Note: Descriptions are shown in the official language in which they were submitted.
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A RECTAL STUMP CLOSURE DEVICE FOR RECTAL RESECTION
DESCRIPTION
The present invention relates to surgical devices and
methods for the resection of the lower rectum,
particularly in the treatment of patients with small or
medium size rectal carcinoid tumors.
A known surgical technique to perform the resection of
the lower rectum is the so called low anterior resection
(LAR) which can be performed either by open surgery or
laparoscopically using the Knight-Griffen technique,
also known as double staple technique. Under general
anesthesia the rectum is mobilized from the sacrum
including division of the lateral ligaments under direct
view of the laparoscope or by open surgery. The bowel is
divided, e.g. between the sigmoid colon and the rectum
using a linear stapler. The lower rectum (containing the
tumor) is then transected using a linear or contour
stapler.
In this way, a stapled proximal colon stump and a
stapled rectal stump are formed, which need to be joined
in order to reestablish colon - rectum continuity.
To this end, an anvil of a circular stapler is
introduced into the proximal colon stump through a small
skin incision, e.g. on the left lower abdomen, and the
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shaft and cartridge device of the circular stapler is
inserted through the rectal stump via the anus. The
shaft and the anvil of the circular stapler are then re-
approximated under laparoscopic view, closed and fired.
During this end-to-end anastomosis, a circular staple
line is fired over the previous lines of staples used to
perform the rectal transection (staple crossing) which
can lead to leakage at the anastomotic site.
Moreover, with known devices and procedures in both
laparoscopic and open surgery, it is difficult for the
surgeon to judge the correct positioning of the stapler
with respect to the tumor to be excised. Particularly in
cases in which the position of the tumor makes it
impossible to evert the rectum through the anal canal
and the transverse transection of the rectal stump is
formed by open or laparoscopic stapling, the excision is
performed blind without direct tumor visualization.
Consequently, with reference to low anterior rectal
resection and end-to-end anastomosis of the colon and
rectal stumps, there is a need to have at one's disposal
a surgical device and method which overcome the
deficiencies of prior art instruments and methods.
The aim of the present invention is therefore to provide
a surgical device for rectal stump closure in a combined
endoluminal-laparoscopic or endoluminal-open rectal
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resection intervention having features which overcome
the drawbacks cited with reference to the prior art.
Within the scope of the above aim, a particular aim of
the present invention is to propose a rectal stump
closure device and method which obviates or reduces the
crossing of staple-lines during the end-to-end
anastomosis of colon and rectal stumps.
A further particular aim of the present invention is to
propose a rectal stump closure device and method which
allows direct eye control of the tumor or lesion to be
excised.
These aims are achieved by a surgical device for rectal
stump closure, comprising:
- a circular anal dilator defining a passage opening,
- an anoscope configured to be insertable through the
passage opening of the circular anal dilator, said
anoscope having a distal end portion,
- a rectal stump closure plug having a first
circumferential tie up surface configured such that
the rectum can be tied up against it from the outside
of the rectum lumen,
- a plug connector removably connecting said rectal
stump closure plug to said anoscope distal end
portion.
The stump closure device enables the surgeon to close
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the rectal stump by tying up the rectum against the
rectal stump closure plug, to stabilize the rectal stump
closure plug and rectum during tightening and resection
by means of the anoscope to which the rectal stump
closure plug is connected, and eventually to remove the
anoscope and leaving the rectal stump closure plug in
place.
This enables the surgeon to create a purse string - like
rectal stump and avoids or at least reduces staple
crossing during the end-to-end anastomosis.
In accordance with an aspect of the invention, the
surgical device comprises a distal plug arranged
distally from the rectal stump closure plug and having a
second circumferential tie up surface configured such
that the rectum can be tied up against it from the
outside of the rectum, wherein the first and second tie
up surfaces define two adjacent tie up planes. A
latching member connects the rectal stump closure plug
and the distal plug between the two adjacent tie up
planes and can be configured to form a cutting block for
a cutting device, e.g. a knife or an RF snare during
resection of the rectum between the two tie up planes.
The latching member can be removably connected to one or
both of the rectal stump closure plug and distal plug or
configured to be cut through by the cutting device, to
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allow removal of the transected portion of the rectum
from the rectal stump.
In accordance with a further aspect of the invention,
the rectal stump closure plug and the distal plug are
5 approximately coaxial to a longitudinal axis of the
anoscope and have a diameter which is smaller than the
diameter of the anoscope and a distal plate is arranged
distally from the distal plug and has a diameter greater
than the diameter of the rectal stump closure plug and
the distal plug. Both the anoscope distal end portion
and the distal plate define window openings which extend
radially beyond the rectal stump closure plug and the
distal plug, thereby providing transanal visual access
to a tumor or other lesion distally from the distal
plate. This enables the surgeon to exactly place the
anoscope and the two adjacent tie up planes with respect
to the tumor before tightening the rectum against the
tie up surfaces of the plugs. In this way, also the
positioning of the transection plane (between the two
adjacent tie up planes) with respect to the tumor is
much more accurate than with known devices.
In accordance with a yet further aspect of the
invention, the tie up surfaces of the rectal stump
closure plug and the distal plug form circumferential
channels to facilitate positioning and tightening snares
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which can be positioned and tightened about the rectum
by open surgery or by laparoscopy.
In accordance with a further aspect of the invention,
the surgical device includes a toothed zip tie for
tightening the rectum against the rectal stump closure
plug and the distal plug, respectively.
In accordance with yet a further aspect of the
invention, the surgical device comprises laparoscopic or
open surgery cutting means, e.g. a radio frequency
snare, to transect the rectum distally from the first
tie up surface and between the first and second tie up
surfaces, respectively.
These and other objects and advantages of the present
invention shall be made apparent from the accompanying
drawings and the description thereof, which illustrate
embodiments of the invention and, together with the
general description of the invention given above, and
the detailed description of the embodiments given below,
serve to explain the principles of the present
invention.
- Figure 1 is an exploded side view of a surgical device
for rectal stump closure according to an embodiment of
the invention;
- Figure 2 is a cross sectional view of the device in
figure 1 in a longitudinal cross sectional plane, the
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device being in an assembled configuration;
- Figures 3 to 14 illustrate the use of the device in
figure 1 together with a tie up device and a resection
device in different phases of a method for rectal
resection, rectal stump closure and colon - rectal stump
end-to-end anastomosis according to an embodiment of the
invention;
- Figures 15 to 17 illustrate the use of the device in
figure 1 together with an alternative tie up device and
resection device in phases of a method for rectal
resection and rectal stump closure according to a
further embodiment of the invention;
- Figure 18 is a partial side view of a surgical device
according to a further embodiment of the invention;
- Figure 19 is an exploded perspective view of the
device in figure 18;
- Figure 20 is a perspective view of a tie up tape
applier according to an embodiment of the invention;
- Figure 21 illustrates a detail of the applier in
figure 20.
Referring to the drawings where like numerals denote
like components throughout the several views, figure 1
depicts a surgical device 1 for rectal stump closure in
a rectal resection intervention.
The device 1 comprises a circular anal dilator 2, an
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anoscope 3, a rectal stump closure plug 4, a plug
connector 5, a distal plate 6 with a distal plug 7 and a
latching member 8.
Throughout the description of the surgical device, the
expressions "distal" and "proximal" are referred to the
surgeons point of view. With reference to the gastric
intestinal tract, the expression "distal" indicates
"toward the mouth" and the expression "proximal"
indicates "toward the anus".
The circular anal dilator 2 (CAD) comprises a circular
cylindrical ring wall 9 adapted to be transanally
inserted into the rectum and defining internally a
passage opening 10 which provides a transanal access
opening for visualization and surgery and protects the
internal sphincter muscle and the anal wall from
damaging. A connecting portion 11 is arranged at a
proximal end of the ring wall 9 and adapted to hold the
ring wall 9 inside the rectum. The connecting portion 11
comprises two flat opposite wings 12, 13 protruding
laterally outward from the ring wall 9 and inclined
proximally to adapt to the anatomy of the anus and
perianal region of the patient. Each wing 12, 13 forms a
narrowed bottleneck section 14 and a ring shaped end
portion 15 adapted to be sutured to the perianal skin of
the patient in order to fixate the position of the
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device 1 inside the anus.
The anoscope 3 comprises a side wall 16 having the shape
of a longitudinally straight cylinder defining a working
channel 17 as well as a distal end portion 18. The side
wall 16 is insertable, longitudinally (in a distal-
proximal direction D-P) translatable and rotatable
inside the ring wall 9 of the circular anal dilator 2
and comprises a proximal edge 19 or flange which might
extend radially beyond the internal surface of the ring
wall 9 to define an end of stroke surface which prevent
the anoscope 3 from being inserted too far through the
ring wall 9 inside the rectum. A flat handle portion 20
protrudes laterally-proximally from the proximal edge 19
and is configured to enable manual rotation and
translation of the anoscope 3 inside the ring wall 9 of
the anal dilator in order to adjust the position of the
distal end portion 18 to which the rectal stump closure
plug and distal plate are connected, with respect to the
tumor or lesion intended to be removed.
The distal end portion 18 of the anoscope 3 comprises a
distal end wall 21 adapted to provide an abutment
surface for the rectal stump closure plug 4 and one or
more seats adapted to receive one or more plug
connectors 5 which hold the rectal stump closure plug 4
firmly against the distal end wall 21 of the anoscope 3.
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In accordance with an embodiment, the distal end wall 21
comprises a substantially flat ring wall arranged
approximately perpendicularly to a longitudinal axis of
the anoscope 3. The ring wall 21 forms a through hole 22
5 dimensioned in a manner that the plug connector 5 can be
passed through the ring wall 21 and engage the rectal
stump closure plug 4, in order to lock the latter
against the anoscope distal end portion 18.
In accordance with an alternative embodiment, the distal
10 end wall 21 defines a seat for directly engaging the
rectal stump closure plug 4, e.g. by snap-engagement by
screwing or by press-fit.
In accordance with a yet further embodiment, the rectal
stump closure plug 4 is integrally formed with the
anoscope 3 and connected to the distal end wall 21 or to
the side wall 16 by a connector, such as a breaking tie,
a breaking rib or a breaking wall having points or lines
at which a break is intended to occur in order to
separate the rectal stump closure plug 4 from the
anoscope 3.
The distal end portion 18 of the anoscope 3 further
comprises one or more window openings 23 which extend
radially beyond the rectal stump closure plug 4 and the
distal plug 5 in order to enable direct transanal
visualization of the tumor 48 or of other lesion and its
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margins. This enables the surgeon to precisely place the
surgical devices with respect to the tumor and, hence,
to better control the location of resection and rectal
stump formation.
In accordance with an embodiment, the distal end portion
18 of anoscope 3 comprises an approximately truncated
cone shaped window ring 24 with at least one, preferably
three or four inclined bars 25 connecting a distal edge
of the cylindrical side wall 16 (which forms the major
base of the truncated cone) to the distal end wall 21
(which forms the minor base of the truncated cone),
wherein the window openings 23 defined between bars 25,
distal end wall 21 and side wall 16 extend radially
outside the distal end wall 21 and provide direct visual
access or also instrument access to the region distally
from the plugs 4 and 7.
At the internal concave surface 26 of the side wall 16,
a graduated sequence of marks 27 indicating e.g. a
centimeter-scale is printed, embossed or otherwise
applied to provide an immediate visual indication of the
depth of insertion of the anoscope and of the distance
of distal end portion 18 from the anal verge. Each mark
27 may comprises a central numeral indicating a distance
from a fixed reference point at the proximal end region
of the side wall 16 and one or two reference lines
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extending on either side of the numeral so that a
certain distance can easily be associated also to
instruments which do not lay very close to the numeral
without being impaired by the difficult visual
prospective provided by the comparatively long tubular
working channel 17.
As already mentioned, the anoscope 3 is slidably and
rotatably received by the ring wall 9 of the circular
anal dilator 2 and has a length such that it protrudes
distally from the ring wall 9 in order to provide access
to a depth of about 5 to 15 cm from the anal verge.
The ring wall 9 of the anal dilator 2 defines at its
internal surface a group of circumferentially extending
parallel latching ribs 67 and the side wall 16 of the
anoscope 3 defines at its external surface a group of
circumferentially extending parallel counter-latching
ribs 68 configured in a manner that the counter-latching
ribs 68 can be engaged and disengaged from the latching
ribs 67 by a rotational movement of the anoscope 2 with
respect to the anal dilator 2, wherein, in the
disengaged configuration the anoscope 3 can translate
inside the anal dilator 2 in a distal - proximal
direction and in the engaged configuration the anoscope
3 is locked with respect to the anal dilator 2.
To this end the latching ribs 67 and the counter-
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latching ribs 68 extend only along a limited portion of
the circumferences of the facing surfaces of the anal
dilator and the anoscope, so that in the unlocked
configuration the latching ribs 67 can be positioned in
a counter-latching rib free zone of the anoscope 3.
The rectal stump closure plug 4 comprises a ring body
with a substantially flat proximal end face 28 adapted
to be held against the distal end wall 21 of the
anoscope 3. A passage zone 29 is formed in the ring body
and configured to enable a trocar 40 of a circular
stapling device 41 to pass through the rectal stump
closure plug 4 in order to couple a staple fastening
assembly 42 and an anvil 43 of the stapling device 41
during the end-to-end anastomosis. Such passage zone 29
can be embodied as a channel 29 or, alternatively, as a
portion made of an easily penetrable material, such as
rubber or expanded polymer. Accordingly, the ring body
of the rectal stump closure plug 4 takes its annular
shape not necessarily from the beginning, but when
pierced through by the trocar 40 of the circular
stapling device 41.
The ring body of the rectal stump closure plug 4
comprises a first external circumferential tie up
surface 30 which extends all around the plug 4 and is
intended to provide an abutment against which the lumen
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of the rectum 46 can be tied up from outside in order to
form a closure of the rectal stump 47.
In accordance with an embodiment, the first tie up
surface 30 comprises a circumferential groove 31 to
facilitate positioning and tightening of a snare 34
which can be positioned about the rectum and
subsequently tightened by open surgery or by
laparoscopy. Thanks to the circumferential groove 31,
during tightening the snare 34, the latter is biased to
position itself exactly above the first tie up surface
30 and a ring of the rectum 46 is pressed between the
snare 34 and the first tie up surface 30 inside the
circumferential groove 31.
The rectal stump closure plug 4 further comprises a
coupling seat 32 which is provided for the connection of
the distal plate 6 to the rectal stump closure plug 4.
In accordance with an embodiment, the coupling seat 32
is formed near a distal end face 33 of the rectal stump
closure plug 4 and may be embodied as a groove or as a
cavity having an undercut suitable for engaging a
corresponding tooth or edge of the distal plate 6 or,
alternatively, of a dedicated separate latching member
8.
The plug connecter 5, if provided, couples the rectal
stump closure plug 4 to the distal end portion 18 of the
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anoscope 3. As already described above, the plug
connecter 5 can be embodied as an integral part of the
anoscope 3 and of the rectal stump closure plug 4 which
are manufactured as a single piece and provided with
5 points or lines at which a break is intended to occur in
order to separate the rectal stump closure plug 4 from
the anoscope 3.
Alternatively, the plug connecter 5 can be embodied as a
connection portion formed on either of the rectal stump
10 closure plug 4 and anoscope distal end portion 18 and
configured to removably engage the other, respectively.
In accordance with the exemplary embodiment illustrated
in figures 1 and 2, the plug connector 5 comprises two
elastic springs 51, 52 which engage both the rectal
15 stump closure plug 4 and connector receiving seats in
the distal end portion 18 of the anoscope. When in their
operational position, the elastic springs 51, 52 extend
through the hole 22 of distal end wall 21 and at least
partially through the passage channel 29 of the rectal
stump closure plug 4. A proximal end portion 49 of
springs 51, 52 is positioned in a manner to be
accessible by a grasping instrument 50 through the
working channel 17 of the anoscope 3. This makes it
possible to grip the springs 51, 52 and remove, cut or
break them to separate the anoscope 3 from the rectal
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stump closure plug 4.
In accordance with an embodiment, the plug connector
comprises a bayonet connector 69 rotatably supported by
the anoscope distal end portion 18. The bayonet
connector 69 comprises a distal bayonet key 70
configured to removably engage a corresponding bayonet
seat 71 formed in the rectal stump closure plug 4 and an
activation portion 72 proximally protruding into the
anoscope working channel 17 and destined to be
transanally grasped and rotated by a surgical grasping
device. The activation portion 72 has a flat plate like
shape and the bayonet connector 69 is configured such
that, in a plug coupling configuration, the activation
portion 72 is aligned with the inclined bars 25 of the
anoscope window ring 24 in order not to obstruct visual
access (figures 18, 19).
The distal plate 6 comprises a distal plug 7 arranged
distally from the rectal stump closure plug 4 and having
a second circumferential tie up surface 52.
Analogously to the rectal stump closure plug 4, also the
second tie up surface 52 may extend all around the
distal plug 7 and is intended to provide an abutment
against which the lumen of the rectum 46 can be tied up
from outside in order to form a closure of the portion
54 of rectum intended to be removed.
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In accordance with an embodiment, the second tie up
surface 52 comprises a second circumferential groove 55
to facilitate positioning and tightening of a second
snare 34' which can be positioned about the rectum 46
and subsequently tightened by open surgery or by
laparoscopy. Thanks to the second circumferential groove
55, during tightening the snare 34', the latter is
biased to position itself exactly above the second tie
up surface 52 and a ring of the rectum 46 is pressed
between the snare 34' and the second tie up surface 52
inside the circumferential groove 55.
The distal plate 6, and more precisely the distal plug 7
thereof, comprises a coupling seat 56 which is provided
for the connection of the distal plate 6 to the rectal
stump closure plug 4.
In accordance with an embodiment, the coupling seat 56
is formed near a proximal end face 57 of the distal plug
7 and may be embodied as a groove or as a cavity having
an undercut suitable for engaging a corresponding tooth
or edge of the rectal stump closure plug 4 or,
alternatively, of the dedicated separate latching member
8.
In accordance with an embodiment, the distal plate 6
comprises a distal widening portion, for instance a
widening ring 58 arranged distally from the distal plug
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7 and having a diameter which is smaller than the
internal diameter of the passage opening 10 of anal
dilator 2, in order to allow insertion of the anoscope 3
equipped with rectal stump closure plug 4 and distal
plate 6.
The widening ring 58 is connected to the distal plug 7
by at least one, preferably three or four inclined bars
59, wherein the free spaces defined between bars 59 and
widening ring 58 provide window openings 60 which extend
radially outside the distal plug 7 and provide direct
visual access or also instrument access to the region
distally from the distal plug 7 and from the widening
ring 58.
In accordance with an aspect of the invention, the
surgical device is designed so that the distance between
the distal widening ring 58 and the distal tie up plane
(defined by distal plug 7 tie up surface 53) as well as
the resection plane (between plugs 4 and 7) provides a
sufficient margin between a tumor or lesion border and
the resection plane and tissue squeezing zone, so that a
correct positioning of widening ring 58 in front of a
tumor automatically determines a standardized and
repeatable positioning of the resection plane.
In accordance with an aspect of the invention the distal
plug 7 is configured as a substantially impermeable
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block, so that leakage and tumor seeding are prevented
both during resection and removal of the rectum portion
54.
The overall truncated cone shape of distal plate 6 and
the overall truncated cone shape of the distal end
portion 18 of anoscope 3 define an overall
circumferential groove which provides guidance and
facilitate the correct positioning of tie up snares 34,
34', bands or tapes 35 which will be described in detail
below.
As already mentioned before, the distal plate 6 can be
connected to the rectal stump closure plug 4 in
different ways. In accordance with an embodiment, a
latching member 8 can be provided, which has a proximal
flange 36 adapted to engage with the coupling seat 32 of
the rectal stump closure plug 4 and a distal flange 37
adapted to engage with the corresponding coupling seat
56 formed in the distal plug 4 of distal plate 6. In
order to separate the healthy rectal stump 47 and the
unhealthy lumen portion containing the tumor 48 after
tightening them around the respective plugs 4, 7, it is
desirable to configure the latching member 8 such that
it provides a removable or reversible connection between
the plugs 4, 7.
This can be obtained by configuring the coupling flanges
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36, 37 of latching member 8 and the respective coupling
seats 32 and 56 of plugs 4, 7 so that they can removably
engage, e.g. by snap-fit or press fit, or by
manufacturing the latching member 8 in a material
5 (rubber, polymer) which can be cut through by the same
cutting device which is employed for rectal resection.
To this end, the latching member 8 can be configured to
form a cutting block for the cutting device, e.g. a
laparoscopic radiofrequency snare 62.
10 Moreover, opposite circumferential guide surfaces 39 can
be formed in the latching member 8 itself or in plugs 4,
7 which define alone or together with the latching
member 8 a circumferential cutting groove 61 which
invites the cutting device to position itself in a
15 predetermined cutting plane between first and second tie
up planes determined by the corresponding first and
second tie up surfaces 30, 53.
In accordance with an embodiment, the rectal stump
closure plug 4 and the distal plug 7 are approximately
20 coaxial to a longitudinal axis L of the anoscope 3 and
have a diameter which is smaller than the diameters of
the anoscope side wall 16 and of the distal plate
widening ring 58 in order to enable direct transanal
tumor visualization over both plugs 4, 7.
Turning again to the tightening snares 34, 34', in
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accordance with an embodiment, toothed zip ties may be
used for tying up the rectum 46 against the rectal stump
closure plug 4 and the distal plug 7, respectively (fig.
4, 6) . The toothed zip ties provide a ratchet like one
way and non return tightening.
The tie up snares 34, 34' can be applied
laparoscopically or by open surgery.
Alternatively (figs. 15 - 17), the tightening snares may
be tied up around the rectum 46 and locked in their
tissue pressing configuration by a locking member, e.g.
a staple or clip 63 or a ratchet like toothed locking
portion.
In accordance with an embodiment, an internal surface of
the tightening snares or a tightening band destined to
face the first and second tie up surfaces 30, 53 are
shaped approximately complementary to the shape of the
tie up surfaces 30, 53, particularly to the shape of
circumferential grooves 31, 55.
It is also contemplated to provide a tie up tape 35
which has a width such as to extend over both the rectal
stump closure plug 4 and the distal plug 7 and which can
be cut through between both tie up planes during rectal
transection by means of the same cutting instrument used
to transect the rectum lumen.
In accordance with an embodiment, the tie up snare and
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the cutting instrument are integrated in a single open
surgery or laparoscopic device including the looped tape
35 having a width covering both the rectal stump closure
plug 4 and the distal plug 7, as well as a cutting
snare, e.g. a radiofrequency snare 64 or mechanical or
mechanical vibrating cutting snare which is fixed to the
looped tape 35 and extends parallel to the extension of
tape 35 along a center line of the latter. In this way
the tightened tape 35 assures a correct position of the
integrated cutting snare (e.g. RF snare 64) during
cutting.
Figures 20, 21 illustrate an exemplary, non limiting
embodiment of an open surgery and or laparoscopic tie up
tape applier 73. The applier 73 comprises a proximal
handle 74, a distal tape fastening assembly 75 and an
elongate straight or curved shaft 79 which extends from
handle 74 to the tape fastening assembly 75. The tape
fastening assembly 75 comprises a tape holder seat 76
which supports the tape 35 during positioning and
tightening, a tape pulling mechanism activatable by a
lever 77 or other manual operating member and a tape
locking device which can be embodied as a staple
fastener, a clip applier, or as a ratchet like toothed
locking seat directly provided at one end of the tape.
The tape applier 73 also comprises a cutting mechanism
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involving a mechanical cutting blade housed in the tape
fastening assembly 75 and connected to a cutting
mechanism which is manually operable through a cutting
activation member, e.g. knob 78. Alternatively, a
heatable e.g. resistive cutting edge with associated
energizing circuit can be provided and activated by
operating an electrical switch at the handle 74.
In case a RF or mechanical cutting snare is integrated
in the tie up tape 35, the tape applier 73 may also
include a cutting snare pulling mechanism and an
energizing circuit for the cutting snare.
In accordance with a further embodiment, a
circumferential cutting blade can be provided between
the first and second tie up surfaces and configured so
that the rectum lumen is pressed against it and cut
through from the inside during cinching of the rectum
against the first and second tie up surfaces.
Alternatively, a cutting blade may be rotatably mounted
between the first and second tie up surfaces and driven
through the lumen wall tissue by a rotating movement
generated by means of a manually operable rotating rod
which torsionally engages the cutting blade and which
extends inside the anoscope working channel 17.
As will be appreciated by those skilled in the art, the
above described tie up tape applier makes it possible to
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comfortably access the low anterior rectal region by
laparoscopy or open surgery and to apply the tie up tape
with controllable pulling force and perform resection in
a more favorable working position compared to prior art
techniques.
In accordance with a further aspect of the present
invention, a circular stapling device 41 is provided
which includes a stapler main body 65 with a handle, an
insertion shaft, a staple fastening assembly 42 to which
an anvil approximating mechanism, a staple driving
mechanism and a cutting mechanism are associated. The
circular stapling device 41 further comprises an anvil
43 with a proximal staple forming surface and a
proximally protruding connecting shaft 44. A connecting
trocar 40 is operatively linked to the anvil
approximating mechanism and protrudes distally from the
staple fastening assembly 42. Connecting trocar 40 and
connecting shaft 44 are configured to removably engage
each other and to couple anvil 43 in a tension force
transmitting manner to the main body 65 of circular
stapling device 41. The circular stapling device 41 is
particularly adapted for an end-to-end anastomosis of
the rectal stump 47 with a proximal colon stump 66. To
this end the external diameter of the staple fastening
assembly 42 is slightly smaller than the internal
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diameter of the passage opening (10) of anal dilator
(2) .
Moreover the staple fastening assembly 42 and or the
anvil 43 define a tissue receiving cavity 45 having a
5 diameter and a depth greater than the external diameter
and axial length of the rectal stump closure plug 4.
Particularly, the tissue receiving cavity 45 has a
diameter and a depth sufficient to receive the rectal
stump closure plug 4 together with the tie up snare
10 (whose overhanging laces can be cut away before
performing the anastomosis) and the clamped tissue ring.
In accordance with a yet further embodiment, the
surgical device comprises illumination means configured
to mark the first and/or second tie up surfaces 30, 53
15 and or the resection plane by a light signal which is
sufficiently strong to be go through the rectal wall and
to be visible from the outside of the rectum lumen in
order to indicate the correct position of the tie up
snares and of the resection. Such illumination means may
20 comprise optical fiber light transmitting means
extending along the anoscope and terminating near the
first and second tie up surfaces 30, 53 which can be at
least partially transparent.
Figures 3 - 14 illustrate a method for performing a
25 rectal resection, rectal stump closure and rectal stump
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end-to-end anastomosis by means of the surgical device
according to the invention.
After introducing the circular anal dilator 2 in the
anus of a patient and fixating it with stay sutures on
the perianal skin, the anoscope 3 holding the rectal
stump closure plug 4 and the distal plate 6 is
introduced in the passage opening 10 of the dilator 2
and locked in position against the latter (fig. 3).
During insertion of the anoscope 3 through the circular
anal dilator 2, the anoscope is held in an angular
position to the anal dilator so that the latching ribs
67 of anal dilator 2 and the counter-latching ribs 68 of
the anoscope 3 do not interfere, thereby enabling
longitudinal (proximal - distal) movement of the
anoscope 3. Once the anoscope 3 is positioned at the
correct insertion depth, it is turned with respect to
the anal dilator 2 so that the latching ribs 67 engage
the counter-latching ribs 68, thereby locking the
anoscope 3 longitudinally with respect to the anal
dilator 2.
First and second tie up snares, particularly zip ties
34, 34' are looped around the rectum 46 by laparoscopy
or by open surgery (fig. 4).
Positioning of the anoscope and the zip ties is assisted
by direct transanal visualization through the window
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openings 23, 60 of the anoscope distal end portion 18
and of the distal plate 6 (fig. 5).
It is to be noted that the surgical device is designed
so that the distance between the distal widening ring 58
and the distal tie up plane (defined by distal plug 7
tie up surface 53) as well as the resection plane
(between plugs 4 and 7) determine a correct margin
between a tumor or lesion border and the resection plane
and tissue squeezing zone. It is therefore possible, by
positioning the distal plate 6 with the distal widening
ring 58 in front of the tumor, to obtain a standardized
and repeatable margin between the tumor and the tissue
squeezing zone and resection plane.
Once the correct positioning of the rectal stump closure
plug 4 with respect to the tumor 48 is achieved, the zip
ties 34 are tightened about the first and second tie up
surfaces 30, 53 of the rectal stump closure plug 4 and
the distal plug 7, respectively, thereby cinching the
rectal stump around the plugs 4, 7 which are supported
and stabilized by anoscope 3 to which they are still
firmly connected. In this stage, the circumferential
grooves 31 and 55 of plugs 4, 7 receive the zip ties 34,
34' and assure their correct positioning (figs. 6, 7).
After having the rectum 46 sealed against the plugs 4,
7, resection can be performed between the two tie up
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planes. To this end, an open surgery or laparoscopic
cutting device is brought into position and the rectum
is transected between both zip ties 34, 34'. In
accordance with an embodiment, the use of an RF snare
(fig. 8) is contemplated, which is inserted over the
rectal stump 47 and tightened between the distal plug 7
and the rectal stump closure plug 4. Thanks to the guide
surfaces 39, a cutting groove 61 is provided between
both plugs 4, 7 which enables self alignment of the RF
snare 62 during transection.
In accordance with an embodiment of the invention, the
cutting instrument cuts completely through both the
rectum and the latching member 8, thereby separating the
rectal stump from the rectal lumen portion 54 to be
removed and the rectal stump closure plug 4 from the
distal plate 6 (figs. 8, 9, 10).
In accordance with another embodiment, the cutting
instrument cuts through the rectum, but it doesn't
transect the latching element 8, which can be
subsequently disengaged from the distal plug or from the
rectal stump closure plug in order to separate them from
one another.
Once the rectal resection is complete (fig. 10), the
unhealthy lumen portion 54 containing the tumor 48 or
lesion is removed from the patient.
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The healthy rectal stump 47 can be thoroughly washed and
rinsed in order to remove residual tumor cells which
might have been accidentally seeded or squeezed into the
healthy tissue.
The healthy rectal stump 47 still bound by the tie up
snare (zip tie 34) is now ready for an end-to-end
anastomosis with the proximal colon stump 66 previously
prepared by a purse string closure or by linear
stapling.
To provide access space for a circular stapling device
41, anoscope 3 must be removed from the circular anal
dilator 2 and, hence, it must be detached from the
rectal stump closure plug 4. This is done by means of a
surgical grasping instrument 50 which is inserted
through the working channel 17 of the anoscope 3 up to
the distal end portion thereof, and subsequently
operated to grasp the proximal portion 49 of plug
connector 5 to disengage the latter from rectal stump
closure plug 4 (figs. 10, 11).
In accordance with an embodiment, anoscope 3 can be
detached from rectal stump closure plug 4 by breaking
one or more connecting bridges between the anoscope
distal end portion 18 and the rectal stump closure plug
4.
Circular stapling device 41 is now introduced through
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the anal dilator 2 until its staple fastening assembly
42 reaches the rectal stump closure plug 4. A connecting
trocar 40 distally projecting from the staple fastening
assembly 42 is inserted or pierced through the passage
5 zone 29 of plug 4. Anvil 43 of circular stapling device
41 is introduced into the proximal colon stump 66
through a small incision and a purse string is performed
around its connecting shaft 44. Shaft 44 and trocar 40
are then connected under laparoscopic view, the stapling
10 device 41 is closed and fired. The so called cut-out
tissue donut together with the rectal stump closure plug
4 and tie up snare 34 is encapsulated inside a dedicated
tissue receiving space 45 (figs. 13, 14).
The circular stapling device 41 is then proximally
15 withdrawn from the patient, tissue donuts are checked
and a leak test is performed to assure that the
anastomosis is air-liquid tight.
The above described device and method have many
advantages. They enable direct eye control of the tumor
20 to be excised prior to the rectal stump creation and
obviate cross-stapling by creating a staple free rectal
stump which can be completely housed in the tissue
receiving cavity of the stapler. This eliminates the
risk of leakage associated with the prior art double
25 staple techniques.
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While the present invention has been illustrated by
description of several embodiments and while the
illustrative embodiments have been described in
considerable detail, it is not the intention to restrict
or in any way limit the scope of the appended claims to
such detail.
