Abstract: Various methods for optimizing coating of medical devices, such as balloon catheters are disclosed. One method configures catheter balloon folds based on balloon diameter and volume. Other methods include using a specifically-sized protective sheath, using a vacuum, using pressure, pulling the balloon through a coating solution, using at least one spacer or a wick between at least one fold for metering a therapeutic coating into the folds of the balloon, placing an intermediate layer between the balloon and the therapeutic coating, placing a soluble film having a therapeutic agent around the catheter balloon or inside the folds, and any combination thereof. Balloon catheters and catheter balloons having a specific folding configuration, a specifically-sized protective sheath, an intermediate layer, or a soluble film are also disclosed.

Abstract: A system for delivering fluid to a patient includes a container suitable for holding a fluid and an enclosure to shield the fluid. The system further includes a pump device capable of pumping fluid from the container and delivering the fluid to the patient, and the container adapted to be attachable to the pump device.

Abstract: A catheter including at least one distal opening positioned at or near the distal end and at least one proximal opening near the proximal end and proximal to the at least one distal opening is described. The catheter may be configured for delivering at least a first fluid through the at least one distal opening to a central circulation system of a patient and delivering at least a second fluid through the at least one proximal opening to a peripheral circulation system of the patient.

Abstract: A hazardous fluid transport container and a hazardous fluid delivery system are disclosed. The hazardous fluid transport container includes a housing enclosing an at least partially shielded enclosure. First and second fluid path elements are disposed within the housing, with the first fluid path element and second fluid path element fluidly coupled together. A pump unit may be provided for dispensing fluid from the first and second fluid path elements optionally into a third fluid path element. Also, methods for priming the hazardous fluid transport container and for mitigating laminar flow injection bolus spreading are disclosed. Additionally, disclosed is a radioactive fluid transport container for a syringe or other container. The radioactive fluid transport container allows the syringe or container to be used in an injection procedure without removal from the container.

Abstract: A system for the collection, management, and dissemination of information relating at least to a medical procedure is disclosed. The system includes a user interface adapted to provide raw data information at least about one of a patient, the medical procedure, and a result of the medical procedure. A medical device communicates with the user interface, receives the raw data information from the user interface, and generates operational information during use. A central database communicates at least with the medical device and receives data from the medical device. The central database is used to create related entries based on the raw data information and the operational information and optionally transmits the related entry to the medical device or the medical device user. The related entry includes information that provides guidance based on previously tabulated, related medical procedures.

Abstract: A catheter includes a pressure actuated seal within a manifold. A catheter body is coupled with the manifold, and a manifold lumen and catheter lumen are configured to receive pressurized fluids. The pressure actuated seal includes a pressure actuated seal element having a seal element lumen. The seal element lumen is in communication with the manifold and catheter lumens. The pressure actuated seal element is deformable between an open configuration and a sealed configuration. In the sealed configuration, the pressurized fluid in the manifold presses on the pressure actuated seal element along a first seal face. The pressure actuated seal element compresses inwardly around the seal element lumen according to the pressure of the pressurized fluid. In the open configuration, the pressure actuated seal element relaxes in the absence of the pressurized fluid, and the seal element lumen is open and configured to allow passage of an instrument.

Abstract: A system for delivering fluid to a patient includes a hazardous material enclosure suitable for holding a first container comprising a first fluid, and a pump device capable of pumping the first fluid from the first container and a second fluid from a second container. The hazardous materials enclosure has a cap which includes a flexible sealing member that cooperates with the first container to create a biohazard seal during connection of the first container to the cap. The system further includes a mixing device associated with the pump for mixing the first and second fluids for delivering the fluid mixture to the patient.

Abstract: A system for the collection, management, and dissemination of information relating at least to a medical procedure is disclosed. The system includes a user interface adapted to provide raw data information at least about one of a patient, the medical procedure, and a result of the medical procedure. A medical device communicates with the user interface, receives the raw data information from the user interface, and generates operational information during use. A central database communicates at least with the medical device and receives data from the medical device. The central database is used to create related entries based on the raw data information and the operational information and optionally transmits the related entry to the medical device or the medical device user. The related entry includes information that provides guidance based on previously tabulated, related medical procedures.

Abstract: A device for inserting a catheter into a blood vessel that uses fluid flow to aid the insertion of the catheter into a patient is described herein. The device includes a catheter retention device that houses a catheter and is configured to attach to an angiocatheter or other blood vessel access device. The catheter retention device receives fluid and guides the catheter into the blood vessel using the flow of fluid to carry the catheter into the blood vessel.

Abstract: An infusion system includes a double action infusion pump. The pump includes a cylinder and a reciprocating piston received within the cylinder, the reciprocating piston separating a first pump chamber from a second pump chamber of the cylinder. A reciprocating motor is coupled with the reciprocating piston, and the first and second pump chambers alternate between filling and evacuating conditions with reciprocation of the reciprocating piston through operation of the reciprocating motor, and the speed of reciprocation is varied to provide a continuous output of fluid between the first and second pump chambers. A fluid source and a catheter are optionally coupled with the double action infusion pump. The catheter includes one or more infusion ports near a catheter distal portion, and the one or more infusion ports receive and expel the continuous output of fluid from the double action infusion pump.

Abstract: A catheter includes a pressure actuated seal within a manifold. A catheter body is coupled with the manifold, and a manifold lumen and a catheter lumen are configured to receive pressurized fluids. The pressure actuated seal includes a pressure actuated seal element having a seal element lumen. The seal element lumen is in communication with the manifold and catheter lumens. The pressure actuated seal element is deformable between an open configuration and a sealed configuration. In the sealed configuration, the pressurized fluids in the manifold press on the pressure actuated seal element along a first seal face. The pressure actuated seal element compresses inwardly around the seal element lumen according to a pressure of the pressurized fluids. In the open configuration, the pressure actuated seal element relaxes in an absence of the pressurized fluids, and the seal element lumen is open and configured to allow passage of an instrument.

Abstract: A medical connector assembly for establishing a fluid connection between a first medical device and a second medical device includes a multi-use connector and a plurality of single-use connectors connected in series. The multi-use connector has a proximal end opposite a distal end along a longitudinal length thereof. The plurality of single-use connectors each have a proximal end opposite a distal end along a longitudinal length thereof. The distal end of the multi-use connector is releasably connected to the proximal end of a first of the serially-connected single-use connectors. When a second of the serially-connected single-use connectors is disconnected from the first single-use connector, the first single-use connector remains connected to the multi-use medical connector as a sterility retaining cover.

Abstract: Various methods for optimizing coating of medical devices, such as balloon catheters are disclosed. One method configures catheter balloon folds based on balloon diameter and volume. Other methods include using a specifically-sized protective sheath, using a vacuum, using pressure, pulling the balloon through a coating solution, using at least one spacer or a wick between at least one fold for metering a therapeutic coating into the folds of the balloon, placing an intermediate layer between the balloon and the therapeutic coating, placing a soluble film having a therapeutic agent around the catheter balloon or inside the folds, and any combination thereof. Balloon catheters and catheter balloons having a specific folding configuration, a specifically-sized protective sheath, an intermediate layer, or a soluble film are also disclosed.

Abstract: A configurable fluid delivery system and methods for its use are disclosed. The system may include one or more control units, fluid delivery units, fluid actuator units, and disposable units. Data sources and sensors on each of the delivery units, actuator units, and disposable units may provide data to the control unit, thereby identifying the components along with the manner in which they may be configured. The control unit may notify a user regarding the status of any one or more of the delivery, actuator, and disposable units to indicate their appropriateness for delivering a fluid according to one or more selected procedures and protocols. Also disclosed are methods by which the configurable fluid delivery unit may provide data to a user to assist the user in assembling and testing a particular fluid delivery configuration for a specific use.

Abstract: A connector assembly for a fluid delivery system includes a conical body defining an interior cavity and a discharge outlet, the discharge outlet defining an internal passage in fluid communication with the interior cavity; and a connector removably attached to the discharge outlet. The connector includes a central body configured to be at least partially positioned within the internal passage of the discharge outlet, and an annular connector portion connected to the central body and configured to releasably engage an exterior of the discharge outlet, the central body defining an internal channel within the central body that is in fluid communication with the interior cavity of the conical body when the connector is attached to the discharge outlet.

Abstract: Vial containers including a collar which is attached to a vial or incorporated into a vial cap, a cap designed to receive a portion of the collar while covering the vial, and a container designed to receive a portion of the collar and encase the body of the vial are described herein. The collar, generally, includes a means for reversibly attaching to the cap and container.

Abstract: Syringe systems and flow control systems configured to detect information associated with a liquid material are described. The syringe systems may include a syringe body for housing the liquid material and an injector piston for expelling the liquid material out of the syringe through a discharge outlet at a distal end of the syringe body. Components of the syringe, such as an injector piston, may include sensors configured to measure and/or detect a property of the liquid material, such as concentration, pH, or radioactivity. The flow control system may include a pinch valve and a platen arranged about a fluid delivery channel. Flow within the fluid delivery channel may be controlled by increasing (squeezing the fluid delivery channel) or decreasing the distance between the pinch valve and the platen. Components of the flow control system may include detectors configured to detect properties of fluid in the fluid control channel.

Abstract: A catheter assembly includes an inner mandrel and an outer sheath slidably coupled along the inner mandrel. The catheter assembly includes a scrubbing assembly coupled between the inner mandrel and the outer sheath. The scrubbing assembly includes a plurality of deformable struts deflectable according to movement of the inner mandrel relative to the outer sheath. The scrubbing assembly includes a proximal shoulder coupled with the outer sheath, and a distal shoulder coupled with the inner mandrel. The plurality of struts extend between the proximal and distal shoulders. The scrubbing assembly is movable between a stored configuration and a deployed configuration according to movement of the inner mandrel relative to the outer sheath. In the stored configuration the proximal and distal shoulders are remote from each other. In the deployed configuration the proximal shoulder is engaged with the distal shoulder, and the deformable struts are deflected into bristles.

Abstract: A system for processing cells (and/or other injectate components) includes a container and a plunger adapted to be slidably positioned within the container. The system includes at least one inlet port through which a fluid can enter the system and at least one effluent port through which an effluent can exit the system. The plunger section forms a sealing engagement with the inner wall of the container such that rearward motion of the plunger is adapted to draw fluid into the system via the inlet and forward motion of the plunger is adapted to force effluent out of the system via the effluent port.

Abstract: Methods and systems for controlled administration of a tracer and quantification of uptake of the tracer by a target organ are described herein.