A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Implantable Components

IEEE Summer School on Implantable Devices – Bogotá, Colombia (July 9 – 12, 2013)

Posted on by Posted in My Portfolio, Tech Talk, Technologies, Ultra-Low-Power ICs, Wireless Power Transmission

IEEE Summer School Implantable Devices David Prutchi PhD Bogota ColombiaI have been honored with an invitation to present at the  Fourth IEEE CASS Summer School on Wearable and Implantable Biomedical Circuits and Systems in Bogotá, Colombia (July 9 – 12, 2013).

I will be giving two 1 hour and 20 minute talks on “A Practical Perspective on Developing Novel Commercial Active Implantable Medical Devices”.  Unlike other commercial devices, developing medical implantable devices takes place in a heavily regulated environment which requires decisive proof of the devices’ safety and efficacy. Costs, schedules, and clinical strategies must be planned accordingly to achieve a successful exit. This two-part lecture will focus on the practical technical and business-oriented aspects of planning and executing the development of implantable medical devices intended for a commercial application.

Continue reading→

Cactus Semiconductor Announces CSI021 Programmable Current Sink/Source IC for Implantable Neurostimulators

Posted on by Posted in Cactus Semiconductor, Ultra-Low-Power ICs

Cactus implantable neurostimulation integrated circuit www.implantable-device.com David Prutchi, PhD

Cactus Semiconductor just announced a compact, versatile, fully programmable IC designed for medical device manufacturers involved in peripheral nerve stimulation and other implantable pulse generator applications.

According to the press release: “Cactus Semiconductor, Inc. is pleased to announce the introduction of our first ASSP (Application Specific Standard Product); developed for medical device designers and manufacturers to reduce risk and development time for implantable neurostimulation, neuromodulation and other Implantable Pulse Generator (IPG) applications. The CSI021 will be most beneficial to medical device manufacturers involved in peripheral nerve stimulation by providing a building block suitable for proof-of-concept, trials and even production; depending on the specific application.

Continue reading→

Boston Scientific Defibrillators Receive CE Mark for 10-Year Longevity Projections

Posted on by Posted in AIMD Business, Boston Scientific, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Power Sources, Tachycardia

 

Boston Scientific Incepta ICD with DF-4 connector

Image Credit: Boston Scientific

Boston Scientific has received CE Mark approval for increased longevity projections for the INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The longevity projections are based on data submitted to the European authorities and vary for each device dependent on the model type and settings.

Projected device longevity exceeds 10 years for some models, approaches eight years for its CRT-D devices, and according to the press release is up to double that of comparable competitive device models. The company supports these devices with warranties of up to 10 years:

Warranties: INCEPTA and ENERGEN VR ICD: 10 years; INCEPTA and ENERGEN DR ICD: eight years; PUNCTUA and TELIGEN ICD: seven years; INCEPTA and ENERGEN CRT-D: six years; and PUNCTUA & COGNIS CRT-D: five years.

Continue reading→

Monash University in Australia Starts Test of Direct-to-Brain Visual Prosthesis Chips

Posted on by Posted in Blindness, Brain Stimulation, Electrode Materials, News, Tech Talk, Ultra-Low-Power ICs
Implantable chip for direct-to-brain visual prosthesis developed by Monash University. www.implantable-device.com

Image Credit: Monash Vision Group, Monash University, Australia

Engineers from the Monash Vision Group (MVG) have begun trialling the ASICs for a direct-to-brain visual prosthesis that is expected to enter human clinical trials in 2014.

The prosthesis will consist of a tiny camera mounted into a pair of glasses, which acts as the retina; a pocket processor, which takes the electronic information from the camera and converts it into signals enabling the brain to build up a visual construct; and cortical implants of several tiles which will be the portal for the stimulation of the visual cortex. Continue reading→

Cool Reed Switch Manufacturing Video

Posted on by Posted in Magnetic Reed Switches, Tech Talk

Reed Switch used in implantable medical devices www.implantable-device.com

Magnetic reed switches are used in active implantable medical devices as a simple way of placing the device in a known operational mode when a programmer is not available.  For example, placing a magnet on a pacemaker sets it to VVI mode with a manufacturer-specified set of parameters.  In other devices (e.g. implantable cardioverter/defibrillators), placing a magnet on the IPG inhibits the delivery of high voltage defibrillation.

Although the reed switches that I use don’t come from Meder Electronics, I came across a very cool video that Meder produced regarding their manufacturing process.   Continue reading→

Micro Systems Technologies Offers Active Implantable Medical Device Development/Manufacturing Services

Posted on by Posted in Biotronik, DYCONEX, LITRONIK Batterietechnologie, Micro Systems Engineering, Micro Systems Technologies
Micro Systems Technologies offers OEM services to AIMDs

Image Credit: Micro Systems Technologies

Micro Systems Technologies (MST) is the vertically-integrated supplier of microelectronics and implantable-grade components to Biotronik.  It now offers its development and manufacturing services to others.

Through its companies, MST offers high-reliability microelectronic modules for implantable medical devices such as pacemakers, defibrillators, neurostimulators, and cochlear implants.

MST can provide integrated solutions encompassing everything from conceptual design through high-volume surface-mount (SMT) assembly of modules. Services include design development of customer-defined electronic modules, custom ASIC design and development, and high-density-interconnect (HDI) substrate and assembly design.

As a OEM, MST offers state-of-the-art automated SMT line, an ISO 13485–compliant process and component verification and validation methodology, a manufacturing execution system that automates data collection, analysis, and process control, and comprehensive supply-chain management and monitoring with 100% traceability. Continue reading→

Biophan’s Implantable Biothermal Power Source

Posted on by Posted in Biophan

 

Implantable biothermal power source generates electricity for implantable device from body heat

Image Credit: Biophan

Today I was going through some papers and found a 2005 brochure for Biophan’s implantable biothermal source – a 3 mm-thick power source for implantable devices capable of generating electricity from body heat.  This power source was being developed by Biophan in collaboration with the NASA Ames Research Center for Nanotechnology.

 The device is covered by U.S. Patent No. 6,640,137, “Biothermal power source for implantable devices” to Stuart G. MacDonald.   It is a power source based on the Seebeck Effect, which allows electrical energy to be generated by heat crossing and array of n and p junctions of a specialized semiconductor.  Biophan and NASA developed materials that matched the size, shape and number of semiconductor junctions to develop sufficient energy to power a pacemaker despite the very slight temperature difference between the body and the subcutaneous layer.  Continue reading→

Original Datasheet for Arco’s Nuclear Pacemakers (ca. 1974)

Posted on by Posted in Arco Medical (1969-1980), Bradycardia, Cardiac Pacing, History, Museum, Nuclear Batteries

Original Arco Medical datasheet for NU5 plutonium-powered nuclear pacemaker

Some time ago, my friend and colleague Paul Spehr gave me a copy of Arco Medical’s product catalog.  I scanned the original datasheets for Arco Medical’s nuclear fixed-rate and demand pacemakers models NU-5 and NU-6 and posted them here in pdf format: Arco_Nuclear_Datasheets

Click here for a color picture and more information on Arco Medical’s nuclear pacemakers.

 

Biotectix

Posted on by Posted in Biotectix, Brain Stimulation, Cardiac Pacing, Electrode Materials, Electrodes, Tech Talk
Biotectix electrically conductive polymers for implantable devices
Image Credit: Biotectix

Biotectix of Ann Arbor, MI recently contacted me to let me know of new conductive polymer materials that they are developing to enhance the performance of next-gen implantable stimulation and sensing devices.

Indeed, their materials sound very promising.  According to Biotectix, their electrode coatings and device components are made from proprietary conducting polymers that provide intimate, long-term electrical and biological connections between implantable electrodes and the target tissue.  They offer the conductivity and stability of metals at a low-cost with the ease of processing and biological functionality of polymers. Continue reading→

Nanowattics: Ultra-Low-Power ASIC Design for Implantable Devices

Posted on by Posted in Nanowattics, Ultra-Low-Power ICs

Nanowattics logo custom IC ASIC design for implantable medical devices

Nanowattics ASIC for an implantable medical device Nanowattics was founded in 2007 to provide development services of ultra-low-power application-specific integrated circuits (ASICs) for safety-critical applications.

Nanowattics’ core team is extremelly experienced in the design of ASICs for implantable medical devices.  Their designs include the main ASIC for a DDDR pacemaker,  a sub-microvolt differential amplifier for electroneurographic signal acquisition, and the chipset for a multi-channel current-mode implantable stimulator.

Besides IC design services, Nanowattics also offers IC development project management through the entire product design cycle, including feasibility studies, translation of requirements, foundry submission, fabrication, packaging, prototype testing, documentation, certifications, and production. Continue reading→

Radiation-Hardened ICs for Implantable Medical Devices

Posted on by Posted in Radiation Oncology, Ultra-Low-Power ICs

Radiation hardened integrated circuits for implantable medical devices

Lately I’ve received many inquiries about the paper on radiation-hardness testing of implantable integrated circuits that I published with Dr. Larry Stotts (now Executive VP R&D at Biotronik), and the late Dr. John Prince.  This is because the effects of medical diagnostic and therapeutic radiation are becoming an issue of concern to physicians who often encounter the need for radiotherapy in the growing population of patients implanted with pacemakers, defibrillators, neural stimulators, and drug-delivery pumps.

Although the paper reported mainly on the test of floating-gate EEPROMs, the modern interest is on the test methods that we developed to test ICs used in implantable devices for hardness to the type of radiation encountered in the medical field.

Click here for our paper: D. Prutchi, J.L. Prince and L.J. Stotts, “X- and Gamma-Ray Hardness of Floating-Gate EEPROM Technology as Applied to Implantable Medical Devices”, IEEE Transactions on Electronic Components and Packaging Technology, 22(3), 390-398, 1999.

Cactus/Freescale Semiconductor ICs for Implantable Medical Devices

Posted on by Posted in Ultra-Low-Power ICs
Freescale/Cactus Semiconductor SOC for AIMDs
Image Credit: Freescale Semiconductor, from “Integrated Circuits for Implantable Medical Devices”

 An article by Steve Taranovich in the December 15, 2011 issue of EDN discussed technologies that are expected to be hot in 2012. One of these is the implantable chipset being developed by a collaborative effort between Cactus Semiconductor of Chandler, AZ and semiconductor giant Freescale.

SOCs developed by the alliance are expected to accelerate the development of innovative AIMDs. Continue reading→

Why Do So Many Novel Implantables Use a “Boxy” Enclosure?

Posted on by Posted in Enclosures, Greatbatch Medical (Power), Heraeus Medical Components, Hudson Technologies, National Manufacturing, Okay Industries

Deep drawn can for implantable medical devices

 

Active implantable medical devices are typically enclosed in a hermetically-sealed titanium housing which provides protection of the circuitry and other components.

Commonly, Grade 1 titanium is formed into the enclosure using stamping. The pretty, rounded shapes of modern pacemakers and ICDs are achieved by having two enclosure halves shallowly stamped from sheet stock material, and are then welded together to form the enclosure.

On the other hand, “boxy” enclosures that were popular in the 1970s are made by deeply drawing the titanium into a seamless can that is then capped by an ellipsoidal lid.  However, many modern start-up companies still develop their early-generation implantable devices in this format because a number of off-the-shelf  implantable-grade cells are available to fit in these deep-drawn enclosures, and the housings can be purchased off-the-shelf from various manufacturers.  In addition, these enclosures provide sufficient volume for electronic assemblies manufactured using off-the-shelf packaged components and printed-circuit-board technology instead of more aggressive manufacturing methods (e.g. bare IC die on ceramic substrates) used by more established companies to miniaturize their mature implantable devices. Continue reading→

EBR System’s Wireless Pacemaker

Posted on by Posted in Bradycardia, Cambridge Consultants, Cardiac Pacing, EBR Systems, Heart Failure (CHF), Ultra-Low-Power ICs, Ultrasonic Transducers, Wireless Power Transmission

EBR Systems, Inc., founded in 2003 and headquartered in Sunnyvale, CA, is developing the WiCS® Wireless Cardiac Stimulation technology to eliminate cardiac pacing leads, historically a major source of complications and reliability issues.  The startup was spun out of research by founder Debra Echt, a former professor of medicine and a cardiologist at Vanderbilt University. Continue reading→

Nanostim’s Leadless Pacemaker

Posted on by Posted in BetaBatt, Bradycardia, Cardiac Pacing, EBR Systems, Medtronic, Nanostim, Nuclear Batteries

Nanostim's leadless pacemakerNanostim is an early-stage AIMD company in Milpitas, CA that is developing a pacemaker that can be implanted inside the heart through a catheter.  The tiny device is attached directly to the heart, eliminating the need for leads.

In May 2011 Nanostim announced that St. Jude Medical had made a substantial investment in the company.

The company is operating in stealth mode, but some details about the leadless pacemaker have emerged from Nanostim’s patents and patent applications.  An interesting detail is about the possible use of a betavoltaic power source: Continue reading→