St. Jude Medical, Cardiology Division, Inc.

Kristen T Morin

Kristopher Henry Vietmeier

Keith T High

Gary Erzberger

Jay Reimer

Trevor Springer

Peter Nicholas Braido

Tracee E Eidenschink

Thomas M Benson

Brett Allen Hillukka

Saravana B Kumar

Andrea N Para

Sounthara Khouengboua

Yousef F Alkhatib

Michael Shane Morrissey

Daniel J Klima

Gaurav Satam

Bruce Moseman

Andrey Samaray

Caytlin Gale

Jaron J Olsoe

Ian Wright

Kenneth L Kelly

Hannah Mitchell

Julia K Roe

Gregory Gabay

Trevor J Springer

Gaurav C Satam

Bruce A Moseman

A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A second cuff having a distal edge facing the outflow end of the stent is disposed about the stent radially outward of the first cuff and the stent. The stent may include a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end adapted to extend radially outward of the corresponding cell. The distal edge of the second cuff may be coupled to the fingers at spaced locations around the circumference of the stent to position the distal edge radially outward from the corresponding cells at the spaced locations. Various stent struts may be tapered to reduce the stent circumference in the collapsed condition, and to improve the fatigue resistance and/or bendability of the stent.

Prosthetic heart valve with paravalvular leak mitigation features

A prosthetic heart valve may include an expandable stent, a cuff attached to an annulus section of the stent, and a plurality of leaflets disposed within an interior region of the stent and attached to at least one of the cuff or the stent. The stent may have a plurality of cells connected to one another in a plurality of annular rows around the stent. The leaflets together may have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. Each leaflet may include a primary leaflet material, as well as features that reinforce specific regions of the leaflet.

Collapsible leaflets for prosthetic heart valves

Described herein is a medical device for treating a target site, the medical device including, a proximal end including a disc and a distal end including a lobe. The disc and the lobe are connected by a connecting member. The lobe includes a proximal portion defining a proximal surface of the lobe, a distal portion defining a distal surface of the lobe, and a middle portion connecting and extending between the proximal portion and the distal portion. A first transition between the proximal portion and the middle portion is curved, and a second transition between the middle portion and the distal portion is curved. The medical device also includes a plurality of stabilizing wires coupled to the lobe at a radially outer surface of the middle portion, each stabilizing wire including a hook portion extending radially outward from the at least one lobe.

Devices and methods for occlusion of vascular system abnormalities

A delivery device is configured for aligning and stabilizing a prosthetic heart valve for deployment in a native heart valve annulus. The device includes a catheter assembly having an inner shaft around which a valve compartment is defined, an outer shaft assembled over the inner shaft and adapted to slide relative to the inner shaft, a distal sheath connected to a distal end of the outer shaft and slidable therewith, an outer tube assembled over the outer shaft, and an alignment and stabilization device having a collapsed condition and an expanded condition. The outer tube is adapted to slide relative to the outer shaft to selectively cover and uncover the alignment and stabilization device.

Multi-step deployment to improve TAVR implant stability

A prosthetic heart valve includes a support structure and a valve assembly disposed within the support structure, the valve assembly including a plurality of leaflets. Each leaflet is formed from a predetermined leaflet material. Some leaflet materials include a metal body with a plurality of openings. The metal body may be coated with a polymer. Other leaflet materials include natural mammalian tissue subjected to a plastination preservation process.

Prosthetic leaflets for valve replacement

A prosthetic heart valve includes a support structure and a valve assembly disposed within the support structure, the valve assembly including a plurality of leaflets. Each leaflet includes a sewing edge and a free edge. The leaflet is formed from a sheet of leaflet material which is processed so that the resulting leaflet has a non-uniform thickness. Various methods may be used to form the leaflet with a non-uniform thickness.

Leaflet thickness via stretching techniques for improved valve durability

A prosthetic heart valve for replacing a native valve includes a stent having a plurality of struts, an inflow end, an outflow end, a collapsed condition and an expanded condition. A valve assembly is disposed within the stent. A first cuff is annularly disposed adjacent the stent, and a second cuff is annularly disposed about the stent radially outward of the first cuff and radially outward of the stent. The second cuff is at least partly radiopaque and may assist in determining the relative position between the second cuff and a patient's anatomy using fluoroscopy during an implantation procedure.

Radiopaque outer cuff for transcatheter valve

Described herein is a medical device for treating a target site. The medical device includes a proximal end including a disc and a distal end including a lobe. The disc and lobe are connected by a connecting member. The disc includes a proximal surface, a distal surface, and a central surface extending between and connecting the proximal surface and distal surface, wherein the central surface separates the proximal surface from the distal surface by a predetermined depth distance.

Devices and methods for the treatment of vascular abnormalities

A prosthetic heart valve may include an expandable stent having a plurality of struts forming cells connected to one another in a plurality of annular rows around the stent, a cuff attached to an annulus section of the stent by cuff sutures that have a plurality of stitches extending through material of the cuff and looping around the struts, and a plurality of leaflets each having a belly attached to the cuff within an interior region of the stent. The leaflets may together have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. The belly of each leaflet may be attached to the cuff by leaflet sutures extending in a path that crosses some of the struts in overlap zones. Those struts may be devoid of the stitches within the overlap zones.

Leaflet/cuff attachment compliance for improved durability

A loading assembly for crimping and loading a prosthetic heart valve into a delivery device includes a loading base, a base funnel, and a compression member. The loading base has a support and a body extending from the support with a recess defined within the body. The recess is configured to receive a substantial portion of the annulus section of the heart valve in an at least partially collapsed condition. The base funnel is configured to be coupled to the loading base and to at least partially collapse the annulus section of the heart valve as it is inserted into the recess in the loading base. The compression member is configured to be coupled to the loading base with the heart valve inserted in the recess for further collapsing the heart valve and loading it into the delivery device.

Folding patterns and loading funnel for improved transcatheter valve loading forces

A prosthetic heart valve may include a collapsible and expandable stent, a cuff attached to an annulus section of the stent, and a plurality of leaflets attached to at least one of the cuff or the stent within an interior region of the stent. The stent may have a plurality of cells connected to one another in a plurality of annular rows around the stent. The leaflets together may have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. Each leaflet may include a flat mesh of braided wire material having a plurality of pores extending therethrough. The leaflets may be devoid of biological material at a time of implantation.

A medical device including stabilizing wires that are selectively movable from a first and second position and a delivery system including the same are described herein. The medical device includes a device body and the stabilizing wires coupled thereto. Each stabilizing wire has a proximal and distal end. In the first position, at least a portion of the distal end extends radially outwardly from the device body, and in the second position, the distal end is retracted within the device body. Each stabilizing wire includes a linear portion at the proximal end, a hook portion at the distal end, and a ramp segment extending between the linear portion and the hook portion, including a ramp incline portion that extends at a first angle from the linear portion to a ramp apex, and a ramp decline portion that extends at a second angle from the hook portion to the ramp apex.

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Saint Paul, MN, United States of America

Kristen T Morin