U.S. patent application number 16/104257 was filed with the patent office on 2019-01-03 for methods and products for reducing tissue trauma using water-absorbing stress-distributing materials.
This patent application is currently assigned to 3M Innovative Properties Company. The applicant listed for this patent is 3M INNOVATIVE PROPERTIES COMPANY. Invention is credited to Stephen E. Krampe, Adolfo Llinas, Patrick J. Parks, Matthew T. Scholz.
Application Number | 20190000436 16/104257 |
Document ID | / |
Family ID | 43607256 |
Filed Date | 2019-01-03 |
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United States Patent
Application |
20190000436 |
Kind Code |
A1 |
Llinas; Adolfo ; et
al. |
January 3, 2019 |
METHODS AND PRODUCTS FOR REDUCING TISSUE TRAUMA USING
WATER-ABSORBING STRESS-DISTRIBUTING MATERIALS
Abstract
Methods and products for protecting tissue of a patient during a
surgical procedure that involve making an incision in the tissue
and retracting the tissue to make a larger opening, wherein the
methods and products use a water-absorbing stress-distributing
layer.
Inventors: |
Llinas; Adolfo; (Bogota,
CO) ; Krampe; Stephen E.; (Maplewood, MN) ;
Scholz; Matthew T.; (Woodbury, MN) ; Parks; Patrick
J.; (Mendota Heights, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
3M INNOVATIVE PROPERTIES COMPANY |
St. Paul |
MN |
US |
|
|
Assignee: |
3M Innovative Properties
Company
|
Family ID: |
43607256 |
Appl. No.: |
16/104257 |
Filed: |
August 17, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13391225 |
Jun 6, 2012 |
10080555 |
|
|
PCT/US2009/054662 |
Aug 21, 2009 |
|
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16104257 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2013/00272
20130101; A61F 2013/4593 20130101; A61F 2013/00182 20130101; A61F
2013/00676 20130101; A61B 2017/00942 20130101; A61B 2046/205
20160201; A61B 90/04 20160201; A61F 2013/15073 20130101; A61B 90/40
20160201; A61F 13/0213 20130101; A61B 17/02 20130101; A61F 13/00038
20130101; A61F 13/00025 20130101; A61B 46/00 20160201; A61F
2013/00306 20130101; A61F 2013/00846 20130101; A61F 13/00029
20130101; A61F 2013/00387 20130101 |
International
Class: |
A61B 17/02 20060101
A61B017/02; A61F 13/00 20060101 A61F013/00; A61B 90/00 20160101
A61B090/00; A61F 13/02 20060101 A61F013/02; A61B 46/00 20160101
A61B046/00 |
Claims
1. A method of protecting tissue of a patient during a surgical
procedure, the method comprising: providing a water-absorbing
stress-distributing layer comprising a hydrogel, a hydrocolloid, or
a combination thereof; wherein the stress-distributing layer has
opposite first and second major surfaces and at least a portion of
the stress-distributing layer is greater than 2 mm thick between
the first and second major surfaces; adhering the
stress-distributing layer to the patient such that it conforms to
the shape of the tissue of the patient; making an incision through
the stress-distributing layer into the tissue; and retracting the
tissue along the incision using a retractor; wherein the
stress-distributing layer undergoes stretching and/or compression
during retraction.
2. The method of claim 1 wherein at least one of the major surfaces
of the stress-distributing layer is attached to a flexible
polymeric film to form a stress-distributing composite, adhering
the stress-distributing layer comprises adhering the
stress-distributing composite to the patient such that the
stress-distributing composite conforms to the shape of the tissue
of the patient, and making an incision comprises making an incision
through the stress-distributing composite into the tissue.
3. The method of claim 1 further comprising: providing a surgical
incise drape comprising a flexible polymeric film having opposite
first and second major surfaces, and a layer of a pressure
sensitive adhesive disposed on at least a portion of one major
surface; adhering the surgical incise drape to the patient; and
attaching the stress-distributing layer to the incise drape;
wherein making an incision comprises making an incision through the
stress-reducing material and the surgical incise drape into the
tissue.
4. The method of claim 1 further comprising: providing a surgical
incise drape comprising a flexible polymeric film having opposite
first and second major surfaces, and a layer of a pressure
sensitive adhesive disposed on at least a portion of one major
surface; adhering the stress-distributing layer to the patient; and
adhering the surgical incise drape to the stress-distributing
layer; wherein making an incision comprises making an incision
through the stress-reducing material and the surgical incise drape
into the tissue.
5. A method of protecting tissue of a patient during a surgical
procedure, the method comprising: providing a flexible polymeric
film having opposite first and second major surfaces; providing a
water-absorbing stress-distributing layer comprising a hydrogel, a
hydrocolloid, or a combination thereof; wherein the
stress-distributing layer has opposite first and second major
surfaces and at least a portion of the stress-distributing layer is
at least 1 mm thick between the first and second major surfaces;
placing the flexible polymeric film and the stress-distributing
layer in contact with one another so that the flexible polymeric
film and the stress-distributing layer are attached together to
form a stress-distributing composite, and the stress-distributing
composite is adhered to the patient such that the
stress-distributing composite conforms to the shape of the tissue
of the patient; making an incision through the stress-distributing
composite into the tissue; and retracting the tissue along the
incision using a retractor; wherein the stress-distributing
composite undergoes stretching and/or compression during
retraction.
6. A method of protecting tissue of a patient during a surgical
procedure, the method comprising: providing a surgical incise drape
comprising a flexible polymeric film having opposite first and
second major surfaces and a pressure sensitive adhesive on at least
a portion of at least one major surface thereof; providing a
free-standing water-absorbing stress-distributing layer comprising
a hydrogel, a hydrocolloid, or a combination thereof; wherein the
stress-distributing layer has opposite first and second major
surfaces; adhering the surgical incise drape to the patient;
adhering the free-standing stress-distributing layer to the
surgical incise drape; making an incision through the incise drape
and the stress-distributing layer into the tissue; and retracting
the tissue along the incision using a retractor; wherein the
surgical incise drape and stress-distributing layer undergo
stretching and/or compression during retraction.
7. The method of any one of the preceding claims wherein the
water-absorbing stress-distributing layer comprises a
hydrocolloid.
8. The method of any one of the preceding claims wherein the
water-absorbing stress-distributing layer is porous.
9. The method of any one of the preceding claims wherein the tissue
of the patient is initially treated with a presurgical skin
preparation.
10. The method of any one of the preceding claims wherein the
tissue of the patient is initially treated with a barrier film.
11. A method of protecting tissue of a patient during a surgical
procedure, the method comprising: providing a presurgical skin
preparation; providing a free-standing water-absorbing
stress-distributing layer comprising a hydrogel, a hydrocolloid, or
a combination thereof, wherein the stress-distributing layer has
opposite first and second major surfaces; treating the patient's
skin with a presurgical skin preparation; adhering the
free-standing water-absorbing stress-distributing layer to the
patient over the area treated with the presurgical skin
preparation; making an incision through the presurgical skin
preparation and the stress-distributing layer into the tissue; and
retracting the tissue along the incision using a retractor; wherein
the presurgical skin preparation and stress-distributing layer
undergo stretching and/or compression during retraction.
12. The method of any one of the preceding claims wherein the
retracting does not displace the stress-distributing layer from the
patient along the incision while undergoing stretching and/or
compression during retraction.
13. The method of any one of the preceding claims wherein the
surgical procedure is a minimally invasive surgical procedure.
14. The method of any one of the preceding claims wherein the
surgical procedure is an open surgical procedure.
15. A kit for use during a surgical procedure to protect tissue of
a patient, the kit comprising: a surgical incise drape comprising a
flexible polymeric film having opposite first and second major
surfaces, a pressure sensitive adhesive disposed on at least a
portion of at least one major surface of the film, and a release
liner disposed on the pressure sensitive adhesive; a
water-absorbing stress-distributing layer having opposite first and
second major surfaces, and a release liner disposed on at least one
of the surfaces; wherein the water-absorbing stress-distributing
layer comprises a hydrogel, a hydrocolloid, or a combination
thereof; and sterile packaging enclosing the surgical incise drape
and stress-distributing layer.
16. A kit for use during a surgical procedure to protect tissue of
a patient, the kit comprising: a water-absorbing
stress-distributing layer having opposite first and second major
surfaces, and a release liner disposed on at least one of the
surfaces; wherein the water-absorbing stress-distributing layer
comprises a hydrogel, a hydrocolloid, or a combination thereof; a
presurgical skin preparation; and sterile packaging enclosing the
stress-distributing layer and the presurgical skin preparation.
17. A kit for use during a surgical procedure to protect tissue of
a patient, the kit comprising: a flexible polymeric film having
opposite first and second major surfaces, a pressure sensitive
adhesive disposed on at least a portion of at least one major
surface of the film, and a release liner disposed on the pressure
sensitive adhesive; a water-absorbing stress-distributing layer
having opposite first and second major surfaces, and a release
liner disposed on at least one of the surfaces; wherein the
water-absorbing stress-distributing layer comprises a hydrogel, a
hydrocolloid, or a combination thereof; a presurgical skin
preparation; and sterile packaging enclosing the surgical incise
drape and stress-distributing layer.
18. A stress-distributing composite adhered to the skin of a
patient, the stress-distributing composite comprising: a
presurgical skin preparation on the skin of the patient; and a
water-absorbing stress-distributing layer having opposite first and
second major surfaces; wherein the water-absorbing
stress-distributing layer comprises a hydrogel, a hydrocolloid, or
a combination thereof; wherein at least a portion of the
stress-distributing layer is at least 1 mm thick between the first
and second major surfaces; wherein the water-absorbing
stress-distributing layer is adhered to the presurgical skin
preparation on the patient's skin.
19. A stress-distributing composite adhered to the skin of a
patient, the stress-absorbing composite comprising: a presurgical
skin preparation on the skin of the patient; a surgical incise
drape comprising a flexible polymeric film having opposite first
and second major surfaces, a pressure sensitive adhesive disposed
on at least a portion of at least one major surface of the film;
and a water-absorbing stress-distributing layer having opposite
first and second major surfaces; wherein the water-absorbing
stress-distributing layer comprises a hydrogel, a hydrocolloid, or
a combination thereof; wherein at least a portion of the
stress-distributing layer is at least 1 mm thick between the first
and second major surfaces; wherein the surgical incise drape is
adhered to the presurgical skin preparation on the patient's skin
by the pressure sensitive adhesive and the water-absorbing
stress-distributing layer is attached to the incise drape on the
surface opposite the pressure sensitive adhesive.
Description
BACKGROUND
[0001] There is a move towards minimally invasive therapy in all
areas of surgery in an effort to accelerate patient recovery,
improve outcomes, and reduce costs. Current efforts in minimally
invasive surgery in orthopedics includes, for example, a single
incision hip replacement process where the incision is
approximately 10 centimeters (cm) in length as opposed to the
approximately 30 cm length used historically. Current literature
refers to the shorter incision as a "reduced incision" process,
with outcomes similar using either length incision; however, tissue
trauma is generally greater with the shorter incision. Tissue
trauma, especially at and near the incisional (i.e., wound) edge,
can be a significant issue in open procedures as well. This tissue
trauma can lead to more prominent scarring.
[0002] Surgical incise drapes are adhesive-coated organic polymeric
drapes that are applied to the patient's skin typically after
applying a presurgical preparation. The practitioner makes the
incision right through the drape. In this manner, on the skin
surface around the incisional site, the drape physically restricts
the migration of bacteria remaining after the surgical prep
procedure. Surgical incise drapes used during such surgeries have
been designed to be very conformable and to have high adherence to
the skin so as to allow surgical skin retraction without the drape
lifting along the incisional edges. However, the materials used for
the film and adhesive have not been designed to protect the skin
from the trauma due to high compressive and/or stretching forces
during tissue retraction which occurs in nearly all procedures to
some degree. These forces, particularly after prolonged retraction
through the surgical procedure, cause capillary blood flow
disruption which can lead to tissue necrosis, significant bruising,
and/or nerve damage with the potential of long term postoperative
pain. Furthermore, prolonged retraction under significant force
also may stretch the skin along the wound edge making reapposition
post surgery difficult. There is a need to reduce such incisional
stress and tissue trauma, thereby providing better patient outcomes
by potentially faster healing and better cosmesis, a potential
reduction in site infections, and possibly reduced post surgery
pain.
SUMMARY
[0003] The present invention is directed to methods and products to
protect tissue during a surgical procedure through the use of a
stress-distributing layer. The use of such a material can assist in
reducing incisional stress and tissue trauma by distributing the
forces caused by retraction over a broad area, thereby providing
the potential for one or more of the following: faster healing;
better cosmesis; reduction in site infections; and reduced post
surgery pain.
[0004] In one embodiment, the present invention provides a method
of protecting tissue of a patient during a surgical procedure,
wherein the method includes: providing a water-absorbing
stress-distributing layer comprising a hydrogel, a hydrocolloid, or
a combination thereof; wherein the stress-distributing layer has
opposite first and second major surfaces and at least a portion of
the stress-distributing layer is greater than 2 mm thick between
the first and second major surfaces; adhering the
stress-distributing layer to the patient such that it conforms to
the shape of the tissue of the patient (wherein the tissue, e.g.,
skin, has typically been treated with a presurgical skin
preparation); making an incision through the stress-distributing
layer into the tissue; and retracting the tissue along the incision
using a retractor; wherein the stress-distributing layer undergoes
stretching and/or compression during retraction.
[0005] For all methods herein, preferably, the stress-distributing
layer does not tear during retraction, and more preferably, it
adheres sufficiently to the patient such that the retraction does
not displace the stress-distributing layer from the patient along
the incision while the stress-distributing layer undergoes
stretching and/or compression.
[0006] In another embodiment, the present invention provides a
method of protecting tissue of a patient during a surgical
procedure, wherein the method includes: providing a flexible
polymeric film having opposite first and second major surfaces;
providing a water-absorbing stress-distributing layer comprising a
hydrogel, a hydrocolloid, or a combination thereof; wherein the
stress-distributing layer has opposite first and second major
surfaces and at least a portion of the stress-distributing layer is
at least 1 mm thick between the first and second major surfaces;
placing the flexible polymeric film and the stress-distributing
layer in contact with one another so that the flexible polymeric
film and the stress-distributing layer are attached together to
form a stress-distributing composite, and the stress-distributing
composite is adhered to the patient such that the
stress-distributing composite conforms to the shape of the tissue
of the patient; making an incision through the stress-distributing
composite into the tissue; and retracting the tissue along the
incision using a retractor; wherein the stress-distributing
composite undergoes stretching and/or compression during
retraction.
[0007] In yet another embodiment, the present invention provides a
method of protecting tissue of a patient during a surgical
procedure, wherein the method includes: providing a surgical incise
drape comprising a flexible polymeric film having opposite first
and second major surfaces and a pressure sensitive adhesive on at
least a portion of at least one major surface thereof; providing a
free-standing water-absorbing stress-distributing layer comprising
a hydrogel, a hydrocolloid, or a combination thereof; wherein the
stress-distributing layer has opposite first and second major
surfaces; adhering the surgical incise drape to the patient
(wherein the tissue of the patient, e.g., skin, has typically been
treated with a presurgical skin preparation); adhering the
free-standing stress-distributing layer to the surgical incise
drape; making an incision through the incise drape and the
stress-distributing layer into the tissue; and retracting the
tissue along the incision using a retractor; wherein the surgical
incise drape and stress-distributing layer undergo stretching
and/or compression during retraction.
[0008] In yet another embodiment, the present invention provides a
method of protecting tissue of a patient during a surgical
procedure, wherein the method includes: providing a presurgical
skin preparation; providing a free-standing water-absorbing
stress-distributing layer comprising a hydrogel, a hydrocolloid, or
a combination thereof, wherein the stress-distributing layer has
opposite first and second major surfaces; treating the patient's
skin with a presurgical skin preparation; adhering the
free-standing water-absorbing stress-distributing layer to the
patient over the area treated with the presurgical skin
preparation; making an incision through the presurgical skin
preparation and the stress-distributing layer into the tissue; and
retracting the tissue along the incision using a retractor; wherein
the presurgical skin preparation and stress-distributing layer
undergo stretching and/or compression during retraction.
[0009] In addition to methods, the present invention provides kits.
One exemplary embodiment of a kit for use during a surgical
procedure to protect tissue of a patient includes: a surgical
incise drape comprising a flexible polymeric film having opposite
first and second major surfaces, a pressure sensitive adhesive
disposed on at least a portion of at least one major surface of the
film, and a release liner disposed on the pressure sensitive
adhesive;
and a water-absorbing stress-distributing layer having opposite
first and second major surfaces, and a release liner disposed on at
least one of the surfaces; wherein the water-absorbing
stress-distributing layer comprises a hydrogel, a hydrocolloid, or
a combination thereof. Typically, the kit includes sterile
packaging enclosing the surgical incise drape and
stress-distributing layer.
[0010] In another embodiment, a kit for use during a surgical
procedure to protect tissue of a patient includes: a
water-absorbing stress-distributing layer having opposite first and
second major surfaces, and a release liner disposed on at least one
of the surfaces; wherein the water-absorbing stress-distributing
layer comprises a hydrogel, a hydrocolloid, or a combination
thereof; and a presurgical skin preparation. Typically, the kit
includes sterile packaging enclosing the stress-distributing layer
and the presurgical skin preparation.
[0011] In yet another embodiment, a kit for use during a surgical
procedure to protect tissue of a patient includes: a flexible
polymeric film having opposite first and second major surfaces, a
pressure sensitive adhesive disposed on at least a portion of at
least one major surface of the film, and a release liner disposed
on the pressure sensitive adhesive; a water-absorbing
stress-distributing layer having opposite first and second major
surfaces, and a release liner disposed on at least one of the
surfaces; wherein the water-absorbing stress-distributing layer
comprises a hydrogel, a hydrocolloid, or a combination thereof; and
a presurgical skin preparation. Typically, the kit includes sterile
packaging enclosing the surgical incise drape and
stress-distributing layer.
[0012] The present invention also provides stress-distributing
composites adhered to the skin of a patient. In one embodiment, the
stress-distributing composite includes: a presurgical skin
preparation on the skin of the patient; and a water-absorbing
stress-distributing layer having opposite first and second major
surfaces; wherein the water-absorbing stress-distributing layer
comprises a hydrogel, a hydrocolloid, or a combination thereof;
wherein at least a portion of the stress-distributing layer is at
least 1 mm thick between the first and second major surfaces;
wherein the water-absorbing stress-distributing layer is adhered to
the presurgical skin preparation on the patient's skin. If desired,
the composite can include an incise drape adhered to the
water-absorbing stress-distributing layer on the patient.
[0013] In another embodiment, a stress-distributing composite
adhered to the skin of a patient includes: a presurgical skin
preparation on the skin of the patient; a surgical incise drape
comprising a flexible polymeric film having opposite first and
second major surfaces, a pressure sensitive adhesive disposed on at
least a portion of at least one major surface of the film; and a
water-absorbing stress-distributing layer having opposite first and
second major surfaces; wherein the water-absorbing
stress-distributing layer comprises a hydrogel, a hydrocolloid, or
a combination thereof; wherein at least a portion of the
stress-distributing layer is at least 1 mm thick between the first
and second major surfaces; wherein the surgical incise drape is
adhered to the presurgical skin preparation on the patient's skin
by the pressure sensitive adhesive and the water-absorbing
stress-distributing layer is attached to the incise drape on the
surface opposite the pressure sensitive adhesive.
[0014] The term "water-absorbing" in the context of a
stress-distributing layer refers to a material (e.g., hydrogel or
hydrocolloid) that will absorb at least 10% of its weight in water
when in the dry form and immersed in 23.degree. C. deionized water
(without a release liner) for 4 hours. Thus, although the
water-absorbing layer may include some material that is not
water-absorbing, the overall layer is water-absorbing.
[0015] The term "hydrogel" as used herein means a polymeric matrix
that is capable of absorbing at least 10% water without dissolving
or disintegrating. Preferred hydrogels are a hydrophilic
crosslinked polymeric matrix.
[0016] The term "hydrocolloid" as used here in means a hydrophobic
polymeric matrix which has dispersed throughout one or more
water-absorbent particulate materials.
[0017] The terms "comprises" and variations thereof do not have a
limiting meaning where these terms appear in the description and
claims.
[0018] The words "preferred" and "preferably" refer to embodiments
of the invention that may afford certain benefits, under certain
circumstances. However, other embodiments may also be preferred,
under the same or other circumstances. Furthermore, the recitation
of one or more preferred embodiments does not imply that other
embodiments are not useful, and is not intended to exclude other
embodiments from the scope of the invention.
[0019] As used herein, "a," "an," "the," "at least one," and "one
or more" are used interchangeably. Thus, for example, a
stress-distributing layer comprising a water-absorbing polymer can
be interpreted to mean that the stress-distributing layer includes
"one or more" water-absorbing materials.
[0020] As used herein, the term "or" is generally employed in its
sense including "and/or" unless the content clearly dictates
otherwise.
[0021] The term "and/or" means one or all of the listed elements or
a combination of any two or more of the listed elements (e.g.,
preventing and/or treating an affliction means preventing,
treating, or both treating and preventing further afflictions).
[0022] Also herein, the recitations of numerical ranges by
endpoints include all numbers subsumed within that range (e.g., 1
to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.).
[0023] The above summary of the present invention is not intended
to describe each disclosed embodiment or every implementation of
the present invention. The description that follows more
particularly exemplifies illustrative embodiments. In several
places throughout the application, guidance is provided through
lists of examples, which examples can be used in various
combinations. In each instance, the recited list serves only as a
representative group and should not be interpreted as an exclusive
list.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 is a cross-section of one embodiment of the invention
including a stress-distributing layer disposed on a release
liner.
[0025] FIGS. 2a and 2b are cross-sections of two embodiments of the
invention including a stress-distributing layer disposed on a
flexible polymeric film.
[0026] FIGS. 3a and 3b are cross-sections of two embodiment of the
invention including a stress-distributing layer having a
non-uniform thickness.
[0027] FIG. 4 is a representation of a kit containing an incise
drape and a stress-distributing layer.
[0028] FIG. 5a is a photograph of a patient hip covered with an
incise drape.
[0029] FIG. 5b is a photograph of a hydrocolloid dressing
(indicated by arrows) applied over the incise drape shown in FIG.
5a.
[0030] FIG. 5c is a photograph of an incision made into the tissue
of the patient's hip through the incise drape and hydrocolloid
dressing shown in FIG. 5b.
[0031] FIG. 6 (Comparative) is a photograph of a retracted incision
using a surgical incise drape.
[0032] FIG. 7 is a photograph of a retracted incision using a
surgical incise drape and a stress-distributing layer of the
present invention.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0033] The present invention is directed to methods and products
for protecting tissue affected by the surgical procedure (e.g., the
skin and underlying tissue of a patient) during a surgical
procedure that involves making an incision in the tissue and
retracting the tissue to make a larger opening. Such methods and
products use a stress-distributing layer. Although minimally
invasive surgical procedures, which typically involve retraction
that can result in significant trauma, can benefit from the methods
and products of the present invention, a wide variety of surgical
procedures can benefit from the present invention. The surgical
procedure can be of a wide variety of procedures that involve
retraction and significant trauma, particularly when automatic
retraction devices (e.g., hand-held retractors, inserted
retractors) and/or leverage is required in the retraction process
(e.g., for removing bones or portions thereof). Such procedures can
be minimally invasive or open, including, for example, transplant
surgeries (e.g., liver transplant), cardiovascular surgeries,
Caesarian sections, and anteroposterior repair (for colorectal
cancer), and hernia repair.
[0034] Specifically, the methods and products involve the use of
stress-distributing layer in a surgical procedure to protect the
tissue (e.g., skin) of a patient. The stress-distributing layer is
water-absorbing as a result of it including a hydrogel, a
hydrocolloid, or a combination thereof. In the methods of the
invention, this stress-distributing layer is adhered to the patient
such that it conforms to the shape of the tissue of the patient. To
accomplish this, the stress-distributing layer can be an inherently
tacky material and directly adhered to the tissue. Alternatively,
it can be adhered to the tissue through a pressure sensitive
adhesive. Alternatively, the stress-distributing layer can be
adhered to an incise drape, which can be adhered to the patient.
Whatever method or mechanism is used to adhere the
stress-distributing layer to the tissue of a patient, methods of
the invention include making an incision through the
stress-distributing layer into the tissue, and retracting the
tissue, wherein the stress-distributing layer undergoes stretching
and/or compression during the retraction. Typically, at least a
portion of the stress-distributing layer is positioned between the
retractor and the tissue, and preferably, the stress-distributing
layer is not torn during retraction. More preferably, the
stress-distributing layer adheres sufficiently to the tissue such
that retracting does not displace the stress-distributing layer
from the patient along the incision while undergoing stretching
and/or compression.
[0035] In certain embodiments, the methods and products involve the
use of a flexible polymeric film, preferably in the form of an
incise drape, and a stress-distributing layer. These materials are
attached together (either before (by the manufacturer or
practitioner) or during the surgical procedure) and adhered to
tissue (e.g., skin) during the surgical procedure. Although these
materials can be opaque, they are preferably sufficiently clear
(transparent or translucent) to allow the practitioner to visualize
the underlying tissue through the flexible polymeric film and the
stress-distributing layer. Methods of the invention involve making
an incision through the flexible polymeric film, the
stress-distributing layer if present, and tissue, and retracting
the incision to allow the practitioner (e.g., surgeon) better
access to the underlying body structures. Typically, at least a
portion of the flexible polymeric film (if present) and
stress-distributing layer is positioned between the retractor and
the tissue and the tissue, flexible polymeric film, and
stress-distributing layer are all retracted, wherein retracting
stretches and/or compresses the flexible polymeric film and
stress-distributing layer.
[0036] Although not intending to be limiting, it is believed that
the stress-distributing layer absorbs, spreads out, and/or
diminishes the force per unit are (pressure) applied by the
retractor, thereby reducing pressure on the capillary bed,
particularly at skin folds. The reduced pressure also may relieve
other potential tissue trauma. For example, it may prevent the
tissue from stretching by reinforcing the tissue. This can result
in one or more of the following: faster healing; better cosmesis;
reduction in site infections; and reduced post surgery pain. It may
also facilitate and speed closure by preventing distention of the
tissue along the wound edge. Thus, the stress-distributing layers
used herein are designed to protect the skin and underlying tissue
from the trauma due to high compressive and/or stretching forces
during tissue retraction, which occurs in nearly all procedures to
some degree.
[0037] The stress-distributing layer can be used with or without a
flexible polymeric film, although using both is generally
preferred. That is, for example, a stress-distributing layer can be
applied to the tissue (e.g., skin) of the patient, which is
typically first treated with a presurgical skin preparation.
Alternatively, a stress-distributing layer can be applied to a
flexible polymeric film, such as an incise drape, which is
typically first applied to the tissue of the patient after being
treated with a presurgical skin preparation. Alternative methods of
use of the stress-distributing layer are also envisioned as further
described herein.
[0038] The stress-distributing layer can be provided as a single
layer 10 of a stress-distributing material, which can be disposed
on a release liner 12, for example, as shown in FIG. 1. A release
liner may be on one or both major surfaces of the
stress-distributing layer. The stress-distributing layer may be
inherently tacky and/or it may include a layer of a pressure
sensitive adhesive thereon.
[0039] Alternatively, as shown in FIG. 2a, a flexible polymeric
film and stress-distributing layer can be provided as a
stress-distributing composite in which the stress-distributing
layer 20 is disposed on (e.g., by coating or extruding) a surface
of the flexible polymeric film 22. In this embodiment, the flexible
polymeric film 22 may or may not include a layer of a pressure
sensitive adhesive 24 on the surface of the flexible polymeric film
22 opposite that on which the stress-distributing layer 20 is
disposed. The embodiment shown in FIG. 2a would typically be
applied to a patient using the pressure sensitive adhesive 24
resulting in the flexible polymeric film being disposed between the
tissue of the patient and the stress-distributing layer.
[0040] Or, as shown in FIG. 2b, a flexible polymeric film and
stress-distributing layer can be provided as a stress-distributing
composite in which the stress-distributing layer 20 is disposed on
(e.g., by coating or extruding) a surface of the flexible polymeric
film 22. In this embodiment, the stress-distributing layer 20 may
or may not include a layer of a pressure sensitive adhesive 24 on
the surface of the stress-distributing layer 20 opposite that on
which the flexible polymeric film 22 is disposed. The embodiment
shown in FIG. 2b would typically be applied to a patient using the
pressure sensitive adhesive 24 resulting in the stress-distributing
layer being disposed between the tissue of the patient and the
flexible polymeric film.
[0041] The stress-distributing layer and flexible polymeric film of
FIGS. 2a and 2b may be attached together directly (without any
intervening materials) or through the use of a pressure sensitive
adhesive, for example. They may be of the same size, or as shown in
FIGS. 2a and 2b, the flexible polymeric film 22 may be larger in
area than that of the stress-distributing layer 20. In each of the
figures presented herein, the relative sizes (e.g., thicknesses and
lengths) of the layers/films are not necessarily in relative
proportion.
[0042] Although the stress-distributing layer is shown in FIGS. 1,
2a, and 2b as having a uniform thickness (between the two major
surfaces), the thickness may vary along the length of the material.
For example, as shown in FIGS. 3a and 3b, the stress-distributing
layer may be thicker at the center and thinner (e.g., tapered as
shown in FIG. 3a) at the edges.
[0043] In some embodiments, the flexible polymeric film and
stress-distributing layer can be provided as two separate articles
in a kit (FIG. 4). For example, a kit 40 can include, within
sterile packaging 41, a surgical incise drape including a flexible
polymeric film 43, a layer of a pressure sensitive adhesive 44, and
a release liner 45, and a stress-distributing layer 46 can include
such layer disposed on a release liner 48. Such stress-distributing
layer can be a commercially available wound dressing, for example.
That is, the stress-distributing layer can be provided in the form
of a commercially available wound dressing containing a
water-absorbing material in combination with a commercially
available surgical incise drape. These two separately provided
articles can then be attached together by the practitioner either
before surgery or during surgery. This allows for the practitioner
to apply the flexible polymeric film (e.g., surgical incise drape)
where desired, and then place the stress-distributing layer (e.g.,
wound dressing) anywhere on the polymeric film.
[0044] In some embodiments, the stress-distributing layer and a
presurgical skin preparation can be provided as two separate
articles in a kit. In other embodiments, the flexible polymeric
film, presurgical skin preparation, and stress-distributing layer
can be provided as separate articles in a kit. Such kits are
typically packaged in sterile packaging.
[0045] Thus, when provided for surgeries, the various articles
(flexible polymeric film, stress-distributing layer, incise drape,
etc.) used herein are sterile. Herein sterilization can be carried
out by any means typically used in the medical industry industry
(e.g., by sterilizing gas such as ethylene oxide or hydrogen
peroxide, by heat, or other radiation techniques such as X-ray,
gamma ray, electron beams, etc.).
[0046] Again, although a stress-distributing layer can be used
alone, it is typically used together with a flexible polymeric
film. The flexible polymeric film (e.g., surgical incise drape) is
typically disposed between the stress-distributing layer and the
tissue (e.g., skin) of the patient for best results. It is
envisioned, however, that the stress-distributing layer can be
disposed between the flexible polymeric film and the tissue. The
latter is less desirable, however, because this could result in
gaps between the flexible polymeric film and the tissue, which
could result in undesirable fluid collection.
Flexible Polymeric Films
[0047] Useful flexible polymeric films are preferably transparent
or translucent polymeric material. The material of the flexible
films preferably allows for moisture evaporation through the film
during prolonged surgeries. Flexible polymeric films of the present
invention are typically provided in the form of incise drapes. The
flexibility is sufficient for the film to conform to body parts of
the patient.
[0048] Incise drapes are commonly used in surgical procedures to
minimize exposure of the surgical wound to bacterial contamination
from bacteria on the patient's skin. Draping of the surgical site
provides a sterile work surface and helps minimize the transfer of
microorganisms between non-sterile areas and the surgical wound.
These measures also may help protect health care professionals from
exposure to pathogens in the patient's blood and other body fluids.
Incise drapes also may be employed to hold other articles such as
fabric drapes securely to the operative site.
[0049] For proper functioning of a surgical incise drape, the
incise drape is wrinkle-free after it is applied, especially
directly at the incision point in order for the practitioner (e.g.,
surgeon) to be able to make a clean surgical incision. Wrinkles in
the drape make it difficult for the practitioner to see through to
the skin (transparency or translucency and visibility are
desirable, but not required). Furthermore, if the incise drape
includes wrinkles, the incise drape may not prevent bacteria on the
skin from getting into the wound due to fluid channeling under the
drape in these wrinkles. Maintaining a sterile surface at the point
of incision helps prevent surgical wound infections.
[0050] The flexible polymeric film of an incise material is usually
a clear polymeric film with an adhesive on one side that is covered
with a release liner. Examples of suitable incise drapes include
those available under the tradenames STERI-DRAPE and IOBAN from 3M
Company, St. Paul, Minn. Such drapes are substantially clear
(transparent or translucent) and include a flexible film with one
major surface coated with a pressure sensitive adhesive that
adheres securely to incisional edges (i.e., wound edges), which
assists in maintaining the barrier to skin flora. Such drapes
conform to the body contours. Other incise drapes are available
from suppliers such as T.J. Smith and Nephew Ltd., Medline, and
Cardinal, for example. Suitable incise drapes are described, for
example, in U.S. Pat. Nos. 4,310,509; 4,323,557; 4,452,845;
4,584,192; 5,803,086; 5,979,450; 5,985,395; 6,939,936; Re. 31,886;
and Re. 31,887.
[0051] Typically incise drapes are formed from a transparent or
translucent flexible polymeric material. The material preferably
allows for moisture evaporation through the film during prolonged
surgeries. Particularly suitable materials for incise drapes
include polyolefins, such as low density polyethylene and
particularly metallocene polyethylenes (e.g., that available under
the tradename ENGAGE polyethylenes from Dow Chemical Co.),
polyurethanes such as polyester or polyether polyurethanes (e.g.,
that available under the tradename ESTANE thermoplastic
polyurethane from B.F. Goodrich, Cleveland, Ohio), polyesters such
as polyether polyester (e.g., that available under the tradename
HYTREL polyester elastomer from Du Pont Co., Wilmington, Del.), and
polyamides such as polyether polyamides (e.g., that available under
the tradename PEBAX Resins from ELF Atochem, North America, Inc.,
Philadelphia, Pa.). Furthermore, the film is flexible, and
preferably somewhat elastomeric, to improve conformability when
applied to a patient. For these reasons, the preferred films are
polyurethanes, polyether polyesters, and polyether polyamides. The
film will typically have a thickness of no greater than 200
microns, often no greater than 130 microns, and even more often no
greater than 52 microns. The film will typically have a thickness
of at least 6 microns, and often at least 13 microns.
[0052] In certain embodiments, at least a major portion of at least
one surface of the flexible film is coated with a pressure
sensitive adhesive. Although the entire length of the flexible film
is coated with the adhesive, any major portion may be coated that
allows the surgical incise drape to serve its useful function,
e.g., the adhesive need not coat the entire width or length of the
drape. For example, non-coated portions may be included at any of
the edges of the flexible film to assist in removal of the drape
from the patient or to assist in attachment of a handle to the
film. The adhesive coating the flexible film is preferably a tacky
pressure sensitive adhesive at body temperature that will adhere
aggressively to the skin. Uniform attachment to the skin surface
helps maintain a sterile surgical field. Aggressive adhesives are
preferred due to the stress the film is under during surgery as a
result of the retraction of the wound (i.e., incision), the warm
moist environment, and the abrasion the film may encounter as the
surgeon's hands and instruments move in and out of the wound.
[0053] Suitable pressure sensitive adhesives are skin compatible
and include those described, for example, in U.S. Pat. Nos.
4,310,509, 4,323,557, 6,216,699, and 5,829,422, as well as PCT
publication Nos. WO 00/56828 and WO 00/78885. Suitable pressure
sensitive adhesives include a polymeric resin composition that can
be coatable, for example, by a hot melt process, the components of
which are selected to provide the desired adhesive properties of
the ultimate adhesive composition. Examples of pressure sensitive
adhesive compositions useful in the present invention include, for
example, those based on natural rubbers, synthetic rubbers, styrene
block copolymers including but not limited to
Styrene-Isoprene-Styrene (SIS), styrene-butadiene, styrene-isoprene
and derivatives thereof such as those available from Kraton
Polymers under the KRATON tradename, polyvinyl ethers, poly
(meth)acrylates (including both acrylates and methacrylates),
polyolefins such as polyalpha olefins, silicones, and blends or
mixtures thereof. Particularly preferred adhesive compositions are
based on poly(meth)acrylates (including both acrylates and
methacrylates). The polyacrylates may also comprise other vinylic
non-acrylate monomers such as but not limited to N-vinyl lactams,
(meth)acrylamides, styrene, methylvinyl ether, polystyrene
macromers, vinyl acetate, and the like. The pressure sensitive
adhesive will typically have a thickness of no greater than 200
microns, often no greater than 150 microns, more often no greater
than 100 microns, and even more often no greater than 50 microns.
The pressure sensitive adhesive will typically have a thickness of
at least 10 microns, often at least 20 microns, and even more often
at least 30 microns.
[0054] The pressure sensitive adhesive may be made from a
formulation of polymers that is inherently tacky. If desired,
tackifiers may be added to a base polymeric formulation to form the
pressure sensitive adhesive. Useful tackifiers include, for
example, rosin ester resins, aromatic hydrocarbon resins, aliphatic
hydrocarbon resins, and terpene resins. Other materials can be
added for special purposes, including, for example, oils,
plasticizers, antioxidants, ultraviolet ("UV") stabilizers,
hydrogenated butyl rubber, pigments, dyes, hydrocolloid particles
such as those used in bioadhesive compositions and wound dressings
disclosed in U.S. Pat. Nos. 5,750,134 and 5,633,010, additional
antimicrobial agents, antioxidants, and curing agents.
[0055] Some incise drapes, such as that available under the
tradename IOBAN, contain an antimicrobial agent, preferably
iodophor, in the adhesive. The addition of antimicrobials to the
drape adhesive provides the added benefit of helping to further
minimize the potential of surgical infections by the maintenance of
a bactericidal/bacteriostatic environments against the skin to
greatly reduce the number of bacteria. Suitable optional
antimicrobial agents are described, for example, in U.S. Pat. No.
5,369,155, at column 12, lines 32-39, which includes iodine and
iodophors. For example, such antimicrobial agents that may
optionally be incorporated in the pressure sensitive adhesive
include alpha-hydroxyacids, such as but not limited to lactic acid,
malic acid, citric acid, 2-hydroxybutanoic acid, 3-hydroxybutanoic
acid, mandelic acid, gluconic acid, tartaric acid, as well as
derivatives thereof (e.g., compounds substituted with hydroxyls,
phenyl groups, hydroxyphenyl groups, alkyl groups, halogens, as
well as combinations thereof); betahydroxyacids such as salicylic
acid; C8-C18 fatty acids; C8-C18 unsaturated fatty acids; C8-C18
alkyl lactylates and their salts; C8-C18 sulfonic acids and there
salts; quaternary ammonium surfactants having at least one alkyl
chain of at least 8 carbon atoms and/or a benzyl group;
parachlorometaxylenol (PCMX); triclosan; hexachlorophene; fatty
acid monoesters of glycerin and propylene glycol, such as but not
limited to glycerol monolaurate, glycerol monocaprylate, glycerol
monocaprate, propylene glycol monolaurate, propylene glycol
monocaprylate, propylene glycol monocaprate; phenols;
polyquaternary amines, such as but not limited to polyhexamethylene
biguanide; chlorhexidine salts; benzethonium halides and
derivatives such as methylbenzethonium chlorides; quaternary
ammonium silanes having at least one alkyl chain of at least 8
carbon atoms; silver and silver salts, such as but not limited to
silver chloride, silver oxide, and silver sulfadiazine; methyl,
ethyl, propyl, and butyl parabens; octenidene; compounds that
generate hydrogen peroxide such as perborates, complexes of
hydrogen peroxide with polyvinylpyrrolidone (e.g., Peroxydone from
ISP), natural oils such as tea tree oil, grape fruit seed extract,
and the like, as well as combinations thereof.
[0056] Drapes typically have a release liner against the adhesive
to protect the sterile adhesive surface prior to use. The release
liner could be made of a variety of materials such as paper,
plastic coated paper, plastic film, woven, non-woven, or knit
textiles, as well as film textile laminates. Preferred release
liner materials include clear polymeric liners that allow the
clinician to see through to the patient and thus accurately place
the film. Preferred clear polymeric liners include polyolefins such
as polyethylene and polypropylene, or polyester liners, as well as
laminates such as polyolefin coated polyester. For products
intended for gamma sterilization, use of a paper, polyethylene,
polyester, or polyethylene coated polyester liner is preferred.
[0057] For those drapes wound onto themselves without release
liners, the flexible films are usually treated on the back side
with a release coating such as silicone. If used such that the
stress-distributing layer is disposed on the back side of the
flexible film, no release coating would typically be used, thereby
ensuring good adhesion between the film and the stress-distributing
layer.
[0058] The flexible film may also be treated prior to coating of
the pressure sensitive adhesive thereon to enhance the adhesion of
the adhesive to the flexible film substrate. Treatments useful for
enhancing the adhesion of a pressure sensitive adhesive and/or the
stress-distributing layer to the flexible film include chemical
priming and corona treatment.
Stress-Distributing Layers
[0059] Stress-distributing layers suitable for use in the present
invention include water-absorbing materials such as hydrogels,
hydrocolloids, or combinations thereof. Such stress-distributing
layers can include a high fluid content (as with a hydrogel), or
they can be capable of absorbing a high fluid content (as with a
hydrocolloid). The stress-distributing layer can be in the form of
a free-standing layer (i.e., a layer of sufficient integrity it
does not need to be disposed on a flexible polymeric film, for
example, although it can optionally be protected by one or more
release liners of the type often used on pressure sensitive
adhesives), or as a layer attached to (e.g., coated or extruded on)
the flexible polymeric film (e.g., that of an incise drape). The
stress-distributing layer can be provided as a portion of a
separate article (e.g., a water-absorbing layer coated on a film or
sandwiched between two films, as in a wound dressing), with
opposite first and second major surfaces.
[0060] In general, the stress-distributing layers are sufficiently
compliant to conform to contours of the body, such as hips or
shoulders. Also, the stress-distributing layer has sufficient
cohesiveness and integrity such that it does not crumble, or
otherwise come apart during use, thereby leaving particulate in the
incision site.
[0061] Either the stress-distributing layers are inherently tacky,
or they are compatible with a pressure sensitive adhesive to
provide excellent attachment to the underlying tissue, to skin
preparation coatings left in place on the skin to reduce bacterial
counts, and/or to the flexible polymeric films (e.g., surgical
drapes that are attached directly to the tissue). If a pressure
sensitive adhesive is used in combination with the
stress-distributing layer (e.g., as a coating on the
stress-distributing layer or a film to which the
stress-distributing layer is attached), it can be of the same type
as that described herein for surgical incise drapes.
[0062] Ideally the stress-distributing layer is clear to allow
visualization of body landmarks and the site where the incision
will be made, although opaque materials can be used. Slight
coloration may be added, however, preferably it is slight in order
to allow good visualization of the site. The material is also
preferably cut easily by a scalpel and allows for penetration
through it such that it does not bind the scalpel while creating
the incisional opening.
[0063] During retraction, the edges of the stress-distributing
layer, and the optional flexible polymeric film, preferably roll
into the incision while not tearing. More preferably, the
stress-distributing layer, does not form a gap or space between it
and the underlying tissue and/or the optional flexible polymeric
film. That is, preferably, the stress-distributing layer and the
flexible polymeric film, if used, are not displaced from the edges
of the tissue along the incision (i.e., the incisional edges).
These gaps or spaces allow irrigation or body fluids to collect
which may increase the potential for infection.
[0064] Stress-distributing layers suitable for incisional stress
redistribution preferably include those materials that have no
biocompatibility issues with the body. Typical biocompatibility
testing includes the determination of cytotoxicity, sensitization,
irritation, genotoxicity, acute system toxicity, hemocompatibility,
and subchronic toxicity among other tests. These tests insure that
the materials used in the product are not injurious to the patient,
that the materials do not cause negative responses when in contact
with body cells and that any material which leaches from the
product due to surgical irrigation or body fluid contact do not
cause systemic toxic effects.
[0065] The stress-distributing layers may be solid or porous.
Porosity may be desirable to allow moisture to evaporate through
the material. Porosity can be imparted by, for example, making the
stress distributing material an open cell foam. Alternatively,
closed cell foams and solid layers of stress-distributing materials
may have through-holes in the material. For example, some materials
can be extruded onto a belt having pins from which it is
subsequently removed to leave holes. Alternatively, holes may be
punched, drilled, burned (e.g., by a laser), or otherwise formed.
The holes may extend through the adhesive coating or not.
[0066] Suitable stress-distributing layers useful in the methods
and products of the present invention include water-absorbing
polymers--hydrogels, hydrocolloids, or combinations thereof. The
term "water-absorbing" in the context of a stress-distributing
layer refers to a layer (including hydrogel and/or hydrocolloidal
polymers) that will absorb at least 10% of its weight in water when
in the dry form and immersed in 23.degree. C. deionized water
(without a release liner) for 4 hours. That is, although the
stress-distributing layer may be applied in a hydrated form, when
it is in a non-hydrated or dry form, it will absorb at least 10% of
its weight in water.
[0067] Hydrogels are typically applied in their hydrated form to
allow for sufficient conformability. Hydrocolloids are typically
applied in their dry form as they are sufficiently conformable
without being in their hydrated form, although they can also be
applied in a hydrated form. In some instances, a hydrocolloid may
need to be are warmed to make it more compliant. Preferred
materials are the hydrocolloids typically because they generally
have more integrity than the hydrogels.
[0068] Suitable hydrogel materials are discussed in "Advanced Drug
Delivery Reviews," 43(2002), 3-12 and include both natural and
synthetic polymers and derivatives. Natural components include
hyaluronic acid, alginic acid, pectin, carrageenan, chondroitin
sulfate, dextran sulfate, chitosan, polylysine, collagen, fibrin,
carboxymethyl chitin, dextran, agarose, lecithin, polysaccharides,
and polysaccharide-based materials among others. Synthetic polymers
and components include acrylate and methacrylate-based hydrogels,
such as poly(2-hydroxyethyl methacrylate) (polyHEMA),
HEMA-methacrylic acid copolymers, HEMA-2-(N,N-diethylamino)ethyl
methacrylate (DEAEMA) copolymers, HEMA-methyl acrylate, HEMA-butyl
acrylate, HEMA-methyl methacrylate, HEMA-N-vinyl-2-pyrrolidone;
acrylamide-based hydrogels, such as polyacrylamide,
poly(N-isopropyl acrylamide) (PNIPAAm)-acrylic acid,
acrylamide-N-vinyl-2-pyrrolidone copolymers, acrylamide-acrylic
acid-acrylonitrile terpolymers, N-(2-hydroxypropyl)methacrylamide;
silicone polymers; and 2-acrylamido-2-methanepropane sulfonic acid
(AMPS); and the like. A considerable number of other monomers may
be reacted to these and other hydrophilic monomers to modify
mechanical properties such as tensile and elongation, or adjust the
balance of hydrophilicity/hydrophobicity.
[0069] Combinations of hydrogel materials to form interpenetrating
networks or combining natural and synthetic polymers are also
possible. A variety of crosslinking mechanisms such as
copolymerization with di- and tri- functional monomers, radiation
crosslinking with e-beam or gamma radiation, or the use of metal
salts to crosslink charged hydrogels or water soluble polymers such
as poly(vinyl alcohol) is possible.
[0070] Examples of suitable hydrogel films are disclosed, for
example, in U.S. Pat. No. 477,943. Examples of water-absorbing
polymers suitable to form stress-distributing layers include, for
example, hydrogels based on polyurethane (such as those described
in U.S. Pat. Nos. 3,822,238; 3,975,350; and 4,454,309), or
polyacrylonitrile (such as those described in U.S. Pat. Nos.
4,420,589; 4,369,294; and 4,379,874).
[0071] Examples of suitable hydrocolloid films include hydrocolloid
adhesive compositions that are often used as wound dressings.
Typically, these compositions comprise a blend of a polymer matrix,
such as a rubbery elastomer like polyisobutylene, in combination
with one or more water-soluble or water-swellable hydrocolloids,
such as a dry powdered mixture of pectin, gelatin and
carboxymethylcellulose.
[0072] A hydrocolloid composition can be used by applying it
directly to the flexible polymeric film prior to surgery (e.g., as
in a coating or extruding method during manufacturing).
Alternatively, it can be provided in a form that allows it to be
attached to the flexible polymeric film during surgery. For
example, it could be provided as a free-standing layer with one or
more release liners attached thereto, or it could be coated on at
least one surface of a water-insoluble film to form an article
similar to commercially available wound dressings.
[0073] Commercially available examples of hydrocolloid wound
dressings that can be used in methods of the present invention to
provide the stress-distributing layer include those available under
the tradenames DUODERM and DUODERM EXTRA-THIN wound dressings
(products of Convatec, Squibb and Sons, Inc., Princeton, N.J.;
believed to be a KRATON-based composition); TEGASORB wound dressing
(a product of 3M Company, St. Paul, Minn.; a polyisobutylene-based
composition); RESTORE wound dressing (a product of Hollister, Inc.,
Libertyville, Ill.; believed to be an ethylene vinyl acetate
(EVA)-based composition); and COMFEEL wound dressing (a product of
Coloplast International, Espergaerde, Denmark; believed to be a
KRATON-based composition). Other suitable hydrocolloids include
those disclosed in U.S. Pat. Nos. 4,231,369; 4,477,325; 4,551,490;
4,738,257 and 5,633,010.
[0074] Depending on the material and its properties (e.g.,
modulus), the thickness of the stress-distributing layer may vary.
The material may also be crosslinked (e.g., by chemical or
radiation means), which can affect the softness or stiffness of the
material.
[0075] The material of the stress-distributing layer may be
inherently tacky. The elasticity of a pressure sensitive adhesive
may be utilized by coating a thick film form to prepare a
stress-distributing layer. Hot melt, solution, emulsion, or
radiation curable techniques are exemplary coating methods. Hot
melt or radiation curable systems are particularly useful in that
drying of a solvent is not necessary to form the thick layers. In
some examples, the delivery system for the stress-distributing
layer is a simple release liner to protect the tacky surface.
Alternatively, a thin, adhesive-coated polymeric backing extended
beyond the edges of the stress-distributing layer can be used to
form a border that will adhere, for example, to the skin and/or
flexible polymeric film (e.g., incise drape) and provide a barrier
to outside contamination.
[0076] The top surface of the stress-distributing material
preferably has a matte finish to prevent reflection and glare which
may be distracting to the surgeon and nurses.
[0077] In some embodiments, the stress-distributing layer can
contain an antimicrobial agent. The addition of antimicrobials to
the stress-distributing layer provides the added benefit of helping
to further minimize the potential of surgical infections by the
maintenance of bactericidal/bacteriostatic environments against the
skin to greatly reduce the number of bacteria. Suitable optional
antimicrobial agents are described, for example, in U.S. Pat. No.
5,369,155, at column 12, lines 32-39, which includes iodine and
iodophors. For example, such antimicrobial agents that may
optionally be incorporated in the pressure sensitive adhesive
include alpha-hydroxyacids, such as but not limited to lactic acid,
malic acid, citric acid, 2-hydroxybutanoic acid, 3-hydroxybutanoic
acid, mandelic acid, gluconic acid, tartaric acid, as well as
derivatives thereof (e.g., compounds substituted with hydroxyls,
phenyl groups, hydroxyphenyl groups, alkyl groups, halogens, as
well as combinations thereof); betahydroxyacids such as salicylic
acid; C8-C18 fatty acids; C8-C18 unsaturated fatty acids; C8-C18
alkyl lactylates and their salts; C8-C18 sulfonic acids and there
salts; quaternary ammonium surfactants having at least one alkyl
chain of at least 8 carbon atoms and/or a benzyl group;
parachlorometaxylenol (PCMX); triclosan; hexachlorophene; fatty
acid monoesters of glycerin and propylene glycol, such as but not
limited to glycerol monolaurate, glycerol monocaprylate, glycerol
monocaprate, propylene glycol monolaurate, propylene glycol
monocaprylate, propylene glycol monocaprate; phenols;
polyquaternary amines, such as but not limited to polyhexamethylene
biguanide; chlorhexidine salts; benzethonium halides and
derivatives such as methylbenzethonium chlorides; quaternary
ammonium silanes having at least one alkyl chain of at least 8
carbon atoms; silver and silver salts, such as but not limited to
silver chloride, silver oxide, and silver sulfadiazine; methyl,
ethyl, propyl, and butyl parabens; octenidene; compounds that
generate hydrogen peroxide such as perborates, complexes of
hydrogen peroxide with polyvinylpyrrolidone (e.g., Peroxydone from
ISP), natural oils such as tea tree oil, grape fruit seed extract,
and the like, as well as combinations thereof.
[0078] Alternatively, the stress-distributing layer and the
flexible polymeric film can be provided as a composite article. For
example, U.S. Pat. No. 5,369,155 discloses a composite of a gel of
swollen hydrocolloid particles dispersed in a pressure sensitive
adhesive matrix. The gel-adhesive composite may be coated on the
flexible polymeric film and provided as a composite article and
used in methods of the present invention. Also, International
Publication Nos. WO2009/088757 and WO2009/091682 disclose adhesive
hydrogel island dressings that could be used as a
stress-distributing layer in methods of the present invention.
[0079] Depending on the material and its properties (e.g.,
modulus), the thickness of the stress-distributing layer may vary.
The thickness of the stress-distributing layer, which has opposite
first and second major surfaces, is typically at least 1 millimeter
(mm), preferably at least 2 mm, between the first and second major
surfaces. A stress-distributing layer of greater than 2 mm is
preferred at least because this thickness is better to distribute
the stresses imposed by retraction as a result of stretching and/or
compression, for example. If the stress-distributing layer is too
thick, the practitioner may not be able to feel the underlying
anatomy (e.g., bony prominences) for effective placement of the
incision. Also, as the thickness of the stress-distributing layer
increases, its conformability over curved body surfaces typically
decreases. The thickness of the stress-distributing layer is
typically no more than 10 mm, often no more than 8 mm, and even
more often no more than 5 mm. An exemplary range of thicknesses is
3 mm to 5 mm. Variations in size of incision, the anatomy at the
incision site, the size of the retractors, and the desired surgical
procedure may require stress-distributing layers of different
thicknesses, which can be determined by the practitioner.
[0080] The size of the stress-distributing layer may be of a wide
variety of sizes depending on the size of the incision to be made.
A typical stress-distributing layer is at least 2 cm longer on each
end than the desired length of the incision. A typical
stress-distributing layer is at least 3 cm, and often no more than
4 cm, wide on each side of the incision (making a typical
stress-distributing layer 6 cm to 8 cm wide). Larger layers can be
used if desired, however, such layers are typically wasteful and
can be harder to apply.
[0081] The thickness of the stress-distributing layer is typically
uniform throughout. It can also be contoured or non-uniform,
however, such that the thickness may vary throughout the material
for desired effect (see, e.g., FIGS. 3a and 3b). For example, it
may be thicker in and around the area for the incision (e.g., at
the center of the material) and thinner over the remainder of the
area (e.g., tapered at the edges of the material), which can result
in more conformability at the edges. A tapered construction (as
shown in FIG. 3a) may be desired in certain embodiments,
particularly where the flexible polymeric material overlies the
stress-distributing layer, as the thinner edges result in less of a
step at the edges.
[0082] Stress-distributing layers may have a release liner against
the stress-distributing material to protect the surface prior to
use. The release liner could be made of a variety of materials such
as paper, plastic coated paper, plastic film, woven, non-woven, or
knit textiles, as well as film textile laminates. Preferred release
liner materials include clear polymeric liners that allow the
clinician to see through to the patient and thus accurately place
the film. Preferred clear polymeric liners include polyolefins such
as polyethylene and polypropylene, or polyester liners, as well as
laminates such as polyolefin coated polyester. For products
intended for gamma sterilization, use of a paper, polyethylene,
polyester, or polyethylene coated polyester liner is preferred.
Presurgical Skin Preparations
[0083] Presurgical skin preparations can be of a variety of
well-known types. As used herein, a presurgical skin preparation
includes antiseptic skin preparations, antiseptic skin preparations
having polymeric film formers, and film forming preparations useful
as microbial sealants or barriers. They are described in a number
of patents including, U.S. Pat. Nos. 4,584,192; 4,542,012;
7,459,167; and 7,030,203, as well as U.S. Pat. Publication Nos.
2008/0046004 and 2007/0147947.
Methods of Use
[0084] Methods of the present invention involve protecting tissue
during a surgical procedure and providing, for example, improved
cosmesis of the healed incision. Typically the methods described
herein include treating the tissue of the patient, e.g., the skin,
with a presurgical skin preparation.
[0085] In certain embodiments, the methods include: applying an
incise drape to a patient (e.g., as shown in FIG. 5a, where a
patient hip is covered with an IOBAN incise drape, available from
3M Co.) over a presurgical skin preparation followed by applying a
stress-distributing layer over the incise drape (e.g., as shown in
FIG. 5b, where a hydrocolloid dressing is applied over the incise
drape shown in FIG. 5a); or applying the stress-distributing layer
to the drape and then applying the composite to the patient; or
applying the stress-distributing layer to the tissue (e.g., skin)
over a presurgical skin preparation followed by applying an incise
drape over the stress-distributing layer; or applying a
stress-distributing layer over a presurgical skin preparation such
as DuraPrep (without the use of an incise drape); or applying a
stress-distributing layer over a presurgical polymeric barrier film
such as that available under the trade designation INTEGUSEAL (a
cyanoacrylate applied directly to skin in place of an incise) from
Kimberly Clark. The methods of the present invention involve making
an incision through such coverings (e.g., an incision through an
incise drape and hydrocolloid dressing into the tissue of the
patient hip as shown in FIG. 5c) and retracting the incised tissue
and the coverings.
[0086] In certain embodiments, the present invention provides a
method of protecting tissue of a patient during a surgical
procedure, wherein the method includes: providing a presurgical
skin preparation; providing a free-standing water-absorbing
stress-distributing layer comprising a hydrogel, a hydrocolloid, or
a combination thereof, wherein the stress-distributing layer has
opposite first and second major surfaces; treating the patient's
skin with a presurgical skin preparation; adhering the
free-standing stress-distributing layer to the patient over the
area treated with the presurgical skin preparation; making an
incision through the presurgical skin preparation and the
stress-distributing layer into the tissue; and retracting the
tissue along the incision using a retractor; wherein the
presurgical skin preparation and stress-distributing layer undergo
stretching and/or compression during retraction. In certain
embodiments, the method further includes adhering an incise drape
to the patient over the area treated with the presurgical skin
preparation before or after adhering the free-standing
water-absorbing stress-distributing layer to the patient. If
"after," the incise drape is adhered to the stress-distributing
layer, which is adhered to the patient's skin over the presurgical
skin preparation. If "before," the stress-distributing layer is
adhered to the incise drape, which is adhered to the patient's skin
over the presurgical skin preparation.
[0087] In certain embodiments, methods of the invention include:
providing a water-absorbing stress-distributing layer comprising a
hydrogel, a hydrocolloid, or a combination thereof; wherein the
stress-distributing layer has opposite first and second major
surfaces and at least a portion of the stress-distributing layer is
greater than 2 mm thick between the first and second major
surfaces; adhering the stress-distributing layer to the patient
such that it conforms to the shape of the tissue of the patient;
making an incision through the stress-distributing layer into the
tissue; and retracting the tissue along the incision using a
retractor; wherein the stress-distributing layer undergoes
stretching and/or compression during retraction. In certain
embodiments, at least one of the major surfaces of the
stress-distributing layer is attached to a flexible polymeric film
to form a stress-distributing composite; adhering the
stress-distributing layer comprises adhering the
stress-distributing composite to the patient such that the
stress-distributing composite conforms to the shape of the tissue
of the patient; and making an incision comprises making an incision
through the stress-distributing composite into the tissue.
[0088] The methods described above can use a stress-distributing
layer alone or it can be used with a flexible polymeric film such
as a surgical incise drape. In this embodiment, the method further
includes: providing a surgical incise drape comprising a flexible
polymeric film having opposite first and second major surfaces, and
a layer of a pressure sensitive adhesive disposed on at least a
portion of one major surface; adhering the surgical incise drape to
the patient; and attaching the stress-distributing layer to the
incise drape; wherein making an incision comprises making an
incision through the stress-reducing material and the surgical
incise drape into the tissue. In an alternative embodiment, the
method further includes: providing a surgical incise drape
comprising a flexible polymeric film having opposite first and
second major surfaces, and a layer of a pressure sensitive adhesive
disposed on at least a portion of one major surface; adhering the
stress-distributing layer to the patient; and adhering the surgical
incise drape to the stress-distributing layer; wherein making an
incision comprises making an incision through the stress-reducing
material and the surgical incise drape into the tissue.
[0089] Preferred methods of the present invention for protecting
tissue of a patient during a surgical procedure involve the use of
a stress-distributing layer and a flexible polymeric film. Such
methods involve: providing a flexible polymeric film having
opposite first and second major surfaces; providing a
water-absorbing stress-distributing layer comprising a hydrogel, a
hydrocolloid, or a combination thereof; wherein the
stress-distributing layer has opposite first and second major
surfaces and at least a portion of the stress-distributing layer is
at least 1 mm thick between the first and second major surfaces;
placing the flexible polymeric film and the stress-distributing
layer in contact with one another so that the flexible polymeric
film and the stress-distributing layer are attached together to
form a stress-distributing composite, and the stress-distributing
composite is adhered to the patient such that the
stress-distributing composite conforms to the shape of the tissue
of the patient; making an incision through the stress-distributing
composite into the tissue; and retracting the tissue along the
incision using a retractor; wherein the stress-distributing
composite undergoes stretching and/or compression during
retraction.
[0090] In one embodiment of such method, placing the flexible
polymeric film and the stress-distributing layer in contact with
one another on the patient includes forming a stress-distributing
composite comprising the stress-distributing layer and the flexible
polymeric film, optionally with a pressure sensitive adhesive
between, and placing the stress-distributing composite on the
patient and adhering the stress-distributing composite thereto. The
flexible polymeric film and the stress-distributing layer can be
attached together to form a stress-distributing composite before
the surgical procedure (for example, by a manufacturer).
[0091] In another embodiment of such method, placing the flexible
polymeric film and the stress-distributing layer in contact with
one another on the patient includes placing one of the flexible
polymeric film and the stress-distributing layer in contact with
the patient before the flexible polymeric film and the stress
reducing material are attached together to form the
stress-distributing composite. For example, placing the flexible
polymeric film and the stress-distributing layer in contact with
one another on the patient includes placing the stress-distributing
layer on the patient and adhering it thereto, and subsequently
placing the flexible polymeric film on the stress-distributing
layer to form the stress-distributing composite. Alternatively,
placing the flexible polymeric film and the stress-distributing
layer in contact with one another on the patient includes placing
the flexible polymeric film on the patient and adhering it thereto,
and subsequently placing the stress-distributing layer on the
flexible polymeric film to form the stress-distributing
composite.
[0092] The stress-distributing layer and the optional flexible
polymeric film preferably do not tear during retraction of the
tissue. More preferably, the stress-distributing layer, and the
optional flexible polymeric film, adheres sufficiently to the
tissue such that the retraction does not displace the
stress-distributing layer from the patient along the edges of the
incision.
[0093] Preferably, the flexible polymeric film and
stress-distributing layers, and any optional pressure sensitive
adhesives are sufficiently clear (either translucent or
transparent) to allow the practitioner to visualize the tissue
through the flexible polymeric film and the stress-distributing
layer. This allows the practitioner to better see the underlying
tissue to be incised, particularly if the practitioner marks the
tissue at the desired location. If desired, the flexible polymeric
film and/or the stress-distributing layer can include a visual grid
(e.g., with 1-cm squares) to assist the practitioner in making
incisions and/or sutures.
[0094] The flexible polymeric film is preferably provided as a
surgical incise drape. In many embodiments, the flexible polymeric
film, the stress-distributing layer, or both comprises a pressure
sensitive adhesive on at least a portion of at least one major
surface thereof. This pressure sensitive adhesive typically
provides the mode of attachment between the flexible polymeric film
and the stress-distributing layer.
[0095] In certain embodiments, the flexible polymeric film is
provided as an incise drape having a first pressure sensitive
adhesive on at least one major surface of the film. In certain
embodiments, the stress-distributing layer comprises a second
pressure sensitive adhesive on at least one major surface thereof.
In certain embodiments, if two such pressure sensitive adhesives
are used together (for example, in a stress-distributing composite
article), the first and second pressure sensitive adhesives are
selected such that, preferably, the incise drape and the
stress-distributing layer remain adhered together and the
stress-distributing composite adhered securely to the edges of the
incision during the surgical procedure.
[0096] In one exemplary embodiment using a surgical incise drape, a
method of the invention includes: providing a surgical incise drape
comprising a flexible polymeric film having opposite first and
second major surfaces and a pressure sensitive adhesive on at least
a portion of at least one major surface thereof; providing a
free-standing water-absorbing stress-distributing layer comprising
a hydrogel, a hydrocolloid, or a combination thereof; wherein the
stress-distributing layer has opposite first and second major
surfaces; adhering the surgical incise drape to the patient;
adhering the free-standing stress-distributing layer to the
surgical incise drape; making an incision through the incise drape
and the stress-distributing layer into the tissue; and retracting
the tissue along the incision using a retractor; wherein the
surgical incise drape and stress-distributing layer undergo
stretching and/or compression during retraction. Preferably, the
retracting does not displace the surgical incise drape and
stress-distributing layer from the patient along the incision while
undergoing stretching and/or compression during retraction.
[0097] In certain embodiments, the stress-distributing layer can be
provided as multiple layers. For example, in one embodiment, the
stress-distributing layer can be folded over on itself and applied
as a double layer. That is, when adhering a free-standing
stress-distributing layer, for example, to a surgical incise drape,
the practitioner can form a double stress-distributing layer (e.g.,
by folding it) and adhere the two layers to the surgical incise
drape.
[0098] The present invention also provides products, in particular
kits that include the stress-distributing layer and the flexible
polymeric film. For example, a kit can include: a surgical incise
drape comprising a flexible polymeric film having opposite first
and second major surfaces, a pressure sensitive adhesive disposed
on at least a portion of at least one major surface of the film,
and a release liner disposed on the pressure sensitive adhesive; a
water-absorbing stress-distributing layer having opposite first and
second major surfaces, and a release liner disposed on at least one
of the surfaces; wherein the water-absorbing stress-distributing
layer comprises a hydrogel, a hydrocolloid, or a combination
thereof; and sterile packaging enclosing the surgical incise drape
and stress-distributing layer. Another kit includes: a
water-absorbing stress-distributing layer having opposite first and
second major surfaces, and a release liner disposed on at least one
of the surfaces; wherein the water-absorbing stress-distributing
layer comprises a hydrogel, a hydrocolloid, or a combination
thereof; a presurgical skin preparation; and sterile packaging
enclosing the stress-distributing layer and the presurgical skin
preparation. Yet another kit includes: a flexible polymeric film
having opposite first and second major surfaces, a pressure
sensitive adhesive disposed on at least a portion of at least one
major surface of the film, and a release liner disposed on the
pressure sensitive adhesive; a water-absorbing stress-distributing
layer having opposite first and second major surfaces, and a
release liner disposed on at least one of the surfaces; wherein the
water-absorbing stress-distributing layer comprises a hydrogel, a
hydrocolloid, or a combination thereof; a presurgical skin
preparation; and sterile packaging enclosing the surgical incise
drape and stress-distributing layer. In each of these kits, at
least a portion of the stress-distributing layer is preferably at
least 1 mm thick between the first and second major surfaces.
[0099] The present invention also provides stress-distributing
composites adhered to the skin of a patient. In one such
embodiment, the stress-distributing composite includes: a
presurgical skin preparation on the skin of the patient; and a
water-absorbing stress-distributing layer having opposite first and
second major surfaces; wherein the water-absorbing
stress-distributing layer comprises a hydrogel, a hydrocolloid, or
a combination thereof; wherein at least a portion of the
stress-distributing layer is at least 1 mm thick between the first
and second major surfaces; wherein the water-absorbing
stress-distributing layer is adhered to the presurgical skin
preparation on the patient's skin. The stress-distributing
composite can further include an incise drape adhered to the
water-absorbing stress-distributing layer.
[0100] In another embodiment, the present invention provides a
stress-distributing composite adhered to the skin of a patient, the
stress-absorbing composite including: a presurgical skin
preparation on the skin of the patient; a surgical incise drape
comprising a flexible polymeric film having opposite first and
second major surfaces, a pressure sensitive adhesive disposed on at
least a portion of at least one major surface of the film; and a
water-absorbing stress-distributing layer having opposite first and
second major surfaces; wherein the water-absorbing
stress-distributing layer comprises a hydrogel, a hydrocolloid, or
a combination thereof; wherein at least a portion of the
stress-distributing layer is at least 1 mm thick between the first
and second major surfaces; wherein the surgical incise drape is
adhered to the presurgical skin preparation on the patient's skin
by the pressure sensitive adhesive and the water-absorbing
stress-distributing layer is attached to the incise drape on the
surface opposite the pressure sensitive adhesive.
Exemplary Embodiments
[0101] 1. A method of protecting tissue of a patient during a
surgical procedure, the method comprising:
[0102] providing a water-absorbing stress-distributing layer
comprising a hydrogel, a hydrocolloid, or a combination thereof;
wherein the stress-distributing layer has opposite first and second
major surfaces and at least a portion of the stress-distributing
layer is greater than 2 mm thick between the first and second major
surfaces;
[0103] adhering the stress-distributing layer to the patient such
that it conforms to the shape of the tissue of the patient;
[0104] making an incision through the stress-distributing layer
into the tissue; and
[0105] retracting the tissue along the incision using a
retractor;
[0106] wherein the stress-distributing layer undergoes stretching
and/or compression during retraction. [0107] 2. The method of
embodiment 1 wherein at least one of the major surfaces of the
stress-distributing layer is attached to a flexible polymeric film
to form a stress-distributing composite, adhering the
stress-distributing layer comprises adhering the
stress-distributing composite to the patient such that the
stress-distributing composite conforms to the shape of the tissue
of the patient, and making an incision comprises making an incision
through the stress-distributing composite into the tissue. [0108]
3. The method of embodiment 1 further comprising:
[0109] providing a surgical incise drape comprising a flexible
polymeric film having opposite first and second major surfaces, and
a layer of a pressure sensitive adhesive disposed on at least a
portion of one major surface;
[0110] adhering the surgical incise drape to the patient; and
[0111] attaching the stress-distributing layer to the incise
drape;
[0112] wherein making an incision comprises making an incision
through the stress-reducing material and the surgical incise drape
into the tissue. [0113] 4. The method of embodiment 1 further
comprising:
[0114] providing a surgical incise drape comprising a flexible
polymeric film having opposite first and second major surfaces, and
a layer of a pressure sensitive adhesive disposed on at least a
portion of one major surface;
[0115] adhering the stress-distributing layer to the patient;
and
[0116] adhering the surgical incise drape to the
stress-distributing layer;
[0117] wherein making an incision comprises making an incision
through the stress-reducing material and the surgical incise drape
into the tissue. [0118] 5. The method of any one of the preceding
embodiments wherein the retracting does not displace the
stress-distributing layer from the patient along the incision while
undergoing stretching and/or compression during retraction. [0119]
6. A method of protecting tissue of a patient during a surgical
procedure, the method comprising:
[0120] providing a flexible polymeric film having opposite first
and second major surfaces;
[0121] providing a water-absorbing stress-distributing layer
comprising a hydrogel, a hydrocolloid, or a combination thereof;
wherein the stress-distributing layer has opposite first and second
major surfaces and at least a portion of the stress-distributing
layer is at least 1 mm thick between the first and second major
surfaces;
[0122] placing the flexible polymeric film and the
stress-distributing layer in contact with one another so that the
flexible polymeric film and the stress-distributing layer are
attached together to form a stress-distributing composite, and the
stress-distributing composite is adhered to the patient such that
the stress-distributing composite conforms to the shape of the
tissue of the patient;
[0123] making an incision through the stress-distributing composite
into the tissue; and
[0124] retracting the tissue along the incision using a
retractor;
[0125] wherein the stress-distributing composite undergoes
stretching and/or compression during retraction. [0126] 7. The
method of embodiment 6 wherein placing the flexible polymeric film
and the stress-distributing layer in contact with one another on
the patient comprises forming a stress-distributing composite
comprising the stress-distributing layer and the flexible polymeric
film, optionally with a pressure sensitive adhesive between, and
placing the stress-distributing composite on the patient and
adhering the stress-distributing composite thereto. [0127] 8. The
method of embodiment 7 wherein the flexible polymeric film and the
stress-distributing layer are attached together to form a
stress-distributing composite before the surgical procedure. [0128]
9. The method of embodiment 6 wherein placing the flexible
polymeric film and the stress-distributing layer in contact with
one another on the patient comprises placing one of the flexible
polymeric film and the stress-distributing layer in contact with
the patient before the flexible polymeric film and the stress
reducing material are attached together to form the
stress-distributing composite. [0129] 10. The method of embodiment
9 wherein placing the flexible polymeric film and the
stress-distributing layer in contact with one another on the
patient comprises placing the stress-distributing layer on the
patient and adhering it thereto, and subsequently placing the
flexible polymeric film on the stress-distributing layer to form
the stress-distributing composite. [0130] 11. The method of
embodiment 9 wherein placing the flexible polymeric film and the
stress-distributing layer in contact with one another on the
patient comprises placing the flexible polymeric film on the
patient and adhering it thereto, and subsequently placing the
stress-distributing layer on the flexible polymeric film to form
the stress-distributing composite. [0131] 12. The method of any one
of embodiments 6 through 11 wherein the flexible polymeric film is
provided as a surgical incise drape. [0132] 13. The method of any
one of embodiments 6 through 11 wherein at least a portion of the
stress-distributing layer has a thickness of greater than 2 mm
between the first and second major surfaces. [0133] 14. The method
of any one of embodiments 6 through 13 wherein the flexible
polymeric film, the stress-distributing layer, or both comprises a
pressure sensitive adhesive disposed on at least a portion of at
least one major surface thereof. [0134] 15. The method of any one
of the preceding embodiments further comprising visualizing the
tissue through the stress-distributing layer prior to making the
incision. [0135] 16. The method of any one of the preceding
embodiments wherein the thickness of the stress-distributing layer
is uniform. [0136] 17. The method of any one of the preceding
embodiments wherein the stress-distributing layer is inherently
tacky. [0137] 18. A method of protecting tissue of a patient during
a surgical procedure, the method comprising:
[0138] providing a surgical incise drape comprising a flexible
polymeric film having opposite first and second major surfaces and
a pressure sensitive adhesive on at least a portion of at least one
major surface thereof;
[0139] providing a free-standing water-absorbing
stress-distributing layer comprising a hydrogel, a hydrocolloid, or
a combination thereof; wherein the stress-distributing layer has
opposite first and second major surfaces;
[0140] adhering the surgical incise drape to the patient;
[0141] adhering the free-standing stress-distributing layer to the
surgical incise drape;
[0142] making an incision through the incise drape and the
stress-distributing layer into the tissue; and
[0143] retracting the tissue along the incision using a
retractor;
[0144] wherein the surgical incise drape and stress-distributing
layer undergo stretching and/or compression during retraction.
[0145] 19. The method of embodiment 18 wherein adhering the
stress-distributing layer to the surgical incise drape comprises
adhering a double stress-distributing layer to the surgical incise
drape. [0146] 20. The method of embodiment 18 or embodiment 19
wherein the retracting does not displace the surgical incise drape
and stress-distributing layer from the patient along the incision
while undergoing stretching and/or compression during retraction.
[0147] 21. The method of any one of the preceding embodiments
wherein the water-absorbing stress-distributing layer comprises a
hydrocolloid. [0148] 22. The method of any one of the preceding
embodiments wherein the water-absorbing stress-distributing layer
is porous. [0149] 23. The method of any one of the preceding
embodiments wherein the water-absorbing stress-distributing layer
has a matte finish. [0150] 24. The method of any one of the
preceding embodiments wherein the tissue of the patient is
initially treated with a presurgical skin preparation. [0151] 25.
The method of any one of the preceding embodiments wherein the
tissue of the patient is initially treated with a barrier film.
[0152] 26. A method of protecting tissue of a patient during a
surgical procedure, the method comprising:
[0153] providing a presurgical skin preparation;
[0154] providing a free-standing water-absorbing
stress-distributing layer comprising a hydrogel, a hydrocolloid, or
a combination thereof, wherein the stress-distributing layer has
opposite first and second major surfaces;
[0155] treating the patient's skin with a presurgical skin
preparation;
[0156] adhering the free-standing water-absorbing
stress-distributing layer to the patient over the area treated with
the presurgical skin preparation;
[0157] making an incision through the presurgical skin preparation
and the stress-distributing layer into the tissue; and
[0158] retracting the tissue along the incision using a retractor;
wherein the presurgical skin preparation and stress-distributing
layer undergo stretching and/or compression during retraction.
[0159] 27. The method of embodiment 26 further comprising adhering
an incise drape to the patient over the area treated with the
presurgical skin preparation before or after adhering the
free-standing water-absorbing stress-distributing layer to the
patient. [0160] 28. The method of any one of the preceding
embodiments wherein the surgical procedure is a minimally invasive
or open surgical procedure. [0161] 29. The method of any one of the
preceding embodiments wherein the surgical procedure is an open
surgical procedure. [0162] 30. A kit for use during a surgical
procedure to protect tissue of a patient, the kit comprising:
[0163] a surgical incise drape comprising a flexible polymeric film
having opposite first and second major surfaces, a pressure
sensitive adhesive disposed on at least a portion of at least one
major surface of the film, and a release liner disposed on the
pressure sensitive adhesive;
[0164] a water-absorbing stress-distributing layer having opposite
first and second major surfaces, and a release liner disposed on at
least one of the surfaces; wherein the water-absorbing
stress-distributing layer comprises a hydrogel, a hydrocolloid, or
a combination thereof; and
[0165] sterile packaging enclosing the surgical incise drape and
stress-distributing layer. [0166] 31. A kit for use during a
surgical procedure to protect tissue of a patient, the kit
comprising:
[0167] a water-absorbing stress-distributing layer having opposite
first and second major surfaces, and a release liner disposed on at
least one of the surfaces; wherein the water-absorbing
stress-distributing layer comprises a hydrogel, a hydrocolloid, or
a combination thereof;
[0168] a presurgical skin preparation; and
[0169] sterile packaging enclosing the stress-distributing layer
and the presurgical skin preparation. [0170] 32. A kit for use
during a surgical procedure to protect tissue of a patient, the kit
comprising:
[0171] a flexible polymeric film having opposite first and second
major surfaces, a pressure sensitive adhesive disposed on at least
a portion of at least one major surface of the film, and a release
liner disposed on the pressure sensitive adhesive;
[0172] a water-absorbing stress-distributing layer having opposite
first and second major surfaces, and a release liner disposed on at
least one of the surfaces; wherein the water-absorbing
stress-distributing layer comprises a hydrogel, a hydrocolloid, or
a combination thereof;
[0173] a presurgical skin preparation; and
[0174] sterile packaging enclosing the surgical incise drape and
stress-distributing layer. [0175] 33. The kit of any one of
embodiments 30 through 302 wherein at least a portion of the
stress-distributing layer is at least 1 mm thick between the first
and second major surfaces. [0176] 34. A stress-distributing
composite adhered to the skin of a patient, the stress-distributing
composite comprising:
[0177] a presurgical skin preparation on the skin of the patient;
and
[0178] a water-absorbing stress-distributing layer having opposite
first and second major surfaces; wherein the water-absorbing
stress-distributing layer comprises a hydrogel, a hydrocolloid, or
a combination thereof; wherein at least a portion of the
stress-distributing layer is at least 1 mm thick between the first
and second major surfaces;
[0179] wherein the water-absorbing stress-distributing layer is
adhered to the presurgical skin preparation on the patient's skin.
[0180] 35. The stress-distributing composite of embodiment 34
further comprising an incise drape adhered to the water-absorbing
stress-distributing layer. [0181] 36. A stress-distributing
composite adhered to the skin of a patient, the stress-absorbing
composite comprising:
[0182] a presurgical skin preparation on the skin of the
patient;
[0183] a surgical incise drape comprising a flexible polymeric film
having opposite first and second major surfaces, a pressure
sensitive adhesive disposed on at least a portion of at least one
major surface of the film; and
[0184] a water-absorbing stress-distributing layer having opposite
first and second major surfaces; wherein the water-absorbing
stress-distributing layer comprises a hydrogel, a hydrocolloid, or
a combination thereof; wherein at least a portion of the
stress-distributing layer is at least 1 mm thick between the first
and second major surfaces;
[0185] wherein the surgical incise drape is adhered to the
presurgical skin preparation on the patient's skin by the pressure
sensitive adhesive and the water-absorbing stress-distributing
layer is attached to the incise drape on the surface opposite the
pressure sensitive adhesive.
EXAMPLES
[0186] Objects and advantages of this invention are further
illustrated by the following examples, but the particular materials
and amounts thereof recited in these examples, as well as other
conditions and details, should not be construed to unduly limit
this invention.
Example 1
Comparative
[0187] After using conventional surgical prepping procedures, a
surgeon placed IOBAN 2 Antimicrobial Incise Drape (a product of 3M
Company, St. Paul, Minn.) over the intended surgical site.
Following incision, the surgeon used retractors to expose the
underlying tissue. Observation of the retracted site showed the
skin and draping material to laterally compress causing a large
number of wrinkles to form indicative of considerable skin stress
as shown in FIG. 6.
Example 2
[0188] On another patient, the same procedure was followed as in
Example 1 with the exception that after placement of the IOBAN 2
Antimicrobial Incise Drape the surgeon centered and attached a
TEGADERM Hydrocolloid (a product of 3M Company, St. Paul, Minn.) to
the top of the IOBAN drape. After incision and retraction, it was
noted that the skin surface surrounding the incisional site did not
exhibit stress wrinkles. This indicates that the stress of
retraction was being dissipated by the hydrocolloid dressing
protecting the skin from compression damage during the course of
the surgery. FIG. 7 exemplifies fewer (essentially no) stress
wrinkles around the incisional site.
[0189] The complete disclosures of the patents, patent documents,
and publications cited herein are incorporated by reference in
their entirety as if each were individually incorporated. Various
modifications and alterations to this invention will become
apparent to those skilled in the art without departing from the
scope and spirit of this invention. It should be understood that
this invention is not intended to be unduly limited by the
illustrative embodiments and examples set forth herein and that
such examples and embodiments are presented by way of example only
with the scope of the invention intended to be limited only by the
claims set forth herein as follows.
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