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Wearable HATH-1 Auditory Therapy: Total Hearing Effect?

Wearable HATH-1 Auditory Therapy: Total Hearing Effect?. Michael DeSalvio , John Chi, Michael Nguyen, Kevin Ip , Khine Win. WHAT: THE?. John Chi – Electrical Engineer: System architecture, Software design Michael J. DeSalvio - Molecular Biologist: Interface design, Biocompatibility

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Wearable HATH-1 Auditory Therapy: Total Hearing Effect?

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  1. Wearable HATH-1 Auditory Therapy: Total Hearing Effect? Michael DeSalvio, John Chi, Michael Nguyen, Kevin Ip, Khine Win

  2. WHAT: THE? • John Chi – Electrical Engineer: System architecture, Software design • Michael J. DeSalvio - Molecular Biologist: Interface design, Biocompatibility • Kevin Ip - Molecular Biologist, Regulatory Contact • Mike Nguyen – Molecular Biologist and Lab Specialist: Drug delivery design, GLP contact • Khine Win – Material Science and Engineering: Fluid transport design, process fabrication • We are not researchers, we are designers!

  3. Problem • Most hearing loss is caused by damaged cochlear hair cells, which do not regenerate • Hearing loss now affects 1 in 5 American teenagers (JAMA, 8-17-2010) • 15% of adults between 20-69, 26 million adults, suffer from noise-induced hearing loss (NIHL, National Institute on Deafness and Other Communication Disorders) • 25-40% of 60+ in US is hearing impaired - worsening (Yueh et al, 2003)

  4. Current Solutions • Cochlear Implant • Hearing Aids • Underlying cause not addressed (hair cell destruction)

  5. Cochlear Implant • FDA approved in 1984 • Approximately $40,000 for procedure • As of 2009, 188,000 worldwide received implants. (Davis, J 2009 Peoria Journal) • Cochlear Implants rely on electrical connections to auditory nerve, destroying existing structures in the ear • Infection, physical damage to unit, wear and tear (permanent) • Developed by Cochlear Limited Australia, Advanced Bionics, Cochlear Corporation, Med-El, etc.

  6. Hearing Aid • Removable prosthetic • Many different shapes and sizes • $150 to $5,000 • Many different manufacturers and designs • No surgery • Can be bulky and cumbersome • Need constant adjustment (feedback, loud noises)

  7. HATH-1 Therapy • Math1 allows transdifferentiation of cochlear cells into functioning auditory hair cells • These transgenic cells shown to be stable and growing after 10 weeks with significant restoration of auditory function (2003, Izumikawa) • Need multiple injection sites • Need to distribute throughout cochlea using micropump to optimize hair cell regeneration densit

  8. HATH-1 Effectiveness

  9. Routes of Entry • Two routes of entry into ear • Systemic Route: drug circulates through blood stream • Local Application to inner ear(targeted drug delivery) www.gizmowatch.com

  10. Device • Microfluidic circulating pump delivers drug safely to delicate cochlear region • Intracochlear drug delivery device to deliver chemotherapy • Built-in Piezoelectric ABR testing • Extracochlear stimulation maintains auditory regions in brain • FDA Class 2 Device and Class 2 Software

  11. Prototype (Animal model)

  12. Advantages • Does not destroy vestibular structure • Temporary prosthetic surgical solution • Permanent hearing restoration • No need for post-treatment prosthetic • Monitored treatment developmet • Maintenance is almost identical to existing cochlear implant

  13. Disadvantages • Suppress vestibular (balance) system function—with sometimes only minor effects on hearing. • Risk of developing meningitis • General risk of infection • Cost: $45,000- $150,000 total cost

  14. Where and When • Business location local to Southern California • Group competencies allow most development to take place in-house • Approximately 3 years to market with drug delivery device • Milestone 1 – Develop prototype • Milestone 2 – 510K Registration with FDA • Milestone 3 – Commence clinical trials • Milestone 4 – Complete clinical trials

  15. How does it work? • Delivering Hath 1 transcription factor and other drugs • Microfluidic pump system with inlet and outlet tubule for delivery • Use of intracochlear imaging system to monitor distribution of delivered substances • Use of Extracochlear stimulation during recovery period • 10 week treatment course Figure: Prototype (Human Model) Khine

  16. How is it Different? • Does not remove vestibular hair cells http://www.surgeryencyclopedia.com/Ce-Fi/Cochlear-Implants.html • Can monitor hair cell growth through non-invasive ABR testing • Higher distribution of delivered substances compared to delivery through RWM • Extracochlear stimulation does not destroy cochlea as opposed to intracochlear device

  17. Cochlear Anatomy • Contains two & three quarter turns (Basal, Middle & Apex) • 3 fluid filled spaces located in parallel • scalavestibuli, tympani & cochlea duct • Fluid contains ionic compositions of Na+, K+, Ca2+ & Cl- (Endolymph & Perilymph)

  18. Surgery • Surgery • Opening in the basal turn is made • Carbide micro drills modified fitted with insertion stops • Medical grade adhesive & dental cement are used • Almost identical to already used implant surgery

  19. System Overview

  20. Extracochlear Stimulator • Can re-stimulate portions of the brain responsible for hearing even after prolonged “atrophy.” Documented patient Baron Jack Ashley, UK House of Lords • Can improve hearing after complete deafness • Reliable and efficient, long life cycle • Restore hearing without damaging structures in ear canal Michael N

  21. Fluid Transport System (overview) Microfluidic pump Microcontroller Reservoir (contains Artificial perilymph solution) Inlet tubule + precision thermal flow sensor Ear outlet tubule + precision thermal flow sensor

  22. Fluid Transport (Materials) • Polyetheretherketone(PEEK) tube • Biocompatible • Excellent mechanical and thermal resistance • Good for application require vacuum environment • ISO 10993 standard & fully USP Class VI, FDA, NSF and European Pharmacopoeia criteria

  23. Fluid Transport (Materials) • Polyetheretherketone (PEEK) tube • Biocompatible • Excellent mechanical and thermal resistance • Good for application require vacuum environment • ISO 10993 standard & fully USP Class VI, FDA, NSF and European Pharmacopoeia criteria

  24. Fluid Transport • Precision thermal sensor • Utilizing temperature shift caused by fluid flow • Relationship between temp and volume of fluid flow • Microfluidic pump • Nano Liter application • Zero net transfer • Continuous inflow and outflow (not reciprocating

  25. QFD – Power Subsystem

  26. QFD – Power Subsystem

  27. QFD - Battery

  28. Input • Tubing Materials • Microprocessors • Casing Materials • Drug • Sensors • Circuitry • Pumps • Software and updates

  29. Change Over Time • Degradation/loosening of seals • Degradation of battery • Wear on moving parts • Degradation of synthetic endolymph • Bodily immune response • Wearing of pumps • Degradation of tubing • Degradation of drug • Circuitry corrosion • Loosening of delivery template

  30. Noise • External heat/cold • Water/humidity • Leaking • User opens device • Device falls off • Blunt force trauma • Bubbles in fluid line • Flow regulation failure • Electromagnetic interference • Intracochlear tissue • Internal heating • Battery failure, leaking • Charging mechanism seizes • Particulates in fluid line • Software bugs • Overheating • Accumulation of biofilm

  31. Control Factors • Redundant systems (firmware,tubing, pumps) • Sealed battery compartment • Accessible internal components for servicing • Use biologically inert materials • Consistent software reviews • Reversible flow – self backflushing • Simulation environments • Water tight seals • Flow rate sensors • Heat sensors • Pressure sensors • Electromagnetic shielding • Ultrasonic agitator for fluid lines, bubble trap

  32. Error States • Water infiltrates system • Infection • Memory/firmware failure • Device fails to charge • Cooked/frozen drug • Short circuit • Clogged pump mechanism • Premature emptying of drug reservoir • Seizure of motor • Cracked casing

  33. Ideal Function • Correct dosage • Distribution of drug • Motors powered correctly • Body accepts implant • No leakage • ABR measurement of intracochlear cell restoration • Healthy cochlea, restored hearing

  34. Summary • Site specific target allows for precise calculation of dosage • Targeted drug delivery which mitigates drug exposure to other tissues (HATH-1 effects in body) • Can be used for middle ear cancers and tumors • Can be used in conjunction with surgery to deliver antibiotics • No additional equipment or maintenance once treatment is complete

  35. Questions?

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