An ingestible sensor for measuring medication adherence.

In this paper, we describe the design and performance of the first integrated-circuit microsensor developed for daily ingestion by patients. The ingestible sensor is a device that allows patients, families, and physicians to measure medication ingestion and adherence patterns in real time, relate pharmaceutical compliance to important physiologic metrics, and take appropriate action in response to a patient's adherence pattern and specific health metrics. The design and theory of operation of the device are presented, along with key in-vitro and in-vivo performance results. The chemical, toxicological, mechanical, and electrical safety tests performed to establish the device's safety profile are described in detail. Finally, aggregate results from multiple clinical trials involving 412 patients and 5656 days of system usage are presented to demonstrate the device's reliability and performance as part of an overall digital health feedback system.

A digital health solution for using and managing medications: wirelessly observed therapy.

Taking oral medication on a prescribed schedule can be a nuisance, especially for elderly individuals and busy people with lots of things on their minds. Nonetheless, taking medication as prescribed is important for maintaining health and well-being. In cases where medication use is part of a clinical trial, taking prescribed medication is important to the entire investigation and outcome of the study, including the determination of whether a drug is effective and safe.

Networked multielectrode left ventricular pacing lead for avoidance of phrenic nerve stimulation in a canine model.

BACKGROUND: In cardiac resynchronization therapy, left ventricular stimulation may lead to concomitant phrenic nerve stimulation (PNS). OBJECTIVE: To evaluate a new networked multielectrode lead with 16 electrode segments (SEGs) configured into groups of 4, forming a virtual band (VBAND) around the lead. Each electrode is individually programmable using an embedded integrated circuit. METHODS: In 8 anesthetized dogs, the lead was positioned in a left ventricular coronary vein. The voltage thresholds for cardiac stimulation and PNS were measured for different electrode configurations, including "VBAND-VBAND" (∼conventional bipolar pacing), "SEG-VBAND", and "SEG-SEG" (anode and cathode within the same VBAND). The measurements were performed (1) with closed chest and (2) after opening the chest and repositioning the phrenic nerve to above the lead, simulating a worst-case scenario. RESULTS: Compared with the conventional VBAND-VBAND stimulation, the SEG-SEG stimulation increased the PNS threshold and raised the difference between phrenic and cardiac thresholds from 6.2 ± 2.3 to 9.5 ±0.3 V in the closed chest condition and from 1.4 ± 1.6 to 9.0 ± 1.0 V in the worst-case scenario (both P < .001). Both SEG-VBAND and SEG-SEG stimulations reduced the cardiac threshold and increased pacing impedance, thus reducing the required cardiac pacing power by 77%-80% (P <.001 and P <.01 for closed and open chest, respectively). CONCLUSION: This novel multielectrode pacing lead achieves low cardiac and high extracardiac stimulation thresholds during left ventricular pacing in a canine model. The virtual elimination of PNS may facilitate and improve the application of cardiac resynchronization therapy.