St. Jude Medical, Cardiology Division, Inc.

Abbott Laboratories Corporation

Jay Reimer

Kristopher Henry Vietmeier

Keith T High

Paul Edward Ashworth

Kristen T Morin

Yousef F Alkhatib

Brandon Moore

Tracee E Eidenschink

Chad Joshua Green

Ryan Finn

Daniel J Klima

Katherine A Ahmann

Peter J Ness

Richard Kaleta

Neelakantan Saikrishnan

Michael Shane Morrissey

David Panus

Jeffrey Paul LaPlante

Mai Moua

Noy Grimmer

Emily M Hagen

Henrique Oliveira Neder

Henrique Neder

David A Panus

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 includes a support structure and a valve assembly. The valve assembly includes a cuff and a plurality of leaflets, each of the prosthetic leaflets being composed of a synthetic material. The prosthetic leaflets have a closed condition in which the prosthetic leaflets coapt to restrict blood from flowing in a retrograde direction through the support structure and an open condition in which the prosthetic leaflets allow blood to flow in an antegrade direction through the structure. The synthetic material may be heat set to bias the leaflets to the open or closed condition, or to bias one portion of the leaflet to the open condition and another portion of the leaflet to the closed condition.

Heat treating to improve synthetic leaflet motion and coaptation

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 delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft, the compartment being sized to receive the prosthetic heart valve in a collapsed condition. The inner shaft and the distal sheath may be movable relative to one another. The delivery device may also include a tube member and an outer sleeve overlying the tube member. The tube member may be configured to rotate or twist upon axial movement of the outer sleeve with respect to the tube member, the rotation or twisting of the tube member configured to rotate the prosthetic heart valve when the prosthetic heart valve is received within the compartment in the collapsed condition.

Active alignment of commissures in prosthetic heart valve implantation

A prosthetic heart valve includes a non-collapsible annular frame extending in a longitudinal direction between an inflow edge and an outflow edge, and a valve assembly connected to the frame. The frame includes a plurality of annularly spaced commissure posts adjacent the outflow edge, each of the commissure posts including a tip and a post slot spaced apart from the tip. The prosthetic heart valve further includes a radiopaque element including an elongated main body having a first end and a second end. The radiopaque element may extend around the tip and through the post slot of at least one of the commissure posts so that a portion of the main body extends between the slot and the tip. Alternatively or additionally, a radiopaque element may be positioned adjacent a base of the frame.

Prosthetic heart valve with radiopaque elements

A stabilized fabric composed of a mesh or a woven fabric is disclosed as are methods of their manufacture, the manufacture of medical devices made using a stabilized fibers and stabilized medical devices are all disclosed. Fabrics can be stabilized by several techniques including: using mechanical, chemical and/or energetic fasteners at warp and weft intersections in the weave; by using various weaving techniques and fibers. Meshes can be stabilized when properly dimensioned and arranged junctions and struts of the necessary properties are used. All of these stabilized fabrics can be made of synthetic polymer materials such as ultrahigh molecular weight PE or PP and expanded PTFE.

Stabilized fabric material for medical devices

A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft. The compartment may be sized to receive the prosthetic heart valve. The inner shaft and the distal sheath may be movable relative to one another. A spine may extend along the outer shaft, the spine biasing the outer shaft so that the outer shaft tends to bend in a pre-determined direction.

Passive alignment of commissures in prosthetic heart valve implantation

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 may include a stent, a valve assembly disposed within the stent, a flange, and a plurality of anchor arms coupled to the stent. The stent may have collapsed and expanded conditions and inflow and outflow ends. The flange may include a plurality of braided wires and may be coupled to the stent and may be positioned adjacent the inflow end of the stent in the expanded condition of the stent. Each anchor arm may have a first end coupled to the stent adjacent the outflow end of the stent, a second end coupled to the stent adjacent the outflow end of the stent, and center portions extending from the first and second ends toward the inflow end of the stent. The center portions may be joined together to form a tip pointing toward the inflow end of the stent in the expanded condition of the stent.

Prosthetic tricuspid valve replacement design

An apparatus for stabilizing a prosthetic heart valve within an atrioventricular valve includes a collapsible and expandable stent having an inflow end, an outflow end, and struts forming a plurality of cells connected to one another in a plurality of annular rows around the stent. The stent further includes a collapsible and expandable valve assembly secured to the stent. The valve assembly includes a cuff and a plurality of leaflets having an open configuration and a closed configuration. A cord connected to the stent includes an attachment device adapted to couple the stent to heart tissue of a patient. A method of stabilizing a prosthetic heart valve within an atrioventricular valve annulus is also described.

Heart valve with chordal capture elements for stabilization

An apparatus for augmenting the length of native chordae tendineae to restore physiological leaflet coaptation. The apparatus includes a delivery device having a lumen therein which at least partially houses a prosthetic cord. The prosthetic cord has a first end with a first clasp configured to attach to a native chordae tendineae and a second end with a second clasp configured to attach to the native chordae tendineae. The native chordae tendineae is severed between the first clasp and the second clasp, and the length of the prosthetic cord between the first clasp and the second clasp is adjusted until physiological leaflet coaptation is restored.

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Saint Paul, MN, United States of America

Jay Reimer