Tuesday, November 3, 2009
Simple iPhone App Measures Spine Angles on X-rays
Dr. Frederic P Jacquot, an orthopedic surgeon from France, developed an innovative iPhone application that could measure spine curvature angles "on the fly." Just like other spine clinicians, Dr. Jacquot was trained to measure the Cobb angle, kyphosis angle, and the sacral slope on spine radiographs. So instead of using a protractor, he realized that he could utilize the accelerometer inside the iPhone to do it.
All that one has to do in using the device is align the side of the iPhone to the standard tracings we use routinely, and the position sensor built in the iPhone will do the rest.The precision of the device itself is 1/10th of a degree, far more precise than the precision of the measure as determined in everyday practice and the literature.
Measures are logged for further use and may be sent by e-mail to the surgeon or staff for recording purposes, with the levels of the measured curve, type of curve and patient id or number. A calibration procedure was also implemented to accurately measure the angle with the horizontal plane as in the sacral slope.
Product page: CobbMeter ...
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Monday, October 26, 2009
TRUMF's OR Table Integrated With Siemens Multi-axis Fluoroscopy Systems
Siemens has just announced that it has integrated the TruSystem 7500 OR table from TRUMPF (Puchheim, Germany) with its Artis zee and Artis zeego fluoroscopy scanners. The TruSystem 7500 adjusts to just about any position imaginable and is transparent to x-rays, and so can be used in almost any surgical or invasive radiological procedure. TruSystem 7500 OR table is illustrated above, and Artis zeego multi-axis interventional fluoroscope is shown in the picture below.
The Trumpf OR table has been designed especially for this integration and is equipped with a onepiece carbon tabletop, which can be replaced by a segmented universal tabletop. The table column enables the two tops to be exchanged easily. The carbon tabletop is transparent to X-rays and thus ensures that there will be no disruptive artifacts in the images. It is suitable for interventional procedures and minimally invasive surgery. The integration of the OR table with the Siemens angiography systems also make fast rotations and 3-D imaging possible with the surgical C-arm. The modular design of the segmented tabletop enables extremely flexible positioning of the patient, particularly important in orthopedics and neuro surgery. Complicated positions, such as the chest side position, can be achieved quickly with great precision as well as comfort for the patient and staff.
Along with the integrated Trumpf OR table, Siemens continues to offer its Artis tables for the entire Artis zee series, which are available in three designs: as a standard table, a table with Trendelenburg tilting and one with Trendelenburg and lateral tilting.
Press release: Siemens integrates Trumpf's OR table in its Artis zeego and Artis zee ceiling angiography systems...
Product pages: TruSystem 7500, Artis zee, Artis zeego
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Wednesday, October 21, 2009
ThumBlade Scalpel Safety System
Here's an interesting new take on improving the safety for scrub techs, nurses and surgeons. ThumBlade™ scalpel system from Precision Medical Devices Inc. (Marlboro, NJ) is a no contact, disposable safety sheath that covers blades, and allows activation of the scalpel with just one hand. So no more sharps and no more mosquito use to mount a blade.
Medgadget has obtained the following details about the device:
Featuring patent pending innovative thumb activation independent mechanisms, PMD’s ThumBlade™ safety scalpels enable one-handed activation smoothly and safely by right or left handed practitioners with no contact with the exposed blade. This activation affords an easy, natural opening motion while keeping the other fingers out of the way. The safety sheath is made from high quality ABS composite with a completely flat and smooth top, providing a stable platform for better control during the procedure. The extra sharp blades are stainless steel, pre-sterilized, and disposable after single use. The blade sheaths and packaging are color coded by size for easy counting and safe use. The stainless steel handles are pre-sterilized for first use and can be re-sterilized and re-used. These handles, available in both #3 and #4 fitments, are premium length and back-weighted for the grip and feel practitioners prefer.
Product page: ThumBlade™ safety scalpel system...
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Tuesday, October 20, 2009
Single Chip Stereo Endoscopy from Visionsense Coming to an OR Near You
Visionsense out of Orangeburg, New York, a company that makes single chip 3D endoscopic vision technology, has raised $8M in VC funds to begin full scale marketing of its unique technology in the US and Europe. The firm's Visionsense Stereoscopic Vision System, designed to improve depth perception and understanding of complex surgical anatomy, can be used for a variety of complex surgeries, such as skull-base and keyhole neurosurgical cases, as well as a wide range of laparoscopic procedures.
Camera Control Unit (CCU) – The CCU consists of a single Pentium PC with proprietary Visionsense hardware and software.
3D Stereoscopic Display - The CCU connects to a stereoscopic display with flexible arm for multiple viewing angles (requires glasses).
Video Cart - specifically designed to maximize surgeon ergonomics and minimize the footprint in the operating room. The VSII is designed to work with:
Cameras - The VSII uses various configurations of cameras specifically designed for transnasal and keyhole neurosurgical applications. Currently, there are 2 lengths (170mm and 300mm) and 2 angles (0 and 30 degree). The cameras are able to be sterilized and are reusable for 40 procedures.
LED Light Source - The VSII uses its own customized light source which uses a few watts of power to illuminate the surgical field.
Digital Recording/playing/editing procedures, in both mono and stereo
Product page: VSII -Visionsense Stereoscopic Vision System
Flashback: Single Chip Stereo Endoscopy from Visionsense
(hat tip: Globes)
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Tuesday, October 13, 2009
Guardian II Hemostasis Valve Gets FDA Nod
The FDA has granted approval to the Guardian II™ Hemostasis Valve produced by Zerusa, a Galway, Ireland firm. The valve, designed for easy movement of catheters and other interventional angio devices while providing hemostasis, has already been approved in Europe. The device will now be distributed in the US by Vascular Solutions out of Minneapolis, MN.
Features from the product page:
Unique Seal TechnologyProvides a cleaner procedural field protecting physicians, staff and patients by reducing the amount of blood in the field.
Allows separation of guidewires and other devices during complex procedures. Click-open and Click-close Design
Allows single handed operation
Unique proximal cap is easily depressed for both opening and closing the lumen.
Distinctive wide “bulls eye” opening in the proximal cap allows for easy insertion of devices along with the ability to separate multiple guidewires and other devices during complex cases. Ergonomic Design
Practical design allows the Guardian to fit comfortably in a physician’s hand.
Subtle finger tabs have been added for improved handling characteristics.
Actual device length 92mm. 8 French Lumen
Allows multiple or large therapeutic devices to be inserted during procedures. Secure Device Lock
Rotating lock-nut has been designed to provide an additional mechanism for securing device position. Lock-nut functions similar to a tuohy borst™ style valve.
Here's a demo animation showing how one operates the device...
Press release: Vascular Solutions and Zerusa Limited Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve...
Product page: Guardian II™...
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Thursday, September 24, 2009
Neuropace Implantable Epilepsy Device Showing Positive Signs in Initial Clinical Study
A clinical trial is underway for a neurostimulator implant that monitors brain activity and then sends an electrical jolt designed to prevent an epileptic seizure. Neuropace has developed the RNS system in Silicon Valley, and is undergoing clinical trials with more than 200 patients across the US. It is being reported preliminarily that RNS implant is effective in treating seizures through the mechanism of responsive stimulation. In this protocol regions of the brain demonstrate erratic electrical signals before a seizure. Through counter electrical stimulation, the seizure can be prevented or minimized.
The RNS is placed under the skull and the electrodes are connected to relevant regions in the brain in order to provide stimulation. The device is controlled wirelessly through an adapter on a laptop which allows a clinician to view the patient's electrocorticographic (ECoG) activity in real-time and the ability to upload the patient's ECoGs that have been stored in the RNS neurostimulator.
The purported design advantage with the RNS system versus other anti-epileptic systems currently employed is that the RNS system does not constantly electrically stimulate the brain, but rather monitors specific regions in the brain for an uptick in electrical activity and only shocks when there is indication of an upcoming seizure. This means the RNS is monitoring more and shocking less.
Singularity Hub : Implant that Shocks Brain to Treat Epilepsy in Clinical Trials...
Company Profile : NeuroPace...
Flashbacks : NeuroPace: Maybe First Since Jesus to Prevent and Treat Epilepsy; Neural Modeling Aims to Explain Seizures
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Monday, September 21, 2009
New Surgical Glue from Lifebond to Offer a Stronger, Tighter Seal
Lifebond out of Caesarea Industrial Park, Israel has developed a new surgical sealant which is apparently stronger than the currently used blood-derived fibrin glues. The LifeSeal SLR staple line reinforcement sealant and LifeSeal Surgery sealant 
for general surgery are two main products from the company that are based on its proprietary hydrogel matrix technology, in which individual protein molecules tend to cross-link and form fibrin-like networks. The company plans to ask for US and European approval to market the material next year.
LifeBond's technology functions through the rapid and biocompatible in situ cross-linking of structural proteins. As they cross-link, proteins in the physiological environment undergo a process of gelation to form an adhesive hydrogel matrix. The properties of the cross-linking reaction and the hydrogel matrix can be controlled to fit a variety of applications.LifeSeal GI is comprised of LifeBond sealant provided in a specialized two-component applicator syringe. The mixed sealant is applied to anastomosis staple-line junctures in the GI tract to fortify the attachment and prevent leakage until full function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the staple-line juncture. The sealant can be applied manually or as a gas-assisted spray.
Application of LifeSeal GI onto the staple line moderates tension on the staple line because it stabilizes the tissue sections in relation to each other and adds adhesive strength to the junction. Furthermore, LifeSeal GI seals off the staple holes and narrows the spaces in between each staple. Thus, leakage, bleeding, and tearing at the staple line can be reduced, especially in diseased and fragile tissue.
LifeSeal Surgical sealant is provided in a variety of specialized two-component applicators. The mixed sealant is applied to a wound site or staple-line juncture to prevent fluid or blood leakage until full physiological function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the wound site or staple-line juncture. The sealant can be applied manually or as a gas-assisted spray. The precise application method can be altered to optimize sealant use for specific applications.
Links: Lifebond technology page; LifeSeal SLR; LifeSeal Surgery
(hat tip: ISRAEL21c)
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Wednesday, September 16, 2009
Medtronic Releases New Intraop Nerve Integrity Monitors
Medtronic has just announced the availability of a couple new intraoperative nerve integrity monitors, primarily for neurosurgeons and arthopods. The NIM-Response® 3.0 and NIM-Neuro® 3.0 help locate critical nerves during surgery and monitor their integrity throughout the procedure. The devices should help prevent nerve damage during surgeries and lead to easier repairs with less fear of damaging fragile nerve tissue.
During minimally invasive or traditional open surgery, Medtronic’s Nerve Integrity Monitor (NIM®) systems enable surgeons to identify and confirm motor nerve function and monitor major motor nerves throughout the body, such as cranial nerves in a patient’s head, face and neck. If there is a change in nerve function, the NIM system provides visual and audible warnings to alert the surgeon and operating room staff. This helps reduce the risk of nerve damage during surgery, improving safety and peace-of-mind for patients and surgeons.The NIM 3.0 systems are the first and only nerve monitors in the marketplace that fully enable:
* Simultaneous monitoring during bipolar cautery
* Artifact detection software that distinguishes artifacts (false signals) from true nerve signals
* Stim Bur technology that combines stimulation with Medtronic’s electric Visao® High-Speed Otologic Drill
* Real-time continuous monitoring of nerve function via APS™ (Automatic Periodic Stimulation)* that provides early warning of a change in nerve functionWith completely redesigned software, the new NIM 3.0 systems are easier to use and more convenient for the operating room than prior models. Users can navigate easily and quickly between three simple modes: Setup, Monitoring and Reports, and use default or custom settings. In addition, the new systems include multiple reporting options that can be easily saved for patient records.
The NIM-Response 3.0 monitors up to four channels of nerve-muscle combinations at a time and is frequently used in skull-based and head and neck procedures. With the NIM-Neuro 3.0, neurotologists and neurosurgeons can monitor up to eight channels of nerve-muscle combinations during complex and delicate surgeries, such as glomus tumor removals. In the future, Medtronic expects a new microscope overlay for the NIM-Neuro 3.0 will help bring monitoring within the surgical field by importing the NIM signal through a high-end microscope as the surgeon operates.
Press release: Medtronic Launches New and Innovative Intraoperative Nerve Integrity Monitors for Surgeons
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Wednesday, September 9, 2009
Brio DBS System Wins EU OK for Parkinson's; First Person Implanted with the Device
St. Jude Medical has received European approval to market the world's smallest implantable deep brain stimulator to help control the symptoms of Parkinson's disease. The Brio device weighs 29 grams (~1 ounce) and has a 10 millimeter profile. The battery is rated to last for up to 10 years with recharges, so the first patient, a 67 year old German man, recently implanted with the device won't need a replacement for up to a decade, maybe until 2019.
From the announcement:
The Brio DBS system delivers mild electrical pulses to specific targets in the brain, stimulating the structures that are involved in motor control. The system consists of a neurostimulator – a surgically implanted battery-operated device that generates the electrical pulses – and leads which carry the pulses to the brain to influence the irregular nerve signals responsible for the symptoms of Parkinson’s disease.In addition to its small size, the Brio neurostimulator has the longest battery life of any rechargeable DBS device currently on the market with a 10-year battery longevity approval. For patients this means the device should provide sustainable therapy and maintain a reasonable recharge interval for at least 10 years of use at high settings. The device’s battery longevity may also maximize the time between device replacement procedures.
The Brio neurostimulator also features:
Constant current circuitry that automatically adjusts to deliver consistent therapy over time.
A dual header that accommodates two leads, allowing for bilateral stimulation from one device.
High power capability, making it an appropriate choice for patients who require high energy settings to control their symptoms.
A rechargeable battery that can be easily charged through a portable, wireless charging system, allowing patients the freedom to recharge comfortably while doing other activities. Additionally, St. Jude Medical has recently received CE Mark approval for the Guardian™ Burr Hole Cover System, a DBS system component that allows physicians to efficiently secure the electrical leads. The Guardian System is compatible with all St. Jude Medical DBS leads.
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Tuesday, August 25, 2009
IsoFlow Catheter Helps Target Tumor During Chemo Infusion
Current methods of delivering chemotherapy and chemoembolization agents have trouble limiting the affected parts of the organ to just the area around the tumor. Dana Blankenhorn, who now blogs at SmartPlanet.com, is reporting that Vascular Designs Inc. out of San Jose, CA 
has received FDA clearance for its IsoFlow infusion catheter that can occlude a section of vasculature, while allowing blood to continue to perfuse through the catheter itself. Once occluded, the chemo agents can be delivered peripherally to the isolated section, while blood is shunted past uninterrupted.
More details from the product page:
The IsoFlow catheter enables sideways perfusion, which gives you the ability to push specified fluids both into side branch and angiogenicly formed vessels, letting medications reach an isolated area in a highly targeted and concentrated fashion. With IsoFlow's unique design, fluids can reach areas that could not previously be treated directly.IsoFlow is inserted with a guide wire and catheter for precise positioning within a patient's body. Once in place, both of IsoFlow's balloons are simultaneously inflated using radiopaque fluid via a single inflation lumen. Physician-specified fluid is introduced through the infusion lumen or the guide wire lumen via the one-way stopcock connection. The mixture of infusion and radiopaque agents is then delivered to the target region between the two balloons. For sideways infusion, the guide wire is retracted to allow blood to bypass the isolated target region via holes in the catheter exterior. Complete removal of the guide wire allows fluid delivery from the distal tip.
Watch the video for how the IsoFlow is operated:
More from Dana Blankenhorn...
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Tuesday, August 4, 2009
FDA OK's PlasmaBlade for Tonsil and Adenoid Tissue Removal
Peak Surgical out of Palo Alto, California has received FDA approval for its tonsil and adenoid tissue dissection device. The PEAK PlasmaBlade TnA, which features interchangeable tips, is based on the recently introduced PlasmaBlade system that aims to replace the Bovie as a standard dissection and coagulation device. The primary advantage of PEAK's technology is the low thermal footprint of the cutting tip, leading to less damage to the tissue around the dissection site.
All of the PlasmaBlade tissue dissection surgical devices are used in conjunction with PEAK Surgical’s PULSAR Generator, which supplies pulsed waveforms that produce short plasma-mediated electrical discharges through the PlasmaBlade. Because the radiofrequency is provided in short on-and-off pulses with low duty cycle, and the blade is insulated, heat diffusion and associated heat damage to surrounding tissues is limited, resulting in less collateral damage and more precise tissue dissection. In contrast, most radiofrequency-based surgical devices use continuous voltage waveforms and un-insulated electrodes to cut tissue.The PlasmaBlade provides surgeons with a single device that offers:
* the precision of a traditional scalpel;
* the bleeding control of traditional electrosurgery technology;
* minimized thermal damage;
* the ability to quickly and easily cut through all types of soft tissue, including skin, fat and muscle;
* the ability to operate in a wet or dry surgical field.
Product page: PlasmaBlade Family...
Press release: PEAK Surgical Introduces PEAK PlasmaBlade™TnA...
Flashbacks: PlasmaBlade Finds New Uses With New Attachments; PlasmaBlade System Gets FDA Go Ahead; Peak PlasmaBlade Wants to Be The New Bovie
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Monday, July 27, 2009
Plato's Cave: New 3D Visualization System
A new radiology visualization platform, called Plato's Cave, has been implemented at The Methodist Hospital in Houston. The engineers and clinicians have pulled expertise from a number of companies in the industry to develop a system that can be utilized for advanced radiology readings or as a technology to perform preoperative surgical planning for advanced cases, such as intracranial aneurysms or facial surgery. The system uses a projector to display images on a screen and specialized glasses to show them in three dimensions. The physician can use a traditional video game controller to navigate through the volumetric visualization.
In Plato’s “Allegory of the Cave,” prisoners saw shadows on a cave wall as reality and blindly accepted it as fact. One day, a prisoner escaped and actually saw the outside world; thus, his experience gave him a more expansive view of reality. Butler calls his venture “Plato’s Cave” because this new visual approach to medicine opens up a whole new world for physicians and patients.Currently, radiation oncologists have limited views of individual slices of the body. However, with this technology, physicians can see inside a patient’s body. By using “Plato’s Cave,” these physicians can maneuver around organs in all directions, allowing them to see more clearly how radiation is deposited around tumors, adjacent organs, arteries, veins, and lymphatics.
“Previously, when we were planning a patient’s treatment, the data might have indicated that a higher than desired dose of radiation would be delivered to a particular organ such as the spinal cord; yet, we were unable to visualize the precise location of that dose or divert it,” Butler said. “Now, I am able to actually see the distribution and have the option to maneuver the excess dose away from the area and deposit it elsewhere.”
Surgeons can also use this technology to their advantage. It will give them the ability to visualize, before the patient arrives in the operating room, potential anatomical obstacles that could complicate performing a procedure.
“For instance, if a surgeon is performing a liver resection, we can simulate removing part of the patient’s liver, and with the push of a button determine how much of the remaining liver will be viable after the operation,” Butler said. “If it’s 20 percent or greater, the procedure can be performed; if less, it cannot. This will take surgical planning to a whole new level.”
More videos from Methodist...
Link: New technology offers virtual visualization of the human body...
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Thursday, July 16, 2009
New Cerebral Oximeter from Nonin Granted US OK
Nonin Medical has received FDA clearance for the Model 7600 regional oximetry system. Similar to other cerebral oximeters, all of which are designed for operating room use on patients undergoing cardiac, vascular and neurosurgical procedures, as well as on patients in critical care units, the 7600 model provides continuous monitoring of cerebral oxygenation, so clinicians can take steps to prevent brain ischemia in susceptible patients.
More details about the device:
Utilizing next-generation near-infrared spectroscopy (NIRS) — Nonin's proprietary EQUANOX™ regional oximetry (rSO2) technology — the Model 7600 measures oxygen saturation in the cerebral cortex. The innovative sensor design effectively removes surface tissue effects that can influence measurement accuracy — isolating measurements of the cerebral cortex and providing rSO2 values. The Model 7600 offers industry-leading signal processing to enhance efficiency and an intuitive user interface with Bluetooth® wireless connectivity to streamline file access and storage.
Features from the product page:
Proven Accuracy: ARMS of 2.7 along trend lines relative to jugular bulb measurements (SjvO2). Enhanced (rSO2) accuracy designed to eliminate the impact of surface effects (i.e. skin, bone, meninges, etc.) Exceptional Repeatability: ± 2 digits Unmatched Convenience and Efficiency: Quick and easy to set up along with improved operational efficiency by eliminating the need to capture a new baseline when sensors are changed or repositioned Fast Readings: Near-instantaneous baseline measurement Superior Sensor Architecture: Dual light emitters enable consistently accurate measurements — even if one emitter is obscured Easy to Use: Intuitive, large-screen display is simple to read and requires minimal training Highly Versatile: Can be used in numerous clinical environments Rugged Durability: A compact, rugged design specifically built to resist the potential hazards in clinical environments
Press release: Nonin Medical Announces FDA Clearance for its Next-Generation Regional Oximetry System...
Product page: Model 7600 Regional Oximetry System...
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Thursday, July 9, 2009
microECoG Electrodes Create New Possibilities to Study, Intervene in Brain Function
Neurosurgeons from the University of Utah have developed new tiny electrode arrays that do not penetrate the surface of the brain, potentially preventing many of the side effects common to modern high precision electrodes. Similar to electrocorticography ECoG arrays, the microECoG devices may be small enough for permanent placement under the skull.
From the University of Utah:
The researchers tested how well the microelectrodes could detect nerve signals from the brain that control arm movements. The two epilepsy patients sat up in their hospital beds and used one arm to move a wireless computer "mouse" over a high-quality electronic draftsman's tablet in front of them. The patients were told to reach their arm to one of two targets: one was forward to the left and the other was forward to the right.The patients' arm movements were recorded on the tablet and fed into a computer, which also analyzed the signals coming from the microelectrodes placed on the area of each patient's brain controlling arm and hand movement.
The study showed that the microECoG electrodes could be used to distinguish brain signals ordering the arm to reach to the right or left, based on differences such as the power or amplitude of the brain waves.
The microelectrodes were formed in grid-like arrays embedded in rubbery clear silicone. The arrays were over parts of the brain controlling one arm and hand.
The first patient received two identical arrays, each with 16 microelectrodes arranged in a four-by-four square. Individual electrodes were spaced 1 millimeter apart (about one-25th of an inch). Patient 1 had the ECoG and microECoG implants for a few weeks. The findings indicated the electrodes were so close that neighboring microelectrodes picked up the same signals.
So, months later, the second patient received one array containing about 30 electrodes, each 2 millimeters apart. This patient wore the electrode for several days.
Images: Top: These two images show two kinds of microelectrode arrays, known and microECoGs, that were placed on the brains of severe epilepsy patients. The patients already had parts of their skulls removed temporarily for placement of larger ECoG electrodes, which are used to locate and treat the brain area responsible for their seizures. These larger, metallic, button-like electrodes are numbered in both images. The left image also shows two microECoG arrays, each with 16 microelectrodes connected to microwires that pass through the orange and green tubes. Because the arrays are made of fine wires embedded in clear silicone, photo-editing software was used to draw in their outlines in both images. The right image shows one microECoG array with 32 individual microelectrodes, connected with microwires entering via a clear tube from the bottom of the image. The green wires are connected to the large, conventional ECoG electrodes. Side: Microwires emerging from the green and orange tubes connect to two arrays of 16 microelectrodes. Each array is embedded in a small mat of clear, rubbery silicone. (University of Utah)
Press release: Reading the Brain without Poking It...
Full article in Neurosurgical Focus: Human neocortical electrical activity recorded on nonpenetrating microwire arrays: applicability for neuroprostheses
(hat tip: Gizmag)
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Wednesday, June 24, 2009
Brain Surgery With MR Guided High Intensity Focused Ultrasound
Performing tumor ablations in the brain can be a very risky venture since getting to the diseased site requires avoiding blood vessels and fragile tissue. Radiation therapy has become a common alternative to going invasive, but it suffers from unnecessary radiation exposure to the patient. High intensity focused ultrasound (HIFU), a technology already commonly used for uterine fibroids, has been looked at as a possible alternative for intracranial ablations. Now clinicians at the University Children's Hospital Zurich successfully performed the first transcranial MR guided HIFU procedure.
From the University of Zurich:
The HIFU system ExAblate® 4000, developed by the cooperation partner InSightec, Tirat Carmel Israel, has been combined with a 3 Tesla high field GE MR-scanner. The two systems together provide a platform for image-guided, non-invasive interventions. Since September 2008 ten patients were treated at the Children's Hospital Zurich with this new neurosurgical procedure in the context of a clinical study. All interventions were completed successfully and without complications. This novel technology now opens up new horizons allowing to develop non-invasive intervention procedures for a variety of brain diseases including brain tumors.The whole surgical procedure is planned and monitored in real time by magnetic resonance imaging (MRI). The HIFU beams produced by 1024 transducers are transferred through the intact skull of the patient into the brain and concentrated onto a focus of 3 to 4 millimeters in diameter. Thus, sharply defined targets deep inside the brain are coagulated by heating them up to a focal temperature of 60 degrees Celsius. The temperature increase during the sequential "sonications", each lasting 10 to 20 seconds, is continuously displayed and controlled on precise MR-temperature distribution maps. The whole surgical procedure lasts several hours and is performed without anaesthesia. Patients are awake and fully conscious during the intervention.
The following video of ExAblate Brain device treatment has been released by the company:
Press release: Successful neurosurgery with transcranial MR-guided high-intensity focused ultrasound
InSightec's HIFU brain surgery info page...
Flashbacks: FDA Expands Indication for Insightec's Uterine Fibroid System ; Ultrasound That Seals Punctured Lungs; Noninvasive Palliation of Pain of Bone Mets; ExAblate Making Waves in US; ExAblate 2000
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Friday, June 19, 2009
Braingate Neural Interface Developing Into Wireless Version
The Braingate project has begun recruiting participants to assess the new wireless version of the brain-computer interface. Dubbed as Braingate2, the new system is meant to be completely implantable, receiving power and maintaining communications via a wireless connection. Power and control of the device is delivered via RF, while the signal from the brain interface comes back via an infrared laser shining through the skull.
More from Singularity Hub...
Medgadget's archives of Braingate coverage...
Link: Braingate2 project page...
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Tuesday, June 9, 2009
US Trial of Libra Deep Brain Stimulation System for Parkinson's Is Moving Along
St. Jude Medical has announced that all the 136 patients in a study testing the effectiveness of Libra DBS for symptoms of Parkinson's have been implanted with the device. The deep brain stimulation system targets either the subthalamic nucleus or globus pallidus interna regions of the brain involved in muscle movement.
From a St. Jude Medical statement:
Ongoing at 15 medical centers in the U.S., this randomized, controlled study is evaluating the St. Jude Medical Libra and LibraXP™ DBS systems, to determine the devices’ safety and effectiveness in controlling many of the motor symptoms of advanced Parkinson’s disease. The study is following 136 participants who have lived with the disease for more than five years and whose symptoms were insufficiently controlled with medication alone.“Ultimately patients benefit from the development of new technologies,” said Michele Tagliati, M.D., associate professor of neurology and division chief of movement disorders at Mount Sinai Medical Center in New York who enrolled the first patient in the study. “We are hopeful the Libra deep brain stimulation systems will prove effective at reducing the symptoms of Parkinson’s disease and provide additional tools to better control this debilitating condition.”
The Libra and LibraXP neurostimulators are constant current devices. The systems consist of a neurostimulator – a surgically implanted battery-operated device that generates mild electrical pulses – and leads, which carry the pulses to a targeted area in the brain.
“The progressive nature of Parkinson’s disease often leads patients to a point where medication management alone can no longer adequately control the symptoms of the disease,” said Bruno Gallo, M.D., assistant professor of neurology at the University of Miami in Florida and an investigator in the study. “Because these patients often become unable to care for themselves, we need to look for additional methods of treating this debilitating condition in order to help improve a patient’s quality of life.”
Press release: St. Jude Medical Completes Implants in U.S. Study of Deep Brain Stimulation for Parkinson's Disease
Flashbacks: Libra DBS for Parkinson's Going Live in Europe; Libra DBS Showing More Promise in Study; European Union Approves Deep Brain Stimulation Systems for Parkinson's; St. Jude Receives Patent for Anti Depression Neurostimulation Method
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Tuesday, June 2, 2009
BRYAN Cervical Disc Gets FDA Approval
BRYAN® Cervical Disc, a product of Medtronic Sofamor Danek we first profiled back in 2007, has now been approved by the FDA. The implant, composed of a polyurethane and titanium discs designed to fit between adjacent vertebral bodies in the neck, is indicated "in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy," according to the FDA.
From the FDA info page on the product:
How does it work? Once the diseased disc is removed, the BRYAN® Cervical Disc is placed in milled pockets in the adjacent vertebral bodies. The device consists of two main metal pieces separated by a polyurethane part.When is it used? The BRYAN® Cervical Disc is intended to be used to replace a cervical disc from C3-C7 following removal of the disc for intractable radiculopathy and/or myelopathy (conditions that result from a diseased or bulging disc). The patient should have failed at least 6 weeks of conservative therapy before receiving this device.
What will it accomplish? The device should help stabilize the operated spinal level. Unlike a fusion procedure, the BRYAN® Cervical Disc is designed to allow motion at the operated spinal level. The effects of the diseased disc removal should include pain relief and improved function.When should it not be used? The BRYAN® Cervical Disc should not be implanted in patients with the following conditions:
* Active systemic infection or infection at the operating site;
* Allergy to titanium, polyurethane, or ethylene oxide residues;
* Osteoporosis defined as a DEXA bone mineral density T-score equal to or worse than -2.5;
* Moderate to advanced spondylosis characterized by bridging osteophytes, marked reduction or absence of motion, or collapse of the intervertebral disc space of greater than 50% of its normal height;
* Marked cervical instability on radiographs (e.g., radiographic signs of subluxation greater than 3.5 mm or angulation of the disc space more than 11 degrees greater than adjacent segments);
* Significant cervical anatomical deformity or compromised vertebral bodies at the index level (e.g., ankylosing spondylitis, rheumatoid arthritis, or compromise due to current or past trauma);
* Significant kyphotic deformity or significant reversal of lordosis; or
* Symptoms necessitating surgical treatment at more than one cervical level.
FDA approval : BRYAN® Cervical Disc - P060023...; Approval Order (.pdf); Summary (.pdf); Labeling (.pdf)
Flashbacks : Medtronic's Bryan® Cervical Disc System; Medtronic's Cervical Discs Deliver Good News to the Company
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Siemens Introduces Cappa C-Nav System for Navigating the Body Without Radiation
At the upcoming Congress of the European Federation of National Associations of Orthopaedics and Traumatology (EFORT), to be held June 3 - 6, 2009 in Vienna, Siemens is planning to unveil a new navigation system for orthopedic and neurological surgeons called Cappa C-Nav. We think this technology can potentially improve outcomes and increase precision for a number of open and percutaneous procedures, such as spinal fusions and hip screws.
Siemens describes its technology:
For surgical interventions, physicians increasingly use modern navigation technologies comparable. With Cappa C-Nav, Siemens Healthcare offers an optical navigation system that is especially suitable for spinal as well as trauma surgery. The new navigation system enables surgeons to perform interventions with greater safety and precision. Additionally, the method also minimizes radiation exposure to the patient as well as the OR staff.
The development of new technologies is propelled forward by the increasing trend toward minimally-invasive operations. Siemens’ years of medical engineering expertise in the OR arena follows this trend and is now offering intra-operative imaging and optical navigation technology. Especially orthopedics and trauma surgeons will benefit from this innovative idea.Precision is a substantial pre-condition in the OR in general, but in particular in spinal and trauma surgery as well as in orthopedics. In spinal surgery for example the new method helps to accurately position pedicle screws in the spine; in orthopedics navigation technology is used to support online visualization during stabilization of degenerated bones. Prior to the operation, the surgeon creates a 3D X-ray data set of the region of interest. This data set is used like a map for orientation during surgical intervention. The surgeon navigates during the operation by using so-called optical tracking via a special stereo camera. The surgeon is able to use the navigation system easily and by himself via a sterile user interface. The surgeon’s instruments and patient’s body region of interest are provided with differently arranged small reflecting marker spheres. The camera continuously acquires the position of these spheres and informs the navigation system of their location. This enables the surgeon to proceed with even greater accuracy during the operation by virtually testing the length of the screws, for example. Also the ability to continuously check the progress and results of an operation may save patients the need for a second surgical intervention.
Cappa C-Nav is optimally tailored for the mobile C-arm Arcadis Orbic 3D and, if needed, can be retrofitted for these systems.
Press release: The optical navigation system Cappa C-Nav facilitates minimally-invasive surgical procedures... (.pdf)
Flashbacks: iGuide CAPPA Knows Where the Tip of the Needle Is
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