Bifurcated endoluminal prosthesis

• US 7,942,919 B2
• Filed: 02/23/2004
• Issued: 05/17/2011
• Est. Priority Date: 02/09/1994
• Status: Expired due to Fees

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Cragg, Andrew H., Dake, Michael D., Hudson, John, Goicoechea, George, Mialhe, Claude
• Primary Examiner(s): Bui; Vy Q
• Application Number:
  US10/784,378
• Publication Number:
  US 20040167599A1
• Time in Patent Office: 2,640 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.13, 623/1.14, 623/1.15, 623/1.16, 623/1.18, 623/1.19, 623/1.2, 623/1.32, 606/108, 606/191, 606/194, 606/195
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2230/0067 conical
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: Y10S 623/903 : Blood vessel
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

The invention comprises:

An introducer for delivering into the vasculature a straight or bifurcated stent or prosthesis; a method for delivering into the vasculature a straight or bifurcated stent or prosthesis; a method of treating and angeological disease using a bifurcated stent; an endoluminal stent having perpendicular hoop members, each hoop member formed of wire in a sinuous configuration, at least some of juxtaposed apices in neighboring hoops being secured to one another, such stents also forming axially aligned segments in straight stents, and segments of bifurcated stents in particular embodiments. Certain embodiments of such stents also include barbs, fabric covering and radiopaque markers.

Claims

1. A prosthesis assembly comprising:

a proximal prosthesis having a proximal end and a distal end, the proximal prosthesis further having a proximal orifice at the proximal end to be located in and when expanded to be supported by a vascular vessel;

at least one distal prosthesis having a proximal end and a distal end;

the proximal prosthesis having at least two transversely placed tapering portions that extend from an intermediate portion to the distal end of the proximal prosthesis to form a bifurcated prosthesis;

the proximal prosthesis also having at least one distal orifice at the distal end of at least one of the tapering portions which when expanded serves to receive the proximal end of the at least one distal prosthesis;

wherein the proximal prosthesis and the at least one distal prosthesis each comprises an expandable stent constructed with a wire skeleton having one or more parts that extends from the respective proximal ends to the respective distal ends;

at least one fabric layer over and/or in the wire skeletons of the expandable stents; and

wherein a cross-sectional area of the at least one distal orifice when expanded is sufficiently less than that of the proximal end of the at least one distal prosthesis when expanded within the at least one distal orifice so as to form a seal between the proximal and distal prostheses.

2. The prosthesis assembly according to claim 1, wherein the distal end of the proximal prosthesis has a first intermediate portion which is extended to form a distal portion, and a second intermediate portion which has a distal orifice which has a relatively short inclined extension to enable the distal prosthesis to be located therein when the short extension has been expanded, the distal prosthesis having the proximal end which when expanded will form a seal with the short extension.

3. The prosthesis assembly according to claim 1, wherein the distal end of the proximal prosthesis has first and second distal portions, the first distal portion having the at least one distal orifice and the second distal portion having another distal orifice for the receipt of the at least one distal prosthesis, each of which will have a stent expandable to a cross-sectional area sufficiently greater than the cross-sectional area(s) of the distal orifices so that effective seals are formed.

4. The prosthesis assembly as claimed in claim 1, wherein a portion of at least one of the proximal prosthesis and the distal prosthesis has a different radiopacity, the portion of different radiopacity facilitating proper alignment of the proximal and distal prostheses.

5. The prosthesis assembly as claimed in claim 1, further comprising:

radiographic indicia defined on at least on of the proximal prosthesis and the distal prosthesis and having different radiopacity from the prosthesis, wherein the composite radiographic image of the radiographic indicia varies with the rotational orientation of the prosthesis;

wherein the rotational orientation of the prosthesis in the body lumen is indicated by the radiographic image for optional adjustment of the rotational orientation.

6. The prosthesis assembly as claimed in claim 1, the prosthesis assembly being configured for placement at an angeological bifurcation of a vessel into two branched vessels, the proximal prosthesis defining two lumens, at least one of which is configured to be disposed entirely within said vessel and is adapted to mate with the distal prosthesis configured to extend into one of the two branched vessels.

7. The prosthesis assembly as claimed in claim 1, the prosthesis assembly further comprising a male engaging portion having a frustoconical configuration that flares outward on the proximal end of the at least one distal prosthesis, and at least one female engaging portion having a frustoconical configuration that tapers inward toward the at least one distal orifice at the distal end of the proximal prosthesis, the male engaging portion being configured to be positioned at least partially within the female engaging portion for inter-engagement between the outer surface of the male engaging portion and the inner surface of the female engaging portion to resist longitudinal movement to prevent separation of the male engaging portion from the female engaging portion, each of the male engaging portion and the female engaging portion comprising a stent with complementary flared and tapered frustoconical wired skeletons.

8. The prosthesis assembly as claimed in claim 7, the prosthesis assembly further comprising at least one of the proximal prosthesis and the distal prosthesis having a fabric layer attached to the stent, the fabric layer being configured to be interposed between the male engaging portion and the female portion to form a substantially fluid-tight seal upon assembly.

9. A prosthesis assembly comprising:

a proximal prosthesis having a proximal end and a distal end, the proximal prosthesis being expandable and having a proximal orifice at the proximal end;

first and second distal prostheses each having a proximal end and a distal end;

the proximal prosthesis having at least two transversely placed tapering portions that extend from an intermediate portion to the distal end of the proximal prosthesis to form a bifurcated prosthesis;

the proximal prosthesis also having a distal orifice at the distal end of at least one of the tapering portions that when expanded receives at least one proximal end of the first and second distal prostheses;

wherein each of the proximal and distal prostheses comprises an expandable stent constructed with a wire skeleton having one or more parts that extends from the respective proximal ends to the respective distal ends; and

wherein a cross-sectional area of at least one distal orifice of the proximal prosthesis when expanded is sufficiently less than a cross-sectional area of a proximal end of the first or second distal prosthesis when expanded within the at least one distal orifice, so as to form a seal with the at least one distal orifice when the proximal end of the first or second distal prosthesis is expanded therein.

10. The prosthesis assemble of claim 9, wherein the proximal prosthesis further comprises at least one fabric layer over and/or in the wire skeletons of the stents.

11. A prosthesis assembly comprising:

a proximal prosthesis and a pair of distal prostheses each having a proximal end and a distal end, the proximal prosthesis being expandable and having the distal end and a proximal orifice at the proximal end, the proximal prosthesis having at least two transversely placed tapering portions that extend from an intermediate portion to the distal end of the proximal prosthesis to form a bifurcated prosthesis, the proximal prosthesis also having at least two distal orifices at the distal ends of the tapering portions which when expanded serve to receive the proximal ends of the pair of distal prostheses, wherein each of the proximal and distal prostheses comprises an expandable stent constructed with a wire skeleton having one or more parts that extends from the respective proximal ends to the respective distal ends and at least one fabric layer over and/or in the wire skeletons of the stents, and wherein cross-sectional areas of the at least two of the distal orifices of the proximal prosthesis when expanded are sufficiently less than cross-sectional areas of the proximal ends of each of the pair of distal prostheses when expanded within the distal orifices so as to form a seal with each of the distal orifices when the pair of distal prostheses are expanded therein.