3D-Printed Skull Implant Ready for Operation
3D printing technology has helped replace 75% of a patient's skull with the approval of U.S. regulators.
The 3D-printed implant can replace the bone in people's skulls damaged by disease or trauma, according to Oxford Performance Materials. The company announced it had received approval from the U.S. Food and Drug Administration for its skull implant on Feb. 18 — a decision that led to the first U.S. surgical operation on March 4.
"We see no part of the orthopedic industry being untouched by this," said Scott DeFelice, president of Oxford Performance Materials.
DeFelice's company is already selling 3D-printed implants overseas as a contract manufacturer. But the FDA decision has opened the door for U.S. operations using the implants.
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3D printing's advantage comes from taking the digitally scanned model of a patient's skull and "printing" out a matching 3D object layer by layer. The precise manufacturing technique can even make tiny surface or edge details on the replacement part that encourage the growth of cells and allow bone to attach more easily.
About 300 to 500 U.S. patients could use skull bone replacements every month, according to DeFelice. The possible patients include people with cancerous bone in their skulls, as well as car accident victims and U.S. military members suffering from head trauma.
DeFelice envisions going beyond the OsteoFab™ Patient Specific Cranial Device to make 3D-printed bone replacements for all parts of the human body. His company has already begun preparing to submit other 3D-printed bone parts for FDA approval — a huge market worth as much as $50 million to $100 million for each bone replacement type.
"If you can replace a bony void in someone's head next to the brain, you have a pretty good platform for filling bony voids elsewhere," DeFelice told TechNewsDaily.
Oxford Performance Materials adapted EOS P800 printing technology to use a special polyetherketoneketone (PEKK) material that has proved suitable for human implants. The company runs a biomedical-compliant manufacturing facility in South Windsor, Conn., that can print bone replacements fitted for specific patients in two weeks or less.
Such possibilities represent just one small part of 3D printing's potential to revolutionize U.S. manufacturing and innovation. Oxford Performance Materials is one of many companies and universities that helped found the U.S. National Additive Manufacturing Innovation Institute — a $30 million pilot institute funded by the U.S. government to help transform 3D printing into a serious manufacturing tool.
Innovative Plastic Helps Mend Broken Bones
A new type of plastic someday could make fixing broken bones a snap.
Richard Oreffo, a professor of Musculoskeletal Science at the University of Southamptonin England, and colleagues have created a blend of three plastics that is tough yet highly porous. This may make it an ideal "scaffold" for a broken bone — a placeholder structure that can be replaced with real bone tissue as the body heals.
The polymer "has this lovely honeycomb structure," Oreffo said. That allows living cells to "crawl all over it. Blood vessels can penetrate it. So it's really nice."
Oreffo's team has tested the polymer using mice that had parts of their femur bones removed. The hole was of a size "that won't heal normally," he said. "We can put these scaffolds into that [gap] and look at their repair over four to eight weeks."
When the scaffold was seeded with human bone stem cells, the bone healed faster, but even without the stem cells, the mice's bones began to fill in along the scaffolding structure.
In humans, the structure should serve to repair bone breaks that are too severe to heal on their own. "If you've had a car accident where you've had significant bone breaks ... ideally, you want your own stem cells in there," Oreffo said. "This is a real opportunity: A scaffold that can be colonized with the patient's own stem cells."
In fact, given enough time, the new material should fully degrade inside a living body, leaving the repaired bone to stand alone.
The scaffold material is a blend of chitosan (derived from shrimp shells), polyvinyl acetate (also a component in Elmer's Glue) and poly-L-lactide, a biodegradable polymer already used in medical applications.
Researchers worldwide are pursuing approaches to healing bones using mixtures of scaffolds and stem cells. A group in Washington state made bone shapes out of a ceramic powder by using a 3D printer; another method involves creating artificial bones in a vacuum out of elastic polymers and nanoparticles.
"It's too early to say one is better than the other. We're looking at a whole range of approaches," Oreffo said. But, he added, his team’s latest approach has the advantage of being successful in animal trials.
"There's a world of difference between seeing the polymers in a slide and seeing the cells bind to it, and in doing it in an animal," he said.
The study was recently published online in the journal Advanced Functional Materials.
Bionic Eye Implant Approved for U.S. Patients
A prosthetic device that can restore some sight to the blind has been approved by the U.S. Food and Drug Administration. The company that makes the device, Second Sight, based in Sylmar, Calif., can now market the retinal prosthetic to patients with advanced retinitis pigmentosa, a degenerative eye disease that can cause blindness. This is the first approved treatment for the disease in the United States.
“This enables people who are completely blind to see enough to improve their mobility,” saysMark Humayun, a professor of biomedical engineering at the University of Southern California in Los Angeles who has been developing the device for the past 25 years. “It allows people to make out the sidewalk and stay on it without twisting an ankle, see unexpected obstacles like parked cars, make out a table, see someone coming through a doorway,” he says. Some patients can make out large letters, but the main function of the implant is to give patients enough sight to restore mobility.
The device, called the Argus II, has three main parts: a glasses-mounted video camera; a portable computer; and a chip implanted near the retina. The video camera sends image data to the computer, which is worn on a belt. The processor converts the image data into electrical signals that are beamed to a chip implanted near the retina. The signals are then sent to an array of 60 electrodes that stimulate the retinal cells. These electrodes essentially do the work of the light-sensing cells that have degenerated. So far, the system can’t help patients make out different colors, but it can provide them with enough visual sensation to sense the outlines of things nearby.
The Argus II was approved for use in Europe in March 2011 and has been implanted in 30 patients in a U.S. clinical trial that started in 2007. The company has not announced its pricing structure in the U.S., but the devices retail for $100,000 in Europe, a price based on the expectation that the implant will last 10 years. Humayun says surgeons around the country, including those in Los Angeles, San Francisco, Philadelphia, and Baltimore, have been trained in the surgery to implant the device.
An estimated 100,000 people in the United States suffer from retinitis pigmentosa, a disease that slowly kills off the light-sensing cells in the retina, starting with the rod cells responsible for periphery and night vision, and eventually the cone cells, which provide central vision. The result is a gradual tunneling in of the vision, leading eventually to complete blindness. Humayun estimates that there are about 2,000 Americans in this late phase of the disease that would benefit from the device.
“This is a really exciting day—this is the first approved treatment for retinitis pigmentosa,” saysJacque Duncan, professor of clinical oncology at the University of California, San Francisco. There are some drugs in clinical trials, and there is some evidence that vitamin A slows the disease’s progress, but until now there has been no way to restore lost vision to the blind. “It’s very exciting to reach this point.”
Existing devices like pacemakers and cochlear implants also use electrodes to interface with the body. But none are as complicated as the retinal prosthetic, says Humayun. Cochlear implants use up to about 20 electrodes; the Argus II uses three times as many, all of which have to be wired up in a compact, biocompatible case that won’t overheat, and can tolerate the frequent movements of the eye. “This is the most complicated medical implant there is, in terms of the number of electrodes,” says Humayun.
Humayun says future software developments will expand the capabilities of the Argus II. The company is developing software that will enable the device to stimulate patients to see color by providing electrical signals at different frequencies.
iRobot's Medical Robot Gets FDA Approval for Hospital Use
You may soon see Rosie the Robot strolling the halls of more hospitals now that iRobot's remote presence robot has been given official FDA clearance. The Remote Presence Virtual + Independent Telemedicine Assistant, or RP-VITA for short, is the first autonomous navigation remote presence robot to receive FDA clearance for use in hospitals.
The RP-VITA was made by iRobot, makers of the Roomba vacuum cleaner robot, in conjunction with InTouch Health, a provider of telemedicine solutions. We first told you about the medical robot this past summer when it started trial rounds in several hospitals.
The robot is designed to allow medical specialists to communicate remotely with patients. Using an iPad interface and sensors to navigate, the doctor can maneuver the hospital corridors virtually by tapping on locations he or she wants the robot to go to.
This is a step-up from InTouch's earlier medical robot, the RP-7, which is in use in over 600 hospitals across the country. That one requires the use of a joystick to operate. With RP-VITA, the doctor controls the robot's movements using an iPad. Yulun Wang, chairman and CEO of InTouch Health, tells Mashable the doctor on the other end can split the screen so the top half is a video image as seen through the robot, and the bottom half can be a map. Tap on a location on the map and the robot navigates there.
Wang tells us the robot has an "environmental awareness, so it can see what's going on around it and act accordingly."
"FDA clearance of a robot that can move safely and independently through a fast-paced, chaotic and demanding hospital environment is a significant technological milestone for the robotics and healthcare industries,” said Colin Angle, chairman and CEO of iRobot.
As companies work to make health care more affordable and accessible, we can expect to see a push towards adoption of virtual health care and telepresence. We saw many instances of this at the recent International CES, where a virtual medical kiosk was among the telehealth items on display.
Wang agrees, saying, "as adoption grows, [telepresence] can become pervasive in health care delivery."
How would you feel about being treated by a virtual doctor? Would you like to see robots in hospitals? Let us know in the comments.
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