Balloon flareable branch vessel prosthesis and method

• US 9,078,780 B2
• Filed: 11/08/2004
• Issued: 07/14/2015
• Est. Priority Date: 11/08/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Schaeffer, Darin G., Hoffa, Michael C., Boatman, Scott E., Roberts, Kimberly D.
• Primary Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US10/984,417
• Publication Number:
  US 20060058864A1
• Time in Patent Office: 3,900 Days
• Field of Search: 623/1.13, 623/1.22, 623/1.3, 623/1.31, 623/1.11, 623/1.12, 623/1.15, 623/1.35, 604/96.01, 604/99.01, 604/103.11, 604/104, 604/106, 60410101-10105, 60410306-10308, 606/190, 606/191, 606/192, 606/194, 606/198
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 : connected peak to peak
• CPC Class Codes: A61F 2002/91566 : connected trough to trough
• CPC Class Codes: A61F 2002/9511 : the retaining means being filaments or wires
• CPC Class Codes: A61F 2210/0076 : multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 : using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0097 : Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

A stent graft system for intraluminal deployment in an aorta and a branch vessel that includes an aorta stent graft for deployment within the aorta and defining a lumen for the passage of blood therethrough, and having a fenestration positioned and sized so as to allow blood to flow to a contiguous branch vessel. The system also includes a branch vessel prosthesis, preferably a stent graft, having a tubular portion and a flaring portion, such that, when deployed, the flaring portion is located within the lumen of the aorta stent graft and the tubular portion passes through the fenestration and into the branch vessel. A balloon expansion catheter expands the tubular portion and flare the flaring portion. The expansion of the tubular portion and the flaring of the flaring portion may occur sequentially or simultaneously.

Claims

1. A stent graft system for intraluminal deployment in an aorta and a branch vessel comprising:

an aorta stent graft for deployment within the aorta and defining a lumen for the passage of blood therethrough, and having a fenestration positioned and sized so as to allow blood to flow to a contiguous branch vessel;

a branch vessel prosthesis having a tubular portion and a flaring portion, such that, when deployed, the flaring portion is located within the lumen of the aorta stent graft and the tubular portion passes through the fenestration and into the branch vessel;

a balloon expansion catheter having first and second balloons,

wherein the first balloon is aligned substantially with the flaring portion and the second balloon is aligned substantially with the tubular portion such that inflation of the first balloon flares the flaring portion and inflation of the second balloon expands the tubular portion, and

wherein the second balloon is less compliant than the first balloon.

2. The system of claim 1 wherein the first and second balloons are located at separate and discrete locations along the balloon expansion catheter.

3. The system of claim 1 wherein the first and second balloons are independently inflatable.

4. The system of claim 1 wherein the first and second balloons are simultaneously inflatable.

5. The system of claim 1 wherein the branch vessel prosthesis is loaded over the balloon expansion catheter in a branch vessel stent graft delivery device.

6. The system of claim 1 wherein the balloon expansion catheter is deployed separately from the branch vessel prosthesis.

7. The system of claim 1 wherein the second balloon of the balloon expansion catheter is adapted to expand at least a portion of the tubular portion to a diameter greater than the diameter of the fenestration.

15. The system of claim 1 wherein the second balloon is constructed of a noncompliant material and the first balloon is constructed of a compliant material.

16. The system of claim 1 wherein the second balloon is constructed of a semi-compliant material and the first balloon is constructed of a compliant material.

8. A method of deploying a stent graft system in an aorta and a branch vessel comprising:

deploying an aorta stent graft within the aorta, which defines a lumen for the passage of blood therethrough, and comprises a fenestration positioned and sized so as to allow blood to flow to a contiguous branch vessel;

deploying a branch vessel prosthesis, which comprises a tubular portion and a flaring portion, so that the flaring portion is located within the lumen of the aorta stent graft and the tubular portion passes through the fenestration and into the branch vessel;

aligning a single balloon expansion catheter having first and second balloons such that the first balloon is aligned substantially with the flaring portion and the second balloon is aligned substantially with the tubular portion, wherein the second balloon is less compliant than the first balloon; and

inflating the first balloon to flare the flaring portion and inflating the second balloon to expand the tubular portion.

9. The method of claim 8 wherein the first and second balloons are inflated independently.

10. The method of claim 8 wherein the first and second balloons are inflated simultaneously.

11. The method of claim 8 wherein the inflated diameter of the second balloon is smaller than the inflated diameter of the first balloon.

12. The method of claim 8 wherein the branch vessel prosthesis is loaded over the balloon expansion catheter in a branch vessel stent graft delivery device.

13. The method of claim 8 wherein the balloon expansion catheter is deployed separately from the branch vessel prosthesis.

14. The method of claim 8 wherein the balloon expansion catheter expands at least a portion of the tubular portion to a diameter greater than the diameter of the fenestration.

17. The method of claim 8 wherein the second balloon is constructed of a noncompliant material and the first balloon is constructed of a compliant material.

18. The method of claim 8 wherein the second balloon is constructed of a semi-compliant material and the first balloon is constructed of a compliant material.