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Last Updated: December 9, 2021

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Claims for Patent: 10,070,977

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Summary for Patent: 10,070,977
Title:Stent apparatuses for treatment via body lumens and methods of use
Abstract: An enhanced stent apparatus, comprising: a support element, wherein the support element is constructed to be positioned in a body lumen; and, a porous structure, the porous structure located on a surface of the support element, and wherein the porous structure is comprised of at least one fiber under 30 microns in diameter, has a coverage area of less than 30% and is provided with apertures.
Inventor(s): Holzer; Zeev Asher (Raanana, IL), Paz; Ofir (Rishon Lezion, IL), Bar; Eli (Moshav Megadim, IL), Cohen; Ilana (Hadera, IL)
Assignee: INSPIRE M.D. LTD (Tel Aviv, IL)
Application Number:11/920,972
Patent Claims:1. An enhanced stent apparatus, comprising: a support element comprising metal struts constructed to be positioned in a body lumen; and a cover disposed over an exterior of the support element, wherein the cover is knitted and consists essentially of a single polymer fiber having a diameter of at least 40 nanometers to 30 microns, the single polymer fiber is biodegradable or bioresorbable, said knitted cover extending over an entire length of the exterior and having apertures sized from 100 microns to 200 microns in diameter to expose the exterior of the support to a luminal wall when the stent apparatus is placed in a body lumen, wherein said single fiber and the apertures are correspondingly sized to facilitate the growth of endothelial cells therethrough, and wherein the knitted cover has sufficient slack in the single fiber as knit to permit the knitted cover to expand upon radial expansion of the support element, wherein the cover is a single knit layer disposed directly over and adjacent to the support element, the cover is configured to hold detached plaque in place thereby preventing it from traveling into a blood stream in the lumen, and the cover is disposed as a single layer at each end of the support element, and wherein the cover and the support element are attached together at a plurality of locations using sliding connections, each sliding connection being a loop of the single polymer fiber connecting the cover and the support element, and the sliding connections providing additional expandability to the cover and allowing the cover to expand differently than the support element.

2. An enhanced stent apparatus according to claim 1, wherein said single fiber has a diameter of 10 microns to 30 microns, wherein the polymer fiber comprises polyethylene terephthalate (PET), and wherein the cover and support element are attached together along the circumference at each end of the support element.

3. An enhanced stent apparatus according to claim 2, wherein at least one of said support element and said cover are balloon-expandable.

4. An enhanced stent apparatus according to claim 2, wherein at least one of said support element and said cover are self-expanding.

5. An enhanced stent apparatus according to claim 2, wherein the cover has a coverage area of less than 30% of the area of the exterior surface of the support element.

6. An enhanced stent apparatus according to claim 5, wherein the apertures comprise at least 70% of the area of the cover.

7. An enhanced stent apparatus according to claim 2, wherein the cover has a coverage area of less than 25% of the area of the exterior surface of the support element.

8. An enhanced stent apparatus according to claim 2, wherein the cover has a coverage area of less than 20% of the area of the exterior surface of the support element.

9. The enhanced stent apparatus of claim 2, wherein the polymer fiber comprises at least one of a thermoplastic polymer, a polyolefin elastomer, a thermosetic polymer, polyester, polyurethane, polyfluoropolymer, and nylon.

10. The enhanced stent apparatus of claim 2, wherein the polymer fiber includes at least one heat-set polymer comprising polypropylene, polyethylene terephthalate (PET), nylon 6/6, polytetrafluoroethylene (PTFE), polyvinyl alcohol (PVA), polyurethane, and poly-1-lactide (PLLA).

11. The enhanced stent apparatus of claim 2, wherein the knitted cover comprises 20 to 50 courses per cm.

12. The enhanced stent apparatus of claim 2, which further comprises an expandable o-ring, c-ring, or both coupled to the cover to facilitate retention of the cover in association with the support element over which the cover is disposed.

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

14. The enhanced stent apparatus of claim 13, wherein the coating comprises a polymer, hyaloronic acid, or hyaluronan.

15. The enhanced stent apparatus of claim 13, further comprising an active pharmaceutical agent eluted from the cover, from a coating disposed over the cover, or both.

16. The enhanced stent apparatus of claim 15, wherein the pharmaceutical agent is time-released.

17. The enhanced stent apparatus of claim 16, wherein the pharmaceutical agent is time-released over 2 hours to a plurality of months.

18. The enhanced stent apparatus of claim 15, wherein the pharmaceutical agent is present in an amount comprising 1 microgram to 200 micrograms per square centimeter of surface area of the cover, the coating disposed over the cover, or both.

19. The enhanced stent apparatus of claim 15, wherein the pharmaceutical agent comprises a liposome, a steroid or a corticosteroid, a statin, gemcitabine, zolimus, zotarolimus, sirolimus, paclitaxel, a taxane, tacrolimus, everolimus, an anti-proliferative agent, an antithrombotic or anticoagulant agent, an antioxidant, a growth factor inhibitor, a collagen inhibitor, endothelial cell seeds, a hydrogel containing endothelial cells, or a combination thereof.

20. The enhanced stent apparatus of claim 15, wherein the anti-proliferative agent is present and comprises sirolimus, zolimus, zotarolimus, a taxane, tacrolimus, everolimus, vincritine, viblastine, a HMG-CoA reductase inhibitor, doxorubicin, colchicine, actinomycin D, mitomycin C, cycloporine, 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.

21. The enhanced stent apparatus of claim 15, wherein the pharmaceutical agent comprises zolimus, zotarilimus, a taxane, paclitaxel, everolimus, tacrolimus, or a combination thereof.

22. The enhanced stent apparatus of claim 13, further comprising an active pharmaceutical agent eluted from the support element, a coating disposed over the support element, or both.

23. The enhanced stent apparatus of claim 22, wherein the pharmaceutical agent is time-released.

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

25. The enhanced stent apparatus of claim 22, wherein the pharmaceutical agent is present in an amount comprising 1 microgram to 200 micrograms per square centimeter of surface area of the support element, the coating disposed over the support element, or both.

26. The enhanced stent apparatus of claim 22, wherein the pharmaceutical agent comprises a liposome, a steroid or a corticosteroid, a statin, gemcitabine, zolimus zotarolimus, sirolimus, paclitaxel, a taxane, tacrolimus, everolimus, an anti-proliferative agent, an antithrombotic or anticoagulant agent, an antioxidant, a growth factor inhibitor, a collagen inhibitor, endothelial cell seeds, a hydrogel containing endothelial cells, or a combination thereof.

27. The enhanced stent apparatus of claim 22, wherein the anti-proliferative agent is present and comprises sirolimus, zolimus, zotarolimus, a taxane, tacrolimus, everolimus, vincritine, viblastine, a HMG-CoA reductase inhibitor, doxorubicin, colchicine, actinomycin D, mitomycin C, cycloporine, 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.

28. The enhanced stent apparatus of claim 22, wherein the pharmaceutical agent comprises zolimus, zotarilimus, a taxane, paclitaxel, everolimus, tacrolimus, or a combination thereof.

29. The enhanced stent apparatus of claim 1, wherein the support element comprises a flexible, biocompatible material.

30. The enhanced stent apparatus of claim 29, wherein the support element comprises a polymer.

31. The enhanced stent apparatus of claim 29, wherein the support element comprises stainless steel, nitinol, cobalt chromium, or a metal alloy thereof.

32. The enhanced stent apparatus of claim 1, wherein the support element comprises non-stretchable wires and the single polymer fiber comprises a stretchable elastomer fiber.

33. The enhanced stent apparatus of claim 1, wherein the support element is self-expanding and adapted to carotid arterial placement, and wherein the body lumen is a carotid artery.

34. The enhanced stent apparatus of claim 1, wherein the cover is secured to an outermost strut of the support element.

35. An enhanced stent apparatus, comprising: a support element comprising metal struts constructed to be positioned in a body lumen; and a cover disposed over an exterior of the support element, wherein the cover is knitted from a single polymer fiber having a diameter of at least 40 nanometers to 30 microns, with a stitch length of 300-400 microns, wherein the single polymer fiber is biodegradable or bioresorbable, wherein the knitted cover comprises 5 to 50 courses per cm, extends over an entire length of the exterior of the support element in a single layer and has approximate apertures sized from 100 microns to less than 200 microns in diameter to expose the exterior of the support to a luminal wall when the stent apparatus is placed in a body lumen, wherein said single fiber and the apertures are correspondingly sized to facilitate the growth of endothelial cells therethrough, and wherein the knitted cover has sufficient slack in the single fiber as knit to permit the knitted cover to expand upon radial expansion of the support element, wherein the cover is a single knit layer disposed directly over and adjacent to the support element, the cover is configured to hold detached plaque in place thereby preventing it from traveling into a blood stream in the lumen, and the cover is disposed as a single layer at each end of the support element, and wherein the cover and the support element are attached together at a plurality of locations using sliding connections, each sliding connection being a loop of the single polymer fiber connecting the cover and the support element, and the sliding connections providing additional expandability to the cover and allowing the cover to expand differently than the support element.

36. The enhanced stent apparatus of claim 35, wherein the polymer fiber comprises polyethylene terephthalate (PET), and wherein the cover and support element are attached together along the circumference at each end of the support element.

37. The enhanced stent apparatus of claim 35, wherein the knit cover resembles a mesh configuration.

38. The enhanced stent apparatus of claim 35, wherein the knit cover expands from a retracted state to an expanded state using the sliding connections.

39. The enhanced stent apparatus of claim 38, wherein the single polymer fiber in the knit cover forms a plurality of circular shaped eyes in the expanded state.

40. The enhanced stent apparatus of claim 35, wherein the support element comprises non-stretchable wires and the single polymer fiber comprises a stretchable elastomer fiber.

41. The enhanced stent apparatus of claim 35, wherein the support element is self-expanding and adapted to carotid arterial placement, and wherein the body lumen is a carotid artery.

42. The enhanced stent apparatus of claim 35, wherein the cover is secured to an outermost strut of the support element.

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