CA2685772A1 - A coupling device for performing endoluminal and/or transluminal surgery - Google Patents

Abstract

A coupling device (1) for coupling a first surgical device to a second surgical device comprises a coupling portion (2) connectable to the first surgical device and comprising an inflatable anchoring head (4), a catching portion (3) connectable to the second surgical device and defining 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) is insertable into the receiving space (9), an activating device (6) connected to the anchoring head (4) and configured to deform the anchoring head (4) such that it can take on an expanded configuration and a retracted configuration. 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.

Description

"A COUPLING DEVICE FOR PERFORMING ENDOLUMINAL AND/OR
TRANSLUMINAL SURGERY"

DESCRIPTION
The present invention relates, in general, to devices and methods for surgically modifying organs and vessels and more particularly to a surgical coupling device and method for performing an endoluminal and or transluminal surgery, e.g. an 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 surgery, e.g. 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 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 surgery in general and to anastomosis in particular 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 exclude operative and post operative complications.

One of the weaknesses of the endoscopic and endoluminal surgery is the coupling of surgical devices and instruments inside the body of the patient. Such a coupling of instruments can be e.g. desirable during the creation of a guide wire loop across natural ducts in order to transport instruments to the operational site and to enable the surgeon to apply reciprocal forces to devices, e.g. to compression rings in order to perform an anastomosis.

The importance of reliable and simple coupling systems becomes even more evident if one considers that endoscopic and endoluminal surgery involves very often balloon catheters and balloon dilators whose flexibility allows generally an easy access to most of the anatomic structures but makes it difficult to connect to other instruments and to transmit push-pull forces.

The object of the present invention is therefore to provide a reliable and preferably releasable coupling device which can be used also in connection with balloon dilators and which can be both engaged and disengaged inside the body of the patient during a surgical intervention.

A further object of the invention is to provide a surgical method for performing an endoluminal or transluminal anastomosis, particularly of the digestive tract, by an endoluminal or endoscopic approach which involves the use of the surgical coupling device.

These and other objects are achieved by a surgical coupling device 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 perspective view of an inflatable coupling portion of a coupling device in a disengaged configuration according to an embodiment of the invention;

- Figure 2 is a perspective view of a catching portion of the coupling device in a disengaged configuration according to an embodiment of the invention;

- Figure 3 is a perspective, sectioned view of the coupling device in an engaged configuration;

- Figure 4 is a sectioned view of a catching portion of the coupling device according to a further embodiment of the invention;

- Figure 5 is a sectioned view of a catching portion of the coupling device according to a further embodiment of the invention;

- Figure 6 is a sectioned view of the coupling device implemented in an endoluminal anastomotic ring applier according to an embodiment of the invention;

- Figure 7 is a perspective view of a detail of the endoluminal anastomotic ring applier in figure 6;

- Figure 8 is a sectioned view of the detail in figure 7;

- Figure 9 is a perspective view of a further detail of the endoluminal anastomotic ring applier in figure 6;

- Figure 10 is a perspective view of the inflatable coupling portion of the coupling device implemented in an endoluminal anastomotic ring carrier device according to an embodiment of the invention;

- Figure 11 is a perspective view of an anastomotic compression ring device intended to be deployed by means of an anastomotic applier coupled by the coupling device 5 according to the invention;

- Figures 12, 13 and 14 illustrate a series of steps of a method for performing a transluminal anastomosis by means of a compression ring deployment system in figures 6 to 11 and the coupling device according to the invention;

- Figure 15 is a perspective view of the coupling device implemented in an endoluminal anastomotic ring applier according to a further embodiment of the invention;

- Figure 16 is a sectioned view of a portion of the endoluminal anastomotic ring applier in figure 15;

- Figure 17 is a sectioned view of a detail of the endoluminal anastomotic ring applier in figure 15;

- Figure 18 is a sectioned perspective view of a further detail of the endoluminal anastomotic ring applier in figure 15;

- Figures 19, 20 and 21 illustrate a series of steps of a method for performing a transluminal anastomosis by means of the compression ring deployment system in figures 15 to 18 and the coupling device according to the invention;

- Figure 22 is a schematic illustration of the general functional units of an anastomotic compression ring deployment system;

- Figure 23 illustrates a creation of a guide wire loop during in preparation of an anastomosis (gastro-jejunostomy);

- Figure 24 illustrates a creation of an anastomosis (gastro-jejunostomy);

Turning to the figures, a coupling device for coupling a first surgical device to a second surgical device during endoluminal and transluminal surgery is denoted by reference numeral 1. 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 surgical device 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. 1) and a retracted configuration (fig. 10).

The catching portion 3 comprises a second connector 58, 7 for connecting the catching portion 3 to the second surgical device which is intended to be coupled with the first surgical device. 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 and an access aperture 10 through which the anchoring head 4 can be inserted from 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 a 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 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.

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 5 of the coupling portion 2 comprises a longitudinal channel 17 which is configured to receive for instance a guide wire 88 of the first surgical device. 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.

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 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 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.

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.

In accordance with an embodiment, the external surface 22 is substantially funnel shaped around the preferably circular central access aperture 10 and its radially internal edge forms a constriction portion 23 which is narrower than the receiving space 9.

In a radial cross-section the external surface 22 has preferably a double curvature with a concave portion 24 near the outer circumference and a convex portion 25 5 near the constriction portion 23, so that the external surface 22 converges at least approximately to a longitudinal direction parallel to the insertion direction X both approaching the outer circumference and the constriction edge 23 (Fig. 5).

10 This particular shape of the external surface 22 makes it possible that the housing of the catching portion 3 together with the portion of the insufflated balloon dilator 11 which protrudes outside the catching portion 3 (dashed line in figure 5) defines a approximately continuous cylindrical guide body for e.g. a guided approximation of anastomotic compression rings.

As is the case with the coupling portion 2, also the catching portion 3 is connected or connectable to a surgical device or instrument.

In accordance with an embodiment, the housing of the catching portion 3 comprises or forms portions which enable the catching portion 3 to be snap connected, friction connected, interference connected or shape connected to the second surgical instrument, for instance a crown of elastic snapper teeth 26 formed at a proximal end of the catching portion 3 and configured to connect the catching portion to a visualization device such as a gastroscope 89 (Fig. 2).

In accordance with one embodiment, the catching portion can be partially housed or encapsulated within the surgical device intended to be coupled to another instrument.

In accordance with a further embodiment, the catching portion 3 is at least partially transparent in order to enable visualization by means of a visualization device (e.g. endoscope, laparoscope) from inside or outside the catching portion 3 across its transparent housing.
Specific advantages of the above described features will become apparent from the following description of exemplary embodiment applications of the coupling device in an endoluminal anastomosis procedure.

For the sake of clarity and for better evidencing the technical effect of the features of the surgical coupling device and its interaction with the particular environment of application, the detailed description of embodiment applications will first deal with a surgical method thought up by the inventors and subsequently describe the anastomotic device and surgical instruments for carrying out the method.

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 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, - Connecting the first and second rings 36, 39, thereby clamping the first and second tissue portions between them, - Widening the tissue internally overhanging the anastomotic ring device to open the anastomotic lumen, - 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, 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.
23 and 24).

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 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, 5 - 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 10 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 15 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 (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 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 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 protective or guiding tube might be pushed through the patients mouth down the esophagus into the stomach and the insertion device can be advantageously guided inside the protective or guiding 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 outside the body of the patient.

- Extracorporeal attachment of the carrier member (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 means. The carrier member 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.

- Subsequently, approximating the proximal tissue portion 45 (e.g. intestinal tissue) 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, 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 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 5 compression ring proximally in engagement with the proximal compression ring. To this end, the anastomotic device includes the coupling device 1 according to the present invention and an approximation device 37. In this way it is possible to couple (preferably in or near 10 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) in order to apply a reciprocal pushing or pulling force on the compression rings.

15 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.
Advantageously, one of the compression rings is firstly 20 pushed against the other compression ring and successively the locking device is pushed in connecting engagement with both the compression rings to connect them.

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 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 ring and the distinct locking device (and, if provided, the needle group) are fixed to the proximal ring carrier device and transported to the anastomotic site and in engagement with the distal compression ring.

Widening the tissue at the anastomotic site 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 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 the same balloon dilator 11 which acts as expandable anchoring head 4 of the coupling device 1. 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 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 anchoring head and the catching portion.

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 catching portion 3. The anastomotic applier with the catching portion 3 are withdrawn from the body of the patient. Also the carrier member with the coupling portion 2 are detached from the proximal first compression ring and removed, 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 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.

Turning now again to the surgical coupling device 1 according to the invention, when implemented or incorporated in an anastomotic applier and used during 5 an anastomosis procedure as described above in general terms, such a coupling device can improve among others the ring approximation function, the ring guidance function and also the loop creation. This will become apparent from the following description of the surgical 10 instrumentation for performing the anastomosis by means of the coupling device according to the invention.
General description of the anastomotic ring applier system With reference to figure 22, an anastomotic ring applier 15 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 20 36 and connectable or connected to the guide wire device 88, preferably to a single guide wire, by means of a locking portion 35 which is configured to prevent the first (jejunal) compression ring 36 from sliding along the guide wire device in a direction opposite the ring 25 approximation direction.

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 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 fluid duct of the balloon dilator to its inflatable head.

According to an embodiment of the invention, 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 described below) by means of the surgical coupling device 1 (double dotted dashed line in figure 22) according to the invention.

The anastomotic applier 32 further comprises a second (gastric) ring carrier 38 adapted to hold a second 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 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 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 an embodiment, the inflatable anchoring head 4 of the coupling device 1, particularly the balloon dilator 11 has, in its expanded (insufflated) configuration an approximately cylindrical shape, except of the constriction caused by the access aperture 10 of the catching portion 3. Thanks to this feature, the anchoring head 4 is adapted not only to connect the first ring carrier device 31 to the anastomotic applier 32, but also to widen the anastomotic lumen in the tissue layers 44, 45 and to provide guidance for both compression rings 36, 39 during approximation and deployment.

Moreover, thanks to the fact that the coupling device 1 connects the first compression ring carrier device 31 and the anastomotic applier 32 at or near the anastomotic site, the ring approximation device 37 can be advantageously arranged inside the anastomotic applier 32, thereby obviating an extracorporeal guide wire pulling and counter-pushing with the anastomotic applier.

In accordance with an aspect of the invention, the ring approximation device 37 of the anastomotic applier 32 can be embodied as a guide wire pulling device, such as a guide wire slidably received in a working channel of an endoscope, e.g. a gastroscope, wherein the pulling action can be exerted either by pulling the guide wire with respect to the scope or by pulling the entire scope together with the guide wire and contemporaneously counter-pushing the support structure of the second ring carrier.

In this example, the second (gastric) ring carrier device 38 can be embodied by means of a ring connector portion which is arranged at a distal end (surgeons point of view) of a flexible tube, such as a gastric protection tube. The preferably transparent tube in turn defines an internal working space which can house the gastroscope. Alternatively, the second (gastric) ring carrier device 38 comprises a ring connector portion formed at or connected to a distal end portion of the gastroscope.

In both cases, the surgical coupling device 1 can be at least partially arranged within the second (gastric) ring carrier device 38.

In accordance with a further embodiment, 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.
In accordance with an embodiment (Figs. 6 to 14, 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 defines a distal opening 52 and a proximal connecting 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) and has a proximal end extending outside the patients body where an appropriate torque and rotary movement can be 5 applied to it by the surgeon. The torque connector 54 can comprise a connecting cap or plug (Fig. 7, 8) connected by radial connecting pins 56 to a tubular ring wall 57 of the outer housing 51 so that it can transmit torque and traction from the torsional cable or rotary 10 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 15 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 20 catching portion 3 and, hence, with respect to the trapped anchoring head 4 of the coupling device 1, a 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 25 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. 6 and 8).

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 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. 9 and 12.

The screw drive device 46 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 completely transparent in order to enable a visualization by the endoscope (e.g. gastroscope) also across the tubular wall of the support structure.

In accordance with a yet further embodiment, the ring approximation device 37 of the anastomotic applier 32 comprises a fluid pressure device 65. In this embodiment, the first portion 42 and the second portion 43 of the ring approximation device 37 are connected to one another by a piston-cylinder thrust unit 66. A
pressure chamber 67 of the piston-cylinder thrust unit 66 is connected through a fluid duct 68 with a fluid pump (not illustrated). In this way, operation of the fluid pump raises the fluid pressure inside the pressure chamber 67 and causes the first and second portions 42, 43 to translate to one another, thereby approximating 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 interconnecting the compression rings 36, 39.

In accordance with an embodiment (Figs. 15 to 21, 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 cylinder device 69. The cylinder device 69 forms a tubular support structure 70, e.g. a rigid or at least partially flexible tube, with a proximal grounding portion 71, the catching portion 3 of the coupling device 1 and a distal pressure chamber 67 in fluid communication with the fluid duct 68 and configured to slidably receive a piston portion 72 of the second portion 43 (which will be described below).
The grounding portion 71 is adapted to connect the support structure 70 to an endoscope (e.g. gastroscope not illustrated in the figures) so that the endoscope can transmit push and/or pull forces to the support structure 70. Alternatively, the support structure 70 can extend outside the body of the patient and the grounding portion 71 can be extracorporeally held or grounded.

As already described with reference to the embodiment of figures 9 and 12, the tubular support structure 70 can be at least partially, preferably completely transparent in order to enable a visualization by the endoscope (e.g. gastroscope) also across the tubular wall of the support structure.

The second portion 43 of the approximation device 37 is embodied as a piston device 73 (Figs. 16, 17).

The piston device 73 comprises a distal ring connector portion 74 and the above mentioned proximal piston portion 72.

The ring connector portion 74 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 snapper teeth, as has been illustrated in Fig. 15 and 17.

The piston portion 72 is slidably housed in the pressure chamber 67 of the cylinder device 69 so that a fluid pressure increase inside the pressure chamber 67 5 (generated by the fluid pump) causes the piston device 73 to translate with respect to the catching portion 3, thereby approximating the first and second ring carrier devices 33, 38.

In accordance with an embodiment, the pressure chamber 10 67 has a generally annular shape and is delimited by an outer tubular wall 75, an inner tubular wall 76 and a proximal base wall 77 which define a distally open cup shaped pressure chamber 67 in which the complementary shaped proximal tubular piston portion 72 of the piston 15 device 73 is slidably received to hermetically close the pressure chamber 67. Preferably but not necessarily, both the tubular walls 75, 76 and the tubular piston portion 72 have circular ring shaped cross sections.

In accordance with an embodiment, the proximal base wall 20 77 is embodied as a circular ring and defines a circumferential distally facing connecting slot 78 which receives a proximal ring shaped edge 79 of the catching portion 3 of the coupling device 1, so that the cylindrical side wall 19 (Fig. 5) of the catching 25 portion 3 acts as the above said inner tubular wall 76.

In this case, the catching portion 3 can be embodied as previously described with reference to fig. 5. This makes it possible to use the distal end portion of the catching device 3 together with the insufflated anchoring head 4 (balloon dilator 11) as a guide for the anastomotic rings during approximation and snap connection.

In order to enable a good visualization of the endoluminal coupling and anastomosis procedure, the catching portion 3 and particularly the receiving space 9 can be proximally open so that the partially introduced balloon dilator 11 can be directly visualized by the endoscope (e.g. gastroscope).

The fluid duct 68 which is not necessarily but preferably integrated in or arranged along a side wall of the tubular support structure 70 can be put in communication with the pressure chamber 67 by means of a passage 80 defined in the proximal base wall 77.

For the sake of completeness of disclosure and with reference to figure 11, an illustrative embodiment of an anastomotic ring device and locking device will be described, which can be deployed by means of the anastomotic applier comprising the coupling device according to the invention.

Figure 11 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 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, 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 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 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 advantageously at least partially made 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 device, a group of needles 81 or staples is provided 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. 11, Fig. 12), 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 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 5 during the period of wound healing.

The locking device 82 is advantageously at least partially made of bio-absorbable or bio- fragmentable material.

As can be appreciated from the foregoing description, 10 the surgical coupling device 1 and its embodiment applications in an anastomotic applier and in anastomotic ring approximating devices has many advantages. The coupling device allows to couple and uncouple surgical devices endoluminally and in 15 particular near the operational site. It can act at the same time as tissue widening device and as guide device, e.g. in endoluminal and transluminal anastomoses.
Although preferred embodiments of the invention have been described in detail, it is not the intention of the 20 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.

Claims (14)

1. A coupling device (1) for coupling a first surgical device to a second surgical device, e.g. during endoluminal surgery, comprising:

- a coupling portion (2) connectable to the first surgical device and comprising an inflatable anchoring head (4), - a catching portion (3) connectable to the second surgical device and defining 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) is insertable from outside the catching portion (3) into the receiving space (9), - an activating device (6) connected to the anchoring head (4) and configured to deform the anchoring head (4) such that it can take on an expanded configuration and a retracted configuration, wherein 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.

2. A coupling device (1) according to claim 1, wherein the anchoring head (4) comprises a balloon dilator (11) and the activating device (6) comprises a fluid pump device connected in fluid communication with the balloon dilator (11).

3. A coupling device (1) according to claim 1 or 2, wherein the anchoring head (4) can assume a substantially elongate filiform retracted shape and, if subject to fluid pressure, a substantially elongate cylindrical expanded shape.

4. A coupling device (1) according to any one of the preceding claims, wherein the anchoring head (4) has an internal inflatable chamber (14) defined by a flexible but inextensible wall (13) such that it can adapt to the shape of the anchoring seat (8) when it is only partially inserted into the receiving space (9).

5. A coupling device (1) according to any one of the preceding claims, wherein the coupling portion (2) comprises a longitudinal channel (17) which is configured to receive a guide wire (88) of the first surgical device.

6. A coupling device (1) according to any one of the preceding claims, wherein the catching portion (3) comprises a housing (18) with a cylindrical side wall (19) and a distal end wall (20) which define at least part of the receiving space (9), said end wall (20) delimiting said access aperture (10) the edge of which constricts the anchoring head (4) when it is expanded.

7. A coupling device (1) according to the preceding claim, in which the end wall (20) comprises an internal locking surface (21) facing into the receiving space (9) and substantially perpendicular to the direction of insertion (X) of the anchoring head (4).

8. A coupling device (1) according to claims 6 or 7, in which 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).

9. A coupling device (1) according to the preceding claim, in which the external surface (22) is substantially funnel shaped around a constriction portion (23) which is narrower than the receiving space (9).

10. A coupling device (1) according to any one of claims 7 to 9, wherein, in a radial cross-section, the external surface (22) has a double curvature with a concave portion (24) near an outer circumference and a convex portion (25) near the constriction portion (23), so that the external surface (22) converges at least approximately to a longitudinal direction parallel to the insertion direction both approaching the outer circumference and the constriction portion (23).

11. A coupling device (1) according to any one of the preceding claims, wherein the housing of the catching portion (3) together with the portion of the expanded anchoring head (4, 11) which protrudes outside the catching portion (3) define a approximately continuous cylindrical guide body.

12. A coupling device (1) according to any one of the preceding claims, comprising an approximating device 37 configured to move said previously coupled first and second surgical devices relative to one another.

13. A coupling device (1) according to the preceding claim, wherein said approximation device (37) comprises a screw drive device (46) comprising:

- a first portion (42) with a first thread 47 and a second portion (43) with a second thread (48) meshing the first thread (47), - a rotary device (49) suitable to rotate the first and second portions (42, 43) to one another such that said first surgical device translates relative to said second surgical device.

14. A coupling device (1) according to claim 12, wherein said approximation device (37) includes a fluid pressure device (65) comprising a first portion (42) and a second portion (43) connected to one another by a piston-cylinder thrust unit (66), wherein a pressure chamber (67) of the piston-cylinder thrust unit (66) is connected by a fluid duct (68) with a fluid pump so suitable to raise the fluid pressure inside the pressure chamber (67) such that said first surgical device translates relative to said second surgical device.