144 1998-02-27
US09/032,144 US6043406A (en) 1998-02-27 1998-02-27 Thin film wound dressing and method for making same

Publications (1)

Publication Number Publication Date
WO1999043279A1 true WO1999043279A1 (en) 1999-09-02

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PCT/US1999/002845 WO1999043279A1 (en) 1998-02-27 1999-02-10 Thin film wound dressing and method for making same

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US (2) US6043406A (en)
EP (1) EP1058526A4 (en)
AU (1) AU729366C (en)
CA (1) CA2321491C (en)
WO (1) WO1999043279A1 (en)

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Also Published As

Publication number Publication date
CA2321491A1 (en) 1999-09-02
AU729366C (en) 2002-03-21
US6346653B1 (en) 2002-02-12
EP1058526A4 (en) 2006-06-21
AU2668399A (en) 1999-09-15
US6043406A (en) 2000-03-28
AU729366B2 (en) 2001-02-01
CA2321491C (en) 2005-11-29
EP1058526A1 (en) 2000-12-13

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