I have written a lot on the use of near ir (NIR) technology for visualizing veins through your skin.  Beyond this use, using wavelengths of light beyond normal human vision is the first application of what I call “future vision” as part of the radical transformation of surgery.  You can read more about type of technology with a video of my veins here and other ideas of mine for surgical microscopy along this line here.

At CES 2007  a new device using this technology for biometrics was shown.  The PalmSecure(TM) authentication system works by capturing a person’s vein pattern image while radiating it with near-infrared rays. The sensor utilizes the latest in biometric security technology.

You can read more about this device here.

According to the manufacturer:

Hey the best and scariest biometric feature is it can tell the difference between a live and a chopped off dead hand.  I do not even want to ask why they felt they had to put that in the promotional materials but the conference is in Vegas..

click for high res

Engadget reports a new Sony OLED HD TV at CES–

I can guarantee you will see OLED’s in a next generation surgical video display and in a surgical HMD

Some people need bigger and better LCDs, but we’re just fine with the 27-inch prototype Sony mentioned during its press conference yesterday. With a contrast ratio of greater than 1,000,000:1 (not a misprint) to go with its 1080p resolution, and >100% NTSC color reproduction, we’ll take this Organic LED great looks in a small package any day. We promised to hunt it down on the show floor and so we did, finding it hiding amongst a rookery of 11-inch displays. Take a look at the gallery for a few more shots of this HDTV and hope it hits shelves someday.

OLED has many attributed making it ideal for a medical display unit.  Especially high contrast and the ability to produce it on a thin flexible film enabling new unimagined displays. Other advantages include:

OLEDs can provide desirable advantages over today’s liquid crystal displays (LCDs), as well as benefits to product designers and end users. OLEDs feature:

 Excellent grayscale
Full-motion video
Wide viewing angles from all directions
A wide range of pixel sizes
Low power consumption
Low operating voltages
Wide operating temperature range
Long operating lifetime
A thin and lightweight form factor
Cost-effective manufacturability

Imagine having a high-definition TV that is 80 inches wide and less than a quarter-inch thick, consumes less power than most TVs on the market today and can be rolled up when you’re not using it.

You can read a lot about how they work here 

structure of OLED’s

  how its made

The first innovation from CES 2007 that caught my eye is ElectriPlast from Integral Technologies. There is not too much information about this available. In short, it is an electrically conductive plastic resin. Today most electric conductive tools (eg electrosurgical instruments) are made of metal with an insulating covering. They have a limited lifespan and inevitably the insulator starts to break down risking electrical patient injuries. In addition, we are fairly limited in the physical characteristics, shapes, and durability of the metal core of the tool.

ElectriPlast provides (according to the manufacturer)

• Dramatic performance improvement.
• Design flexibility – molded resin, ability to miniaturize.
• Raw materials and manufacturing capacity readily available.
• Broad functionality and applicability.

Since this is a resin based material it can be cast or estruded and entire new shapes and configuration of tools could be produced.

Electriplast is a highly conductive recipe that can be molded into virtually any shape or dimension associated with the range of plastics, rubbers and polymers CES chose this technology with a 2007 Innovation honoree for enabling technologies. Now it’s just a matter of convincing manufacturers to look at the small medical tool market and not focus on its current #1 use- next generation cell-phone antenna.

Plus how many new products have their own blog?

CES 2007 is in full swing in Las Vegas.  As you know thi sis a pure consumer gadget conference.  What’s this got to do with med tech you ask?  Every year there is some new innovative technology shown that I predict could be used to enable some new development in medical tools.  Unfortunately, the medical market pales in comparison with the size of the consumer electronic marketplace.  Back in 2001 when I performed the first HDTV laparoscopy I tried desperately to convince the consumer electronics giant who made the camera to expand into the medical endoscopy business.  The entire potenetial medical market was so small that it was just a distraction for them and they decided not to go med.  Today finally this technology has reached mainstream medical endoscopy.

Stay tuned for a series of new developments from CES as I uncover the best new tech that could cross over to the medical side.

Stemcapture is a new company commercializing a neat device licenses from the University of Rochester.  As reported in what’s next in health

Associate Professor Michael King of the University of Rochester Biomedical Engineering Department has invented a device that filters the blood for cancer and stem cells. When he captures cancer cells, he kills them. When he captures stem cells, he harvests them for later use in tissue engineering, bone marrow transplants, and other applications that treat human disease and improve health. With Nichola Charles, Jared Kanofsky, and Jane L. Liesveld of the University of Rochester, King wrote about his discoveries in “Using Protein-Functionalized Microchannels for Stem Cell Separation,” Paper No. ICNMM2006-96228, Proceedings of the ASME, June 2006. King’s team includes scientists at StemCapture, Inc., a Rochester company that bought the University patent for King’s technique in November 2005 to build the cancer-killing and stem cell-harvesting devices. The technique can be used in vivo, meaning a device is inserted in the body, or in vitro, in which case the device resides outside of the body – either way, the device kills cancer cells and captures stem cells, which grow into blood cells, bone, cartilage, and fat.

Basically this is a high tech molecular based blood filter.  It has great potential for cancer therapeutics.

Read much more about the technology and the research behind it (along with a video of the mechanism) here at the U or R

How the stem cell capture works- Selectins:

When King was working at the University of Pennsylvania from 1999 to 2001, one of his labmates discovered that bone marrow stem cells stick to adhesive proteins called selectins more strongly than other cells — including blood cells — stick to selectins.  When King came to the University of Rochester in early 2002, he started studying the adhesion of blood cells to the vascular wall, the inner lining of the blood vessels.  During inflammation, the vascular wall presents surface selectins that adhere specifically to white blood cells.  These selectins cause the white blood cells to roll slowly along the vascular wall, seeking signals that tell them to crawl out of the bloodstream.  This is how white blood cells migrate to bacterial infections and tissue injuries.  King set out to find a way to duplicate this natural process.

How the tumor capture works

Another exciting application of King’s invention is filtering the blood for cancer cells and triggering their death, an innovative, new method to prevent the spread of cancer.  When someone has a primary cancer tumor, a small number of cancer cells circulates through the bloodstream.  In a process called metastasis, these cells are transmitted from the primary tumor to other locations in the body, where they form secondary, cancerous growths. 

As a cancer cell flows along the implanted surface, King’s device captures it and delivers an apoptosis signal, a biochemical way of telling the cancer cell to kill itself.  Within two days, that cancer cell is dead.  Normal cells are left totally unharmed because the device selectively targets cancer cells. 

The apoptosis signal is delivered by a molecule called TRAIL that coats the cancer-killing device.  Cancer cells have five types of proteins that recognize and bind to TRAIL, but only two trigger cell death.  The other three are called decoy receptors.  Healthy cells contain a lot of decoy receptors, giving them a natural protection against TRAIL, whereas cancer cells mainly express the two receptors that signal cell death.

Defensetech reports on DARPA’s new “smell-out the terrorist program“.  Ok stop laughing and read on:

Cutting edge military R&D from DARPA has developed a way to smell out bad guys- literally.  Move over fingerprints and biometrics- this is what I call “smellcheck”.

Darpa’s “Unique Signature Detection Project (formerly known as the Odortype Detection program)” aims to sniff out genetic markers in “human emanations (urine, sweat, etc.)” that “can be used to identify and distinguish specific high-level-of-interest individuals within groups of enemy troops.”

Sniffing out Organ Donors:  There is real science behind this.  National Geographic reported on some of the basic science mouse research behind this.  Michael Leon, a neurobiologist at the University of California, Irvine studied mice and found that specific molecules excreted in urine were related to MHC molecules.  The MHC (major histocompatibility complex) antigens are molecules on the surface of cells that the body uses to recognize self vs non-self.  The MHC genes are the genes that code for these molecules.  Whena person is “matched” for an organ or bone marrow transplant these are the factors that are being matched. 

Read more very technical article about the details of tissue typing for transplants with HLA and MHC typing here

Read about the standard methods of matching and volunteer to be a bone marrow donor at the national marrow donation program here

Therefore– this new military technology being used to sniff out terrorists in a group could be used to rapidly and noninvasively screen large groups of people for potential transplant matches. 

This medical concept has already been tested.  An article in Nature Genetics from UC Illinois reported that:

The smell signature also applies to health. Beauchamp’s team at Monell discovered that mice, for example, can distinguish older and younger genetically identical mice. They also use odor to identify animals infected with the Mammary Tumor Virus before any signs of disease are present. In Cambridge, England, dogs are being tested for their ability to sniff out traces of human prostate cancer in urine samples. Beauchamp anticipates that many diseases may have chemical signatures that may provide early diagnoses.

DT reports- Darpa’s smell detector is part of a larger, $15 million-per-year effort to develop “novel sensors” for U.S. troop operating in “urban settings.” The goal of the Urban Vision program is “to enable the warfighter to ’see’ movers within a building using a variety of fused multi-spectral techniques.” The “Enemy Dismount Intrusion Detection program,” on the other hand, “will develop a chemical sensor that is capable of providing an advanced warning of the presence of enemy troops or combatants by detecting the chemical emissions… that are common to all humans.”

Update:  docinthemachine nominated for best medical technology blog of 2006 - please vote for us here

The 2006 medical weblog award voting at medgadget has opened.  I am honored that docinthemachine is a nominee in the best medical technology and best new medical blog categories.  If you enjoy what you see here please cast your vote for docinthemachine especially in the medical tech category here. 

Thaks to all those who niminated this blog - I really appreciate the support and recognition of my vision for the impact of future technology on medicine.  Thanks to everyone who voted for us in the 2006 weblog awards were we placed 4th for overall best medical blog 2006.  This is fantastic considering that this blog has only been up since 9/11/06 and we were competing with all the big gun standards of the blogosphere!

Stay tuned for more future tech posts this week including body hacking, FDA regulations, military med tech and more!

I also really enjoyed checking out some of the new blog I had not yet seen.  It’s worth a visit.  The full list of categories and finalists is here.

Nick Genes the creator of Grand Rounds has taken the helm for this weeks Grand rounds - the best of the medical blogosphere.  This edition over at blogborygmi is the highlights of the best posts of the year. Officially edition 3.14 it is a great wide range of posts and styles.  Levity, medical news, poetics it’s all there!!

Thanks to Nick for including not one but two posts from yours truly docinthemachine right up there as the first set of links!.  As Nick writes:

Bloggers are renowned for their abilities to comment on the news (often, in pajamas) but on a few memorable occasions, bloggers can report news, too. Such is the case with Dr. Steven Palter of Doc in the Machine, who announced his award-winning endometriosis diagnosis technology on his blog. It’s part of a series Dr. Palter has written, on the radical transformation of surgery.

Thanks Nick for creating GR and for the recognition!

The FDA approved a device set for fetal surgery from Karl Storz Endoscopy America (KSEA) under its little known humanitarian device exemption (HDE) program.  Interestingly many of the devices approved under this program are artificial hearts or heart assist devices.  It’s worth checking out the link above to see what sort of things fall into this category by the FDA.

First a bit of interesting background on the FDA HDE Program:  As the FDA says

On June 26, 1996, FDA issued a final rule to carry out provisions of the Safe Medical Devices Act of 1990 regarding humanitarian use devices (HUDs). This regulation became effective on October 24, 1996. An HUD is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year. A device manufacturer’s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. FDA, therefore, developed and published this regulation to provide an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations.

The regulation provides for the submission of an humanitarian device exemption (HDE) application, which is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application, however, must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market.

An approved HDE authorizes marketing of the HUD. However, an HUD may only be used after IRB approval has been obtained for the use of the device for the FDA approved indication. The labeling for an HUD must state that the device is an humanitarian use device and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been demonstrated.

Why HDE is so important:  In addition to being a fertility specialist I work on and consult with industy on surgical device development.  Countless times I have seen a wonderful device that fills a clinical need to help my patients.  Unfortunately, the cold reality of what it will cost to bring the device to market often prohibits anyone making it!  I am not talking about an idea that is not pursued (that happens every day) but about real devices that exist and have completed trails showing they work– only to be killed off prior to commercialization because the millions it will take would not be recouped by sales.  It can easily cost $5 million to take a product through a clinical trial and FDA approval process. If it’s just an idea in the hands of a start up it can cost $25 million to develop and bring it to market. Hense the “well doc it’s important for the disease you treat but unlessyou can tell me how to sell millions I can’t bring this to market” conversation.  You can read how military research with medical trickle-down overcomes this hurdle often here. 

The approval of this device for twin-to-twin transfusion syndrome:  I myself have performed this exact kind of fetal surgery. Back when I was at Yale I led a team of gyn endoscopic surgerons, general surgery laparoscopy specialists, and maternal fetal medicine specialists trying to save a twin pregnancy that was dying from twin-to-twin transfusion syndrome.  Additional information about the disease is available at the twin-twin transfusion syndrome foundation and in a detailed medical tech post here and a list of fetal therapy centers here and a list of treatment options here.  In this disease, there is an abnormal link in the blood supply between two twins (they are normally totaly separate).  What happens is that the blood from one overwhelms the other twin causing multisystem failure and ultimately death.  Back when we did this there were no approved devices but we used this exact type of equipment. The manufacturer here did not invent somethig new but is getting approval to market and use the device which will hopefully make it easier for doctors to use it. This approval from the FDA is for a special kind of microlaproscope (read about the history and uses of tiny microlaparoscopes here)

How the new set works: 

The Karl Storz Fetoscopy Instrument Sets are surgical tools used in the treatment of twin-to-twin transfusion syndrome (TTTS). TTTS is a rare condition in which there is an imbalance in the amniotic fluid of some identical twins. This imbalance is caused by an uneven flow of blood between the twins through shared blood vessels that are present when the twins share one placenta.

The Karl Storz Fetoscopy Instrument Sets consist of a fetoscope (telescopic camera used to view a fetus) and sheaths which are used to pass other surgical instruments and/or fluid through the entry site. After identifying the shared blood vessels on the placenta with the fetoscope, a laser can be passed through a sheath. The laser, which is already cleared for marketing, is used to photocoagulate (destroy with heat) the shared vessels which should help to normalize the flow of blood between the twins.

How does it work? After a tiny cut in the mother’s abdomen is made, the fetoscope and sheath are inserted through the mother’s abdomen and uterus under ultrasound guidance. Through the fetoscope the surgeon is able to view the placenta and determine which blood vessels are being shared by the twins and which ones are not. The Fetoscopy Instrument Set provides a pathway for a laser that can be used to destroy these shared or shared vessels after they have been identified. After all of the target vessels are identified and treated, the laser, fetoscope and sheath are removed.  

Stay tuned for posts reviewing the FDA device approval process in more detail as well as my thoughts on how profoundly the medical device climate has changed in the last decade.

I previously wrote about the government cutting the soldier of the future LandWarrior program.  The point of my post was the myriad next-generation medical developments destined to come from the program that would be lost in the military cutbacks.  The post was picked up widely including slashdot and grandrounds.  Many commenters were angry at the concept of spending hundreds of millions of dollars on military development to get medical byproducts rather than spending less money more efficiently directly on medical development.  The point of that post and this one is not to say war is great because it leads to medical advances.  Here I will review why and how breakthroughts come from the military and not from other avenues which is suprising (and upsetting) to many.

This military effect applies to all science and not just medicine.  A summary of this concept is here. As they write:

The sheer scale of military funding for science since World War II has instigated a large body of historical literature analyzing the effects of that funding, especially for American science. Since Paul Forman’s 1987 article “Behind quantum electronics: National security as a basis for physical research in the United State, 1940-1960,” there has been an ongoing historical debate over precisely how and to what extent military funding affected the course of scientific research and discovery. Forman and others have argued that military funding fundamentally redirected science—particularly physics—toward applied research, and that military technologies predominantly formed the basis for subsequent research even in areas of basic science; ultimately the very culture and ideals of science were colored by extensive collaboration between scientists and military planners. A more traditional view (consistent with that of many of the involved scientists themselves) has been defended by Daniel Kevles, that while military funding provided many new opportunities for scientists and dramatically expanded the scope of physical research, scientists by-and-large retained their intellectual autonomy.

What are some examples of military medical offshoots?:  microwave therapies for tumors, ultrasound diagnostics, active prostetics, head mounted endoscopic displays, surgical robots.

Why does military research lead to these bold new medical developments rather than medical research directly?  To put it simply, because they can and have to.  I have spoken to quite a few venture capitalists while reviewing devices for development and commercialization.  Universally they tell me of the enormous costs of development and the fixed time frame to commercialize.  Products looking too far in the future or with too high development costs are often simply too much risky business to bet on. 

The military is different for better or for worse.  First a budget overrun of 500% can be absorbed by the military while it can spell death for a medical start-up.  In times of war, there is often no limit to the resources that can be expended to achieve an important goal.  A review of the history of medical breakthroughts resulting from wars can be found here.  Medicaladvances achieved during the civil war are reviewed here WWI here In addition, the military has a R&D arm that focuses on very long term high risk huge payoff projects– DARPA.

Defense Technology International has a lead article about DARPA and Risky Business Research that no one else will do.  As they write about DARPA:

The mission of the Defense Advanced Research Projects Agency (Darpa) is “to maintain the technological superiority of the U.S. military and prevent technological surprise by sponsoring revolutionary, high-payoff research that bridges the gap between fundamental discoveries and their military use.” Its traditional strength has been its ability as a small, technology seed money agency with an expert technical staff and minimum bureaucratic red tape to respond to emerging military needs and technological opportunities and to independently pursue revolutionary solutions. In fact, to maintain its entrepreneurial atmosphere and flow of high-risk technical ideas, Darpa rotates program managers in and out of the agency, with most of them serving only 4-6 years.

Dr. Anthony J. (“Tony”) Tether, Darpa’s director since 2001 says of the agency:

Darpa’s job is to show that something is technically feasible. It doesn’t mean that people are automatically going to use it, because there are funding and other issues involved. But they can’t say that it can’t be done.

While we’re on the subect- here are some more things coming down the pike from the military courtesy of defensetech.org

Remore control neural activation covered here

Details of this emerged in a heavily-censored document released to Ed Hammond of the Sunshine Project under the Freedom if Information Act. Called “Sensory consequence of electromagnetic pulsed emitted by laser induced plasmas,” it described research on activating the nerve cells responsible for sensing unpleasant stimuli: heat, damage, pressure, cold. By selectively stimulating a particular nociceptor, a finely tuned PEP might sensations of say, being burned, frozen or dipped in acid — all without doing the slightest actual harm

While using this to remotely trigger pain or disable an attacker sounds ominous, the same technology could lead to revolutionary pain blocking or anesthetic techniques. 

New trauma surgery development is here and remote vehicles as prototypes of implantable rovers here.