Abstract: A heart valve therapy system including a delivery device and a stented valve. The delivery device includes an outer sheath, an inner shaft, an optional hub assembly, and a plurality of tethers. In a delivery state, a stent frame of the prosthesis is crimped over the inner shaft and maintained in a compressed condition by the outer sheath. The tethers are connected to the stent frame. In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand. Tension in the tethers prevents the stent frame from rapidly expanding and optionally allowing recapture. Upon completion of the stent frame expansion, the tethers are withdrawn.

Abstract: Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. Catheter assemblies according to the present invention can include a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly can include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A safety button can be included on the handle assembly to allow for precise and consistent positioning of the prosthetic valve in the body. A valve retaining mechanism can be included to assist in retaining the prosthetic valve prior to deployment.

Abstract: An arteriovenous shunt assembly including a shunt having a hollow bore between open first and second ends thereof and a valve slidably disposed through the hollow bore. The valve includes means for retaining the valve in a closed position or in any of various selected open positions that provide corresponding different rates of blood flow through the shunt assembly. In some embodiments, the AV shunt assembly is self-expandable from a collapsed tow-profile configuration employed during transluminal delivery. The valve position in the hollow bore may be adjusted in vivo by inflating a catheter balloon in a blood vessel to bear against an end of the valve. Methods for using the shunt assembly are also disclosed.

Abstract: Valve retainers and delivery systems with valve retainers are disclosed. In certain embodiments, a portion of the valve retainer can rotate about a central axis of the delivery system relative to a different portion of the valve retainer. In certain embodiments, a first portion of the valve retainer can include a plurality of first orientation markings. In certain embodiments, a second portion of the valve retainer can include a second orientation marking, which can be aligned with a first orientation marking on the first portion of the valve retainer.

Abstract: Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. Catheter assemblies according to the present invention can include a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly can include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A safety button can be included on the handle assembly to allow for precise and consistent positioning of the prosthetic valve in the body. A valve retaining mechanism can be included to assist in retaining the prosthetic valve prior to deployment.

Abstract: Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

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: A crimping tool includes a housing portion defining a funnel segment and a suture locking mechanism positioned to lock sutures therein. One or more sutures can be coupled with a prosthesis and secured to the suture locking mechanism. The suture locking mechanism can be operated to draw the prosthesis through the funnel segment.

Abstract: A medical device delivery system can include a dilator including a tip having a taper in a distal direction, a coupler, and a flap that radially protrudes from the tip. The flap can be configured to bend against a body lumen to cover at least a portion of the delivery system when the dilator is tracked through the body lumen. A medical device delivery system can include a dilator including a tip having a lumen and a coupler having a lumen. The coupler can be configured to securely connect to the tip such that the lumen of the tip is aligned with the lumen of the coupler to allow a guide wire to pass therethrough. Methods for loading a medical device into a delivery catheter are also disclosed.

Abstract: The delivery systems disclosed herein can create simultaneous movement of an inner and an outer sheath of the delivery system. The delivery systems can generally include a handle assembly and a delivery catheter. In certain embodiments, the inner shaft and the outer sheath can be slidably controlled by a control element in the handle. The handle assembly can include a housing with a thumbwheel acting as the control element. In certain embodiments, movement of the inner shaft and the outer sheath can be caused via a gear-type system. In certain embodiments, the handle assembly can include a rotatable housing. A control element can rotate the housing, which can cause a first boss associated with the outer sheath and a second boss associated with the inner shaft to move in opposite directions.

Abstract: A valve prosthesis and methods for implanting the prosthesis are provided. The prosthesis generally includes a self-expanding frame and two or more engagement arms. A valve prosthesis is sutured to the self-expanding frame. Each engagement arm corresponds to a native mitral valve leaflet. At least one engagement arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The prosthetic mitral valve frame also includes two or more anchor attachment points. Each anchor attachment point is attached to one or more anchors that help attach the valve prosthesis to the heart.

Abstract: Heart valve delivery systems and methods of delivering and implanting heart valves using delivery catheters are disclosed. The delivery systems can include a handle assembly with a rotatable control knob and a catheter including an introducer shaft, an intermediate shaft extending from the handle assembly, an inner shaft extending from the handle assembly, and a capsule for containing a prosthesis. The distal end of the capsule can be connected to a distal end of the inner shaft, which can be moved in a distal direction by the rotatable control knob to deploy the prosthesis. By advancing the introducer through the deployed prosthesis and retracting the capsule to mate with the introducer, a smooth profile can be created for retraction of the system through the deployed prosthesis, minimizing hang-ups and snagging.

Abstract: Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. In one embodiment, a catheter assembly according to the present invention includes a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly cap include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A valve retaining mechanism ears be included to assist in retaining the prosthetic valve prior to deployment. Each control knob on the handle assembly controls a portion of the components on the distal tip of the catheter by allowing for precise manipulation of various delivery shafts. Each delivery shaft extends from the handle assembly to respective positions towards the distal end of the catheter.

Abstract: A delivery system for percutaneously delivering and deploying a stented prosthetic heart valve. The delivery device includes a delivery sheath slidably disposed over an inner shaft, and a capture assembly. The capture assembly includes at least one release feature for releasing the stented prosthetic heart valve from the delivery device.

Abstract: Heart valve prosthesis recapture devices and methods for recapture are disclosed, which can be used for recapturing a partially deployed heart valve prosthesis. The recapture device comprises a recapture sleeve, configured to envelop and collapse a partially deployed heart valve prosthesis. The recapture sleeve comprises a distal end, configured to be securely attached to a guide wire, and a proximal end, comprising an opening along a longitudinal axis of the recapture sleeve. The opening can be configured to expand as it engages the heart valve prosthesis, and be biased toward a closed configuration. An attachment element can interface with the distal end of the recapture sleeve and be securely attached to a guide wire, such as by crimping. The recapture sleeve can include a support structure comprising at least one spine and a plurality of ribs.

Abstract: Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. In one embodiment, a catheter assembly according to the present invention includes a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly can include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A valve retaining mechanism can be included to assist in retaining the prosthetic valve prior to deployment. Each control knob on the handle assembly controls a portion of the components on the distal tip of the catheter by allowing for precise manipulation of various delivery shafts. Each delivery shaft extends from the handle assembly to respective positions towards the distal end of the catheter.

Abstract: An arteriovenous shunt assembly including a shunt having a hollow bore between open first and second ends thereof and a valve slidably disposed through the hollow bore. The valve includes means for retaining the valve in a closed position or in any of various selected open positions that provide corresponding different rates of blood flow through the shunt assembly. In some embodiments, the AV shunt assembly is self-expandable from a collapsed tow-profile configuration employed during transluminal delivery. The valve position in the hollow bore may be adjusted in vivo by inflating a catheter balloon in a blood vessel to bear against an end of the valve. Methods for using the shunt assembly are also disclosed.

Abstract: A catheter assembly according to the present invention includes a handle assembly, an introducer sheath, and a distal tip assembly. The distal tip assembly can include first and second retaining sleeves and a slotted tip with a non-traumatic tip guard positioned at the proximal end of the slotted tip. The handle assembly can include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. Each control knob on the handle assembly controls a portion of the components on the distal tip of the catheter by allowing for precise manipulation of various delivery shafts. Each delivery shaft extends from the handle assembly to respective positions towards the distal end of the catheter.

Abstract: A bifurcated catheter includes a first catheter branch having a first distal portion and a second catheter branch having a second distal portion. The first and second distal portions are releasably linked together for delivery to a bifurcated region of a body vessel. Upon delivery to the bifurcated region, the first and second distal portions are released from each other such that the first and second catheter branches may be tracked into first and second vessel branches, respectively.