AU2010201069B1

AU2010201069B1 - Introducer with extension

Info

Publication number: AU2010201069B1
Application number: AU2010201069A
Authority: AU
Inventors: Werner D. Ducke; David Ernest Hartley; Piotr Miroslaw Kasprzak
Original assignee: Cook Medical Technologies LLC
Current assignee: Cook Medical Technologies LLC
Priority date: 2010-03-19
Filing date: 2010-03-19
Publication date: 2011-05-26
Anticipated expiration: 2030-03-19

Description

Regulation 3.2 AUSTRALIA PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT ORIGINAL Name of Applicants: William A Cook Australia Pty Ltd Cook Incorporated Actual Inventors: Krasnodar Ivancev David Ernest Hartley Werner D. Ducke Address for Service: Cl- MADDERNS, Level 4, 19 Gouger Street, Adelaide, South Australia, Australia Invention title: INTRODUCER WITH EXTENSION The following statement is a full description of this invention, including the best method of performing it known to us.

FIELD This invention relates to a medical device and more particularly to a device for assisting the endovascular deployment of a stent graft into the aorta of a patient. 5 BACKGROUND A stent graft is used to bridge a defect such as an aneurism in a portion of the vasculature of a patient. The stent graft is introduced in a contracted state through the vasculature by an introduction device and released at a desired location. Where such a portion of the vasculature includes side branch vessels it is necessary to have one or more fenestrations or side arms on the stent graft to enable fluid access to 0 the side branch vessels. Once the stent graft with fenestrations or side arms has been placed in position in the vasculature it is often necessary to catheterise the fenestrations or side arms and deploy extension side arms which extend from the fenestrations or side arms into the branch vessels. Where the stent graft is to be deployed into the portion of the aorta above the renal arteries it can be difficult to catheterise such side arms from a femoral region of the vasculature and hence it may be more 5 desirable to deploy a side branch stent graft from a brachial entry region. SUMMARY It is an object of this invention to provide a stent graft introduction device which will assist with catheterising the side arms in such stent grafts. !0 Throughout this specification the term distal with respect to a portion of the aorta, a deployment device or a prosthesis means the end of the aorta, deployment device or prosthesis further away in the direction of blood flow away from the heart and the term proximal means the portion of the aorta, deployment device or end of the prosthesis nearer to the heart. When applied to other vessels similar 25 terms such as caudal and cranial should be understood. In one form therefore although may not necessarily be the only or broadest form the invention is said to reside in a stent graft delivery device comprising an introducer portion, the introducer portion comprising a distal handle portion to remain outside a patient in use and a proximal portion for 30 endovascular introduction into a patient in use, and an elongated extension piece extending from the proximal end of the introducer portion, the elongate extension piece being selectively separable from the introducer portion and a plurality of auxiliary guide wires extending from the distal end of the introducer portion through the introducer portion and through the dilator extension piece, whereby the stent graft delivery device can be introduced into a patient via a femoral artery and the elongated 35 extension piece can extend out an artery of the thoracic arch whereby to extend the auxiliary guide wires out of such an artery to give selective access to the stent graft from that artery or to give through and through guide wires.

It will be seen that by this invention there is provided an arrangement which enables a through and through guide wire set to be introduced into a patient so that relatively easy access can be had to catheterise and deploy side branches into branch vessels such as the renal arteries. 5 The elongate extension piece is essentially long enough that at least when a stent graft carried on the introduction device is at a desired release position the proximal end of the elongate extension piece extends out through a puncture in the left subclavian artery for instance. Preferably the elongate extension piece comprises an elongate extension sheath and a extension dilator 0 in the extension sheath and extending proximally thereof, the extension dilator comprising a plurality of longitudinal grooves on an outside surface thereof; the elongate extension sheath being engaged with a proximal end of the nose cone dilator and being selectively separable from the nose cone dilator; 5 Preferably a stent graft is carried on the introducer portion and the stent graft comprises a tubular body, the tubular body comprising proximal and distal open ends and a plurality of fenestrations or side arms, each of the auxiliary guide wires extending through a respective fenestration or side arm, the auxiliary guide wires extending through the tubular body proximally of the fenestrations or side arms and then outside the tubular body distally of the fenestrations or side arms. .O Preferably the proximal introduction portion comprises a pusher catheter, a guide wire catheter within the pusher catheter, the guide wire catheter being movable with respect to the pusher catheter, a proximal nose cone dilator at the proximal end of the guide wire catheter and the nose cone dilator comprising a plurality of longitudinal grooves on an outside surface thereof. 25 In one embodiment the elongate extension piece is selectively engaged with the proximal portion by being a friction fit therewith. Alternatively the elongate extension piece is selectively engaged with the proximal portion and including a trigger wire release mechanism, whereby upon release of the trigger wire release mechanism the elongate extension piece can be removed from the proximal portion. 30 In one embodiment the auxiliary guide wires extend through the introducer portion to the handle portion. Alternatively the auxiliary guide wires terminate within the introducer portion distally of the stent graft. The auxiliary guide wires can include markers at either or both of their proximal or distal ends. 35 In an alternative form the invention comprises a stent graft delivery device and stent graft in combination, the stent graft being loaded onto the delivery device; the delivery device comprising an introducer portion and an elongated extension piece extending from the proximal end of the introducer portion, the introducer portion comprising a distal handle portion to remain outside a patient in use and a proximal portion for endovascular introduction into a patient, the elongate extension piece selectively separable from the introducer portion and a plurality of auxiliary 5 guide wires extending from the distal end of the introducer portion through the introducer portion and through the elongate extension piece, the stent graft comprising a tubular body, the tubular body comprising proximal and distal open ends and a plurality of fenestrations or side arms; each of the auxiliary guide wires extending through a respective fenestration or side arm, the auxiliary 0 guide wires extending through the tubular body proximally of the fenestrations or side arms and outside the tubular body distally of the fenestrations or side arms; whereby the stent graft delivery device can be introduced into a patient via a femoral artery and the elongate extension piece can extend out a thoracic arch artery whereby to extend the auxiliary lead wires out of such an artery. 5 Preferably the proximal introduction portion comprises a pusher catheter, a guide wire catheter within the pusher catheter, the guide wire catheter being movable with respect to the pusher catheter, a proximal nose cone dilator at the proximal end of the guide wire catheter and the nose cone dilator comprising a plurality of longitudinal grooves on an outside surface thereof. !0 Preferably the elongate extension piece comprises an elongate extension sheath and a extension dilator in the extension sheath and extending proximally thereof, the extension dilator comprising a plurality of longitudinal grooves on an outside surface thereof; the elongate extension sheath being engaged with a proximal end of the nose cone dilator and being 25 selectively separable from the nose cone dilator. Preferably the stent graft comprises a tubular body, the tubular body comprising proximal and distal open ends and a plurality of fenestrations or side arms, each of the auxiliary guide wires extending through a respective fenestration or side arm, the auxiliary guide wires extending through the tubular 30 body proximally of the fenestrations or side arms and outside the tubular body distally of the fenestrations or side arms. In one embodiment the elongate extension piece is selectively engaged with the proximal portion by being a friction fit therewith. Alternatively the elongate extension piece is selectively engaged 35 with the proximal portion and including a trigger wire release mechanism, whereby upon release of the trigger wire release mechanism the elongate extension piece can be removed from the proximal portion.

A

In an alternative form the invention comprises a stent graft delivery device and stent graft in combination, the stent graft being loaded onto the delivery device; the delivery device comprising an introducer portion and an elongate extension piece extending from 5 the proximal end of the introducer portion, the introducer portion comprising a distal handle portion to remain outside a patient in use and a proximal introduction portion for endovascular introduction into a patient, the proximal introduction portion comprising a pusher catheter, a guide wire catheter within the pusher catheter, the guide wire catheter being movable with respect to the pusher catheter, a proximal 0 nose cone dilator at the proximal end of the guide wire catheter, the nose cone dilator comprising a plurality of longitudinal grooves on an outside surface thereof; the elongate extension piece comprising an extension sheath and a extension dilator in the extension sheath and extending proximally thereof, the extension dilator comprising a plurality of longitudinal grooves on an outside surface thereof; 5 the extension sheath being engaged with a proximal end of the nose cone dilator and being selectively separable from the nose cone dilator; a plurality of auxiliary guide wires extending from the distal end of the introducer portion through the pusher catheter, along the longitudinal grooves in the nose cone dilator, into and through the extension sheath in the longitudinal grooves on the extension dilator, !0 the stent graft comprising a tubular body, the tubular body comprising proximal and distal open ends and a plurality of fenestrations or side arms; each of the auxiliary guide wires extending through a respective fenestration or side arm, the auxiliary guide wires extending through the tubular body proximally of the fenestrations or side arms and outside the tubular body distally of the fenestrations or side arms; 25 whereby the stent graft delivery device can be introduced into a patient via a femoral artery and the elongated dilator extension can extend out of a thoracic arch artery whereby to extend the auxiliary guide wires out of such an artery and subsequently to deploy side arm extension along the respective guide wires into the respective fenestrations or side arms. 30 In one embodiment the elongate extension piece is selectively engaged with the proximal portion by being a friction fit therewith. Alternatively the elongate extension piece is selectively engaged with the nose cone dilator and including a trigger wire release mechanism, whereby upon release of the trigger wire release mechanism, operable from the distal handle portion, the elongate extension piece can be separated from the nose cone dilator. 35 This then generally describes the invention but to assist with understanding reference will now be made to the accompanying drawings which show preferred embodiments of the invention and a process for use of the device of the present invention. 5 In the drawings Figures IA and IB show a stent graft delivery advice according to one embodiment of the present invention; Figure 2 shows a stent graft suitable for the present invention with pre-loaded guide wires; Figure 3 shows detail of a portion of the delivery device shown in Figure 1; 0 Figures 3A to 3C show cross sectional views of portions of the delivery device according to the present invention; Figures 3D and 3F show longitudinal section views of alternative connection arrangements between the nose cone dilator and the elongate extension piece; Figures 3G and 3H show an alternative arrangement of the auxiliary guide wires in the 5 extension piece; Figures 4A to 4K show various stages in the deployment of a stent graft using a delivery device according to the present invention; and Figures 5A and 5B show a stent graft delivery advice according to an alternative embodiment of the present invention. t0 Now looking at the drawings in more detail and in particular Figures IA and I B in which a stent graft deployment device of one embodiment of the present invention is shown. Figure I A shows the stent graft delivery device in a condition for introduction into a patient and 25 Figure 1 B shows the device of Figure 1 A with the sheath withdrawn to show the stent graft. The particular configuration shown in Figure 1 B would not actually occur in use as because by the time that the sheath has been withdrawn to expose the stent graft the extension piece would have been withdrawn as is discussed below. 30 The delivery device I comprises a handle portion 2 and an introduction portion 3. The handle portion is intended to remain outside a patient in use and the introduction portion is intended to be introduced into a patient via a puncture into a artery such as the femoral artery. A pusher catheter 6 extends proximally from a trigger wire release region 5 of the handle 2. A sheath 8 and sheath hub 10 extends over the pusher catheter 6. The sheath 8 extends proximally to a nose cone dilator 35 12. The sheath can be retracted to expose a stent graft retained below it as is discussed below. A guide wire cannula 14 extends from a Luer lock hub 16 at the distal end of the device through the handle and pusher catheter to extend to and through the nose cone dilator 12. The Luer lock hub 16 is used to introduce liquids such as contrast media to enable tracking of the progress of an operation. The nose cone dilator 12 has a plurality of longitudinal grooves 18 on its outside longitudinal 5 surface. The grooves are shown in detail in Figure 3A. Into these grooves 18 lie auxiliary guide wires 50 as will be discussed below in more detail. An elongate extension piece 20 is releasably mounted to the proximal end 12a of the nose cone dilator 12. The releasable mounting may be achieved by a friction fit between the tapered tip 12a 0 of the nose cone dilator 12 as is shown in Figure 3D or it may be by a trigger wire system as is shown and discussed in relation to Figure 3E. Other methods of releasably retaining the elongate extension piece 20 to the proximal end 12a of the nose cone dilator 12 are also within the scope of the invention. 5 As can be seen in Figure 1 B a stent graft 40 is releasably retained on the introduction device I at the proximal end thereof and distal of the nose cone dilator. The stent graft is retained in a compressed condition under the sheath 8 just distal of the nose cone dilator by releasable trigger wires (not shown) and when the sheath is withdrawn the stent graft expands to the configuration shown in Figure lB. In this configuration the proximal end 47 of the stent 40 is retained to the !0 introducer device at a point just distal of the nose cone dilator 12 but access through the open lobes of graft material 47a can be achieved to track an access catheter over the auxiliary guide wires as is discussed below. The stent graft 40 has a tubular body 42 of a biocompatible graft material which is supported by self expanding zig zag stents 44. The stent graft 40 has a number of low profile side arms 46a, 46b, 46c and 46d each of which open outside the stent graft facing 25 distally. These side arms are for receiving side arm extensions to extend to the side branch arteries in the region of the renal arteries. The side branch arteries in the region of the renal arteries are the left and right arteries and the superior mesenteric and the celiac arteries. As an alternative to low profile side arms there may be fenestrations or other forms of aperture in the sent graft wall. 30 As can be seen in detail in Figure 3 the elongate extension piece 20 comprises an outer sheath 24 and a dilator 26. The dilator has a plurality of longitudinal groves 28 on its outside surface in it as can also be seen in the cross section shown in Figure 3C which shows a cross section of the elongate extension piece. Into these grooves 28 lie the auxiliary guide wires 50 as will be 35 discussed below in more detail. The elongate extension piece 20 also has a guide wire lumen 30. The auxiliary guide wires 50 extend within the sheath 24 in the longitudinal grooves 28 nearly to the proximal end 26a of the dilator 26.

The friction fit between the tapered tip 12a of the dilator 12 and the elongate extension piece 24 as is shown in Figure 3D may be achieved by a flexible sleeve 32 which is affixed to the outer sheath 24 of the elongate extension piece and extends distally of the outer sheath 24 and which engages 5 with the proximal end 12a of the nose cone dilator 12 and is retained there by friction. When the elongate extension piece is to be removed from the nose cone dilator, as is discussed below, a sharp pull on the elongate extension piece from its proximal end would be sufficient to release it from the nose cone dilator. 0 An alternative arrangement for the retention of the elongate extension piece on the nose cone dilator comprises a trigger wire system between the tapered tip 12a of the dilator 12 and the elongate extension piece 24 as is shown in Figure 3E. A trigger wire 34 extends out of an elongate aperture 12c in the nose cone dilator and through an aperture 36 in the outer sleeve 24 of the elongate extension piece 20 and back onto the nose cone dilator through aperture 12d and thereby 5 retains the outer sleeve to the nose cone dilator. The trigger wire 34 can extend to a trigger wire release mechanism 5 on the handle 2 of the introducer device 1. When the trigger wire is withdrawn by activation of the trigger wire release mechanism 5 during a deployment procedure the sleeve 24 can be removed from the nose cone dilator. !0 Figure 3F shows an alternative arrangement for retaining the extension piece onto the nose cone dilator. In this embodiment the nose cone 12 has an proximal recess 12b into which the distal end 26b of the extension dilator 26 fits with a push fit. The extension sleeve 24 has a slightly flared distal end 24a to fit over the nose cone dilator 12. 25 Figures 3G and 3H show an alternative arrangement of the auxiliary guide wires in the extension piece. In this embodiment there are a number of longitudinal lumens 26d through the extension dilator and the auxiliary guide wires 50 extend through these lumens and just extend to the proximal end 26a. 30 Figure 2 shows a stent graft suitable for use with the present invention. The stent graft 40 has a tubular body 42 of a biocompatible graft material which is supported by self expanding zig zag stents 44. The stent graft 40 has a number of low profile side arms 46a, 46b, 46c and 46d each of which open outside the stent graft facing distally. Four auxiliary guide wires 50 extend through the stent graft from a proximal end 47 and out through the low profile side arms 46a, 46b, 46c and 35 46d respectively and extend outside the stent graft distally of the respective low profile side arms 46a, 46b, 46c and 46d. At some distance before the distal end 48 of the stent graft the extend into the interior of the stent graft through the biocompatible material wall and continue on distally. As 0 can be seen in Figure IA the auxiliary guide wires 50 extend into the lumen 49 of the pusher catheter 6 and exit at the distal end of the handle 5. Each of the auxiliary guide wires 50 can have a marker tag connected to the wire where it exits from the distal end of the handle 5 so that a physician knows which wire extends through which side arm or fenestration. 5 Figures 4A to 4K show various stages in the deployment of a stent graft using a delivery device according to the present invention. Figures 4A to 4K show a schematic view of the vasculature of a human body. The vasculature 0 shows an aorta 60 extending from a heart 62 over a thoracic arch 64 to an aortic bifurcation 66. At the aortic bifurcation, iliac arteries 68a and 68b extend down to respective femoral arteries 70a and 70b. From the thoracic arch the brachiocephalic artery 72, the carotid artery 74 and the left subclavian artery 76 extend. In the aorta, there are renal arteries 77 and 78 extending from the aorta and little above them the superior mesenteric artery 79 and celiac artery 80. These four 5 arteries can generally be referred to as the pararenal arteries. The aorta 60 is depicted with an aneurism 82 which has occurred in the region of the pararenal arteries and it is desired to deploy a stent graft into the aorta to span the aneurism while at the same time allowing catheterisation and side arm deployment into the renal arteries, the superior mesenteric artery and the celiac artery. !0 In the first stage of the process as is shown in Figure 4A, a guide wire 90 is introduced through a femoral puncture 91 into the femoral artery and extended up through the femoral artery 70b, the iliac artery 68b and into the aorta 60 until it is just proximal of the pararenal arteries. A 12 French sheath 92 with sheath hub 94 is introduced via a brachial puncture in the left subclavian artery and the sheath extended down through the left subclavian artery into the descending aorta 60a. 25 As can be seen in Figure 4B, a grasper device 96 with a snare 98 is introduced through the sheath hub 94 and down the sheath 92 until the snare 98 can engage the guide wire 90. As can be seen in Figure 4C, the snare 98 is used to draw the guide wire 90 back through the 30 sheath 92 so that it extends out of the hub 94. This establishes a femoral to subclavian through and through wire. As can be seen in Figure 4D, the deployment device 1 according to the present invention is introduced into the femoral artery 70b through the femoral puncture 91 over the guide wire 90. 35 The elongate extension 20 of the introduction device 1 tracks over the guide wire 90 until it extends into the sheath 92 and out through the hub 94 as is shown in Figure 4E. At this stage, the nose cone dilator 12 of the introduction device is in such a position in the aorta 60 that the stent graft retained within the sheath 8 is in proximity to its desired final position. In the next stage as is shown in Figure 4F, the elongate extension piece 20 is removed from its 5 selective engagement with the proximal end 12a of the nose cone dilator 12. The elongate extension piece is removed from its selective engagement with the proximal end 12a of the nose cone dilator 12 by giving it a sharp pull where it extends out of the hub 94 and the elongate extension piece is removed through the hub 94 of the sheath 92 such that the auxiliary guide wires 50 remain in place and extend out through the hub 94. 0 Alternatively where the retention of the elongate extension piece 20 to the proximal end 12a of the nose cone dilator 12 is by the use of a trigger wire system, one possible embodiment of which is shown in Figure 3E, selective removal can be achieved by release of the trigger wire at it release point at the handle of the introduction device and removal of the elongate extension piece 5 20. The auxiliary guide wires 50 are then essentially through-and-through guide wires along with the main guide wire 90. The guide wires 50 can be marked at their distal ends where they extend from the handle of the introduction device (see Figure 1) and by individual movement of each wire it .0 can be determined which wire extends through which of the side arms of the stent graft. Alternatively the guide wire can be colour coded so that an physician knows which auxiliary guide extends through which of the low profile side arms in the stent graft. In the next stage as shown in Figure 4G, the sheath hub 10 is retracted to withdraw the sheath 8 25 from the stent graft 40 so that the stent graft 40 is at least partially exposed but the proximal end 47 is still retained by means not shown just distal of the nose cone dilator 12. A 7 French vessel access sheath 98 can then be advanced over one of the auxiliary guide wires 50 into the hub 94 and through the sheath 92 to exit from the distal end 92a of the sheath 92 and to 30 extend into the interior of the stent graft 40 through the open end as discussed in relation to Figure IB and out through the distal opening of one of the low profile side arms 46a. This stage is shown in Figure 41. At this stage, the auxiliary guide wire 50 still extends through the material of the stent graft distal 35 of the low profile side arm. The dilator 98a of the vessel access sheath 98 can then be retracted from the brachial end of the arrangement and a further guide wire 99 introduced to catheterise the celiac artery 80 (for instance) as is shown in Figure 4J. The auxiliary guide wire 50 which still l A extends through the material of the stent graft distal of the low profile side arm assists in stabilising the vessel access sheath 98 where it extends from the low profile side arm Standard catheter and wire techniques can then be used to manipulate the catheter and stiff wire 5 into the selected target vessel to deploy side arms and/or covered bridging stents into each of the pararenal vessels as is shown in Figure 4K. As each side arm is deployed the respective auxiliary guide wire 50 can be removed. 0 The sheath 8 can then be retracted to release the distal end 40b of the stent graft 40 and the proximal retention mechanisms can be activated to release the proximal end 47 to fully deploy the stent graft 40. The introduction device I can then be retracted through the femoral puncture 91 and the access sheath 92 retracted through the brachial puncture 93. 5 Figures 5A and 5B show an alternative embodiment of a stent graft delivery system according to the present invention. In this embodiment many items correspond to the embodiment shown in Figures IA and I B and the same reference numerals are used for those items. Figure 5A shows the stent graft delivery device in a condition for introduction into a patient and .0 Figure 5B shows the device of Figure SA with the sheath withdrawn to show the stent graft. The particular configuration shown in Figure 5B would not actually occur in use as because by the time that the sheath has been withdrawn to expose the stent graft the extension piece would have been withdrawn as is discussed below. 25 The delivery device I comprises a handle portion 2 and an introduction portion 3. The handle portion is intended to remain outside a patient in use and the introduction portion is intended to be introduced into a patient via a puncture into a artery such as the femoral artery. A pusher catheter 6 extends proximally from a trigger wire release region 5 of the handle 2. A sheath 8 and sheath hub 10 extends over the pusher catheter 6. The sheath 8 extends proximally to a nose cone dilator 30 12. The sheath can be retracted to expose a stent graft retained below it as is discussed below. A guide wire cannula 14 extends from a Luer lock hub 16 at the distal end of the device through the handle and pusher catheter to extend to and through the nose cone dilator 12. The Luer lock hub 16 is used to introduce liquids such as contrast media to enable tracking of the progress of an operation. 35 The nose cone dilator 12 has a plurality of longitudinal grooves 18 on its outside longitudinal surface. The grooves are the same as shown in detail in Figure 3A. Into these grooves 18 lie auxiliary guide wires 50 as will be discussed below in more detail. 5 An elongate extension piece 20 is releasably mounted to the proximal end 12a of the nose cone dilator 12. The releasable mounting may be achieved by a friction fit between the tapered tip 12a of the nose cone dilator 12 as is shown in Figure 3D or it may be by a trigger wire system as is shown and discussed in relation to Figure 3E. Other methods of releasably retaining the elongate extension piece 20 to the proximal end 12a of the nose cone dilator 12 as also within the scope of 0 the invention. As can be seen in Figure 5B a stent graft 40 is releasably retained on the introduction device I at the proximal end thereof and distal of the nose cone dilator. The stent graft is retained in a compressed condition under the sheath 8 just distal of the nose cone dilator by releasable trigger 5 wires (not shown) and when the sheath is withdrawn the stent graft expands to the configuration shown in Figure 5B. In this configuration the proximal end 47 of the stent graft 40 is retained to the introducer device at a point just distal of the nose cone dilator 12 but access through the open lobes of graft material 47a can be achieved to track an access catheter over the auxiliary guide wires as is discussed below. The stent graft 40 has a tubular body 42 of a biocompatible graft !0 material which is supported by self expanding zig zag stents 44. The stent graft 40 has a number of low profile side arms 46a, 46b, 46c and 46d each of which open outside the stent graft facing distally. These side arms are for receiving side arm extensions to extend to the side branch arteries in the region of the renal arteries. The side branch arteries in the region of the renal arteries are the left and right arteries and the superior mesenteric and the celiac arteries. As an 25 alternative to low profile side arms there may be fenestrations. As is shown in detail in Figure 3 the elongate extension piece 20 comprises an outer sheath 24 and a dilator 26. The dilator has a plurality of longitudinal groves 28 on its outside surface in it as can also be seen in the cross section shown in Figure 3C which shows a cross section of the elongate 30 extension piece. Into these grooves 28 lie the auxiliary guide wires 50 as will be discussed below in more detail. The elongate extension piece 20 also has a guide wire lumen 30. The auxiliary guide wires 50 extend within the sheath 24 in the longitudinal grooves 28 nearly to the proximal end 26a of the dilator 26. 35 The four auxiliary guide wires 50 extend through the stent graft from a proximal end 47 and out through the low profile side arms 46a, 46b, 46c and 46d respectively and extend outside the stent 1II1 graft distally of the respective low profile side arms 46a, 46b, 46c and 46d. In this embodiment the four auxiliary guide wires 50 terminate just distal of the stent graft. In this embodiment the proximal ends of the auxiliary guide wires may have some form of 5 marking such as colour, surface material or finish or the like so that a physician can identify which auxiliary guide wire extends through which low profile side arm or fenestration. 0

Claims

1. A stent graft delivery device comprising an introducer portion, the introducer portion 5 comprising a distal handle portion to remain outside a patient in use and a proximal portion for endovascular introduction into a patient in use, and an elongated extension piece extending from the proximal end of the introducer portion, the elongate extension piece being selectively separable from the introducer portion and a plurality of auxiliary guide wires extending from the introducer portion through the introducer portion and through the elongate extension piece, whereby the stent graft 0 delivery device can be introduced into a patient via a femoral artery and the elongated extension piece can extend out an artery of the thoracic arch whereby to extend the auxiliary guide wires out of such an artery.

2. A stent graft delivery device as in Claim I wherein the elongate extension piece comprises an 5 elongate extension sheath and a extension dilator in the extension sheath and extending proximally thereof, the extension dilator comprising a plurality of longitudinal grooves on an outside surface thereof; the elongate extension sheath being engaged with a proximal end of the nose cone dilator and being selectively separable from the nose cone dilator; 0

3. A stent graft delivery device as in Claim I wherein a stent graft is carried on the introducer portion and the stent graft comprises a tubular body, the tubular body comprising proximal and distal open ends and a plurality of fenestrations or side arms, each of the auxiliary guide wires extending through a respective fenestration or side arm, the auxiliary guide wires extending through the tubular 25 body proximally of the fenestrations or side arms and then outside the tubular body distally of the fenestrations or side arms.

4. A stent graft delivery device as in Claim I wherein the proximal introduction portion comprises a pusher catheter, a guide wire catheter within the pusher catheter, the guide wire catheter 30 being movable with respect to the pusher catheter, a proximal nose cone dilator at the proximal end of the guide wire catheter and the nose cone dilator comprising a plurality of longitudinal grooves on an outside surface thereof.

5. A stent graft delivery device as in Claim 1 wherein the elongate extension piece is removably 35 engaged with the proximal portion by being a friction fit therewith.

6. A stent graft delivery device as in Claim I wherein the elongate extension piece is removably engaged with the proximal portion and including a trigger wire release mechanism, whereby upon I A release of the trigger wire release mechanism the elongate extension piece can be removed from the proximal portion.

7 A stent graft delivery device as in Claim I wherein the auxiliary guide wires extend through 5 the introducer portion to the handle portion.

8 A stent graft delivery device as in Claim I wherein the auxiliary guide wires include markers at either or both of their proximal or distal ends. 0

9. A stent graft delivery device and stent graft in combination, the stent graft being loaded onto the delivery device; the delivery device comprising an introducer portion and an elongated extension piece extending from the proximal end of the introducer portion, the introducer portion comprising a distal handle portion to remain outside a patient in use and a proximal portion for endovascular introduction into a patient, the 5 elongate extension piece selectively separable from the introducer portion and a plurality of auxiliary guide wires extending from the distal end of the introducer portion through the introducer portion and through the elongate extension piece, the stent graft comprising a tubular body, the tubular body comprising proximal and distal open ends and a plurality of fenestrations; .0 each of the auxiliary guide wires extending through a respective fenestration, the auxiliary guide wires extending through the tubular body proximally of the fenestrations and outside the tubular body distally of the fenestrations; whereby the stent graft delivery device can be introduced into a patient via a femoral artery and the elongate extension piece can extend out a thoracic arch artery whereby to extend the auxiliary lead 25 wires out of such an artery.

10. A stent graft delivery device as in Claim 9 wherein the proximal introduction portion comprises a pusher catheter, a guide wire catheter within the pusher catheter, the guide wire catheter being movable with respect to the pusher catheter, a proximal nose cone dilator at the proximal end of 30 the guide wire catheter and the nose cone dilator comprising a plurality of longitudinal grooves on an outside surface thereof.

11. A stent graft delivery device as in Claim 9 wherein the elongate extension piece comprises an elongate extension sheath and a extension dilator in the extension sheath and extending proximally 35 thereof, the extension dilator comprising a plurality of longitudinal grooves on an outside surface thereof; the elongate extension sheath being engaged with a proximal end of the nose cone dilator and being selectively separable from the nose cone dilator;

12. A stent graft delivery device as in Claim 9 wherein the stent graft comprises a tubular body, 5 the tubular body comprising proximal and distal open ends and a plurality of fenestrations; each of the auxiliary guide wires extending through a respective fenestration, the auxiliary guide wires extending through the tubular body proximally of the fenestrations and outside the tubular body distally of the fenestrations; 0

13. A stent graft delivery device as in Claim 9 wherein the elongate extension piece is removably engaged with the proximal portion by being a friction fit therewith.

14. A stent graft delivery device as in Claim 9 wherein the elongate extension piece is removably engaged with the proximal portion and including a trigger wire release mechanism, whereby upon 5 release of the trigger wire release mechanism the elongate extension piece can be removed from the proximal portion.

15 A stent graft delivery device as in Claim 9 wherein the auxiliary guide wires extend through the introducer portion to the handle portion. .O

16 A stent graft delivery device as in Claim 9 wherein the auxiliary guide wires include markers at either or both of their proximal or distal ends.

17. A stent graft delivery device and stent graft in combination, the stent graft being loaded onto 25 the delivery device; the delivery device comprising an introducer portion and an elongate extension piece extending from the proximal end of the introducer portion, the introducer portion comprising a distal handle portion to remain outside a patient in use and a proximal introduction portion for endovascular introduction into a patient, 30 the proximal introduction portion comprising a pusher catheter, a guide wire catheter within the pusher catheter, the guide wire catheter being movable with respect to the pusher catheter, a proximal nose cone dilator at the proximal end of the guide wire catheter, the nose cone dilator comprising a plurality of longitudinal grooves on an outside surface thereof; the elongate extension piece comprising an extension sheath and a extension dilator in the extension 35 sheath and extending proximally thereof, the extension dilator comprising a plurality of longitudinal grooves on an outside surface thereof, 1t; the extension sheath being engaged with a proximal end of the nose cone dilator and being selectively separable from the nose cone dilator; a plurality of auxiliary guide wires extending from the distal end of the introducer portion through the pusher catheter, along the longitudinal grooves in the nose cone dilator, into and through the extension 5 sheath in the longitudinal grooves on the extension dilator, the stent graft comprising a tubular body, the tubular body comprising proximal and distal open ends and a plurality of fenestrations; each of the auxiliary guide wires extending through a respective fenestration, the auxiliary guide wires extending through the tubular body proximally of the fenestrations and outside the tubular body 0 distally of the fenestrations; whereby the stent graft delivery device can be introduced into a patient via a femoral artery and the elongated dilator extension can extend out of a thoracic arch artery whereby to extend the auxiliary guide wires out of such an artery and subsequently to deploy side arm extension along the respective guide wires into the respective fenestrations. 5

18. A stent graft delivery device and stent graft in combination as in Claim 17 wherein the elongate extension piece is removably engaged with the nose cone dilator by being a friction fit therewith. !0

19. A stent graft delivery device and stent graft in combination as in Claim 17 wherein the elongate extension piece is removably engaged with the nose cone dilator and including a trigger wire release mechanism, whereby upon release of the trigger wire release mechanism, operable from the distal handle portion, the elongate extension piece can be separated from the nose cone dilator. 25

20 A stent graft delivery device as in Claim 17 wherein the auxiliary guide wires extend through the introducer portion to the handle portion.

21 A stent graft delivery device as in Claim 17 wherein the auxiliary guide wires include markers at either or both of their proximal or distal ends. 30 1 "7