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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Binghamton University Scientists Develop Biobattery That Powers Ingestible Devices and Biosensors Inside the Human Small Intestine

Biobattery might one day power clinical laboratory testing devices designed to function in vivo to measure and wirelessly report certain biomarkers

Clinical laboratories may one day regularly process biomarker data sent by ingested medical devices from inside the human body, such as the colon and intestines. But powering such devices remains a challenge for developers. Now, researchers at Binghamton University in New York have developed a biobattery that derives its power based on pH reactions when it comes in contact with acids inside the gut.

The battery uses “bacteria to create low levels of electricity that can power sensors and Wi-Fi connections as part of the Internet of Things,” according to a Binghamton University news release.

The biobattery uses microbial fuel cells with spore-forming bacteria for power and it remains inactive until it reaches the small intestine.

Ingestible devices, such as wireless micro cameras, are being utilized more frequently to investigate a myriad of activities that occur in vivo. But traditional batteries that power ingestible diagnostic gadgets can be potentially harmful and are less reliable.

In addition, the small intestine in humans is typically between 10 and 18 feet in length and it folds several times to fit the abdomen. Thus, the inside area can be very difficult to reach for diagnostic purposes.

The scientists published their research in the journal Advanced Energy Materials titled, “A Biobattery Capsule for Ingestible Electronics in the Small Intestine: Biopower Production from Intestinal Fluids Activated Germination of Exoelectrogenic Bacterial Endospores.”

Seokheun “Sean” Choi, PhD

“There are some regions in the small intestine that are not reachable, and that is why ingestible cameras have been developed to solve this issue,” said Seokheun “Sean” Choi, PhD (above), Professor of Electrical and Computer Engineering at Binghamton University, in a news release. “They can do many things, such as imaging and physical sensing, even drug delivery. The problem is power. So far, the electronics are using primary batteries that have a finite energy budget and cannot function for the long term.” As these technologies develop, clinical laboratories may play a role in collecting biomarker data from these devices interpretation by physicians. (Photo copyright: Binghamton University/Jonathan Cohen.)

How Binghamton Researchers Developed Their Biobattery

To develop their new biobattery, the Binghamton researchers encased Bacillus subtilis, a bacterium found in the gastrointestinal tract of humans, in a graphene integrated hydrogel that excels at grabbing moisture from the air.

The dime-sized fuel cell assembly is then sealed with a piece of Kapton tape, which can withstand temperatures from -500 to 750 degrees Fahrenheit. When the tape is removed, moisture mixes with a chemical germinant that causes the bacteria to begin manufacturing spores. 

“We use these spores as a dormant, storable biocatalyst,” explained Seokheun “Sean” Choi, PhD, Professor of Electrical and Computer Engineering at Thomas J. Watson College of Engineering and Applied Science, Binghamton University, in the news release. “The spores can be germinated when the nutrients are available, and they can resume vegetative life and generate the power.”

The biobattery generates around 100 microwatts per square centimeter of power density, but it can take up to an hour to germinate completely. After one hour, the energy generated from the device can power an LED light, a small clock, or a digital hygrometer, as well as a micro camera for in vivo use.

“We wanted to make these bio-batteries for portable, storable, and on-demand power generation capabilities,” Choi said in the news release.

“The problem is, how can we provide the long-term storage of bacteria until used? And if that is possible, then how would you provide on-demand battery activation for rapid and easy power generation? And how would you improve the power?” Choi added.

Heating the fuel cell decreased the time it took to reach full power to 20 minutes, and increasing the humidity resulted in higher electrical output.

Potential for Long-term Power Storage

In addition, after a week of being stored at room temperature, the activated battery had only lost 2% of its power. The researchers also believe that the device could function properly in an inactivate state for up to 100 years, provided there is enough moisture to activate the bacteria after the Kapton tape is removed.

“The overall objective is to develop a microbial fuel cell that can be stored for a relatively long period without degradation of bio-catalytic activity, and also can be rapidly activated by absorbing moisture from the air,” said Choi in the news release. 

The federal Office of Naval Research funded the study.

More research and studies are needed to confirm the biobattery performs properly and is feasible for general use. This experimentation would require both animal and human testing, along with biocompatibility studies.

“I think this is a good start,” Choi added. “Hopefully, we can make a commercial product using these ideas.”

If the biobattery can power an ingestible medical device for a reasonable period of time, then this invention may be able to power a clinical laboratory testing device that could function in vivo to measure and wirelessly report certain biomarkers inside the body. 

—JP Schlingman

Related Information:

Tiny Biobattery with 100-year Shelf Life Runs on Bacteria

Capsule-Sized Ingestible Biobatteries Could Allow New View of Digestive System

Bacteria-based Biobattery Could Power Devices in the Small Intestine

A Biobattery Capsule for Ingestible Electronics in the Small Intestine: Biopower Production from Intestinal Fluids Activated Germination of Exoelectrogenic Bacterial Endospores

Spore-producing Bacteria Battery Could Last 100 Years on the Shelf

Scientists Create Stretchable Battery Made Entirely Out of Fabric

Researchers Develop ‘Smart’ Microneedle Adhesive Bandage System for Monitoring Sodium, Glucose, pH, and More

Platform could be next breakthrough in quest for painless technology to replace in-patient phlebotomy blood draws for many clinical laboratory tests

In a proof-of-concept study, scientists from Israel and China have developed a “smart” microneedle adhesive bandage that measures and monitors in real time three critical biomarkers that currently require invasive blood draws for medical laboratory tests commonly performed on patients in hospitals.

The “smart” microneedle system developed by Israeli scientists from Technion-Israel Institute of Technology working with their Chinese counterparts from the Eighth Affiliated Hospital Sun Yat-Sen University in Shenzhen, Lanzhou University, and Xidian University in Xi’an, continuously monitors patients’ sodium, glucose, and pH levels.

According to a Technion news release, the microneedles are short, thin, and relatively painless because they only extend through the outer layer of skin to reach the interstitial fluid underneath. The needle system attaches to the patient’s skin using an adhesive patch and transfers data wirelessly to both doctor and patient in real time through cloud and Internet of Things (IoT) technologies.

Such a novel technology that allows inpatients to be monitored for key biomarkers without the need for a phlebotomist to collect blood for testing will be attractive and would likely improve the patient’s experience.

It also could reduce the volume of specimen required, potentially eliminating the invasive specimen collection procedure altogether.

The researchers published their findings in the journal Advanced Materials, titled, “A Wearable Microneedle-Based Extended Gate Transistor for Real-Time Detection of Sodium in Interstitial Fluids.”

Hossam Haick, PhD
“To adapt the technology to daily life, we have developed a unique [adhesive bandage] made of a flexible and soft polymer that stretches and contracts along with the skin and therefore does not interfere with any action whatsoever,” said Hossam Haick, PhD (above), in a Technion news release. “Since it is important for us that the system is available to everyone, we made sure to use relatively inexpensive materials, so the final product will not be expensive. The technology we have developed represents a leap forward in diagnosing diseases and continuous physiological monitoring at home and in the clinic.” Such a real-time monitoring device could eliminate clinical laboratory testing for certain biomarkers that currently require invasive blood draws. (Photo copyright: Technion-Israel Institute of Technology.)

Leap Forward in Diagnostic Testing and Disease Monitoring

As pathologists and medical laboratory scientists are aware, sodium is a prominent prognostic biomarker for assessing certain blood conditions such as dysnatremia, the presence of too much or too little sodium. It’s an essential element found in blood cells and blood fluid that plays a vital role in transmitting signals to the nervous system, as well as in other biological functions.

Currently, a patient’s sodium levels are monitored using a sodium blood test, which may be included in both a basic metabolic panel and a comprehensive metabolic panel.

Led by Hossam Haick, PhD, head of the LNDB (Laboratory for Nanomaterials-based Devices) group and Dean of Certification Studies at Technion, the team of scientists tested their device’s effectiveness at monitoring patients’ blood for both hypernatremia (high concentration of sodium in the blood) as well as hyponatremia (low concentration of sodium in the blood).

Both conditions can affect neurological function and lead to loss of consciousness and coma. Thus, early monitoring is critical.

“As of now, detection and monitoring of sodium levels in the human body is carried out by means of laborious and bulky laboratory equipment, or by offline analysis of various bodily fluids,” the study’s authors explained in the news release. Use of the smart microneedle patch, they added, allows the patient to continue about their day as normal, as well as gives their doctor time to attend to more patients.

The “innovative stretchable, skin-conformal and fast-response microneedle extended-gate FET (field-effect transistor) biosensor [integrated with] a wireless-data transmitter and the Internet-of-Things cloud for real-time monitoring and long-term analysis [could] eventually help [bring] unlimited possibilities for efficient medical care and accurate clinical decision-making,” noted the study’s authors in Advanced Materials.

More research will be needed to determine whether this latest medical technology breakthrough will lead to a viable minimally invasive method for measuring, diagnosing, and monitoring medical conditions, but Technion’s platform appears to be another step toward a long-sought alternative to painful blood draws.

Further, pathologists and clinical laboratory managers should expect more products to hit the market that are designed to collect a lab specimen without the need for a trained phlebotomist. Companies developing these products recognize that recruiting and retaining trained phlebotomist is an ongoing concern for medical labs. Thus, to have a method of collecting a lab specimen that is simple and can be done by anyone—including patients themselves—would be an important benefit.

Andrea Downing Peck

Related Information:

A Wearable Microneedle-Based Extended Gate Transistor for Real-Time Detection of Sodium in Interstitial Fluids

Researchers at the Technion Developed a Flexible Microneedles Platform That Provides Quick, Continuous, and Pain-Free Diagnosis

Microneedle Drug Delivery Systems Market Are Slated to Increase at Healthy 6.6% CAGR Over the Forecast Period

Blockchain Technology Could Impact How Clinical Laboratories and Pathology Groups Exchange Lab Test Data

Insurers might use blockchain technology to enable instantaneous verification and interoperability of healthcare records, which could impact clinical laboratory payment systems

Medical laboratories and anatomic pathology groups are keenly aware that connected, secure, interoperable health records are critical to smooth, efficient workflows. However, the current often dysfunctional state of health information technology (HIT) in America’s healthcare system often disrupts the security and functionality of information exchange between hospital and ancillary practice patient record systems.

One solution to this could be blockchain technology. With its big data and abundant touchpoints (typically: insurer, laboratory, physician, hospital, and home care), the healthcare industry could be ripe for blockchain information exchanges. Blockchain might enable secure and trusted linkage of payer, provider, and patient data. But what exactly is blockchain technology and how might it impact your laboratory?

Blockchains Could Transform Healthcare

Blockchain refers to a decentralized and distributed ledger that enables the interface of computer servers for the purpose of making, tracking, and storing linked transactions.

“At its core, blockchain is a distributed system recording and storing transaction records. More specifically, blockchain is a shared, immutable record of peer-to-peer transactions built from linked transaction blocks and stored in a digital ledger,” explained risk-management group Deloitte in a report, which goes on to state:

  • “Blockchain technology has the potential to transform healthcare, placing the patient at the center of the healthcare ecosystem and increasing the security, privacy, and interoperability of health data. This technology could provide a new model for health information exchanges (HIE) by making electronic medical records more efficient, disintermediated, and secure.
  • “Blockchain relies on established cryptographic techniques to allow each participant in a network to interact (e.g., store, exchange, and view information), without pre-existing trust between the parties.
  • “In a blockchain system, there is no central authority; instead, transaction records are stored and distributed across all network participants. Interactions with the blockchain become known to all participants and require verification by the network before information is added, enabling trustless collaboration between network participants while recording an immutable audit trail of all interactions.”

Key principles of blockchain (above) demonstrate the decentralization of the healthcare data. In some ways, this resembles electronic health record (EHR) systems that feature federated databases, rather than centralized databases. (Image copyright: Deloitte.)

Instant Verifications and Authorizations at Point-of-Care

In a Healthcare Finance News (HFN) article, insurers acknowledged blockchain’s potential for information verification and authorizations in real-time, fast payments, and access to patient databases that could fulfill population health goals.

“Everybody that is part of a transaction has access to the network. There’s no need for an intermediary. Blockchain allows for verification instantly,” noted Chris Kay, JD, Senior Vice President and Chief Innovation Officer at Humana, in the HFN article.

At clinical laboratories, blockchain could enable nearly instantaneous verification of a patient’s health insurance at time of service. Blockchain also could enable doctors to review a patient’s medical laboratory test results in real-time, even when multiple labs are involved in a person’s care.

“Everyone has to have a node on the blockchain and have a server linked to the blockchain. The servers are the ones talking to one another,” explained Kay. “What’s really transformative about this is it takes the friction out of the system. If I see a doctor, the doctor knows what insurance I have because it’s on the network. All this is verified through underlying security software.”

Healthcare Obstacles to Overcome

Breaking down data silos and loosening proprietary holds on information can help healthcare providers prepare for blockchain. However, in our highly regulated industry, blockchain is at least five years away, according to blockchain experts in a Healthcare IT News (HIT News) article.

“We’re hearing that blockchain is going to revolutionize the way we interact with and store data. But it’s not going to happen tomorrow. Let’s find smaller problems we can solve as a starting point—projects that don’t have the regulatory hurdles—and then take baby steps that don’t require breaking down all the walls,” advised Joe Guagliardo, JD, Intellectual Property/Technology Attorney and Chair of the Blockchain Technology Group at Pepper Hamilton, a Philadelphia-based law firm, in the HIT News article.

Healthcoin: Rewarding Patients for Improved Biomarkers

One company has already started to work with blockchain in healthcare. Healthcoin is a blockchain-based platform aimed at prevention of diabetes, heart disease, and obesity. The idea is for employers, insurers, and others to use Healthcoin (now in pre-launch) to reward people based on biomarker improvements shown in medical laboratory tests.

Healthcoin’s Chief Executive Officer Diego Espinosa and Chief Operating Officer Nick Gogerty, founded the company in 2016 after Espinosa, who had been diagnosed with diabetes, made diet changes to reverse it, according to an article in Bitcoin Magazine.

“When I saw my blood labs, the idea for Healthcoin was born—shifting the focus of prevention to ‘moving the needle’ on biomarkers, as opposed to just measuring steps,” Espinosa told Bitcoin Magazine.

Blockchain Provides Security

What does blockchain provide that isn’t available through other existing technologies?  According to Deloitte, it’s security and trust.

“Today’s health records are typically stored within a single provider system. With blockchain, providers could either select which information to upload to a shared blockchain when a patient event occurs, or continuously upload to the blockchain,” Deloitte notes. “Blockchain’s security and ability to establish trust between entities are the reasons why it can help solve the interoperability problem better than today’s existing technologies.”

Should Clinical Laboratories Prepare for Blockchain?

It’s important to note that insurers are contemplating blockchain and making relevant plans and strategies. Dark Daily believes the potential exists for blockchain technology to both disrupt existing business relationships, including those requiring access to patient test data, and to create new opportunities to leverage patient test data in real-time that could generate new revenue sources for labs. Thus, to ensure smooth payments, medical laboratory managers and pathology group stakeholders should explore blockchain’s value to their practices.

—Donna Marie Pocius

 

Related Information:

Blockchain Opportunities for Health Care: A New Model for Health Information Exchanges

Blockchain Will Link Payer, Provider, Patient Data Like Never Before

Old Ways of Thinking Won’t Work for Blockchain, Experts Say

Blockchain-Styled Solutions for Healthcare on the Rise

Can Blockchain Give Healthcare Payers Better Analytical Insight?

Blockchain in Health and Life Insurance: Turning a Buzzword into a Breakthrough

Does Blockchain Have a Place in Healthcare?

Improvements to Fitness Wearables Help Stream Data from Consumers’ Homes to EHRs and Clinical Pathology Laboratories

As technologies used by fitness wearables mature, medical laboratories will want to develop ways to access and process the flood of data that will become available

Point-of-care testing and remote patient monitoring are two technologies that could be disruptive to the clinical laboratory industry, particularly if use of these devices was to reduce the volume of patient specimen that are referred to the nation’s large, centralized medical laboratories.

This is one reason why savvy pathologists watch the stream of new products designed to allow athletes and consumers to monitor their fitness and other characteristics of good health. These devices are at the very front of the curve for remote monitoring of an athlete’s performance during training and competition, as well as enabling consumers to track different parameters of their health. What’s a toy for today’s sophisticated consumers could later be easily adopted for clinical diagnostic purposes.

One great example of how swiftly technology advances are changing remote diagnostic monitoring involves heart rate monitors. It wasn’t long ago that even basic heart rate monitors were a pricey purchase for consumers. But thanks to strong interest in gathering healthcare data, costs are dropping. (more…)

Stanford’s New Ant-sized Radio Could Accelerate Massive Connectivity through the Internet of Things and Enable Real-time Medical Laboratory Testing

Micro-miniature intelligent radio devices are poised to revolutionize the connectivity of objects in ways that could open doors to new diagnostic devices to help pathologists detect disease

In the future, both in vitro diagnostics and in vivo diagnostics will utilize ever-smaller devices. The shrinking size of these analytical devices will give pathologists and clinical laboratory scientists new tools to detect disease earlier, while monitoring patient with chronic conditions in real-time in consultation with attending physicians.

Now comes news of a significant breakthrough that will allow researchers to shrink down the size of devices used for a wide range of applications, including medical laboratory testing. Engineers from Stanford University and the University of California, Berkeley, have created a prototype radio-on-a-chip the size of an ant.

Their invention could enable a vast assortment of gadgets to connect and communicate with each other, and with physicians, via the Internet. The new device has the potential for numerous applications for pathology and medical laboratories, and could be used in many types of diagnostic testing devices, including in vivo diagnostics. (more…)

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