Abstract: An anchoring delivery system for use in an intracranial artery is provided including a tethering device having an elongated tether and an anchor coupled to a distal end of the tether. The anchor is deployable from a low profile configuration to a higher profile configuration to fix the distal end of the tether at an anchoring site in an anchoring vessel. The tethering device is configured to be used with a guide-sheath having a lumen configured to receive the tether. Related devices, systems, and methods are also described.

Abstract: In some examples, an introducer sheath extends from a proximal end to a distal end, and includes a hub disposed at the proximal end, and a body coupled to the hub and extending between the proximal end and the distal end, the body defining a lumen and having a collapsed condition and an expanded condition, the body having a braided material and an elastomeric material covering the braided material, the body having a flared distal end.

Abstract: A loading device configured to radially collapse an expandable medical implant may include an operating handle having an opening therein extending along a longitudinal axis, a native sheath coupled to the operating handle and partially extending into the opening, such that the native sheath is configured to translate relative to the operating handle parallel to the longitudinal axis, a removable sheath removably coupled to the native sheath, an actuation rod extending parallel to the longitudinal axis at least partially through the opening, a lumen of the native sheath, and a lumen of the removable sheath, a distal end of the actuation rod being configured to be removably coupled to the expandable medical implant, and a first control element movable relative to the operating handle and coupled to the native sheath, the first control element being configured to translate the native sheath and the removable sheath relative to the operating handle.

Abstract: The present disclosure describes devices, systems, and methods for intravascularly delivering an intravascular device to a targeted cardiac valve. In one aspect, a medical device includes a body and a plurality of positional markers positioned on the body, the plurality of positional markers being defined in part by at least one cutout and having at least one parameter selected such that the plurality of positional markers vibrates, in response to an ultrasound signal, at a resonant frequency.

Abstract: The present disclosure describes devices, systems, and methods for intravascularly delivering an implantable device to a targeted anatomical site such as the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. A delivery catheter is concentrically positioned within an outer member and configured to advance the intravascular device relative to the outer member. The delivery catheter includes a distal can structure configured to house at least a portion of the intravascular device in a compressed, pre-deployed position.

Abstract: A retrieval catheter for retrieving a partially deployed medical device held at the end of a catheter includes an inner shaft, an intermediate shaft and an outer shaft. The inner shaft engages the catheter in a manner that prevents translation of the inner shaft relative to the catheter. The intermediate shaft is assembled around the inner shaft and includes inner threads that engage with outer threads on the inner shaft such that rotation of the intermediate shaft translates it relative to the inner shaft and the catheter. The outer shaft is assembled around the intermediate shaft and includes a valve cover at its distal end. The valve cover is operatively connected to the intermediate shaft such that translation of the intermediate shaft translates the valve cover. Components of the medical device delivery system are disassembled from the catheter and the retrieval catheter is assembled thereover to retrieve the medical device.

Abstract: A delivery system for delivering a medical device includes a delivery device. The delivery device may include an outer delivery sheath having a compartment at a distal end thereof, the compartment configured to receive the medical device. The delivery device may also include a nosecone catheter positioned radially within the outer delivery sheath, the nosecone catheter having an inner tube configured to receive a guidewire therethrough, and an outer tube, an inflation lumen defined between the inner tube and the outer tube. The delivery device may further include a nosecone that has a length that may be adjusted by pushing an inflation medium into the balloon nosecone or withdrawing the inflation medium from the balloon nosecone via the inflation lumen, the balloon nosecone being reversibly coupled to the nosecone catheter.

Abstract: The present disclosure describes devices, systems, and methods for intravascularly delivering an implantable device to a targeted anatomical site such as the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. A delivery catheter is concentrically positioned within an outer member and configured to advance the intravascular device relative to the outer member. The delivery catheter includes a distal can structure configured to house at least a portion of the intravascular device in a compressed, pre-deployed position.

Abstract: A delivery system for delivering an implantable medical device, such as a prosthetic heart valve, intravascularly to a target site, such as a heart valve annulus in a patient. The system includes an outer sheath, a connecting arm connected to the outer sheath, a valve cover at the distal end of the outer sheath and a steering catheter within the outer sheath. A handle is connected to the steering catheter so that rotation of the handle rotates the steering catheter. A coupling mechanism has a first condition rotationally coupling the outer sheath to the steering catheter, and a second condition in which the outer sheath is rotationally uncouple from the steering catheter.

Abstract: A prosthetic heart valve for replacing a native atrioventricular valve includes a collapsible and expandable frame having atrial and ventricular portions each including a circumferential row of cells, and a center portion extending between the atrial and ventricular portion. The atrial portion and the ventricular portion may flare radially outwardly from the center portion in an expanded condition of the frame. A plurality of prosthetic leaflets may be mounted to the frame.

Abstract: A prosthetic atrioventricular valve may include a collapsible frame including an atrial disk, a ventricular disk, and a center portion between the two. The frame may include commissure attachment features (“CAFs”) that include struts extending from the center portion. Prosthetic leaflets may be mounted to the CAFs. A sealing fabric may be coupled to the frame. A commissure support ring may couple to and extend around the plurality of CAFs. The atrial disk and the ventricular disk may each flare outwardly from the center portion of the frame. The center portion of the frame may define a minimum diameter of the frame. Each of the CAFs may be spaced from adjacent ones of the CAFs so that gaps in the frame are present between adjacent ones of the CAFs.

Abstract: A prosthetic heart valve system may include a collapsible anchor frame which may include a support frame that has a central portion, and atrial and ventricular portions flared radially outwardly from the central portion. The atrial and ventricular portions may be sized to sandwich or clamp an annulus of the heart valve. An atrial sheet may be coupled to the atrial portion of the support frame and may extend radially inwardly to a central aperture in the atrial sheet, the atrial sheet being formed of a material that is substantially impermeable to blood. The system may include a leaflet support structure, an inflow end of the leaflet support structure coupled to the atrial sheet. The atrial sheet may define an opening positioned radially outside of the leaflet support structure so that blood flowing around an exterior of the leaflet support structure passes through the opening.

Abstract: A system for heart valve repair includes a collapsible and expandable replacement heart valve and a delivery device for implanting the implanting the valve. The delivery device includes a base unit positioned at a proximal end of the delivery device, an outer catheter extending from the base unit, a first inner catheter positioned within the outer catheter, a second inner catheter positioned within the first inner catheter, a mandrel positioned within the second inner catheter, and a nosecone adapted to be couple to the second inner catheter.

Abstract: A medical device delivery system includes a steering catheter including a first steering ring having a plurality of apertures positioned in the wall of the first steering ring. The plurality of apertures are positioned at spaced distances around a circumference of the first steering ring. A first steering cable passes through a first one of the apertures, and a first return cable passes through a second one of the apertures. A second steering cable passes through a third one of the apertures, and a second return cable passes through a fourth one of the apertures. The first steering cable is positioned about 180 degrees from the second steering cable. A handle is operably coupled to a proximal end of the steering catheter. A first control member controls the first steering and first return cable, and a second control member controls the second steering and second return cable.

Abstract: A steerable catheter has a body with an outer surface and an inner surface defining a central lumen. The outer surface and inner surface define a wall of the body, which has a plurality of steering lumen and control lumen extending longitudinally therethrough. The body includes a body material. The steering lumen and control lumen have a control lumen lining and steering lumen lining, respectively, with a higher durometer than the body material. A steering wire is positioned within the steering lumen and a control wire is positioned within the control lumen.

Abstract: A prosthetic tricuspid heart valve system includes a collapsible anchor frame and a collapsible prosthetic heart valve. The anchor includes a support structure having a waisted central portion, and atrial and ventricular flared portions sized to clamp a native valve annulus. Atrial and ventricular sheets are coupled to the atrial and ventricular flared portions, and each include a central aperture. A generally cylindrical fabric valve-receiving member has an inflow end coupled to the atrial sheet and an outflow end coupled to the ventricular sheet to provide a conduit through the valve-receiving member between the atrial and ventricular sheet. The prosthetic heart valve may include a stent and a plurality of prosthetic leaflets, the prosthetic heart valve configured to be expanded into and received within the valve-receiving member of the anchor frame.

Abstract: The present disclosure describes devices, systems, and methods for loading, delivering, positioning, and deploying an artificial heart valve device at the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. The valve device is attached at the distal end of the delivery member, and is constrained within a valve cover of an outer sheath. A delivery catheter is configured to advance the valve relative to the outer sheath, and a suture catheter includes sutures/tethers which maintain proximal tension on the valve prior to deployment.

Abstract: The present disclosure describes devices, systems, and methods for intravascularly delivering an implantable device to a targeted anatomical site such as the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. A delivery catheter is concentrically positioned within an outer member and configured to advance the intravascular device relative to the outer member. The delivery catheter includes a distal can structure configured to house at least a portion of the intravascular device in a compressed, pre-deployed position.

Abstract: An intravascular device delivery system has an elongated member with a flexible hypotube. The hypotube can be rotationally keyed to a steerable catheter. The flexible hypotube includes one or more cuts to allow bending of the flexible hypotube within a first plane. The steerable catheter is steerable to bend the flexible hypotube within the first plane, and longitudinally movable relative to the flexible hypotube to allow distal movement of the steerable catheter relative to a distal end of the flexible hypotube.

Abstract: The present disclosure provides replacement heart valves that include an outer frame, an inner frame, and arms extending therebetween. The outer frame and inner frame may be formed by a plurality of cells, such as diamond shaped cells. The arms may extend from an apex of a diamond shaped cell on the inner frame and be fastened to an apex where adjacent cells of the outer frame adjoin. The arms may include one or more bends. For example, the arms may extend in a first direction for a predefined length, have a bend point, and then extend in a second direction opposite the first. The arms may isolate the inner frame from the outer frame such that forces exerted on the outer frame are absorbed by the arms and do not deform the inner frame.