Abstract: A prosthetic heart valve includes an annular frame that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The frame has a plurality of circumferentially extending rows of angled struts, each row of angled struts comprising angled struts arranged in a zig-zag pattern. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame. The sealing member has an undulating outflow edge portion forming a plurality of triangular projections that are connected to and shaped to correspond to the zig-zag pattern of one of the rows of angled struts. The outer sealing member is sized to fit snugly against the outer surface of the frame when the frame is in the expanded configuration.

Abstract: Pinch devices and access systems that can be used to secure a prosthetic heart valve to a heart valve annulus and to treat valvular insufficiency. A pinch device can be a separate expandable element from the prosthetic heart valve that is first advanced to the annulus and deployed, after which an expandable prosthetic heart valve can be advanced to within the annulus and deployed. The two elements can clamp/pinch the heart valve leaflets to hold the prosthetic heart valve in place. The pinch device can have a flexible, expandable annular frame. A combined delivery system can deliver the pinch device and prosthetic heart valve with just a single access point and aid more accurate coaxial deployment. The pinch device can be mounted near distal end of an access sheath, and a catheter for delivering the prosthetic heart valve can be passed through a lumen of the same access sheath.

Abstract: Expandable docking stations for docking an expandable valve can include a valve seat, one or in ore sealing portions, and one or more retaining portions. A system for deploying an expandable docking station can include a catheter having a sleeve for retaining the docking station.

Abstract: A prosthetic heart valve includes an annular frame that has an inflow end and an outflow end and is radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame and adapted to seal against surrounding tissue when the prosthetic heart valve is implanted within a native heart valve annulus of a patient. The sealing member can include a mesh layer and pile layer comprising a plurality of pile yarns extending outwardly from the mesh layer.

Abstract: Pinch devices and access systems that can be used to secure a prosthetic heart valve to a heart valve annulus and to treat valvular insufficiency. A pinch device can be a separate expandable element from the prosthetic heart valve that is first advanced to the annulus and deployed, after which an expandable prosthetic heart valve can be advanced to within the annulus and deployed. The two elements can clamp/pinch the heart valve leaflets to hold the prosthetic heart valve in place. The pinch device can have a flexible, expandable annular frame. A combined delivery system can deliver the pinch device and prosthetic heart valve with just a single access point and aid more accurate coaxial deployment. The pinch device can be mounted near distal end of an access sheath, and a catheter for delivering the prosthetic heart valve can be passed through a lumen of the same access sheath.

Abstract: An expandable docking station frame includes a waist portion, a sealing portion connected to the waist portion, and a retaining portion connected to the sealing portion. The sealing portion is expandable radially outward of the waist portion to provide a seal against a first location of an inner surface of a circulatory system at a deployed position over a range of sizes of expansion. The retaining portion is expandable radially outward to engage a second location of the inner surface of the circulatory system at the deployed position, to retain the docking station at the deployed position in the circulatory system. When the expandable docking station frame is in an expanded and unconstrained state, the sealing portion and the retaining portion are joined by a concave profile portion radially inward of each of a first outermost diameter of the sealing portion and a second outermost diameter of the retaining portion.

Abstract: In a method of installing an expandable stent in a right ventricular outflow tract, a frame of the expandable stent is positioned at a deployed position in the right ventricular outflow tract, the frame including a waist portion, and first and second opposed sealing portions extending from the waist portion. The frame is expanded such that the waist portion expands to a first diameter, the first sealing portion expands to a second diameter larger than the first diameter and into contact with a first portion of an inner surface of the right ventricular outflow tract, and the second sealing portion expands to a third diameter larger than the first diameter and into contact with a second portion of the inner surface of the right ventricular outflow tract, wherein the waist portion is spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a waist portion that expands to a deployed size having a first diameter, first and second sealing portions extending in opposite directions from the waist portion and expanding radially outward of the waist portion. The first and second sealing portions are sized to seal against first and second portions of the inner surface of the right ventricular outflow tract at the deployed position over a range of sizes of expansion larger than the first diameter. A band is secured to the waist portion of the frame, restricting expansion of the waist portion substantially beyond the first diameter, such that the waist portion is configured to be spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

Abstract: Expandable sheaths and introducers are disclosed herein. In some examples, the expandable introducer includes an elongated body member, an inflatable balloon disposed between a proximal and distal end of the elongated body member, and an inflation lumen in fluid communication with the inflatable balloon. A portion of the balloon is sized and configured to pass through a distal opening of an expandable introducer sheath when in the deflated condition, and to dilate the distal end of the introducer sheath as the balloon expands from the deflated configuration to the inflated configuration. Methods of making and using the devices disclosed herein are also disclosed.

Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a plurality of struts that define a repeating pattern of cells. The repeating pattern of cells comprises a column of exactly three generally diamond shaped cells positioned in end-to-end alignment, and a column of exactly two generally diamond shaped cells positioned in end-to-end alignment. The frame has a substantially hourglass shape with a narrow portion in between a proximal end portion and a distal end portion, wherein the proximal end portion and the distal end portion are configured to expand radially outward to contact a right ventricular outflow tract.

Abstract: A prosthetic heart valve includes an annular frame that has an inflow end and an outflow end and is radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame and adapted to seal against surrounding tissue when the prosthetic heart valve is implanted within a native heart valve annulus of a patient. The sealing member can include a mesh layer and pile layer comprising a plurality of pile yarns extending outwardly from the mesh layer.

Abstract: Pinch devices and access systems that can be used to secure a prosthetic heart valve to a heart valve annulus and to treat valvular insufficiency. A pinch device can be a separate expandable element from the prosthetic heart valve that is first advanced to the annulus and deployed, after which an expandable prosthetic heart valve can be advanced to within the annulus and deployed. The two elements can clamp/pinch the heart valve leaflets to hold the prosthetic heart valve in place. The pinch device can have a flexible, expandable annular frame. A combined delivery system can deliver the pinch device and prosthetic heart valve with just a single access point and aid more accurate coaxial deployment. The pinch device can be mounted near distal end of an access sheath, and a catheter for delivering the prosthetic heart valve can be passed through a lumen of the same access sheath.

Abstract: In a method of installing an expandable stent in a right ventricular outflow tract, a frame of the expandable stent is positioned at a deployed position in the right ventricular outflow tract, the frame including a waist portion, and first and second opposed sealing portions extending from the waist portion. The frame is expanded such that the waist portion expands to a first diameter, the first sealing portion expands to a second diameter larger than the first diameter and into contact with a first portion of an inner surface of the right ventricular outflow tract, and the second sealing portion expands to a third diameter larger than the first diameter and into contact with a second portion of the inner surface of the right ventricular outflow tract, wherein the waist portion is spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a waist portion that expands to a deployed size having a first diameter, first and second sealing portions extending in opposite directions from the waist portion and expanding radially outward of the waist portion. The first and second sealing portions are sized to seal against first and second portions of the inner surface of the right ventricular outflow tract at the deployed position over a range of sizes of expansion larger than the first diameter. A band is secured to the waist portion of the frame, restricting expansion of the waist portion substantially beyond the first diameter, such that the waist portion is configured to be spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a plurality of struts that define a repeating pattern of cells. The repeating pattern of cells comprises a column of exactly three generally diamond shaped cells positioned in end-to-end alignment, and a column of exactly two generally diamond shaped cells positioned in end-to-end alignment. The frame has a substantially hourglass shape with a narrow portion in between a proximal end portion and a distal end portion, wherein the proximal end portion and the distal end portion are configured to expand radially outward to contact a right ventricular outflow tract.

Abstract: An expandable docking station frame includes a waist portion, a sealing portion connected to the waist portion, and a retaining portion connected to the sealing portion. The sealing portion is expandable radially outward of the waist portion to provide a seal against a first location of an inner surface of a circulatory system at a deployed position over a range of sizes of expansion. The retaining portion is expandable radially outward to engage a second location of the inner surface of the circulatory system at the deployed position, to retain the docking station at the deployed position in the circulatory system. When the expandable docking station frame is in an expanded and unconstrained state, the sealing portion and the retaining portion are joined by a concave profile portion radially inward of each of a first outermost diameter of the sealing portion and a second outermost diameter of the retaining portion.

Abstract: Pinch devices and access systems that can be used to secure a prosthetic heart valve to a heart valve annulus and to treat valvular insufficiency. A pinch device can be a separate expandable element from the prosthetic heart valve that is first advanced to the annulus and deployed, after which an expandable prosthetic heart valve can be advanced to within the annulus and deployed. The two elements can clamp/pinch the heart valve leaflets to hold the prosthetic heart valve in place. The pinch device can have a flexible, expandable annular frame. A combined delivery system can deliver the pinch device and prosthetic heart valve with just a single access point and aid more accurate coaxial deployment. The pinch device can be mounted near distal end of an access sheath, and a catheter for delivering the prosthetic heart valve can be passed through a lumen of the same access sheath.

Abstract: The present application discloses novel systems for conducting the filtration of blood using manifolds. The manifolds integrate various sensors and have fluid pathways formed therein to direct fluids from various sources through the requisite blood filtration or ultrafiltration system steps.

Abstract: A prosthetic heart valve includes an annular frame that has an inflow end and an outflow end and is radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame and adapted to seal against surrounding tissue when the prosthetic heart valve is implanted within a native heart valve annulus of a patient. The sealing member can include a mesh layer and pile layer comprising a plurality of pile yarns extending outwardly from the mesh layer.

Abstract: Expandable docking stations for docking an expandable valve can include a valve seat, one or more sealing portions, and/or one or more retaining portions. The valve seat can be unexpandable or substantially unexpandable beyond a deployed size. The one or more sealing portions can be connected to the valve seat and extend radially outward of the valve seat. The one or more sealing portions can be constructed to expand outward of the valve seat and provide a seal over a range of sizes. The one or more retaining portions can be connected to the one or more sealing portions. The one or more retaining portions are configured to retain the docking station at a deployed position.