Abstract: Disclosed herein are combined devices and methods of manufacturing such combined devices. The combined devices disclosed herein include an analyte sensor including a sensor probe; an infusion set hub including a cannula; and a flexible base. The analyte sensor and infusion set hub are attached to the flexible base such that movement of one of the analyte sensor and the infusion set hub is substantially not transferred to the other one of the analyte sensor and the infusion set hub.

Abstract: Patient monitoring systems and related medical devices and methods are provided. One method involves obtaining historical usage data associated with a patient for a plurality of potential site locations for a medical device, classifying one or more site locations of the plurality of potential site locations into a viable group of potential site locations for the patient based at least in part on the historical usage data, and providing, at a client device, graphical indicia of the one or more site locations classified into the viable group of potential site locations.

Abstract: A bubble detector, a medical device system that includes the detector, and a related operating methodology are disclosed here. The detector is designed and operated to detect presence of bubbles in a fluid delivery tube. The detector includes a capacitive sensor, a control circuit to control operation of the sensor to measure capacitance associated with fluid in the fluid delivery tube, a power source to provide voltage across the capacitor electrodes and to provide operating power to the control circuit, a communication module to communicate sensor data from the detector, and a housing with structural features to secure the detector to the fluid delivery tube and to maintain the capacitor electrodes in position relative to the fluid delivery tube. The sensor data is indicative of the measured capacitance associated with the fluid in the fluid delivery tube.

Abstract: Medical devices and methods and apparatuses for identifying fluids in a conduit of a device are provided. An exemplary medical device includes a reservoir for holding a fluid and a conduit for dispensing the fluid from the reservoir. Further, the medical device includes a spectroscopy device for examining the fluid.

Abstract: A fluid infusion device includes a housing having a reservoir chamber that receives a fluid reservoir. The fluid reservoir has a first end and a second end. The fluid infusion device includes a connector system having a first body section coupled to a second body section. The first body section defines a bore in communication with a chamber and a counterbore of the second body section to define a fluid flow path. The chamber of the second body section is in fluid communication with a vent subsystem defined through the second body section. The vent subsystem terminates in an outlet, and the vent subsystem is to direct gas in the fluid flow path through the second body section to the outlet. The fluid infusion device includes at least one ring disposed within the reservoir chamber that cooperates with the connector system to securely couple the connector system to the housing.

Abstract: Medical devices and methods and apparatuses for identifying fluids in a conduit of a device are provided. An exemplary apparatus for identifying an infusate in a conduit of an infusion device includes a transmitter element for transmitting a beam of energy for interaction with the infusate. Further, the apparatus includes a receiver element for receiving a signal from the beam of energy after interaction with the infusate. Also, the apparatus includes an identifier element coupled to the receiver element for analyzing the signal to identify the infusate. The transmitter element and receiver element may form a spectroscopy device and may transmit and receive a beam of infrared light or near infrared light.

Abstract: Methods and devices are provided for reducing a diabetic patient's foreign body immune response, including infusion site-loss and/or occlusion. Such foreign body responses are associated with the treatment of the diabetic patient where the treatment requires subcutaneous implantation of a foreign body, such as a cannula or catheter. In certain embodiments of the invention, a response-inhibiting agent is administered to a patient at the site of cannula/catheter insertion, thereby facilitating delivery of insulin to the diabetic patient and mitigating site-loss and/or occlusion over a period of time.

Abstract: A set connector system for venting a gas from a fluid reservoir of a fluid infusion device is provided. The set connector system includes a connector system having a first body section coupled to a second body section. The first body section defines a bore in communication with a chamber and a counterbore of the second body section to define a fluid flow path from the fluid reservoir. The chamber of the second body section is in fluid communication with a vent subsystem defined through the second body section. The vent subsystem terminates in an outlet, and the vent subsystem directs gas in the fluid flow path through the second body section to the outlet.

Abstract: Methods and devices are provided for reducing a diabetic patient's foreign body immune response, including infusion site-loss and/or occlusion. Such foreign body responses are associated with the treatment of the diabetic patient where the treatment requires subcutaneous implantation of a foreign body, such as a cannula or catheter. In certain embodiments of the invention, a response-inhibiting agent is administered to a patient at the site of cannula/catheter insertion, thereby facilitating delivery of insulin to the diabetic patient and mitigating site-loss and/or occlusion over a period of time.

Abstract: An adhesive patch for a medical device having a hub, such as an infusion device, is provided. The adhesive patch includes a first backing layer to be coupled to the medical device. The first backing layer is composed of a first material. The adhesive patch includes a first adhesive layer coupled to the first backing layer and a second backing layer coupled to the first adhesive layer. The second backing layer is composed of a second material, and the second material is different than the first material. The adhesive patch includes a biocompatible second adhesive layer coupled to the second backing layer, and the second adhesive layer is to be coupled to an anatomy.

Abstract: A fluid delivery system and a fluid conduit assembly suitable for use with the system are disclosed herein. The system includes a fluid infusion pump and a fluid conduit assembly coupled to the pump to deliver medication fluid to a user. The fluid conduit assembly includes a structure defining a flow path for the medication fluid, and a gas trapping filter coupled to the structure and positioned in the flow path. The gas trapping filter functions to filter particulates from the medication fluid and retain gas bubbles from the medication fluid.

Abstract: A medical device includes a hub and an adhesive patch coupled to the hub. The adhesive patch is to couple the hub to an anatomy. The adhesive patch defines an edge that extends along a perimeter of the adhesive patch. The medical device includes an anisotropic shim coupled to the adhesive patch along the perimeter of the adhesive patch proximate the edge to resist an uncoupling of the adhesive patch from the anatomy. The shim has an inner periphery spaced apart from an outer periphery and the shim is locally rigid between the inner periphery and the outer periphery.

Abstract: A fluid delivery system and a fluid conduit assembly suitable for use with the system are disclosed herein. The system includes a fluid infusion pump and a fluid conduit assembly coupled to the pump to deliver medication fluid to a user. The fluid conduit assembly includes a structure defining a flow path for the medication fluid, and a gas trapping filter coupled to the structure and positioned in the flow path. The gas trapping filter functions to filter particulates from the medication fluid and retain gas bubbles from the medication fluid.

Abstract: The present invention describes improved systems and methods for attaching external medical devices to the body of a patient using a multilayer attachment apparatus. Medical devices that require attachment to the body, including monitoring devices, drug-infusing devices and the like, can utilize embodiments of the attachment apparatus and method described herein. Embodiments of the invention include new adhesive and hook and loop attachment mechanisms and methods for using embodiments of the multilayer attachment apparatus to attach medical device and/or medical device components to the body.

Abstract: Medical devices and methods and apparatuses for identifying fluids in a conduit of a device are provided. An exemplary apparatus for identifying an infusate in a conduit of an infusion device includes a transmitter element for transmitting a beam of energy for interaction with the infusate. Further, the apparatus includes a receiver element for receiving a signal from the beam of energy after interaction with the infusate. Also, the apparatus includes an identifier element coupled to the receiver element for analyzing the signal to identify the infusate. The transmitter element and receiver element may form a spectroscopy device and may transmit and receive a beam of infrared light or near infrared light.

Abstract: Apparatuses and methods for identifying an infusate in a reservoir of an infusion device and systems for use in filling fluid delivery devices are provided. An exemplary apparatus for identifying an infusate in a reservoir of an infusion device includes a chamber in selective fluid communication with the reservoir. Further, the apparatus includes an indicator located in the chamber. The indicator exhibits a visual change when contacted by an infusate. The apparatus also includes a detector arrangement to identify the infusate by detecting the visual change in the indicator. An exemplary detector arrangement may include a camera to capture an image of the infusate and indicator in the chamber, and an identifier element to compare image data to a library of stored image data.

Abstract: This invention pertains to systems and components useful for infusing medications such as insulin. Typically, the components are used to deliver insulin to a diabetic patient at a site of infusion over a period of time greater than 4 days. The system components typically comprise a cannula adapted for subcutaneous insertion into a diabetic patient. The system further comprises a fluid conduit adapted to deliver the insulin solution from a medication reservoir to the site of infusion and a depot in operable contact with the fluid conduit. The depot comprises selected materials including a site-loss mitigating agent (such as heparin) which inhibits inflammation at the site of infusion, and encapsulation of the cannula at the site of infusion. The site-loss mitigating agent is not premixed with the insulin, and instead is adapted to contact the insulin solution in the depot as the insulin solution flows from the medication reservoir to the site of infusion.

Abstract: A set connector system for venting a gas from a fluid reservoir of a fluid infusion device is provided. The set connector system includes a connector system having a first body section coupled to a second body section. The first body section defines a bore in communication with a chamber and a counterbore of the second body section to define a fluid flow path from the fluid reservoir. The chamber of the second body section is in fluid communication with a vent subsystem defined through the second body section. The vent subsystem terminates in an outlet, and the vent subsystem directs gas in the fluid flow path through the second body section to the outlet.

Abstract: A fluid delivery system and a fluid conduit assembly suitable for use with the system are disclosed herein. The system includes a fluid infusion pump and a fluid conduit assembly coupled to the pump to deliver medication fluid to a user. The fluid conduit assembly includes a structure defining a flow path for the medication fluid, and a gas trapping filter coupled to the structure and positioned in the flow path. The gas trapping filter functions to filter particulates from the medication fluid and retain gas bubbles from the medication fluid.

Abstract: Syringe pistons for a fluid syringe, and related sealing elements, are presented here. A syringe piston includes a piston body having a fluid end, an actuator end, and an outer seal-retaining surface between the fluid end and the actuator end. The syringe piston may utilize a piston sealing sleeve or a piston sealing cover. The sleeve can be coupled to the piston body around the outer seal-retaining surface, the piston sealing sleeve having a fin-shaped fluid seal element to form an interference fluid seal with an interior wall of a syringe barrel. The sealing cover can be coupled overlying the tip of the piston body. The cover has a fin-shaped fluid seal element to form an interference fluid seal with an interior wall of a syringe barrel.