Hydrogel jacketed stents

• US 9,572,653 B2
• Filed: 10/10/2011
• Issued: 02/21/2017
• Est. Priority Date: 10/11/2010
• Status: Active Grant

• Current Assignee: Peter S. Dardi
• Original Assignee: Peter S. Dardi
• Inventors: Dardi, Peter S.
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US13/269,863
• Publication Number:
  US 20120089218A1
• Time in Patent Office: 1,961 Days
• Field of Search: 623 118- 119
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2/915 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Hydrogel jacketed stents provide the ability to fill in the stent frame in vivo to at least partially cover the interior of the surface of the stent following deployment while having the convenience of attaching the jacket to the exterior of the stent. The hydrogel can be pleated and/or folder over the exterior of the stent to provide for extension of the stent without damaging the hydrogel. The hydrogel sheet can be secured at one or more points along the circumference to associate the sheet of hydrogel with the exterior surface of the stent frame. The stent can be conveniently delivered using similar technology as conventional stents if desired. The hydrogel can provide for drug delivery if desired.

Claims

1. A jacketed stent for placement in a bodily vessel comprising a stent frame having an inner surface, an exterior surface, an extended configuration and an un-extended diameter, the jacketed stent having a hydrogel sheet associated with the exterior surface such that the hydrogel sheet forms a tubular jacket over and around a circumference of the stent frame upon extension of the stent frame to its extended configuration, wherein the stent frame is non-self extendable, wherein the hydrogel sheet has a thickness and comprises polyurethanes, polyacrylic acid and esters thereof, polymethacrylic acid and esters thereof, polyacrylonitrile, polyethylene glycol and derivatives thereof, polyacrylamide, epoxy polymers, copolymers thereof or mixtures thereof, wherein the hydrogel sheet is configured to swell when placed in water to a swollen state in which the hydrogel sheet at least partially covers the inner surface of the stent frame in the extended configuration in water and wherein the jacketed stent has an open inner lumen and wherein the hydrogel sheet has an un-hydrated thickness from 0.05 mm to 0.3 mm.

2. The jacketed stent of claim 1 wherein the ratio of an extended diameter of the stent frame in the extended configuration to the un-extended diameter of the stent frame is from about 2 to about 6.

3. The jacketed stent of claim 1 wherein the stent frame has an open wall.

4. The jacketed stent of claim 1 wherein the stent frame comprises a metal.

5. The jacketed stent of claim 1 wherein the hydrogel sheet swells by a factor of at least about 1.5 in thickness relative to its un-hydrated thickness upon exposure to the water.

6. The jacketed stent of claim 1 wherein the hydrogel sheet covers the exterior surface of the stent frame except for a portion at the ends of the stent frame.

7. The jacketed stent of claim 1 wherein the hydrogel sheet does not cover a portion of the stent frame and the jacketed stent further comprising radiopaque markers indicating the uncovered portion of the stent frame.

8. A medical device comprising a delivery catheter, a delivery actuator supported by the delivery catheter and a jacketed stent of claim 1 operably connected with the delivery actuator to control deployment of the jacketed stent in a vessel.

9. The medical device of claim 8 wherein the delivery actuator comprises a balloon that is positioned on the deliver catheter such that expansion of the balloon expands the jacketed stent, and wherein the delivery catheter further comprises a balloon flow channel operably connected to a fluid reservoir such that fluid from the reservoir can be transported in a controlled way to expand the balloon.

10. A medical device comprising the jacketed stent of claim 1, a delivery catheter and a sheath that slides relative to the delivery catheter and wherein the sheath has a configuration in which the jacketed stent is constrained between the deliver catheter and the sheath and a configuration in which the jacketed stent is unconstrained.

11. The jacketed stent of claim 1 wherein the hydrogel sheet in the swollen state covers the entire exterior surface of the stent frame.

12. The jacketed stent of claim 1 wherein the hydrogel sheet forms a cylinder.

13. The jacketed stent of claim 1 wherein the hydrogel sheet is free of folds and is attached at specific points of attachment.

14. The jacketed stent of claim 1 wherein the hydrogel sheet is free of folds and is dried onto the stent frame.

15. A jacketed stent comprising a stent frame having an outer surface, an inner surface and an un-extended diameter, the jacketed stent having a hydrogel sheet associated with the outer surface of the stent frame, wherein the hydrogel sheet is folded to accommodate a larger surface area of the hydrogel sheet relative to the outer surface of the stent frame and comprises polyurethanes, polyacrylic acid and esters thereof, polymethacrylic acid and esters thereof, polyacrylonitrile, polyethylene glycol and derivatives thereof, polyacrylamide, epoxy polymers, copolymers thereof or mixtures thereof and wherein the stent frame deploys to an extended configuration with the hydrogel sheet stretched along the outer surface of the stent frame and wherein the hydrogel sheet has a dry thickness from about 0.05 mm to about 0.3 mm and wherein the hydrogel sheet is configured to swell when placed in water.

16. The jacketed stent of claim 15 wherein the hydrogel sheet is pleated.

17. The jacketed stent of claim 15 wherein the hydrogel sheet is wrapped around the stent frame.

18. The jacketed stent of claim 15 wherein the hydrogel sheet is secured along a point on a circumference of the stent frame.

19. The jacketed stent of claim 15 wherein the hydrogel sheet is secured along a plurality of points on a circumference of the stent frame.

20. The jacketed stent of claim 15 wherein the extended configuration has an extended diameter and wherein a ratio of the extended diameter of the stent frame to the un-extended diameter of the stent frame is from about 2 to about 6.

21. The jacketed stent of claim 15 wherein the hydrogel sheet swells by a factor of at least about 1.5 in thickness relative to its dry thickness upon exposure to water.

22. The jacketed stent of claim 15 wherein the hydrogel sheet has a dry thickness from about 0.05 mm to about 0.3 mm.

23. The jacketed stent of claim 15 wherein the jacketed stent has an open central lumen.

24. The jacketed stent of claim 15 wherein the hydrogel sheet following hydration covers the outer surface of the stent frame over its entirety.

25. The jacketed stent of claim 15 wherein the hydrogel sheet is configured to swell when placed in water to a swollen state in which the hydrogel sheet at least partially covers the inner surface of the stent frame in the extended configuration.