CIVCO's RAD-GUIDE

CIVCO Medical Solutions, the leading provider of ultrasound needle guidance solutions, is committed to introducing new guidance solutions across the different imaging modalities. At RSNA 2011, CIVCO is introducing RAD-GUIDE™, a needle guidance solution for CT and Fluoroscopy. “As imaging modalities evolve, CIVCO is committed to translating our expertise in ultrasound needle guidance to other modalities,” said Robin Therme, VP of Multi-Modality Imaging for CIVCO. “RAD-GUIDE is the first of many such products to come.” RAD-GUIDE demonstrations are available at CIVCO’s RSNA booth, #8309.

RAD-GUIDE is a needle guide designed with simplicity and flexibility in mind. The device allows physicians a method for introducing needles under CT or Fluoroscopy by visualizing and adjusting planned punctures prior to needle entry.

“RAD-GUIDE was invented to facilitate needle insertion by holding the needle in the correct orientation, especially for difficult angulation and positioning,” said Dr. Luc Lacoursière, MD, FRCPC. “RAD-GUIDE helps reach difficult targets, including those that are small and deep inside the body. It also reduces procedure length and reduces x-ray exposure for both the patient and the radiologist.”

The guide allows proper needle support and orientation for everyday problems such as needle navigation while corresponding to a CT image. RAD-GUIDE is intended for use in procedures such as biopsy, drainage, injection and ablation.

RAD-GUIDE and CT Needles

The RAD-GUIDE design gives added needle support for superficial as well as deep puncture procedures, providing the flexibility to perform a wide variety of CT guided procedures. RAD-GUIDE consists of a teal needle guide base, Top-Plate and adhesive strip. Once in position, centered above the skin entry point, the adhesive strip allows the guide base to be securely positioned. The grid-like perforation pattern on the Top-Plate provides sturdy support for multiple instruments. RAD-GUIDE allows physicians to introduce needles with accurate orientation by aligning the appropriate path to the anatomic target.

“Needles, especially longer and heavier needles, do not hold proper orientation at the beginning of procedures, especially when the supporting tissues are thin, such as the chest wall,” said Lacoursière. “In order to avoid redirecting the needle many times before advancing it to the target, a device should hold the needle at the right angle and orientation. This method avoids losing time, decreases x-ray exposure and avoids incorrect needle insertion.”

Preliminary clinical use demonstrates improved accuracy and reduced needle re-positioning with use of a needle guide. RAD-GUIDE enables greater efficiency and a reduction in procedure time for clinicians, resulting in a higher throughput of patients. Further, RAD-GUIDE offers an opportunity to improve patient care while minimizing hospital risk. RAD-GUIDE facilitates improved visualization of the needle trajectory and a reduction in the number of needle re-positions and punctures during a procedure. Through these benefits, hospitals are able to minimize the risks associated with accidental puncture.

RAD-GUIDE in use.

Additionally, RAD-GUIDE allows physicians to reduce high dose radiation exposure with a “hands-free” approach to punctures. “The RAD-GUIDE addresses concerns about precision, safety, rapidity and radiation exposure,” said Lacoursière. “It is very simple to use, and you do not have to expose your fingers to x-rays anymore!” Improved success rates and reduced radiation exposure both help raise clinical confidence in needle punctures and improving patient and staff safety.

For more information on RAD-GUIDE, contact your CIVCO account rep or visit www.CIVCO.com.

CIVCO’s MMI products include a wide range of infection control products, including ultrasound and CT covers, as well as ultrasound and CT device guidance, positioning, electromagnetic tracking and needle tracking for image fusion. At RSNA 2011, CIVCO is focusing on needle and instrument guidance for image fusion, CT and ultrasound.

Image Fusion: CIVCO’s Needle Guidance Solutions

eTRAX During Procedure

CIVCO recognizes that at any given time, a hospital imaging department has numerous imaging modalities in use. Traditional ultrasound imaging has multiple advantages: images are viewed in real-time, no radiation is delivered and ultrasound is comparatively inexpensive. However, modalities like CT and MRI deliver much more highly detailed images. By fusing the real-time ultrasound image with the more detailed, static CT or MRI image, interventional radiologists can gain the best of both devices.

CIVCO’s eTRAX™ and VirtuTRAX™ needle tracking systems increase clinical confidence and accuracy in targeting the type of difficult-to-access lesions frequently treated using image fusion. Both facilitate electromagnetic needle tip tracking in real-time and in conjunction with pre-acquired 3D volume datasets like those from CT or MRI scans.  When using either system, the location and orientation of the needle is clearly displayed on-screen, reducing procedure time, improving workflow and increasing patient safety. eTRAX and VirtuTRAX are frequently used for biopsy, drainage and ablation procedures.

CT Guidance: RAD-GUIDE™ by CIVCO

CIVCO's RAD-GUIDE

CIVCO’s newest introduction is RAD-GUIDE, a CT needle guide designed with simplicity and flexibility in mind. RAD-GUIDE allows proper needle support and orientation for everyday problems such as needle navigation while corresponding to a CT image. The device facilitates the introduction of needles under CT or Fluoroscopy by visualizing and adjusting planned punctures prior to needle entry.

“RAD-GUIDE was invented to facilitate needle insertion by holding the needle in the correct orientation, especially for difficult angulation and positioning,” said Dr. Luc Lacoursière, MD, FRCPC, President of Datum Medical and inventor of RAD-GUIDE. “RAD-GUIDE helps reach difficult targets, including those that are small and deep inside the body. It also reduces procedure length and reduces x-ray exposure for both the patient and the radiologist.”

RAD-GUIDE is intended for use in procedures such as biopsy, drainage, injection and ablation. For a full video demonstration of RAD-GUIDE, click here.

Ultrasound Guidance: CIVCO Needle Guidance and Infection Prevention

CIVCO's Infiniti needle guidance system

CIVCO is the industry leader in ultrasound needle guidance and infection prevention. We design, manufacture and market general purpose, endocavity and specialty needle guidance solutions for all major OEMs. Our needle guides are available in both disposable and reusable configurations, and all endocavity guides correspond to on-screen software guidelines. CIVCO’s ultrasound covers & equipment drapes protect against the risks associated with cross-contamination and are available in a wide range of materials and sizes. When used together, CIVCO’s ultrasound products provide for patient and staff safety during ultrasound and interventional procedures.

Visit our RSNA booth #8309 to see the full range of CIVCO needle guidance for image fusion, CT and ultrasound as well as our line of infection prevention solutions.

Dr. Juan Ramirez with young patients.

Rotary District 7980 Gift of Life Foundation has joined hands with numerous organizations to provide a safe, cost-effective, loving and sustainable solution for kids from the Dominican Republic and surrounding areas with congenital heart defects (CHD). These organizations include the Santiago Monumental Rotary Club, Rotary District 4060, Fundacion Corazones del Cibao, Dominican Republic Ministry of Health, Arturo Grullon Children’s Hospital and many other non-governmental organizations (NGOs), Rotary Clubs and Gift of Life Organizations.

According to the Dominican Minister of Health, CHDs are the 4^th leading cause of death in Dominican children under the age of 5 years. One percent of all live births will have a CHD, and at present, 5,000 kids are awaiting heart surgery in the Dominican Republic. Sadly, an estimated 25% of these children die annually due to the lack of available pediatric cardiac care.

The Pediatric Cardiac Surgical Program was established during 2002 in Santiago at the Hospital Infantil Universitario Dr. Arturo Grullon, through the tireless efforts of Rotarian Dr. Juan Ramirez, a pediatric cardiologist. “When these children receive treatment on time, they become healthy kids and return to their families, to grow and develop normally,” said Ramirez. They have the opportunity to become useful citizens to society. That’s the reason this program is a true Gift of Life.”

As a partnership, these organizations support multiple activities benefiting children with CHD.

• Organize multi-national volunteer surgical mission teams comprised of pediatric cardiovascular surgeons, cardiologists, anesthesiologists, PICU physicians and nurses and biomedical engineering support. Teams provide cardiac care to between 20-25 kids on each two-week trip four times a year.
• Volunteer team members work with the local Dominican medical team, providing training, exchange of ideas, techniques, cultural exchange and creating friendships.
• Fundraise for the critical purpose of purchasing desperately needed medical supplies, medications and instrumentation.
• Support the establishment of a new Pediatric Cardiac Care Institute through capital fundraising efforts. This public/private partnership is governed by the PCCI Board of Directors. The model has been used with the creation of children’s burn and oncology centers. Once the institute is fully staffed and functional, about 1,000 kids per year can be given the Gift of Life.

Lynda Hammond comforts a patient.

“The Pediatric Cardiac Surgical Program has provided the opportunity for me and my fellow team members to come together with incredible strength, commitment to our kids, their families and each other,” said Lynda Hammond, President of the Rotary District 7980 Gift of Life Foundation. “We, as a team, operate on a very high emotional level enabling us to share our emotions, support, sincere friendship and love extending beyond the time spent on missions. Rotary doesn’t get any better than this!”

Presently, two facilities provide pediatric cardiac surgery in the Dominican Republic; Cedimate, a private hospital in Santo Domingo, and Arturo Grullon Children’s Hospital, a public teaching facility located in Santiago. Neither site performs more than 100 surgeries per year; without an expanded facility the waiting list for kids needing surgery will continue to grow at approximately 400 kids a year. Gift of Life is helping to lessen that waiting list.

“The Dominican pediatric cardiac surgical physicians sometimes feel frustrated when we want to do things for patients and our environment limits us,” said July June, MD, Santiago, Dominican Republic. “This program (Gift of Life’s Pediatric Cardiac Surgical Program) has broken these boundaries, given us and ourchildren a thing that everybody deserves: opportunity. Because of this program, we have equipment, sponsors, volunteers and training for our team. We have met all these great, wonderful and loving people that teach us, share their experiences and are willing to help us reach the goal of being independent in the medical area, to grow as a multidisciplinary team.”

Dr. July June

Hammond views Gift of Life’s Pediatric Cardiac Surgical Program as the epitome of being a Rotarian. “This is what Rotary is all about – coming together to form lasting partnerships and friendships with like-minded people committed to making this world just a bit better than we found it,” she said. “On behalf of our kids, please consider helping us fix their little broken hearts and the hearts of the kids to come in the future.”

To donate, please contact lynda.hammond1@sbcglobal.net.

eTRAX provides significant clinical advantages over other technologies, including increased clinical confidence in targeting difficult-to-access lesions, improved workflow, reduced procedure time and increased patient safety. Dr. Hisham Tchelepi identifies two situations in which eTRAX is highly advantageous.  “The first is when accessing lesions in the dome of the liver where it is almost impossible to reach using the freehand technique or the conventional transducer guide, even for experienced radiologists performing such procedures,” he explained. “The second is when one is trying to access a lesion off plane to the ultrasound beam. You do not see the needle well, but the graphic illustration on the screen telling you where the needle tip is is quite impressive.” In this way, the needle does not have to be close to the transducer, leaving physicians able to “start the needle insertion on the lateral side of the patient while following the reduced trajectory from the front. This is excellent for procedures like PTC (percutaneous transhepatic cholangiography),” said Tchelepi.

In addition to increasing the clinical ease of procedures, eTRAX allows clinicians to be more confident with difficult or precise procedures. “Definitely I would say I have done procedures which I would have otherwise cancelled or turfed to CT,” said Tchelepi. “I would also say the precision eTRAX provides makes me comfortable placing needles near sensitive structures that I may not have attempted without it.” eTRAX is recommended for clinical applications including core biopsy, drainage, fluid aspirations and therapeutic delivery.

Tchelepi sees eTRAX tracking and guidance as promising for future development. “I would love to see it applied to radiofrequency ablation – treating small liver and kidney tumors with better accuracy and precision,” he said. “I use it now to place fiducial markers in tumors for purposes of radiotherapy, and I believe there is a need for variety of needle sizes to broaden the spectrum of interventional applications.” Ideally, Tchelepi would like to see an RFA eTRAX system that allows the usage of RFA or microwave probes.

CIVCO continues to develop and expand the technology. Currently, eTRAX is compatible with ultrasound systems from leading manufacturers, and Ultra-Pro e is compatible with all eTRAX and Ultra-Pro style brackets. The system consists of a custom reusable bracket and a disposable snap-on guide. Ultra-Pro e is available in 14 and 16 gauge sizes, offers multiple angle capabilities for shallow and deep access and is designed to increase the productivity of ultrasound-guided procedures.  The open channel design of the guide allows instruments to be positioned in the scan plane. Sterile replacement kits include guide, transducer cover, gel packet and colored elastic bands.

For more information about eTRAX and Ultra-Pro e, visit www.CIVCO-eTRAX.com or CIVCO’s RSNA booth, #8308.

Such infection control measures rely upon clinicians for implementation. Stephanie Pitts, Clinical Coordinator of the Vascular Access Team at St. Joseph’s Children’s Hospital of Tampa, Florida, is a nurse trained in sonography to facilitate vascular access. “I don’t think healthcare providers fully understand the role they play in hospital acquired infections,” said Pitts. “Healthcare providers go to work to help people. I think if they really realized that they were spreading disease they would be more compliant with infection control procedures.” Given thorough infection control procedures and the cooperation of hospital staff, Pitts’ vascular access program has yet to have an insertion related infection.

In a recent study at the Mayo Clinic, just 14 out of 13,354 patients undergoing percutaneous ultrasound-guided procedures over a two year period developed an infection likely related to the procedure.[iv] Nearly every patient with an infection improved with antibiotic treatment alone.  Mayo Clinic facilities employ a rigorous infection control process for ultrasound-guided procedures. In hospitals worldwide, sonographers and clinicians who use sonography are focused on preventing HAI within their departments.

Infection Prevention Across the Department: Invasive and Noninvasive Ultrasound Procedures

Some of the simplest infection prevention methods are recommended prior to both the most basic external scans and invasive ultrasound-guided interventional procedures. “Hand washing before and after every exam is the best method to reduce infection,” said Stephanie Ellingson, Director of the Medical Sonography Program at the University of Iowa Hospitals and Clinics in Iowa City, Iowa. “Regardless of the type of scan, we also wear a glove on the scanning hand at a minimum, and we disinfect all our transducers with their cords after each exam, with either wipes or T-Spray.” Each OEM has recommended methods of disinfecting their transducers.  

Active prevention methods increase with risk level. “Any type of procedure where you open the body, even to a needle, there is a known risk for infection,” emphasized Ellingson. For invasive procedures, her department employs a two person approach, with one sterile healthcare provider, usually the physician, operating the transducer and patient contact, while a non-sterile sonographer operates the instrument panel and may handle the transducer cord if needed. “In the case that a patient arrives with an open wound, or even a significant open skin infection, rash or ulcer, we absolutely use sterile gel and a sterile probe cover for the transducer,” said Ellingson. Probe covers are also used during intracavitary exams, and sterile gel is used during neonatal exams as well.

Pitts echoes Ellingson’s emphasis on hand washing and sterility during invasive procedures. “Everything poses an infection threat to the patient,” said Pitts. “I can’t emphasize enough the importance of excellent hand hygiene.” During PICC insertion procedures, Pitts’ team uses multiple layers of sterile protection.

Pitts is most often involved in venous access procedures. “We use sterile drapes to provide the maximum barrier protection, and sterile gloves, mask and gown for the inserter to best protect the patient from any germs that the inserter may present,” she explained. “We always use a sterile probe cover, because that sterile cover allows the probe to be inside the sterile field.” St. Joseph’s also requires that anyone in the room wear a cap and mask, and tries to limit traffic into and out of the room.   

After intracavitary exams, Ellingson’s department disinfects the transducer with Cidex OPA, and the transducer is thoroughly cleaned before being placed in in the liquid. “It’s critical to remember that the disinfectant has to be in contact with the transducer surface to work,” points out Ellingson. “You absolutely have to remove the gel, clean with enzymatic cleaner, rinse and dry, before disinfecting the transducer in OPA.” Each time a transducer is disinfected, it is noted in a log.

Pitts’ team uses hospital-approved cleaning wipes for each transducer. “It’s important to check with the manufacturer of the transducer to ensure that the cleaner that is used will not harm the device,” said Pitts. Ellingson agrees, “Transducers are expensive devices, and I’ve seen facilities use solutions on transducers that will eventually cause them harm.”

Further, given the ability of gel bottles to harbor germs[v], the University of Iowa empties and cleans gel bottles once a week and sonographers never touch a patient with the tip of the gel bottle. In vascular labs, where the risk of transmitting infection is high, the various blood pressure cuffs used during procedures are disinfected between patients and open wounds are wrapped with cellophane to prevent contamination of the cuffs during usage.

Patients and Hospital Acquired Infection: Awareness and Conversations

MRSA (methicillin-resistant staphylococcus aureus), an often nasty infection frequently transmitted in hospitals, has received a lot of media attention over the last few years. How much that publicity has made patients aware of the danger is debatable. “Patients do not usually have a lot of knowledge related to hospital acquired infections,” said Pitts. “It is something they have heard about, but they don’t think it could ever happen to their child. When we teach families about the PICC, the majority of our teaching is on infection prevention.” Pitts’ group educates parents so they know what to expect from the hospital staff, and they generally cover hand hygiene, sterile technique and the proper way to “scrub-the-hub.”

Ellingson agrees that hospital acquired infection is not generally a topic patients ask about, however, they are more observant and sensitive to infection concerns than in years past. “I tell my students to wash their hands, both before and after the procedure, inside the treatment room,” she said. “That way, even if the patient is too timid to ask, they are able to see you take care to be as clean as possible. Patients definitely notice and appreciate this.”

As the risks are higher with invasive procedures, staff has the opportunity to educate the patient fully prior to the procedure. “For invasive procedures, our patients have to go through an informed consent process,” explained Ellingson. “There, they are informed about the risks of the procedures, including risks of infection. We tell them that we do everything we can to minimize that risk.” For noninvasive procedures, where no informed consent process is required, Ellingson tells her students to be aware patients may have concerns they are too hesitant to voice, and to answer any questions asked as best they can.

Pitts notes that the issue of infection and invasive, ultrasound-guided procedures is not always clear cut.  When the patient presents with an already positive blood culture, they may still need venous access. “There are times that PICC lines are not placed in patients because they have a positive blood culture, however, sometimes patients are so sick that they need central access,” said Pitts. “It is not always a black and white scenario. Our health care team uses evidence-based practice to determine what is best for each individual patient.” In these cases, the sterile procedures, including sterile probe covers, ensure the patient does not contaminate equipment like transducers.

Vigilance Keeps Ultrasound Safe

Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention, has named hospital acquired infection one of “six winnable battles in healthcare,” and has committed the CDC to focusing on the issue.[vi] Recent publications about ultrasound and infection transmission have shown both that the potential for disease transmission is present[vii], but that even ultrasound-guided interventional procedures are overwhelmingly safe for patients. As demonstrated by Ellingson and Pitts, the battle against hospital acquired infections involving sonography definitely requires a level of constant vigilance and attention. As shown by the recent Mayo Clinic study, given healthcare providers’ willingness to follow infection control procedures, HAI involving sonography can be reduced to a very low level. From sterile probe covers to consistent hand washing, infection control procedures are simple to implement and save numerous patients’ from infection each year.

[ii] Ridge, Christy. “Sonographers and the Fight Against Nosocomial Infections: How Are We Doing?.” Journal of Diagnostic Medical Sonography. 21. (2005): 7-11. Print.

[iii] Cervini, Patrick, Gina Hesley, Rodney Thompson, Priya Sampathkumar, and Knudsen John. “Incidence of Infectious Complications After An Ultrasound-Guided Intervention.” American Journal of Roentgenology. 195. (2010): 846-850. Print.

[iv] Cervini, Hesley, Thompson, Sampathkumar, and John 846-850

[v] Ohara, T., Y. Itoh, and K. Itoh. “Ultrasound instruments as possible vectors of staphylococcal infection.” Journal of Hospital Infection. 40. (1998): 73-77. Print.

[vi] Stobbe, Mike. (2010, September 30). Cdc chief picks 6 ‘winnable battles’ in health. Retrieved from http://www.msnbc.msn.com/id/39442567/ns/health-health_care/

[vii] Ohara, T., Y. Itoh, and K. Itoh.

Dr. Robert Raw, M.D., is Director of the Regional Anesthesia Study Center of Iowa (RASCI) at the University of Iowa Hospitals and Clinics, and has practiced using both conventional and ultrasound guided regional anesthesia. Dr. Rajnish Gupta, M.D., Assistant Professor of Anesthesiology at Vanderbilt University School of Medicine, was introduced to ultrasound guidance as a resident. Both are leaders in the field today.

A New Technique Emerges

Robert Raw, MD

Raw pursued USGRA as soon as it became truly feasible in a clinical environment. He saw basic questions surrounding the early practice of USGRA – most notably, how did ultrasound guidance equate with the utility, advisability and advantages of nerve-stimulation? “As an academic regional anesthesia teacher, it was clear I needed to be a debater rather than a listener,” Raw said. “Since the department would not buy an ultrasound for regional anesthesia, at that time, I bought my own system and regarded the machine costs simply as the cost of a learning course. The answers to those early questions are now largely answered, but many new questions have been raised since then.” Raw’s department has subsequently purchased 6 ultrasound systems dedicated to regional anesthesia, and Raw sold his early machine.

Gupta began learning ultrasound guided regional anesthesia during his residency at the University of Michigan. “At the beginning of my residency, about four years ago, students became frustrated pretty quickly with regional anesthesia delivery, partly because it’s difficult to gain a comfort level using nerve stimulators and landmarks to deliver anesthesia,” Gupta said. “During my last year, the hospital acquired a SonoSite MicroMaxx^™, and a few of us had our interest piqued by the machine. We got as much out of that ultrasound system as possible.” Much like Raw, Gupta has seen interest among existing faculty members and residents at Vanderbilt increase over the last few years.

Rajnish Gupta, MD

“When I arrived at Vanderbilt, they had already purchased an ultrasound system for regional anesthesia,” Gupta said. “However, not very many people were comfortable with it. I pushed to learn more, and the value was evident – you could see structures, visualize the variability in people, see the needle and the anesthetic surround the nerves, it was amazing.” Significant advancements in ultrasound technology have continued to increase the level of detail and clarity available to anesthesiologists.

Both Raw and Gupta actively participate in research to advance the field of ultrasound guided regional anesthesia. Raw focuses primarily on clinical delivery of USGRA. “My specific interest will always be primarily in the clinical delivery of regional anesthesia to the benefit of patients and in persuading other anesthesiologists and also surgeons of those benefits,” explained Raw. “Therefore, I seek to design better blocks, better room setups, and better techniques that are more time efficient.” Additionally, Raw explores ultrasound as an investigational tool in studying nerve block injury, and he considers the information derived from the use of ultrasound in regional anesthesia research to be revolutionary.

Gupta agrees, particularly with regard to the study of anatomy related to nerve blocks. “We’re finding out that the structure model we were taught for a long time isn’t always right,” Gupta said. “You can mark the landmarks, and the nerve should be right underneath that, but when you use ultrasound, you discover the rule is actually variation.” Physicians are consistently finding variations of multiple kinds, from the nerve location itself to the relationship with surrounding tissue, and ultrasound facilities the visualization of the nerve location and the surrounding vascular, bony, muscular and visceral structures. Other modalities, including CT and MRI, could also provide guidance in this regard, but ultrasound is by far the most practical modality available.

Gupta’s research focuses on the training of doctors and resident in ultrasound guided regional anesthesia technique, a step key to the further adoption of USGRA. “There’s a huge variation in physical skill sets, the caliber of those skills and in levels of previous training,” Gupta said. “This means we need to find the best ways to get doctors up to speed accurately and effectively.”

Regional Anesthesia and Needle Guidance

Needle guide and sterile cover as used during nerve block

Needle guidance companies, including CIVCO, have developed new needle guidance technology for the regional anesthesia market. CIVCO has multiple regional anesthesia solutions, including the Infiniti Needle Guidance system and the SonoSite L25 Series Needle Guide.  As with many ultrasound guided procedures, some clinicians prefer needle guidance for USGRA, while others choose to freehand during procedures.

Gupta has not relied upon needle guidance during the past, but is open to the possibility in the future, particularly while training residents. “Personally, I haven’t normally used one,” explained Gupta. “In the past, I’ve tried older systems, but they were designed for biopsy and vascular procedures, not regional anesthesia. They were made to be used out of plane. Recently, I’ve been investigating concepts similar to CIVCO’s Infiniti guide, which is constrained in the appropriate dimensions and flexible in others.” Infiniti provides accurate in-plane guidance, and offers multiple angle capabilities for both shallow and deep access.

Gupta admits that watching residents learn two-handed technique in potentially dangerous anatomical areas can be nerve-wracking. “As trainers, we need to improve their success rates and skills quickly,” he said. One of the most common problems is drift. “Your eyes are looking at the ultrasound screen, but you may not maintain alignment with your hands – the probe drifts away from the needle,” explained Gupta. “There are a variety of ways to maintain alignment, so we teach these and investigate the best solutions. CIVCO’s Infiniti^™ needle guide is one of these solutions.” The key to making needle guidance a useful training tool for regional anesthesia is specializing the technology to this intended use.

Raw, on the other hand, does not use a needle guidance system for regional anesthesia. “I certainly can see some merit in it for aspiration of large fluids collection and for biopsy of large tissue lesions,” Raw said.

Both Raw and Gupta use sterile covers in more complex regional anesthesia procedures. “We use a full sleeve sterile over when performing large, complex procedures, such as placing perineural catheters,” Raw explained. “This is when we use full wide field sterility, gowns, mask and gloves as well.”

Procedures are similar in Gupta’s facility. “We use sterile probe covers when placing nerve catheters since they are going to stay in for several days,” Gupta said. CIVCO offers a wide variety of probe covers to meet numerous clinical infection control needs.

With prominent clinicians on both sides of the issue, it remains to be seen whether needle guidance becomes a standard of care in regional anesthesia. Constant innovation on the part of ultrasound OEMs and needle guidance developers may well provide clinicians with further solutions, making needle guidance advantageous. Further, as noted by Gupta, needle guidance has huge potential as a training tool for physicians. As young doctors are trained using needle guidance for USGRA, they may continue to do utilize it beyond their training programs.

The Future of Ultrasound Guided Regional Anesthesia

Gupta and Raw agree that ultrasound’s role in regional anesthesia is permanent. “The last decade has been spent defining ultrasound’s role, and it’s pretty well established at this point,”

CIVCO's Infiniti needle guidance system

explained Gupta. “Ultrasound guidance isn’t a necessity, and many people do well without it, but it’s an integral part of current available tools. For many people, it’s an essential tool.” Over time, Gupta feels ultrasound guidance will lead to higher success rates and fewer complications in regional anesthesia.

Raw looks at the future of this field in two facets: clinical applications and technology advances. “Future clinical applications will be a steady process of evolution as doctors simply try things out,” Raw said. “Some ideas will be silly and some will be brilliant. Each new USGRA idea will be brilliant to its own inventor, but broad clinical process will slowly clarify the basic questions: is it safer, is it more effective, and is it easier?” This process of physician innovation will continue to improve and increase the clinical application of USGRA.

Expansion in transducer technology will be a key advancement over the next decade. “A greater variety of transducers being made available gives us more selection flexibility,” Raw said. “I see regional anesthesia dedicated transducers being designed with better hand holding ergonomics. I see multi-scan transducers that are actually complex multiple transducers in one, exploiting better and faster computing capacity of machines. The challenge is to see deeper, better, with faster frame refresh rates.” Raw also envisions enhanced fusion and high frequency transducers and faster refresh rates for portable ultrasound.

Raw emphasizes the importance of increased computing capacity and cart design in future ultrasound systems. “There will be a move towards fixed mini-cart mounted systems with very high computing capabilities,” he explained. “Cart mounted systems also need to have un-interruptible power systems built in. Foot print size is everything and slim, vertical carts are starting to get more common. We need slim standing high capacity systems, something between the mega top-end TEE grade machines, and the low-end hand portable machines.”

From his perspective, Gupta focuses on techniques for improvement in clinical delivery. “I’m not sure which techniques will win out over the next decade, but reducing hand-eye difficulties and maintaining the stability of the probe at the same time will be important,” he said. “Imaging techniques are constantly evolving, with higher resolution and then 3D visualization.” Gupta does see development in the application of 3D imaging to USGRA, which can be more difficult than application to tumor imaging or biopsy. “At a recent ASRA meeting, Ultrasonix displayed a pseudo-3D tracking system – you can see the tip tracking, but the image actually looks like the 2D image that you are used to,” Gupta said. “This kind of tip tracking increases accuracy, precision and speed, acquiring the image like it’s needed for medication delivery.” The SonixGPS technology mentioned by Gupta incorporates CIVCO’s eTRAX™ needle tip tracking system.

Ultrasound guidance for regional anesthesia traces its roots back to 1978, when the first procedure was performed and described for publication. Since then, a dedicated group of clinicians have researched and practiced the technique, and ultrasound OEMs have continually delivered advanced technology. “The level of detail we’re seeing now that we couldn’t see even five years ago is unbelievable,” commented Gupta. The past five years have marked a paradigm shift within regional anesthesia.[ii] Given the ability of USGRA to minimize patient discomfort, procedure length and nerve injuries while increasing success rates, ultrasound guidance for regional anesthesia will continue to expand and mature over the next decade.

[ii] “Center for Ultrasound-Guided Regional Anesthesia.” Dartmouth-Hitchcock Medical Center. . N.p., n.d. Web. 17 Jun 2010. <http://www.dhmc.org/dhmc-internet-upload/file_collection/reg_anes_for_web.pdf>.

eTRAX: CIVCO’s Breakthrough Needle Guidance System

CIVCO Medical Solutions has introduced eTRAX, a breakthrough needle guidance system, expanding real-time image-guided navigation into a new dimension. Featuring an electromagnetic sensor embedded into the needle tip, eTRAX is an image-guidance tool kit which supports image fusion for ultrasound and enables real-time 3D instrument guidance in a variety of clinical settings. eTRAX acts as a real-time, 3D anatomical roadmap for the body, aiding in minimally invasive procedures.

Paired with a sterile sheath, eTRAX’s electromagnetic (EM) tracking needle guidance enables accurate placement of a broad spectrum of standard instruments using co-axial technique. Given the ability to fuse other imaging modalities with ultrasound, eTRAX provides physicians with a greater range of choices for targeting and supremely accurate tool for tracking of the tip of a needle under real-time, image-guided navigation.  “The eTRAX tool kit is unique in both its design and clinical versatility,” said Dr. Bill Whitmore, MD, Chief Medical Officer at CIVCO. “The system is also designed to allow indefinite re-use of the relatively expensive active EM tracking sensors.”

EM tracking with eTRAX provides significant clinical advantages, including increased clinical confidence in targeting difficult to access lesions. “Ultrasound alone cannot always provide clinical confidence, often due to multiple tissue interfaces, bone or air blockages,” explained Jack Scully, Vice President of Ascension Technology Corporation. Ascension developed and manufactures the EM tracking sensors used in eTRAX.  “Importantly, EM tracking allows both in and out-of-plane navigation to optimize the needle’s trajectory to a lesion,” continued Scully. “With 3D guidance, the physician can independently position both the biopsy needle and an ultrasound transducer for the safest and fastest target access.”

With eTRAX, ultrasound brackets enable attachment of a sensor for real-time image fusion and also support an in-plane mechanical guide for ease of instrument orientation during ultrasound assisted targeting. Coupled with an OEM ultrasound system, eTRAX can improve the safety, speed and accuracy of instrument placement and save costs by reducing both procedure time and complications.

eTRAX in Action

eTRAX Guidance User Interface

Dr. Thierry de Baere, head of Interventional Radiology at the Institut Gustave Roussy in Villejuif, France, worked with CIVCO to validate the eTRAX system. “The system components are easy to work with, fast to setup before a biopsy, and very intuitive,” said de Baere.  CIVCO’s guidance system may be used with devices for numerous applications; de Baere and his group initially used the system for tissue biopsy, but plan to utilize eTRAX during ablation procedures as well.  “We biopsied six patients using the eTRAX guidance system, and all patients were successfully biopsied with rapid placement of the needle within the target,” said de Baere. “eTRAX allows you to follow the progression of your needle tip more easily, due to the excellent accuracy of the system.”

de Baere also took advantage of eTRAX’s flexibility during the validation testing. “It allows different access routes for the needle and the imaging, which is really useful when an intercostal access is chosen for a liver biopsy,” he said. “We could appreciate that in two of our six biopsies. It is much more flexible than any guiding kit linked to the probe.”

Scully emphasizes the safety aspect of EM tracking for interventional procedures, such as those performed by de Baere. “Faster, more accurate and safer procedures reduce costs and patient trauma,” he said. “For deep-seated lesions, the data is showing EM tracking facilitates 100% success with a single needle stick. The technology is especially helpful in enabling biopsy procedures to be performed successfully by less experienced physicians while significantly shortening an otherwise steep learning curve.” de Baere, a highly experienced physician, also appreciates eTRAX’s short learning curve, as well as the easy to understand display provided by OEM software.

As eTRAX continues to develop and is used by more clinicians, de Baere sees continued benefits to both patient and clinician. “In the future, it will probably contribute to shortening the overall biopsy time, namely the duration of the needle placement itself,” he said. “Consequently, the procedure will be better tolerated by the patient. In a few cases, it might reduce the number of punctures.”

Whitmore agrees and underscores the increase in clinical confidence gained through eTRAX usage. “Any physician using images for guiding a medical procedure wishes to ‘see’ and to feel comfortable knowing exactly where they are going, in real-time, as accurately as possible,” he said. “Electromagnetic instrument tracking and multi-modality image fusion with accurate registration is the current state of the art for satisfying this need.”

Evolution and Future of Tracking Technology

eTRAX During Procedure

The EM tracking technology at the core of eTRAX has a significant history, developing from a military technology to a commercially viable medical accessory over the course of the last 30 years.  Vermont-based Ascension Technology Corporation supplies eTRAX’s EM tracking sensors. “Sensor-driven ultrasound is the ultimate hand-eye coordinator,” said Scully. “It lets the physician see the needle tip, the internal target, and the anatomy in real-time – without radiating the patient or the clinician.”

eTRAX enhances the value of image fusion, which in itself has been a major technological advancement in the image-guidance industry recently. GE Healthcare’s LOGIQ E9^©, Ultrasonix’s SonixTOUCH^™ and Esaote’s Virtual Navigator^™ all offer image fusion and assisted navigation for interventional and ultrasound procedures.  Philips Healthcare recently acquired Toronto-based Traxtal, Inc. Traxtal has been a pioneer in EM tracking and guidance with their PercuNav computer assisted image-guidance system. PercuNav, like eTRAX, utilizes both multi-modality image fusion and EM tracking needle guidance.

eTRAX and PercuNav are today’s cutting-edge technology – developed to better patient care and enhance clinicians’ capabilities. Whitmore and Scully see EM tracking becoming the stand of care for image-guided procedures. As that happens, the technology involved will continue to develop rapidly. Whitmore sees software, hardware and robotics advancing congruently. “Hardware will advance in parallel to the point where precise 4D instrument navigation using active tracking will be paired with robotics,” said Whitmore. “This will enable a qualified clinician to precisely and safely target a lesion with a single pass of the instrument anywhere in the body from a remote console using something similar to a joystick in a video game. This will be dramatically safer for both the patient and the physician.”

Scully believes eventually there will be a progressive reduction in the cost of EM tracking sensors. “The next frontier will be truly disposable, low-cost sensors,” said Scully. “It will happen once sensor-driven ultrasound becomes standard practice. We also will see steady advances in signal processing and metal immunity that will widen applications and acceptability in numerous new image-guidance procedures. Long-term, first embedded, and then wireless sensors will make tracking less obtrusive and permit tighter integration into medical instruments become standard issue.”

eTRAX Sensor and Cord

The evolution of EM tracking for image-guided medical interventions will continue to benefit both patient and clinician. “Electromagnetic tracking alone and possibly in combination with other tracking methods will increasingly be applied for image-guided medical interventions,” said Whitmore. “As imaging technology advances and image management and workflow software improves, more accurate diagnoses, treatment planning and faster, safer targeting will be further supported by increasingly accurate and continuously updated image fusion.”

eTRAX, and its counterparts, are a significant step in this direction. For more information on eTRAX, please visit www.CIVCO-etrax.com.