Granted Patent B2

US 12,599,339 · App. 18/296,873 · Granted Apr 14, 2026

Inventors: Steven L. Waldhauser (Savage, MN); Todd Alan Kerkow (Stacy, MN); Alan David Eskuri (Hanover, MN)

Assignee: Cardionomix, Inc.

A61B5/6858A61B18/1492A61N1/0551A61N1/0553A61N1/0558A61N1/3605A61N1/368A61B2018/0016A61B2018/00214A61B2018/00267A61B2018/00279A61M25/09A61M25/1011A61N1/36542A61N1/3655A61N1/36557A61N1/36564

Abstract

Claims (63)

1 . An expandable member for supporting an electrode array, the expandable member being self-expanding between a compressed state and an expanded state, the expandable member comprising:

a proximal end;

a distal end;

a longitudinal axis;

a plurality of wires extending from the proximal end to the distal end, wherein each the plurality of wires includes:

a proximal portion extending parallel to the longitudinal axis from the proximal end for attachment to an elongate member toward the distal end;

an intermediate portion including a first bend away from the longitudinal axis and a second bend back toward the distal end; and

a distal portion extending between the intermediate portion and the distal end, the distal portion comprising:

a distal bend including a first segment and a second segment extending away from opposite sides thereof,

the first segment of the distal portion extending from the second bend to the distal bend, and

the second segment of the distal portion extending from the distal bend toward but terminating before the second bend, wherein the second segment includes a terminal end disposed between the distal end and the second bend,

wherein the intermediate portions of the plurality of wires form spokes extending radially away from the longitudinal axis away from one another,

wherein the distal bends of the plurality of wires define the distal end of the expandable member,

wherein the first and second segments extending away from the distal bends are intertwined for a longitudinal distance from the distal bend towards the proximal end.

2 . The expandable member of claim 1 , wherein the spokes are perpendicular to the longitudinal axis.

3 . The expandable member of claim 1 , wherein the distal portion comprises a first portion having a braid property and a second portion having a second braid property different than the first braid property.

4 . The expandable member of claim 3 , wherein the first braid property comprises braid angle and the second braid property comprises braid angle, and wherein the second braid angle is greater than the first braid angle.

5 . The expandable member of claim 1 , wherein the distal portion has a consistent braid angle.

6 . A catheter system comprising:

a distal member configured to be inserted into vasculature of a subject, the distal member comprising:

the expandable member of claim 1 ; and

a plurality of electrode assemblies.

7 . The catheter system of claim 6 , wherein the plurality of wires extend to a proximal hub system.

8 . The catheter system of claim 7 , wherein the proximal hub system comprises:

an outer band;

an inner band radially inward of the outer band; and

an adapter including a first longitudinal segment radially inward of the outer band and a second longitudinal segment radially inward of the inner band, the proximal portions of the wires radially inward of the inner band.

9 . The catheter system of claim 8 , further comprising:

an outer sheath; and

an inner member radially inward of the outer sheath, the proximal hub system coupled to the inner member.

10 . The catheter system of claim 9 , wherein the outer sheath is configured to maintain the expandable member in the compressed state.

11 . The catheter system of claim 10 , wherein the expandable member is configured to expand from the compressed state towards the expanded state upon relative longitudinal movement of the outer sheath proximally to the inner member and wherein the expandable member is configured to compress towards the compressed state upon relative longitudinal movement of the outer sheath distally to the inner member.

12 . The catheter system of claim 9 , wherein the inner member comprises:

an elongate tube comprising a sidewall around a lumen;

a first radiopaque marker;

a second radiopaque marker distal to the first radiopaque marker;

a first port through the sidewall, the first port proximate to the first radiopaque marker; and

a second port through the sidewall, the second port distal to the first port, the second port proximate to the second radiopaque marker, the second port circumferentially spaced from the first port,

the catheter system comprising:

a first pressure sensor in fluid communication with the first port; and a second pressure sensor in fluid communication with the second port.

13 . The catheter system of claim 7 , wherein the proximal hub system comprises:

a metal outer band;

a polymer adapter inward of the metal outer band and comprising:

a distal segment comprising a plurality of radial protrusions, a channel between pairs of radial protrusions of the plurality of radial protrusions configured to accept one wire of the plurality of wires; and

a proximal segment proximal to the distal segment of the polymer adapter, the proximal segment of the polymer adapter free of radial protrusions;

a central lumen extending through the distal segment of the polymer adapter and the proximal segment of the polymer adapter; and

a metal inner band around the proximal segment of the polymer adapter and inside the metal outer band, an arcuate space between the metal inner band and the proximal segment of the polymer adapter configured to accept the plurality of wires, at least one of the metal inner band or the metal outer band being radiopaque.

14 . The catheter system of claim 6 , wherein each of the plurality of electrode assemblies comprises:

a first insulating layer;

a second insulating layer;

a plurality of electrodes between the first insulating layer and the second insulating layer; and

a plurality of conductors between the first insulating layer and the plurality of electrodes, each of the plurality of conductors electrically connected to one of the plurality of electrodes.

15 . The catheter system of claim 14 , wherein at least one of the plurality of electrodes is recessed in the second insulating layer, wherein at least one of the plurality of electrodes is flat, and wherein at least one electrode of the plurality of electrodes comprises a distal tab coupled to a conductor of the plurality of conductors on a side opposite an active surface of the electrode.

16 . The catheter system of claim 14 , wherein at least one of the plurality of electrodes comprises an obround shape comprising:

a first semicircular portion;

a second semicircular portion; and

a rectangular portion longitudinally between the first semicircular portion and the second semicircular portion.

17 . The catheter system of claim 16 , wherein a ratio of a length of the rectangular portion to a diameter of the first and second semicircular portions is between 1:3 and 3:1.

18 . The catheter system of claim 6 , wherein each of the plurality of electrode assemblies comprises:

a first insulating layer comprising a tube having an open proximal end and an open distal end;

a second insulating layer coupled to the first insulating layer, the first insulating layer and the second insulating layer forming a channel in fluid communication with the tube, the channel having a closed proximal end and a closed distal end;

a plurality of electrodes between the first insulating layer and the second insulating layer, each electrode of the plurality of electrodes having an obround shape and comprising a proximal tab and a distal tab; and

a plurality of conductors in the channel, each conductor of the plurality of conductors electrically connected to an inner side of the distal tab of one electrode of the plurality of electrodes.

Assignments (3)

Continuity (7)

References Cited (400)