Abstract: An expandable introducer includes a hub and a tubular sheath (121) coupled thereto. The tubular sheath (121) defines a central lumen (103). A circumference of the tubular sheath includes a full thickness region (162) having a first wall thickness (T2) and a reduced thickness region (161) having a second wall thickness (T1) smaller than the first wall thickness (T2). The reduced thickness region (162) is configured to be folded such that the tubular sheath includes an unexpanded, folded state and is configured to expand to an expanded, unfolded state in response to a device passing though the central lumen (103). A first outer diameter of the tubular sheath in the unexpanded, folded state is smaller than a second outer diameter of the tubular sheath in the expanded, unfolded state.

Abstract: An expandable introducer device includes an introducer hub and an introducer sheath coupled to the hub and extending distally therefrom. The introducer sheath includes a mesh tube, a liner disposed within the mesh tube, and an axial strip disposed between the mesh tube and the liner. The introducer sheath is radially-expandable from a first diameter to a second diameter larger than the first diameter in response to a device being advanced through the introducer sheath.

Abstract: A transcatheter heart valve delivery assembly includes a first shaft portion including a first wall surrounding a first chamber. A second shaft portion is attached to a distal end of the first shaft portion and includes a second wall surrounding a second chamber. A funnel portion is attached to a distal end of the second shaft portion and includes a funnel wall surrounding a funnel chamber. The funnel portion moves between a radially-compressed position, in which the funnel chamber includes a first diameter that is less than or equal to a diameter of the second chamber, and a radially-expanded position, in which the funnel chamber includes a second diameter that is greater than the first diameter. The funnel portion is biased into the radially-compressed position. Methods of recapturing a heart valve prosthesis are provided.

Abstract: A system includes an inflow loading assembly configured to compress an inflow portion of the implantable medical device as the implantable medical device is advanced through the inflow loading assembly. The system also includes an outflow loading assembly removably coupled to the inflow loading assembly. The outflow loading assembly is configured to partially compress an outflow portion of the implantable medical device during coupling to the inflow loading assembly. The inflow loading assembly includes one or more biasing features that are configured to asymmetrically compress the inflow portion of the implantable medical device.

Abstract: An expandable introducer includes a hub having a distal end and a proximal end, and a sheath coupled to the hub and extending distally therefrom, the sheath defining a central lumen. The sheath is configured to radially expand from a radially unexpanded, folded state having a first diameter and to a radially expanded, unfolded state having a second diameter larger than the first diameter in response to a device passing through the central lumen. A wall of the sheath includes a thick wall region having a first wall thickness and a thin wall region having a second wall thickness smaller than the first wall thickness, wherein the thick wall region includes a coil embedded within the wall of the sheath.

Abstract: An advancer includes an advancer hub and an advancer shaft extending distally from the advancer hub. The advancer shaft includes a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The advancer shaft is configured to be disposed around an outer shaft of a delivery catheter, and includes a split line configured to enable splitting the shaft to enable removal of the shaft from the outer shaft. The advancer hub configured to be mounted on the outer shaft of the delivery catheter, and includes a parting line to enable splitting of the advancer hub.

Abstract: A method include of delivering a heart valve prosthesis includes loading the heart valve prosthesis in a crimped configuration within a dilator shaft, tracking the dilator shaft within a vasculature of a patient to a desired site with the heart valve prosthesis loaded therewithin, advancing a delivery device through the dilator shaft to the distal end of the dilator shaft, advancing the delivery device through the heart valve prosthesis to load the heart valve prosthesis onto the delivery device, advancing the delivery device with the heart valve prosthesis mounted thereon past the distal end of the dilator shaft to a treatment site within the vasculature of the patient, and deploying the heart valve prosthesis from the delivery device at the treatment site.

Abstract: Balloon catheters for delivery of prosthetic hear valves is provided. The balloon catheters are configured to deploy a prosthetic heart valve through inflation. The balloon catheters are further configured with one or more retention bumpers to reduce or prevent migration of the prosthetic heart valve during delivery. Balloon catheters described herein are configured with substantially incompressible retention bumpers that promote longitudinal inflation fluid flow.

Abstract: An elastic percutaneous elastic introducer sheath is disclosed which can locally expand and reduce to accommodate a transcatheter medical device. The elastic introducer sheath includes a non-circumferentially continuous elastic frame, a liner, and a jacket.

Abstract: Aspects of the present disclosure provide a delivery device including a tubular outer jacket having a distal end and a tyne assembly including a shaft supporting at least one tyne. In some aspects, an inner jacket is positioned within the outer jacket, wherein the tyne assembly is positioned between the outer jacket and the inner jacket. The delivery device has a delivery configuration in which the tynes are maintained within the outer jacket and a deployed configuration in which the tynes extend from a distal end of the tubular outer jacket. Aspects of the disclosure also provide methods of conducting a percutaneous coronary intervention including utilizing one or more tyne assemblies to engage the tynes of each tyne assembly with the frame to maintain the position of the delivery device.

Abstract: Balloon catheters for delivery of prosthetic hear valves is provided. The balloon catheters are configured to deploy a prosthetic heart valve through inflation. The balloon catheters are further configured with one or more retention bumpers to reduce or prevent migration of the prosthetic heart valve during delivery. Balloon catheters described herein are configured with substantially incompressible retention bumpers that promote longitudinal inflation fluid flow.

Abstract: A system includes an inflow loading assembly configured to compress an inflow portion of the implantable medical device as the implantable medical device is advanced through the inflow loading assembly. The system also includes an outflow loading assembly removably coupled to the inflow loading assembly. The outflow loading assembly is configured to partially compress an outflow portion of the implantable medical device during coupling to the inflow loading assembly. The inflow loading assembly includes one or more biasing features that are configured to asymmetrically compress the inflow portion of the implantable medical device.

Abstract: Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

Abstract: Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

Abstract: An elastic percutaneous elastic introducer sheath is disclosed which can locally expand and reduce to accommodate a transcatheter medical device. The elastic introducer sheath includes a non-circumferentially continuous elastic frame, a liner, and a jacket.

Abstract: An elastic percutaneous elastic introducer sheath is disclosed which can locally expand and reduce to accommodate a transcatheter medical device. The elastic introducer sheath includes a non-circumferentially continuous elastic frame, a liner, and a jacket.

Abstract: Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

Abstract: The present disclosure is directed to a metal-containing apparatus including a substrate member constructed of a metal that is highly resistant to pitting corrosion and wear in aggressive media. An exemplary metal-containing apparatus is a plate heat exchanger. The metal includes an oxidation layer on the surface thereof and a thin metal oxide nanoporous film on top of the oxidation layer. The nanoporous film is highly compliant and is comprised of oxygen and aluminum, titanium, silicon, zirconium and combinations thereof.

Abstract: The present disclosure is directed to a metal-containing apparatus including a substrate member constructed of a metal that is highly resistant to pitting corrosion and wear in aggressive media. An exemplary metal-containing apparatus is a plate heat exchanger. The metal includes an oxidation layer on the surface thereof and a thin metal oxide nanoporous film on top of the oxidation layer. The nanoporous film is highly compliant and is comprised of oxygen and aluminum, titanium, silicon, zirconium and combinations thereof.

Abstract: The present disclosure is directed to a metal-containing apparatus including a substrate member constructed of a metal that is highly resistant to pitting corrosion and wear in aggressive media. An exemplary metal-containing apparatus is a plate heat exchanger. The metal includes an oxidation layer on the surface thereof and a thin metal oxide nanoporous film on top of the oxidation layer. The nanoporous film is highly compliant and is comprised of oxygen and aluminum, titanium, silicon, zirconium and combinations thereof.