Development of an ultrasonic device for the estimation of implant osseointegration – OsseoWave

The technology presented in this project can be applied to all indications involving a bone-implant interface. We chose to start developing the aspect of monitoring dental implants for which the market is faster accessible.
Benefits are expected for clinicians (decision support system to secure implant surgery), patients (vulgarization literature on osseointegration) and industrial companies (collaborations with implant and biomaterials companies).
The objective is to transfer the technology to the start-up WaveImplant currently incubated and supported by OSEO.
A strategy of patenting is expected before publications will be made in acoustic newspaper, biomechanics, modeling and dental and orthopedic surgery.

The technology presented in this project can be applied to end all indications involving bone-implant interfaces. We chose to begin developing the aspect of monitoring dental implants because the market is easier to address.
Our technology will then lead to products that can handle even the most disabling diseases (spinal fusion, hip replacements and ankle). Finally, the success of this project will lead to the creation of a new company (incubated by the incubator Descartes).
The acoustical model has been validated (task 2) and an article is in revision.
We have obtained very interesting results concerning task 7 since two papers have been published.
Moreover,, two review articles have been published.

The goal of this project is to reach a stage where it will be possible to conduct clinical trials on a larger scale, with a CE marked optimized final prototype and responding to the market needs. This useful technology will then enter an industrial development and become a mandatory reference in the context of this type of surgery.

Vayron, R., Soffer, E., Anagnostou, F., and Haïat, G., «Ultrasonic evaluation of dental implant osseointegration«, J Biomech 47 (2014) pp. 3562-3568.
Vayron, R., Mathieu, V., Michel, A., Loriot, D. and Haïat, G., «Assessment of the in vitro dental implant primary stability using an ultrasonic method«, Ultrasound Med Biol 40(12) (2014) pp. 2885-94.
Mathieu, V., Vayron, R., Richard, G., Lambert, G., Naili, S., Meningaud, JP and. Haïat, G., «Biomechanical determinants of the stability of dental implants: influence of the bone-implant interface properties«, J Biomech 47(1) (2014) pp 3-13.
Haiat, G., Wang, H.L. and Brunski, J.B., «Effects of biomechanical properties of the bone-implant interface on dental implant stability: from in silico approaches to the patient's mouth«, Annu Rev Biomed Eng. 11(16) (2014) pp. 187-213.
Vayron, R., Mathieu, V., Michel, A., Loriot, D. and Haïat, G., «Assessment of the in vitro dental implant primary stability using an ultrasonic method«, in press to Ultrasound Med Biol
Michel, A., Bosc, R., Mathieu, V., Hernigou, P., and Haïat, G., «Monitoring the press-fit insertion of an acetabular cup by impact measurement: influence of bone abrasion« Proc Inst Mech Eng H. 228(10) (2014) pp. 1027-34.
Michel, A., Bosc, R., Mathieu, V., Hernigou, P., and Haïat, G., «In vitro evaluation of the acetabular cup primary stability by impact analysis« J Biomech Eng 137(3) (2015) pp. 031011.
Vayron, R., Nguyen, V.-H., Bosc, R., Naili, S. and Haïat, G., «Finite element simulation of ultrasonic wave propagation in a dental implant for biomechanical stability assesment« in press to Biomech Model Mechanobiol
Mathieu, V., Soffer, J.E., Anagnostou, F., and Haïat, G., «Erratum: Numerical simulation of ultrasonic wave propagation for the evaluation of dental implant biomechanical stability. [J Acoust Soc Am 129, 4062-4072 (2011)]«, J Acoust Soc Am, 137(2) (2015) pp. 1048

The increases of population lifetime and of the accidents are the two main reasons explaining the growing interest of the scientific community in studying the osteoarticular system. Although implant and osteoarticular prostheses have been widely used in clinical routine since more than 30 year and have allowed considerable therapeutic and esthetic improvements, a lot of optimizations and developments of their performances remain to be done.
In particular, dental implants are widely used for maxillofacial rehabilitation purposes, with more than 400 000 implant surgery per year in France. Many cases of failure still happen due to a bad timing in the implant loading with the prosthesis. This is due to the fact that a reliable tool capable of verifying the quality of osseointegration is still missing. Such failures induce pain, degraded mastication conditions for patients and increased costs for dental surgeons. It still remains difficult to assess the stability of a dental implant and in particular the biomechanical properties of newly formed bone tissue around the implant.
OsseoWave aims at developing an evaluation tool to assess the implant stability and to follow the implant osseointegration in the osteoarticular system. The first application to be transferred will be dental implants.
The MSME laboratory of University Paris-Est has developed a new method for the follow-up of implants, which is sensitive to the bone-implant interface quality, the only accurate criteria for the implant surgical success. The system uses quantitative ultrasound analysis, which is a non invasive, non radiating and relatively cheap approach. A proof of concept has been demonstrated ex vivo and in vivo, which has allowed a French and PCT patent application and a new statement of invention.
We intend to keep on working on in vivo validation experiments in rabbits and to start new ones in dogs in conditions closer to the clinical situation. Moreover, the development of numerical simulation tools will lead to the optimization of the signal processing methods used in the software of the device, which will improve the overall performances of the device. An industrialization study aim at conceiving and manufacturing the final version of the device. Then, the device will be validated in the framework of a preliminary clinical study and the results will be protected through new patent applications. The present project will bring the technology to the CE certification, which is necessary in order to carry out a clinical investigation at a larger scale in the framework of a PHRC funding. The present project will pave the way towards for other applications (ankle, hip and spine among others).
The team is constituted by members with complementary skills (dental surgeons experts in oral biology of bone remodeling and researchers specialized in quantitative ultrasound imaging). The project has won the concours national de Création d’entreprise in Emergence and was founded through an Aima project by the Centre Francilien pour l’Innovation and through the ANR project WaveImplant (end: September 2013). These funding have been used to realize an intellectual property study which has shown the freedom to operate of the device and a first in vivo validation. Moreover, the laboratory has been contacted by two leading companies of the dental field (Septodont and Zimmer Dental) for the realization of a dedicated study. The developed technology has been under industrial transfer since mid-2009 which will be concretized through a grant of patent and know-how license to a company to be created and already incubated.
The developed technology has the potential to justify a start-up creation because of:
- An important, international and growing market with no effective competitors
- Multiple possible applications of the technology
- Need for a technical expertise but also for a strong industrial and marketing environment