Periodic Reporting for period 3 - MIRACLE (Mid-infrared arthroscopy innovative imaging system for real-time clinical in depth examination and diagnosis of degenerative joint diseases)
Período documentado: 2021-01-01 hasta 2022-03-31
MIRACLE aims to build the first mid-infrared (MIR) arthroscopy system prototype to enable quantitative evaluation of articular cartilage composition enabling quantitative diagnosis of cartilage injuries and degenerative joint diseases such as osteoarthritis (OA). The proposed medical device is intended for use during a minimally invasive surgery (arthroscopy). MIRACLE intends to:
• Provide an unique medical device for qualitative and real-time articular cartilage diagnosis during arthorscopy.
• Impact on surgeon’s decision-making reducing patient’s visits to hospital and surgical interventions.
• Develop and bring to the market novel photonics components which will be part of the first MIR arthroscopy system.
• Prototype and demonstrate the first MIR arthroscopy system in clinical settings.
As the first medical device to provide quantitative examination of cartilage tissue in real-time, it is expected that MIRACLE arthroscopy system will bring innovation to the arthroscopy market valued at $4 billion in 2015. Furthermore, it is expected that MIRACLE will bring to the market three novel photonics components:
• Tailored quantum cascade lasers (QCL) for biodiagnostics by nanoplus.
• Integrated beam combiner for efficient radiation coupling by Ulm University.
• MIR sensing probe by art photonics.
These components will be assembled into the first MIR arthroscopy system prototype, which will be validated via in vitro studies. The final prototype will be evaluated in ex vivo and in vivo scenarios within MIRACLE. The MIRACLE project will also address the data processing and analysis to enable real-time grading of the cartilage tissue. To achieve these goals, MIRACLE has an active medical team participating in each step of the device development ensuring that the clinical needs will be achieved according to the surgeon’s expectations. It is intented that the medical device will be used during arthroscopy without interfering with the current surgery protocols ensuring a smooth transition from R&D to clinical use.
• Provide an unique medical device for qualitative and real-time articular cartilage diagnosis during arthorscopy.
• Impact on surgeon’s decision-making reducing patient’s visits to hospital and surgical interventions.
• Develop and bring to the market novel photonics components which will be part of the first MIR arthroscopy system.
• Prototype and demonstrate the first MIR arthroscopy system in clinical settings.
As the first medical device to provide quantitative examination of cartilage tissue in real-time, it is expected that MIRACLE arthroscopy system will bring innovation to the arthroscopy market valued at $4 billion in 2015. Furthermore, it is expected that MIRACLE will bring to the market three novel photonics components:
• Tailored quantum cascade lasers (QCL) for biodiagnostics by nanoplus.
• Integrated beam combiner for efficient radiation coupling by Ulm University.
• MIR sensing probe by art photonics.
These components will be assembled into the first MIR arthroscopy system prototype, which will be validated via in vitro studies. The final prototype will be evaluated in ex vivo and in vivo scenarios within MIRACLE. The MIRACLE project will also address the data processing and analysis to enable real-time grading of the cartilage tissue. To achieve these goals, MIRACLE has an active medical team participating in each step of the device development ensuring that the clinical needs will be achieved according to the surgeon’s expectations. It is intented that the medical device will be used during arthroscopy without interfering with the current surgery protocols ensuring a smooth transition from R&D to clinical use.
The MIRACLE structure combines horizontal activities (ethics, management, communication, dissemination, exploitation) and vertical activities (knowledge breakthrough, components development, prototyping, validation, demonstration, development of market strategies).
During the 36 months of MIRACLE project a substantial amount of effort has been devoted to:
• Kick-start the project and starting to address the main technical challenges by active communication among the clinical and technical teams.
• Put in place all the necessary project committees and management structure.
• Create a Project Quality Handbook establishing practical guidance to ensure high quality of project, which is regularly updated.
• Document all the technical requirements and specifications related to the clinical applicability of the medical device to be developed.
• Request the ethical approval.
• Develop the clinical protocols for the use of the device.
• Establish the visual identity of the project and the communication channels for project dissemination.
• Launch and update the MIRACLE website (http://miracleproject.eu/(se abrirá en una nueva ventana)).
• Take part in relevant events to disseminate the project.
• Perfom Intellectual Properties Rights (IPR) analysis to ensure freedom of operate and patentablity of the results.
• Identify the relevant standards related to MIRACLE development.
Currently, MIRACLE project faces a 6 months delay in the technical development and subsequent tasks due to the COVID19 outbreak. Yet, the following achievements have been successfully delivered:
• Spectra from 150 samples (including bovine, equine and human tissues) were measured using MIR spectrometer and analysed allowing the consortium to identify together with the medical team the relevant spectrum peaks that are directly related to the assessment of cartilage quality.
• Tailored QCLs corresponding to the identified relevant clinical peaks were developed and the prototypes were delivered.
• Unforeseen QCL adaptors for facilitate effective coupling were designed and manufactured.
• Three different strategies for iBEAM combiner for efficient radiation coupling have been explored, prototyped and tested.
• Simulations on the MIR probe design according to the surgeon’s requirements have been performed and a decision on the two most promising designs was made.
• A hook shaped MIR test probe has been prototyped for the surgeons to test if the design is suitable for arthroscopy procedure, receiving positive feedback.
• A prototype for the MIR straight probe has been delivered for pre-validation studies and is now in optimization phase.
• 2 generations of the hook shaped ATR diamond probe were prototyped, tested and delivered.
• Unforeseen fiber loop probe is under development.
• The assembling of the main unit system combining all the prototyped components was achieved.
• Pre-validation studies (i.e. establish correlation between the relevant clinical wavenumbers and OA grading) have been performed using three different commercial MIR spectrometers.
• A systematic study was performed using bovine samples (72 samples) with controlled mechanical or enzymatic degradation (something that cannot be achieved with human samples).
• Pre-validation studies have been delivered including 377 human samples and 242+648 equine samples.
• First version for the end user software is implemented in the main unit.
During the 36 months of MIRACLE project a substantial amount of effort has been devoted to:
• Kick-start the project and starting to address the main technical challenges by active communication among the clinical and technical teams.
• Put in place all the necessary project committees and management structure.
• Create a Project Quality Handbook establishing practical guidance to ensure high quality of project, which is regularly updated.
• Document all the technical requirements and specifications related to the clinical applicability of the medical device to be developed.
• Request the ethical approval.
• Develop the clinical protocols for the use of the device.
• Establish the visual identity of the project and the communication channels for project dissemination.
• Launch and update the MIRACLE website (http://miracleproject.eu/(se abrirá en una nueva ventana)).
• Take part in relevant events to disseminate the project.
• Perfom Intellectual Properties Rights (IPR) analysis to ensure freedom of operate and patentablity of the results.
• Identify the relevant standards related to MIRACLE development.
Currently, MIRACLE project faces a 6 months delay in the technical development and subsequent tasks due to the COVID19 outbreak. Yet, the following achievements have been successfully delivered:
• Spectra from 150 samples (including bovine, equine and human tissues) were measured using MIR spectrometer and analysed allowing the consortium to identify together with the medical team the relevant spectrum peaks that are directly related to the assessment of cartilage quality.
• Tailored QCLs corresponding to the identified relevant clinical peaks were developed and the prototypes were delivered.
• Unforeseen QCL adaptors for facilitate effective coupling were designed and manufactured.
• Three different strategies for iBEAM combiner for efficient radiation coupling have been explored, prototyped and tested.
• Simulations on the MIR probe design according to the surgeon’s requirements have been performed and a decision on the two most promising designs was made.
• A hook shaped MIR test probe has been prototyped for the surgeons to test if the design is suitable for arthroscopy procedure, receiving positive feedback.
• A prototype for the MIR straight probe has been delivered for pre-validation studies and is now in optimization phase.
• 2 generations of the hook shaped ATR diamond probe were prototyped, tested and delivered.
• Unforeseen fiber loop probe is under development.
• The assembling of the main unit system combining all the prototyped components was achieved.
• Pre-validation studies (i.e. establish correlation between the relevant clinical wavenumbers and OA grading) have been performed using three different commercial MIR spectrometers.
• A systematic study was performed using bovine samples (72 samples) with controlled mechanical or enzymatic degradation (something that cannot be achieved with human samples).
• Pre-validation studies have been delivered including 377 human samples and 242+648 equine samples.
• First version for the end user software is implemented in the main unit.
In the current clinical settings, no devices/solutions for quantitative assessment of articular cartilage are available. MIRACLE device will enable accurate and quantitative assessment of cartilage tissue composition intraoperatively (i.e. during arthroscopy procedure). Although it is virtually impossible to trace the overall impact of new devices, even based on results from previous innovations (Gelijns AC et al. (1991) The Change Economics of Medical Technology, Committee on Technology Innovation Medicine, National Academic Press.), MIRACLE aims at reducing the number of visits of the patient to the hospital and procedures they might need to undergo due to cartilage degradation, by providing an efficient tool to the orthopaedic surgeons. This would have a positive impact on the patient’s quality of life as well as in the health care costs.
Beside the (human) patient market, MIRACLE is also aiming to reach the veterinarian market, focusing on arthroscopic interventions in horses. As requirements for veterinarian market are less strict than the ones for patient market, it is expected this will lead to a quicker market entry of the MIRACLE device, increasing MIRACLE potential to succeed in the global market.
To achieve the final MIRACLE device, several cutting-edge solutions are under development and are expected to reach the photonics market, promoting the Europe industrial leadership. (i) The tailored QCLs could potentially be used in other fields such as environment, space and biotechnology. (ii) The MIR-ATR probe could be further development as diagnostic tool for other tissue-related diseases as well as for reaction monitoring for on-site observations. (iii) The iBEAM solutions can be used in several optical applications. Finally, (iv) the integrated OEM system can be exploited for other sensing applications including in health, pharmaceutical and environmental fields.
Beside the (human) patient market, MIRACLE is also aiming to reach the veterinarian market, focusing on arthroscopic interventions in horses. As requirements for veterinarian market are less strict than the ones for patient market, it is expected this will lead to a quicker market entry of the MIRACLE device, increasing MIRACLE potential to succeed in the global market.
To achieve the final MIRACLE device, several cutting-edge solutions are under development and are expected to reach the photonics market, promoting the Europe industrial leadership. (i) The tailored QCLs could potentially be used in other fields such as environment, space and biotechnology. (ii) The MIR-ATR probe could be further development as diagnostic tool for other tissue-related diseases as well as for reaction monitoring for on-site observations. (iii) The iBEAM solutions can be used in several optical applications. Finally, (iv) the integrated OEM system can be exploited for other sensing applications including in health, pharmaceutical and environmental fields.