EP4304493A1

EP4304493A1 - Ancillary device and kit for anastomosis

Info

Publication number: EP4304493A1
Application number: EP22792803.3A
Authority: EP
Inventors: Salam Abou Taam
Original assignee: Easy Vascular Cure
Current assignee: Easy Vascular Cure
Priority date: 2021-09-21
Filing date: 2022-09-21
Publication date: 2024-01-17
Also published as: EP4151161A1; WO2023046759A1; CA3232678A1

Abstract

The present invention relates to an ancillary device capable of assisting the two anastomosis procedures necessary for replacing a segment of a corporeal duct with a prosthesis, and the joining of said prosthesis without the need for sutures. The invention also relates to an optimised kit for anastomosis comprising said ancillary device. In particular, the invention proposes an ancillary device (100) for anastomosis, said device (100) comprising an elongate body provided with a longitudinal through-channel (12) intended to receive a tubular prosthesis (3) inside of same, the body of the device comprising, on a proximal side, a handling portion (10) and, on a distal side, a shaping assembly (20) formed by a plurality of lamellae (22) defining a compression zone (21) of said prosthesis, characterised in that: - the body of the device comprises a reclosable longitudinal opening providing access to the longitudinal channel (12) intended for receiving said prosthesis (3).

Description

ANCILLARY DEVICE AND ANASTOMOSIS KIT

Field of invention

The present invention relates to the field of anastomosis intervention aid devices. More particularly, the invention relates to an ancillary device for placing a connection assembly in a bodily conduit for producing a suture between two extracorporeal and bodily conduits. The invention also relates to a kit comprising said ancillary device and at least one connection assembly comprising a radial enlargement sleeve with spikes and an inflation balloon.

State of the art

An anastomosis refers in the present invention to a connection between two tubular body structures, such as blood vessels, bronchi or segments of intestine. Anastomoses are very common to remedy vascular problems, for example to treat a thrombosed or aneurysmal artery by cutting and removing its pathological part, and then reconnecting the two segments of the artery by means of a prosthesis.

To reconnect the vessel segments, it is known practice to perform a surgical manual suture. This type of anastomosis, which is the most common in vascular surgery, makes it possible to respond to the majority of clinical situations involving arterial repair. However, it is observed that the operating time required to perform such a manual suture is relatively long. However, during a vascular repair for example, the anastomosis requires vascular clamping to avoid any bleeding. The duration of this clamping on the one hand, constitutes a cardiac stress test for the patient which can lead to a coronary syndrome and on the other hand, generates an ischemia of the tissues vascularized by the downstream arterial axis.

In addition, such a manual intervention imposes wide accessibility so that the practitioner can carry out the operative gestures necessary for connecting the two segments together. This accessibility is as decisive as the dexterity of the practitioner in the proper accomplishment of the suture.

However, such accessibility can only be obtained through a large exposed operating surface, which leads, for example, in the context of aortic surgery, to negative repercussions on post-operative pain, resumption of intestinal transit, pneumonia, coronary artery disease and length of hospital stay. Conventional surgery by mini-approach, as well as laparoscopic aortic surgery, make it possible to resolve such inconveniences and reduce the repercussions for the patient. Nevertheless, conventional surgery by mini-approach and laparoscopic aortic surgery offer reduced accessibility conditions, making it difficult to perform the surgical gestures necessary for vascular suturing by removing a section of the vessel and connecting the two ends produced using of a prosthesis.

In order to substitute this manual suture, it is known to use a very specific stent (or connector) in terms of design and function, which comes in the form of an expandable metal sleeve with barbs on its outer surface. This spiked stent is mounted on an inflation balloon and introduced at one end of the prosthesis to be connected with the body conduit. When the end of the prosthesis is inserted into the conduit, the balloon is inflated so as to increase the diameter of the sleeve, the pins thus perforate the prosthesis and the body conduit to ensure the connection between these two elements.

This connection technique is very advantageous but poses some problems in practice, in particular for positioning the spiked stent in the prosthesis and the body conduit. Patent EP 2638 869 B1 proposes an ancillary device specially designed to facilitate anastomosis using a spiked stent and an inflation balloon. In particular, this document proposes an ancillary device comprising a hollow tubular body comprising a handling part and a shaping assembly, said body comprising a through orifice into which said prosthesis is inserted with the spiked stent mounted on the balloon. The conformation assembly makes it possible to compress the prosthesis sufficiently to allow its insertion into the body canal, while limiting said compression so as not to damage the pimples or the prosthesis before the inflation step. This document also suggests using a protective wrap around the spiked stent. The stent and the prosthesis are thus protected during its manipulation until its insertion into the body canal. Of course, the envelope must be removed before the inflation step.

In practice, said ancillary device is very advantageous for assisting with the fitting of the prosthesis and of the spiked stent during the first anastomosis. However, this device is unsuitable for assisting the second anastomosis. That is to say, when a segment of a body conduit is replaced by a prosthesis, the complete replacement procedure requires two connections, a first anastomosis to connect one end of the prosthesis to the so-called "high" end of the body conduit, and a second anastomosis to connect the so-called "low" end of the body conduit and the other end of the prosthesis. The inconvenience of said ancillary device of the state of the art is therefore not to be able to assist in the second anastomosis.

Indeed, a segment to be replaced of the body conduit, and therefore of the prosthesis, often has a limited length sometimes of the order of two centimeters. Once the first anastomosis is made, the length of the free segment of the prosthesis is very limited. On the other hand, the body of the ancillary device has a length of about 20 cm, and the prosthesis is introduced into said device through an inlet opposite to the compression zone of the prosthesis and from which said prosthesis is introduced into the conduit. It is therefore not possible to introduce the second end of the prosthesis all along the ancillary device, and as far as said compression zone. In addition, certain difficulties are observed in properly positioning the balloon with the stent in the ancillary device, and in removing the protective envelope from the balloon.

Disclosure of Invention

The object of the present invention is to provide an ancillary device capable of assisting the two anastomosis procedures necessary to replace a segment of the body conduit with a prosthesis, and the connection of said prosthesis without the need for sutures. The invention also relates to an optimized kit for anastomosis comprising said ancillary device.

To this end, the invention proposes an ancillary device for anastomosis, said device comprising an elongated body provided with a longitudinal and crossing channel intended to receive inside it a tubular prosthesis, the body of the device comprising on a proximal side a part of manipulation] formed by a hollow envelope, preferably of tubular shape and on a distal side a shaping assembly formed by a plurality of lamellae defining a compression zone of said prosthesis, characterized in that:

- the body of the device comprises a closable longitudinal opening giving access to the longitudinal channel at the level of said manipulation part and of the shaping assembly.

Advantageously, the longitudinal opening makes it possible to provide access to the channel of the device, and therefore to precisely position the prosthesis at the level of the conformation assembly, in particular when the length of the prosthesis is insufficient to maneuver said prosthesis after the first anastomosis. . In addition, this resealable opening makes it easy to disengage the ancillary device following insertion of the second end of the prosthesis into the body conduit, during the second anastomosis.

In a non-limiting embodiment, the ancillary device may also include the following technical characteristics in any technically operable combination:

- the longitudinal opening is configured as a hinged opening opening said body in two parts, and preferably in two symmetrical parts;

- the longitudinal opening is configured as an opening opening in two parts said body, and in which the two parts are assembled together by means of at least one rail and one groove cooperating with each other and being provided respectively on each of the two parts along the body of the handling part - the device comprises an open configuration, and a closed configuration defined respectively by the opening or the closing of said longitudinal opening, and a locking means of said closed configuration;

- the device comprises an open configuration, and a closed configuration controllable by the engagement and disengagement of the rail in the groove, and preferably a locking means of said closed configuration;

- the slats of the shaping assembly are arranged circumferentially and at predefined intervals around the manipulation part and along a longitudinal axis of the device, and in which device the slats comprise a released position and a tight position respectively defining a initial diameter and a reduced diameter of the channel receiving the prosthesis at said compression zone;

- the handling part comprises one or more projecting parts at a junction zone with the slats of the shaping assembly, said projecting part making it possible to compress the slats radially when it is pushed towards the inside of the device ;

- the device comprises an outer ring movable in translation along the body of the device, said ring being able to engage on the projecting part(s) to activate the closed position of the slats. This movable outer ring also makes it possible to secure the two symmetrical parts of the body in the closed position;

- said device comprises an actuating means configured to radially compress said slats and activate their clamped position, such as said outer ring;

The invention also relates to a kit for anastomosis optimized to cooperate with the ancillary device of the invention, said kit comprising:

- an ancillary device according to one of the preceding claims;

- a connection assembly comprising at least one radial widening sleeve with pins and an inflation balloon; and preferably

- a prosthesis or vascular substitute.

In one embodiment, the kit comprises an insertion guidance system comprising a set of stop elements on the body of the ancillary device and on the connection assembly, configured and arranged to limit the insertion depth of the connecting assembly in the channel of the ancillary device.

In one embodiment, the inflation balloon includes a catheter for connecting said balloon to an inflation syringe, and said catheter includes one or more fins configured to anchor to the body of the ancillary device or to the prosthesis, and limit a depth of insertion of said inflation balloon in the channel of the ancillary device. Preferably, the wings comprise peripheral hooks configured to hook onto a proximal end of the handling part of the ancillary device. Preferably, the fins are movable in translation along the catheter and comprise a locked configuration and an unlocked configuration, respectively limiting or allowing mobility of the fins.

In one embodiment, the kit includes a peelable or severable protective envelope surrounding the spiked radial expansion sleeve. To this end, the envelope has at least one peelable or divisible longitudinal axis.

Finally, the kit also comprises a diameter tester comprising at least one tubular body of predefined diameter connected to a handle, and preferably a plurality of tubular bodies respectively connected to a handle. Said tubular bodies being intended to be introduced into a body conduit to determine a diameter of the prosthesis to be inserted, said diameter being identified when one of said tubular bodies is introduced into the body conduit with a limited clearance.

Brief description of the drawings

The invention will be better understood on reading the following description and on examining the accompanying figures. These are presented for information only and in no way limit the invention.

Fig. 1 An example of an anastomosis kit comprising an ancillary device according to the invention

Fig. 2 A schematic representation of the relaxed position (detail a) and the tightened position (detail b) of the conformation assembly of the ancillary device of the invention.

Fig. 3 A schematic representation of the removal of the ancillary device after the first anastomosis.

Fig.4 A schematic representation of the ancillary device of the invention in the open configuration and of the reception of the prosthesis after the first anastomosis.

Fig.5 A schematic representation of the ancillary device of the invention in open configuration and of a variant for receiving the prosthesis after the first anastomosis.

Fig.6 A schematic representation of the radial enlargement of a pin stent in a body conduit.

Fig. 7 A schematic representation of the inflation balloon provided with a stopper element of the anastomosis kit according to the invention.

Fig. 8 A schematic representation of the kit of the invention showing the protective envelope inserted into the channel of the ancillary device

Fig. 9 A schematic representation of a diameter tester of the invention kit.

Fig. 10 A schematic representation of a cross-section of the handling part according to one embodiment of the invention.

The present invention relates to a device for aiding the placement of a prosthesis in a body conduit, said device being referred to as an ancillary device in the present invention. In particular, the object of the invention is to propose an ancillary device configured to assist in the fitting of two opposite ends of a prosthesis and their junction with a body conduit. The invention also relates to a sutureless anastomosis kit comprising said ancillary device.

Figure 1 illustrates from left to right, a connection assembly 4 (detail not visible), a prosthesis 3, and the ancillary device 100 of the invention in a closed configuration.

The ancillary device 100 is a tool allowing manipulation of the prosthesis 3 in complete safety, as well as facilitating its connection to the body conduit by means of the connection assembly 4.

The ancillary device 100 comprises an elongated body comprising on a proximal side a manipulation part 10, and on another distal side a shaping assembly 20 provided with a compression zone 21 at a distal end of the device. The body of the device also comprises a longitudinal channel, intended to receive the prosthesis 3, and passing through said manipulation part and the shaping assembly. In the illustrated embodiment, the manipulation part 10 is presented as a hollow tubular envelope, the hollow interior of its body defining the channel at the level of said manipulation part. The prosthesis is in particular inserted into the channel of the device from a side inlet 11 of the handling part 10 and until one end of the prosthesis 3 is positioned at the level of said compression zone 21, the latter having a diameter of linear channel of decreasing diameter according to the actuation of the shaping assembly to compress said prosthesis until a predefined reduced diameter is obtained. Alternatively, the prosthesis can be introduced from the compression zone as will be detailed later in the text.

In particular, the conformation assembly 20 makes it possible to pinch one end of the prosthesis 3 to compress it radially and facilitate its insertion into the conduit 30 of the body. To this end, the shaping assembly comprises a plurality of strips 22 arranged circumferentially around the handling part 10 and along a longitudinal axis of the device. Said slats 22 extend the tubular body of the handling part 10 and make it possible to define the through channel at the level of the shaping assembly 20. As illustrated in FIG. 2, the slats are arranged at regular intervals, leaving empty spaces between the slats.

The shaping assembly 20 comprises a relaxed position (FIG. 2, detail a) and a tight position (FIG. 2, detail b). In the relaxed position, the lamellae 22 define the diameter of the channel 12 making it possible to easily insert the prosthesis up to the compression zone 21. In the tight position, the lamellae 22 are tightened, and the diameter of the channel is reduced, in particular at the compression zone, so that the inner lamella walls compress the prosthesis. Preferably, the diameter of the transverse channel is constant at the compression zone 21 and so as to allow uniform compression of the prosthesis in this zone. The diameter of the channel 12 passing through the rest of the device is greater than a diameter of the prosthesis, thus achieving a abutment preventing the device from being introduced too far into the body conduit so that the assembly is introduced without damaging or compressing said body conduit. The dimensions of the ancillary device 100 are therefore dependent on the dimensions of the prostheses to be used, and the same device can be produced with a range of different sizes. In a preferred embodiment, the lamellae give an elongated frustoconical shape to the shaping assembly 20, and have a triangular shape before being flat at the level of the compression zone.

According to the illustrated embodiment, the ancillary device 100 comprises an outer ring 15 acting as a means of actuating the clamped position. Indeed, this ring 15 is movable in translation along the device, and makes it possible to push all of the slats towards the central axis of the channel, in particular when this ring 15 is moved towards or on the slats 22 connected to the part of handling. To this end, the handling part 10 receiving the slats, or a base of slats comprises a projecting part on which the ring is engaged to radially compress the slats. In the illustrated embodiment, this projection 16 takes the form of an outer diameter of the manipulation part gradually increasing at the level of the manipulation part receiving the base of the lamellae. Alternatively, this projection 16 can be integrated at the level of the base of the slats 22 (see FIG. 8). In both cases, the tight position is activated by the engagement of the ring 15 on this projecting part 16. Of course, the material of the ancillary device has a certain flexibility allowing this change of position. For example, the slats are made of titanium or 316L stainless steel and the handling part such as the ring are made of biocompatible resin.

In other embodiments, other actuating means configured to tighten the slats radially can be used, see manual actuation.

Thus, during the first anastomosis, the practitioner inserts the prosthesis along the crossing channel, and reduces the diameter of the end of the prosthesis by activating the tight position of the conformation assembly. The practitioner then uses the ancillary device to guide and insert the prosthesis into the so-called upper end of the body conduit 30. The ancillary device is then removed by pulling it out, for example towards the free end of the prosthesis (Fig. 3).

The present invention is very advantageous in that it provides an ancillary device optimized to assist in the second anastomosis as well. To this end, the invention proposes to provide the ancillary device 100 with a closable and longitudinal opening giving access to the longitudinal channel 12, and so that a practitioner can easily bring the free end of the prosthesis connected to the body conduit up to to the compression zone 21 of said device (FIG. 4). This opening therefore makes it possible to carefully manipulate the free end of the prosthesis in order to position it in said compression zone and without having to pass it through the entire body of the ancillary. In addition, when the length of the prosthesis is limited, it will be possible to directly position the last millimeters of the prosthesis 3 at the level of the compression zone. 21 and to bring out the rest of the prosthesis 3 through one of the empty spaces between the lamellae

22 (fig. 5).

The resealable opening is also very advantageous in that it facilitates the removal of the ancillary device when the two anastomoses have been performed, and that there is no longer any free end towards which to remove this device.

In a preferred embodiment, the longitudinal opening is configured as a hinged opening opening in two parts the body of the ancillary device (Fig. 4). This articulation is present along the manipulation part and divides the device into two parts, with opening axes coinciding with the empty spaces between the slats.

In one embodiment, the actuating ring 15 acts as a closing means making it possible to maintain the closed position when said ring is engaged at the level of the manipulation part, and allowing opening when it is disengaged from the body of the device. (Figure 4), or when it is also open in two parts. In another embodiment not illustrated, the handling part 20 incorporates attachment means in said handling part. For example a hook, a clip system etc.

In another embodiment which can be combined with any characteristic of the embodiments described above, the manipulation part of the body of the ancillary device can be opened in two parts which are assembled together by means of at least one rail sliding in a groove along the body of the handling part. The opening of the body of the device can therefore be carried out gently and in a controlled manner to gradually disengage the rail from the groove and expose the prosthesis while maintaining support for the latter, and until the complete removal of the ancillary device. In the embodiment illustrated in FIG. 10, the hollow envelope of the manipulation part 10 is divided longitudinally into two detached parts, and each part is provided at the level of a longitudinal junction wall between said two parts with a rail 19 and a groove 18 cooperating with each other.

As illustrated in Figure 10, the body of the ancillary device is divided into two parts detached at its handling part 10, which fit together by sliding one over the other, in particular two hollow hemi-cylinders, each hemi cylinder being provided longitudinally at one of its ends with said rail 19, and at the other end with a groove 18 cooperating with the rail 19 and the groove 18 of the other half-cylinder. The device is thus gradually divided into two detached parts. Alternatively, one hemi-cylinder can be provided with a pair of rails sliding in a pair of grooves of the other hemi-cylinder.

The invention also relates to an anastomosis kit without manual suturing. This anastomosis kit comprising:

An ancillary device 100 according to the invention;

A prosthesis 3 or vascular substitute; A connection assembly 4 comprising at least one radial enlargement sleeve with spikes 46 and an inflation balloon 40.

As already mentioned, the connection assembly 4 is very advantageous in that it allows the connection of the prosthesis 3 with the body conduit 30 without the need for manual suturing. As schematically illustrated in FIG. 6, radial enlargement sleeve with spikes 46, also called spiked stent, is able to perforate the prosthesis 3 and the body conduit 30 during its radial expansion, which makes it possible to secure these elements together. . The present invention proposes a connection assembly 4 designed to cooperate with the ancillary device 100 of the invention, and to facilitate the anastomosis operation.

In particular, the radial expansion of the pinned radial expansion sleeve 46 is achieved by inflation of the inflation balloon therein. For its part, the inflation balloon 40 (fi g. 7) is provided at one end with a catheter 41 connecting said balloon 40 with an inflation syringe 44. This catheter 41 therefore has a length greater than the length necessary to cross the channel of the ancillary device 100. In order to insert the balloon 40 and the prosthesis 3 with precision, the invention proposes to provide the connection assembly 4 with an insertion guidance system to define the level of insertion of said connection assembly into the ancillary device, and in the bodily conduit. This guidance system is for example a set of stop elements on the body of the ancillary device and on the connection assembly, configured to limit the depth of insertion of the latter.

In one embodiment schematically illustrated in FIG. 7, the catheter 41 of the inflation balloon 40 is provided with a stopper element 45 of the guidance system in the form of wings comprising peripheral hooks configured to be fixed at the inlet 11 of the ancillary device or at one end of the prosthesis. The connecting assembly 4 is therefore inserted into the channel of the ancillary device until it stops by anchoring the hooks of the fins 45 of the catheter 41 to the ancillary device. The fins 45 have for example at least two branches, and preferably four or six branches which fit into the hollow cylindrical base of the ancillary.

In another embodiment, the fins 45 define abutments configured to enter the channel of the ancillary device 100 and be stopped at the level of the internal abutments of the ancillary device or by a wall of the prosthesis. In a preferred embodiment, the fins 45 are movable in translation along the catheter 41. A practitioner can thus limit the depth of insertion of the connecting assembly on a case-by-case basis, which is very advantageous during the second anastomosis. Indeed, during the second anastomosis, the positioning of the stent and the prosthesis must be done under visual control, and on a case-by-case basis. When this desired level of insertion is determined, the practitioner can change the position of the wings so that they abut against the prosthesis and the connecting assembly is immobilized. In one embodiment illustrated in FIG. 8, the kit also comprises an envelope 60 for protecting said radial widening sleeve with spikes 46 making it possible to preserve the integrity of the spikes until they are inserted into the body canal, and in particular during of the compression step of the prosthesis 3. This envelope is placed around the spiked stent 46, said spiked stent being inserted into the prosthesis mounted on the balloon 40 and surrounded by said protective envelope. In particular, a diameter of the envelope surrounding the balloon is slightly smaller than the diameter of the internal orifice at the level of the compression zone 21, said envelope is therefore not compressed, but only the end of the prosthesis to be introduced into the body conduit 30 without being able to compress the barb stent 46 protected by the envelope 60.

The protective envelope 60 is also retained during the step of inserting the prosthesis and the connecting assembly 4 into the body duct 30, to then be removed before the step of inflating the balloon 40. Advantageously , the invention proposes to provide said envelope 60 with a peelable or breakable system making it possible to open said envelope by pulling from its proximal end extending towards the outside of the body duct. In Figure 8, the dotted lines indicate peelable or breakable axes allowing the envelope to be divided into two parts to facilitate its removal. Preferably, and in an embodiment not shown, a proximal end of the wrapper 60 is split at four levels to facilitate peeling of the wrapper for removal. Advantageously, this embodiment also facilitates the passage of the fins

Finally, the kit of the invention also comprises a diameter tester 50 comprising a set of tubular bodies 51, such as hollow cylinders 51 having different diameters, each cylinder 51 comprising a handle 52 from which the practitioner manipulates the cylinder to insert it into the body canal (fig. 9). In particular, the practitioner tests the different cylinders until he finds the diameter of the cylinder that can be inserted into the body duct with limited play in said duct. The diameters of the cylinders 51 are therefore slightly smaller than the internal diameters of the body conduits for which the anastomosis is provided. These cylinders can also allow for additional external compression of the prosthesis when necessary.

The invention thus proposes an anastomosis kit making it possible to perfectly position a prosthesis in a body conduit, said prosthesis associated with a stent with pins to ensure the junction of said prosthesis without manual suturing. In particular, the device of the invention is very advantageous in that it makes it possible to assist during the joining of two ends of the prosthesis thanks to its characteristic reclosable opening.

Claims

1. Ancillary device (100) for anastomosis, said device (100) comprising an elongated body provided with a longitudinal and crossing channel (12) intended to receive inside it a tubular prosthesis (3), the body of the device comprising a proximal side a manipulation part (10) formed by a hollow envelope, preferably of tubular shape and on a distal side a shaping assembly (20) formed by a plurality of lamellae (22) defining a compression zone (21 ) of said prosthesis, characterized in that:

- the body of the device comprises a closable longitudinal opening giving access to the longitudinal channel (12) at the level of said manipulation part and of the shaping assembly.

2. Device (100) according to claim 1, wherein the longitudinal opening is configured as an opening opening in two parts said body, and wherein the two parts are assembled together by means of at least one rail and a groove cooperating with each other and being respectively provided on each of the two parts along the body of the manipulation part

3. Device according to one of the preceding claims, wherein the device comprises an open configuration, and a closed configuration controllable by the engagement and disengagement of the rail in the groove, and preferably a locking means of said closed configuration.

4. Device according to one of the preceding claims, the slats (22) of the shaping assembly (20) are arranged circumferentially and at predefined intervals around the handling part (10) and along a longitudinal axis of the device (100), and in which device the lamellae (22) have a relaxed position and a tight position respectively defining an initial diameter and a reduced diameter of the channel (12) receiving the prosthesis (3) at the level of the said compression zone ( 21).

5. Device according to claim 4, said device comprising an actuating means configured to radially compress said slats (22) and activate their clamped position.

6. Device according to one of the preceding claims, in which the handling part comprises one or more projecting parts (16) at the level of a junction zone with the strips (22) of the shaping assembly, said part projecting (16) for radially compressing the slats when it is pushed towards the inside of the device.

7. Device according to claim 6, comprising an outer ring (15) movable in translation along the body of the device, said ring being able to engage on the projecting part(s) (16) to activate the tight position of the slats (22).

8. Kit for anastomosis comprising:

- an ancillary device (100) according to one of the preceding claims;

- a prosthesis (3) or vascular substitute

- a connection assembly (4) comprising at least one radial enlargement sleeve with pins (46) and an inflation balloon (40).

9. Kit for anastomosis according to claim 8, said kit comprising an insertion guidance system comprising a set of stop elements on the body of the ancillary device and on the connection assembly, configured to limit the depth of insertion of the connecting assembly in the channel of the ancillary device.

10. Kit for anastomosis according to one of claims 8 or 9, wherein the inflation balloon (40) comprises a catheter (41) for connecting said balloon (40) to an inflation syringe (44), and said catheter (41) comprises one or more fins (45) configured to anchor to the body of the ancillary device (100) or to the prosthesis (3), and limit a depth of insertion of the connection assembly (4) in the channel (12) of the ancillary device.

11. Anastomosis kit according to claim 10, wherein the wings (45) have peripheral hooks configured to hook to a proximal end of the manipulation part of the ancillary device or to an end of the prosthesis.

12. Kit for anastomosis according to one of claims 10 or 11, wherein the fins (45) are movable in translation along the catheter (41) and comprise a locked configuration and an unlocked configuration, respectively limiting or allowing mobility of the fins (45).

13. Kit for anastomosis according to one of claims 8 to 12, comprising a peelable or breakable protective envelope (60) surrounding the radial enlargement sleeve with studs (46).

14. Kit for anastomosis according to claim 13, in which the envelope (60) comprises at least one peelable or divisible longitudinal axis.

15. Kit for anastomosis according to one of claims 8 to 14, comprising a tester (50) of diameter comprising at least one tubular body (51) of diameter predefined connected to a handle (52), and preferably a plurality of the tubular bodies (51) respectively connected to a handle (52).