Abstract: Embodiments of negative pressure wound therapy systems, apparatuses, and methods for operating the systems and apparatuses are disclosed. In some embodiments, the apparatus includes a negative pressure source, a connector port, at least one switch, and a controller. The negative pressure source is connected through the connector port to either (i) a wound dressing having a canister configured to store fluid aspirated from the wound or (ii) a wound dressing without a canister between the connector port and the wound dressing. The controller determines, based on a signal received from the at least one switch, whether the canister is positioned in the fluid flow path and adjusts one or more operational parameters of negative pressure wound therapy based on the determination. The switch is activated by the connection of either the canister or canisterless wound dressing to the apparatus.

Abstract: Methods and devices useful for determining the analyte concentration of a sample using output currents obtained from an input potential in the kinetic potential region of a redox mediator are disclosed. Preferably, the input potential used to generate the output currents from the kinetic potential region of the redox mediator is continually increasing with time after initiating the analysis. A method of selecting an initial input potential within the kinetic potential region of a redox mediator based on the sensitivity of an individual or batch of subcutaneously insertable test sensors also is described. A method of selecting an analysis input potential within the kinetic potential region of redox mediator based on the sensitivity of an individual subcutaneously inserted test sensor also is described where the analysis input potential is increased with insertion time.

Abstract: Described herein are systems and methods for sensing an analyte concentration and delivering a composition to a subcutaneous space of a subject comprising a sensing cannula, which comprises an electrode for detecting the analyte concentration in the subcutaneous space.

Abstract: Described herein are systems and methods for creating a transport tube comprising a plurality of passages configured to deliver an composition from a source into the human subcutaneous space.

Abstract: A device for delivery of an insulin or insulin analog formulation and measurement of subcutaneous glucose concentration may comprise a hollow tube, and an amperometric glucose sensor located proximal to a distal end of the hollow tube. The amperometric glucose sensor may comprise a redox mediator and an enzyme comprising glucose oxidase or glucose dehydrogenase. An applied bias potential may allow an electrode layer of the amperometric glucose sensor to undergo substantially no electropolymerization of an excipient of the insulin or insulin analog formulation during continuous operation of amperometric glucose sensor. A sensitivity of the amperometric glucose sensor to the subcutaneous glucose concentration may be maintained in presence of the insulin or insulin analog formulation.

Abstract: By combining analyte concentration monitoring electrodes and infusion functions into a single subcutaneous element, the described sensing cannulae having a rectangular cross-section avoids the need for two separate devices for insulin delivery and glucose concentration determination. The substantially flat, thus planar, surface of the sensing cannula provides a substrate for deposition of one or more sensing electrodes, preferably through a lithographic-type process. The inner lumen of the sensing cannula serves as a conduit for drug delivery and is formed in a manner that is compatible with lithographic-type electrode formation. The rectangular cross-section of the sensing cannula also allows face and side ports establishing fluid communication between the inner lumen and tissue that preferably reduces the incidence of occlusion of the inner lumen of the sensing cannula.

Abstract: The present disclosure provides methods of measuring of an analyte in a subject to remove a measurement artifact by using a forecasting model to determine the true analyst concentration in a subject. Also herein, the present disclosure provides parameters and models to estimate the true analyte concentration in a subject.

Abstract: The present disclosure provides systems and methods for managing blood glucose in a subject. An insulin delivery cannula may comprise a hollow tube comprising a proximal end and a distal end, wherein the proximal end is in fluid communication with a source of a concentrated insulin or insulin analog formulation of at least about 150 units per milliliter. The distal end may be configured to deliver the concentrated insulin or insulin analog formulation into a subcutaneous space. A continuous amperometric or coulometric glucose sensor may located no more than a pre-determined distance away from the distal end. An insulin pump may be fluidically coupled to the proximal end, and may be attached to the insulin delivery cannula directly or via an intervening tube. The glucose sensor and the insulin delivery cannula may be configured to be inserted into the subcutaneous space simultaneously by a single insertion device.

Abstract: The present disclosure provides systems and methods for managing blood glucose in a subject. An insulin delivery cannula may comprise a hollow tube comprising proximal and distal ends, the proximal end in fluid communication with an insulin source, and the distal end configured to deliver insulin into a subcutaneous space. An insulin infusion pump may be fluidically coupled to the proximal end, and attached to the insulin delivery cannula directly or via an intervening tube. The glucose sensor and the insulin delivery cannula may be configured to be inserted into the subcutaneous space simultaneously by a single insertion device. A lumen of the insulin delivery cannula may be contiguous with a lumen of tubing from the insulin infusion pump. Electrical conductors for the electrodes may be disposed on a wall of the tubing or attached to a surface of the tubing, and establish an electrical connection with an electronic module.

Abstract: The present disclosure provides systems and devices for combining analyte monitoring with fluid delivery, including devices that are adapted for use with combined sensors and cannulas having sensors and cannulas on a single component. These systems and devices may be used in various applications with simultaneous in vivo monitoring of analyte concentrations and delivery of medications.

Abstract: In an aspect, the present disclosure provides a combined drug delivery cannula and continuous glucose sensor that measures glucose without interference from the drug excipient, said cannula being a hollow tube, the outer wall of which includes: an electrode layer with at least one indicating electrode, said layer underlying a redox-catalytic layer that includes an osmium compound bound to a ligand, and either glucose oxidase or glucose dehydrogenase.

Abstract: This disclosure teaches the concept, and method of creating, a dual use device intended for persons who take insulin. In one embodiment, the novel device is an insulin delivery cannula, the outer wall of which contains electrodes, chemical compounds and electrical interconnects that allow continuous glucose sensing and delivery of data to a remote device. Heretofore, the main problem in attempting to sense glucose at the site of insulin delivery has been the high current resulting from oxidation by the sensor of the preservatives in the insulin formulations. One means of eliminating these interferences is to poise the indicating electrode(s) of the sensor at a bias sufficiently low to avoid the signal from oxidation of the preservatives. One way of obtaining a glucose signal at a low bias is to use an osmium-ligand-polymer complex instead of conventional hydrogen peroxide sensing.

Abstract: This disclosure teaches the concept, and method of creating, a dual use device intended for persons who take insulin. In one embodiment, the novel device is an insulin delivery cannula, the outer wall of which contains electrodes, chemical compounds and electrical interconnects that allow continuous glucose sensing and delivery of data to a remote device. Heretofore, the main problem in attempting to sense glucose at the site of insulin delivery has been the high current resulting from oxidation by the sensor of the preservatives in the insulin formulations. One means of eliminating these interferences is to poise the indicating electrode(s) of the sensor at a bias sufficiently low to avoid the signal from oxidation of the preservatives. One way of obtaining a glucose signal at a low bias is to use an osmium-ligand-polymer complex instead of conventional hydrogen peroxide sensing.

Abstract: This disclosure teaches the concept, and method of creating, a dual use device intended for persons who take insulin. In one embodiment, the novel device is an insulin delivery cannula, the outer wall of which contains electrodes, chemical compounds and electrical interconnects that allow continuous glucose sensing and delivery of data to a remote device. Heretofore, the main problem in attempting to sense glucose at the site of insulin delivery has been the high current resulting from oxidation by the sensor of the preservatives in the insulin formulations. One means of eliminating these interferences is to poise the indicating electrode(s) of the sensor at a bias sufficiently low to avoid the signal from oxidation of the preservatives. One way of obtaining a glucose signal at a low bias is to use an osmium-ligand-polymer complex instead of conventional hydrogen peroxide sensing.

Abstract: This disclosure teaches the concept, and method of creating, a dual use device intended for persons who take insulin. In one embodiment, the novel device is an insulin delivery cannula, the outer wall of which contains electrodes, chemical compounds and electrical interconnects that allow continuous glucose sensing and delivery of data to a remote device. Heretofore, the main problem in attempting to sense glucose at the site of insulin delivery has been the high current resulting from oxidation by the sensor of the preservatives in the insulin formulations. One means of eliminating these interferences is to poise the indicating electrode(s) of the sensor at a bias sufficiently low to avoid the signal from oxidation of the preservatives. One way of obtaining a glucose signal at a low bias is to use an osmium-ligand-polymer complex instead of conventional hydrogen peroxide sensing.

Abstract: This invention pertains to the concept of creating a strip that contains one or more amperometric biosensing electrodes and integrating this strip into the outer wall of a hollow catheter (cannula). The electrodes can be used for continuous sensing of an analyte such as glucose and the hollow lumen can be used concurrently for delivery of a drug such as insulin. There is a risk for electrode films to break apart during impact. However, if there is a metallic foil beneath (underlying) the thin film metal electrodes, durability and fatigue resistance are markedly improved. The term “foil” indicates a metal layer that is 2-15 ?m in thickness. Foils can be created by rolling, hammering, electroplating, printing, or vacuum-deposition. A foil-polymer laminate is suitable as a substrate because it permits low-cost patterning and assembly into a durable, fatigue-resistant sensor.

Abstract: A durable device is disclosed. This device allows concurrent measurement of an analyte such as glucose, and delivery of a glucose-active drug such as insulin. In order to carry out both functions, only one tubular structure is necessary. In one embodiment of the invention, wires or rings of platinum, gold, or carbon which serve as indicating electrodes are circumferentially disposed around a tubular reference electrode. In an embodiment, the reference electrode is made up of a hollow silver or silver-coated tube. The hollow characteristic is necessary in order to allow concurrent delivery of insulin or other drug through the lumen. In order to optimize sensor accuracy, there are multiple individually-addressable indicating electrodes circumferentially disposed around the shaft.

Abstract: A sensing assembly (10), including a body (12) and one or more first indicating electrodes disposed on the body (26). The first indicating electrodes include an electrochemically active layer (32) and a layer (38) of an active functioning enzyme of a first enzyme type on top of the electrochemically active layer. Also, one or more second indicating electrodes (24) are disposed on the body and include an electrochemically active layer (32) and a layer (36) of an inactivated enzyme of the first enzyme type on top of the electrochemically active layer. A reference electrode (22) is also disposed on the body. Finally, an electrical and data processing system (18) is adapted to bias the electrodes and measure electrical signals from the electrodes, and uses said signals to determine an analyte concentration and communicates the analyte concentration to a location apart from the first and second indicating electrodes.

Abstract: Embodiments of the present invention provide a device and method for treating animal skin to produce tautness in the skin during the insertion of an analyte sensor. A device in accordance with embodiments of the present invention includes a housing that partially encloses a cavity and is adapted for mounting onto animal skin and a sensor insertion module adapted to insert an analyte sensor through animal skin.

Abstract: Embodiments of the present invention provide a device and method for treating animal skin to produce tautness in the skin during the insertion of an analyte sensor. A device in accordance with embodiments of the present invention includes a housing that partially encloses a cavity and is adapted for mounting onto animal skin and a sensor insertion module adapted to insert an analyte sensor through animal skin.