Proven Process Medical Devices: Case Studies

DSP Based Telemetry System An intelligent interface card to communicate with implantable defibrillators and pacemakers

Totally Implantable Ventricular Assist Device (VAD) A small, totally implantable, pulsatile pump with no external venting

Totally Implantable Blood Pressure Sensor World's first totally implantable, long-term blood pressure monitoring sensor

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DSP Based Telemetry System to Communicate with Implantable Defibrillators and Pacemakers

challenge: Design a PC card to implement new communications protocol with customers' new line of implantable pacemakers and defibrillators, keeping compatibility with all previous models, significantly increasing the data bandwidth, improving immunity to EMI, and improving the interface to facilitate development of application software.

concept: An intelligent interface card, with the ability to access commands from a host computer containing message packets to be formatted and transmitted to the implanted device, and to receive, decode, and format the responses of the implanted devices.

solution: An ISA bus card was developed to process the signals from an existing, handheld coil. Data bandwidth was increased an order of magnitude over existing products. Noise immunity was improved by processing the low-level pulses in the frequency domain using a digital signal processor. Proven Process engineers designed and developed the DSP based electronics circuitry, the printed circuit board layout, the firmware that was resident on the board, Microsoft Windows based software drivers for the host computer,and a Windows based test application suite.

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Totally Implantable Ventricular Assist Device (VAD)

challenge: Develop an improved, long-term, totally implantable ventricular assist device (VAD) based on licensed technology.

concept: A small, totally implantable, pulsatile pump with no external venting that includes an integral frictionless hydrodynamic bearing to significantly reduce long-term wear, hemolysis, and thrombosis.

solution: A ventricular assist mechanism was developed and prototyped that has a single rigid moving part that works in conjunction with two FDA approved mechanical heart valves, providing a pulsatile assist for an ailing ventricle. The single rigid moving part, a hollow piston, not only pumps blood but also provides a hydrodynamic means of lubricating itself with the patient’s blood. The two mechanical heart valves gate blood flow in a single direction and function as safety check valves for fail-safe operation. Unique to the design was the development of a novel multi-motion motor that rotates and translates the piston simultaneously for pumping action and to maintain the hydrodynamic blood bearing. To develop the VAD mechanism, our engineers utilized sophisticated 3-D Modeling, Finite Element Analysis and Control System Simulation tool sets for optimal performance.

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Totally Implantable Blood Pressure Sensor

challenge: Develop the world's first totally implantable, long-term blood pressure monitoring sensor.

concept: A flow-through, hemocompatible, electrical resistance strain-gauge sensor with zero “dead volume.”

solution: A tubular, strain-gauge based sensor was developed, fabricated and tested that demonstrated high accuracy with minimal disruption to the blood flow. Using a flow-through configuration with zero dead-volume, changes to blood shear, blood flow interruption and blood flow separation were minimized. Computational Fluid Dynamics Analysis was used during the design of the blood flow path. The sensor used a novel proprietary thin-film process for depositing the strain gauge directly onto the sensor diaphragm, thus eliminating the need for adhesive bonds that negatively impact the performance of pressure sensors. Extensive Finite Element Analysis was used to find the optimal locations for depositing strain gauges on the outside surface of the diaphragm.



	Case Studies DSP Based Telemetry System An intelligent interface card to communicate with implantable defibrillators and pacemakers Totally Implantable Ventricular Assist Device (VAD) A small, totally implantable, pulsatile pump with no external venting Totally Implantable Blood Pressure Sensor World's first totally implantable, long-term blood pressure monitoring sensor top of page DSP Based Telemetry System to Communicate with Implantable Defibrillators and Pacemakers challenge: Design a PC card to implement new communications protocol with customers' new line of implantable pacemakers and defibrillators, keeping compatibility with all previous models, significantly increasing the data bandwidth, improving immunity to EMI, and improving the interface to facilitate development of application software. concept: An intelligent interface card, with the ability to access commands from a host computer containing message packets to be formatted and transmitted to the implanted device, and to receive, decode, and format the responses of the implanted devices. solution: An ISA bus card was developed to process the signals from an existing, handheld coil. Data bandwidth was increased an order of magnitude over existing products. Noise immunity was improved by processing the low-level pulses in the frequency domain using a digital signal processor. Proven Process engineers designed and developed the DSP based electronics circuitry, the printed circuit board layout, the firmware that was resident on the board, Microsoft Windows based software drivers for the host computer,and a Windows based test application suite. top of page Totally Implantable Ventricular Assist Device (VAD) challenge: Develop an improved, long-term, totally implantable ventricular assist device (VAD) based on licensed technology. concept: A small, totally implantable, pulsatile pump with no external venting that includes an integral frictionless hydrodynamic bearing to significantly reduce long-term wear, hemolysis, and thrombosis. solution: A ventricular assist mechanism was developed and prototyped that has a single rigid moving part that works in conjunction with two FDA approved mechanical heart valves, providing a pulsatile assist for an ailing ventricle. The single rigid moving part, a hollow piston, not only pumps blood but also provides a hydrodynamic means of lubricating itself with the patient’s blood. The two mechanical heart valves gate blood flow in a single direction and function as safety check valves for fail-safe operation. Unique to the design was the development of a novel multi-motion motor that rotates and translates the piston simultaneously for pumping action and to maintain the hydrodynamic blood bearing. To develop the VAD mechanism, our engineers utilized sophisticated 3-D Modeling, Finite Element Analysis and Control System Simulation tool sets for optimal performance. top of page Totally Implantable Blood Pressure Sensor challenge: Develop the world's first totally implantable, long-term blood pressure monitoring sensor. concept: A flow-through, hemocompatible, electrical resistance strain-gauge sensor with zero “dead volume.” solution: A tubular, strain-gauge based sensor was developed, fabricated and tested that demonstrated high accuracy with minimal disruption to the blood flow. Using a flow-through configuration with zero dead-volume, changes to blood shear, blood flow interruption and blood flow separation were minimized. Computational Fluid Dynamics Analysis was used during the design of the blood flow path. The sensor used a novel proprietary thin-film process for depositing the strain gauge directly onto the sensor diaphragm, thus eliminating the need for adhesive bonds that negatively impact the performance of pressure sensors. Extensive Finite Element Analysis was used to find the optimal locations for depositing strain gauges on the outside surface of the diaphragm.