Image credit: Affluent Medical
Walking down MD&M Minneapolis’ aisles, I saw an implantable device that I hadn’t seen before. It is an artificial mechanical sphincter being developed by Affluent Medical based in Aix-en-Provence, France. The device is aimed at treating stress urinary incontinence, which is a disabling condition that results in uncontrolled urinary leakage during effort such as coughing or sport.
On September 13, 2024 it was announced that Dyconex officially joined the SOMACIS Group headquartered in Italy.
Dyconex is a Swiss company specializing in high-reliability PCBs for medical implantable devices. It formerly belonged to Biotronik’s MST group, putting it out of reach from many implantable companies that Biotronik saw as potential competitors. However, their high-rel PCB manufacturing is open to anyone in the Industry. Details about the acquisition haven’t been made public.
Image Credit: Resonetics
Resonetics announced that it has acquired EaglePicher Technologies’ Medical Power business, a leading manufacturer of implantable batteries for critical medical devices based near Vancouver, British Columbia.
Resonetics was founded in 1987 as a provider of engineering and manufacturing solutions for the life sciences industry. Resonetics offers laser processing, centerless grinding, nitinol processing, thin-wall stainless steel & precious metal tubing, photochemical machining, microfluidics manufacturing, and sensor technology. The acquisition of EaglePicher’s medical battery division expands on the components that it can provide to the AIMD industry.
From the announcement:
“EaglePicher Medical Power has been designing and manufacturing batteries for medical devices for over 25 years and produced one of the first lithium-ion cells for an implantable medical device. The Vancouver site features a modern 60,000 square foot facility with extensive application engineering resources and manufacturing expertise. Chris Huntington, President, EaglePicher Medical Power, will join Resonetics as its Chief Commercial Officer.”
My daughter Shanni and I just came back from Hsinchu, Taiwan where I was invited to deliver a keynote lecture at the 2014 International Symposium on VLSI Design, Automation and Test.
The lecture was titled “Electroceuticals – Replacing Drugs by Devices Enabled through Advanced VLSI Technologies” Here is the abstract:
Electroceuticals are medical devices that employ electrical currents to affect and modify body functions as an alternative to drug-based interventions.In contrast to pacemakers and other classical excitable-tissue stimulators, modern electroceuticals employ sophisticated control strategies that go beyond simple stimulation-response mechanisms in order to modulate physiological regulation loops. Examples include modulation of cardiac contractility as a therapy for heart failure, modulation of gastric contractility as a therapy for diabetes, and modulation of vagus nerve traffic as a therapy for epilepsy and inflammatory diseases. Electroceutical research is still in its early stages, and thus represents an enormous opportunity for which advanced VLSI technologies can enable the development of novel devices and therapies. Unlike other commercial devices however, developing microsystems for therapeutic applications 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 success. This keynote lecture will focus on the opportunities and challenges presented by this exciting new field in healthcare.
It was a great experience, and I hope that it will foment cooperation between the AIMD Industry and chipmakers to develop novel platforms that can be used to develop a new wave of electroceutical devices.
Yesterday I visited the Udvar-Hazy Center of the Smithsonian Air & Space Museum in Chantilly, VA. There I found this demo rechargeable pacemaker being displayed as a spinoff of NASA’s technology with the following explanation:
I can’t remember exactly where I found the picture of a Pacesetter model BD102 VVI, but the story behind it is documented by Kirk Jeffrey in “Machines in our Hearts”:
“In 1968, Robert Fischell, of the Applied Physics LOaboratory at Johns Hopkins University, and cardiologist Kenneth B. Lewis had begun a collaboration that led in 1973 to a new kind of Ni-Cad battery able to function more effectively at body temperature and hermetically sealable. Alfred E. Mann, a California entrepreneur with background in the aerospace industry, had provided some financial support to the Hopkins group. Eventually Mann founded a small company to develop a pacemaker for the rechargeable battery; this was the origin of Pacesetter Systems. The rechargeable pacemaker reached the market in the summer of 1973, just as CPI introduced its lithium pacer.”
Researchers at Harvard University and the University of Illinois at Urbana-Champaign have created and tested 3D printing inks that are electrochemically active, and with which microbatteries can be fabricated.
The ink for the anode incorporates nanoparticles of one lithium metal oxide compound, while the ink for the cathode has another type of nanoparticles. A 3D printer laid the ink onto the teeth of two gold combs to create tightly interlaced stack of anodes and cathodes. The whole setup gets packaged into a tiny container and filled with an electrolyte solution to complete the battery.
Harvard engineering professor Jennifer Lewis said: “Not only did we demonstrate for the first time that we can 3D-print a battery; we demonstrated it in the most rigorous way.” Lewis is the senior author of a study on the batteries published online in the journal Advanced Materials. The researchers say their tiny batteries have electrochemical performance is comparable to commercial batteries in terms of charge and discharge rate.
ASIC designer NanoWattICs (Uruguay) and Rosellini Scientific (Dallas, TX) have announced they have entered into a collaborative relationship for the development of a suite of neurostimulation devices comprising implantable, wireless and non-invasive technologies. From the press release:
Rosellini Scientific, LLC (“Rosellini Scientific”; Dallas, TX, USA) and NanoWattICs SRL (“NanoWattICs”; Montevideo, UY) are pleased to formally announce their collaborative working relationship. For the past twelve months, NanoWattICs has provided support for the engineering efforts required by portfolio companies belonging to Rosellini Scientific.
Rosellini Scientific and NanoWattICs share common developmental interests and possess complementary strengths and expertise, which has produced a fruitful collaboration to date. The continuation of this long-term alliance will allow NanoWattICs to continue growing its team while participating in the development of innovative medical technologies guided by Rosellini Scientific.
“NanoWattICs are world-class engineers striving to develop the next generation of innovative medical technologies,” said Austin Duke, Director of Emerging Therapies at Rosellini Scientific. “We believe that combining their engineering expertise with the Rosellini Scientific vision will greatly enhance the process of bringing high-quality, life-changing medical technologies to the global market.”
“We are extremely pleased and excited about this collaboration opportunity with Rosellini Scientific. The combined knowledge of the two teams can hardly be matched by other players of our size in the industry,” said Pablo Aguirre, Director and Co-Founder of NanoWattICs. “We look forward to expanding our team and together bringing to market the next generation of medical devices.”
Currently, Rosellini Scientific and NanoWattICs are developing a suite of neurostimulation devices comprising implantable, wireless and non-invasive technologies. This work is being supported in part by a recently awarded grant funded by Agencia Nacional de Investigación e Innovación (ANII) in Uruguay. The devices are being developed for a variety of clinical indications, including cardiac arrhythmias, migraines and neuropathic pain.
Previously, NanoWattICs provided engineering support for Rosellini Scientific to assist in the development of a non-invasive medical imaging system (Spectral MD Inc.) and wireless telemetry capabilities for a novel glaucoma implant (collaborative development with ISTAR Medical SA).
UPDATE Jan 19, 2017: Rosellini Scientific merged with Nexeon MedSystems
The current issue of Medical Design Briefs carries an interesting article titled “Designing an ASIC Chip to Control an Implantable Glucose Measurement Device” by Uwe Guenther of ZMDI (Dresden, Germany) and Andrew DeHennis of Senseonics (formerly known as “Sensors for Medicine and Science, Inc.” in Germantown, MD).
Zentrum Mikroelektronik Dresden AG (ZMDI), Dresden, Germany, partnered with Senseonics and developed a new microchip for use in Senseionics’ fluorescence-based implantable glucose sensor. According to the article, “ZMDI’s design specifications for this application-specific integrated circuit (ASIC), which is implemented as a system- on-a-chip (SoC) for control and analysis had to meet the following main requirements: LED driver, measurement and analysis of reflected light, data pre-processing, memory, wireless interface for data transfer, no battery due to extremely low power and low voltage requirements, medical certification, and special form factor.”
Click here for the online article. Click here for a local pdf printout.
EnerSys, a global leader in stored energy solutions for industrial applications, announced that it has entered into an agreement to acquire Quallion LLC, a manufacturer of lithium ion cells and batteries for high integrity applications for $30 million. Quallion’s innovative cells – especially rechargeable Zero-Volt ™ lithium-ion batteries – are used in quite a few implantable devices.
According to the press release:
Headquartered in Sylmar, CA, Quallion’s products include lithium ion cells and batteries for diverse applications including medical devices, defense, aviation and space. The closing of the transaction is subject to customary closing conditions.
Active Implantable Medical Devices generate heat as a result of resistive losses in their circuitry, exothermic reaction in their batteries, eddy-current heating due to inductive recharge, friction between mechanical components, etc. The European Standard which regulates AIMDs limits the heating of the outer surface of an AIMD to 2ºC above normal body temperature. Despite the rapid growth in the use of AIMDs, the relationship between AIMD endogenous heat generation and tissue temperature has not been quantified. In the attached paper we aimed at determining the limit of endogenous heat that can be dissipated in-vivo by the surface area of an AIMD to remain compliant with the 2ºC temperature increase limit. In our study, four Sinclair mini-pigs underwent implantation of AIMD simulants instrumented to dissipate heat and measure temperature internally, as well as the device/tissue interface temperature.
We found that for a device with the surface area and geometry that we used, approximately 1W can be dissipated before reaching the 2ºC temperature increase limit.
Click here for a preprint of this paper
Valtronic is offering advanced glass encapsulation for active implantable devices. Their first commercial application for this product is for an ingestible pill, but this technology is suitable for many long-term implants that can take advantage of its high density feed-through reliability, intrinsic miniaturization, and radio frequency/light transparency (e.g. implantable RFID tags, sensors, microstimulators, etc.)
Glass encapsulation has been used in other high-tech industries and is a proven technology. Hermetic glass encapsulation provides a totally leak-proof housing for an implant. Glass-sealed packages are used mostly in critical components and assemblies solving several problems in the development and manufacture of active implants due to its strong properties and extended life.
In a recent press release, Jim Ohneck, Valtronic’s Chief Marketing Officer stated:
“This new capability provides Valtronic with a unique opportunity to reduce an implant’s power consumption and increase its functionality while reducing its size. We have exclusive rights to this technology for the medical industry worldwide and are excited about this great opportunity.”
Valtronic has released an interesting, very informative, and technically-oriented white paper about the technology. Click here for the pdf file of the white paper.
This month’s Medical Device and Diagnostic Industry (MD+DI) magazine carried an interesting article by David Schatz – WiTricity’s VP Sales – on their efforts to develop highly resonant wireless power transfer technology for use in AIMDs. The article is available online at http://www.mddionline.com/article/wireless-power-medical-devices.
The article mentions the work that WiTricity has been doing with Thoratec to wirelessly power a HeartMate II® LVAD, and which was announced back in May 2011. David told me that for this project, WiTricity has been able to transfer 20 Watts over 20 cm, with SAR and temperature-rise compliance, and without the use of resonant repeaters.
If these levels scale well to small receiver units, I believe that this technology would enable not only the development of deep-implant AIMDs that are currently outside the range of classical resonant-inductive TET, but would also allow the development of more patient-friendly rechargeable AIMDs that don’t require dedicated recharge sessions, but rather receive their charge from a WiTricity transmitter under the patient’s bed while the patient sleeps. From the MD+DI article:
“A circulatory assist device like an LVAD is just one example of a medical device that can harness the benefits of highly resonant wireless power transfer. There is also promise for other implanted devices, including neurostimulators, implantable defibrillators and pacemakers, implantable drug-delivery pumps, electronic ophthalmic and cochlear implants, and rechargeable hearing aids.
In this broad range of implanted medical devices, high-resonance wireless power transfer can enable higher charge rates than would be possible with traditional magnetic induction. Higher charge rates allow for device implantation deeper within the body and enable more flexible charger configurations outside of the body.
For example, the wireless charger for ophthalmic or cochlear implants could be deployed in a pair of eyeglasses or a pillow. The wireless charger for a neurostimulator implanted in the lower back could be deployed in a chair or bed. Hearing aids could be recharged by simply placing them in a charging box on one’s nightstand, without requiring precise fixturing or galvanic contacts as do today’s rechargeable hearing aids.”
Greatbatch Medical, which moved its headquarters to the Dallas, TX area last year, announced that it has set a target of at least 5%/yr organic growth. To accomplish this growth, the Company recently announced consolidating operations of its various divisions in order to create efficiency.
In addition however, Greatbatch is diversifying from being strictly a developer of implantable-grade components into a firm capable of developing complete medical devices. Greatbatch’s CEO Thomas Hook announced in March 2013 that Greatbatch is internally developing its own spinal cord stimulation system. The device, called Algostim, is nearing completion of development and will be moving into the commercialization phase. The company is looking for a partner to take the Algostim device into the $1.4 billion spinal cord stimulation market, which has been growing at more than 10%/yr.
Click here for an extract describing Algostim from Greatbatch’s investor day of March 2013.
On June 5, 2013 Greatbatch, Inc. announced that it would combine Greatbatch Medical and Electrochem Solutions – which have been operating independent operations and sales & marketing groups – into singular sales & marketing and operations groups serving the entire Greatbatch organization. According to the press release:
“We’ve spent the past eight years successfully integrating and consolidating our organization. With that mission accomplished, we can set our sights squarely on our growth target to achieve 5 percent organic growth or better,” said Greatbatch President & Chief Executive Officer Thomas J. Hook. “As we shared with investors earlier this year, the company is progressing from strictly a developer of components and sub-assemblies to an organization capable of developing complete medical devices for OEM customers. Our realignment into a more unified Greatbatch will allow us to reinvest in both our core business as well as emerging platforms in pursuit of substantial growth.”
Miniature, ultra-flexible electrode (credit: EPFL)
Aleva Neurotherapeutics is a spinoff of the Swiss Federal Institute of Technology (EPFL) Microsystems Laboratory. Aleva is developing unique microfabricated devices to more specifically target deep-brain stimulation.
kurtzweilai.net recently published an interesting blog about the technology. From the post:
“Miniature, ultra-flexible electrodes could be the answer to more successful treatment for Parkinson’s diseases, according to Professor Philippe Renaud of the École Polytechnique Fédérale de Lausanne (EPFL) in Switzerland.
He has developed soft arrays of miniature electrodes in his Microsystems Laboratory that open new possibilities for more accurate and local deep brain stimulation (DBS).