Innovative Medical Devices

Small gadgets, big impact

There is a continual flow of new medical devices and tools being brought to market, some will succeed, some will fail. Middle East Health looks at a small selection of new innovative devices that look certain, not only to succeed, but have a lasting influence on medical practice.

Innovations in technology, new scientific discoveries and man’s continual endeavor to
improve the world he in which he lives, to make it an easier, better, safer and more enjoyable place is cause for an incessant stream of inventions to facilitate these aspirations, to make real what was once only dreamed. The result is an eruption of tools and devices, automatons and instruments, vehicles and machines to fill every conceivable niche in all spheres of human existence, not least in healthcare.

The rapid pace with which new medical devices are being launched on the market is unprecedented. More money than ever before is being spent on research and development
of these tools of medicine, more scientists, engineers, technicians and medical specialists than every before are working on theorising, developing and bringing to market these innovations and, presumably, the demand for these devices is greater than every before too, although this is ultimately the factor by which they are judged to be
successful or be ignominiously assigned to the waste bin of history.

Middle East Health looks at a handful of medical devices that are about to reach market or have just done so recently, devices that look set not merely to be successful in the marketplace, but, in their own small way, change the way medicine is practiced.

The cutting edge of neurosurgery

A new, first-of-its-kind, flexible CO2 laser scalpel is changing the way neurosurgeons operate. The new BeamPath NEURO, developed by US-based OmniGuide, is enabling neurosurgeons to perform precise, no-touch, microsurgical central nervous system procedures including intracranial tumour surgeries, spine tumour surgeries and transnasal pituitary surgeries. The device is designed for operating near critical structures, for accessing difficult to reach regions of the brain and for minimising thermal injury to adjacent healthy tissue of the brain or spine.

OmniGuide explains that the clinical benefits of CO2 lasers for neurosurgery were recognised some 30 years ago, but prior to the BeamPath CO2 lasers could only be delivered through a large articulated arm system and were limited to “line-of-sight” procedures, which meant for the past 20 years or so CO2 lasers have rarely been used in neurosurgery.

The BeamPath NEURO flexible CO2 laser has taken neurosurgery a major step forward and enables neurosurgeons to perform precise dissection, cutting, debulking – which reduces the tumour mass in a layer-by-layer fashion – and microvascular coagulation, The cutting edge of neurosurgery which enables the surgeon to operate on appropriate tumours within a clean field. The no-touch tool also reduces tissue retraction and manipulation leading to limited post-op edema and possibly quicker recovery.

Robert F. Spetzler, MD, FACS, Director, Barrow Neurological Institute, J.N. Harbor Chairman of Neurological Surgery in Phoenix, Arizona, said: “Neurosurgeons have long realised the benefits of CO2 lasers for microsurgery, but the traditional means of delivering the laser were too rigid and unwieldy for microsurgery, limiting lasers' use in our specialty.

“A flexible CO2 laser is ideal for removing small tumours that are in close proximity to critical structures, including very sensitive areas of the brain and spinal cord, as well as for tumours in deep holes, when the most precise, no-touch surgical tool is essential.”

Yoel Fink, OmniGuide cofounder and CEO, said: “OmniGuide is experiencing strong demand for our precision surgical systems across a multiplicity of clinical verticals including head and neck cancer, otology and airway surgery.

In August this year OmniGuide announced the results of a study comparing three treatment options – external surgical excision, lineof- sight CO2 laser and the BeamPath flexible CO2 laser fiber. Thirty paediatric patients with an average age of three years underwent procedures to remove suprastomal tracheal fibromas in their windpipe. The study compared operatingroom time, hospitalisation time, need for follow-up procedures, and the success rate of immediate post-operative removal of a tracheal tube, a process called decannulation. The study, led by Jerome Thompson, MD, MBA, Chairman, Department of Otolaryngology, Head and Neck Surgery at University of Tennessee Health Science Center, was presented recently at the Combined Otolaryngology Spring Meetings (COSM-2008) in Orlando, Florida, US. “The paediatric suprastomal fibroma study demonstrated that the use of a flexible CO2 laser fiber improves quality of care and clinical outcomes on several levels,” said Dr Thompson.

“The rate of immediate removal of the tracheal tube was four times greater in the flexible fiber group than the external excision group and two times greater than the line-of-sight CO2 laser group. Additionally, half of the patients who underwent treatment with the fiberoptic CO2 laser carrier had already undergone external excision prior and had experienced recurrence. After then undergoing treatment with the fiberoptic CO2 laser fiber, three of the five patients had their tracheal tube removed immediately and did not experience recurrence of fibroma. Lastly, while the external excision patients are always monitored overnight in the hospital, the endoscopic procedures were performed on an outpatient basis and the children were usually sent home after three to four hours.”

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‘Lab-on-a-chip’ for diagnostic tests
at point-of-care

Low-cost, disposable cartridges that would let doctors perform diagnostic tests at the point-ofcare look set to speed up diagnosis and treatment while lowering costs.

Researchers in the European SEMOFS (Surface Enhanced Micro Optical Fluidic Systems) team knew that, to reach their goal of disposable cartridges capable of performing complex medical diagnostic tests quickly and at low cost, they would have to push existing technology to the limit.

“We are targeting state-of-the- art sensitivities or better,” says Jerôme Gavillet, the dissemination coordinator of SEMOFS, “in a system that could be available anywhere for less than €50 (about US$ 63).”

The team’s goal is a polymerbased device the size of a credit card that would incorporate sophisticated technologies to control the movement of biological fluids, detect the presence of specific proteins, for example early signs of cancer, and analyse the results.

“For each patient, a physician would open the package, put some blood or serum on the card, let it work, and then connect it to a card reader,” says Gavillet.

The relatively inexpensive card reader would display and record what the card had measured.


The EU-funded SEMOFS team says that it has made the greatest progress in two areas – microfluidics and plasmonics.

Microfluidics involves materials and techniques for controlling the movement of minute quantities of fluids. The SEMOFS card moves blood, serum and other fluids through channels slightly wider than a human hair.

In order to control the movement of biological fluids through such tiny channels imprinted into the polymer card, the researchers developed ways to make the surfaces of the channels ‘super-hydrophyllic’ or ‘super-hyrdrophobic’.

Hydrophilic surfaces wet easily. Glass is hydrophilic, which is why a thin glass tube will draw water into itself via capillary action.

In contrast, hydrophobic surfaces like Teflon repel water. The SEMOFS researchers used nanotechnology to structure the interior surfaces of the device’s channels to make them far more hydrophilic than glass or far more hydrophobic than Teflon, as needed.

The super-hydrophilic channels guide the fluids to their destinations without the need for any kind of pump.

In contrast, small areas with super-hydrophobic surfaces act as valves, temporarily stopping the flow of a fluid until sufficient pressure is applied to force it through.

That added pressure comes from puffs of a hydrogenoxygen gas mixture generated by an electric voltage directed to tiny chambers filled with a water-saturated polymer gel.

“When you have a meeting point of two, three, or many channels, you may want to have sequential managing of different liquids,” says Gavillet. “It’s like a railway – you make one train wait until another one has gone by.”


Once the biological sample and the fluids necessary to process it have interacted in the proper sequence, the device uses plasmonics to determine if proteins from the sample have bonded to the detecting surfaces inside the card.

Plasmonics utilises the properties of the ‘gas’ or plasma of free electrons moving inside or along the surface of a conductor.

The electron gas inside the SEMOFS detector resonates at particular frequencies when it is stimulated by light. When proteins bond to antigens on the detector surface, their presence forces a slight change in that resonant frequency.

The researchers found that, by carefully engineering a stack of conductive and dielectric layers, topped by the layer primed to bond with the target protein, they could push the device’s sensitivity beyond current limits.

“The final objective is to reach one picogram per square millimetre,” says Gavillet, ”in other words to reach state-ofthe- art sensitivity even on a low-cost disposable chip.”

A picogram is one trillionth of a gram.

The final challenge the SEMOFS team faces is integrating the technologies they have honed into a single, easily reproduced card or cartridge.

They plan to pack everything – light sources and dectector, waveguides, and the microfluidic system – into one polymer-based card.

The electronics that will read the cards and display the results will be a separate unit.

They are working to finalise the card in the eight months before the project, funded by the European Commission’s Sixth Framework Programme for research, comes to an end.

The researchers expect that the technologies they have refined and integrated will prove useful not just in clinics and doctors’ offices, but in other areas where inexpensive but extremely sensitive detectors are needed.

“There’s a market anywhere you want to probe a liquid or a gas,” says Gavillet.

Implantable neurostimulator provides relief from chronic pain

For those people who suffer the horrendously debilitating effects of chronic pain, a treatment may be in the offing. In September this year St. Jude Medical announced the first patient implant of an Eon Mini, the world's smallest, longestlasting, rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery.


Similar in function and appearance to a cardiac pacemaker, the implantable pulse generator delivers mild electrical pulses to the spinal cord, which interrupt or mask the pain signals’ transmission to the brain.

The device is small, with a thin 10mm profile and weighing just 29 grammes it can be
implanted up a depth of 2.5cm, the deepest implant depth of any similar device so the device can be placed more discreetly.

Along with its small size, a key facet of the Eon Mini is its long lasting battery life. It is the only small rechargeable neurostimulator to receive a 10-year battery longevity approval by the FDA. For patients this means the device should provide sustainable therapy and maintain a reasonable recharge interval for 10 years of use at high settings. The device’s battery longevity also may mean that patients require fewer battery replacement surgeries.

Adam Hammond, the first patient to receive the implant, was injured in a parachuting
accident in 2006. He spent the next two years undergoing multiple surgeries and physical
therapy, but chronic pain from his injuries impacted his rehabilitation.

Tim Deer, MD, president and CEO, Center for Pain Relief in Charleston, West Virginia, US, explains: “Neurostimulation helps us control Adam's pain so he can continue his rehabilitation and decrease his pain medications. Our main goal is to use spinal cord stimulation to help him return to his everyday activities.”

The Eon Mini also allows patients the freedom to comfortably recharge the device’s battery while taking a walk, cooking a meal or shopping because the charging system is fully portable.

The Eon Mini also has the following features:

– Enhanced microchip and software (NeuroDynamix) technology that continuously selects the most efficient power management mode, preserving the battery’s capacity to deliver

– Constant current circuitry that automatically adjusts power output to deliver consistent therapy over time.

– Advanced programming capability that allows physicians to treat up to eight pain areas simultaneously to address complex pain patterns.

The device has received FDA and European CE Mark approvals.

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SerpENT instrument articulates like a snake

A Texas, US-based company ENTrigue Surgical has recently released commercially the first in a range SerpENT Articulating Instruments, which offer innovative solutions for ENT surgery. The SerpENT instruments utilise a patented technology that enables instruments to bend around corners, resulting in less invasive and more efficient surgical procedures.

The SerpENT enables surgeons to use a less invasive procedure while improving surgical access. For the first time, surgeons can reach around corners and, even at extreme angles, perform precise dissection.

The articulating instrument allows surgeons to introduce a straight instrument into the nasal anatomy and then move a functional tip over 240 degrees, side to side. It has seven locking positions.

The surgeon’s ability to manoeuvre the instrument tip independently while in the sinuses could facilitate less invasive procedures, yet enhance surgical access. Also, a single SerpENT could replace the typical range of angled instruments required to access hard to reach anatomy in the maxillary, frontal, and sphenoid sinuses, resulting in a more efficient procedure.

The SerpENT has a variety of tip configurations with articulating thru-cutting forceps and articulating grasping forceps.

Prasad Nalluri, Director, Marketing & Business Development, speaking to Middle East Health, explained that the instrument is made from stainless steel and nitinol components, which enables it to withstand thorough cleaning and sterilisation procedures.

“The SerpENT Articulating Instruments are unique in their application to otolaryngology procedures. They enable the surgeon to bend the instruments as needed within the anatomy and thereby enable less invasive procedures,” he said.

Regarding the instrument’s availability internationally he said the company was working on their CE mark registrations “and busy exploring our strategy for the international markets”.

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GPS for body makes external beam radiation therapy more accurate

A private medical device company in the US, Calypso Medical Technologies, which has developed a real-time localisation system for tracking tumours in the body also known as “GPS for the body”, will collaborate with Siemens Healthcare to integrate its tumour tracking system with Siemens’ linear accelerator products.

Calypso Medical’s “GPS for the Body” technology uses tiny electromagnetic transponders placed in or around the tumour to provide precise, continuous information on the location of the tumour at all times during external beam radiation therapy. This real-time information is critical in cases where the tumour may move due to normal physiological processes or if the patient moves during treatment. These types of movement may cause the radiation to miss its intended target and hit adjacent healthy tissue. In contrast to other tumour targeting solutions, Calypso’s GPS for the Body technology provides continuous tumour position information, thereby optimising the delivery of radiation to the tumour and minimising misapplied radiation to normal tissue.

The first application to be addressed under this agreement will include adaptive gating, the capability of automatically interrupting the radiation beam from a linear accelerator in response to patient motion, organ motion or tumour position.

Proton therapy

Meanwhile, in a separate development, Calypso Medical has received a US$1 million grant from the University of Pennsylvania Health System to develop a compatible version of the Calypso 4D Localization System that would enable real-time tumour tracking during proton therapy for cancer treatment. This funding will go toward developing a modified version of the Calypso system, utilising GPS for the Body technology, to function with its current high degree of accuracy in a proton therapy environment.

Proton therapy is an advanced form of external beam radiation whereby protons rather than photons are directed at cancerous tissue. Proton therapy in theory has a significant advantage: protons can be delivered to deposit all of their energy in a single location. Proton therapy is highly precise and able to deliver higher doses of radiation to the tumour, lower doses of radiation to healthy tissue and a lower whole body dose compared to conventional photon therapy. As a result, when used with continuous targeting technology, proton therapy may provide better tumour control with reduced post-treatment side effects for a wide range of cancers requiring radiation therapy.

James Metz, MD, Clinical Director, Department of Radiation Oncology, at The University of Pennsylvania Health System, explained: “Today, we use Calypso Medical’s GPS for the Body technology to guide treatment and manage motion for patients undergoing conventional photon radiation therapy treatment for our prostate cancer patients. The proton project collaboration has the potential of incorporating pinpoint accuracy and real-time tumour tracking in the proton environment. There are a variety of cancers where the tumour target is moving continuously and accurate real-time tracking would enable a wider population of cancer patients to benefit from the combination of proton therapy with the Calypso system.”

Wireless wearable monitor gives
patients mobility

German company Dräger has developed and has recently implemented in a few hospitals an innovative patient-worn monitor. The Infinity M300 provides the performance of a full-size patient monitor, packaged in a compact patient-worn telemetry device for adult and paediatric patients.

The key benefit of this device is that it enables patients to be mobile in the hospital. It is now commonly thought that the earlier a patient returns to mobility the quicker their healing and return to good health.

In addition to monitoring ECG and SpO2, the device has built-in algorithms to enhance ECG processing and reduce false alarms, such as pacer detection software and ACE (Arrhythmia Classification Expert), an arrhythmia analysis tool.

Infinity M300 can run on a hospital’s existing 802.11 b/g wireless network.

Dina LaTulippe, Director of Product Management, Central Monitoring Solutions at Monitoring, Systems & IT in Andover, Massachusetts, USA, said: “Infinity M300 represents a major innovation in telemetry monitoring. We’re very excited about the system’s potential to help address the challenges of today’s busy ambulatory environments.

“Because Infinity M300 has a built-in display and alarms, it enables the clinical staff to be alerted to patient conditions without having to use additional devices.” Dräger says the Infinity M300 addresses the three major challenges of telemetry monitoring. The first is viewing patient information at the patient’s side. Unlike traditional telemetry devices which have no screen, Infinity M300 has a colour display that shows the patient’s ECG for all monitored leads, heart rate, SpO2, and electrode status – enabling the clinical staff to access monitored data and react promptly without having to go to the central monitoring station. The display also shows patient demographics to help confirm the patient’s identification before giving medication, taking blood samples, or performing treatments.

The second telemetry challenge is hearing and responding to alarms. The patient-worn monitor has alarm alerts at the patient’s side and the Infinity CentralStation, Dräger’s central monitoring workstation.

The third challenge of telemetry monitoring, is battery power. Disposable batteries can be very costly. This system has a built-in battery, which can be recharged via a bedside charger while the patient is wearing the device, or at a multi-device charger at the central monitoring station.

ate of upload: 16th November 2008

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