Abstract: Various systems and methods are provided for reducing pressure at an outflow of a duct such as the thoracic duct or the lymphatic duct. In one embodiment, an indwelling catheter can be configured to be at least partially implanted within a vein of a patient in the vicinity of an outflow port of a duct of the lymphatic system. The catheter can include first and second restrictors each configured to at least partially occlude the vein within which the catheter is implanted and thus to restrict fluid flow within the vein when the restrictors are activated. The restrictors can each be configured to move between an activated configuration, in which the restrictor occludes the vein, and a relaxed configuration, in which the restrictor does not occlude the vein. The catheter can include a pump, such as an axial motor pump, configured to pump fluid through the catheter.

Abstract: A fluid infusion system includes an air pump connected to an accumulator tank to produce pressurized air that is stored in the accumulator tank. The system can include one or more fluid bag chambers wherein each fluid bag chamber includes an inflatable bladder positioned inside the fluid bag chamber to apply pressure on the fluid bag supported inside the chamber. The fluid bag can be connected by a tube set to deliver fluid from the fluid bag to a surgical tool at a surgical site. The fluid can, for example, be irrigation fluid or distention fluid. The system can include a controller connected to the pump to control the pump to produce the pressurized air and an adjustable pressure regulator can be connected between the accumulator tank and the inflatable bladder to control the pressure of air delivered to the inflatable bladder and the pressure that the fluid is delivered to the surgical tool.

Abstract: Catheters and methods for supporting a guidewire or delivering a radiopaque, diagnostic or therapeutic agent through a vessel stenosis or other tortuous anatomy are disclosed. A catheter can comprise an elongate shaft body and a tip member disposed at a distal end of the shaft body. The shaft body can extend from a proximal end to the distal end and can define an inner lumen. The shaft body can include a liner, a braid member surrounding the liner, a multi-layer coil surrounding the braid member, and a polymer cover surrounding the multi-layer coil. An outer surface portion of the polymer cover can include one or more helical threads, which can be enveloped in an outer wrapper. The tip member can be made from a metal or a polymer. Polymer tip members can include a hard or semi-hard distal tip.

Abstract: An intravascular catheter device includes a handle assembly, an inner member which accommodates a guide wire, an outer member disposed about the inner member, and a balloon. A proximal end of the balloon is attached to a distal end of the outer member. The balloon surrounds a portion of the inner member and the distal end of the balloon is attached to a distal end of the inner member. A sheath is selectively disposed about, and adapted for movement relative to, the balloon. A clamp at the handle assembly selectively secures the outer member at a number of positions relative to the sheath to selectively expose a variable portion of the balloon for movement into an inflated state. A balloon recapture device is located at a distal end of the sheath and aids the balloon in reentering the sheath following deployment.

Abstract: Eliminating leaks of molded fluid channels by providing a front housing, rear housing, and a gasket, wherein the front housing has one or more molded fluid channels and one or more seal channels, and wherein at least a portion of the gasket is located between the front and rear housing; molding the gasket onto the rear housing to create a single unit, wherein the gasket has one or more seal lips configured and dimensioned to couple with the one or more seal channels; and assembling the front housing to the rear housing having the gasket, wherein the one or more seal lips couple with the seal channels. A surgical cassette manifold having a front and rear housing, and a gasket therebetween. The front housing having molded fluid channels that mate with the gasket and the gasket having multiple valves and a sensor/diaphragm accessible through the rear housing.

Abstract: An intravascular balloon catheter device is disclosed having an inner member, an outer member disposed about the inner member and further comprising a balloon. A sheath is disposed about the outer member that moves relative to the balloon so as to selectively expose a first portion of the balloon for inflation. A clamp may be used to selectively secure the sheath at a desired position relative to the balloon wherein the desired position is less than full retraction such that a second portion of the balloon remains within the sheath.

Abstract: An apparatus for use with a syringe to provide a safety syringe, the apparatus including: a sheath deployable for at least partially covering a needle of the syringe; a sheath actuator for deploying the sheath; and a ratioed mechanism linking the sheath and the sheath actuator and configured such that a magnitude of movement of the sheath is greater than a magnitude of movement of the sheath actuator during deployment of the sheath.

Abstract: A handset for operation and locking of an occlusion clearing device includes a body and movable cover. Valve(s) in fluid communication with tubing for aspiration or irrigation are located within the body. A locking mechanism having first and second components affixed at different points in the handset which are selectively movable relative to one another to transition between locked and unlocked positions. The first component is connected to and selectively movable relative to the cover. The second component engages a portion of the first component, causing the cover to move in an engagement direction as the first component is moved to a locked position. Movement of the cover in an engagement direction causes the valve(s) to change from a first to second position which controls the flow of fluid therethrough. An engagement surface of the second component engages and retains the first component in a locked position.

Abstract: A pump apparatus and method for extracting breastmilk is disclosed. A pump head comprises a funnel-shaped breast shield portion and a neck portion leading to a collection container. A deformable elastic component is sealed within an opening formed in the neck portion and manipulated to engage the user's nipple to simulate the suckling of an infant. The deformable elastic component is configured to move into the interior volume of the neck portion under an applied positive pressure to compress the nipple and control nipple edema. The deformable elastic component is also configured to move away from the axial center of the neck portion under an applied negative pressure to create suction and extract breastmilk in a manner that closely replicates the suckling of an infant. The pump may also include another deformable elastic component to stimulate a Milk Ejection Reflex (MER).

Abstract: The present disclosure is directed to a dose setting mechanism that may be used with a drug delivery device. The dose setting mechanism may include an inner body having a helical thread along an outer cylindrical surface of the inner body, and a drive sleeve for driving a piston rod in an axial direction, the drive sleeve positioned within at least a portion of the inner body. The dose setting mechanism may further include a dose dial sleeve rotatably engaged with the helical thread of the inner body and a dial grip connected to the dose dial sleeve and releasably connected to the drive sleeve. Further when a dose is set, the dial grip is rotated so that both the dose dial sleeve and the drive sleeve rotate with respect to the inner body.

Abstract: A delivery device includes a durable housing portion and a separable disposable portion that selectively engage and disengage from each other. The disposable housing portion secures to the patient and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient or with infusion media are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports other components such as electronics for controlling delivery of infusion media from the reservoir and a drive device and drive linkage.

Abstract: Expandable intubation assemblies and methods for using and making the same are provided.

Abstract: The present disclosure relates to a drug delivery device for dispensing of a liquid medicament, the device comprising: a housing to accommodate a cartridge filled with the medicament and having a piston slidably displaced inside the cartridge along an axial direction and sealing a proximal end of the cartridge, a drive mechanism having a piston rod extending along the axial direction and being at least displaceable from a proximal end position in distal direction to displace the piston in distal direction, at least one distal support facing in proximal direction to axially abut a distally facing support face of the cartridge, wherein an axial distance between the distal support and a distal end of the piston rod when in the proximal end position is smaller than an effective length of the cartridge, which effective length is determined as the axial distance between a proximal face of the piston and the distally facing support face.

Abstract: The present disclosure describes effector deployment systems and devices that can be coupled adjunctively to a shaft of a concentric cylinder system, to provide additional functionality during intravascular procedures.

Abstract: Implantable drug delivery devices are provided to have a deployment shape for implantation in the body and a retention shape for retention in the body. The device may have one or more elongated drug reservoirs containing a drug, and the drug reservoir may be formed from a deformable material. In one case, a first filament is attached to the first end of the drug reservoir and second filament is attached to the second end of the drug reservoir, wherein a fastener is positioned about the first and second filaments to permit shortening and prevent lengthening of the filaments with reference to the ends of the drug reservoir, as a means for transforming the device from the implantation shape to the retention shape.

Abstract: A device and method for delivering a high viscosity composition is described. The composition includes a bioactive agent for delivery to a subject in need thereof. The method delivers the bioactive agent at a high bioavailability and with little loss of agent to the natural defense mechanisms of the body. The device includes one or more microneedles with structures fabricated on a surface of the microneedles to form a nanotopography. A random or non-random pattern of structures may be fabricated such as a complex pattern including structures of differing sizes and/or shapes.

Abstract: A method of embolizing a tumor includes advancing a distal end of a device having a catheter body and an occlusion structure to a target tumor site within a blood vessel of a body. The occlusion structure is activated within the blood vessel, and a real time pressure measurement in the vascular space distal to the activated occlusion structure is monitored. The method further includes waiting for a pressure drop in the vascular space distal to the activated occlusion structure and for the pressure drop to cause a blood flow reversal in branch vessels antegrade to the occlusion. An embolic substance is injected from the distal end of the delivery device to permit the reversed blood flow to carry the embolic substance into the vasculature of the target tumor and the device is withdrawn from the body. Other catheter assemblies and methods of use are also disclosed.

Abstract: The invention relates to administration of clinical anesthesia. Particular embodiments provide systems and methods for controlled delivery of a combination of an analgesic agent and a hypnotic agent. More specifically, the invention relates to closed-loop control systems/methods for automatically controlling the administration of a combination of a hypnotic agent and an analgesic agent in a clinical anesthesia setting which incorporate feedback based on one or more indirect measures/indicia of analgesia. The invention further relates to such control systems/methods that account for limitations of such indirect measures/indicia of analgesia.

Abstract: A novel intraluminal therapy system for providing a quick and effective way to treat gastrointestinal infections. The invention includes a brand new system of treating Helicobacter pylori infections and an agent dispenser for an endoscope apparatus, comprising a pump, a catheter connected to the pump and a nozzle connected to the catheter. The devices are used along with a complex of antibiotic and/or antimicrobial agents to eradicate Helicobacter pylori while performing an endoscopic procedure.

Abstract: A low-cost and simple-to-use system and method to facilitate a prophylactic pleural lavage protocol at the time of thoracostomy tube placement for traumatic hemothorax in order to reduce the need for secondary intervention for the management of retained hemothorax. The invention may be used in conjunction with existing chest tubes and be administered at the time of initial chest tube placement, and continued at the bedside (by a bedside nurse) over the duration of chest drainage, as necessary. The system includes an operator device that semi-automatically administers a pleural lavage protocol consisting of saline instillation, and suction to slow the clotting process, prevent “gelling” of blood, and maintain drainability.