Detailed Descriptions

VeritiumLiveTM Web Network (2010-2014)

Co-designed a geographically decentralized real-time data network-based remote data viewing system which enables measuring, collating, recording, reporting, customizing and transmitting data over the Internet or other network and is a software based service designed for use with the Veritium Research Model 8000 gateway device and its hardware and software variants.

The system provides connectivity, virtualization, data aggregation, and remote monitoring solutions for medical device manufacturers, lab equipment manufacturers, the military and commercial companies. The system provides clients with the ability to remotely visualize and monitor devices, connected to the Internet and transmitting real-time data to the user, regardless of the viewing device used and its associated Operating System. The system was designed to support all desktop, laptop, and tablet computers running MS Windows, Linux, and Apple OS along with smartphones running the Android and Apple OS operating systems.

Additionally, for customers who desired this functionality built-in to their existing products, a specialized software interface was designed for integration into their specific device, collecting and transmitting real-time data over the network.

An organization requiring central access to information already produced at locations scattered all over the planet can utilize VeritiumLiveTM to automatically consolidate those channels into the network. The network featured geographic load-balancing and transparent switch-over in the case of catastrophe.

Lastly, VeritiumLiveTM featured customized user interfaces to display real-time data using

the latest technology, rich interface applications for web users, desktop applications for automation tasks or data channels for automated applications.

Veritium Model 8000 Network Interface Unit (2010-2011)

Designed system architecture, all electronics, sheet metal, overlay artwork, and firmware for the Veritium Research Model 8000 Network Interface Unit. This is a complete turnkey system designed to easily connect existing customer equipment to the Internet. Data is automatically routed through a dedicated web network for real-time remote viewing, processing, and archiving. The system may connect to the Internet via an internal Ethernet port or optionally through the latest Wireless 3G Cellular Network. VeritiumLiveTM All connectors are located on the rear panel and a simple status screen on the front panel displays system information. The system can virtualize customer data from eight isolated analog inputs and two isolated RS-232 ports. An optional Bluetooth® 2.0 + EDR subsystem provides wireless connectivity to those customer devices which are Bluetooth® compatible. The system is ideally suited for use in remote monitoring of industrial, scientific, and medical devices. Legacy equipment can now be easily connected to the Internet for remote viewing over the World Wide Web. Any combination of analog and digital data may be combined for presentation on the remote client side. Data from multiple units may also be routed to a single remote client page if desired.

MicroMed Heart Attendant (2008-2009)

Designed system architecture, all electronics, and firmware of the Heart Attendant® System. This is a portable, computer based system designed to function with the DeBakey VAD® Ventricular Assist Device (VAD). The system provides highly isolated power, real-time control and monitoring of the pump, and a four channel battery charger/discharger system for patient batteries. The user interface includes a full color touch screen panel with patient display, battery information, pump control, and data acquisition screens. The system is fully web-enabled allowing physicians to access real-time and historic patient data remotely from their personal computers and mobile phones.

Veritium Research Model 8222 Analyzer / Calibrator (2008)

Designed and developed all aspects of the Veritium Research Model 8222 Analyzer/Calibrator. This precision traceable reference standard is used to analyze gas flows and pressures either locally or via a remote LAN/WAN connection. The system is capable of measuring low and high differential pressures and low and high flow rates on air and air/oxygen. Percent oxygen and barometric pressure are also measured.

Veritium Research Model 8016 Advanced Signal Analyzer (2006)

Designed and developed all aspects of the Veritium Research Model 8016 Advanced Signal Analyzer. This portable instrument was designed to aid its user in visualizing real-time signals in traditional and unique ways. Analog input signals may be viewed in various domains to enhance the user’s understanding and comprehension of the signals’ characteristics and behavior. The user may select from three primary display modes including the time domain, frequency domain, and phasor domain. Additionally, several split-screen modes may be selected to enable comparative analysis between domains. A numerical display mode is provided in the event that target values are of greatest interest. Provisions for connection to external networks, peripherals, and video displays further enhance the system’s versatility. An eight channel data acquisition and storage sub-system is also included.

DeBakey Integrated File Viewer (2006)
Designed and developed a unified PC based software application to enable physicians, surgeons, and in-house clinical support personnel to view files generated and stored on the DeBakey VAD® CDAS Clinical Data Acquisition System. These files include Snap Files, Holter Files, Daily Status Log Files, Patient Data Files, and Alarm History Files. Data is extracted and displayed textually and graphically.

DeBakey Remote Data Monitor For Heart Pump System (2005)

The remote monitor is approximately 3 inches wide by 2 inches high by 1 inch thick, weighs less than 5 oz., includes a wrist-strap such that it may be worn by the caregiver or patient on the wrist, and includes a combination belt clip/tilt stand for use on the patient’s or caregiver’s belt or nightstand. The device may be powered from an internal rechargeable battery to be completely portable or it may be plugged into the ac mains using an optional power adapter. Additionally, the device may be plugged into an automotive power outlet for continuous operation while on long trips in an automobile or airplane. The device will support simultaneous charging of the internal battery while monitoring the VAD controller (e.g. at night while patient and parent/caregiver are sleeping).

The remote monitor’s user interface is identical to the VAD controller interface and includes a tricolor light emitting diode (LED) backlit graphic liquid crystal display (LCD) to display multi-lingual diagnostic and emergency messages, a sealed two-button keypad with tactile feedback and rim-embossing to silence alarms and scroll through diagnostic message displays, three bicolor LEDs indicating individual battery status and fail-safe mode operation, two distinct, variable pitch, variable loudness audible enunciators, and an optional audible voice output for diagnostic and emergency alarms.

The backlit LCD can indicate functional pump information to the patient and/or caregiver, and in exemplary embodiments, the backlight utilizes multiple colors to convey functional and alarm information to the patient and caregiver (e.g. green=normal, yellow-diagnostic alarm, red=emergency alarm).

The audible alarms may be elicited through piezo buzzer enunciators. The variable loudness audible enunciators maybe be operated such that the pitch and/or volume changes proportionally to the length of time that the alarm is activated. The audible voice output may be elicited through a voice coil type speaker element. A natural language speech synthesizer may be employed, including a phoneme based speech synthesizer enabling audible speech to be generated in a multiplicity of languages. Further, the natural language voice’s pitch and cadence may be programmed to simulate a male or female adult voice based on the patient or caregiver’s preference. Still further, the natural language voice output’s pitch and cadence may be programmed to simulate a less-intimidating child’s voice for pediatric cases. A motor with integral eccentric may be enabled to vibrate during any alarming condition to help in alerting the patient or caregiver.

Optionally, in pediatric applications, a wireless audio channel may be added to integrate the functionality of a commercial “baby monitor” into the system. A transmitter with a microphone or other sound detecting device transmits audio signals to a receiver integrated into the remote monitor, which further includes an output device such as a speaker. This minimizes the number of different systems the parent or caregiver must use and manage. This function would also include a volume control to allow the parent or caregiver to set the device’s output to the desired audio level.

DeBakey TAH® System (2005)
Designed and developed a dual pump control system as a platform to implement and clinically test physiologic control and suction detection algorithms for a total artificial heart system. The system may work autonomously or in conjunction with MicroMed’s standard Clinical Data Acquisition System. Due to initial testing to be performed on animals, MicroMed’s standard clinical pump controllers were modified to include expanded speed and flow measurement ranges and related software was modified accordingly.

Voice Interactive Computer Control Interface (VICCI) For Use with the DeBakey® VAD System (2004)

The Voice Interactive Computer Control Interface (VICCI) pronounced “Vicky” is a computer controlled voice synthesis and speech recognition system designed for use in the DeBakey® VAD System. The system has been designed to receive commands from a surgeon and respond accordingly with the appropriate action and/or verbal response. Actions include turning the pump on and off, speeding the pump up and down, clearing alarms, etc. Verbal responses include command acknowledgements and providing general data regarding pump performance (e.g. “the pump flow is 3.5 liters per minute, current is 1.2 Amps, etc.).

“Vicky” is a low cost system which may reside in the DeBakey® VAD Controller, in the Clinical Data Acquisition System (CDAS), and/or Patient Home Support System (PHSS). The system’s voice is that of an American female but it may also be programmed to sound like a small child for pediatric applications, or as an adult male for those preferring a masculine voice. The speech recognition system must be trained once by the physician to learn his/her voice. This training ensures that the system will only respond to commands invoked by the surgeon or physician; commands from other parties shall be ignored. Critical commands shall always be followed by a confirmation request.

Intraoperatively, the surgeon may speak his commands across the operating room or, if preferred, he or she may wear a small wireless or tethered microphone and/or headset.

Postoperatively, “Vicky” can be used to enhance the user-interface for the patient and bedside clinician. Along with the existing bicolor LEDs, LCD messages, and audible annunciators, “Vicky” can provide highly intelligible voice information in a non-intimidating manner.

Preoperatively, “Vicky” may be used to aid in performing system self-tests, confirming programmed language messages, and even help run through the sterile and non-sterile assistant’s respective checklists.

In conclusion, a safe, consistent, and reliable mechanism has been developed to add highly intelligible speech synthesis and voice recognition capabilities to the existing DeBakey® VAD System.

DeBakey VAD® System Flow Estimation System (2004)
Designed and developed a flow-estimation system that derives blood flow rate information from intrinsic pump signals. The system may function autonomously or in conjunction with a dedicated real-time flow meter to yield a highly efficient disciplined flow estimation algorithm.

DeBakey VAD® Handheld FSB Programmer (2003)
Designed and developed a handheld, battery-powered programming system used by production personnel and global support engineers to program/reprogram calibration constants into MicroMed’s latest generation real-time blood flow rate meter.

DeBakey VAD® Closed Loop Control System (2001)

Designed and developed an isolated interface module to allow a tertiary computer, running newly developed physiologic control algorithms developed in Matlab/Simulink, to control the existing DeBakey VAD® System clinically. The system was subsequently used to verify the performance of the physiologic control and suction detection algorithms on 19 patients clinically in the ICU, during recovery, and post discharge.

DeBakey VAD® Auxiliary Daughterboard (2001)

Designed a digital signal processor (DSP) based electronic circuit module that will be used to implement MicroMed’s clinically tested physiologic control and suction detection algorithms. Additional algorithms for signal validation will also be implemented.

DeBakey VAD® Suction Detection Algorithms (2001)
Developed frequency domain and time domain based suction detection algorithms to reliably detect the imminence of ventricular suction/collapse using real-time blood flow rate information. The time domain based suction detection algorithms were implemented and tested clinically with success.

DeBakey VAD® Physiologic Control Algorithms (2001)
Utilized the previously developed SNAP Flow Rate Analysis Software to analyze hundreds of in vivo snap files. Mathematical and statistical analysis techniques were used to formulate physiologic control strategies and optimize MicroMed’s suction detection and physiologic control algorithms. Time domain physiologic control algorithms were developed and tested clinically.

SNAP Blood Flow Rate Analysis Software Program (1999)

Designed and developed a sophisticated PC application used to analyze 5 second snapshot (SNAP Files) acquired with the DeBakey VAD® Clinical Data Acquisition System (CDAS). The application software graphed the flow waveform in the time and frequency domains, extracted parametric data including mean flow, min flow, max flow, rms flow, peak-to-peak flow, heart rate, etc. and applied frequency domain based suction detection algorithms to provide the user with indices used to detect the imminence of ventricular collapse.

DeBakey Ventricular Assist Device (VAD) Controller (1997)

Designed all phases of an electronic control system to power, control, and monitor the DeBakey Ventricular Assist Device (VAD). The VAD has been designed to provide a “Bridge to Transplant” and functions as a continuous axial flow pump. The controller contains five primary functional blocks that provide power management, pump speed control, data acquisition, and a user interface. The controller communicates with smart batteries via the I2C Smart Battery Bus and with a Clinical Data Acquisition System via a standard RS-232 communication interface. Along with the VAD Controller Design, an “ammunition” style belt assembly, smart battery charger, percutaneous tether, and connecting cables were also designed.

Complete Product Requirements Specification (PRS), Product Development Plan (PDP), block diagrams, schematics, Software Requirements Specification (SRS), Fault Tree Analysis (FTA), Failure Modes Effects and Criticalities Analysis (FMECA), mechanical drawings, parts lists, source code listings, software verification and validation documents (white and black box testing), board level and system level Acceptance Test Specifications (ATS) were generated. The design complies with the European Medical Device Directive, EMC Directive, FDA GMP’s, and has been designed in accordance with IEC-60601 with regard to safety. The device also complies with NSTB specifications for mechanical shock and vibration. Device performance over temperature tests were performed in accordance with the Product Requirements Specification.

The device is powered by a Lithium Iodide cell and contains a precision current regulation circuit, an over-current protection circuit, a precision voltage-regulation circuit, and telemetry transmission circuitry. The device requires approximately 23 A to operate.

The device can be configured at the time of manufacture to generate various output current levels. EBI now utilizes current outputs of 20 A, 40 A, 100 A, and 120 A.

Complete schematic, error budget, statistical circuit analysis, mechanical tolerance analysis, parts list, test procedure, electronic specification, coating specification, and pertinent FDA documentation were generated.

Additional design work involved working with vendors to achieve a usable iridium-oxide coating, a custom glass-to-metal feedthrough, and the selection of an implant-grade battery.