U.S. patent application number 11/301196 was filed with the patent office on 2006-07-20 for surgical access port.
Invention is credited to Richard Beane, Maureen E. Carroll, Steve Ek, Randall J. Hasslinger, Allison C. Niemann, Edward I. JR. Stamm, Javier Verdura.
Application Number | 20060161049 11/301196 |
Document ID | / |
Family ID | 26980300 |
Filed Date | 2006-07-20 |
United States Patent
Application |
20060161049 |
Kind Code |
A1 |
Beane; Richard ; et
al. |
July 20, 2006 |
Surgical access port
Abstract
A device for retracting edges of an incision in a surface to
form an opening including: a flexible, tubular skirt having an
upper end, a lower end, and a channel therebetween; a ring
connected to the lower end of the skirt for maintaining the lower
end in an open configuration and defining an exit opening to the
channel; and an inflatable collar connected to the skirt and
surrounding the upper end. The ring is designed to fit through the
incision and remain under the surface when it is oriented parallel
to surface. The collar, when inflated, maintains the upper end in
an open configuration and defines an entry opening to the channel.
During use, the ring is inserted through the incision and the
collar is inflated while remaining outside of the incision, thereby
drawing the skirt against the edges of the incision and retracting
the edges of the incision to form the opening. The retracting
device can be included in a surgical access port, which further
includes a flexible sleeve connected to at least one of the
inflatable collar and the skirt, extending the channel from the
exit opening of the skirt to an open end of the flexible sleeve
distal to the skirt. The device can include a light source in the
vicinity of the exit opening.
Inventors: |
Beane; Richard; (Hingham,
MA) ; Ek; Steve; (Bolton, MA) ; Niemann;
Allison C.; (Brighton, MA) ; Carroll; Maureen E.;
(Atlanta, GA) ; Hasslinger; Randall J.;
(Alpharetta, GA) ; Stamm; Edward I. JR.; (Atlanta,
GA) ; Verdura; Javier; (Marietta, GA) |
Correspondence
Address: |
FISH & RICHARDSON PC
P.O. BOX 1022
MINNEAPOLIS
MN
55440-1022
US
|
Family ID: |
26980300 |
Appl. No.: |
11/301196 |
Filed: |
December 12, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10186806 |
Jul 1, 2002 |
7008377 |
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11301196 |
Dec 12, 2005 |
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09642438 |
Aug 21, 2000 |
6440063 |
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10186806 |
Jul 1, 2002 |
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09316192 |
May 21, 1999 |
6142936 |
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09642438 |
Aug 21, 2000 |
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08847155 |
Apr 30, 1997 |
5906577 |
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09316192 |
May 21, 1999 |
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Current U.S.
Class: |
600/207 |
Current CPC
Class: |
A61B 2090/306 20160201;
A61B 17/00234 20130101; A61B 17/3462 20130101; A61B 42/00 20160201;
A61B 2017/3484 20130101; A61B 17/3423 20130101; A61B 17/0293
20130101; A61B 2017/3419 20130101; A61B 2017/00557 20130101; A61B
90/40 20160201; A61B 90/30 20160201; A61B 42/10 20160201; A61B
17/3431 20130101; A61B 2017/3449 20130101 |
Class at
Publication: |
600/207 |
International
Class: |
A61B 1/32 20060101
A61B001/32 |
Claims
1-33. (canceled)
34. A surgical access port comprising: a retracting device
comprising an upper portion configured to overlie tissue
surrounding an incision into a patient, a lower portion insertable
through the incision and configured to underlie the tissue
surrounding the incision, and a flexible, gas-impermeable skirt
having an upper end connected to the upper portion and a lower end
connected to the lower portion, wherein the lower portion is
configured to be drawn tightly against an inner surface of the
tissue and to maintain the lower end in an open configuration, and
wherein the skirt, upper portion, and lower portion define an open
channel extending through the incision; and a seal removably
secured to the upper portion of the retracting device and
configured to selectively seal an upper end of the channel or to
seal around an object inserted through the seal.
35. The surgical access port of claim 34, wherein the skirt
comprises rubber.
36. The surgical access port of claim 34, wherein the lower portion
comprises a ring.
37. The surgical access port of claim 36, wherein the skirt
includes a hem-shaped pocket that encloses the ring.
38. The surgical access port of claim 36, wherein the ring is
formed by filling a pocket with at least one of a gas, a liquid,
and a gel.
39. The surgical access port of claim 36, wherein the ring
comprises a metal, plastic, hard rubber, or foam.
40. The surgical access port of claim 36, wherein the ring is
circular.
41. The surgical access port of claim 36, wherein the ring is
elliptical.
42. The surgical access port of claim 34, wherein the seal
comprises a valve.
43. The surgical access port of claim 34, wherein the seal
comprises an iris valve.
44. The surgical access port of claim 34, wherein the seal
comprises a cap that seals the upper end of the channel.
45. The surgical access port of claim 44, wherein the cap comprises
hard rubber, plastic, or foam.
46. A method of using the surgical access port of claim 34, the
method comprising: inserting the lower portion through the
incision; and using the flexible skirt to draw the lower portion
tight against an inner surface of the tissue, the lower portion
forming a seal around a perimeter of the incision along the inner
surface of the tissue.
47. A surgical access port comprising: a retracting device
comprising an upper portion configured to overlie tissue
surrounding an incision into a patient, a lower portion insertable
through the incision and configured to underlie the tissue
surrounding the incision, and a flexible, gas-impermeable skirt
having an upper end connected to the upper portion and a lower end
connected to the lower portion, wherein the lower portion is
configured to be drawn tightly against an inner surface of the
tissue and to maintain the lower end in an open configuration, and
wherein the skirt, upper portion, and lower portion define an open
channel extending through the incision; and a mechanical sealing
means secured to the upper portion of the retracting device and
configured to selectively seal the upper end of the channel or to
seal around an object inserted through the mechanical sealing
means.
48. The surgical access port of claim 47, wherein the lower portion
comprises a ring having a circular or elliptical shape.
49. The surgical access port of claim 48, wherein the skirt
includes a hem-shaped pocket that encloses the ring.
50. The surgical access port of claim 48, wherein the ring is
formed by filling a pocket with at least one of a gas, a liquid,
and a gel.
51. The surgical access port of claim 48, wherein the ring
comprises a metal, plastic, hard rubber, or foam.
52. The surgical access port of claim 47, wherein the mechanical
sealing means comprises at least one of a valve, an iris valve, and
a cap.
53. The surgical access port of claim 52, wherein the cap comprises
hard rubber, plastic or foam.
54. A method, comprising: inserting a lower portion of a flexible,
gas-impermeable skirt of a retracting device through an incision in
a surface of a tissue in a patient and orienting the lower portion
to underlie an inner surface of tissue surrounding the incision;
orienting an upper portion of the skirt to overlie an outer surface
of tissue surrounding the incision; and using the flexible skirt to
draw the lower portion tight against the inner surface of tissue
surrounding the incision to form a seal around a perimeter of the
incision along the inner surface, and to further retract the
incision into an opening and provide a channel through the
incision.
55. The method of claim 54, further comprising sealing the channel
by attaching to the upper portion at least one of a valve, an iris
valve, and a cap.
56. The method of claim 54, further comprising releasably attaching
to the upper portion a gas-impermeable sleeve in order to extend
the channel away from the incision.
57. A method of performing minimally invasive surgery, the method
comprising: extending the channel away from the incision using the
method of claim 56; and accessing an interior of the patient
through the channel.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates to the field of surgical devices.
More particularly, the invention relates to a surgical access port,
which provides a gas-tight seal for a hand or instrument to be
inserted through the opening into a patient's body cavity.
[0002] Abdominal surgery typically involves an incision in the
abdominal wall large enough to accommodate a surgeon's hands,
multiple instruments, and illumination of the body cavity. While
large incisions simplify access to the body cavity during a
surgery, they also increase trauma, require extended recovery time,
and can result in unsightly scars. In response to these drawbacks,
minimally invasive surgical methods have been developed.
[0003] In minimally invasive abdominal surgery, several smaller
incision are made into the abdominal wall. One of the openings is
use to inflate the abdominal cavity with gas, which lifts the
abdominal wall away from underlying organs and provides space to
perform the desired surgery. This process is referred to as
insufflation of the body cavity. Additional openings can be used to
accommodate instruments for illuminating and viewing the cavity, as
well as instruments involved in actually performing the surgery,
e.g., instruments to manipulate, cut, or resect organs and tissue.
While minimally invasive surgical methods overcome certain
drawbacks of traditional methods, there are still various
disadvantages. In particular, there is limited tactile feedback
from the manipulated tissue to the surgeon hands. Also, tissue that
is to be removed from the body cavity must be removed in pieces
that are small enough to fit through one of the incisions.
[0004] Recently, new surgical methods have been developed that
combine the advantages of the traditional and minimally invasive
methods. In these new methods, small incisions are still used to
inflate, illuminate, and view the body cavity, but in addition, an
intermediate incision is made into the abdominal wall to
accommodate the surgeon's hand. The intermediate incision must be
properly retracted to provide a suitable-sized opening, and the
perimeter of the opening is typically protected with a surgical
drape to prevent bacterial infection. A sealing mechanism is also
required to prevent the loss of insufflation gases while the
surgeon's hand is either inserted into or removed from the body
cavity though the retracted incision.
SUMMARY OF THE INVENTION
[0005] The invention features a surgical access port that allows a
surgeon's hand or instrument to access a patient's body cavity
through a sealed opening. The access port includes two parts, a
wound retractor and a sealing sleeve. The wound retractor is
designed to retract the edges of an incision made into a body
cavity into an opening, and to seal around the edges of the
opening, thereby forming a gas-tight connection between the body
cavity and the interior of the access port. The sealing sleeve
connects to the wound retractor external to the body cavity and
provides a path for a surgeon to insert his hand through the
opening formed by the wound retractor. The sealing sleeve seals
around a surgeon's arm or a surgeon's glove, when the surgeon's
hand is inserted into the body cavity, and seals the opening when
the surgeon's hand is removed from the access port. Thus, the port
provides hand access to the body cavity, and prevents gases in the
body cavity, such as insufflation gases, from escaping into the
surroundings.
[0006] In general, in one aspect, the invention features a device
for retracting edges of an incision in a surface to form an
opening. The device includes: a flexible, tubular skirt having an
upper end, a lower end, and a channel therebetween; a ring
connected to the lower end of the skirt for maintaining the lower
end in an open configuration and defining an exit opening to the
channel; and an inflatable collar connected to the skirt and
surrounding the upper end. The ring is designed to fit through the
incision and remain under the surface when it is oriented parallel
to the surface. The collar, when inflated, maintains the upper end
in an open configuration and defines an entry opening to the
channel. During use, the ring is inserted through the incision and
the collar is inflated while remaining outside of the incision,
thereby drawing the skirt against the edges of the incision and
retracting the edges of the incision to form the opening.
[0007] The retracting device can include the following features.
The collar when fully inflated has an inner aperture having a
diameter greater than the length of the incision. The device can
also include a light source, such as an optic fiber or fiber optic
cable, connected to the lower end of the skirt. The skirt can
include a hem-shaped pocket that encloses the ring. The ring can be
formed by filling a pocket with at least one of a gas and a liquid.
The ring can have a substantially elliptical shape. The device can
also include a second ring adjacent to an outer perimeter of the
inflatable collar for reinforcing the entry opening, as well as a
detachable cap, adapted to be received by the second ring, for
sealing the entry opening. Furthermore, the device can include an
inflatable cuff connected to an inner wall of the skirt and
surrounding the entry opening for sealing around a surgeon's arm
inserted into the channel, as well as a detachable plug, adapted to
be received by the inflatable cuff, for covering the entry
opening.
[0008] The retracting device can be included in a surgical access
port, which further includes a flexible sleeve connected to at
least one of the inflatable collar and the skirt, extending the
channel from the exit opening of the skirt to an open end of the
flexible sleeve distal to the skirt. In some embodiments, the
flexible sleeve can be removed and reattached to the device, or it
can be permanently affixed. The access port can include a light
source connected to the skirt in the vicinity of the exit opening,
and the flexible sleeve can include an iris valve.
[0009] In one embodiment of the access port, the flexible sleeve
includes an inner sleeve and an outer sleeve forming a chamber
therebetween, and an inlet port for inflating the chamber, whereby
inflating the chamber compresses together a central portion of the
inner sleeve, thereby sealing the channel. A pair of drawstrings
can be attached to opposite sides of the central portion of the
inner sleeve and pull the sides in opposite directions toward the
outer sleeve, thereby collapsing the central portion of the inner
sleeve into two flattened portions contacting each other to form a
seal. Furthermore, the central portion of the inner sleeve can
include two sealed regions opposite one another in which
immediately adjacent portions of the inner sleeve are welded
together, thereby dividing the central portion into two
substantially flattened portions extending along the length of the
channel adjacent to one another.
[0010] In another embodiment, the access port includes a flap valve
that connects to the open end of the flexible sleeve and extends
into the channel. The flap valve seals the channel when there is a
positive pressure differential between the channel and the
surroundings. A pair of drawstrings can be attached to opposite
ends of the flap valve and pull the ends in opposite directions to
enhance the sealing ability of the flap valve.
[0011] In a further embodiment, the access port includes an
inflatable cuff attached to an inner surface of the sleeve for
sealing around a surgeon's arm. The inflatable cuff can be
surrounded by a backing of a substantially non-expandable material.
Furthermore, a second ring can be connected to the sleeve and
surround the open end of the sleeve. To seal the open end, a
detachable cap adapted to be received by the second ring can be
used.
[0012] In another embodiment, the access port can include a sealing
collar attached to the sleeve and surrounding the open end, and a
glove having a flange at the open end of the glove. The sealing
collar can have a groove along its inner perimeter that mates with
or engages the flange and seals the channel when inserted into the
groove.
[0013] In a related embodiment, the access port includes a sealing
collar attached to the sleeve and surrounding the open end, and a
glove having an enlarged cuff. The sealing collar including an
inwardly expanding inflatable bladder that mates with the enlarged
cuff and seals the opening when the glove is inserted into the
sleeve.
[0014] In another related embodiment, the access port includes a
sealing collar attached to the sleeve and surrounding the open end,
a bracelet having a fixed diameter, and a surgical glove. The
sealing collar has a groove along its inner perimeter that mates
with the bracelet. During use, the bracelet is worn by a surgeon
underneath the surgical glove and is mated to the sealing collar so
that a portion of the glove is held within the groove by the
bracelet, thereby sealing the channel.
[0015] In another aspect, the invention features a surgical access
port, for use with a surgical glove, including a device for
retracting the edges of a surgical incision to form an opening into
a patient's body cavity, a sealing sleeve attached to the device
external to the body cavity, and a semi-rigid bracelet having a
fixed diameter. The sealing sleeve includes a flexible sleeve
providing a channel from its open end distal to the retracting
device through to the opening, and a sealing collar attached to the
sleeve and surrounding the open end that mates with the bracelet.
During use, the bracelet is worn by a surgeon underneath the
surgical glove and is mated to the sealing collar, thereby
fastening a portion of the glove to the sealing collar and sealing
the channel. In some embodiments, the access port further includes
the surgical glove.
[0016] The invention also features a method of using the new access
ports. The steps include: placing the bracelet around an arm of the
surgeon; placing the glove over a hand of the surgeon so that the
glove extends over the bracelet; inserting the gloved hand into the
access port; and attaching the portion of the inserted glove to the
access port by mating the bracelet with the sealing collar of the
access port.
[0017] In further aspects, the invention features a surgical access
port including a device for retracting the edges of a surgical
incision to form an opening into a patient's body cavity and a
sealing sleeve attached to the device external to the body cavity.
The sealing sleeve includes a flexible sleeve providing a channel
from its open end distal to the retracting device through to the
opening and a mechanism for sealing the channel. The mechanism
includes drawstrings.
[0018] In one embodiment, the sealing sleeve further includes an
outer sleeve surrounding the flexible sleeve and forming a chamber
therebetween, and an inlet port for inflating the chamber.
Inflating the chamber compresses together a central portion of the
flexible sleeve, thereby sealing the channel. The drawstrings
attach to opposite sides of the central portion of the flexible
sleeve, pulling the sides in opposite directions toward the outer
sleeve, thereby imparting a preferred flattened geometry to the
central portion of the inner sleeve and enhancing the seal.
[0019] In another embodiment, the mechanism further includes a flap
valve that connects to the open end of the flexible sleeve and
extends into the channel. The flap valve seals the channel when
there is a positive pressure differential between the channel and
the surroundings. The drawstrings attach to opposite ends of the
flap valve, pulling the ends in opposite directions, enhancing the
sealing ability of the flap valve.
[0020] Unless otherwise defined, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs. Although
methods and materials similar or equivalent to those described
herein can be used in the practice or testing of the present
invention, suitable methods and materials are described below. All
publications, patent applications, patents, and other references
mentioned herein are incorporated by reference in their entirety.
In case of conflict, the present specification, including
definitions, will control. In addition, the materials, methods, and
examples are illustrative only and not intended to be limiting.
[0021] The invention has the following advantages.
[0022] Since the edges of the incision are retracted by simply
inflating the collars, the wound retractor is easy to use.
Furthermore, the wound retractor provides a seal around the
perimeter of a retracted wound, from the inner abdominal wall to
the surface of the skin. The seal prevents infection and provides a
gas-tight connection between the body cavity and the remainder of
the access port.
[0023] In the sealing sleeve portion of the access port, the flap
valve and the inner sleeve, which is compressed by the inflatable
chamber, provide a gas-tight seal around a surgeon's arm when the
surgeon's hand is inserted into a patient's body cavity. This seal
prevents insufflation gases from escaping. The effectiveness of
this seal is improved by the drawstrings.
[0024] A light source connected to the base of the wound retractor
can be used to illuminate the body cavity, making additional
incisions for endoscopic illuminating means unnecessary.
[0025] Other features and advantages of the invention will be
apparent from the following detailed description, and from the
claims.
BRIEF DESCRIPTION OF THE DRAWING
[0026] FIG. 1 is a cross-sectional view of a surgical access
port.
[0027] FIGS. 2A to 2E illustrate the steps in using the wound
retractor portion of the access port of FIG. 1.
[0028] FIG. 3 is a cross-sectional view of a another embodiment the
surgical access port of FIG. 1.
[0029] FIG. 4 is a cross-sectional view of a another embodiment of
a surgical access port.
[0030] FIG. 5 is a schematic of a modular surgical access port.
[0031] FIGS. 6A and 6B are schematic views of an iris valve in open
and closed configurations, respectively.
[0032] FIGS. 7A and 7B are a cross-sectional views of another
embodiment of a surgical access port.
[0033] FIG. 8 is a cross-sectional view of an embodiment of a wound
retractor.
[0034] FIG. 9 is a cross-sectional view of another embodiment of a
wound retractor.
[0035] FIG. 10 is a perspective view of an embodiment of the access
port employing a glove.
[0036] FIG. 11 is a perspective view of another embodiment of the
access port employing a glove.
[0037] FIG. 12 is a perspective view of a further embodiment of the
access port employing a glove.
[0038] FIG. 13 is a schematic of a wound retractor having a light
source for illuminating the body cavity.
DETAILED DESCRIPTION
[0039] The surgical access port is best described as having two
parts, a wound retractor and a sealing sleeve.
[0040] The wound retractor includes a flexible tubular skirt having
a first end reinforced with a stiff ring so that the first end is
maintained in an open orientation, and a second end surrounded by
one or more inflatable collars. The reinforced first end is
inserted into the body cavity through an incision, providing a
channel through the skirt from the outside to the inside of the
body cavity. During use, the collars are inflated, thereby drawing
out skirt within the incision and pulling the reinforced first end
of the skirt tight against the inner wall of the patient's skin. As
a result, the edges of the incision are retracted into an opening
and the skirt seals around the perimeter of the opening along the
inner abdominal wall to the outer surface of the skin.
[0041] A sealing sleeve is attached to the wound retractor portion
above the inflatable collars. The sealing sleeve has an entry
opening distal to the collars and extends the channel provided by
the skirt. Within the sealing sleeve, a gas-tight seal is provided
for conforming to the shape of an object (e.g., a hand or
instrument) inserted through the channel into the body cavity.
[0042] Alternatively, the sealing sleeve can include means for
attaching a surgeons glove to the entry opening of the sleeve. In
these cases, the exterior of the glove seals the channel while a
surgeon's hand can be inserted into the interior of the glove and
access the body cavity.
Surgical Access Ports
[0043] As shown in FIG. 1, surgical access port 62 is a sleeve-like
device having an entry opening 12 and an exit opening 18. During
use, a surgeon inserts a hand into the entry opening 12 and
accesses a patient's body cavity through exit opening 18, after the
access port is inserted into the body cavity through an incision,
and prevents gases used to insufflate the body cavity from escaping
through the incision. A flexible skirt 66 surrounds exit opening 18
and has a hem-like pocket 63 at its end proximal to exit opening
18. Pocket 63 encloses a ring 64 so that the skirt and exit opening
18 are maintained in an open, substantially circular or elliptical
orientation. Skirt 66 extends upward from exit opening 18 towards
one or more inflatable collars 68 and 69 that surround skirt 66.
The upper end of skirt 66 is connected to the upper-most collar 69,
from the inner circumference of collar 69 to the top of collar 69.
Each of the inflatable collars 68 and 69 respectively enclose an
annular region. The annular regions may or may not be in fluid
contact with one another, but they are isolated from the rest of
the sleeve, body cavity, and surrounding. The collars 68 and 69 are
inflated through one or more inlet ports 11. When collars 68 and 69
are in fluid communication with one another, only a single inlet
port 11 is required.
[0044] An outer sleeve 10 is attached to the upper end of skirt 66
and extends upward towards entry opening 12. Outer sleeve 10
encloses an upper chamber 16, which is in fluid contact with gases
from the body cavity when exit opening 18 is inserted through an
incision into the body cavity. Outer sleeve 10 is inverted at the
entry opening 12 forming a flap valve 14, which seals upper chamber
16 from the surroundings external to entry opening 12.
[0045] The lower portion of access port 62, which includes ring 64,
skirt 66, and inflatable collars 68 and 69, form the wound
retractor. During use, an incision 50, e.g., in the shape of a slit
(FIG. 2A) is first made in the patient's abdominal wall 52. Ring 64
and the attached portion of skirt 66 are then inserted into the
body cavity through incision 50 with collars 68 and 69 being
uninflated and remaining external to incision 50 (FIG. 2B). If ring
64 is circular and has a diameter less than the length of incision
50, it is inserted perpendicular to abdominal wall 52.
Alternatively, if ring 64 is circular and its diameter is greater
than the length of incision 50, ring 64 must be flexible enough to
fit through incision 50 in a deformed state. Most preferably, ring
64 is rigid and has an elliptical shape with a maximum diameter
longer than the length of incision 50 and a minimum diameter
shorter than the length of incision 50. In this case, rigid ring 64
is inserted into the body cavity by orienting its minimum diameter
parallel to incision 50.
[0046] Once ring 64 is within the body cavity, it is oriented so
that it is parallel to the abdominal wall 52 (FIGS. 2C and 2D).
FIGS. 2C and 2D are cross-section views along the length and width,
respectively, of incision 50, with collars 68 and 69 remaining
uninflated. In this configuration, the diameter and stiffness of
ring 64 are sufficient to prevent it from being pulled back through
incision 50. The collars 68 and 69, which have diameters equal to
or greater than the length of incision 50, are then inflated though
inlet port 11. Collars 68 and 69 initially rest above abdominal
wall 52 around incision 50. As collars 68 and 69 are inflated, they
expand upward and their inner circumferences expand radially
outwardly (FIG. 2E). Since the upper end of skirt 66 is connected
to the inner circumference of the upper-most collar 69, skirt 66 is
also drawn upwards and radially outward, thereby drawing ring 64
tightly against the inner surface of abdominal wall 52. As a
result, the intermediate portion of skirt 66 is drawn tightly
against the edges of incision 50, retracting the adjacent tissue
and producing an opening into the body cavity and a gas-tight seal
between the body cavity and the remainder of access port 62. FIG.
2E illustrate a cross-sectional view of incision 50 with collars 68
and 69 being inflated.
[0047] Once the wound retractor of access port 62 has provided a
gas-tight seal around incision 50, the body cavity is inflated with
gas. The gas also expands into upper chamber 16, inflating the
upper portion of access port 62. The pressure within upper chamber
16 seals flap valve 14, which prevents gas from escaping through
entry opening 12. The portion of flap valve 14 distal to entry
opening 12 has a preferred flattened orientation formed by heat
sealing side portions 15a and 15b of flap valve 14 (FIG. 3). As the
flap valve extends upward towards entry opening 12, it opens into
an approximately circular geometry. During use, the surgeon inserts
his hand into upper chamber 16 through entry opening 12 and flap
valve 14. Insertion of the surgeon's hand momentarily breaks the
seal between side portions 15a and 15b of flap valve 14, but
thereafter the pressure within upper chamber seals flap valve 14
around the surgeon's arm. The loss of insufflation gases is thereby
minimized during insertion and subsequent removal of the surgeon's
hand. Since these gas losses are small, they can be compensated for
easily by known pumping means used for inflating and regulating
pressure in the body cavity.
[0048] To prevent flap valve 14 from everting as a result of
positive pressure in the upper chamber, the portion of the access
port extending from the upper portion of outer sleeve 10 toward
flap valve 14 along entry opening 12 can be reinforced with
additional material to stiffen the access port in this region, and
to maintain the preferred orientation, i.e., to prevent
eversion.
[0049] In addition or alternatively, heat-sealed side portions 15a
and 15b can be provided with eyelet openings 20a and 20b through
which drawstring 22a and 22b are attached (FIG. 3). Drawstrings 22a
and 22b extend in opposite directions such that tension placed upon
them pulls the two walls of flap valve 14 into close approximation.
The drawstrings pass through the walls of outer sleeve 10 via
drawstring ports 24a and 24b. Drawstring ports 24a and 24b form a
friction fit around drawstrings 22a and 22b sealing upper chamber
16 from the surroundings and fixing the respective lengths of the
drawstrings in upper chamber 16. Tension on drawstrings 22a and 22b
can be increased by pulling on the drawstrings from the outside of
outer sleeve 10, even as access port 62 is in use. In certain
embodiments, drawstring ports 24a and 24b can further include
one-way releasable locking mechanisms so that tension on the
drawstrings can be increased and decreased from the outside of
outer sleeve 10. The drawstrings prevent the inversion of flap
valve 14 when upper chamber 16 is inflated and enhance the
effectiveness of the flap valve seal, with and without insertion of
a surgeon's hand.
[0050] In an alternative embodiment, drawstrings 22a and 22b are
made of an elastic material and fixedly attached to the inner wall
of outer sleeve 10. In this embodiment, the drawstrings do not
extend outward through outer sleeve 10 and so the tension on them
is not adjustable. Instead, the drawstrings are cut to a specific
length to provide a preset tension on the flap valve opening when
the upper chamber is fully expanded.
[0051] FIG. 4 shows another embodiment of hand access port 62,
which differs from the embodiments described previously in the
following way. Flap valve 14 is replaced with a flexible and
expandable inner sleeve 30 that extends from entry opening 12 and
attaches to skirt 66 near the upper-most collar. As a result, upper
chamber 32 is completely isolated from the body cavity and the
surroundings. Instead of being inflated by insufflation gases from
the body cavity, upper chamber 32 is inflated separately through
inlet port 34.
[0052] The interior of inner sleeve 30 provides a channel from
entry opening 12 to the wound retractor. When upper chamber 32 is
inflated, the positive pressure in upper chamber 32 collapses
together the walls of expandable inner sleeve 30, thereby sealing
the channel, or alternatively, sealing inner sleeve 30 around the
arm of a surgeon.
[0053] Inner sleeve 30 includes a central portion having a
flattened orientation formed by heat sealing side portions 38a and
38b. Hence, the circumference of inner sleeve 30 begins
substantially circular near entry opening 12, becomes elongate in
the vicinity of side portions 38a and 38b, and becomes
substantially circular again in the vicinity of collars 68 and 69.
As described previously, the access port can also include eyelet
openings 40a and 40b in side portions 38a and 38b, through which
drawstrings 42a and 42b are attached, respectively. The drawstrings
extend outwardly through drawstring ports 44a and 44b. When upper
chamber 32 is inflated to a pressure greater than the pressure in
the body cavity and the surroundings, the positive pressure
collapses together the walls of inner sleeve 30 between side
portions 38a and 38b, sealing the body cavity from entry opening
12. As a result of drawstrings 42a and 42b, this seal is
enhanced.
[0054] During use of this embodiment, the wound retractor portion
of access port 62 is implemented as described previously (and shown
in FIGS. 2A-2E). Upper chamber 32 is then inflated, sealing the
body cavity from the surroundings. Following this step, the body
cavity is insufflated. If the pressure in the body cavity is
greater than pressure in upper chamber 32, the seal will leak
insufflation gas to the surroundings, otherwise the seal will be
maintained. In this way, the isolated upper chamber 32 insures that
the insufflation pressure in the body cavity will remain below the
pressure in the upper chamber. As the surgeon inserts his hand
through access port 62 and into the body cavity, the positive
pressure from upper chamber 32 will force inner sleeve 30 to
conform to the shape of the surgeon's arm, thereby maintaining the
seal. As mentioned before, any loss of insufflation gas during the
insertion and removal of the surgeon's hand can be compensated for
by the insufflation pump.
[0055] Access port 62 may further include a one-way relief valve
46, such as a duck-billed relief valve, between upper chamber 32
and a region within inner sleeve 30 proximal to inflatable collars
68 and 69. A duck-billed relief valve is a one-way valve that opens
when there is a sufficient pressure differential between opposite
sides of the valve. In this embodiment, relief valve 46 would begin
to leak if the pressure in upper chamber 32 became too large. For
example, when the surgeon's arm is within inner sleeve 30, the
volume of upper chamber 32 becomes compressed, thereby increasing
the pressure within upper chamber 32 and against the surgeon's arm.
This may be uncomfortable for the surgeon. Advantageously, relief
valve 46 would optimize the effectiveness of the seal around the
surgeon's arm and the comfort of the surgeon by releasing gas from
upper chamber 32 to the body cavity. The insufflation pump used to
inflate upper chamber 32 could compensate for any loss of gas from
upper chamber 32 that may be required to maintain an effective seal
once the surgeon removes his hand.
[0056] Relief valve 46 also allows the body cavity to be
insufflated with the same pump used to inflate upper chamber 32.
Once the pressure in upper chamber 32 reaches a preset value, gas
will leak through relief valve 46 insufflating the body cavity. The
seal between the entry opening and the body cavity will be
maintained since the pressure in upper chamber will remain larger
than the pressure in the body cavity. In a further embodiment, the
access port includes a second one-way relief valve extending from
inflatable collars 68 and 69 to the upper chamber. Thus, a single
pumping means could be used to first inflate collars 68 and 69,
then inflate upper chamber 32, and finally inflate the body cavity.
The relief valves would require that the pressure in collars 68 and
69 is greater than the pressure in upper chamber 32, which is
greater than the pressure in the body cavity.
[0057] A relief valve may also be positioned between upper chamber
32 and a region of inner sleeve 30 proximal to entry opening 12. In
this case gas will leak for the upper chamber into the
surroundings.
Access Port Variations
[0058] In another embodiment, the access port described above
having an inner and outer sleeve can also include a second pair of
drawstrings for imparting a second region of the inner sleeve with
a preferred flattened geometry. Thus, when the seal formed by the
first flattened region is broken during the insertion or removal of
a surgeon's hand, pressure from the inflated upper chamber provides
a second seal at the second flattened region, or vice-versa.
[0059] Alternatively, for any of the embodiments described
previously, a flap valve can be connected to the skirt and extend
into the wound retractor, thereby providing a second seal on the
surgeon's arm. Thus, when the surgeon's hand breaks either seal,
the remaining seal prevents the escape of insufflation gases.
[0060] In a further embodiment, the surgical access port can be
modular as shown in FIG. 5, comprising a wound retractor 200 (as
described above) and a sealing sleeve 202. Depending on the
particular embodiment, the sealing sleeve could, for example,
include an outer sleeve having a flap valve seal within an entry
opening (e.g., the embodiment shown in FIG. 1) or an inflatable
chamber formed between an inner and outer sleeve (e.g., the
embodiment shown in FIG. 4). For surgical procedures that do not
require insufflation of the body cavity, the wound retractor can be
used on its own for retracting an incision to make an opening into
the body cavity. When insufflation of the body cavity is necessary,
the sealing sleeve is attached to the wound retractor using a
reusable gas-tight attachment means 204, such as a zip-lock seal.
Alternatively, for example, the attachment means can include a
compression or threaded fit between a pair of semi-rigid collars
attached to the sealing sleeve and wound retractor, respectively.
Otherwise, the surgical access port is structured and functions
similarly to the embodiments described above.
[0061] In other embodiments, the wound retractors described herein
can be used with other types of sealing sleeves. In particular,
rather than sealing means based on inflation, mechanical sealing
means well known in the art can be provided. For example, as shown
in FIGS. 6A and 6B, the sealing sleeve can include an iris valve 76
attached to the upper end of the skirt above the inflatable
collars. The iris valve is formed from two stiff rings 70 and 72
attached to opposite ends of a tubular piece 74 of elastic material
(FIG. 6A). In this configuration, iris valve 76 is open. To seal
the opening, or alternatively, to seal around a surgeon's arm
inserted through the opening, the upper ring 72 is rotated relative
to the lower ring 70, as a result tubular piece of elastic material
74 becomes twisted and the opening through the tubular piece
contracts (FIG. 6B). To lock the relative positions of the upper
and lower rings, the rings are attached to one another using a
clasping mechanism 78 and 80, e.g., a latch.
[0062] Alternatively, for example, the lower ring can be provided
with upright pegs evenly spaced around its circumference. The
upright pegs fit into corresponding openings in the upper ring, so
that when the upper ring is placed on the lower ring the rotational
position of the rings relative to one another is fixed.
[0063] Another embodiment of a sealing sleeve 101 is shown in FIGS.
7A and 7B. The top end 108 of sleeve 10 is maintained in an open
configuration by its connection to a rigid ring 110. Just below
rigid ring 110, the inner wall of sleeve 100 is connected to an
inflatable cuff 112, which is made out of an expanding, elastomeric
material (e.g., rubber). Surrounding inflatable cuff 112 on the
outside of sleeve 10 is a stiff backing 100 of a close-fitting
non-expanding material (e.g., a nylon weave). Since backing 100 is
non-expanding, cuff 112 will expand inward when inflated, thereby
sealing around a surgeon's arm when the surgeon's hand is inserted
through the channel formed by wound retractor 106. Furthermore,
since there is a region of flexible material between cuff 112 and
wound retractor 106, the surgeon can easily alter the angle of his
arm and the penetration depth of his hand, without jeopardizing the
seal formed by cuff 112. When the surgeon's hand is removed from
the access port, cuff 112 can be inflated further to completely
seal the channel.
[0064] Alternatively, to seal the channel when the surgeon's hand
is removed, rigid ring 110 can receive a snap-on cap 114 (FIG. 7B),
which covers the opening at the top end 108 of sleeve 100. The cap
is made of a semi-flexible material, which includes, for example,
hard rubber, polyvinyl chloride (PVC), and foam. Cap 114 includes a
groove 117, above a lower inner lip 116, that mates with rigid ring
110. The mechanical pressure created by a slight undersizing of the
diameter of groove 117 above inner lip 116 relative to the diameter
of rigid ring 110 forms a tight seal. Cap 114 can also include
instrument ports 118 and 120, which provide gas-tight sealable
openings into the body cavity for surgical instruments (e.g.,
trocars, cannulas, and endoscopes).
[0065] In another embodiment, shown in FIG. 8, the wound retractor
described previously can further include a rigid ring 210
surrounding the outer perimeter of inflatable collars 68 and 69.
For example, skirt 66 can extend over, and connect to, the outer
perimeter of inflatable collars 68 and 69, enclosing rigid ring 210
between these collars. Alternatively, for example, one of the
inflatable collars can include additional material for enclosing
rigid ring 210 around the outer perimeter of that collar. Rigid
ring 210 will help prevent collars 68 and 69 from deforming in
response to forces from the retracted opening when inflated, and
will provide structure to the top part of a wound retractor 212
when collars 68 and 69 are uninflated. Furthermore, rigid ring 210
allows snap-on cap 114 to directly cover the channel provided by
wound retractor 212. Cap 114 is mounted onto ring 210 by a
compression fit. The diameter of rigid ring 210 is slightly larger
than the diameter of groove 117 above lower lip 116, thereby
forming a tight seal.
[0066] As shown in FIG. 9, wound retractor 224 can further include
an inflatable cuff 220 attached directly to skirt 66 of the wound
retractor adjacent to the inner perimeter of inflatable collars 68
and 69. In this case, wound retractor 224 includes a sealing means
for the channel into the body cavity (i.e., cuff 220) and a sealing
sleeve is unnecessary. Cuff 220 is made of an expandable,
elastomeric material and will expand inward when inflated, sealing
around a surgeons arm that is inserted through the channel formed
by wound retractor 224. When the surgeon's arm is removed, cuff 220
can either be inflated to completely seal the channel, or
alternatively, cuff 220 can receive a sealing plug 230. After plug
230 is inserted into wound retractor 224, inflated cuff 220, when
inflated, fits securely within recessed groove 232, thereby sealing
the channel. As with cap 114, sealing plug 230 can include one or
more sealable instrument ports 234 for inserting instruments into
the body cavity through wound retractor 224.
Access Port Variations Using a Glove
[0067] In another series of embodiments shown in FIGS. 10-12, a
seal is made between the cuff of a glove worn by the surgeon and
the opening of the sealing sleeve. A wound retractor 300 of an
access port 302 provides an opening through an abdominal wall 304
into a body cavity 306. A flexible tubular sleeve 310 is attached
to wound retractor 300 external to body cavity 306, extending the
channel formed by wound retractor 300 to an entry opening 312 of
sleeve 310. A sealing collar 314 is connected to sleeve 310
surrounding entry opening 312. Sealing collar 314 is for mating to
an enlarged cuff 317 of a glove 316 worn by a surgeon, thereby
sealing the channel from the surroundings.
[0068] Sleeve 310 can be provided with a means for closing the
channel along an intermediate portion 318 of sleeve 310 to seal the
opening to body cavity 306. For example, along a circumference 322
of intermediate portion 318, sleeve 310 can attach to a drawstring
320, which can be drawn up external to sleeve 310 (FIG. 10). When
drawstring 320 is drawn up, circumference 322 contracts until the
channel into body cavity 306 is completely covered by sleeve 310.
In another embodiment, shown in FIG. 11, intermediate portion 318
can be closed by a "bear-trap" clamp 330 comprising two hinged
arcuate bands 332 and 334 connected to the base of sleeve 310. When
bands 332 and 334 extend away from one another, they surround the
base of sleeve 310 and the channel remains open. As bands 332 and
334 are brought together above wound retractor 300, they force
together opposite inner surfaces of sleeve 310, thereby closing the
channel and sealing the opening to body cavity 306.
[0069] In a further embodiment, shown in FIG. 12, inner surfaces of
intermediate portion 318 of sleeve 310 include a zip-lock seal 340
for sealing the opening to body cavity 306. In other embodiments, a
separate mechanical clamp can be used to hold inner surfaces of
intermediate portion 318 together, thereby closing the channel.
[0070] During use, the closing means is used to seal the opening
into body cavity 306 formed by wound retractor 300. Body cavity 306
is then insufflated, with the closing means preventing the escape
of insufflation gases into the surroundings. Cuff 317 of surgeon's
glove 316 is then mated with sealing collar 314 and the closing
means is released so that the surgeon's gloved hand can access body
cavity 306. The open end of sleeve 310 is sealed to enlarged cuff
317, preventing the escape of insufflation gases even though the
closing means surrounding intermediate portion 318 is not in use.
The length of flexible sleeve 310 provides the surgeon's arm with a
sufficient movement range. When the surgeon brings his gloved hand
above intermediate portion 318, the closing means can be reset,
thereby resealing the opening to body cavity 306. Thereafter,
enlarged cuff 317 is detached from sealing collar 314 and the
surgeon's gloved hand is removed from access port 302.
[0071] In one embodiment, enlarged cuff 317 includes a
radially-outwardly extending flange 350 that mates with an inner
groove 352 within sealing collar 314. Flange 350 is made of a
semi-rigid material (e.g., plastic or rubber) that is sufficiently
deformable for flange 350 to be inserted into sealing collar 314
and mate with groove 352 (FIG. 10).
[0072] In the above embodiment, glove 316 can be a standard
surgical glove and flange 350 can be formed by placing a bracelet
over the surgeon's gloved hand and mounting the bracelet to the
wrist portion of the glove using an adhesive material. In order to
seal the channel, the bracelet is designed to mate with groove
352.
[0073] Alternatively, a bracelet 360 can be worn underneath glove
316 (FIGS. 11-12). Again, glove 316 is a standard surgical glove,
which is typically made of a flexible and semi-elastic material
(e.g., latex, natural rubber, or polymeric materials). In this
case, the surgeon places a bracelet 360 around his wrist and then
pulls glove 316 over his hand and the bracelet. Glove 316 conforms
to the shape of bracelet 360, thereby forming enlarged cuff 317,
which completely surrounds the wrist of the surgeon and can mate
with sealing collar 314.
[0074] In these embodiments, bracelet 360 is made of a
substantially rigid or semi-rigid material (e.g., an o-ring made of
hard rubber) and has a fixed diameter. Sealing collar 314 can
comprise an inflatable bladder 364 for expanding against and mating
with enlarged cuff 317 (FIG. 11). Sealing collar 314 can also be
made of a semi-compressible material (e.g., foam or a gel-filled
bladder), which provides an interference fit with enlarged cuff
317. Alternatively, bracelet 360 can have a cross-sectional shape
designed to fit with an inner groove 370 of sealing collar 314
(FIG. 12). Glove material pressed between fitted collar 314 and
bracelet 360 functions as a gasket, enhancing the effectiveness of
the seal.
[0075] In any of the embodiments using the bracelet and glove, the
seal is maintained without constricting the surgeons arm, which can
be a source of discomfort. The surgeon's arm is not constricted
because bracelet 360 has a fixed diameter and need only fit loosely
around the surgeon's arm. However, by mating with sealing collar
314, bracelet 360 securely attaches glove 316 to entry opening 312
of sleeve 300, sealing the opening to the body cavity, and allowing
access to the body cavity via glove 316.
[0076] Preventing the constriction of a surgeon's arm can be
further achieved by an embodiment in which the cross-sectional
diameter of bracelet 360 along the length of the surgeons arm is
slightly larger than the corresponding dimension of groove 370.
Hence, an interference fit between the mating components is
provided along a direction parallel to the surgeon's arm, and
bracelet 360 is not compressed along a direction that will
constrict a surgeon's arm.
[0077] In some embodiments, it is desirable for the diameter of
bracelet 360, and the glove itself, to be large enough that the
surgeon can remove his hand from glove 316 without detaching glove
316 from sleeve 310. In this case, access port 300, glove 316 and
bracelet 360 combine to form a detachable glove box, in which,
during use, the surgeon can insert and remove his hand from the
body cavity at will (via glove 316) with no loss of insufflation
gas, and when the procedure is completed, glove 316 can be detached
from access port 300.
[0078] It is worth pointing out, however, that the diameter of
bracelet 360 should not be too large to prevent a surgeon's range
of movement. In particular, the diameter of enlarged cuff 317
formed by bracelet 360 should be smaller than the diameter of the
retracted incision. As a result, the surgeon can completely insert
his gloved hand and arm, including enlarged cuff 317, through the
retracted opening into the body cavity. Alternatively, the glove
and cuff can be designed such that the glove extends up to, for
example, a surgeon's elbow, and the cuff fits around the surgeon's
upper forearm or elbow to provide the surgeon a sufficient reach
inside the body cavity.
[0079] In other embodiments, a separate mechanical or elastic clamp
can be used to attach glove 316 to the entry opening 312 of sleeve
310. Furthermore, in any of the above embodiments, additional
mechanical or elastic, clamping or tightening means (e.g., elastic
bands, drawstrings, or incremental tightening rings) can be used to
enhance the seal provided by the connection of enlarged cuff 317 to
sealing collar 314.
Inclusion of a Light Source
[0080] In further embodiments, any of the embodiments described
previously can include a light source connected to a portion of the
wound retractor inserted into and facing the body cavity. For
example, referring to FIG. 13, a wound retractor 130 includes
inflatable collar 132 surrounding an entry opening 133 external to
a patient's abdominal wall 135, a skirt 134 extending from
uppermost collar 132 through an incision into a body cavity 138,
and a ring 136 reinforcing the substantially circular opening of
the end of skirt 134 distal to uppermost collar 132. Encased within
skirt 134 is a plurality of optical fibers 142 extending along the
length of skirt 134 toward ring 136. The optical fibers can also be
adhered to the inner or outer walls of skirt 134. The ends of fiber
optic cables 142 face into the body cavity and extend around the
perimeter of exit opening 140 adjacent to ring 136. The optical
fibers 142 pass through skirt 134 to the outer perimeter of entry
opening 133 where they are bundled together and connected to an
external light source 144.
[0081] Other light sources can also be used. For example the ring
could be luminescent and the skirt pocket transparent. In
particular, the ring could be electroluminescent, so that when a
current or a voltage is applied, the ring emits light. Wire used to
pass current or voltage into the ring could be encased in the skirt
as was described above for fiber optic cables. In another
embodiment, the ring material is phosphorescent and is "charged-up"
by it exposing it to light, e.g., ultraviolet light, prior to use.
In a further embodiment, the ring could enclose chemiluminescent
material. In this case, a seal within the ring is ruptured
immediately prior to use, thereby mixing a plurality of materials
that react with one another and emit light from the ring.
Materials and Manufacture
[0082] In the above embodiments, a gas-tight, flexible, and
partially elastic material, such as a plastic or a rubber, is used
for the skirt, collars, and the inner and outer sleeves. For
example, polyethylene, polypropylene, urethane, natural rubber, or
latex can be used. The material for the ring provides stiffness to
the lower end of the skirt. In particular, the ring should be stiff
enough that it will not pass through the incision when it is
initially parallel to the inner wall of a patient's skin and a
force is drawing it tight against the inner wall. The ring can be
made of, e.g., metals, polyvinyl chloride (PVC), hard rubber, and
foam. Alternatively, the hem-shaped pocket could be gas-tight and
the ring pneumatic, with the pocket being filled with a gas,
liquid, or gel. During use, the pocket is filled prior to the
insertion of the exit opening into the body cavity. Methods of
molding or heating-sealing together flexible plastic materials into
prescribed medically-approved objects are well known in the art and
can be carried out by commercial entities (e.g., Dielectrics
Industries, Chicopee, Mass.).
Other Embodiments
[0083] It is to be understood that while the invention has been
described in conjunction with the detailed description thereof,
that the foregoing description is intended to illustrate and not
limit the scope of the invention, which is defined by the scope of
the appended claims. For example, the surgical access port can also
be used and adapted for insertion of a surgical tool rather than,
or in addition to, a surgeon's hand. Moreover, the sealing sleeve
can be provided with a plurality of access openings to
simultaneously accommodate a plurality of hands and/or instruments
that are be inserted into the body cavity. Also, the rings, collars
and entry and exit openings, are not limited to substantially
circular shapes, instead they could, for example, have an
elliptical shape to better accommodate the inserted object and
provide the desired retraction of the incision. Furthermore, the
length of the sealed side portions in the sealing sleeve can also
be optimized to more effectively seal the inserted object.
[0084] The retractor and sealing sleeve are not limited to surgical
applications. They can be used in any application in which the
edges of an incision into a surface is retracted into an opening,
and where appropriate, a seal is used to prevent the escape of
gases through the opening.
[0085] Other aspects, advantages, and modifications are within the
scope of the following claims.
* * * * *