Abstract: Aspects of positioning devices, methods, and systems are disclosed. An exemplary method comprises: moving a distal end of a tube into a body, the tube including a lumen and a shaft in the lumen, the shaft having a transducer; sending a first signal to the transducer; passing, with the transducer, in response to the first signal, a wave energy into the body; receiving, with the transducer, a reflected portion of the wave energy; generating, with the transducer, a second signal in response to the reflected portion of the wave energy; determining, with a processor, an indicia of the body in response to the second signal; and identifying, with the indicia, a targeted issue in the body; positioning the distal end of the tube at the targeted tissue in response to the indicia; and removing a portion of the targeted tissue with the distal end of the tube.

Abstract: Embodiments include devices, methods, and systems for positioning devices. An exemplary method comprises: moving a distal end of a tube into a body, the tube including a lumen and a shaft in the lumen, the shaft having a transducer; sending a first signal to the transducer; passing, with the transducer, in response to the first signal, a wave energy into the body; receiving, with the transducer, a reflected portion of the wave energy; generating, with the transducer, a second signal in response to the reflected portion of the wave energy; determining, with a processor, an indicia of the body in response to the second signal; and identifying, with the indicia, a targeted issue in the body; positioning the distal end of the tube at the targeted tissue in response to the indicia; and removing a portion of the targeted tissue with the distal end of the tube.

Abstract: A replacement heart valve implant may include an expandable framework having a plurality of frame struts defining a lattice structure, each frame strut having a thickness in a radial direction from a central longitudinal axis; and a plurality of valve leaflets coupled to the expandable framework. The plurality of frame struts defines a lower crown proximate an inflow end of the lattice structure and upper crown proximate an outflow end of the lattice structure and a plurality of stabilization arches extending downstream from the outflow end of the lattice structure. The lattice structure includes a first circumferential row of x-connectors upstream of the upper crown and a second circumferential row of x-connectors downstream of the lower crown. The thickness of at least some frame struts connecting the first and second circumferential rows of x-connectors is less than the thickness of other frame struts of the plurality of frame struts.

Abstract: A balloon valvuloplasty catheter may include an elongate shaft having a guidewire lumen and a device lumen extending longitudinally therein, an expandable balloon secured to a distal portion of the elongate shaft, and an intravascular ultrasound catheter slidably disposed within the device lumen. The device lumen is in fluid communication with an interior of the expandable balloon. A method of preparing a native aortic heart valve of a patient's heart for transcatheter aortic valve replacement may include using the balloon valvuloplasty to observe via intravascular ultrasound and evaluate a position of the native leaflets relative to the left and right coronary artery ostia to determine if the native leaflets block the left coronary artery ostium and/or the right coronary artery ostium when the expandable balloon is inflated.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example device may include an elongate shaft having a distal end region. An expandable framework may be disposed adjacent to the distal end region. An ultraviolet light-emitting member may be disposed within the expandable framework. A covering may be disposed along an outer surface of the expandable framework.

Abstract: A radiopaque anchor and delivery device system may comprise a pigtail catheter and a radiopaque anchor. The pigtail catheter may be a dual lumen catheter configured to deploy the radiopaque anchor and delivery a radiopaque fluid or contrast agent. The implantable radiopaque anchor may be slidably disposed within and deployable from a lumen of the elongate shaft.

Abstract: Methods and systems for securing a medical implant at a valve. An illustrative method may include advancing a delivery system though a vasculature to a target location. At the target location, the delivery system may be proximally retracted to expose a medical implant carried within a lumen of the delivery system. The medical implant may be radially expanded from a collapsed delivery configuration an expanded deployed configuration. A fixation mechanism delivery system may be advanced through the vasculature to the target location. A first fixation mechanism configured to engage a native tissue and a portion of the medical implant may be deployed from the fixation mechanism delivery system. After deploying the fixation mechanism, the medical implant may be released from the delivery system.

Abstract: An occlusive implant includes an expandable framework that is configured to shift between a collapsed configuration and an expanded configuration. An occlusive member is disposed along at least a portion of the expandable framework. At least part of the occlusive implant is configured to repel fibrinogen. In some cases, the occlusive implant may be configured for placement within a left atrial appendage (LAA) of a patient's heart.

Abstract: An implant system and method of delivery includes a catheter system including a sling catheter having a plurality of distal openings and a delivery catheter, disposed within the sling catheter and having a distal port. Suture coupled anchors may be sequentially delivered by the delivery catheter to a cardiac treatment site by aligning the port of the delivery catheter with different openings of the sling catheter and pushing the anchor through the port and the sling catheter to embed the anchor into cardiac tissue such as tissue of a papillary muscle. Each anchor may have a linear configuration for translation within the delivery catheter and a biased configuration that inhibits its reentry into the sling catheter once deployed. Once all anchors are deployed, the suture may be tightened, the anchored portion of the sling catheter may be detached, and the catheter system withdrawn.

Abstract: A system for transluminal delivery of cardiac repair components into a heart includes a visualization catheter having an imaging device disposed at a distal end. An anchor lumen extends through the visualization catheter to an anchor port disposed on its distal wall. An adjustment mechanism is translatably disposed within the visualization catheter and configured to adjust a height of the anchor port relative to a septum of the heart. The imaging device may be used to visualize the placement of anchors expelled from the port into a tissue target. The adjustment mechanism enables accurate placement of multiple anchors along a consistent axis within the heart by rotating the visualization catheter to align the port with different tissue targets. The anchors may be coupled to sutures and the tissue targets may include papillary muscles that are reconfigured by pulling together and securing the sutures to approximate a healthy papillary structure.

Abstract: An occlusive implant includes an expandable framework that is configured to shift between a collapsed configuration and an expanded configuration. An occlusive member is disposed along at least a portion of the expandable framework. At least part of the occlusive implant is configured to repel fibrinogen. In some cases, the occlusive implant may be configured for placement within a left atrial appendage (LAA) of a patient's heart.

Abstract: A guidewire system may include a guidewire having a relatively stiff proximal section and a relatively flexible distal section joined by a transition region, and a TAVI device slidably disposed on the guidewire. The guidewire may include an expandable element disposed about the transition region. The expandable element may be configured to expand from a collapsed configuration to an expanded configuration. The guidewire may include an expandable element disposed at the distal end. The distal section may be pre-configured to form more than one distal loop. A method of protecting an apex of a left ventricle during a TAVI procedure may include inserting a guidewire into the left ventricle, positioning a transition region adjacent the apex, expanding an expandable element such that the expandable element spans the apex, advancing a TAVI device distally over the guidewire to an aortic valve, and performing a TAVI procedure at the aortic valve.

Abstract: Medical systems and methods for making and using medical systems are disclosed. An example may include a catheter, a sensor, and a pump configured to remove contrast from a vascular system. The catheter may have a lumen through which the pump may suction contrast. The sensor may be positioned distal of and upstream of a distal end of the aspiration lumen and the pump may initiate suction through the lumen in response to a value sensed by the sensor reaching and/or going beyond a threshold value. The catheter may include an expandable member configured to expand in response to a value sensed by the sensor reaching and/or going beyond a threshold value. The sensor may be supported by a distal extension of the catheter or an elongate member configured to extend through and/or along the catheter to position the sensor distal of the distal end of the aspiration lumen.

Abstract: A left atrial appendage closure device system may include an access sheath having a lumen, a delivery sheath slidably disposed within the lumen of the access sheath, and a left atrial appendage closure device slidably disposed within a distal portion of the delivery sheath. The access sheath may include a pre-curved portion adjacent a distal tip of the access sheath. A method of deploying a left atrial appendage closure device may include advancing an access sheath through the superior vena cava and into the right atrium of the heart, advancing a delivery sheath through the access sheath into the left atrium, and deploying the left atrial appendage closure device within the ostium of the left atrial appendage.

Abstract: Aspects of positioning devices, methods, and systems are disclosed. An exemplary method comprises: moving a distal end of a tube into a body, the tube including a lumen and a shaft in the lumen, the shaft having a transducer; sending a first signal to the transducer; passing, with the transducer, in response to the first signal, a wave energy into the body; receiving, with the transducer, a reflected portion of the wave energy; generating, with the transducer, a second signal in response to the reflected portion of the wave energy; determining, with a processor, an indicia of the body in response to the second signal; and identifying, with the indicia, a targeted issue in the body; positioning the distal end of the tube at the targeted tissue in response to the indicia; and removing a portion of the targeted tissue with the distal end of the tube.

Abstract: A guidewire system may include a guidewire having a relatively stiff proximal section and a relatively flexible distal section joined by a transition region, and a TAVI device slidably disposed on the guidewire. The guidewire may include an expandable element disposed about the transition region. The expandable element may be configured to expand from a collapsed configuration to an expanded configuration. The guidewire may include an expandable element disposed at the distal end. The distal section may be pre-configured to form more than one distal loop. A method of protecting an apex of a left ventricle during a TAVI procedure may include inserting a guidewire into the left ventricle, positioning a transition region adjacent the apex, expanding an expandable element such that the expandable element spans the apex, advancing a TAVI device distally over the guidewire to an aortic valve, and performing a TAVI procedure at the aortic valve.

Abstract: A guidewire system may include a guidewire having a relatively stiff proximal section and a relatively flexible distal section joined by a transition region, and a TAVI device slidably disposed on the guidewire. The guidewire may include an expandable element disposed about the transition region. The expandable element may be configured to expand from a collapsed configuration to an expanded configuration. The guidewire may include an expandable element disposed at the distal end. The distal section may be pre-configured to form more than one distal loop. A method of protecting an apex of a left ventricle during a TAVI procedure may include inserting a guidewire into the left ventricle, positioning a transition region adjacent the apex, expanding an expandable element such that the expandable element spans the apex, advancing a TAVI device distally over the guidewire to an aortic valve, and performing a TAVI procedure at the aortic valve.

Abstract: A medical device for permanent implantation in a circulatory system of a patient may include an implant configured for percutaneous or minimally-invasive insertion into the patient, at least one connector fixedly attached to the implant and configured to releasably attach to a delivery device, the at least one connector being exposed to blood flow within the circulatory system following implantation, and an anti-thrombus feature configured to transition from an undeployed state to a deployed state.

Abstract: A catheter is disclosed, which is capable of delivering embolization beads for treating uterine fibroids. The elongate catheter shaft includes a radially expandable portion at its distal end, which can expand radially locally when an embolization bead passes through it. In some cases, the catheter shaft includes a non-expandable portion, with an inner diameter comparable to the bead diameter, between the handle and the radially expandable portion. In some cases, the radially expandable portion is made from a tubular braid, stretched longitudinally over a mandrel, and encased in a lubricious soft polymer while still stretched. In other cases, the radially expandable portion is made from a slotted nitinol tube, encased in a lubricious soft polymer below the nitinol transition temperature. The polymer is thick enough to prevent the encased element from returning to its unstretched diameter or a larger size above the transition temperature.

Abstract: A guidewire system may include a tubular guidewire including at least one lumen and a plurality of apertures disposed through an outer wall, and at least one pressure wire slidably disposed within the at least one lumen, the at least one pressure wire having at least one pressure sensor disposed thereon. A method of measuring a blood pressure gradient across a treatment site may include advancing the tubular guidewire to the treatment site, positioning at least one aperture distal and at least one aperture proximal of the treatment site, translating the pressure wire within the tubular guidewire, positioning the pressure wire such that a distal pressure sensor is disposed adjacent the at least one aperture distal of the treatment site, and a proximal pressure sensor is disposed adjacent the at least one aperture proximal of the treatment site, and measuring a blood pressure gradient across the treatment site.