Twin bifurcated stent graft

• US 10,143,576 B2
• Filed: 07/17/2017
• Issued: 12/04/2018
• 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: Greenberg, Roy K., Hartley, David E., Lawrence-Brown, Michael
• Primary Examiner(s): Dang, Son
• Application Number:
  US15/651,837
• Publication Number:
  US 20170325978A1
• Time in Patent Office: 505 Days
• Field of Search: 623 113, 623 124, 623 125, 623 128, 623 129
• 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 delivery system for delivering a stent graft to a body vessel of a patient comprising:

a first delivery device having an inner cannula configured to receive a first guidewire in a lumen of the inner cannula, a nose cone extending from the inner cannula at a delivery end of the delivery device, a stent graft disposed over the inner cannula adjacent to the nose cone, and a retractable sheath disposed over the stent graft;

wherein the stent graft has a tubular body of a biocompatible graft material having a main lumen, a bifurcation in the tubular body at one end and a first leg and a second leg extending from the bifurcation, the first and second legs having respective first and second lumens and the first and second lumens being in fluid communication with the main lumen;

wherein the first leg has a sidewall, a first fenestration in the side wall, a side arm attached to the sidewall and extending from the fenestration to define a side arm lumen in fluid communication with the first leg, a valved fenestration in the sidewall circumferentially spaced from the first fenestration, a valve to prevent fluid flow the valved fenestration from inside of the first leg to outside of the first leg, and an indwelling catheter disposed at least partially in and extending through the lumen of the side arm and out of the valved fenestration and along a length of the stent graft to the nose cone; and

wherein all portions of the stent graft, with the indwelling catheter, are disposed as a single over the inner cannula and within the sheath of the single delivery device prior to delivery to the patient.

2. The stent graft delivery system of claim 1, wherein the side arm extends from the first fenestration in a distal direction and partially helically around the first leg.

3. The stent graft delivery system of claim 2, wherein the first leg is longer than the second leg.

4. The stent graft delivery system of claim 1, wherein the nose cone has a longitudinal groove and a proximal portion of the indwelling catheter resides within the groove and is held there by the retractable sheath.

5. The stent graft delivery system of claim 4, wherein the proximal portion of the indwelling catheter is pre-curved.

6. A stent graft delivery system comprising:

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

,

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 shorter than the first leg extending from the bifurcation, 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 attached to the side wall and 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;

an indwelling catheter disposed at least partially within the lumen of the side arm and out of the aperture, and

a single deployment device including a retractable sheath having an inner lumen, wherein all portions of the stent graft, along with the indwelling catheter disposed at least partially within the lumen of the side arm and out of the aperture, are disposed together within the sheath in the predeployment configuration prior to delivery of the single stent graft to the patient.

7. The stent graft delivery system of claim 6, wherein the side arm is at least partially corrugated.

8. The stent graft delivery system of claim 7, wherein the side arm extends at least partially helically about the first leg.

9. The stent graft delivery system of claim 6, wherein the valve comprises a flap of graft material.

10. The stent graft delivery system of claim 9, wherein the indwelling catheter holds the valve in the open configuration.

11. A stent graft delivery system comprising:

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

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,

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 attached to the side wall and extending from the fenestration;

an indwelling catheter disposed at least partially within the lumen of the side arm and out of the aperture and along side the stent graft toward the stent graft proximal end, and

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

12. The stent graft delivery system of claim 11, wherein the delivery device has a nose cone at the proximal end of the delivery device and the delivery device extends to the nose cone.

13. The stent graft delivery system of claim 12, wherein the nose cone comprises a longitudinal groove and where a portion of the indwelling catheter is disposed within the longitudinal groove and held there by the retractable sheath in the predelivery configuration.

14. The stent graft delivery system of claim 13, wherein a proximal end of the indwelling catheter is curved and held in a straightened configuration within the groove in the predelivery configuration.

15. The stent graft delivery system of claim 11, wherein the side arm is corrugated.

16. A stent graft system comprising:

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

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,

an indwelling catheter disposed at least partially within the lumen of the at least partially helical side arm and out of the aperture and along side the stent graft toward the stent graft proximal end, and

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, the at least partially helical side arm, and the indwelling catheter are all disposed together within the single sheath in the predeployment configuration prior to delivery of the single stent graft to the patient.