Valve-in-Stent Device for Patulous Eustachian Tubes
Problem Statement
Problem Statement
Adults with a patulous eustachian tube need a safe and effective solution to block internal body sounds from traveling to the middle ear via the eustachian tube without inhibiting middle ear ventilation.
Adults with a patulous eustachian tube need a safe and effective solution to block internal body sounds from traveling to the middle ear via the eustachian tube without inhibiting middle ear ventilation.
What are Patulous Eustachian Tubes?
What are Patulous Eustachian Tubes?
Patulous Eustachian Tubes (pET) are a pathology of the tube that connects a person's middle ear to the nasopharynx. The function of this tube is to provide pressure relief periodically throughout a day. Additionally, since the tube is closed in its resting state, it insulates the middle ear from the noises in the nasopharynx such as breathing, swallowing, and speaking. The patulous condition of the Eustachian Tubes means that the tube is unable to be closed properly by surrounding muscles.
Patulous Eustachian Tubes (pET) are a pathology of the tube that connects a person's middle ear to the nasopharynx. The function of this tube is to provide pressure relief periodically throughout a day. Additionally, since the tube is closed in its resting state, it insulates the middle ear from the noises in the nasopharynx such as breathing, swallowing, and speaking. The patulous condition of the Eustachian Tubes means that the tube is unable to be closed properly by surrounding muscles.
A Relief from Symptoms without Compromise
A Relief from Symptoms without Compromise
Patients will experience sound insulation from the nasopharynx without the physician needing to place pressure equalization (PE) tubes through the tympanic membrane.
Patients will experience sound insulation from the nasopharynx without the physician needing to place pressure equalization (PE) tubes through the tympanic membrane.
Valve Functionality with Stented Stability
Valve Functionality with Stented Stability
The device benefits from pneumatic, flexure based valve functionality while being stabilized and held in place with the reliable, well understood stenting technology.
The device benefits from pneumatic, flexure based valve functionality while being stabilized and held in place with the reliable, well understood stenting technology.
The Prototype
The Prototype
The current state of the device is a to-be-tested, functional valve made of PDMS. It is mounted in an FDM 3D-printed rigid body made of PLA. This rigid body is to be molded into the stent scaffold for placement.
The current state of the device is a to-be-tested, functional valve made of PDMS. It is mounted in an FDM 3D-printed rigid body made of PLA. This rigid body is to be molded into the stent scaffold for placement.
The Path Forward
The Path Forward
With a domestic market size of $1.5B, product development efforts over the next two years will be followed by animal studies to prove safety and efficacy, human clinical trials to establish acceptability for human use, and finally FDA approval for sale in the US.