Abstract: A device and method for selectively engaging or penetrating a layer of a luminal organ wall where the luminal organ wall has a plurality of layers including an outermost layer and an innermost layer adjacent to the lumen of the organ. The device and method select one of the plurality of layers of the organ wall other than the innermost layer and deploy from within the lumen of the organ a tissue device through the innermost layer to a specific depth to engage or penetrate the selected one of the plurality of layers. The device and method may be employed to create luminal pouches or restrictive outlets. In a stomach organ, the device and methods may be employed to treat obesity by forming a gastric pouch with or without a restrictive outlet.

Abstract: A novel neural injection system and related methods are herein disclosed. Various embodiments of an embodiment of a neural injection system of the present invention provide for at least one benefit of enhanced injection characteristics, increased operational efficiency, reduced cost per unit, reduced incidence of injury through intraneural/intravascular injection, reduced incidence of injury through pricking/piercing, and/or the like.

Abstract: Fluid supply systems and methods for therapeutic fluid delivery systems, including those used for negative pressure wound therapy (NPWT) systems and methods.

Abstract: A device for dispensing fluid to a patient and indicating a fluid flow condition. The device includes a reservoir configured to provide a source of fluid under pressure. A continuous flow path in fluid communication with the source of fluid provides a continuous and substantially constant flow rate of fluid from the source to a patient. The device further includes at least one pre-biased indicator in fluid communication with the continuous flow path. The pre-biased indicator is configured to provide a discrete visual signal that the pressure of the fluid in the continuous flow path is different from a predetermined level of pressure, thereby indicating a fluid flow condition.

Abstract: A system and method of treating urinary incontinence including a catheter and injection guide operatively disposed together. At least one needle is operatively disposed within at least one lumen and at least one channel extending through the catheter and injection guide respectively. The injection guide is transformable from a pre-injection configuration for placement in the bladder to an injection configuration for injection of a pharmaceutical such as botulinum toxin into the bladder tissue. Upon introduction of the pharmaceutical to the bladder tissue, symptoms of incontinence are alleviated.

Abstract: Methods and compact automatic devices are provided for delivery of micro doses of liquid drugs to a patient. Devices have a fluid supply reservoir comprising an expandable indicator supplied with a sensor, a mechanism forcing the fluid to squeeze predetermined dose out, and a processor treating sensor's signals accordingly to preprogrammed algorithm. The method comprises steps: (a) initiating the delivery cycle, (b) acquiring sensor's signals, (c) treating signals in order to integrate an intensity of output flow and to determine when the squeezing-out force must be terminated, (d) terminating the cycle accordingly to processor's command. Self-testing of devices occurs while each fluid delivery cycle. Their high dosing precision exceeds that of known analogs about two orders of magnitude. A possibility to use low cost disposable exit port assembly and/or easy replaceable factory pre-filled cartridges is an additional advantage eliminating risks of overdosing, air bubbles, and/or compromised sterility.

Abstract: Tissue markers, systems for marking tissue, and methods of using tissue markers. A tissue marker may have a body with a first surface and a second surface, a plurality of coupling sites, and a plurality of elongate members. The tissue marker may include a remotely visible material. The tissue marker may have a delivery configuration that is different from a deployed configuration.

Abstract: An injection system (108) includes a sterilization port (130) operable to sterilize a tube set connector (116) inserted therein. The sterilization port (130) may include a single sterilization port opening (132) through which the tube set connector (116), in an unconnected state, may be inserted. The sterilization port (130) may include an ultraviolet light source (158) capable of irradiating the tube set connector (116) with ultraviolet radiation when the tube set connector (116) is disposed within the sterilization port (130). The sterilization port (130) may include a movable member or door (136) capable of closing around the inserted tube set connector (116) and/or a tubing (118) connected to the tube set connector (116) to reduce the amount of ultraviolet light that may escape from the sterilization port (130). A sensor (194) may be included to determine if the tube set connector (116) has been inserted into the sterilization port (130).

Abstract: A non-compliant medical balloon, where the non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon, is made with a first fiber layer, a second fiber layer over said first fiber layer such that the fibers of the first fiber layer and the fibers of the second fiber layer form an angle and a binding layer coating the first fiber layer and said second fiber layer. The interior surface area of the non-compliant medical balloon remains unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: An apparatus includes a housing, a medicament container, an actuator, and a biasing member. The actuator is configured to move the medicament container within the housing when the actuator is moved from a first configuration to a second configuration. The actuator includes a gas container and a puncturer. When the actuator is in the first configuration, a portion of the puncturer is disposed apart from the gas container. When the actuator is in the second configuration, the portion of the puncturer is disposed within the gas container. The gas container has a longitudinal axis offset from a longitudinal axis of the medicament container. The biasing member is configured to bias the actuator toward the second configuration.

Abstract: A single operator exchange biliary catheter having a tubular member extending proximally from the proximal guidewire port. The tubular member defines a guidewire lumen extension adapted to permit the guidewire to be retracted from guidewire lumen and re-inserted therein. By retracting the guidewire from the guidewire lumen and into the guidewire lumen extension, fluid may be readily injected via the guidewire lumen without encountering resistance to fluid flow from the guidewire. The guidewire lumen extension also maintains guidewire lumen access such that the guidewire may be easily re-inserted into the guidewire lumen.

Abstract: A cryosurgical probe that is operative to bring target nerve tissue to a temperature below about ?140° C. so as to reduce or eliminate regeneration of the nerve tissue by growing an ice ball. The probe comprises a thermally conductive body, a thermally insulating body and a temperature sensor. The thermally conductive body has a conductive portion adapted to contact the tissue and form an ice ball thereat during use. The thermally insulating body is adjacent to the conductive portion onto which the ice ball forms during use. The temperature sensor is positioned at a predetermined position on the thermally insulating body with respect to the conductive portion. The predetermined position corresponds to a predetermined size of the ice ball grown in the tissue when the sensor reads a predetermined temperature. The insulating body provides sufficient thermal insulation between the conductive body and the surrounding tissue so that the sensor detects freezing of.

Abstract: A controlled volume inflation-deflation device to inflate a balloon to occlude a blood vessel by dialing a knob that locks at rotational positions to locate a plunger at equally spaced locations within a syringe of the inflation-deflation device. The inflation-deflation device includes a releasable latch to lock the proximal and distal housings together to hold the plunger forward for occlusion, and to separate and hold the proximal and distal housings to retract the plunger for perfusion. When the inflation-deflation device is returned to the latched position, the balloon is re-inflated to its previous occlusive diameter. Also, an extension tube made of a lower modulus outer material co-extruded over and miscible with a higher modulus inner material may be used to produce a suitably low compliance extension tube for the inflation-deflation device.

Abstract: A predilation device may comprise a shaft portion and a distal tip having helical threadings. The predilation device may further include a rapid exchange element rotatably coupled to the shaft portion. A guidewire may slidably engage the rapid exchange element and may guide the predilation device to a lesion site. The predilation device may be positioned with the distal tip abutting the lesion. The shaft portion may be rotated, thereby rotating the tip and causing the tip to pass through the lesion and predilate the lesion. In some embodiments, the tip may remove lesion material.

Abstract: A method of dispensing fluid includes three processes. A first one of these processes includes pumping fluid into a resilient variable-volume dispensing chamber. The dispensing chamber is in series with a normally present finite fluid impedance and an output. The impedance is sufficient so as to cause expansion of the dispensing chamber as it receives pumped fluid even while some fluid flows through the output. Another one of these processes includes repeatedly measuring a parameter related to volume of the dispensing chamber over time. A third one of these processes includes controlling the pumping of fluid based on repeated measurements of the parameter to produce a desired fluid flow through the output. A corresponding system for dispensing fluid implements these processes.

Abstract: A wearable infusion pump assembly includes a reusable housing assembly, and a disposable housing assembly including a reservoir for receiving an infusible fluid. The wearable infusion pump assembly also includes a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly. A switch assembly of the wearable infusion pump assembly is configured to effectuate a functionality of the infusion pump assembly.

Abstract: The present invention provides an improved vascular access port comprising a port base with a metallic dish insert molded (or bonded) into the bottom of the reservoir. In one embodiment, a single reservoir is provided. In another embodiment, plural reservoirs are provided. The metallic bottom of the reservoir provides a hard surface that will resist abrasion and puncture by the access needles used to infuse medication or withdraw blood. Additionally, the single and dual ports can include exit ports that are intended to better anatomically fit into the subcutaneous areas around muscle tissue.

Abstract: Devices, such as medical devices, are provided which include a body portion having at least one reservoir which has two or more openings, the two or more openings being defined in part by a reservoir cap support; reservoir contents, such as a drug formulation or sensor, disposed inside the reservoir; and a reservoir cap which closes off the two or more reservoir openings. The reservoir cap, which can be ruptured, controls release or exposure of the reservoir contents. In one embodiment, the device is an implantable medical device and provides for the controlled release of drug or exposure of a sensor.

Abstract: A system and method for assessing a degree of coupling between an electrode and tissue in a body is provided. Values for first and second components of a complex impedance (e.g., resistance and reactance or impedance magnitude and phase angle) between the electrode and the tissue are obtained. These values are used together with a standardization value indicative of a deviation from a reference standard by a parameter associated with at least one of the body, the electrode and another component of the system to calculate a coupling index that is indicative of a degree of coupling between the electrode and the tissue. The coupling index may be displayed to a clinician in a variety of ways to indicate the degree of coupling to the clinician. The system and method find particular application in ablation of tissue by permitting a clinician to create lesions in the tissue more effectively and safely.

Abstract: Apparatus and methods are disclosed for medical treatment comprising bone, tissue or duct dilatation using inflatable dilatation elements together with apparatus and techniques for tensioning, stretching, folding, and/or wrapping the dilatation elements externally as well as in situ to facilitate insertion, positioning and withdrawal procedures.