(19)
(11)EP 3 031 426 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
20.07.2022 Bulletin 2022/29

(21)Application number: 16150470.9

(22)Date of filing:  12.10.2004
(51)International Patent Classification (IPC): 
A61F 2/95(2013.01)
A61F 2/07(2013.01)
(52)Cooperative Patent Classification (CPC):
A61F 2/07; A61F 2/962; A61F 2002/067; A61F 2002/9511; A61F 2/954; A61F 2/966; A61F 2/89; A61F 2002/061; A61F 2002/075

(54)

INTRODUCER FOR AN ILIAC SIDE BRANCH DEVICE

EINFÜHRVORRICHTUNG FÜR EINE ILIAKALE SEITENVERZWEIGUNGSVORRICHTUNG

DISPOSITIF D'INTRODUCTION POUR UN DISPOSITIF DE RAMIFICATION LATÉRALE ILIAQUE


(84)Designated Contracting States:
DE GB IE

(30)Priority: 14.10.2003 US 510823 P
13.08.2004 US 601485 P

(43)Date of publication of application:
15.06.2016 Bulletin 2016/24

(62)Application number of the earlier application in accordance with Art. 76 EPC:
04794818.7 / 1691719

(73)Proprietors:
  • Cook Medical Technologies LLC
    Bloomington, IN 47404 (US)
  • THE CLEVELAND CLINIC FOUNDATION
    Cleveland, OH 44195 (US)

(72)Inventors:
  • GREENBERG, Roy K.
    Bratenahl, OH Ohio 44108 (US)
  • HARTLEY, David Ernest
    Wannanup, Western Australia 6210 (AU)
  • ANDERSON, John Lennon
    Bellvue Heights, South Australia 5050 (AU)
  • STELTER, Wolfe
    65812 Bad Soden (DE)

(74)Representative: Williams Powell 
5 Chancery Lane
London WC2A 1LG
London WC2A 1LG (GB)


(56)References cited: : 
EP-A2- 0 508 473
EP-A2- 0 904 745
WO-A1-98/53761
WO-A2-99/44539
US-A1- 2003 153 969
EP-A2- 0 684 022
EP-B1- 0 684 022
WO-A2-01/67993
US-A1- 2001 012 943
US-A1- 2003 181 923
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    Technical Field



    [0001] This invention relates to a medical device and more particularly to a medical device adapted for deployment of a stent graft within a human or animal body.

    Background of the Invention



    [0002] Existing documents include US 2001/012943 A1, WO 99/44539 A2, EP 0 904 745 A2, EP 0 508 473 A2, US 2003/153969 A1, WO 98/53761 A1, US 2003/181923 A1, WO 01/67993 A2, EP 0 684 022 A2.

    [0003] This invention will be generally discussed in relation to deployment of a stent graft into an iliac artery where it is necessary to extend a side branch from a stent graft into an internal iliac artery but it is to be understood that the invention is not so limited and may relate to any body lumen in which such a deployment is required.

    [0004] Throughout this specification the term distal with respect to a portion of the aorta, a deployment device or a prosthesis is 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 terms such as caudal and cranial should be understood.

    [0005] Stent grafts are used for treatment of vasculature in the human or animal body to bypass a repair or defect in the vasculature. For instance, a stent graft may be used to span an aneurism which has occurred in or associated with the iliac artery. In many cases, however, such a damaged or defective portion of the vasculature may include a branch vessel such as an internal iliac artery. Bypassing such a branch vessel without providing blood flow into it can cause problems and hence it has been proposed to provide a side branch on a stent graft which when deployed is positioned over the opening to the internal iliac artery and then another stent graft can be deployed through the side branch into the internal iliac artery to provide a blood flow path to the internal iliac artery.

    [0006] Generally, when deploying an endovascular stent graft into a body lumen, it is possible to obtain access to such a body lumen from each end of the lumen where necessary, thereby facilitating placement of a device in the lumen. The internal iliac artery which extends from the common iliac artery below the aortic bifurcation is for all intents and purposes a blind vessel because there is no practical way of performing an endovascular minimally invasive procedure into that vessel other than by entry from the common iliac artery. The term blind vessel is used herein to describe such a vessel.

    [0007] There have been proposals to deploy a branched stent graft into the common iliac artery via a femoral artery from a femoral incision with the branched stent graft having a side arm to extend into or at least adjacent the internal iliac artery, however, the use of such devices is very dependent upon favourable layout of the arteries and in many cases, access is extremely difficult. This invention proposes an alternative method for approaching the common iliac artery and a deployment device to enable such a method to be practised.

    [0008] It is the object of this invention therefore to provide an improved deployment device or at least to provide a physician with a useful alternative.

    Summary of the Invention



    [0009] According to an aspect of the invention, there is provided an assembly as in claim 1.

    [0010] Some embodiments can provide an arrangement for introducing a stent graft into an internal iliac artery, the arrangement having means to enable a guide wire to be extended so that it can be snared from a contra-lateral iliac artery so as to enable access to the internal iliac artery via an aortic bifurcation from the contra-lateral iliac artery.

    [0011] Generally it will be seen that by the use of such a device, the deployment of a stent graft into the internal iliac is more favourable when approached from the aortic bifurcation because the geometry of the branch between the common iliac artery and the internal iliac artery is more favourable when approached from that direction.

    [0012] Some embodiments include an introducer device having arrangement for retaining a stent graft thereon, an indwelling catheter having a guide wire therethrough associated with the introducer device, the indwelling catheter extending to the proximal end of the introducer device whereby the guide wire can be advanced beyond the proximal end of the introducer device so that it can be snared.

    [0013] By this arrangement, the guide wire can be extended beyond the introducer device so that it can be snared from the contra-lateral iliac artery and drawn over the aortic bifurcation and down the contra-lateral iliac artery so that the guide wire can be used to enter the internal iliac artery from over the aortic bifurcation.

    [0014] The stent graft is of a type which includes a branch extending therefrom and the indwelling catheter extends through the branch whereby preferably a deployment device for a side arm can be deployed over the guide wire, once snared, to enter the branch so that the side arm can be deployed into and extending from the branch.

    [0015] Some embodiments include an introduction arrangement for a branched stent graft intended for deployment into the lumen of a vessel having a blind vessel extending therefrom; the branched stent graft having a main tubular body having a distal end and a proximal end with a main lumen therethrough, a side arm extending from the main body and having a side arm lumen therethrough and in fluid communication with the main lumen, the introduction arrangement including an introducer, the introducer having a distal end intended to remain outside a patient in use and a proximal end, the proximal end having a nose cone dilator and an arrangement to retain the branched stent graft distally of the nose cone dilator, the branched stent graft being retained on the introducer and a sheath on the introducer extending over the branched stent graft to the nose cone dilator, an indwelling catheter extending from the distal end of the introducer through an introducer lumen in the introducer to the branched stent graft, exiting from the introducer lumen at a distal end of the branched stent graft and entering the distal end of the side arm through the side arm lumen to the main lumen and extending out of the proximal end of the branched stent graft to the nose cone dilator, the indwelling catheter having a guide wire extending therethrough, whereby the guide wire can be extended beyond the nose cone dilator in use before the sheath is withdrawn from the branched stent graft.

    [0016] It will be noted that by this form of introducer and branched stent graft assembly the indwelling catheter is external of the stent graft for part of its extent but during deployment it is covered by the introducer sheath.

    [0017] It will be seen that by this arrangement, an introducer can be introduced into an artery such as an iliac artery and before the stent graft is exposed by retraction of the sheath the guide wire can be extended beyond the nose cone dilator to enable it to be snared from the contra-lateral iliac artery and then the guide wire can be used as will be discussed below for deployment of a leg extension or side arm stent graft into the internal iliac artery.

    [0018] Preferably the nose cone dilator has a longitudinal groove thereon to receive the indwelling catheter.

    [0019] The means to retain the branched stent graft on the introducer may include trigger wires extending to the distal end of the introducer and release arrangements for separate release of the proximal and distal ends of the stent graft from the introducer.

    [0020] US Patent No. 5,387,235 entitled "Endovascular Transluminal Prosthesis For Repair Of Aneurysms" discloses apparatus and methods of retaining grafts onto deployment devices. These features and other features disclosed in US Patent No. 5,387,235 could be used with the present invention

    [0021] U.S. Patent No. 5,720,776 entitled "Barb and Expandable Transluminal Graft Prosthesis For Repair of Aneurysm" discloses improved barbs with various forms of mechanical attachment to a stent. These features and other features disclosed in U.S. Patent No. 5,720,776 could be used with the present invention.

    [0022] US Patent No. 6,206,931 entitled "Graft Prosthesis Materials" discloses graft prosthesis materials and a method for implanting, transplanting replacing and repairing a part of a patient and particularly the manufacture and use of a purified, collagen based matrix structure removed from a submucosa tissue source. These features and otherfeatures disclosed in US Patent No. 6,206,931 could be used with the present invention.

    [0023] PCT Patent Publication No. WO98/53761 entitled "A Prosthesis and a Method of Deploying a Prosthesis" discloses an introducer for a prosthesis which retains the prosthesis so that each end can be moved independently. These features and other features disclosed in PCT Patent Publication No. WO98/53761 could be used with the present invention.

    [0024] U.S. Patent No. 6,524,335 and PCT Patent Publication No. WO 99/29262 entitled "Endoluminal Aortic Stents" disclose a fenestrated prosthesis for placement where there are intersecting arteries. This feature and other features disclosed in U.S. Patent No. 6,524,335 and PCT Patent Publication No. WO 99/29262 could be used with the present invention.

    [0025] U.S. Patent Application Serial No. 10/280,486, filed October 25,2002 and published on May 8, 2003 as U.S. Patent Application Publication No. US-2003-0088305-A1 and PCT Patent Publication No. WO 03/034948 entitled "Prostheses For Curved Lumens" discloses prostheses with arrangements for bending the prosthesis for placement into curved lumens. This feature and other features disclosed in U.S. Patent Application Serial No. 10/280,486, and U.S. Patent Application Publication No. US-2003-0088305-A1 and PCT Patent Publication No. WO 03/034948 could be used with the present invention.

    [0026] U.S. Provisional Patent Application Serial No. 60/392,682, filed June 28, 2002, U.S. Patent Application Serial No. 10/447,406, filed May 29, 2003, and Published on December 18, 2003, as U.S. Patent Application Publication No. US-2003-0233140-A1, and PCT Patent Publication No. WO 03/101518 entitled "Trigger Wires" disclose release wire systems for the release of stent grafts retained on introducer devices. This feature and other features disclosed in U.S. Provisional Patent Application Serial No. 60/392,682, U.S. Patent Application Serial No. 10/447,406, and U.S. Patent Application Publication No. US-2003-0233140-A1, and PCT Patent Publication No. WO 03/101518 could be used with the present invention.

    [0027] U.S. Provisional Patent Application Serial No. 60/392,667, filed June 28, 2002, and U.S. Patent Application Serial No. 10/609,846, filed June 30, 2003, and Published on May 20, 2004, as US Patent Application Publication No. US-2004-0098079-A1, and PCT Patent Publication No. WO 2004/028399 entitled "Thoracic Deployment Device" disclose introducer devices adapted for deployment of stent grafts particularly in the thoracic arch. This feature and other features disclosed in U.S. Provisional Patent Application Serial No. 60/392,667, U.S. Patent Application Serial No. 10/609,846, and US Patent Application Publication No. US-2004-0098079-A1, and PCT Patent Publication No. WO 2004/028399 could be used with the present invention.

    [0028] U.S. Provisional Patent Application Serial No. 60/392,599, filed June 28, 2002, and U.S. Patent Application Serial No. 10/609,835, filed June 30, 2003, and published on June 3, 2004, as U.S. Patent Application Publication No.

    [0029] US-2004-0106978-A1, and PCT Patent Publication No. WO 2004/002370 entitled "Thoracic Aortic Aneurysm Stent Graft" disclose stent grafts that are useful in treating aortic aneurysms particularly in the thoracic arch. This feature and other features disclosed in U.S. Provisional Patent Application Serial No 60/392,599, U.S. Patent Application Serial No. 10/609,835, and U.S. Patent Application Publication No. US-2004-0106978-A1, and PCT Patent Publication No. WO 2004/002370 could be used with the present invention.

    [0030] U.S. Provisional Patent Application Serial No. 60/391,737, filed June 26, 2002, U.S. Patent Application Serial No. 10/602,930, filed June 24, 2003, and published on March 18, 2004, as U.S. Patent Application Publication No. US-2004-0054396-A1, and PCT Patent Publication No. WO 2004/002365 entitled "Stent-Graft Fastening" disclose arrangements for fastening stents onto grafts particularly for exposed stents. This feature and other features disclosed in U.S. Provisional Patent Application No. 60/391,737, U.S. Patent Application Serial No. 10/602,930, and U.S. Patent Application Publication No. US-2004-0054396-A1, and PCT Patent Publication No. WO 2004/002365 could be used with the present invention.

    [0031] U.S. Provisional Patent Application Serial No. 60/405,367, filed August 23, 2002, U.S. Patent Application Serial No. 10/647,642, filed August 25, 2003, and PCT

    [0032] Patent Publication No. WO 2004/017868 entitled "Asymmetric Stent Graft Attachment" disclose retention arrangements for retaining onto and releasing prostheses from introducer devices. This feature and other features disclosed in U.S. Provisional Patent Application Serial No. 60/405,367, filed August 23, 2002, U.S. Patent Application Serial No. 10/647,642, filed August 25,2003, and PCT Patent Pu blication No. WO 2004/017868 could be used with the present invention.

    [0033] U.S. Patent Application Serial No. 10/322,862, filed December 18, 2002 and published as Publication No. US2003-0120332, and PCT Patent Publication No. WO03/053287 entitled "Stent Graft With Improved Adhesion" disclose arrangements on stent grafts for enhancing the adhesion of such stent grafts into walls of vessels in which they are deployed. This feature and other features disclosed in U.S. Patent Application Serial No. 10/322,862, filed December 18, 2002 and published as Publication No. US2003-0120332, and PCT Patent Publication No. WO03/053287 could be used with the present invention.

    [0034] U.S. Provisional Patent Application Serial No. 60/405,769, filed August 23, 2002, U.S. Patent Application Serial No. 10/645,095, filed August 23, 2003, and PCT Patent Publication Number WO 2004/017867 entitled "Composite Prostheses" discloses prostheses or stent grafts suitable for endoluminal deployment. These prostheses and other features disclosed in U.S. Provisional Patent Application Serial No. 60/405,769, filed August 23, 2002, U.S. Patent Application Serial No. 10/645,095, filed August 23, 2003, and PCT Patent Publication Number WO 2004/017867 , could be used with the present invention.

    Brief Description of the Drawing



    [0035] This then generally describes the invention but to assist with the understanding, reference will now be made to the accompanying drawings which show a preferred embodiment of the invention and a method by which the preferred embodiment of the invention may be used to deploy a stent graft into the internal iliac artery.

    In the drawings;



    [0036] 

    Figures 1 to 6 show the various stages of deployment of a stent graft on a deployment device into an iliac artery according to one embodiment of the present invention;

    Figure 7 shows a schematic view of a deployment device with a stent graft mounted thereon according to one embodiment of the invention;

    Figure 8 shows a schematic view of a deployment device with a stent graft mounted thereon;

    Figure 9 shows a further schematic view of the deployment device shown in Figure 8;

    Figure 10 shows a stage of deployment of the stent graft as shown in Figures 8 and 9 corresponding to the stage of deployment shown in Figure 5 above;

    Figure 11 shows a schematic view of a deployment device with a stent graft mounted thereon according to a further embodiment of the invention;

    Figure 12 shows a side view of one method of proximal retention suitable for the present invention;

    Figure 13 shows a cross sectional view of the arrangement shown in Figure 12 ;

    Figure 14 shows a side view of one method of distal retention suitable for the present invention; and

    Figure 15 shows a side view of an alternative method of distal retention suitable for the present invention.


    Detailed Description



    [0037] Now looking first at Figure 7, the introducer with a stent graft mounted onto it according to one embodiment of the present invention is shown schematically.

    [0038] The introducer generally shown as 1 has an introducer catheter 3 extending over a guide wire catheter 5. The guide wire catheter 5 extends from the distal end 7 of the introducer 1 to immediately distal of the nose cone dilator 11. A branched stent graft 13 is retained at its proximal end by a retention arrangement (see Figure 12 and 13 for one example of a proximal retention arrangement) onto the introducer immediately distal of the nose cone dilator 11. The branched stent graft 13 is retained at its distal end by another retention arrangement (see Figure 14 and 15 for examples of a proximal retention arrangement) onto the introducer. A sleeve 15 operated by a sleeve manipulator 17 is mounted on the introducer catheter 3 and in the ready to deploy position the sleeve 15 extends over the branched stent graft 13 to the nose cone dilator 11. As illustrated in Figure 7, however, the sleeve 15 is withdrawn so that the branched stent graft is exposed to show detail of the assembly. A handle 19 at the distal end of the introducer catheter 3 enables manipulation of the introducer 1. An indwelling catheter 21 enters a lumen (not shown) of the introducer catheter 3 at the handle 19 and exits from the introducer catheter 3 at the distal end 23 of the branched stent graft 13.

    [0039] The branched stent graft 13 has a substantially tubular body with a main lumen through the main tubular body and a side lumen through the branch 25. The indwelling catheter 21 enters the lumen of the branch 25 from its distal end 26 and hence it passes outside the main tubular body of the branched stent graft before it enters the branch lumen. The indwelling catheter then exits from the main body adjacent the nose cone dilator and extends along the side of the nose cone dilator in a groove 27 in the nose cone dilator.

    [0040] Within the indwelling catheter 21, there is a guide wire 29. This guide wire 29 can be pushed through the indwelling catheter so that it extends beyond the tip 31 of the nose cone dilator so that it can be snared as will be discussed in relation to Figures 1 to 6 showing one embodiment of the stent graft placement procedure. Preferably the tip 32 of the indwelling catheter is tapered around the guide wire 29 to prevent blood loss through the indwelling catheter.

    [0041] Now looking at Figures 1 to 6, it will be seen that there is schematically illustrated a series of arteries within the human body, although as discussed earlier, the invention is not restricted to this particular application.

    [0042] A descending aorta 40 extends down to an aortic bifurcation 42 from which extend common iliac arteries 44 and 46. From each of the common iliac arteries an internal iliac artery 48 and 150 respectively, extends. As discussed earlier, the internal iliac arteries 48 and 150|cannot be practically accessed from their distal ends remote from the junction with the common iliac artery.

    [0043] As shown in Figure 1, a guide wire 50 for the deployment device 152 has been extended into a femoral artery via a femoral incision (not shown) and extended up beyond the aortic bifurcation 42 to the aorta 40. The introducer 1 has then been deployed over the guide wire with the nose cone dilator 11 extending nearly up to the aortic bifurcation. At this stage, the sleeve 15 on the deployment device extends up to the nose cone dilator 11 but has been withdrawn slightly to expose the proximal end 32 of the indwelling catheter 21.

    [0044] As can be seen in Figure 2, the guide wire 29 from the indwelling catheter 21 has been extended so that it extends up beyond the aortic bifurcation but only a short distance up the aorta 40. A snare catheter 52 has been deployed via the contra-lateral iliac artery 46 and by suitable radiographic techniques the loop 54 of the snare catheter 52 is used to catch the guide wire 29.

    [0045] Figure 2A shows an alternative step in the process. In this step the indwelling catheter 21 and the guide wire 29 have been advanced together to the aortic bifurcation 42 and so that the indwelling catheter 21 is beyond the nose cone dilator 11. The guide wire 29 is then advanced so that it can be snared by the loop 54 of the snare catheter. By this alternative step the guide wire 29 is held more firmly and there is less likelihood that it will become entangled with the main guide wire 50.

    [0046] As shown in Figure 3, the guide wire 29 has been withdrawn through the contra-lateral iliac artery 46 and the indwelling catheter 21 has been advanced over the guide wi re so that it extends over the aortic bifurcation 42 and down the contra-lateral iliac artery 46. To assist this process, the sheath 15 has been withdrawn to the distal end 23 of the branched stent graft 13 so that it is just distal of the proximal end of the introducer catheter 3. At this stage the branched stent graft 13 is partially freed but is still retained by retention arrangements at at least the proximal and distal ends of the branched stent graft and is hence in an unexpanded or not fully expanded condition.

    [0047] Figure 4 shows the next stage of the process where a sheath 58 of a suitable size has been advanced over the guide wire 29 via the contra-lateral artery and indwelli ng catheter 21 so that it enters the proximal end 60 of the branched stent graft 13. At this stage, the indwelling catheter and guide wire 29 still extends down the iliac artery 44 on the introducer 1 so that the sheath 58 can be manipulated to successfully enter the proximal end of the branched stent graft so that it extends towards and into the branch 25 on the stent graft 13. At this stage, the indwelling catheter 21 and guide wire 19 can be withdrawn either from the contra-latera l iliac artery 46 or from the iliac artery 44 and another guide wire 62 introduced via the sheath 58. This guide wire 62 can then be manipulated so that it enters the internal iliac artery 48.

    [0048] As shown in Figure 5, a further deployment device 63 can then be introduced via the sheath 58 from the contra-lateral iliac artery 46 to extend out of the distal end of the branch 25 of the branched stent graft 13 so that a leg extension 64 can be deployed to extend from the branch 25 of the branched stent graft 13.

    [0049] As shown in Figure 6, the sheath 58 from the contra-lateral iliac artery 46 can then be withdrawn and the release mechanisms at each end of the stent graft 13 can be released and the leg extension 64 released so that the branched stent graft with leg extension is then deployed in the common iliac artery.

    [0050] The introducer 1 can then be withdrawn although in some situations it may be desirable to leave the sleeve 15 in position so that further deployment of a stent g raft into the aorta such as a bifurcated stent graft can be achieved through the sheath 15.

    [0051] In summary therefore, the steps in the graft placement procedure accordingly using the device of the present invention may be as follows:
    1. 1. Deploy an introducer into a femoral artery via a femoral incision and extend the introducer up to the aortic bifurcation.
    2. 2. Withdraw the sheath to expose the proximal end of an indwelling catheter associated with the introducer.
    3. 3. Advance an indwelling guide wire through the indwelling catheter beyond the nose cone dilator of the introducer.
    4. 4. Introduce a snare catheter into the contra-lateral iliac artery via a femoral route and snare the indwelling guide wire.
    5. 5. Withdraw the indwelling guide wire through the contra-lateral iliac artery and advance the indwelling catheter around the aortic bifurcation to protect the aortic bifurcation during subsequent steps.
    6. 6. Withdraw the main sheath to expose the branched stent graft but still have the branched stent graft retained at each of its ends.
    7. 7. Deploy an auxiliary sheath over the indwelling guide wire up the contra-lateral iliac artery and into the branched stent graft via the proximal end of the branched stent graft.
    8. 8. Advance the auxiliary sheath into the short leg of the branched stent graft via the indwelling catheter guide wire or another guide wire which has been deployed through the sheath which has been placed via the contra-lateral iliac artery.
    9. 9. Remove the indwelling catheter and indwelling guide wire.
    10. 10. Advance a guide wire through the auxiliary sheath via the contra-lateral iliac artery and manipulate it into the internal iliac artery. Atthis stage, it may be necessary to withdraw the deployment device or rotate it slightly to guide the branch of the branched stent graft towards the internal iliac artery.
    11. 11. Advance a short leg introducer with a leg stent graft over the guide wire in the contra-lateral iliac artery and through the auxiliary sheath and into the internal iliac artery.
    12. 12. Release the proximal distal ends of the branched stent graft
    13. 13. Release the leg stent graft from the short leg introducer or balloon expand the leg stent graft.
    14. 14. Withdraw the contra-lateral iliac artery auxiliary sheath, introducer and guide wire.
    15. 15. Withdraw the main introducer.


    [0052] As discussed earlier it may be necessary or desirable to leave the sheath of the main introducer and/or the main guide wire to enable deployment of further stent grafts within the aorta and aortic bifurcation.

    [0053] Now looking at Figures 8 and 9, an introducer with a stent graft mounted onto it is shown schematically. The same reference numerals are used for corresponding features to those of Figure 7.

    [0054] The introducer generally shown as 1 has an introducer catheter 3 extending over a guide wire catheter 5. The guide wire catheter 5 extends from the distal end 7 of the introducer 1 to immediately distal of the nose cone dilator 11 which is at the proximal end 9 of the introducer. A fenestrated stent graft 70 is retained by a retention arrangement (not shown) onto the introducer immediately distal of the nose cone dilator 11. A sleeve 15 operated by a sleeve manipulator 17 is mounted on the introducer catheter 3 and in the ready to deploy position the sleeve 15 extends over the stent graft 70 to the nose cone dilator 11. As illustrated in Figure 7, however, the sleeve 15 is withdrawn so that the stent graft is exposed to show detail of the assembly. A handle 19 at the distal end of the introducer catheter 3 enables manipulation of the introducer 1. An indwelling catheter 21 enters a lumen (not shown) of the introducer catheter 3 at the handle 19 and exits from the introducer catheter at the distal end 23 of the stent graft 70.

    [0055] The stent graft 70 has a substantially tubular body with a main lumen through the main tubular body and a fenestration 71. The indwelling catheter 21 enters the fe nestration 71 from outside the stent graft and hence it passes outside the main tubular body of the stent graft at the distal end thereof, before it enters fenestration. The indwelling catheter then passes through the main lumen of the stent graft to its proximal end and exits from the main body adjacent the nose cone dilator 11 and extends along the side of the nose cone dilator in a groove 27 in the nose cone di lator.

    [0056] Within the indwelling catheter 21, there is a guide wire 29. This guide wire 29 can be pushed through the indwelling catheter so that it extends beyond the tip 31 of the nose cone dilator so that it can be snared as discussed in relation to Figures 1 to 6 showing a stent graft placement procedure. Preferably the tip 32 of the indwel ling catheter is tapered around the guide wire 29 to prevent blood loss through the indwelling catheter.

    [0057] Figure 10 shows a stage of deployment of the stent graft as shown in Figures8 and 9 corresponding to the stage of deployment shown in Figure 5 above. The same reference numeral are used for corresponding features to those of Figures 1 to 6.

    [0058] Prior to the stage shown in Figure 10 a guide wire 50 for the deployment device 52 has been extended into a femoral artery via a femoral incision (not shown) and extended up beyond the aortic bifurcation 42 into the aorta 40. An introducer 1 has then been deployed over the guide wire with the nose cone dilator 11 extending nearly up to the aortic bifurcation. At this stage, the sleeve 15 on the deployment device extends up to the nose cone dilator but has been withdrawn slightly to expose the proximal end of the indwelling catheter 21. Next a guide wire from an indwelling catheter (not shown in Figure 10) has been extended so that it extends up beyond the aortic bifurcation but only a short distance up the aorta 40. A snare catheter has been deployed via the contra-lateral iliac artery 46 and by suitable radiographic techniques the loop of the snare catheter has been used to catch the guide wire. The guide wire has then been withdrawn through the contra-lateral iliac artery 46 and the indwelling catheter has been advanced over the guide wire so that it extends over the aortic bifurcation 42 and down the contra-lateral iliac artery 46. To assist this process, the sheath 15 has been withdrawn to just distal of the fenestration 25 and still covering the distal end 23 of the stent graft 70. At this stage the stent graft 13 is partially freed but is still retained by a retention arrangements at the proximal end 60 of the stent graft and by the sheath at the distal end. The exposed portion of the stent graft between the proximal end and the fenestration can expand although there may be diameter reducing ties (not shown) to restrict the amount of expansion. Next a sheath 58 of a suitable size has been advanced over the guide wire 29 and indwelling catheter 21 so that it enters the proximal end 60 of the branched stent graft 70. At this stage, the indwelling catheter and guide wire 29 still extends down the iliac artery 44 on the introducer 1 so that the sheath 58 can be manipulated to successfully enter the proximal end of the branched stent graft 60 so that it extends towards and into the fenestration 71 on the stent graft 70. At this stage, the indwelling catheter 21 and guide wire 19 can be withdrawn, either from the contra-lateral iliac artery 46, or from the iliac artery 44 and another guide wire 62 introduced via the sheath 58. This guide wire 62 can then be manipulated so that it enters the internal iliac artery 48.

    [0059] As shown in Figure 10, a further deployment device 63 has then been introduced via the sheath 58 from the contra-lateral iliac artery 46 to extend out of the fenestration 71 of the stent graft 70. The further deployment device 63 carries a leg extension 64. The leg extension 64 can be deployed to extend from the fenestration 71 of the stent graft 70. The leg extension 64 can be a covered balloon expandable stent for instance, which is carried on a balloon in the deployment device so that it can be deployed and expanded with its proximal end retained in the fenestration and extending into the internal iliac artery 48.

    [0060] Now looking at Figure 11, an introducer with a stent graft mounted onto it according to an alternative embodiment of the present invention is shown schematically.

    [0061] In this embodiment the stent graft 90 has a fenestration 94 in the wall of the stent graft 90 and an internal leg extension 92 extending inwardly and toward the proximal end 74 of the stent graft 90 from the fenestration 94. The indwelling catheter 80 extends into the fenestration 94 and into the internal leg extension 92 and toward the proximal end 74 of the stent graft 90. The indwelling catheter 80 then exits from the main body adjacent the nose cone dilator 82 and extends along the side of the nose cone dilator 82 in a groove 81 in the nose cone dilator 82.

    [0062] Figures 8 to 11 show various embodiments of the present invention in a stylised manner. It should be noted that the configuration with the main sheath withdrawn completely off the stent graft but with the indwelling catheter and guide wire in its initial position would not occur in practice.

    [0063] Figure 12 shows a side view of one method of proximal retention suitable for the present invention and Figure 13 shows a cross sectional view of the arrangement shown in Figure 12. The same reference numerals are used for corresponding features to those of Figure 7 for corresponding items.

    [0064] The guide wire catheter 5 extends to a nose cone dilator 11 and the proximal end of the stent graft 13 is retained onto the guide wire catheter just distal of the nose cone dilator. Retention is by means of a pair loops of suture material 101 each of which is engaged with a trigger wire 103 extending from an aperture in the guide wire catheter 5. The loops are placed so that there is formed a smaller 105 and larger fold 107 of the stent graft 13 at its proximal end. The indwelling catheter passes through the region defined by the larger fold 107 and therefore when the sheath 58 (see Figure 4) has been advanced over the guide wire then it can more easily enter the lumen of the stent graft.

    [0065] Figure 14 shows a side view of one method of distal retention suitable for the present invention. The same reference numerals are used for corresponding features to those of Figure 7 for corresponding items. In this embodiment the distal end 23 of the stent graft 13 is retained onto the guide wire catheter 5 just proximal of the deployment catheter 3 by means of a suture loop 109 engaged into the stent graft 13 and a loop of trigger wire 111 extending from the deployment catheter 3. Removal of the trigger wire 111 when required will release the distal end 23 of the stent graft 13.

    [0066] Figure 15 shows a side view of an alternative method of distal retention suitable for the present invention. The same reference numerals are used for corresponding features to those of Figure 7 for corresponding items. In this embodiment the distal end 23 of the stent graft 13 is retained onto the guide wire catheter 5 just proximal of the deployment catheter 3 by means a loop of trigger wire 113 extending from the deployment catheter 3 and passing through a portion of the stent graft 13. Removal of the trigger wire 113 when required will release the distal end 23 of the stent graft 13.


    Claims

    1. An assembly including a branched stent graft (13) and an introducer (1) configured to deploy the branched stent graft into a body vessel having a main vessel (40), the body vessel having a first branch vessel (44) extending from the main vessel, a second branch vessel (46) extending from the main vessel, a bifurcation (42) between the first and second branch vessels, and a third vessel (48) extending from the first branch vessel and having an ostium, the branched stent graft comprising a main body having a distal end, a proximal end with a main lumen therethrough, at least two main body stents, and a branch (25) extending from the main body between the main body distal end and the main body proximal end more proximate the proximal end, the branch having a branch lumen therethrough in fluid communication with the main lumen, a distal open end, and a stent adjacent the distal open end;

    the introducer comprising a sleeve (15) disposed over the branched stent graft, and a first guide wire catheter (5) configured to receive a first guide wire (50),

    characterised by a second guide wire catheter (21) configured to receive second guide wire (29), wherein the second guide wire catheter has a portion that extends from distal of the distal end of the main body, a portion that extends outside of and at least partially along the main body of the branched stent graft, a portion that extends into the distal open end of the branch and through the branch lumen to the main lumen, and a portion that extends out of the main lumen at the proximal stent graft end and along a side of a nose cone dilator.


     
    2. The combination of claim 1 wherein the deployment system comprises an auxiliary sheath (58) that can be advanced into the second branch vessel (46), over the bifurcation (42) and into the branch of the branched stent graft (13).
     
    3. The combination of claim 2 wherein the deployment system comprises a third guide wire (62) that can be advanced through the auxiliary sheath (58) and into the branch of the branched stent graft (13).
     
    4. The combination of claim 3 wherein the deployment system comprises a second delivery device including a stent graft extension (64) can be advanced over the third guide wire (62), through the auxiliary sheath (58), into the proximal end of the main body, into the branch of the branched stent graft (13), and into the third branch vessel (48).
     
    5. The combination of any preceding claim, wherein the deployment system comprises a snare (54) that can be introduced into the second branch vessel (46) and the snare can be advanced to proximate the bifurcation (42).
     
    6. The combination of any preceding claim, wherein the second guide wire catheter (21) extends from distal of the distal end of the branched stent graft (13) to the branched stent graft.
     


    Ansprüche

    1. Anordnung, aufweisend einen verzweigten Stentgraft (13) und einen Einführer (1), der dazu ausgestaltet ist, den verzweigten Stentgraft in einem Körpergefäß mit einem Hauptgefäß (40) abzulegen, wobei das Körpergefäß ein erstes abzweigendes Gefäß (44), das sich von dem Hauptgefäß erstreckt, ein zweites abzweigendes Gefäß (46), das sich von dem Hauptgefäß erstreckt, eine Gabelung (42) zwischen dem ersten und dem zweiten abzweigenden Gefäß und ein drittes Gefäß (48) hat, das sich von dem ersten abzweigenden Gefäß erstreckt und ein Ostium hat, wobei der verzweigte Stentgraft einen Hauptkörper mit einem distalen Ende und einem proximalen Ende mit einem dort hindurchgehenden Hauptlumen, mindestens zwei Hauptkörperstents und einen Ast (25) umfasst, der sich von dem Hauptkörper zwischen dem distalen Ende des Hauptkörpers und dem proximalen Ende des Hauptkörpers proximaler zu dem proximalen Ende erstreckt, wobei der Ast ein dort hindurchgehendes Astlumen, das in Fluidverbindung zu dem Hauptlumen steht, ein distales offenes Ende und einen dem distalen offenen Ende benachbarten Stent hat,

    wobei der Einführer eine Hülse (15), die über dem verzweigten Stentgraft angeordnet ist, und einen ersten Führungsdrahtkatheter (5), der zur Aufnahme eines ersten Führungsdrahts (50) ausgestaltet ist, umfasst,

    gekennzeichnet durch einen zweiten Führungsdrahtkatheter (21), der zur Aufnahme eines zweiten Führungsdrahts (29) ausgestaltet ist, wobei der zweite Führungsdrahtkatheter einen Abschnitt, der sich von distal des distalen Endes des Hauptkörpers erstreckt, einen Abschnitt, der sich außerhalb des Hauptkörpers des verzweigten Stentgrafts und mindestens teilweise an diesem entlang erstreckt, einen Abschnitt, der sich in das distale offene Ende des Asts und durch das Astlumen zu dem Hauptlumen erstreckt, und einen Abschnitt hat, der sich aus dem Hauptlumen an dem proximalen Ende des Stentgrafts und entlang einer Seite eines Nasenkonus-Dilatators erstreckt.


     
    2. Kombination nach Anspruch 1, wobei das Ablegesystem eine Hilfshülse (58) umfasst, die in das zweite abzweigende Gefäß (46), über die Gabelung (42) und in den Ast des verzweigten Stentgrafts (13) vorgeschoben werden kann.
     
    3. Kombination nach Anspruch 2, wobei das Ablegesystem einen dritten Führungsdraht (62) umfasst, der durch die Hilfshülse (58) und in den Ast des verzweigten Stentgrafts (13) vorgeschoben werden kann.
     
    4. Kombination nach Anspruch 3, wobei das Ablegesystem eine zweite Zuführvorrichtung einschließlich einer Stentgraftverlängerung (64) umfasst, die über den dritten Führungsdraht (62), durch die Hilfshülse (58), in das proximale Ende des Hauptkörpers, in den Ast des verzweigten Stentgrafts (13) und in das dritte abzweigende Gefäß (48) vorgeschoben werden kann.
     
    5. Kombination nach einem der vorhergehenden Ansprüche, wobei das Ablegesystem einen Fangdraht (54) umfasst, der in das zweite abzweigende Gefäß (46) eingeführt werden kann, und der Fangdraht zu proximal der Gabelung (42) vorgeschoben werden kann.
     
    6. Kombination nach einem der vorhergehenden Ansprüche, wobei sich der zweite Führungsdrahtkatheter (21) von distal des distalen Endes des verzweigten Stentgrafts (13) zu dem verzweigten Stentgraft erstreckt.
     


    Revendications

    1. Ensemble comprenant une endoprothèse ramifiée (13) et un introducteur (1) configuré pour déployer l'endoprothèse ramifiée dans un vaisseau corporel ayant un vaisseau principal (40), le vaisseau corporel ayant un premier vaisseau (44) de ramification s'étendant à partir du vaisseau principal, un deuxième vaisseau (46) de ramification s'étendant à partir du vaisseau principal, une bifurcation (42) entre les premier et deuxième vaisseaux de ramification, et un troisième vaisseau (48) s'étendant depuis le premier vaisseau de ramification et ayant un ostium, l'endoprothèse ramifiée comprenant un corps principal ayant une extrémité distale, une extrémité proximale avec une lumière principale à travers celle-ci, au moins deux stents de corps principal, et une ramification (25) s'étendant depuis le corps principal entre l'extrémité distale du corps principal et l'extrémité proximale du corps principal plus proche de l'extrémité proximale, la ramification ayant une lumière de ramification à travers celle-ci en communication fluidique avec la lumière principale, une extrémité ouverte distale, et un stent adjacent à l'extrémité distale ouverte ;

    l'introducteur comprenant un manchon (15) disposé sur l'endoprothèse ramifiée, et un premier cathéter (5) de fil de guidage configuré pour recevoir un premier fil de guidage (50),

    caractérisé par un second cathéter (21) de fil de guidage configuré pour recevoir un second fil de guidage (29), dans lequel le second cathéter de fil de guidage a une partie qui s'étend à partir de la partie distale de l'extrémité distale du corps principal, une partie qui s'étend à l'extérieur et au moins partiellement le long du corps principal de l'endoprothèse ramifiée, une partie qui s'étend dans l'extrémité ouverte distale de la ramification et à travers la lumière de la ramification vers la lumière principale, et une partie qui s'étend hors de la lumière principale au niveau de l'extrémité proximale de l'endoprothèse et le long d'un côté d'un dilatateur de pointe avant.


     
    2. Association selon la revendication 1 dans laquelle le système de déploiement comprend une gaine auxiliaire (58) qui peut être avancée dans le deuxième vaisseau (46) de ramification, sur la bifurcation (42) et dans la ramification de l'endoprothèse ramifiée (13).
     
    3. Association selon la revendication 2 dans laquelle le système de déploiement comprend un troisième fil de guidage (62) qui peut être avancé à travers la gaine auxiliaire (58) et dans la ramification de l'endoprothèse ramifiée (13).
     
    4. Association selon la revendication 3 dans laquelle le système de déploiement comprend un second dispositif de mise en place comprenant une extension (64) d'endoprothèse pouvant être avancée sur le troisième fil de guidage (62), à travers la gaine auxiliaire (58), dans l'extrémité proximale du corps principal, dans la ramification de l'endoprothèse ramifiée (13), et dans le troisième vaisseau (48) de ramification.
     
    5. Association selon toute revendication précédente, dans laquelle le système de déploiement comprend un collet (54) qui peut être introduit dans le deuxième vaisseau (46) de ramification et le collet peut être avancé pour s'approcher de la bifurcation (42).
     
    6. Association selon toute revendication précédente, dans laquelle le second cathéter à fil de guidage (21) s'étend du côté distal de l'extrémité distale de l'endoprothèse ramifiée (13) vers l'endoprothèse ramifiée.
     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description