B1*
OrbitaTreat - A Device and System for a Minimally Invasive Orbital Floor Fracture Implantation
Prof. Thomas Schratzenstaller, OTH Regensburg; Dr Moritz Burger, OTH Regensburg; Prof. Thomas Kühnel, Universitätsklinikum Regensburg
Bayerische Patentallianz GmbH
Challenge
Orbital floor fractures are breaks of the thin bone wall between the eye orbit and the maxillary sinus below. They account for approximately 4% to 16% of all bone fractures in the facial region and typically result from a frontal impact such as a punch or a traffic- or sport accident, for example from a tennis ball hitting the eye. An orbital floor fracture can cause soft tissues to prolapse through the fractured bone into the maxillary sinus and thereby lead to a number of symptoms including orbital pain, eye displacement (enophthalmos) and -if the nerves in the orbital area are damaged- eye motility and vision disorders such as seeing-double (diplopia). The standard corrective surgery for treating these fractures involves inserting an implant through an incision formed in the eye itself (transconjunctival incision) or via infraorbital or lower eyelid incision (subciliary incision). Complications can arise when creating the access and inserting the implants include the risk of damage to the mobility of the lower eyelid, such as eyelid closure and tear transport, or, due to the pressure load on the orbital contents during implantation, impaired vision or even blindness.
Technology
The innovation provides an implantation system and implant for an alternative surgical method using an access route through the nasal passage to the maxillary sinus. This prevents unnecessary stress on the orbit and means that no implant remains in the eye socket. A demonstrator consisting of an implantation system and an implant was developed, which enables the folded (crimped) implant to be inserted into the fracture in a minimally invasive manner via a surgically created pre-lacrimal window in the maxillary sinus. Once positioned there, the implant is enlarged in shape using the implantation system and anchored in the maxillary sinus. Further elongation of the implant results in bridge formation and thus contact with the fracture. The implant can then be modeled to the shape of the orbital floor using standard surgical instruments, thus providing permanent support for the fracture.
Commercial Opportunity
About 1500 cases of orbital floor fracture are treated yearly in the conventional complication-prone way only in Germany. The innovation provides a less invasive treatment possibility for orbital floor fractures with a reduced risk of secondary effects and increased surgical simplicity.
Development Status
The function and biocompatibility of the demonstrator have been proven in extensive preclinical trials.
Patent Situation
Filed in EP and US
Further Reading
EP4333771A1
