Twin bifurcated stent graft

• US 9,707,113 B2
• Filed: 04/19/2007
• Issued: 07/18/2017
• Est. Priority Date: 04/19/2006
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation, Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cleveland Clinic Foundation, Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Lawrence-Brown, Michael, Greenberg, Roy K., Hartley, David Ernest
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): LEVINE, JOSHUA H
• Application Number:
  US11/788,285
• Publication Number:
  US 20070250154A1
• Time in Patent Office: 3,743 Days
• Field of Search: 623 113, 623 116, 623 124, 623 125, 623 128, 623 129, 623 132, 623 139, 604 9
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A stent graft has a tubular body with a first bifurcation with first and second legs extending from the bifurcation. One of the legs has a further bifurcation to define a side arm. The stent graft can be deployed into the vasculature of a patient with the tubular body being in an aorta of the patient, a first leg extending down an iliac artery, a second leg being directed towards a contralateral iliac artery and the side arm directed to an internal artery of one of the iliac arteries. One of the legs can include a valved aperture to enable the placement of an indwelling catheter therethrough.

Claims

1. A stent graft system comprising:

a single stent graft unit having a predeployment configuration and a deployed configuration, where the single stent graft unit is one undivided piece deployed from a single deployment device, the single stent graft unit comprising;

a single body of a biocompatible graft material defining a main lumen therethrough, a bifurcation in the tubular body at one end thereof and a first leg and a second leg extending from the bifurcation, the first leg being a long leg and the second leg being a short leg, the first and second legs having respective first and second lumens therethrough and the first and second lumens being in fluid communication with the main lumen, characterized by the first long leg comprising a side arm with a side arm lumen therethrough and the side arm lumen being in fluid communication with the first leg lumen, whereby the single stent graft unit is configured to be deployed into the vasculature of a patient with the tubular body being an aorta of the patient, the first leg configured to extend down a common iliac artery past an internal iliac artery, the second leg being directed towards a contralateral common iliac artery and the side arm on the first leg directed to the internal iliac artery of the iliac artery, wherein the single stent graft unit is delivered to and deployed in the vasculature as a single unit; and

the stent graft system further comprising the single deployment device including a sheath having an inner lumen, wherein all portions of the single stent graft unit are disposed together within the sheath in the predeployment configuration prior to delivery of the single stent graft to the patient.

2. The stent graft system as in claim 1 wherein the side arm comprises a tube of corrugated biocompatible graft material and the tube extends part helically around the first leg.

3. A stent graft as in claim 1 wherein the side arm comprises a tube of biocompatible graft material and at least one self expanding stent on the tube of biocompatible graft material.

4. The stent graft system as in claim 1 wherein the first leg comprises an aperture in the side arm and a valve arrangement to prevent fluid flow through the aperture from inside of the leg to outside of the leg.

5. The stent graft system as in claim 4 wherein the aperture includes a resilient reinforcement ring around the aperture.

6. The stent graft system as in claim 4 wherein the valve arrangement comprises a sleeve of a biocompatible graft material within the first leg and a self expanding stent within the sleeve, the sleeve being fastened at its proximal end to the first leg proximal of the aperture and the self expanding stent being fastened to the sleeve, whereby the self expanding stent forces the sleeve against the inner surface of the first leg around the aperture to prevent fluid flow through the aperture from inside of the leg to outside of the leg.

7. A stent graft as in claim 6 wherein the sleeve of a biocompatible graft material comprises a cylindrical form.

8. The stent graft system as in claim 6 wherein the sleeve of a biocompatible graft material comprises a semi-cylindrical form.

9. The stent graft system as in claim 4 wherein the valve arrangement comprises a valve assembly comprising a self expanding stent to which a part cylindrical portion of biocompatible graft material is stitched along spaced apart struts of the self expanding stent.

10. The stent graft system as in claim 9 wherein the valve assembly further comprises a semi-circular resilient wire around the distal end of the part cylindrical portion of biocompatible graft material forming the valve member.

11. A stent graft system comprising:

a single delivery device having an inner cannula and a retractable sheath disposed at least partially over the inner cannula;

a single stent graft unit having a predeployment configuration and a configuration, the single stent graft unit comprising a tubular body of a biocompatible graft material defining a main lumen therethrough, a bifurcation in the tubular body at one end thereof and a first leg and a second leg extending from the bifurcation, the first leg being a long leg and the second leg being a short leg, the first and second legs having respective first and second lumens therethrough and the first and second lumens being in fluid communication with the main lumen, characterised by the first long leg comprising a side arm with a side arm lumen therethrough and the side arm lumen being in fluid communication with the first leg lumen, whereby the stent graft can be deployed into the vasculature of a patient with the tubular body being in an aorta of the patient, the first leg configured to extend down a common iliac artery and past an internal iliac artery, the second leg being directed towards a contralateral common iliac artery and the side arm on the first leg directed to an internal iliac artery of the iliac artery, wherein the side arm comprises a tube of corrugated biocompatible graft material and the tube extends part helically around the first leg stent graft, the first leg comprising an aperture in the side arm and a valve arrangement to prevent fluid flow through the aperture from inside of the leg to outside of the leg and the valve arrangement comprising a sleeve of a biocompatible graft material within the first leg and a self expanding stent within the sleeve, the sleeve being fastened at its proximal end to the first leg proximal of the aperture and the self expanding stent being fastened to the sleeve, whereby the self expanding stent forces the sleeve against the inner surface of the first leg around the aperture to prevent the fluid flow through the aperture, wherein the stent graft is delivered to and deployed in the vasculature as a single unit; and

wherein all portions of the single stent graft unit are disposed at least partially over the cannula of the single delivery system and all portions of the single stent graft unit are disposed together within the sheath of the single delivery system prior to delivery to the patient.

12. A stent graft system comprising:

a single stent graft unit having a predeployment configuration and a deployed configuration, the single stent graft unit having a terminal proximal end, a terminal distal end, wherein the single stent graft unit is one undivided piece from the terminal proximal end to the terminal distal end, the single stent graft unit comprising, as a single piece from the terminal proximal end to the terminal distal end;

a first tubular portion having a proximal end and a distal end,

a bifurcation extending from the first tubular portion distal end,

a first leg extending from the bifurcation and having a side wall,

a second leg extending from the bifurcation, wherein the first leg is longer than the second leg and has a proximal end at the bifurcation and a distal end below the bifurcation and defining the terminal distal end of the single stent graft unit,

a fenestration in the side wall of the first leg between its proximal and distal ends,

an aperture in the side wall of the first leg between its proximal and distal ends and disposed substantially opposite the fenestration,

an at least partially helical side arm extending from the fenestration,

a valve disposed over the aperture, the valve having a proximal closed portion, a distal portion, an open configuration and a closed configuration, wherein both the open and closed configuration, the proximal closed portion remains closed and substantially prevents fluid from flowing through the aperture; and

a single deployment device including a single sheath having an inner lumen, wherein all portions of the single stent graft unit are disposed together within the sheath in the predeployment configuration prior to delivery of the single stent graft to the patient.

13. A stent graft system comprising:

a single stent graft unit having a predeployment configuration and a deployed configuration, the single stent graft unit having a terminal proximal end, a terminal distal end, wherein the single stent graft unit is one undivided piece from the terminal proximal end to the terminal distal end, the single stent graft unit comprising, as a single piece from the terminal proximal end to the terminal distal end;

a first tubular portion having a proximal end and a distal end,

a bifurcation extending from the first tubular portion distal end,

a first leg extending from the bifurcation and having a side wall,

a second leg extending from the bifurcation, wherein the first leg is longer than the second leg and has a proximal end at the bifurcation and a distal end below the bifurcation defining the terminal distal end of the single stent graft unit,

a fenestration in the side wall of the first leg between its proximal and distal ends,

an aperture in the side wall of the first leg between its proximal and distal ends and disposed substantially opposite the fenestration,

a side arm extending from the fenestration,

a valve disposed over the aperture, the valve having an open configuration and a closed configuration, wherein the valve is biased in the closed configuration and wherein fluid is substantially prevented from flowing through the aperture in both the open and closed configurations; and

a single deployment device including a single sheath having an inner lumen, wherein all portions of the single stent graft unit are disposed together within the sheath in the predeployment configuration prior to delivery of the single stent graft to the patient.

14. A stent graft system comprising:

a single stent graft unit having a predeployment configuration and a deployed configuration, the single stent graft unit having a terminal proximal end, a terminal distal end, wherein the single stent graft unit is one undivided piece from the terminal proximal end to the terminal distal end, the single stent graft unit comprising, as a single piece from the terminal proximal end to the terminal distal end;

a first tubular portion having a proximal end and a distal end,

a bifurcation extending from the first tubular portion distal end,

a first leg extending from the bifurcation and having a side wall,

a second leg extending from the bifurcation, wherein the first leg is longer than the second leg and has a proximal end at the bifurcation and a distal end below the bifurcation defining the terminal distal end of the single stent graft unit,

a fenestration in the side wall of the first leg between its proximal and distal ends,

an at least partially helical side arm extending from the fenestration,

a single deployment device including a single sheath having an inner lumen, wherein the first tubular portion, the bifurcation, the first leg, the second leg, the fenestration, and the at least partially helical side arm are all disposed together within the single sheath in the predeployment configuration prior to delivery of the single stent graft to the patient.