Device for, and method of, blocking emboli in vessels such as blood arteries

• US 7,918,820 B2
• Filed: 09/11/2009
• Issued: 04/05/2011
• Est. Priority Date: 12/30/1999
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Stalker, Kent C. B.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US12/557,609
• Publication Number:
  US 20100004674A1
• Time in Patent Office: 571 Days
• Field of Search: 604104-109, 604/96.01, 606/200, 606/198, 606/127
• US Class Current: 604/104
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• 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 2230/008 paraboloidal

Abstract

A filtering device has a directional member and filtering member disposable in a vessel (e.g. blood artery) at a position past a lesion in the direction of fluid flow. The filtering member is made from a resilient material having properties of passing the fluid while blocking the passage of emboli in the fluid. This material may be selected from a group consisting of blood filter material and a braided/woven biocompatible material with the properties specified above. The inner end of the filtering member is attached to a shaft which provides for the disposition of the members in the vessel at the position past the lesion and the withdrawal of the members from the vessel. The directional member has a length extending at least to the vessel wall. The directional member is made from a pliable and elongatable material with properties of blocking fluid and emboli passage. The directional member is deployable within the vessel by the fluid flow in the vessel and directs the fluid in the vessel and any emboli in the fluid into the filtering member. The filtering and directional members are disposed at an acute angle relative to the shaft to create a trapping pocket. Restraining wires attached to the directional member are used to collapse the directional member and draw at least a part of the directional member into an outer sheath to prevent emboli from backflowing into the vessel.

Claims

1. A filtering device for blocking the passage of emboli through a body vessel, comprising:

a directional member made from a pliable, fluid impermeable material, the directional member being movable from a collapsed position to an expanded, deployed position by the fluid flow in the body vessel, the directional member having a truncated conical shape which includes an inlet opening for receiving fluid flow therethrough and an outlet opening through which fluid passes through;

a filtering member made from a material which blocks passage of emboli entrained in the fluid by allows passage of the fluid therethrough, the filtering member being attached to the directional member so that fluid directed into the directional member passes through the filtering member;

an elongate tubular member having an internal lumen and a distal section and proximal section, the elongate tubular member having an outer diameter sized to allow an interventional device to be advanced over it to position an interventional device within the body vessel, wherein the directional member and filtering member are maintained in the collapsed position within the internal lumen of distal section of the tubular member, the proximal section of the elongate member being located outside of the body vessel when the directional member and filtering member are placed within the body vessel;

a shaft member having a distal end and a proximal end, the shaft member being slidably disposed within the lumen of the elongate tubular member for moving the directional and filtering member out of the lumen of the elongate tubing tubular member for deployment by the fluid flow in the body vessel, the shaft member being movable from a location outside the body vessel to move the directional member and filtering member from the collapsed position; and

a restraining wire attached to the directional member which extends along the length of the elongate tubular member, the restraining wire being retractable from a location outside the body vessel to move the directional member and filtering member back to the collapsed position.

2. The filtering device of claim 1, wherein:

the directional member is elongated and adapted to be disposed against the wall of the body vessel when placed in the expanded, deployed position.

3. The filtering device of claim 1 wherein:

the directional member directs body fluid into the filtering member.

4. The filtering device of claim 1, wherein:

the filtering member has an inlet opening and the restraining wire is adapted to draw at least the inlet opening of the filtering member into a recovery sheath.

5. The filtering device of claim 1, wherein:

the restraining wire extends within the lumen of the elongate tubular member.

6. The filtering device of claim 1, wherein:

the shaft member contacts the interior of the filtering member to move the filtering member and directional member out of the lumen of the elongate tubular member.

7. The filtering device of claim 1, wherein:

the restraining wire extends outwardly from the lumen when the filter is deployed.

8. A method of filtering emboli entrained in the body fluid in a body vessel, comprising:

providing a filtering device having a directional member made from a pliable, fluid impermeable material, the directional member being movable from a collapsed position to an expanded, deployed position by the fluid flow in the body vessel, the directional member having a truncated conical shape which includes an inlet opening for receiving fluid flow therethrough and an outlet opening through which fluid passes through;

a filtering member made from a material which blocks passage of emboli entrained in the fluid by allows passage of the fluid therethrough, the filtering member being attached to the directional member so that fluid directed into the directional member passes through the filtering member;

an elongate tubular member having an internal lumen and a distal section and proximal section, the elongate tubular member having an outer diameter sized to allow an interventional device to be advanced over it to position an interventional device within the body vessel, wherein the directional member and filtering member are maintained in the collapsed position within the internal lumen of distal section of the tubular member, the proximal section of the elongate member being located outside of the body vessel when the directional member and filtering member are placed within the body vessel;

a shaft member having a distal end and a proximal end, the shaft member being slidably disposed within the lumen of the elongate tubular member for moving the directional and filtering member out of the lumen of the elongate tubing for deployment by the fluid flow in the body vessel, the shaft member being movable from a location outside the body vessel to move the directional member and filtering member from the collapsed position; and

a restraining wire attached to the directional member which extends along the length of the elongate tubular member, the restraining wire being retractable from a location outside the body vessel to move the directional member and filtering member back to the collapsed position;

placing the directional member and filtering member into the lumen of the distal section of the elongate tubular member;

advancing the filtering device into a desired body vessel;

manipulating the shaft member to allow the directional member and filtering member to exit the lumen of the elongate tubular member;

allowing fluid flow in the body vessel to expand the directional member into its expanded, deployed position;

advancing interventional device over the elongate tubular member to a desired location in the body vessel;

performing an interventional procedure in the body vessel;

capturing emboli entrained in the body fluid in the filtering member;

removing the interventional device from the body lumen;

retracting the proximal end of the restraining wire to pull at least a portion of the directional member into the lumen of the elongate tubular member; and

removing the filtering device from the body vessel.