ImmuneRegen BioSciences, a company out of Scottsdale, Arizona, has inititated a new study at the Oak Ridge National Laboratory (ORNL) to further evaluate its drug Radilex™, to support its submission to the FDA in the future. The drug is thought to be a possible treatment of the effects of acute radiation exposure. Radilex™ is an analog of Substance P (Sar9, Met (O2)11-Substance P), widely distributed throughout the body neuropeptide.
Read more about this interesting and promising product and its history on the company’s product page…
Archives: 8/2006
Boing Boing points us to an amazing website of past technology, called Modern Mechanix (“Yesterday’s tomorrow, today!”) and a scary dental device (isn’t that redundant?) known as the gnathograph:
WITH the aid of the “gnathograph,” an instrument as mouth-filling as its name, a dentist’s patients may now be assured of a perfect fit for artificial teeth. Fitted to the jaws as shown above, the new device registers the arrangement of the teeth and the direction of the “bite,” to guide the dentist in straightening teeth or fitting inlays, crowns, bridges, and plates. Its inventor, Dr. Beverly B. McCollum of Los Angeles, Calif., demonstrates in the picture at the right how the instrument is then mounted for use in tooling a plate to just the right shape to give the
most comfortable fit in the mouth.
We’re not tooth experts, but we think dentists today accomplish similar measurements with soft alginate molds. Alginate, of course, is also used in cake frosting. This, dear readers, is progress…
According to Red Herring, Zogenix, Inc., a privately held pharmaceutical company, raised $60 million to help it bring to market the Intraject® system. This needle-free, single use, pre-filled and disposable subcutaneous delivery system of sumatriptan should make the treatment of migraines easier for patients.
Check out the product page here…
Researchers led by Dr Eli Peli at the Schepens Eye Research Institute, (a Harvard Medical School affiliate) have produced a vision aid system that superimposes parts of their outer field of view onto the center of their vision. More from the press release…
Peli’s new visual aid – which he developed with the help of MicroOptical Corp. of Westwood, MA- allows the patients to see detailed visual information through the transparent display, while also viewing a superimposed minified outline version of a wider visual field. The tiny computer-video system provides updated outline information 30 times per second. When a patient becomes aware of a possible obstacle or important object in the superimposed outline image, he can move his head and eyes to look directly at the object through the display.
The purpose of the current study was to evaluate how effective the device would be in helping people with tunnel vision when searching for objects. Twelve patients with tunnel vision were asked to find targets that were projected outside their residual visual fields. The researchers found that the search directness was greatly improved for all patients when the device was used. They also found a significant reduction in search time (22%) in patients with a visual field wider than 10 [degrees].
Peli and his team believe that the performances of patients could be improved further -with additional training – even for those with smaller visual fields. “All patients only had an hour of training on this device before they were tested,” says Luo “The search directness was improved for all subjects, which means they were not searching aimlessly, as they did without the device. However, the speed of head and eye movements was reduced when patients used the yet unfamiliar device. We believe that a few days of training would improve their speed and thus increase their search abilities dramatically.”
Based on these results, and following further improvement of the device, the team will test the usefulness of the device by providing it to patients for use in their homes and for outdoor activities.
The press release is even so kind as to link directly to the abstract for the article it’s covering in Investigative Ophthalmology and Visual Science. For examples on how to poorly cover science, see our previous work (…that is, on pointing out bad coverage, not executing it).
Also: MicroOptical Corp, who worked on the more gadgety side of things.
Scientists at Purdue University have discovered some pretty interesting properties of silicon nanocantilevers, miniature sensors that one day might become the engines for future medical diagnostic devices:
The nanocantilevers, which resemble tiny diving boards made of silicon, could be used in future detectors because they vibrate at different frequencies when contaminants stick to them, revealing the presence of dangerous substances. Because of the nanocantilever’s minute size, it is more sensitive than larger devices, promising the development of advanced sensors that detect minute quantities of a contaminant to provide an early warning that a dangerous pathogen is present.
The researchers were surprised to learn that the cantilevers, coated with antibodies to detect certain viruses, attract different densities — or quantity of antibodies per area — depending on the size of the cantilever. The devices are immersed into a liquid containing the antibodies to allow the proteins to stick to the cantilever surface.
“But instead of simply attracting more antibodies because they are longer, the longer cantilevers also contained a greater density of antibodies, which was very unexpected,” said Rashid Bashir, a researcher at the Birck Nanotechnology Center and a professor of electrical and computer engineering and biomedical engineering at Purdue University. The research also shows that the density is greater toward the free end of the cantilevers.
The engineers found that the cantilevers vibrate faster after the antibody attachment if the devices have about the same nanometer-range thickness as the protein layer. Moreover, the longer the protein-coated nanocantilever, the faster the vibration, which could only be explained if the density of antibodies were to increase with increasing lengths, Bashir said. The research group also proved this hypothesis using optical measurements and then worked with Ashraf Alam, a researcher at the Birck Nanotechnology Center and professor of electrical and computer engineering, to develop a mathematical model that describes the behavior…
The work, funded by the National Institutes of Health, is aimed at developing advanced sensors capable of detecting minute quantities of viruses, bacteria and other contaminants in air and fluids by coating the cantilevers with proteins, including antibodies that attract the contaminants. Such sensors will have applications in areas including environmental-health monitoring in hospitals and homeland security. So-called “lab-on-a-chip” technologies could make it possible to replace bulky lab equipment with miniature sensors, saving time, energy and materials. Thousands of the cantilevers can be fabricated on a 1-square-centimeter chip, Bashir said.
Link…
Engineers at Rutgers hacked an Xbox and its Essential Reality P5 glove controller and developed a system to assist patients status post stroke with hand rehab:
The Rutgers hand rehabilitation system is an example of virtual rehabilitation, which combines virtual reality – computer-generated interactive visual environments in which users control actions in a lifelike way – with traditional therapy techniques. Virtual rehabilitation gives therapists new tools to do their jobs more effectively and engages patients who may otherwise lack interest or motivation to complete normal exercise regimens…
Rutgers’ low-cost hand rehabilitation system is based on the commercially available Microsoft Xbox video game and Essential Reality P5 gaming glove that detects finger and wrist motions to manipulate on-screen images. The engineers made minor modifications to the equipment and created software that delivers two types of finger flexing exercises needed to help recover hand functions in stroke patients.
In one exercise, a patient attempts to wipe clean four vertical bars of “dirty” pixels that obscure a pleasant image on a computer display. The bars are erased in proportion to each finger’s flexing motion, giving the patient immediate feedback on his or her performance. And in an exercise to promote finger flexing speed, a patient tries to make a fist quickly enough to “scare away” a butterfly flitting around on the screen.
The engineers noted that the gaming glove they use doesn’t have the accuracy and resolution of gloves designed specifically for rehabilitation, nor can it measure exact joint movement or provide force feedback. But such systems may be attractive for clinics that can’t afford more expensive equipment and could open the door for supplemental home training with remote monitoring by a clinician over an Internet connection.
Link…
On August 25, US Marshals seized a batch of defective infusion pumps in a Cardinal Health Care (the pump’s manufacturer) facility. Apparently, Alaris (part of Cardinal) had failed to follow FDA regulations in the wake of two warning letters issued back in 98 and 99, and continued to manufacture the pumps without fixing the flaw. According to the FDA…
The seized infusion pumps have a design defect called “key bounce” that may cause potential over-infusion of medications. This seizure was intended to ensure that infusion pumps located at Alaris’ manufacturing facility are not distributed unless the problem is corrected.
Key bounce occurs when a number pressed on the pump registers twice although the operator only pressed the key once.
The infusion pumps were seized by the U.S. Marshals Service at Alaris’ manufacturing facility in San Diego, California. The seized devices valued at more than an estimated 1.8 million dollars. Alaris has distributed these products nationally and internationally. No products were seized from healthcare facilities or individual users, and there are no plans to do so.
That last bit shows that the FDA was really looking to drive the point home to Alaris that they need to follow the rules. If this were really a major crisis, they would have seen to it that devices in the field were retired as well. There’s a list of recommendations to users of the devices that basically says to be careful and double check what you entered. (We’d recommend to dial back the caffeine as well – the shakes can’t help with this).
Of course Cardinal/Alaris has no mention of US Marshals in their press release, but they make sure to keep from spooking the investors:
There have been approximately 140,000 Alaris SE infusion pumps distributed worldwide during the past 12 years and the product line currently represents less than 1 percent of annual revenue for Cardinal Health’s Clinical Technologies and Services segment.
More from the FDA…
Nobody likes dying. And now environmentalists are even making us feel bad about it!
As a body goes underground, we see a loved one being laid to rest. There are others, however, who see loads of toxic formaldehyde going into our beloved earth. Cremation apparently is not very eco-friendly either. So our concerned Swedish friends at Promessa have developed a method that is safe for the environment, but leaves your powdered corpse with little dignity. From their website:
The method behind ecological burial is crystal-clear, easy to grasp and accept. It is based on a new combination of tried-and-tested techniques that prepare the corpse for a natural process of decomposition. The procedure is justifiable in terms of ethical, moral, environmental and technical considerations, and does not subject the body to violent or destructive handling.
An important part of the solution is to remove that which is least important; the water that makes up 70 percent of a normal-sized body. Technically speaking, this is done using an entirely closed individual process in which the corpse is freeze-dried in liquid nitrogen.
Within a week and a half after death, the corpse is frozen to minus 18 degrees Celsius and then submerged in liquid nitrogen. This makes the body very brittle, and vibration of a specific amplitude transforms it into an organic powder that is then introduced into a vacuum chamber where the water is evaporated away.
The now dry powder then passes through a metal separator where any surgical spare parts and mercury are removed. In a similar way, the powder can be disinfected if required. The remains are now ready to be laid in a coffin made of corn starch. There is no hurry with the burial itself. The organic powder, which is hygienic and odorless, does not decompose when kept dry. The burial takes place in a shallow grave in living soil that turns the coffin and its contents into compost in about 6-12 months time. In conjunction with the burial and in accordance with the wishes of the deceased or next of kin, a bush or tree can be planted above the coffin. The compost formed can then be taken up by the plant, which can instill greater insight in and respect for the ecological cycle, of which every living thing is a part.
It appears a lot of thought has gone into this process, and it does appear to have some environmental value… But being freeze-dried, vibrated until I turn into a powder, and then filtered for toxic metals does not sound like I’m not subject to any “violent and destructive handling.” Furthermore, if water is 70% of your body, isn’t it the most important part? Without it one would resemble beef jerky more than a person. Finally, I’m a little confused about the corn starch coffin. Is something wrong with the styrofoam coffin I was planning on using?
Read more at the company website…
(Hat tip: discover.com)
We recently learned of a Michigan startup company that makes display models and test pieces for medical device firms. Why should we bring this to your attention? Because the pieces are apparently very accurate stand-ins for human flesh and bone. The company is Medical Engineering and Design, based in Michigan, founded last year by Robin Williams (no, not the actor) and Michael Zeeff:
An upper torso that includes the upper back, shoulders, neck and head produced in urethane by her company costs between $400 and $700. Real human cadavers start at about $5,000, according to Annie Cheney, author of “Body Brokers: Inside America’s Underground Trade in Human Remains.”
Aside from the cost, Williams said, rules and regulations about the use of cadavers have become much more stringent…
…Zeeff said employees are taught anatomy “one bone at a time.” He said he has faced a steep learning curve as he’s tried to master all of the 400 different bones in the body.
“A full spine will take about six hours to make and contains about 26 individual pieces,” Zeeff said. “As I get to know each step, I’m learning to make a model to make a part.”
Williams said the company carries no inventory because its sales are custom orders – for a replica of a human head with a tumor inside, for example, or a spinal column with a deformity that simulates a real malady. Medical-products makers use such items to show how their products can be applied.
The company is apparently too small to have a website, or pictures, which is really a shame. We’re very curious as to how their human models have nearly twice as many bones as, say, real humans. Still, we bet orders would start pouring in, if people could see their wares online.
The company won’t fill orders that Williams and Zeeff consider morally or ethically inappropriate.
Damn. We suppose “pranks at the nursing station” may fall under that category…
Update: The firm does indeed have a website, and a beautiful one it is, with multiple photos…
