Granted Patent B2

US 12,653,659 · App. 18/345,590 · Granted Jun 16, 2026

Inventors: Stephen J. Kleshinski (Fremont, CA); Scott M. Russell (Santa Cruz, CA); Masao Drexel (Santa Cruz, CA); Amir Belson (Savyon, IL); Eric Storne (Menlo Park, CA); Matthew Davis (Auburn, CA)

Assignee: Emboline, Inc.

A61F2/013A61F2/011A61F2/2433

Abstract

Claims (40)

1 . A method of positioning an embolic filter in a patient's aortic arch, said method comprising:

providing an embolic filter positioning assembly including (1) a vascular delivery sheath, (2) a filter catheter slidably received in an open lumen of said vascular delivery sheath, (3) an elongate dilator having a guidewire lumen slidably received in a central lumen of the filter catheter, (4) a tapered dilator tip attached at a distal end of the elongate dilator, and (5) an embolic filter carried on a distal portion of the filter catheter;

expanding and positioning the tapered dilator tip to extend distally beyond and cover an open distal end of the vascular delivery sheath;

introducing the expanded tapered dilator tip of the embolic filter positioning assembly though an arteriotomy, over a first guidewire received in the guidewire lumen of the elongate dilator, and into the patient's arterial vasculature;

advancing a distal end of the embolic filter positioning assembly to position the embolic filter carried on the distal portion of the filter catheter in the patient's aortic arch;

retracting a distal potion of the vascular delivery sheath from over the embolic filter and expanding the embolic filter within the patient's aortic arch; and

contracting the tapered dilator tip and retracting said tip proximally into or through the central lumen of the filter catheter.

2 . The method of claim 1 , wherein expanding the tapered dilator tip comprises inflating the tapered dilator tip and contracting the tapered dilator tip comprises deflating the tapered dilator tip.

3 . The method of claim 1 , wherein the tapered dilator tip has a conical geometry with a base and positioning the tapered dilator tip to extend distally beyond and cover an open distal end of the vascular delivery sheath comprises detachably mating the base with the open distal end of the vascular delivery sheath.

4 . The method of claim 3 , wherein the base of the tapered dilator tip is cylindrical and configured to fit inside the open distal end of the vascular delivery sheath.

5 . The method of claim 1 , further comprising closing a proximal end of the embolic filter and retracting the filter back into the vascular delivery sheath.

6 . The method of claim 5 , wherein closing the proximal end of the embolic filter comprises a ratcheting a lasso on the proximal end of the embolic filter.

7 . The method of claim 1 , wherein the embolic filter self-expands within the patient's aortic arch after the distal portion of the vascular sheath is retracted from over the embolic filter.

8 . A method for implanting a prosthetic aortic valve in a patient, said method comprising:

placing an embolic filter in the patient's aortic arch as in claim 1 ;

advancing the prosthetic aortic valve through the embolic filter; and

deploying the prosthetic aortic valve in the patient's aortic annulus while the embolic filter remains in place in the aortic arch.

9 . The method of claim 8 , wherein advancing the prosthetic aortic valve through the embolic filter comprises:

removing the elongate dilator from the central lumen of the filter catheter leaving the first guidewire in place in the central lumen of the filter catheter;

exchanging the first guidewire for an angiography pigtail catheter;

advancing one or more valve placement guidewires through the embolic filter and over the aortic arch in parallel to the embolic filter positioning assembly; and

advancing a valve placement catheter carrying the prosthetic valve over the one or more valve placement guidewires.

10 . An embolic filter positioning system comprising:

a vascular delivery sheath having a proximal hemostasis valve, an open distal end, and an open lumen extending from the open distal end to the hemostasis valve;

a filter catheter having a proximal end, a distal end, and a central lumen therethrough;

a self-expanding embolic filter attached to the distal end of the filter catheter;

an elongate dilator having a proximal end, a distal end, and a guidewire lumen therethrough;

a tapered dilator tip attached at the distal end of the elongate dilator;

wherein the elongate dilator is configured to be slidably received in the central lumen of the filter catheter, the filter catheter is configured to be slidably received in the open lumen of the vascular delivery sheath, the tapered dilator tip is positionable distally of the distal end of the vascular delivery sheath, and the self-expanding embolic filter is configured to be radially constrained in a proximal portion of the open lumen of the vascular delivery sheath; and

wherein the tapered dilator tip has an expanded configuration where it covers the open distal end of the vascular delivery sheath and facilitates entry though an arteriotomy and a contracted configuration where it can be retracted through the central lumen of the filter catheter.

11 . The embolic filter positioning system of claim 10 , wherein the tapered dilator tip has a conical geometry with a base configured to detachably mate with the open distal end of the vascular delivery sheath.

12 . The embolic filter positioning system of claim 11 , wherein the base of the tapered dilator tip is cylindrical and configured to fit inside the open distal end of the vascular delivery sheath.

13 . The embolic filter positioning system of claim 10 , further comprising a handle attached to the proximal end of the filter catheter.

14 . The embolic filter positioning system of claim 13 , wherein the handle comprises a mechanism for closing a proximal end of the embolic filter prior to retraction of the filter back into the vascular delivery sheath.

15 . The embolic filter positioning system of claim 14 , wherein the mechanism for closing a proximal end of the embolic filter comprises a ratcheting retractor coupled to a lasso on the proximal end of the embolic filter.

16 . The embolic filter positioning system of claim 10 , wherein the embolic filter comprises a cylindrical body configured to self-expand in and conform to the inner wall of the patient's aortic arch.

17 . The embolic filter positioning system of claim 16 , wherein the embolic filter further comprises a port extending across a central passage of cylindrical body, wherein the port is expandable and configured to seal against the outer surfaces of catheters and guidewires advanced therethrough.

18 . The embolic filter positioning system of claims 16 , wherein the cylindrical body comprises a porous material comprising a fabric of knitted, woven, or nonwoven fibers, filaments, or wires.

19 . The embolic filter positioning system of claim 18 , wherein the porous material is made of a resilient metal, polymer material, a malleable material, a plastically deformable material, a shape-memory material, or combinations thereof.

20 . The embolic filter positioning system of claim 18 , wherein the porous material has a pore size chosen to prevent emboli over a predetermined size from passing through.

Assignments (1)

Continuity (4)

References Cited (290)