Flared ostial endoprosthesis and delivery system

• US 20040093058A1
• Filed: 01/27/2003
• Published: 05/13/2004
• Est. Priority Date: 01/28/2002
• Status: Active Grant

• Current Assignee: OrbusNeich Medical Pte Ltd
• Original Assignee: Orbusneich Medical Incorporated (Orbusneich Medical)
• Inventors: Cottone, Robert J., Becker, Gary J.
• Granted Patent: US 8,221,482 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 2/91 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• 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 2250/0073 Force-limiting means

Abstract

An intraluminal endoprosthesis having a conically shaped first end and a tubular shaped balloon-expandable stent for a main body is disclosed. The conically shaped first end may form a flare to the main body and is particularly well suited for in ostium use. The first end is preferably self-expanding and the main body is preferably balloon-expandable. Also disclosed is a delivery device for delivering intraluminal ostial endoprosthetic devices, especially those disclosed herein, to a site for deployment. The delivery device may comprise an over-the-wire system or may comprise a rapid-exchange shuttle system. The self-expanding portion of the endoprosthesis is encapsulated in a sheath or other restraining apparatus on the delivery device. The balloon-expandable stent portion of the endoprosthesis is crimped onto a balloon delivery device. The delivery system and endoprosthesis of the present invention allow the endoprosthesis to be partially expanded and relocated if it is determined that it is not located in the proper location. To aid in positioning, the delivery device may comprise marker bands.

Claims

1. An intraluminal endoprosthesis comprising:

a self-expanding section, the self-expandable section, when expanded, having a flared shape;

a balloon-expandable stent section; and

a membrane at least partially covering the self-expanding section and the balloon-expandable stent section and connecting the balloon-expandable stent to the self-expanding section

2. The endoprosthesis of claim 1, wherein the membrane acts as a drug delivery platform.

3. The endoprosthesis of claim 1, wherein exposed sections thereof act as a delivery platform for theraputic agents.

4. The endoprosthesis of claim 1, wherein the membrane is a flouropolymer.

5. The endoprosthesis of claim 1, wherein the membrane is erodable.

6. The endoprosthesis of claim 1, wherein the membrane is manufactured from PTFE.

7. The endoprosthesis of claim 1, 2, 3, 4, 5, or 6 wherein, when it is deployed, the self-expanding section has an outer edge with a radius greater than the expanded radius of the balloon-expandable stent section.

8. The endoprosthesis of claim 1, wherein the self-expandable section is manufactured from NiTi.

9. The endoprosthesis of claim 1, wherein the self-expanding section is manufactured from spring stainless steel.

10. The endoprosthesis of claim 1, further comprising hooks on an outer end of the self-expanding section.

11. The endoprosthesis of claim 10, wherein the balloon-expandable section comprises a plurality of helical segments.

12. An apparatus for delivering to an intralumen site an endoprosthesis having a self-expanding region and a balloon-expandable section, the apparatus comprising:

a distal region;

a balloon delivery device that encapsulates at least a portion of distal region and on which the balloon-expandable stent section is crimped;

a pull-back sheath for encapsulating at least a portion of the self-expanding region, the pull-back sheath surrounding part of the distal region of the apparatus;

one or more marker bands located on the distal region for locating the position of the balloon-expanding section when the endoprosthesis is in a lumen of a vessel.

13. The apparatus of claim 12, wherein one marker band is distinguishable from another when the delivery device is in a lumen of a vessel.

14. The apparatus of claim 12 or 13, further comprising a guidewire and wherein the distal region traverses the guidewire en route to the site.

15. The apparatus of claim 12 or 13, further comprising a rapid exchange shuttle, wherein the the distal region traverses the rapid exchange shuttle en route to the site.

16. The apparatus of claim 12 or 13, wherein the number of marker bands is three.

17. A method for deploying a flared intraluminal ostial endoprosthetic device, the method comprising the steps of:

mounting a balloon-expandable portion on a balloon delivery device;

encapsulating at least a portion of a self-expanding portion in a sheath;

inserting the endoprosthesis in a region of a lumen near an ostial legion;

radiologically determining the location of a distal region of the delivery device on which the endoprosthesis is mounted;

partially inflating the balloon delivery device;

radiologically verifing that the endoprosthesis is in a proper location;

after determining that the endoprosthesis is not in the proper location, moving the endoprosthesis to the proper location;

inflating the balloon device further;

causing the sheath to be removed from the self-expanding region;

removing the sheath and the balloon delivery device from the lumen.

18. A method for delivering an ostial endoprosthesis having a balloon-expandable portion and a self-expanding portion, the method comprising:

transporting the endoprosthesist to an intralumen site for deployment on a delivery device;

verifying the location of the delivery device;

partially expanding a portion of the endoprosthesis;

verifying that the endoprosthesis is in a desired location at the site via radiopaque marker bands on a delivery apparatus;

repositioning the endoprosthesis, if it is not in a desired location; and

expanding the remainder of the endoprosthesis.

19. The method of claim 18, wherein the step of partially expanding a portion of the endoprosthesis comprises inflating a balloon apparatus.

20. The method of claim 19, wherein the step of expanding the remainder of the endoprosthesis comprises, balloon inflating the portion of the endoprosthesis and causing a restraining assembly to be removed from a self-expanding portion of the endoprosthesis, thereby allowing the self-expanding portion to expand.

21. An intraluminal endoprosthetic device comprising:

a first self-expanding end, the self expanding end forming a generally cone shaped structure when the endoprosthesis is deployed;

a second end having a square edge;

a tubular balloon-expandable stent body disposed between the second end and the first self-expanding end; and

an encapsulating material connecting the first self-expanding end to the balloon-expandable stent body.

22. The endoprosthesis of claim 21, further comprising a transition region between the stent body and the square end.

23. The endoprosthesis of claim 21, wherein the first self-expanding region has a flared portion.

24. The endoprosthesis of claim 23, wherein the flared portion is comprised of hooks.

25. The endoprosthesis of claim 24, wherein the hooks form compound angles.

26. The endoprosthesis of claim 21, wherein the encapsulated portion of the self expanding region is formed prior to mounting the endoprosthesis in a delivery catheter.

27. A method for deploying an intraluminal endoprosthesis having a self-expanding portion and a balloon-expandable portion, the method comprising:

delivering the endoprosthesis to a site via a delivery apparatus;

at least partially expanding a balloon-expandable portion of the endoprosthesis;

radiologically verifying that the delivery apparatus is in a proper location; and

removing a restraining means from a self-expanding portion of the endoprostheis.

28. The method of claim 27, further comprising inflating further the balloon-expandable portion.

29. The method of claim 27 or 28, wherein the delivery apparatus travels over a guide wire en route to the site.

30. The method of claim 27 or 28, wherein the delivery apparatus comprises a rapid exchange shuttle.