Interventional catheter for retrograde use having embolic protection capability and methods of use

• US 20070142858A1
• Filed: 12/21/2005
• Published: 06/21/2007
• Est. Priority Date: 12/21/2005
• Status: Active Grant

• Current Assignee: Nexeon MedSystems, Inc.
• Original Assignee: Paragon Intellectual Properties, LLC
• Inventors: Bates, Mark
• Granted Patent: US 7,837,702 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0097 Harpoon-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Interventional catheters are disclosed for use in performing diagnostic and therapeutic procedures in vessels that are accessed retrograde to blood flow. The catheters include an elongated shaft slidably disposed within a sheath, a distal region having an end effector and a filter disposed proximal to the end effector to capture emboli liberated during the diagnostic or therapeutic procedure. The filter includes a plurality of struts that cooperate with an exterior surface of the catheter to define a reservoir to retain captured emboli, the reservoir configured so that advancement of the sheath contracts the filter without squeezing or dislodging captured emboli beyond a distal end of the filter.

Claims

1. An interventional catheter for use in a vessel, comprising:

an elongated shaft having an exterior surface, a proximal end, a distal end and a distal region having a diagnostic or therapeutic end effector, and a guide wire lumen extending the distal region;

a filter coupled to the exterior surface of the elongated shaft in the distal region proximal to the end effector, the filter comprising a plurality of struts supporting a filter mesh, each one of the plurality of struts having a proximal end and a distal end, the proximal ends of the plurality of struts coupled to the elongated shaft, the struts configured to transition between a contracted position, wherein the distal ends of the struts contact the exterior surface of the elongated shaft, and an expanded position, wherein the distal ends of the struts contract an interior surface of the vessel and define a distal opening of the filter, the filter and the exterior surface of the elongated shaft cooperating to define a reservoir for retaining emboli captured by the filter; and

a sheath having a distal end slidably disposed on the elongated shaft, the sheath movable from a retracted position, wherein the distal end of the sheath is located proximal of the filter, to an extended position, wherein the distal end of the sheath collapses the filter against the exterior surface of the elongated shaft to seal the reservoir and prevent emboli from passing beyond the distal opening of the filter.

2. The catheter of claim 1 wherein the reservoir further comprises a reduced diameter section of the elongated shaft, the plurality of struts spanning the shaft in the contracted position.

3. The catheter of claim 1 wherein the end effector comprises a balloon.

4. The catheter of claim 3 further comprising a stent disposed on the balloon.

5. The catheter of claim 1 wherein the filter mesh has a multiplicity of pores, the size of the pores sufficient to permit blood to pass through the filter, but to capture embolic material.

6. The catheter of claim 5 wherein the pore size is smaller than 500 micrometers.

7. The catheter of claim 1 wherein the plurality of struts comprises four or more struts.

8. The catheter of claim 1 further comprising one or more radiopaque markers affixed to the elongated shaft.

9. The catheter of claim 1 further comprising one or more radiopaque markers affixed to plurality of struts.

10. The catheter of claim 1 wherein the struts self-expand upon retraction of the sheath.

11. The catheter of claim 1 wherein each strut includes a concave indentation adjacent to the distal end of the strut.

12. The catheter of claim 11 wherein the concave indentations of the plurality of struts give the filter an amphora shape when the struts are in the expanded position.

13. The catheter of claim 12 wherein a proximal portion of the filter defines the reservoir.

14. The catheter of claim 11 wherein the concave indentation is configured so that when the sheath is advanced to urge the plurality of struts to the contracted position, the distal ends of the plurality of struts contact the elongated shaft before more proximally-located portions of the struts.

15. A catheter for use in an interventional or diagnostic procedure in a vessel, the catheter comprising:

an elongated shaft having a exterior surface and a distal region having a diagnostic or therapeutic end effector and a guide wire extending through the distal region;

a filter coupled to the elongated shaft in the distal region proximal to the end effector, the filter having a delivery position, wherein the filter is contracted distal against the exterior surface of the elongated shaft, and a deployed position, wherein a distal edge of the filter contacts an interior surface of the vessel, the filter and the exterior surface of the elongated shaft cooperating to define a reservoir for retaining emboli captured by the filter; and

a sheath having a distal end slidably disposed on the elongated shaft, the sheath movable from a retracted position, wherein the distal end of the sheath is located proximal of the filter, to an extended position, wherein the distal end of the sheath causes the filter to contact the exterior surface to seal the reservoir and prevent dislodgement of emboli beyond the distal edge of the filter.

16. The catheter of claim 15 wherein the reservoir further comprises a reduced diameter section of the elongated shaft.

17. The catheter of claim 15 wherein the filter has a multiplicity of pores, the size of the pores sufficient to permit blood to pass through the filter, but to capture embolic material.

18. The catheter of claim 17 wherein the pore size is smaller than 500 micrometers.

19. The catheter of claim 15 wherein the filter further comprises a plurality of struts.

20. The catheter of claim 15 further comprising one or more radiopaque markers affixed to one of the elongated shaft or the sheath.

21. The catheter of claim 15 wherein the filter self-expands upon retraction of the sheath.

22. The catheter of claim 15 wherein the filter comprises a plurality of struts, each strut having a proximal end coupled to the catheter and a distal end including a concave indentation.

23. The catheter of claim 22 wherein the concave indentations of the plurality of struts give the filter an amphora shape in the deployed position.

24. The catheter of claim 23 wherein a proximal portion of the filter defines the reservoir.

25. The catheter of claim 24 wherein the concave indentation is configured so that when the sheath is advanced to transition the filter to the delivery position, the distal ends of the struts contact the elongated shaft before more proximally-located portions of the struts.