Abstract: Embodiments of a catheter assembly are disclosed. The catheter assembly comprises a shaft; a connector assembly comprising a first connector portion and a second connector portion, wherein the first connector portion is fixedly coupled to a distal end of the shaft, and is rotatably coupled to the second connector portion by at least one radially extending pin retained within at least one slot on the second connector portion, wherein the at least one slot has an oversized circumferential dimension that allows limited rotation of the second connector portion relative to the first connector portion about a longitudinal axis of the shaft.

Abstract: A cardiac implant includes a frame forming an inner lumen and sized for delivery into a blood vessel and a covering extending at least partially along the frame to at least partially restrict lateral blood flow from one or more branching blood vessels into the blood vessel. The covering forms one or more folds at or near a distal end of the frame.

Abstract: A system includes a lock and release connector, an implantable medical device, and an outer tube. The lock and release connector includes a connector body defining a recess extending to an axial end portion of the connector body. The implantable medical device has an extension receivable in the recess and extending through the axial end portion. The outer tube extends over the recess to retain the extension in the recess. The lock and release connector further includes a retention element receivable in the recess to secure the extension in the recess. When the outer tube is axially withdrawn from the recess, the retention element is movable from a retaining position to a releasing position to permit disengagement of the extension from the recess for deployment of the implantable medical device.

Abstract: A system includes a lock and release connector, an implantable medical device, and an outer tube. The lock and release connector includes a connector body defining a recess having planar lateral head portions extending to and intersecting with a cylindrical surface of the connector body, and a longitudinal neck portion extending from the head portion. The implantable medical device has an extension including a neck portion receivable in the longitudinal neck portion of the recess and a head portion receivable in the lateral head portions of the recess. The outer tube extends over the recess to retain the extension in the recess.

Abstract: A medical implant for managing blood flow through a blood vessel comprises a stent body forming a proximal portion and a tapered distal end, the tapered distal end being angled relative to the proximal portion to face a direction of blood flow and limit blood flow into an inner lumen of the stent body, and the tapered distal end having a flexible structure to allow the tapered distal end to bend and straighten in response to blood flow, and a covering extending along the stent body.

Abstract: Implant devices are provided for restoring compliance characteristics to blood vessels. An exemplary implant device includes an outer tubular frame having a diameter than varies along a longitudinal axis and a radially expandable tube disposed within the frame. Further disclosed are implant devices including a frame having an axially convex form that expands in diameter moving from first and second axial ends of the frame to a medial portion of the frame, and a cylindrical toroidal balloon member comprising one or more gas-filled chambers disposed at least partially within the frame. Further disclosed are implant devices including a tubular frame comprising a first axial segment and a second axial segment, a radially expandable tube disposed within the first axial segment of the frame, and a one-way valve disposed within the second axial segment of the frame.

Abstract: An implant for adding compliance to a blood vessel includes a first elongate rail shaped to contact an inner wall of a blood vessel and a second elongate rail shaped to contact an opposing inner wall of the blood vessel. Connectors extend between the first and second rails for providing a separation therebetween and maintaining the rails at locations on opposing sides of the lumen after implantation. The connectors push the rails outwardly for biasing the blood vessel toward a substantially oval shape. The connectors are preferably flexible for allowing the blood vessel to change shape during use for adding compliance to the blood vessel. The elongate rails are preferably curved or hemi-spherical for conforming to the shape of the inner wall of the blood vessel.

Abstract: A catheter includes a magnetic release mechanism formed by a magnet disposed within a distal region of a lumen of the catheter. A spacer wall preferably encloses the lumen within the distal region. The magnet is located proximal to the spacer. In one use, a catheterization procedure includes guiding the catheter to an attachment point and rotating a knob on the catheter handle to rotate the magnet. Rotation of the magnet induces rotation of an implant retained along a distal end of the catheter. Disengaging the magnetic release mechanism decouples the implant from the catheter.

Abstract: An insertion catheter for a circulatory support catheter having a circulatory support device carried by an elongate flexible catheter shaft. The insertion catheter comprises a tubular body with a distal portion configured to axially movably receive the circulatory support device. A diameter of the distal portion is greater than a diameter of a mid portion of the tubular body. The insertion catheter may be inserted into an introducer sheath for delivery of the MCS device. A distal end of the insertion catheter may be located distally of a distal end of the introducer sheath and distally of the arterial bifurcation. The distal portion of the insertion catheter containing the MCS device may be located distally of the bifurcation, with a distal end of the MCS device slightly offset from the distal end of the tubular body.

Abstract: A tapered medical access sheath can comprise an access sheath hub and an access sheath shaft extending distally from the access sheath hub. The access sheath shaft can comprise a first delivery lumen extending from a proximal end of the access sheath shaft to a side opening on a distal portion of the access sheath shaft, the first delivery lumen having a width configured to slidably receive a distal portion of a medical device disposed around a guidewire. The access sheath shaft can comprise a tapered distal end portion disposed distally of the side opening. A recess can extend along a longitudinal dimension of the tapered distal end portion from a proximal end to a distal end of the tapered distal end portion. The recess can be in fluid communication with the first delivery lumen and have a width smaller than the diameter of the first delivery lumen.

Abstract: A medical access system can comprise an expandable access sheath and an introducer. The expandable access sheath can comprise a sheath shaft comprising an expandable distal end portion, and a shaft delivery lumen extending therethrough. The introducer can comprise an introducer shaft configured to be at least partially disposed within the shaft delivery lumen. The introducer shaft can comprise a first distal portion comprising a first diameter and a second distal portion proximal of the first distal portion and having a second diameter larger than the first diameter. A second externally oriented surface portion defining the second distal portion, and an externally oriented transition surface portion extending between a first externally oriented surface portion defining the first distal portion and the second externally oriented surface, can be angled relative to one another, such as forming an angle between about 80 degrees and about 100 degrees.

Abstract: A sensor implant device comprising a sensor body comprising at least a first sensor component, one or more anchors coupled to the sensor body and configured to anchor the sensor body within a tissue wall, a detachable tip, and a tether connecting the detachable tip to the sensor body.

Abstract: A delivery sheath includes an outer tubular layer and an initially folded inner tubular layer. When an implant passes therethrough, the outer tubular layer expands and the inner tubular layer unfolds into an expanded lumen diameter. The sheath may also include selectively placed longitudinal support rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion, thereby reducing the push force needed to advance the implant through the sheath's lumen.

Abstract: A delivery sheath includes an outer tubular layer and an initially folded inner tubular layer. When an implant passes therethrough, the outer tubular layer expands and the inner tubular layer unfolds into an expanded lumen diameter. The sheath may also include selectively placed longitudinal support rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion, thereby reducing the push force needed to advance the implant through the sheath's lumen.

Abstract: Introducers and dilators that include expansion features configured to dilate expandable access sheaths, and expandable access sheaths, are described herein. The introducer can include an expansion feature disposed on an elongate shaft. The expansion feature can include a larger outer diameter than the distal end of the elongate shaft or another portion of the elongate shaft. The expansion feature can be configured to dilate a portion of an expandable access sheath when the elongate shaft is translated within the expandable access sheath. Expandable access sheaths can comprise expandable distal end portions configured to be maintained in a closed state by, for example, a tensioned cord portion disposed around a circumferential portion of the expandable distal end portion, a plurality of pleats comprising material configured to attract one another, a circumferential portion with a weakened joint, and/or a weakened portion on a sidewall of the expandable distal end portion.

Abstract: A medical device delivery system can comprise a delivery catheter and an in-line sheath, the delivery catheter being preloaded within the in-line sheath. The delivery catheter can comprise a catheter hub and a catheter shaft. The catheter shaft can comprise a proximal portion extending distally from the hub and slidably receiving a proximal narrow portion of a medical device, and a distal portion slidably receiving a distal wide portion of a medical device. The in-line sheath can comprise a sheath hub and a sheath shaft. The sheath shaft can comprise a proximal portion extending distally from the sheath hub and slidably receiving at least a portion of the proximal portion of the catheter shaft, and an expandable distal portion slidably receiving the distal portion of the catheter shaft.

Abstract: A shunt implant device includes one or more anchor arms and first and second barrel wings configured to curve to form a tubular barrel form. In some implementations, shunt implant devices of the present disclosure include a shunt barrel formed at least in part by a plurality of arcuate panels configured in an at least partially cylindrical form, a first anchor arm projecting from a first axial side of the shunt barrel and deflected radially outward in a first radial direction, and a second anchor arm projecting from a second axial side of the shunt barrel and deflected radially outward in the first radial direction.

Abstract: An implant delivery system comprises a distal portion configured to naturally assume a first width and expand beyond the first width in response to an implant device being inserted into the distal portion via an opening at a distal end of the distal portion and a proximal portion configured to generally maintain the first width

Abstract: Several heart wall remodeling devices and methods are disclosed. One heart wall remodeling device includes an anchoring portion having an elongated anchor body with a distal anchor end portion and a proximal anchor end portion opposite the distal anchor end portion, a rotation joint portion having a distal joint end portion fixedly attached to the proximal anchor end portion and a proximal joint end portion opposite the distal joint end portion and a hemostasis element having a distal hemostasis end portion detachably connected to the proximal joint end portion. One heart wall remodeling device includes a tensioner that applies a variable tension between anchors.

Abstract: Devices for puncturing, anchoring in the tissue of a human heart, and sealing the puncture and methods of puncturing, deploying anchors, and sealing the puncture are disclosed. The anchors are used to remodel the shape of the heart. The devices and methods use sealing structures to prevent blood leak through a passage formed by puncturing the heart tissue.