Periodic Reporting for period 2 - AUTOCAPSULE (Autonomous multimodal implantable endoscopic capsule for the gastrointestinal tract)
Reporting period: 2022-05-01 to 2023-10-31
AUTOCAPSULE aims at demonstrating the viability of a technology for early diagnosis of Inflammatory Bowel Disease (IBD) 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 (IBD) 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.
In the course of the AUTOCAPSULE project two parallel tracks will be followed to demonstrate the technology vision, each focusing on a subset of the vision capsule features. One track focuses on the development and demonstration of an untethered autonomous robotic capsule, capable of micro ultrasound imaging and white light imaging. The other focuses on the development and demonstration of an implantable capsule, capable of operating with sub-mW wireless power supply and of being implanted in the GI tract for several weeks. AUTOCAPSULE will demonstrate capsules with partial complementary implementations of the technology vision and will show a path towards the fabrication and industrial development of the full vision capsule.
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 (IBD) 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.
In the course of the AUTOCAPSULE project two parallel tracks will be followed to demonstrate the technology vision, each focusing on a subset of the vision capsule features. One track focuses on the development and demonstration of an untethered autonomous robotic capsule, capable of micro ultrasound imaging and white light imaging. The other focuses on the development and demonstration of an implantable capsule, capable of operating with sub-mW wireless power supply and of being implanted in the GI tract for several weeks. AUTOCAPSULE will demonstrate capsules with partial complementary implementations of the technology vision and will show a path towards the fabrication and industrial development of the full vision capsule.
The architectural design of the two capsules has been performed and of the electronics for wireless power transfer, wireless data transfer, and on board power and data routing.
For the robotic capsule, a wireless power receiver integrated circuit has been designed based on power telemetry and power transfer optimization. Various intelligent control strategies for magnetic manipulation have been developed that include closed-loop teleoperation, autonomous navigation, assisted biopsy, active stabilization, and obstacle avoidance.
We have also obtained progress in the integration of μUS within the robotic system and in communication between the various subsystems. In addition, an oloid shaped capsule has been explored to increase the manipulability of a magnetically actuated endoscope. A careful process was used to choose the linear mUS array for imaging, resulting in the use of a state of the art commercial 28 MHz 128-element piezocrystal array. The design, fabrication and testing of a first custom ASIC for driving the linear mUS array has been completed and second custom ASIC design has been designed and sent for fabrication.
Finally, we have performed the design and test of a first demonstrator of the white light imaging interface and have designed a second compact demonstrator.
Regarding the implantable capsule demonstrator, a custom wireless power transfer system design is proceeding according to plans: a receiver integrated circuit has been recently taped out, and evaluation boards are being designed for future testing and system assembling. Finally, the first implantable capsule (ICD1) was designed, implemented, and successfully tested in vitro (with wired power supply).
For the robotic capsule, a wireless power receiver integrated circuit has been designed based on power telemetry and power transfer optimization. Various intelligent control strategies for magnetic manipulation have been developed that include closed-loop teleoperation, autonomous navigation, assisted biopsy, active stabilization, and obstacle avoidance.
We have also obtained progress in the integration of μUS within the robotic system and in communication between the various subsystems. In addition, an oloid shaped capsule has been explored to increase the manipulability of a magnetically actuated endoscope. A careful process was used to choose the linear mUS array for imaging, resulting in the use of a state of the art commercial 28 MHz 128-element piezocrystal array. The design, fabrication and testing of a first custom ASIC for driving the linear mUS array has been completed and second custom ASIC design has been designed and sent for fabrication.
Finally, we have performed the design and test of a first demonstrator of the white light imaging interface and have designed a second compact demonstrator.
Regarding the implantable capsule demonstrator, a custom wireless power transfer system design is proceeding according to plans: a receiver integrated circuit has been recently taped out, and evaluation boards are being designed for future testing and system assembling. Finally, the first implantable capsule (ICD1) was designed, implemented, and successfully tested in vitro (with wired power supply).
A series of subsystems for the wireless powering, the magnetic manipulation and the ultrasound imaging have been designed, that represent significant improvements with respect to the state of the art, in terms of performance and of level of integration.
These subsystems can have a broader use beyond the scope of the projects, and can contribute to the developments of know how in Europe on implantable medical devices.
The oloid shape for the robotic capsule demonstrator represents a promising innovation, in terms of simplifying the magnetic driving of the capsule. Finally, the implantable capsule demonstrator is very innovative in terms of level of integration and size.
These subsystems can have a broader use beyond the scope of the projects, and can contribute to the developments of know how in Europe on implantable medical devices.
The oloid shape for the robotic capsule demonstrator represents a promising innovation, in terms of simplifying the magnetic driving of the capsule. Finally, the implantable capsule demonstrator is very innovative in terms of level of integration and size.