Note: Descriptions are shown in the official language in which they were submitted.
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SURGICAL TISSUE RETRIEVAL INSTRUMENT
1. Field of the Invention.
This invention relates to the field of surgical instruments for retrieving
internal
body tissue and, more particularly, to a surgical instrument used in
endoscopic
surgery for retrieving internal body tissue with an endoscopic pouch.
2. Background of the Invention.
Tissue retrieval devices have been developed for use in endoscopic surgery
to remove tissue from a patient's body. Typically these devices comprise a
specimen-collecting pouch placed at the distal end of a pusher rod. The pusher
rod
is inserted into the patient's body via a tiny insertion and the pouch is
deployed once
it is near the surgical site. Gaining close proximity to the tissue to be
removed,
placing the tissue in the pouch, closing the pouch, and removing the now-
filled pouch
from the body are the main steps to be performed with the device.
Pouches used with tissue retrieval devices often employ a means for closing
the pouch to prevent spillage of tissue or fluids into the patient's body.
Typical
closure means include a drawstring or a wire loop.
In many state of the art devices, the mouth of the pouch does not allow for
easy collection of the sample and/or removal of the pouch from the patient's
body.
This is because of problems associated with the slipknot often used to
initially close
the pouch. For example, in some prior art devices, once the pouch is closed it
cannot be reopened until the pouch is removed from the patient.
A surgical retrieval device with a drawstring for closing the pouch is
disclosed
by Clayman et al., U.S. Pat. No. 5,037,379. The drawstring is used to close
the bag
closed and pul the bag from the body cavity through a tube_
Kindberg et al., U.S. Pat. No. 5,143,082, discloses a surgical device for
enclosing a body organ or tissue and which includes a strand extending through
a
tube and formed into a noose about the open end of a surgical bag.
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Wetter et at., U.S. Pat. No. 5,190,555, discloses another endoscopic tissue
retrieval device that includes a drawstring used for closing arid opening a
funnel-
shaped bag.
U.S, Patents Nos 5,465,731 and 5,647,372 disclose yet another endoscopic
tissue retrieval comprising a pouch supported by a closed metal loop. The bag
is
ripped away from the metal loop during the drawstring closure along a
perforated line
circumscribing the mouth of the pouch.
The aforementioned patents and device are not admitted to be prior art by
their mention in this Background section.
Many state-of-the-art pouches fail during their removal from the patient. This
is because a great deal of force is applied to a filled bag as a surgeon
attempts to
pull it through the typically tiny laproscopic surgical incision made in the
skin and
muscle layers of the patient.
Separately, bags often come into contact with sharp surgical instruments and
rip as a result.
A need exists in the art for a reliable tissue retrieval device comprising a
sturdy bag with a large mouth that is securely attached to its support but
that can be
released from the support without having to close the mouth of the bag. Such a
device should also allow full access to the retrieval pouch prior to insertion
into the
patient so as afford in situ pre-treatment of the bag. Furthermore, the device
should
provide a means for preventing accidental deployment or closure of the pouch
as
well as accidental removal of the pouch from its support during collection of
tissue.
The device should also provide a means to scrape tissue from adjacent adhering
structures for more efficient tissue extraction from the body.
3. Summary of the Invention.
An object of this invention Is to provide a tissue retrieval device for use in
endoscopic surgery that overcomes many of the disadvantages in the prior art.
Another object of the invention is to provide a surgical tissue retrieval
device
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comprising a pouch which is securely but removably attached to a support_ A
feature
of this invention is a means for facilitating repeated deployment, opening,
and closing
of the pouch while the pouch is still confined inside the patient. An
advantage of this
invention is that it allows quick release of the pouch from its support
without having
to lock or close the mouth of the pouch. Another advantage of this invention
is that it
allows a surgeon to serially collect samples while the device remains inside
the body
and to securely close and reopen the pouch.
Yet another object of the invention is to provide an endoscopic collection
device that enables a surgeon to remove tissue and treat unremoved tissue. A
feature of an embodiment of this invention is a pouch propped open by two
elongated substrates of unequal length that are slidably received by the
pouch, and
held in position by the action of a controlling toggle. An advantage of this
invention is
that a portion of the mouth of the pouch remains taut while the pouch is open
and
can be used as a straight scraping edge. Another advantage of this invention
is that
it allows the pouch to be rotated or moved transversely while the pouch is
either
closed or opened. This allows a surgeon to retrieve tissue that tends to
adhere to
nearby anatomical structures such as organs, Mesentery, and surrounding
structures. Another advantage of this invention is that it allows a surgeon to
retrieve
tissue by providing a means for positioning the tissue-collecting portion of
the device
in regions located generally perpendicular to or lateral from the longitudinal
axis of
the device.
A further of the present invention is to provide a tissue retrieval tool for
use in
laproscopic procedures. A feature of the device is a means for reversibly
deploying
the tissue removal bag and reversibly opening and closing the bag both inside
and
outside the body. An advantage of the invention is that a deployed bag outside
the
body allows medical personnel to manipulate the bag and to pretreat the bag
prior to
inserting the bag into its delivery sleeve in preparation for entry into the
patient.
Another advantage of the invention is that it allows a bag, once deployed
inside the
body to be repeatedly closed and reopened inside the body, thereby enabling a
surgeon to collect tissue while preventing any spillage thereof during
varying,
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protracted harvesting procedures conducted inside the body.
In brief, this invention provides a surgical device for retrieving internal
body tissue
during laproscopic and other surgical procedures, the device comprising a
sleeve
having a proximal end and a distal end, said distal end adapted for insertion
in a
cannula, a rod in slidable and rotatable communication with said sleeve, said
rod having
a distal end supporting a toggle and laterally biased jaws and a proximal end
comprising
a handle to manipulate the rod, and a pouch in slidable communication with the
jaws
and toggle, wherein the toggle facilitates simultaneous detachment of the
pouch from
the jaws and the rod.
The invention also provides a device for removing tissue from a patient's
body,
the device comprising: a sleeve having a proximal end and a distal end, said
distal end
adapted for insertion in a cannula; a pusher rod in slidable communication
with said
sleeve, the rod having a distal end terminating in laterally biased jaws and a
proximal
end terminating in a handle; a toggle pivotally mounted to the rod
intermediate the
proximal end and the distal end, such that the toggle swings from a first
spring loaded
position to a second resting position; and a pouch in slidable communication
with the
jaws and toggle; wherein the toggle allows disengagement of the pouch from the
jaws
when in the second resting position.
The invention also provides a tissue retrieving device comprising: a sleeve
having a proximal end and a distal end, said distal end adapted for insertion
in a
cannula; a rod in slidable and rotatable communication with the said sleeve,
said rod
having a distal end supporting a post rotating around a pivot and laterally
biased jaws
and a proximal end comprising a handle to manipulate the rod; a pouch in
slidable
communication with the jaws and the post; wherein said jaws and post is a
means for
deployment and control of repeated opening and closing of said pouch when said
rod is
in a predetermined alignment with said sleeve; and, a channel adapted to
simultaneously receive a drawstring and said jaws; wherein said post rotates
in a plane
perpendicular to a plane containing said jaws.
The invention also provides for a device for removing tissue from a patient's
body, the device comprising: a sleeve having a proximal end and a distal end,
said
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4a
distal end adapted for insertion in a cannula; a pusher rod in slidable
communication
with said sleeve, the rod having a proximal end terminating in a handle and a
distal end
terminating in laterally biased jaws; a toggle mechanism adapted for insertion
in a
sleeve, said toggle mechanism comprising a V-shape substrate with the open end
of the
V-shaped substrate pivoting around a pivot point mounted to the rod
intermediate the
proximal end and the distal end, such that the toggle swings from a first
spring loaded
position to a second resting position; a pouch in slidable communication with
the jaws
and toggle; wherein the toggle allows disengagement of the pouch from the jaws
when
in the second resting position.
4. Brief Description of the Drawings.
The foregoing and other objects, aspects, and advantages of this invention
will
be better understood from the following detailed description of the preferred
embodiments of the invention with reference to the drawing, in which:
FIG, 1 is an overall perspective view of an exemplary embodiment of a surgical
device for retrieving internal body tissue, in accordance with features of the
present
invention;
FIG. la is a cross-sectional view of FIG. 1 along line la-la;
FIG, 2a is a profile exploded view of an exemplary embodiment of a surgical
device for retrieving internal body tissue, in accordance with features of the
present
CA 02628969 2008-04-09
invention;
FIG. 2b is a perspective exploded view of an exemplary embodiment of a
surgical device for retrieving internal body tissue, in accordance with
features of the
present invention;
FIG. 20 is a plan exploded view of pouch supports of an exemplary
embodiment of a surgical device for retrieving internal body tissue, in
accordance
with features of the present invention;
FIG. 2d is a profile view of FIG. 2c taken along line 2d -2d.
FIG. 2e Is a detail view of a pouch support for a surgical device for
retrieving
internal body tissue, in accordance with features of the present invention;
FIG. 3 is a schematic plan view of a pouch opening for a surgical device for
retrieving internal body tissue, In accordance with features of the present
Invention;
FIG. 4a is a detailed profile view of a toggle mechanism for a surgical device
for retrieving internal body tissue, in accordance with features of the
present
invention;
FIG. 4b is a detailed plan view of a toggle mechanism for a surgical device
for
retrieving internal body tissue, in accordance with features of the present
invention;
FIG. 40 is a profile view of an alternative embodiment of a toggle mechanism
for a surgical device for retrieving internal body tissue, in accordance with
features of
the present invention;
FIG. 4d is a view of FIG. 4c taken along Ilne 4d-4d;
FIG. 4e is a profile view of an alternative embodiment of a toggle mechanism
for a surgical device for retrieving internal body tissue, with said mechanism
engaged
in the hem of the device's pouch, in accordance with features of the present
invention;
FIG. 4f is a view of the toggle mechanism for a surgical device for retrieving
internal body tissue depicted in FIG. 4e with said toggle about to be
disengaged from
the hem of the device's pouch, in accordance with features of the present
invention;
FIG. 4g Is a vlew of the toggle mechanism for a surgical device for retrieving
internal body tissue depicted in FIG. 4e with said toggle disengaged from the
hem of
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the device's pouch, in accordance with features of the present invention;
FIG. 4h is a detail view of an alternative embodiment of a toggle mechanism
for a surgical device for retrieving internal body tissue depicted in FIG. 4e,
in
accordance with features of the present invention;
FIG. 4i is a detail view of a toggle mechanism and retrieval pouch for a
surgical device for retrieving internal body tissue, in accordance with
features of the
present invention;
FIG. 4j is a detail view of an aftemative embodiment of a toggle mechanism
and retrieval pouch for a surgical device for retrieving internal body tissue,
in
accordance with features of the present invention;
FIG. 5a is a detailed view of an alternative embodiment of a toggle
mechanism for a surgical device for retrieving internal body tissue, wfth said
toggle
fully contained in an introducer tube, in accordance with features of the
present
invention;
FIG. 5b is a detailed view of the toggle depicted in FIG. 5a with said toggle
partially contained In an introducer tube, in accordance with features of the
present
invention;
FIG. 5c is a detailed view of the toggle depicted in FIG. 5a after said toggle
has exited an introducer tube, in accordance with features of the present
invention;
FIGS 6a-6d Is a sequence of detailed views of the relative orientation of a
pouch and a toggle post for a surgical device for retrieving internal body
tissue, in
accordance with features of the present invention;
FIGS 7a and 7b are, respectively, schematic front and back views of a handle
assembly for a surgical device for retrieving intemal body tissue, in
accordance with
= features of the present invention;
FIG. 7c is a detailed view of the orientation of the handle assembly depicted
in FIGS 7a and 7b when the surgical device for retrieving intemal body tissue
is
inserted in a patient, in accordance with features of the present invention;
FIGS 8a-8f is a sequence of views Illustrating the operation of a surgical
device for retrieving internal body tissue; In accordance with features of the
present
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invention;
FIG. 8e1 is a detailed view of the fork, pusher rod, and handle assembly
comprised in the surgical device for retrieving internal body after this
assembly is
removed from a patient, in accordance with features of the present invention;
and
FIG. 8e2 is a detailed view of the relative handle and handle housing
orientation depicted in FIG. 8e for the surgical device for retrieving
internal body
when this device is removed from a patient, in accordance with features of the
present invention.
5. Detailed Description of the Invention.
The present invention provides a surgical tissue retrieval device for use in
endoscopic surgery which overcomes disadvantages in the prior art. The device
comprises a collapsible pouch defining a mouth, the mouth defined by a
periphery
which removably receives a plurality of elongated support jaws; and a toggle
mechanism serving as a means for controlling the deployment, opening, and
closing
of the support jaws, and, therefore, the opening and closing of the mouth of
the
pouch.
The present invention also provides a device for removing tissue from a
patient's body comprising a sleeve having a proximal and and a distal end,
with said
distal end adapted for insertion into a cannula; a rod in slidable and
rotatable
communication with said sleeve, the rod having a distal and terminating in a
plurality
of laterally biased jaws. A toggle is also positioned on the rod Intermediate
the jaws
and proximal the end. A pouch is in slidable communication with the jaws and
the
toggle, wherein the toggle facilitates loading of the pouch during collection
of tissue
and detachment of the pouch from the jaws when this collection is terrninated.
FIG. 1 is an overall perspective view of an exemplary embodiment of the
invented device 10. The device facilitates retrieval of internal body tissue
through a
sleeve (i.e. an 'introducer') 35 inserted into the body wall of a patient
through a
cannula (not shown). The surgical device further comprises an elongated
substrate
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30 such as pusher rod. The rod 30 is terminated by a plurality 40 of elongated
jaws
41, 42 which when fully deployed in a spring biased position and viewed
together
resembles a circle when. The pusher rod 30 is slidably received by the
introducer
35. A proximal end of the rod terminates into a handle assembly comprising a
handle 71 in slidable communication wfth a handle housing 72 containing a
gasket
81 positioned through which the pusher rod 30 is slid through. The gasket is
in
frictional contact with both the rod and an inside surface of the introducer
tube so as
to prevent fluid communication (e.g. gas leakage) from the distal end to the
proximal
end of the sleeve 35. The top face 76 of the handle 71 comprises a protrusion
75
adapted to rest within a slot 83 on the top face 80 of the housing 72. (See
detailed
discussion Infra of the handle assembly and its operation as related to FIGS 7
and
8.)
In one embodiment, two elongated jaws are provided, with one jaw longer
than the other such that the heretofore mentioned circular shape terminates in
a cord
line CL, so designated in FIG. 1. (Jaws of equal length can also be used.)
These
elongated jaws 41, 42 resemble a hanger or fork which slidably receives a
collar
(defining a mouth) of a collapsible pouch 20, such that the pouch, when so
engaged,
depends from the distal end of the pusher rod 30. The elongated jaws 41, 42
are
spring biased such that when deployed (i.e. slid clear of the confines of the
introducer 35), the jaws extend laterally (i.e., perpendicularly away from the
longitudinal axis a of the device) to prop open the mouth of the pouch.
The cord line CL of the pouch serves as a straight edge, held taught by the
biasing configuration of the deployed jaws, so as to provide a scraping
function to the
distal end of the device along that edge.
As can be seen in FIG. 2c, the device provides a means for repeatedly opening
and closing the mouth of the pouch. Specifically, when the rod 30 is pulled
toward the
proximal end, the roots 44 of the jaws contact the distal end 31 of the
introducer tube
35 so as to cause the jaws to converge, thereby closing the pouch. When the
rod is
pushed towards its distal end, the Jaws bias laterally as described supra,
allowing the
mouth to prop up again.
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Deployment and manipulation of the pouch 20 is also controlled by a toggle
mechanism 50. The toggle mechanism 50 also serves as a means for decoupling
the
elongated jaws 41, 42 from the pouch 20. As noted supra, while engaged in the
pouch, the jaws allow repeated partial opening and closing of the device so
that a
surgeon can collect a specimen at one site, partially close the jaws, move the
pouch
to another site, reopen the pouch, collect another specimen, and repeat these
steps
until all the required specimens are collected.
FIGS, 2a and 2b are exploded views of a preferred embodiment of the surgical
device 10 for retrieving internal body tissue. The introducer tube 35 is used
to insert a
pusher rod 30 into a patient via a cannula. The pusher rod 30 is terminated by
the
two jaws (i.e. elongated spring-biased substrates) such that when fully
deployed
outside of the introducer, the jaws resemble two curved forks shaped as a
partial
circle. The collapsible pouch 20 is supported by equal length jaws 41, 42, so
as to
hang downwardly by the force of gravity.
The opening or mouth 25 of the pouch 20 is propped open by the laterally
extended elongated jaws 41, 42. Specifically, the jaws are removably received
by a
collar or hem 27 defining the mouth 25 of the pouch 20. A perspective view of
the
pouch and jaws is found in FIG. 2b. The collar defines a channel 23 that
circumscribes the mouth 25 of the pouch 20, with each end of the channel
terminating
with openings 29 positioned side by side and at a proximal region of the
collar. The
openings 29 provide a means for the elongated jaws to access the channel 23
and to
slidably communicate with the pouch so as to define the shape of the mouth 25
of the
pouch 20.
Intermediate the channel openings is a region of the pouch defining an
aperture 28 adapted to removably receive the distal end 67 of the toggle 50.
5. a. Jaws Detail.
The elongated jaws 41, 42 are formed of reversibly deformable material and, in
their unconstrained state (i.e. their fully deployed uncompressed state), they
form a
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loop 43, or a portion thereof, and such that the mouth 25 of the pouch 20
assumes
the shape of the loop 43, with a gap 143 between the jaws. In an alternative
embodiment, one elongated jaw forming substrate may be straight and the other
one
curved. The jaws may be of equal length (See FIG. 2b) or one may be longer
than the
other (See FIG. 20). Each of the jaws can be chosen of variable lengths to
shape the
mouth 25 into the desired shape. For example, they can be compressed (i.e.
reversibly deformed) to form two parallel linear members slidably received
(with the
jaws in their compressed state, i.e in an undeployed configuration) by the
distal end
31 of the introducer 35 for later deployment of the mouth 25 of the pouch 20
inside
the patient. This is particularly advantageous as the invented device is
delivered to
the surgeon with the bag engaged by the pincers and deployed from the
introducer
tube. This allows the surgeon or the surgical suite personnel to pre-treat the
bag prior
to loading it into the distal end of the introducer tube.
Pincers of uneven length provide an appreciable amount of flexibility to left-
handed or right-handed surgeons, allowing them to select the pincer
configuration
most convenient to them depending on the area where they are operating and
special
precautions that must be taken to avoid impacting neighboring organs.
FIG. 2c is a top view of the fork, toggle, and pusher rod assembly and FIG. 2d
is a profile view of the fork, toggle, and pusher rod assembly taken along
line 2d-2d of
FIG. 2c.
Preferably, each of the elongated jaws 41, 42, have an oblong cross section
47, with the longer dimension of the cross section perpendicular to the plane
p
(phantom triangle depicted in dotted lines), as depicted in FIG 2e. This
feature limits
bending of the jaws orthogonally to said plane when the jaws encounter
resistance as
the pouch collects a sample or when the filled pouch is weighed down by the
tissue
contained therein. The jaws have preformed curvatures which force the jaws
41,32
into an expanded (i.e. relaxed) loop shape 43 when the jaws are extended or
deployed from the distal end of the introducer 35. The Jaws are flexible
enough to be
deformed into parallel rectilinear members that can br slid through the
introducer 35
.=
A rigid but light material such as Nitinol (R), a super-elastic alloy
manufactured
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from nickel and titanium is especially suited for fabrication of the jaws.
Other suitable
materials are stainless steel and forrned plastic. The jaws are manufactured
from the
selected material by forming the material in the required shape and heat-
treating the
material to fix that shape without further deformation.
As depicted in FIG. 2b, an embodiment of this invention features two jaws 41,
42 of equal length, where, for example, a first jaw 41 is longer than a second
jaw 42.
It is envisioned that different combinations of jaws would be made available
so that a
surgeon may choose the combination best suited for the operation to be
performed.
With jaws of unequal length, the shape of any one jaw can be manipulated to
increase the collection ability of the pouch by increasing the arc available
from that
pincer. This arrangement allows the surgeon to exert a force along a line
nearly
parallel to the introducer 30. The surgeon may attempt tissue removal at
several sites
along a line extending parallel to the pusher rod axis a. It can be
appreciated that this
aspect of the invention would facilitate scraping or avulsing of tissue
adhering to a
surrounding region.
5. b. Pouch Detail
=
This invention incorporates a pouch 20 bordered by a mouth 25 as depicted in
FIG. 3. In general, Nylon or other plastics are suitable materials for
fabrication of the
pouch. In one embodiment, a two-layer configuration is used, one layer being a
polyurethane laminate and the other rip-stop nylon.
A toggle 50, the function of which is described infra, is admitted through the
aperture 28 described supra formed in a region of the collar of the pouch such
that
when the pouch is attached to the jaws the aperture is positioned in close
spatial
relationship to the distal end of the sleeve 35. The pouch further comprises a
means
for receiving a drawstring 89 such that the drawstring receiving means also
serve as
the jaw receiving means of the pouch, such means being the channel 23 formed
by
the collar 27. The drawstring traverses the channel 23 such that the ends of
the string
89 protrude from the proximal end of the sleeve 35 so as to provide the
surgeon a
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means for providing tension to the drawstring. This string facilitates closing
of the
mouth of the pouch after the jaws are retracted from the channel 23 formed in
the
hem 27 of the pouch, and prior to the tissue sample being retrieved from the
surgical
site.
FIG. la is a cross-sectional view of FIG. 1 along the line la-la. It depicts
the
rusher rod 30 and two ends of the drawstring 89 as they are received in the
introducer
tube 35. In an alternative embodiment, one end of the string 89 is attached to
the
pouch hem at the orifice 28 and the other end of the string Is threaded
through the
channel 23 so as to exit from the collar through the orifice 28 and be
threaded through
the introducer tube 35. In both embodiments, the open end of the drawstring 89
are
received by the handle housing 72 (see FIG. 1),
In an exemplary embodiment, the fabric comprising the pouch is a rip-stop
nylon cross-stitched polyamide 66 material with a polyurethane laminate, with
thickness between 0.0035 and 0.0045 inches. This material to has substantially
higher puncture strength than other commonly used tissue pouch materials. For
example, when a 5 mm diameter full radius rounded probe was used to simulate a
5
mm 1aproscopic instrument, the puncture strength of the material was measured
using
a ChatlIon 50 pound test device. A force in excess of 26 pounds was required
to
puncture the material.
The hem 27 of the pouch is radio-frequency welded to form the channel 23
which receives the jaws 41 and 42 so that the pouch depends from the Jaws
forming a
continuous, homogeneous, perforation-free substrate with a stitch-free seam.
This
arrangement provides a tear-resistant construction that prevents the pouch
from being
accidentally ripped away from the jaws. The side 21 and bottom 22 of the pouch
are
also radio-frequency welded thus providing a totally impermeable pouch.
As shown in FIG. 8a, the invented device is delivered with the bag somewhat
extended out of the introducer tube. The surgeon or the surgical suite
personnel can
pre-treat the bag with antibiotic, or saline solution, or some sort of
solution that would
optimize use of the bag in the body. For example, treating the bag with
sterile saline
solution dulls the surface of the bag making it less shiny so as to reduce
glare by
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surgical lights also inserted within the body.) Aside from the saline
pretreatment, the
bag can also be swabbed with antibiotic, or some sort of a marker that
fluoresces
when it contacts cancerous materials (or one may use fluorescent DNA tags
where
the DNA is complementary to whatever protein coat is associated with the
target
cancer tissue).
The fabric of the pouch can be selected to hang downwardly from the jaws,
per the effect of gravity, as noted supra. Alternatively, the pouch comprises
a stiffer
material so as to retain its shape, volume and depth, no matter how it is
positioned
relative to gravity.
5. c. Toggle Structure and Function.
Another feature of the invention is a toggle and handle arrangement where the
pusher rod handle must be in a predetermined alignment with the proximal end
of the
introducer handle in order to allow full protrusion, and therefore release, of
the toggle
from the introducer tube. This toggle/handle arrangement prevents accidental
separation of the pouch from the jaws 41, 42. This full protrusion/handle
arrangement
also provides a movement of the toggle that is also controlled by a locking
means for
preventing rotation of the bag relative to the introducer tube. (See
discussion infra
related to FIGS 7 and 8.)
Toggle mechanisms are depicted in FIGS 4a through 4i. One embodiment of
the toggle means is depicted in FIGS 4a and 4b. It comprises a two-position
post 50
that rotates about a pivot 51, such that the toggle post 50 swings through the
arc "S" in
the plane of the Figure, a plane orthogonal to the plane defined by the
elongated
substrates 41, 42 forming the hanger or jaws. The pivot 51 Is situated
intermediate the
distal and proximal ends of the rod and in rotatable communication with the
rod. FIG.
41 is a detail view of the toggle mechanism depicted in FIG. 4a with the
toggle 50
entering the channel 23 through the aperture 28 and the jaws 41, 42 entering
the
channel 23 through the apertures 29.
FIGS 4c and 4d are profile and top views of an alternative embodiment for the
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toggle 50. As shown in FIG 4d, the toggle has a U-shape with the open end of
the U
pivoting around the pivot point 51. FIG. 4h is a detail view of the toggle
mechanism
depicted in FIG. 4c, in an alternative configuration to that depicted in FIG.
4i, with the
toggle 50 and the jaws 41, 42 entering the channel 23 through the same
aperture 28.
=
FIGS 4e, 4f, and 4g depict yet another altemative embodiment for the toggle
mechanism. The toggle mechanism is provided by a bendable metal or plastic
curved
member 49 that is either removably attached to or integrally molded to the
distal end
31 of the pusher rod 30 (the member 49 may be in the shape of a loop or a
tongue or
may comprise one or more antennae). In FIG. 4e the member is depicted in a
bent
configuration after it has been threaded through the toggle-receiving aperture
28: in
this configuration the toggle is bent half-a-circle and made to lie parallel
to the pusher
rod 30 as it is received in the introducer tube 35, with the tip 63 of the
member pointing
toward to the handle of the introducer. FIG. 4f depicts the situation when the
pusher
rod 30 has been pushed in the direction marked by the arrow I and the pouch is
deployed so that the member 49 is in position 49b as it is about to disengage
from the
hem of the pouch. FIG. 4g depicts the situation when the rod is pulled back in
the
direction marked by the arrow J and the member 49 is in its relaxed position
49a and
disengaged from the hem of the pouch. As noted supra, the toggle and jaws are
both
mounted in the rod such that the surgeon pulls the pusher rod and jaws into
the
introducer tub, the toggle slides completely Out of the bag aperture 28 (FIG.
4g).
Continued pulling of the rods causes the jaws 41, 42 to pull out of the
channel 23 and
through the introducer tube at the same time as the jaws. In FIG. 4h the
member 49 is
depicted in a bent configuration so as to lie parallel and proximal to the
jaws 41,42 and
constrained to be engaged in the an aperture 28 in the channel 23 in the hem
of the
pouch. This embodiment has the advantage of comprising no external spring and
no
detachable parts.
As shown in FIG. 6a, when the device is assembled, a distal end 68 of the post
50 is inserted in the aperture 28 (optionally defined by a grommet) at the
same time as
the jaws 41, 42 are inserted in the channel 23 defined by the hem 27. This is
designated the toggle "open" position (Depicted as "0" In FIG. 4a). The handle
71 of
CA 02628969 2008-04-09
the pusher rod 30 Is designed so that when it completely nests within the
handle
saddle 85 of the introducer 35, in a male/female configuration, the distal end
of the rod
emerges from the distal end of the introducer 35 to a distally biased position
so as to
allow the toggle free range of motion along a 180 degree arc such that the
free end of
the toggle extends away from the handle 71 and toward the pouch 20 (see
discussion
infra related to FIGS 7c and 8a through 8d). In one embodiment of the
invention, the
toggle post 50 will not exit from the Introducer tube until the handle 71 and
the handle
housing 72 are aligned In a complementary configuration depicted in FIG. 7a,
the
handle being provided with markings to serve as a visual cue to the surgeon
that the
device is now configured to detach the pouch from the pusher rod assembly (see
discussion infra related to FIGS 7c and 8e). When the handle and the handle
housing
are so positioned, the two interlock and the toggle 50 will exit from the
distal end of the
introducer and from the slit 28 and bias to a position intermediate the closed
"C" and
open "0" positions coming to rest against the distal end 31 of the pusher rod
30.
Toggle length is chosen to ensure that it cannot rotate through the
aforementioned arc unless the pusher rod 30 it is fully extended (distally)
from the
introducer tube 35. While still constrained by the interior surfaces of the
introducer
tube, the toggle remains in an undeployed position and in frictional
engagement with
the interior surface of the introducer tube. This constraint serves as a means
to
prevent the jaw-forming elongated substrates 41, 42 from accidentally being
retracted from the pouch hem, retreating into the introducer, and causing a
premature
detachment of the pouch from the pusher rod.
When the surgeon is ready to remove the pouch from the body (for example,
after the pouch is loaded with tissue), the pusher rod 30 is fully extended
distally so as
to extend through the introducer tube and therefore clear the toggle from the
confines
of the interior surface of the introducer tube 35. At that point, the spring
bias toggle
flips to an intermediate retaining configuration, between positions "0" and
"C:, by still
remaining protruding through the eyelet 28 formed on the proximal side of the
pouch
collar. A definitive tug away from the body cavity by the surgeon on the
handle of the
pusher rod causes the toggle post to engage the distal lip of the distal end
of the
CA 02628969 2008-04-09
16
introducer tube, thereby forcing the toggle to pivot about the pusher rod and
toward the
pouch such that the toggle end extends in a direction (designated as position -
0")
away from the surgeon.
This configuration, with the toggle pointing away from the surgeon, enables
the
toggle to slide out of (or otherwise disengage from) the eyelet 28 as the
pusher rod 30
is pulled in a proximal direction to retract further yet out of the
introducer.
Concomitantly, the hanger 40 comprised of the jaws 41, 42, (heretofore
described as
attached to the distal end of the pusher rod 30), are pulled out of the
channel 23 and
retreat with the toggle post into the Introducer. These actions leave the
pouch 20
behind.
Once the pouch hanger 40 and pusher rod 30 are fully extracted from the
introducer tube 30, the surgeon closes the pouch by pulling on ends of the
drawstring
89. As noted supra, inasmuch as the drawstring resides in the channel 23
defined by
the pouch hem, i.e,, the same channel in which the jaws are positioned.
Pulling on the
drawstring protruding from the proximal positioned end 39 of the introducer
tube 35
serves to constrict and ultimately close the pouch opening to assure
containment of
the tissue residing in the pouch during extrication of the pouch from the
body. Further
pulling of the pouch drawstring draws the closed pouch into the distal end of
the
cannula.
The spring-biased action of the toggle (from position 0 to position C)
disclosed
above may be achieved by a helical spring 53 affixed to the pivot 51 and the
post 50
(See FIGS. 2a through 2d) so as to cause the post 50 to spring back towards
the
introducer end 36 (i.e. towards the surgeon) once the post is released from
the pouch
hem 27. In still another embodiment, a torsion spring 52 may be affixed to the
pivot 51
and the post 50 (See FIG. 4b) so as to cause the post 50 to spring back
towards the
introducer distal end 36. In another alternative embodiment of the toggle
mechanism
the toggle 50 constitutes a blunt end of a torsion spring 52 attached to the
pusher rod
30.
CA 02628969 2008-04-09
17
In another embodiment, the toggle mechanism is actuated without the use of
an external spring. As shown in FIG. 5a, the post 50 may be chosen to be of a
diameter such that there is a frictional interaction between the pusher rod 30
assembly and the inside wall 37 of the introducer. Thus there is an outward,
radially-
directed pressure (i.e, a pressure applied in a direction perpendicular to and
away
from the longitudinal axis a of the introducer) on the introducer as the
pusher rod and
toggle are pushed through it. Elastic radial contraction of the introducer 35
when the
toggle post 50 Is released causes the toggle post to rotate proximally, (i.e.,
toward the
proximal or surgeon end of the introducer (i.e. such that the post distal end
67 points
away from the fork 40 as indicated by the arrow T in FIG. 5b).
As the toggle post exits the introducer 35, there is a configuration depicted
in
FIG. 5b where the point 61, nearest to the pivot 51, has already exited from
the
introducer 35, while the diametrically opposite point 62 is still in the
introducer where it
experiences an inward radial force F due to the compression of the introducer
35.
This unbalanced force F results in a clockwise torque about the pivot 51 and a
consequent clockwise rotation of the post towards the end 36 of the introducer
35 as
shown by the arrow T. This rotation is also facilitated by the drag on the
device due
to the surrounding body tissue, an effect that can be enhanced if the distal
end 60 of
the post 50 that exits from the hem 27 is cut at angle with respect to the
length of the
post. (See FIG. 5c), In this embodiment, the proximal end 60 of the toggle
post 50
terminates in a plane that is at angle of roughly 45 degrees to the
longitudinal axis a of
the pusher rod 30 as the toggle comes to rest against the distal end 39 of the
= introducer. The toggle must be such that the distance between the pivot
point 51 and
the point 62 on the toggle face 67 is such that the toggle can reenter the
introducer
=
sleeve when the pusher rod is retracted.
Of course, one may combine two or more of the spring-back mechanisms
suggested above.
In another alternative embodiment, the toggle Is bent at a point 57
intermediate the pivot point 51 and the distal end 67 projecting above the
plane
defined by the pincer fork 40 (in the opposite direction of the pouch 20) (See
FIG. 4
i).
CA 02628969 2008-04-09
18
The toggle may be manufactured from steel, from the same material as the
pincers, or from any other suitable material. Also, the toggle may be
manufactured
as part of the of the pusher rod mechanism, comprising a bent loop within the
introducer tube that acts as a toggle.
FIGS. 6a through 6d illustrate in further detail the function of the toggle
mechanism. FIG 6a shows the toggle post 50 engaged with the pouch 20 wherein
the
distal end 67 is nested in the hem 27 through the aperture 28. It must be
appreciated
that the hem/aperture/toggle orientation is obtained by means of tension
provided by
the toggle post 50. As soon as the toggle post is withdrawn from the hem 27,
and
especially when the pouch is filled with a tissue specimen, the slit 28 is
displaced with
respect to the toggle post 50 and the pusher rod 30 (See FIG. 6b). FIG. 6c
shows the
toggle post at 90 degrees to the pusher rod 30. FIG. 6d shows the toggle post
coming to rest against the introducer 35. When the final tissue sample has
been
collected the pusher rod 30 is retracted into the introducer 35, so that the
above
sequence is reversed from FIG. ea to 6c to 6b. At this juncture, one cannot
reinsert
the toggle post 50 into the slit 28 of the hem 27 because the post and the
slit are now
misaligned. Further retraction of the pusher rod 30 toward the surgeon= brings
the
toggle post 50 against, but not inside, the hem 27 so that the toggle post now
detaches the pouch from the fork 40.
While the preceding discussion emphasized operation of the device with the
= toggle received in a channel 23 in the hem of the pouch through an
orifice 28 when
the device is first inserted in the patient, this is not necessary for
effective operation of
the device. The functions of the toggle can be equally well performed without
the
toggle having been inserted in the orifice 28 or with the toggle having been
accidentally disengaged from the hem of the pouch before deployment of the
device.
5. d. Handle Detail.
FIGS. 7a and 7b are schematic front and back views of an exemplary
embodiment of a handle assembly 70 that can be advantageously used with the
invented device and FIGS. 8a through 8f illustrate the use of this handle
assembly.
CA 02628969 2008-04-09
19
The handle assembly comprises a handle 71 that is rigidly attached to the
pusher rod
30 and a housing 72 that is rigidly attached to the introducer tube 35, so as
to render
the housing 72 in rotatable communication with the handle 71 through a bore 73
traversing the housing. The housing 72 also comprises a groove 79 adapted to
receive a portion 78 of the handle 71 in a male-female configuration. The
assembly
70 has a front face depicted in FIG. 7a comprising a first surface 76 of the
handle 71
defining a protrusion 75 aligned with the axis a of the pusher rod 30. A first
surface
80 of the housing 72 comprises a slot 83 or saddle adapted to slidably receive
the
protrusion 75. The first surface 80 of the housing 72 further comprises a slit
74
adapted to frictionally receive the ends of the drawstring 89. Also, the first
surface 76
of the handle 71 comprises a marking 91, such as the word "UP" to distinguish
it from
the back face 92 of the handle depicted in FIG. 7b. Stripes 121 on the first
surface of
the housing come into alignment with stripes 122 on the protrusion when the
handle is
fully Inserted and this serves as a visual indicator to the surgeon that the
handle is
fully inserted Indeed.
FIG. 7b depicts the back face of the handle assembly, showing that the second
surface 82 of the housing 72 comprises a marking 99 such as a semi-circular
arrow
99 together with a directive such as "TO UNLOAD".
FIG. 7c depicts the orientation of the handle assembly when the device is
inserted in the patient. The surgeon inserts the device with the first surface
76 of the
handle 71 coplanar to the second surface 82 of the housing 72 so that the
protrusion
75 abuts the proximal edge 84 of the housing 72 and the pusher rod 30 is
prevented
from fully exiting the introducer tube 30.
5. e. Operation of the Device.
Figures 8a through 8g illustrate the operation of the device. In FIGS. 8a
through 8d the first surface 76 of the handle 71 is facing in the same
direction as the
second suface 82 of the housing 72 so that the protrusion 75 abuts the
proximal edge
84 of the housing (See FIG. 7c). In FIG. 8a the pouch 20 is shown extending
from the
distal end of the introducer tube 35. This allows for pretreatment. In FIG. 8b
the
CA 02628969 2008-04-09
pouch is shown being withdrawn into the introducer tube 35 (Throughout this
sequence the arrow 95 indicates the direction in which the handle 71 is
moved). In
FIG. 8c the device Is introduced through a trocar port 93 connected to a
patient. The
surgeon places the pouch into position, pushes the handle towards the housing
and
the pouch deploys automatically when the handle 71 comes into contact with the
housing 72 so that the protrusion 75 abuts the housing 72 (see FIG. 7c). FIG.
8d
depicts the surgeon placing a tissue sample 96 into the pouch. Then the
surgeon
rotates the housing 180 degrees as directed by the semi-circular arrow 99
while
keeping the handle immobile in the "up" position. In FIG. Be the surgeon
inserts the
protrusion 75 into the slot 83 so as to cause the rod to extend to its distal-
most
position. (See FIG. 8e2 showing the protrusion 75 fully received in the slot
83 with the
= stripes 121 on the housing brought into alignment with the stripes 122 on
the
protrusion.) Finally, the surgeon pulls the handle 72, pusher rod 30, and fork
assembly 40 from the pouch and the introducer tube 35 as shown in the detail
FIG.
8e1.
In FIG. 8f the mouth of the pouch is dosed by pulling on the draw string and
then the surgeon removes the introducer tube 35 and the trocar 93 outside the
patient
and brings the mouth of the pouch to outside the abdomen. The tissue is
removed
from the pouch and then the pouch Is removed from Inside the patient,
5. f. Outside the Patient (Proximal) Portion of the Device.
The proximal end of the device Is designed so as to aid the surgeon in
ascertaining the position and functioning of the distal end of the device. In
one
embodiment, the plane defined by the fully deployed hanger 40 (comprised of
the
elongated substrates) is fixed in relation to the handle 71 orientation. This
requires
the elongated substrates 41, 42, to be rigidly attached to the distal end of
the pusher
rod 30, so as not to be In rotatable communication with the rod. As such, the
handle
71, pusher rod 30, and hanger 40 move as a single unit when the rod is
rotated,
and/or slid in and out of the introducer tube 35. FIGS. 7a and 7b depict means
to
indicate to the surgeon the orientation of the pouch.
CA 02628969 2008-04-09
21
The introducer tube 35 comprises at its proximal end 39 a handle housing 72
adapted to receive a handle 71 in two different configurations.
FIG. 7c depicts the orientation of the handle assembly when the device is
Inserted in the patient. The surgeon inserts the device with the front face 76
of the
handle 71 facing in the same direction as the back face 82 of the housing 72
so that
the protrusion 75 abuts the proximal edge 84 of the housing 72.
When the handle 71 is fully inserted in the housing 72 (FIGS 7a and 7b) the
pusher rod 30 and the introducer 35 are locked relative to each other, such
that one is
not rotating about or within the other. It is in this fully nested position
that the toggle
emerges from the distal end of the introducer tube, is released from the pouch
20,
and springs back to its "closed" or "C" position. Pulling of the pusher rod in
a
proximal direction (i.e., toward the surgeon or operator of the device) causes
the
toggle arm to engage with the distal lip or periphery of the introducer tube,
thereby
forcing the toggle to reset to a pouch-releasing configuration (position "011)
as
proximally directed force on the pusher rod" is maintained.
The toggle also facilitates loading of the device by acting on the pouch and
pulling it into the introducer tube. The device is loaded by the scrub nurse
or assistant
and delivered to the surgeon in a loaded condition with the pusher and toggle
positioned in the bag slit 28 and also in the introducer tube. The surgeon or
an
attendant now pulls on the handle of the introducer and pulls the pusher, the
toggle,
and the pouch into the introducer tube. The tight fit between the pusher
handle and
the introducer handle prevents accidental unloading of the toggle from the
distal end
= of the introducer tube. The toggle not only facilitates deployment of the
pouch but
allows loading of the pouch into the introducer tube without using long tails
to push
the pouch or complicated structures to which the pouch is attached.
While the invention has been described in the foregoing with reference to
details of the illustrated embodiment, these details are not intended to limit
the scope
of the invention as defined In the appended claims.
