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

• US 6,755,856 B2
• Filed: 09/28/2001
• Issued: 06/29/2004
• Est. Priority Date: 09/05/1998
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Limited (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Laboratories Limited (Abbott Laboratories Incorporated)
• Inventors: Fierens, Joost J., Seibold, Gerd, von Oepen, Randolf, Schaffner, Silvio R., Gianotti, Marc
• Primary Examiner(s): Truong, Kevin T.
• Application Number:
  US09/967,789
• Publication Number:
  US 20020035394A1
• Time in Patent Office: 1,005 Days
• Field of Search: 623/1-1-, 623/1.2, 623/1.39, 623/1.44, 606/191, 606/194, 606/195, 606/198
• 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 of bone tissue onto implantable joints A61F2002/3093
• 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. Apparatus for stenting comprising:

a stent having an interior surface and 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,

wherein the web structure consists of a plurality of neighboring web patterns of alternating concavity, each web pattern having a plurality of adjoining webs, a subset of the webs of adjacent web patterns interconnected by substantially straight elements.

2. The apparatus of claim 1, further comprising a graft material affixed to at least a portion of the stent between the proximal and distal ends, wherein the graft material defines a multiplicity of pores that permit endothelization of the interior surface of the stent while inhibiting emboli release.

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

.

4. The apparatus of claim 3, wherein the multiplicity of pores have a maximum width of no more than approximately 100μ

.

5. The apparatus of claim 4, wherein the multiplicity of pores have an average width of approximately 80μ

.

6. The apparatus of claim 2, wherein the graft material 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, nonautologous vein, biodegradable materials, Polylactate, Polyglycolic Acid, and combinations thereof.

7. The apparatus of claim 2, further comprising a coating disposed on the graft material.

8. The apparatus of claim 7, wherein the coating comprises a therapeutic agent configured for release when introduced into a body lumen.

9. The apparatus of claim 8, wherein the therapeutic agent is chosen from the group consisting of attached active groups, radiation, gene vectors, medicaments, and thrombin inhibitors.

10. The apparatus of claim 2, wherein the graft material is disposed on at least an exterior surface portion of the stent.

11. The apparatus of claim 2, wherein the graft material is disposed on at least the interior surface of the stent.

12. The apparatus of claim 2, wherein the graft material is sintered into apertures of at least a portion of the stent.

13. The apparatus of claim 2, wherein a portion of the multiplicity of pores comprises an altered porosity as compared to a remainder of the multiplicity of pores, the portion or the multiplicity of pores of altered porosity configured for positioning at a vessel side branch to ensure blood flow through the side branch.

14. The apparatus of claim 2, wherein the graft material is attached to the stent along discrete point.

15. The apparatus of claim 2, wherein the graft material is attached to the stent along defined planes.

16. The apparatus if claim 15, wherein the defined planes are chosen from the group consisting of longitudinal seams, helical seams, and circumferential bands.

17. The apparatus of claim 2, wherein the graft material is attached to the stent along a majority of the web structure.

18. The apparatus of claim 1, wherein the stent comprises a self-expanding stent.

19. The apparatus of claim 3, wherein the self-expanding stent comprises a resilient weave pattern.

20. The apparatus of claim 1, wherein the stent is chosen from the group consisting of balloon expandable, bi-stable cell, and metal mesh stents.

21. The apparatus of claim 20, wherein the stent comprises a deformable material.

22. The apparatus of claim 21, wherein the deformable material is chosen from the group consisting of stainless steel and titanium.

23. The apparatus of claim 1, wherein the apparatus is configured to distribute forces applied by or to the apparatus across a portion of the apparatus.

24. The apparatus of claim 1, wherein the apparatus is configured for recrossing of the lumen of the stent when the stent is in the expanded deployed configuration.

25. The apparatus of claim 1 further comprising a radiopaque feature.

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

27. The apparatus of claim 1, wherein the graft material defined a multiplicity of pores along its entire length, the pores having diameters larger than about 30μ

and smaller than about 100μ

, wherein the material is attached to the stent along discrete points or defined planes.

28. A method for stenting comprising the steps of:

providing apparatus comprising a stent having an interior surface and proximal and distal ends, a lumen extending therebetween, and a graft material permanently affixed to at least a portion of the stent along defined planes or discrete points, the graft material comprising a multiplicity of pores that permit endothelization of the interior surface of the stent while inhibiting embodi release;

advancing the apparatus in a collapsed delivery configured to a treatment site within a patient'"'"'s vessel;

expanding the apparatus to a deployed configuration in which the apparatus engages the patient'"'"'s vessel at the treatment site; and

promoting endothelial cell ingrowth through the multiplicity of pores to cover the interior surface of the stent while the graft material simultaneously seals dangerously large embodi at the treatment site against a wall of the patient'"'"'s vessel.

29. The method of claim 28, wherein the graft material seals embodi larger having a width of more than about 100μ

against the wall of the patient'"'"'s vessel.

30. The method of claim 28, wherein providing apparatus further comprises providing apparatus having an opening through a lateral surface of the stent and the graft material.

31. The method of claim 30, wherein advancing the apparatus to a treatment site further comprises aligning the opening with a side branch of the patient'"'"'s vessel.

32. The method of claim 28, wherein providing apparatus further comprises providing apparatus having a coating comprising therapeutic agents.

33. The method of claim 28, wherein providing apparatus further comprises providing apparatus having a radiopaque feature.

34. The method of claim 28, wherein expanding the apparatus to the deployed configuration further comprises anchoring the apparatus to a wall of the patient'"'"'s vessel at the treatment sit.

35. The method of claim 28, wherein the stent has a tubular body with a wall having web structure configured for expansion from a collapsed delivery configuration,

wherein the web structure consists of a plurality of neighboring web patterns of alternating concavity, each web pattern having a plurality of adjoining webs, a subset of the webs of adjacent web patterns interconnected by substantially straight elements.