3D Printing or more accurately, Additive Manufacturing, is quickly finding more and more medical applications. Several of these applications are in radiology. Radiologists are taking note as was evidenced by the sold out session at RSNA 2014, “Fundamentals of 3D Printing” on Sunday morning.
At this session, the team from the 3D Medical Applications Center at Walter Reed National Military Medical Center reported 3 areas of applications for 3D Printing. 1) Medical Models for use in surgical planning, patient education and consent and a pre and post-op record. 2) Virtual Surgery to actually perform the technique on a model. 3) Device design to create custom implants and surgical tools.
Full size models for use in surgical planning and reference during the surgery have proved to be so successful that orthopedic surgeons at Walter Reed use the models for all surgeries.
Frank J. Rybicki, M.D., radiologist and director of Brigham and Women’s Applied Imaging Science Laboratory reported on their experience with 3D Printed models to plan and perform face transplantation procedures. It was so successful it is now a mandatory step in surgical planning for these procedures. (RSNA Press Release)
Cleveland Clinic has also used 3D printed models in face transplantation. In addition the clinic employs 3D planted models in other surgeries. 3D printed models are employed in complex liver surgeries. No two livers are exactly alike and the damaged areas of the liver need to be removed without damaging the inner blood vessels while keeping the healthy areas of the liver intact. Surgeons study the 3D models which include the inner vessels prior to surgery and have the models available in the operating room during the procedure. ( Cleveland Clinic Makes Surgery more Personal)
Over the last two years, the use of 3D printed models has spread rapidly at Children’s Hospitals. These include the Children’s Hospital of Illinois, Boston Children’s Hospital, New York-Presbyterian Morgan Stanley Children’s Hospital, C.S. Mott Children’s Hospital, Miami Children’s Hospital, Phoenix Children’s Hospital, Texas Children’s Hospital, Lurie Children’s Hospital of Chicago, Children’s National Medical Center, Children’s Hospital of Philadelphia, and Kosair Children’s Hospital in Louisville among others.
A common application at children’s hospitals is the use of 3D printed hearts in surgical planning. Dr. Matthew Bramlet, a pediatric cardiologist at Children’s Hospital of Illinois in Peoria is taking it a step further. He has started a “library” of 3D printed hearts as a teaching tool. ( “Library of Hearts”)
Traditionally, physicians have used pathologic libraries but the hearts in these libraries have started falling apart. Due to the cost and difficulty of acquiring replacements, the pathologic libraries are closing. Dr. Bramlet has put out a nationwide call for pre and post op MRI and CT scans of congenital heart diseases of all ages. The online library will be housed at the Jumptrading Simulation and Education Center which is partnering with the NIH Print Exchange.
Boston Children’s Hospital added 3D printed models to its simulation program in early 2014. It has been rapidly adopted for surgical planning in many different types of surgery, including cerebrovascular. In the first year, over 100 3D models have been printed. It is becoming the standard for every patient in the Cerebrovascular Surgery and Interventions Center based on such successes as successful intervention in a case of infantile spasms. (Doctor turns to 3D Printers)
Currently, 3D printing activity is centered in the academic centers and specialty institutions, especially children’s hospitals. Typically 3D printed models cost in the $100 – $1000 range. Sophisticated models can cost much more and there is the cost of the labor required to process the data prior to printing. The capital investment is usually not large compared to imaging equipment costs. However, with no reimbursement, 3D printed models is not expected to be a service for most radiologists in the near future.
Many practitioners currently employing 3D printing believe that it will become commonplace in radiology practices. Rajesh Krishnamurthy, MD, director for research and the cardiovascular imaging program at Texas Children’s Hospital’s EB Singleton Department of Pediatric Radiology says that in addition to the other advantages, it makes a huge difference to patient and care team comprehension of the procedure. Frank J. Rybicki, M.D., radiologist and director of Brigham and Women’s Applied Imaging Science Laboratory says that there is no doubt that 3D printing will be part of radiology practices. (“Ready to Hit Print?”)
Introduction As recently as the early ‘60s, doctors commonly made house calls carrying a black bag with the basic tools of their profession: stethoscope; thermometer; tongue depressor; otoscope; blood pressure cuff; an assortment of bandages; needles and surgical thread; and a variety of pills. House calls gradually became the rare exception instead of the rule, and the tools of the profession expanded beyond the bag to sophisticated devices housed in labs and operated by trained specialists. These tools included ECG tests, high tech imaging exams such as ultrasound, blood and urine tests, blood oxygen saturation, and others.
All of these high tech tests were ordered by the physician, performed in the hospital or clinic, and the results were sent back to the physician as part of determining the diagnosis and care plan. This process involved several steps from the initial office visit, ordering the tests, scheduling the tests, which may or may not be done that day, getting the test results, scheduling another office visit to discuss the results and the subsequent plan with the patient. The process became another reason for the physician to stay in the office.
However, the iPhone with specialized attachments and other mobile diagnostic devices allow the diagnostic process to be streamlined and free physicians to diagnosis on the road. It has become possible to carry a black bag again, a more powerful bag. The new bag now carries an iPhone, some attachments, and small mobile diagnostic devices. Many of these devices are available now, and more are coming. Here is just a sample of what the new “black bag” may carry.
Tricorder There are variety of sensors available that measure various vital signs and send the readings to a smart phone for recording. One of the more intriguing is the Scanadu Scout, a palm sized device that measures vital signs in 10 seconds by pressing it against a forehead. Initially it will measure temperature, heart rate, respiratory rate, and blood pressure and send the results to an app on a smart phone. More measurements are being developed, and the initial release is planned for March 2014.
Kinsa Smart ThermometerThermometer Available sooner than the Scandu are a variety of sensors and apps to take and record vital signs. Temperature can be measured and recorded with the Kinsa smart thermometer, coming in November 2013. The thermometer plugs into the iPhone audio jack to power the thermometer and transmit the results to the phone. Other thermometers are in the works that employ non-contact infrared technology.
Withings Blood Pressure MonitorBlood Pressure Blood pressure and heart rate can be obtained with blood pressure cuffs, such as the Withings BP monitor, that plugs into the iPhone. An app inflates the cuff, measures the blood pressure and heart rate and records the results.
iHealth Pulse Oximeter Pulse Oximeter A wireless pulse oximeter is available from iHealth Lab that measures the SpO2, pulse rate, and stores the results in an app on an iPhone. iHealth also has wireless blood pressure monitors and a scale.
Withings Smart Scale Smart Scale Smart scales measure weight and calculate BMI sending these measurements to an iPhone app using a Bluetooth connection. The scale from Withings is about the size of a laptop computer.
Sanofi Glucose Monitor Blood Glucose Monitoring Glucose testing is a difficult issue due to the need to test glucose levels multiple times a day and keep a diary of the results, associated meal times, exercise and other variables. Sanofi’s iBGStar is an iPhone attachment and app that greatly simplifies the testing and data logging process.
When plugged into the phone, the phone recognizes an inserted blood glucose strip and opens the app. After 6 seconds, the result is displayed on the screen and color coded to emphasize hyperglycemia and hypoglycemia conditions.
Biosense Technologies Urine Analysis SystemUrine Analysis A urine analysis system from Biosense Technologies uses the iPhone’s camera to automatically read commercial urine dipsticks using a peripheral, the cuboid and a color mat to standardize the reading conditions. It is intended to perform analysis of 10 common analytes in urine listed on their web site. Processing takes about 30 seconds once the strip is in the mat and placed in the cube. It is available in several countries in Europe, the middle East and Asia and is awaiting FDA clearance in the U.S.
Blood Tests Mobile blood tests are rather limited at the moment but a new development by Sharp Laboratories of Europe promises to change that in the next few years. Microfluidics allows the development of a lab-on-chip about 4-5 cm that is a mobile lab. Results are now known in minutes instead of hours, and it requires just a drop of blood. The goal is to move this to commercialization in the next few years.
Cellscope OtoscopeEar Test In addition to vital signs apps and attachments, there are a variety of more specialized tests available with Iphone attachments. Cellscope makes a smartphone otoscope attachment that captures photos or videos of the ear. The stored images allow diagnosis, remote consultation, and tracking of changes over time. Pediatric ear infection is one common ailment that is targeted by Cellscope.
GE UltrasoundUltrasound Ultrasound exams can be done with a pocket, flip phone scanner such as the Vscan from GE Healthcare. The Vscan has the capability to provide at quick look abdominal, urology, fetal/OB, and cardiac anatomy. This can speed diagnosis and subsequent treatment. Currently an ultrasound exam is ordered, scheduled, and performed in lab. With a hand held scanner, it can be done immediately as part of a physical exam.
AliveCor ECG System Cardiology The cardiologist has been a big beneficiary of mobile technology with just two devices: an attachment for the iPhone to generate, display and store ECG’s and mobile ultrasound devices that are more effective than just relying on the stethoscope for an initial work up. The Alivecor Heart Monitor was cleared by the FDA in November of 2012 and is now available for both the iOS and Android smartphones. It generates a single lead ECG that can be annotated, stored, and reviewed. The device is available for physicians and can be prescribed for patients to record intermittent events and send the ECG to their cardiologist.
GE Cardiac Ultrasound ExamThe GE Vscan portable ultrasound also performs 2D echocardiograms including color flow for assesment of the valves, left ventricle, and pericardium. Both devices can be used in the cardiologists office for a more complete initial assessment and anywhere else the cardiologist happens to be.
Dr. Eric Topol, chief academic officer at Scripps Health has used the AliveCor twice on airplanes. Answering the call “is there a doctor on board”, he used the AliveCor as part of his diagnosis. Once he recommended an emergency landing to get immediate treatment and the other time, an emergency landing was not necessary.
Dr. Topol no longer does a formal cardiogram. He uses his iPhone to get the ECG and if indicated, prescribes an AliveCor device for the patient to record intermittent events. He also says that he hasn’t used a stethoscope for 2 years. Instead Topol pulls out his Vscan and does a full echo of the patient’s heart.
Sleep-wearable Physiological RecorderSleep Apnea Watermark Medical has developed a device to diagnose obstructive sleep apnea at home. The WM Sleep Portal and integrated home sleep technology replaces a more expensive overnight stay at a hospital’s sleep laboratory.
After vetting the candidate patient as appropriate for the study, the wearable device is either provided to the patient by their physician or is mailed directly to the patient’s home. Upon completion of the study, the information is uploaded, auto-processed, undergoes a QA audit and professional interpretation by a Watermark network board certified sleep physician. The report is then sent to the ordering physician. All this is done within 48 hours.
EyeNetra Refraction SystemEye Test EyeNetra has under test a refraction system, NetraG, for a smartphone that will generate a prescription for eyeglasses and contact lenses. It corrects for nearsightedness, farsightedness, and astigmatism and measures the distance between the eyes.
The Netra is an inexpensive clip-on eyepiece that goes on top of a cell phone. The user looks through this eye piece and interactively aligns the displayed patterns by clicking the buttons. The number of clicks required to bring the patterns into alignment indicates the refractive error. The device is not available commercially yet and is currently being optimized with eye care professionals. However, its target market is the developing world where the need is great.
Mixed Blessing The new black bag presents problems as well as opportunities for physicians. The mobile diagnostic devices described here barely scratch the surface of what is available. The number of devices makes choosing a set for a physician’s black bag an imposing task.
The number of manufacturers is almost as large as the number of devices. All of these manufacturers will have different database schema. Pulling all this disparate data into an EMR is a daunting prospect. At least one company is addressing the problem of mobile device interoperability. Qualcomm Life, a Qualcomm company, has developed a platform, 2net, which is a set of wireless heath solutions.
The 2net Platform is a cloud-based system designed to be universally interoperable with different mobile medical devices and applications. Qualcomm Life says that 2net will enable end-to-end wireless connectivity and allow both device users and their physicians to easily access biometric data. The 2net solution set supports secure socket layer (SSL). It is listed as a Class I Medical Device data System in the U.S, CE listed in Europe, and Class I in Canada and is installed in several European countries.
While CMS is focused on patient portals in EHRs to engage patients, patients have been engaging themselves with the aid of smartphones. Smartphones have been supplemented with a variety of external sensors which track health parameters, providing information for the patient to manage their healthcare. These devices attack chronic health issues such as obesity, noncompliance with medication, diabetes, and heart disease.
The first step to improvement is to measure the condition. The first measurement establishes a baseline and continued measurements track how well the program is progressing. “If you cannot measure it, you cannot improve it.” – Lord Kelvin. The mantra is embodied by the Quantified Self movement which promotes “self knowledge through numbers”. This web site serves the QS user community with forums and international meetings. You name it and someone in the QS community has tracked it and reported on it. From weight, fitness, sleep, moods, stress, to reading habits, nothing seems to be left out.
Fitbit Flex Wristband
The number of fitness and weight loss apps are legion. Wearable and not wearable sensors aid in measuring and tracking fitness goals.The Fitbit Flex is a wristband that tracks steps, distance, food intake and calories burned during the day and sleep quality at night. It is water resistant and handles laps in the pool.
The Flex automatically syncs the stats wirelessly to computers and smartphones allowing real-time monitoring of progress. It does more than track. Lights on the band show how close one is to reaching the daily goal and when that goal is reached, it vibrates. As motivation, progress can be shared and compared with friends. The wrist band itself is a tangible reminder about fitness and occasionally blinks and vibrates to say stop sitting and move.
Withings Smart Scale
In the not wearable category for fitness tracking are the smart scales such as the one from Withings which not only measures weight, but body composition, heart rate and air quality. It measures the body fat percentage and calculates BMI. Standing heart rate is an indicator of improved fitness if it drops over time. Indoor air quality measures temperature and carbon dioxide and sends an alert when it is time to clear the air.
The scale automatically syncs wirelessly to smartphones and tablets to a Withings Health Mate app or several others such as My FitnessPal. The app tracks progress towards goals, sets reminders to weigh in and offers encouragement.
Medisafe Virtual Pill Box
Medication adherence is one of the largest and most expensive problems in healthcare. It is estimated that 50% of the US population take medication on a regular basis and of those, only half take their medications as prescribed. Healthcare costs, caused by improper and unnecessary use of medicines, exceeded $200 billion in 2012, according to the IMS Institute for Healthcare Informatics.
A variety of apps and mobile health tools address the issue of medication noncompliance. Medisafe is a smartphone app that creates a virtual toolbox that holds medications, instructions and refill reminders for regular medications.
uBox Smart Pill Box
Abiogenix has developed a smart pill box, the uBox, that pairs with a smart phone or computer. The box is locked until it’s time to take the medication when it and/or the phone sends a reminder to take the medication and the box is unlocked allowing it to advance to the next dose. The uBox tracks medications taken and notifies family members about missed doses. The locking feature on smart pill boxes combined with the dispenser prevents over dosing
Blood Glucose Monitoring System
Diabetes management is a difficult issue due to the need to test glucose levels multiple times a day and keep a diary of the results, associated meal times, exercise and other variables. Sanofi’s iBGStar is an iPhone attachment and app that greatly simplifies the testing and data logging process.
The attachment plugs directly into the iPhone, reads the test strip, and reports the result on the attachment and on the phone. The attachment can be used independently from the phone to read the test strip, but connecting the attachment to phone, provides the real benefits.
When plugged into the phone, the phone recognizes an inserted strip, opens the app, and plays a video demonstrating proper sample application technique. After 6 seconds, the result is displayed on the screen and is color coded to emphasize hyperglycemia and hypoglycemia conditions.
The result is auto-tagged for time of day and noted for post breakfast, pre dinner based on meal time pre-sets entered by the patient. Notes can be added to the result by selecting from those on the app, e.g., “light exercise”, “fatty meal” or manually entered. Similar screens allow for entering carbs, insulin and manual blood glucose readings.
Data can be viewed on a trend chart, logbook, or presented as average results over various time periods. Results can be quickly emailed to the healthcare team.
Blood Pressure Cuff for iPhone
Monitoring heart disease can be done with devices attached to smartphones that can also communicate results to the healthcare team. Blood pressure cuffs controlled by a smartphone app, such as Withings blood pressure monitor, automatically take blood pressure and heart rate and save it to the iPhone or iPad stamped with the time and date. The measurements history can be emailed to a physician for advice.
AliveCor ECG System
For more advanced monitoring, the AliveCor Heart Monitor device snaps onto an iPhone like a back and takes a single lead ECG by either placing one’s thumbs on the senors or by placing on the chest. The Heart Monitor sends the ECG wirelessly to the phone where it is displayed and can be sent to an AliveCor server for review by a cardiologist. This device is being prescribed by cardiologists to patients with intermittent events and being used by cardiologists as part of a patient’s exam.
Owlet Baby Monitor Many more monitoring apps with sensors have been released. One of the more ambitious devices aimed at consumers is the Owlet baby monitor. The Owlet monitors heart rate, blood oxygen levels, temperature, sleep quality, and provides rollover alerts. All this data is collected with a “smart sock” worn by the baby, sent to a smart phone or PC app that syncs with an Owlet server proving access via any web browser.
Another patient engagement phenomena, that may be even more far reaching, is growing use of “peer-to-peer” social networks allowing patients to share data about treatments, how well they worked, and other tips about their specific disease. These networks range from the very specific, e.g., Crohnology for Crohn’s disease with 4200 members to networks with a broad scope of many diseases, such as Patients Like Me with 220,000 members. These sites allow patients to access real data as to what works in the real world and obtain more data than a single physicians experience allows.
The wealth of health and wellness apps and sensors combined with social networks allows patients to collect and monitor more data about their specific conditions and goals than ever before. Plans for management of their disease or for achieving wellness goals can be individually tailored. The result is patients not just engaging in their healthcare, but taking control of their healthcare.
Patients will be better informed and equipped to engage their healthcare team with more data about their condition that any single visit to the office could ever provide. Patients can collect detailed healthcare records and analyze different therapies based on what has worked in their social network. This could level the playing field of the doctor patient relationship.