System for, and method of, blocking the passage of emboli through a vessel

• US 6,443,971 B1
• Filed: 12/21/1999
• Issued: 09/03/2002
• Est. Priority Date: 12/21/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Simpson, John A., Boylan, John F.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/469,933
• Time in Patent Office: 987 Days
• Field of Search: 606/200, 606/1, 606/113, 606/114, 606/127, 606/194, 606/191, 606/192, 606/198, 623/1.11
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A self-expanding filter has a deployable resilient distal portion with properties of passing fluid (e.g. blood) in a vessel (e.g. an artery) and blocking the passage of emboli in the fluid. The self-expanding filter is disposed in the vessel, in the direction of fluid flow in the vessel, with its resilient proximal and distal ends at positions past a lesion in the vessel. The distal end of the self-expanding filter is then deployed against the vessel wall. An interventional device, such as an expandable member (e.g. balloon) and expandable stent are disposed in the vessel at the position of the lesion in the vessel. The expandable member is then dilated to expand the expandable stent against the vessel wall and open the vessel at the lesion position. Fluid (blood) flows through the deployed distal end of the self-expanding filter and emboli created during the procedure are trapped by the deployed distal end of the filter. The expandable member is then collapsed after all of the emboli have been trapped by the deployed distal end of the self-expanding filter. The resilient proximal end of the self-expanding filter is thereafter deployed against the vessel wall. This causes the emboli to be trapped between the vessel wall and the proximal and distal ends of the self-expanding filter. Alternatively, the expandable member may be deflated and withdrawn from the vessel after the proximal end of the filter has been deployed against the wall of the vessel.

Claims

1. A system for expanding a vessel at a position of a lesion in the vessel and for passing a fluid in the expanded vessel, and for blocking the passage through the vessel of emboli in the fluid, comprising:

an expandable member constructed for disposition at the position of the lesion in the vessel;

a stent disposed on the expandable member for expansion against the vessel when the expandable member is expanded; and

a self-expanding filter constructed for disposition in the vessel at a position distal to the lesion in the direction of the fluid flow and constructed to be partially deployed against the wall of the vessel to pass the fluid and block the passage of emboli released into the vessel and constructed to be fully deployed against the wall of the vessel to create a trapping pocket with the wall of the vessel for retaining trapped emboli against the wall of the vessel.

2. A system as set forth in claim 1, wherein:

the self-expanding filter has proximal and distal deployable portions with respective proximal and distal ends, wherein the distal end of the filter is deployed in the partially deployed state of the filter and the proximal and distal ends of the filter are deployed in the fully deployed state of the filter.

3. A system as set forth in claim 1, wherein:

a proximal end and a distal end of the filter are formed from resilient members constructed for disposition against the wall of the vessel when deployed therein and

the proximal and distal ends of the filter are constrained from being expanded against the wall of the vessel until they are ready to be deployed.

4. A system as set forth in claim 1, including:

a restraining sheath for holding the collapsed filter, the sheath being movable to provide for initial deployment of the distal end of the filter against the wall of the vessel and for subsequent deployment of the remainder of the filter against the wall of the vessel.

5. A system for expanding a vessel, defined by a wall, at the position of a lesion in the vessel and for passing fluid in the expanded vessel and for blocking the passage through the vessel of emboli in the fluid, comprising:

an expandable member disposable at the position of the lesion and having properties of being expandable;

a stent disposed on the expandable member and having properties of being expanded against the wall of the vessel to open the vessel at the position of the lesion when the expandable member is expanded; and

a self-expanding filter having resilient proximal and distal portions with properties of being deployed against the wall of the vessel for passing fluid in the vessel and for blocking the passage of emboli in the fluid, the filter being movable to a position distal to the lesion in the direction of the fluid flow in the vessel for deployment of the proximal and distal portions against the wall of the vessel.

6. A system as set forth in claim 5, wherein:

the distal portion of the filter is deployable against the wall of the vessel before the expandable member is inflated and the stent expanded against the vessel at the position of the lesion.

7. A system as set forth in claim 6, wherein:

the proximal portion is deployable against the wall of the vessel after the expandable member has been expanded and the stent has been expanded against the wall of the vessel at the position of the lesion.

8. A system as set forth in claim 5, wherein:

the distal portion of the filter is deployable against the wall of the vessel before the expandable member is dilated and the stent is expanded against the vessel at the position of the lesion, and

the proximal portion of the filter is deployable against the wall of the vessel after the expandable member is collapsed.

9. A system for expanding a vessel at a position of a lesion in the vessel and for passing a fluid in the expanded vessel, and for blocking the passage through the vessel of emboli in the fluid, comprising:

an expandable member constructed for disposition at the position of the lesion in the vessel;

a self-expanding filter constructed for disposition in the vessel at a position distal to the lesion in the direction of the fluid flow and constricted to be partially deployed against the wall of the vessel to pass the fluid and block the passage of emboli released into the vessel;

wherein the self-expanding filter is constructed to be fully deployed against the wall of the vessel to create a trapping pocket with the wall of the vessel for retaining trapped emboli against the wall of the vessel.

10. A system as set forth in claim 9, wherein:

a proximal end and a distal end of the filter are formed from resilient members constructed for disposition against the wall of the vessel when deployed therein and

the proximal and distal ends of the filter are constrained from being expanded against the wall of the vessel until they are ready to be deployed.

11. A device for passing a fluid in a vessel having a lesion and for blocking the passage through the vessel of emboli in the fluid, comprising:

an expandable filter having a distal portion constructed for disposition in the vessel at a position past the lesion in the direction of fluid flow in the vessel and constructed to be deployed against the wall of the vessel at the position past the lesion before the creation of the emboli in the fluid and to pass the fluid and block the passage of the emboli;

the expandable filter having a proximal portion constructed to be deployed against the wall of the vessel after the creation of the emboli in the fluid to cooperate with the distal portion of the filter in pinning the emboli against the wall of the vessel between the proximal and distal portions of the filter.

12. A device as set forth in claim 11, wherein:

the proximal and distal portions of the filter are resilient and are constrainable to positions separated from the wall of the vessel during the movement of the filter in the vessel to the position distal to the lesion and are deployable against the wall of the vessel when the constraint is released.

13. A device as set forth in claim 12, wherein:

the constraint is provided by a restraining sheath in which the forward and distal portions of the filter are deployed by the movement of the restraining sheath.

14. A system for blocking the passage of emboli in fluid flowing through the vessel, comprising:

an elongate member;

a sheath slidably disposed on the elongate member;

a self-expanding filter contained between the sheath and the elongate member, wherein the self-expanding filter is constructed to be partially deployed against the wall of the vessel to pass the fluid and block the passage of emboli in the vessel when the sheath is partially retracted, and the self-expanding filter is constructed to be fully deployed against the wall of the vessel to trap the emboli between the filter and the wall of the vessel when the sheath is fully retracted to release the self-expanding filter.

15. The system of claim 14, wherein the elongate member further includes a shoulder located proximally to the filter, wherein the shoulder prevents proximal movement of the filter when the sheath is retracted.

16. The system of claim 14, wherein the self-expanding filter includes a resilient proximal portion and a resilient distal portion, and a filtering material attached to the resilient proximal portion and to the resilient distal portion, wherein the proximal portion does not contact the vessel wall when the self-expanding filter is partially deployed and the distal portion and the proximal portion contact the vessel wall when the self-expanding filter is fully deployed.

17. The system of claim 14, wherein the self-expanding filter includes a filtering material and a plurality of self-expanding rings attached to the filtering material so as to form a generally cylindrical shape when the self-expanding filter is fully deployed.

18. The system of claim 14, wherein the self-expanding filter includes a stent device having small openings to prevent the emboli from passing therethrough.

19. The system of claim 14, further comprising:

a catheter having an expandable member and a lumen;

a stent disposed on the expandable member;

wherein the sheath and the elongate member are dimensioned so as to be movable through the lumen of the catheter.

20. A system for expanding a vessel at a position of a lesion in the vessel and for blocking the passage of emboli in the fluid flowing through the vessel, comprising:

a catheter having an expandable member and a lumen;

a stent disposed on the expandable member;

an elongate member dimensioned to be movable through the lumen of the catheter;

a sheath slidably disposed on the elongate member;

a filter contained between the sheath and the elongate member, wherein the filter is constructed to be partially deployed against the wall of the vessel to pass the fluid and block the passage of emboli in the vessel when the sheath is partially retracted, and the filter is constructed to be fully deployed against the wall of the vessel to trap the emboli between the filter and the wall of the vessel when the sheath is filly retracted to release the filter.

21. The system of claim 20, wherein the elongate member further includes a shoulder located proximally to the filter, wherein the shoulder prevents proximal movement of the filter when the sheath is retracted.

22. The system of claim 20, wherein the filter includes a resilient proximal portion and a resilient distal portion, and a filtering material attached to the resilient proximal portion and to the resilient distal portion, wherein the proximal portion does not contact the vessel wall when the self-expanding filter is partially deployed and the distal portion and the proximal portion contact the vessel wall when the self-expanding filter is fully deployed.

23. The system of claim 20, wherein the filter includes a filtering material and a plurality of self-expanding rings attached to the filtering material so as to form a generally cylindrical shape when the filter is filly deployed.

24. The system of claim 20, wherein the self-expanding filter includes a stent device having small openings to prevent the emboli from passing therethrough.