WO2013026585A1

WO2013026585A1 - Endoprosthesis fenestration device

Info

Publication number: WO2013026585A1
Application number: PCT/EP2012/051340
Authority: WO
Inventors: Pascal BRANCHERAU; Pierre ALRIC
Original assignee: Centre Hospitalier Universitaire Nimes
Priority date: 2011-08-22
Filing date: 2012-01-27
Publication date: 2013-02-28
Also published as: FR2979229A1

Abstract

The present invention concerns an endoprosthesis fenestration device, characterised in that it comprises a flexible elongated tube (2), the distal end of which is equipped with a hollow needle (4), with a common canal (3) passing through said tube (2) and needle (4); a guide (5) capable of sliding in the canal (3). The present invention also concerns a method of fenestration of an endoprosthesis.

Description

Endoprosthesis fenestration device

GENERAL TECHNICAL FIELD The present invention concerns the field of aortic endoprostheses.

STATE OF THE ART

An aneurysm is a localised dilation of the wall of an artery. It usually adopts the shape of a pouch and its diameter may extend to several centimetres. One speaks of an aneurysm when parallelism between the edges of the vessel is lost and the calibre of the latter exceeds twice its normal size.

It may manifest itself by secondary signs, particularly compression of nearby organs , but m ore often than not its presence i n itse lf is unproblematic. It is the com plications which it m ay cause that are dangerous.

Owing to modification of the calibre of the artery, the blood flow, which was normally laminar, becomes turbulent at the site of the aneurysm. This turbulence may result in formation of a thrombus (a blood clot) which may at some stage subsequently become detached and move to cause a serious embolism (by blocking a smaller calibre artery downstream).

The essential risk however is that of rupture of the aneurysm , resulting in massive haemorrhage. Death usually occurs within a few tens of minutes.

Although all arteries may be affected, the aorta is frequently involved. This is the largest artery in the human body. Whereas its normal diameter is between 1 .5 cm and 2.5 cm , it may sometimes exceed 1 3 cm in the presence of an aneurysm.

All aortic aneurysms inexorably increase in size over time and the risk of rupture increases as soon as the diameter of the aorta exceeds 5 cm. Death occurs in 75 to 90% of cases in case of rupture. If however an aneurysm is detected in time, it is possible to prevent its rupture by vascu lar surgery. Surgery on the aorta is nevertheless extremely heavy and risky. Since the early 1990's, less invasive treatment by insertion of an endoprosthesis from the femoral artery has been proposed: endoluminal repair. The endoprosthesis is a stent (a meshed metallic device commonly known as a spring) covered with an impermeable wall (which is also known as a "stent graft" or a "greffe de stent" in French) unfolded inside the artery at the location of the aneurysm . It isolates the latter from the blood and recreates a cylindrical section of artery in its place.

Now, as can be seen in figure 1 , the aorta A has the specific shape of an arch. It is divided into two parts: the abdominal aorta A1 (bottom section, under the diaphragm) and the thoracic aorta A2 (upper section, above the diaphragm). Treatment of aneurysms on the straight parts of the thoracic aorta A2 (descending thoracic aorta A21 and ascending thoracic aorta A23) is relatively well known since a cylindrical endoprosthesis is sufficient.

Two parts of the aorta prove tricky to equip with an endoprosthesis: the abdom inal aorta A1 and above all the aortic arch A22. Indeed, the abdom inal aorta A1 branches out into two iliac arteries, left A1 1 and right A12; and three major vessels (the brachiocephalic arterial trunk, the left primary carotid artery and the left subclavian artery) start from the upper surface of the aortic arch A12, almost at a right angle.

E uropean patent E P 1 1 59024 describes a Y-shaped abdom inal endoprosthesis which adapts to the shape of the abdominal aorta A1 . This endoprosthesis indeed comprises a structure in which two tubular sleeves are longitud inal ly inserted into a m ain body, with the tubular sleeves corresponding to the iliac arteries A1 1 and A12. This endoprosthesis cannot be adapted to the aortic arch A22 from which the ram ifications branch off laterally at a right angle.

International patent application WO2007/028086 describes a thoracic endoprosthesis adapted to the aortic arch A22 by means of the presence of "windows" in the wall of the stent opposite the three vessels, with these windows allowing the blood to flow through. This endoprosthesis however only allows treatment of aneurysms located in the lower part of the aortic arch A22 and not those situated at the junction with the three vessels in the upper part. Furthermore, insertion of this endoprosthesis is tricky, since its appearance is cylindrical: care must be taken to ensure that it does not rotate during introduction; otherwise the windows will not be positioned opposite the vessels, which would immediately constitute a risk of death for the patient.

Patent application FR1 150285 describes a new "T-shaped" thoracic endoprosthesis allowing treatment of all thoracic aortic aneurysms which proves entirely satisfactory. Nevertheless, this endoprosthesis needs almost customised production in some cases of aneurysms located between the major vessels of the arch requiring an endoprosthesis with several jambs.

A portion of the aorta furthermore remains where no endoprosthesis alone allows treatment of an aneurysm: this is the area of junction with the renal arteries A1 3. The solution involves surgically reconnecting these arteries to the aorta higher up or lower down (according to the position of the aneurysm).

It would be of value to have a "universal" endoprosthesis capable of satisfactorily treating all aortic aneurysms, regardless of their size and position, whether abdominal or thoracic and indeed with ease and at no extra cost.

PRESENTATION OF THE INVENTION The aim of the present invention is to treat all aortic aneurysms with maximum safety, while reducing the complexity of the surgical intervention.

The present invention therefore refers to an endoprosthesis fenestration device, characterised in that it comprises

a flexible elongated tube, the distal end of which is equipped with a hollow needle, with a common canal passing through said tube and needle;

a guide capable of sliding in the canal. According to other advantageous and non-restrictive characteristics:

• the device furthermore comprises an introducer in which the tube is capable of sliding;

• the tube is a catheter with a diameter of between 4 and 5 french;

· the hollow needle has a length of between 8 and 10 mm;

• the guide is of a rigidity greater than that of the tube;

• the guide is a metal wire with a diameter of approx. 0.035 inches.

According to another aspect, the invention concerns a method of fenestration of a tubular endoprosthesis implemented by means of a device according to the first aspect of the invention, characterised in that it comprises stages of:

(a) Positioning of the endoprosthesis,

(b) Introduction of the guide until in contact with the endoprosthesis at the desired fenestration point,

(c) Moving of the tube along the guide up to the endoprosthesis,

(d) Withdrawal of the guide such that it no longer protrudes from the hollow needle,

(e) Application of a pushing force on the device such as to perforate the endoprosthesis in an orifice.

According to other advantageous and non-restrictive characteristics:

• the process furthermore comprises a stage (f) of reintroduction of the guide until it passes through the orifice created;

• The process furthermore comprises a stage (g) of withdrawal of the tube, such that an insertion system of a jamb can be inserted into the orifice in order to assemble it with the endoprosthesis;

• the guide is maintained during the stage (g), said guide serving as a carrier guide for an insertion system of a jamb.

PRESENTATION OF THE FIGURES Other characteristics and advantages of the present invention will be apparent in reading the following description of a preferential embodiment. This description will be provided with reference to the appended drawings, in which:

- figure 1 described above is a diagram of the aorta;

- figure 2 is a diagram of the endoprosthesis according to the invention;

- figure 3 is a diagram of the flange of an endoprosthesis according to the invention;

- figure 4 is a perspective view of an endoprosthesis according to the invention;

- fi g u re 5 i s a d i ag ram of a dev ice fo r fen estrati on of an endoprosthesis according to the invention;

- figure 6a is a diagram of a first embodiment of an insertion system of the flange of a lateral jamb of an endoprosthesis according to the invention in the folded position;

- figure 6b is a diagram of a first embodiment of an insertion system of the flange of a lateral jamb of an endoprosthesis according to the invention in the semi-unfolded position;

- figure 7a is a diagram of a second embodiment of an insertion system of the flange of the lateral jamb of an endoprosthesis according to the invention in the folded position;

- figure 7b is a diagram of a second embodiment of an insertion system of the flange of a lateral jamb of an endoprosthesis according to the invention in the unfolded position;

- figure 8 is a diagram of an endoprosthesis according to the invention with one jamb positioned in the left subclavian artery;

- figure 9 is a diagram of an endoprosthesis according to the invention with two jambs positioned in the renal arteries.

DETAILED DESCRIPTION Principle of the invention

The endoprostheses commonly used in vascular surgery are of various different shapes. As explained above, it is known how to produce endoprostheses with one or several lateral jambs. A surgeon wishing to treat a patient thus selects an endoprosthesis, the shape of which is adapted to the location of the aneurysm and subsequently implants it in the patient's aorta.

In view of the large number of possible locations, it is therefore necessary to have several endoprostheses available. Furthermore, no two individuals will ever have exactly the same aorta and an endoprosthesis may be suitable for one person but may not be suitable for another, even though they might have the same aneurysm.

The universal aortic endoprosthesis which is the object of the invention is an endoprosthesis "in kit form" which the surgeon custom-builds for his/her patient. Consequently, the surgeon can produce any type of aortic endoprosthesis from standard building blocks. As will be described in detail further below, these bui ld ing blocks com prise a main tubu lar endoprosthesis 10 and one or several lateral jambs 100.

Structure of the assembled endoprosthesis

An endoprosthesis 1 according to the invention is represented in figure 2. It therefore comprises a main tubular endoprosthesis 10 designed to be placed in the aorta and typically consisting of a "stent graft" described above. It advantageously comprises in this case a main tubular body and at least one stent, said at least one stent being at least partially covered by the main tubular body and the main tubular body being made of a biocompatible material forming a sealed envelope, said tubular body thus recreating a cylindrical vessel isolating the pouch formed by the aneurysm from the bloodstream. The m a i n tubu lar body is therefore advantageous ly but non- restrictively made of stratified Teflon® or Dacron®, with these materials being commonly used in simple endoprostheses. Furthermore, the outer diameter and the length of the unfolded main tubular endoprosthesis 10 are advantageously chosen between 20 and 42 mm and between 100 and 150 mm respectively in order to fit perfectly with the morphology of the patients' aorta. The invention is not however limited to specific dimensions or materials. A person skilled in the art will be able to adapt it according to the case.

The stent(s) is/are for example Z-stents® (a stent consisting of a concatenation of cylindrical elements formed of a zigzagging metal wire) made of Chrome and Cobalt alloy. The size of its mesh is proportional to its diameter.

The endoprosthes i s 1 accord i ng to the i nvention furthermore comprises at least one lateral jamb 100. This lateral jamb 100, in a side and top view respectively in figure 2 and in particular in figure 4, has itself an endoprosthesis structure: it comprises a tubular jamb body 1 1 0 and a jamb stent 120, advantageously respectively similar to the main tubular body and to the at least one stent of the main tubular endoprosthesis 1 0. The jamb stent 20 is therefore, for example, in turn a Z-stent® (with a fine mesh in view of the smaller diameter).

Furthermore, the jamb stent 120 is at least partially covered by the tubular jamb body 1 1 0 and above all the proximal end 1 1 1 of the lateral jamb 100 comprising a flange 30 substantially extending in the direction of the distal end 1 12 of the lateral jamb 100 when it departs from the tubular jamb body 1 10.

Jamb flange The flange 30, shown in greater detail in figure 3, has in other words a skirt shape. This shape, described for example by international patent application WO 2004/0001 67, is known to improve the seal between the edge of a blood vessel and the endoprosthesis in some cases. It is noted that it may equally well extend towards the outside of the stent as towards the exterior.

In the endoprosthesis according to the invention, the flange 30 has an entirely different use: the lateral jamb 1 00 is in fact, as can be seen in figure 2, inserted into an orifice 130 of the main tubular endoprosthesis 10, such that the flange 30 rests on the inside surface 20 of the main tubular endoprosthesis 10. In other words, the flange 30 plays a role as a locking element of the jamb 100 and forms what may be regarded as the "barbs" of a harpoon.

It is therefore very easy to insert the flange 30 into the orifice 1 30 (with the flange 30 naturally flattening), but it can no longer come out of it again, as the bearing force on the inside surface 20 causes an increase in the opening angle of the flange 30. In order to withdraw the latter, it would be necessary to pull strongly until the flange 30 is turned inside out in the manner of an umbrella.

The assembly formed by the flange 30 and the tubular jamb body 1 10 can be realised as one- single-piece component. Alternatively, the flange 30 of the lateral jamb 1 00 is sutured to the tubular jamb body 1 10. The suture must guarantee the seal of the junction between the jamb body 100 and the flange 30. As illustrated in figure 2, this suture is advantageously offset by approximately 1 mm from the proximal end 1 1 1 of the jamb 1 00 (offset 35) in order to increase the surface of the band of the tubular jamb body 1 10 to which the suture is applied and therefore reinforce it while allowing variation in the opening angle of the flange 30.

As can be seen in figure 3, the flange 30 (when intended to be sutured to the tubular jamb body 1 1 0) advantageously comprises a flange body 32 (which is advantageously sim i lar in turn to the tubular bodies described above) displaying the shape of a truncated cone and a flange stent 31 , said flange stent 31 being covered by the flange body 32. Said flange stent 31 allows stiffening of the flange 30 and transfer of the force from the contact area with the inside surface 20 to the jamb body 1 00. It may advantageously consist of a Z-stent® distorted in order to adopt a conical shape (for example by compressing one of its ends, with the stent being naturally cylindrical).

The flange 30 may furthermore comprise a crimping wire 34 defining the distal end of the flange 30 and in other words a wire, more particularly made of metal, circling the contour of the free end of the flange 30 and stiffening the latter. The crim ping wire 34 corresponds moreover to the contact area between the flange 30 and the inside surface 20 of the main tubular endoprosthesis 1 0. The rigidity of the wire prevents the flange 30 from being damaged or even torn during assembly of the endoprosthesis 1 , during which the flange is "pressed" against the surface 20 (see below).

The truncated cone shape can be achieved by producing the flange body 32 from a circular sector (in other words a piece of a disc, the edge of which is formed by two disc diameters and two circular arcs) with flanks joined by a suture 33. A circular sector is in fact the pattern of a cone.

Lateral jamb structure

Once mounted on the main tubular endoprosthesis 10, the jamb 1 00 as illustrated in the figures departs orthogonally from the body of the main tubular endoprosthesis 10, hence the T shape. The endoprosthesis is not however restricted to th is ang le: the j am b 1 00 m ay be not perfectly cylindrical, with the proximal end 1 1 1 being cut "at a slant" in relation to the distal end 1 12. The axis of the flange 30 deviates in this case by a given angle from the axis of the remainder of the jamb 1 00 and hence once the endoprosthesis 1 is assembled, sees the jam b 1 00 deviate by the same given angle in relation to the perpendicular to the axis of the main tubular body 10.

The endoprosthesis 1 according to the invention may therefore e q u a l l y w e l l b e a " Y-shaped" endoprosthesis as a "T-shaped" endoprosthesis. It is therefore not only particularly suitable for treatment of aneurysms of the aortic arch, from which the three major arteries (the brachiocephalic arterial trunk, the left primary carotid artery and the left subclavian artery) depart at a right angle and for treatment of aneurysms at the junction with the renal arteries, but also for treatment of aneurysms of the abdominal aorta. As explained, the main tubular endoprosthesis 1 0 is indeed positioned in the aortic arch and the jamb 1 00 is inserted into one of the other arteries.

Owing to this structure the endoprosthesis 1 displays excel lent stability, presents few risks for the patient and above all allows, as has just been seen above, treatment of all aneurysms of the aorta.

The tubular jam b body 1 1 0 in addition to the flange body 32 are advantageously chosen made of stratified Teflon® or Dacron® in the same manner as the main tubular body. Furthermore, the outer diameter and the length of the unfolded tubular jamb body 1 1 0 are advantageously chosen between 4 and 16 mm and between 10 and 35 mm respectively according to the artery in which the jamb 1 00 is positioned, in order to adapt perfectly to the morphology of the arteries originating from the aorta of any patient whatsoever. The invention is not however limited to specific dimensions or materials. A person skilled in the art will be able to adapt it according to the case.

I n a particu larly preferred m anner, the endoprosthesis 1 m ay comprise two or even three jambs 1 00. The only requirement is as many orifices 130 as necessary, said orifices 130 being positioned in the correct places.

In a particularly preferred manner, on the one hand the diameter and length of the tubular jam b bodies 1 1 0a, 1 1 0b and possibly 1 1 0c of the different jambs 100a, 1 00b and possibly 100c, are respectively adapted to the several arteries in which they are inserted.

A customised multi-jamb endoprosthesis allows effective treatment of any kind of aneurysm by means of a simple surgical intervention; there is no need for surgery on the aorta. One may even consider general use of endoprostheses 1 according to the invention in the body and not only in the aorta. Examples

Figure 8 illustrates an example of an endoprosthesis 1 with one jamb 100 positioned in the left subclavian artery. The flange 30 of the jamb 100 in the open position resting against the inside surface 20 of the main tubular endoprosthesis 10 is clearly visible.

Furthermore, the axes of the jambs 100 are not necessarily parallel and may be completely offset according to the area of the aneurysm. In particular, figure 9 illustrates an endoprosthesis 1 with two diametrically opposed jambs 100 inserted into the renal arteries.

Jamb alone According to a second aspect, the invention concerns a lateral jamb

100 of an endoprosthesis as described above, taken alone. An example of a jamb 100 can be seen in figure 4.

As explained, a jamb 100 comprises a tubular jamb body 110 and a jamb stent 120, said jamb stent 120 being at least partially covered by the tubular jamb body 110, characterised in that the proximal end 111 of the lateral jamb 100 comprises a flange 30 substantially extending in the direction of the distal end 112 of the lateral jamb 100.

One may in fact consider marketing solitary jambs 100 alone for surgeons to allow the latter to combine them with conventional endoprostheses which they can subsequently use as main tubular endoprostheses 10 by creating the orifices 130 in the latter according to the position of the aneurysm to be treated and the patient's anatomy.

Method of assembly of the endoprosthesis

According to a third aspect, the invention concerns a method of assembling an endoprosthesis according to the invention. This method is particularly advantageous in that it can be employed under conditions of any kind, including directly inside the patient, remotely!

This innovative method is characterised in that it comprises stages of: (a) Positioning of a main tubular endoprosthesis 10,

(b) I nsertion of a lateral jam b 1 00 into the orifice 1 30 of the main tubular endoprosthesis 10,

(c) Moving of the lateral jamb 1 00 in the direction of its distal end 1 12 such as to bring the flange 30 to rest on the inside surface 20 of the tubular endoprosthesis 10,

(d) Inflation of a balloon 201 in the jamb 1 00 in order to unfold the latter.

The succession of stages (b) to (d) may furthermore be employed several times in order to assemble several jambs 1 00 on the main tubular endoprosthesis 10.

The idea of the method therefore involves inserting and unfolding the main tubular endoprosthesis 1 0, for example in the aorta and subsequently proceeding to bring in the jambs 1 00 folded in order to be able to insert the flange 30 into the orifice 130 without any need for the slightest force.

Hence, the lateral jam b 1 00 is advantageously kept in a folded position and the flange 30 is pressed against the lateral jam b 1 00 by a sheath 202 during stage (b) of insertion, as can be seen in figure 6a.

Two alternatives subsequently exist: it is then possible either to release the entire lateral jamb 100 by removing the sheath 202 immediately before stage (c) of m ovem ent rearwards ; preferab ly however, th is withdrawal is performed in two stages.

In this manner, the method initially comprises a stage of release of the flange 30 by partial removal of the sheath 202 immediately before stage (c) and subsequently a stage of release of the lateral j am b 1 00 by withdrawal of the remainder of the sheath 202 immediately after stage c. Therefore, at the time of stage (c) of rearwards movement of the jamb 100, the sheath 202 is in an intermediate position illustrated in figure 6b. In this position, the flange 30 is free and is therefore no longer pressed against the tubular jamb body 110, whereas the remainder of the jamb 100 is still kept folded with the jamb stent 120 being trapped under the sheath 202. This means that the diameter of the jamb remains minimal; it is therefore able to slide into the orifice 130 without the slightest resistance, while having the distal edge of the flange 30 (at the level of the crimping wire 34). When the jamb 100 is pulled rearwards, it initially moves linearly until the flange 30 contacts the inside surface 20. If traction is continued, the flange 30 distorts and increasingly opens in umbrella fashion. The opening angle, advantageously initially between 20 and 30° at the outset of stage (c), i.e. before contact, increases and may reach more than 80°. The contact surface and consequently the stability of the jamb increases.

It should be noted that this opening increases the diameter and therefore the periphery of the circle defining the distal end of the flange 30, in other words the crimping wire 34. This is why the crimping wire is advantageously folded and curled up on itself when the flange 30 is in the state of being pressed against the tubular jamb body 110 and is gradually tensioned during opening of the flange 30 following contact with the inside surface 20. The total length of the crimping wire is defined in order to correspond to the maximum opening position that is the most stable.

The remainder of the jamb 100 is subsequently released by withdrawing the remainder of the sheath 202, which results in causing the diameter of the tubular jamb body 110 to increase slightly owing to the elasticity of the jamb stent 120 (stents are generally completely or partially self-expanding, but one may however consider shape-memory materials, stents expandable on application of an electrical voltage or even pre- inflation of the balloon 201... A person skilled in the art will be able to adapt the method to use of different method of guidance and/or deployment of stents). The tubular jamb body 110 and the edge of the orifice 130 come into contact, which locks the jamb 100 in translation in the orifice 130, thereby preventing the flange 30 from moving.

The final stage (d) involves inflation of a balloon 201 (seen folded in figures 6) in the jamb 100, resulting in completion of its unfolding by significantly increasing its diameter. The edge of the orifice 1 30 bites into the tubular jam b body 1 1 0. With the orifice 1 30 distorting, this ensures perfect interlocking and a tension guaranteeing contact. The seal of the assembly is therefore impregnable and moreover at two levels for double safety: at the level of the orifice 130 as explained, but also at the level of the contact surface between the flange 30 and the inside surface 20 of the main tubular endoprosthesis 10.

It is important to note that the sequence of the stages of insertion of the jamb 100 into the orifice 130 and subsequently movement of the lateral jamb 100 in the direction of its distal end 1 12 does not necessarily imply that the jamb "advances" and subsequently "retreats".

It may for example be envisaged that the jamb be mounted on the balloon 201 in the opposite direction to that illustrated in figures 6. This embodiment can be seen in figures 7a and 7b.

The jamb 100 is in this case conveyed to the orifice 1 30 by passing through the inside of the main tubular endoprosthesis 10 and is inserted into the latter in the direction opposite to that previously described (starting with the distal end 1 1 2). The flange 30 never passes through the orifice 1 30. Once the tubular jamb body 1 1 0 has penetrated into the orifice 1 30, the sheath 202 is removed (with the jamb 100 installed backwards, the flange 30 is released last. It is therefore only possible to release the entire jamb 1 00 at a single stroke). With the flange 30 being released, stage (c) of placing the flange 30 in contact with the inside surface 20 is implemented. The jamb 100 indeed moves in the same direction as in the first case, i.e. from the proximal end 1 1 1 towards the distal end 1 1 2: it only "retracts" during the entire im plementation of the method, even if for the person performing assembly, "pushing" is rather more involved instead of "pulling".

Th i s e m bod i m ent offers a n a d v a n t a g e : t h e m a i n t u b u l a r endoprosthesis 10 and subsequently the jamb 100 are brought via the same artery. It consequently does not require any access to the artery in which it will be finally positioned. This is highly useful in the case of short arteries to which access is difficult without a dangerous and unsightly incision, for example the renal arteries (refer to figure 9): the latter, connecting the aorta to the kidneys, are only a few centimetres long and are deeply buried in the abdomen.

Principle of in situ fenestration

Assembly of the endoprosthesis according to the invention requires, as explained, orifices 130 to face the arteries in which a jamb 100 is inserted.

The surgeon can prepare his/her main tubular endoprosthesis 10 before implantation based on a standard endoprosthesis without holes and perforate the orifices 130 according to the imaging produced on the patient.

Alternatively, in a highly ingenious and particularly preferred manner, the invention proposes that the method according to the invention shall comprise an additional stage of perforation of the main tubular endoprosthesis 10 between stages (a) and (b) in order to create the orifice(s) 130, in order words that production of the orifices 130 (or "fenestration" of the main tubular endoprosthesis 10) shall be performed in situ, i.e. on a standard main tubular endoprosthesis 10 without an orifice 130 already in position and deployed.

Although surprising, this idea offers many advantages. This therefore allows adaptation of the position of the orifices 130 as perfectly as possible to the patient, hence customised adjustment of the jambs 10, without the surgeon's having to take the slightest measurement or even observe the positions of the lateral arteries in which the jambs 100 are intended to be inserted. Indeed, it is the arteries themselves that serve to guide a fenestration device 11 developed for use in combination with the endoprostheses 1 according to the invention.

Endoprosthesis fenestration device The endoprosthesis fenestration device 1 1 m entioned above comprises a flexible elongated tube 2, the distal end of which is equipped with a hollow needle 4, with a common canal 3 passing through said tube 2 and needle 4, in addition to a guide 5 capable of sliding in the canal 3.

It i s i l l u strated i n f i g u re 5. As ca n be seen i n th i s fi g u re , it advantageously comprises an introducer 6 in which the tube 2 is capable of sliding. The introducer 6 is an object commonly used for catheter insertion and also easily allowing introduction of the fenestration device 1 1 into the patient's artery. In this case, it involves in particular a non-peelable long introducer, i.e. a cylindrical sheath, the length of which may sometimes exceed 100 cm.

The device 1 1 corresponds to a cutting tool remotely movable on a "rail" formed by the guide 5, advantageously a 0.035-diameter standard metal wire, inside the introducer 6 which protects the walls of the vessels passed through from any injury that might be caused by the needle 4. The tube 2 sliding on this guide 5 is advantageously a catheter with a diameter of between 4 and 5 french (the unit commonly used to measure catheter diameter, also known as "Charriere" and equal as a reminder to a third of a mi l l im etre) , with the d iam eter of the canal 3 bei ng chosen such that movement on the guide 5 is possible without any particular resistance and the diameter of the introducer being likewise selected such that movement of the tube 2 is possible without any particular resistance.

The material of the tube 2 is advantageously a material of rigidity less than that of the material of the guide 5, typically a flexible biocompatible plastic. This is advantageously also the case with the introducer 6.

The hollow needle 4 is the organ of the fenestration device 1 1 that in particular allows perforation of the main tubular endoprosthesis. Hollow needle implies for example a syringe needle with a bevelled shape, having a sharp elliptical edge at least at its highest point (in this case, the orifice 130 is created by forcibly stretching the fibres of the endoprosthesis 1 0 starting from the initial perforation and by pushing any metal wire of a stent of the main tubular endoprosthesis 1 0 which the needle 4 might encounter. This embodiment is interesting if an orifice 1 30 of small size is desired and advantageously over almost its entire periphery (a "hinge" is formed in the uncut area). Indeed if the needle were sharp over its entire periphery, a piece of "confetti" corresponding to the disc of cut out material would fall into the aorta.

A needle of this kind is provided with a canal substantially coinciding with the canal 3 of the tube 2. This allows the end of the guide 5 to also slide through the hollow needle 4 until it protrudes from the end of the latter. I n such a configuration (the guide 5 protruding from the needle 4), the needle cannot prick even if it were to project from the end of the introducer 6. The needle 4 can therefore be safely moved along the guide 5 in the pat i e nt' s a rte ry th ro u g h t h e i ntrod u ce r 6 u p to the main tubular endoprosthes is 1 0. Al l that is needed in order to m ake the need le 4 operational is to slightly withdraw the guide 5 such that the pointed end of the need le 4 once again protrudes. Th is hol low need le 4 of an outer diameter substantially coinciding with the outer diameter of the tube 2 advantageously has a length of between 8 and 10 mm.

Perforation is achieved by applying a pushing force simultaneously to the tube 2 and the guide 5. The latter serves as a force "carrier": the fact that it is highly rigid means that the force is almost completely transm itted from the distal end of the device 1 1 to the needle 4. fenestration process The fenestration device 1 1 described above allows implementation of a method of fenestration of a tubu lar endoprosthesis 1 0. This method comprises stages of:

(a) Positioning of the endoprosthesis 10,

(b) Introduction of the guide 5 until in contact with the endoprosthesis 10 at the desired fenestration point,

(c) Moving of the tube 2 along the guide 5 up to the endoprosthesis 10, (d) Withdrawal of the guide 5 such that it no longer protrudes from the hollow needle 4,

(e) Application of a pushing force on the device 1 1 such as to perforate the endoprosthesis 10 in an orifice 130.

The same stages mentioned in the preceding section are to be found.

Following the stage (e), the fenestration process advantageously comprises in addition a stage (f) of reintroduction of the guide 5 until the latter passes through the orifice 130 created, in other words, of movement of the guide 5 again in the canal 3 until the needle 4 no longer projects and subsequently until the guide 5 enters the orifice 1 30 and therefore penetrates into the tubular endoprosthesis 10.

The fenestration process may furthermore comprise a stage (g) of withdrawal of the tube 2, such that an insertion system of the flange 30 of a jamb 10 can be inserted into the orifice 130 in order to assemble this jamb

100 with the main tubular endoprosthesis 10.

Flange insertion system According to a fourth aspect, the invention concerns an insertion system of the flange 30 of a lateral jamb 1 00 into an orifice 1 30 of a main tubular endoprosthesis 10 which can be used particularly for implementation of the stages (b) to (d) of the assem bly method described above. This system allows introduction of the folded lateral jamb 1 00 into the patient's vascular system up to the main tubular endoprosthesis already in position, its remote guidance to the deployment point (in particular an orifice 130) and subsequently its introduction and delivery at this point after deployment.

This insertion system visible in figures 6 comprises in addition to the jamb 1 00, the sheath 202 mentioned above, a balloon 201 (also mentioned above) and a guide 203 interdependent with the balloon 201 , said lateral jam b being mounted on the balloon 201 , the sheath 202 enclosing the lateral jamb 1 00 such as to keep the jamb stent 120 folded and press the flange 30 against the lateral jamb 100.

The guide 203, for exam ple a conventional guide 0.035 inches in diameter, advantageously has a carrier guide longitudinally passing through it on wh ich it is capab le of m ovi ng . I n a particu larly advantageous embodiment, this carrier guide is the guide 5 of a fenestration device 1 1 : once fenestration is com pleted (during stage (g) of the fenestration process), the tube 2 is removed but not the guide 5 and the insertion system is mounted on this guide 5. The intervention is shortened accordingly.

The guide 203 allows movement of the balloon 201 and therefore of the jamb 1 00 crimped to the balloon 201 (for as long as the jamb stent 120 is folded, it encloses the balloon 201 ). The three elements move in one single piece. In this condition, only the sheath 202 is capable of moving in relation to them.

The guide 203 thus allows the change in position of the jamb 1 00 required during stage (c) of the method according to the invention. By holding the guide 203 immobile in relation to the sheath 202, the movement of the jamb 1 00 is controlled both in propulsion and in traction. All that is needed is to allow the sheath 202 to move in relation to the guide 203 in order to induce its controlled withdrawal from the surface of the jamb 1 00 and therefore release of the flange and subsequently the entire jamb 100.

Following inflation of the balloon 201 and complete deployment of the jamb 100, the balloon 201 is deflated and the jamb 100 detaches itself from the latter. It is subsequently completely released and the guide 203 can be withdrawn taking the balloon 201 .

The invention is not however limited to this particularly advantageous insertion system and the person skilled in the art will be able to use known systems. Assembly kit According to a fifth aspect, the invention concerns an assembly kit for an endoprosthesis of the kind described above, characterised in that it comprises a main tubular endoprosthesis 10 and at least one lateral jamb 1 00, said at least one lateral jam b 1 00 being mounted on an insertion system also described above.

This kit, which can be marketed in sterile packaging, contains all the elements required in order to assemble an endoprosthesis 1 according to the invention. It could also be marketed with the endoprosthesis fenestration device 1 1 .

Complete implantation of the endoprosthesis

Implantation of the endoprosthesis 1 according to the invention using the method(s) described above only requires a few tiny incisions: an incision from below (at the level of the femoral artery) and an incision from above (in one or several arteries allowing access to the arteries in which the jamb 100 wi l l be i nserted , for exam ple the carotid artery, one of the hum eral arteries... ); it is however possible to dispense with this second incision in some cases as described above. It is performed by an operating surgeon.

Implantation, a particularly advantageous embodiment of which will now be described, begins by introduction via the femoral route of a delivery guide followed by the folded main tubular endoprosthesis. The latter is positioned in the patient's aorta at the required site using known methods.

The free end of the g u ide 5 of the fenestrati on dev ice 1 1 is subsequently introduced, either through the second incision or through the first in the case of implantation with a single incision. It should be noted that in the case of a single incision, it remains preferable to create the orifices 130 before inserting the main tubular endoprosthesis 10. Indeed, if the main tubular endoprosthesis is in a straight section of aorta from which the lateral a rte ry i n wh i ch th e j a m b 1 00 i s to be p laced departs substantially orthogonally, it is only possible to create the orifice 130 by approaching from this lateral artery and therefore from another incision. The device 1 1 inserted into the aorta would move in fact tangently in relation to the wall of the main tubular prosthesis 10 without coming into contact with the latter.

In the exam ple of a jamb 1 00 to be inserted into an artery of the aortic arch, the guide 5 is inserted from above by means of an introducer 6 (the latter being subsequently peeled) unti l it contacts the wal l of the endoprosthesis 10 already installed in the aortic arch. The continuation of the endoprosthesis fenestration process is implemented.

Once the orifice 1 30 has been obtai ned with the gu ide bei ng introduced into the latter, the jam b 1 00 is in turn introduced from above, mounted on its insertion system for the flange 30, the guide 203 of which (the guide on which the balloon 201 is crimped) is threaded on to the guide 5.

The jamb 100 is guided to the aorta. This stage in addition to all the others is advantageously monitored by medical imaging, with the guides being radiopaque.

The assembly method of the endoprosthesis 1 based on the main tubu lar endoprosthesis 1 0 and the j am b 1 00 descri bed above can subsequently be implemented . The sheath 202 , the gu ide 203 and its deflated balloon 201 and finally the guide are subsequently successively withdrawn from the upper incision.

The endoprosthesis 1 is then completely positioned. The stages of fenestration and subsequently insertion of a flange 30 in case of multiple jambs 100 can be repeated via another incision.

An operation of th is kind only lasts a few m inutes and presents almost no risk to the patient, unlike the major surgical interventions required up to now in the case of many aortic aneurysms.

Claims

1. Endoprosthesis fenestration device, characterised in that it comprises

a flexible elongated tube (2), the distal end of which is provided with a hollow needle (4), with a common canal (3) passing through said tube (2) and needle (4);

a guide (5) capable of sliding in the canal (3).

2. Device accord i ng to the above clai m , furtherm ore comprising an introducer (6), in which the tube (2) is capable of sliding.

3. Device according to any of the above claims 1 to 2, in which the tube (2) is a catheter with a diameter of between 4 and 5 french.

4. Device according to any of claims 1 to 3, in which the hollow needle (4) has a length of between 8 and 10 mm.

5. Device according to any of claims 1 to 4, in which the guide (5) has rigidity greater than that of the tube (2).

6. Device according to claim 5, in which the guide (5) is a metal wire with a diameter of approx. 0.035 inches.

7. Method of fenestration of a tubular endoprosthesis (10) implemented by means of a device according to any of the above claims, characterised in that it comprises stages of:

(a) Positioning of the endoprosthesis (10),

(b) Introduction of the guide (5) until in contact with the endoprosthesis

(10) at the desired fenestration point, (c) Moving of the tube (2) along the guide (5) up to the endoprosthesis (10),

(d) Withdrawal of the guide (5) such that it no longer protrudes from the hollow needle (4),

(e) Application of a pushing force on the device ( 1 1 ) such as to perforate the endoprosthesis (10) in an orifice (130).

8. Method of fenestration according to the above claim, furthermore comprising a stage (f) of reintroduction of the guide (5) until it passes through the orifice (130) created.

9. Method of fenestration according to claim 8, furthermore comprising a stage (g) of withdrawal of the tube (2), such that an insertion system of a jamb (1 00) can be inserted into the orifice (130) in order to assemble it with the endoprosthesis (10).

10. Method of fenestration according to claim 9, in which the guide (5) is maintained during the stage (g), said guide (5) serving as a carrier guide for an insertion system of a jamb.