Periodic Reporting for period 1 - 2ND-CHANCE (Implantable sensors and ultrasonic data link with triggered bioresorption for next-gen wireless cardiac monitoring)
Período documentado: 2022-06-01 hasta 2024-11-30
Cardiovascular diseases are the leading cause of death globally, highlighting the critical need for effective monitoring of heart functions, especially after cardiac surgery. Early detection of ischemia and other cardiac complications is vital for patient survival and reducing the risk of recurrent heart failures. Current standard monitoring methods, such as echocardiograms and ELISA blood tests, provide only single-time measurements and are limited to hospital settings.
Implantable medical devices offer a potential solution for continuous monitoring; however, their non-resorbable nature necessitates additional surgeries for removal. These secondary procedures pose risks of infection, increase patient stress, and add to the financial burden on healthcare systems. Consequently, there is a significant unmet need for innovative monitoring solutions that are safe, effective, and do not require secondary interventions.
The vision of bioresorbable implants presents a transformative approach to postoperative cardiac care. By implanting a small, bioresorbable patch onto the heart during surgery, continuous monitoring can be achieved without the need for later removal. Once the monitoring period concludes, the implant can be dissolved through a trigger mechanism, such as exposure to a specific light source, eliminating the necessity for additional surgical procedures.
Overall Objectives
The 2ND-CHANCE project aims to turn this vision into reality by developing the essential components of next-generation wireless implants with triggered bioresorption for cardiac surgery. The interdisciplinary objectives of the project are:
Development of Bioresorbable Sensors: Create sensors compatible with the in-body environment that can accurately monitor cardiac functions over the required timeframe.
Battery-Free Ultrasonic Communication: Implement wireless communication methods that do not rely on batteries, utilizing ultrasonic technology to transmit data from the implant to external devices.
Triggered Bioresorption Encapsulation: Develop an encapsulation layer for the implant that can undergo bioresorption upon triggering, ensuring the safe dissolution of the device without surgical intervention.
Integration and Testing: Integrate the developed components into a functional implantable device and conduct animal tests to evaluate performance, safety, and efficacy.
Implantable medical devices offer a potential solution for continuous monitoring; however, their non-resorbable nature necessitates additional surgeries for removal. These secondary procedures pose risks of infection, increase patient stress, and add to the financial burden on healthcare systems. Consequently, there is a significant unmet need for innovative monitoring solutions that are safe, effective, and do not require secondary interventions.
The vision of bioresorbable implants presents a transformative approach to postoperative cardiac care. By implanting a small, bioresorbable patch onto the heart during surgery, continuous monitoring can be achieved without the need for later removal. Once the monitoring period concludes, the implant can be dissolved through a trigger mechanism, such as exposure to a specific light source, eliminating the necessity for additional surgical procedures.
Overall Objectives
The 2ND-CHANCE project aims to turn this vision into reality by developing the essential components of next-generation wireless implants with triggered bioresorption for cardiac surgery. The interdisciplinary objectives of the project are:
Development of Bioresorbable Sensors: Create sensors compatible with the in-body environment that can accurately monitor cardiac functions over the required timeframe.
Battery-Free Ultrasonic Communication: Implement wireless communication methods that do not rely on batteries, utilizing ultrasonic technology to transmit data from the implant to external devices.
Triggered Bioresorption Encapsulation: Develop an encapsulation layer for the implant that can undergo bioresorption upon triggering, ensuring the safe dissolution of the device without surgical intervention.
Integration and Testing: Integrate the developed components into a functional implantable device and conduct animal tests to evaluate performance, safety, and efficacy.
Regarding the implantable strain sensor, we completed the design, manufacturing, and characterization of a strain sensor using non-bioresorbable materials. The sensor was engineered with multiple layers of varying modulus values to optimize performance within the in-body environment. By conducting simulation studies, the optimal placement of electrodes and the ideal thickness and modulus of each layer were determined. The fabrication process employed silicone-based polymers and precise laser micromachining to integrate electrodes seamlessly into the polymer layers. This work established a robust design that will facilitate the subsequent development of bioresorbable sensors.
Then, we focused on the development of an electrochemical sensor for monitoring biomarkers for cardiac events. The project team developed a model to determine the necessary electrode area for effective detection. Utilizing high-resolution 3D printing and molding techniques, a bioresorbable micro-needle structure was fabricated. Laser micromachining was then used to create precise masks for metal evaporation, enhancing the sensor's functionality. The successful rapid detection of troponin using this bioresorbable microneedle structure marks a significant milestone, demonstrating the sensor's capability for real-time cardiac monitoring.
For communication, advancements were made in the design and implementation of a battery-free ultrasonic wireless data transmission system. We introduced a frequency-based passive ultrasonic communication method, enabling electronics-free data transfer from deep tissue capacitive sensor implants. A prototype device featuring an ultrasonic antenna made from a single piezoceramic crystal and a capacitive sensor was developed and successfully demonstrated in vitro. This system effectively detected resonance frequency shifts corresponding to sensor responses, showcasing its potential for reliable, real-time data transmission.
For encapsulation, we developed an encapsulation layer with triggered bioresorption to regulate the implant's lifespan. We synthesized and conducted comprehensive material characterizations to assess the reliability and predictability of the degradation profile of the developed polymer. A notable achievement was the demonstration of light triggered degradation of the bioresorbable polymer, providing a controlled mechanism for implant dissolution without requiring additional surgical procedures. Ongoing studies continue to explore the polymer's degradation limits, ensuring its performance meets practical application standards.
By the conclusion of the first half of the 2ND-CHANCE project, we have successfully developed and tested critical components essential for bioresorbable, wireless cardiac monitoring implants. The project has advanced sensor technologies, developed innovative wireless communication systems, and established a reliable bioresorption mechanism. These accomplishments lay a solid foundation for integrating all components into a functional implantable device, poised for further testing and future applications.
Then, we focused on the development of an electrochemical sensor for monitoring biomarkers for cardiac events. The project team developed a model to determine the necessary electrode area for effective detection. Utilizing high-resolution 3D printing and molding techniques, a bioresorbable micro-needle structure was fabricated. Laser micromachining was then used to create precise masks for metal evaporation, enhancing the sensor's functionality. The successful rapid detection of troponin using this bioresorbable microneedle structure marks a significant milestone, demonstrating the sensor's capability for real-time cardiac monitoring.
For communication, advancements were made in the design and implementation of a battery-free ultrasonic wireless data transmission system. We introduced a frequency-based passive ultrasonic communication method, enabling electronics-free data transfer from deep tissue capacitive sensor implants. A prototype device featuring an ultrasonic antenna made from a single piezoceramic crystal and a capacitive sensor was developed and successfully demonstrated in vitro. This system effectively detected resonance frequency shifts corresponding to sensor responses, showcasing its potential for reliable, real-time data transmission.
For encapsulation, we developed an encapsulation layer with triggered bioresorption to regulate the implant's lifespan. We synthesized and conducted comprehensive material characterizations to assess the reliability and predictability of the degradation profile of the developed polymer. A notable achievement was the demonstration of light triggered degradation of the bioresorbable polymer, providing a controlled mechanism for implant dissolution without requiring additional surgical procedures. Ongoing studies continue to explore the polymer's degradation limits, ensuring its performance meets practical application standards.
By the conclusion of the first half of the 2ND-CHANCE project, we have successfully developed and tested critical components essential for bioresorbable, wireless cardiac monitoring implants. The project has advanced sensor technologies, developed innovative wireless communication systems, and established a reliable bioresorption mechanism. These accomplishments lay a solid foundation for integrating all components into a functional implantable device, poised for further testing and future applications.
The development of a strain sensor uniquely optimized to be insensitive to internal body pressures represents a significant innovation. This sensor maintains high accuracy and reliability despite the complex and dynamic environment of the human heart, enabling continuous and precise monitoring that was previously unattainable with existing single-time measurement methods.
We introduced a novel bioresorbable electrochemical sensor designed as a microneedle structure for the rapid detection of troponin levels, a critical biomarker for cardiac events. This sensor's ability to provide real-time detection without the need for removal surgery marks a substantial improvement over traditional non-resorbable implants, offering a practical and advanced solution for early intervention in heart attacks.
For wireless communication, the project pioneered a frequency-based passive ultrasonic communication method that facilitates electronics-free data transfer from deep tissue capacitive sensor implants. This innovative approach eliminates the need for custom integrated circuits and power harvesting components, significantly simplifying implant design and enhancing reliability. The successful in vitro demonstration of wireless ultrasonic data transmission not only validates the method but also opens the door to fully bioresorbable systems capable of seamless ultrasonic communication
For encapsulation, we achieved a major breakthrough with the demonstration of light triggered degradation of a bioresorbable polymer. This controlled degradation mechanism allows precise regulation of the implant's lifespan, ensuring that the device functions effectively for the required monitoring period before safely dissolving without additional surgical procedures. This advancement in transient electronics significantly enhances the functionality and longevity of implantable medical devices.
We introduced a novel bioresorbable electrochemical sensor designed as a microneedle structure for the rapid detection of troponin levels, a critical biomarker for cardiac events. This sensor's ability to provide real-time detection without the need for removal surgery marks a substantial improvement over traditional non-resorbable implants, offering a practical and advanced solution for early intervention in heart attacks.
For wireless communication, the project pioneered a frequency-based passive ultrasonic communication method that facilitates electronics-free data transfer from deep tissue capacitive sensor implants. This innovative approach eliminates the need for custom integrated circuits and power harvesting components, significantly simplifying implant design and enhancing reliability. The successful in vitro demonstration of wireless ultrasonic data transmission not only validates the method but also opens the door to fully bioresorbable systems capable of seamless ultrasonic communication
For encapsulation, we achieved a major breakthrough with the demonstration of light triggered degradation of a bioresorbable polymer. This controlled degradation mechanism allows precise regulation of the implant's lifespan, ensuring that the device functions effectively for the required monitoring period before safely dissolving without additional surgical procedures. This advancement in transient electronics significantly enhances the functionality and longevity of implantable medical devices.