AU2010249296B8 - Introducer with extension and return guide wires - Google Patents

Introducer with extension and return guide wires Download PDF

Info

Publication number
AU2010249296B8
AU2010249296B8 AU2010249296A AU2010249296A AU2010249296B8 AU 2010249296 B8 AU2010249296 B8 AU 2010249296B8 AU 2010249296 A AU2010249296 A AU 2010249296A AU 2010249296 A AU2010249296 A AU 2010249296A AU 2010249296 B8 AU2010249296 B8 AU 2010249296B8
Authority
AU
Australia
Prior art keywords
extension
dilator
stent graft
proximal end
nose cone
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
AU2010249296A
Other versions
AU2010249296B1 (en
Inventor
Werner D. Ducke
David Ernest Hartley
Piotr Miroslaw Kasprzak
Blayne A. Roeder
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
William A Cook Australia Pty Ltd
Cook Inc
Cook Research Inc
Original Assignee
William A Cook Australia Pty Ltd
Cook Inc
MED Institute Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by William A Cook Australia Pty Ltd, Cook Inc, MED Institute Inc filed Critical William A Cook Australia Pty Ltd
Priority to AU2010249296A priority Critical patent/AU2010249296B8/en
Assigned to COOK INCORPORATED, WILLIAM A COOK AUSTRALIA PTY LTD, MED INSTITUTE, INC. reassignment COOK INCORPORATED Request for Assignment Assignors: COOK INCORPORATED, WILLIAM A COOK AUSTRALIA PTY LTD
Priority to EP11711223.5A priority patent/EP2547293B1/en
Priority to US13/635,573 priority patent/US8663306B2/en
Priority to PCT/US2011/029037 priority patent/WO2011116308A1/en
Publication of AU2010249296B1 publication Critical patent/AU2010249296B1/en
Application granted granted Critical
Publication of AU2010249296B8 publication Critical patent/AU2010249296B8/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Abstract

A stent graft delivery device has an elongated extension piece extending from its proximal end of the introducer portion. The elongate extension piece is selectively separable from the introducer portion. Two auxiliary guide wires extend from the introducer through the stent graft delivery device and 5 through the elongate extension piece to the proximal end where they cross over and return to the introducer portion. The stent graft 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. The two wires can then be cut there to give four through and through guide wires. Catheterisation of pararenal arteries is then possible via a brachial route 0 using each of the four auxiliary wires.

Description

Regulation 3.2 AUSTRALIA PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT ORIGINAL Name of Applicants: Cook Incorporated William A Cook Australia Pty Ltd Actual Inventors: Poitr Miroslav Kasprzak David Ernest Hartley Werner Dieter Ducke Blayne A Roeder Address for Service: C/- MADDERNS, Level 4, 19 Gouger Street, Adelaide, South Australia, Australia Invention title: INTRODUCER WITH EXTENSION AND LOOPED GUIDE WIRE The following statement is a full description of this invention, including the best method of performing it known to us. 13 DEC 2010 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. 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, 0 deployment device or end of the prosthesis nearer to the heart. When applied to other vessels similar terms such as caudal and cranial should be understood. Throughout this discussion the term "stent graft" is intended to mean a device which has a tubular body of biocompatible graft material and at least one stent fastened to the tubular body to define a 25 lumen through the stent graft. The stent graft may be bifurcated and have fenestrations, side arms or the like. Other arrangements of stent grafts are also within the scope of the invention. SUMMARY It is an object of this invention to provide a stent graft introduction device which will assist with 30 catheterising the side arms in such stent grafts. In one 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 endovascular introduction into a patient in use, the proximal portion comprising 35 a proximal end, 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, the elongate extension piece comprising a proximal end and a distal end, a plurality of auxiliary guide 2 wires extending from the distal handle portion through the introducer portion and through the elongate extension piece, the plurality of auxiliary guide wires comprising a first and a second continuous wire each extending from the distal handle portion to the proximal end of the elongate extension piece and returning to the distal handle portion, whereby the stent graft delivery device can be introduced into a 5 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 to give selective access 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 first and second 0 guide wires to be through and through guide wires and these can in use be cut at the proximal end of the elongate extension piece to give four individual through and through guide wires which can be used to catheterise and deploy side branches into branch vessels such as the renal, celiac and superior mesenteric 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. The elongate extension piece can then be extracted enough to expose the first and second guide wires and these can then be cut to give four individual through and through guide wires. 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 selectively separable from the nose cone 25 dilator. Preferably the extension dilator comprise first and second apertures between adjacent longitudinal grooves at the proximal end of the extension dilator and the first and the second continuous wire extend through the respective first and second apertures and cross over between the adjacent grooves 30 to return to the distal handle portion. Alternatively the extension dilator comprises a plurality of longitudinal apertures and the auxiliary guide wires extend through the longitudinal apertures and a pair of scallops extend into the extension dilator at the proximal end of the extension dilator between adjacent longitudinal apertures so that the 35 auxiliary wires can cross over to return in an adjacent longitudinal aperture. 3 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 5 arms and then outside the tubular body distally of the fenestrations or side arms. 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 0 comprising a plurality of longitudinal grooves on an outside surface thereof. In one embodiment the elongate extension piece is selectively engaged with the proximal portion by being a friction fit therewith. In this arrangement the proximal nose cone dilator at the proximal end of the guide wire catheter comprises a distally extending recess in the proximal end thereof and the distal 5 end of the elongate extension piece is removably engaged into the distally extending recess. The auxiliary guide wires can include markers at their proximal ends. In an alternative form the invention comprises a stent graft delivery device and stent graft in 0 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 elongated extension piece comprising a proximal end and a distal end, 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 25 selectively separable from the introducer portion and a plurality of auxiliary guide wires extending from the distal handle portion through the introducer portion and through the elongate extension piece, the plurality of auxiliary guide wires comprising a first and a second continuous wire each extending from the distal handle portion to the proximal end of the elongate extension piece and returning to the distal handle portion, 30 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 and outside the tubular body distally of the fenestrations; 35 whereby the stent graft delivery device can be introduced into a patient via a femoral artery and the elongate extension piece can extend out of a thoracic arch artery whereby to extend the auxiliary guide 4 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. Preferably the proximal introduction portion comprises a pusher catheter, a guide wire catheter within 5 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. Preferably the elongate extension piece comprises an elongate extension sheath and a extension dilator D 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 the extension dilator comprise first and second apertures between adjacent longitudinal grooves at the proximal end of the extension dilator and the first and the second continuous wire extend through the respective first and second apertures and cross over between the adjacent grooves to return to the distal handle portion. 0 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 body proximally of the fenestrations or side arms and outside the tubular body distally of the fenestrations or side arms. 25 In one embodiment the elongate extension piece is selectively engaged with the proximal portion by being a friction fit therewith. In this arrangement the proximal nose cone dilator at the proximal end of the guide wire catheter comprises a distally extending recess in the proximal end thereof and the distal end of the elongate extension piece is removably engaged into the distally extending recess. 30 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 the proximal end of the introducer portion, the introducer portion comprising a distal 35 handle portion to remain outside a patient in use and a proximal introduction portion for endovascular introduction into a patient, 5 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 nose cone dilator 5 comprising a distally extending recess in the proximal end 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; the extension dilator being engaged in the distally extending recess in the proximal end of the D 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, the plurality of auxiliary guide wires comprising a first and a second continuous wire each extending from the distal handle 5 portion and to the proximal end of the elongate extension piece and returning to the distal handle portion, the extension dilator comprise first and second apertures between adjacent longitudinal grooves at the proximal end of the extension dilator and the first and the second continuous wire extend through the respective first and second apertures and cross over between the adjacent grooves 0 to return to the distal handle portion. The stent graft comprising a tubular body, the tubular body comprising proximal and distal open ends and a plurality of fenestrations; and each of the auxiliary guide wires extending through a respective fenestration, the auxiliary 25 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 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 30 respective guide wires into the respective fenestrations. 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 35 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, 6 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 four longitudinal grooves on an outside surface thereof, the nose cone dilator comprising a 5 distally extending recess in the proximal end 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 four longitudinal apertures; the extension dilator being engaged into the distally extending recess in the proximal end of D 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 apertures in the extension dilator, the plurality of auxiliary guide wires comprising a first and a second continuous wire each extending from the distal handle 5 portion and to the proximal end of the elongate extension piece and returning to the distal handle portion, the extension dilator comprising first and second scallops extending into the extension dilator at the proximal end of the extension dilator between adjacent longitudinal apertures whereby the first and second continuous wires can cross over to return in an adjacent longitudinal aperture, and the first 0 and the second continuous wires extending through the respective scallops and crossing over between the adjacent apertures to return to the distal handle portion. The stent graft comprising a tubular body, the tubular body comprising proximal and distal open ends and a plurality of fenestrations; and 25 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 elongated dilator extension can extend out of a thoracic arch artery whereby to extend the 30 auxiliary guide wires out of such an artery and subsequently to deploy side arm extension along the respective guide wires into the respective fenestrations. In a further form the invention comprises a manifold adaptor piece comprising a spigot to engage into the haemostatic seal of an endovascular port hub, a substantially funnel shaped body extending from 35 the spigot and at least one port, the at least one port comprising a seal disc. 7 In an alternative embodiment the manifold adaptor piece comprises five individual ports, each port comprising a sealing disc. BRIEF DESCRIPTION OF THE DRAWINGS 5 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. In the drawings D Figures IA and lB 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 showing the placement of the pre-loaded auxiliary guide wires; Figure 3 shows detail of a portion of the delivery device shown in Figure 1; 5 Figures 3A to 3D show transverse cross sectional views of portions of the delivery device shown in Figure 3 according to the present invention; Figure 3E shows a longitudinal section view of a connection arrangement between the nose cone dilator and the elongate extension piece according to one embodiment of the present invention; 0 Figures 3F and 3G show an alternative arrangement for the connection arrangement between the nose cone dilator and the elongate extension piece; Figure 3H shows a still further arrangement for the connection arrangement between the nose cone dilator and the elongate extension piece; Figure 31 shows a transverse cross sectional view of a proximal end of the extension piece 25 showing an alternative embodiment according to the present invention; Figures 4A to 4N show various stages in the deployment of a stent graft using a delivery device according to the present invention; and Figure 5A shows a manifold adaptor piece for use with the present invention; Figures 5B and 5C show an alternative embodiment of a manifold adaptor piece for use with 30 the present invention; and Figure 6 shows the use of the manifold adaptor piece shown in Figure 5B. DESCRIPTION OF PREFERRED EMBODIMENTS Now looking at the drawings in more detail and in particular Figures I A and 1 B in which a stent graft 35 deployment device of one embodiment of the present invention is shown. 8 Figure IA shows the stent graft delivery device in a condition for introduction into a patient and Figure lB shows the device of Figure lA 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 5 withdrawn as is discussed below. The delivery device 1 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 an artery such as the femoral artery. A pusher catheter 6 extends 0 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 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 5 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 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. 0 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 discussed below in more detail. 25 The elongate extension piece 20 also has a guide wire lumen 30. As can be seen in particular in Figure 3E the longitudinal grooves 28 terminate at 28a before the distal end 26b of the dilator 26. The auxiliary guide wires 50 extend from the handle portion 2 of the delivery device I through the introduction portion 3 to nose cone dilator 12 and along the plurality of longitudinal grooves 18 on its 30 outside longitudinal surface. The auxiliary guide wires 50 then extend into the elongate extension piece 20 and into the grooves 28 within the sheath 24 in the dilator 26 nearly to the proximal end 26a of the dilator 26. At the proximal end 26a of the dilator 26 the wires cross over in recesses 26c (See Figure 3D) which extend between adjacent grooves 28 so that the wires 50 cross over from one groove to an adjacent one at a bend 50a and extend down the adjacent groove and return to the handle portion 35 2 of the delivery device I via the introduction portion 3 and the nose cone dilator 12. This means that there are first and second wires each of which extend to the proximal end of the elongate extension 9 piece and then return in an adjacent groove. In use the wires 50 at the bend 50a can be cut to give four individual auxiliary guide wires as is discussed below. The elongate extension piece 20 is releasably mounted to the proximal end 12a of the nose cone 5 dilator 12. As shown in more detail in Figure 3E the extension piece fits into the nose cone dilator. The nose cone dilator 12 has a proximal recess 12b into which the distal end 26b of the extension dilator 26 fits with a push fit. The extension sleeve 24 terminates at its distal end 24a just where it reaches the nose cone dilator 12. D The distal end 26b of the extension dilator 26 fits into the proximal recess 12b in the nose cone dilator 12 and is retained there with a combination of factors. First the push fit provides a degree of retention. Second, the terminating recesses 28a mean that if the dilator 26 is pulled independently of the sheath 24 the wires 50 entering the grooves 28 interfere and prevent the removal. Third, the auxiliary guide wires can be locked at the handle portion and with the bend at 50a the extension piece cannot move 5 forward and thereby holds the distal end 26b of the dilator 26 in the recess 12b. As can be seen in Figure lB and Figure 2 a stent graft 40 is releasably retained on the introduction device 1 at the proximal end thereof and distal of the nose cone dilator 12. The stent graft is retained in a compressed condition under the sheath 8 just distal of the nose cone dilator by releasable trigger 0 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 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 25 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 renal arteries and the superior mesenteric and the celiac arteries. As an alternative to low profile side arms there may 30 be fenestrations or other forms of aperture in the stent graft wall. 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 35 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 46d respectively and extend outside the stent graft distally of the respective low profile side arms 46a, 46b, 46c and 46d. At 10 some distance before the distal end 48 of the stent graft they extend into the interior of the stent graft through the biocompatible material wall, such as at 45 and continue on distally. As can be seen in Figure I A 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 5 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. Figures 3F and 3G show an alternative arrangement for the connection arrangement between the nose cone dilator and the elongate extension piece. In this embodiment the same reference numerals are 0 used for corresponding items to those shown in Figures 3 to 3E. As can be seen in detail in Figure 3F 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. Into these grooves 28 lie the auxiliary guide wires 50. The elongate extension piece 20 also has a guide wire 5 lumen 30. The longitudinal grooves 28 terminate at 28a before the distal end 26b of the dilator 26. The distal end 26b of the extension dilator 26 fits into the proximal recess 12b in the nose cone dilator 12. At the distal end of the outer sheath a sleeve 27 is shrink fitted and/or glued onto the outer sheath and includes an elongate tab 27a which extends distally along the nose cone dilator 12 when the distal end of the dilator is received into the proximal recess 12b in the nose cone dilator 12. At the end of the 0 elongate tab 27a is a hole 27b. A corresponding hole 12c extends through the nose cone dilator and opens into proximal recess 12b in the nose cone dilator 12. A trigger wire 29 which extends from the handle of the delivery device enters the hole 27b and then the hole 12c and then into the longitudinal groove 28 just proximal of the end 28a of the groove 28 as can be see in Figure 3G. 25 Hence the distal end 26b of the extension dilator 26 fits into and is retained in proximal recess 12b in the nose cone dilator 12 by a combination of factors. First the push fit of the distal end 26b of the extension dilator 26 in the proximal recess 12b provides a degree of retention. Second, the terminating recesses 28a mean that if the dilator 26 is pulled independently of the sheath 24 the trigger wire 29 in the grooves 28 interferes and prevent the removal. Third, the trigger wire engaged into the aperture 30 12c prevents the sleeve 27 which is shrink fitted and/or glued onto the sheath being pulled distally until the trigger wire has been removed. Fourthly, the auxiliary guide wires can be locked at the handle portion and with the bend at 50a the extension piece cannot move forward and thereby holds the distal end 26b of the dilator 26 in the recess 12b. 35 Figure 3H shows a still further arrangement for the connection arrangement between the nose cone dilator and the elongate extension piece. In this embodiment the same reference numerals are used for corresponding items to those shown in Figures 3 to 3E. 11 As can be seen in detail in Figure 3H 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. Into these grooves 28 lie the auxiliary guide wires 50. The elongate extension piece 20 also has a guide wire 5 lumen 30. The longitudinal grooves 28 terminate at 28a before the distal end 26b of the dilator 26. The distal end 26b of the extension dilator 26 fits into the proximal recess 12b in the nose cone dilator 12. At the distal end of the outer sheath a sleeve 25 is shrink fitted and/or glued onto the outer sheath and distal of the distal end 24a of the sheath 24 the sleeve 25 is shrunk to the size of the dilator to hold the auxiliary wires into their respective grooves in the dilator. In this embodiment a hole 12c extends ) through the nose cone dilator and opens into proximal recess 12b in the nose cone dilator 12. A trigger wire 29 which extends from the handle of the delivery device enters the hole 12c and then into the longitudinal groove 28 just proximal of the end 28a of the groove 28 as can be seen in Figure 3G. Hence, in this embodiment the distal end 26b of the extension dilator 26 fits into and is retained in 5 proximal recess 12b in the nose cone dilator 12 by a combination of factors. First the push fit of the distal end 26b of the extension dilator 26 in the proximal recess 12b provides a degree of retention. Second, the terminating recesses 28a means that if the dilator 26 is pulled independently of the sheath 24 the trigger wire 29 in the grooves 28 interferes and prevents the removal. Third, the auxiliary guide wires can be locked at the handle portion and with the bend at 50a the extension piece cannot move ) forward and thereby holds the distal end 26b of the dilator 26 in the recess 12b. Figure 31 show a transverse cross sectional view of a proximal end of the extension piece showing an alternative embodiment according to the present invention. In this embodiment the same reference numerals are used for corresponding items to those shown in Figures 3 to 3E. In this embodiment 5 instead of grooves in the outer surface of the extension dilator 26 there are four longitudinal apertures 28b into which the auxiliary wires 50 are received to extend from the distal end 26b of the extension dilator to the proximal end 26a. At the proximal end 26a of the extension dilator 26 a scallop 33 is cut into the extension dilator to expose two adjacent longitudinal apertures 28b so that the auxiliary wire 50 and cross over at 50a to extend back down the adjacent longitudinal groove 28b. 0 Figures 4A to 4N show various stages in the deployment of a stent graft using a delivery device according to the present invention. Figures 4A to 4N show a schematic view of the vasculature of a human body. The vasculature shown 5 comprises 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 12 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 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 5 aneurism while at the same time allowing catheterisation and side arm deployment into the renal arteries, the superior mesenteric artery and the celiac artery. 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 70a and extended up through the femoral artery 70a, the 0 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 76 and the sheath 92 extended down through the left subclavian artery into the descending aorta 60a. As can be seen in Figure 4B, a grasper device 96 with a snare 98 is introduced through the sheath hub 5 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 sheath 92 so that it extends out of the hub 94. This establishes a femoral to subclavian through and through wire. 0 In an alternative arrangement the grasper device with a snare can be introduced through a femoral artery puncture 91 and the guide wire can be introduced through the sheath hub 94 until the snare can engage the guide wire. The snare is then used to draw the guide wire back through the femoral puncture 91. This establishes a femoral to subclavian through and through wire. 25 As can be seen in Figure 4D, a dilator 93 and catheter 95 is introduced through the hub 94 and tracked over the through and through guide wire 90 until it exits the femoral puncture 91 as shown in Figure 4E. The dilator 95 is then removed leaving the catheter 93 in place. As shown in Figure 4F the proximal end of the extension dilator 26 of the deployment device 1 30 according to the present invention is introduced into the femoral artery 70b over the guide wire 90 and engaged with the catheter 93. This assembly is then deployed through the femoral puncture 91. The catheter 93, the elongate extension 20 of the introduction device 1 track over the guide wire 90 as shown in Figure 4G. 35 This is continued until the catheter 93 is completely withdrawn and the extension catheter 24 and extension dilator extend into the sheath 92 and out through the hub 94 as is shown in Figure 4H. At 13 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 41, auxiliary guide wires 50 are released from the handle 5 portion of the delivery device 1 so that auxiliary guide wires 50 can be separated from the elongate extension piece 20 and cut to give four separate auxiliary guide wires. The elongate extension piece 20 can then be removed from its 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 0 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. At this stage an adaptor piece 110 (see Figures 5 and 6) has the four auxiliary wires 50 and the main guide wire deployed into its seals and the adaptor piece is fitted into the hub 94 (see Figure 6). 5 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 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 0 which of the low profile side arms in the stent graft. In the next stage as shown in Figure 4J, the sheath hub 10 is retracted to withdraw the sheath 8 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. 25 A 7 French vessel access sheath 98 can then be advanced over one of the auxiliary guide wires 50 through the adaptor piece 1 10 into the hub 94 and through the sheath 92 to exit from the distal end 92a of the sheath 92 and to extend into the interior of the stent graft 40 through the open end as discussed in relation to Figure lB and out through the distal opening of one of the low profile side arms 46a. 30 This stage is shown in Figure 4K. At this stage, the auxiliary guide wire 50 still extends through the material of the stent graft distal 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 35 80 (for instance) as is shown in Figure 4M. The auxiliary guide wire 50 which still 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. 14 Standard catheter and wire techniques can then be used to manipulate the catheter and stiff wire into the selected target vessel to deploy side arms and/or covered bridging stents 101 into each of the pararenal vessels as is shown in Figure 4N. 5 As each side arm is deployed the respective auxiliary guide wire 50 can be removed. 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. 0 The introduction device 1 can then be retracted through the femoral puncture 91 and the access sheath 92 retracted through the brachial puncture 93. Figures 5A, 5B and 5C show alternative embodiments of adaptor pieces used to help preventing tangling and to facilitate placement of catheters over the auxiliary guide wires. Figure 5A shows one 5 embodiment of a manifold adaptor piece for use with the present invention and Figures 5B and 5C show an alternative embodiment of a manifold adaptor piece for use with the present invention. Figure 6 shows the use of the manifold adaptor piece shown in Figure 5B. In Figure 5A a longitudinal cross sectional view of a manifold adaptor piece is shown. The adaptor 0 piece 120 has a spigot 122 which is adapted to engage into the haemostatic seal of an endovascular port hub 94 as that shown in Figures 4H to N. The spigot has a annular recess 123 which acts to engage the haemostatic seal 94a of the hub 94. The adaptor piece 120 has a flared body 124 and a large seal disc 126 through which guide wires can be extended in a sealing manner. The adaptor piece in this embodiment essentially provides a larger area sealing surface than that of the hub 94 through 25 which the various guide wires can be extended and be sealed around and which will prevent loss of blood through inadequate sealing due to crowding of the seal. The seal disc can be made from silicone or a similar material. Figures 5B and 5C show an alternative embodiment of a manifold adaptor piece. In this embodiment 30 the adaptor piece 130 has a spigot 132 which is adapted to engage into the haemostatic seal of an endovascular port hub 94 as that shown in Figures 4H to N. The adaptor piece 130 has a flared body 134 and a number of individual ports 136 each of which is provided with a seal disc 138. In use as shown in Figure 6 the spigot 132 is engaged into the haemostatic seal 94a of the 35 endovascular port hub 94 and the guide wires 90 and 50 extend through the hub and a selected one of the individual ports 136 through its respective seal 138. 15 The manifold adaptor piece of either embodiment can be supplied for use with a plurality of pre placed catheters into which the main guide wire 90 and the auxiliary guide wires 50 can be placed before engaging the spigot 122, 132 into the haemostatic seal 94a. Alternatively a needle can be used to pierce the large seal 126 or the individual seals 138, the respective guide wire placed through the 5 needles and the needle removed to leave the guide wires through the seal. 16

Claims (12)

  1. 2. A stent graft delivery device as in Claim 1 wherein the proximal end of the proximal portion of the introducer portion comprises a nose cone dilator and the elongate extension piece comprises an elongate extension sheath and an extension dilator in the extension sheath and the extension dilator 0 extending proximally of extension sheath, the extension dilator comprising a plurality of longitudinal grooves on an outside surface thereof; the elongate extension piece being engaged with a proximal end of the nose cone dilator and being selectively separable from the nose cone dilator.
  2. 3. A stent graft delivery device as in Claim 1 wherein the extension dilator comprise first and 25 second apertures between adjacent longitudinal grooves at the proximal end of the extension dilator and the first and the second continuous wire extend through the respective first and second apertures and cross over between the adjacent grooves to return to the distal handle portion.
  3. 4. A stent graft delivery device as in Claim I wherein a stent graft is carried on the introducer 30 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. 35
  4. 5. A stent graft delivery device as in Claim 1 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 nose cone dilator at the proximal end of the guide 17 wire catheter and the nose cone dilator comprising a plurality of longitudinal grooves on an outside surface thereof.
  5. 6. A stent graft delivery device as in Claim 5 wherein the nose cone dilator at the proximal end 5 of the guide wire catheter comprises a distally extending recess in the proximal end thereof and the distal end of the elongate extension piece is removably engaged into the distally extending recess.
  6. 7. A stent graft delivery device as in Claim 1 wherein the auxiliary guide wires include markers at their distal ends. 0
  7. 8. A stent graft delivery device as in Claim I wherein the elongate extension piece comprises an elongate extension sheath and an extension dilator in the extension sheath and the extension dilator extending proximally of extension sheath, the extension dilator comprising a plurality of longitudinal apertures and the auxiliary guide wires extending through the longitudinal apertures, a pair of scallops 5 extending into the extension dilator at the proximal end of the extension dilator between adjacent longitudinal apertures whereby the auxiliary wires cross over to return in an adjacent longitudinal aperture, the elongate extension piece being engaged with a proximal end of the nose cone dilator and being selectively separable from the nose cone dilator. 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 elongated extension piece comprising a proximal end and a distal end, the introducer portion comprising a distal handle portion to remain 25 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 guide wires extending from the distal handle portion through the introducer portion and through the elongate extension piece, the plurality of auxiliary guide wires comprising a first and a second continuous wire each extending from the distal handle portion to the proximal end of the elongate 30 extension piece and returning to the distal handle portion, 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 and outside 35 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 of a thoracic arch artery whereby to extend the 1 R 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.
  8. 10. A stent graft delivery device as in Claim 9 wherein the proximal introduction portion 5 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, the nose cone dilator comprising a distally extending recess in the proximal end thereof and a distal end of the elongate extension piece being removably engaged into the distally 0 extending recess. 1L. A stent graft delivery device as in Claim 9 wherein the proximal end of the proximal portion of the introducer portion comprises a nose cone dilator and the elongate extension piece comprises an elongate extension sheath and an extension dilator in the extension sheath and the extension dilator 5 extending proximally of the extension sheath, the extension dilator comprising a plurality of longitudinal grooves on an outside surface thereof; a distal end of the extension dilator being engaged with a proximal end of the nose cone dilator and being selectively separable from the nose cone dilator. 0 12. A stent graft delivery device as in Claim 11 wherein the extension dilator comprise first and second apertures between adjacent longitudinal grooves at the proximal end of the extension dilator and the first and the second continuous wire extend through the respective first and second apertures and cross over between the adjacent grooves to return to the distal handle portion. 25 13. A stent graft delivery device as in Claim 8 wherein the stent graft comprises 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 distally of the fenestrations. 30
  9. 14. A stent graft delivery device as in Claim 9 wherein the auxiliary guide wires include markers at their distal ends.
  10. 15. A stent graft delivery device and stent graft in combination, the stent graft being loaded onto 35 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 19 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 5 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 nose cone dilator comprising a distally extending recess in the proximal end 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 0 longitudinal grooves on an outside surface thereof; the extension dilator being engaged into the distally extending recess in the 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 5 the extension sheath in the longitudinal grooves on the extension dilator, the plurality of auxiliary guide wires comprising a first and a second continuous wire each extending from the distal handle portion and to the proximal end of the elongate extension piece and returning to the distal handle portion, the extension dilator comprising first and second apertures between adjacent longitudinal 0 grooves at the proximal end of the extension dilator and the first and the second continuous wire extend through the respective first and second apertures and cross over between the adjacent grooves to return to the distal handle portion, the stent graft comprising a tubular body, the tubular body comprising proximal and distal open ends and a plurality of fenestrations; and 25 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 elongated dilator extension can extend out of a thoracic arch artery whereby to extend the 30 auxiliary guide wires out of such an artery and subsequently to deploy side arm extension along the respective guide wires into the respective fenestrations.
  11. 16. A stent graft delivery device as in Claim 12 wherein the auxiliary guide wires include markers at their distal ends. 35
  12. 17. A stent graft delivery device and stent graft in combination, the stent graft being loaded onto the delivery device; 20 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, 5 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 nose cone dilator at the proximal end of the guide wire catheter, the nose cone dilator comprising four longitudinal grooves on an outside surface thereof, the nose cone dilator comprising a distally extending recess in the proximal end thereof; 0 the elongate extension piece comprising an extension sheath and a extension dilator in the extension sheath and extending proximally thereof, the extension dilator comprising four longitudinal apertures; the extension dilator being engaged into the distally extending recess in the proximal end of the nose cone dilator and being selectively separable from the nose cone dilator; 5 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 apertures in the extension dilator, the plurality of auxiliary guide wires comprising a first and a second continuous wire each extending from the distal handle portion and to the proximal end of the elongate extension piece and returning to the distal handle 0 portion, the extension dilator comprising first and second scallops extending into the extension dilator at the proximal end of the extension dilator between adjacent longitudinal apertures whereby the first and second continuous wires can cross over to return in an adjacent longitudinal aperture, and the first and the second continuous wires extending through the respective scallops and crossing over between 25 the adjacent apertures to return to the distal handle portion. the stent graft comprising a tubular body, the tubular body comprising proximal and distal open ends and a plurality of fenestrations; and 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 30 body 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. 21
AU2010249296A 2010-03-19 2010-12-13 Introducer with extension and return guide wires Active AU2010249296B8 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU2010249296A AU2010249296B8 (en) 2010-12-13 2010-12-13 Introducer with extension and return guide wires
EP11711223.5A EP2547293B1 (en) 2010-03-19 2011-03-18 Introducer with extension
US13/635,573 US8663306B2 (en) 2010-03-19 2011-03-18 Introducer with extension
PCT/US2011/029037 WO2011116308A1 (en) 2010-03-19 2011-03-18 Introducer with extension

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AU2010249296A AU2010249296B8 (en) 2010-12-13 2010-12-13 Introducer with extension and return guide wires

Publications (2)

Publication Number Publication Date
AU2010249296B1 AU2010249296B1 (en) 2011-12-22
AU2010249296B8 true AU2010249296B8 (en) 2012-04-19

Family

ID=45442677

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2010249296A Active AU2010249296B8 (en) 2010-03-19 2010-12-13 Introducer with extension and return guide wires

Country Status (1)

Country Link
AU (1) AU2010249296B8 (en)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7537606B2 (en) * 2003-04-03 2009-05-26 Cook Incorporated Branch stent graft deployment and method

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7537606B2 (en) * 2003-04-03 2009-05-26 Cook Incorporated Branch stent graft deployment and method

Also Published As

Publication number Publication date
AU2010249296B1 (en) 2011-12-22

Similar Documents

Publication Publication Date Title
US8663306B2 (en) Introducer with extension
US10166095B2 (en) Introducer for a side branch device
US9808365B2 (en) Introducer for an iliac side branch device
CN105007860B (en) Minimization of stent-graft migration during implantation
JP5109193B2 (en) Intravascular delivery device
EP1517652B1 (en) Thoracic introducer
AU2009200350B1 (en) Preloaded stent graft delivery device
EP3345571B1 (en) Fenestrated endoluminal prosthesis deployment system
EP2626045B1 (en) Length extending module for an endovascular delivery device
EP2777605B1 (en) Endovascular grafts for treating the iliac arteries
AU2010249296B8 (en) Introducer with extension and return guide wires
AU2010201069B1 (en) Introducer with extension

Legal Events

Date Code Title Description
PC1 Assignment before grant (sect. 113)

Owner name: MED INSTITUTE, INC.; COOK INCORPORATED; WILLIAM A

Free format text: FORMER APPLICANT(S): COOK INCORPORATED; WILLIAM A COOK AUSTRALIA PTY LTD

FGA Letters patent sealed or granted (standard patent)
TH Corrigenda

Free format text: IN VOL 25, NO 50, PAGE(S) 6390 UNDER THE HEADING APPLICATIONS ACCEPTED - NAME INDEX UNDER THE NAME MED INSTITUTE, INC., APPLICATION NO. 2010249296, UNDER INID (54) CORRECT THE TITLE TO READ INTRODUCER WITH EXTENSION AND RETURN GUIDE WIRES