Bifurcated endoluminal prosthesis

• US 5,916,263 A
• Filed: 06/13/1996
• Issued: 06/29/1999
• Est. Priority Date: 02/09/1994
• Status: Expired due to Fees

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: Boston Scientific Technology Incorporated (Boston Scientific Corporation)
• Inventors: Cragg, Andrew H., Dake, Michael D., Hudson, John, Goicoechea, George, Mialhe, Claude
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/662,484
• Time in Patent Office: 1,111 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195
• US Class Current: 623/1.11
• 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

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 method for delivering, into the vasculature at an angeological bifurcation where a blood vessel branches into two branched vessels, an endoluminal prosthesis having a proximal stent portion, and a distal stent portion, said method comprising the steps of:

(a) inserting an introducer containing said prosthesis into a body to a predetermined delivery location, said introducer comprising an outer sheath, a proximal stent portion pusher, a distal stent portion pusher, and a balloon catheter having a balloon attached thereto;

(b) partially withdrawing said outer sheath of said introducer while maintaining said proximal stent portion pusher in a fixed position until said proximal stent portion of said prosthesis is deployed from said introducer into said blood vessel;

(c) further withdrawing said outer sheath and partially withdrawing said proximal stent portion pusher while maintaining said distal stent portion pusher in a fixed position until said distal stent portion of said prosthesis is deployed from said introducer into said blood vessel;

(d) inflating said balloon inside said endoluminal prosthesis after said endoluminal prosthesis is deployed in order to model said endoluminal prosthesis; and

(e) withdrawing said introducer from the body.

2. A method for delivering a bifurcated endoluminal stent or prosthesis near an angeological bifurcation of a vessel into a first branched vessel and a second branched vessel, said method comprising the steps of:

(a) placing a bifurcated section of said stent or prosthesis in said vessel with a first extension thereof extending at least partially into said first branched vessel and a second extension thereof extending toward said second branched vessel;

(b) placing a branch section of said stent or prosthesis in an introducer having an outer sheath and a pusher disposed at least partially within said outer sheath;

(c) inserting said introducer containing said branch section into at least a portion of said second branched vessel; and

(d) withdrawing said outer sheath while maintaining said pusher in a fixed position until said branch section is deployed from said introducer such that a proximal end of said branch section securely connects to said second extension of said bifurcated section and such that a distal end of said branch section extends at least partially into said second branched vessel.

3. A system for delivering a bifurcated endoluminal stent or prosthesis near an angeological bifurcation of a vessel into a first branched vessel and a second branched vessels said system comprising:

a bifurcated section configured to be placed in said vessel with a first extension thereof extending at least partially into said first branched vessel and a second extension thereof extending toward said second branched vessel;

an introducer having an outer sheath and a pusher configured to be disposed at least partially within said outer sheath;

a branch section configured to be placed in said introducer;

said introducer being configured for insertion into at least a portion of said second branched vessel for delivery of said branch section; and

wherein withdrawal of said outer sheath while maintaining said pusher in a fixed position deploys said branch section from said introducer such that a proximal end of said branch section securely connects to said second extension of said bifurcated section and such that a distal end of said branch section extends at least partially into said second branched vessel upon deployment.

4. The system as recited in claim 3, wherein at least one of said second extension of said bifurcated section and said branch section comprises a portion of different radiopacity positioned for aligning said branch section properly with said second extension.

5. The system as recited in claim 3, wherein each of said second extension of said bifurcated section and said branch section comprises a portion of different radiopacity positioned for aligning said branch section properly with said second extension.

6. The system as recited in claim 3, wherein at least one of said second extension of said bifurcated section and said branch section comprises a radiopaque marker positioned for aligning said branch section properly with said second extension.

7. The system as recited in claim 3, wherein said bifurcated section comprises at least two radiographic indicia having different radiopacity from said bifurcated section and the composite radiographic image of said radiographic indicia varies with the rotational orientation of said bifurcated section, wherein the rotational orientation of said bifurcated section is indicated by said radiographic image for optionally adjusting the rotational orientation.

8. The system as recited in claim 3, wherein said bifurcated section comprises at least one proximal radiographic indicium having different radiopacity from said bifurcated section, wherein said proximal radiographic indicium can be fluoroscopically visualized to ensure the intended position of said bifurcated section in said vessel.

9. The system as recited in claim 3, wherein said bifurcated section is provided in a cover, wherein said cover containing said bifurcated section can be inserted into said vessel and said cover can be withdrawn until said bifurcated section is deployed from said cover.