Radiopaque distal embolic protection device

• US 20020188314A1
• Filed: 06/07/2002
• Published: 12/12/2002
• Est. Priority Date: 06/07/2001
• Status: Abandoned Application

• Current Assignee: ev3, Inc. (Medtronic Plc)
• Original Assignee: Microvena Corporation
• Inventors: Anderson, Kent D., Kusleika, Richard S., Baden, Jeannine B., Huettl, Kelly J.
• Application Number:
  US10/165,803
• Publication Number:
  US 20020188314A1
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices artificial blood vessels A61L27/507
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

The present invention is a radiopaque distal embolic protection device for use in a lumen of a patient'"'"'s body, such as a blood vessel. The protection device has an expandable and retractable filter attached to a distal portion of a guidewire. At least a portion of the filter has a radiopaque coating for viewing under fluoroscopy during use. The radiopaque coating allows the operator to ensure that the periphery of the filter has fully engaged the wall of a blood vessel and to take appropriate measures in recovery of the protection device after capture of emboli and particulate matter.

Claims

1. A device to be disposed in a patient'"'"'s body, comprising:

a guidewire; and

a filter formed of a multiplicity of filaments, expandable and collapsible with respect to said guidewire, wherein at least a portion of said filter is radiopaque to enable viewing of a spatial relationship between said filaments, said guidewire and the patient'"'"'s body under fluoroscopy.

2. A. device according to claim 1 wherein said filaments have a radiopaque coating.

3. A device according to claim 1 wherein said filaments have a radiopaque core.

4. A medical device for use in a lumen of a vascular system, comprising:

an elongate member having a distal portion; and

a filter being expandable about said distal portion, said filter formed from a plurality of filaments defining a lip having a periphery for engaging a wall of the lumen, at least a portion of said periphery being radiopaque for viewing under fluoroscopy.

5. The medical device according to claim 4 wherein said lip of said filter defines an entry to said filter into which emboli are received.

6. The medical device according to claim 4 wherein a majority of said filaments are radiopaque.

7. A device according to claim 4 wherein said filaments have a radiopaque coating.

8. The medical device according to claim 4 wherein said filaments have a radiopaque core.

9. The medical device according to claim 7 wherein said radiopaque coating overlies an adhesion layer.

10. The medical device according to claim 7 wherein said radiopaque coating has an overlying drug coating.

11. The medical device according to claim 10 wherein said drug coating has anti-coagulation properties.

12. The medical device according to claim 7 wherein said radiopaque coating is a polymeric compound.

13. The medical device according to claim 7 wherein said radiopaque coating is a polymer matrix.

14. The medical device according to claim 7 wherein said radiopaque coating contains a metal.

15. The medical device according to claim 7 wherein said radiopaque coating contains a ceramic.

16. The medical device according to claim 7 wherein said radiopaque coating has temporary radiopacity.

17. The medical device according to claim 7 wherein said radiopaque coating is a polymer film.

18. The medical device according to claim 17 wherein said polymer film having embedded micro spheres.

19. The medical device according to claim 10 wherein said drug coating is covalently bonded heparin.

20. The medical device according to claim 10 wherein said drug coating is an antiplatelet agent.

21. A blood permeable filter assembly insertable into the vasculature of a patient, comprising:

a guidewire insertable into the vasculature;

a filter having an expanded configuration wherein a periphery of said filter is defined by a plurality of filaments expanding outwardly from said guidewire to conformingly engage a wall of a lumen, and a retracted configuration wherein said periphery is collapsed toward said guidewire to allow said filter to be advanced within said lumen, at least a portion of said filaments having a radiopaque coating for viewing of positioning and configuration of said expandable filter under fluoroscopy.

22. The filter assembly according to claim 21 wherein at least a portion of said radiopaque coating is at a periphery of said filter.

24. The protection device according to claim 23 wherein at least a portion of said filaments have a radiopaque core.

25. The protection device according to claim 24 wherein said at least a portion of said filaments have a length wherein said at least a portion of said filaments are radiopaque extending over said length.

26. The protection device according to claim 23 wherein at least a portion of said filaments have a radiopaque coating.

27. The protection device according to claim 26 wherein at least a portion of said radiopaque coating is at a periphery of said filter.

28. The protection device according to claim 26 wherein said at least a portion of said filaments have a length and have a radiopaque coating over at least a portion of said length.

29. The protection device according to claim 26 wherein said at least a portion of said filaments have a length and have a radiopaque coating extending over said length.

23. A protection device, comprising:

a guidewire having a distal portion for advancing or withdrawing within a lumen;

a plurality of filaments forming a filter being expandable and collapsible about said distal portion of said guidewire, at least a portion of said filaments being radiopaque for viewing said filaments under fluoroscopy for determining an obstruction that impedes said guidewire from advancing or withdrawing within the lumen.

30. A method of using a radiopaque protection device comprising the steps of:

a) advancing a protection device having a radiopaque filter to a predetermined position within a lumen;

b) expanding said radiopaque filter within said lumen; and

c) viewing said radiopaque filter under fluoroscopy to ensure said radiopaque filter engages said lumen.

31. A method of using a radiopaque protection device for recovering said radiopaque protection device from a lumen comprising the steps of:

a) retracting said radiopaque protection device within the lumen;

b) viewing said radiopaque protection device under fluoroscopy to assess an obstruction; and

c) handling said radiopaque protection device to overcome the obstruction.

32. A method of using a radiopaque protection device for recovering said protection device containing emboli from a lumen, comprising the steps of:

a) advancing said radiopaque protection device within the lumen;

b) viewing said radiopaque protection device under fluoroscopy; and

c) aspirating said lumen with a catheter for removing a portion of the emboli.

33. A method of using a radiopaque protection device for recovering said protection device containing emboli from a lumen, comprising the steps of:

a) advancing said radiopaque protection device within the lumen;

b) viewing said radiopaque protection device under fluoroscopy; and

c) determining a device recovery strategy based at least in part on image of radiopaque protection device under fluoroscopy.

34. A method of making a radiopaque protection device comprising the steps of:

a) applying a radiopaque coating to a plurality of filaments; and

b) cycling said plurality of filaments from a collapsed state to an expanded state for preventing immobilization of a filament at a filament crossings.

35. A method of making a radiopaque protection device comprising the steps of:

a) cycling a plurality of filaments from a collapsed state to an expanded state for preventing immobilization of a filament at a filament crossings while simultaneously applying a radiopaque coating to said plurality of filaments.

36. A method of using a radiopaque protection device comprising the step of:

cycling said radiopaque protection device from a retracted state to an expanded state to break attachments between filament crossings.