Polymeric stent suitable for imaging by MRI and fluoroscopy

• US 6,585,755 B2
• Filed: 06/29/2001
• Issued: 07/01/2003
• Est. Priority Date: 06/29/2001
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Jackson, Gregg A., Pacetti, Stephen D.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Ho, Tan-Uyen T.
• Application Number:
  US09/897,719
• Publication Number:
  US 20030004563A1
• Time in Patent Office: 732 Days
• Field of Search: 623/1.1, 623/1-5-, 623/1.34, 623/1.38
• US Class Current: 623/1.15
• 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 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: G01R 33/285 Invasive instruments, e.g. catheters or biopsy needles, specially adapted for tracking, guiding or visualization by NMR

Abstract

An endovascular implant, stent or other medical device formed from a polymeric material, compounded with one or more materials to render the stent visible under both magnetic resonance imaging and x-ray based fluoroscopy procedures. The stent is adaptable to be placed in any body lumen and is contemplated to be a permanent or a biodegradeable implant.

Claims

1. A stent for implantation within a body lumen of a patient, comprising:

a body defined by a pattern of interconnected strut;

a wherein the struts are made from polymeric material;

a radiopaque material; and

an MRI material designed to remain permanently in a body lumen;

wherein the stent is imageable both under x-ray based fluoroscopy and MRI when placed in the body lumen and wherein the radiopaque material and the MRI material is compounded into the body of the stent.

2. The stent of claim 1, the body further comprising a helical shaped member defining a cylindrical profile.

3. The stent of claim 1, the body further comprising a knitted structure defining a cylindrical profile.

4. The stent of claim 1, wherein the body is self-expanding.

5. The stent of claim 1, wherein the body is expandable by a radial force.

6. The stent of claim 1, the body further comprising at least one ratchet mechanism.

7. The stent of claim 6, the ratchet mechanims further comprising a plurality of teeth configured to engage catching structure.

8. The stent of claim 1, the body further comprising a longitudinally extending slit.

9. The stent of claim 1, wherein the body can be folded longitudinally to assume a radially compressed configuration.

10. The stent of claim 1, wherein the polymeric material comprises at least one material from the group including polyetheretherketone (peek), polyetherketone, polymethylmethacrylate, polycarbonate, polyphenylenesulfide, polyphenylene, polyamide, polyvinylfluoride, polyvinylidene fluoride, polypropylene, polyethylene, poly(vinylidene fluoride-co-hexafluoropropylene), poly(ethylene-co-hexafluoropropylene), poly(tetrafluoroethyelene-co-hexafluoropropylene), poly(tetrafluoroethyelene-co-ethylene), polyethyleneterephthalate and polyetherimide, glass fiber, carbon fiber, Spectra™

, Kevlar™

, poly(L-lactide), polyglycolide, poly(D, L-lactide), copolymers of lactide and glycolide, polycaprolactone, polyhydroxyvalerate, polyhydroxybutyrate, polytrimethylenecarbonate, polyorthoesters, polyanhydrides, and polyphosphazenes.

11. The stent of claim 1, wherein the stent provides sufficient mechanical strength to maintain patency of the body lumen.

12. A stent for implantation within a vessel lumen of a patient, which is visible under magnetic resonance imaging and fluoroscopy, comprising:

a pattern of struts interconnected to form a structure that contacts the lumen to maintain the patency thereof, wherein the struts are made from a polymeric material;

a material designed to remain permanently in a body lumen, compounded into the stent, to generate a magnetic susceptibility artifact of the stent; and

a material, compounded into the stent, to enhance radiopacity of the stent.

13. The stent of claim 12, wherein the polymeric material embodies shape memory characteristics.

14. The stent of claim 13, wherein the polymeric material contains methacrylate or acrylate.

15. The stent of claim 13, wherein the polymeric material is a thermoplastic polymer.

16. The stent of claim 13, wherein a state transition is caused by heat.

17. The stent of claim 13, wherein a state transition is caused by absorption.

18. The stent of claim 13, wherein a state transition is caused by a change in pH.

19. The stent of claim 13, wherein the polymeric material is a thermoset or light-activated polymer.

20. The stent of claim 12, wherein the polymeric material comprises at least one material from the group including polyetheretherketone (peek), polyetherketone, polymethylmethacrylate, polycarbonate, polyphenylenesulfide, polyphenylene, polyamide, polyvinylfluoride, polyvinylidene fluoride, polypropylene, polyethylene, poly(vinylidene fluoride-co-hexafluoropropylene), poly(ethylene-co-hexafluoropropylene), poly(tetrafluoroethyelene-co-hexafluoropropylene), poly(tetrafluoroethyelene-co-ethylene), polyethyleneterephthalate and polyetherimide, glass fiber, carbon fiber, Spectra™

, Kevlar™

, poly(L-lactide), polyglycolide, poly(D, L-lactide), copolymers of lactide and glycolide, polycaprolactone, polyhydroxyvalerate, polyhydroxybutyrate, polytrimethylenecarbonate, polyorthoesters, polyanhydrides, and polyphosphazenes.

21. The stent of claim 12, wherein the material compounded into the stent to generate a magnetic susceptibility artifact comprises at least one material from the group including metal particles of gadolinium, iron, cobalt, nickel, dysprosium, dysprosium oxide, platinum, palladium, cobalt based alloys, iron based alloys, stainless steel or other paramagnetic or ferromagnetic metals, gadolinium salts, gadolinium complexes, Gd-DTPA (gadolinium diethylenetriaminepentacetic acid), gadopentetate dimeglumine, compounds of copper, nickel, manganese, chromium, dysprosium and gadolinium, and chelates of gadolinium and other paramagnetic metals such as iron or manganese.

22. The stent of claim 12, wherein the material compounded into the stent to enhance radiopacity comprises at least one material from the group including powders of barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, tungsten, tantalum, iridium, gold, or other dense metals, particles of an iodinated contrast agent, and bismuth salts.

23. The stent of claim 12, wherein the material compounded into the stent may be distributed uniformly throughout the stent or confined to selected regions.

24. The stent of claim 12, wherein the stent is self-expanding.

25. The stent of claim 12, wherein the stent may be expanded by force.

26. The stent of claim 12, wherein the stent provides sufficient mechanical strength to maintain patency of the vessel lumen.

27. A stent for implantation within a vessel lumen of a patient, which is visible under magnetic resonance imaging and fluoroscopy, comprising:

a plurality of cylindrical rings interconnected to form the stent, each cylindrical ring having a first delivery diameter and a second expanded diameter;

each cylindrical ring having a proximal end and a distal end and a cylindrical wall extending circumferentially between the proximal end and the distal end of the cylindrical ring;

at least one connecting link attaching each cylindrical ring to an adjacent cylindrical ring;

the cylindrical rings and connecting links being formed from a polymeric material;

a first material designed to remain permanently in a body lumen to generate a magnetic susceptibility artifact of the stent; and

a second material to enhance radiopacity of the stent;

wherein one of the first material and the second material is compounded into the stent.

28. The stent of claim 27, wherein the polymeric material comprises at least one material from the group including polyetheretherketone (peek), polyetherketone, polymethylmethacrylate, polycarbonate, polyphenylenesulfide, polyphenylene, ethers, polyamides, polyvinylfluoride, polyvinylidene fluoride, polypropylene, polyethylene, poly(vinylidene fluoride-co-hexafluoropropylene), poly(ethylene-co-hexafluoropropylene), poly(tetrafluoroethyelene-co-hexafluoropropylene), poly(tetrafluoroethyelene-co-ethylene), polyethyleneterephthalate and polyetherimide, and polyetherimide, glass fiber, carbon fiber, Spectra™

, Kevlar™

, poly(L-lactide), polyglycolide, poly(D, L-lactide), copolymers of lactide and glycolide, polycaprolactone, polyhydroxyvalerate, polyhydroxybutyrate, polytrimethylenecarbonate, polyorthoesters, polyanhydrides, and polyphosphazenes.

29. The stent of claim 27, wherein the first material first comprises at least one material from the group including metal particles of gadolinium, iron, cobalt, nickel, dysprosium, dysprosium oxide, platinum, palladium, cobalt based alloys, iron based alloys, stainless steel, or other paramagnetic or ferromagnetic metals, gadolinium salts, gadolinium complexes, Gd-DTPA (gadolinium diethylenetriaminepentacetic acid), gadopentetate dimeglumine, compounds of copper, nickel, manganese, chromium, dysprosium and gadolinium, and chelates of gadolinium and other paramagnetic metals such as iron or manganese.

30. The stent of claim 27, wherein the second material comprises at least one material from the group including powders of barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, tungsten, tantalum, iridium, gold, or other dense metals, particles of an iodinated contrast agent, and bismuth salts.

31. The stent of claim 27, wherein the first and second materials are distributed uniformly throughout the stent or confined to selected regions.

32. The stent of claim 27, wherein the stent is self expanding.

33. The stent of claim 27, wherein each cylindrical ring comprises a plurality of peaks and valleys.

34. The stent of claim 27, wherein the peaks of each cylindrical ring are axially aligned with the valleys of each adjacent cylindrical ring.

35. The stent of claim 27, wherein the first and second materials are both compounded into the stent.

36. The stent of claim 27, wherein one or more of the first or second materials are dip coated on the polymeric material.

37. The stent of claim 27, wherein one or more of the first or second materials are plasma sprayed on the polymeric material.

38. The stent of claim 27, wherein one or more of the first or second materials are plasma etched on the polymeric material.

39. The stent of claim 27, wherein one or more of the first or second materials are applied by thermal pressure on the polymeric material.

40. The stent of claim 27, wherein one or more of the first or second materials are applied by heat and pressure on the polymeric material.

41. The stent of claim 27, wherein one or more of the first or second materials are mixed with a biocompatible epoxy resin and coated on the polymeric material.

42. The stent of claim 27, wherein one or more of the first or second materials are blended with a primacor solution and applied on the polymeric material.

43. The stent of claim 27, wherein one or more of the first or second materials are applied only to portions of the polymeric material.

44. The stent of claim 27, wherein the stent is configured for use with SMASH, FLASH, or turbo FLASH MRI imaging protocols.

45. The stent of claim 27, wherein the stent is configured for use with open or closed MRI systems.

46. The stent of claim 27, wherein the stent is configured for use with combined XMR type systems that combine x-ray and MR systems along a common track.

47. The stent of claim 27, wherein the stent is configured for use with an MR-compatible version of an optical tracking system.

48. The stent of claim 27, wherein the stent provides sufficient mechanical strength to maintain patency of the vessel lumen.

49. A system including a medical device, the medical device comprising:

a body including struts made from a polymeric material;

a first material;

a second material;

wherein the first material guarantees a magnetic susceptibility artifact and the second material enhances the radiopacity of the device, and wherein one of the first material and second material is compounded into the body of the medical device.