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: 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.

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: A catheter structure, such as a balloon catheter (30), guidewire, or the like, with markings (32) perceptible outside of the vasculature is for use in determining at a location external to the body the position of the catheter structure relative to a treatment area. Related kits are also disclosed.

Abstract: An apparatus for scoring and treating a lesion includes a catheter, a scoring device, in the form of a rotary scoring element, and a drive unit for displacing the rotary scoring element and slicing the lesion. The rotary scoring element is displaceable between a stowed position fully contained within the catheter and a deployed position partially projecting from the catheter.

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. The scoring wires are 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. The scoring wires attach to a source of vibrations. The scoring wires are made of a helical coil.

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. The scoring wires are 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. The scoring wires attach to a source of vibrations. The scoring wires are made of a helical coil.

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 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. The delivery assembly further includes a sled assembly removably coupled to the console at the vial containment region and a safety shield removably coupled to the console over the vial containment region such that the vial engagement mechanism and the sled assembly are encapsulated within the safety shield when the safety shield is coupled thereto. The sled assembly, the vial assembly, and the safety shield are configured to inhibit radioactive emissions from within the vial containment region.

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: 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: 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 scoring and treating a lesion includes a catheter, a scoring device, in the form of a rotary scoring element, and a drive unit for displacing the rotary scoring element and slicing the lesion. The rotary scoring element is displaceable between a stowed position fully contained within the catheter and a deployed position partially projecting from the catheter.