Abstract: Embodiments of the present invention are directed to guidewire advancement and blood flashback systems. In particular, an insertion tool includes a frangible guidewire lever configured to break and prevent further movement of a guidewire if the guidewire becomes caught. Such a feature can prevent breakage of a distal portion of the guidewire which otherwise could undesirably lead to an embolism. The insertion tool can further include a blood flash indicator that has a simplified coupling with a needle. The insertion tool can further include a guidewire advancement assembly configured to allow a clinician to hold the insertion tool proximate a distal end and operate the guidewire advancement with one hand while providing increased control over the insertion tool. The insertion tool can further include a safety clip coupled with a catheter hub and configured to close about a tip of the needle when a catheter is detached from the insertion tool.

Abstract: An intradermal fluid delivery device that uses a processor controlled electromechanical delivery mechanism is provided. An air pump pushes fluid containing medication or saline from a fluid compartment through a microneedle array into a person's skin. The processor repeatedly turns the air pump on or off, for the fluid to gradually be injected into the person's skin. The processor may be configured to control the total fluid delivery time as well as the granularity of the fluid delivery. The total fluid delivery time may be set to T, and the time period T may be divided into smaller periods t1 to tn, where the fluid may be administered in a period t1, the fluid delivery may then be stopped for a period t2, followed by another fluid delivery period, etc. The periods t1 to tn may be the same or of different lengths.

Abstract: An assembly for a medication delivery device includes a body, a piston rod, rotatable with respect to the body, for setting a dose of a medication, and axially movable in a distal direction for delivering the set dose, wherein, in cross-section, the piston rod includes a plurality of ratchet teeth to enable rotation of the piston rod during setting of a dose, and a stop member secured against axial and rotational movement, wherein the stop member mechanically cooperates with the piston rod, wherein, when setting the dose, the piston rod becomes aligned with the stop member, and wherein, when delivering the set dose, the piston rod is moved in the distal direction towards the stop member such that the piston rod and the stop member abut at the end of the dose delivery operation and further distal movement of the piston rod is prevented after dose delivery.

Abstract: A pressure jacket configured for connecting to an injector head of a fluid injector has an open distal end, an open proximal end, and a sidewall defining a throughbore extending between the distal end and the proximal end along a longitudinal axis. The throughbore is configured for receiving at least a portion of a syringe. The pressure jacket has at least one syringe retaining element positioned at least partially within the throughbore. The at least one syringe retaining element is configured for engaging at least a portion of the syringe during pressurized delivery of fluid from the syringe to prevent or limit a distal movement of the syringe relative to the pressure jacket.

Abstract: A method for operating a catheter provides a mechanical stiffener to a catheter shaft portion, the shaft comprising an inner sheath having a distal end and an outer surface and defining an access lumen extending distally to the distal end and an outer sheath having an inner surface surrounding the inner sheath distally to the distal end, defining an annulus between the outer and inner surfaces, the annulus having a connection at which vacuum applies to the annulus, and having a substantially constant outer diameter over the portion to the distal end. A tool is shaped and sized to pass through the access lumen and past the distal end. The portion is placed in an increased stiffened state by applying vacuum to create a stable base with at least a shaft segment within the anatomy that atraumatically resists reaction forces applied to the shaft by the tool.

Abstract: A controllable stiffness catheter includes a shaft comprising inner and outer sheaths, the sheaths each having proximal and distal ends. The outer surrounds the inner from the proximal to the distal end of the inner sheath, defining an annulus therebetween including a proximal portion having a vacuum connection to which vacuum is applied. The distal ends of the sheaths are longitudinally fixed to one another and sized for neurological vascular procedures. The outer has a substantially constant outer diameter over a distal portion of the annulus proximate to the distal ends. A vacuum device fluidically connects to the vacuum connection and is configured to apply vacuum thereto. Responsive to vacuum, annulus pressure lowers to draw the sheaths toward one another and stiffen the shaft over at least the distal portion to substantially and passively stiffen and maintain a current shape of the shaft over at least the distal portion.

Abstract: A catheter having a selectively inflatable external balloon and an internal balloon, where the internal balloon is operable as a valve to control fluid flow through a channel.

Abstract: A peritoneal dialysis machine carries out of a peritoneal dialysis treatment having recurring cycles, the recurring cycles involving an inflow phase, a dwell period and a drainage phase for a dialysis fluid, wherein the peritoneal dialysis machine has a control unit and a measurement apparatus for determining the inflow rate and/or drainage rate of the dialysis fluid to and from a patient, wherein the control unit is configured to carry out a comparison between a time progression curve of the inflow rate and/or of the drainage rate determined by the measurement apparatus during the inflow phase and/or the drainage phase and a corresponding reference curve and to recognize on the basis of the comparison a disturbance in inflow and/or drainage of the dialysis fluid to and from the patient.

Abstract: Devices, assemblies, systems, and techniques described herein may facilitate the delivery of medical fluid, such as an adhesive, to a patient. For example, a medical assembly may include a flexible catheter configured to be disposed within an anatomical structure of a patient, wherein the flexible catheter defines a lumen configured to contain a volume of medical adhesive. The medical assembly may also include a shaft defining a shaft cross-sectional dimension smaller than a lumen cross-sectional dimension of the lumen, wherein advancement of the shaft through at least a portion of the lumen forces at least a portion of the volume of medical adhesive out of the distal opening of the lumen of the flexible catheter.

Abstract: Examples of catheter devices, removable needle devices and kits are disclosed. Also methods for accessing a hollow organ are disclosed. The catheter devices include a body extending longitudinally from a proximal end to a distal end, wherein the body includes an elongated channel along a longitudinal length of the body extending from the proximal end to the distal end of the body, wherein the channel is configured to receive an elongated needle of a removable needle device, and the body includes one or more cutting edges extending in a proximal direction from the distal end of the body. The body of the catheter device includes one or more recesses adapted to mate with one or more catches of the removable needle device for coupling the needle device to the catheter devices. Also methods of using the catheters, removable needle devices and the kits are disclosed.

Abstract: A tamper resistant catheter device preventing unauthorized access, while permitting authorized intravenous medications through an inlet port. The device comprises a catheter line retainer having a base supporting the catheter line, a lumen adaptor engaged with the catheter line, and a locking clamp for clamping the catheter line within the catheter line retainer. An installation tool is provided having a breakaway handle and a locking cap for covering the lumen adaptor. Finally, a slotted retaining sleeve is installed using the breakaway handle of the installation tool for engagement with the locking cap and around the lumen adaptor. The slotted retaining sleeve engages the locking clamp to block removal of the locking clamp from the line retainer. Once the slotted retaining sleeve and locking cap are installed, the breakaway handle is removed. A removal tool disengages the locking cap from the slotted retaining sleeve for authorized access.

Abstract: Provided are a method of applying a microneedle array, and a patch or an assistant tool used therefor. When skin is to be stretched and punctured with microneedles, the microneedle array can be prevented from detaching from the skin by providing adhesive layers, with the microneedle array therebetween, in a direction different from the direction in which the skin is stretched. Additionally, the application method can be appropriately implemented by producing a patch or an assistant tool having a rigid flat plate. As a result, the microneedle array can be punctured more accurately with less stress.

Abstract: Medical instruments having a translatable spool are disclosed. In one aspect, a medical instrument configured for use with a robotic system includes an instrument base configured to couple to a robotic drive mechanism of the robotic system and an elongate shaft coupled to the instrument base. The elongate shaft has a distal end. The medical instrument also includes a pull wire fixedly coupled to the distal end of the elongate shaft, the pull wire being configured to actuate the elongate shaft, and a rotatable spool in the instrument base. The rotatable spool is configured to direct the pull wire to the elongate shaft at an angle. The rotatable spool is configured to translate in coordination with actuation of the elongate shaft to control the angle of the pull wire relative to the elongate shaft.

Abstract: The purpose of the present invention is to provide a microneedle array and a microneedle manufacturing method, which improves medical solution delivery efficiency and facilitates manufacturing. The microneedle array is provided with a first divisional element, a second divisional element to be bonded to the first divisional element, a longitudinal passage formed between the first divisional element and the second divisional element bonded to each other; and a horizontal hole, having an orifice on a lateral side and formed in a direction parallel to a bonding surface of the first divisional element with the second divisional element, and communicating to the longitudinal passage.

Abstract: The disclosure generally relates to adjustable sheath devices for insertion into the body to provide intravascular access to various medical devices, involving a dynamically expandable sheath capable of expanding within the blood vessel when a medical device is passed through the sheath and retracting back to almost its original size when the medical device is removed from the sheath. Embodiments generally comprise a rigid collar and an elongated sleeve comprising a continuous elastomeric outer layer and an expandable inner layer.

Abstract: A controller assembly of a fluid delivery apparatus includes a body component and a plunger component slidably coupled to the body component. The plunger is positionable between a first position in which the plunger is nearest to the body component, and a second position in which the plunger component is furthest from the body component. A bias assembly positioned between the body component and the plunger component applies a two stage force profile to the plunger component. The bias assembly includes a first and a second biasing member. In the first position, the first and second biasing members apply first and second forces profiles, respectively, to the plunger component. In the second position, the first biasing member is prevented from applying the first force profile to the plunger component, and the second biasing member applies the second force profile to the plunger component.

Abstract: The invention relates to a microneedle array and to the use thereof for intradermal delivery, comprising a plurality of microneedles on a carrier, wherein this microneedle array is suitable for penetrating the skin of humans or animals and includes at least one color change indicator.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver a bolus amount of fluid influencing a physiological condition in a body of a user involves identifying, based on measurement values for the physiological condition, a residual value for the physiological condition resulting from the bolus amount of the fluid and determining an updated ratio for a subsequent bolus by adjusting an initial ratio influencing the bolus amount to compensate for the residual value. The updated ratio may be stored in a data storage element for use in determining a subsequent bolus amount in lieu of the initial ratio value.

Abstract: An injection device comprises a housing having a longitudinal axis, an axially-depressible dose button (430), a dose indicator (418), a dose setting mechanism operatively coupled to said dose indicator and capable of setting a dose to be ejected from the injection device and spring capable of storing energy necessary for ejecting the dose from the injection device. The spring (420) is coupled to the dose setting mechanism such that a charging force can be transferred from the dose setting mechanism to the spring to increase the energy stored by the spring.

Abstract: An injection system includes an injector head that is configured to control delivery of a designated fluid to a patient. The injector head includes a syringe interface along an active side of the injector head. The syringe interface has a receiving cavity that is configured to receive a syringe barrel. The injector head also includes an internal sensor. A magnetic switch has an external magnet outside of the injector head. The external magnet is operable to modify a magnetic field experienced by the internal sensor to activate the internal sensor.