Embolic protection device

• US 6,336,934 B1
• Filed: 11/09/1998
• Issued: 01/08/2002
• Est. Priority Date: 11/07/1997
• Status: Expired due to Term

• Current Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Original Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Inventors: Brady, Eamon, Vale, David, Taylor, Charles, Maher, Padraig, Gilson, Paul
• Primary Examiner(s): Chaudhuri, Olik
• Assistant Examiner(s): Trinh, (Vikki) Hoa B.
• Application Number:
  US09/188,472
• Time in Patent Office: 1,156 Days
• Field of Search: 606/200, 606/194, 606/108, 604/96, 604/104-106
• US Class Current: 606/200
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• 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 2002/015 Stop means therefor
• 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 2230/0006 circular
• 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 2230/0097 Harpoon-shaped

Abstract

An embolic protection device has a collapsible filter element (105) mounted on a carrier such as a guidewire (101). The filter element (105) collapses into the outer end of a catheter (118) for deployment and retrieval through a vascular system of a patient. The filter element (105) has a collapsible filter body with a proximal inlet end and a distal outlet end. The proximal inlet end has inlet openings sized to allow blood and embolic material enter the filter body. The outlet end has outlet openings which allow through passage of blood but retain embolic material within the filter body. After use, the catheter (118) is movable along the guidewire (101) to engage the proximal end of the filter element and close the inlet openings before sliding over the filter element from the proximal end to the distal end to progressively collapse the filter body on the guidewire (101) for retrieval. The filter element (105) may conveniently be mounted on a tubular sleeve (104) which is slidable and rotatable on the guidewire (101) between spaced-apart stops (106, 120) on the guidewire (101) which allows some manipulation of the guidewire independently of the filter when the filter is in use.

Claims

1. A vascular filtration device for removing embolic material in body fluid, said device comprising:

a delivery system having a longitudinal axis, distal and proximal portions, said distal portion of the delivery system being removably advanceable into the vasculature of a patient;

a collapsible filter body having a longitudinal axis, a proximity tapering proximal end and a distal end, and further having a collapsed configuration and an expanded deployed configuration, the collapsed configuration permitting delivery and withdrawal of the filter body from the vasculature of a patient;

the filter body defining an interior space when in said expanded configuration;

at least one fluid inlet on the proximal end of the filter body, the inlet being open to admit blood and embolic material into said interior space when the filter body is in the expanded configuration, and substantially closed to fluid flow when the filter body is in the collapsed configuration;

a plurality of outlet openings at the distal end of the filter body, the outlet openings being open to fluid flow from said interior space when the filter body is in the expanded configuration;

the outlet openings being sized to allow through passage of blood but retaining undesired embolic material within the filter body;

wherein the filter body is moved between the collapsed and expanded configurations through relative motion of portions of the filter delivery system with respect to the filter body;

said proximal end of the filter body being collapsible on transition to the collapsed configuration thereby firstly substantially closing said at least one fluid inlet to ensure retention of any collected embolic material in the interior space and then collapsing the remainder of the filter body; and

the delivery system includes a guidewire, and the filter body is rotatable relative to the delivery system.

2. A device as claimed in claim 1, wherein said delivery system further comprises a tubular member, the filter body being moved between the collapsed and expanded configurations through relative motion of the tubular member with respect to the filter body.

3. A device as claimed in claim 1, wherein said filter body is defined by a generally elongated shape having an axial dimension greater than the transverse dimension when in an expanded configuration.

4. A device as claimed in claim 1, wherein the filter body has generally circular transverse cross sections along its longitudinal axis and an associated outer surface, and at least one of a rib and groove disposed about said associated outer surface.

5. A device as claimed in claim 1, wherein the delivery system further comprises a tubular filter retrieval device having an open distal end for reception of the filter body in the collapsed configuration, said open distal end of the filter retrieval device being engagable with the proximal end of the filter body thereby firstly substantially closing said at least one fluid inlet and being slidable relative to the filter body thereby progressively collapsing the remainder of the filter body and receiving the filter body within the retrieval device.

6. A device as claimed in claim 1, wherein said filter body is slidably disposed on the guidewire when the filter body is in said expanded deployed configuration.

7. A device as claimed in claim 6, further comprising at least one stop for limiting the range of longitudinal movement of the filter body on the guidewire.

8. A device as claimed in claim 7, wherein at least one of said at least one stop is located within the interior space when the filter body is in said expanded deployed configuration.

9. A device as claimed in claim 7, wherein the stop is mounted on the guidewire.

10. A device as claimed in claim 1, wherein the filter body is mounted on a sleeve member which is slidably disposed on said guidewire.

12. A device as claimed in claim 10, further including at least one stop for limiting the range of longitudinal movement of the sleeve member on the guidewire.

13. A device as claimed in claim 12, wherein said at least one stop comprises at least a first and second stop, wherein the length of the sleeve member is less than the distance between the stops.

14. A device as claimed in claim 10, wherein the sleeve member further comprises a guide olive located distal to the filter body and tapering distally and inwardly.

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

preparing an embolic protection device comprising a guidewire having a proximal end and a distal end, a collapsible filter body mounted adjacent the distal end of the guidewire, the filter body having a proximally tapering proximal end and a distal end and being movable between a collapsed stored position against the guidewire and an expanded position extending laterally outwardly of the guidewire;

sliding a catheter along the guidewire and over the filter body from a proximal inlet end of the filter to collapse and house the filter in a distal end of the catheter;

introducing the distal end of the catheter into the vascular system of a patient;

positioning the distal end at a desired location in the blood vessel;

holding the guidewire and retracting the catheter to release the filter body from the catheter into the expanded position;

filtering blood in the vessel during the interventional procedure;

after the interventional procedure, advancing a retrieval catheter along the guidewire to engage a proximal inlet end of the filter collapsing the filter into the distal end of the cather by firstly substantially closing an inlet to the filter body to ensure retention of any collected embolic material in an interior space of the filter body and then collapsing the remainder of the filter body; and

withdrawing the cather from the patient.

36. A method as claimed in claim 11, wherein the filter body is slidable along the guidewire.

37. A method as claimed in claim 11, wherein the filter body is rotatable relative to the guidewire.

38. A method as claimed in claim 11, wherein the release of the filter body from the catheter allows for control of the movement of the filter body solely by movement of the guidewire.

15. A vascular filtration device for removing embolic material in body fluid, said device comprising:

a delivery system having a longitudinally axis, distal and proximal portions, said distal portion of the delivery system being removably advanceable into the vasculature of a patient;

a collapsible filter body having a longitudinal axis, a proximally tapering proximal end and a distal end, and further having a collapsed configuration and an expanded deployed configuration, the collapsed configuration permitting delivery and withdrawal of the filter body from the vasculature of a patient;

the filter body defining an interior space when in said expanded configuration;

at least one fluid inlet on the proximal end of the filter body, the inlet being open to admit blood and embolic material into said interior space when the filter body is in the expanded configuration;

a plurality of outlet openings at the distal end of the filter body, the outlet openings being open to fluid flow from said interior space when the filter body is in the expanded configuration;

the outlet openings being sized to allow through passage of blood but retaining undesired embolic material within the filter body;

wherein the filter body is moved between the collapsed and expanded configurations through relative motion of portions of the filter delivery system with respect to the filter body;

said proximal end of the filter body being collapsible on transition to the collapsed configuration thereby firstly substantially closing said at least one fluid inlet to ensure retention of any collected embolic material in the interior space and then collapsing the remainder of the filter body; and

the filter delivery system includes a guidewire and the filter body is detached from the delivery system so as to permit longitudinal movement of the filter body relative to the delivery system when the filter body is in the expanded deployed configuration.

16. A device as claimed in claim 15, wherein said delivery system comprises a tubular member, the filter body being moved between the collapsed and expanded configurations through relative motion of the tubular member with respect to the filter body.

17. A device as claimed in claim 15, wherein the delivery system comprises a tubular filter retrieval device having an open distal end for reception of the filter body in the collapsed configuration, said open distal end of the filter retrieval device being engageable with the proximal end of the filter body thereby firstly substantially closing said at least one fluid inlet and being slidable relative to the filter body thereby progressively collapsing the remainder of the filter body and receiving the filter body within the retrieval device.

18. A device as claimed in claim 15, wherein the detachment of the filter body from the guidewire allows for rotational movement of the filter body relative to the guidewire.

19. A device as claimed in claim 18, wherein both the proximal and distal ends of the filter body are detached from the guidewire.

20. A device as claimed in claim 18, further including at least one stop for limiting the range of longitudinal movement of the filter body on the guidewire.

21. A device as claimed in claim 20, wherein at least one of said at least one stop is located within the interior space when the filter body is in said expanded deployed configuration.

22. A device as claimed in claim 20, wherein the stop is mounted on the guidewire.

23. A device as claimed in claim 15, wherein the filter body is mounted on a sleeve member which is slidably disposed on said guidewire.

24. A device as claimed in claim 23, further including at least one stop for limiting the range of longitudinal movement of the sleeve member on the guidewire.

25. A device as claimed in claim 24, wherein said at least one stop comprises at least a first and second stop, wherein the length of the sleeve member is less than the distance between the stops.

26. A device as claimed in claim 23, wherein the sleeve member further comprises a guide olive located distal to the filter body and tapering distally and inwardly.

27. A vascular filtration device for removing embolic material in body fluid, said device comprising:

a delivery system having a longitudinal axis, distal and proximal portions, said distal portion of the delivery system being removably advanceable into the vasculature of a patient;

a collapsible filter body having a longitudinal axis, proximal and distal ends and further having a collapsed configuration and an expanded deployed configuration, the collapsed configuration permitting delivery and withdrawal of the filter body from the vasculature of a patient;

the filter body defining an interior space when in said expanded configuration;

at least one fluid inlet on the proximal end of the filter body, the inlet being open to admit blood and embolic material into said interior space when the filter body is in the expanded configuration, and substantially closed to fluid flow when the filter body is in the collapsed configuration;

a plurality of outlet openings at the distal end of the filter body, the outlet openings being open to fluid flow from said interior space when the filter body is in the expanded configuration;

the outlet openings being sized to allow through passage of blood but retaining undesired embolic material within the filter body;

wherein the filter body is moved between the collapsed and expanded configurations through relative motion of portions of the filter delivery system with respect to the filter body; and

wherein the filter body has a generally circular transverse cross sections along its length forming an associated outer surface, and at least one of a protruding rib and recessed groove disposed about said associated outer surface.

28. A device as claimed in claim 27, wherein the filter body includes a said recessed groove extending 360 degrees around said associated outer surface.

29. A device as claimed in claim 27, wherein the filter body includes a said protruding rib extending 360 degrees around said associated outer surface.

30. A device as claimed in claim 27, wherein said associated outer surface forms a generally cylindrical portion between said proximal and distal end of the filter body, the cylindrical portion having a maximum axial dimension greater than a maximum transverse dimension when in the expanded configuration.

31. A device as claimed in claim 30, wherein filter body includes a tapering distal end.

32. A device as claimed in claim 27, wherein the outlet openings are generally circular.

33. A device as claimed in claim 27, wherein the filter body comprises a filter frame, the frame being movable between a collapsed position when the filter body is in a collapsed configuration and an extended outwardly projecting position in the expanded deployed configuration.

34. A device as claimed in claim 33, wherein the frame is formed of one of a shape memory and elastic memory material.

35. A device as claimed in claim 27, wherein the filter body comprises a porous barrier, the barrier forming the at least one fluid inlet and the outlet openings, the outlet openings being smaller in size than the at least one fluid inlet, and wherein the porous barrier is collapsible into a small diameter delivery catheter and is expandable upon deployment to a shape which is remembered by the porous barrier either through one of a shape memory characteristics and elastic memory characteristics.