Abstract: A transseptal access system is disclosed. The system includes a radiofrequency perforation device including a core, a functional tip coupled to a distal end of the core, and a conductor extending along a length of the core. The conductor is insulated along a portion of its length and is electrically coupled to the functional tip.

Abstract: A perforation device for transseptal access system is disclosed. The perforation device includes an electrically conductive core comprising a proximal portion having a proximal portion length, and a distal portion having a distal portion length. The proximal portion is formed from a first material having a first modulus of elasticity, and the distal portion is formed from a second material having a second modulus of elasticity that is lower than the first modulus of elasticity. The perforation device further includes an exposed electrically conductive functional tip at a distal end of the core. Finally, the perforation device also includes an insulation layer over a portion of the core.

Abstract: Example cardiac pump systems are disclosed. An example cardiac pump system includes a cardiac pump coupled to a console. Further, the console includes a first display including a first visual representation of a first parameter of the cardiac pump system. Further, the first display includes a first status indicator and a second status indicator corresponding to the first parameter. Further, the first display is configured to display the first status indicator when the first parameter satisfies a first condition, and wherein the first display is configured to display the second status indicator when the first parameter satisfies a second condition.

Abstract: A safety lancet transseptal access system is disclosed. The system includes a housing having a proximal end and a distal end, the proximal end having an opening with a plunger and the distal end terminating in a housing wall, a housing lumen extending through the housing and a release mechanism coupled to the housing. The system further includes a puncture device spring connected to the plunger and a disk. The system further includes a puncture device connected to the disk. When the plunger is pushed towards the distal end of the housing, the puncture device spring compresses triggering the release mechanism which then causes the puncture device to be deployed past the housing wall. Additionally, once deployed, tension from the puncture device spring pulls the disk and the puncture device back into the housing to a neutral position.

Abstract: A dilator for facilitating access to a patient's heart and for coupling with a sheath including a sheath hub is disclosed. The dilator includes a dilator body having a proximal end portion and an opposite distal end portion, the distal end portion having a tapered tip portion, the body having a cylindrical wall defining an inner surface and an outer surface, the inner surface defining a dilator lumen extending through an entire length of the body. The dilator further includes an expandable membrane disposed over the body in the distal end portion, the membrane having an inner region in fluid communication with the dilator lumen.

Abstract: A pacing tool adapted for use with a guidewire to allow the guidewire to be used for pacing includes a body defining an elongate cavity adapted to receive a guidewire. A compressible electrical contact is disposed at a proximal end of the elongate cavity and is adapted to shorten axially when a proximal end of the guidewire makes contact with the compressible electrical contact. An electrical cable is electrically coupled with the compressible electrical contact and is adapted to be electrically coupled with a pacing system. The pacing tool may include a guidewire holder for releasably securing the guidewire within the elongate cavity.

Abstract: A guidewire may be used for delivering and implanting a replacement heart valve implant and may also be used for pacing the patient's heart during implantation of the replacement heart valve implant. The guidewire includes an elongate shaft including a distal section and a proximal section extending proximally from the distal section, a coiled portion disposed within the distal section, and one or more electrodes disposed within the coiled portion, the one or more electrodes adapted for pacing the heart. The proximal section is adapted to provide an electrical connection with a pacing system.

Abstract: A transseptal access system is disclosed. The system includes a radiofrequency perforation device having a proximal portion and a distal portion. The proximal portion has an electrically insulated outer surface, the distal portion is electrically conductive and terminates at a functional tip, and at least part of the distal portion is uninsulated. A tubular dilator is further disclosed comprising an elongated body terminating in a distal tip, a hub at the proximal end of the body, and a dilator lumen extending through the hub and the body. The dilator lumen is dimensioned to slidingly receive the radiofrequency perforation device. An electrical contact element disposed within the hub adjacent to the dilator lumen is also disclosed. When the radiofrequency perforation device is in a first position within the dilator lumen, the electrical contact element is in electrical engagement with the distal portion of the radiofrequency perforation device.

Abstract: A valve assembly embodiment includes first and second valve devices and a coupling mechanism. Each of the first and second valve devices can include first and second fluid pathways and first and second valve members respectively positioned at the first and second fluid pathways. Both the first and second valve members can have an open position that permits fluid flow and a closed position that prevents fluid flow along the first and second fluid pathways past the first and second valve members. The coupling mechanism can couple to each of the first and second valve members. When the valve assembly is actuated, the coupling mechanism can be configured to transition one or both of the first and second valve members between the open and closed positions.

Abstract: A hand-control device for controlling the operation of an injection system is described herein. The hand-control device includes one or more input components that receive input to control various operations of the injection system, including commanding the injection to perform a particular operation, changing an operational aspect of the injection system, and selecting an operational mode for the injection system. A communication unit of the hand-control device generates and conveys a signal for the injection system, and receives a command signal from the injection system. An output component outputs an indication, such as a light emission, a sound, or haptic feedback, in response to receiving the command signal. In some instances, this indication acts as a confirmation or failure of the intended input.

Abstract: An injection setup kit can include a manifold connector, a first packaging container, and a fluid line. The first packaging container can define a first closed interior volume that includes a patient interface connector having a patient interface inlet, a first patient interface outlet, and a valve configured to selectively permit fluid communication through the patient interface connector. The patient interface inlet can be fluidly connected to the manifold outlet. The fluid line can have a first fluid line end and a second fluid line end. The first fluid line end can be connected to the patient interface inlet within the first closed interior volume. The second fluid line end can extend outside of the first closed interior volume and be connected to a manifold outlet outside of the first closed interior volume.

Abstract: Conductors within an implantable medical lead that carry stimulation signal signals are at least partially embedded within a lead body of the medical lead over at least a portion of the length of the conductors while being surrounded by a radio frequency (RF) shield. A space between the shield and the conductors is filled by the presence of the lead body material such that body fluids that infiltrate the lead over time cannot pool in the space between the shield and the conductors. The dielectric properties of the lead body are retained and the capacitive coupling between the shield and the conductors continues to be inhibited such that current induced on the shield is inhibited from being channeled onto the conductors. Heating at the electrodes of the medical lead is prevented from becoming excessive.

Abstract: A shield located within an implantable medical lead may be terminated in various ways. The shield may be terminated by butt, scarf, lap, or other joints between insulation layers surrounding the lead and an insulation extension. For lap joints, a portion of an outer insulation layer may be removed and a replacement outer insulation layer is positioned in place of the removed outer insulation layer, where the replacement layer extends beyond an inner insulation layer and the shield. The replacement layer may also lap onto a portion of the insulation extension. The barbs may be located between the replacement layer and the inner insulation layer or the insulation extension. The shield wires have ends at the termination point that may be folded over individually or may be capped with a ring located within one of the insulation layers of the jacket.

Abstract: A shield located within an implantable medical lead may be terminated in various ways at a metal connector. The shield may be terminated by various joints including butt, scarf, lap, or other joints between insulation layers surrounding the lead and an insulation extension. The shield may terminate with a physical and electrical connection to a single metal connector. The shield may terminate with a physical and electrical connection by passing between an overlapping pair of inner and outer metal connectors. The metal connectors may include features such as teeth or threads that penetrate the insulation layers of the lead. The shield may terminate with a physical and electrical connection by exiting a jacket of a lead adjacent to a metal connector and lapping onto the metal connector.

Abstract: An injection setup kit can include a manifold connector, a first packaging container, and a fluid line. The first packaging container can define a first closed interior volume that includes a patient interface connector having a patient interface inlet, a first patient interface outlet, and a valve configured to selectively permit fluid communication through the patient interface connector. The patient interface inlet can be fluidly connected to the manifold outlet. The fluid line can have a first fluid line end and a second fluid line end. The first fluid line end can be connected to the patient interface inlet within the first closed interior volume. The second fluid line end can extend outside of the first closed interior volume and be connected to a manifold outlet outside of the first closed interior volume.

Abstract: A touchscreen cover assembly embodiment is configured to create a sterile interface between a touchscreen and a user and includes a sterile frame and a sterile cover member. The sterile frame includes a forward frame surface and a rearward frame surface opposite the forward frame surface. The sterile frame defines an interior opening, and the sterile frame is configured to be secured to the touchscreen such that the rearward frame surface faces the touchscreen and the interior opening is aligned with a user interface of the touchscreen. The sterile cover member includes a forward cover portion and a rearward cover portion. The sterile cover member is configured to be secured to the touchscreen by the sterile frame such that the forward cover portion is positioned between the interior opening and the user interface of the touchscreen and the rearward cover portion is positioned over a housing of the touchscreen.

Abstract: Radiopaque markers represent that a lead is suitable for a particular medical procedure such as a magnetic resonance image scan and are added to the lead or related device. The markers may be added after implantation of the lead in various ways including suturing, gluing, crimping, or clamping a radiopaque tag to the lead or to the device. The markers may be added by placing a radiopaque coil about the lead, and the radiopaque coil may radially contract against the lead to obtain a fixed position. The markers may be added by placing a polymer structure onto the lead where the polymer structure includes a radiopaque marker within it. The polymer structure may include a cylindrical aperture that contracts against the lead to fix the position of the polymer structure. The polymer structure may form a lead anchor that includes suture wings that can be sutured to the lead.

Abstract: A hand-control device for controlling the operation of an injection system is described herein. The hand-control device includes one or more input components that receive input to control various operations of the injection system, including commanding the injection to perform a particular operation, changing an operational aspect of the injection system, and selecting an operational mode for the injection system. A communication unit of the hand-control device generates and conveys a signal for the injection system, and receives a command signal from the injection system. An output component outputs an indication, such as a light emission, a sound, or haptic feedback, in response to receiving the command signal. In some instances, this indication acts as a confirmation or failure of the intended input.

Abstract: A shield located within an implantable medical lead may be terminated in various ways at a metal connector. The shield may be terminated by various joints including butt, scarf, lap, or other joints between insulation layers surrounding the lead and an insulation extension. The shield may terminate with a physical and electrical connection to a single metal connector. The shield may terminate with a physical and electrical connection by passing between an overlapping pair of inner and outer metal connectors. The metal connectors may include features such as teeth or threads that penetrate the insulation layers of the lead. The shield may terminate with a physical and electrical connection by exiting a jacket of a lead adjacent to a metal connector and lapping onto the metal connector.

Abstract: Medical lead bodies that are paired each include a braided conductive shield. The braided conductive shield of one lead body has a value for a physical parameter that differs from a value for the physical parameter of the second lead body. The difference in values of the physical parameter for the paired lead bodies results in a reduction in heating from exposure of the lead bodies to radiofrequency energy at electrodes associated with the lead bodies. The lead bodies may be paired by being implanted adjacently to one another. The lead bodies may be further paired by being coupled to a same distal body, such as a paddle containing the electrodes.