Highly Durable Dual Use Catheter for Analyte Sensing and Drug Delivery
First Claim
1. A single-walled hollow catheter, whose indwelled length is 5-15 mm, that allows simultaneous analyte sensing within, and passage of a liquid drug into, a mammalian body,wherein the outer wall of said catheter includes one or more indicating electrode films (film thickness <
- 500 nm) and one or more reference electrode films (film thickness <
900 nm),wherein an enzyme layer is located external to the outer surface of said indicating electrode,wherein said indicating and reference electrodes are in direct contact with an underlying metal foil, said foil being internal to said electrodes, andwherein said foil is in contact with an underlying polymer layer, said polymer layer being internal to the foil.
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Accused Products
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 μm 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.
13 Citations
20 Claims
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1. A single-walled hollow catheter, whose indwelled length is 5-15 mm, that allows simultaneous analyte sensing within, and passage of a liquid drug into, a mammalian body,
wherein the outer wall of said catheter includes one or more indicating electrode films (film thickness < - 500 nm) and one or more reference electrode films (film thickness <
900 nm),wherein an enzyme layer is located external to the outer surface of said indicating electrode, wherein said indicating and reference electrodes are in direct contact with an underlying metal foil, said foil being internal to said electrodes, and wherein said foil is in contact with an underlying polymer layer, said polymer layer being internal to the foil. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
- 500 nm) and one or more reference electrode films (film thickness <
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11. A method for the simultaneous measurement of a subcutaneous analyte concentration and continuous drug infusion through the use of a single-walled hollow catheter, whose indwelled length is 5-15 mm, and a drug pump,
wherein retrograde flow (escape from the body) of interstitial fluid or blood is prevented by its connection with said pump that maintains a constant positive pressure, wherein the outer wall of said catheter includes one or more indicating electrode films (film thickness < - 500 nm) and one or more reference electrode films (film thickness <
900 nm),wherein an enzyme layer is located external to the outer surface of said indicating electrode, wherein said indicating and reference electrodes are in direct contact with an underlying metal foil, said foil being internal to said electrodes, and wherein said foil is in contact with an underlying polymer layer, said polymer layer being internal to the foil. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
- 500 nm) and one or more reference electrode films (film thickness <
Specification