Bifurcated endoluminal prosthesis

• US 5,938,696 A
• Filed: 10/30/1997
• Issued: 08/17/1999
• Est. Priority Date: 02/09/1994
• Status: Expired due to Term

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: Boston Scientific Technology Incorporated (Boston Scientific Corporation)
• Inventors: Hudson, John, Goicoechea, George, Mialhe, Claude
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/961,548
• Time in Patent Office: 656 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195, 606/198
• US Class Current: 606/194
• 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 a bifurcated stent or prosthesis to a bifurcation site where a blood vessel branches into a first branched vessel and a second branched vessel, said method comprising the steps of:

(a) providing a first section of said bifurcated endoluminal stent or prosthesis including a proximal portion and a first distal portion, said proximal portion including a radiopaque marker;

(b) providing a first introducer having an outer sheath, a proximal portion pusher disposed at least partially within said outer sheath, and a distal portion pusher disposed at least partially within said proximal portion pusher;

(c) placing said first section of said bifurcated endoluminal stent or prosthesis within said first introducer such that said proximal portion of said first section of said bifurcated endoluminal stent or prosthesis is disposed within said outer sheath, and such that said distal portion of said bifurcated endoluminal stent or prosthesis is disposed within said proximal portion pusher;

(d) inserting said first introducer containing said first section of said bifurcated endoluminal stent or prosthesis into a body to a predetermined delivery location at said bifurcation site;

(e) partially withdrawing said outer sheath of said first introducer while maintaining said proximal portion pusher in a fixed position until said proximal portion of said first section of said bifurcated endoluminal stent or prosthesis is deployed from said first introducer into said blood vessel at said bifurcation site;

(f) either before or after step (e), rotationally aligning said first section of said bifurcated endoluminal stent or prosthesis by detecting said radiopaque marker disposed on the proximal portion of said first section;

(g) further withdrawing said outer sheath and partially withdrawing said proximal portion pusher while maintaining said distal portion pusher in a fixed position until said first distal portion of said first section of said bifurcated endoluminal stent or prosthesis is deployed from said first introducer at least partially into said first branched vessel;

(h) fully withdrawing said first introducer from the vasculature;

(i) providing a second section of said bifurcated endoluminal stent or prosthesis including a second distal portion;

(j) providing a second introducer having an outer sheath and a pusher disposed at least partially within said outer sheath;

(k) placing said second section of said bifurcated endoluminal stent or prosthesis within the outer sheath of said second introducer;

(l) inserting said second introducer containing said second section of said bifurcated endoluminal stent or prosthesis into the body to said bifurcation site;

(m) partially withdrawing said outer sheath of said second introducer while maintaining said pusher of said second introducer in a fixed position until said second distal portion of said second section of said bifurcated endoluminal stent or prosthesis is deployed from said second introducer such that a proximal end of said second distal portion securely connects to said proximal portion of said first section of said bifurcated endoluminal stent or prosthesis, and such that a distal end of said second distal portion extends at least partially into said second branched vessel; and

(n) fully withdrawing said second introducer from the body.

2. A method for delivering a bifurcated stent or prosthesis as claimed in claim 1 wherein said second distal portion includes a second radiopaque marker, further comprising, after step (1), rotationally aligning said second section of said bifurcated endoluminal stent or prosthesis by detecting a second radiopaque marker disposed on the second distal portion of said second section.

3. A method for delivering a bifurcated stent or prosthesis as claimed in claim 2 wherein at least one of said first and second radiopaque markers are in a "V" shape and said step of rotationally aligning the section or sections including said marker or markers includes rotating said section until only the profile of said marker is seen.

4. A method for delivering a prosthesis into a body lumen and for determining rotational orientation of said prosthesis in the body lumen, said method comprising the steps of:

(a) providing a first introducer having an outer sheath and a pusher disposed at least partially within said outer sheath;

(b) providing a first section of said prosthesis within said first introducer such that said first section of prosthesis is disposed at least partially within said outer sheath, said first section including a radiopaque marker;

(c) inserting said first introducer containing said first section of said prosthesis into the body lumen;

(d) withdrawing said outer sheath of said first introducer while maintaining said pusher in a fixed position until said first section of said prosthesis is deployed from said first introducer into the body lumen;

(e) either before or after step (d), rotationally aligning said first section of said prosthesis by detecting said radiopaque marker;

(f) withdrawing said first introducer from the body lumen;

(g) providing a second introducer having an outer sheath and a pusher disposed at least partially within said outer sheath;

(h) providing a second section of said prosthesis at least partially within said outer sheath of said second introducer;

(i) inserting said second introducer containing said second section of said prosthesis into the body lumen;

(j) withdrawing said outer sheath of said second introducer while maintaining said pusher of said second introducer in a fixed position until said second section of said prosthesis is deployed from said second introducer such that said second section of said prosthesis connects to said first section of said prosthesis; and

(k) withdrawing said second introducer from the body lumen.

5. A method as claimed in claim 4 wherein said second section includes a second radiopaque marker, further comprising rotationally aligning said second section of said prosthesis by detecting said second radiopaque marker disposed on said second section.

6. A method as claimed in claim 5 wherein at least one of said first and second radiopaque markers are in a "V" shape and said step of rotationally aligning the section or sections including said marker or markers includes rotating said section until only the profile of said marker is seen.