Abstract: A device can be introduced into the right atrium of a subject's heart by introducing the distal end of a hollow, straight, and stiff shaft into the subject's right internal jugular vein, and advancing the distal end of the shaft into the right atrium via the superior vena cava. The position of the distal end of the shaft is adjusted by manipulating a handle affixed to a portion of the shaft that remains outside the subject's body. The handle can be used to rotate the shaft about its longitudinal axis, rotate the shaft about an anterior-posterior axis, rotate the shaft about a medial-lateral axis, and/or advance the shaft in the caudal direction. A device is advanced through the interior of the shaft until the device extends beyond the distal end of the shaft and into the right atrium.

Abstract: A method of deploying a blood-flow controlling device is described for treating a native mitral or tricuspid valve. The blood-flow controlling device includes a blood-flow blocking portion that is slidable over an elongate body portion. The blood-flow blocking portion is preferably an elongate structure fillable with blood having a portion adapted for placement between leaflets of the native valve. An anchor is located on a distal end of the elongate body portion for engagement with heart tissue adjacent a heart apex. An anchor delivery catheter is advanced through the native valve and into an adjacent ventricle. The anchor is then expelled from the anchor delivery catheter into ventricular tissue. The blood-flow blocking portion is then slid along the elongate body portion and positioned between the native leaflets. A locking catheter is then slid along the elongate body portion for locking the blood-flow blocking portion to the elongate body portion.

Abstract: A method of treating a defective heart valve includes inserting a delivery catheter through a small incision in a patient's groin, wherein the delivery catheter has a prosthetic device positioned along a distal end. The prosthetic device includes an insert member and an anchoring member. The insert member is positioned between the native heart valve and is allowed to self-expand. The anchoring member is preferably a stent connected to the insert member by at least one elongate member. The stent is deployed within an adjacent blood vessel for anchoring the insert member between the native leaflets. After deployment of the prosthetic device, the native leaflets of the heart valve form a tight seal against the insert member for preventing regurgitation through the native heart valve during ventricular systole.

Abstract: A prosthetic heart valve for replacing a defective aortic valve includes a self-expandable annular frame made of shape-memory material. A one-way valve structure is disposed within an interior of the frame. The frame includes a plurality of posts projecting axially from an outflow end portion of the frame, wherein each of the posts includes an axial post portion and a terminal post portion. The terminal post portions have greater circumferential dimensions than the axial post portions. The terminal post portions are preferably formed with concave inner surfaces and convex outer surfaces for conforming to the shape of a delivery catheter. Each of the posts is shaped for placement within a corresponding recess along a distal end portion of the delivery catheter for ensuring that the prosthetic heart valve remains coupled to the delivery catheter while the prosthetic heart valve is expanded within the defective aortic valve.

Abstract: A heart valve annulus repair device having a tissue engaging member and a plurality of anchors. The tissue engaging member includes a loop of wire. Each of the anchors has a pointy front end and a back end and a slot that runs in a front-to-back direction. The anchors are distributed about the loop of wire with the front ends of the plurality of anchors facing the heart valve annulus and with the loop of wire passing through the slots. The device further includes means for implanting the anchors into the heart valve annulus tissue so that the tissue engaging member becomes affixed to the heart valve annulus.

Abstract: A prosthetic heart valve delivery system can include a catheter portion having a sheath that can cover and uncover the prosthetic heart valve mounted on an inner shaft, a handle having a sheath actuator operatively coupled to a proximal portion of the sheath, the inner shaft extending through the handle, and a shaft retractor releasably coupled to a proximal portion of the handle and fixedly coupled to a proximal portion of the inner shaft. A sheath actuator can move the sheath axially relative to the inner shaft when the shaft retractor is coupled to the handle, and a proximal movement of the sheath relative to the inner shaft can cause the sheath to uncover the prosthetic heart valve. The shaft retractor can be operable to retract the inner shaft and the nosecone proximally relative to the sheath when the shaft retractor is released from the handle.

Abstract: A handle assembly for a transvascular prosthetic heart valve delivery apparatus including a handle housing, a main shaft extending distally from the handle housing, the main shaft configured to be coupled to a distal valve sheath that is configured to retain a prosthetic heart valve in a radially compressed state within the valve sheath, a screw shaft, a control knob that is rotatable relative to the handle housing and the screw shaft, a screw engagement latch that is adjustable between an engaged position and a disengaged position. In the engaged position, the latch can couple the control knob to the screw shaft such that rotation of the control knob relative to the handle housing causes the main shaft to move axially relative to the handle housing. In the disengaged position, the latch can decouple the control knob from the screw shaft such that the main shaft can move axially relative to the handle housing without rotation of the control knob.

Abstract: A method of delivering a prosthetic heart valve to a native aortic heart valve region of a patient can include introducing a prosthetic heart valve on a transvascular delivery apparatus into an artery of the patient, advancing the delivery apparatus through an aorta of the patient to the native aortic heart valve region, and releasing the prosthetic heart valve from the delivery apparatus. The delivery apparatus can have a shaft with a valve connection portion that is releasably coupled to posts of the prosthetic heart valve. The delivery apparatus can have a delivery sheath positioned around the prosthetic heart valve and the valve connection portion. The releasing the prosthetic valve can include moving the delivery sheath proximally relative to the shaft and the prosthetic heart valve such that the delivery sheath uncovers the prosthetic heart valve and the prosthetic heart valve can self-expand.

Abstract: An assembly for replacing a native heart valve can have a prosthetic heart valve with an annular metal frame made from shape-memory material and a valve member disposed in an interior of the metal frame. The assembly can have a delivery apparatus with a handle, a shaft with a proximal end portion and a distal end portion. The proximal end portion can be coupled to the handle and the distal end portion can be releasably coupled to the prosthetic heart valve. The delivery apparatus can also have a delivery sheath and a hydraulic power source operatively connected to the delivery sheath. The prosthetic heart valve can be positioned within the delivery sheath in a radially compressed state. The hydraulic power source can be configured to move the delivery sheath longitudinally relative to the valve to allow the valve to self-expand from the radially compressed state to a radially expanded state.

Abstract: A prosthetic heart valve for replacing a defective aortic valve includes a self-expandable annular frame made of shape-memory material. A one-way valve structure is disposed within an interior of the frame. The frame includes a plurality of posts projecting axially from an outflow end portion of the frame, wherein each of the posts includes an axial post portion and a terminal post portion. The terminal post portions have greater circumferential dimensions than the axial post portions. The terminal post portions are preferably formed with concave inner surfaces and convex outer surfaces for conforming to the shape of a delivery catheter. Each of the posts is shaped for placement within a corresponding recess along a distal end portion of the delivery catheter for ensuring that the prosthetic heart valve remains coupled to the delivery catheter while the prosthetic heart valve is expanded within the defective aortic valve.

Abstract: A delivery assembly includes a prosthetic device, a catheter shaft, a release wire, a first line, and a second line. The prosthetic device has a first arm and a second arm. The release wire extends through the catheter shaft. The first line includes a first loop. The first line extends from the catheter shaft, through the first arm of the prosthetic device, and to the release wire, where the release wire extends through the first loop. The second line includes a second loop. The second line extends from the catheter shaft, through the second arm of the prosthetic device, and to the release wire, where the release wire extends through the second loop.

Abstract: Embodiments of the present disclosure provide methods of loading a prosthetic heart valve within a delivery apparatus such that it can be used for delivery of the prosthetic heart valve to a native valve site via the human vasculature. The methods can include attaching the prosthetic heart valve to a valve-retaining mechanism at a distal end of the catheter and causing a torque shaft of the delivery apparatus to rotate relative to the catheter, wherein the torque shaft extends within the catheter and is coupled to the valve delivery sheath. Rotation of the torque shaft relative to the catheter can cause relative longitudinal movement between the valve sheath and the prosthetic heart valve such that the prosthetic heart valve is covered by the valve sheath.

Abstract: Embodiments of the present disclosure provide a prosthetic heart valve usable with a heart valve delivery apparatus for delivery of the prosthetic heart valve to a native valve site via the human vasculature. In one embodiment, a self-expanding valve comprises an expandable stent that is shaped to maintain the valve in the aortic annulus against axial without anchors or retaining devices that engage the surrounding tissue. The prosthetic heart valve can have a curved shape that tapers inwardly from the inflow end to a reduced diameter section, increases in diameter from the reduced diameter section to an intermediate section, and then tapers from the intermediate section to the outflow end.

Abstract: An assembly for transvascular replacement of a native aortic heart valve can have a radially collapsible and self-expandable prosthetic heart valve and a delivery apparatus. The valve can have an annular metal frame made of a shape-memory material with a plurality of posts extending from an end portion of the frame. The delivery apparatus can have a shaft comprising a valve connection portion that is releasably coupled to the posts of the valve. The valve connection portion can have a plurality of discrete radially facing recesses that receive the posts. The delivery apparatus can have a delivery sheath that is positioned around the prosthetic heart valve and the valve connection portion of the shaft to maintain the prosthetic heart valve in a radially compressed state and maintain the posts within the recesses. The delivery apparatus can cause relative axial motion between the delivery sheath and the valve.

Abstract: A handle assembly for a transvascular prosthetic heart valve delivery apparatus including a handle housing, a main shaft extending distally from the handle housing, the main shaft configured to be coupled to a distal valve sheath that is configured to retain a prosthetic heart valve in a radially compressed state within the valve sheath, a screw shaft, a control knob that is rotatable relative to the handle housing and the screw shaft, a screw engagement latch that is adjustable between an engaged position and a disengaged position. In the engaged position, the latch can couple the control knob to the screw shaft such that rotation of the control knob relative to the handle housing causes the main shaft to move axially relative to the handle housing. In the disengaged position, the latch can decouple the control knob from the screw shaft such that the main shaft can move axially relative to the handle housing without rotation of the control knob.

Abstract: A prosthetic heart valve delivery system can include a catheter portion having a sheath that can cover and uncover the prosthetic heart valve mounted on an inner shaft, a handle having a sheath actuator operatively coupled to a proximal portion of the sheath, the inner shaft extending through the handle, and a shaft retractor releasably coupled to a proximal portion of the handle and fixedly coupled to a proximal portion of the inner shaft. A sheath actuator can move the sheath axially relative to the inner shaft when the shaft retractor is coupled to the handle, and a proximal movement of the sheath relative to the inner shaft can cause the sheath to uncover the prosthetic heart valve. The shaft retractor can be operable to retract the inner shaft and the nosecone proximally relative to the sheath when the shaft retractor is released from the handle.

Abstract: A method of treating a defective heart valve includes inserting a delivery catheter through a small incision in a patient's groin, wherein the delivery catheter has a prosthetic device positioned along a distal end. The prosthetic device includes an insert member and an anchoring member. The insert member is positioned between the native heart valve and is allowed to self-expand. The anchoring member is preferably a stent connected to the insert member by at least one elongate member. The stent is deployed within an adjacent blood vessel for anchoring the insert member between the native leaflets. After deployment of the prosthetic device, the native leaflets of the heart valve form a tight seal against the insert member for preventing regurgitation through the native heart valve during ventricular systole.

Abstract: A loop of material can be affixed to a cardiac annulus using a plurality of anchors. Each of these anchors is launched into the annulus by a respective anchor launcher, and each of these anchor launchers is triggered by pulling on a respective pull wire. This application is directed to methods and apparatuses that automate the pulling of these pull wires using a plurality of actuators. Each actuator includes a channel with a compressed spring disposed in a distal portion of the channel. A tab is affixed to the proximal end of the spring. When the tab is moved from a first position to a second position, the spring becomes free to expand. The expanding springs pull the pull wires in a proximal direction, which triggers the anchor launchers.

Abstract: A method of delivering a prosthetic heart valve to a native aortic heart valve region of a patient can include introducing a prosthetic heart valve on a transvascular delivery apparatus into an artery of the patient, advancing the delivery apparatus through an aorta of the patient to the native aortic heart valve region, and releasing the prosthetic heart valve from the delivery apparatus. The delivery apparatus can have a shaft with a valve connection portion that is releasably coupled to posts of the prosthetic heart valve. The delivery apparatus can have a delivery sheath positioned around the prosthetic heart valve and the valve connection portion. The releasing the prosthetic valve can include moving the delivery sheath proximally relative to the shaft and the prosthetic heart valve such that the delivery sheath uncovers the prosthetic heart valve and the prosthetic heart valve can self-expand.

Abstract: An assembly for transvascular replacement of a native aortic heart valve can have a radially collapsible and self-expandable prosthetic heart valve and a delivery apparatus. The valve can have an annular metal frame made of a shape-memory material with a plurality of posts extending from an end portion of the frame. The delivery apparatus can have a shaft comprising a valve connection portion that is releasably coupled to the posts of the valve. The valve connection portion can have a plurality of discrete radially facing recesses that receive the posts. The delivery apparatus can have a delivery sheath that is positioned around the prosthetic heart valve and the valve connection portion of the shaft to maintain the prosthetic heart valve in a radially compressed state and maintain the posts within the recesses. The delivery apparatus can cause relative axial motion between the delivery sheath and the valve.