Apparatus and methods for endoluminal graft placement

• US 8,317,854 B1
• Filed: 07/19/1996
• Issued: 11/27/2012
• Est. Priority Date: 06/08/1994
• Status: Expired due to Fees

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Ryan, Timothy J., Fogarty, Thomas J., Lenker, Jay A., Freislinger, Kirsten
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US08/684,508
• Time in Patent Office: 5,975 Days
• Field of Search: 623/1.1, 623 111- 154, 606/108, 606190-200, 606151-156
• US Class Current: 623/1.35
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/90 characterised by a net-like or mesh-like structure
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0019 : differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2250/0029 : differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0048 : differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

A vascular graft comprises a perforate tubular compressible frame having a fabric liner disposed over at least a portion of the frames lumen. The graft may be used in combination with a base structure to form a bifurcated graft in situ. The base structure compresses a compressible frame having a fabric liner which defines a pair of divergent legs. The base structure is positioned within the aorta so that one leg enters each iliac. The tubular grafts can then be introduced into each leg to form the bifurcated structure. A graft delivery catheter includes a controllably flared sheath which facilitates recapture of a partially deployed graft.

Claims

1. A system for forming a bifurcated graft in situ in a primary lumen bifurcating into first and second branch lumens, said system comprising:

a bifurcated base structure including a proximal anchor comprised of a radially compressible perforate tubular frame having a proximal end, a distal end and a lumen therebetween and a trouser-shaped liner attached within the tubular frame lumen and having a pair of legs which extend distally from the distal end of the tubular frame, wherein the pair of legs define first and second divergent flow lumens from a common flow lumen of the liner, wherein a length of the trouser-shaped liner is dimensioned such that distal ends of the pair of legs lie within the primary lumen in situ;

a first tubular graft having a proximal end anchored within the distal end of a first of the pair of liner legs and having a flow lumen that forms a continuous extension of the first divergent flow lumen, wherein a length of the first tubular graft is dimensioned to bridge a distance between the distal end of the first liner leg and the first branch lumen; and

a second tubular graft having a proximal end anchored within the distal end of a second of the pair of liner legs and having a flow lumen that forms a continuous extension of the second divergent flow lumen, wherein a length of the second tubular graft is dimensioned to bridge a distance between the distal end of the second liner leg and the second branch lumen,

wherein each of the first and second tubular grafts further comprises,

(a) a radially compressible perforate tubular frame having a proximal end, a distal end, and a lumen therebetween and

(b) a liner extending over an interior lumen surface of the tubular frame to define the respective tubular graft flow lumen therethrough, and

wherein the first and second tubular grafts are configured to be joined to the bifurcated base structure in situ after the bifurcated base structure is anchored within the primary lumen to form the bifurcated graft.

2. A system as in claim 1, wherein the tubular frame of the proximal anchor has a length in a range from 5 mm to 50 mm and a diameter in a range from 4 mm to 30 mm.

3. A system as in claim 2, wherein a proximal end of the trouser-shaped liner is attached to the perforate tubular frame of the proximal anchor at a location spaced-inward from the proximal end of the frame by a distance in a range from 1 mm to 5 mm.

4. A system as in claim 1, wherein each of the tubular frames of the first and second tubular grafts has a length in a range from 50 mm to 500 mm and a diameter in a range from 4 mm to 45 mm.

5. A system as in claim 4, wherein each of the liners of the first and second tubular grafts is circumferentially sealed to its respective perforate tubular frame at least one end.

6. A system as in claim 5, wherein the circumferential seal is spaced-inward from an end of the perforate tubular frame by a distance in a range from 1 mm to 20 mm.

7. A system for forming a bifurcated graft in situ in a primary lumen bifurcating into first and second branch lumens, said system comprising:

a base structure including a proximal anchor comprising a radially compressible tubular frame and a liner secured therein, wherein the liner defines a common flow lumen at a proximal end thereof and has a pair of connector legs which define first and second divergent flow lumens from the common flow lumen, wherein a length of the liner is dimensioned such that the distal ends of the pair of connector legs lie within the primary lumen in situ;

a first tubular graft comprising a radially compressible tubular frame having a proximal end positioned within and anchored to a first of the connector legs and having a liner secured to the tubular frame to define a lumen that forms a continuous extension of the first divergent flow lumen, wherein a length of the first tubular graft is dimensioned to bridge a distance between the distal end of the first of the connector legs and the first branch lumen; and

a second tubular graft configured to be anchored within a second of the connector legs to form a continuous extension of the second divergent flow lumen, wherein a length of the second tubular graft is dimensioned to bridge a distance between the distal end of the second of the connector legs and the second branch lumen,

and wherein the first and second tubular grafts are configured to be joined to the base structure in situ after the base structure is anchored within the primary lumen to form the bifurcated graft.

8. A system as in claim 7, wherein the proximal anchor of the base structure has a length in the range from 5 mm to 50 mm and a diameter in a range from 4 mm to 30 mm.

9. A system as in claim 7, wherein the second tubular graft comprises (a) a radially compressible perforate tubular frame having a proximal end, a distal end, and a lumen therebetween and (b) a liner extending over an interior lumen surface of the tubular frame.

10. A system as in claim 9, wherein the tubular frame of the second tubular graft has a length in a range from 50 mm to 500 mm and a diameter in a range from 4 mm to 45 mm.

11. An apparatus for constructing a vascular graft for a primary lumen bifurcating into first and second branch lumens, said apparatus comprising:

an anchor section comprising an expandable supporting frame for anchoring said graft within the primary lumen upstream of the first and second branch lumens;

tubular liner means attached to said anchor section and defining a first distal opening and a second distal opening, wherein a length of said tubular liner means is dimensioned to position said first and second distal openings within the primary lumen in vivo;

means for joining a first graft to said anchor section at said first distal opening, said first graft being of a length dimensioned to extend a distance between said first distal opening and the first branch lumen; and

means for joining a second graft to said anchor section at said second distal opening, wherein said second graft is of a length dimensioned to extend a distance between said second distal opening and the second branch lumen,

wherein upon construction of the vascular graft in vivo said first graft and said second graft are configured to be joined to the anchor section in vivo after the anchor section is anchored within the primary lumen.