Methods and apparatus for stenting comprising enhanced embolic protection coupled with improved protections against restenosis and thrombus formation

• US 7,811,314 B2
• Filed: 04/02/2007
• Issued: 10/12/2010
• Est. Priority Date: 09/05/1998
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories Vascular Enterprises Limited (Abbott Laboratories)
• Original Assignee: Abbott Laboratories Vascular Enterprises Limited (Abbott Laboratories)
• Inventors: Fierens, Joost J., Seibold, Gerd, von Oepen, Randolf, Schaffner, Silvio R., Gianotti, Marc
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US11/732,244
• Publication Number:
  US 20070179601A1
• Time in Patent Office: 1,289 Days
• Field of Search: 623 111- 12, 623/1.39, 606191-198
• US Class Current: 623/1.15
• 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 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• 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 2220/005 using adhesives
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Apparatus and methods for stenting are provided comprising a stent attached to a porous biocompatible material that is permeable to endothelial cell ingrowth, but impermeable to release of emboli of predetermined size. Preferred stent designs are provided, as well as preferred manufacturing techniques. Apparatus and methods are also provided for use at a vessel branching. Moreover, embodiments of the present invention may comprise a coating configured for localized delivery of therapeutic agents. Embodiments of the present invention are expected to provide enhanced embolic protection, improved force distribution, and improved recrossability, while reducing a risk of restenosis and thrombus formation.

Claims

1. A method of reducing thrombus formation in a vessel of a vasculature comprising:

providing an apparatus having a tubular expandable member and a membrane, the tubular expandable member having inner and outer surfaces and proximal and distal ends, the membrane being disposed about the tubular member, the membrane including a plurality of pores, the pores having a minimum width to promote endothelial cell ingrowth and a maximum width to prevent release of a predetermined size of emboli;

coupling the tubular member to a delivery system;

advancing the tubular member in a collapsed delivery configuration within the vessel; and

deploying the apparatus from a collapsed configuration to an expanded configuration in which the apparatus engages a wall of the vasculature at a treatment site, the membrane providing a smooth surface for fluid flow, promoting endothelial cell ingrowth, and preventing release of the predetermined size of emboli.

2. The method according to claim 1, wherein the tubular member is constructed of a metal mesh.

3. The method according to claim 2, wherein the membrane is disposed about the outer surface of the tubular member.

4. The method according to claim 3, wherein the membrane extends beyond the proximal and distal ends of the tubular member.

5. The method according to claim 1, wherein the membrane is disposed about the inner surface of the tubular member.

6. The method according to claim 1, wherein the membrane is produced by a weaving, knitting, or braiding process.

7. The method according to claim 1, wherein the pores have the minimum width of approximately 30 μ

m or more.

8. The method according to claim 7, wherein the pores have the maximum width of approximately 100 μ

m or less.

9. The method according to claim 1, wherein at least one of the pores is sized to allow blood flow therethrough.

10. The method according to claim 9, further including a radial opening formed in the web pattern, wherein at least one of the pores configured to allow blood flow therethrough is positioned within the radial opening.

11. The method according to claim 1, wherein the tubular member is self-expanding.

12. The method according to claim 1, wherein the tubular member is balloon expandable.

13. The method according to claim 1, wherein the pores formed in the membrane are uneven in size and placement.

14. The method according to claim 1, wherein the tubular member is a stent.

15. The method according to claim 1, further including the step of recrossing a lumen of the stent with a balloon catheter and of expanding the balloon within the lumen of the stent.