U.S. patent application number 11/330661 was filed with the patent office on 2006-07-06 for sealed surgical access device.
This patent application is currently assigned to Applied Medical Resources Corporation. Invention is credited to Charles C. Hart, Scott Taylor.
Application Number | 20060149306 11/330661 |
Document ID | / |
Family ID | 31993914 |
Filed Date | 2006-07-06 |
United States Patent
Application |
20060149306 |
Kind Code |
A1 |
Hart; Charles C. ; et
al. |
July 6, 2006 |
Sealed surgical access device
Abstract
A surgical access device is adapted to facilitate access through
an incision in a body wall having an inner surface and an outer
surface, and into a body cavity of a patient. The device includes
first and second retention members adapted to be disposed in
proximity to the outer surface and the inner surface of the body
wall, respectively. A membrane extending between the two retention
members forms a throat which is adapted to extend through the
incision and form a first funnel extending from the first retention
member into the throat, and a second funnel extending from the
second retention member into the throat. The throat of the membrane
has characteristics for forming an instrument seal in the presence
of an instrument and a zero seal in the absence of an instrument.
The first retention member may include a ring with either a fixed
or variable diameter. The ring can be formed in first and second
sections, each having two ends. Couplings can be disposed between
the ends to accommodate variations in the size of the first
retention member. The first retention member can also be formed as
an inflatable toroid, a self-expanding foam, or a circumferential
spring. A plurality of inflatable chambers can also provide the
surgical access device with a working channel adapted for
disposition across the body wall. A first retention member with a
plurality of retention stations functions with a plurality of
tethers connected to the membrane to change the shape of the
membrane and the working channel. A stabilizing platform can be
used to support the access device generally independent of any
movement of the body wall.
Inventors: |
Hart; Charles C.;
(Summerville, SC) ; Taylor; Scott; (Mission Viejo,
CA) |
Correspondence
Address: |
APPLIED MEDICAL RESOUCES CORPORATION
22872 Avenida Empresa
Rancho Santa Margarita
CA
92688
US
|
Assignee: |
Applied Medical Resources
Corporation
|
Family ID: |
31993914 |
Appl. No.: |
11/330661 |
Filed: |
January 12, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10399057 |
Apr 11, 2003 |
|
|
|
PCT/US01/50160 |
Oct 20, 2001 |
|
|
|
11330661 |
Jan 12, 2006 |
|
|
|
Current U.S.
Class: |
606/191 |
Current CPC
Class: |
A61B 17/3423 20130101;
A61B 90/50 20160201; A61B 17/0293 20130101; A61B 2017/3484
20130101; A61B 2017/3486 20130101; A61B 17/3498 20130101; A61B
17/3462 20130101; A61B 2017/3405 20130101; A61B 2017/3482 20130101;
A61B 2017/3492 20130101; A61B 2017/00265 20130101 |
Class at
Publication: |
606/191 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1-23. (canceled)
24. A combination for facilitating a surgical procedure on a
patient supported on a surgical table, comprising: an access device
including a membrane defining a working channel adapted for
disposition across a body wall of the patient to provide instrument
access into a body cavity of the patient; a stabilizing platform
supporting portions of the access device generally independent of
any movement of the body wall; and the stabilizing platform having
a base in a fixed relationship with the surgical table, and a cross
member in a fixed relationship with the portions of the access
device.
25. The combination recited in claim 24, further comprising: at
least one arm extending between the base and the cross member.
26. The combination recited in claim 25, wherein at least one arm
has a pivotal relationship with the base.
27. The combination recited in claim 26, wherein the cross member
has an axis and is rotatable on its axis relative to the arm.
28. The combination recited in claim 25 wherein at least one arm is
releasably attached to the base.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This is a non-provisional application claiming the priority
of provisional application Ser. No. 60/241,953 filed on Oct. 19,
2000, entitled "Hand-Assisted Laparoscopy Apparatus and Method", as
well as the PCT application serial no. PCT/US01/29682, filed on
Sep. 21, 2001, and entitled "Surgical Access Apparatus and Method,"
both of which are fully incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of Invention
[0003] This invention relates generally to surgical access devices,
and more specifically to access devices adapted for use in minimal
invasive surgery to provide sealed instrument access across a body
wall and into a body cavity.
[0004] 2. Discussion of Related Art
[0005] Surgical access to a body cavity, such as the abdominal
cavity, is referred to as "open laparotomy" or "closed
laparoscopy." An open procedure involves an incision of sufficient
size to allow a surgeon to place hands and instruments within the
surgical site. In addition, the site must be open enough for the
surgeon to clearly see what he or she is doing. There is often a
need for multiple retractors, clamps, and sponges. All of these
devices compete for room within the surgical site.
[0006] Laparoscopic or closed surgery eliminates many of the issues
surrounding open laparotomy. In a typical pressurized laparoscopy,
the abdominal wall is punctured and at least one trocar is inserted
into the peritoneum. Gas is introduced into the abdominal cavity
and to elevate the abdominal wall away from the internal organs.
This results in a large, clear operating field. Additional trocars
can be inserted as needed for various procedures. A laparoscope is
used to provide visualization of the surgical site. The
instrumentation for laparoscopic procedures has developed
prolifically in recent years and the surgeons have become
comfortable with a "remote-control" approach to various aspects of
surgery. Cutting, dissecting, cauterizing, stapling and suturing
have all been addressed by laparoscopic device manufacturers.
[0007] Despite the many advantages of laparoscopic surgery, there
remain a few complex procedures that make laparoscopy difficult or
risky. In some of these cases, a hybrid procedure makes the most
sense. If one could have the visibility and open field of a
laparoscopic procedure and the control of an open procedure, one
would truly have it all. However, the two modalities tend to
obviate each other. Indeed, there are some who would argue that the
advances of laparoscopy would be in vane if an open procedure were
added as a default.
[0008] In recent years, a few enterprising surgeons have advanced a
method that they call "hand-assisted" laparoscopy or "handoscopy."
This involves placing one of the surgeon's hands inside the patient
through an enlarged incision, while under laparoscopic
visualization. With no protruding instrumentation normally used in
closed laparoscopy, it is not required to perform overly
challenging maneuvers
[0009] The challenge now facing the surgeon in this procedure is
providing an adequate sealing means within the enlarged incision.
The surgeon's hand must be comfortable, properly placed and free to
move with a normal range of motion. In addition, the surgeon should
be able to remove and replace his/her hand into the abdominal
cavity without loss of pneumoperitoneum.
[0010] Several devices have been proposed in an attempt to satisfy
the requirements of the "handoscopist." They generally involve an
elastomeric seal that fits through an incision and is held in place
by retention means on either or both sides of the abdominal wall.
The devices are generally complex and require several steps to
place. One of the devices requires an adhesive to be placed on the
exterior abdominal wall (skin) as the seal is adhered to the skin.
This requires not only application of the adhesive but also a
drying time. Allergic reactions and other complications must be
considered when using this product. Another device makes use of a
"toroidal balloon" that inflates to position the device and seal
the incision. The surgeon must overcome the friction and sealing
pressure of this device when inserting and withdrawing his/her hand
from the surgical site. A further device involves the use of a
built-in glove or sleeve. This arrangement diminishes the range of
motion and the tactile sensation of the hand.
[0011] U.S. Pat. No. 5,848,992 discloses a surgical access device
that allows the conversion of an open procedure to a laparoscopic
procedure. In addition, the '992 patent discloses the use of such a
device in a case where a large organ is to be removed. In this
instance, an incision of adequate size is made initially and sealed
with the device at the same time the trocars are being inserted
[0012] Notwithstanding these proposed devices, there remains a
continuing need for a surgical access device that provides a
flexible, simple and complete seal within an incision of adequate
size for introduction of a human hand.
SUMMARY OF THE INVENTION
[0013] The present invention satisfies the requirements of a
surgical access device for use with surgical instruments including
the surgeon's hand. With this access device, "hand-assisted"
laparoscopy is greatly facilitated within a closed surgical
environment.
[0014] The present invention makes use of an internal retention
member and an external retention member connected by a flexible,
lubricious material. At least one of the retention members is
tensionable to provide adequate stability to the incision site.
[0015] The present invention also provides a sealing portion that
allows the largest range of hand motion without leakage of
insufflation gas. The seal is formed of a material that responds
well to the presence of glove material such as Natural Latex,
Poly-isoprene, Nitrile, Vinyl or Polyurethane.
[0016] In one aspect of the invention, the surgical access device
is adapted to facilitate access through an incision in a body wall
having an inner surface and an outer surface, and into a body
cavity of a patient. The device includes a first retention member
configured to surround the incision in proximity to the outer
surface of the body wall. A second retention member is configured
to surround the incision in proximity to the inner surface of the
body wall. A membrane extending between the first retention member
and second retention member forms a throat adapted for disposition
through the incision. A first funnel extends from the first
retention member into the throat and a second funnel extends from
the second retention member into the throat. The throat of the
membrane has characteristics for forming an instrument seal in the
presence of an instrument, any zero seal in the absence of an
instrument.
[0017] In another aspect of the invention, the first retention
member comprises a ring having a first section with a first end and
a second end, and a second section with a third end moveable
relative to the first end to the first retention member and a
fourth end moveable relative to the second end of the first
retention member. A coupling is disposed between the first end of
the first retention member and the third end of the second
retention member. This coupling is operable to vary the distance
separating the first end and the third end to control the shape of
a working channel formed by the membrane. A second coupling or a
hinge may be provided between the second end of the first retention
member and the fourth end of the second retention member.
[0018] In a further aspect of the invention, the first retention
member has a shape that is variable to control the shape of the
working channel formed by the membrane. The first retention member
can be formed as an inflatable structure such as a toroid. The
first retention member may also include self expanding foam for a
circumferential spring.
[0019] In still a further aspect of the invention, a surgical
access device can include a plurality of inflatable chambers each
extending in a plane passing through the axis of the device. These
chambers collectively define a working channel that is adapted for
disposition across the body wall. The chambers may have a straight
or U-shaped configuration.
[0020] In another aspect of the invention, the device includes a
first retention member including a ring with a plurality of
retention stations. The membrane is attached to a plurality of
tethers that can be coupled to the ring at an associated one of the
retention stations to provide the membrane with a desired
shape.
[0021] In still a further aspect of the invention, a stabilizing
platform is proposed to support the access device generally
independent of any movement associated with the body wall.
[0022] These and other features and advantages of the invention
will become more apparent with a description of preferred
embodiments in reference to the associated drawings.
DESCRIPTION OF DRAWINGS
[0023] FIG. 1 is a side view drawing of a surgical patient in a
laparoscopic procedure;
[0024] FIG. 2 is a front view drawing of a surgical patient in a
"hand-assisted" surgical procedure;
[0025] FIG. 3 is a front view drawing of a preferred embodiment of
the present invention in place;
[0026] FIG. 4 is an oblique view drawing of the present invention
showing two retention members;
[0027] FIG. 5 is an oblique view drawing of the invention in an
alternate embodiment;
[0028] FIG. 6 shows the present invention having an alternate
exterior retention member;
[0029] FIG. 7A illustrates a folded retention member of the present
invention in a closed condition;
[0030] FIG. 7B illustrates the folded member in an opening
condition;
[0031] FIG. 7C shows the folded member in a half open
condition;
[0032] FIG. 7D shows the folded member in a fully open condition
with the seal material tensioned;
[0033] FIG. 8A illustrates an alternate embodiment of the folded
retention member closed;
[0034] FIG. 8B illustrates the alternate embodiment partially
open;
[0035] FIG. 8C shows the half open retention member having a
transverse seal opening;
[0036] FIG. 8D shows the transverse seal opening fully tensioned
along its length;
[0037] FIG. 9 shows an adjustable external retention member opening
the seal portion;
[0038] FIG. 10 shows the adjustable retention member with a seal
portion under minimum tension;
[0039] FIG. 11 illustrates an adjustable retention having a hinge
and jackscrew combination;
[0040] FIG. 12 shows the hinge and jackscrew placing opening
tension on the seal member;
[0041] FIG. 13 shows the retention member having two jackscrew
adjustments and having the seal member in a transverse position and
under minimum tension;
[0042] FIG. 14 shows the retention member where the seal member is
under maximum tension;
[0043] FIG. 15 illustrates an embodiment of the retention member
wherein the tensioning of the seal member is provided by detente
folding spacers;
[0044] FIG. 16 shows the detente spacers in an over-center or
locked position and applying tension to the seal member;
[0045] FIG. 17 is an oblique view of the external retention member
having a ratchet for holding the seal member at a preferred
tension;
[0046] FIG. 18 illustrates an alternate embodiment of the present
invention wherein the external retention member is an un-inflated
but inflatable or fillable hollow torrus;
[0047] FIG. 19 shows the inflatable retention member fully inflated
and tensioning the sealing member to provide sealing pressure;
[0048] FIG. 20 illustrates the present invention having two
un-inflated but inflatable retention members and the seal member at
minimum tension;
[0049] FIG. 21 shows the two inflatable retention members fully
inflated and the seal member fully tensioned;
[0050] FIG. 22 illustrates an alternate embodiment of the present
invention where the un-inflated retention members and the seal
portion are integrally formed of connected tubular segments;
[0051] FIG. 23 shows the alternate embodiment in an inflated
condition and shaped as would be the case if the device were
inserted within a surgical incision;
[0052] FIG. 24 illustrates an alternate embodiment wherein the
external retention member is a coil spring;
[0053] FIG. 25 illustrates the alternate embodiment wherein the
external and the internal retention members are coil springs;
[0054] FIG. 26 illustrates an alternate embodiment of the present
invention wherein a strap is used to maintain a position over a
surgical incision;
[0055] FIG. 27 illustrates an embodiment of the present invention
wherein preferred embodiments of the retention member and the seal
member are held in place by a strap;
[0056] FIG. 28 illustrates an additional preferred embodiment of
the present invention wherein the sleeve/membrane has tensioning
tethers in a first condition;
[0057] FIG. 29 illustrates the tethers in a second condition;
[0058] FIG. 30 illustrates the tethers in an irregular, non-uniform
configuration;
[0059] FIG. 31 illustrates the tethers in a regular, uniform
configuration; and
[0060] FIG. 32 is a perspective view of an access device in
combination with a stabilizing platform.
DESCRIPTION OF PREFERRED EMBODIMENTS AND BEST MODE OF THE
INVENTION
[0061] In FIG. 1, a patient is illustrated in a prone or supine
position and designated by the reference numeral 10. The patient 10
has an abdomen 12 which includes a body or abdominal cavity 16
defined by an abdominal wall 18. A plurality of trocars 20, 21, and
22 are placed so as to provide surgical access to the abdominal
cavity 16. Various instruments 23, 24, 25 are illustrated for use
through the trocars 20, 21, and 22.
[0062] In FIG. 2, a "hand-assisted" laparoscopic procedure is
shown. The patient 10 is supine and the abdominal cavity 16 is
insufflated. In addition to the trocars 20, 21, and 22, there is an
additional surgical access device 50 that has been placed relative
to a surgical incision 100. This access device 50 is adapted to
receive a hand 160 of a surgeon, as it is placed through the access
device 50 and into the abdominal cavity 16 of the patient 10. The
surgeon is able to use the inserted hand 160 to perform tasks that
are too difficult or not safe for the instruments normally used in
laparoscopy. The access device 50 provides a gas tight seal so that
the insufflated, pressurized abdomen at cavity 16 does not
collapse. The access device 50 may also accommodate large,
contaminated specimens or diseased organs or tissue. Furthermore,
instrumentation or tools that might otherwise be too large for a
trocar may be introduced through the access device 50 and
subsequently attached to device drivers operated through the
trocars 20, 21, and 22. Specimen bags that are introduced through a
trocar may be removed through the access device 50 when fully
burdened.
[0063] The access device 50 is placed through the surgical incision
100, FIG. 3, and retained against the external abdominal wall 17 by
a first retention member or retainer 55, and against the internal
abdominal wall 18 by a second retention member or retainer 65. The
external, first retainer 55 supports a gas tight sleeve or membrane
75 at a first end 76. The internal, second retainer 65 supports the
gas tight sleeve or membrane 75 at the second, opposite end 86. The
two opposing ends 76 and 86 maintain a communicating surface 77
that passes through the incision 100. The material of the surgical
access device 50 provides a durable and non-permeable surface
against the incised tissue defining the incision 100.
[0064] With particular reference to FIGS. 4, 5, 6, a preferred
embodiment of the access device 50 has a first end 51, a second end
52 and a communicating middle portion 53. The first end 51, in a
preferred embodiment, is external to a body cavity 16 and comprises
an enlarged and adjustable portion 55. The exact shape of the first
end portion 55 may be circular, ovoid, rectangular, square,
triangular or the like. The first end portion 55 is sized and
configured to be adjustable in area so that a surface 77 of a
sleeve or membrane 75 is appropriately stretched or tensioned.
[0065] A preferred embodiment of the access device 50 employs an
overlapping leaf spring 56 that is biased to the open condition. As
opposing ends 57, 58 of the spring 56 spread apart, appropriate
tension is exerted upon the sleeve/membrane 75. The applied tension
causes a pulling force to be exerted through the communicating
middle portion 53. This force approximates the second, internal, or
distal end 52 of the access device 50 to the inner surface of the
abdominal wall 18.
[0066] The second retaining portion 65 is preferably constructed of
a flexible material that allows it to be inserted into the surgical
incision 100 in a folded form or reduced profile. The second
retaining portion 65 is preferably self-deploying or, at least, has
sufficient memory to return to a preferred, somewhat circular, or
pre-determined shape or condition without manipulation. The
material choices for such a configuration may include flexible
vinyl, rubber, silicone, or other elastomeric. The materials may
also include rigid materials like rigid plastic or metal with a
hinged or flexible portion.
[0067] In addition, the construction of either the first or second
retention members 55 and 65, respectively, may include the use of
elastomeric components that have been fitted with or have been
molded to include shape memory metals, such as Nickel-Titanium
(NiTinol). In any case, the second retention member 65 is easily
deformable to a condition or shape that facilitates introduction
into the smallest possible surgical incision 100. It must be kept
in mind that the second retention member 65 must be sized and
configured to retain the access device 50 in place during the
rigors of an active surgical procedure, and do so without causing
tissue damage such as tissue necrosis or abrasion. A preferred
embodiment of the second retention member 65 comprises a ring 66 of
soft silicone or vinyl with an internal, encapsulated or insert
molded Nickel-Titanium support ring. This embodiment may be
introduced in a very deformed condition and will subsequently
recover the preferred shape and size upon completion of
introduction into the body cavity 16.
[0068] As an alternative, the super-elastic and shape-memory
properties of Nickel-Titanium may be drawn from temperature
transition properties of the alloy. For instance, the second
retention member 65 may be cooled to a temperature where the ring
66 is easily, deformable to a high degree, then, as the alloy warms
to body temperature, the retention member 65 returns to a
programmed shape, size or configuration.
[0069] The sleeve/membrane portion 75 is shaped by the tension
between the first retention member 55 and the second retention
member 65. The sleeve/membrane 75 may initially define an orifice
78 which may be a slit or a hole or the like that communicates
between the exterior and the interior of the body cavity 16 through
a lumen 80. The lumen 80 exhibits a first condition when the
sleeve/membrane 75 is not under tension and a second condition when
the sleeve/membrane 75 is under tension.
[0070] In a preferred embodiment, the tensioning of the
sleeve/membrane 75 adjusts the lumen 80 to a preferred size and
configuration. Such a configuration might be the creation of the
radiused, funnel-shaped orifice 78 transitioning to the smaller
diameter in the middle portion 53 and again transitioning to a
funnel-shaped enlargement 67 distally at the second retention
member 65.
[0071] The material of a preferred embodiment of the
sleeve/membrane 75 may include a non-distensible or non-elastic
material such as polyethylene, polyurethane or reinforced
elastomeric. The choice of polyethylene for the sleeve/membrane 75
provides the surface 77 with nearly friction-free characteristics
against most glove materials. Since the polyethylene material is
non-elastic, the sleeve/membrane 75 will fold into discrete
"fan-fold" segments 79. Such a condition will allow the material of
the sleeve/membrane 75 to be compressed radially by the adjacent
body tissue so that it forms a throat 90 or nearly occluded middle
portion 53 when no hand or instrument is present within the lumen
80 of the device 50. Thus, in the absence of the hand or
instrument, the throat functions as a zero seal. When a hand or
instrument is present within the lumen 80, the fan-folded material
at the throat 90 of the sleeve/membrane 75 yields to the size and
shape of the inserted hand or instrument yet forms an occlusive
instrument seal. Bearing in mind that the normal pneumoperitoneum
is about 0.18 to 0.28 psi, the throat 90 of the present invention
is adequate to form both the zero seal and the instrument seal.
[0072] The embodiment of FIG. 5 is similar to that of FIG. 4 except
that the membrane 75 in proximity to the first retention member 55
has the configuration of a septum. In this case, the orifice 78 is
formed as a slit which transitions into the throat 90 of the
device. Fan-fold segments 79 extend to the ends of the slit or
orifice 78 in this embodiment of FIG. 5. These fan-fold segments 79
are absent in the embodiment of FIG. 6.
[0073] With reference to FIGS. 7A-D, a preferred embodiment of the
surgical access device 50 of the present invention comprises a
first retention member 155 that is folded so that it resembles a
taco. The folding of the first retention member 155 relaxes the
member 75, allowing the second retention member 65 to be easily
inserted into a surgical incision 100 (FIG. 2). The subsequent
unfolding of the first retention member 155, for example, by
forcing apart a pair of separable members 156, 157, results in a
stretching of the sleeve/membrane 75. In this position, the two
members 156, 157 of the first retention member 155 are locked in a
single plane or flattened condition with the sleeve/membrane 75 in
tension.
[0074] In a preferred embodiment of the folded first retention
member 155 the orifice 78 is elongate and in line with a fold 159
of the sleeve/membrane 75 as well as a pair of hinged portions 158
of the first retention member 155. In an alternative embodiment
illustrated in FIGS. 8A-8D, the orifice 78 that is elongate and
transverse to both the fold 159 of the sleeve/membrane 75 and the
hinged portions 158 of the first retention member 155.
[0075] With reference to FIGS. 9-17, a surgical access device 50 is
shown with the first retention member 155; however, in this case
the member 155 is adjustable in area or circumference. In this
embodiment, the two separable members 156, 157 of the first
retention member 155 may be separated along a common plane by a
pair of actuating adjusting sleeves 200, 220 operating against
adjusting screws 210, 230. This action will place the
sleeve/membrane 75 under tension so as to prepare the orifice 78
for use. There may be a several of the adjusting members 200, 220,
for example, two, three, four, or more, that cooperate to stretch
the sleeve/membrane 75. This stretching may be uniform or
non-uniform.
[0076] Specifically referring to FIGS. 11, 12, a further embodiment
of the surgical access device 50 is shown to have at least one
hinge 260 that permits the separate members 156, 157 to pivot on
each other in opposing directions upon application of a spreading
force. In this case, the spreading force is applied by rotation of
a jackscrew and thumb-wheel combination 265. The resulting
non-uniform spreading force causes the orifice 78 to assume a
preferred condition.
[0077] With reference to FIGS. 13, 14, there is shown another
embodiment of the surgical access device 50 according to the
present invention wherein the elongate orifice 78 is positioned so
as to be stretched along its lengthwise midline 278. This
configuration causes the orifice 78 to assume a more closed natural
condition than would be the case wherein the elongate orifice 78 is
transverse to the stretching moment. A combination of in-line and
transverse stretching of the sleeve/membrane 75 and the orifice 78
can result in a more symmetrical or uniform opening of the orifice
78.
[0078] Referring now to FIGS. 15, 16, another embodiment of the
surgical access device 50 is shown, according to the present
invention. In this embodiment the separable members 156 and 157 are
moveable in a single plane between an expanded position illustrated
in FIG. 15 and a contracted position illustrated in FIG. 16. In
this case, the separable member 156 has ends 161 and 163 while the
separable member 157 has ends 160 and 162. Folded separation
members 285 and 296 are disposed between the ends 160, 161, and the
ends 162, 163, respectively. In the compressed state of the
separable members 156, 157, the separable members 285 and 296 are
in a folded condition with the first ends 160 and 162 abutting the
ends 161 and 163, respectively. When the separable members 156 and
157 are spread to the expanded state illustrated in FIG. 15, these
separation members 285 and 296 are moved to an unfolded, flattened
or over-centered condition as illustrated in FIG. 16. In this
condition, the separation members 285 and 295 maintain the
separable members 156 and 157 in the expanded state thereby
stretching the membrane 175.
[0079] An elongate orifice 78 may be orientated either in-line or
transverse to the direction of stretch. An additional embodiment of
the surgical access device 50 may comprise a plurality of the
foldable separation members 285, 296 wherein the stretching of the
sleeve/membrane 75 is more or less uniform. The foldable separation
members 285, 295 may be constructed of metal, with or without a
discrete hinge, or plastic having either discrete or "living"
hinges.
[0080] FIG. 17 depicts a further embodiment of the surgical access
device 50 according to the present invention. In this case, the
first retention member 155 comprises a length of rigid or
semi-rigid material formed into a hoop or coil 290. This coil 290
has opposing ends 291 and 292 as well as an outer surface 293 and
an inner surface 294. When the ends 291, 292 are spread relative to
each other, the coil 290 assumes a larger diameter and area so that
the tension upon the attached sleeve/membrane 75 is increased.
[0081] The position of the coil ends 291 and 292 can be maintained
by a series of ratchet teeth 295 and an associated ratchet pawl
296. In the illustrated embodiment, the ratchet teeth 295 are
formed on the outer surface 293 and the ratchet pawl 296 is formed
on the end 292. Alternatively, a second series of ratchet teeth can
be formed on the inner surface 294, and an associated second
ratchet pawl can be formed on the end 291. This double-ended,
double-sided ratchet configuration results in a very large
distention potential for the first retention member 155 and,
concomitantly, the sleeve/membrane 75.
[0082] In this embodiment, the first retention member 155, as well
as the ratchet teeth 295, and the ratchet pawl 296, are preferably
constructed of a rigid plastic material such as polycabonate, ABS,
PBC or other filled or non-filled material. In a further
embodiment, the first retention member 155 may be formed from a
metal so that it is sterilizable and reusable. Such an embodiment
may still include the disposable sleeve/membrane 75 and the second
retention member 65.
[0083] With reference now to FIGS. 18, 19, 20, 21, a surgical
access device 50 according to the present invention is shown having
an inflatable or fillable first retention member 300, and a
malleable, foldable or otherwise deformable second retention member
65. In a preferred embodiment, the inflatable or fillable retention
member 300 comprises a closed, hollow structure 310 which may be
circular or toroidal. The hollow structure 310, when un-inflated or
un-filled exerts very little, if any, stretching or tensioning
force upon the sleeve/membrane 75. When the hollow structure 310 is
inflated, however, it assumes a larger diameter and area which
results in the desired stretching or tensioning of the
sleeve/membrane 75. Preferred embodiments of the hollow structure
310 can be formed from either elastic or non-distensible
materials.
[0084] Similarly, the sleeve or membrane 75 can be formed from an
elastic material although in a preferred embodiment the membrane 75
is non-distensible. In this embodiment, expansion of the hollow
structure 310 also stretches the sleeve/membrane 75 so that the
throat 90 of the access device 50 is also placed under tension.
This tensioning of throat 90 which connects the first retention
member 300 and the second retention member 65, causes the second
retention member 65 to be appropriately drawn into sealing
engagement with the interior surface of the abdominal wall 18 (FIG.
1). This will result in a gas-tight seal around the access device
50. In the embodiment of FIG. 19, the membrane 75 is in the form of
a septum.
[0085] With attention drawn specifically to FIGS. 20, 21, there is
shown a surgical access device 50 according to the present
invention wherein a first retention member 300 includes the
inflatable or fillable structure 310, and a second retention member
365 also includes an inflatable or fillable structure 375. The
second retention member 365, when un-inflated or un-filled may be
easily inserted through an incision 100 into a body cavity 16 and
subsequently inflated or filled to assume a more-or-less rigid or
definite shape and configuration within the body cavity 16. The
first retention member 300 may then be inflated or filled to
provide the external retention and the concurrent stretching or
tensioning of the sleeve/membrane 75. Although it is apparent that
the sleeve/membrane 75 can also be formed with a double wall
structure that is inflatable, this is not the case with the
embodiments of FIGS. 20 and 21. In these illustrated embodiments,
the sleeve/membrane 75 that connects the two inflatable or fillable
retention members 300, 365, is formed of a single layer or
thickness of non-dispensable or non-elastic material. With this
construction, the membrane 75 is not inflatable and relies on a
minimum of intrusive material along the middle portion or throat 90
and through the incision 100. At this throat 90 of the access
device 50, the sleeve/membrane 75 remains smooth, lubricious, thin,
and non-bulky.
[0086] An additional embodiment of the access device 50 of the
present invention is shown in FIGS. 22, 23 wherein an open-ended,
generally cylindrical sleeve 450 is constructed of a plurality of
axially aligned, communicating, hollow, inflatable, fillable
members 455. The communicating members 455 are inflatable or
fillable by means of an inflation tube 458. Particularly when
uninflated, the generally cylindrical shape (FIG. 23) of the access
device 450 may be easily distorted so that a distal end 460 may be
placed through the surgical incision 100 and the abdominal cavity
16. As the access device 450 is inflated or filled, it assumes an
"hour-glass" shape, and develops a first retention portion 470 and
a second retention portion 480 joined by a middle section 490.
[0087] A non-distensible or non-elastic material is also stipulated
for use in this preferred embodiment so that friction is minimized,
and so that the material of the middle section 490 does not gather
or fold as a gloved hand or large instrument is repeatedly inserted
and withdrawn through the access device 450.
[0088] In the illustrated embodiment, the individual inflatable or
fillable members 455 form axial chambers and abutments 495 which
prevent material motion and also minimize surface contact between a
gloved hand and the material which forms the seal with the
abdominal wall 18. The lumen of the middle section 490 may be
lubricated with a thick or viscous material which can be stored
along the seams of the abutting or adjoining inflatable or fillable
members 455. The lubricating product may also function to perfect
the instrument seal in the present of a gloved hand or instrument,
or to perfect the zero seal in the absence of the gloved hand or
instrument.
[0089] With reference to FIG. 24, a surgical access device 50
according to the present invention is shown wherein a compressible
helical coil member 500 forms a first retention member 550. The
coil member 500 may be deformed so as to minimize the tension upon
an attached sleeve/membrane 75 and a middle portion 560 thereof. A
second retention member 565 may be deformed and placed within the
surgical incision 100, so that upon release or decompression of the
coil 500 of the first retaining member 550 the second retaining
member 565 is appropriately approximated to the interior wall of a
body cavity. For packaging and shipping, the coil 500 of the first
retaining member 550 may be maintained within a containment pouch,
bag, box, or the like (not shown) in its most-compact condition. In
this condition, the first retaining member 550 will exert a minimum
of tension upon the attached sleeve/membrane 75.
[0090] In a similar embodiment illustrated in FIG. 25, a second
retaining member 563 is also provided with a second retention coil
member 565. This second retaining coil member 565 may be introduced
through the incision 100 in a compact configuration and
subsequently released to assume an enlarged diameter. This provides
the access device 50 with an increased area of contact at the inner
surface of the abdominal wall 18. As the second retention coil 565
is released to assume its enlarged diameter, it also functions to
stretch or tension the attached sleeve/membrane 75.
[0091] With reference to FIGS. 26, 27, there is shown a surgical
access device 50 according to the present invention that is adapted
to be held in position over the surgical incision 100 by, a strap
or belt 600 which surrounds the abdomen 12 of the patient 10 (FIG.
1). In this embodiment, the access device 50 may include the strap
or belt 600 and associated closure members or buckles 610. The
access device 50 in the embodiment of FIG. 26 is illustrated as a
septum seal 615. In the embodiment of FIG. 27, the access device is
similar to that described with reference to FIG. 19 and designated
with the reference numeral 300.
[0092] Turning now to FIGS. 28 and 29, the surgical access device
50 is shown with a membrane 75 extending between the first
retention member 55 and the second retention member 65. In this
embodiment, the first retention member 55 includes a solid, rigid
ring 700 that is disposed in a plane generally perpendicular to the
axis of the access device 50. On the side of the ring 700 opposite
the second retaining portion 65, a plurality of slits 710 are
provided which extend radially of the ring 700. In this embodiment,
a plurality of tethers 715 are attached to the membrane 75 at
different radial locations. The tethers 715 are attached to the
membrane 75 at an inner end 16 and are provided with an enlargement
feature 717 at an outer end 718. In this embodiment, the slits 710
of the ring 700 are sized and configured to engage and confine at
least one of the tethers 715. In such an embodiment, the
enlargement features 715 can act to prevent the tethers 715 from
being drawn back through the slits 710. The enlargement feature 717
can also function as handles facilitating engagement of each of the
tethers 717, as it is drawn outwardly through the associated slit
710 to tension the membrane 75.
[0093] In such an embodiment, it may be desirable to form the slits
710 so that they are tapered toward the bottom of the slit 710.
This will facilitate compression of the associated tether 715 to
increase the frictional engagement between the tether 715 and the
ring 700. In this manner, the tethers 715 can be collectedly
adjusted to provide the membrane 75 with the desired shape and seal
characteristics. The membrane 75 can be released from the ring 700
by merely lifting the tethers 715 to disengage their associated
slits 710. In FIG. 30, the tether 715 is tensioned non-uniformly to
provide the membrane 715 with an irregular shape. This
configuration can be compared with that illustrated in FIG. 31
wherein the tethers are tensioned uniformly to provide the membrane
75 with a uniform configuration.
[0094] In FIG. 32, the access device 50 is illustrated in
combination with a stabilizing platform 800. Initially, it will be
noted that the access device 50 which is illustrated, is that
described generally with reference to FIGS. 28-31. However, it will
be apparent that the stabilizing platform 800 can be adapted to
receive and function with any of the foregoing embodiments of the
access device 50, in order to achieve the advantageous discussed
below.
[0095] In this embodiment, the stabilizing platform 800 includes a
base having a generally planer configuration with a pair of support
flanges 805 and 807 extending perpendicular on opposing sides of
the base 803. A pair of upstanding arms 110 and 112 are pivotally,
and perhaps releasably attached to the associated flanges 805 and
807. A cross member 814 is pivotally and perhaps releasably
connected between the arms 810 and 812. This cross member 814 in a
preferred embodiment is perpendicular to the arms 810 and 812 and
parallel to the plane of the base 803. The access device 50 is
supported by the cross member 814, with its axis 816 generally
perpendicular to the cross member 814. With this orientation, the
first retention member 855, represented by the ring 700, is
disposed in a plane which may be pivoted relative to the upstanding
arms 810, 812, as well as the base 803.
[0096] In operation, the base 803 is disposed beneath the patient
10 (FIG. 1) in contact with the back of the patient 10. The
upstanding arms 810 and 812 can then be mounted to the flanges 805
and 807, respectively, on either side of the patient 10. The cross
member 814 can then be attached to the arms 810 and 812.
[0097] The support platform 800 can be of considerable advantage in
a hand-assisted laparoscopic procedure which requires that a human
hand being inserted and withdrawn several times while maintaining
the abdominal pressure or pneumoperitoneum. As noted, the sealing
port or throat 90 (FIG. 4) of the access device 50 must tightly fit
around the wrist or arm of the surgeon. When the hand of the
surgeon is removed, the throat 90 must close tightly to form a zero
seal. This closed sealing attachment to the hand or arm of the
surgeon can cause the abdominal wall 18 (FIG. 1) to change in shape
and particularly in elevation as the hand is inserted and removed.
If the access device 50 is directly attached to the abdominal wall
18, this movement of the wall 18 can result in movement of the
access device 50 causing other surgical instruments, such as a
laparoscope, to be moved or displaced. It is the purpose of the
stabilizing platform 800 to support the access device 50
independently of the abdominal wall 18. With this stabilization,
movement of the surgeon's hand through the abdominal wall 18 will
be less apt to move the access device 50. This greatly stabilizes
the surgical field and particularly the instruments inserted
through the access device 50. Appropriate pivoting of the cross
member 814 and the arms 810 and 812 enable the access device 50 to
be swiveled to a position appropriate to patients of various size
and weight. In an alternative embodiment, the base may be formed as
part of a surgical table with at least one support member, such as
the arms 810, 812, extending from one or both sides of the patient
to support the cross member 814.
[0098] Given the many embodiments disclosed herein for the access
device 50, many other embodiments will now become apparent with
changes in structure or materials. For that reason, one is
cautioned not to limit the scope of the invention only to the
disclosed embodiments, but only with reference to the following
claims.
* * * * *