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.

Abstract: Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.

Abstract: A sheath assembly can comprise a removable hub. The removable hub can have a lumen extending therethrough and comprise a first circumferential hub portion that spans a first circumferential segment about a longitudinal axis of the removable hub, a second circumferential hub portion that spans a second circumferential segment about the longitudinal axis of the removable hub, and first and second connector portions connecting the first circumferential hub portion and the second circumferential hub portion. The second circumferential segment can be greater than the first circumferential segment. The sheath assembly can comprise a removable shaft configured to extend distally from a distal end of the removable hub, the removable shaft being configured such that separation of the first circumferential hub portion from the second circumferential hub portion causes a first circumferential shaft portion to separate from a second circumferential shaft portion.

Abstract: A method comprises delivering a first implant to an orifice of a chamber of a heart, anchoring the first implant at the orifice, delivering a sensor device to the orifice, and coupling the sensor device to the first implant.

Abstract: A sensor implant system comprises a shunt implant comprising a central flow portion configured to maintain an opening through a tissue wall and a sensor implant device. The sensor implant device comprises a shunt body configured to fit at least partially within the central flow portion of the shunt implant and a sensor device coupled to the shunt body.

Abstract: A sensor implant device includes a sensor device, an anchor base structure secured to the sensor device, a first helical tissue anchor secured to at least one of the sensor device or the anchor base structure, the first helical tissue anchor winding in a first direction, and a second helical tissue anchor secured to at least one of the sensor device or the anchor base structure, the second helical tissue anchor winding in a second direction opposite the first direction.

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: Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.

Abstract: Embodiments of a catheter assembly are disclosed. The catheter assembly comprises a shaft; at least one connector assembly. The connector assembly can comprise 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 coupled to the second connector portion with a limited degree of freedom of movement by at least one radially extending pin retained within at least one slot on the second connector portion. The at least one slot can have 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 sensor implant device can include a shunt body that forms a fluid conduit, a first anchor structure associated with a first axial end of the shunt body, a second anchor structure associated with a second axial end of the shunt body, and a first sensor device coupled to the first anchor structure, the first anchor structure being configured to hold the first sensor device in a sensing position over a channel area of the fluid conduit.

Abstract: A sensor implant device includes a shunt body that forms a fluid conduit, a first anchor structure associated with a first axial end of the shunt body, and a first sensor-retention structure associated with a second axial end of the shunt body, the first sensor-retention structure being configured to hold a first sensor device in a sensing position in which a sensor transducer of the first sensor device is disposed at least partially radially outside of a channel area of the fluid conduit.

Abstract: A sensor implant device includes a shunt body that forms a fluid conduit, the fluid conduit having an axis, a first anchor structure associated with a first end of the shunt body, and a first sensor device coupled to the first anchor structure such that a sensor transducer of the first sensor device projects into a channel area defined by a radial boundary around the axis of the fluid conduit, the radial boundary being defined by the fluid conduit.

Abstract: A prosthetic valve can comprise a body member having a first end and a second end, the body member defining a conduit and being configured to assume a compressed configuration and an expanded configuration, a lateral dimension of the body member being larger in the expanded configuration than that in the compressed configuration. An elongate member can have a first end associated with the first end of the body member, the elongate member being configured to move between a longitudinal orientation and a diametrical orientation. A covering can be coupled to the elongate member and configured to cover at least a portion of the conduit at the first end of the body member when the elongate member is in the diametrical orientation.