"A CONNECTOR FOR CONNECTING A CATHETER TO A HOLLOW ORGAN"

The present invention relates, in general, to devices and methods for surgically influencing the digestion of a patient with the aim to treat metabolic disorders, such as morbid obesity and related co-morbidities, such as diabetes, heart disease, stroke, pulmonary disease, and accidents.

Numerous non-operative therapies for morbid obesity have been tried in the past with virtually no permanent success.

Surgical methods of treating morbid obesity, such as open , laparoscopic and endoluminal gastric bypass surgery aiming to permanent malabsorption of the food, have been increasingly used with greater success. However, current methods for performing a gastric bypass involve time-consuming and highly dexterity dependent surgical techniques as well as significant and generally highly invasive modifications of the patients gastrointestinal anatomy. These procedures are reserved only for the severely obese patients because they have a number of significant complications, including the risk of death . In order to avoid the drawbacks of gastric bypass surgery and to influence the digestion of a patient in a more specific and aimed way, the present invention focuses on methods and devices for primarily influencing and modifying the entero-hepatic bile cycling rather than the digestive tract itself. To this end, the following possible approaches and mechanisms of action on the entero-hepatic bile cycling are contemplated:

- modification of the entero-hepatic bile cycling frequency, particularly bile cycle acceleration;

- modification of the physiological signaling triggered by the contact and interaction of the bile with the food in the intestine and by the contact of the bile with the intestinal wall;

- modification of the food absorbability by modifying the contact space and time between the bile and the food or chime in the intestine as well as by an aimed separation of the bile from the food.

A known minimally invasive bypass system and method for modifying the location at which bile and pancreatic secretions interact with nutrients in a gastrointestinal tract has been discussed in US 2005085787 A1 . The known conduit catheter extends inside the intestine and tend to bundle up and to be displaced by the peristalsis of the intestinal tract so that the distal end of the catheter is frequently relocated far away from the target position intended by the surgeon.

Moreover, in order to follow the winding path of the intestine, the known endoluminal conduit must have a significant length which undesirably increases the flow resistance and decreases the flow rate of the bile to the distal target location in the Gl tract. Accordingly, the known conduit is not suitable to obtain a significant acceleration of the bile cycling compared to the natural entero-hepatic bile cycling velocity.

In view of the drawbacks of the known art, an aim of the invention is to provide a connecting device for connecting a catheter or conduit to a hollow organ in order to enable a transluminal diversion of bodily fluid between two target locations which obviate undesired relocations of the conduit from the target locations.

A further object of the invention is to provide a connecting device which addresses the needs for easy installation also in very small spaces and which reduces the risk of trauma of neighboring tissue adjacent the connecting region of the catheter to the hollow organ.

A yet further object of the invention is to provide a connecting device for coupling a catheter to a hollow organ, in which the risk of obstruction of the catheter flow path is reduced.

A yet further object of the invention is to device a connector which occupies less space inside the hollow organ in order to reduce e.g. bowel obstruction.

At least part of the above identified aims are achieved by a connector for connecting a conduit to a hollow organ, the connector comprising:

- a first connecting portion with an annular first connecting seat adapted to receive an edge of a tissue wall of the hollow organ in a connection plane,

- a second connection portion defining a conduit axis and adapted to be coupled with a conduit end so that the conduit end is aligned parallel to the conduit axis,

- an internal channel extending from the second connecting portion to the first connecting portion to put the conduit end in flow communication with the hollow organ,

wherein the conduit axis is approximately parallel to the connection plane, i.e. the conduit axis and the connection plane include an angle of between 0° and 15°, preferably between 0° and 5° . Even more preferably, the conduit axis is substantially parallel to the connection plane.

In accordance with a further aspect of the invention, a connector for connecting a conduit to a hollow organ comprises:

- a tubular first connecting portion extending along a connection axis and having a distal aperture and a proximal aperture formed at opposite ends thereof:

- an annular distal connecting seat formed on the first connecting portion at the distal aperture and adapted to receive a peripheral edge of a distal tissue wall of a hollow organ stump,

- an annular proximal connecting seat formed on the first connecting portion at the proximal aperture and adapted to receive a peripheral edge of a proximal tissue wall of a hollow organ stump,

- a second connection portion defining a conduit axis and adapted to be coupled with a conduit end so that the conduit end extends along the conduit axis,

- an internal channel extending from the second connecting portion to the first connecting portion to put the conduit end in flow communication with the hollow organ. The conduit axis lays at least approximately, preferably substantially in a tangent plane to the first connection portion.

The tangent plane may be a tangent plane to a surface of a round cylinder generated about the connection axis and having a radius equal to the radial distance of the second connecting portion from the connection axis.

The conduit axis intersects (or, in other words, meets) the tangent plane at the second connection portion, defining an angle of from 0° to 15°, preferably between 0° to 5°, even more preferably an angle of 0° therebetween.

At least part of the above identified aims are also achieved by a method for connecting a conduit to a hollow organ, the method comprising the steps of:

- placing a connecting device and a conduit in the body of a patient, the connecting device having a first connecting portion adapted to be fixated to a section of tissue wall of a hollow organ, a second connection portion adapted to be coupled with a conduit end of the condu it and an internal channel extending from the first connecting portion to the second connecting portion to put the conduit end in flow communication with the hollow organ,

- connecting the first connecting portion of the connecting device to a selected target section of tissue wall of a hollow organ,

- connecting an end of the conduit to the second connecting portion of the connecting device such that said end of the cond uit extends in a direction approximately parallel to said target section of tissue wall, i.e. they include an angle of between 0° and 15°, preferably between 0° and 5°. Even more preferably, the target section of tissue wall and the conduit end direction are substantially parallel.

Thanks to the approximately parallel or tangential extension of the catheter end with respect to the tissue wall of the hollow organ, the connection requires very little space and doesn't involve cumbersome or excessively protruding parts which may cause trauma to neighboring tissue.

The conduit may comprise artificially grafted conduits, such as a catheter, or natural conduits, such as a section of a vein, a section of biliary duct or a section of small bowel. The hollow organ may include e.g. any organ of the Gl-tract or the gallbladder.

These and other aspects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof, which illustrate embodiments of the invention and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.

- Figure 1 illustrates a translumenal diversion of bile using a connection device, conduit and method for connecting a conduit to a hollow organ in accordance with embodiments of the invention;

- Figures 2 through 7 show longitudinal cross-sections of connection devices coupled to a conduit end and to a hollow organ in accordance with embodiments of the invention.

Referring to the drawings where like numerals denote like features throughout the several views, figure 1 is a partial view of the abdominal cavity of a patient, depicting the stomach 1 , duodenum 2, jejunum 3, ileum 4 and colon 5, as well as the biliary tree 7 with gall bladder 8, the pancreatic duct 9 and the mayor duodenal papilla of Vater 10 through which the bile and pancreatic fluid normally enter the duodenum 2. Figure 1 shows further a method and a device for diverting biliary fluid translumenally from a biliary fluid flow path, defined by the biliary tree 7 and the gallbladder 8, to a target location in the intestine distal of the papilla of Vater 10.

The target location of the intestine may be a portion of the small intestine, e.g. a distal portion of duodenum 2, a portion of jejunum 3 or ileum 4 or a portion of the large intestine 5, such as for example the transverse or sigmoid colon. A conduit 1 1 , e.g. an artificially grafted catheter or a tubular section grafted from natural tissue such as a vein or a portion of biliary duct, can be extended from the biliary fluid flow path to the target location of the Gl tract. A proximal end portion of the conduit 1 1 can be anchored inside the biliary tree 7, e.g. inside the common bile duct or connected to the gallbladder e.g. by means of a connector 12. Analogously a similar connector 12 may be used to connect a distal conduit end 19 of conduit 1 1 to the target location of the intestine.

In accordance with an embodiment (Figs. 2 to 5), the connector 12 comprises a first connecting portion 13 with an annular first connecting seat 14 adapted to receive an edge 15 of a tissue wall of the hollow organ 6 in a connection plane 16. The connector 12 comprises further a (preferably tubular) second connection portion 17 which defines a conduit axis 18 and which is adapted to be coupled with a conduit end 19 so that the conduit end 19 extends along the conduit axis 18. An internal channel 20 extends inside the connector 12 from an inlet at the second connecting portion 17 to an outlet 27 at the first connecting portion 13 to put the conduit end 19 in flow communication with the hollow organ 6. The conduit axis 18 is approximately parallel to the connection plane 16, i.e. the conduit axis 18 and the connection plane 16 include an angle of between 0° and 1 5° , preferably between 0° and 5°. Even more preferably, the conduit axis 18 is substantially parallel to the connection plane 16.

This provides an at least approximately parallel or tangential orientation of the conduit end 1 9 with respect to the tissue wall of the hollow organ 6, thereby reducing the space required by the connection and obviating cumbersome or excessively protruding parts which may cause trauma to neighboring tissue.

The first connecting portion 13 forms a distal wall 21 defining the outlet 27 of the internal channel 20 and arranged or exposed inside the hollow organ 6, and a proximal wall 22 arranged outside the hollow organ when the latter is attached to the first connecting seat 14. The second connecting portion 17 extends from the proximal wall 22 on a side opposite the distal wall 1 and is configured such that the conduit end 19 (fastened to the second connecting portion 17) remains outside the hollow organ 6. This obviates an undesired occupation of the internal space of the hollow organ 6 and reduces the risk of obstruction, particularly in the case of a connection of a catheter to the intestine.

In accordance with an exemplary embodiment, the first connecting seat 14 comprises an annular groove formed between the proximal wall 22 and the distal wall 21 of the first connecting portion 13 and which lays in the connecting plane 16. The edge 15 of an otomy performed in the hollow organ 6 can be inserted in the groove and circumferentially cinched and locked by means of a purse string suture. For this purpose, the groove may form a radially external guide portion 24 or flare with an outwardly enlarged cross-section that facilitates the insertion of the tissue wall and the placement of a cinching loop or purse string suture.

The coupling of the conduit end 19 with the second connecting portion 17 may be accomplished e.g. by inserting the conduit end 19 over the tubular connecting portion 17 or vice versa, screwing them to one another provided they are threaded, by insertion and additional gluing with an adhesive, by insertion of the conduit end 19 over the tubular connecting portion 17 and additional cinching with a tightening wire or suture, etc..

The second connecting portion 17 may be formed monolithically or, in other words, as a single piece with the first connecting portion 13. Alternatively, the second connecting portion 1 7 may be formed in an adapter piece 25 which can be reversibly or irreversibly coupled to the first connecting portion 13, e.g. by means of snap-on or press-fit connecting features. This allows to split the connection procedure in three distinct phases (connecting the conduit end to the second connecting portion of the adapter piece, connecting the first connecting portion to the hollow organ, connecting the adapter piece to the first connecting portion) which can be performed independently from one another and in any sequence deemed appropriate.

In accordance with an embodiment, the adapter piece 25 may be connectable to the first connecting portion 13 in different relative angular positions e.g. about an adjustment axis 42 normal to the connecting plane 16.. Similarly, the adapter piece 25 may be connected or connectable to the first connecting portion 13 such that they may rotate to each other to enable an angular adjustment therebetween e.g. about an adjustment axis 42 normal to the connecting plane 16.

In accordance with an embodiment (Figs. 3 - 5), the first connecting portion 13, particularly the distal wall 21 , forms a unilateral protection wall 26 on at least one leading side of the outlet 27 of the internal channel 20 in a manner to shield and protect the outlet 27 from contents flowing in the hollow organ 6 in a flow direction (arrow 28) parallel to the connection plane 16, while exposing the outlet 27 on an opposite trailing side thereof, such that fluids can exit the outlet 27 in the hollow organ 6 in the direction of flow 28. At the same time undesired backflow of contents from the hollow organ 6 in the internal channel 20 is prevented.

In accordance with a further embodiment (Figs. 4, 5), the unilateral protection wall 26 has a wall portion 29 which extends opposite the outlet 27 and at a certain distance thereof, thereby protecting and shielding the outlet 27 from contents flowing in the hollow organ 6 in a perpendicular direction to the connection plane 16. Advantageously, an outlet portion of the internal channel 20 defining the outlet 27 extends in an outlet direction 41 approximately parallel to the connection plane 16 and provides only one outlet aperture facing in an approximately parallel direction with respect to the connecting plane.

Figures 6 and 7 illustrate an alternative connector 30 which also implements many of the above described inventive concepts, but which is particularly adapted to be applied to two opposite stumps of a completely resected hollow organ, such as a resected section of small bowel. The connector 30 for connecting a conduit 1 1 to a hollow organ 6 comprises a tubular first connecting portion 31 extending along a connection axis 32 between a proximal open end 33 and a distal open end 34. The distal open end 34 of the first connecting portion 31 forms an annular distal connecting seat 35 adapted to receive a peripheral edge 36 of a distal tissue wall of a hollow organ stump 37. Similarly, the proximal open end 33 of the first connecting portion 31 forms an annular proximal connecting seat 38 adapted to receive a peripheral edge 39 of a proximal tissue wall of a hollow organ stump 40. In conformity with the previously described embodiments (Figs 2 through 5), the connector 30 in figures 6 and 7 comprises a (preferably tubular) second connection portion 17 which defines a conduit axis 18 and which is adapted to be coupled with a conduit end 19 so that the conduit end 19 extends along the conduit axis 18. An internal channel 20 extends inside the connector 30 from an inlet at the second connecting portion 17 to an outlet 27 at the first connecting portion 31 to put the conduit end 19 in flow communication with the hollow organ 6.

The conduit axis 1 8 lays at least approximately, preferably substantially in a tangent plane 47 to the first connection portion 31 .

The tangent plane 47 may be a tangent plane to a surface of a round cylinder 48 generated about the connection axis 32 and having a radius equal to the radial distance of the second connecting portion 17 from the connection axis 32. Expressed in more rigorous geometrical terms, the round cylinder 48 generated about the connection axis 32 has a radius equal to the smallest distance between the conduit axis 18 and the connection axis 32.

The conduit axis 18 intersects or meets the tangent plane 47 at the second connection portion 17, defining an angle of from 0° to 15°, preferably between 0° to 5°, even more preferably an angle of 0° therebetween.

As already evidenced in connection with the embodiments of figures 2 through 5, also the embodiments of figures 6 and 7 provide an at least approximately tangential extension of the conduit end 19 with respect to the hollow organ 6 and the tubular first connecting portion, thereby reducing the space required by the connection and obviating cumbersome or excessively protruding parts which may cause trauma to neighboring tissue.

The first connecting portion 31 forms a generally cylindrical side wall 43 with an internal surface 44 defining the outlet 27 of the internal channel 20 and arranged or exposed inside the hollow organ 6, and an external surface 45 facing towards the outside of the hollow organ 6 when both opposing stumps 37, 40 of it are attached to the distal and proximal connecting seats 35, 38. The second connecting portion 17 extends from the external surface 45 on a side opposite the internal surface 44 and is configured such that the conduit end 19 (fastened to the second connecting portion 17) remains outside the internal lumen formed by the hollow organ 6 together with the connector 30. This obviates an undesired occupation of the internal space of the hollow organ 6 and reduces the risk of obstruction, particularly in the case of a connection of a catheter to the intestine.

In accordance with an exemplary embodiment, any of the distal and proximal connecting seats 35, 38 may comprise an annular radially outward projecting retaining shoulder 46 or, alternatively, an annular groove, extending around a circumference of the side wall 43. Preferably, the annular shoulder 46 lays in a plane substantially perpendicular to the connection axis 32.

The edges 36, 39 of hollow organ stumps 37, 40 can be inserted over retaining shoulders 46 or grooves and circumferentially cinched and/or locked by means of a purse string suture.

The coupling of the conduit end 19 with the second connecting portion 17 may be accomplished as described in connection with the embodiments of Figs 2 to 5. The second connecting portion 17 may be formed monolithically or, in other words, as a single piece with the first connecting portion 31 . Alternatively, the second connecting portion 17 may be formed in an adapter piece 25 which can be reversibly or irreversibly coupled to the first connecting portion 31 , e.g. by means of snap-on or press-fit connecting features. This embodiment allows to split the connection procedure in three distinct phases (connecting the conduit end to the second connecting portion of the adapter piece, connecting the first connecting portion to the hollow organ, connecting the adapter piece to the first connecting portion) which can be performed independently from one another and in any sequence deemed appropriate.

The adapter piece 25 may be connectable to the first connecting portion 31 in different relative angular positions e.g. about an adjustment axis 42 with the only condition that the conduit axis 18 remains substantially in the tangent plane 47. Similarly, the adapter piece 25 may be connected or connectable to the first connecting portion 13 such that they may rotate to each other to enable an angular adjustment therebetween while the conduit axis 18 remains substantially in the tangent plane 47.

The first connecting portion 31 , particularly the internal surface 44, forms a unilateral protection wall 26 on at least one leading side of the outlet 27 of the internal channel 20 in a manner to shield and protect the outlet 27 from contents flowing in the hollow organ 6 i n a flow d irection (arrow 28) paral lel to the connection axis 32, while exposing the outlet 27 on an opposite trailing side thereof, such that fluids can exit the outlet 27 in the hollow organ 6 in the direction of flow 28 but undesired backflow of contents from the hollow organ 6 in the internal channel 20 is prevented. The unilateral protection wall 26 has a wall portion 29 which extends opposite the outlet 27 and at a certain distance thereof, thereby protecting and shielding the outlet 27 from contents flowing in the hollow organ 6 in a perpendicular direction to the connection plane 16.

In accordance with a yet further embodiment, the unilateral protection wall 26 forms a circumferentially extending annular leading wall portion 49 and an axially extending tubular wall section 50 which define together with the internal surface 44 a ring space 51 closed towards a leading side (against the direction of flow of e.g. intestinal contents) and on a radially internal side, but open on a trailing side (e.g. in an intestinal flow direction) of the outlet 27.

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 embodiments, but to cover all modifications and alternative constructions falling within the scope of the invention.