Wearable HATH-1 Auditory Therapy: Total Hearing Effect? Michael DeSalvio, John Chi, Michael Nguyen,...
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Transcript of Wearable HATH-1 Auditory Therapy: Total Hearing Effect? Michael DeSalvio, John Chi, Michael Nguyen,...
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 tumors
Can be used in conjunction with surgery to deliver antibiotics
No additional equipment or maintenance once treatment is complete
Questions?