Note: Descriptions are shown in the official language in which they were submitted.
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DESCRIPTION
"AN ANASTOMOTIC APPLIER AND METHOD FOR PERFORMING
ENDOLUMINAL AND/OR TRANSLUMINAL ANASTOMOSIS"
The present invention relates, in general, to devices
and methods for surgically modifying organs and vessels
and more particularly to a surgical instrument and
method for performing an endoluminal and or transluminal
anastomosis, particularly of the digestive tract, such
as gastro-jejunostomy, jejuno-jejunostomy or similar
interventions as for example colo-proctostomy, jejuno-
colostomy or anastomoses involving the Chole duct, by
applying an anastomotic ring device comprising two snap-
connectable rings.
The known surgical methods and instruments for
performing the above mentioned anastomoses by applying
anastomotic ring devices involve traditional open
surgery or laparoscopic surgical techniques, which are
rather invasive and require the use of quite complex and
cumbersome surgical devices. As a result the risk of
post-operative complications is undesirably high.
Moreover, the known devices and methods are not suitable
to perform the anastomosis by a pure or at least
partially endoscopic or endolumenal approach.
Such an endolumenal approach, if assisted by a suitable
instrumentation, would sensibly reduce the disadvantages
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of the traditional open surgery and laparoscopic
methods. Particularly, endolumenal operations would
reduce the invasiveness of the intervention, thereby
reducing the risk of complications and shortening the
post operative course of the patient.
Even though the endoscopic and endolumenal approach to
anastomosis is very promising, it is presently very
difficult to use such an approach in practice, e.g. for
performing an anastomosis of the digestive tract, since
neither the instrumentation nor the methods are mature
enough to assure for instance an adequate ring
positioning, a controlled tissue approximation and a
reliable alignment and connection of the rings during
deployment. As a result, operative and post operative
complications cannot be excluded.
The object of the present invention is therefore to
provide a surgical instrumentation, particularly an
anastomotic applier, especially developed and adapted
for performing endoluminal or transluminal anastomoses,
particularly of the digestive tract, by an endolumenal
approach.
A further object of the invention is to provide a
surgical method for performing an endolumenal or
translumenal anastomosis, particularly of the digestive
tract, by an endolumenal or endoscopic approach which is
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less invasive than the currently employed open surgery
and laparoscopic approaches.
These and other objects are achieved by an anastomotic
compression ring applier system according to claim 1 and
by the method described in the following description.
Advantageous embodiments are claimed in the dependent
claims.
For better understanding the invention and appreciating
the related advantages, a detailed and non limiting
description of embodiments is provided with reference to
the accompanying drawings, in which:
- Figure 1 is a sectioned view of an endoluminal
anastomotic ring applier according to an embodiment of
the invention;
- Figure 2 is a perspective view of a detail of the
endoluminal anastomotic ring applier in figure 1;
- Figure 3 is a sectioned view of the detail in figure
2;
- Figure 4 is a perspective view of a further detail of
the endoluminal anastomotic ring applier in figure 1;
- Figure 5 is a perspective view of an inflatable
coupling portion of a coupling device of an endoluminal
anastomotic ring carrier device according to an
embodiment of the invention;
- Figure 6 is a perspective view of an anastomotic
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compression ring device intended to be deployed by means
of an anastomotic applier according to the invention;
- Figures 7, 8 and 9 illustrate a series of steps of a
method for performing a transluminal anastomosis by
means of the anastomotic ring applier system in figures
1 to 6 according to the invention;
- Figure 10 is a perspective view of an inflatable
coupling portion of a coupling device of the anastomotic
applier system in a disengaged configuration according
to an embodiment of the invention;
- Figure 11 is a perspective, sectioned view of the
coupling device of figure 10 in an engaged
configuration;
- Figure 12 is a schematic illustration of the general
functional units of an anastomotic compression ring
deployment system according to the invention;
- Figure 13 illustrates a creation of a guide wire loop
in preparation of an anastomosis (gastro-jejunostomy);
- Figure 14 illustrates a creation of an anastomosis
(gastro-jejunostomy).
For the sake of clarity and for better evidencing the
technical effect of the features of the anastomotic
applier system according to the invention and its
interaction with the particular environment of
application, the following detailed description of the
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invention will first deal with the surgical method
thought up by the inventors and subsequently describe
the anastomotic applier and surgical instruments for
carrying out the method.
5 Overall procedure to perform the anastomosis
A method for performing an endoluminal or transluminal
anstomosis, such as e.g. a gastro-jejunostomy, a jejuno-
jejunostomy, a colo-proctostomy, a jejuno-colostomy or
anastomoses of the chole duct, comprises generally the
following steps:
- Creating a loop of guide wire means by placing guide
wire means 88 in the body of a patient in a way that the
guide wire means 88 extend from an extracorporeal
proximal end 88' into the body where it goes through a
proximal first tissue portion 45 and through a distal
second tissue portion 44 which are planned to be joined
in anastomosis and out of the body up to an
extracorporeal distal end 88''.
In the following, if not otherwise specified, the terms
"proximal" and "distal" are referred to the directions
along the guide wire loop and to the above defined
proximal 88' and distal ends 88'' thereof.
- Fixing a proximal first ring 36 of an anastomotic ring
device to the proximal end 88' of the guide wire means
88 and delivering the proximal first ring 36 to the
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proximal first tissue portion 45 by pulling the distal
extracorporeal end 88'' of the guide wire means 88 in a
distal direction until the proximal first ring 36
reaches the proximal first tissue portion 45,
- Slidably connecting a distal second ring 39 of the
anastomotic ring device to the distal end 88'' of the
guide wire means 88 and pushing it proximally along the
guide wire means 88 until it reaches the distal second
tissue portion 44.
- Contemporaneously pulling the proximal first
compression ring 36 distally and pushing the second
distal compression ring 39 proximally to approximate the
proximal and distal rings, thereby tearing the first and
second tissue portions 45, 44 situated upon the guide
wire means 88 between the first and second rings 36, 39
in compression contact to another,
- Widening the tissue internally overhanging the
anastomotic ring device to open the anastomotic lumen,
- Connecting the first and second rings 36, 39, thereby
clamping the first and second tissue portions between
them,
- Pulling the proximal end 88' of the guide wire means
88 to remove the guide wire means 88 from the body.
The loop of the guide wire means 88 starts and ends
either in natural orifices, like mouth, nose, anus or,
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alternatively, in artificially created openings in the
body, such as colostomy, abdominal incisions, wound or
fistulas. Preferably, the guide wire means enters and
exits the body through natural ducts (e.g. mouth, Figs.
13 and 14).
While the guide wire means can comprise one or more
single flexible guide wires, it is preferable to provide
only one single guide wire which penetrates the proximal
and distal tissue portion.
Creation of the loop of the guide wire means
The loop of the guide wire means 88 can be created by
means of the following procedural steps:
- Transluminally (e.g. transorally) introducing an
elongate insertion device through the proximal inlet
port (e.g. mouth) for the guide wire means and pushing
the insertion device from outside the body distally
towards the proximal tissue portion (e.g. a jejunal
anstomotic site),
- Transporting the distal end of the guide wire means to
the proximal tissue portion through one or more guide
wire canals formed in the insertion device and
perforating the proximal tissue portion with the guide
wire end or needle guide wire end. Alternatively, the
proximal tissue portion is perforated by a distinct
radio frequency needle device having a sheath which is
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insertable along the guide wire canal and which defines
two or more internal canals (one for the RF needle and
one for the guide wire).
In this way the distal guide wire end protrudes distally
from the proximal tissue portion (e.g. into the
previously C02 insufflated abdominal space),
- Removing the insertion device from the body by pulling
it proximally out of the proximal inlet port (e.g.
mouth) and leaving the guide wire means in place,
- Transluminally introducing a grasping device through
the distal inlet port for the guide wire means which
might but need not coincide with the proximal inlet port
(e.g. mouth) and pushing the grasping device from
outside the body proximally (with reference to the loop
direction) towards the distal tissue portion, e.g. the
gastric wall tissue,
- Creating a hole in the distal tissue portion, e.g. by
means of a radiofrequency needle or equivalent
penetration devices and, preferably, widening the hole
with a balloon catheter which is preferably transported
to the distal tissue portion through a working channel
of the grasping device.
- Passing the grasping device through the previously
widened hole (gastrotomy) of the distal tissue portion
into the same space where the distal guide wire end lays
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(e.g. in the previously C02 insufflated abdominal space)
and pushing it towards the distal end of the guide wire
means.
- Inserting a snare through the working or instrument
delivery canal formed in the grasping device and
advancing the snare proximally until it exits from the
grasping device and reaches the distal guide wire end.
- Feeding the snare over the distal guide wire end and
closing or tightening it around the guide wire means in
order to catch it, subsequently pulling the snare
together with the distal end of the guide wire means
distally through the perforation of the distal tissue
portion (e.g. gastric wall) and distally withdrawing the
grasping device together with the distal guide wire end
through the distal inlet port (e.g. transorally) out of
the body.
Advantageously, the transluminal introduction of the
grasping device and the snare is performed by a pure
endoscopic or endolumenal approach. Alternatively, this
procedural step is performed under laparoscopic
supervision. In this case the hole does not need to be
widened and only the snare (preferably a radio frequency
snare adapted to pierce through the gastric wall)
creates the hole and is passed through it into the
abdominal space. The distal guide wire end is then
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laparoscopically fed into the snare hole to be caught by
the latter.
In case of a gastro-jejunostomy, the insertion device
needs to be advanced transorally through the esophagus
5 and the stomach and across the pylorus into the
duodenum, which is not always easy to point at. During
this step of the procedure a guiding or protective tube
might be pushed through the patients mouth down the
esophagus into the stomach and the insertion device can
10 be advantageously guided inside the guiding or
protective tube up to and across the pylorus.
Delivering the proximal ring of the anastomotic ring
device to the anastomotic site and approximation of the
proximal and distal tissue portions
The proximal first ring 36 is delivered to the
anastomotic site by means of the following procedural
steps:
- Detachably connecting the proximal ring with a,
preferably distinct, carrier member 33 outside the body
of the patient.
- Extracorporeal attachment of the carrier member 33
(which holds the proximal ring) to the proximal end 88'
of the guide wire means 88, e.g. by inserting it over
the single guide wire, and locking the carrier member in
a manner to prevent it from sliding along the guide wire
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means. The carrier member 33 is preferably locked by
means of locking elements, such as clips which can be
clamped around the guide wire and which are adapted to
provide an obstacle against sliding of the carrier
member. After having connected the carrier member to the
proximal guide wire end, it is introduced in the
proximal endoscopic inlet port and pulled to the
anastomotic site, i.e. to the proximal first tissue
portion (e.g. intestinal wall 45) by pulling the distal
guide wire end 88'' distally.
Alternatively, the locking of the carrier member to the
guide wire might be obtained by locking features, for
instance clamping portions, integrated in the carrier
member. According to a yet further embodiment, the
carrier member has been fabricated and distributed
together with the guide wire or previously connected to
it in a manner that, after completion of the guide wire
loop, it is sufficient to introduce the carrier member
together with the proximal ring into the proximal inlet
port (e.g. mouth and esophagus) and deliver it to the
proximal tissue portion 45 by pulling the distal guide
wire end 88' distally.
Alternatively, the carrier member can be slid along the
guide wire up to the proximal tissue layer, wherein the
guide wire acts as a guide rail for the carrier member.
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- Subsequently, the proximal tissue portion 45 (e.g.
intestinal tissue) can be approximated towards the
distal tissue portion 44 (e.g. gastric wall) until they
are in intimate contact by pulling the distal guide wire
end 88'' distally so that the carrier member urges the
proximal ring, particularly a distal tissue contact
surface thereof, against the proximal tissue portion and
moves the latter distally towards and in contact with
the distal tissue portion.
Delivering the distal ring of the anastomotic ring
device to the anastomotic site and connection of the
distal and proximal rings
The distal ring is delivered to the anastomotic site by
means of the following procedural steps:
- Inserting the distal second compression ring 39 over
the distal guide wire end 88'' and pushing it proximally
along the guide wire means 88 towards the anastomotic
site and, hence, towards the proximal first compression
ring 36. Thanks to the guide wire loop and possibly
further guide means, the first and second compression
rings 36, 39, together with the first and second tissue
portions 45, 44 are axially aligned in the anastomotic
site.
According to an embodiment, the distal compression ring
is pushed along the guide wire by means of an apposite
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anastomotic applier which is advantageously adapted to
perform an angular positioning, if required, of the
distal compression ring with respect to the proximal
compression ring in order to enable their mutual
connection. Alternatively, the compression rings are
provided with connecting features which enable their
mutual connection in different angular positions or
independently from their reciprocal angular position.
- Connecting the compression rings and, hence the tissue
portions clamped between them, by pushing the distal
compression ring proximally in engagement with the
proximal compression ring or pulling the proximal
compression ring distally in engagement with the distal
compression ring. To this end, the anastomotic applier
system includes a coupling device 1 and an approximation
device 37. In this way it is possible to couple
(preferably in or near the operational site) the carrier
of the first compression ring to the approximation
device 37 (which in turn is connected to the second
compression ring) and to apply a reciprocal pushing or
pulling force on the compression rings.
In accordance with an embodiment, the compression rings
are connected by applying a distinct locking device
adapted to engage both compression rings and to maintain
them connected at a desired reciprocal distance.
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The method of connecting the compression rings to
another can additionally comprise the step of fixating
the tissue portions to the compression rings in order to
effectively prevent the tissue from radially slipping
out of the grip engagement with the compression rings.
This additional step might be performed before or
contemporaneously with the application of the locking
device. This additional fixation step is preferably
performed by compressing the tissue portions between the
distal and proximal ring device and by driving a
plurality of needles into and across the ring device and
the tissue portions so that the needles provide the
above said additional fixation.
As the delivery of the locking device and the group of
needles (if provided) to the anastomotic site is
concerned, according to an embodiment of the method, the
locking device is inserted extracorporeally over the
distal guide wire end 88' and pushed proximally along
the guide wire 88 towards the anastomotic site and
towards the proximal compression ring. Preferably, both
the distal compression ring and the distinct locking
device (and, if provided, the needle group) are arranged
on a distal end (here the term "distal" is referred to
the surgeons viewpoint and not to the guide wire loop)
of the anastomotic applier and pushed by means of the
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latter to the anastomotic site and in engagement with
the proximal compression ring.
Alternatively, and inversely with respect to the above
described embodiment both the proximal first compression
5 ring and the distinct locking device (and, if provided,
the needle group) are fixed to the proximal ring carrier
device 33 and transported to the anastomotic site and
urged in engagement with the distal compression ring.
Widening the tissue at the anastomotic site
10 The distal and proximal tissue portions intended to be
joined in anastomosis are widened by means of the
following procedural steps:
- widening the passage apertures of the tissue portions
through which the guide wire means, preferably a single
15 guide wire, passes by cutting or forced tissue extension
after the tissue portions have been approximated in
mutual contact but, preferably, before the distal and
proximal compression rings are definitely connected.
According to an advantageous embodiment, the passage
openings of the tissue portions are widened by a balloon
dilator 11 which can also act as expandable anchoring
head 4 of the coupling device 1 (which will be described
further ahead) . The balloon dilator 11 can be inserted
over the guide wire 88 and delivered towards and at
least partially across the passage openings in the
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tissue portions. Successively, the balloon dilator 11 is
insufflated to an extent that it fills approximately a
central aperture of the distal compression ring, thereby
widening the anastomotic lumen to substantially the same
extent and at the same time performing the coupling
action between the first ring carrier and the
anastomotic applier.
In accordance with an advantageous embodiment, prior to
or after the inflation of the balloon dilator 11 of the
coupling device 1, the proximal first compression ring
(the locking device together with the needle group is
preferably preassembled with one of the compression
rings) is inserted over a portion of the balloon dilator
11 such that the inflated balloon dilator provides a
guide for the successive approximation and alignment of
the compression rings.
Removing the instrumentation and guide wire means from
the body of the patient
After the connection of the compression rings, the
balloon dilator is deflated and detached from the a
catching portion 3 of the anastomotic applier. The
anastomotic applier with the catching portion 3 are
withdrawn from the body of the patient. Also the carrier
member 33 with the coupling portion 2 are detached from
the proximal first compression ring and removed,
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preferably together with the guide wire 88, by pulling
the proximal guide wire end 88' in proximal direction.
As the proximal first ring is definitely locked to the
distal ring, during proximal traction of the guide wire
88 the carrier member (which received the proximal ring
by a weaker connection, e.g. by friction fit) detaches
from the proximal compression ring which rests connected
to the distal compression ring.
Even though the method of performing an anastomosis has
been described and illustrated with reference to a
gastro-jejunostomy which is performed starting from the
jejunum, such a gastro-jejunostomy might also be
performed starting from the stomach. In this case, it
might be advantageous to introduce a shielding device
into the jejunum in order to prevent piercing of the
intestine wall opposite the one intended to be
anastomized.
Possibly, the tightness of the anastomosis can be tested
using methylene blue.
The above described method can be advantageously
performed endolumenally or partially endolumenally
during a gastro-jejunostomy. In case the above described
method forms part of a procedure for creating a gastro-
intestinal bypass, it is possible to proceed with a
performance of a further anastomosis involving the small
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intestine (e.g. a jejuno-jejunostomy or an ileo-
jejunostomy), possibly by applying the above described
steps in analogous manner also to the further
anastomosis.
From the foregoing description of the general steps of
the method and of their specific application to a
gastro-jejunostomy, those skilled in the art will
appreciate that the method enables a continuous control
of the positioning and of the forces applied to the
single parts of the anastomotic ring device during
deployment. The method further consents to perform the
anstomosis endoluminally even though laparoscopic o
partially laparoscopic steps in assisting and performing
the anastomosis are not excluded.
The described method, particularly the use of an
anastomotic applier having coupling and ring
approximating features is not only advantageous for
gastro-jejunostomy and jejuno-jejunostomy, but also for
performing for example colo-proctostomy, jejuno-
colostomy or anastomoses involving the Chole duct.
In the following, an anastomotic ring applier system
will be described which has been especially developed
and adapted for performing an anastomosis in accordance
with the proposed method.
The instrumentation comprises advantageously one or more
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of the following components:
- first and second anastomotic rings 36, 39;
- fixation needles 81;
- first ring carrier member 33;
- locking device 82;
- insertion device (not illustrated in the figures);
- grasping device (not illustrated in the figures);
- anastomotic applier 32;
- anchoring head/balloon dilator 14/11;
- guide wire 88;
- snare (not illustrated in the figures),
some of which will be in the following described in
further detail by means of illustrative embodiments.
General description of the anastomotic ring applier
system
With reference to figure 12, an anastomotic ring applier
system 30 comprises a first compression ring carrier
device 31 (dashed line --- ) and an anastomotic applier
32 (dotted dashed line -.-). The first compression
ring carrier device 31 comprises a first (e.g. jejunal)
ring carrier 33 adapted to hold a first compression ring
36 and connectable or connected to the guide wire device
88. The first ring carrier 33 can be connected to a
balloon dilator 11 which is built up around the guide
wire and which can be connected to the guide wire
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outside the body of the patient or near an inflatable
head of the balloon dilator, e.g. by means of a discrete
gluing point (or more generally a locking portion 35)
which doesn't hinder the fluid communication from the
5 fluid duct of the balloon dilator to its inflatable
head.
The first compression ring carrier device 31 can be
coupled to and uncoupled from the ring approximation
device 37 of the anastomotic applier 32 (which will be
10 described below) by means of the previously mentioned
coupling device 1(-..-..- double dotted dashed line in
figure 12).
The anastomotic applier 32 further comprises a second
(gastric) ring carrier 38 adapted to hold a second
15 compression ring 39 for instance by means of a ring
connecting portion 40 which is configured to engage the
second (gastric) compression ring 39 by snap-fit or
friction-fit or press-fit.
The anastomotic applier 32 further comprises a ring
20 approximation device 37 with a first portion 42
connectable by means of the coupling device 1 to the
first ring carrier device 31 and a second portion 43
connected or connectable to the second ring carrier
device 38.
The first and second portions 42, 43 of the ring
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approximation device 37 are movable to one another in a
way to approximate the first and second ring carrier
devices 31, 38 thereby approximating the two tissue
layers (e.g. gastric tissue layer 44 and jejunal tissue
layer 45) held between the two compression rings 36, 39
and interconnecting the compression rings 36, 39 to
complete the anastomosis.
In accordance with the invention, the ring approximation
device 37 of the anastomotic applier 32 comprises a
screw drive device 46, wherein the first portion 42
forms a first thread 47 and the second portion 43 forms
a second thread 48 meshing the first thread 47 and a
rotary device 49 cooperates with at least one of the
first and second portions 42, 43 to rotate them to one
another. The relative rotation of the first and second
portions 42, 43 causes them to translate to one another
and to approximate the first and second ring carrier
devices 31, 38 and the two tissue layers (e.g. gastric
tissue layer 44 and jejunal tissue layer 45) held
between the two compression rings 36, 39 and to
interconnect the compression rings 36, 39.
As mentioned before, the anastomotic ring applier system
as a whole may further comprise a coupling device 1
and, hence, the anastomotic applier 32 may comprise a
25 coupling portion 2 or a catching portion 3 of such
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coupling device 1 to allow reversible coupling of the
anastomotic applier 32 to the first ring carrier device
31 (compare figure 12) at or near the operational site.
Embodiment description of the coupling device 1 of the
anastomotic ring applier system 30
According to an embodiment, the coupling device 1
comprises a coupling portion 2 and a catching portion 3
configured to trap and hold the coupling portion 2. The
coupling portion 2 comprises a first connector 5 for
connecting the coupling portion 2 to the first ring
carrier device 31 and an inflatable anchoring head 4, as
well as an activating device 6 connected to the
anchoring head 4 and suitable to deform (insufflate and
deflate) the anchoring head 4 such that it can take on
an expanded configuration (Fig. 10) and a retracted
configuration (Fig. 5, 7).
The catching portion 3 comprises a second connector 58,
7 for connecting the catching portion 3 to the
anastomotic applier 32, particularly to the second ring
carrier device 38 thereof, which is intended to be
coupled with the first ring carrier device 31. The
catching portion 3 further comprises an anchoring seat 8
which defines a receiving space 9 for receiving at least
part of the anchoring head 4 and an access aperture 10
through which the anchoring head 4 can be inserted from
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outside the catching portion 3 into the receiving space
9. The access aperture 10 is configured to allow
insertion and withdrawal of the anchoring head 4 when it
is retracted and to lock the at least partially inserted
anchoring head 4 to the catching portion 3 when it is
expanded.
In accordance with an embodiment, the anchoring head 4
comprises said balloon catheter or balloon dilator 11
which can be actuated by a fluid pump device which is
connected in fluid communication with the balloon
dilator 11 through a preferably flexible pressure fluid
duct 12. As illustrated in figures 1, 5 and 10
respectively, the balloon dilator 11 can assume a
substantially elongate filiform retracted shape and, if
subject to fluid pressure, a substantially elongate
cylindrical expanded shape.
In accordance with an embodiment, the balloon dilator 11
has an internal inflatable chamber 14 defined by a
flexible (in the sense of bending deformation) but
inextensible wall 13 such that it can adapt to the shape
of the anchoring seat 8 even and particularly if it is
only partially inserted into the receiving space 9. The
balloon dilator 11 has a tapered distal (from a surgeons
point of view) insertion end 15 which is preferably
substantially convex and narrowed towards the end, e.g.
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ogive shaped, and which can further have a central pin
shaped tip 16 or needle in order to facilitate the
insertion of the anchoring head through tissue portions
and into the access aperture 10 of the catching portion
3.
According to an embodiment, the first connector of the
coupling portion 2 comprises a longitudinal channel 17
which is configured to receive for instance the guide
wire 88 of the first ring carrier device 31. The guide
wire channel 17 is advantageously coaxial to the
cylindrical expanded shape of the balloon dilator 11 and
can be directly glued to the guide wire 88 or,
alternatively, the balloon dilator 11 can be latched to
the guide wire 88 by clamping devices such as clips etc.
Turning again to the catching portion 3, in accordance
with an embodiment of the invention the catching portion
3 comprises a housing 18 with a preferably but not
necessarily cylindrical side wall 19 and a distal end
wall 20 which define together at least part of the
receiving space 9. The end wall 20 delimits the above
said access aperture 10 through which the inflatable
anchoring head 4 can be at least partially introduced
into the receiving space 9 and the edge of which
constricts the anchoring head 4 after it has been
expanded.
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In accordance with an embodiment, the end wall 20 has an
internal locking surface 21 which faces into the
receiving space 9 and which is substantially
perpendicular to the direction of insertion (X) of the
5 anchoring head 4 or defines a circumferential shoulder
inclined towards the inside of the receiving space 9 so
that it locks the partially introduced, expanded and
constricted anchoring head 4 in order to prevent
slippage of the latter once it undergoes traction
10 forces.
In accordance with an embodiment, the internal locking
surface 21 defines an undercut for preventing the
insufflated anchoring head 4 from slipping out of
engagement with the catching portion 3.
15 Preferably, an external surface 22 of the distal end
wall 20 defines a guide for facilitating the insertion
of the anchoring head 4 into the anchoring seat 8.
Detailed description of embodiments of the anastomotic
ring applier system
20 In accordance with the embodiment illustrated in Figs. 1
to 9, (the terms "proximal" and "distal refer to the
surgeons point of view), the first portion 42 of the
approximation device 37 is embodied as a rotor assembly
50 with an externally threaded outer housing 51 which
25 defines a distal opening 52 and a proximal connecting
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26
portion 53. A torque connector 54 connects a torsional
cable or rotary rod 55 to the proximal connecting
portion 53. The torsional cable or rotary rod 55 can be
passed through a working channel of an endoscope (e.g.
gastroscope, not illustrated) and has a proximal end
extending outside the patients body where an appropriate
torque and rotary movement can be applied to it by the
surgeon. The torque connector 54 can comprise a
connecting cap or plug (Fig. 2, 3) connected by radial
connecting pins 56 to a tubular ring wall 57 of the
outer housing 51 so that it can transmit torque and
(possibly but not necessarily) traction from the
torsional cable or rotary rod 55 to the threaded outer
housing 51.
In this embodiment, the catching portion 3 of the
coupling device 1 is arranged inside the outer housing
51 and free to rotate with respect to the latter. The
access aperture 10 of the catching portion 3 is arranged
in alignment with a distal end surface and preferably
coaxial to the distal opening 52 of the outer housing
51.
In order to facilitate the free rotation of the outer
housing 51 of the rotor assembly with respect to the
catching portion 3 and, hence, with respect to the
trapped anchoring head 4 of the coupling device 1, a
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27
rotational bearing 58 can be interposed between the
outer housing 51 and the catching portion 3.
In accordance with an embodiment, the access aperture 10
of the catching portion 3 is defined by a short tubular,
preferably cylindrical collar having a diameter which is
smaller than the diameter or transversal extension of
the receiving space 9. The tubular collar has an outer
cylindrical surface which engages an internal surface of
the rotational bearing 58 which, in turn, is connected
to the outer housing 51 near its distal opening 52
(compare Figs. 1 and 3).
In this embodiment, the second portion 43 of the ring
approximation device 37 is embodied as a jackscrew
device 59. The jackscrew device 59 comprises a tubular
support structure 60, e.g. a rigid or at least partially
flexible tube, with a proximal grounding portion 61, a
distal ring connector portion 64 and an internal thread
48 which is configured to mesh with the external thread
47 of the rotor assembly 50.
The grounding portion 61 is adapted to connect the
support structure 60 to an endoscope (e.g. gastroscope
not illustrated in the figures) so that the endoscope
can transmit push and/or pull forces and torque to the
support structure 60. Alternatively, the support
structure 60 can extend outside the body of the patient
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and the grounding portion 61 can be extracorporeally
torsionally and axially held or grounded.
The distal ring connector portion 64 is configured to
hold the second (e.g. gastric) compression ring 39, e.g.
through a snap-fit, press-fit or friction-fit action
which can be provided by a crown of elastic teeth, as
has been illustrated in Fig. 4 and 7.
The coupling device 1 makes it possible to firmly couple
the rotor assembly 50 to the first ring carrier device
33 by partially inserting and subsequently insufflating
the anchoring head 4 inside the catching portion 3 and
contemporaneously providing both a tissue widening means
and a cylindrical guide (expanded anchoring head -
balloon dilator 11) for the compression rings during
approximation and snap-connection. After having coupled
the first ring carrier means to the rotor assembly, a
rotary movement of the torque cable can rotate the outer
housing of the rotor assembly with respect to the
axially and torsionally locked support structure 60,
thereby causing the rotor assembly 50 together with the
catching portion 3 to translate and, hence, to
approximate and interconnect the anastomotic compression
rings 36, 39.
In accordance with a further embodiment, the tubular
support structure 60 is at least partially, preferably
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completely transparent in order to enable a
visualization by the endoscope (e.g. gastroscope) also
across the tubular wall of the support structure.
For the sake of completeness of disclosure and with
reference to figure 6, an illustrative embodiment of an
anastomotic ring device and locking device will be
described, which can be deployed by means of the
anastomotic applier according to the invention.
Figure 6 is a perspective view of an anastomotic ring
device with the first (jejunal) ring 36 and the second
(gastric) ring 39 which is not only but particularly
adapted to perform a gastro-jejunostomy according to the
previously described method. The first compression ring
36 (or "bowel ring" or "intestinal ring" 36) is adapted
to bear against the first tissue portion 45 (jejunal
tissue), while the second compression ring 39 (or
"gastric ring" 39) is adapted to bear against the second
tissue portion 44 (gastric tissue) opposite the first
tissue portion 45 and the first ring 36.
The first and second rings 36, 39 are adapted to be
latched together in at least one, preferably two or more
locking positions corresponding to different compression
rates acting on the tissue portions 44, 45 clamped
between the rings.
Both the first 36 and second compression ring 39 have a
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preferably closed circular annular shape (Fig. 11, 12)
in order to enable their mutual alignment and connection
independently from their relative angular position.
The pressure surfaces of the first and second rings 36,
5 39 destined to contact and clamp the first and second
tissue portions 45, 44 are substantially plane or
circumferentially wavy in order to increase the
circumference of the anastomotic lumen with respect to
the external ring circumference (not shown in the
10 figures). Advantageously, the pressure surfaces are
roughened or locally profiled in order to prevent the
tissue 45, 44 to squeeze radially out of the ring device
in response to the axial pressure.
In accordance with a preferred embodiment, the second
15 compression ring 39 (gastric ring) comprises a shape or
a specific interaction portion suitable to be engaged
(e.g. by snap-fit, friction-fit, shape-fit or press-fit)
by the second ring carrier 38.
Both compression rings are made advantageously partially
20 or completely of bio-absorbable or bio- fragmentable
material.
In order to provide an additional fixation of the tissue
portions to the compression rings 36, 39 to prevent the
tissue from slipping out of engagement with the ring
25 device, a group of needles 81 or staples is provided
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which is anchored in at least one of the compression
rings and adapted to pierce through the tissue clamped
therebetween.
The needles 81 can be directly fixed to a compression
ring or to a ring locking device 82 or, as shown in
figure 11, the group of needles 81 comprise a self
supporting needle ring 83 which can be e.g. received by
an apposite seat defined at the locking device 82 in
order to anchor the needles 81 reliably to the ring
device during and after its deployment.
Both the needles and the needle ring are advantageously
but not necessarily made of bio-absorbable or bio-
fragmentable material.
Turning now to the locking device itself, in accordance
with an embodiment (e.g. fig. 6, Fig. 7), the locking
device 82 comprises an annular proximal shoulder 84 with
a distal engaging surface 85 suitable to engage the
proximal end surface of the first (jejunal) compression
ring 36 and a tubular longitudinal portion 86 which
protrudes distally from the proximal shoulder 84. The
longitudinal portion 86 has a shape adapted to be
inserted through the central openings of both the first
and second compression rings 36, 39 and forms one or
more elastically supported snapper teeth 87 adapted to
snap engage a corresponding edge or surface of the
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second (gastric) compression ring 39 (in the description
of the locking device 82 the terms "proximal" and
"distal" are referred to the direction of deployment).
The provision of a distinct locking device allows the
compression rings to be designed specifically to meet
the requirements of the delivery and anastomosis,
thereby avoiding compromises between these requirements
and those of the connection of the compression rings.
The tubular shape of the locking device 82 stabilizes
the shape of the anastomotic lumen and provides a
protective lining which isolates the tissue portions 45,
44 clamped between the compression rings from fluids and
contents passing through the anastomotic lumen at least
during the period of wound healing.
The locking device 82 is made advantageously partially
or completely of bio-absorbable or bio-fragmentable
material.
As can be appreciated from the foregoing description,
the anastomotic ring applier system 30 has many
advantages. Its coupling device allows to couple and
uncouple the first ring carrier device with respect to
the second ring carrier device endoluminally at or near
the operational site and the screw drive approximating
device allows to approximate the compression rings in a
well controllable manner without any need to apply the
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push-pull forces from outside the body of the patient
along the entire instrument path up to the anastomotic
rings. Furthermore, the expandable anchoring head of the
coupling device can act at the same time as tissue
widening device and as guide device for the compression
rings.
Although preferred embodiments of the invention have
been described in detail, it is not the intention of the
applicant to limit the scope of the claims to such
particular embodiment, but to cover all modifications
and alternative constructions falling within the scope
of the invention.
