St. Jude Medical, Inc.

St. Jude Medical, Cardiology Division, Inc.

Abbott Laboratories Corporation

Paul Edward Ashworth

Peter Nicholas Braido

Julia Ann Schraut

Neelakantan Saikrishnan

Jay Reimer

Chad Qingshen Cai

Bob Allan

Lise LaChance

Mina Safwat Fahim

Loell Boyce Moon

Steven D Kruse

Chad Joshua Green

Steven Frederick Anderl

Jason White

Morgan Low

Yousef F Alkhatib

Aaron J Chalekian

Brandon Moore

Catherine A Pipenhagen

Matthew Frank Ogle

Daniel J Klima

Keith T High

Julia Ann Neuman

David Panus

Steve D Kruse

Katherine A Ahmann

Richard Kaleta

Sheila Jeanne Kelly

Ryan Finn

Andrea L Johnson

Daniel Paul McTavish

Scott R Lien

Julia A Neuman

David A Panus

Julia A Neumann

Jason A White

Lise Lachance

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, comprising (a) a stent body including a generally tubular annulus region having a tubular wall and a proximal-to-distal axis, the stent body having a radially expanded condition when the stent body is implanted, (b) one or more prosthetic valve elements mounted to the stent body and operative to allow blood flow in a distal direction through the annulus region but to substantially block blood flow in a proximal direction through the annulus region, (c) a cuff coupled to the stent body, and (d) a water-absorbing polymer coupled to the cuff.

Collapsible and re-expandable prosthetic heart valve cuff designs and complementary technological applications

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 prosthetic heart valve includes (a) a stent body including a generally tubular annulus region having a tubular wall and a proximal-to-distal axis, the stent body having a radially expanded condition when the stent body is implanted, (b one or more prosthetic valve elements mounted to the stent body and operative to allow blood flow in a distal direction through the annulus region but to substantially block blood flow in a proximal direction through the annulus region, (c) a cuff coupled to the stent body, and (d) one or more biasing elements connected to the stent body and to the cuff, the biasing elements being adapted to bias at least a portion of the cuff outwardly with respect to the stent body.

A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

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

A surgical heart valve includes a non-collapsible frame having features that enable the frame to expand from an initial condition having a first diameter to an expanded condition having a second diameter larger than the first diameter after the valve has been implanted within a patient. The frame may include members that prevent the unintended expansion of the frame, such as during implantation, and members that prevent the over-expansion of the frame. The surgical heart valve further includes a valve assembly connected to the frame and including a plurality of leaflets.

Methods for surgical valve expansion

Methods of preparing a solid reference material so as to elicit a positive control response when tested for in-vitro complement activation include providing biological tissue; treating the tissue with an aqueous cellulose solution for a time sufficient to allow fluid in the tissue to be replaced by the aqueous cellulose solution; drying the cellulose-treated tissue by a vacuum-drying process or a lyophilization process to form dried tissue; and storing the dried tissue in a dry, ambient environment. The tissue prepared by these methods and its use in an in-vitro complement assay and diagnostic kit are also described.

Dried cellulose-treated tissue for in-vitro complement activation assays and diagnostic kits

Methods of preparing calcification-resistant bioprosthetic tissue include providing fresh biological tissue, cross-linking the tissue, treating the cross-linked tissue with an alcohol for a time sufficient to allow the alcohol to be diffused into the tissue, and treating the alcohol-treated fixed tissue with a polyol for a time sufficient to allow fluid in the tissue to be replaced by the polyol. The methods may include sterilizing the cross-linked tissue in a solution including propylene oxide or peracetic acid either before or after the alcohol treatment step; or drying the alcohol/polyol-treated, cross-linked tissue, sterilizing the dried tissue by exposure to ethylene oxide or peracetic acid, and storing the sterilized tissue in a dry, ambient environment. The treated tissue may be a tissue component for a bioprosthetic valve, a valve assembly for a bioprosthetic valve or a fully assembled bioprosthetic valve incorporating the tissue.

Method of preparing calcification-resistant bioprosthetic tissue

Prosthetic heart devices may be implanted into the heart with a sensor coupled to the device, the sensor being configured to measure physiological data, such as blood pressure, in the heart. Devices that may employ such sensors include prosthetic heart valves and occlusion devices, although sensor systems may be deployed in the heart separate from other implantable devices. The sensors may include a body with different configurations for attaching to the implantable device, such as apertures for sutures or fingers for connecting to structures of the implantable device. The sensors may provide data that allow a determination of aortic regurgitation or other information indicative of function of the implantable device and patient health during and after implantation of the device.

Sensors for prosthetic heart devices

A prosthetic device for implanting in a patient's heart includes (i) a therapeutic device capable of restoring function to a native heart valve; and (ii) at least one sensor including a body, an inductor coil disposed within the body, and a capacitor in communication with the inductor coil, the at least one sensor being coupled to the therapeutic device, and being configured to monitor proper function of the therapeutic device within the patient's heart.

Prosthetic heart devices having diagnostic capabilities

A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Prosthetic heart valve including stent structure and tissue leaflets, and related methods

Growing community of inventors

Wyoming, MN, United States of America

Paul Edward Ashworth