SBIR-STTR Award

A minimally invasive, single incision, rechargeable spinal cord Stimulation system for chronic pain
Award last edited on: 4/6/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NIBIB
Total Award Amount
$256,046
Award Phase
1
Solicitation Topic Code
286
Principal Investigator
Dane William Grasse

Company Information

Teliatry Inc

1301 North Plano Road
Richardson, TX 75081
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Location: Single
Congr. District: 32
County: Dallas

Phase I

Contract Number: 1R43EB031671-01
Start Date: 4/1/2021    Completed: 4/30/2022
Phase I year
2021
Phase I Amount
$256,046
Teliatry proposes to build world's smallest (0.75cc), most cost-effective, minimally invasive singleincision surgery, 16-channel, rechargeable, Spinal Cord Stimulator (SCS) system to bring provenSCS therapy to mainstream chronic pain management. It eliminates the need for creating an IPGpocket, eliminates tunneling, exploits a novel shape memory polymer (SMP)lead that can be insertedpercutaneously without altering current surgical technique but "unrolls" into a paddle in epidural space. Italso softens to conform to the epidural space mitigating issues with lead migration and lead breakage. Theelectrodes on the paddle are high surface area, low polarization, fractal topology Titanium Nitride (TiN) thatfurther reduce the energy required by up to 70% of percutaneous cylindrical electrodes. This in turn reducesthe battery capacity requirement and allows us to exploit a miniature, multi-stack solid state battery (SSB)architecture that is manufactured at wafer level on a glass substrate. It is intrinsically safe, MRI compatibleand has extremely high charge & discharge rate (20C) and high recharge cycle (2000+) equating to 10+years lifetime. This further eliminates the need for repeat battery replacement surgery every few years. Inrecent times, miniature, battery less SCS systems have entered the market but they limit patients comfortand lifestyle by forcing external power & communications module(PCM) to be worn at all times and alsohave issues with alignment of the PCM with the implant for proper power coupling. Our proposed system iseven smaller than these batteries less system and with an average recharge time of <10 minute/day in theworst case, it eliminates the external wearable PCM and long recharge cycles wait time that hinder patient'slifestyle. In addition, our systems low production costs due to parallel fabrication of multiple implants on oneglass wafer will improve the short-term cost effectiveness (currently @ 40%) to its long term costeffectiveness (80%) making this a mainstream electroceutical for pain management and in turn reducingdependence on Opioids for chronic pain sufferers. We will perform feasibility study on all criticalcomponents and aspects of the system architecture in Phase 1 allowing us to build a successful prototypeduring Phase 2. We propose a system design including IPG architecture, battery and lead design that areall based on our proven technology and will enable us to realize a novel SCS system by synergisticallycombining advantages and on-going advancements of these core technologies 1) glass IPG, 2) glass SSB,3)new softening and unrolling leads. SCS therapy for chronic back pain is our prime target speciallybecause there is high level of evidence for safety, efficacy, and long-term cost-effectiveness of SCS withmore than half of all patients experiencing sustained and significant levels of pain reduction following SCStreatment. We believe we will not only bring SCS to mainstream pain management, but our modulartechnology platform will impact the entire neuromodulation industry.

Public Health Relevance Statement:
Project Narrative Teliatry, Inc., proposes to build the smallest (0.75cc), rechargeable, cost-effective, minimally invasive, 16 channel spinal cord stimulator (SCS) in the world for mainstream chronic back pain management. The proposed research is relevant to public health because chronic back pain is the single leading cause of disability worldwide. Missed work and disability related to low back pain costs over $50 billion each year in the US.

Project Terms:
Pain management ; Pain Control ; Pain Therapy ; pain treatment ; Architecture ; Engineering / Architecture ; Charge ; Communication ; cost effectiveness ; Electrodes ; Electronics ; electronic device ; Elements ; epidural space ; Feasibility Studies ; Fracture ; bone fracture ; Glass ; Industry ; Laminectomy ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Life Style ; Lifestyle ; Low Back Pain ; Low Back Ache ; Low Backache ; Lumbago ; Magnetic Resonance Imaging ; MR Imaging ; MR Tomography ; MRI ; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance ; NMR Imaging ; NMR Tomography ; Nuclear Magnetic Resonance Imaging ; Zeugmatography ; Mainstreaming ; Educational Mainstreaming ; achievement Mainstream Education ; Memory ; Muscle ; Muscle Tissue ; muscular ; Pain ; Painful ; Patients ; Polychlorinated Biphenyls ; PCBs ; Polychlorobiphenyl Compounds ; polychlorobiphenyl ; Polymers ; Production ; Public Health ; Research ; Resort ; Safety ; Signal Transduction ; Cell Communication and Signaling ; Cell Signaling ; Intracellular Communication and Signaling ; Signal Transduction Systems ; Signaling ; biological signal transduction ; Spinal Cord ; Medulla Spinalis ; Spinal cord injury ; Spinal Cord Trauma ; Spinal Trauma ; Spinal cord injured ; Traumatic Myelopathy ; Post-Traumatic Stress Disorders ; PTSD ; Post-Traumatic Neuroses ; Posttraumatic Neuroses ; Posttraumatic Stress Disorders ; post-trauma stress disorder ; posttrauma stress disorder ; traumatic neurosis ; Stroke ; Apoplexy ; Brain Vascular Accident ; Cerebral Stroke ; Cerebrovascular Apoplexy ; Cerebrovascular Stroke ; brain attack ; cerebral vascular accident ; cerebrovascular accident ; Family suidae ; Pigs ; Suidae ; Swine ; porcine ; suid ; Technology ; Temperature ; Thinness ; Leanness ; Time ; Titanium ; Ti element ; Vagus nerve structure ; Cranial Nerve X ; Pneumogastric Nerve ; Tenth Cranial Nerve ; Vagus Nerve ; Work ; Wound Infection ; infected wound ; chronic pain ; electric impedance ; Electrical Impedance ; Impedance ; base ; sensor ; improved ; Surgical incisions ; Otomy ; incision ; Site ; Area ; Surface ; Encapsulated ; Phase ; Fractals ; disability ; Stimulus ; Neurosurgeon ; neuro-surgeon ; Opioid ; Opiates ; Collaborations ; Shapes ; Pulse ; Physiologic pulse ; Level of Evidence ; Spinal Cord Stimulation ; Neurostimulation procedures of spinal cord tissue ; Dependence ; Techniques ; System ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; experience ; solid state ; neural control ; neural regulation ; neuromodulation ; neuromodulatory ; neuroregulation ; neural ; relating to nervous system ; novel ; Modeling ; Data ; Characteristics ; Process ; Development ; developmental ; cost ; data modeling ; model of data ; model the data ; modeling of the data ; design ; designing ; cost effective ; migration ; Coupling ; Implant ; implantation ; prototype ; minimally invasive ; effective therapy ; effective treatment ; chronic back pain ; system architecture ; Bluetooth ; Wait Time ; pain reduction ; reduce pain ; chronic pain management ;

Phase II

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Start Date: 00/00/00    Completed: 00/00/00
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