U.S. patent application number 14/173603 was filed with the patent office on 2014-06-05 for method and apparatus for surgically closing an open abdomen.
The applicant listed for this patent is Andrew Dennis. Invention is credited to Andrew Dennis.
Application Number | 20140155935 14/173603 |
Document ID | / |
Family ID | 45527492 |
Filed Date | 2014-06-05 |
United States Patent
Application |
20140155935 |
Kind Code |
A1 |
Dennis; Andrew |
June 5, 2014 |
METHOD AND APPARATUS FOR SURGICALLY CLOSING AN OPEN ABDOMEN
Abstract
An open abdomen wound as a result of injury or surgery is closed
using hook and loop fastener sheets that are attached at opposing
edges of the wound using bolsters through which surgical suture
threat is passed to secure the abdominal wall between the fastener
sheets and the bolsters. Tension forces are exerted on the fastener
sheets and the sheets secured to one another in one or more steps
drawing the wound edges toward one another. The tension forces are
distributed by the bolsters to avoid loss of tissue at the wound
edges. Successful closure of the wound is possible.
Inventors: |
Dennis; Andrew; (Chicago,
IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Dennis; Andrew |
Chicago |
IL |
US |
|
|
Family ID: |
45527492 |
Appl. No.: |
14/173603 |
Filed: |
February 5, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13188549 |
Jul 22, 2011 |
8679153 |
|
|
14173603 |
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61369320 |
Jul 30, 2010 |
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Current U.S.
Class: |
606/216 ;
606/228 |
Current CPC
Class: |
A61F 17/00 20130101;
A61B 17/06166 20130101; A61B 17/08 20130101 |
Class at
Publication: |
606/216 ;
606/228 |
International
Class: |
A61B 17/08 20060101
A61B017/08; A61B 17/06 20060101 A61B017/06 |
Claims
1. A method for closing an open abdomen wound, comprising the steps
of: positioning a first bolster along a first edge of the abdominal
wound; securing a first fastener sheet to the first edge of the
wound by suturing through the first fastener sheet and through the
abdominal wall and through the first bolster to secure the
abdominal wall between the first fastener sheet and the first
bolster; positioning a second bolster along a second edge of the
abdominal wound; securing a second fastener sheet to the second
edge of the wound by suturing through the second fastener sheet and
through the abdominal wall and through the second bolster to secure
the abdominal wall between the second fastener sheet and the second
bolster; applying tension to at least one of said first and second
fastener sheets to draw the first and second edges of the wound
toward one another; attaching said first fastener sheet to said
second fastener sheet while under tension so as to apply static
tension to opposing sides of the abdominal wound; repeating said
steps of applying tension to at least one of said first and second
sheets and attaching said first and second sheets to one another as
needed to draw the first and second edges of the wound in
proximity; and surgically closing the abdominal wound by suturing
the first and second edges to one another.
2. A method as claimed in claim 1, wherein said first and second
fastener sheets include a hook fastener sheet and a loop fastener
sheet.
3. A method as claimed in claim 1, further comprising the steps of:
applying a hydrocortoid sheets on skin of the abdomen; and wherein
said step of positioning the bolsters positions the bolsters on the
hydrocortoid sheets.
4. A method as claimed in claim 1, wherein said step of positioning
said bolsters follows positioning of the first and second fastener
sheets.
5. A method as claimed in claim 1, where said bolsters are
positioned at or adjacent a patient's rectus muscles.
6. A method as claimed in claim 1, wherein steps of securing the
first and second fastener sheets includes suturing through all
layers of the abdominal wall.
7. A method as claimed in claim 1, wherein said step of steps of
securing said first and second fastener sheets includes the
sub-steps of: sewing a suture: through a first opening in a first
of said bolsters, through the abdominal wall, through the fastener
sheet at a first location, back through the fastener sheet at a
second location, back through the abdominal wall, and through a
second opening in said first bolster that is spaced from said first
opening; tying ends to said suture that extends from the first
opening and from said second opening to one another to form a loop
of suture affixing the fastener sheet to the bolster through the
abdominal wall; repeating the sewing and tying steps at further
pairs of openings in the first bolster to form loops of suture
along a length of the first bolster; and repeating the sewing and
tying steps with a second bolster.
8. A method as claimed in claim 7, wherein said first bolster is
formed of a soft inner material and a hard outer material, and
wherein said step of tying the ends of the suture positions in a
knot of suture that is on the hard outer material of the first
bolster.
9. A method as claimed in claim 7, wherein said loops of suture are
substantially evenly spaced along a length of the bolster.
10. A kit for use in closing an abdominal wound, comprising: first
and second fastener sheets for selective engagement with one
another; a plurality of bolsters, each bolster being an elongated
strip defining a plurality of holes along its length, each bolster
having a relatively rigid strip portion and a cushioning portion
attached to said rigid strip portion; a viscera protective barrier
sheet; and a skin protective barrier.
11. A kit as claimed in claim 10, wherein said viscera protective
barrier sheet includes a polyurethane soft visceral protection
barrier
12. A kit as claimed in claim 10, wherein said skin protective
barrier includes hydrocolloid adhesive dressings.
13. A kit as claimed in claim 10, wherein said bolsters each have
an elongated rigid plastic strip having the holes formed therein
and an elongated foam strip affixed to said elongated rigid
strip.
14. A kit as claimed in claim 10, wherein said bolsters each have
an elongated metal strip having the holes formed therein and an
elongated foam strip affixed to said elongated rigid strip.
15. A kit as claimed in claim 14, wherein said metal strip is
formed of aluminum.
16. A kit as claimed in claim 10, wherein said first and second
fastener sheets include a hook fastener sheet and a loop fastener
sheet.
17. A method for stretching retracted lateral muscles of a
patient's abdomen, comprising the steps of: positioning bolsters on
the patient's abdomen; affixing first and second fastener sheets to
said bolsters, said affixing step including suturing through at
least portions of the patient's abdominal wall and through the
fastener sheets and through the bolsters; exerting a tension force
on at least one of said fastener sheets; and fastening said
fastener sheets to one another so as to exert a static tension
force on the lateral muscles of the patient's abdomen.
18. A method as claimed in claim 17, further comprising the step
of: repeating the steps of exerting a tension force and fastening
said fastener sheets to further stretch the retracted lateral
muscles.
19. A method as claimed in claim 17, further comprising the step
of: surgically closing an open abdomen after stretching the
retracted lateral muscles of the patient's abdomen.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional application of U.S.
application Ser. No. 13/188,459, filed Jul. 22, 2011, which claims
the benefit of U.S. Provisional Patent Application Ser. No.
61/369,320, filed Jul. 30, 2010, which is incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to a method and
apparatus for surgically closing an open abdomen of a patient, and
more particularly to a method and apparatus for surgically closing
acute and chronic open abdomen wounds.
[0004] 2. Description of the Related Art
[0005] A variety of different medical conditions or accidental
injuries can result in a patient having an open abdomen wound. For
instance, in some medical conditions, the viscera within the
abdomen swells which causes the viscera to be compressed by the
abdominal wall of the person. Unless decompressed, the compression
results in loss of circulation to the viscera and to tissue death,
which may result in death of the patient. The pressure within the
abdomen can be relieved by surgical opening of the abdomen, such as
by a ventral incision, as a prophylactic procedure. While the risk
of death and visceral tissue loss is decreased by the decompression
while the tissues heal, the abdominal incision must be closed after
the swelling decreases. The muscles of the abdominal wall, however,
generally retract while the incision is open, pulling the wound
open and preventing the wound from being closed. This is referred
to as lost domain, and the result is a patient with an open
abdominal wound, referred to as the complex open abdomen.
[0006] Injuries to the viscera such as from a gunshot or knife
wound, vehicular accident or other injury can also cause swelling
of the viscera, particularly where a surgical repair of the bowels,
intestines and other organs are required. The act of operating on
the abdominal tissues may also cause the tissues to swell or
otherwise change in a way that causes issues in attempting to close
the wound. At the conclusion of the surgery to repair the injury,
the swelling as well as any muscle retraction prevents closure of
wound in the abdominal wall. As a result, an open abdomen can
result that is not immediately able to be surgically closed without
risk to the patient. This is referred to as an acute open
abdomen.
[0007] Contemporary surgeons struggle with the complex open
abdomen. In years past, it was rare to have a persistently open
abdomen. In contrast, for a number of reasons, contemporary
practitioners routinely leave abdomens open after ceilotomy.
Complex open abdomens are often the result of damage control
laparotomy for trauma, decompression for abdominal compartment
syndrome, and massive, possibly excessive, fluid resuscitations
resulting in bowel and abdominal wall edema. It is estimated that
up to one in nine patients undergoing laparotomy for trauma is not
closed at the time of initial surgery.
[0008] In some patients who have had need for an open abdomen, the
open wound has been closed by a skin graft, thus essentially
forming a large ventral hernia on the abdomen. This is referred to
as a chronic open abdomen. While the skin graft encloses the
viscera within the skin, it does not provide the protection for the
viscera that the muscles and other structures of the abdominal wall
provide. The patient no longer has integrity of the abdominal wall,
which may limit many of the activities that the patient may wish to
engage in. In addition, the rectus muscles, those which allow one
to flex the abdomen in doing a "sit up" type maneuver, end up very
lateral and no longer attached to one another. By being so lateral
and not bound to each other, the individual is unable to flex the
torso, thus being functionally impaired.
[0009] Several options exist for the management of the increasingly
common open abdomen wound. However, due to idiosyncratic
complexities associated with this group of patients as well as
institutional variability, no single technique can be universally
employed to manage these cases. Current techniques include planned
ventral hernia with placement of absorbable mesh and/or skin graft
as noted above, vacuum assisted closure, complex abdominal wall
repairs, and a variety of temporary closures with serial attempts
at tightening. The complex repairs include component separation, in
other words, separation of the muscles and other tissues in the
abdominal wall from one another and connecting just some components
together. Among the serial tightening techniques is the Wittmann
patch, which is an artificial bur which serves as a temporary
abdominal fascial prosthesis in cases where the abdomen cannot be
closed due to abdominal compartment syndrome or because multiple
further operations are planned (staged abdominal repair). It
consists of a sterile hook and a sterile loop sheet made from
propylene or other polymer.
[0010] In particular, the Wittmann patch includes two sheets of a
biocompatible polymer; one sheet is covered with micro hooks or
mushrooms and the other with loops. These sheets have been
traditionally sutured to the fascial edges of an open abdomen and
then pressed together to adhere. When adhered to each other, these
sheets can withstand shear forces similar to normal intact fascia.
The patch sheets are sequentially trimmed and progressively pulled
tighter across the open abdomen to slowly stretch the abdominal
wall, regain domain and eventually re-approximate the fascia, or
close the open wound.
[0011] In recent years, several doctors have reported improved
success by combining the Wittmann patch with vacuum assisted
dressings. Doctors report following the same method of implanting
the patch by sewing it directly to the fascial edge. Fixing the
patch to the leading edge of the fascia places substantial force on
a focused area of tissue. As a result, complications of fascial
necrosis and tearing where the patch interfaces with the fascial
edge are often reported. This loss of fascial integrity is
sometimes of sufficient extent to cause patch failure. The tissues
won't hold the suture. In an attempt to prevent tissue damage, less
tension forces are applied to the patch so that it won't tear
through the facial wall there it has been sewn. More importantly,
this method of Wittmann patch fixation often sacrifices several
centimeters of precious abdominal wall which could be used to
restore abdominal integrity. The result may be a hernia rather than
a successful closure of the abdominal wall structures.
[0012] The health of the patient plays a roll in the ability to
close an open abdomen. For example, patients with a condition such
as diabetes may have poor tissue quality at the abdominal wall
anyway. Efforts to close the open abdomen can result in further
tissue degradation.
[0013] Another approach has been to provide elastomeric bands that
span the open wound. The elastomeric bands apply a dynamic tension
to the tissues by exerting a dynamic pull on the muscles and other
tissues. The constant application of the dynamic forces causes the
muscles to tire and weaken.
SUMMARY OF THE INVENTION
[0014] The present invention provides a method and apparatus by
which an open abdomen wound may be closed with little or no loss of
the tissue at the fascial edge of the wound. In a patient with an
open abdomen wound, or in a patient who has previously had an open
abdomen wound that has been covered by a skin graft, for example,
the abdominal wound is covered by a fastener sheet or sheets that
is secured to the opposing edges of the wound by suturing through
the abdominal walls. The fastener sheet is positioned under the
abdominal wall. In a preferred embodiment, the fastener sheet
extends laterally to the edge of the rectus muscle on either side
of the wound. Bolsters are positioned at the outside of the
abdominal wall. In a preferred embodiment, the bolsters are
fastened over skin at the lateral edge of the rectus muscle. In one
example, the bolsters are attached at approximately 2 inches from
the wound edge.
[0015] A hydrocolloid adhesive dressing is preferably placed over
the skin before positioning of the padded bolsters so that the
dressing is between the bolster and the skin to protect the skin.
Suture is passed through a bolster hole, through all layers of the
abdominal wall, through the fastener sheet, back through the
abdominal wall and through a different bolster hole and is tied.
This process is repeated several times through each bolster to
secure the abdominal wall between the underlying fastener sheet and
the external bolsters. Tension is exerted on the fastener sheet to
gradually draw the edges of the wound toward one another.
Preferably, static tension is applied by the fastener sheets to
lengthen the muscles on each side of the wound, permitting the
edges to come together. Upon drawing the wound edges near one
another, the wound can be closed using surgical closure techniques.
A bio-compatible plastic barrier is placed into the abdomen during
this entire process to keep the viscera from adhering to the
underside of the abdominal wall.
[0016] The components of this invention allow for the application
of a static tension to stretch the retracted lateral abdominal
muscles. These muscles are held in the stretched position over a
period of, for example, 36 to 72 hours, during which time they
gradually lengthen and relax. This step is repeated until the
midline facial edges are brought close enough to be suture closed.
The stretching forces are applied without damaging fascial
integrity. Once the edges of the wound have been brought together,
the wound can be closed surgically.
[0017] The present method and apparatus allows for the closure of
both acute and chronic open abdomens.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a cross sectional view through an open abdominal
wound of a patient showing a method and apparatus for closing the
open abdomen according the principles of the present invention;
[0019] FIG. 2 is a top perspective view of a bolster as used in the
present method and apparatus;
[0020] FIG. 3 is a bottom perspective view of the bolster of FIG.
2;
[0021] FIG. 4 is an enlarged bottom view of an end of the bolster
of FIG. 2;
[0022] FIG. 5 is a top view of a second embodiment of a bolster for
use in the present method and apparatus;
[0023] FIG. 6 is a bottom view of the second embodiment of the
bolster of FIG. 5;
[0024] FIG. 7 is a side view of the second embodiment of the
bolster of FIG. 5;
[0025] FIG. 8 is a top perspective view of an abdomen of a patient
with an open abdomen wound that is being prepared for closure using
the present method and apparatus;
[0026] FIG. 9 is a top perspective view of the abdomen of the
patient of FIG. 8 showing a step in the abdomen closure method;
[0027] FIG. 10 is top perspective view of the abdomen of the
patient of FIG. 8 showing another step in the abdomen closure
method;
[0028] FIG. 11 is top perspective view generally from the side of
the abdomen of the patient of FIG. 8 showing an intermediate stage
in the abdomen closure method;
[0029] FIG. 12 is top perspective view of the abdomen of the
patient of FIG. 8 showing a further step in the abdomen closure
method;
[0030] FIG. 13 is top perspective view of the abdomen of the
patient of FIG. 8 showing a suturing step in the abdomen closure
method;
[0031] FIG. 14 is top perspective view of the abdomen of the
patient of FIG. 8 showing the abdomen closed according to the
present method and apparatus;
[0032] FIG. 15 is a top perspective view of a kit according to the
present method and apparatus; and
[0033] FIG. 16 is a flow chart showing steps in the present
method.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0034] Turning first to FIG. 1, a patient 10 has an abdominal wall
12 within which is the patient's bowel and other visceral organs
14. The abdominal wall 12 includes muscles 16, fat 18, connective
tissues 20, and skin 22. An opening 24 in the abdominal wall 12 has
been formed, usually by a surgical incision although it is possible
the opening 24 may have been the result of an injury or
otherwise.
[0035] The patient's bowel and viscera 14 may have been injured as
a result of disease, accident, battlefield injury, gunshot or stab
wound, or otherwise which requires the abdominal wall to be opened
so that the surgeon can repair the injury, treat the disease,
relieve pressure within the abdominal cavity, or for other reasons.
The opening 24 in the abdominal wall 12 may not be closed at the
conclusion of the initial treatment, for example if the bowel and
viscera 14 are swollen, if the surgical repair or treatment
requires additional steps that require opening of the abdominal
cavity, or for other reasons. The result is an open abdomen wound.
The open abdomen wound may remain open for days or weeks, though
the internal organs are generally covered by a barrier sheet which
the abdominal wall is open. During this time, the muscles 16, which
include the rectus muscles as well as the transverse abdominal
muscles and the lateral oblique muscles and other tissues of the
abdominal wall retract laterally, so that it is no longer possible
to close the wound 24 by conventional surgical techniques. In
particular, the muscle fibers of the oblique and transverse muscles
of the abdomen extend horizontally and after opening of the abdomen
the unopposed forces of the oblique and transverse muscles cause
the edges of the opening to pull away from each other and prevent
the edges of the opening from being connected together again. This
is referred to as loss of domain.
[0036] A common location for the surgical opening of the abdomen is
between the two halves of the rectus muscle at the midline of the
abdomen. The pulling forces of the oblique and transverse muscles
pull the halves of the rectus muscles apart. The facial connected
between the rectus muscle halves is lost and it is desirable that
the patient regain this muscle connection. The present method and
apparatus seeks to restore anatomical integrity, the original
anatomy, of the patient.
[0037] According to the present method, a bather sheet 26 is placed
over the bowel and viscera 14. A sheet 28 of a material having a
loop structure of a hook and loop fastener is fastened in the inner
surface (the peritoneal surface) of the abdominal wall 12 at one
side of the opening 24. The loop sheet 28 is fastened by suture
stitches 30 through the loop sheet 28, and through the abdominal
wall 12 including through muscle, connective tissue, fat and skin.
The suture 30 is passed through a bolster 32 that is positioned on
the outside of the abdominal wall 12 on the surface of the skin 22.
The suture 30 is preferably tied off on the top surface of the
bolster 32. The bolster 32 acts to spread the forces that are
transmitted from the loop sheet 28 through the sutures 30 over a
larger area of the skin and thereby prevent the forces from being
concentrated on a small area.
[0038] A hook sheet 34 is secured to the abdominal wall 12 at the
opposing side of the opening 24 from the loop sheet 28. The hook
sheet 34 is sutured to the inside of the abdominal wall 12 by
suture stitches 36 and extend to a bolster 38 that is positioned on
the surface of the skin 22. The suture 36 is tied off on the
bolster 38. The hook sheet 34 is attached with the hook surface
facing toward the bowel 14 and the loop sheet 28 is attached with
the loop surface facing away from the bowel 14 so that the sheets
28 and 34 can be attached to one another. The sheets 28 and 34 form
a hook and loop fastener sheet that resists static tension forces
along the plane of the sheets and so permits the doctor to draw the
opposing sides of the opening 24 toward one another and secure the
sheets 28 and 34 to one another to hold the sides of the opening in
place, allowing the muscles and other tissues to stretch under
static tension. The tension forces exerted by the sheets 28 and 34
is distributed by the bolsters 32 and 38.
[0039] The present apparatus provides a static tensioner that
applies a static pulling force to the muscles and other tissues of
the abdominal wall. By applying the static tension or pulling
force, the muscles that have been stretched will gradually relax.
As the muscles relax, the muscles lengthen. The hook and loop
sheets loosen with the lengthening of the muscle fibers, indicating
to the medical personnel that the sheets can be again tensioned.
The tension forces are applied in steps or blocks rather than
constantly. The distribution of forces at the facial edge permits
significant forces to be applied at each step.
[0040] The loop sheet 28 and the hook sheet 34 together form a
fastener sheet. Other forms of fastener sheets are possible
according to the present invention as well. For example, plastic,
woven or non-woven fabric or other materials formed into sheets and
need not include hook and loop fasteners. The sheets should be of
sufficiently heavy material to be able to resist the tension
forces. The sheets may be folded together, rolled together,
gathered together, wrapped on one another, or otherwise secured to
one another. A fastener may be applied to the folded, rolled, or
gathered sheets to resist tension forces on the sheets. For
example, the folded, rolled or gathered portions of the sheets may
be stitched or sewn to one another, such as by suture. As the wound
closes, further folding, rolling or gathering of the sheets
together applies further tension forces to the sheets thereby
applying static tension to the wound edges. The fastener to secure
the sheets to one another may include clamps, laces, staples,
stitches, snaps, zippers, zip fasteners, or other fastener types.
In one embodiment, suture is stitched through the folded over
portions of the sheets to secure them to one another and apply the
tension that enables the present method and apparatus to close an
abdominal wound. The fasteners preferably hold the sheets together
sufficiently strongly to resist tension forces applied to the
sheets by the patient's abdominal muscles. References to hook and
loop fasteners herein encompass other fastener types as well.
[0041] The fastener sheets of a preferred embodiment are adjustable
so that as the wound is closed, additional tightening forces can be
applied. Additionally, if the need exists to release some of the
pressure from the internal organs, such as during the healing
process, the fastener sheets can be adjusted to permit the edges of
the abdominal wound to temporarily move apart reduce pressure
during the healing process.
[0042] It is envisioned that the bolster and fastener sheet
apparatus could be affixed to the abdominal wall while the viscera
is still in the swelled and healing state and the patient has an
open abdomen. The fastener sheets could be left unfastened until
the doctor is ready to close the abdominal wound. Instead, the
fastener sheets could be fastened to one another at a lower tension
to reduce the extent to which the abdominal muscles withdraw during
the open abdomen, healing stages so that less domain has to be
recovered during the abdomen closing stages. With the bolsters and
fastener sheets already in place, one less surgical procedure is
required in the closure process.
[0043] In FIG. 2, a bolster 40 of a preferred embodiment is shown.
The bolster 40 includes an elongated hard strip 42 of a flexible
plastic material that is set into a soft strip 44 of a cushioning
material such as a foam, hydrocolloid or other soft material. In
one embodiment, the soft strip is a non-latex closed cell foam. A
series of holes 46 is formed in the bolster 40 through both the
hard strip 42 and the soft strip 44, for example, along the
centerline of the elongated bolster so that the suture is passed
through the holes. In one embodiment, the holes 46 are positioned
approximately one inch apart or at another appropriate distance to
distribute the compressive forces when the suture knot is
tightened. The material of the hard strip 42 is generally a hard
plastic that resists cutting by the suture, even when subject to
considerable force. The edges of the holes are preferably rounded,
beveled or smoothed so as to avoid abrading the suture material.
The plastic strip 42 can twist and torque without deforming and it
provides a place to tie a knot in the suture. Other materials are
of course possible The soft strip 44 extends a distance beyond the
edges of the hard strip 42 to cushion the edges of the hard strip
42 from direct contact with the patient's skin. In one embodiment,
the foam 44 extends by 1/8 to 1/4 of an inch beyond the edges of
the plastic strip. The corners of the bolster 40 may be rounded to
avoid sharp corners that might dig into the patient's skin.
[0044] FIG. 3 shows the bolster 40 from the skin contact side. The
soft strip 44 covers the underside of the bolster 40 completely.
The holes 46 extend through the soft strip 44. The material of the
soft strip 44 is a biocompatible material.
[0045] Turning to FIG. 4 the bolster 40 is shown from the bottom
with a person pulling the soft strip 44 away from the hard strip 42
to reveal a slight recess 48 in the soft strip 44 into which the
hard strip 42 fits. The foam strip 44 is glued to the hard strip 42
except that an approximately one inch portion at the ends of the
hard strip 42 are not glued to the foam 44. It is also possible
that the hard strip 42 presses an indentation in the soft strip 44
or sits on top of the soft strip. The hard strip 42 and soft strip
44 may be molded together or glued together or otherwise affixed to
one another. As shown in the figure, the soft strip 44 can be
readily pulled from the hard strip 42. This permits the bolster 40
to be more easily trimmed or shortened as needed.
[0046] An alternative embodiment of a bolster 50 is shown in FIG.
5. The bolster 50 includes an elongated metal strip 52, that in one
embodiment is of aluminum although other materials may be provided
instead. The metal strip 52 has a series of holes 54 generally
along its centerline. The bolster 50 is shown from the underside in
FIG. 6. The underside is formed of foam 56. The foam strip 56
cushions the bolster 50 to prevent contact between the patient and
the metal backing strip 52. A side view of the bolster 50 is shown
in FIG. 7. The metal strip 52 on the top surface is relatively thin
so as to be flexible yet hard so as to prevent pull-through by the
sutures. The foam strip 56 or other cushioning material is
relatively thicker than the metal strip 52 and preferably several
times thicker. The metal strip 52 and foam strip 56 may be secured
to one another by glue that can be peeled apart. As the bolster is
shortened during the progression of the treatment, the foam can be
cut off and the metal strip can be coiled up at the ends should the
bolster need to be shortened.
[0047] Bolsters of two different configurations have been shown.
Other shapes, sizes, proportions, and materials of bolsters are
also possible and are within the scope of the present invention.
Utilization of the bolsters in conjunction with securing the
securing of the bolsters and fastener sheets through the abdominal
wall, preferably laterally of the rectus muscles, enables a maximum
tightening force to be applied to the abdominal wall to provide the
greatest extent of closing to the wound in the shortest time. The
bolsters and fastening arrangement enable the application of static
tension forces that allow the muscles of the abdominal wall to both
relax and lengthen.
[0048] The use of the bolsters with the through-the-abdominal-wall
attaching technique provides a facial preservative technique in
which the tissues at the edges or facia of the wound are retained
substantially without damage and with little loss of the tissues.
The bolsters are attached with regularly spaced sutures as a result
of the holes formed therein, providing a distribution of the forces
on the abdominal wall to avoid tissue damage.
[0049] In FIG. 8, a patient 60 has had a medical issue that has
caused swelling of the viscera within the abdominal cavity. The
medical issue may be, among other things, abdominal compartment
syndrome, complex abdominal trauma, profound acidosis, or other
causes. The patient has been given a laparotomy, also known as a
coeliotomy, which is a large incision in the abdominal wall to gain
access to the abdominal cavity. In the illustrated example, the
patient has been given a midline incision 62. Pressure and tissue
swelling within the abdominal cavity has caused the bowel 64,
including the large and small intestine to extend out of the
incision (bowel distension), here the result of a condition known
as edematous bowel which may have resulted from a severe motor
vehicle crash, for example. The incision 62 relieves the pressure
within the abdominal cavity, referred to as a decompressive
laparotomy, to thereby prevent the pressure from causing tissue
death within the abdominal cavity. However, the incision cannot be
closed until the swelling of the viscera decreases and the viscera
64 can be put back into the abdominal cavity.
[0050] Bolsters 66 are positioned on either side of the incision to
begin the closure of the open abdomen. The bolsters 66 are
preferably placed atop hydrocolloid sheets 68 so that a barrier is
provided between the patient's skin and the bolsters 66. The
bolsters 66 are positioned with the soft material side against the
patient and the hard side away from the patient.
[0051] In FIG. 9, the viscera or bowel 14 is covered with an
abdominal dressing 26, which is preferably a biocompatible plastic
barrier to keep the viscera from adhering to the underside of the
abdominal wall. The hook sheet 34 and the loop sheet 28 are
positioned over the biocompatible barrier and are sutured into
place through the abdominal wall and through the bolsters. The hook
and loop sheets 34 and 28 and the bolsters 66 are positioned so as
to be at or adjacent the rectus muscle of the patient for midline
incisions. Typically, the hook and loop sheets extend under the
abdominal wall several inches from the edges of the wound. The
sutures pass through all the layers of the abdominal wall. The
suture threads are tied in knots that rest on the bolsters 66. The
hook and loop sheets are compressed together to form a closure. In
its most common embodiments a negative pressure dressing is placed
over the hook sheet and loop sheet closure and negative pressure is
applied.
[0052] With reference to FIG. 10, the hook and loop fastener sheets
34 and 28 have been attached to the patient 60 using the bolsters
66 to spread the force of the sheets on the patient's tissues. The
doctor is pulling on one of the hook and loop sheets 34 and 28 to
stretch the muscles and tissues of the abdominal wall so that the
edges or facia 70 of the wound can be drawn toward one another. The
stretching of the muscles and tissues is a gradual process that is
typically performed in stages, with time between each application
of tension to permit the tissues to stretch.
[0053] Turning to FIG. 11, the hook and loop sheets 34 and 28 are
anchored along the edges of the wound with the bolsters. A strong
tension force is exerted on the tissues of the abdominal wall by
the hook and loop sheets 34 and 28 which is the result of the
tension applied by the doctor. The muscles and tissues of the
abdominal wall are stretched so that the wound is made smaller and
the edges or facia 70 are brought closer together. The bolsters 66
distribute the forces of the hook and loop fasteners 34 and 28
without damage to or loss of tissue at the edges of the wound, in
other words without loss of domain.
[0054] In FIG. 12, the closing of the wound is progressive with
further closure being accomplished in steps. Here, one doctor is
pushing the loop fastener sheet 28 in one direction to exert
tension on one edge 70 of the wound while a second doctor pulls the
hook fastener sheet 34 up and then over to engage the two sheets
with one another to further close the wound. Over the course of one
or several steps, the edges or facia 70 of the wound are brought
sufficiently close to permit the wound to be closed by surgical
methods.
[0055] FIG. 13 shows a wound 24 that has had the opposing edges or
facia 70 brought sufficiently close to one another that surgical
joining of the edges of the wound can proceed. The hook and loop
fasteners 34 and 28 and the bolsters 66 remain in place as surgical
rejoinder is begun to prevent loss of the progress made during the
closing steps. When the tissues of the abdominal cavity are
reattached to one another, the bolsters 66 and hook and loop
fasteners 34 and 28 are removed and the closure of the wound is
completed.
[0056] For wounds in which the periphery of the wound is large yet
as the wound is brought to a close position, the bolters may need
to be shortened as the closing progresses. The bolsters formed of
the plastic strip and foam can be cut by surgical instruments as
shortening is required. For the embodiments of the bolsters formed
of foam and a metal strip, the foam is cut from the end of the
bolster and the end of the metal strip that overlaid the foam is
cut away or coiled so that it is out of the way
[0057] In FIG. 14, the patient 60 shown in this procedure has had
the wound 24 closed. The abdominal walls edges 70 have been drawn
together and the tissues at the edges of the wound have retained
their integrity during the tensioning process so that the closure
doesn't have to accommodate tissue loss at the edges of the wound.
A single midline scar 72 will result without the need for a skin
graft to cover the viscera. Drain tubes 74 remain extending through
the abdominal wall on a temporary basis following the surgical
closure to permit any fluids to drain. The patient 60 can now
proceed with the healing process with a closed abdomen, without the
need for a skin graft over the viscera, and without the risk that
would be involved in closing the abdomen while the viscera was in
the swollen state. The rectus muscles are reattached so that the
patient is no longer functionally impaired.
[0058] FIG. 15 shows a kit 80 of components used by the doctor in
performing the method as shown. The kit of the preferred embodiment
includes four bolsters 66, a hook and loop fastener sheet set 82,
four or more adhesive sheets of hydrocolloid dressing 84, and a
polyurethane bio compatible viscera protecting barrier 86 to be
inserted into the abdomen while the device is in place. The kit
also includes directions to the doctor to ensure proper use of the
components of the kit. Suture for fastening the bolsters 66 and
hook and loop sheets 82 is recommended to be a number 5 braided
polyester suture (such as sold under the trade names Ethibond or
Tycron) A negative pressure dressing such as the one made by KCI or
Smith and Nephew is recommended to be used as a topical
dressing.
[0059] Other components may be provided in the kit as well. For
example, the kit may include more than four bolsters or fewer than
four bolsters. Other types of dressing sheets and barriers may be
provided instead of those mentioned above, or these may be left out
with the doctor providing his or her own choice of barrier and
dressing. Needles may be provided in the kit and the kit may even
provide the suture thread to be used to attach the hook and loop
sheets and the bolsters to the patient.
[0060] A flowchart of steps according to the present method is
shown in FIG. 16. The steps according to one embodiment of the
method include a step 90 begins the process with a patient who has
an open abdomen wound by prepping the patient and bringing them
into an operating room if not already there as a result of a prior
procedure. In step 92, the viscera including the bowel and other
organs that are exposed as a result of the open abdomen are covered
by a protective sheet. Step 94 provides that the loop sheet is
positioned at the underside or inside of the abdominal wall along a
first side of the wound. With a midline incision, the loop sheet is
inserted at least to the outer edge of the rectus muscle. Step 94
starts with positioning the loop sheet, but the doctor may chose to
begin with the hook sheet instead. The order of the steps set forth
here provide one example and other orders of steps may be performed
and are within the scope of the invention.
[0061] In step 96, the skin along the edges of the wound are
covered with a protective sheet such as a hydrocolloid sheet. Other
protective materials such as sheets or barriers may be provided as
desired. The hydrocolloid sheet or other material may be applied
only to the first side in this step, or two both sides of the
wound. This step may be performed sooner in the process, so long as
the hydrocolloid sheet or other material is in place, if desired,
prior to the attachment of the bolsters.
[0062] In step 98, the bolster is positioned on the outside of the
abdominal wall along the first edge of the wound and opposite a
portion of the loop sheet that has been positioned inside the
abdominal wall. In a midline incision, the bolster is positioned to
the outside of the rectus muscle, which typically is about two
inches from the edge of the wound.
[0063] Sewing or suturing of the loop sheet to the edge of the
abdominal wall is carried out in step 100. The suture material is
passed through an opening in the bolster, then through all the
layers of the abdominal wall and through the loop sheet using a
needle. The suture is brought back through the loop material a
distance from the initial stitch and is brought through all the
layers of the abdomen and through another opening in the bolster
using the needle. The suture may be tied off on top of the bolster
material so that a loop of the suture extends through the bolster
and abdomen wall and loop material. Another loop of suture is
formed by the same technique in an adjacent pair of holes in the
bolster. The suturing of the loop material continues along the
length of the bolster. The doctor may form suture loops through
each adjacent pair of holes in the bolster or may skip holes as
desired. It is also possible that the doctor may choose to form a
running stitch through several bolster holes or may use other
stitching techniques.
[0064] After the loop sheet has been installed, the hook sheet is
installed in much the same way as the attachment of the loop sheet.
In step 102, the hook sheet is positioned on the inside of the
abdominal wall along the second side of the wound. The hook sheet
edge is inserted to an outer edge of the rectus muscle in the
example. As noted above, the hook sheet may be installed first
before the loop sheet. The bolster is positioned on the outside of
the abdominal wall on the hydrocolloid sheet in step 104. As noted
for the loop sheet, in the example, the bolster is positioned at
the outside edge of the rectus muscle. Step 106 has the doctor
sewing the hook sheet and bolster to the abdominal wall using the
techniques noted above.
[0065] Two bolsters may be positioned along each side of the wound
so that the curved or arced edge of the wound is accommodated while
the wound is wide open by positioning the bolsters at an angle to
one another. As the wound is closed and the edges become more
linear, the angle between the two bolsters decreases until they are
generally in alignment with one another. A single bolster may be
provided on each side of the wound, or three or more bolsters may
be provided on each side as desired.
[0066] With the bolsters and hook and loop sheets in place, tension
is exerted on the sheets to draw sides of the wound toward one
another, as shown in step 108. The reinforced connection of the
sheets to the abdominal wall provided by the bolsters enables the
doctors to exert a great deal of tension force on the abdominal
wall to really stretch the muscles so as to regain domain without
damage to the tissues at the edges of the wound. In some
embodiments, the doctor can actually lift the patient from the
operating table by pulling on the hook or loop sheet. While
applying the tension forces to the sheets, the doctor affixes the
hook sheet to the loop sheet.
[0067] After the hook and loop sheets have been attached under
tension, the patient leaves the operating room and is given time
for the muscles to stretch to bring the edges of the wound closer
to one another at step 110. This time may vary depending on the
patient, the length of time that the patient had the open abdomen
(such as whether the open wound is the result of an earlier closure
by a skin graft or if it is the result of a recent medical
procedure) and other factors. In step 112, the patient is returned
to the operating room, the hook and loop sheets are disconnected
from one another and further tension forces are exerted on the
sheets to further pull the edges of the wound toward one another.
If the wound is not sufficiently closed to close the wound
surgically, as determined in step 114, the process returns to step
110 waiting for the abdominal wall to stretch.
[0068] Further tensioning steps are applied as needed until the
wound is closed sufficiently to permit the doctor to surgically
close the wound. If the determination has been made at step 114 of
sufficient closure, the wound is sutured closed at step 116. The
protective sheet, the hook and loop fasteners and the bolsters are
removed as the wound is closed. The patient may now continue
healing with a closed abdomen.
[0069] The distribution of the forces from the hook and loop
fastener sheets by the bolsters prevent damage to the tissues at
the wound edge. Tissues are not lost during the closure process,
speeding the closure process. The bolsters work with the hook and
loop sheets to close the wound.
[0070] Thus, an open abdomen wound as a result of injury or surgery
is closed using hook and loop fastener sheets or other fastener
sheets that are attached at opposing edges of the wound using
bolsters through which surgical suture thread is passed to secure
the abdominal wall between the fastener sheets and the bolsters.
Tension forces are exerted on the fastener sheets and the sheets
secured to one another in one or more steps drawing the wound edges
toward one another. The tension forces are distributed along the
length of the bolsters to avoid loss of tissue at the wound edges.
The static tension applied by the fastener sheets to the retracted
lateral muscles of the abdomen allow the muscles to be stretched to
a new relaxed position so that the open abdomen can be sutured
closed. The muscles are restored to their correct anatomical
position. The distribution of forces through the use of the
bolsters prevents damage to the facial edges of the wound to
provide a definitive facial closure. Successful closure of the
wound is thus possible.
[0071] Although other modifications and changes may be suggested by
those skilled in the art, it is the intention of the inventor to
embody within the patent warranted hereon all changes and
modifications as reasonably and properly come within the scope of
his contribution to the art.
* * * * *