Abstract: Devices and methods are provided for sealing a catheter insertion site to maintain sterility. In one aspect of the invention, mounting handle/dressing assemblies and kits are disclosed for creating a sterile sealed environment around a catheter insertion site. For example, the dressings of the present invention can be pre-disposed around a mounting handle and connector. The connector is joined to the proximal end of the catheter and then the dressing can be slid along the mounting handle until it surrounds the insertion site. Once the dressing is adhesively applied to the skin and locked into place by an annular fitting between the dressing and the connector, the handle can be removed and discarded, leaving only the dressing, and catheter connector in place. The catheter connector preferably has a needle-free connector port at its proximal end for connection to IV lines or other infusion devices.

Abstract: An infusion pump includes a housing, a wireless transceiver, a pump motor mounted within the housing, a location sensor configured to provide information associated with a location of the infusion pump, a battery conductively coupled to the wireless transceiver, the pump motor, the location sensor and processor(s), and memory. The infusion pump is configured to monitor, using the location sensor, a geofence parameter of the infusion pump, determine a change in the location of the infusion pump based on the geofence parameter, identify an operation mode of the infusion pump associated with the geofence parameter, and automatically switch, responsive to the changed location, the operation mode of the infusion pump from a first mode currently programmed for care of a patient to a second mode, the second mode using different parameters than the first mode to control elements of the infusion pump.

Abstract: A valve for controlling delivery of fluid includes a valve seat comprising a fluid inlet, a fluid outlet, a well having a passage, and a valve membrane comprising a conical portion having a base and a tip. The conical portion is configured to fit within the passage of the valve seat. The valve membrane is configured to fluidly connect the fluid inlet to the fluid outlet when the valve membrane is in an undeformed position and fluidly disconnect the fluid inlet from the fluid outlet when the valve membrane is in a radially deformed position.

Abstract: Methods and devices for eradicating biofilms and planktonic bacteria are provided. In on embodiment, a therapeutic delivery device comprised of at least a port and a antimicrobial releasing pouch and one or more therapeutic agents is provided to the mammal. In one aspect of at least one embodiment the releasing pouch has an internal reservoir comprised of a membrane that is configured to contain the one or more therapeutic agents that is to be administered to the mammal and the port is in fluid communication with the pouch and configured such that the pouch can be refilled with one or more therapeutic agents via the port. In other aspect of at least one embodiment the method is able to fully eradicate 109 colony forming units (CFU) of methicillin-resistant Staphylococcus aureus (MRSA) within a 24 hr period.

Abstract: A method of operating a system having a fluid pump mechanism and a related controller involves: operating the system in a first mode to automatically deliver the medication in accordance with a therapy control algorithm; and receiving stress-identifying data generated at least in part from gesture data for the user. The gesture data is provided by a gesture-based physical behavior detection system. The method determines, from the stress-identifying data, that the user is under stress while the medication delivery system is operating in the first mode. In response to detecting stress, the system is operated in a second mode to automatically deliver the medication to the user in accordance with a stress-correlated therapy control algorithm. The second mode compensates for user stress as determined from the stress-identifying data.

Abstract: An ambulatory medical device can detect a device condition and determine if the device condition satisfies a set of normal operating parameters. If the normal operating parameters are not satisfied, the ambulatory medical device can determine if the device condition stratifies a set of minimum operating parameters. If the minimum operating parameters are satisfied, the ambulatory medical device can maintain a delivery of therapy to a subject and generate an alert based on the device condition.

Abstract: A therapeutic delivery device that provides a controlled release of high doses of a therapeutic agent in a local area, sustains the high dose controlled release with a percutaneous port for refilling the device, and is versatile for use with multiple types of therapeutic agents and/or implant systems. A rate determining/controlled release membrane is used to decrease the molecular mobility of the therapeutic compounds thereby controlling the therapeutic release profile. The therapeutic delivery device includes a body defining an internal reservoir for receiving a therapeutic agent and including a first membrane for providing a controlled release of the therapeutic agent to the surgical site, a port in fluid communication with the reservoir, a sleeve configured to encapsulate the body, and a rigid housing configured to support the body and a portion of the sleeve, the rigid housing configured to release the body and the sleeve after the body and the sleeve are anchored position relative to the surgical site.

Abstract: A therapeutic delivery device that provides a controlled release of high doses of a therapeutic agent in a local area, sustains the high dose controlled release with a percutaneous port for refilling the device, and is versatile for use with multiple types of therapeutic agents and/or implant systems. A rate determining/controlled release membrane is used to decrease the molecular mobility of the therapeutic compounds thereby controlling the therapeutic release profile. The therapeutic delivery device includes a body defining an internal reservoir for receiving a therapeutic agent and including a first membrane for providing a controlled release of the therapeutic agent to the surgical site, a port in fluid communication with the reservoir, a sleeve configured to encapsulate the body, and a rigid housing configured to support the body and a portion of the sleeve, the rigid housing configured to release the body and the sleeve after the body and the sleeve are anchored position relative to the surgical site.

Abstract: A therapeutic delivery device that provides a controlled release of high doses of a therapeutic agent in a local area, sustains the high dose controlled release with a percutaneous port for refilling the device, and is versatile for use with multiple types of therapeutic agents and/or implant systems. A rate determining/controlled release membrane is used to decrease the molecular mobility of the therapeutic compounds thereby controlling the therapeutic release profile. The therapeutic delivery device includes a body defining an internal reservoir for receiving a therapeutic agent and including a first membrane for providing a controlled release of the therapeutic agent to the surgical site, a port in fluid communication with the reservoir, a sleeve configured to encapsulate the body, and a rigid housing configured to support the body and a portion of the sleeve, the rigid housing configured to release the body and the sleeve after the body and the sleeve are anchored position relative to the surgical site.

Abstract: Disclosed herein are catheter assemblies (100) with a locator tip (134) proximal to the distal tip (112) of a catheter tube (110). The locator tip is sized to remain outside a female urethra and configured to allow the catheter tube to pass there through. As an example, the locator tip allows a woman using a urinary catheter to target her urethra without exposing the catheter tube to tissue until the urethra is located and insertion is initiated. This avoids infecting the urethra with a catheter tube that has been contaminated by bacteria around the urethra.

Abstract: An infusion set includes a base (221) and a flexible catheter (242) movable from a first catheter position disposed substantially entirely within the base (221) to a second catheter position in which a free end of the catheter (242) is disposed externally of the base (221). An introducer needle (234) is located within the catheter (242) and is movable between a first introducer needle position disposed substantially entirely within the base (221) and a second introducer needle position in which a free end of the introducer needle (234) is disposed externally of the bases (221). A spring (281) is activated to move the catheter (242) from the first to the second catheter position and the introducer needle (234) from the first to the second introducer needle position to facilitate insertion of the catheter (242).

Abstract: A processor-implemented method for closed-loop control in steady-state conditions includes determining, based on data including historical bolus information but excluding historical basal information, an amount of unmetabolized therapeutic substance in a patient; determining, based on a difference between a most recent measurement of a physiological condition of the patient and a target value for the physiological condition, a first amount or rate of a basal dosage for delivery to the patient; adjusting, based on the amount of unmetabolized therapeutic substance, the first amount or rate of the basal dosage to determine a second amount or rate of the basal dosage; and causing delivery of the second amount or rate of the basal dosage based on communicating the second amount or rate in a delivery command.

Abstract: A multi-port medical syringe comprises a port body, a syringe barrel, and a plunger. The port body comprises a cylindrical cavity with at least three ports. The three port are configured to connect the cylindrical cavity of the port body with three medical devices: a first port configured for attachment to a medical device such as an input fluid source; a second port configured for fluid transmission through a urinary catheter to a bladder of a human or animal; and a third port configured for attachment to a medical device such as a drainage fluid storage vessel. The syringe barrel comprises a cylindrical tube, at least a portion of which fits snugly inside the cylindrical cavity of the port body. The syringe barrel further comprises a syringe barrel port located proximate to, or in, an otherwise closed end of the syringe barrel.

Abstract: A method and system of providing a needle-less injector specifically configured to the needs of a user. The method includes assembling a needle-less injector by positioning an inner housing within the outer housing such that the inner housing is axially movable within the outer housing between a ready position and a firing position. The method further includes receiving a user selection of a delivery spring weight from a plurality of available delivery spring weights. Then a delivery spring having the selected spring weight is placed within the inner housing. The completed needle-less injector having a delivery spring with the selected weigh may then be delivered to the user. In alternative injector configurations, the user may also select one or more of a skin tensioning spring weight or a hammer length along with or instead of the delivery spring weight.

Abstract: The present invention relates to a medicament delivery device comprising a housing, a compartment inside said housing for positioning a medicament container, an injection needle arranged to said housing, being connectable to said medicament container for delivering a dose of medicament, a manually operated activation mechanism for activating said device, an actuation mechanism operably connected to said activation mechanism and arranged to, upon activation of said activation mechanism, extend said injection needle from a first position inside said housing to a second position wherein a penetration of a patient is performed, a plunger rod arranged in said housing capable of acting on said medicament container for delivering a dose of medicament through said injection needle, a driver capable of acting on said plunger rod for delivering a dose of medicament.

Abstract: The present disclosure provides improved technologies relating to medical fluid heating systems and apparatus. In certain embodiments, the present disclosure relates to systems and apparatus for heating a fluid and, more particularly, for quickly and controllably heating a flow of blood or a blood product, for example, for infusion into a patient or for hyperthermia treatment. In particular, in a first aspect, the present disclosure is directed to a system and apparatus featuring single flow path fluid heating (“single path flow”). Moreover, in a second aspect, the present disclosure is directed to a system, apparatus, and related method for efficiently utilizing the thermal energy of an infusate stored in a reservoir (“slack time heating”). Furthermore, in a third aspect, the present disclosure is directed to a fluid heating system and apparatus featuring a vacuum release valve designed to prevent the undesired orientation of deformed inflow tubing (“vacuum release valve”).

Abstract: A catheter system may include a catheter adapter and a catheter extending distally from the catheter adapter. The catheter system may include a needle assembly, which may include a plug, an outer housing, and an introducer needle. An outer surface of the plug may include multiple grooves, which may be in fluid communication with the introducer needle and configured to receive blood flashback. The grooves may include a first groove having a first surface-area-to-volume ratio, and a second groove having a second surface-area-to-volume ratio. The first surface-area-to-volume ratio may be less than the second surface-area-to-volume ratio. The first groove may have a greater volume than the second groove. The outer housing may seal a top of the first groove and a top of the second groove to prevent blood from flowing out the top of the first groove and the top of the second groove.

Abstract: A drug delivery device includes a reservoir for containing a medical product, a distally projecting end-piece having an outer surface and a total length measured along a longitudinal axis of said end-piece, said end-piece defining an axial passageway for the transfer of said medical product contained in said reservoir, wherein a gripping surface is provided on a portion of said outer surface, said portion being located in a distal region of said end-piece, the length of said portion representing at most 40%, preferably less than 33%, of the total length of the end-piece. An assembly includes such a drug delivery device and an adaptor intended to be mounted onto the end-piece.

Abstract: A body-fluid-and-medication leak-proof and closed medical connector has a first connecting assembly and a second connecting assembly. The first connecting assembly has a first sleeve and a first resilient valve. The first resilient valve tends to seal a first opening of the first sleeve. The second connecting assembly has a second sleeve and a second resilient valve. The second resilient valve tends to seal a second opening of the second sleeve. The two resilient valves can avoid leakage of the medication remaining in an injector and a vial, or remaining in a fluid infusion tube and a catheter. The two resilient valves also can seal in two directions to avoid leakage during connecting or separating the two connecting assemblies after supplying medication. Therefore, the transfer of the medication is more hygienic and safe, and the waste of medical resources is effectively reduced.

Abstract: Devices, systems, and methods for sealing medical devices, particularly during intravascular access, are disclosed herein. Some aspects relate to a hemostatic valve for sealing a wide range of medical devices, such as catheters, wires, embolectomy systems. The valve can include an elongate member having a first end, a second end, and a central lumen extending therebetween. A reinforcement structure extends along at least a portion of the elongate member and is coupled to the elongate member. A shell defining a first aperture and a second aperture may be included, which first and second apertures can be fluidly coupled by the elongate member. A tensioning mechanism is coupled to the shell and to the elongate member, the tensioning mechanism can be moveable between a first configuration wherein the tensioning mechanism is collapsed and the central lumen is sealed and a second configuration wherein the central lumen is open.