Carotid stent apparatus and methods for treatment via body lumens

• US 10,058,440 B2
• Filed: 09/29/2014
• Issued: 08/28/2018
• Est. Priority Date: 05/24/2005
• Status: Active Grant

• Current Assignee: Inspired Industry, LLC, InspireMD, Ltd.
• Original Assignee: InspireMD, Ltd.
• Inventors: Bar, Eli, Holzer, Zeev Asher, Paz, Ofir
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): HOLLM, JONATHAN A
• Application Number:
  US14/500,759
• Publication Number:
  US 20150032197A1
• Time in Patent Office: 1,429 Days
• Field of Search: 606108, 623 111- 113, 623 123, 623 138- 139, 623 142, 623 144
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61L 2300/20 containing or releasing organic materials
• CPC Class Codes: A61L 31/10 Macromolecular materials

Abstract

A stent assembly adapted to carotid arterial placement that includes a self-expanding support element comprising metal struts constructed to be positioned in a body lumen and expanded from a retracted state to an expanded state, and a knitted cover disposed over an exterior of the support element and along an entire length thereof, wherein the knitted cover comprises a single polymer fiber having a diameter of at least 40 nanometers to 30 microns, wherein the self-expanding support element and knitted cover together have apertures sized 20 microns to smaller than 100 microns in diameter to block larger debris when the stent assembly is placed in a carotid artery and expanded to the expanded state. Methods of stenting a carotid artery by applying the stent assembly to the carotid artery of a patient in need of treatment and expanding the stent assembly in situ are disclosed.

Claims

1. A carotid stent assembly adapted to carotid arterial placement, comprising:

a self-expanding support element having a distal end and a proximal end and comprising metal struts, including a distal strut disposed at the distal end and a proximal strut disposed at the proximal end, the support element constructed to be positioned in a body lumen and expanded from a retracted state to an expanded state; and

a knitted cover disposed over an exterior of the support element and along an entire length thereof, wherein the knitted cover and the support element are attached together only at the distal strut at a distal end of the knitted cover and the proximal strut at a proximal end of the knitted cover, wherein the knitted cover comprises a single polymer fiber having a diameter of at least 40 nanometers to 30 microns, wherein the self-expanding support element and knitted cover together have apertures sized 20 microns to smaller than 100 microns in diameter to block larger debris when the carotid stent assembly is placed in a carotid artery and expanded to the expanded state,

wherein the knitted cover and the support element are attached together by sliding connections, wherein the sliding connections comprise one or more flexible loops formed from the single polymer fiber, the sliding connections being formed in the knitted cover and attached to a flexible portion of the support element, wherein a first flexible loop of the one or more flexible loops is attached to the distal strut and slides only along the distal strut and a second flexible loop of the one or more flexible loops is attached to the proximal strut and slides only along the proximal strut to permit radial sliding of the knitted cover relative to the support element at the distal strut and the proximal strut.

2. The stent assembly of claim 1, wherein the single polymer fiber has a diameter of 10 microns to 30 microns.

3. The stent assembly of claim 1, wherein the single polymer fiber and the apertures are sized to encourage growth of endothelial cells therethrough.

4. The stent assembly of claim 1, wherein the single polymer fiber of the knitted cover has slack to enable the knitted cover to expand upon radial expansion of the support element.

5. The stent assembly of claim 1, wherein the single polymer fiber is biodegradable or bioresorbable.

6. The stent assembly of claim 1, wherein the knitted cover has a coverage area of less than 25% of an area of the exterior of the support element.

7. The stent assembly of claim 1, wherein the knitted cover has a coverage area of less than 20% of an area of the exterior of the support element.

8. The stent assembly of claim 1, wherein the knitted cover has an approximate aperture size of 20 microns to 50 microns.

9. The stent assembly of claim 1, wherein the single polymer fiber comprises at least one of a thermoplastic polymer, a polyolefin elastomer, a thermosetic polymer, polyester, polyurethane, polyfluoropolymer, and nylon.

10. The stent assembly of claim 9, wherein the single polymer fiber comprises at least one heat-set polymer comprising polypropylene, polyethylene terephthalate (PET), nylon 6/6, polytetrafluoroethylene (PTFE), polyvinyl alcohol (PVA), polyurethane, and poly-l-lactide (PLLA).

11. The stent assembly of claim 1, wherein the knitted cover comprises 20 to 50 courses per cm.

12. The stent assembly of claim 1, further comprising a coating disposed on the knitted cover, the metal struts, or both.

13. The stent assembly of claim 12, wherein the coating comprises a polymer, hyaluronic acid, or hyaluronan.

14. The stent assembly of claim 12, which further comprises an active pharmaceutical agent eluted from the knitted cover, from a coating disposed over the knitted cover, or both.

15. The stent assembly of claim 14, wherein the pharmaceutical agent is time-released.

16. The stent assembly of claim 14, wherein the pharmaceutical agent is present in an amount comprising 1 microgram to 200 micrograms per square centimeter of surface area of the knitted cover, the coating disposed over the knitted cover, or both.

17. The stent assembly of claim 14, wherein the pharmaceutical agent is time-released over 2 hours to a plurality of months.

18. The stent assembly of claim 14, wherein the pharmaceutical agent comprises a zolimus, zotarolimus, sirolimus, tacrolimus, everolimus, or a combination thereof.

19. The stent assembly of claim 18, wherein the pharmaceutical agent further comprises an anti-proliferative agent, an antithrombotic agent, a growth factor inhibitor, a steroid or corticosteroid, a statin, or a combination thereof;

wherein the anti-proliferative agent is present and comprises a taxane, vincritine, viblastine, a HMG-CoA reductase inhibitor, doxorubicin, colchicine, actinomycin D, mitomycin C, cyclosporine, mycophenolic acid, triazolopyrimidine, or a combination thereof;

wherein the antithrombotic agent is present and comprises heparin, a heparin-like dextran derivative, acid citrate dextrose, coumadin, warfarin, streptokinase, anistreplase, tissue plasminogen activator (tPA), urokinase, abciximab, or a combination thereof;

wherein the growth factor inhibitor is present and comprises tranilast, angiopeptin, or a combination thereof;

wherein the steroid or corticosteroid is present and comprises cortisone, prednisolone, or both;

wherein the statin is present and comprises simvastatin, lovastatin, or a combination thereof;

or any combination of the foregoing.

20. The stent assembly of claim 12, further comprising an active pharmaceutical agent eluted from the support element, a coating disposed over the support element, or both.

21. The stent assembly of claim 20, wherein the pharmaceutical agent is time-released.

22. The stent assembly of claim 20, wherein the pharmaceutical agent is present in an amount comprising 1 microgram to 200 micrograms per square centimeter of surface area of the knitted cover, the coating disposed over the knitted cover, or both.

23. The stent assembly of claim 20, wherein the pharmaceutical agent is time-released over 2 hours to a plurality of months.

24. The stent assembly of claim 20, wherein the pharmaceutical agent comprises a zolimus, zotarolimus, sirolimus, tacrolimus, everolimus, or a combination thereof.

25. The stent assembly of claim 24, wherein the pharmaceutical agent further comprises an anti-proliferative agent, an antithrombotic agent, a growth factor inhibitor, a steroid or corticosteroid, a statin, or a combination thereof;

wherein the anti-proliferative agent is present and comprises a taxane,-vincritine, viblastine, a HMG-CoA reductase inhibitor, doxorubicin, colchicine, actinomycin D, mitomycin C, cyclosporine, mycophenolic acid, triazolopyrimidine, or a combination thereof;

wherein the antithrombotic agent is present and comprises heparin, a heparin-like dextran derivative, acid citrate dextrose, coumadin, warfarin, streptokinase, anistreplase, tissue plasminogen activator (tPA), urokinase, abciximab, or a combination thereof;

wherein the growth factor inhibitor is present and comprises tranilast, angiopeptin, or a combination thereof;

wherein the steroid or corticosteroid is present and comprises cortisone, prednisolone, or both;

wherein the statin is present and comprises simvastatin, lovastatin, or a combination thereof;

or any combination of the foregoing.

26. The stent assembly of claim 1,

wherein the tension of the sliding connections is controlled by tightening the one or more flexible loops,

wherein the distal strut and the proximal strut are formed in a zigzag pattern having a plurality of distal points and a plurality of proximal points,

wherein the first flexible loop is attached to a distal point of the distal strut and the second flexible loop is attached to a proximal point of the proximal strut,

wherein the first flexible loop is configured to travel between the distal point of the distal strut and a proximal point of the distal strut, wherein the second flexible loop is configured to travel between the proximal point of the proximal strut and a distal point of the proximal strut.

27. A method of stenting a carotid artery which comprises:

applying the stent assembly of claim 1 to the carotid artery of a patient in need of treatment; and

expanding the stent assembly in situ in the carotid artery of the patient so as to trap debris dislodged from the body lumen during the stenting of the carotid artery.

28. The method of claim 27, wherein the expanding comprises from 2 mm to 8 mm.

29. The method of claim 27, wherein the applying and expanding reduces thrombosis in the carotid artery compared to applying and expanding a stent lacking the knitted cover.

30. A method of treating embolic showers at insertion of a catheter, which comprises applying the stent assembly of claim 1 and expanding the stent assembly in situ in the carotid artery of a patient.