Bifurcated endoluminal prosthesis

• US 5,716,365 A
• Filed: 06/05/1995
• Issued: 02/10/1998
• 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: Goicoechea, George, Hudson, John, Mialhe, Claude, Cragg, Andrew H., Dake, Michael D.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): Yu, Justine R.
• Application Number:
  US08/461,513
• Time in Patent Office: 981 Days
• Field of Search: 606/198, 606/191, 606/194, 606/108, 606/192, 606/195, 623/9, 623/11, 623/12, 623/1
• US Class Current: 623/1.16
• 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 stent joining means for joining a first endoluminal stent to a second endoluminal stent to define a continuous lumen through the first and second endoluminal stents, said stent joining means comprising:

a male engaging portion on said first endoluminal stent which has an outer surface and can be compressed radially inwardly; and

a female portion on said second endoluminal stent cooperating with said male engaging portion, said female portion having an inner surface;

wherein said first endoluminal stent and said second endoluminal stent consist of a shape memory alloy and the male engaging portion can be entered into the female portion in a radially compressed state and thereafter thermally induced to expand in the female portion and wherein a frictional inter-engagement between said outer surface of the male engaging portion and said inner surface of the female portion prevents longitudinal movement of the first endoluminal stent relative to the second endoluminal stent.

2. A stent joining means as claimed in claim 1 wherein a proximal end of said second endoluminal stent is flared radially outwardly towards a proximal end extremity;

said extremity thereby being adapted to engage an endoluminal surface of the blood vessel thereby to resist longitudinal movement of the second endoluminal stent.

3. A stent joining means as claimed in claim 1 wherein each of said first and second endoluminal stents comprises a sinuous wire formed into a tubular configuration.

4. A stent joining means as claimed in claim 1 wherein each of said first and second endoluminal stents is formed from a shape memory nitinol wire.

5. A stent joining means as claimed in claim 1 wherein said second endoluminal stent is adapted to extend across a bifurcation in a blood vessel such that in use a proximal end of the second endoluminal stent is disposed proximally of the bifurcation, and a distal end of the second endoluminal stent is disposed in one of the branched blood vessels;

said female portion is disposed intermediate said proximal and distal ends; and

said first endoluminal stent is adapted to extend in the other branched blood vessel.

6. A stent joining means as claimed in claim 1 wherein at least one of said first endoluminal stent and said second endoluminal stent includes a portion having a graft layer disposed internally and externally of said stent.

7. A stent joining means as claimed in claim 1 wherein the male engaging portion is at a proximal end of said first stent.

8. A stent joining means as claimed in claim 1 wherein the female portion is at a distal end of said second stent.

9. A stent joining means as claimed in claim 1 wherein said male engaging portion is flared radially outwardly towards a proximal end.

10. A stent joining means as claimed in claim 1 wherein the female portion is tapered radially inwardly towards a distal end.

11. A stent joining means as claimed in claim 1 wherein the male engaging portion comprises a frustoconical wall flaring outwardly towards a longitudinal extremity.

12. A stent joining means as claimed in claim 1 wherein the female portion comprises a frustoconical wall tapering radially inwardly towards a longitudinal extremity.

13. A stent joining means as claimed in claim 1 wherein said male engaging portion and said female portion are substantially untapered.

14. A stent joining means as claimed in claim 1 wherein said male engaging portion and said female portion are substantially cylindrical.

15. A stent joining means as claimed in claim 1 wherein said male engaging portion is resiliently compressible in a radially inwards direction such that in a radially compressed state the male engaging portion is capable of self re-expansion to engage the female portion.

16. A stent joining means as claimed in claim 1 wherein each of said first and second endoluminal stents is compressible and expandable.

17. A stent joining means as claimed in claim 1 wherein said second endoluminal stent has two transversely spaced distal female portions.

18. A stent joining means as claimed in claim 17 wherein one of said two transversely spaced distal female portions is adapted for connection to said male engaging portion of said first endoluminal stent and said one spaced distal female portion and said first and second endoluminal stents, in combination, extend across a bifurcation in a blood vessel into two respective branched blood vessels.

19. A method of joining a first endoluminal stent having an outer surface with a second endoluminal stent having an inner surface within the vasculature of a body comprising the steps of inserting an end of said first endoluminal stent at least partially into an end of said second endoluminal stent, and allowing said end of said first endoluminal stent to expand by thermal transformation and contact said end of said second endoluminal stent such that said outer surface of said first endoluminal stent frictionally engages said inner surface of said second endoluminal stent to prevent relative longitudinal movement of said first and second endoluminal stents.

20. A method of forming an endoluminal stent within the vasculature of a body comprising inserting an end of a first stent portion having an outer surface at least partially into an end of a second stent portion having an inner surface, and allowing said end of said first stent portion to expand by thermal transformation and contact said end of said second stent portion such that said outer surface of said first stent frictionally engages said inner surface of said second stent to prevent relative longitudinal movement of said first and second stents.

21. A method as claimed in claim 20 wherein a tubular graft layer comprised of a bio-compatible fabric is disposed in juxtaposition with each of said first stent portion and said second stent portion.

22. A stent joining means for joining a first endoluminal stent to a second endoluminal stent comprising:

a male engaging portion on said first endoluminal stent, having a first graft layer disposed externally of said male engaging portion, wherein the male engaging portion can be compressed radially inwardly; and

a female portion on said second endoluminal stent cooperating with said male engaging portion and having a second graft layer disposed internally of said female portion;

wherein the male engaging portion can be entered into the female portion in a radially compressed state and thereafter caused or allowed to expand in the female portion and wherein a frictional inter-engagement of the first graft layer of the male engaging portion and the second graft layer of the female portion prevents relative movement of the first endoluminal stent and the second endoluminal stent.

23. A stent joining means for joining a first endoluminal stent having a male portion end to a second endoluminal stent having a female portion end comprising:

a male engaging portion on said male portion end of said first endoluminal stent, defining a first frustoconical wall which is flared radially outwardly towards said male portion end, and which can be compressed radially inwardly; and

a female portion on said female portion end of said second endoluminal stent cooperating with said male engaging portion and defining a second frustoconical wall which is tapered radially inwardly towards said female portion end;

wherein the male engaging portion can be entered into the female portion in a radially compressed state and thereafter caused or allowed to expand in the female portion and wherein a frictional inter-engagement of the male engaging portion and the female portion prevents relative movement of the first stent and the second stent.

24. A stent joining means for joining a first endoluminal stent to a second endoluminal stent comprising:

a first stent including a radially inwardly compressible male engaging portion, having a first graft layer disposed externally of said male engaging portion; and

a second stent including a female portion cooperating at a distal end with a proximal end of said male engaging portion and having a second graft layer disposed externally of said female cooperating portion and which folds over the distal end of said female engaging portion to form an inner sleeve which contacts said first graft layer to form a substantially blood-tight seal;

wherein the male engaging portion can be entered into the female portion in a radially compressed state and thereafter caused or allowed to expand in the female cooperating portion and wherein the inter-engagement of the first graft layer of the male engaging portion and the inner sleeve of the female cooperating portion resists longitudinal separation of the first stent from the second stent.