wearable hath-1 auditory therapy: total hearing effect?
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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
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!
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)
Current Solutions
Cochlear Implant Hearing Aids Underlying cause
not addressed (hair cell destruction)
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.
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)
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
HATH-1 Effectiveness
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
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
Prototype (Animal model)
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
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
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
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
Khine Figure: Prototype (Human Model)
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
Cochlear Anatomy Contains two & three
quarter turns (Basal, Middle & Apex)
3 fluid filled spaces located in parallel
scala vestibuli, tympani & cochlea duct
Fluid contains ionic compositions of Na+, K+, Ca2+ & Cl- (Endolymph & Perilymph)
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
System Overview
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
Fluid Transport System (overview)
Microfluidic pump
Inlet tubule +
precision thermal flow sensor
Reservoir(contains Artificial
perilymph solution)
outlet tubule +
precision thermal flow sensor
Ear
Microcontroller
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
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
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
QFD – Power Subsystem
QFD – Power Subsystem
QFD - Battery
Input
Tubing Materials Microprocessors Casing Materials Drug Sensors Circuitry Pumps Software and updates
Change Over Time
Wearing of pumps Degradation of
tubing Degradation of drug Circuitry corrosion Loosening of
delivery template
Degradation/loosening of seals
Degradation of battery Wear on moving parts Degradation of
synthetic endolymph Bodily immune
response
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
Control Factors Water tight seals Flow rate sensors Heat sensors Pressure sensors Electromagnetic
shielding Ultrasonic
agitator for fluid lines, bubble trap
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
Error States
Cooked/frozen drug Short circuit Clogged pump
mechanism Premature emptying
of drug reservoir Seizure of motor Cracked casing
Water infiltrates system
Infection Memory/firmware
failure Device fails to
charge
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
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 tumorsCan be used in conjunction with surgery to deliver
antibiotics No additional equipment or maintenance once
treatment is complete
Questions?