U.S. patent application number 14/996610 was filed with the patent office on 2016-07-14 for pneumoperitoneum device.
This patent application is currently assigned to ATROPOS LIMITED. The applicant listed for this patent is ATROPOS LIMITED. Invention is credited to Frank Bonadio, Lucy Dolores Halpin, Shane Joseph Macnally, Kirk Anthony Shibley, Trevor Vaugh, Stephen Williams.
Application Number | 20160199051 14/996610 |
Document ID | / |
Family ID | 47471838 |
Filed Date | 2016-07-14 |
United States Patent
Application |
20160199051 |
Kind Code |
A1 |
Shibley; Kirk Anthony ; et
al. |
July 14, 2016 |
PNEUMOPERITONEUM DEVICE
Abstract
A method for performing a laparoscopic procedure may include
inserting a bag through an opening. The method may also include
delivering tissue into the bag, sealing the bag, and inflating the
bag to create an artificial pneumoperitoneum that extends the
abdomen and provides additional working and viewing space. Further,
the method may include carrying out a procedure on the tissue
located in the inflated bag.
Inventors: |
Shibley; Kirk Anthony;
(Wayzata, MN) ; Bonadio; Frank; (Bray, IE)
; Vaugh; Trevor; (Birr, IE) ; Macnally; Shane
Joseph; (Delgany, IE) ; Halpin; Lucy Dolores;
(Dublin, IE) ; Williams; Stephen; (County Dublin,
IE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ATROPOS LIMITED |
Bray |
|
IE |
|
|
Assignee: |
ATROPOS LIMITED
Bray
IE
|
Family ID: |
47471838 |
Appl. No.: |
14/996610 |
Filed: |
January 15, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14584865 |
Dec 29, 2014 |
9265492 |
|
|
14996610 |
|
|
|
|
14251362 |
Apr 11, 2014 |
8920431 |
|
|
14584865 |
|
|
|
|
13725148 |
Dec 21, 2012 |
|
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14251362 |
|
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|
61968770 |
Mar 21, 2014 |
|
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|
61940681 |
Feb 17, 2014 |
|
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|
61839461 |
Jun 26, 2013 |
|
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|
61742125 |
Aug 3, 2012 |
|
|
|
61580088 |
Dec 23, 2011 |
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Current U.S.
Class: |
606/114 |
Current CPC
Class: |
A61B 2017/00659
20130101; A61J 1/10 20130101; A61B 2017/0225 20130101; A61B
2017/320024 20130101; A61B 2017/4216 20130101; A61B 2017/3466
20130101; A61B 2017/00951 20130101; A61M 13/003 20130101; A61B
17/0218 20130101; A61B 2017/00946 20130101; A61B 2017/3429
20130101; A61B 2017/3447 20130101; A61B 17/0293 20130101; A61B
2017/00557 20130101; A61B 2017/22061 20130101; A61B 17/22 20130101;
A61B 17/3423 20130101; A61B 2017/00287 20130101; A61B 17/00234
20130101; A61B 17/3474 20130101 |
International
Class: |
A61B 17/00 20060101
A61B017/00; A61B 17/02 20060101 A61B017/02 |
Claims
1-60. (canceled)
61. A bag for insertion into a body cavity to receive tissue for
morcellation, the bag comprising: a body portion having a width; a
first access channel opening to the body portion, the first access
channel having a width; and a second access channel opening to the
body portion, the second access channel having a width, the width
of the body portion being greater than the width of the first
access channel and the width of the second access channel.
62. The bag of claim 61, wherein the first access channel includes
an opening at a proximal end, and the body portion is wider than
the opening.
63. The bag of claim 62, further including a self-expanding collar
forming the opening.
64. The bag of claim 61, wherein each of the first access channel
and the second access channel includes an opening, and the body
portion is wider than the opening of the first access channel and
the opening of the second access channel.
65. The bag of claim 61, wherein the body portion is rounded.
66. The bag of claim 61, wherein a length of the first access
channel is between 100 and 300 mm.
67. The bag of claim 61, wherein the first access channel and the
second access channel are the only access channels opening to the
body portion.
68. The bag of claim 61, wherein the body portion and at least one
of the first access channel and the second access channel are
formed of a continuous sheet of material.
69. The bag of claim 61, wherein a length of the bag is between 300
and 600 mm.
70. The bag of claim 61, wherein a width of the body portion is
between 200 and 500 mm.
71. A bag for insertion into a body cavity to receive tissue for
morcellation, the bag comprising: a body portion; a first access
channel extending from the body portion, the body portion changing
in width adjacent the first access channel; and a second access
channel extending from the body portion, the second access channel
changing in width adjacent the body portion.
72. The bag of claim 71, wherein the body portion changes in width
by decreasing in width adjacent the first access channel.
73. The bag of claim 71, wherein the second access channel changes
in width by increasing in width adjacent the body portion.
74. The bag of claim 71, wherein the first access channel is wider
than the second access channel.
75. The bag of claim 71, wherein a length of the bag is between 300
and 600 mm.
76. The bag of claim 71, wherein a width of the body portion is
between 200 and 500 mm.
77. The bag of claim 71, wherein a length of the first access
channel is between 100 and 300 mm.
78. A bag for insertion into a body cavity to receive tissue for
morcellation, the bag comprising: an open end portion having an
opening; a closed end portion opposite the open end portion, the
closed end portion being at least as wide as the opening; a side
wall extending between the open end portion and the closed end
portion, the side wall and the closed end portion defining a
chamber; and an access channel opening to the chamber, the access
channel extending from an intermediate portion of the side wall,
the intermediate portion being spaced apart from the open end
portion and the closed end portion.
79. The bag of claim 78, wherein the access channel is a first
access channel, and the bag further comprises a second access
channel opening to the chamber, the second access channel forming
the open end portion.
80. The bag of claim 79, wherein the first access channel has a
first central axis, the second access channel has a second central
axis, and the central axis of the first access channel and the
central axis of the second access channel form an acute angle.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation-in-Part of U.S.
application Ser. No. 13/725,148, filed Dec. 21, 2012, and claims
the benefit of U.S. Provisional Patent Application Nos. 61/580,088
filed on Dec. 23, 2011, and 61/742,125 filed on Aug. 3, 2012, the
entire contents of all of which are incorporated herein by
reference. Additionally, this application claims the benefit of
U.S. Provisional Patent Application Nos. 61/839,461, filed on Jun.
26, 2013, 61/940,681 filed on Feb. 17, 2014, and 61/968,770, filed
on Mar. 21, 2014, the entire contents of all of which are
incorporated herein by reference.
INTRODUCTION
[0002] This invention relates to a pneumoperitoneum device. The
invention also relates to a method of performing a surgical
procedure.
STATEMENTS OF INVENTION
[0003] According to the invention there is provided an artificial
pneumoperitoneum device (e.g., a bag) for receiving tissue, tissue
isolation, and/or extraction in a laparoscopic procedure.
[0004] In one aspect the invention provides an apparatus for use in
during laparoscopic surgery comprising an inflatable bag having a
tissue-receiving opening at a proximal end thereof and a cuff at
the proximal opening, the cuff having a closed configuration for
delivery and retrieval of the bag and an open configuration to
receive tissue, the cuff being biased into the open
configuration.
[0005] In one embodiment the bag has a main body which extends from
the cuff and the main body of the bag is more flexible than the
cuff. The cuff may be of a different material than that of the main
body of the bag. The cuff may be of a stiffer material than that of
the main body of the bag.
[0006] In some embodiments the cuff extends for a distance of
between 2 and 20 cm, between 2 and 10 cm, or about 5 cm.
[0007] In one embodiment the bag comprises a biasing element (e.g.,
a ring) that extends at least partially around the opening. The
biasing element (e.g., ring) is preferably flexible to facilitate
entry through an incision and/or an instrument access port. That
is, the biasing element (e.g., ring) may bias the cuff into the
open configuration.
[0008] In one case the biasing element (e.g., ring) comprises a
loop (e.g., an O-ring) extending around the cuff. The loop may be
of a shape memory material such as Nitinol. The loop may comprise a
single loop element which is open or closed.
[0009] In one case the loop comprises a plurality of loop
parts.
[0010] In some embodiments at least one of the loop parts is
movable relative to another of the loop parts. At least one of the
loop parts may be movable circumferentially relative to another
ring element.
[0011] In one case the apparatus comprises a retainer for opening
the bag.
[0012] The retainer may comprise at least one ring element which
extends at least partially around the opening. The ring element may
be flexible to facilitate entry through an incision and/or an
instrument access port. In one case the ring element comprises an
O-ring.
[0013] In one embodiment the retainer comprises ring parts.
[0014] There may be two separate ring parts.
[0015] In one embodiment the apparatus (e.g.,bag) comprises a
tether for each of the ring parts.
[0016] In some embodiments, the bag may comprise a tether extending
proximally from the cuff. The cuff may comprise a tab for use in
grasping the bag.
[0017] In one aspect the retainer has an insertion configuration
and an expanded deployed configuration. The retainer may be biased
into the deployed configuration.
[0018] In one case the bag is foldable for insertion.
[0019] The invention also provides an apparatus comprising an
introducer sheath or pouch for containing the bag in an insertion
configuration. The introducer sheath or pouch may be at least
partially insertable through an opening and/or an incision and/or
an access port.
[0020] In one case the apparatus comprises an activator for
delivering the bag from the pouch, on insertion. The activator may
comprise a tab. In one case the activator comprises a plunger.
[0021] In one embodiment the apparatus comprises a user tether
attached to the bag.
[0022] In one case the bag comprises a neck region. The neck region
may be adjacent to the retainer.
[0023] In one embodiment the bag itself comprises a port. The port
may be an exit port and/or an entrance port. The bag may comprise a
plurality of ports.
[0024] In some embodiments the port comprises a valve. The valve
may comprise a choke valve or a cuff valve. In one case the valve
comprises an elastomeric material such as a gel.
[0025] In some embodiments the apparatus comprises a proximal
tether and a distal tether.
[0026] The distal tether may be movable relative to the proximal
tether.
[0027] In one case the proximal tether comprises a loop through
which the distal tether is movable.
[0028] There may be a lock to restrict movement of the distal
tether. In one case the lock is provided by or on the proximal
and/or the distal tether. The lock may comprises a projection on
the distal tether which is engagable by the proximal tether.
[0029] In one embodiment the apparatus further comprises an access
port to which the bag is mounted or mountable. The access port may
comprise a retractor having a distal anchoring element for location
within a wound interior, a proximal member for location externally
of a wound opening and a retractor member extending proximally from
the distal anchoring element to retract laterally the sides of an
incision.
[0030] The bag may be mountable to the proximal member of the
retractor.
[0031] In one embodiment the apparatus further comprises a cap for
closing the proximal side of the retractor. The cap may comprise an
access device for an instrument or a surgeons hand/arm. The access
device may be mountable to the proximal member of the
retractor.
[0032] The invention also provides apparatus for use in
laparoscopic surgery comprising a bag of the invention and a
retractor. The apparatus may further comprise an access port.
[0033] The invention also provides a viscera retainer comprising an
apparatus of the invention.
[0034] In another aspect the invention provides a method for
performing a laparoscopic procedure comprising the steps of: [0035]
inserting a bag according to the invention through an opening;
[0036] inflating the bag; [0037] delivering tissue into the bag
before or after inflating the bag; and [0038] carrying out a
procedure on the tissue located in the inflated bag.
[0039] In one embodiment the opening is an opening into a body
cavity.
[0040] The opening may be provided, at least in part, by an
incision.
[0041] In one embodiment the method comprises providing a trocar
and inserting the bag through the trocar.
[0042] The method may comprise providing a retractor in the opening
and inserting the bag through the retracted opening.
[0043] The tissue may be delivered into the bag before inflating
the bag.
[0044] The method may comprise the step, either before or after
delivery of the tissue into the bag, of mounting the bag to the
retractor.
[0045] In one embodiment the method comprises passing an instrument
into the inflated bag to carry out a procedure.
[0046] In one case the method comprises inserting a trocar into the
bag.
[0047] The method may comprise the steps of providing an access
port in the bag and passing an instrument and/or tissue through the
access port.
[0048] In one embodiment the method comprises sealing the access
port prior to and/or subsequent to passage of an instrument and/or
tissue through the access port.
[0049] The device of the invention comprises at least one
instrument seal to effect a seal around at least one instrument
extended through the device, the instrument seal being configured
to be arranged in sealing relationship to a body of a patient. The
device preferably has a distal anchoring member for location within
a wound interior. The device preferably also has a retractor member
extending proximally from the distal anchoring member to retract
laterally the sides of a wound opening. Preferably the device
comprises a first instrument seal to effect a seal around a first
instrument extended through the device, and a second instrument
seal to effect a seal around a second instrument extended through
the device. By providing the two seal arrangement, this ensures
that insertion or manipulation or removal of the second instrument
does not adversely effect the seal around the first instrument. The
device may comprise a third instrument seal to effect a seal around
a third instrument extended through the device. The first
instrument seal may be spaced apart from the second instrument
seal. The first instrument seal may be formed separately from the
second instrument seal. The first instrument seal may have a larger
radial dimension than the second instrument seal. The instrument
seal may be a valve. Alternatively, the seal is of a gelatinous
elastomeric material.
[0050] In one case the device comprises a proximal member for
location externally of a wound opening. The retractor member may
extend at least between the distal anchoring member and the
proximal member. The retractor member may extend in two layers
between the distal anchoring member and the proximal member. A
first end portion of the retractor member may be fixed to the
proximal member. The retractor member may be movable relative to
the distal anchoring member. A second end portion of the retractor
member may be movable relative to the proximal member. The
retractor member may extend distally from the proximal member to
the distal anchoring member, may be looped around the distal
anchoring member, and may extend proximally from the distal
anchoring member to the proximal member. The proximal member may
comprise an inner part and an outer part. The retractor member may
extend between the inner part and the outer part.
[0051] In another embodiment the instrument seal is spaced
proximally of the proximal member. The device may comprise at least
one connector member to connect the proximal member to the at least
one instrument seal. The connector member facilitates a degree of
lateral movement of the instrument while maintaining the seal. The
connector member may comprise a sleeve. The connector member may be
of a laterally flexible material. The connector member may be of a
longitudinally rigid material. The connector member may be of a
rubber-like material. The connector member may be of a
longitudinally flexible material.
[0052] In another case the instrument seal is mounted to the
connector member. The instrument seal may be releasably mounted to
the connector member. The instrument seal may comprise a mounting
part to mount the instrument seal to the connector member. The
mounting part may be of a rigid material. The instrument seal may
comprise a sealing part to effect a seal around an instrument
extended through the device, the sealing part being overmoulded
over at least part of the mounting part.
[0053] In one embodiment, a method for performing a laparoscopic
procedure may include inserting a bag through a patient opening,
delivering tissue into a bag opening of the bag, withdrawing the
bag opening back through the patient opening, sealing the bag,
inflating the bag to create an artificial pneumoperitoneum that
extends the abdomen, conforms to the peritoneal cavity, and
provides additional working and viewing space; and carrying out a
procedure on the tissue located in the inflated bag.
[0054] In another embodiment, a method for performing a
laparoscopic procedure includes inserting a bag through a patient
opening and into a peritoneal cavity, delivering tissue into the
bag in an insufflated peritoneal cavity, sealing the bag, inflating
the bag to apply a retracting force to the materials outside the
bag thereby enlarging the peritoneal cavity, carrying out a
procedure on the tissue located in the inflated bag; and allowing
the peritoneal cavity to uninsufflate so that the inflated bag is
located in an uninsufflated peritoneal cavity.
[0055] In yet another embodiment, a method for performing a
laparoscopic procedure includes inserting a bag through a patient
opening and into a peritoneal cavity, delivering tissue into the
bag, sealing the bag, inflating the bag to retract surrounding
structures and organs and urge the bag against the abdominal wall,
piercing the bag by one or more trocars at a location where the bag
is urged against the abdominal wall, carrying out a procedure on
the tissue located in the inflated bag, and communicating the
peritoneal cavity with the atmosphere prior to carrying out a
procedure on the tissue located in the inflated bag.
[0056] In a further embodiment, a method for performing a
laparoscopic procedure includes insufflating the peritoneal cavity
to provide a working and viewing space, excising tissue within the
working and viewing space, inserting a bag into the working and
viewing space, delivering the excised tissue into the bag, sealing
the bag, inflating the bag to replace the working and viewing space
of the insufflated peritoneal cavity with a working and viewing
space within the bag, and carrying out a procedure on the tissue
located in the inflated bag.
[0057] The methods for performing a laprascopic procedure may
further include one or more of the following features: the opening
may be a naked incision in the abdominal wall; the opening may be
one of an opening through a retractor device coupled to an
incision, or an opening through a trocar coupled to an incision;
the inserting of a bag through an opening may include inserting the
bag through a valve; the extending of the abdomen includes the bag
contacting both the anterior abdominal wall and the abdominal
visecera; the opening may be an opening through the retractor
device, and the sealing of the bag may include sealing the bag to a
proximal end of the retractor device with a cap; the delivering of
tissue into the bag may be performed in an insufflated peritoneal
cavity; the carrying out of a procedure in the inflated bag may be
performed in an uninsufflated peritoneal cavity; the inflating of
the bag may include inflating the bag to retract surrounding
structures and organs and urge the bag against the abdominal wall;
piercing the bag with one or more trocars at a location where the
bag may be urged against the abdominal wall; the carrying out of a
procedure may include sealably inserting a morcellator into the bag
and morcellating the tissue; and retrieving the tissue by pulling
the bag out through the opening.
[0058] In yet another embodiment, an inflatable artificial
pneumoperitoneum bag includes a length and a width, an artificial
pneumoperitoneum bag neck portion having a first end and a second
end, the first end forming a bag opening, an artificial
pneumoperitoneum bag body portion forming a closed cavity in fluid
communication with the second end of the neck portion, the body
portion having a length and width greater than a length and width
of the neck portion, and a ring located at the bag opening, the
ring configured to bias the bag opening toward an open
condition.
[0059] In yet another embodiment, an inflatable artificial
pneumoperitoneum bag, including a first planar sheet portion and a
second planar sheet portion, the first and second planar sheet
portions having joined edges to form the pneumoperitoneum bag
having a length and a width, a neck portion having a first end and
a second end, the first end forming a bag opening, a body portion
forming a closed cavity in fluid communication with the second end
of the neck portion, the body portion having a length and width
greater than a length and width of the neck portion, and a ring
located at the bag opening, the ring configured to bias the bag
opening toward an open condition.
[0060] The inflatable artificial pneumoperitoneum bag may further
include one or more of the following features: a length of the bag
is between 300 and 600 mm when the bag is uninflated, and a maximum
width of the bag is between 200 and 500 mm when the bag is
uninflated; the neck portion has a diameter of between 100 and 220
mm when in the open condition; the neck portion has a length of
between 100 and 300 mm when the bag is uninflated; a
width-extending cross-section of the body portion includes an oval
shape when the bag is inflated; the bag includes sterilized
polyester polyurethane planar sheet portions having joined edges;
the bag is symmetric about two planes that are normal to one
another; the neck portion includes edges that extend parallel to a
lengthwise axis of the bag; and the ring is formed of a shape
memory material and is received through loops in the neck
portion.
[0061] In another embodiment, a method includes creating an
artificial pneumoperitoneum in a patient using an artificial
pneumoperitoneum bag, the artificial pneumoperitoneum bag including
a length and a width, a neck portion having a first end and a
second end, the first end forming a bag opening, a body portion
forming a closed cavity in fluid communication with the second end
of the neck portion, the body portion having a length and width
greater than a length and width of the neck portion, and a ring
located at the bag opening, the ring configured to bias the bag
opening toward an open condition.
[0062] In another embodiment, a method includes creating an
artificial pneumoperitoneum in a patient using an artificial
pneumoperitoneum bag, the artificial pneumoperitoneum bag including
a first planar sheet portion and a second planar sheet portion, the
first and second planar sheet portions having joined edges to form
the pneumoperitoneum bag having a length and a width, a neck
portion having a first end and a second end, the first end forming
a bag opening, a body portion forming a closed cavity in fluid
communication with the second end of the neck portion, the body
portion having a length and width greater than a length and width
of the neck portion, and a ring located at the bag opening, the
ring configured to bias the bag opening toward an open condition,
and the creating of the artificial pneumoperitoneum includes
positioning the joined edges in alignment with the lateral walls of
the abdomen.
[0063] The methods for performing a laprascopic procedure may
further include one or more of the following features: the length
of the bag is between 300 and 600 mm when the bag is uninflated,
and a maximum width of the bag is between 200 and 500 mm when the
bag is uninflated; the neck portion has a diameter of between 100
and 220 mm when in the open condition; the neck portion has a
length of between 100 and 300 mm when the bag is uninflated; a
width-extending cross-section of the body portion includes an oval
shape when the bag is inflated; the bag is formed of sterilized
polyester polyurethane planar sheet portions having joined edges;
the bag is symmetric about two planes that are normal to one
another; the neck portion includes edges that extend parallel to a
lengthwise axis of the bag; the ring is formed of a shape memory
material and is received through loops in the neck portion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0064] The invention will be more clearly understood from the
following description of some embodiments thereof, given by way of
example only, with reference to the accompanying drawings, in
which:
[0065] FIG. 1 is an isometric view of a pneumoperitoneum device
according to the invention;
[0066] FIG. 2 is another isometric view of the device of FIG.
1;
[0067] FIGS. 3 to 5 are views of another pneumoperitoneum device
according to the invention;
[0068] FIGS. 6 to 18 are diagrams illustrating the use of the
device of FIGS. 1 to 5;
[0069] FIGS. 19 to 20 are diagrams illustrating another use of the
device of FIGS. 1 to 5;
[0070] FIGS. 23 to 24 are diagrams illustrating a further use of
the device of FIGS. 1 to 5;
[0071] FIGS. 25 to 30 are diagrams illustrating various ways in
which a device according to the invention may be introduced;
[0072] FIGS. 31 to 35 are diagrams illustrating the device, in
use;
[0073] FIG. 36 is a diagram of another device according to the
invention;
[0074] FIGS. 37 to 45 are diagrams illustrating the device of FIG.
36, in use;
[0075] FIG. 46 is a diagram of another device according to the
invention;
[0076] FIGS. 47 to 54 are diagrams illustrating the device of FIG.
46, in use;
[0077] FIG. 55 is a diagram of a further device according to the
invention;
[0078] FIGS. 56 to 63 are diagrams illustrating the device of FIG.
55, in use;
[0079] FIG. 64 is a diagram of another device according to the
invention;
[0080] FIGS. 65 to 74 are diagrams illustrating the device of FIG.
64, in use;
[0081] FIG. 75 is a diagram of a device according to the invention
for use as a visceral retainer;
[0082] FIGS. 76 to 78 are diagrams illustrating the device of FIG.
75, in use;
[0083] FIG. 79 is a diagram of the device of FIGS. 75 to 78 with an
associated grommet;
[0084] FIGS. 80 and 81 are diagrams illustrating the device of
FIGS. 75 to 78 in use;
[0085] FIGS. 82 to 87 are isometric views of alternative
grommets;
[0086] FIG. 88 is an isometric view of another device according to
the invention with a multi-lumen access port removed;
[0087] FIG. 89 is an isometric, partially cut-away view of the
device of FIG. 88 with an access port in position for use;
[0088] FIG. 90 is an isometric view of a device according to the
invention.
[0089] FIG. 91 is another view of the device of FIG. 90 with an
access port in position for use;
[0090] FIGS. 92(a) and 92(b) are isometric views of single lumen
access ports for use with the devices of the invention;
[0091] FIG. 93 is an isometric view of a pneumoperitoneum device
according to another embodiment of the invention with an exit port
from the device;
[0092] FIG. 94 is an isometric view of another device similar to
FIG. 93 with a number of exit ports;
[0093] FIG. 95 is an isometric view illustrating devices of the
types of FIGS. 93 and 94, in use;
[0094] FIGS. 96 to 98 are views of various seals that may be used
in association with the device;
[0095] FIGS. 99 to 110 illustrate one method of use of devices
according to the invention;
[0096] FIGS. 111 to 113 are views illustrating a locking detail of
the device of FIGS. 99 to 110;
[0097] FIGS. 114 to 117 are views of a device according to the
invention, in use in the colon;
[0098] FIG. 118 is an isometric view of another device according to
the invention;
[0099] FIG. 119 is an isometric view of a further device according
to the invention;
[0100] FIG. 120 is an isometric view of a pneumoperitoneum device
according to the invention loaded in an introducer;
[0101] FIG. 121 is an isometric view of a bag according to the
invention;
[0102] FIG. 122 is a cross sectional view on the line A-A in FIG.
121;
[0103] FIGS. 123 to 126 are isometric views illustrating the
insertion of the bag through an opening;
[0104] FIGS. 127 and 128 are isometric views illustrating the
delivery of tissue into the bag;
[0105] FIGS. 129 and 130 are isometric views illustrating the
closing of the bag;
[0106] FIGS. 131 to 133 are isometric views illustrating the
presentation of the bag to the tissue opening, subsequent inflation
of the bag, and procedures such as morcellation being carried out
on tissue in the inflated bag;
[0107] FIGS. 134 to 138 are diagrams illustrating various
alternative arrangements of trocar(s) and instrument(s) used in
performing procedures on tissue in the inflated bag;
[0108] FIGS. 139 to 143 are various views of a biasing loop
comprising loop sections which are movable relative to one
another;
[0109] FIGS. 144 to 149 are various views of another biasing
loop;
[0110] FIGS. 150 to 153 are various views of a further biasing
loop;
[0111] FIGS. 154 to 156 are various views of another biasing
loop;
[0112] FIGS. 157 to 160 are diagrams illustrating another bag
device of the invention;
[0113] FIGS. 161 to 164 illustrate another bag device of the
invention in use;
[0114] FIG. 165 is an isometric view illustrating closing of a bag
device;
[0115] FIGS. 166 to 168 are isometric views of further bag devices
according to the invention with a retaining ring in place in a cuff
of the bags;
[0116] FIGS. 169(a)-169(c) and 170 illustrate the mounting of a
ring to the cuff of the bag of FIG. 168;
[0117] FIG. 171 shows a protector cap for a bag device;
[0118] FIGS. 172 to 176 illustrate an introducer for use in
deploying and manipulating a bag device;
[0119] FIGS. 177 to 180 are views of further introducers with
various pressure dissipating features;
[0120] FIGS. 181 to 184 illustrate another bag device having a
generally ovoid shape;
[0121] FIGS. 185 and 186 illustrate a retaining ring of the
bag;
[0122] FIGS. 187(a) to 187(f) are views illustrating the loading of
a bag device into an introducer;
[0123] FIG. 188 is an illustration of a bag device with a
re-inforced section;
[0124] FIG. 189 shows an introducer with a valve;
[0125] FIGS. 190(a) to 190(c) illustrate the use of a bag device in
transvaginal procedures;
[0126] FIG. 191 is a view of a part of a bag with a threaded bung
or trocar in place;
[0127] FIGS. 192(a) and 192(b) illustrate the closing of a chimney
of a bag, prior to deflation; and
[0128] FIGS. 193(a) to 193(c) illustrate the use of the bag devices
of the invention with various access devices.
DETAILED DESCRIPTION
[0129] The invention provides an artificial pneumoperitoneum device
for tissue isolation and/or extraction in a laparoscopic
procedure
[0130] The device is used to safely reduce and remove resected
tissue from within the abdomen via small laparoscopic incisions.
The bag creates an artificial pneumoperitoneum containing the
specimen and eliminating the dissemination of tissue and cellular
fluids within the peritoneal cavity. The device facilitates
effective and safe isolation of tissue/organs within an artificial
pneumoperitoneum for improved surgical procedures and subsequent
safe tissue extraction.
[0131] A tissue bag is inserted within the peritoneal cavity
through an incision in the abdominal wall or vagina.
[0132] In one case the bag with one or more openings is placed
within the abdomen. Excised tissue is placed within the opening of
a deflated bag. One or more openings of the bag are withdrawn
outside the abdomen and the bag is inflated. Instruments including
laparoscopic visualization are placed within the inflated bag that
remains within the peritoneal cavity. Visualisation tools may also
be provided external of the bag. The tissue retained within the bag
is morcellated/crushed/reduced and removed. The bag is deflated and
removed with residual tissue/blood/fluids inside. A major advantage
is that the tissue to be removed is retained in the bag which
prevents potentially harmful material such as cancerous cells from
being released in the body cavity.
[0133] Referring to the drawings, and initially to FIGS. 1 and 2
thereof, there is illustrated an apparatus for use in laparoscopic
surgery comprising a bag 1 having an opening 2 to receive tissue
and a ring element 3 extending around the opening 2. The bag is
inflatable.
[0134] Referring to FIGS. 3 to 5, there is illustrated another bag
device according to the invention which is similar to the bag
device of FIGS. 1 and 2 and like parts are assigned the same
reference numerals. In this case the bag 1 has a necked region 5 to
reduce the amount of material near the ring 3. This facilitates
attachment of the bag 1 to an external element.
[0135] The bag device 1 is suitable for use during laparoscopic
surgery to facilitate procedures on tissue in an insufflated cavity
while maintaining pneumoperitoneum.
[0136] The bag device 1 may be mounted to a retractor. One such
retractor comprises a distal anchoring ring 10, a retractor member
such as a sleeve 11, and a proximal ring assembly 12.
[0137] One such retractor is described in US 2005-0090717 A, the
entire contents of which are incorporated herein by reference. The
distal anchoring ring 10 is located within a wound interior, in
use. In this case the distal anchoring ring 10 is provided in the
form of an O-ring. The proximal ring assembly 12 is located
externally of a wound opening, in use. The retractor member 11 may
be employed to retract laterally the sides of a wound opening. In
this case, the retractor member is provided in the form of a
sleeve.
[0138] The proximal end of the retractor 11 is closable by a cap
which in this case comprises an instrument access device 30 which
may have a number of instrument ports 31 to effect a seal around an
instrument extended through the device 30. The instrument access
device 30 may be releaseably mountable to the proximal ring
assembly 12. At least some of the instrument ports may include a
stalk 32 which is laterally flexible and longitudinally rigid.
[0139] FIG. 6 illustrates an instrument 51 being introduced under
vision provided by a camera 52 through an instrument access port
31.
[0140] FIG. 7 shows an organ or tissue such as an uterus 35 which
has, been severed from it's retaining structures.
[0141] FIG. 8 illustrates the bag device 1 being inserted into the
abdominal cavity at the beginning of a procedure or as and when
required. The bag 1 is inserted in a small flattened state for ease
of insertion through a small opening such as an incision. As shown
in FIG. 8, the bag device 1 is inserted through an opening that is
open to the atmosphere, and thus the peritoneal cavity is
uninsufflated in this embodiment. The bag may also be introduced
through a valve without the need to remove the access cap 30. One
such arrangement is illustrated in FIG. 10, and this allows the bag
device to be inserted into an insufflated peritoneal cavity.
[0142] When the bag 1 is inserted in the insufflated or
uninsufflated peritoneal cavity, it is opened up (FIG. 9). An organ
is then readily manipulated for insertion into the bag 1 as
illustrated in FIG. 11. The rigidity of the O-ring 3 keeps the bag
open to facilitate insertion of an organ.
[0143] FIG. 12 shows the organ located in the bag 1 and the O-ring
3 being grasped to facilitate manipulation of the bag towards the
opening. As shown in FIG. 12, removal of access cap 30 provides an
uninsufflated peritoneal cavity prior to inflating the bag device
1. The uninsufflated nature of the peritoneal cavity helps the bag
device 1 expand as shown in FIG. 16, and apply a retracting force
to the materials outside the bag thereby creating additional space
(FIG. 76). It is understood that the bag device 1 could be inflated
while the peritoneal cavity is insufflated if there is one or more
openings to the peritoneal cavity that allow the insufflation gas
to escape to the cavity. One such opening could be provided through
an open trocar device or trocar incision opening that was used to
carry out the tissue excising explained above. The O-ring 3 is
pulled out through the opening (FIG. 13) and the bag 1 is mounted
to the proximal ring assembly 12 and the cap 30 is mounted to the
proximal assembly 12 (FIG. 14). FIG. 15 illustrates the device in
place with an organ enclosed within the bag 1.
[0144] The bag 1 is then inflated through an insufflation port 40.
The inflation of the bag has the additional benefit of applying a
retracting force to the materials outside the bag 1 thereby
creating additional space (FIG. 16). Thus, the artificial
pneumoperitoneum created in the uninsufflated peritoneal cavity,
and within the inflated bag device 1, serves to extend the abdomen
and provide additional working and viewing space within the bag
device 1.
[0145] FIG. 17 shows an organ being worked on in the inflated bag
1. In this case the organ is morcellated. The material is all
retained safely within the bag and is not released into the cavity
which could cause major difficulties.
[0146] When the organ has been morcellated, the bag is readily
removed through the original opening. All waste, blood, tissue and
the like are safely removed and sealed within the bag 1.
[0147] FIG. 19 shows the bag device being inserted through a
standard naked incision. Once the specimen has been inserted into
the bag 1 (FIG. 20) the ring 3 is pulled back out through the
incision (FIG. 21) and a trocar 60 is inserted to create a gas seal
(FIG. 22). It may also be possible to insert the bag device 1
directly through a trocar.
[0148] In all cases there may be one or more access trocars used in
addition to the primary port. Thus, the invention includes
procedures which involve two or more incision laparoscopy.
[0149] For example, FIGS. 23 and 24 show one arrangement in which
an additional trocar 70 is inserted. In some cases, the additional
trocar 70 may be extended through the bag whilst maintaining a
seal.
[0150] A bag 1 is illustrated which has some depth which is
preferred. However, a flat material can be used to form a holder in
situ and the edges of the material pulled out through an incision
and sealed outside, for example by an access device 30.
[0151] The invention provides a method of inserting a large bag
into the abdominal cavity to allow the insertion of a specimen into
the bag. The bag is then sealed and inflated and procedure carried
out within the bag.
[0152] FIGS. 25 to 30 show various ways a bag 79 may be introduced
into the abdomen.
[0153] In FIG. 25 the device may be inserted directly through an
incision 80.
[0154] Referring to FIG. 26, the device may be inserted through a
trocar 81.
[0155] In FIG. 27 a device may be inserted through a base retractor
82.
[0156] Referring to FIG. 28 a device may be inserted through a low
profile port 83.
[0157] As shown in FIG. 29 the device may be inserted through a
Multi-port device 84. The multiport device may, for example, be of
the type described in U.S. Pat. No. 8,187,178 or US 20110071389A,
the entire contents of which are incorporated herein by
reference.
[0158] Referring to FIG. 30 the device may be inserted through the
base 85 of a multi-port device.
[0159] As illustrated in FIG. 31, once the bag 79 has been inserted
the specimen is placed inside.
[0160] FIG. 32 the lip of the bag 79 is pulled out through the
opening.
[0161] FIG. 33 the bag 79 is sealed by re-inserting the trocar 60,
replacing the cap or inserting a morcallator 78. If necessary an
extra seal may be applied to the neck of the bag 79.
[0162] As shown in, FIG. 34, once the bag 79 is inflated additional
trocars may be inserted into the abdomen as normal and pierced
through the bag 79. FIG. 34 also shows a morcallator 78 inserted
through a trocar 60.
[0163] FIG. 35 shows the morcallator 78 being inserted without the
need for a trocar. A sealing ring 77 may be applied around the
shaft of the morcallator 78 if necessary to hold back gas.
[0164] Referring to FIGS. 36 to 45 a method of inserting a large
bag 100 into an abdominal cavity which may automatically open to
allow the insertion of a specimen is illustrated. The bag 100 is
foldable and has a top opening 105 which may be biased into the
open configuration by retaining elements which in this case
comprise semi-circular ring parts 101, 102 which have attached
tether elements 104, 103 respectively. A pouch 110 is used to house
the bag 100 in a folded/retracted configuration. The pouch 110 has
a grasping tab 111 and a pull string 115.
[0165] FIG. 36 illustrates the main components of the automatically
opening bag device.
[0166] FIG. 37 illustrates a folded bag 100 inside the pouch 110.
In FIG. 38 the pouch 110 is inserted into the abdominal cavity with
the aid of the grasping tab 111. When the pouch is inside, the
distal pull tether 104 is pulled forward and the bag 100 is
released. A rear pull string 115 is pulled in the opposite
direction to aid release.
[0167] Referring to FIG. 40, it will be noted that as the distal
end of the bag 100 is pulled forward the rear of the bag 100 is
pulled in the opposite direction as it is attached to the pouch 110
with the connecting tether 103. This action opens the mouth of the
bag 100 sufficient to ease the inserting of specimens.
[0168] FIG. 41 shows specimens being placed on top of the bag
opening 105.
[0169] Referring to FIG. 42, by pulling the distal pull tether 104
back and over the specimen, the bag 100 begins to unroll and the
specimen travels deeper insider the bag 100. Referring to FIG. 43,
as the front and back retaining elements 101, 102 of the bag
opening are pulled outwards, the specimen travels further into the
bag 100.
[0170] FIG. 44 shows the rim of the bag being opened up and the
incision being cleared of excess bag material.
[0171] Referring to FIG. 45, the opening is re-sealed by attaching
a cap, by inserting a trocar, or by inserting a morcallator through
the opening.
[0172] Referring to FIGS. 46 to 54 there is illustrated another
device according to the invention. The device is similar to that of
FIGS. 36 to 45 and like parts are assigned the same reference
numerals. In this case a bag 120 is housed within a cartridge 121
for delivery and automatically opens when it exits the cartridge
121 on insertion into the abdominal cavity. In this case the ring
part 102 remains attached to the cartridge 121. A tether 125
extends between the distal end of the cartridge 121 and the ring
element 102. The ring element 101 has a tether element 126 which is
grasped by an instrument 127 to pull the bag 120 from the cartridge
121.
[0173] FIGS. 46 to 54 show the bag 120 housed in the cartridge 121
which can be inserted into a valve on an access port/trocar 130.
The cartridge 121 remains in place during the procedure.
[0174] Referring to FIG. 46, the loaded cartridge 121 is placed
through a valve on the port 130. FIG. 47 shows the distal pull
tether 126 that is positioned so that it is easily grasped with an
instrument 127. In FIG. 48 an instrument 127 is inserted and the
pull tether 126 is grasped.
[0175] Referring to FIG. 49, as the instrument/grasper 127 is
pushed forward the bag 120 is released from the cartridge 121. As
shown in FIG. 50, once the bag is in far enough, the tether 125
which connects the back side of the bag 120 to the cartridge 121
begins to open the bag 120 up.
[0176] Referring to FIG. 51, when the mouth of the bag 120 is
sufficiently open a specimen may be placed inside. When the distal
pull tether 126 is pulled back as illustrated in FIG. 52 this
forces the bag 120 to unroll and the specimen to travel deeper into
the bag 120.
[0177] Referring to FIG. 53, the cap/trocar 130 is then removed and
the rim of the bag 120 is pulled out through the incision and
mounted to the retractor 135. FIG. 54 shows the cap, trocar, or
morcallator reconnected. The bag 120 is then inflated.
[0178] Referring to FIGS. 55 to 63, there is illustrated a
removable cartridge 140 with a manually opened bag 141 for
insertion through a single port 142. These drawings illustrate a
method of inserting a large bag 141 which will be manually opened
by the user when inserted into the abdominal cavity. FIGS. 55 to 63
show a bag 141 housed in a cartridge 140 which plugs into a valve
142 on an access port/trocar 130. The bag 141 is ejected from
cartridge 140 using a plunger 145 and the cartridge 140 is removed.
As shown, for example, in FIG. 54, inflating the bag device 1
creates the artificial pneumoperitoneum and urges the bag against
the abdominal wall. This arrangement allows one or more additional
trocars 70 to extend through the abdominal wall and directly and
sealingly pierce the inflated bag device 1 where the bag device is
urged against the abdominal wall. See, for example, FIGS. 24, 34,
and 35. Further facilitating this sealing of the additional trocars
70 to the inflated bag device 1 is the fact that the inflated bag
device 1 is applying a retracting force to the materials outside
the bag device and is thus secured in place against the abdominal
wall.
[0179] Referring to FIG. 55, the bag 141 is loaded into a cartridge
140 which is then inserted through a valve 142 on the port/trocar
130. When the cartridge 140 is in place of the plunger 145 is
inserted through the proximal end of the cartridge 140 as
illustrated in FIG. 56. Pushing the plunger 145 down as illustrated
in FIG. 57 forces the bag 141 to eject into the abdominal
cavity.
[0180] Referring to FIG. 58, when the bag 141 has been ejected, the
cartridge 140 may be removed, leaving an activation tether 147 in
place. An instrument 148 is inserted as illustrated in FIG. 59 and
the instrument 148 is used to grasp the distal pull tether 149
which is attached to the front band or ring part/element 101 on the
bag 141.
[0181] Referring to FIG. 60, the specimen is then lifted into the
open mouth of the bag 141. The surgeon can control the mouth of the
bag 141 using the activation tether 147. When both the front and
the back ring elements 101, 102 of the bag 141 are grasped as
illustrated in FIG. 61, the bag 141 can be pulled towards the
incision, forcing the specimen to travel deeper into the bag
141.
[0182] FIG. 62 shows the valve/trocar 130 being removed and the rim
of the bag being pulled out through the incision. In FIG. 63, the
rim of the bag 141 is opened up, and the valve/trocar 130 are
replaced to seal the bag 141. The bag 141 is then inflated and the
procedure carried out within.
[0183] Referring to FIGS. 64 to 74 there is illustrated a removable
cartridge 150 with a manually opened bag 151 (laparoscopic). These
drawings show a method of inserting a large bag 151 which can be
manually opened by the user when inserted into the abdominal
cavity.
[0184] Referring to FIG. 64, the loaded cartridge 150 is inserted
through a pre-made incision. When the cartridge 150 is in place a
plunger 152 is inserted as illustrated in FIG. 65. The plunger 152
is pushed all the way down and the bag 151 is ejected as shown in
FIGS. 66 and 67.
[0185] Referring to FIG. 68 an instrument 155 is inserted through a
trocar/access port 156 and is used to grasp a distal pull tether
157 which is attached to the front band on the bag. Once the distal
tether 157 is held, pulling on the activation tether 158 opens the
mouth of the bag 151 and forces the excess material to unroll. The
specimen may now be lifted into the open mouth of the bag as shown
in FIG. 69. The surgeon can control the mouth of the bag 151 to
some degree with an activation tether 158.
[0186] Referring to FIG. 70, with the back end of the bag 151
grasped, the bag 151 can be pulled towards the incision, forcing
the specimen to travel deeper into the bag 151. The valve/trocar is
removed and the rim of the bag is pulled out through the incision
as illustrated in FIG. 71. The rim of the bag 151 is opened up, and
the morcallator is inserted to seal the bag as shown in FIG. 72.
The bag is then inflated and the procedure carried out within.
[0187] As illustrated in FIGS. 73 and 74, when the bag 151 is
inflated trocars 159 can be pierced through to allow access for
additional instruments 160.
[0188] Referring to FIGS. 75 to 87 there is illustrated the use of
a bag 170 as described above as a visceral retainer. The bag 170 is
first inserted and positioned where required (FIG. 75). As the bag
170 is inflated, surrounding structures and organs (abdominal
visecera) are retracted as shown in FIG. 76.
[0189] As shown in FIGS. 77 and 78, it may be of benefit to fill,
or partially fill the bag 170 with a liquid. These benefits may
include: 1) The specimen floats to the top of the bag and therefore
the risk of bag damage at the base may be reduced. 2) Liquid may
reduce smoke build up in the bag. 3) Blood will be diluted and may
therefore allow for enhanced visibility.
[0190] Referring to FIG. 79, when the bag 170 is in place and the
neck has been pulled through the incision there is often a lot of
excess material in the incision. A grommet 175 may be inserted
through the bag/incision to keep excess material away from the
incision as illustrated in FIG. 80. This will help prevent damage
to the bag 170 and aid visibility and gas flow. With the grommet
175 in place instruments can be inserted with ease as shown in FIG.
81.
[0191] The grommet 175 may be used with multiport or single port
access devices (FIG. 82).
[0192] In some cases the grommet 175 have an
insufflation/desufflation line 176 built in (FIG. 83).
[0193] As illustrated in FIG. 84 the grommet may include a series
of slits 177 which allow it to conform to various incision
dimensions.
[0194] The grommet may include a valve system 178 as illustrated in
FIG. 85.
[0195] An instrument locking mechanism 179 may also be included
(FIG. 86).
[0196] In some cases, as illustrated in FIG. 87, the grommet may
have a series of lumens 180 to aid with
ventilation/insufflation.
[0197] Referring to FIGS. 88 and 89 there is illustrated a bag
device 200 according to the invention. In this case, the bag 200 is
shown in the inflated configuration within a body cavity such as
the abdomen. A tissue sample 201 is contained within the bag. An
incision is made in the abdomen 202 and the incision is retracted
using a retractor 203 as described above. In this case the
retractor 203 has an outer proximal ring 204 and a multilumen
access port 205 is releasable mounted to the ring 204. The bag 200
extends through the retracted incision and terminates in a retainer
ring 206.
[0198] FIGS. 90 and 91 illustrate a bag device similar to that
shown in FIGS. 88 and 89 but in this case a single instrument lumen
access port 211 is mountable to a proximal part of the refractor
assembly. The access port 211 may have a cannula section that
extends through the refractor or may be an access port 212 with a
short proximal leg.
[0199] The bag device may itself have an access port to facilitate
passage of instruments into and out of the bag and/or to facilitate
passage of a tissue sample into the bag.
[0200] Referring to FIG. 93 the bag has a single access port 220.
However, there may be a plurality of such access ports as
illustrated in FIG. 94. Passage of a tissue sample 225 through an
access port 220 is illustrated in FIG. 95. The access port 220 may
be provided with any suitable valve such as a choke valve, for
example, for example a drawstring 226 as illustrated in FIG. 96, a
cuff valve 227 as illustrated in FIG. 97, or an elastomeric valve
228 as illustrated in FIG. 98. The valve 228 may be of any suitable
plastics, rubber or gel material.
[0201] Referring to FIGS. 99 to 110 there is illustrated various
steps in methods involving the use of the bag devices of the
invention. In the example illustrated the device is of the type
described above. The methods involve the use of a bag device 250, a
retractor 251, an external access port system 252 and is used to
access tissue 253 such as a specimen or an organ through an opening
254 in the body, in this particular case in the abdomen 255. The
bag device has a delivery configuration in which it is housed in a
retracted condition in a cartridge 260. A plunger 261 is used to
deliver the retracted bag device out of the cartridge 260. The bag
device 250 has an opening which is biased into an open
configuration by a retainer ring 265. The ring 265 may be of a
shape memory material as described above. A proximal tether which
in this case is in the form of a ring or loop 267 is provided on
one side of the ring 265 and a distal tether 268 extends from the
side of the ring 265 generally opposite to the proximal tether
267.
[0202] In FIG. 99 the bag device is placed in the delivery
configuration in the cartridge or pouch 260. In this case the
access port device 252 is in situ on top of the retractor 251 and
the cartridge 260 is inserted through one lumen of the access port
(FIG. 100). The plunger 261 is used to push the bag device 250 out
of the cartridge 260 (FIG. 101). In this particular case the bag
device is not tethered to the user, on delivery. On delivery into
the body cavity, such as the abdomen, the retractor ring is free to
move to its normally expanded configuration in which it opens up
the bag opening (FIG. 102). The bag is folded in the delivery
configuration. Using various instruments 270 a clinician
manipulates a tissue specimen, organ or the like and then delivers
it into the bag 250 through the open mouth of the bag (FIGS. 103,
104). FIGS. 105 and 106 illustrate one particular way in which the
bag containing the tissue is retrieved. A grasper type instrument
275 is led through the proximal tether loop 267 and is used to
grasp the distal tether 268 (FIG. 105). The distal tether 268 is
pulled through the proximal tether loop 267 which ensures that the
clinician has control over the bag as it is moved up towards the
body opening (FIG. 106). As the retaining ring 265 engages with the
retractor 251 it retracts allowing it to be pulled up through the
body opening (FIG. 107). The access port 252 is removed and the
retaining ring 265 is again free to expand (FIG. 108).
[0203] The access port 252 is re-attached and the bag is inflated
to increase the operative field. The tissue sample can then readily
by worked on (FIGS. 109, 110) without the risk of any potentially
harmful material being released into the body cavity.
[0204] In some cases there may be a lock feature which prevents
movement of one tether relative to the other in some directions.
One such lock feature is illustrated in FIGS. 111 to 113. The
distal tether has a one-way step feature 280 which permits the
distal tether to pass through the proximal loop tether but once it
has passed through this reverse movement is prevented as
illustrated in FIG. 113. This ensures even greater control on the
movement of the retaining ring 265 to aid closing of the bag as the
ring 265 is being withdrawn.
[0205] As discussed above, the devices of the invention may be used
in any suitable body cavities. One such use is in the colon and one
embodiment for this use is illustrated in FIGS. 114 to 117. The
device may be inserted as described above. Once in place and
inflated a clinician can inspect the wall of the colon for any
unusual features such as a growth. One such growth 280 is
illustrated in FIG. 115. In this case, when a growth 280 is
identified some or all of the growth 280 may be accessed by cutting
a hole in the wall of the bag which remains in place by virtue of
its engagement with the rest of the colon. Using various
instruments, at least a portion of the growth 280 can be excised
and removed through the bag. As in the other embodiments described
a major advantage is that the tissue to be removed is retained in
the bag which prevents potentially harmful material such as
cancerous cells from being released in the body cavity.
[0206] Referring to FIG. 118 there is illustrated another bag
device 400 of the invention. The bag device has a neck or collar
region 401 between a retaining ring 402 and the main body of the
bag. Because the retaining ring 402 is of smaller diameter than
that of the bag it is more easily inserted through an access port.
As shown in FIG. 118, the bag device 400 includes joined planar
sheet portions forming the neck region 401 and a body portion 403.
Also as shown in FIG. 118, the body portion 403 forms a closed
cavity in fluid communication with the neck region 401, and the
body portion 403 has a length and width greater than a length and
width of the neck region 401. As also shown in FIG. 118, the
retaining ring 402 is configured to bias the bag opening toward an
open condition.
[0207] FIG. 119 illustrates another bag device 410 and shows how
the main body of the bag may be folded in the retracted delivery
configuration.
[0208] Referring to FIGS. 121 and 122, there is illustrated a bag
500 for use in laparoscopic surgery having an opening 502 to
receive tissue and a cuff or collar 503 extending around the
opening 502. The bag 500 may be inflatable.
[0209] The bag 500 comprises a main body 505 which extends from the
cuff 503. The main body 505 is more flexible than the cuff 503 to
assist in retaining the bag 500 open in the deployed configuration.
The cuff 503 may be of a different material than that of the bag
500 or may comprise the same or a similar material which is thicker
than that of the main body 505 of the bag 500. In one case the cuff
503 is of a plastics material and the main body 505 of the bag 500
is of a plastics material which is more flexible than that of the
cuff 503. However, the cuff 503 is sufficiently flexible to allow
closing of the opening 502. A joint 507 between the cuff 503 and
the main body 505 of the bag may be reinforced in any suitable
manner such as by using a double layer of the cuff material as
illustrated in FIG. 3.
[0210] The cuff 503 has an axial extent which is important in
maintaining the opening 502 in a fully open configuration. This has
the major advantage that tissue can be more readily manoeuvred into
the opening 502 by the surgeon performing a laparoscopic procedure
through a small opening. When the bag 500 is in the open
configuration the surgeon is able to concentrate on manipulation of
the tissue/material to be inserted into the bag 500 without the
added task of complex manipulation of the bag 500 at the same time
as the material is being manipulated. Thus, the bag 500 greatly
facilitates the laparoscopic surgical procedure.
[0211] The cuff 503 extends axially for a length which is
sufficient to ensure that the opening 502 remains open to provide
an axially extending delivery mouth into the main body 505 of the
bag 500. For example the cuff 503 may extend for an axial length of
from 2 to 20 cm, 2 to 10 cm, or about 5 cm. Alternative size
dimensions for the cuff or collar 503, as well as sizes for other
features of the bag, will be discussed in more detail below.
[0212] In the invention the cuff 5033 is biased into the open
configuration. In this case the bag 500 comprises a biasing element
to bias the cuff 503 into the open configuration.
[0213] The biasing element may comprise a loop 510 extending around
the cuff 503. The loop may be of a shape memory material such as
Nitinol. The loop 510 extends round the cuff 503 in any suitable
manner. It may, for example, be threaded through the cuff as
illustrated or may extend through a table or track provided in or
on the cuff 503.
[0214] The cuff 503 has tabs 511, 512 which may be used for more
readily grasping the bag during a laparoscopic procedure.
[0215] A tether 515 extends from the cuff 503 and may be used to
activate the opening and/or closing of the bag 500.
[0216] Referring to FIG. 120, the bag 500 is folded and housed in
an introducer sheath or pouch 520 ready for deployment. Any
suitable insertion tool may be used to deliver the bag 500 through
an opening. The bag 500 may be deployed in any suitable manner such
as by using a plunger 516 which a user activates to deliver the bag
from the introducer 520.
[0217] The deployment of the bag 500 through an opening such as a
retracted incision 525 is illustrated in FIGS. 123 to 126. As soon
as the bag starts to exit the pouch the cuff 503 opens up and when
fully deployed defines an axially extending open mouth. FIGS. 127
and 128 illustrate tissue 530 being manipulated into the open mouth
of the bag 500 using an instrument such as a grasper 531. When the
tissue 530 is in the bag 500 the tether 515 is used to pull the
cuff 503 which initially closes the opening and is then pulled out
through the tissue opening 525. When the proximal end of the bag
500 has passed through the tissue opening the bag 500 may be
inflated and a procedure carried out on the tissue isolated within
the bag 500. This may be carried out in several different ways,
depending on the procedure being performed. For example, the bag
entrance may be closed with an access port 540 as illustrated in
FIG. 133 which facilitates access of any suitable instruments to
perform procedures such as morcellation of the tissue within the
bag 500. Alternatively access is gained to the captured tissue
without a requirement for an access port--see FIGS. 134, 135 and
138. Alternatively a trocar 545 may be provided through which an
instrument is passed (FIG. 136). There may be additional trocars
550 used (see FIG. 137, for example).
[0218] The collar/cuff 503 may be collapsible to allow tissue to be
rolled into the bag opening 502 rather than being lifted into the
bag opening 502.
[0219] The bag 500 may be mounted to a retractor. One such
retractor comprises a distal anchoring ring, a retractor member
such as a sleeve, and a proximal ring assembly. One such retractor
is described in US 2005-0090717 A, the entire contents of which are
incorporated herein by reference. The distal anchoring ring is
located within a wound interior, in use. In this case the distal
anchoring ring is provided in the form of an O-ring. The proximal
ring assembly is located externally of a wound opening, in use. The
retractor member may be employed to retract laterally the sides of
a wound opening. In one case the retractor member is provided in
the form of a sleeve.
[0220] The proximal end of the retractor is closable by a cap which
may comprise an instrument access device 540 which may have a
number of instrument ports to effect a seal around an instrument
extended through the device. The instrument access device may be
releaseably mountable to a proximal ring assembly of a retractor.
At least some of the instrument ports may include a stalk which is
laterally flexible and longitudinally rigid. One such instrument
access port is described in U.S. Pat. No. 8,187,178 or
US2011-0071389A, the entire contents of which are incorporated
herein by reference.
[0221] FIG. 127 shows an organ or tissue such as an uterus which
has been severed/amputated from it's retaining structures.
[0222] FIGS. 123 to 126 illustrate the bag device being inserted
into the abdominal cavity at the beginning of a procedure or as and
when required. The bag is inserted in a small flattened state for
ease of insertion through a small opening such as an incision. The
bag may also be introduced through a valve without the need to
remove an access cap.
[0223] When the bag is inserted it is opened up. An organ 530 is
then readily manipulated for insertion into the bag as illustrated
in FIG. 128. The relative rigidity of the cuff 503 keeps the bag
open to facilitate insertion of an organ.
[0224] FIG. 129 shows the organ located in the bag and the cuff 503
being grasped to facilitate manipulation of the bag towards the
opening. The cuff 503 is pulled out through the opening. The bag
may be mounted to a proximal ring assembly of a retractor and a cap
may be mounted to the proximal assembly. FIG. 131 illustrates the
device in place with an organ enclosed within the bag.
[0225] The bag is then inflated (FIG. 132) through an insufflation
port. The inflation of the bag has the additional benefit of
applying a retracting force to the materials outside the bag
thereby creating additional space.
[0226] FIG. 133 shows an organ being worked on in the inflated bag.
The organ may be morcellated. The material is all retained safely
within the bag and is not released into the cavity which could
cause major difficulties. The bag is retained externally, for
example by clamping/connecting to a retractor.
[0227] When the organ has been morcellated the bag is readily
removed through the original opening. All waste, blood, tissue and
the like are safely removed and sealed within the bag.
[0228] The bag device may be inserted through a standard naked
incision. Once the specimen has been inserted into the bag an
opening such as a cuff 503 is pulled back out through the incision
and a trocar may be inserted to create a gas seal. The bag device
may also be inserted directly through a trocar as illustrated in
FIG. 136.
[0229] In some cases there may be one or more access trocars used
in addition to the primary port. Thus, the invention includes
procedures which involve two or more incision laparoscopy.
[0230] For example, FIG. 137 shows one arrangement in which an
additional trocar is inserted. In some cases, the additional trocar
may be extended through the bag whilst maintaining a seal.
[0231] The invention provides a method of inserting a large bag
into the abdominal cavity to allow the insertion of a specimen into
the bag. The bag is then sealed and inflated and procedure carried
out within the bag.
[0232] As discussed above, the devices of the invention may be used
in any suitable body cavities. One such use is in the colon. The
device may be inserted as described above. Once in place and
inflated a clinician can inspect the wall of the colon for any
unusual features such as a growth. In this case, when a growth is
identified some or all of the growth may be accessed by cutting a
hole in the wall of the bag which remains in place by virtue of its
engagement with the rest of the colon. Using various instruments,
at least a portion of the growth can be excised and removed through
the bag. As in the other embodiments described a major advantage is
that the tissue to be removed is retained in the bag which prevents
potentially harmful material such as cancerous cells from being
released in the body cavity.
[0233] Referring to FIGS. 139 to 155 various embodiments of biasing
loop elements which may be used in the bag device of the invention
to assist in maintaining the bag open are illustrated. In these
cases the loop comprises a number of loop parts which are movable
relative to one another for loading deployment, and/or
retrieval.
[0234] Referring to FIGS. 139 to 143 in this case there are two
joined loop parts 551a, 551b which are movable circumferentially
through hoops 552. In some cases a single piece loop is
sufficiently flexible to allow manipulation.
[0235] Referring to FIGS. 144 and 149 in this case a loop 560 is
configured in the manner of a noose with a leg 561 extending from
the loop which may be pulled to reduce the diameter of the loop.
There is a closed loop 562 on one end and a kink 563 on the other
end which links into the loop 562 to facilitate reducing the
diameter of the loop 560.
[0236] Referring to FIGS. 150 to 153 in this case there may be
closed loops 570, 571 at each end of the retaining loop 572. These
may be used as tether attachment points.
[0237] Referring to FIGS. 154 to 156 in this case the ends of a
retaining loop 580 have bends 581, 582 and extend to define arms
583, 584 which facilitate manipulation of the loop for
retrieval.
[0238] The device of the invention may include features to isolate
the contents of the bag from the wound opening and hence protect
from escape of material as could occur with seeding of cancer cells
and the like.
[0239] Referring to FIGS. 157 to 160 in this case the bag comprises
a small opening 600 which remains closed under insufflation
pressure. The opening 600 is opened on insertion of an implement
such as a trocar 601 through the opening 600. The bag has excess
material in the region of the opening 600 which defines a sleeve or
chimney 603 which seals along part of the length of the trocar
shaft when the shaft is in place in the opening 600. The opening
600 is located at the top of the bag, in use i.e. in the region
that touches the abdominal wall. A trocar 601 may be inserted in a
region of the abdominal wall remote from key organs and manipulated
under full vision to locate the opening. The opening stays closed
whilst there is internal insufflation pressure and the sleeve or
chimney 603 collapses around the trocar to create a seal.
[0240] Referring to FIGS. 161 to 163, in this case any excess bag
material 604 may be grasped using a grasper 605 inserted through a
trocar 606. The end of the excess material may then be cut (FIG.
162) creating a chimney 607 extending from the bag. The chimney 607
is then sealed--for example using a threaded trocar 608 which is
twisted inside the chimney 607 to create a seal. The chimney 607
prevents contact between the wound and debris created during
morcellation. In this case the surgeon is provided with an
additional port into the bag for use during the procedure. One such
procedure may involve insertion of a laparascope or a grasper, for
example through the secondary port.
[0241] Referring to FIG. 164, in another embodiment a bung 610 may
be placed inside the trocar 606, sealing the bag to the trocar. An
implement such as a laparascope 611 may be inserted through the
bung 610.
[0242] Referring now to FIG. 165, in this case the bag has a cuff
620 and a tether 621 loop is threaded through the cuff. The tether
621 has a strap 622 which may be used to pull on the tether from a
location external of the abdomen. The cuff 620 also has grasping
tabs 623, 624. In this case a grasper 625 may be used to grip the
tab 623 as illustrated and then push the cuff towards the opposite
side of the bag, towards the tab 624, thus closing the bag. The
strap 622 enables the bag to be held firmly whilst being closed
within the pneumoperitoneum.
[0243] In some cases the bag is retained in the normally open
configuration by a retainer ring of a shape memory material such as
Nitinol. It has been found that a single ring formed by attaching,
for example by welding, together the ends of a ring-forming member
is most efficient in achieving rapid deployment. Referring to FIGS.
185 and 186 the retaining ring of the bag may be manufactured in
any suitable manner. In one case, for example, a shape memory
material 675 is formed into a loop, shape set and welded. A tether
strap 676 may also be attached in any suitable manner.
[0244] In some cases the cuff of the bag may have features to
facilitate mounting of the pre-formed ring to the bag.
[0245] In one embodiment illustrated in FIG. 166 the bag has a cuff
630 through which a loop 631 of a shape memory material such as
Nitinol is led. Internal capturing regions 632 for the retaining
loop 631 are created by cutting panels in the material of the bag
and folding down over the retaining loop 631 and sealing using a
suitable tool such as a circular sealing tool. A tether strap 632
is mounted to the loop 631 and extends through an access port 633
to maintain control over the bag.
[0246] Referring to FIG. 167, in this case pressed out attachments
635 are folded over a closed retaining loop 636 of a shape memory
material such as Nitinol and sealed, for example by heating. A
front grasping tab 637 includes reinforced attachment loops
638.
[0247] FIGS. 168 to 170 illustrate another method of attaching a
retaining loop 640 to a cuff 641 of a bag according to the
invention. In this case the material of the collar or cuff 641 is
punched out with a cut detail 642 extending from a hole 643
(through which the retaining ring 640 is extended) to the edge of
the cuff. The cuff is formed into a collar 641 as illustrated in
FIGS. 169(a) to 169(c). The retaining ring 640 is inserted through
the cut details 642 and into the receiving holes 643. Using a
circular sealing tool, the tabs are folded down to create an
alternating overlap. The cuff is then sealed, for example by heat
sealing to close the holes 643. In this way a closed loop 640 of a
shape memory material such as Nitinol is attached to the bag to
maximise the opening and facilitate insertion of tissue
laparascopically when the bag is within the abdomen.
[0248] In some embodiments the abdominal bag is protected from
damage during use of a morcellator. For example, as illustrated in
FIG. 171 an insert/cannula 650 may be inserted to isolate a
morcellator from the material of the bag. The insert 650 may for
example be rigid, flexible or of a segmented rigid material. An
access port or cap 651 may be releasably mountable to the insert
650.
[0249] The device used to introduce the bag into an insufflated
abdomen may be adapted to control the opening of the bag. For
example, as illustrated in FIGS. 172 to 176 a tip 655 of an
introducer sheath 656 may have mirrored slots 657 which allow a
retaining ring of the bag to start to expand before the full bag is
inserted. Such an introducer will aid manuevering of the bag into a
desired position before the bag becomes detached from the
introducer. In addition, the deployed bag can be partially
withdrawn into the introducer to enable further rigid movement of
the bag to optimise positioning.
[0250] To limit blood or other material being pushed into the
introducer by the positive insufflation pressure within the abdomen
the tip of the introducer may have pressure dissipating features.
For example, as illustrated in FIGS. 177 to 180 the introducer tip
may have various slots 660, holes 661 and/or tapering features
662.
[0251] In another embodiment as illustrated in FIG. 189 to restrict
blood or other material from entering the introducer, a shaft 695
of the introducer may have a valve 696 at the proximal end. The
valve 696 may be openable on insertion of a pusher 697 used to
deploy the bag device from the introducer.
[0252] It will be appreciated that the bag of the invention may
comprise different materials to fulfil different requirements for
sections of the bag. For example, as illustrated in FIGS. 181 and
182 a main body 665 of the bag may be made from a relatively thin
flexible material and a collar 666 of a thicker, more rigid
material. For example, the main body 665 may include a sterilized
polyester polyurethane, such as SS-1495-95 (95 shore A polyester
polyurethane blown film with high slop surface and good clarity),
and the collar or neck portion 666 may includes a sterilized
polyether polyurethane, such as ST-625-85 (85 Shore A polyether
polyurethane formulated for medium/high slip with good
sealability).
[0253] The bag may also be of any desired shape/profile. For
example, the bag may be of oval or elliptical profile as
illustrated in FIGS. 181 to 184. This shape assists in pushing
organs such as a section of bowel away from the abdominal wall
which prevents the bowel from migrating over the top of the bag. As
shown in FIG. 184, the creation of the artificial pneumoperitoneum
includes positioning the joined edges 671 of the bag in alignment
with the lateral walls of the abdomen 672 such that one of the
planar sheet portions of the bag faces, and is in contact with, the
anterior abdominal wall, and the other sheet portion of the bag
faces and contacts the visecera. Tissue 670 is illustrated in FIGS.
183 and 184 within the bag.
[0254] The bag may be sized to be larger than the peritoneal cavity
of the patient so as to provide apposition against the abdominal
wall after inflation. The oversized nature of the bag, and the
loading of the bag into the introducer as described below in
connection with FIGS. 187(a) to 187(f), allows any additional bag
material after inflation to remain rolled at the bottom of the bag.
This helps to minimize pleats or folds of the inflated bag from
extending into the artificial pneumoperitoneum. Consistent with
this, and as shown in FIG. 181, the bag may be sized to include a
total bag length 661 of between 300 and 600 mm, or between 400 and
550 mm, or approximately 500 mm, all in an uninflated condition.
The bag may also include a maximum width 677, for example in the
body portion 665, of between 200 and 500 mm, or between 300 and 400
mm, or approximately 350 mm, all in the uninflated condition. The
collar or neck 666 may include a constant width 663 of between 150
and 350 mm, or between 180 and 320 mm, or approximately 250 mm, all
in a bag uninflated condition and when the neck 666 is flattened as
shown in FIG. 181. The collar or neck 666 may also include a length
664 of between 100 and 300 mm, or between 100 and 200 mm, or
approximately 150 mm, in a bag uninflated condition. The main body
665 may include a main body length 667 (not including the neck) of
between 200 and 500 mm, or between 300 and 400 mm, or approximately
350 mm. Also, main body 665 may be configured to have a maximum
width to maximum length ratio of approximately 1:1.
[0255] Also, as noted above, the bag may be retained in the
normally open configuration by a retainer ring of a shape memory
material such as Nitinol. Referring to FIGS. 166-170, the retaining
ring of the bag may be formed into a loop, shape set and welded.
The diameter of the bag opening when the retaining ring is in an
open configuration may be between 100 and 220 mm, or between 120
and 200 mm, or approximately 160 mm.
[0256] Referring again to FIGS. 181 and 182 the bag may be formed
from shaped flat sheet laid on top of one another and attached at
the edges 671, for example by welding. When inflated (FIG. 182),
the bag expands into an ovoid type shape with rounder corners which
can more closely align with the contours of the abdomen. Also as
shown in FIGS. 118, 181, and 182, the bag may be shaped to be
symmetric about two different planes (668, 669) that are normal to
one another. In addition, as shown in FIGS. 118 and 181, neck or
collar portion (401, 666) may be shaped to extend parallel to a
longitudinal axis 273 of the bag, and thus edges 674 of the neck or
collar portion (401, 666) may extend parallel to the longitudinal
axis 273 of the bag.
[0257] The bag of the invention in some cases may be manipulated to
optimise ease of loading into an introducer and/or to optimise
deployment. For example, as illustrated in FIGS. 187(a) to 187(f)
the bag may be wider at certain sections 680. These extra width
sections may be folded inwardly from the side to form pleats 681.
The bag may then be rolled from the bottom up towards the neck 682
of the bag. The neck 682 of the bag may then be scrunched down and
loaded into an introducer 683.
[0258] Referring to FIG. 188 in some cases sections of the bag may
be of a different material and or material thickness in order to
provide desired properties. For example, a bottom section 690 of
the bag may be of a stranger/more rigid material to resist the
action of a morcellator. The section 690 may be of a rip-stop nylon
material, by way of example.
[0259] FIGS. 190(a) to 190(c) illustrate the use of the bag device
of the invention in transvaginal procedures, for example
hysterectomies. In some cases (FIGS. 190(a) and 190(b)) the bag
device may be inserted and used directly without an access port. In
other cases, the device may be used as described in other
embodiments with an access port 730 (FIG. 190(c)).
[0260] Referring to FIG. 191, in some cases the twisting action of
a threaded trocar or bung 700 may assist in putting the bag up
through the wound.
[0261] In some embodiments, in order to seal the hole into the
chimney before the bag is deflated a closure device or valve may be
deployed. For example, as illustrated in FIGS. 192(a) and 192(b) a
closure device 710 may be inserted into the chimneys in a collapsed
configuration and deployed at the distal end of the chimney. The
closure device may be retained in place using any suitable
retaining means such as an adhesive pad(s) 711.
[0262] The abdominal bag device of the invention may be used with
any suitable access port system 730 as illustrated, for example, in
FIGS. 193(a) to 193(c). In some cases the access port is mounted
within the neck of the bag.
[0263] Various features of the invention are described and
illustrated. It will be appreciated that at least some of the
features described in relation to one embodiment may be used not
only in the embodiment specifically described but also in other
appropriate embodiments. As used herein, the term "approximately"
or "about" is understood to mean close in value or amount, but not
precise. To the extent that such a definition for "approximate" or
"about" is not considered sufficiently definite, approximate is
understood to mean plus or minus 5% of the relevant parameter.
[0264] The invention is not limited to the embodiments hereinbefore
described, with reference to the accompanying drawings, which may
be varied in construction and detail.
* * * * *