Abstract: Medical devices including a balloon and methods of making medical devices including a balloon are provided. The medical device includes a tubular element, a balloon, and a barrier between the tubular element and the balloon. When air is pushed into one end of the medical device, the balloon may be inflated. The method includes applying a barrier to a tubular element, applying an elastomer solution to the barrier and at least a part of the tubular element to form a coating, and curing the coating to form the balloon.

Abstract: Medical devices including a balloon-actuated sheath are provided. The medical devices include a tubular body, a tooltip, a balloon, and a tubular sheath translatably coupled to the balloon. Medical devices including a balloon-actuated distal cap are provided. The medical devices include a tubular body, a tooltip, a balloon, and a distal cap translatably coupled to the balloon. When air is pushed into one end of the medical device, the balloon may inflate, translating the tubular sheath or distal cap along a longitudinal axis from a retracted position to an extended position. When in the extended position, the tubular sheath at least partially surrounds the tooltip. When in the extended position, the distal cap at least partially opens fluid communication between the tooltip and the environment.

Abstract: Systems and methods of manufacturing 3D printed medical devices. The method includes feeding a first filament and a second filament into an interior cavity of a heating cartridge and melting each of the filaments on a substrate. The heating cartridge is then moved linearly and rotationally relative to the substrate to form a jacket including material from each of the first and second filaments. Further, rotating the substrate provides a uniform mixture and creates support rings between the filament materials within the structure of the jacket.

Abstract: Systems and methods for manufacturing elongate medical devices including internal components embedded between multiple jacket layers. The system including a heating cartridge, a heating element, a filament handling system, a substrate handling system, and a controller to feed and melt each of the filaments for forming the multiple jacket layers. The system may include a single heating cartridge adapted to make multiple passes to form a first and second jacket or multiple heating cartridges that sequentially form a first and second jacket.

Abstract: Systems and methods for manufacturing an elongate medical device including various surface features. The system including a heating cartridge, a heating element, a filament handling system, a substrate handling system, a controller, and one or more additional components adapted to form the surface features on the medical device. The heating element melts a filament material within the heating cartridge to form a jacket of the medical device and the one or more additional components engages the outer surface of the jacket to create surface features.

Abstract: Systems and methods for manufacturing elongate medical devices including internal components embedded between multiple jacket layers. The system including a heating cartridge, a heating element, a filament handling system, a substrate handling system, and a controller to feed and melt each of the filaments for forming the multiple jacket layers. The system may include a single heating cartridge adapted to make multiple passes to form a first and second jacket or multiple heating cartridges that sequentially form a first and second jacket.

Abstract: A medical lead system including an elongated lead body configured to extend through vasculature of a patient. The lead body mechanically supports a fixation member extending distal to a distal end of the lead body. A balloon is affixed to a distal portion of the lead body. The balloon is configured to inflate to extend distal to the distal end of the lead body. The fixation member is configured to extend within a distal cavity defined by the inflated balloon. The medical lead system is configured such that an electrode mechanically supported by the fixation member may electrically communicate with tissue of the patient when the balloon is in the inflated configuration.

Abstract: Implantable apparatus includes two or more alignable marker elements, and systems and methods for manufacturing such implantable apparatus, and methods to utilize such implantable apparatus. For example, the implantable apparatus may include a first alignable marker element and a second alignable marker element that may be used to ensure proper alignment with a target site.

Abstract: Medical devices that provide for selected curve deflection in multiple planes such that three-dimensional shapes can be formed in the medical devices by placing a pull wire extending through the catheter in tension, as well as methods of manufacturing and using the medical devices. The medical devices may include selected portions in which the location of the pull wire changes circumferentially and/or radially to provide for the selected curve deflection. The medical devices may include, in addition to, or in place of changes in pull wire location, selected portions having exhibiting changes in rigidity to provide for the selected curve deflection.

Abstract: Medical devices that provide for selected curve deflection in multiple planes such that three-dimensional shapes can be formed in the medical devices by placing a pull wire extending through the catheter in tension, as well as methods of manufacturing and using the medical devices. The medical devices may include selected portions in which the location of the pull wire changes circumferentially and/or radially to provide for the selected curve deflection. The medical devices may include, in addition to, or in place of changes in pull wire location, selected portions having exhibiting changes in rigidity to provide for the selected curve deflection.

Abstract: Systems and methods of manufacturing 3D printed medical devices. The method includes feeding a first filament and a second filament into an interior cavity of a heating cartridge and melting each of the filaments on a substrate. The heating cartridge is then moved linearly and rotationally relative to the substrate to form a jacket including material from each of the first and second filaments. Further, rotating the substrate provides a uniform mixture and creates support rings between the filament materials within the structure of the jacket.

Abstract: Systems and methods for manufacturing elongate medical devices including internal components embedded between multiple jacket layers. The system including a heating cartridge, a heating element, a filament handling system, a substrate handling system, and a controller to feed and melt each of the filaments for forming the multiple jacket layers. The system may include a single heating cartridge adapted to make multiple passes to form a first and second jacket or multiple heating cartridges that sequentially form a first and second jacket.

Abstract: Systems and methods for manufacturing an elongate medical device including various surface features. The system including a heating cartridge, a heating element, a filament handling system, a substrate handling system, a controller, and one or more additional components adapted to form the surface features on the medical device. The heating element melts a filament material within the heating cartridge to form a jacket of the medical device and the one or more additional components engages the outer surface of the jacket to create surface features.

Abstract: A filament wrapping and reflow system and a method therefrom. The method including wrapping a filament around an elongate substrate along a longitudinal direction between a proximal end of the elongate substrate and a distal end of the elongate substrate. The method also including melting the filament to form at least a portion of the elongate medical device. The system including a substrate system, a filament system, a heater, one or more actuators, and a controller.