Radiopaque fibers and filtration matrices

• US 20070172526A1
• Filed: 11/21/2006
• Published: 07/26/2007
• Est. Priority Date: 11/22/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Galdonik, Jason, Ogle, Matthew, Ebner, Bruce
• Granted Patent: US 8,052,714 B2
• Time in Patent Office: Days
• US Class Current: 424/484
• CPC Class Codes: A61K 49/0409 Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is not a halogenated organic compound

Abstract

Medical devices with radiopaque three dimensional filtration matrices provide for improved visualization of the device within a vessel. In some embodiments, the three dimensional filtration matrix comprises fibers, such as surface capillary fibers. Visualization of the three dimensional filtration matrix provides for an evaluation of the proper deployment of the three dimensional filtration matrix. Radiopaque surface capillary fibers can be advantageously incorporated into other medical devices. Radiopaque surface capillary fibers can be formed by extrusion of a radiopaque polymer or polymer composite.

Claims

1. A medical device comprising a three dimensional filtration matrix having a deployment configuration with a relatively low profile relative to an axis and a filtering configuration with a relatively large profile relative to the axis, the three-dimensional filtration matrix comprising a radiopaque material.

2. The medical device of claim 1 wherein the three dimensional filtration matrix comprises a fiber comprising the radiopaque material.

3. The medical device of claim 1 further comprising a tether operably connected to the three dimensional filtration matrix.

4. The medical device of claim 1 wherein the three dimensional filtration matrix comprises a plurality of fibers in a bundle, the deployment configuration having the bundle of fibers in an aligned configuration and the filtering configuration having the fibers in a mat of bent fibers.

5. The medical device of claim 4 wherein the fibers comprise a radiopaque coating.

6. The medical device of claim 4 wherein the three dimensional filtration matrix comprises one or more radiopaque metal wires.

7. The medical device of claim 4 further comprising an integrated guide structure comprising an overtube and a corewire extending within the overtube, wherein one end of the fibers in the bundle is operably connected to the corewire and a second end of the fibers is operably connected to the overtube, the relative movement of the overtube and corewire resulting in a transition of the three dimensional filtration matrix between the deployment configuration and the filtration configuration.

8. The medical device of claim 7 wherein the fibers are surface capillary fibers.

9. The medical device of claim 7 wherein radiopaque marker bands are located near the respective ends of the fiber bundle.

10. The medical device of claim 1 wherein the radiopaque material comprises a composite comprising a polymer and inorganic particles.

11. The medical device of claim 10 wherein the composite comprises at least about 15 weight percent inorganic particles and wherein the inorganic particles are radiopaque.

12. A filtration device comprising a guide structure and a filter element comprising a radiopaque composition operably connected to the guide structure, the filter element having a delivery configuration and a deployed configuration with a profile that extends outward from the guide structure relative to the delivery configuration, the filter element having an x-ray image in its deployed configuration with a peak intensity greater than the peak intensity of the x-ray image in its delivery configuration when the x-ray source is oriented perpendicular to the axis aligned through the center of the vessel at the filter.

13. A method for filtering flow within a vessel of a patient, the method comprising visualizing the interface of a filter element with the vessel to determine if the filter is properly deployed, wherein the filter element comprises a three dimensional filtration matrix.

14. The method of claim 13 wherein the filter element is connected to a tether and further comprising delivering the filter element into the vessel by advancing the tether through the vessel.

15. The method of claim 13 wherein the filter element comprises a bundle of fibers and the three dimensional filtration matrix is formed by a mat of bent fibers.

16. The method of claim 13 further comprising performing a treatment within the vessel upstream from the filter element, wherein performing the treatment comprises deployment of a stent or performance of an angioplasty procedure.

17. The method of claim 13 further comprising:

visualizing the location of the filter element in a deployment configuration with a relatively low profile; and

deploying the filter element by transitioning the filter element from the deployment configuration to a filtering configuration with a relatively large profile formed by the three dimensional filtration matrix, prior to visualizing the interface of the filter element with the vessel.

18. The method of claim 13 wherein the three dimensional filtration matrix comprises a radiopaque materials and wherein the visualization comprises taking an x-ray image.

19. A medical device comprising a surface capillary fiber comprising a biocompatible, radiopaque material.

20. The medical device of claim 19 wherein the biocompatible, radiopaque material comprises a composite of a polymer and radiopaque inorganic particles.

21. The medical device of claim 19 wherein the medical device comprises a filter element comprising the surface capillary fiber and a plurality of additional surface capillary fibers in a bundle having a deployed configuration with a mat of bent fibers.

22. A method for forming a radiopaque biocompatible fiber, the method comprising extruding a radiopaque, biocompatible material to form a fiber, the radiopaque, biocompatible material comprising a polymer.

23. The method of claim 22 wherein the radiopaque, biocompatible materials further comprising radiopaque inorganic particles bound within the polymer.

24. The method of claim 22 wherein the extrusion is performed through a die to generate a fiber with a non-circular cross section.

25. The method of claim 22 wherein the fiber is a surface capillary fiber.

26. The method of claim 22 wherein the fiber has an oval cross section.