You are here

Tympanic Membrane Repair Material

Description:

TECHNOLOGY AREA(S): Bio Medical 

OBJECTIVE: The development of an innovated material/device that can be used to repair tympanic member perforations with limited or no anesthesia. The material can be in the form of a gel, 3d printed material, and other bio material and be used with endoscopes or minimal operative equipment. The material will be employed at level III battlefield of care after injury. 

DESCRIPTION: The last 20 years of armed conflict has resulted in exposure of service members to high intensity sound or blast overpressure waves. The direct consequences of high-intensity noise and blast injuries to the auditory system are hearing loss and tympanic membrane rupture in some cases. Rupture of the eardrum or tympanic membrane (TM) was reported in over 10,000 service members during evaluation at field level III of care. The resultant injury may not receive definitive care for several months post injury until care is accomplished at level IV of care. The result is loss of return to duty status. The injury is a burden to the individual due to hearing loss. Many otologic surgeons contributed to the development and refinement of tympanoplasty techniques. Tympanoplasty surgery is quite successful in the modern area in the operative theater. The plethora of surgical techniques currently employed, the wide variety of autograft, homograft and synthetic materials are available and the continued innovation in biosynthetic materials for otologic use all attest to the fact that reconstructing the tympanic membrane continues to evolve. However, the current cost of performing tympanoplasty in the hospital operating room can be very expensive. The cost of health care continues to increase, the need for performing surgery in the office is now more a common place. We propose to develop a minimally invasive surgical material to repair tympanic membrane perforation that can occur far forward in the battlefield which has the potential to quickly return service members to duty. 

PHASE I: During Phase one, determine and define the material composition that will be tolerated within the middle ear and close/repair a tympanic membrane perforation. The product has no ototoxic potential to both the auditory or vestibular system. Design requirements may include ease of use, minimal equipment or activation process and be delivered minimally invasive. It must be stable, have ease of storage (heat and cold tolerance) and be applied with ease. Demonstration of a prototype is desirable with some early in vitro data. The product should have function and closure rates of tympanic membrane repair that meets the industry standard. The product should be easily removed from the graft site during early healing stages, if necessary, otherwise it should dissolve or incorporate into the healed tympanic membrane. Model key elements of tympanoplasty repair biomechanics, which may include detailed analysis of auditory performance. Design/develop an innovative concept along with limited testing of potential materials. The product will be used by Otolaryngologist at level 3-4 of care. 

PHASE II: Detail analysis of the selected material/device that will include optimal biological properties that are safe and perform equal or better outcomes than standard tympanoplasty. The material should be delivered with minimal surgical tools with no need for an operative suite. The in vivo efficacy will be established. Parameters include ease of use and overall stability across a wide range of conditions. Validation of efficacy will be determined through animal models, histology, and/or other appropriate measures. Clinical experts with insight into tympanic membrane trauma and relevant patient populations should be consulted during optimization and animal validation. Early clinical trials should be considered. Potential commercial and clinical partners for Phase III and beyond should be identified, and a detailed explanation should be provided for how the small business will obtain a monetary return on investment. Phase II should outline an FDA regulatory plan as well consult subject matter experts with military experience. 

PHASE III: During Phase III, additional in vivo experiments will be performed as necessary to prepare for FDA review. It is required that this device to commercialized and made available to the military and as well to the private sector. Clinical trials should be underway. Close communication with military surgeons on the development on the product should be considered. Small business should have a strategy in place to secure funding from the private sector. Device a plan that will bridge the gap between laboratory-scale innovation and entry into a recognized Food and Drug Administration (FDA) regulatory pathway leading to commercialization of the product that will be made available for purchase by the military health system and private sector. 

REFERENCES: 

1: S. N. Merchant · M. J. McKenna · J. J. Rosowski Current status and future challenges of tympanoplasty Eur Arch Otorhinolaryngol (1998) 255 : 221–228

2:  R.T. Chavan, S.M. Ingole and S.N. Birajdar Overview of Tympanoplasty techniques and results Int. J. of Oto and Head and Neck Surg

3:  Carlos R Esquivel, Mark Parker, Kwame Curtis, Andy Merkley, Phil Littlefield, George Conley, Sean Wise, Brent Feldt, Lynn Henselman, Zsolt Stockinger

4:  Aural Blast Injury/Acoustic Trauma and Hearing Loss, Military Medicine, Volume 183, Issue suppl_2, 1 September 2018, Pages 78–82,

5:  Helling ER: Otologic blast injuries due to the Kenya Embassy Bombing. Mil Med 2004

6:  169(11): 872–76.14.

KEYWORDS: Tympanoplasty, Endoscopes, Technique, Hearing, Ototoxicity 

US Flag An Official Website of the United States Government