Abstract: A device for introduction into a body vessel includes a shaft (105), a balloon (115) positioned at the distal end of the shaft (105), and at least one longitudinal scoring wire (135) to score a vascular lesion attached to the distal end of the shaft (105), disposed over the balloon (115). The shaft (105) includes a support (119), such as a wire or tube having one or more spirally cut portions (119A, 119B), which improves pushability and trackability, thereby allowing for use with an external guidewire in a “short rapid exchange” (SRX) format. The balloon (115) expands when fluid is delivered to the balloon (115) through the inflation lumen. This expansion pushes the scoring wire and guidewire against the vascular lesion.

Abstract: Radiation sealing assemblies and methods of use of a radiation containment component for sealing a microcatheter used to deliver a mixed particulate from a particulate delivery device for disposal, which may include a proximal end and a distal end disposed opposite the proximal end. The proximal end is configured to connect to and cover a distal portion of a delivery line connector of the particulate delivery device, the delivery line connector configured to receive the mixed particulate from the particulate delivery device. The distal end is configured to be disposed over and contain the microcatheter connected to the delivery line connector after use, and the distal end is configured to seal together to contain the microcatheter prior to disposal.

Abstract: A vial assembly includes a vial and a needle with at least one port. The vial includes a particulate material, a septum, a neck region including a first width, and a particulate region including a second width greater than the first width. The vial assembly is configured to move to a locked position. The needle may be configured to puncture the septum with the at least one port configured to be in the neck region when in the locked position. The at least one port may be configured to inject a fluid into the vial assembly to mix with the particulate material upon actuation of a vial engagement mechanism in a first direction and to receive a resulting mixed fluid from the vial assembly upon actuation of the vial engagement mechanism in a second direction opposite the first direction.

Abstract: A septum for sealing a vial assembly having a vial including a neck region including a first width comprises a top surface, a bottom surface disposed opposite the top surface, a radially extending outer side surface disposed between the top surface and the bottom surface, a plurality of ribs disposed on the top surface, and a plurality of valleys. Each valley may be disposed between to space apart at least two ribs of the plurality of ribs. The plurality of ribs may include at least an interior first rib, an intermediate rib, and an exterior outer rib. The interior first rib may include an outer wall, the outer wall configured to radially compress against an interior wall of the neck region of the vial, the outer wall including a height that is greater than a height of the intermediate rib and the exterior outer rib.

Abstract: Systems and methods involve a vial assembly system comprising a vial assembly and needle. The vial assembly comprises a septum, neck region, and particulate region comprising a bypass valve, the neck region comprising a top, bottom, and sidewall. The needle comprises a port and a tip configured to puncture the septum that is configured to receive the needle such that the port is disposed in the neck region. A bypass path includes a first end and a second end, the bypass valve is connected to the first end, the second end ends at or within the sidewall, the bypass path is configured to provide a fluid flow path to the needle alternate to a first path upon a build-up of pressure for fluid flow in the vial assembly, and the first path is directly disposed in the vial assembly between the particulate region and the neck region.

Abstract: A device for introduction into a body vessel includes a shaft, a balloon positioned at the distal end of the shaft, a guidewire disposed longitudinally within the shaft to receive a guidewire during use, a balloon disposed at the distal end of the shaft, and longitudinal scoring wires to score a vascular lesion attached to the distal end of the shaft, disposed over the balloon and disposed within the shaft. The proximal ends are welded or otherwise affixed to a spring mounted in the handle. The balloon expands when fluid is delivered to the balloon through the inflation lumen. This expansion pushes the scoring wires against the vascular lesion.

Abstract: In one aspect, a connector assembly includes a delivery conduit defining a conduit lumen and a securable connector configured to secure the delivery conduit to a medical device hub defining a medical device hub lumen. The conduit lumen includes a constant diameter region along a portion of the delivery conduit and a transition region extending from the delivery conduit to the distal end. A transition region diameter of the transition region gradually increases from the constant diameter region to a distal end of the delivery conduit. The securable connector is coupled to an outer surface of the delivery conduit and is slidable along a portion thereof. The securable connector is configured to receive the medical device hub. The securable connector is secured relative to the delivery conduit so as to fluidically couple the conduit lumen with the medical device hub lumen.

Abstract: A medical device for treating coronary artery disease, peripheral arterial disease or varicose veins includes an elongated support and a heat expandable element of muscle polymer carried on that elongated support. The medical device may also include a heating element. When activated, the heating element produces heat that causes the muscle polymer to expand into a position in closer proximity to the tissue to be treated.

Abstract: Systems and methods to use an adaptor component for a particulate material delivery assembly to deliver a mixed particulate solution to a patient, the adaptor component including at least a pair of device connector ports. Each device connector port is configured to connect to a corresponding delivery line connector of a particulate delivery device to receive the mixed particulate solution. The adaptor component further includes a guidewire connector port configured to connect to a containment bag unit, the containment bag unit including a guidewire disposed therein and a catheter connector port configured to connect to a microcatheter to deliver the mixed particulate solution to the patient. The guidewire is configured to retract into and extend from the containment bag unit to position the microcatheter within the patient without disconnecting at least one of the pair of device connector ports from the delivery line connector of the particulate delivery device.

Abstract: Methods and systems for determination of flow parameters of administered fluid from a radioembolization delivery device may include translationally moving a device delivery arm of the radioembolization delivery device in a translational direction, wherein the device delivery arm is coupled to a syringe holder such that move in the translational direction one of proximally or distally advances the syringe holder; sensing, via one or more pattern sensors, a corresponding movement of a pattern associated with the translational device delivery arm movement as a sensed pattern movement; generating, via the one or more pattern sensors, one or more output signals based on the sensed pattern movement; and generating, via a processor, a flow rate of the administered fluid, a flow amount of the administered fluid, and/or the translational direction of movement of the device delivery arm with respect to the syringe holder based on the one or more output signals.

Abstract: In the present disclosure, embodiments of dual-stage syringes are disclosed along with delivery systems incorporating the dual-stage syringes. Embodiments of the dual-stage syringes described herein include sleeved dual-stage syringes, turn-key dual-stage syringes and dual-stage syringes including one or more one-way valves.

Abstract: A tubing component, and methods of forming, for a particulate material delivery assembly including a particulate delivery device to deliver a mixed particulate solution to a patient. The tubing component includes a material including a material density, and a determined thickness sufficient to shield a delivery line connector of a particulate delivery device from at least 90% of a radiation dose. The delivery line connector is configured to receive the mixed particulate solution from the particulate delivery device of the particulate material delivery assembly, and the determined thickness of the tubing component is calculated based on the material density to achieve shielding of the delivery line connector by the material of at least 90% of the radiation dose. The tubing component includes an integral wall of the delivery line connector, an outer sleeve configured to be removably disposed about the delivery line connector, or combinations thereof.

Abstract: An apparatus for demonstrating the use of a medical device includes a body adapted for receiving the medical device. The body includes at least a portion adapted for viewing the medical device when positioned in the body. A cover is provided for selectively covering the portion of the body adapted for viewing the medical device. A kit and related methods are also disclosed.

Abstract: Methods and systems for selection of dosimetry levels and sphere amounts of radioactive compounds for use in a radioembolization procedure for procedure planning may include inputting activity parameter information into a dosimetry portal of a dosimetry selection tool; determining a customized activity based on the activity parameter information and one or more customized activity algorithms; generating one or more sphere amount and dosage recommendations based on the customized activity and one or more dosimetry selection algorithms; selecting one of the one or more sphere amount and dosage recommendations as a selected sphere amount and dosage recommendation; and generating a radioactive compound order for the radioembolization procedure based on the customized activity and the selected sphere amount and dosage recommendation.

Abstract: An apparatus for cutting a wall of a vessel, such as scoring or slicing a lesion associated therewith. A catheter (10) includes a shaft (12) having a distal portion supporting a housing (20) including a first lateral passage (20a). A cutter (22) is adapted for moving from a retracted position within the housing (20) to a deployed position for at least partially projecting from the passage (20a). A expandable actuator (24) within the housing (20), such as an inflatable balloon (26), actuates the cutter (22) to move from the retracted position fully within the housing (20) to the deployed position at least partially projecting from the housing (20). More than one cutter (22?) may be provided, which cutters (22?) may be simultaneously actuated by the same actuator (26?).

Abstract: A device for introduction into a body vessel includes a shaft, a balloon positioned at the distal end of the shaft, a guidewire disposed longitudinally within the shaft to receive a guidewire during use, a balloon disposed at the distal end of the shaft, and longitudinal scoring wires to score a vascular lesion attached to the distal end of the shaft, disposed over the balloon and disposed within the shaft. The proximal ends are welded or otherwise affixed to a spring mounted in the handle. The balloon expands when fluid is delivered to the balloon through the inflation lumen. This expansion pushes the scoring wires against the vascular lesion.

Abstract: A device for introduction into a body vessel includes a shaft, a balloon positioned at the distal end of the shaft, a guidewire disposed longitudinally within the shaft to receive a guidewire during use, a balloon disposed at the distal end of the shaft, and longitudinal scoring wires to score a vascular lesion attached to the distal end of the shaft, disposed over the balloon and disposed within the shaft. The proximal ends are welded or otherwise affixed to a spring mounted in the handle. The balloon expands when fluid is delivered to the balloon through the inflation lumen. This expansion pushes the scoring wires against the vascular lesion.

Abstract: A vial assembly includes a vial and a needle with at least one port. The vial includes a particulate material, a septum, a neck region including a first width, and a particulate region including a second width greater than the first width. The vial assembly is configured to move to a locked position. The needle may be configured to puncture the septum with the at least one port configured to be in the neck region when in the locked position. The at least one port may be configured to inject a fluid into the vial assembly to mix with the particulate material upon actuation of a vial engagement mechanism in a first direction and to receive a resulting mixed fluid from the vial assembly upon actuation of the vial engagement mechanism in a second direction opposite the first direction.

Abstract: A delivery assembly includes a console including a vial containment region and a vial engagement mechanism extending from the console within the vial containment region. The engagement mechanism is configured to engage a vial assembly including a particulate material. The delivery assembly further includes a multi-port needle with a top distal port and bottom proximal port(s), the needle configured to puncture a septum of the vial assembly when the vial assembly is in the locked position, in which the top distal port is at a distance above the particulate material in the vial assembly. The ports are configured to inject a fluid into the vial assembly to mix with the particulate material upon actuation of the vial engagement mechanism in a first direction and to receive a resulting mixed fluid from the vial assembly upon actuation of the vial engagement mechanism in a second opposite direction.

Abstract: A medical device for treating coronary artery disease, peripheral arterial disease or varicose veins includes an elongated support and a heat expandable element of muscle polymer carried on that elongated support. The medical device may also include a heating element. When activated, the heating element produces heat that causes the muscle polymer to expand into a position in closer proximity to the tissue to be treated.