Wireless bowel sensor
Inventors
Smiley, Aref • Bourbeau, Dennis • Damaser, Margot S. • Majerus, Steve • Zutshi, Massarat • Mcadams, Ian
Assignees
Cleveland Clinic Foundation • MetroHealth System • US Department of Veterans Affairs
Publication Number
US-11241189-B2
Publication Date
2022-02-08
Expiration Date
2039-07-17
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Abstract
A sensing device can be placed within the colon to study bowel function. The sensing device can include a flexible printed circuit board that includes at least one senor configured to record data related to bowel activity from a patient's colon; and a wireless transmitter configured to send the data from the patient's colon to an external device. The sensing device can also include at least one mucosal clip configured to fix the sensor board to a wall of the patient's colon for a measurement period. The flexible printed circuit board and/or the at least one mucosal clip are configured to be passed from the patient's colon after the measurement period through normal defecation.
Core Innovation
The invention relates to a sensing device that can be placed within the colon to make continuous measurements of data related to bowel function and send this data to an external device. The device includes a flexible printed circuit board with at least one sensor configured to record bowel activity data and a wireless transmitter to send the data. It is anchored to the colon wall by at least one mucosal clip during a measurement period and is designed to be passed through the colon via normal defecation thereafter.
The problem being solved is the insufficient understanding and diagnosis of bowel function due to limitations of existing methods. Current approaches, such as pressure manometry and anal electromyogram, are costly, uncomfortable, impractical for daily activities, and fail to provide continuous data needed for chronic, ambulatory sensing of bowel fullness and activity. Additionally, methods involving ingestion of markers do not yield continuous data and newer technologies face issues like unclear anatomical localization of recordings.
The invention overcomes these limitations by providing a wireless, catheter-free sensor that can remain fixed in the colon for extended periods (days to weeks), capable of recording high-fidelity data from one location continuously. This enables better diagnosis and individualized treatment of bowel disorders by providing objective, continuous physiological data. After measurement, the device is naturally expelled, minimizing invasiveness and discomfort. The design mimics intestinal parasites that anchor to the mucosa, supporting long-term placement.
Claims Coverage
The patent presents two independent claims covering a sensing device and a method for measuring bowel activity, encompassing main inventive features of device structure, sensor configuration, anchoring, wireless data transmission, and post-measurement passage.
Sensing device with flexible printed circuit board and wireless transmission
A sensing device includes a flexible printed circuit board that houses at least one sensor configured to record data related to bowel activity from a patient's colon and a wireless transmitter configured to send this data to an external device.
Mucosal clip anchoring and passage through defecation
The sensing device includes at least one mucosal clip configured to fix the sensor board to a wall of the patient's colon for a measurement period, with the device and/or clip configured to pass from the colon through normal defecation after the measurement period.
Sensor modalities on the printed circuit board
The at least one sensor comprises pressure, conductance, and capacitance sensors, where the pressure sensor is located at a head of the printed circuit board and metal mesh electrodes for conductance and capacitance sensors are located at the tail, including three cathodes and one anode at varying distances.
Method for recording, transmitting, and passing sensor device
The method involves recording data related to bowel activity during a measurement period by a sensor on a flexible printed circuit board anchored with mucosal clip(s), sending the data wirelessly to an external device, and passing the board and/or clip from the colon via normal defecation after measurement.
Together, these features provide a novel apparatus and method for continuous, wireless measurement of bowel function using a flexible, anchored sensor device capable of natural expulsion post-use, facilitating improved bowel disorder diagnosis and monitoring.
Stated Advantages
Provides continuous measurement of bowel function data over extended periods in a less expensive and less uncomfortable manner than previous solutions.
Enables chronic, ambulatory sensing of bowel fullness and activity without the impracticalities of wired or tethered devices.
Eliminates discomfort associated with fluid-filled balloon catheters and avoids radiation exposure inherent in imaging methods.
Allows for high fidelity data recording from a single location within the bowel, supporting individualized diagnosis and therapy for bowel disorders.
Facilitates objective evaluation of treatment efficacy and the development of improved therapies.
Designed to be biomimetic, allowing secure attachment during measurement and natural passage through normal defecation to avoid invasive retrieval.
Documented Applications
Diagnosis and monitoring of bowel dysfunction conditions such as fecal incontinence, constipation, inflammatory bowel disorders, and Crohn's disease.
Research studies aimed at understanding neural control and function of the bowel by enabling simultaneous, continuous measurement of bowel activity and neural recordings.
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