Autonomous multimodal implantable endoscopic capsule for the gastrointestinal tract

Project Information

AUTOCAPSULE

Grant agreement ID: 952118

DOI

10.3030/952118

Project closed

EC signature date 4 June 2020

Start date 1 November 2020

End date 31 October 2025

Funded under

• EXCELLENT SCIENCE - Future and Emerging Technologies (FET)

Total cost

€ 3 992 860,00

EU contribution

€ 3 992 860,00

Coordinated by

UNIVERSITA DI PISA
Italy

Periodic Reporting for period 3 - AUTOCAPSULE (Autonomous multimodal implantable endoscopic capsule for the gastrointestinal tract)

Reporting period: 2023-11-01 to 2025-10-31

Summary of the context and overall objectives of the project

AUTOCAPSULE aimed at demonstrating the viability of a technology for early diagnosis of Inflammatory Bowel Disease and bowel cancer and for monitoring of treatment effectiveness at primary or secondary point of care. The technology vision (Fig. 1) is based on an untethered autonomous capsule that is both implantable in the gastro-intestinal (GI) tract for several weeks in order to monitor a specific area, and that can explore the GI tract for endoscopy in a point of care, through magnetic manipulation with an external robotic arm and limited training of the operator. The capsule is capable of multimodal sensing, including micro- ultrasound imaging, white light imaging, pH and inflammation monitoring.

The GI system is highly complex, subject to frequent external stimulus through eating and digestion, and carries an extremely high burden of disease: 15 – 40% of the European population report functional GI conditions. However, the range of conditions encompassed is too diverse a target for immediate action and we will therefore focus on inflammatory bowel disease and colorectal cancer. Even for those diseases alone, the affected European populations are large, with colorectal cancer being the most common cancer in men (30% of all new cancers) and second most common in women (25% of all new cancers) with a total of about 350,000 cases in the EU in 2012. Moreover, the burden on healthcare systems is rising worldwide, with increased screening cited as the primary reason.

To demonstrate the vision, AUTOCAPSULE pursued two parallel development tracks, each addressing a subset of the target capabilities. The first focused on an untethered robotic capsule with wireless power and telemetry, capable of micro-ultrasound and white-light imaging. The second focused on an implantable capsule designed for sub-mW wireless power operation and multi-week residence in the GI tract. The project developed and validated in vivo demonstrators for both capsule types and evaluated two clinical applications in detail: (i) colonoscopy using a magnetically manipulated flexible endoscope with in-situ polyp analysis via micro-ultrasound imaging, and (ii) clinical diagnostics of functional gastrointestinal diseases.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

One of the key objectives of Autocapsule was to demonstrate in vitro and in vivo a Robotic Capsule Demonstrator (RCD) capable to perform microultrasound array imaging and white light imaging of the GI tract, that can explore the GI tract via magnetic manipulation using. In this respect, all key subsystems of the RCD (wireless power transfer with telemetry, wireless image and data transfer, microultrasound imaging) have been successfully tested in the lab and in vivo. The complete RCD has been demonstrated in the lab. It has not been possible to demonstrate the fully integrated wireless RCD in vivo, because the reliability and the total volume of the final demonstrator do not guarantee a safe in-vivo experiment.

Another key objective was to demonstrate in vitro and in vivo an Implantable Capsule Demonstrator (ICD) capable to continuously monitor a specific area of the GI tract for several weeks through measurement of pH and temperature, fully untethered thanks to wireless power transfer and data transfer via a wearable external power transmitter and data receiver. To this aim, a custom multi-modal sensing ASIC for ISFETs, potentiometric, amperometric and temperature sensors was designed and tested. This chip was integrated in the design of variants of the second demonstrator (ICD2): a variant with wireless power transfer (WPT) including also the WPT ASIC reported earlier, and a variant using batteries. The second variant has been successfully tested in the lab and in vivo, exhibiting the required 30 days of fully untethered operation.
The project has enabled the advancement of a broad set of enabling technologies for implantable medical devices, culminating in the demonstration of robotic and implantable capsules and in the realization of second-generation wireless power and imaging subsystems ready for integration in future devices:
- A range of intelligent control strategies for magnetic manipulation within the Autocapsule system, encompassing closed-loop teleoperation, autonomous navigation, active stabilization has been implemented and experimentally validated.
- Integration of µUS technology into a small endoscopic capsule and into the robotic system has been achieved, enabling high-resolution subsurface imaging assessed in porcine models.
- Adaptable Wireless Power Transfer techniques compliant with SAR levels have been significantly advanced and demonstrated for both the RCD and ICD capsules, across different power levels, including a tri-axis active rectifier for RCD2 and a dedicated WPT ASIC for ICD2. These represent core technologies for a wide range of implantable medical devices.
- Wireless data transfer solutions have been developed for different power budgets and data rates, from energy-efficient low-rate telemetry in ICD2 to high-rate Wi-Fi HaLow links supporting real-time image transmission in the robotic capsule, establishing a versatile communication toolkit for future implantable medical devices.
Project results have been disseminated through peer-reviewed publications and international conferences in medical robotics and electronics. The work involved multiple PhD students and postdoctoral researchers, strengthening and expanding the project know-how base. Project IP has been generated and is under evaluation for potential protection.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Results have significantly advanced the state of the art in Autocapsule technology and in implantable medical devices in general. In the final phase, the project focused on two clinical application pathways:
1. Colonoscopy with flexible endoscope.
2. Clinical diagnostics of functional gastrointestinal diseases.
An overall technology assessment was performed against the needs of these two applications, and an exploitation roadmap was defined. This roadmap outlines the required next technology steps, the IP strategy, an analysis of competing technologies, and the route to technology transfer, including an exploitation plan.

Illustration of Autocapsule use case