Branch vessel prothesis with positional indicator system and method

• US 9,974,674 B2
• Filed: 11/08/2004
• Issued: 05/22/2018
• 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.
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US10/984,416
• Publication Number:
  US 20070179592A1
• Time in Patent Office: 4,943 Days
• Field of Search: 623 111, 623 112
• 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 includes an aorta stent graft with a fenestration aligned with a branch vessel and a branch vessel prosthesis with a flaring portion at a proximal end and a tubular portion. When deployed, the flaring portion of the branch vessel prosthesis is retained within the aorta stent graft, and the tubular portion extends through the fenestration and into the branch vessel. The system includes at least one positional indicator, including a positional indicator associated with the branch vessel prosthesis for indicating the position of a point along the branch vessel prosthesis predetermined for optimal alignment with the fenestration during deployment.

Claims

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

an aorta stent graft with a fenestration configured to be aligned with a branch vessel;

a branch vessel prosthesis having proximal and distal ends, and further having a flaring portion, a tubular portion, and a bending portion disposed between the flaring portion and the tubular portion, wherein, when deployed, the flaring portion is retained within the aorta stent graft, and the tubular portion is configured to extend through the fenestration and into the branch vessel; and

a first positional indicator positioned at and indicating the bending portion, between the tubular portion and the flaring portion of the branch vessel prosthesis, wherein the first positional indicator aligns with the fenestration during deployment,

wherein the branch vessel prosthesis comprises an undeployed state prior to flaring of the flaring portion, and further comprises a deployed state in which the flaring portion is flared outward relative to the tubular portion,

wherein the bending portion comprises at least two alternating strut segments joined by a bend, and the first positional indicator is disposed at the bend between the two strut segments.

2. The system of claim 1 further comprising a second positional indicator on the aorta stent graft indicating the position of the fenestration.

3. The system of claim 2 further comprising a third positional indicator associated with the branch vessel prosthesis for indicating the position of the distal end of the branch vessel prosthesis during deployment.

4. The system of claim 3 further comprising a fourth positional indicator associated with the branch vessel prosthesis for indicating the position of the proximal end of the branch vessel prosthesis.

5. The system of claim 1 wherein the first positional indicator is located on the branch vessel prosthesis.

6. The system of claim 1 wherein the first positional indicator comprises a radiopaque material.

7. The system of one of claim 1, 2, 3, or 4 wherein at least one of the positional indicators is shaped so as to indicate position and orientation of the branch vessel prosthesis.

8. The system of one of claim 1, 2, 3, or 4 wherein at least one of the positional indicators is v-shaped with one leg longer than the other.

9. The stent graft system of claim 1 wherein the first positional indicator is disposed at a location just distal to the flaring portion.

10. The stent graft system of claim 1 wherein the bending portion comprises a “

V”

shaped-segment in the undeployed state, and wherein the first positional indicator is positioned within a vertex of the “

V”

shaped-segment.

11. The stent graft system of claim 1 wherein the bending portion comprises one of a “

V”

shaped-segment, a “

W”

shaped-segment, and an “

S”

shaped-segment in at least the undeployed state.

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

an aorta stent graft with a fenestration configured to be aligned with a branch vessel;

a branch vessel prosthesis having proximal and distal ends, and further having a flaring portion, a tubular portion, and a bending portion disposed between the flaring portion and the tubular portion, wherein, when deployed, the flaring portion is retained within the aorta stent graft, and the tubular portion is configured to extend through the fenestration and into the branch vessel; and

an introducer configured to deploy the branch vessel prosthesis,

wherein a first positional indicator is disposed on the introducer at the location of, and indicating the position of, the bending portion of the branch vessel prosthesis that aligns with the fenestration during deployment,

wherein the branch vessel prosthesis comprises an undeployed state prior to flaring of the flaring portion, and further comprises a deployed state in which the flaring portion is flared outward relative to the tubular portion, and

wherein the first positional indicator indicates a bending portion of the branch vessel prosthesis that comprises one of a “

V”

shaped-segment, a “

W”

shaped-segment, and an “

S”

shaped-segment in at least the undeployed state.

13. The system of claim 12 further comprising a second positional indicator on the introducer, wherein the second positional indicator indicates the proximal end of the branch vessel prosthesis.

14. The system of claim 13 further comprising a third positional indicator on the introducer, wherein the third positional indicator indicates the position of the tubular portion of the branch vessel prosthesis.

15. The system of claim 14 further comprising a fourth positional indicator on the introducer, wherein the fourth positional indicator indicates the distal end of the branch vessel prosthesis.

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

an aorta stent graft with a fenestration configured to be aligned with a branch vessel;

a branch vessel prosthesis having proximal and distal ends, and further having a flaring portion, a tubular portion, and a bending portion disposed between the flaring portion and the tubular portion, wherein, when deployed, the flaring portion is retained within the aorta stent graft, and the tubular portion is configured to extend through the fenestration and into the branch vessel; and

a delivery system comprising a balloon catheter having a balloon configured to deploy the branch vessel prosthesis,

wherein the balloon catheter comprises a first positional indicator disposed at the location of, and indicating the position of, the bending portion of the branch vessel prosthesis that aligns with the fenestration during deployment,

wherein the branch vessel prosthesis comprises an undeployed state prior to flaring of the flaring portion, and further comprises a deployed state in which the flaring portion is flared outward relative to the tubular portion, and

wherein the first positional indicator indicates a bending portion of the branch vessel prosthesis that comprises one of a “

V”

shaped-segment, a “

W”

shaped-segment, and an “

S”

shaped-segment in at least the undeployed state.

17. The system of claim 16 further comprising a second positional indicator on the balloon catheter, wherein the second positional indicator indicates the proximal end of the branch vessel prosthesis.

18. The system of claim 17 further comprising a third positional indicator on the balloon catheter, wherein the third positional indicator indicates the distal end of the branch vessel prosthesis.