Abstract: Systems and methods and devices are provided for treating conditions such as heart failure and/or pulmonary hypertension by at least partially occluding flow through the superior vena cava for an interval spanning multiple cardiac cycles. A catheter with an occlusion device is provided along with a controller that actuates a drive mechanism to provide at least partial occlusion of the patient's superior vena cava, which reduces cardiac filling pressures, and induces a favorable shift in the patient's Frank-Starling curve towards healthy heart functionality and improved cardiac performance. The occlusion device may include a lumen obstructed by a relief valve that may permit fluid flow through the occlusion device to release an excessive build-up of pressure.

Abstract: An apparatus for controlling fluid flow to provide long-term access to the vascular system, and methods of making the same, are disclosed. Exemplary embodiments of the present invention describe a wedge or other similarly shaped geometrical features for fixing an elastic component and controlling an internal stress of the elastic component.

Abstract: The present disclosure concerns a bearing for a piston rod body for a drug delivery device. The bearing has an axis and comprises a first and a second surface which are spaced apart in the direction of the axis and a third surface, wherein the third surface connects the first and the second surface, wherein an opening is provided in each of the first and the third surface, and wherein the opening in the first surface is connected to the opening in the third surface. Further, the present disclosure concerns a piston rod body and a piston rod arrangement comprising said bearing and the piston rod body.

Abstract: Techniques for aligning a medical instrument for percutaneous access to a location within the human anatomy can include determining an orientation of the medical instrument, determining a target location within the human anatomy, and determining a target trajectory for percutaneous access of the target location. Further, the techniques can include causing display of an interface that includes an instrument-alignment element indicative of an alignment of the orientation of the medical instrument to the target trajectory.

Abstract: A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. The housing includes a retractable guard and an interference component, e.g., a lock ring, adjacent to the retractable guard that interferes with the movement of the retractable guard. An energy source is configured for biasing the plunger to produce an injecting pressure to jet inject the medicament from the fluid chamber through the needle to an injection site.

Abstract: A method of manufacturing a catheter shaft includes extruding an inner polymeric layer having a main lumen and two or more side lumens spaced about the main lumen; forming an outer polymeric layer about the inner polymeric layer; and inserting at least one elongate member, such as a wire, through each side lumen of the inner polymeric layer. The side lumens are less than about ? the size of the main lumen. The method may further include the step of forming a braided layer between the inner polymeric layer and the outer polymeric layer. In an alternate embodiment, the method includes co-extruding an inner polymeric layer and a multi-lumen layer, the multi-lumen layer having two or more side lumens; forming an outer polymeric layer about the multi-lumen layer; and inserting at least one elongate member through each side lumen. Catheter assemblies made according to the described methods are also disclosed.

Abstract: Methods and apparatus for treating disorders of the ear, nose, throat or paranasal sinuses, including methods and apparatus for dilating ostia, passageways and other anatomical structures, endoscopic methods and apparatus for endoscopic visualization of structures within the ear, nose, throat or paranasal sinuses, navigation devices for use in conjunction with image guidance or navigation system and hand held devices having pistol type grips and other handpieces.

Abstract: A wearable drug delivery device includes an injector having a housing, a reservoir, a needle or cannula, a drive mechanism for urging drug product out of the reservoir, through the needle or cannula, and to a patient, and an activator mechanism disposed on a surface of the housing for activating the drive mechanism. An activation prevention mechanism is coupled to the injector housing and/or activation prevention mechanism to prevent inadvertent actuation of the activator mechanism.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device involves obtaining one or more measurement values of a physiological condition in the body of a user during an initial monitoring period and determining a fasting reference value for a metric based on the one or more measurement values. After the initial monitoring period, the method continues by obtaining an updated measurement value during a fasting period, determining a current value for the metric based at least in part on the updated measurement value, and generating a notification in response to a deviation between the current value and the fasting reference value exceeding a threshold indicative of insertion site loss or other loss of effectiveness.

Abstract: An apparatus for insertion into a body through a working channel of an endoscope includes a catheter including a dilator, a guide tube disposed in a lumen of the catheter, and a handle including a puncturing actuator operatively coupled to the proximal end of the guide tube. The dilator may be a cautery device and/or a balloon. The apparatus may also include a stylet needle that includes a cutting distal end for puncturing tissue and extends through a lumen in the guide tube. The handle may further include a stopper detachably coupled to the puncturing actuator to fix a position of the puncturing actuator on the handle, and moveable on the handle independently of the puncturing actuator when detached from the puncturing actuator. The disclosed embodiments also include a method for forming a passageway in a wall of a hollow body organ using the apparatus.

Abstract: A fluid-management system for selectively draining fluid from a body cavity includes a valve assembly and a tube for carrying fluid from a body cavity of a person to the valve assembly. The valve assembly is configured to be positioned external to the person's body and comprises (i) an inlet, (ii) an outlet, (iii) one or more one-way valves positioned between the inlet and outlet that are each configured to open and close based on fluctuations in pressure between the person's body cavity and the one-way valve, and (iv) an adjustable outlet lock configured to selectively prevent fluid movement through the outlet.

Abstract: The invention comprises an indwelling medical device which is capable of delivering a therapeutic agent evenly along the length of the indwelling portion, including the outer wall, of the device.

Abstract: A balloon catheter including a heating element disposed about a portion of an outer surface of a catheter shaft; a balloon mounted about the outer surface of the catheter shaft to coincide with the heating element; and thermally expandable material disposed inside the mounted balloon. The balloon catheter eliminating the need for pressurized liquid inflation media to be dispensed into/expelled from the balloon in order to inflate/deflate, respectively, the balloon.

Abstract: The present invention relates to a cutting device comprising a manual gripping element (100) and a cutting assembly (200) that is positioned on one end of the gripping element (100) and comprises a punch (210) split into at least two cutting tips (220, 230), at least one of these tips (220, 230) being hinged on the gripping element (100) in order to be movable between a rest and cutting position in which the tips (220, 230) are adjacent and a working and injection position in which the tips (220, 230) are spaced apart, and urging means (250) designed to move each movable tip (220, 230) into the working position when these urging means (250) press against the skin.

Abstract: A catheter assembly comprises a catheter (18), a needle (12) having a sharp distal tip disposed within the catheter (18), a catheter hub (14) connected to the catheter (18) having the needle (12) passing therethrough, the catheter hub (14) including a valve (38) that selectively permits or blocks a flow of fluid through the catheter (18), a valve actuator (54) that moves between a first position and a second position, and a return member (56) that returns the valve actuator (54) from the second position to the first position, and a needle protection member (176) that encloses the sharp distal tip of the needle (12).

Abstract: An elongated access device used in a medical system. The elongated access device slidably receives a medical tool and an ultrasound probe. The elongated access device includes a sheath and an intraluminal tip attached to the distal end of the sheath. The intraluminal tip includes ramp and nose donuts being spaced apart from one another and configured to be attached to one or more elongated sleeves. One or more orientation pins are engaged with the respective ramp and nose donuts and may be anchored within the sheath. The medical tool is engaged with a ramp formed in the ramp donut or a ramp received within the ramp donut. The ultrasound probe is configured to engage with the intraluminal tip so as to ensure that the medical tool directionality is oriented toward a target during a procedure.

Abstract: A passive safety needle shield (300) is provided. The needle shield comprises a base (302) fixed to a proximal end of a needle, and an enclosure housing (304) initially disposed at a distal end of the needle, and enclosing the end of the needle. A hinged arm (306) connects the base (302) and the enclosure housing (304). The enclosure housing (304) is slidable along the needle length, and the hinged arm (306) flexes to permit the enclosure housing (304) to move along the needle as the needle is inserted into a user, thereby hiding the needle end, and providing support to the needle to avoid bends or buckles in the needle. The hinged arm (306) is biases in the initial position so that the enclosure housing (304) returns to the end of the needle as the needle is withdrawn.

Abstract: A medical device includes: a tube through which fluid flows; a handle part coupled to a proximal end part of the tube; an electrode tip coupled to a distal end part of the tube; a fluid injection part configured to inject fluid into the tube; one or more openings formed in the tube; and a guide member disposed in the tube, and having an inclined part to guide the direction of the fluid sprayed out through the opening.

Abstract: In some embodiments, disclosed herein are systems and methods of treating a patient that can include the steps of accessing the sphenopalatine fossa, and cannulating the inferior orbital fissure from the sphenopalatine fossa to access the retro-orbital space. The sphenopalatine fossa can be accessed via various routes, including percutaneously. Accessing the sphenopalatine fossa can include the step of inserting a needle-catheter system into the sphenopalatine fossa. Integrated needle-catheter systems as described herein can also be configured to access the trigeminal ganglion, epidural space, intrathecal space, and other desired anatomical locations.

Abstract: One or more embodiments of the disclosure are related, generally, to a reusable accessory for a manual medication delivery device. Such a reusable accessory may include a wireless communication interface, a detection circuitry, and a recommendation system. In one or more embodiments, an adapter may be configured to reversibly couple such a reusable accessory to a manual medication delivery device. Dosing events may be detected that are associated with dosing at the manual medication delivery device. Dose recommendations may be provided responsive to analyte measurements and/or dosing events.