GB2437058A

GB2437058A - Kit for endovascular repair

Info

Publication number: GB2437058A
Application number: GB0607332A
Authority: GB
Inventors: Peter Lyon Harris
Original assignee: VORTEX INNOVATIONS Ltd
Current assignee: VORTEX INNOVATIONS Ltd
Priority date: 2006-04-12
Filing date: 2006-04-12
Publication date: 2007-10-17
Also published as: GB0607332D0

Abstract

In repairing aneurysms in blood vessels with expandable grafts side vessels may be covered. To overcome this problem one or more fenestrations are formed in the graft in-situ. The graft may be perforated from the blood vessel or from the side vessel. The kit comprises a graft; a catheter for delivery and positioning of the graft; and a device for endovascular penetration of the graft at the location of the side vessel. The graft may be standard or initially perforated and the perforations enlarged from the inside of the graft by means of one or more side balloons 31 on the catheter to form fenestrations or openings. These fenestrations may be further supported and maintained by stents placed in the side vessels 16 which stents can be delivered from either side of the fenestration. The catheter may be a multi-lumen balloon catheter with a lumen for inflation and one or more lumens for guide wires which extend through side balloons into side vessels. Alternatively the graft can be perforated from the side vessel by means of a cutting catheter or an inflatable catheter with a cutting wire.

Description

Vascular Graft The present invention relates to vascular grafts.

Particularly, but not exclusively the present invcntion relates to a vascular graft for the repair of aneurysms.

An aneurysm is a localised dilation of a blood vessel. There are several known causes of aneurysms including congenital weakness in the vessel wall, hypertension, disease, bacterial or fugal infection or trauma. While aneurysms can occur in any vessel they most commonly occur in the vessels at the base of the brain (intra cranial aneurysm) and in the aorta (aortic aneurysm). If left untreated an aneurysm may become progressively larger and there is a serious risk of a sudden rupture of the weakened vessel wall leading to potentially life-threatening haemorrhaging.

Accordingly, dependent upon the size of the dilation of the aneurysm, surgical repair may he necessary.

Conventional repair of an aortic aneurysm is by open surgery. For example, a cut is made in the abdomen or chest and the abnormal blood vessel is replaced by a synthetic graft. Alternatively the abnormal blood vessel may be left in situ with a surgical graft placed within or around the abnormality. More recently, techniques have been developed for repairing abnormal blood vessels by minimally invasive surgical methods (i.e. surgery which is performed without making a major incision or opening).

In these techniques a small incision is typically made in the patients groin area and a catheter used to guide a graft along the blood vessels and to position it within the abnormal section of the blood vessel. This procedure is known in the art as Endovascular repair, and in the case of repair of aortic aneurysms "Endovascular Repair of Aortic Aneurysm" (or EVAR). Endovascular techniques have been found to provide a lower mortality rate and facilitate a faster recovery following the operation.

Known grafts which are suitable for use in EVAR (which may be referred to in the art as "endografts") may typically comprise a supporting structure, or stent, and an associated membrane (for example a PTFE or DacronTM polyester tube) which, once in position, lines the abnon-nal section of the blood vessel. Over time the aneurysm may shrink around the graft.

The graft must be collapsible to facilitate endovascular delivery. Once in position the graft may be inflated using an inflatable catheter or balloon. Alternatively, the stent may be arranged to self-expand upon release by the delivery device. For example, a self-expanding graft may comprise a stent having a memory metal structure (for example, formed of stainless steel or nickel titanium alloy).

Depending upon the profile of the vessel into which the graft is being placed it may simply be a straight section or may be bifurcated to allow placement within the region of a vessel junction, such as the division of the aorta into the two common iliac arteries.

One problem with deploying a graft within the aorta is that there are numerous side branches from the blood vessel that may be covered when the graft is positioned.

As such, grafts are made suitable for use in EVAR having a plurality of fenestrations in its membrane to allow for the existence of side branches along the portion of the vessel within which the repair is required.

The graft also needs to be of adequate length beyond such fenestration to provide for a good seal zone between the graft and the artery.

All such grafts are customized for individual patients. The position of the fenestrations is determined from CT scans of the patient. This requires a high level of technical skill, considerable time (delay) and cost.

It is an object of the present invention to obviate or mitigate the above problems.

Accordingly, a first aspect of the present invention provides a method of endovascular repair of an aneurysm, comprising the steps of: positioning a graft within an abnormal section of the vessel, such that the graft covers at least one side vessel; and perforating the graft at the location of the at least one side-vessel.

The side vessel(s) may be intentionally covered, so as to extend the sealing zone between the endo graft and the artery, particular when the aneurysm is close to the side vessels. Alternatively, the side vessel(s) could be accidentally covered as a complication of a standard EVAR procedure; as such the present invention may provide an emergency procedure for use during EVAR. Once the perforation has been performed it will be appreciated that the present invention allows the target vessel or organ to be perfused.

Examples of side vessels to which the present invention may be applied include the sub-clavian artery, the carotid artery and the brachio-cephalic artery from the aortic arch. The branches of the abdominal aorta to which the invention could, for example, be applied include the renal artery, the coeliac trunk and the superior mesenteric artery (the SMA). Other branches to which the method could be applied will be apparent to those skilled in the art.

It will be appreciated that depending upon the position of the graft within the body either a single vessel or a plurality of side vessels may be covered.

The perforation of the graft could be carried out in several ways, the particular method chosen may depend upon a number of factors such as the location of the aneurysm, which side vessel has been covered and the type of graft that has been used.

In one embodiment the graft may be perforated from the inside (i.e. from the aorta into the branch vessel). In other embodiments it may be preferred to perforate the graft from the vessel which has been covered (i.e. into the aorta).

The device for perforating the graft must be suitable for endovascular use and can preferably be operated via a catheter. The preferred perforation device will depend upon several factors, for example the material from which the graft is made and the position of the required opening, however a needle, stiff wire or heating system could be used to make the initial perforation. In one currently preferred embodiment the perforation takes the form of a linear incision or cut and most preferably a plurality of crossed linear incisions or cuts.

It is important that perforation of the graft is substantially centralised, so as to avoid stress being created on the graft. To that end we propose use of a catheter having means for centralisation thereof within the ostuim of a side branch, such a catheter preferably is a balloon catheter wherein the balloon is at the end of the catheter. Thus, the end of the catheter may be positioned in the ostium without extending into the artery and inflation of the balloon will locate and substantially centralise the catheter. Thus, a perforating device, such as a perforating wire can be fed through the catheter to perforate the graft substantially centrally of the side vessel.

It is to be noted that conventional balloon catheters have their expandable balloon positioned away from the end of the catheter.

Accordingly another aspect of the invention provides a balloon catheter having its expandable balloon at an end of the catheter.

Another way of perforating the graft through a side vessel may be to use a catheter having its end provided with a cutting edge. Such a catheter preferably has a withdrawable sheath to cover the cutting edge as the catheter is fed through an arnterial side vessel, in order to protect the side vessel from damage. A wire fed through the catheter may be used to perforate the graft initially followed by withdrawal of the sheath and completion of the perforation by means of the cutting edge of the catheter.

The cutting edge of the catheter is preferably formed at an angle to the axis of the catheter, so that it forms a point.

Accordingly a further aspect of the invention provides a catheter having a cutting edge at one end.

According to a second aspect of the present invention, there is provided a kit for endovascular repair of an aneurysm comprising: a graft; a catheter for endovascular delivery and positioning of said graft; and a device for endovascular penetration of the graft at the location of a side vessel.

After perforating the graft at the side vessel location the perforation is preferably enlarged to form a fenestration, which enables a sufficient flow of blood to the target side-vessel. Thus, in its preferred embodiment at least, the present invention may provide a method and kit for performing in-situ fenestration during EVAR.

In one embodiment the enlargement could be achieved by using, subsequently to the initial perforation, a catheter having a larger penetrating device (such as a needle or wire). Progressively larger devices could then be sequentially used until the fenestration was of the desired size. Preferably, however, the initial penetration is enlarged using a suitably sized inflatable catheter or balloon, which may be carefully positioned within the initial perforation before being inflated so as to stretch the initial perforation. For example a standard percutanious trans-luminal angioplasty (or PTA) balloon could be used. Such balloons are conventionally used to open up blocked or narrowed arteries.

In other embodiments a cutting balloon may be used. in further embodiments a vascular or cardiac coronary balloon could be utilised. Other devices that may be of use for perforating and/or enlargement to form a fenestration include percutaneous nephrostomy devices.

Thus, in a preferred embodiment the method according to the first aspect of the present invention further comprises the step of enlarging the perforation to form a fenestration by means of a balloon. The kit of the second aspect preferably further comprises a balloon suitable for endovascular insertion and inflation.

When perforating the graft and/or expanding the perforation into a fenestration, care must be taken not to damage the graft. For example, it may be desirable to ensure that the perforation avoids the graft stent. Thus, in a preferred embodiment a modified graft comprises at least one non-stented portion in a region where a fenestration may be required. A specifically adapted graft may be provided with areas suitable for forming a fenestration at locations which are likely to coincide with a side vessel when placed within the abnormal vessel. Alternatively the graft may simply be provided with regularly spaced areas suitable for perforation. For example, in a preferred embodiment the graft may comprise a wide spacing stent. In a further embodiment a graft comprises a plurality of stents with a space between adjacent stents.

Therefore, the method or kit of the preferred embodiment may comprise a standard graft or may comprise a graft which is specifically adapted to provide a region adapted to be perforated in-situ.

Various materials may be suitable for forming a graft. In a preferred embodiment the graft comprises PTFE, which has the advantage of being easy to perforate. However, in other preferred embodiments the graft may comprise Dacron, which is more resistant to initial perforation but which the applicant considers to be stronger and thicker than a PTFE graft.

In some embodiments it may be sufficient to simply leave the enlarged opening as a fenestration in front of the targeted vessel. Preferably, however, the fenestration is reinforced to improve the stability of the hole in the graft. Preferably the reinforcement extends around substantially the entire circumference of the opening formed in the graft.

In some embodiments the re-enforcement may comprise a reinforcement ring.

Preferably, the reinforcement comprises a stent extending from the interior of the graft into the target vessel. Preferably, the stent has a tubular structure. Preferably the stent lines at least a portion of the side vessel, preferably the portion adjacent to the junction of the vessels. In some embodiments the stent may be a covered stent.

Thus, it will be appreciated that the method in accordance with the first embodiment of the present invention may further comprise positioning a stent within the perforation of the graft and the kit according to the second aspect of the present invention may further comprise a stent for positioning within the graft.

Stents used in the invention may be self expanding, such as those including shape memory reinforcement, whilst others may be balloon expandable.

Preferably once positioned within the graft a portion of the stent extends into the interior of the graft. This inner portion of the tubular stent may be bent outwardly in its radial direction so as to form a flange, which is flattened against the inner wall of the graft. Thus, the inner portion of the stent will not obstruct flow within the graft and the flange will act to appose the fabric at the margins of the fenestration against the wall of the vessel.

More preferably the stent has a self-flaring neck portion. The neck portion may be made of shape memory material. Such a stent may be delivered through the artery or side vessel in a sheath and then after positioning the sheath is withdrawn allowing the shape memory neck portion to flatten against the inner wall of the arterial graft.

In a preferred embodiment, the invention may utilise a novel inflatable catheter. The balloon or inflatable catheter preferably comprises a multi-lumen conduit having a first lumen arranged to supply fluid to the catheter for inflation and at least one further lumen arranged to allow a guide wire to be passed through the catheter and into a side vessel. To this end, a third aspect of the present invention provides an inflatable catheter comprising a multi-lumen conduit having a first lumen arranged to supply fluid to the catheter for inflation and at least one further lumen arranged to allow a guide wire to be passed through the catheter and into a side vessel. It is to be appreciated that the catheter according to the third aspect is preferably used in the method of the first aspect and included in the kit according to the second aspect of the present invention.

The inflatable catheter preferably comprises a first portion comprising a compliant body to provide good anchorage with the abnormal vessel, for example the aorta, and to be adaptable for use in different positions. The inflatable catheter preferably further comprises at least one side balloon, which is arranged to extend from the abnormal vessel into the side vessels. The side balloon may preferably be non-compliant (for example, similar to a PTA balloon) to prevent injury. Preferably the inflatable catheter comprises two side balloons, which may preferably be in opposed positions on the inflatable catheter. The conduit preferably comprises a lumen for directing a wire through each side balloon into a side vessel. The advantage of such an arrangement is that it permits the balloon to expand/inflate thus flattening the proximal end of the stent to provide a neck for securing the stent within the fenestration of the graft without damaging the distal end of the stent.

It will be appreciated that the inflatable catheter could be used for expanding a perforation to form a fenestration and/or expanding and locking in position the stents positioned in the fenestration.

All of the features described herein (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined with any of the above aspects in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Other preferred features of the invention will become apparent from the

description below.

Specific embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: 1 5 Figure 1 is a perspective schematic showing a section of graft following an initial perforation; Figure 2 is a perspective schematic showing a balloon being used to enlarge the initial perforation; Figure 3 is a schematic representation of a graft in-situ, wherein the graft further comprises stents extending into side vessels; Figure 4 is a schematic representation of the graft of figure 4, wherein the stents have been bent into position; and Figure 5 is a schematic representation of a balloon for use in the preferred embodiment; Figure 6 is shows a balloon catheter for use in the invention; Figure 7 shows how the balloon catheter of Figure 6 may be made; Figure 8 shows a deployment of the balloon catheter of Figure 6; Figure 9 shows a delivery system for a self-expanding stent; Figure 10 shows a deployed self-expanding stent; and Figure 11 shows a cutting catheter for use in the invention.

According to the preferred embodiment a graft 1 for use in repairing an abdominal aortic aneurysm comprises a tubular membrane 2 formed from PTFE and a stent 3 formed from NitinolTM memory alloy or shape memory alloy. The stent is arranged so as to support the graft in position and to be collapsible to allow transluminal placement by means of a catheter.

Once positioned and expanded within the aorta the graft may intentionally or accidentally cover a side vessel, thereby impeding blood flow to the vessel. Thus, in preferred embodiments, a fenestration is formed in the graft in-situ (i.e. while in position within the aorta) at the location of the side vessel. The first step of forming the fenestration is to perforate the graft using a catheter. As shown in figure 1 the perforation 5 may be cross cut to allow subsequent enlargement. A balloon 10 may be used to enlarge the perforation 5 as shown in figure 2.

The applicant carried out a simple experiment to compare the effect of different methods of forming the fenestration on the graft. The tensile strength of sections of PTFE graft membrane having a fenestration therein was compared to a section of a non-perforated graft. Three different methods of performing an in-situ fenestration were used for comparison. The methods compared were: a properly cut circular hole; a needle perforation enlarged using a balloon; and a cross blade cut enlarged using a balloon. After creating the fenestration, the membrane of each graft (and that of an un-perforated graft) was carefully removed from the stent and cut into a small piece (20mm by 50mm) with the fenestration at the centre. A tensile testing machine was then used to test the yield strength and strain of the pieces.

The un-perforated section of graft ruptured at 48N (having stretched by approximately 7mm). The section of graft having a properly cut hole fenestration ruptured at 21 N (having stretched by approximately 5mm). The section of graft having a properly cut hole ruptured at 21N (having stretched by approximately 5mm). The section of graft having a cross-cut, balloon enlarged fenestration ruptured at 32N (having stretched by approximately 6mm). The section of graft having a needle perforation, balloon enlarged fenestration ruptured at 22N, having stretched by 5mm.

Thus, it can be seen that the cross-cut, balloon enlarged fenestration was found to have significantly less effect on the yield strength than a properly cut hole or a needle perforated, balloon enlarged fenestration.

Figure 3 represents the graft I of the preferred embodiment positioned within the aorta 15. Two side vessels 16 have been covered by the graft 1 which has, therefore, been provided with fenestrations 5 to perfuse the side-vessels. A stent 20 has been positioned within each fenestration 5 extending from within the graft I (and, therefore, the aorta) into the side vessel 16. The stents serve to support and maintain the fenestration at the side vessel junction. Once positioned the interior end of each stent 20 may be flattened against the inside of the graft 1 to prevent it inhibiting the flow of blood within the graft I and to provide a flange 21 to appose the fabric at the margin of the fenestration 5 against the wall of the vessel as shown in Figure 4.

A specially adapted balloon may be used to perform the expansion of the perforation and/or the bending of the end of the stent to form the flange 21. As seen in Figure 5, one such balloon comprises a triple lumen conduit 25 and a substantially cross-shaped balloon 30, having two side balloons 31. The main body 32 of the balloon is a compliant body to provide good anchorage within the aorta. The side balloons 31 are non-compliant bodies (similar to a PTA balloon). The triple lumen conduit 25 comprises an inflation lumen having an opening 26 at its end, and two lumen associated with the side balloons each having a respective openings 27 and 28 at there end. Thus a guide wire or the like can be directed through the openings 27 and 28, along the lumen through the balloon and into the side vessel.

Referring to Figures 6, 7 and 8, there is shown a balloon catheter 50 for use in perforating an arterial graft 52 substantially centrally within the opening of a side vessel 54.

A characteristic of this catheter is that the balloon is located at the tip and is flat ended.

The balloon catheter 50 comprises a main catheter tube 56 over which is a flexible sheath 58 having an expandable portion 60 at the leading end of the catheter tube. In Figure 6, the expandable portion or balloon 60 is shown inflated but the catheter will, of course, be inserted with the balloon deflated. The balloon is expanded by introduction of fluid between the sheath 58 and the tube 56. The tube does not protrude beyond the end of the balloon.

It is possible to make a balloon catheter 50 as shown in Figure 7 by securing an end of the sheath 58 onto the end of the tube 56 at 62 with the sheath extending away from the tube, folding the sheath back over the tube and providing a second securement 1 5 64 spaced from the first to create the expandable or balloon portion.

The balloon catheter 50 can be positioned in the side vessel 54 with the balloon portion 60 right at the end of the side vessel (see Figure 8). Then, when the balloon is inflated the catheter tube 56 becomes centralised, so that a cutting wire 68 or a cutting catheter 100 (see Figure 11) deployed through the catheter tube can create an opening through the graft 52 generally centrally of the side vessel. In this way undue stress on the grail in the region of the side vessel opening may be avoided.

Turning to Figures 9 and 10, where it is described to provide a side vessel stent, such a stent may be delivered either through the artery 76 or through the side vessel 78.

For example, deployment in a renal artery will need to be through the aorta itself. A suitable side vessel stent 80 has a self-flaring flange 82.

The flange 82 is of shape memory metal, so that it can be delivered in a constrained condition and then released to flare and anchor the stent in position (see Figure 10).

The flange 82 can be welded onto the struts of the stent 80, so that the stent can be of the self-expanding or the balloon expanding type.

Figure 9 of the drawings shows a delivery system for the stent 80 when it is to be delivered to, for example, a renal artery through the aorta. A catheter 84 carries the stent 80 with the neck portion 82 away from the leading end of the catheter. The flared 82, is constrained within a withdrawable sheath 86. The catheter carrying the stent is fed in through the aorta and the stent manoeuvred into the renal artery. Then the sheath 85 is withdrawn and the shape memory flange 84 opens out to grip the margin of the fenestration. The body of the balloon or self-expanding stent can then be deployed within the target side branch.

When the stent 80 is to be delivered from a side branch to the oarta. A catheter carries the stent with the flared portion 82 at the leading end of the catheter. The flared portion 82 is constrained within the sheath 86 (see Figure 11). The catheter carrying the stent is fed in through the side branch. The flanged portion is released within the lumen of the endograft. The stent is then positioned within the end of the side branch such that the fabric at the margin of the fenestration is apposed against the wall of the aorta by the flange. The body of the stent is then released or balloon inflated to secure it within the side branch.

Finally, Figure 12 shows a cutting catheter 100 for use in perforating a graft 102 for communication with a side vessel 104. The cutting end 106 of the catheter may be shaped to improve its efficiency on a cutting tool. The cutting end of the catheter is covered by a sheath 108 for deployment of the catheter to prevent damage being caused to the side vessel 104. Once the catheter is in cutting position, the sheath is withdrawn and the catheter can be pushed forward to cut through the graft. A wire 110 through the catheter may be used as a cutting guide.

Claims

CLAIMS

1. A method of endovascular repair of an aneurysm, comprising the steps of: positioning a graft within an abnormal section of the vessel, such that the graft covers at least one side vessel; and perforating the graft at the location of the at least one side-vessel.

2. The method of claim 1, further comprising the step of enlarging the perforation so as to form a fenestration.

3. The method of claim 2, wherein the perforation is enlarged by means of an inflatable catheter or balloon.

4. The method of claim 2, wherein the perforation is enlarged by a catheter having 1 5 a cutting end.

5. The method of claim 2, 3 or 4, further comprising the step of reinforcing the fenestration.

6. The method of claim 5, wherein the reinforcement extends around substantially the entire circumference of the fenestration.

7. The method of any one of claims 2 to 6, further comprising positioning a stent within the fenestration.

8. The method of claim 7, wherein the stcnt is positioned so as to extend into the side vessel.

9. The method of claim 8, wherein the stent is arranged so as to line at least a portion of the side vessel.

10. The method of claim 7, 8 or 9, wherein the stent has a self-expanding neck portion for anchoring within the graft.

11. The method of any preceding claim, wherein the step of perforating the graft comprises making an incision.

12. The method of claim 11, wherein the step of perforating the graft comprises making a plurality of crossed incisions.

13. A kit for endovascular repair of an aneurysm comprising: a graft; a catheter for cndovascular delivery and positioning of said graft; and a device for endovascular penetration of the graft at the location of a side vessel.

14. The kit of claim 13, further comprising a device for enlarging the penetrated portion of the graft to form a fenestration.

15. The kit of claim 14, wherein the enlarging device comprises a balloon suitable for endovascular insertion and inflation.

16. The kit of claim 15, wherein the balloon comprises a percutaneious trans-lurninal angioplasty balloon.

17. The kit of claim 14, wherein the enlarging device comprises a percutaneous nephrostomy device.

18. The kit of claim 14, wherein the enlarging device is a catheter having a cutting end.

19. The kit of any of claims 13 to 1 8, further comprising a device for reinforcing the perforated region of the graft.

20. The kit of claim 19, wherein the reinforcement device comprises a stent for positioning within the graft.

21. The method or kit of any preceding claim, wherein the graft is adapted to provide a region suitable for perforation.

22. The method or kit of as claimed in claim 21, wherein said region comprises at least one non-stented portion.

23. The method or kit of as claimed in claim 21 or 22, wherein the graft comprises a plurality of stents with a space between adjacent stents.

24. An inflatable catheter comprising a multi-lumen conduit having a first lumen arranged to supply fluid to the catheter for inflation and at least one further lumen arranged to allow a guide wire to be passed through the catheter and into a side vessel.

25. The inflatable catheter as claimed in claim 24, having a first portion comprising a compliant body.

26. The inflatable catheter of claim 24 or 25, further comprising at least one side balloon, arranged to extend into a side vessel.

27. The inflatable catheter of claim 26, wherein the at least one side balloon comprises a non-compliant body 28. The inflatable catheter of any of claim 26 or 27, comprising a pair of opposed side balloons.

29. The inflatable catheter of any of claims 23 to 25, wherein the guide wire may extend through the at least one side balloon into the side vessel.

30. An inflatable catheter as claimed in any one of claims 24 to 29 for use in the method or kit of any one of claims 1 to 23.

31. A balloon catheter having its expandable balloon at an end of the catheter.

32. A catheter having a cutting edge at one end.

33. A method of endovascular repair of an aneurysm substantially as hereinbefore described with reference to the accompanying drawings.

34. A kit for endovascular repair of an aneurysm substantially as hereinbefore described with reference to and as illustrated in any of the accompanying drawings.

Amendments to the claims have been filed as follows Claims 1. A kit for endovascular repair of an aneurysm comprising: a graft; a catheter for endovascular delivery and positioning of said graft; and a device for endovascular penetration of the graft at the location of a side vessel, wherein the catheter comprises a multi-lumen conduit having a first lumen arranged to supply fluid to the catheter for inflation and at least one further lumen arranged to allow a guide wire to be passed through the catheter and into a side vessel.

2. The kit of claim 2 further comprising a device for enlarging the penetrated portion of the graft to form a fenestration.

3. The kit of claim 2, wherein the enlarging device comprises a balloon suitable for endovascular insertion and inflation.

4. The kit of claim 3, wherein the balloon comprises a percutaneous trans-luminal angioplasty balloon.

5. The kit of claim 2, wherein the enlarging device comprises a percutaneous nephrostomy device.

6. The kit of claim 2, wherein the enlarging device is a catheter having a cutting end.

7. The kit of any of claims 1 to 6 further comprising a device for reinforcing the perforated region of the graft.

8. The kit of claim 7, wherein the reinforcement device comprises a stent for positioning within the graft.

9. The kit of any preceding claim, wherein the graft is adapted to provide a region suitable for perforation.

10. The kit as claimed in claim 9, wherein said region comprises at least one non-stented portion.

11. The kit as claimed in claim 9 or 10, wherein the graft comprises a plurality of stents with a space between adjacent stents.

12. An inflatable catheter comprising a multi-lumen conduit having a first lumen arranged to supply fluid to the catheter for inflation and at least one further lumen arranged to allow a guide wire to be passed through the catheter and into a side vessel.

13. The inflatable catheter as claimed in claiml2 having a first portion comprising a compliant body.

14. The inflatable catheter of claim 12 or 13 further comprising at least one side balloon, arranged to extend into a side vessel.

15. The inflatable catheter of claim 14, wherein the at least one side balloon comprises a non-compliant body 16. The inflatable catheter of claim 15 or 16 comprising a pair of opposed side balloons.

17. The inflatable catheter of claim 14, 15 or 16, wherein the guide wire may extend through the at least one side balloon into the side vessel.

18. An inflatable catheter as claimed in any one of claims 24 to 29 for use in the method or kit of any one of claims ito 23.

19. An inflatable catheter as claimed in any one of claims 12 to 18 having an expandable balloon at an end of the catheter.

20. An inflatable catheter as claimed in any one of claims 12 to 19 having a cutting edge at one end.

21. A kit for endovascular repair of an aneurysm substantially as hereinbefore described with reference to and as illustrated in any of the accompanying drawings.

22. An inflatable catheter substantially as hereinbefore described with reference to and as illustrated in any of the accompanying drawings.