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

• US 7,927,365 B2
• Filed: 03/29/2007
• Issued: 04/19/2011
• Est. Priority Date: 09/05/1998
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories Limited (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Laboratories Limited (Abbott Laboratories Incorporated)
• Inventors: Schaffner, Silvio R., Gianotti, Marc, Fierens, Joost J., Seibold, Gerd, Von Oepen, Randolf
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US11/731,820
• Publication Number:
  US 20070179593A1
• Time in Patent Office: 1,482 Days
• Field of Search: 623 111- 12, 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 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. A method for stenting a vascular system comprising:

providing an apparatus comprising a stent and a material disposed about the stent, the stent having proximal and distal ends, and a lumen extending therebetween, the material having a multiplicity of pores selectively arranged along a length of the stent, at least some of the pores having a minimum width to enable endothelial cell ingrowth and a maximum width to prevent release of emboli larger than a predetermined size, at least some the pores allowing continued blood flow therethrough;

advancing the apparatus in a collapsed delivery configuration to a treatment site within a vascular system;

deploying the apparatus to an expanded configuration to engage a wall of the vascular system at the treatment site; and

enabling the endothelial cell ingrowth through the pores permeable to endothelial cell ingrowth to cover at least a portion of an interior surface of the stent while retaining the emboli larger than the predetermined size against the wall of the vascular system.

2. The method according to claim 1, wherein providing the apparatus comprises having the material disposed about an outer surface of the stent.

3. The method according to claim 2, wherein disposed about the outer surface of the stent comprises bonded to the outer surface of the stent.

4. The method of claim 1, wherein impermeable to the emboli larger than the predetermined size comprises impermeable to emboli having a width of more than about 100 micrometers.

5. The method of claim 1, wherein providing the apparatus further comprises aligning at least a portion of the pores configured to allow continued blood flow therethrough with entry to a side branch vessel.

6. The method of claim 5, wherein providing the apparatus further comprises providing the apparatus with a lateral opening formed between the proximal and distal ends, and wherein advancing the apparatus further comprises aligning the portion of the pores configured to allow continued blood flow therethrough with the radial opening.

7. The method of claim 6, wherein the pores aligned with the radial opening have a size different than the pores disposed at other areas along the length of the stent.

8. The method of claim 1, wherein providing the apparatus further comprises providing the apparatus with a coating comprising a therapeutic agent.

9. A method for stenting a common carotid artery comprising:

providing a tubular expandable member and a material having a plurality of pores, the tubular expandable member having an inner surface, an outer surface and proximal and distal ends, the material being disposed about the tubular member, a first portion of the pores having a minimum width to enable endothelization of the inner surface of the tubular member while having a maximum width to inhibit passage of emboli larger than a predetermined size, a second portion of the pores having a minimum width to allow blood flow therethrough;

advancing the tubular member in a collapsed configuration within the common carotid artery;

aligning a portion of the tubular member with an internal carotid artery, the portion of the tubular member comprising the second portion of the pores; and

deploying the apparatus from the collapsed configuration to an expanded configuration to engage a wall of the common carotid artery at a treatment site to enable endothelization of the inner surface of the tubular member while inhibiting passage of the predetermined size emboli.

10. The method according to claim 9, wherein the material is formed by a weaving, knitting, or braiding process.

11. The method according to claim 10, wherein the weaving, knitting, or braiding process determines pore sizes.

12. The method according to claim 9, wherein disposed about the tubular member comprises attached to at least a portion of the tubular member.

13. The method according to claim 12, wherein attached comprises attaching with a bonding or sintering process.

14. The method according to claim 9, wherein attached comprises attaching at least one discrete location along the tubular member.

15. The method according to claim 9, wherein providing the tubular member further comprises providing the tubular member with a radial opening defined in the area of the second portion of the pores.

16. The method according to claim 15, wherein the pores in the first portion have a size between about 30 μ

m and 100 μ

m.

17. The method according to claim 9, wherein the material comprises a biocompatible material selected from the group consisting of a biocompatible polymer, a modified thermoplastic polyurethane, polyethylene terephthalate, polyethylene tetraphthalate, expanded polytetrafluoroethylene, polypropylene, polyester, Nylon, polyethylene, polyurethane, a homologic material, an autologous or non-autologous vessel, polylactate, polyglycolic acid, and a combination thereof.

18. The method according to claim 9, wherein the plurality of pores increase from a first predetermined size in the collapsed configuration to a second predetermined size in the expanded configuration of the tubular member.

19. The method according to claim 9, wherein the material further includes a coating disposed on the surface of the material, the coating being configured to be absorbed or absorb on the surface of the material.

20. The method according to claim 9, wherein the material includes a coating comprising a therapeutic agent.