Embolic protection systems

• US 6,656,202 B2
• Filed: 06/29/2001
• Issued: 12/02/2003
• Est. Priority Date: 07/14/2000
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Tarapata, Christopher, Papp, John E., Patel, Anuja, Stalker, Kent B.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): DAVIS, DANIEL J
• Application Number:
  US09/896,142
• Publication Number:
  US 20020177872A1
• Time in Patent Office: 886 Days
• Field of Search: 606/200, 606/113, 606/114, 606/191, 606/192, 606/193, 606/194, 606/195, 606/196
• US Class Current: 606/200
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical

Abstract

A system for enabling the insertion and removal of an embolic protection device, for capturing and retaining embolic debris which may be created during the performance of a therapeutic interventional procedure in a stenosed or occluded region of a blood vessel. The system, in an embodiment thereof, enables the device to be snap-fitted so as to engage the distal end of a guide wire, to be pre-formed for expansion thereof so as to seal off the inner surface of a blood vessel, to inhibit the forming of a gap therein, for inhibiting embolic material from passing therethrough, and to be foreshortened to enable insertion thereof through confined spaces. The system, in another embodiment thereof, enables expandable material to be formed into an expandable configuration of an embolic protection device for capturing embolic material, which is capable of sealing off the inner surface of the blood vessel.

Claims

1. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to an interventional procedure site; and

a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an engaging element, for enabling the filter device to be snap-fitted so as to engage the distal end of the guide wire.

2. The system of claim 1, wherein the filter device includes a pre-formed expandable shape thereof, including a pre-formed expandable maximum outer diameter portion, adapted to expand against the inner surface of the wall of the blood vessel, and to extend along and seal off the inner surface of the blood vessel wall, upon expansion of the filter device for deployment thereof, so as to inhibit the formation of a gap between the filter device and the blood vessel wall through which embolic material may otherwise flow.

3. The system of claim 2, wherein the filter device includes a cage, adapted to be engaged with the distal end of the guide wire, and wherein the cage includes a plurality of struts.

4. The system of claim 3, wherein the cage includes a pre-formed expandable shape thereof, including a pre-formed expandable maximum outer diameter portion, adapted to expand against the inner surface of the wall of the blood vessel, and to extend along and seal off the inner surface of the blood vessel wall, upon expansion of the cage for deployment thereof, so as to inhibit the formation of a gap between the cage and the blood vessel wall through which embolic material may otherwise flow, and wherein the plurality of struts include a plurality of proximal ribs, a plurality of distal ribs, and a ring extending intermediate the plurality of proximal ribs and the plurality of distal ribs and comprising the pre-formed expandable maximum outer diameter portion of the cage.

5. The system of claim 4, wherein the ring includes a plurality of segments.

6. The system of claim 5, wherein the plurality of segments include adjacent pairs of segments.

7. The system of claim 6, wherein each adjacent pair of segments forms a generally v-shaped section of the ring.

8. The system of claim 2, wherein the pre-formed expandable shape of the filter device comprises a heat-treated shape.

9. The system of claim 1, wherein the length of the filter device is foreshortened, such that the length thereof is shortened for insertion thereof through the patient'"'"'s vasculature.

10. The system of claim 9, wherein the foreshortened length of the filter device is between about 1 centimeter and 1.5 centimeters.

11. The system of claim 1, wherein the filter device, upon being snap-fitted to the distal end of the guide wire, is adapted to enable rotational movement of the filter device independent of rotational movement of the guide wire, and to inhibit translational movement of the filter device relative to the guide wire.

12. The system of claim 1, further including a proximal stop and a distal stop, adapted to be secured to the distal end of the guide wire, and having a space between the proximal stop and the distal stop, and adapted to enable the engaging element of the filter device to be engaged with the proximal stop and the distal stop in the space between the proximal stop and the distal stop.

13. The system of claim 1, wherein the filter device includes a cage, adapted to be engaged with the distal end of the guide wire, and filter material, for filtering embolic material, secured to the cage.

14. The system of claim 13, wherein the cage includes a plurality of struts.

15. The system of claim 14, wherein each of the plurality of struts is adapted to absorb pulsations in the patient'"'"'s vasculature.

16. The system of claim 15, wherein the plurality of struts includes a plurality of proximal ribs, and each of the plurality of proximal ribs is generally s-shaped.

17. The system of claim 13, wherein the cage includes a proximal end, and the engaging element is located at the proximal end of the cage.

18. The system of claim 13, wherein the guide wire includes a tip coil, at the distal end of the guide wire, the tip coil includes a proximal portion, the filter material includes a distal portion, and the distal portion of the filter material is adapted to extend over the proximal portion of the tip coil.

19. The system of claim 1, wherein the guide wire includes a tip coil, at the distal end of the guide wire, the tip coil includes a proximal portion, and the system further comprises an obturator, which includes a distal portion, wherein the distal portion of the obturator is adapted to extend over the proximal portion of the tip coil.

20. The system of claim 19, wherein the cage includes a distal end, wherein the filter device includes a cage adapted to be engaged with the distal end of the guide wire, the cage includes a distal end, the obturator further includes a proximal portion, and the proximal portion of the obturator is adapted to extend over the distal end of the cage.

21. The system of claim 19, wherein the filter device includes a cage, adapted to be snap-fitted onto the distal end of the guide wire, and filter material, for filtering embolic material, and the filter material includes a proximal end, secured to the cage, and a distal portion, and the proximal portion of the obturator extends over the distal portion of the filter material.

22. The system of claim 1, wherein the filter device includes a proximal end and a distal end, the proximal end includes the engaging element, and the distal end is freely moveable along the guide wire.

23. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to an interventional procedure site; and

a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including a pre-formed expandable shape thereof, which includes a pre-formed expandable maximum outer diameter portion, adapted to expand against the inner surface of the wall of the blood vessel, and to extend along and seal off the inner surface of the blood vessel wall, upon expansion of the filter device for deployment thereof, so as to inhibit the formation of a gap between the filter device and the blood vessel wall through which embolic material may otherwise flow, and which further includes an engaging element, for enabling the filter device to be snap-fitted so as to engage the distal end of the guide wire.

24. The system of claim 23, wherein the length of the filter device is foreshortened, such that the length thereof is shortened for insertion thereof through the patient'"'"'s vasculature.

25. The system of claim 23, wherein the filter device includes a proximal end and a distal end, the proximal end includes the engaging element, and the distal end is freely moveable along the guide wire.

26. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to an interventional procedure site; and

a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, wherein the length of the filter device is foreshortened, such that the length thereof is shortened for insertion thereof through the patient'"'"'s vasculature, which includes an engaging element, for enabling the filter device to be snap-fitted so as to engage the distal end of the guide wire.

27. The system of claim 26, wherein the filter device includes a pre-formed expandable shape thereof, including a pre-formed expandable maximum outer diameter portion, adapted to expand against the inner surface of the wall of the blood vessel, and to extend along and seal off the inner surface of the blood vessel wall, upon expansion of the filter device for deployment thereof, so as to inhibit the formation of a gap between the filter device and the blood vessel wall through which embolic material may otherwise flow.

28. The system of claim 26, wherein the filter device includes a proximal end and a distal end, the proximal end includes the engaging element, and the distal end is freely moveable along the guide wire.

29. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to an interventional procedure site;

a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an engaging element, for enabling the filter device to be snap-fitted so as to engage the distal end of the guide wire; and

a proximal stop and a distal stop, adapted to be secured to the distal end of the guide wire, and having a space between the proximal stop and the distal stop, and adapted to enable the engaging element of the filter device to be engaged with the proximal stop and the distal stop in the space between the proximal stop and the distal stop;

wherein the engaging element of the filter device comprises at least one tab, adapted to engage the proximal stop and the distal stop in the space between the proximal stop and the distal stop.

30. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to an interventional procedure site;

a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an engaging element, for enabling the filter device to be snap-fitted so as to engage the distal end of the guide wire;

a proximal stop and a distal stop, adapted to be secured to the distal end of the guide wire, and having a space between the proximal stop and the distal stop, and adapted to enable the engaging element of the filter device to be engaged with the proximal stop and the distal stop in the space between the proximal stop and the distal stop; and

a hypotube, adapted to extend about the proximal stop, the engaging element of the filter device, the distal stop, and a portion of the guide wire.

31. The system of claim 30, wherein the hypotube includes a distal end, and the distal end of the hypotube is variably flexible.

32. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to an interventional procedure site;

a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an engaging element, for enabling the filter device to be snap-fitted so as to engage the distal end of the guide wire, and further including a pre-formed expandable shape thereof, including a pre-formed expandable maximum outer diameter portion, adapted to expand against the inner surface of the wall of the blood vessel, and to extend along and seal off the inner surface of the blood vessel wall, upon expansion of the filter device for deployment thereof, so as to inhibit the formation of a gap between the filter device and the blood vessel wall through which embolic material may otherwise flow; and

a cage, adapted to be engaged with the distal end of the guide wire, and wherein the cage includes a plurality of struts, wherein the cage includes a pre-formed expandable shape thereof, including a pre-formed expandable maximum outer diameter portion, adapted to expand against the inner surface of the wall of the blood vessel, and to extend along and seal off the inner surface of the blood vessel wall, upon expansion of the cage for deployment thereof, so as to inhibit the formation of a gap between the cage and the blood vessel wall through which embolic material may otherwise flow, and wherein the plurality of struts include a plurality of proximal ribs, a plurality of distal ribs, and a ring extending intermediate the plurality of proximal ribs and the plurality of distal ribs and comprising the pre-formed expandable maximum outer diameter portion of the cage;

wherein the filter device further includes filter material, for filtering embolic material, secured to the cage, and wherein the filter material is attached to the pre-formed expandable maximum outer diameter portion of the cage so as to extend under the distal portion of the ring and over the proximal portion of each of plurality of ribs.

33. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to an interventional procedure site;

a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an engaging element, for enabling the filter device to be snap-fitted so as to engage the distal end of the guide wire, and further including a pre-formed expandable shape thereof, including a pre-formed expandable maximum outer diameter portion, adapted to expand against the inner surface of the wall of the blood vessel, and to extend along and seal off the inner surface of the blood vessel wall, upon expansion of the filter device for deployment thereof, so as to inhibit the formation of a gap between the filter device and the blood vessel wall through which embolic material may otherwise flow; and

a cage, adapted to be engaged with the distal end of the guide wire, and wherein the cage includes a plurality of struts, wherein the cage includes a pre-formed expandable shape thereof, including a pre-formed expandable maximum outer diameter portion, adapted to expand against the inner surface of the wall of the blood vessel, and to extend along and seal off the inner surface of the blood vessel wall, upon expansion of the cage for deployment thereof, so as to inhibit the formation of a gap between the cage and the blood vessel wall through which embolic material may otherwise flow, and wherein the plurality of struts include a plurality of proximal ribs, a plurality of distal ribs, and a ring extending intermediate the plurality of proximal ribs and the plurality of distal ribs and comprising the pre-formed expandable maximum outer diameter portion of the cage;

wherein the filter device further includes filter material, for filtering embolic material, secured to the cage, and wherein the filter material is attached to the pre-formed expanded maximum outer diameter portion of the cage, so as to extend over the distal portion of the ring and over each of the plurality of ribs.