Abstract: Fluid delivery systems and methods of delivering an agent and treating a disorder are disclosed that include a subcutaneously implantable port having a body defining a chamber with an open top and a delivery opening and a septum coupled to the body to extend over the open top of the chamber. The systems and methods can further include an intrathecal catheter having an proximal end configured to be coupled to the port and fluidly coupled to the delivery opening of the chamber and a plug having a body with a passage to receive the intrathecal catheter therethrough. The plug can be configured to be inserted into the fascia to protect against leakage of cerebrospinal fluid.

Abstract: The present specification relates to a syringe comprising a barrel, a plunger moveably arranged within the barrel and a plunger rod for driving the plunger, and a mechanism for providing feedback to a user as the plunger rod is moved relative to the barrel for driving said plunger such that feedback is given to a user as the plunger rod is moved relative to the barrel for driving the plunger. The plunger rod is arranged to drive the plunger such that a predetermined relative movement between at least a portion of the plunger rod and the plunger is allowed. The present specification further relates to a plunger assembly wherein a predetermined relative movement between at least a portion of the plunger rod and the plunger is allowed.

Abstract: The present invention is a decompression needle assembly having a needle that is removable received into to a catheter. The catheter can include a rigid portion and a deformable portion wherein the deformable portion can be multi-ported at its distal end. A one-way valve contained in a catheter hub attached to the catheter wherein the one way valve is in an open position when the needle is received in the catheter. Lateral catheter openings can be defined in the catheter and disposed adjacent to a distal end of the catheter. A plunger can be received within the needle and have an visual and auditory indicator that can be appreciated through the needle hub.

Abstract: A gastrointestinal-tract constricting method comprises: while observing the gastrointestinal tract with an endoscope inserted into the gastrointestinal tract, placing a protection substance, which does not damage tissue, in at least one of a region between the mucosal layer and muscular layer of the gastrointestinal tract and a region in a mucosal surface of the mucosal layer so as to form a protection region that protects the mucosa basal layer from a medical substance that damages the tissue; and, after forming the protection region, supplying the medical substance to a mucosal surface in a target region, which is at a position different from the protection region in a circumferential direction of the gastrointestinal tract, or to a position between the mucosal layer and the muscular layer.

Abstract: A kit for the direct use of a variety of medical ampoules of differing sizes, with a syringe, the kit having: a syringe body; a syringe plunger having a hollow interior volume; and a plurality of ampoule interface elements, each one being interchangeably received within the hollow interior volume and configured for deployment between an outer surface of the medical ampoule and a surface of the hollow interior volume so as to hold the medical ampoule therein, each of the plurality of ampoule interface elements having an outside diameter sized to fit an inside diameter of the hollow interior volume, wherein a first of the ampoule interface elements has an inside diameter for receiving a medical ampoule of a first size, and a second of the ampoule interface elements has an inside diameter different from the first inside diameter for receiving a medical ampoule of a second size.

Abstract: Provided herein is an implant for delivering a hydrophobic active agent to a target tissue. The implant may include a scaffold defining a first surface and a second surface opposite the first surface, wherein the scaffold is substantially impermeable to a hydrophobic active agent, and a silicone tubing having a wall permeable to the active agent, wherein a first length of the silicone tubing is affixed to the first surface of the scaffold, wherein the two ends of the silicone tubing extend from the first surface, and wherein a path outlined by a second length of the tubing within the first length is circuitous. Also provided is a method of using the implant to locally deliver a hydrophobic active agent to a target tissue, and kits that find use in performing the present method.

Abstract: A method and system to monitor and autonomously configure an intravascular assembly without medical staff involvement or presence. In this solution, a robotic device is associated with an intravascular assembly, which has tubing through which fluids are delivered intravenously. Monitoring of the tubing is initiated. In response to the monitoring, an errant flow through the tubing is detected; typically, the errant flow results from one of: a kink or twist in the tubing, an air bubble in the tubing, an occlusion or clot in the tubing, and pressure variations. In response to detecting the errant flow, and in advance of an audible alarm being generated in association with the intravascular assembly, a command is then issued to the associated robotic device. The command is configured to initiate, by the robotic device, physical engagement with and mechanical manipulation of the tubing, thereby remediating the errant flow automatically.

Abstract: A method of localized delivery of a therapeutic and/or diagnostic agent to nasal tissue or cavities includes inserting a catheter into a nasal cavity, the catheter having an outer balloon with at least one opening therethrough and an inner surface, and an inner balloon disposed in the outer balloon and at least partially enclosing an inflation chamber and having an outer surface defining a space between the outer surface of the inner balloon and the inner surface of the outer balloon, supplying the agent to the space between the outer surface of the inner balloon and the inner surface of the outer balloon via a first lumen of the catheter, and inflating the inner balloon by supplying fluid to the inflation chamber via a second lumen of the catheter to urge the agent out of the opening in the wall of the outer balloon and into nasal tissue.

Abstract: Actuators for steerable medical devices are disclosed that not only deflect or steer a portion of a medical device (e.g., a distal portion of a catheter shaft), but also include mechanisms for actively returning the deflected portion of the medical device to an initial configuration (e.g., straight or substantially straight). These active return-to-straight mechanisms may return a catheter shaft from a deflected configuration to a substantially straight configuration throughout a medical procedure, may employ one or more tension members extending along the catheter shaft, and may comprise a gross return actuator and a fine return actuator. For example, the gross return actuator may be configured to partially reverse the deflection of the distal portion of the catheter; and the fine return actuator may be configured to continue reversing the deflection. The gross return actuator may automatically trigger or actuate (mechanically or electromechanically) the fine return actuator.

Abstract: Systems and methods for treating a blood clot include a catheter to be inserted into a patient. The catheter is used to deliver low stability microbubbles toward the blood clot in the patient. A thrombolytic agent is delivered toward the blood clot, and ultrasonic energy is applied to the microbubbles to vibrate the microbubbles.

Abstract: A catheter that prevents excessive concentration of stress while providing sufficient flexibility to a distal end portion of the catheter, even when the catheter is inserted and curved in patient's a blood vessel. Thus, breakage of the catheter at a radiopaque marker is prevented/reduced. The catheter includes a catheter tube and the radiopaque marker, which is disposed in the catheter tube. The radiopaque marker is fixed in the catheter so that a gap is provided between the radiopaque marker and the catheter tube in a radial direction of the catheter tube.

Abstract: A needle safety system for a syringe having a generally cylindrical barrel extending along a longitudinal axis, the barrel having a hub from which a needle extends distally. The needle safety device has a sleeve at least partially enclosing the needle. A guide track is formed in the sleeve. A multi-part collar disposed in the sleeve has an inner collar which is fixedly connectable to the hub of a syringe barrel. An outer collar is rotatably attached to the inner collar. A guide pin extending radially outwardly from the outer collar slideably engages the guide track. A torqueable compression spring extending between the outer collar and the sleeve biases the sleeve in a distal direction and also biases the outer collar in rotation relative to the sleeve.

Abstract: A syringe system, piston seal systems, stopper systems, and methods for assembling and using the syringe systems. The piston seal system including a piston seal member and a piston head member. The injection system including a container, a piston seal system positioned within the container, and a stopper system coupled to an end of the container. The method of assembling an injection system, the method includes obtaining a container, a piston seal system, and a stopper system. The method also includes inserting the piston seal system into a cavity within the container. The method further includes securing the stopper system at an end of the container in an opening of the cavity. Methods of using the syringe system, piston seal systems, and stopper systems are also disclosed.

Abstract: Embodiments provide swallowable devices, preparations and methods for delivering viable cells (VC) into the GI tract including GI wall tissue or other tissue site. Particular embodiments provide a swallowable device such as a capsule for delivering VC into an intestinal wall or other site. The VC can be contained within a tissue-penetrating shell disposed in the capsule that protects the VC as they pass through the GI tract until they are inserted into GI tract tissue or other location. The shell desirably has shape, size and material consistency to be contained in a swallowable capsule, delivered from the capsule into solid tissue by the application of force on the shell and biodegrade within the solid tissue to release the VC into the tissue. Within the shell or other structure the VC can be maintained in a viability-sustaining gel that preserves the viability of the VC for selected time periods.

Abstract: An apparatus for use with a syringe for providing a safety syringe, the apparatus including a sheath (100; 300; 500) deployable for at least partially covering a needle (126) of the syringe; and a sheath actuator (102; 302; 502) for deploying the sheath by interaction with a sheath deployment mechanism (104; 304; 504); the sheath being configured to be stationary in relation to the needle until a syringe plunger (116; 316; 516) reaches a sheath release point on its inward stroke, and the sheath actuator being configured for deployment of the sheath on movement of the sheath actuator relative to the syringe plunger after the sheath release point.

Abstract: A male connector (1) includes a luer portion (10) connected to the upstream end of a tube (8) used in enteral feeding, and a lock portion (20) that is removably attached to the luer portion. The luer portion (10) includes a tubular male luer (11) in which a channel (17) in communication with the tube (8) is formed. The lock portion (20) has a hollow tubular shape and is open at two ends, and includes female threading (21) that opposes the male luer on the inner circumferential face of the lock portion (20). The male luer (11) is inserted into the lock portion (20). Rotation prevention mechanisms (16, 26) that engage with one another are provided on the luer portion (10) and the lock portion (20) such that the lock portion (20) does not rotate relative to the luer portion (10).

Abstract: An external medical device includes a fluid inlet, an inlet valve in fluid communication with the fluid inlet to control fluid flow through the fluid inlet in response to fluid inlet control signals, a fluid outlet in fluid communication with a fluid reservoir, a fluid pump configured to deliver a therapeutic fluid from the fluid reservoir through the fluid outlet in response to fluid outlet control signals, a fluid sensor configured to monitor the therapeutic fluid between the fluid pump and the fluid outlet and further configured to output sensor data corresponding to a monitored condition of the therapeutic fluid, and a control module configured to receive the sensor data and output, based on the sensor data, the fluid inlet control signals to the inlet valve and the fluid outlet control signals to the fluid pump.

Abstract: The present invention provides a device (1) for monitoring the application of a drug to a patient by means of a drug pen (100), whereby the drug pen comprises a front end provided with an injection needle and a rear end provided with an actuation pushbutton, the device comprising a body (2) which can be dismountably coupled to the pen; an injection detection means determining when a drug injection is carried out; and a processing means configured for storing the date and time of the injection when the injection detection means detects that a drug injection is carried out, whereby the body is configured to be coupled to the pushbutton of the pen such that the pushbutton is actuated by pushing directly on the body, whereby the injection detection means is implemented as actuation detector configured for detecting said pushing action.

Abstract: The present application relates to a device for treating skin using non-thermal plasma. It comprises a housing having a skin interface electrode for application to skin during treatment, a generator for generating non-thermal plasma at the skin interface electrode; and an isolating element to isolate a region surrounding said skin interface electrode other than during treatment so that non-thermal plasma generated at the skin interface electrode within said region sterilises the skin interface electrode.

Abstract: Needle assemblies and related methods are disclosed having a needle hub with a needle, a catheter tube with a catheter hub and having the needle extending through the catheter tube; and a valve positioned in an interior cavity of the catheter hub, the valve having a first section with a first chord, a second chord, and a plurality of slits defining a plurality of flaps, a second section attached to the first section, and a third section attached to the first section; an inside edge formed on the second section and pressed against the first section; an inside edge formed on the third section and pressed against the first section; and wherein a first flow path is provided adjacent the first chord and a second flow path is provided adjacent the second chord.