Abstract: Pulsatile balloon catheter systems are provided. Aspects of the systems include: a pulse generator; and a balloon catheter assembly operably connected to the pulse generator. In embodiments, the balloon catheter assembly includes: a proximal connector operably connecting the balloon catheter assembly to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy; a distal balloon; and a catheter component, where the catheter component includes a fluidic passage operably positioned between the proximal connector and the distal balloon, which passage is configured to propagate the second pulse energy from the proximal connector along the fluid passage to the distal balloon. Also provided are balloon catheter assemblies and kits that include the same. Also provided are systems and methods for assessing vessel compliance in-vivo. Also provided are systems and methods for determining system state of balloon catheter systems.

Abstract: Microcatheter systems for crossing total occlusions are provided. Aspects of the systems include: a distal crosser unit and an actuator. In embodiments, the distal crosser unit comprises: a microcatheter having a guidewire lumen; a guidewire present in the guidewire lumen and extending beyond the distal end of the microcatheter; a proximal balloon attached to both the microcatheter and the guidewire, wherein the proximal balloon is configured to longitudinally expand; and a distal anchor member present on the guidewire. In such embodiments, the actuator is configured to sequentially inflate and deflate the proximal balloon such that the distal crosser unit progressively moves across a chronic total occlusion. Also provided are methods for modulating a total occlusion, e.g., by crossing a total occlusion or modifying a proximal cap thereof, e.g., by producing a divot or hole in the proximal cap.

Abstract: A microcatheter system for crossing total occlusions including a distal crosser unit and an actuator is disclosed. The distal crosser unit comprises: a microcatheter having a guidewire lumen; a guidewire present in the guidewire lumen and extending beyond the distal end of the microcatheter; a proximal balloon attached to both the microcatheter and the guidewire, wherein the proximal balloon is configured to longitudinally expand; and a distal anchor member present on the guidewire. And the actuator is configured to sequentially inflate and deflate the proximal balloon such that the distal crosser unit progressively moves across a chronic total occlusion.

Abstract: Pulsatile balloon catheter systems are provided. Aspects of the systems include: a pulse generator; and a balloon catheter assembly operably connected to the pulse generator. In embodiments, the balloon catheter assembly includes: a proximal connector operably connecting the balloon catheter assembly to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy; a distal balloon; and a catheter component, where the catheter component includes a fluidic passage operably positioned between the proximal connector and the distal balloon, which passage is configured to propagate the second pulse energy from the proximal connector along the fluid passage to the distal balloon. Also provided are balloon catheter assemblies and kits that include the same. Also provided are systems and methods for assessing vessel compliance in-vivo. Also provided are systems and methods for determining system state of balloon catheter systems.

Abstract: Pulsatile balloon catheter systems are provided. Aspects of the systems include: a pulse generator; and a balloon catheter assembly operably connected to the pulse generator. In embodiments, the balloon catheter assembly includes: a proximal connector operably connecting the balloon catheter assembly to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy; a distal balloon; and a catheter component, where the catheter component includes a fluidic passage operably positioned between the proximal connector and the distal balloon, which passage is configured to propagate the second pulse energy from the proximal connector along the fluid passage to the distal balloon. Also provided are balloon catheter assemblies and kits that include the same. Also provided are systems and methods for assessing vessel compliance in-vivo. Also provided are systems and methods for determining system state of balloon catheter systems.

Abstract: Systems configured for performing atherectomy and pulsatile intravascular lithotripsy are provided. Aspects of the systems include a console; and a handle, wherein the handle is configured to be interchangeably operably connectable to: an atherectomy subsystem, and a pulsatile intravascular lithotripsy subsystem. Also provided are components of the systems that include the same. The systems and assemblies find use in a variety of different applications, including combined atherectomy and pulsatile intravascular lithotripsy procedures as well as balloon angioplasty applications.

Abstract: Pulsatile balloon catheter systems are provided. Aspects of the systems include: a pulse generator; and a balloon catheter assembly operably connected to the pulse generator. In embodiments, the balloon catheter assembly includes: a proximal connector operably connecting the balloon catheter assembly to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy; a distal balloon; and a catheter component, where the catheter component includes a fluidic passage operably positioned between the proximal connector and the distal balloon, which passage is configured to propagate the second pulse energy from the proximal connector along the fluid passage to the distal balloon. Also provided are balloon catheter assemblies and kits that include the same. Also provided are systems and methods for assessing vessel compliance in-vivo. Also provided are systems and methods for determining system state of balloon catheter systems.

Abstract: A microcatheter system for crossing total occlusions including a distal crosser unit and an actuator is disclosed. The distal crosser unit comprises: a microcatheter having a guidewire lumen; a guidewire present in the guidewire lumen and extending beyond the distal end of the microcatheter; a proximal balloon attached to both the microcatheter and the guidewire, wherein the proximal balloon is configured to longitudinally expand; and a distal anchor member present on the guidewire. And the actuator is configured to sequentially inflate and deflate the proximal balloon such that the distal crosser unit progressively moves across a chronic total occlusion.

Abstract: Pulsatile balloon catheter systems are provided. Aspects of the systems include: a pulse generator; and a balloon catheter assembly operably connected to the pulse generator. In embodiments, the balloon catheter assembly includes: a proximal connector operably connecting the balloon catheter assembly to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy; a distal balloon; and a catheter component, where the catheter component includes a fluidic passage operably positioned between the proximal connector and the distal balloon, which passage is configured to propagate the second pulse energy from the proximal connector along the fluid passage to the distal balloon. Also provided are balloon catheter assemblies and kits that include the same. Also provided are systems and methods for assessing vessel compliance in-vivo. Also provided are systems and methods for determining system state of balloon catheter systems.

Abstract: A dynamic balloon angioplasty system for applying a dynamic pressure to fracture hardened materials embedded within an elastic conduit. The system having a pressure source system outputting at least a first predetermined pressure from a pressure source outlet, and an angioplasty unit fluidly coupled to the pressure source outlet receiving at least the first predetermined pressure. The angioplasty unit having an angioplasty inflation device, an angioplasty balloon connector, and an oscillating mechanism selectively actuated to output a plurality of pressure pulses to the angioplasty balloon via a fluid communication path. A control system is configured to determine an optimal hydraulic pressure oscillation frequency and amplitude for a given procedure and output a control signal to the oscillating mechanism, and monitor a pressure signal to detect fracture of the hardened material within the elastic conduit or system failure or leakage.

Abstract: Pulsatile balloon catheter systems are provided. Aspects of the systems include: a pulse generator; and a balloon catheter assembly operably connected to the pulse generator. In embodiments, the balloon catheter assembly includes: a proximal connector operably connecting the balloon catheter assembly to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy; a distal balloon; and a catheter component, where the catheter component includes a fluidic passage operably positioned between the proximal connector and the distal balloon, which passage is configured to propagate the second pulse energy from the proximal connector along the fluid passage to the distal balloon. Also provided are balloon catheter assemblies and kits that include the same. Also provided are systems and methods for assessing vessel compliance in-vivo. Also provided are systems and methods for determining system state of balloon catheter systems.

Abstract: A dynamic balloon angioplasty system for applying a dynamic pressure to fracture hardened materials embedded within an elastic conduit. The system having a pressure source system outputting at least a first predetermined pressure from a pressure source outlet, and an angioplasty unit fluidly coupled to the pressure source outlet receiving at least the first predetermined pressure. The angioplasty unit having an angioplasty inflation device, an angioplasty balloon connector, and an oscillating mechanism selectively actuated to output a plurality of pressure pulses to the angioplasty balloon via a fluid communication path. A control system is configured to determine an optimal hydraulic pressure oscillation frequency and amplitude for a given procedure and output a control signal to the oscillating mechanism, and monitor a pressure signal to detect fracture of the hardened material within the elastic conduit or system failure or leakage.

Abstract: Methods related to catheter-based procedures are provided. Aspects of the methods of embodiments of the invention include performing a catheter-based procedure and communicating data regarding the catheter-based procedure to and/or from a catheter-based procedure information module. Catheter-based procedure information modules may be remote modules. Also provided are systems comprising a first processor comprising memory operably coupled to the first processor, wherein the memory comprises instructions stored thereon, which, when executed by the first processor, cause the first processor to: receive data regarding a catheter-based procedure from a catheter-based system, and transmit data regarding a catheter-based procedure to a catheter-based system.

Abstract: Systems for imparting pulsatile energy to cardiovascular tissue are provided. Aspects of the systems include a console assembly comprising a potential source, a manifold assembly operably connected to an output of the console assembly, wherein the manifold assembly comprises an oscillator configured to generate pulse energy from energy transmitted from the potential source and a catheter assembly operably connected to an output of the manifold assembly.

Abstract: A dynamic balloon angioplasty system for applying a dynamic pressure to fracture hardened materials embedded within an elastic conduit. The system having a pressure source system outputting at least a first predetermined pressure from a pressure source outlet, and an angioplasty unit fluidly coupled to the pressure source outlet receiving at least the first predetermined pressure. The angioplasty unit having an angioplasty inflation device, an angioplasty balloon connector, and an oscillating mechanism selectively actuated to output a plurality of pressure pulses to the angioplasty balloon via a fluid communication path. A control system is configured to determine an optimal hydraulic pressure oscillation frequency and amplitude for a given procedure and output a control signal to the oscillating mechanism, and monitor a pressure signal to detect fracture of the hardened material within the elastic conduit or system failure or leakage.

Abstract: An additively manufactured ankle-foot orthosis. The ankle-foot orthosis includes an additively manufactured footplate and a calf cuff separate from the additively manufactured footplate. A pre-fabricated strut connects the additively manufactured footplate to the additively manufactured calf cuff and includes thickness and width adapted to define a patient-specific stiffness about an ankle joint of a patient. The stiffness of the pre-fabricated strut is suited to one or more of a gait need or a gait requirement of each patient, and the additively manufactured footplate has a portion with a shape complementary to a shape of a portion of the pre-fabricated strut. So configured, a collective shape and volume of the additively manufactured footplate and the pre-fabricated strut together are adapted to fit inside a shoe of the patient.

Abstract: A dynamic balloon angioplasty system for applying a dynamic pressure to fracture hardened materials embedded within an elastic conduit. The system having a pressure source system outputting at least a first predetermined pressure from a pressure source outlet, and an angioplasty unit fluidly coupled to the pressure source outlet receiving at least the first predetermined pressure. The angioplasty unit having an angioplasty inflation device, an angioplasty balloon connector, and an oscillating mechanism selectively actuated to output a plurality of pressure pulses to the angioplasty balloon via a fluid communication path. A control system is configured to determine an optimal hydraulic pressure oscillation frequency and amplitude for a given procedure and output a control signal to the oscillating mechanism, and monitor a pressure signal to detect fracture of the hardened material within the elastic conduit or system failure or leakage.

Abstract: Pulsatile balloon catheter systems are provided. Aspects of the systems include: a pulse generator; and a balloon catheter assembly operably connected to the pulse generator. In embodiments, the balloon catheter assembly includes: a proximal connector operably connecting the balloon catheter assembly to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy; a distal balloon; and a catheter component, where the catheter component includes a fluidic passage operably positioned between the proximal connector and the distal balloon, which passage is configured to propagate the second pulse energy from the proximal connector along the fluid passage to the distal balloon. Also provided are balloon catheter assemblies and kits that include the same. Also provided are systems and methods for assessing vessel compliance in-vivo. Also provided are systems and methods for determining system state of balloon catheter systems.

Abstract: A mechanical arm assembly is generally presented. The mechanical arm assembly comprises a plurality of joints including a first joint, one or more intermediate joints, and a terminal joint connected in consecutive series and each configured to rotate with respect to any respective adjacent joints. The first, intermediate, and terminal joints are configured with their base and top arranged at a given angle with respect to the normal plane of the joint, such as parallel to the normal plane or 22.5 degrees with respect to the normal plane. Rotation of the joints is controlled by control wires. The control wires may be routed internally through the joints or externally outside of the joints.