In vivo sensing and infusion devices
Inventors
Shah, Rajiv • MESSER, Ellen • Wolfe, Katherine • Pendo, Shaun
Assignees
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Publication Number
US-11806135-B2
Publication Date
2023-11-07
Expiration Date
Abstract
Sensing and infusion devices are described. In one embodiment, a sensing and infusion device may include an implantable segment having a sensor. The sensing and infusion device may also include a catheter, and a sensor channel may be formed in the catheter. The sensor channel may be configured to retain at least a portion of the implantable segment.
Core Innovation
The invention provides a sensing and infusion device that combines sensing with catheter-based infusion. The device includes a first sensor strip having at least one working electrode and a catheter having an inner infusion lumen. The catheter further includes a first elongate sensor channel formed on an outer surface of the catheter external to the inner infusion lumen, and the first sensor channel is open to an exterior of the catheter and configured to receive and hold the first sensor strip.
A wall of the catheter separates the inner infusion lumen from the first sensor channel, and the catheter includes an opening formed in that wall. The opening provides access into the inner infusion lumen so that a distal portion of the first sensor strip passes into the inner infusion lumen, while the distal end of the first sensor strip is disposed within the inner infusion lumen and the at least one working electrode remains within the first elongate sensor channel.
The disclosure further describes implantable sensor segments in catheter sensor channels, positioning and spacing features for sensor placement and interstitial fluid interface management, and multiple embodiments addressing coupling, anchoring, sensor positioning within or adjacent to the infusion lumen, and backflow mitigation through structural features. The document also describes insertion at a single implantation site and an on-body worn device for fluid-tight infusion and electrical interfacing, with medical and veterinary use cases such as artificial pancreas and diabetes treatment.
Claims Coverage
The independent claim covers a catheter-based sensing-and-infusion device with a sensor strip that spans from an external elongate sensor channel into an inner infusion lumen while keeping the working electrode within the external channel. The claim set further includes five additional inventive features covering channel orientation, channel extent, a second sensor channel, a backflow barrier, and pressure detection of infusate within the inner infusion lumen.
Sensor strip spanning catheter wall opening into inner infusion lumen
A first sensor strip having at least one working electrode is received and held by a first elongate sensor channel formed on an outer surface of a catheter external to an inner infusion lumen, wherein an opening in a catheter wall separating the inner infusion lumen from the first sensor channel allows a distal portion of the first sensor strip to pass into the inner infusion lumen so that a distal end of the first sensor strip is disposed within the inner infusion lumen while the at least one working electrode remains within the first elongate sensor channel.
External sensor channel longitudinal orientation parallel to infusion lumen axis
A first sensor channel has a longitudinal dimension that is parallel to an axis of the inner infusion lumen.
External sensor channel along entire catheter length
The first sensor channel runs along the entire length of the catheter.
Additional elongate sensor channel for a second sensor strip
A catheter includes a second elongate sensor channel formed on an outer surface of the catheter external to the inner infusion lumen, where the second sensor channel is open to an exterior of the catheter to receive and hold a second sensor strip and extends longitudinally parallel to the axis of the infusion lumen.
Annular radially-projecting backflow barrier over distal external sensor-channel region
An annular, radially-projecting backflow barrier covers a portion of the first sensor channel distal to one or more sensors disposed on the first sensor strip and exposed within the first sensor channel.
Infusate pressure detection with a pressure sensor in the inner infusion lumen
A sensor includes a pressure sensor configured to detect the pressure of an infusate within the inner infusion lumen.
Across the claim set shown, the core inventive arrangement is an external elongate sensor channel that holds a sensor strip while a catheter-wall opening allows a distal portion of that sensor strip to enter the inner infusion lumen, keeping the working electrode within the external channel. Dependent claims further define the external channel’s longitudinal relationship and extent, optionally add a second external sensor channel, provide a structural backflow barrier for the distal external sensor-channel region, and add pressure detection of infusate within the inner infusion lumen.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Artificial pancreas; diabetes treatment.
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