St. Jude Medical, Cardiology Division, Inc.

Abbott Laboratories Corporation

Keith T High

Kristen T Morin

Jay Reimer

Kristopher Henry Vietmeier

Tracee E Eidenschink

Yousef F Alkhatib

Richard C Kaleta

Ian Wright

Paul Edward Ashworth

Ryan Finn

Richard Kaleta

Paul E Ashworth

At least a portion of fabrics for use in medical devices is formed from polymeric materials. The fabrics may be uncoated, partially coated or fully coated with one or more layers of a polymer. The fabrics may be used for the leaflets and/or cuffs of prosthetic heart valves and as a component of other medical devices.

Fabric material for medical devices

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

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 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 prosthetic heart valve includes a collapsible and expandable stent with a valve assembly disposed therein. A first cuff is positioned on the lumenal or ablumenal surface of the stent. A second cuff is positioned radially outward of the stent and the first cuff. The second cuff may include apertures that allow blood to pass through the second cuff into the spaces between the first and second cuffs. The second cuff may include a proximal edge with a plurality of notches that may be closed to create puckered areas in the second cuff to facilitate the movement of blood in the spaces between the first and second cuffs. The stent may include struts adjacent the second cuff that bow radially inwardly to create additional space for blood to flow in the spaces between the first and second cuffs.

Prosthetic heart valve with paravalvular leak mitigation features

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 delivery system has a delivery capsule with a detachable portion including first and second open ends with a tapered wall extending therebetween to compress and guide a collapsible heart valve into the delivery capsule. The detachable portion may be detached from the delivery capsule after loading the collapsible heart valve to leave a smooth distal surface on the delivery capsule. Detachment of the detachable portion may occur by breaking or removing a frangible member interposed between the detachable portion and the delivery capsule.

Delivery system and method for loading a self-expanding collapsible heart valve

An assembly for loading a self-expanding prosthetic heart valve into a delivery device includes a support member including a body and a backing plate. The body has a longitudinal axis, a base end, a second end, and a recess extending along the longitudinal axis from the second end toward the base end. The recess has a bottom member defining a seating surface adapted to support the prosthetic heart valve. The backing plate is fixed to the body so as to define a void space between the backing plate and the body. The backing plate includes an inlet port and the recess includes a plurality of outlet ports. The inlet and outlet ports are in fluid communication with the void space. When the heart valve is received on the seating surface, each outlet port is rotationally aligned with a corresponding pocket formed between first and second cuffs of the heart valve.

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White Bear Lake, MN, United States of America

Keith T High