Raising The Bar For Endoscopy

High-definition endoscopy has turned to ultra-high definition and advanced imaging modalities within the camera system enhance the view of anatomy including fine detail, contrast, and improved clarity of tissue structures.

Over the past decade, the endoscope has become an essential medical instrument that enables physicians to access internal organs with magnified visualization. Endoscopy was mainly purposed to investigate the unusual symptoms associated with the interior of the body, but now it is used in a host of medical procedures that assist not only in the diagnosis, but also in the staging of diseases, biopsy, local therapy, and minimally invasive surgery. The endoscope is now finding application in numerous fields, including gastroenterology, orthopedics, urology, obstetrics/gynecology, otolaryngology, neurology, and anesthesiology.

In general, there have been improvements in both diagnostic endoscopy and therapeutic endoscopy. In terms of diagnostics, endoscopes have improved the ability to see more, to see better, and to see even smaller things than in the past. The images have become clearer, and the contrast has improved. This has led to improved diagnostic tools. Along with that, manufacturers have been developing quality measures in endoscopy, which allows physicians to be better at diagnosis. So, whether it is picking up more polyps during colonoscopy or diagnosing more dysplasia in Barrett’s or inflammatory bowel disease, diagnostic endoscopy has become an important part of diagnosis. On the therapeutic side, there are new techniques, as well as new accessories and tools to help treat these areas that are now being diagnosed more often. So, for instance, when diagnosing more flat polyps in the colon, physicians now have the ability to demarcate the polyps better by diagnostic endoscopy.

Throughout the last couple of decades there have been minimal changes to the overall design and functionality of endoscopes. Most changes in design over the years have been done to reduce the size of the scopes, while more recent developments offer scopes with rotation and steering, design changes that aid in easier cleaning, and more options for sterilization compatibility. The most significant advancements have come in the form of image technology. High definition has turned to ultra-high definition and advanced imaging modalities within the camera system, enhancing the view of anatomy including fine detail, contrast, and improved clarity of tissue structures. These advancements are accomplished with changes to the scope optics and/or the camera settings. Despite the multiple benefits of using endoscopy, the routine endoscopic procedures are usually confined to clinics. Moreover, most of the endoscope system itself is not suitable for remote consultation and point-of-care (PoC) diagnosis at developing areas or in low-resource settings.

Indian Market Dynamics
The Indian endoscopy equipment in 2017 is estimated at Rs. 943 crore, with the rigid endoscopes segment valued at Rs. 650 crore and the flexible endoscopes segment at Rs. 280 crore. Capsules contributed Rs. 13 crore in 2017.

The flexible segment is dominated by Olympus. Karl Storz, Fujifilm, and Pentax are also aggressive. Karl Storz is the clear leader in the rigid segment. Olympus and Stryker are also aggressive players. Other brands, which are present, are Richard Wolf, Escolab, and Surgdent. Local, regional, and Chinese players continue to offer flexible and rigid endoscopes. The capsule endoscopes market is dominated by Medtronic.

Flexible endoscopy is expected to maintain its lead due to its high precision, sensitivity, specificity, and safety as compared to others at economical cost. The scope of flexible endoscopy has increased too. Fueled by the demand for less invasive treatment options, and by improvements in instrument design and manufacturing, it is now possible to avoid open surgery in some cases. Flexible endoscopic surgical components are becoming smaller and more complex every day, and surgeons are now able, with the right tools, to see internal tissues clearly, remove samples for biopsies, make incisions, and create sutures. The concept of submucosal endoscopy with a mucosal flap safety valve has enabled endoscopists to securely use the submucosal space, or third space. In stomach cancer cases, the endoscopic procedures help screen high-risk patients and diagnose this disease earlier; and endoscopic mucosal resection, a less invasive alternative to surgery for removing abnormal tissues from the lining of the digestive tract is recommended to remove certain early-stage cancers or precancerous growth.

Karl Storz pioneered the idea of cold light illumination, introducing into the body, via a flexible fiber-optic cable bright light generated by an external source. The company’s range of endoscopic instruments for human medicine, veterinary medicine, and industrial endoscopy now includes more than 15,000 products. The most recent developments are in digital documentation systems and comprehensive operating room concepts. As a system supplier, the company combines its expertise in endoscopy with software solutions to achieve integration in the operating room and to support clinical process and resource management.

Olympus technology continues to advance the art of endoscopy. Its latest introduction, the new EVIS Lucera Elite endoscopy system, is setting new standards for technologies focusing on advancing control and advancing visualization. The buyers are looking forward to enhanced image quality from its two latest models GIF-HQ290 and CF-HQ290L/I, which employ advanced Olympus optics, improved image sensors and the new CV-290 video processor delivers exceptionally clear, high-resolution images. The great performance of both GIF-HQ290 and CF-HQ290L/ I, and the Evis Lucera Elite system combine to achieve ideal imaging results. In the Evis Lucera Elite generation, high-definition imaging has become standard in the core range of endoscopes.

In May 2018, Fujifilm exhibited its new 700 series endoscopes, which feature enhancements in usability and visualization, and are compatible with Eluxeo, a next-generation endoscopic video imaging system introduced in October 2017, to provide optimal results in illumination. Fujifilm’s 700 series endoscopes are equipped with CMOS chip-in-the-tip technology for noiseless and brilliant image transmission, as well as the new G7 grip for superior comfort and in daily practice. The new flexibility adjuster allows the stiffness of the flexible portion of the scope to be adjusted to the user’s preference. The product’s one step connector allows scopes to connect to the light source in just one step.

In July 2017, Fujifilm announced the launch of two new additions to its advanced endoscopic platform including ClutchCutter and FlushKnife devices. Designed for use with compatible endoscopes, these devices aid clinicians in performing effective endoscopic submucosal dissection (ESD) interventions within the digestive tract. These latest devices for ESD procedures are practical tools that allow gastroenterologists and surgeons to treat lesions with the goal of improving patient outcomes.

In September 2017, Pentax Medical obtained  CE mark for its new duodenoscope with a disposable elevator cap – the DEC duodenoscope. This innovative product provides a breakthrough solution in infection prevention with increased reprocessing operational efficiency, while ensuring reliable therapeutic performance. The new DEC duodenoscope provides a pioneering solution for diagnostic and therapeutic endoscopic retrograde cholangio-pancreatography (ERCP) procedures world-first combination of advanced cleaning capabilities for infection prevention, with the added advantage of high definition (HD) image quality and procedural performance. The DEC single-use, sterile, distal end cap is unique in the market. This innovative feature responds to the need for single-use products in endoscopy as a result of increasing incidences of carbapenem-resistant Enterobacteriaceae (CRE) infections that may be linked to improper cleaning or disinfection of the elevator mechanisms of duodenoscopes.

During the same period, Pentax Medical and Hitachi Medical Systems also announced renewed joint collaborative efforts to enable further innovations in the development of endoscopic ultrasound (EUS). In this latest joint development, the two companies are launching a new ultrasound video bronchoscope for endobronchial ultrasound (EBUS) – the EB19-J10U. This features crystal clear ultrasound and endoscopic imaging to provide advanced diagnostic accuracy, contributing to a smooth facilitation of EBUS-TBNA and maximizing patient safety. It is ergonomically designed for ease of operation and high working comfort.

In July 2017, Pentax Medical and Shanghai Aohua Photoelectricity Endoscope Co., Ltd. announced the creation of a joint venture to develop products in the field of flexible medical endoscopy. The new company will offer global endoscopy solutions and will initially focus on the needs of emerging markets. This collaboration with Aohua will further advance Pentax Medical mission to improve the standard of patient care and quality of healthcare around the world. The complementary nature of Pentax Medical and Aohua’s capabilities will address key healthcare challenges and the two companies share a vision of delivering improved healthcare through early detection of cancer and other GI diseases in these growing markets.

Medtronic’s PillCam capsule endoscopy platform uses innovative visualization technology to produce clear images of the esophagus, stomach, small bowel, and colon. This noninvasive platform allows physicians to detect GI abnormalities, monitor disease activity, and assess treatment efficacy. The products are marketed in India by Covidien.

Global market
In recent years, endoscopy devices are in huge demand due to increasing preference for minimally invasive surgeries. This is expected to majorly contribute to the growth of the global endoscopy devices market in coming years. As these surgeries considerably reduce the duration of hospital stay for the patients, the number of endoscopy procedures performed around the world is increasing at a significant rate. The global endoscopy equipment market is projected to reach USD 34.82 billion by 2022 from a value of USD 25.58 billion in 2017, reflecting a CAGR of 6.4 percent, projects MarketsandMarkets. The key factors driving the growth of the market include favorable government initiatives, rising number of hospitals and growing hospital investments in endoscopy facilities, technological advancements, and rising prevalence of diseases that require endoscopy.

In 2017, the endoscopes segment accounted for the largest share of the global market which can be primarily attributed to rising adoption of minimally invasive procedures, increasing technological advancements, and disposable endoscopes along with the corresponding need to repeat the purchase of single-use products.

Technological advances
Endoscopes are now being made smaller and with more technology packed into each device. There have been significant advances in the light output of rigid endoscopes over the past 5–10 years. Other milestones in the technology, however, have occurred in the functional aspects of rigid scopes, which have added new capabilities at times. Significant advancements also have been made in flexible scope technologies.

HD endoscopy and virtual chromoendoscopy. High-definition (HD) endoscopy allowed physicians to have a HD TV along with a HD camera, so that they can take better pictures and look at them on a bigger and better screen. Virtual chromoendoscopy is almost like a smart TV and a smart camera, in which with a switch of a button, one can change the contrast, which gives a better definition of the blood levels, of the surface patterns, and also helps demarcate the lesions better.

Video capsule endoscopy. VCE technology offers greater magnification compared to traditional endoscopy while also providing excellent resolution. It is a clinically useful tool for detecting occult bleeding and superficial lesions that are not radiographically observed; it may also provide functional information as the capsule moves passively through the small intestine. Much of the small bowel is not accessible with traditional endoscopy or even push endoscopy but is made possible with the VCE. Investigators have capitalized on the advantages of this approach, revealing an expanding list of clinical indications. Now, the research is being conducted to develop magnetically guided capsule endoscopy (MGCE), which makes use of extracorporeal magnetic fields to guide, orient, power, and operate the capsule and its mechanisms.

LED technology. For several decades, xenon bulbs have been the gold standard in endoscopy systems. However, more recently, LED technology is becoming the preferred light source for endoscopy because of its long life, stability, reliability, and ease of integration into endoscopy units. More modern LED systems allow for active CCT adjustment in the field. Having white light consist of separate RGB lasers or LEDs allows the users to adjust the level of each visible color to their comfortable white or CCT level. This variable feature reduces surgeons’ eyestrain and optimizes contrast of the tissue morphology under observation. Fluorescence technologies are advancing as fast as LED and laser technologies. Studies are ongoing to identify molecules that will target specific tissues and provide ample fluorescence for quantitative rather than qualitative diagnosis and treatments.

AI-assisted endocytoscopy. The new computer-aided diagnostic system uses an endocytoscopic image – a 500-fold magnified view of a colorectal polyp – to analyze approximately 300 features of the polyp. The system compares the features of each polyp against more than 30,000 endocytoscopic images that were used for machine learning, allowing it to predict the lesion pathology in less than a second. The most remarkable breakthrough with this system is that artificial intelligence (AI) enables real-time optical biopsy of colorectal polyps during colonoscopy, regardless of the endoscopists’ skill. This allows the complete resection of adenomatous polyps and prevents unnecessary polypectomy of non-neoplastic polyps.

Smartphones-based endoscope systems. Although smartphone technology has already been applied to endoscopic devices, previous works showed only proof of concept while not considering its diagnostic value as well as the user interface. Furthermore, previously developed smartphone-based endoscope devices utilized the built-in camera software in the smartphone which only provided limited functionalities for the endoscopic imaging. The new full smartphone-based endoscope system combines the custom hardware/software, light source, as well as a head-mounted display (HMD) for quick office procedures and remote care settings. Rather than simply capturing endoscope images with enhanced mobility, the system has shown a possibility to provide more advanced imaging modalities with various contents to the field applications.

Chip-on-the-tip video endoscopes. Previous chip-on-the-tip endoscopes used fixed focus optics, and were able to provide optimum display for only one object distance. If the object was at a different distance, the image lost focus. The latest chip-on-the-tip endoscopes integrate an actuator between the optics and the image processing chip, making it possible to achieve variable focusing, and the whole abdomen or objects with variable distances can be displayed in sharp focus. The potential installation space with diameter of no more than 10 mm is very small. Smallest piezomotors and magnetic miniature drives open up new possibilities for the optical focus and zoom function in chip-on-the-tip endoscopes.

Hybrid endoscopes. The Institute of Biological and Medical Imaging at Helmholtz Zentrum München is heading the hybrid optical and optoacoustic endoscope for esophageal tracking (ESOTRAC) research project, in which engineers and physicians are together developing a novel hybrid endoscopic instrument for early diagnosis and staging of esophageal cancer. The interdisciplinary, five-country research team will develop an innovative endoscope that combines sensing of pathophysiological tissue signatures resolved by multi-spectral optoacoustic (photoacoustic) tomography (MSOT) with morphological disease signatures provided by optical coherence tomography (OCT). The resulting system will operate in label free mode and, due to its tomographic ability, visualize sub-surface tissue features, providing superior information of the esophageal wall compared to conventional video endoscopes.

Magnetic flexible endoscopes. Gastroenterologist Keith Obstein and a team of engineers in the STORM (Science and Technology of Robotics in Medicine) Lab are using the principles of robotics to change the way colonoscopies are performed, with the goal of reducing the risk of adverse events and making the procedure more widely available. The STORM Lab team has built a magnetic flexible endoscope that is driven from the front, using magnetics. The endoscope head contains the camera, magnet, and channels for therapeutic devices such as biopsy forceps or polypectomy loops. A robotic arm that is external to the patient holds an actuating magnet and moves the capsule head forward by magnetic coupling with the endoscope, thus pulling the tubing behind it, using algorithms developed by the group. The team has automated a maneuver called retroflexion, where the endoscopist flips the endoscope tip backward. This is the first example of a completely autonomous maneuver in endoscopy.

The team is also developing teloperation control for the magnetic endoscope, which may make it possible for an endoscopist to operate the equipment from a remote location with a local technologist present to advance any needed instruments. The idea is to have the same diagnostic and therapeutic capabilities as a current endoscope, but to change the dynamics of how it is driven to reduce looping, possibly mitigate the need for sedation, reduce adverse events, and be able to offer the procedure more widely.

Ultrathin endoscopes. Researcher Shay Ohayon of the James DiCarlo’s lab at the Massachusetts Institute of Technology has recently developed an endoscope as thin as a human hair. Because it is so thin, the endoscope can reach deep into the brain, giving researchers access to areas that cannot be seen with microscopes or other types of endoscopes. The new endoscope is based on an optical fiber just 125 microns thick. Because the device is five to ten times thinner than the smallest commercially available microendoscopes, it can be pushed deeper into the brain tissue without causing significant damage. Even though the endoscope is currently being tested on animal models,  researchers believe it might one day be useful for certain applications in humans. For instance, it could offer a smaller, and thus more comfortable, instrument for imaging within the nasal cavity.

Moving forward
The field of endoscopy is still expanding, in particular in gastroenterology and surgery. It is becoming impossible for a single endoscopist to master all aspects of flexible endoscopy. Accessories will continue to grow in number and variety with accessories specific for a single type of procedure and specific indication. New endoscopes will be designed to allow easier performance of existing procedures, or to enable altogether new procedures. Three-dimensional vision with natural depth of view may be introduced into the general endoscopy practice. In laparoscopic surgery, single port systems are being developed with the goal of reducing the number of small scars from three or four to only one, ideally in a location where it is barely or not at all noticed such as the navel. For both flexible and rigid endoscopic systems, the future likely will include stereoscopic high-definition video presented via a wearable head-up display to all members of the operating team.

Endoscopy is still mostly an operator-dependent technology. In some ways, handling an endoscope is similar to driving a car: one can go forward and backward, slow and fast, and ideally look all around for looming dangers. Yet, soon driving a car may be something of the past as autonomous vehicles are in advanced stages of development; similarly, it can be expected that driving of the endoscope will become automated as well. There is no doubt that AI systems will gradually be introduced in endoscopy and the small bowel may be the first area where this will happen. Indeed, automation, miniaturization, self-propelling mechanisms, stabilization and tissue targeting systems, and tissue cutting or destroying capabilities in theory can all be combined in a longer, flexible, multi-compartment disposable capsule or snake that can enter a patient via a natural orifice and move itself through the intestines while scanning the mucosal surface and removing, or destroying, lesions that are readily recognized as abnormal. All the mechanisms in the handling of current flexible endoscopes (e.g., navigation, lens cleaning, and instrument manipulation) need to be electronically controlled, instruments need to be packed within the body of the device but the AI driving the scope may reside outside the body where it controls the scope and instruments using wireless communication.