IP Library Granted Patent US 12678191
Granted Patent B2
US 12678191 · App. 17/507,734 · Granted Jul 14, 2026

Anchor for transcatheter access into the coronary sinus

Inventors: Linda Thai (Mission Viejo, CA); Michael G. Valdez (Riverside, CA); Tarannum Ishaq Gutierrez (Ladera Ranch, CA); Don Huy Tran (Westminster, CA)
Assignee: Edwards Lifesciences Corporation
A61B17/3423A61B17/3468A61B2017/00243A61B2017/00292A61B2017/3425A61B2017/3486A61M25/1002
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Quick Facts
Patent No.
US 12678191
App. No.
17/507,734
Granted
Jul 14, 2026
Kind
B2
Abstract

A delivery sheath can comprise an elongate tubular member and an anchor on a distal portion of the elongate tubular member, the anchor being configured to engage with the coronary sinus ostium, or both the coronary sinus ostium and a portion of the coronary sinus adjacent to the ostium, so as to provide stable transcatheter access into the coronary sinus. The anchor can be configured to permit blood flow through the ostium while in engagement with the ostium.

Claims (37)

1 . A method of accessing a heart location, the method comprising:

providing a steerable sheath comprising an elongate tubular member, a circumferential balloon anchor circumferentially positioned around a distal portion of the elongate tubular member and a plurality of cords circumferentially distributed around the circumferential balloon anchor longitudinally, the plurality of cords being movable relative to the elongate tubular member along a longitudinal axis of the elongate tubular member;

introducing the distal portion of the elongate tubular member through an inferior vena cava or a superior vena cava, and into a right atrium;

inserting a distal end of the elongate tubular member through an ostium of a coronary sinus into the coronary sinus from the right atrium, and positioning the distal end at a target location within the coronary sinus;

inflating the circumferential balloon anchor and moving the plurality of cords proximally relative to the elongate tubular member to tension the plurality of cords to engage an inflated circumferential balloon anchor with the plurality of cords to create corresponding circumferentially distributed longitudinal indentations on the inflated circumferential balloon anchor; and

positioning the inflated circumferential balloon anchor partially in the coronary sinus and engaging a distal portion of the inflated circumferential balloon anchor having a longitudinal taper with the ostium of the coronary sinus while permitting blood flow through the ostium past the inflated circumferential balloon anchor along a path defined at least in part by the circumferentially distributed longitudinal indentations.

2 . The method of claim 1 , wherein respective distal ends of the plurality of cords are coupled to corresponding locations on a distal balloon portion, and wherein moving the plurality of cords longitudinally compresses the inflated circumferential balloon anchor to provide the corresponding circumferentially distributed indentations on the inflated circumferential balloon anchor.

3 . The method of claim 1 , further comprising inserting into an inner lumen of the elongate tubular member a delivery catheter carrying a therapy device, and advancing a distal end of the delivery catheter from the distal end of the elongate tubular member for positioning at the target location.

4 . The method of claim 3 , wherein inserting into the inner lumen of the elongate tubular member a delivery catheter carrying a therapy device comprises inserting a shunt delivery catheter carrying an atrial shunt device.

5 . The method of claim 1 , wherein engaging the distal portion of the inflated circumferential balloon anchor having the longitudinal taper with the ostium comprises engaging a curved convex taper of the distal portion with the ostium.

6 . The method of claim 1 , further comprising longitudinally dividing the circumferential balloon anchor into a plurality of portions equal to a quantity of the plurality of cords, such that the plurality of portions have a uniform size and shape, based on moving the plurality of cords to tension the plurality of cords.

7 . The method of claim 1 , wherein the circumferential balloon anchor has a proximal balloon portion and a distal balloon portion, with each portion having a tapered longitudinal profile including a curved convex taper, from a mid-portion of the circumferential balloon anchor toward a proximal end and a distal end of the circumferential balloon anchor, respectively.

8 . The method of claim 1 , wherein the circumferential balloon anchor has a maximum cross-sectional size at a mid-portion of the circumferential balloon anchor.

9 . A method of accessing a heart location, the method comprising:

providing a steerable sheath comprising an elongate tubular member and an anchor positioned on a distal portion of the elongate tubular member, a plurality of cords circumferentially distributed around the anchor longitudinally to the anchor, the plurality of cords being movable relative to the elongate tubular member along a longitudinal axis of the elongate tubular member;

providing a delivery catheter sized for advancement through an inner lumen of the elongate tubular member, the delivery catheter carrying a shunt;

advancing the distal portion of the elongate tubular member through an inferior vena cava or a superior vena cava, and into a right atrium;

inserting a distal end of the elongate tubular member through an ostium of a coronary sinus into the coronary sinus from the right atrium;

expanding the anchor and moving the plurality of cords proximally relative to the elongate tubular member and the anchor to tension the plurality of cords onto the expanded anchor, engaging the expanded anchor to form corresponding longitudinal indentations on the expanded anchor;

engaging a distal portion of the anchor with the ostium of the coronary sinus, the anchor being formed with the longitudinal indentations for permitting blood flow through the ostium past the anchor;

advancing a distal portion of the delivery catheter out of the distal end of the elongate tubular member to deploy the shunt; and

deploying the shunt through a wall of the coronary sinus to allow blood to pass from a left atrium into the coronary sinus and alleviate elevated left atrial pressure,

wherein engagement of the anchor with the ostium stabilizes the delivery catheter during deployment of the shunt.

10 . The method of claim 9 , further comprising inserting into the inner lumen of the elongate tubular member the delivery catheter carrying the shunt.

11 . The method of claim 9 , wherein expanding the anchor and engaging the distal portion of the anchor with the ostium of the coronary sinus comprises positioning the anchor partially within the coronary sinus and engaging a curved convex taper of the distal portion with the ostium.

12 . A method of accessing a heart location, the method comprising:

providing a steerable sheath comprising an elongate tubular member, an inflatable balloon anchor on a distal portion of the elongate tubular member, a plurality of cords circumferentially distributed around the inflatable balloon anchor longitudinally, the plurality of cords being movable relative to the elongate tubular member along a longitudinal axis of the elongate tubular member, and a distal portion of the inflatable balloon anchor having a longitudinal profile comprising a taper toward a distal end of the inflatable balloon anchor;

inserting a distal end of the elongate tubular member through an ostium of a coronary sinus into the coronary sinus from the right atrium; and

positioning the inflatable balloon partially in the coronary sinus and engaging the distal portion of the inflatable balloon anchor having the taper with the coronary sinus ostium while permitting blood flow through the ostium past the inflatable balloon anchor.

13 . The method of claim 12 , wherein engaging the inflatable balloon anchor with the coronary sinus ostium comprises inflating the inflatable balloon anchor to engage the inflatable balloon anchor with the coronary sinus ostium.

14 . The method of claim 12 , wherein providing the inflatable balloon anchor comprises providing a circumferentially disposed inflatable balloon anchor, the method further comprising compressing the circumferentially disposed inflatable balloon anchor along a longitudinal axis of the elongate tubular member to form a plurality of circumferentially distributed indentations on the inflatable balloon anchor.

15 . The method of claim 14 , wherein compressing the inflatable balloon anchor comprises tensioning the plurality cords to engage the inflatable circumferential balloon anchor in an inflated state.

16 . The method of claim 15 , further comprising moving the plurality of cords proximally relative to the elongate tubular member to tension the plurality of cords to engage the inflated circumferential balloon anchor with the plurality of cords to form the circumferentially distributed longitudinal indentations on the inflatable circumferential balloon anchor, and dividing the inflated circumferential balloon anchor into a quantity of portions equal to a quantity of the longitudinal indentations.

17 . The method of claim 12 , wherein providing the inflatable balloon anchor comprises providing an inflatable balloon anchor comprising a curved convex taper tapering towards a distal end of the inflatable balloon anchor.

18 . The method of claim 17 , wherein providing the inflatable balloon anchor comprises providing an inflatable balloon anchor comprising a curved convex taper tapering towards a proximal end of the inflatable balloon anchor from a mid-portion of the inflatable balloon anchor.

19 . The method of claim 12 , further comprising deploying a shunt through a wall of the coronary sinus, via the elongate tubular member, to allow blood to pass from a left atrium into the coronary sinus and alleviate elevated left atrial pressure.

20 . The method of claim 12 , further comprising providing the inflatable balloon anchor to have a shape and a size to engage with the ostium of the coronary sinus and a portion of the coronary sinus without occluding the ostium of the coronary sinus, thereby permitting blood flow through the ostium of the coronary sinus past the inflatable balloon anchor.