Periodic Reporting for period 2 - PALPABLE (Multi-sensing tool for Minimally Invasive Surgery)
Periodo di rendicontazione: 2024-07-01 al 2025-12-31
Minimally Invasive Surgery (MIS), which includes both traditional laparoscopic and modern robot-assisted techniques, has become the standard of care due to its profound benefits for patients, such as reduced tissue damage, diminished blood loss, and significantly shorter hospital stays. Despite these advancements, a critical drawback of MIS is the surgeon's inability to directly palpate the internal tissues being operated on. In open surgery, doctors rely heavily on their sense of touch to identify the varying stiffness of tissues, which is essential for locating hidden tumors and defining healthy versus cancerous margins. Because current endoscopic and commercial robotic tools severely restrict degrees of freedom and lack true tactile or haptic feedback, surgeons are forced to rely almost entirely on visual cues.
To address this critical gap, the PALPABLE project aims to revolutionize MIS by developing a first-of-its-kind, multi-sensing tactile probe that effectively restores the surgeon's sense of touch. The consortium's core objective is to create a miniaturized (15 mm diameter), soft, pneumatically actuated end-effector capable of bending and steering within the confined spaces of the body. This probe will house highly advanced but low-cost optical sensing technologies, including a non-planar polymeric photonics circuit and Fiber Bragg Grating (FBG) optical fibers, to simultaneously measure tissue deformation and contact forces. Pressure measurements are fed into a dedicated machine learning algorithm so that the system can identify reconstruct the stiffness profile of the tissue and ultimately display it as an intuitive "stiffness heatmap" overlaid on the surgeon's surgical monitor.
Providing surgeons with real-time stiffness maps will enable them to precisely localize tumors and define their margins, thereby ensuring the complete removal of unhealthy tissue while sparing surrounding healthy nerves and blood vessels. The project is expected to further reduce average hospital stays; for instance, even a half-day reduction in hospital stays for prostate cancer MIS procedures across Europe could yield nearly €90 million in annual savings, significantly freeing up public healthcare resources and reducing clinician burnout.
On a broader strategic level, PALPABLE is positioned to capture a first-mover advantage within the rapidly expanding multi-billion-euro markets for MIS devices, medical robotics, and photonics. While leading commercial robotic systems (such as the da Vinci or Hugo RAS) offer high precision, they still lack true intraoperative tactile feedback—a massive unmet clinical need. Furthermore, the project addresses the European Union’s strategic goal of open autonomy in the healthcare sector.
Through the European Association for Endoscopic Surgery (EAES) and clinical partners, the consortium regularly surveys a diverse community of surgeons to evaluate user acceptance, workflow integration, and usability preferences. The tool's design, such as determining optimal probe diameters, display interfaces, and pricing, is shaped around these practitioner insights. Thus, PALPABLE ensures that the resulting technology is genuinely valuable and seamlessly adoptable by the medical community.
To address this critical gap, the PALPABLE project aims to revolutionize MIS by developing a first-of-its-kind, multi-sensing tactile probe that effectively restores the surgeon's sense of touch. The consortium's core objective is to create a miniaturized (15 mm diameter), soft, pneumatically actuated end-effector capable of bending and steering within the confined spaces of the body. This probe will house highly advanced but low-cost optical sensing technologies, including a non-planar polymeric photonics circuit and Fiber Bragg Grating (FBG) optical fibers, to simultaneously measure tissue deformation and contact forces. Pressure measurements are fed into a dedicated machine learning algorithm so that the system can identify reconstruct the stiffness profile of the tissue and ultimately display it as an intuitive "stiffness heatmap" overlaid on the surgeon's surgical monitor.
Providing surgeons with real-time stiffness maps will enable them to precisely localize tumors and define their margins, thereby ensuring the complete removal of unhealthy tissue while sparing surrounding healthy nerves and blood vessels. The project is expected to further reduce average hospital stays; for instance, even a half-day reduction in hospital stays for prostate cancer MIS procedures across Europe could yield nearly €90 million in annual savings, significantly freeing up public healthcare resources and reducing clinician burnout.
On a broader strategic level, PALPABLE is positioned to capture a first-mover advantage within the rapidly expanding multi-billion-euro markets for MIS devices, medical robotics, and photonics. While leading commercial robotic systems (such as the da Vinci or Hugo RAS) offer high precision, they still lack true intraoperative tactile feedback—a massive unmet clinical need. Furthermore, the project addresses the European Union’s strategic goal of open autonomy in the healthcare sector.
Through the European Association for Endoscopic Surgery (EAES) and clinical partners, the consortium regularly surveys a diverse community of surgeons to evaluate user acceptance, workflow integration, and usability preferences. The tool's design, such as determining optimal probe diameters, display interfaces, and pricing, is shaped around these practitioner insights. Thus, PALPABLE ensures that the resulting technology is genuinely valuable and seamlessly adoptable by the medical community.
During the reporting period, technical efforts were heavily directed towards advanced component miniaturization and the integration of various subsystems into a unified operational prototype. A major architectural achievement was the redesign of the PALPABLE probe to a diameter of 15 mm, ensuring compatibility with standard commercial trocar ports used in minimally invasive surgery. To navigate 3D space, the soft pneumatic actuator (SPA) was miniaturized and optimized to operate with a single pneumatic chamber capable of bending up to 90 degrees. This actuator is driven by a newly developed, highly compact electropneumatic control setup that utilizes a custom syringe pump for precise flow regulation. To power and control these sensing and actuating subsystems, the Optical Readout and Pneumatic Control Unit (ORPCU) was designed and prototyped through multiple iterations.
The tactile sensing architecture was upgraded to include an optical proximity sensing spring structure paired with a silicone dome, allowing for direct measurement of both force and displacement. Additionally, a novel air jet-based non-contact palpation probe was developed, which estimates soft tissue stiffness by measuring substrate deformation caused by controlled pneumatic excitation. For haptic interrogation, a planar polymer waveguide foil was enhanced with an optical coupler Meanwhile, 3D shape and surface curvature reconstruction were advanced using bend-sensitive 4-core Fiber Bragg Grating (FBG) optical fibers.
Finally, deep learning frameworks, including a Multi-Layer Perceptron (MLP) model, were trained to convert FBG core shifts and pressure feedback into 3D spatial coordinates, successfully realizing real-time proprioceptive visualization of the soft actuator's shape. For vision-based localization, a custom-built, high-fidelity gastrointestinal phantom setup was engineered to train a two-stage U-Net image processing pipeline. This pipeline achieves precise tool segmentation and tissue contact area estimation, maintaining localization accuracy even during complex visual occlusions by utilizing a novel self-supervised Contrastive Learning Variational Encoder (CL-VE). These algorithmic and sensing achievements culminated in the development of a unified Operator User Interface (UI).
The tactile sensing architecture was upgraded to include an optical proximity sensing spring structure paired with a silicone dome, allowing for direct measurement of both force and displacement. Additionally, a novel air jet-based non-contact palpation probe was developed, which estimates soft tissue stiffness by measuring substrate deformation caused by controlled pneumatic excitation. For haptic interrogation, a planar polymer waveguide foil was enhanced with an optical coupler Meanwhile, 3D shape and surface curvature reconstruction were advanced using bend-sensitive 4-core Fiber Bragg Grating (FBG) optical fibers.
Finally, deep learning frameworks, including a Multi-Layer Perceptron (MLP) model, were trained to convert FBG core shifts and pressure feedback into 3D spatial coordinates, successfully realizing real-time proprioceptive visualization of the soft actuator's shape. For vision-based localization, a custom-built, high-fidelity gastrointestinal phantom setup was engineered to train a two-stage U-Net image processing pipeline. This pipeline achieves precise tool segmentation and tissue contact area estimation, maintaining localization accuracy even during complex visual occlusions by utilizing a novel self-supervised Contrastive Learning Variational Encoder (CL-VE). These algorithmic and sensing achievements culminated in the development of a unified Operator User Interface (UI).
The PALPABLE project has achieved results beyond the state of the art by developing a novel optical-pneumatic tactile sensing probe designed to restore the "missing sense of touch" in Minimally Invasive Surgery (MIS) and Robotic-Assisted Surgery (RAS). Key results include the successful miniaturization of the probe to a <15 mm diameter (compatible with standard commercial trocars), the integration of multi-modal sensing elements such as Fiber Bragg Gratings and polymer waveguides, and the creation of AI-driven algorithms that provide real-time tissue stiffness heatmaps superimposed directly onto laparoscopic video feeds. This technology addresses a critical unmet need and offers a distinct competitive advantage, as leading commercial surgical robotic systems currently rely primarily on visual and auditory cues rather than true tactile feedback.
To ensure further uptake and commercial success, several key needs have been identified through the project's evolving exploitation strategy:
• Supportive regulatory and standardization framework: The system faces stringent regulatory requirements and extended timelines. It must comply with the EU Medical Device Regulation (MDR 2017/745) for CE marking (initially categorized as Class IIa or IIb), along with essential standards like ISO 14971 for risk management, ISO 10993 for biological risks, and IEC 60601-2-18 for endoscopic equipment safety.
• Commercialisation and IPR support: Robust Intellectual Property protection is actively being secured through the preparation of joint patent application. The commercialization roadmap relies on a phased go-to-market strategy that targets early-adopter university hospitals and surgical centers first, followed by scaling through licensing and integration agreements with MedTech and robotic surgical Original Equipment Manufacturers (OEMs)
To ensure further uptake and commercial success, several key needs have been identified through the project's evolving exploitation strategy:
• Supportive regulatory and standardization framework: The system faces stringent regulatory requirements and extended timelines. It must comply with the EU Medical Device Regulation (MDR 2017/745) for CE marking (initially categorized as Class IIa or IIb), along with essential standards like ISO 14971 for risk management, ISO 10993 for biological risks, and IEC 60601-2-18 for endoscopic equipment safety.
• Commercialisation and IPR support: Robust Intellectual Property protection is actively being secured through the preparation of joint patent application. The commercialization roadmap relies on a phased go-to-market strategy that targets early-adopter university hospitals and surgical centers first, followed by scaling through licensing and integration agreements with MedTech and robotic surgical Original Equipment Manufacturers (OEMs)