Abstract: A replacement heart valve system may include a replacement heart valve implant comprising an expandable framework configured to shift from a radially collapsed configuration to a radially expanded configuration, and a plurality of valve leaflets disposed within and secured to the framework, and an implant delivery system comprising a handle assembly and an elongate shaft assembly extending distally from the handle assembly. The elongate shaft assembly may include an inner shaft axially secured to the handle assembly, an outer tubular member axially secured to the handle assembly and disposed about the inner shaft, and an implant holding portion. The implant holding portion is configured to constrain the implant in the radially collapsed configuration when the implant holding portion is disposed in a delivery configuration, wherein the implant holding portion is rotatable relative to the outer tubular member.

Abstract: A system for use in replacement heart-valve implant procedures, the system including a guidewire and an elongate member. The elongate member having a side port disposed proximal of a distal tip of the elongate member. The guidewire slideably disposed within a first lumen of the elongate member and configured to be advanced out the side port proximate a leaflet of a native heart valve of a patient. The side port includes an angled wall on the distal end of the port configured such that when the guidewire is advanced out of the side port, it extends out at an angle relative to the elongate member.

Abstract: An implant delivery system for delivering a replacement heart valve implant to a native valve annulus may include an elongate shaft assembly including an implant holding portion configured to constrain a replacement heart valve implant in a radially collapsed configuration. The elongate shaft assembly includes a primary visual indicator configured to be visible under fluoroscopy with an imaging device. The elongate shaft assembly includes a secondary visual indicator configured to be visible under fluoroscopy with the imaging device when the imaging device is aligned with a reference plane associated with the native valve annulus. The secondary visual indicator is not visible under fluoroscopy with the imaging device when the imaging device is misaligned with the reference plane associated with the native valve annulus.

Abstract: A replacement heart valve system may include a replacement heart valve implant including an expandable framework configured to shift from a radially collapsed to a radially expanded configuration, wherein the framework is self-biased toward the radially expanded configuration, and a plurality of valve leaflets attached to the framework. The replacement heart valve system may include an implant delivery system including a handle and an elongate shaft assembly including a tubular member fixedly attached to the handle, and an implant holding portion configured to constrain the framework in the radially collapsed configuration. The elongate shaft assembly includes an expandable balloon disposed on the tubular member within the implant holding portion, the balloon being configured to shift between deflated and inflated configurations. When the framework is constrained within the implant holding portion, at least a portion of the framework extends distal of the balloon in the deflated configuration.

Abstract: A system for delivering a replacement heart valve implant may include a handle and a valve capsule, an inner shaft extending from the handle to the capsule, an outer sheath over the inner shaft and extending from the handle to the capsule, a positioning sheath over the outer sheath and extending from the handle, a guide tube within the handle, and a distal hub attached to the positioning sheath. The distal hub may be disposed within and movable relative to the guide tube via rotation of the positioning sheath. A method of manufacturing the system may include positioning proximal and distal hubs within the guide tube, setting a first predetermined distance between proximal and distal capsule portions, moving the positioning sheath relative to the outer sheath to set a second predetermined distance between the hubs, and securing the distal hub within the guide tube at the second predetermined distance.

Abstract: A valve-coupler system has a lever that extends under a length axis of the valve body to enable one-handed operation. The valve-coupler body has an opening that is configured over a valve stem and a seal actuator having a lever that can be rotated about a pivot with a single hand to create a seal around the valve stem. Additionally, a valve-coupler may have a gas inlet valve that can be activated by the same single hand to open the valve and allow gas to flow into the valve stem. The inlet valve may be configured in line with the lever whereby the inlet valve is opened when the lever is rotated about the pivot to contact the inlet valve. The inlet valve may be configured on the valve body for manipulation by a user's finger or thumb. The inlet valve may be on the top of the valve body.

Abstract: A valve-coupler system has a lever that extends under a length axis of the valve body to enable one-handed operation. The valve-coupler body has an opening that is configured over a valve stem and a seal actuator having a lever that can be rotated about a pivot with a single hand to create a seal around the valve stem. Additionally, a valve-coupler may have a gas inlet valve that can be activated by the same single hand to open the valve and allow gas to flow into the valve stem. The inlet valve may be configured in line with the lever whereby the inlet valve is opened when the lever is rotated about the pivot to contact the inlet valve. The inlet valve may be configured on the valve body for manipulation by a user's finger or thumb. The inlet valve may be on the top of the valve body.

Abstract: A swivel elbow and connector assembly for a patient interface system includes a ring configured to be sealingly secured in an aperture of the patient interface system. The ring includes a first side in an interior of the patient interface system and a second side at an exterior of the patient interface system when the ring is secured in the aperture. The ring also includes a plurality of vents configured to permit flow of gases from the interior to the exterior of the patient interface system. The swivel elbow and connector assembly includes an elbow swivelably secured in the ring. A patient interface system for delivering a flow of breathable gas to a user includes a patient interface structure configured to sealing engage the face of the user. The patient interface structure includes an aperture. A swivel elbow and connector assembly is sealingly secured in the aperture.

Abstract: A device provides respiratory treatment such as for sleep disordered breathing and other respiratory conditions in a discreet configuration to provide a minimally invasive system. The system may include a flow pressurizer apparatus configured to generate a pressurized flow of air through a fine bore delivery conduit toward a patient interface. The system may further include a treatment compensator coupled with the fine bore delivery conduit. The treatment compensator may be configured at the patient interface to reduce pressure for patient inspiration. A processor may control adjustments to the pressure generated by the flow pressurizer apparatus.