Catheter assembly for making a connection passage in an ETS and / or STS anastomotic surgery

Abstract

The invention relates to a catheter assembly for making an ETS and / or STS anastomotic surgery using a clip of a type comprising a ring structure and one or two two-prong forks. The catheter assembly comprises a laser catheter, and a fixation device to receive the distal end of the catheter. The catheter comprises a tubular arrangement of optical fibres, and a tubular sheath around the optical fibres. The optical fibres extends from the tubular sheath. The sheath is provided with a protuberance around the sheath. The fixation device defines a channel for receiving the distal end of the catheter. The channel has a circumferential protuberance recess configured to receive the protuberance in a locking manner. The channel further has a clip gripper configured to receive part of the clip in a locking manner preventing the clip from moving in axial direction with respect to the fixation device.

Description

[0001] P37073PC00

[0002] Title: Catheter assembly for making a connection passage in an ETS and / or STS anastomotic surgery.

[0003] The invention relates to the field of anastomosis clips for connecting vessels in a human or animal body. The vessels may be blood vessels, like natural and / or artificial blood vessels. In case of natural blood vessels, these may be native vessels of the patient herself / himself or these may be donor vessels harvested from other humans or animals. Both in case of native vessels or donor vessels, the vessels optionally may have been treated.

[0004] More specifically, the invention relates to a catheter assembly for making a connection passage in an ETS and / or STS anastomotic surgery using a clip of a type comprising a ring structure and one or two two-prong forks.

[0005] BACKGROUND OF THE INVENTION

[0006] Anastomoses can be sub-divided into three groups: ETS-anastomoses (ETS=end-to- side), STS-anastomoses (STS=side-to-side), and ETE-anastomoses (ETE=end-to-end).

[0007] Traditionally, an anastomosis is established by sewing two vessels together. This is laboursome. Many anastomosis tools, such as clips, have been developed to facilitate or even avoid this labour-intensive process of sewing.

[0008] Some examples of such tools and clips can be found in EP 2.265.191 , EP 2.663.243, EP 2.929.843, US 2018-221.025, WO-2011 / 062495, WO 2013 / 105.848, and WO 2023 / 247.508. These tools / clips have a ring structure and a one or two two-prong forks with sharp tips at the free ends of the prongs. A two prong fork is pierced from the outside through the side wall of the blood vessel into the inside of the vessel - the S-vessel of an ETS- anastomosis or STS-anastomosis - and may subsequently also be pierced (back) from the inside of the vessel through the side wall to the outside of the vessel. In case of one two- prong fork, the ring structure serves as an aid for attaching the other one the vessels of the anastomosis to be established, for example an end of other one of the vessels may be attached to the ring structure. In case of two two-prong forks, one two-prong fork is pierced through the side wall of the first vessel and the other two-pronk fork is pierced through the side wall of the second vessel, and the ring structure may be an intermediate part lying so to say in between the first vessel of the anastomosis and the second vessel of the anastomosis.

[0009] When making an anastomosis using a clip of a type comprising a ring structure and one or two two-prong forks, an obstructing part of the vessel wall ‘between’ the prongs of the two-prong forks and or part of the vessel wall ‘within’ the ring is to be removed to provide (part of) the anastomotic passage between the two vessels to be connected. In this respect it is, with respect to the ‘between’ and ‘within’, to be noted that the prongs, respectively, ring may lie on the vessel wall. For removing said obstructing part a laser catheter may be used to burn away the obstructing part or to burn away a circular or non-circular ring around the obstructing part allowing the part surrounded by the burned away ring to be removed.

[0010] Such a laser catheter for bypass surgery is known from EP 750,476. This document describes the use in the ELANA ® (Excimer Laser Assisted Non-occlusive Anastomosis) operating technique.

[0011] The catheter disclosed in EP 750,476 is used for performing an ETS-anastomosis (ETS = End To Side) between a graft vessel and a target vessel. The graft is fixed with an end to the side of the target vessel, while the blood flow through the target vessel, also called recipient vessel, is not interrupted, i.e. blood continues to flow through the target vessel while performing the anastomosis. According to EP 750,476, first the graft vessel is fixed to the target vessel and subsequently, after this fixation is established, the flow connection between the target vessel and graft vessel is made by removing an obstructing part of the wall of the target vessel which lies in front of the fixed end of the graft vessel. The obstructing part is removed by means of a tubular arrangement of optical fibres emitting a tubular bundle of laser light originating from the fibres. The tubular bundle of the laser light beam burns a circle into the wall of the target vessel, resulting in a circular passage connecting the lumens of the graft vessel and target vessel. The circular wall part of the target vessel - i.e. the part lying inside said circle - is gripped and removed. Originally, this Elana technique used a ring attached at an end of the graft vessel and the target and graft vessel were connected, already before the ablation, by sewing.

[0012] Later on, the Elana technique developed further. Amongst others, it started using a clip of a type comprising a ring structure and one or two two-prong forks, and also STS anastomosis became possible using these clips. With an STS-anastomosis, the vessel wall of both the graft vessel and target vessel may have an obstructing part to be removed. Taking into account that the graft vessel will in general be empty (not filled with blood) before establishing the anastomosis, the obstructing part in the graft vessel may be removed already before the clip is attached to the target vessel by piercing the prongs of the two-prong fork through the wall of the target vessel.

[0013] The original Elana technique as well as the further developed Elana technique using a clip of a type comprising a ring structure and one or two two-prong forks, is largely manual and precise work, which requires a steady hand from the surgeon and is relatively time consuming due to the work being very precise. SUMMARY OF THE INVENTION

[0014] It is an object of the invention to provide a catheter assembly for making at least one connection passage, in particular one or two such passages, in an ETS and / or STS anastomotic surgery using a clip of a type comprising a ring structure and one or two two- prong forks, which assembly supports and / or facilitates the surgeon's work.

[0015] C1 : One or more of the above objects are according to a first aspect of the invention achieved by providing a catheter assembly for making a connection passage in an ETS and / or STS anastomotic surgery using a clip of a type comprising a ring structure and one or two two-prong forks; wherein:

[0016] - in case of one two-prong fork, the one two-prong fork is configured to be attached to a target vessel and the ring structure is attached or configured to be attached to the graft vessel, or

[0017] - in case of two two-prong forks, the two-prong forks are configured to be attached to the target vessel and graft vessel, respectively; wherein the catheter assembly comprises:

[0018] - a laser catheter having a distal end part, and

[0019] - a fixation device configured to receive the distal end part of the catheter; wherein the laser catheter comprises:

[0020] - a tubular arrangement of optical fibres having distal ends defining a ring-shaped light emitting surface, and

[0021] - a tubular sheath provided around the tubular arrangement of optical fibres; wherein, at the distal end part of the catheter, the tubular arrangement of optical fibres extends from the tubular sheath; wherein the tubular sheath is, at the distal end part of the catheter, provided with a protuberance, such as a protuberance extending around the sheath; wherein the fixation device is configured to define a channel for receiving the distal end part of the catheter such that the distal ends of the tubular arrangement of optical fibres project from the distal end of the channel; wherein the channel has a protuberance recess, such a protuberance recess extending in circumferential direction of the channel, which protuberance recess is configured to receive the protuberance in a locking manner; and wherein the channel has, at the distal end of the channel, a clip gripper configured to receive the ring structure and / or at least one of the one or two two-prong forks in a locking manner preventing the clip from moving in axial direction with respect to the fixation device and optionally also preventing the clip from rotation with respect to the fixation device.

[0022] The clip gripper may for example be a clip recess extending in circumferential direction of the channel.

[0023] The fixation device is configured to be provided around part of the graft vessel and the distal end part of the catheter inserted in said part of the target vessel. Providing the fixation device around part of the graft vessel and the distal end part of the catheter inserted, provides that surgeon can grip the fixation device instead of the target vessel, thus preventing the target vessel from being damaged. This as such already increases the ease of use for the surgeon, as the surgeon need be less concerned about unintentionally damaging the graft vessel. The fixation device may further be configured to prevent the distal end of the laser catheter from flexing. This may for example be achieved by configuring the fixation device rigid. A rigid fixation device facilitates the surgeon in accurate manipulation of the graft vessel with inserted catheter.

[0024] By providing the tubular sheath, at the distal end part of the catheter, with a protuberance, for example a protuberance extending around the sheath, and by providing, in the channel, a protuberance recess, for example a protuberance recess extending in circumferential direction of the channel, and configuring the protuberance recess to receive the protuberance in a locking manner, such as a formfitting and / or enclosing manner, the distal end of the catheter is prevented from moving in axial direction with respect to the fixation device. For the surgeon this further improves the ease of use and the accuracy when manipulating during the surgery, and because axial relative movement between the catheter and the fixation device is prevented, the risk of damaging the graft vessel is further reduced.

[0025] By providing the channel with a clip gripper, for example a clip recess extending in circumferential direction of the channel, and the clip gripper being configured to receive the ring structure and / or at least one of the one or two two-prong forks in a locking and / or enclosing manner, the clip is prevented from moving in axial direction with respect to the fixation device. This further reduced the risk of damaging the graft vessel, and for the surgeon the ease of use and the accuracy when manipulating during the surgery is further improved. In addition the clip gripper and / or clip may also be configured to prevent the clip from rotating with respect to the fixation device. When the protuberance and / or protuberance recess are - as is preferred - configured to prevent the catheter and fixation device from rotating from each other, and when the clip and / or clip gripper are also prevented from rotation with respect to each other, the clip is prevented from rotation with respect to the catheter.

[0026] The catheter may extend in a direction essentially perpendicular to the plane defined by the ring structure, respectively, to the plane defined by the two prongs of a said two-prong fork. C2: According to a further embodiment of the first aspect of the invention, the distance between the clip gripper and protuberance recess is, viewed in length direction of the catheter, at least 5 mm, such as at least 10 mm or at least 15 mm or at least 20 mm. A distance of at least 5 mm between the clip gripper and protuberance recess, allows the channel to receive a length of graft vessel (through which the laser catheter is inserted) which allows, after withdrawing the catheter, this part of the graft vessel to be closed, temporarily or permanently, by a closing clip or clamp. The larger said distance, the longer the length of the graft vessel which may be accommodated in the channel between the clip gripper and protuberance recess. The longer said accommodated length of the graft vessel, the easier it will be to provide a closing clip or clamp on this length of graft vessel once the catheter has been withdrawn.

[0027] C3+4: According to another further embodiment of the first aspect of the invention, the fixation device is configured to be transferable from a closed state / position to an open state / position and vice versa, wherein, in the closed state / position, the distal end part of the catheter is received in the channel, and wherein, in the open state / position, the distal end part of the catheter is allowed to be removed from the channel and / or to be placed into the channel. In use, the distal end part of the catheter will first have been inserted into (part of) the graft vessel before the distal end part of the catheter is received in the channel. In other words, in use and in closed state / position, both the distal end part of the catheter and the part of the graft vessel into which the distal end part of the catheter has been inserted will be received in the channel, and, in use and in open state / position, the distal end part of the catheter and the part of the graft vessel into which the distal end part of the catheter has been inserted will be allowed to be removed from the channel, or vice versa, will be allowed to be placed into the channel. According to a further embodiment of this embodiment, the fixation device may comprises a first part - such as a first half - and a second part - such as a second half -, the first and second part being movable with respect to each other to define the closed state and the open state / position, wherein, in the closed state / position, the channel is defined between the first and second part lying against each other. The first part and second part may for example be hinged with respect to each other.

[0028] C5: According to a another further embodiment of the first aspect of the invention, the channel is, between the clip gripper and protuberance recess, oversized with respect to tubular arrangement of optical fibres. This oversizing reduces the risk that a (part of the) graft vessel with inserted catheter accommodated in the channel will be damaged by the fixation device and / or the laser catheter. C6: According to another further embodiment of the first aspect of the invention, the cross- sectional inner dimensions of the channel are, in a section extending from the clip gripper to the protuberance recess, at least 0.15 mm larger, such as at least 0.2 mm larger or at least 0.4 mm larger, than the cross-sectional outer dimensions of the tubular arrangement of optical fibres. Assuming the distal end part of the catheter is concentric with respect to the channel, this means that there is between the distal end part of the catheter and the channel a clearance all around the distal end part of the catheter of at least 0.5 mm, respectively, at least 1 mm. This clearance allows graft vessel of varying wall thickness to be accommodated about freely in the clearance, so that the chance of damaging this graft vessel is reduced and so that the graft vessel can have an inner diameter larger than the outer diameter of the catheter part to be received in it, which in turn makes insertion of the catheter into the graft vessel and withdrawing the catheter from the graft vessel easier and also further reduces the risk of damaging the graft vessel.

[0029] C7: According to another further embodiment of the first aspect of the invention, the tubular arrangement of the optical fibers has a circular or oval-like crosse-section.

[0030] C8: According to another further embodiment of the first aspect of the invention, the distance, viewed in axial direction of the catheter, from the distal ends of the optical fibers to the distal end of the fixation device is more than 0 mm, such as at least 0.3 mm. This distance may for example be at least 0.5 mm, such as about 0.7 mm. This distance being more than 0 mm ensures that, when a part of the wall of a target or graft vessel is burned away, the protruding end of the optical fibers push themselves into and through the opening burned into the vessel wall. This distance being at least 0.5 mm ensures that, when a part of a wall of graft vessel is burned away and subsequently also a part of the wall of a target vessel, the protruding end of the optical fibers push themselves into and through the opening burned in both the graft vessel wall and target vessel wall.

[0031] C9: According to another further embodiment of the first aspect of the invention, the distance, viewed in axial direction of the catheter, the distance from the distal ends of the optical fibers to the distal end of the fixation device is at most 1.5 mm, such as at most 1 mm. This distance being at most 1.5 mm reduces the risk that other tissue, like another part of the vessel wall, is damaged by the laser light emitted by the laser catheter. This risk is further reduced, in particular in case of smaller target vessels, when this distance is at most 1.0 mm.

[0032] C10: According to another further embodiment, the length of protrusion of the optical fibers may alternatively or additionally be expressed as, viewed in axial direction of the catheter, the distance from the distal ends of the optical fibers to a distally facing side of the ring structure being more than 0 mm, such as at least 0.3 mm or at least 0.5 mm. This distance may for example be at least 0.5 mm, such as about 0.7 mm. This distance being more than 0 mm ensures that, when a part of the wall of a target or graft vessel is burned away, the protruding end of the optical fibers push themselves into and through the opening burned into the vessel wall. This distance being at least 0.5 mm ensures that, when a part of a wall of graft vessel is burned away and subsequently also a part of the wall of a target vessel, the protruding end of the optical fibers push themselves into and through the opening burned in both the graft vessel wall and target vessel wall.

[0033] C11 : According to another further embodiment, the length of protrusion of the optical fibers may alternatively or additionally be expressed as, viewed in axial direction of the catheter, the distance from the distal ends of the optical fibers to a distally facing side of the ring structure being at most 1.5 mm, such as at most 1 mm. This distance being at most 1.5 mm reduces the risk that other tissue, like another part of the vessel wall, is damaged by the laser light emitted by the laser catheter. This risk is further reduced, in particular in case of smaller target vessels, when this distance is at most 1.0 mm.

[0034] C12: According to another further embodiment of the first aspect of the invention, the distal end part of the catheter is received in the channel with the protuberance received in the protuberance recess.

[0035] C13: According to a second aspect of the invention, one or more objects of the invention are achieved by providing a clip-catheter-assembly comprising:

[0036] - a catheter assembly according to the first aspect of the invention, and

[0037] - a said clip.

[0038] C14: According to a further embodiment of the second aspect of the invention, the catheter assembly is the catheter assembly in which the distal end part of the catheter is received in the channel with the protuberance received in the protuberance recess, wherein the clip is received by the gripper and wherein the protuberance is received in the protuberance recess.

[0039] C15: According to a third aspect of the invention, one or more objects of the invention are achieved by a graft-clip-catheter-assembly, comprising:

[0040] - a clip-catheter-assembly according to the second aspect of the invention, and

[0041] - a graft vessel;

[0042] In this third aspect, the graft-clip-catheter assembly is detached from the patient. C16: According to a further embodiment of the third aspect of the invention, the clip-catheter assembly is the clip-catheter-assembly according to claim 14, and a first part of the graft vessel extends in the channel around the tubular arrangement of optical fibers; wherein:

[0043] - in case of a clip with one two-prong fork, the ring structure is attached to a distal end of the graft vessel and received in the clip gripper, or

[0044] - in case of a clip with two two-prong forks, the prongs of a proximal one of said two-prong forks have been inserted through the wall of the graft vessel (and optionally then inserted back out again through the wall of the graft vessel) and the ring structure and / or said proximal two-prong fork is received in the clip gripper.

[0045] C17: According to a further embodiment of the third aspect of the invention, there is, between the prongs of the proximal two-prong fork and in the extension of the tubular arrangement of optical fibers, a said connection passage, which has been made through the wall of the graft vessel, said connection passage preferably has been made by light emitted from the distal ends of the tubular arrangement of optical fibers.

[0046] BRIEF DESCRIPTION OF THE DRAWING

[0047] The invention will be explained further with reference to the drawings. In these drawings:

[0048] Figure 1 shows a perspective view of an embodiment of the invention.

[0049] Figures 2-14 show, very schematically, how the embodiment shown in figure 1 may be used in practise in a surgical anastomosis procedure. In these figures:

[0050] Figure 2 shows a first step of a surgical anastomosis procedure,

[0051] Figure 3 shows a second step of a surgical anastomosis procedure,

[0052] Figure 4 shows a third step of a surgical anastomosis procedure, Figure 5 shows a fourth step of a surgical anastomosis procedure, Figure 6 shows a fifth step of a surgical anastomosis procedure, Figure 7 shows one half of a fixation device in front view onto the inside (Fig. 7A) and in side view (Fig. 7B) according to the arrow VII,

[0053] Figure 8 shows a sixth step of a surgical anastomosis procedure,

[0054] Figure 9 shows an seventh step of a surgical anastomosis procedure,

[0055] Figure 10 shows a n eight step of a surgical anastomosis procedure, Figure 11 shows a ninth step of a surgical anastomosis procedure, Figure 12 shows an tenth step of a surgical anastomosis procedure, Figure 13 shows an eleventh step of a surgical anastomosis procedure,

[0056] Figure 14 shows a twelfth step of a surgical anastomosis procedure, Figure 15 shows an example of a distal part of a catheter in cross-section (Fig. 15A) and in bottom view (Fig. 15B) according to arrow XV, and

[0057] Figure 16 shows an example of a clip of the type having a ring structure and at least one two-prong forks, Fig.16A showing a side view, and Fig. 16B showing a top view of a two-prong fork in the direction of arrow XVI .

[0058] DETAILED DESCRIPTION OF THE EMBODIMENTS

[0059] Fig. 1 shows in perspective view an embodiment of the invention. Figs 2-14 show highly schematically further details of the embodiment of Fig. 1 and how it is used. Fig. 15 shows more detailed (but not on scale) an example of the distal part of a catheter which may be used in the embodiment of figures 1-14. . Fig. 16 shows more detailed an example of a clip of the type having a ring structure and at least one two-prong fork, which clip may be used in the embodiment of Figs. 1-14. Throughout the Figs. 1-16 same reference numbers have been used for same or similar parts. Not all reference numbers are shown in each figure, but taking into account the similarity between figures in case an item misses a reference number, it will be clear from another figure which reference number belongs to said item.

[0060] Referring to the Figs. 1-16, the catheter assembly 1 comprises a laser catheter 10 and a fixation device 12.

[0061] The laser catheter has a distal end part 11 , as indicated in Figs. 5 and 15A. Referring in particular to Fig. 15, the laser catheter has a tubular arrangement 14 of optical fibres 15. The distal ends 16 of the optical fibres 15 define a ring shaped light emitting surface 17. In the example shown in Fig. 15, the ring shape of the ring shaped light emitting surface is a pure circle, but the ring shape may also be an oval, ellipse, or any other ring shape. Further in the example shown in the ring shape of the ring shaped light emitting surface is a pure circular ring with a central zone 41 without optical fibres 15, but the ring shape may also be circle, oval, ellipse, or any other ring shape having the entire surface of the circle, oval, ellipse, or any other ring shape filled with the optical fibres. The catheter as shown in Fig. 15 has a perforated disk 41 with openings 43 defining the end of a suction channel 42 inside the catheter. This suction channel may assist in gripping a part of wall tissue which has been separated from the vessel wall by burning a ring into the vessel wall by laser light emitted from the emitting surface in distal direction of the laser catheter. It is noted that in Fig. 15A the diameter of the catheter is shown exaggerated (oversized) with respect to the distance A. The laser catheter 10 further has a tubular sheath 18 around the tubular arrangement 14 of optical fibres 15. The optical fibres extend, in the example shown, from the distal end of the sheath over a distance A - see Fig. 15A - of about 15 mm. This distance A may also be smaller or larger. As can be seen in the Figs. The tubular sheath 18 is, at its distal end, provided with a protuberance 19. In the example shown, the protuberance 19 is ring shaped and extends all around the catheter 10. However, it will be clear or become clear that this protuberance does not need to extend all around the catheter. The protuberance may, viewed in circumferential direction of the catheter, also be a locally projecting part or locally projecting discrete parts, such as three discrete parts arranged at an angular distance of 120 degrees.

[0062] The catheter assembly 1 further comprises fixation device 12 configured to receive the distal end part 11 of the laser catheter. Fig. 1 shows this fixation device in perspective view, and Fig. 7 shows one half 12a of this fixation device in side view - Fig. 7B - and in longitudinal plan view onto the inner side of this oner half 12a. In the example shown in the Figs. The fixation device is made of two halves 12a and 12b, each halve having so to say the form of a half tube. The halve 12b - not shown in Fig. 7 - may be mirror symmetrical to halve 12a, the mirror plane being the plane of the paper onto which Fig. 7A is printed. The halves 12a, 12b are in this example mounted on the ends of pincer arms 54a, respectively, 54b of a pincers 54. By squeezing together the ends 55a and 55b - see Fig. 1 - of the pincer arms, against a spring force, the halves 12a and 12b are moved to an open position allowing a laser catheter (whether or not inserted in a graft vessel 9) to be placed in between the halves 12a, 12b, in the channel 20 defined by these two halves, or vice versa allowing a laser catheter (whether or not inserted in a graft vessel 9) to be displaced from in the channel 20, in between the two halves 12a, 12b, to a location out of reach of the two halves 12a, 12b.

[0063] The fixation device 12 has a protuberance recess 22 configured to receive the protuberance 19 of the catheter 10. In the example shown, the protuberance recess in each halve is about a half circle. The fixation device further has a clip gripper 24 at its distal end 25. In the example shown, the clip gripper 24 defines a clip recess into which the ring structure 5 and / or one two-prong fork 6 of a clip 4 can be received.

[0064] Now turning to Fig. 16, an example of a clip 4 of the type having a ring structure 5 and at least one two-prong fork 6, in this example two two-prong forks 6, 7. A clip as shown in Fig. 16 is quite detailed described in WO-2023 / 247508, see for example Figs. 2A to 2J of WO- 2023 / 247508 and text associated for a clip with two two-prong forks and Figs. 1A to 1F of WO-2023 / 247508 and text associated for a clip with one two-prong fork. As explained in said WO-2023 / 247508, the two-prong forks 6, 7 can be manipulated selectively with respect to each other as well as with respect to the ring structure 5 by squeezing together the grips 46 and 48 - against a spring force - to obtain the positions shown in Fig. 16A, by squeezing together the grips 47 and 48 to open the two-prong fork 7 with respect to the ring structure 5 whilst allowing the two-prong fork 6 and the ring structure 5 to be pressed against each other by the spring force, and by squeezing together the grips 46 and 47 to open the two-prong fork 6 with respect to the ring structure 5 whilst allowing the two-prong fork 7 and ring structure 5 to be pressed against each other by the spring force. When none of the grips are squeezed together, the said spring force will keep both two-prong forks 6, 7 pressed against the ring structure 5. Fig. 16B shows a view according to arrow XVI (in Fig. 16A) onto the first two prong fork 6. One can see here the two prongs 44 and 45 of the first two prong fork 6. The second two prong fork 7 may be shaped similarly.

[0065] Referring to Figs. 2-14, the use and functioning of the catheter assembly according to the invention is elucidated.

[0066] Fig. 2 shows a graft vessel 9 and a clip 4 of the type having a ring structure 5, a first two prong fork 6 and a second two-prong fork 7. The graft vessel 9 may be detached from the patient or one end of the graft vessel 9, the left end in Figs. 2-14, may be attached to the patient, or in other words may continue in a vessel of the patient.

[0067] As shown in Fig. 2 the first two-prong fork 6 is in its open position and the second two- prong fork 7 is in its closed position lying against the ring structure 5. The first two-prong fork 6 in open position allows the two prongs 44, 45 of this two-prong fork being pierced through the wall of the graft vessel 9 into the lumen of the graft vessel. Next, optionally, the two prongs 44, 45 may be pierced back out again through the wall of the graft vessel 9, and the ring structure 5 may move towards the first two-prong fork 6 resulting in a configuration like shown in Fig. 3. It is noted here that the prongs 44, 45 may also not be pierced back through the wall of the graft vessel but, instead may stay inside the lumen of the graft vessel.

[0068] Next, if not already done when piercing the prongs through the wall of the graft vessel 9, the right part of the graft vessel 9 may be bend to a position about perpendicular to the left part of the graft vessel, resulting in the configuration of Fig. 4.

[0069] With respect to Figs. 3-6 and 8-9, it is noted that the second two-prong fork 7 is shown in its open position for reasons of clarity of the drawings. In practise however, the second two- prong fork 7 preferably is in closed position in Figs. 1-6 and 9. In fig. 9 the second two-prong fork may be in closed position as well, but to prevent the second two prong fork 7 from being caught by the clip gripper 24 the second two prong fork 7 may be in open position, when arranging the fixation device 12 around the distal end part 11 of the laser catheter 10.

[0070] Next, after the graft vessel 9 having been bend to the position shown in Fig. 4, or before bending the graft vessel 9 to the position shown in Fig. 4, the laser catheter 10 may be inserted into the left part of the graft vessel 9, as indicated by arrow B in figure 5. The bending of the graft vessel 9 to the position as shown in Figs. 4-5 may also take place while inserting the laser catheter 10 into the graft vessel. The laser catheter 10 is inserted up to the distal ends 16 of the optical fibres 15 reach the clip 4 and / or the part 49 of the wall of the graft vessel. As shown in Fig. 6 the distal ends of the optical fibres may contact the part 49 of the wall of the graft vessel 9, but this is not perse required.

[0071] After having mounted the clip 4 to the graft vessel 9 by means of the first two-prong fork 6 or to the ring structure 5 in case the two prong fork 6 is absent, after having inserted the catheter 10 into the graft vessel, and after having brought the assembly of graft 9, clip 4 and catheter 10 into the condition shown in Fig. 6 the fixation device 12 (shown in Fig. 1 and 7) is provided around the distal end part 11 of the catheter 10. This may for example be done by squeezing together the ends 55a and 55b of the pincer arms 54a, 54b against a spring force so that the halves 12a and 12b of the fixation device open and the distal end part 11 of the catheter inserted in the graft vessel and provided with the clip 4, can be moved relative to fixation device to in between the halves 12a and 12b. The first two-prong fork 6 and / or the ring structure 5, on the one hand, and the protuberance 19 on the other hand will be manipulated to be received in the clip gripper 24 and protuberance recess 22, respectively, and the pincers arms 54a and 54b may be closed by the spring action, resulting in the condition as shown in Fig. 8 (which shows only one halve 12a and leaves away the other halve 12b to allow a view onto the inside of a closed fixation device enclosing the distal end part 11 of the catheter 10. After having reached the condition shown in Fig. 8, the second two-prong fork 7 may be allowed to close.

[0072] In the condition shown in Fig. 8 (and also in the conditions shown in Figs. 9-12:

[0073] - the protuberance recess 22 enclosing the protuberance 19, prevents the laser catheter 10 from moving axially with respect to the fixation device, and may (optionally) also prevent the laser catheter 10 from rotating with respect to the fixation device 12, and

[0074] - the clamp gripper 4 gripping the first two-prong fork 6 and / or the ring structure, prevents the clip from moving axially and, preferably, also rotationally with respect to the fixation device.

[0075] This results in a solid and rigid unit of parts unmovable with respect to each other, this solid unit comprising the (right) graft vessel part into which the catheter 10 has been inserted, the distal part 11 of the laser catheter 10, and the clip 4.

[0076] The next step, is removing the part 49 of the wall of the graft vessel 9 in order to provide a passage 50 through this wall of the graft vessel 9. This is done by switching on the laser so that a ring of laser light is emitted in distal direction from the distal ends 16 of the optical fibres. This results in the condition as shown in Fig. 9, where the part 49 to be removed has gone, and where the distal ends 16 of the optical fibres 15 are exposed / u ncovered .

[0077] Next, or before removing the part 49 (by laser burning), the prongs of the second two- prong fork 7 may be opened (as shown in Fig. 9) and pierced through the wall of the target vessel 8 into the lumen of the target vessel 8. The prongs of the second two-prong 7 fork may be left inside the lumen of the target vessel 8, or may be pierced back (as shown in the example of Fig. 10) through the wall of the target vessel 8, resulting in the condition as shown in Fig. 10. Next, the second two prong fork 7 may be allowed to close, resulting in the condition as shown in Fig. 11. In this condition the distal ends 16 of the optical fibbers lie close to the prongs of the second two-prong fork, or said differently, in this condition the distal ends 16 of the optical fibbers lie, viewed in axial direction, at the level of the prongs of the second two-prong fork 7.

[0078] Then in a next step the part 51 of the wall of the target vessel 8 may be removed to provide a passage 52 through the wall of the target vessel. This removing of the part 51 may be done by starting the laser so that the emitting surface 17 emits laser light in distal direction. In case the passage 50 has not been provided yet, the parts 49 and 51 may be removed about directly after each other by starting the laser. Both ways, it results in the condition as shown in Fig. 12, in which the passage 52 through the wall of the target vessel 8 and the passage 50 through the wall of the graft vessel have been made so that fluid communication between the graft vessel 9 and target vessel 8 is possible via a short channel through the opening between the prongs of the first two prong fork 6, through the opening in the ring structure 5, and through the opening between the prongs of the second two prong fork 7.

[0079] Next the catheter 10 may be withdrawn from the graft vessel in the direction opposite to the arrow B in Fig. 5, resulting in the condition as shown in Fig. 13. As a next step, the right part of the graft vessel 9 may be closed by means of a clamp 53.

[0080] LIST OF RFEFERENCE NUMBERS USED IN THE DRAWINGS

[0081] 1 catheter assembly

[0082] 2 clip-catheter assembly

[0083] 3 graft-clip-catheter assembly

[0084] 4 clip

[0085] 5 ring structure

[0086] 6 first two-prong fork

[0087] 7 second two-prong fork

[0088] 8 target vessel

[0089] 9 graft vessel

[0090] 10 laser catheter

[0091] 11 distal end part of laser catheter

[0092] 12 fixation device

[0093] 12a one part of fixation device

[0094] 12b other part of fixation device

[0095] 14 tubular arrangement of optical fibres

[0096] 15 optical fibres

[0097] 16 distal ends of optical fibres

[0098] 17 ring shaped light emitting surface

[0099] 18 tubular sheath

[0100] 19 protuberance

[0101] 20 channel of fixation device

[0102] 21 distal end of channel

[0103] 22 protuberance recess

[0104] 23 graft recess

[0105] 24 clip gripper

[0106] 25 distal end of fixation device

[0107] 41 disk

[0108] 42 suction channel

[0109] 43 opening in disk

[0110] 44 prong

[0111] 45 prong

[0112] 46 upper grip

[0113] 47 middle grip

[0114] 48 lower grip

[0115] 49 part to be removed 50 connection passage

[0116] 51 part to be removed

[0117] 52 connection passage

[0118] 53 clamp 54 pincers

[0119] 54a first pincers arm

[0120] 54b second pincers arm

[0121] 55a end of first pincer arm

[0122] 55b end of second pincer arm

Claims

CLAIMS1] Catheter assembly (1; 2; 3) for making a connection passage in an ETS and / or STS anastomotic surgery using a clip (4) of a type comprising a ring structure (5) and one or two two-prong forks (6, 7); wherein:- in case of one two-prong fork (6), the one two-prong fork (6) is to be attached to a target vessel (8) and the ring structure (5) is attached or to be attached to the graft vessel (9), or- in case of two two-prong forks (6, 7), the two-prong forks are to be attached to the target vessel (8) and graft vessel (9), respectively; wherein the catheter assembly comprises:- a laser catheter (10) having a distal end part (11), and- a fixation device (12) configured to receive the distal end part (11) of the catheter; wherein the laser catheter comprises:- a tubular arrangement (14) of optical fibres (15) having distal ends (16) defining light emitting surface (17), and- a tubular sheath (18) provided around the tubular arrangement (14) of optical fibres (15); wherein, at the distal end part (11) of the catheter, the tubular arrangement (14) of optical fibres (15) extends from the tubular sheath (18); wherein the tubular sheath (18) is, at the distal end part (11 ) of the catheter, provided with a protuberance (19); wherein the fixation device (12) is configured to define a channel (20) for receiving the distal end part (11) of the catheter such that the distal ends (16) of the tubular arrangement (14) of optical fibres (15) project from the distal end (21) of the channel (20); wherein the channel (20) has a protuberance recess (22) configured to receive the protuberance (19) in a locking manner; and wherein the channel (20) has, at the distal end (21) of the channel, a clip gripper configured to receive the ring structure and / or at least one of the one or two two-prong forks in a locking manner preventing the clip from moving in axial direction with respect to the fixation device.2] Catheter assembly (1 ; 2; 3) according to claim 1 , wherein the distance between the clip gripper (24|) and protuberance recess (22) is, viewed in length direction of the catheter (10), at least 5 mm, such as at least 10 mm or at least 15 mm or at least 20 mm.3] Catheter assembly (1; 2; 3) according to any of the preceding claims, wherein the fixation device (12) is configured to be transferable from a closed state to an open state and vice versa, wherein, in the closed state, the distal end part of the catheter is received in the channel, and wherein, in the open state, the distal end part of the catheter is allowed to be removed from the channel and / or to be placed into the channel.4] Catheter assembly (1; 2; 3) according to claim 3, wherein the fixation device (12) comprises a first part (12a) and a second part (12b), the first and second part being movable with respect to each other to define the closed state and the open state; wherein, in the closed state, the channel (20) is defined between the first part (12a) and second (12b) part lying near or against each other.5] Catheter assembly (1 ; 2; 3) according to any of the preceding claims, wherein the channel (20) is, between the clip gripper (24) and protuberance recess (22), oversized with respect to tubular arrangement (14) of optical fibres (15).6] Catheter assembly (1; 2; 3) according to any of the preceding claims, wherein the cross-sectional inner dimensions of the channel (20) are, in a section extending from the clip gripper (24) to the protuberance recess (22), at least 0.15 mm larger than the cross-sectional outer dimensions of the tubular arrangement (14) of optical fibres (15).7] Catheter assembly (1; 2; 3) according to any of the preceding claims, wherein the tubular arrangement (14) of the optical fibers (15) has a circular or oval-like cross-section.8] Catheter assembly (1 ; 2; 3) according to any of the preceding claims, wherein, viewed in axial direction of the catheter (10), the distance from the distal ends (16) of the optical fibers (15) to the distal end (25) of the fixation device (12) is more than 0 mm, such as at least 0.3 mm or at least 0.5 mm.9] Catheter assembly (1; 2; 3) according to any of the preceding claims, wherein, viewed in axial direction of the catheter (10), the distance from the distal ends (16) of the optical fibers (15) to the distal end (25) of the fixation device (12) is at most 1.5 mm, such as at most 1 mm.10] Catheter assembly (1; 2; 3) according to any of the preceding claims,18 wherein, viewed in axial direction of the catheter (10), the distance from the distal ends (16) of the optical fibers (15) to a distally facing side of the ring structure (5) is more than 0 mm, such as at least 0.3 mm or at least 0.5 mm.11] Catheter assembly (1; 2; 3) according to any of the preceding claims, wherein, viewed in axial direction of the catheter, the distance from the distal ends of the optical fibers to a distally facing side of the ring structure is at most 1.5 mm, such as at most 1 mm.12] Catheter assembly (1; 2; 3) according to any of the preceding claims, wherein the distal end part (11) of the catheter (10) is received in the channel (20) with the protuberance (19) received in the protuberance recess (22).13] Clip-catheter-assembly (2; 3) comprising:- a catheter assembly (1) according to any of the preceding claims, and- a said clip (4).14] Clip-catheter-assembly (2; 3) according to claim 13, wherein the catheter assembly (1) is the catheter assembly according to claim 12, and wherein the clip (4) is received by the clip gripper (24) and wherein the protuberance (19) is received in the protuberance recess (22).15] Graft-clip-catheter-assembly (3), comprising:- a clip-catheter-assembly (2) according to claim 13 or claim 14; and- a graft vessel (9).16] Graft-clip-catheter assembly (3) according to claim 15, wherein the clip-catheter assembly (2) is the clip-catheter-assembly according to claim 14; wherein a first part of the graft vessel (9) extends, in the channel (21), around the tubular arrangement (14) of optical fibers (15); wherein:- in case of a clip (4) with one two-prong fork (7), the ring structure (5) is attached to a distal end of the graft vessel (9) and received in the clip gripper (24), or- in case of a clip with two two-prong forks (6, 7), the prongs of a proximal one (6) of said two-prong forks have been inserted through the wall of the graft vessel (9) and the ring structure (6) and / or said proximal two-prong fork (6) is received in the clip gripper (24).17] Graft-clip-catheter assembly (3) according to claim 16, wherein, between the prongs (44, 45) of the proximal two-prong fork (6) and in the extension of the tubular arrangement (14) of optical fibers (15), a said connection passage (50) has been made through the wall of the graft vessel (8), said connection passage (50) preferably has been made by light emitted from the distal ends (16) of the tubular arrangement (14) of optical fibers (15).

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