Embolic protection system

• US 8,123,776 B2
• Filed: 06/01/2005
• Issued: 02/28/2012
• Est. Priority Date: 11/07/1997
• Status: Expired due to Fees

• Current Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Original Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Inventors: Gilson, Paul, Taylor, Charles, Griffin, Patrick, Nielan, John, Vale, David, Brady, Eamon
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US11/141,709
• Publication Number:
  US 20070005096A1
• Time in Patent Office: 2,463 Days
• Field of Search: 606/200
• US Class Current: 606/200
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/015 Stop means therefor
• 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

Abstract

An embolic protection system 1 comprises a guidewire 99 for advancing through a vasculature, the guidewire 99 having a distal end and a proximal end; an embolic protection filter 1 having a filter body 41 with a distal end and a proximal end, the filter body 41 providing for a collapsed configuration and an expanded deployed configuration. The embolic protection filter body 41 has a guidewire path for slidably receiving the guidewire 99 to permit movement of the filter 1 relative to the guidewire 99 when the filter 1 is in the collapsed configuration and the expanded deployed configuration. A delivery catheter 2 is advanceable over the guidewire 99 for delivery of the embolic protection filter 1; the delivery catheter 2 having a proximal end and a distal end. The filter 1 is deployed from the distal end of the delivery catheter 2 into the expanded deployed configuration. A retrieval catheter 3 is also advancable over the guidewire 99 for retrieval of the filter 1, the retrieval catheter 3 having a distal end and a proximal end; and engagement elements for engaging the embolic protection filter 1 with the guidewire 99 for retrieval of the filter 1 into the retrieval catheter 3 in the collapsed configuration.

Claims

1. An embolic protection device comprising:

a collapsible filter element for delivery through a vascular system of a patient;

the filter element comprising a collapsible filter body and a collapsible filter support frame contacting the filter body;

the filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter body;

the filter support frame being movable between a collapsed position for movement through the vascular system and an extended outwardly projecting position to support the filter body in an expanded position;

the filter support frame having an intermediate section to urge the filter body in the expanded position into apposition with a vessel wall, and a proximal section extending radially inwardly of the intermediate section;

wherein the filter body comprises linking webs between adjacent inlet openings,

the proximal section of the filter support frame comprises a first frame element having a section that extends proximally, radially inwardly in alignment with a first linking web, and a second frame element having a section that extends proximally, radially inwardly in alignment with a second linking web, and

the number of inlet openings is two and the number of linking webs is two.

2. A device as claimed in claim 1 wherein the filter support frame is gold-plated and electropolished.

3. A device as claimed in claim 1, wherein the filter support frame further comprises a third support element, the third support element spaced distally of the first and second support elements.

4. A device as claimed in claim 3, wherein the third frame element is aligned in the longitudinal and radial directions with one of the two inlet openings.

5. A device as claimed in claim 4, wherein the filter support frame further comprises a fourth support element, the fourth support element spaced distally of the first and second support elements, and the fourth support element being aligned in the longitudinal and radial directions with the other of the two inlet openings.

6. A device as claimed in claim 1, wherein the first and second frame elements are disposed on opposite sides of the longitudinal axis of the filter element.

7. An embolic protection system comprising:

a guidewire for advancing through a vasculature, the guidewire having a distal end and a proximal end;

the embolic protection device according to claim 1;

the filter element having a guidewire path for slidably receiving the guidewire to permit movement of the filter relative to the guidewire when the filter is in the collapsed configuration and the expanded deployed configuration;

a delivery catheter advanceable over the guidewire for delivery of the embolic protection filter;

the delivery catheter having a proximal end and a distal end, the filter being deployed from the distal end of the delivery catheter into the expanded deployed configuration;

engagement elements for engaging the filter with the guidewire for retrieval of the filter into the retrieval catheter in the collapsed configuration.

8. An embolic protection system as claimed in claim 7 wherein the guidewire path is in isolation from the embolic material captured within the filter body.

9. An embolic protection system as claimed in claim 7 or 8 wherein the tubular guidewire path is defined by a tubular sleeve.

10. An embolic protection system as claimed in claim 9 wherein the tubular sleeve extends from the proximal end to the distal end of the filter.

11. An embolic protection system as claimed claim 7 wherein the guidewire path is a tubular guidewire path.

12. An embolic protection system as claimed in claim 7 wherein the engagement elements comprise a guidewire engagement element on the guidewire and a filter engagement element on the filter, the engagement elements co-operating to provide selective engagement and positioning of the filter with respect to the guidewire.

13. An embolic protection system as claimed in claim 12 wherein the engagement element of the guidewire comprises a guidewire abutment on the guidewire.

14. An embolic protection system as claimed in claim 13 wherein the guidewire abutment is located at the distal end of the guidewire.

15. An embolic protection system as claimed in claim 13 wherein the guidewire abutment is located proximal of the distal and of the guidewire.

16. An embolic protection system as claimed in any of claims 12 to 15 wherein the engagement element of the filter comprises a filter abutment on the filter.

17. An embolic protection system as claimed in claim 16 wherein the filter abutment is a distal abutment on the filter.

18. An embolic protection system as claimed in claim 16 wherein the filter abutment is a proximal abutment on the filter.

19. An embolic protection system as claimed in claim 16 wherein the tubular guidewire path is defined by a sleeve and the filter abutment is provided by the sleeve.

20. An embolic protection system as claimed in claim 7 wherein the engagement elements comprise releasable locking elements.

21. An embolic protection system as claimed in claim 20 wherein the releasable locking elements comprise a taper lock.

22. An embolic protection system as claimed in claim 21 wherein the guidewire engagement element comprises a locking ring on the guidewire and the filter engagement element comprises a tapered surface of the filter, the locking ring having a tapered surface which is engagable with the tapered surface of the filter to lock the filter to the guidewire.

23. An embolic protection system as claimed in claim 22 wherein the locking ring is a split ring.

24. An embolic protection system as claimed in claim 22 or 23 including a tube advanceable over the guidewire, the locking ring being located between a distal end of the tube and the filter for retrieval of the filter.

25. An embolic protection system as claimed in claim 24 wherein the releasable locking means includes a tether engagable with the filter for retrieving the filter into the retrieval catheter.

26. An embolic protection system as claimed in claim 7 comprising deployment means for moving the collapsed filter relative to the distal end of the delivery catheter.

27. An embolic protection system as claimed in claim 20 wherein the deployment means comprises a tube which is advanceable over the guidewire for engagement with the proximal end of the filter, the tube being movable longitudinally relative to the delivery catheter for deployment of the filter from the distal end of the delivery catheter.

28. An embolic protection system as claimed in claim 7 including loading means for loading the filter into the delivery catheter.

29. An embolic protection system as claimed in claim 28 wherein the loading means comprises a funnel having a narrowed portion disposed at the distal end of the delivery catheter and an enlarged portion for receiving a proximal portion of the filter in the expanded configuration, the filter being progressively collapsed as it is moved through the funnel for loading into the delivery catheter.

30. An embolic protection system as claimed in claim 7 including engagement means for engaging the filter within the retrieval catheter.

31. An embolic protection system as claimed in claim 30 wherein the engagement means comprises a frictional engagement between the filter body and an internal surface of the distal end of the retrieval catheter.

32. An embolic protection system as claimed in claim 30 or 31 wherein the engagement means comprises projections on the inner surface of the retrieval catheter adjacent the distal end thereof.

33. An embolic protection system as claimed in claim 7 wherein the delivery catheter includes an elongate slot disposed in a first sidewall thereof at a first distal location which is spaced a relatively longer distance from the proximal end of the delivery catheter than from the distal end of the delivery catheter, and wherein the inner deployment catheter includes an aperture disposed in a second sidewall thereof at a second distal location which substantially corresponds with said first distal location for said elongate slot, thereby permitting co-operative movement of said filter with respect to said guidewire and associated delivery and deployment catheters for selective deployment of the filter while facilitating the rapid exchange of said catheter and filter assembly over a guidewire without the utilization of exchange wires or extension wires.

34. An embolic protection system as claimed in claim 7 comprising a guide olive provided at the distal end of the filter body.

35. An embolic protection system as claimed in claim 34 comprising an inner elongate sleeve to which the filter body and the filter support frame are mounted, the sleeve having a proximal end and a distal end, the guide olive extending distally of the sleeve distal end.

36. A system as claimed in claim 35 wherein the proximal end of the filter support frame and the inlet end of the filter body are attached to the proximal end of the sleeve.

37. A system as claimed in any of claims 34 to 36 wherein the guide olive is integral with the filter body.

38. A system as claimed in any of claims 34-36 wherein the guide olive tapers distally inwardly.

39. A method for the capture and removal of embolic material from a blood vessel during an interventional procedure comprising the steps of:

advancing a guidewire through a vasculature;

crossing a desired treatment location with the guidewire;

introducing over the guidewire the embolic protection device according to claim 1;

deploying the filter distal to the treatment location;

carrying out the interventional procedure, embolic material generated during the treatment procedure being captured by the deployed filter;

advancing a retrieval catheter over the guidewire;

collapsing the filter into the retrieval catheter and with it the captured embolic material;

withdrawing the retrieval catheter and the collapsed filter from the vasculature leaving the guidewire in the vasculature.

40. A method as claimed in claim 39 comprising the step of providing a catheter over the guidewire after withdrawal of the retrieval catheter.

41. A method as claimed in claim 39 or 40 including the step of moving the guidewire after withdrawal of the retrieval catheter and the collapsed filter from the vasculature to re-position the guidewire in the vasculature.

42. A method as claimed in claim 40 wherein the catheter is a catheter for delivery of a diagnostic medium.

43. A method as claimed in claim 40 wherein the catheter is a catheter for delivery of a lytic agent.

44. A method as claimed in any of claim 39 to 40, 42 or 43 wherein the filter is slidably disposed on the guidewire when the filter is in the expanded deployed configuration.

45. A method as claimed in any of claim 39 to 40, 42 or 43 wherein the filter is rotatably disposed on the guidewire when the filter is in the expanded deployed configuration.

46. A method as claimed in any of claim 39 to 40, 42 or 43 including the steps of:

loading the filter in a collapsed configuration within a delivery catheter;

advancing the delivery catheter and filter over the guidewire to deliver the filter to a desired location; and

deploying the filter from the delivery catheter at the desired location.

47. A method as claimed in claim 46 including the steps of:

collapsing the filter from an expanded configuration for loading the filter into the delivery catheter;

the filter being expanded to a deployment configuration on release from the delivery catheter.

48. A method as claimed in claim 47 wherein the treatment location is a region of stenosis.

49. A method as claimed in claim 48 wherein the interventional procedure includes a balloon dilation of the stenosis while the filter is deployed.

50. A method as claimed in claim 48 wherein the interventional procedure includes a stenting of the treatment location while the filter is deployed.

51. An embolic protection system as claimed in claim 1, the delivery catheter comprising:

an outer catheter tube defining a distal end; and

an inner catheter tube defining a distal end;

the outer tube being at least partially movable relative to the inner tube between a delivery configuration in which the distal end of the outer tube extends distally of the distal end of the inner tube to define a reception space for an embolic protection filter within the outer tube, and a deployment configuration in which the distal end of the inner tube extends distally of the distal end of the outer tube for deployment of the embolic protection filter;

the inner catheter tube providing compressive resistance and the outer catheter tube providing stretch resistance.

52. An embolic protection system claimed in claim 51 wherein the inner catheter tube at least partially comprises a relatively stiff core encased in a more pliable body.

53. An embolic protection system claimed in claim 51 or 52 wherein the outer catheter tube at least partially comprises a relatively stiff core encased in a more pliable body.

54. An embolic protection system claimed in claim 51 or 52 wherein the core is oriented to prevent elongation of the outer catheter tube and/or compression of the inner catheter tube.

55. An embolic protection system claimed in claim 51 or 52 wherein the core comprises a mesh.

56. An embolic protection system claimed in claim 52 wherein the core comprises a plurality of longitudinally oriented strips of a stiff material.

57. An embolic protection system claimed in claim 52 wherein the core comprises a plurality of circumferentially oriented strips of a stiff material.

58. An embolic protection system claimed in claim 52 wherein the core is of a metallic material.

59. An embolic protection system claimed in claim 58 wherein the metal is stainless steel.

60. An embolic protection system claimed in claim 59 wherein the pliable body is of a plastics material.

61. An embolic protection system as claimed in claim 60 wherein the plastic is polyamide.