Lone Star Neuromodulation

Transcription

1 Lone Star Neuromodulation Disruptive Pulse-Generator Technology Platform 1

2 Our Vision Target unmet clinical needs by creating a disruptive device platform that offers promising solutions for lowering costs, realizing higher returns and effectively addressing more therapeutic indications. Our Strategy Leverage advancements in electronic-component technologies and capitalize on state-of-the-art device-miniaturization techniques to eliminate the cost of complete customization. Incorporate highly customizable C programming software. Design an innovative, cost-effective and ergonomic pulse-generator package with economy of production in mind. Create a versatile technology platform that is easily customizable to a multitude of indications. Save the acquiring entity years of research and development time and significantly minimize loss-of-earning opportunity. 2

3 Lone Star Neuromodulation Technology Platform Pulse Generator Full-Featured Implantable Pulse Generator 17 Tri-State Electrodes User Controller Near/Far-Field RF Interface Charging with Sure-Aim RF Tuning RF Wand Battery Charging Near-Field Half-Duplex Communication Demonstration GUI Software USB Interface Basic Features to Demonstrate System Attributes Feasibility Platform Design 3

4 Pulse Generator Electrical Attributes 16 Electrodes via 2 Leads 1 Can/Indifferent Electrode Rechargeable Li-Ion Battery Powered by Li-Ion Battery or Directly from External RF Feed Two Temperature Sensors Defibrillator Protection Designated to Facilitate Compliance with EN and EN Constant Current/Constant Voltage Mixed Current/Voltage Electrodes Grouped as (1, 5, 11, 15); (2, 6, 12, 16); (4, 8, 10, 14); (3, 7, 9, 13, 17) Each group can support either constant current or constant voltage; thus, mixing is possible across groups Adjustable Amplitude Constant Current mA Constant Voltage 0-11V Active or Passive Discharge Battery-Charging/LF Communication Range Up to 1.75 Inches (from the Face of the Wand to the Face of the Pulse Generator) 4

5 Pulse Generator Software Attributes Popular Microcontroller (MCU) Strong Industry Support for C-Language Firmware Development Platforms Autonomous Safety Features Alien Charger Detection/Rejection Automatic Overcharge Protection Automatic Overdischarge Protection Near-Field RF Communications MedRadio-Band Far-Field Communications Single frequency only Adjustable Pulse Attributes Amplitude, Pulse Width, Frequency Conventional Low-Frequency Pulse-Generation Support High-Frequency Support (Greater than 10KHz) Impedance Measurement Feasibility Platform Design 5

6 Pulse Generator Physical Attributes Ergonomic Implant Contoured & Thin for Patient Comfort Medical-Grade Liquid Silicone Rubber (LSR) Connector Housing Dual Suture Holes for Stability No-Back-Out Set Screw Lead Retention Option 1: Near-Hermetic Enclosure Medical-Grade Conformal Coatings Molded Medical-Grade PEEK Enclosure Medical-Grade Epoxy Backfill RF Transparent Option 2: Hermetic Enclosure Brazed Titanium & Laser-Welded Ceramic Assembly RF Transparent Volume: 19.5cc Footprint: 24.3cm 2 Weight: 37 Grams 6

7 Pulse Generator Physical Attributes Option 1: Near-Hermetic Enclosure Medical-Grade Conformal Coatings Molded Medical-Grade PEEK Enclosure Medical-Grade Epoxy Backfill Option 2: Hermetic Enclosure Brazed Titanium & Laser-Welded Ceramic Assembly 1 PEEK Assembly 2 Ceramic Assembly Laser-Welded Hermetic Seal 7

8 Wand Controller Module Attributes Powered by DC Wall Adapter Audio and Visual Feedback Operations Strongly-Coupled Magnetic Resonance (SCMR) RF for: Battery Charging Direct RF Feeding of Pulse Generator Near-Field Communication Up to 1.75-Inch Operation in Air RF Battery-Charge Power Control/Auto-Tuning Sure-Aim Pulse-Generator Locator for Charging Pulse-Generator Battery-Voltage Monitor Half-Duplex LF Near-Field Communication MedRadio-Band; 403MHz Far-Field Communication USB Interface to Personal Computer Feasibility Design 8

9 RF Wand Attributes Handheld with Sure-Aim Initiation Button Battery Charging via Strongly-Coupled Magnetic Resonance Up to 1.75 Inches in Air Half-Duplex Near-Field Communication Up to 1.75 Inches in Air Feasibility Design 9

10 Demonstration GUI Software Tri-State Electrode/Arbitrary Selection Demo GUI Pairs Any Two Electrodes Square-Wave Section Amplitude Frequency Sleep Time (Cycling) Near- and Far-Field Communication LF Communications: Battery-Voltage Inquiry Battery-Temperature Inquiry Charging Control UHF (403MHz) Communication Impedance Measurement Pulse Generator Case-Temperature Measurement Battery-Voltage Inquiry Pulse and Discharge Mode Controls Feasibility Design 10

11 Pulse Mode & Longevity Constant Current/Active Discharge Low Setting CC-L-AD Nominal Setting CC-M-AD High Setting CC-H-AD Amplitude 3.2 ma 6.5 ma 8.6 ma Cathodic Pulse Width 200µS 200µS 200µS Frequency 70 Hz 70 Hz 70 Hz Avg. Current Consumption 1.68mADC [1] 2.01mADC [1] 2.22mADC [1] Time Between Recharges ~5.3 days [2] [3] ~4.5 days [2] [3] ~4.1 days [2] [3] [1] Measured across a 1-Ohm precision resistor in series with battery feed in the mv range of the meter for accuracy [2] Assumes only 78% of overall battery capacity is used (full charge is limited to 80%; discharge is halted at 2%) [3] Battery-longevity calculation includes MedRadio idle power consumption of 0.129mA average (70mS on time and 8.9 seconds sleep time) 11

12 Pulse-Mode Demonstration Constant Current Low/Mid/High Passive Discharge (CC-L/M/H-PD) Low Setting CC-L-PD Nominal Setting CC-M-PD High Setting CC-H-PD Amplitude 3.2 ma 6.5 ma 8.6 ma Cathodic Pulse Width 200µS 200µS 200µS Frequency 70 Hz 70 Hz 70 Hz 12

13 Pulse-Mode Demonstration Constant Voltage Low/Mid/High Active Discharge (CV-L/M/H-AD) Amplitude Low Setting CV-L-AD Nominal Setting CV-M-AD High Setting CV-H-AD Voltage applied to provide 3.2 ma to a load of 500 Ohms Voltage applied to provide 6.5 ma to a load of 500 Ohms Voltage applied to provide 8.6 ma to a load of 500 Ohms Cathodic Pulse Width 200µS 200µS 200µS Frequency 70 Hz 70 Hz 70 Hz 13

14 Pulse-Mode Demonstration Constant Voltage Low/Mid/High Passive Discharge (CV-L/M/H-PD) Amplitude Low Setting CV-L-PD Nominal Setting CV-M-PD High Setting CV-H-PD Voltage applied to provide 3.2 ma to a load of 500 Ohms Voltage applied to provide 6.5 ma to a load of 500 Ohms Voltage applied to provide 8.6 ma to a load of 500 Ohms Cathodic Pulse Width 200µS 200µS 200µS Frequency 70 Hz 70 Hz 70 Hz 14

15 Burst-Mode Demonstration Burst-Mode GUI Controls Amplitude Frequency Sleep Time (Cycling) 15

16 Waveform Options & Features Applies to All 17 Electrodes Independent Sources 2 Constant Currents, OR 2 Constant Voltages, OR 1 Current AND 1 Voltage Discharge Methods Active Discharge Passive Discharge Programmable Features Amplitude: mA / 0 11V (0.1mA or 0.01V Steps) Pulse Width: 10µS 1000µS (10µS Steps ) Frequency: Hz Traditional 1 12KHz High Frequency Active Discharge Passive Discharge 16

17 Sure-Aim Charging Location Demo Sure-Aim Push-Button Feature Locates the Pulse Generator Auto-Tunes the SCMR RF Generator Provides Audio-Visual Feedback ** Click on this image for a video demonstration of Sure-Aim ** Feasibility Design 17

18 Additional Features Sure-Hold Temporary Suspension of Operation Operation of the pulse generator can be temporarily suspended via an external magnet. Upon removal of the magnet, the controller can issue a command to resume operation. Sure-Protect The pulse generator can detect high voltages being transmitted by alien RF sources and open the power path for safety. Sure-Power The pulse generator can be operated via external RF power while also charging even when the battery is fully discharged. 18

19 Optional Features Note: The following features have not been implemented in the demonstration firmware, but the hardware circuitry allows for these capabilities. Sure-Temp Charging Current Adjustment Based Upon the User s Body Temperature If the user is running a fever, charging current can be programmed to be lower. Sure-Lock The pulse generator can authenticate a charging power source through the use of a unique serial number located in the pulse generator s hardware. Power from an alien source can then be blocked if authentication fails. Sure-Gauge The pulse generator can also measure current into and out of the battery in order to battery capacity. gauge 19

20 Product Note The Lone Star Neuromodulation system has not as yet been subjected to clinical trials to evaluate its safety and efficacy. However, safety and efficacy were carefully considered in the design and manufacturing of the device and in laboratory testing to date. Lone Star Neuromodulation is optimistic that the product will successfully complete any required testing and evaluation. As with any implantable medical product, the results of future testing may vary. 20