Batteries made from pigments found in cuttlefish ink may lead to edible, dissolvable power sources for new kinds of medical devices. Researchers led by Carnegie Mellon University materials scientist Christopher Bettinger demonstrated the new battery. “Instead of lithium and toxic electrolytes that work really well but aren’t biocompatible, we chose simple materials of biological origin,” Bettinger says.
The BioPen, developed by researchers from the UOW-headquartered Australian Research Council Centre of Excellence for Electromaterials Science (ACES), will give surgeons greater control over where the materials are deposited while also reducing the time the patient is in surgery by delivering live cells and growth factors directly to the site of injury, accelerating the regeneration of functional bone and cartilage.
The BioPen works similar to 3D printing methods by delivering cell material inside a biopolymer such as alginate, a seaweed extract, protected by a second, outer layer of gel material. The two layers of gel are combined in the pen head as it is extruded onto the bone surface and the surgeon ‘draws’ with the ink to fill in the damaged bone section.
A low powered ultra-violet light source is fixed to the device that solidifies the inks during dispensing, providing protection for the embedded cells while they are built up layer-by-layer to construct a 3D scaffold in the wound site.
Once the cells are ‘drawn’ onto the surgery site they will multiply, become differentiated into nerve cells, muscle cells or bone cells and will eventually turn from individual cells into a thriving community of cells in the form of a functioning a tissue, such as nerves, or a muscle.
The device can also be seeded with growth factors or other drugs to assist regrowth and recovery, while the hand-held design allows for precision in theatre and ease of transportation.
The BioPen prototype was designed and built using the 3D printing equipment in the labs at the University of Wollongong and was this week handed over to clinical partners at St Vincent’s Hospital Melbourne, led by Professor Peter Choong, who will work on optimising the cell material for use in clinical trials.
The BioPen will help build on recent work by ACES researchers where they were able to grow new knee cartilage from stem cells on 3D-printed scaffolds to treat cancers, osteoarthritis and traumatic injury.
Professor Peter Choong, director of orthopaedics at St Vincent’s Hospital Melbourne and the Sir Hugh Devine Professor of Surgery, University of Melbourne said:
“This type of treatment may be suitable for repairing acutely damaged bone and cartilage, for example from sporting or motor vehicle injuries. Professor Wallace’s research team brings together the science of stem cells and polymer chemistry to help surgeons design and personalise solutions for reconstructing bone and joint defects in real time.”
The BioPen will be transferred to St Vincent’s for clinical projects to be carried out at the proposed Aikenhead Centre for Medical Discovery in Melbourne.
“The combination of materials science and next-generation fabrication technology is creating opportunities that can only be executed through effective collaborations such as this,” ACES Director Professor Gordon Wallace said.
“What’s more, advances in 3D printing are enabling further hardware innovations in a rapid manner.”
Design expertise and fabrication of the BioPen was supported by the Materials Node of the Australian National Fabrication Facility, hosted at the University of Wollongong’s Innovation Campus.
Source: University of Wollongong (UOW)
Given that the malfunction of a device can lead to a fatality, there is a crucial need to ensure that these devices are safe and are monitored effectively. Any complaints on devices need to be monitored so that if there is a need to recall the device, it can be done efficiently without any further impact to patients. One of the biggest challenges for many medical device manufacturers is the ability to collect data from different sources such as hospitals, doctors, and patients. In addition, the various regulations tied to the medical device safety industry elevate the need to audit compliance programs.
Marcelo Trevino weighs in on the various international regulations and audits in the medical device industry in January 2014 in Las Vegas at the 2nd Annual Medical Device Safety Monitoring and Reporting Conference. Trevino shares his thoughts on maintaining compliance.
How do you best prepare for internal and external compliance audits? How do you demonstrate your organization has a quality system in place to ensure safety and effectiveness of a medical device?
Oticon Medical has obtained 510(k) clearance from the U.S. Food and Drug Administration to market Ponto Plus, the company’s newest family of bone anchored sound processors. New Ponto Plus is available in regular and power versions and is designed for use with Oticon Medical’s proprietary OptiFit/OptiGrip implant design concepts that have also been cleared by the FDA for use in tissue-preserving surgery.
Built on the Inium platform, the latest chip technology from OM’s sister company Oticon, Ponto Plus features a new powerful transducer, efficient and innovative Inium feedback shield and newest Bluetooth 2.4GHz wireless technology, all designed to deliver better sound quality, less feedback and fewer artificial sounds.
Available in regular (down to a hearing loss of 45dB) and power (down to a hearing loss of 55dB) versions, Ponto Plus is the most powerful ear-level bone anchored sound processor family. The optimized design of the transducer enables Ponto Plus solutions to reproduce louder sounds so that users can enjoy more everyday sounds without sounds becoming distorted.
Used in combination with Oticon Medical’s newly FDA cleared OptiFit and OptiGrip implant design concepts, Ponto Plus supports exciting new tissue-preserving surgical possibilities for clinicians to increase long term prospects and well-being for new and experienced users of hearing implant technology.
Innovative wireless capabilities make it possible to connect Ponto Plus directly to smart phones, loop systems in public venues and other modern communication devices to allow conversation, music and other sounds to transmit from the Ponto Streamer directly to the sound processor. The Ponto Streamer can also act as a remote control, creating an easy way for users to change programs or adjust volume, and built-in jacks allow simple connections to FM systems, music players and computers.
Ponto Plus has been robustly designed to meet the challenges of active lives and everyday activities, and is IP57 certified. The durable, reliable design reduces wind noise and limits water, dust, and debris from getting inside the processor. The housing is nano-coated to repel water. In addition to IP57 certification, Ponto Plus is now FDA cleared, CE marked and meets EU safety requirements.
Source: Oticon Medical
DePuy Synthes Trauma* officials announce that the company is launching the new Radial Head Prosthesis System for primary and revision joint replacement of the radial head to restore joint function. The System offers several benefits over current technologies.
"This system is a comprehensive solution for the radial head replacement that permits the surgeon to choose whether a long or short stem is best for the proximal radius," said Harry Hoyen,** M.D., Department of Orthopedic Surgery, MetroHealth Medical Center, Cleveland, Ohio. "With the system, a novel surface etching permits on-growth and stability, the head element can be placed onto either stem and is designed to take into account the PRUJ and radiocapitellar articulation for each respective size. There also is a side-loading option for intraoperative assembly."
The modularity of the system – 24 heads and 10 stems allowing for 240 possible implant combinations – enables surgeons to restore the appropriate height, which may aid in elbow stability. The side-loading capability facilitates in-situ insertion and assembly, which may allow for a smaller incision than a top-loading device, while the stem texture ensures a uniform press fit in the radial canal. The system also provides an integrated connection screw to facilitate assembly, along with simple instrumentation.
Source: DePuy Synthes Trauma
*DePuy Synthes Trauma is a division of DePuy Orthopaedics, Inc.
**Consultant to DePuy Synthes Trauma