Flared ostial endoprosthesis and delivery system

• US 8,221,482 B2
• Filed: 01/27/2003
• Issued: 07/17/2012
• Est. Priority Date: 01/28/2002
• Status: Expired due to Fees

• Current Assignee: OrbusNeich Medical Pte Ltd
• Original Assignee: Orbusneich Medical Incorporated (Orbusneich Medical)
• Inventors: Cottone, Robert J., Becker, Gary J.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US10/352,328
• Publication Number:
  US 20040093058A1
• Time in Patent Office: 3,459 Days
• Field of Search: 623/1.11, 623/1.15, 623/1.36, 606/108, 606/194, 606/195, 606/198
• 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 first component that is a self-expanding stent, the self-expanding-stent component, when expanded, having a flared portion;

a second component, separated from the first component, that is a balloon-expandable stent; and

a connecting membrane at least partially covering the self-expanding-stent component and the balloon-expandable-stent component and thereby providing a connection between the separate balloon-expandable-stent component and the self-expanding-stent component;

wherein, when it is deployed, the self expanding stent component has an outer edge with a radius greater than the expanded radius of the balloon expandable stent component; and

wherein the outer end of the self expanding stent component forms hooks.

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 therapeutic agents.

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

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

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

7. The endoprosthesis of claim 1, wherein the self-expanding-stent component is manufactured from NiTi.

8. The endoprosthesis of claim 1, wherein the self-expanding-stent component is manufactured from spring stainless steel.

9. The endoprosthesis of claim 1, wherein the balloon-expandable-stent component comprises a plurality of helical segments.

10. An intraluminal endoprosthetic device comprising:

a first, self-expanding end, the self-expanding end forming a generally cone-shaped portion 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 separated from the first end; and

an encapsulating material that serves to connect the first, self-expanding end and the separate balloon-expandable stent body to each other;

wherein the first self expanding end has a flared portion;

wherein the flared portion forms hooks.

11. The endoprosthesis of claim 10, further comprising a transition region between the stent body and the square end.

12. The endoprosthesis of claim 10, wherein the hooks form compound angles.

13. The endoprosthesis of claim 10, wherein the encapsulated portion of the self-expanding end is formed prior to mounting the endoprosthesis in a delivery catheter.