Abstract: Disclosed herein are apparatuses and methods for improved use of infusion sites for infusion pumps. Apparatuses and methods for delivery of medicaments such as insulin disclosed herein can increase the effectiveness of therapy by more accurately determining when an infusion site is no longer absorbing insulin at an acceptable rate as well as determining the effectiveness of different infusion sites on the body with respect to each other and over time.

Abstract: A microneedle device of the present invention comprises a substrate, microneedles disposed on the substrate, and a coating layer formed on the microneedles, wherein a length of the microneedles is 300 to 500 ?m, the microneedles are disposed on the substrate at a density of 28 to 80 needles/cm2, and the coating layer comprises a biologically active substance. The microneedle device allows the skin irritation caused by administration of an agent to be reduced.

Abstract: A catheter tip having a spring element that imparts longitudinal flexibility, pushability and radial rigidity to the catheter tip, thereby improving deliverability, is provided. The spring element also provides radial support to the distal edge of the catheter tip. The spring element may taper distally, but may have a substantially constant inner luminal diameter. The spring element may be partially covered or embedded, leaving its distal end exposed. The spring element may also include spaced coils in a proximal region. The apparatus may be used with any interventional catheter system, but is particularly suitable for use with balloon-expandable stent systems and balloon-angioplasty systems, where flexibility of the catheter tip and minimal flaring of the distal edge of the catheter tip is desirable.

Abstract: An injection device comprising a housing (112), and a dose selector (116) operatively connectable to a dose indicator positioned within the housing. The dose selector and the dose indicator (118, 119) are capable of cooperating to set a dose to be ejected from the injection device. The injection device further comprises a spring (120) capable of storing energy necessary for ejecting the dose from the injection device. The spring is locked to the dose indicator such that a charging force can be transferred from the dose selector to the spring via the dose indicator to increase the energy stored by the spring.

Abstract: An applicator and method for applying a microneedle array to skin. The applicator can include a body having a first portion and a second portion defining a cavity, the second portion having a slot presented on an outside surface for insertion of the microneedle array into the cavity. The first portion and the second portion are slidable relative to one other along an axis enabling the body to be in an unprimed configuration and a primed configuration. The applicator further includes a door operable with the second portion, the door being movable from a first door position to a second door position, wherein when the device is in the unprimed configuration, the door at least partially obstructs the slot and access into the cavity. When the device is in the primed configuration, the door does not obstruct the slots and enables access into the cavity.

Abstract: A vacuum aspiration system may be used to treat thromboembolic disease, such as deep vein thrombosis or pulmonary embolism. The system includes a housing, and a fluid flow path extending through the housing. A first catheter is in fluid communication with the flow path, and a connector is configured to place a source of aspiration in communication with the flow path. A clot container is carried by the housing. A hemostasis valve is provided in the housing, and configured to receive a second catheter and direct the second catheter through the first catheter.

Abstract: PIVCs with extension sets can include one or more flow diverting features for maximizing the amount of flushing that occurs within the interior of the catheter adapter. These flow diverting features can therefore minimize the amount of residual blood, medicament, or other fluid that may exist within the catheter adapter after the PIVC has been flushed via the extension set. The flow diverting features may be in the form of structural modifications to the side port of the extension set, separate components that are contained within the side port or catheter adapter, integrated components within the side port or catheter adapter, other features or some combination of any of these features.

Abstract: A catheter system for atraumatic placement along a guidewire includes: a catheter including a cylindrical catheter body that defines a longitudinally extending interior lumen; and a guide device. The guide device includes: a conduit member for insertion into the interior lumen of the catheter body; a leading structure connected to a forward end of the conduit member, the leading structure including a cone and a sleeve extending forward from the cone; and an inner guide hole extending longitudinally through the leading structure and conduit member. In use, the guide device and catheter body are coaxially arranged, the cone is forward of the catheter, and the sleeve extends forward from the cone. The cone includes a shoulder, and a tapered exterior that increases diametrically from the sleeve to the shoulder. The shoulder abuts a distal end of the catheter to register insertion of the guide device in the catheter.

Abstract: An injection device comprises a housing having a first longitudinal axis (L). The injection device further comprises a medicament cartridge holder and a drive assembly including a drive shaft. The drive shaft is arranged around the first longitudinal axis. The drive assembly is capable of providing an axial force for ejecting a dose of medicament from the injection device. The medicament cartridge holder and at least part of said drive assembly are arranged around a second longitudinal axis (LC) which is substantially parallel to but offset from the first longitudinal axis.

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. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.

Abstract: Disclosed is a flow detector (1) for releasable coupling with a flow channel (20) in a channel coupling area and detecting a flow of liquid drug in the flow channel (20), the flow detector including: an upstream thermoelectric element (10a) and a downstream thermoelectric element (10b), wherein the upstream thermoelectric element (10a) and the downstream thermoelectric element (10b) are arranged spaced apart from each other and movable independent from each other; an upstream biasing element (15a) and a downstream biasing element (15b), wherein the upstream biasing element (15a) acts on the upstream thermoelectric element (10a), thereby biasing the upstream thermoelectric element (10a) towards the channel coupling area, and the downstream biasing element (15b) acts on the downstream thermoelectric element (10b), thereby biasing the downstream thermoelectric element (10b) towards the channel coupling area independently from the upstream biasing element (15a).

Abstract: A data collection device comprises: a first portion having one or more features configured for attaching of the first portion to a dosage knob of an injection device; a second portion rotatably coupled with the first portion, wherein at least part of the second portion is movable axially relative to the first portion; a sensor arrangement configured to detect rotation of the first portion relative to the second portion; and a processor arrangement configured to, based on said detected movement, determine a medicament amount expelled by the injection device, wherein the coupling arrangement is configured to provide a non-permanent coupling between the first portion and the dosage knob of the injection device.

Abstract: A split dilator aspiration system is disclosed. The system includes a catheter, having an elongate, flexible tubular body with a proximal end, a distal end, a side wall defining a central lumen, and a handle on the proximal end. A dilator is advanceable through the central lumen, the dilator having an elongate body, cannulated to receive a guidewire, and an axially extending split along at least a portion of the elongate body, configured to allow removal of a portion of the dilator laterally from the guidewire.

Abstract: A smart patch and a method for fabricating the same are provided. The smart patch includes: a substrate, a detecting component arranged on the substrate, and a reminding component connected with the detecting component, wherein the detecting component is configured to detect a stretch degree of the substrate; and the reminding component is configured to transmit a reminding signal when the stretch degree of the substrate, detected by the detecting component, meets a preset condition.

Abstract: Infusion devices, systems, and related operating methods are provided. A method of detecting an anomalous condition with respect to a fluid path based on operation of an actuation arrangement configured to deliver fluid via the fluid path involves providing input power to the actuation arrangement to produce actuation of the actuation arrangement, identifying an active amount of actuation of the actuation arrangement concurrent to the input power being provided to the actuation arrangement, disabling the input power to the actuation arrangement, identifying a passive amount of actuation of the actuation arrangement after disabling the input power to the actuation arrangement, and detecting the anomalous condition based on a relationship between the active amount and the passive amount.

Abstract: A fluid transfer device for parenterally transferring fluid to and/or from a patient includes a housing, a needle, and an occlusion mechanism. The housing defines a fluid flow path and is couplable to a fluid reservoir. The needle has a distal end portion that is configured to be inserted into the patient and a proximal end portion that is configured to be fluidically coupled to the fluid flow path of the housing, and defines a lumen therebetween. The occlusion mechanism selectively controls a fluid flow between the needle and the fluid flow path. The occlusion mechanism includes an occlusion member that is movable between a first configuration where the lumen of the needle is obstructed during insertion into the patient and a second configuration where the lumen of the needle is unobstructed after the needle has been inserted into the patient allowing fluid transfer to or from the patient.

Abstract: A microneedle structure and a biodegradable microneedle thereof are provided. The biodegradable microneedle defining a central axis includes a first step portion and a second step portion that is taperedly extending from the first step portion along the central axis. The biodegradable microneedle has a total height along the central axis and a maximum internal diameter along a direction perpendicular to the central axis. The total height is within a range of 380-430 ?m, and an aspect ratio defined by the total height divided by the maximum internal diameter is within a range of 1.2-2.2. In a cross section of the biodegradable microneedle having the central axis, a part of the second step portion arranged away from the first step portion having a corner. The corner has an angle within a range of 65-100 degrees and faces toward the first step portion.

Abstract: Various embodiments of the present disclosure can include flexible catheter tip. The flexible catheter tip can include an inboard understructure that defines a tip longitudinal axis, wherein the inboard understructure can be formed from a first continuous element that includes a first rectangular cross-section. An intermediate inboard covering can be disposed about the first continuous element that forms a distal portion of the inboard understructure. An outboard understructure can extend along the tip longitudinal axis, wherein the outboard understructure can be formed from a second continuous element that includes a second rectangular cross-section. An intermediate outboard covering can be disposed about the second continuous element that forms a distal portion of the outboard understructure.

Abstract: A control device for a blood treatment machine performs a connection test (50) by causing the blood treatment machine to switch (51, 53) between a first and a second operating state by reversing a blood pump so as to change a flow direction of blood through both a dialyzer and access devices connected to a patient. Based on an output signal of at least one sensor in the blood treatment machine (52, 54), the control device computes (55) an efficiency change parameter that represents a change in in-vivo clearance of the blood treatment machine during the switch of the blood treatment machine between the first and second operating states. The control device evaluates (56) the efficiency change parameter to jointly detect connection errors at the dialyzer, resulting in co-current flow of treatment fluid and blood through the dialyzer, and at the access devices, resulting in access recirculation of blood.

Abstract: The present invention relates to a microneedle array and a method for manufacturing the same, the microneedle array comprising: a support; and a plurality of microneedles loaded with a solid-phase formulation which protrude from the upper portion of the support, wherein a liquid-phase formulation is applied or added dropwise onto an area of the upper portion of the support in which the microneedles are not formed, or in a case where one or more holes are formed in the support, the liquid-phase formulation is released, through the holes, onto the area of the upper portion of the support in which the microneedles are not formed.