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

• US 8,814,926 B2
• Filed: 04/18/2011
• Issued: 08/26/2014
• 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., Schaffner, Silvio R., Gianotti, Marc, Seibold, Gerd, von Oepen, Randolf
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US13/089,039
• Publication Number:
  US 20110270381A1
• Time in Patent Office: 1,226 Days
• Field of Search: None
• US Class Current: 623/1.13
• 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. An apparatus for stenting comprising:

a balloon-expandable stent having proximal and distal ends, and a lumen extending therebetween, the stent having a tubular body with a wall having a web structure configured for expansion from a collapsed delivery configuration to an expanded deployed configuration,

the web structure comprising a plurality of interconnected, neighboring web patterns, each web pattern having a plurality of adjoining webs, each adjoining web comprising a central section interposed between first and second lateral sections,

wherein, each of the first lateral sections joins the central section at a first angle, each of the second lateral sections joins the central section at a second angle, and adjacent ones of the neighboring web patterns have alternating concavity; and

a biocompatible material layer attached to at least a portion of the stent between the proximal and distal ends only along discrete points or defined planes, and wherein the biocompatible material layer comprises a porous woven, knitted or braided material, the biocompatible material layer comprising pores having a substantially uniform, round shape and a substantially uniform size.

2. The apparatus of claim 1, wherein along a length of the biocompatible material layer the pores are dimensioned for enabling endothelial cell in-growth while preventing passage of emboli larger than a predetermined size.

3. The apparatus of claim 2, wherein the pores comprise a minimum width of no less than approximately 30 μ

m, thereby reducing a risk of restenosis and thrombus formation;

wherein the pores comprise a maximum width of no more than approximately 100 μ

m, thereby enhancing embolic protection.

4. The apparatus of claim 3, wherein the stent comprises a deformable material.

5. The apparatus of claim 2, wherein the pores are configured to allow blood flow through the pores.

6. The apparatus of claim 1, wherein the web structure defines apertures, the pores of the biocompatible material layer being smaller than the apertures of the web structure.

7. The apparatus of claim 6, wherein the web structure comprises a resilient weave pattern.

8. The apparatus of claim 1, wherein a material making up the biocompatible material layer is chosen from the group consisting of biocompatible polymers, modified thermoplastic Polyurethane, Polyethylene Terephthalate, Polyethylene Tetraphthalate, expanded Polytetrafluoroethylene, Polypropylene, Polyester, Nylon, Polyethylene, Polyurethane, homologic materials, autologous vein, non-autologous vein, biodegradable materials, Polylactate, Polyglycolic Acid, and combinations thereof.

9. The apparatus of claim 1,

wherein a material making up the biocompatible material layer is disposed on at least an exterior surface portion of the stent;

or

wherein a material making up the biocompatible material layer is disposed on at least an interior surface portion of the stent;

or

wherein a material making up the biocompatible material layer is sintered into apertures of at least a portion of the stent;

or

wherein the apparatus is configured to distribute forces applied by or to the apparatus across a portion of the apparatus;

or

wherein the apparatus is configured for recrossing of the lumen of the stent when the stent is in the expanded deployed configuration.

10. The apparatus of claim 1, wherein the apparatus comprises at least one opening configured to be positioned at a vessel side branch;

or

wherein the apparatus further comprises a coating disposed on a material making up the biocompatible material layer wherein the coating comprises a therapeutic agent configured for release when introduced into a body lumen.

11. The apparatus of claim 1, wherein the defined planes are chosen from the group consisting of longitudinal seams, helical seams, and circumferential bands.