Special Focus-The New Medical Marvels-October 2011
Attaching Muscle to Bone
A rotator cuff tear, where tendon and muscle tissue is uprooted from a bone in the shoulder, can make it hard to do normal things, such as lifting your arm to brush your teeth, and it’s a leading cause of shoulder pain. When nonsurgical rehabilitation fails and pain persists, patients may require rotator cuff surgery to reattach the torn tissue to the head of the upper arm bone (humerus). In the past, open surgery was the norm for repairing this injury. But minimally invasive arthroscopic therapies for rotator cuff tears have become more popular during the last 10 to 15 years, according to Andy Joiner, vice president and general manager of U.S. commercial operations at Tornier, an orthopedic medical device firm in Edina.
Tornier’s ArthroTunneler is a one-use device that enables surgeons to arthroscopically place intersecting tunnels in the arm bone and pass multiple sutures through it to “tie” the rotator cuff muscle back to the bone. And it’s the only device that allows surgeons to do a minimally invasive procedure without anchors.
Traditionally, metal anchors are used to hold sutures in place, but ArthroTunneler only uses sutures to secure tissue to the bone. A surgery may require up to four or five anchors, costing as much as $500 apiece, so eliminating the anchors reduces the cost of the operation. In addition, there’s a risk that patients’ bodies will reject the anchors. Patients recover from the anchor-less surgery in about four to six weeks.
The ArthroTunneler is inserted though the top of the shoulder; a 1.8 mm drill bores into the bone about 2.22 mm deep, depending on the patient. Another tunnel is drilled perpendicular to the first. “So you tunnel down and intercept that tunnel, reinsert that suture wrapper, and pull that suture up and out of the rotator cuff tissue, and now externally you have two suture [ends] and you can tie knots and slide back down,” Joiner says.
A Visible Path
Imricor Medical Systems, Burnsville
Heart ablations, where tissue is strategically burned to stop electrical conduction causing atrial fibrillation or ventricular tachycardia, are typically done with x-ray guidance. But Imricor Medical Systems’ Steve Wedan, CEO of the Burnsville-based cardiac device company, says the doctor can’t see the soft tissue he’s trying to ablate because x-rays register only bones and hard objects, such as tools and the catheter itself.
Atrial fibrillation (AF) affects more than five million patients in the U.S., according the Mayo Clinic, and can leave patients lightheaded and put them at a higher risk for stroke. The first course of action for stopping AF is drug therapy. If that doesn’t work, doctors may recommend ablation. Ablation is also used for those with ventricular tachycardia, a more serious irregular heartbeat that puts patients at risk of sudden cardiac death.
Imricor developed the Vision MR EP Ablation Catheter with magnetic resonance (MR) coils in the tip, allowing the catheter to be tracked using MR imaging instead of an x-ray as it’s advanced through the inferior vena cava in the groin and into the heart. Soft tissue and hard objects are visible on a screen linked to the MR imaging system, so a doctor can track the device and confirm that the ablation was a success; burned areas appear in bright color and other tissues are gray.
At a time when people are worried about radiation and its effects, it’s a “radiation-free procedure that’s faster and more effective,” Wedan says. It’s faster because it’s like “taking off the blinders so doctors can see exactly what they’re doing,” he says, and it’s more effective because doctors are more likely to ablate the right areas.
Five years after the procedure, atrial fibrillation ablations using x-rays are only 29 percent effective, Wedan says. After multiple procedures, the success rate goes up to 63 percent. “A good amount of patients get an ablation and then find that the atrial fibrillation returns, and so then they have a second ablation or third ablation,” he says.
“What we’re hoping is to show that ablation is so effective, and so cost effective, that under MR guidance it becomes the first line of therapy.” That puts Imricor in a sweet spot because, Wedan says, the company has patented the technology: “Nobody else can make a catheter that is safe for use in MR.”
Speaking the Language
GeaCom, Inc., Duluth
Imagine you’re in a country where English is not spoken widely, and you end up in the hospital. How do you talk to the doctor? Duluth medical device company GeaCom, Inc., has developed the Phrazer, a handheld touchscreen device that allows medical personnel to “speak” to their patients in any language.
First, Phrazer determines a patient’s language. Michelle Laurion, global sales and marketing manager at GeaCom, says a patient can use Phrazer’s interactive map and point to his or her country and choose from a list of the most commonly spoken languages there, or just choose from a list of languages.
“Once their language is identified, they begin their interaction with Phrazer,” Laurion says. A culturally appropriate doctor appears in a pre-recorded video and asks a patient for his or her name and basic information, medical history, insurance, current symptoms, and complaints. The patient wears headphones and answers questions via the touch screen, pointing out on a picture of the human body where the symptoms are occurring. The information is instantly uploaded to the electronic medical records system and sent wirelessly to the caregiver’s headphones. The caregiver hears the information in his or her own language.
Scripted, pre-recorded videos are played in a sequence indicated by the patient’s symptoms. For example, videos could show how x-rays or blood draws happen, or a doctor explaining medical protocols. The device also asks for consent to treatment. Phrazer runs on the Google Android operating system, is battery powered, and has Bluetooth wireless connectivity.
Laurion says the product is available in the U.S. and is targeted at hospitals and clinics for use at the point of admission and especially in emergency situations. “When somebody comes in, without having to get an interpreter on the phone, or try and find one in the hospital system, [Phrazer] can quickly determine who this person is and what their current symptoms and complaints are so that the doctor can begin the diagnosis and treatment of the patient,” Laurion says.
Tactile Systems Technology, Inc., Minneapolis
Lymphedema, a pooling of fluids in the limbs and trunk due to an impaired lymph system, can happen for a number of reasons, including a congenital malformation or disruption from radiation therapy, infection, or trauma. Without a way to flush the lymph system, which carries toxins cleansed from the blood, swelling occurs.
One way to combat the swelling is with manual lymphatic drainage massage from a therapist, but that’s time consuming and expensive. Tactile Systems’ Flexitouch mimics the motions of a therapist with a garment that contains 27 to 32 air chambers that inflate and deflate sequentially. For instance, the garment’s pockets may work from the thigh to the calf to the foot and back again, directed by a pre-programmed controller. Flexitouch works by moving fluids through the lymph system, allowing the body to dispose of excess fluid.
However, some patients need larger Flexitouch garments because they are physically bigger or because they have severe swelling. So Tactile Systems spent a year redesigning the system and launched the Flexitouch EXT in January. “We had to do some technical changes to it to make sure that it applied the right kind of pressure when [the garment] was extra large,” says Kathy Horton, marketing communications manager for Tactile Systems. The EXT line has relocated air hoses that can be used as handles to position the product. Flexitouch EXT is made of soft, durable fabric with Velcro closures, and most insurance companies cover its cost with a doctor’s prescription.
Patients get measured much like they would for clothing. Tactile Systems pre-programs the controller to meet the specific needs of the patient. “We then send a trainer to their home to teach them how to put it on, how to run the machine, and all they have to do is press the on and off button,” Horton says. Typically, a one-hour program does an entire limb. The same work could take a massage therapist several hours.
Horton says, “It’s a very gentle pressure, and it moves the fluid from the farthest part of your limb all the way up to your trunk.” The lightweight, portable controller is easy to use with large buttons and an LCD screen.
Bracing for Less Pain
OrthoCor Medical, Minneapolis
Fifty percent of Americans will likely experience knee pain at some point in their lives, so the market for knee pain relief is enormous. Prepared to capitalize on this fact is OrthoCor Medical, a Minneapolis-based medical device company that developed a brace approved for temporary relief of joint pain, and postoperative pain and swelling for superficial soft tissue. John Dinusson, CEO and president of the company, says the OrthoCor Active Knee System is prescribed by physical therapists and, increasingly, orthopedic doctors to offer a noninvasive, surgery-free option for pain relief.
While it looks similar to regular knee braces, the OrthoCor brace uses pulsed electromagnetic frequency (PEMF) technology and heat to alleviate pain. Patients can’t feel the PEMF field, but “internally it is creating frequencies that we’ve proven create calcium calmodulin ionic bonding, which creates more nitric oxide, which replicates the body’s natural healing process, and reduces pain and edema,” Dinusson says. Radio frequency coils embedded in the fabric generate the PEMF waves.
The heat is supplied by thermal pods—like the oxygen-activated heat wraps found at the drugstore—that slip into the brace on either side of the knee. This automatically starts the PEMF therapy, which lasts about two hours and can be repeated during the day. The heat reduces inflammation and soothes sore muscles and tendons.
According to the Orthopedic Research Society, a research organization in Illinois, people using OrthoCor Active Knee brace had a 45 percent reduction in pain. OrthoCor hopes to gain approval for similar devices for wrists, elbows, ankles, and backs in the next few months.
The OrthoCor Active Knee brace comes with a charger and battery and a two-week supply of pods. “We’re an alternative for pills and knee replacement,” Dinusson says, adding that the brace is a complementary therapy to surgery, cortisone injections, and anti-inflammatory medications such as ibuprofen.
Interrad Medical, Plymouth
It doesn’t happen too often, but when a central venous access catheter becomes dislodged, the results can be life threatening if medication or nourishment to a patient is cut off. For the most part these catheters—which provide access to a patient’s vascular system, typically in the hand, arm, or neck—are secured with sutures or adhesive. Sutures can tug on skin and, in some instances, pop out. Adhesives can be irritating to the skin, and some patients are allergic to them. The adhesives can also break down over time due to oils in the skin.
Like many doctors who’ve been called upon to redo a dislodged catheter, Dr. Michael Rosenberg, the inventor of SecurAcath, thought there must be a better way to secure them. Jeff Killion, vice president and chief marketing officer, says Dr. Rosenberg had an idea: “‘Instead of trying to strap things down on top of the patient’s skin,’ he thought, ‘why don’t we put something underneath the skin.’”
SecurAcath is faster to place than suturing (which takes five to six minutes) and using adhesives (three to four minutes). Once a catheter has been placed, SecurAcath is folded in half; two knobs, or anchors, are slipped under skin in the opening. The device then unfolds and the anchors spread out in the tissue just beneath the skin. Above the skin, the device is secured to the catheter. SecurAcath reduces catheter wiggle, which can lead to irritation in the skin and infection, and makes it easier to clean the catheter site. The device is approved to stay in place as long as the catheter is in place. Killion says one patient he knows of had a peripherally inserted central catheter in his arm for seven months.
Interrad has gotten a positive response from clinicians who would prefer not to suture catheters in place, since it exposes them to the possibility of needle sticks and blood-borne disease. There’s nothing sharp about SecurAcath, so there’s no way to prick your skin with it.
SecurAcath received its European CE mark and Health Canada clearance for use in those markets last year. It also has FDA clearance. With an estimated 15 million central venous access catheters placed in patients around the world each year, Killion thinks SecurAcath could become the standard for securing catheters.
Growing Lifesaving Cells
Wilson Wolf Corporation, New Brighton
In a study of its own processes, Baylor College of Medicine in Houston found it saved $6,600 in cell culture materials and reduced the number of its cell culture devices from 318 to 12 when it employed the G-Rex (which stands for gas permeable rapid cell expansion) device from Wilson Wolf Corporation. John Wilson, CEO of the New Brighton–based cell culture technology company says, “The whole process of growing cells has been stagnant, I think, for about 150 years.” A far cry from the glass bottles used in the 1850s and contemporary cell culture devices such as flasks and bags, the G-Rex allows researchers to grow more cells SecurAcath from Interrad Medical ensures that central venous access catheters don’t get dislodged. OrthoCor’s Active Knee System combines a brace with pulsed electromagnetic frequency technology. in a smaller space more quickly.
Researchers in the biomedical industry are constantly growing cells for studies, but Wilson says an exciting development lies in adoptive cell therapy (ACT), in which cells from a cancer patient are withdrawn in a blood sample; certain disease-fighting attributes from the cells are grown to a high cell quantity, then infused back into the patient to fight cancer.
Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute in Bethesda, Maryland, and a pioneer in gene therapy and immunotherapy, found out about G-Rex from the Baylor study, and is now using it in his treatment of late-stage melanoma. “They’re identifying ways to make cells from the patient’s immune system, called T-cells,” Wilson says, then growing them in G-Rex. The survival rate of late-stage melanoma is less than 1 percent, Wilson says, but in a study of 93 Rosenberg patients who received this therapy, more than 20 percent experienced complete remission.
Rosenberg is using the soda can– sized G-Rex because it can grow 10 to 20 times more cells than a regular culture device. Cells are placed in growth-enabling glucose water and have access to unlimited oxygen via a proprietary gas permeable membrane at the bottom of the device. Cells are heavier than the liquid, so they fall toward the permeable membrane.
“Normally, the oxygen has to come from the top of the liquid,” Wilson says of the traditional culture devices. But liquid doesn’t hold much oxygen, so researchers put a small amount of liquid on the cells; that way, the cells are close to the oxygen. But with so little liquid, and the growing cells consuming the glucose in it very quickly, lab workers need to replenish the media every other day. With the G-Rex, researchers can in some cases fill it, place it in an incubator, and forget it, and won’t have to intervene much while the cells are growing.
The goal is to use the G-Rex as a springboard for any kind of emerging adoptive cell therapy and to provide those using G-Rex with a patent license. Wilson holds a patent in conjunction with Baylor College of Medicine. “We found a really clever way to grow more cells in a shorter amount of time, and that’s a big deal for people who are more or less on death row,” he says.
Circle Biologics, Plymouth
Tiger Woods did it and other pro athletes are doing it, too. They’re requesting cellular therapy to help heal torn tendons faster and make them stronger. Surgeons say their patients have less pain, less bleeding, and faster recovery using a patient’s own cells, whether from blood, bone marrow, or fat tissue, to assist in speedy recoveries. Circle Biologics, a biologic material management company based in Plymouth, is poised to capitalize on this trend.
Circle’s Autologous Fluid Concentrator (AFC) system uses a proprietary filter to separate patient cells into materials that are incorporated back into the body to help it heal. Matthew Kyle, the company’s president, uses the example of knee replacement surgery to describe how AFC works, but the same concept could be used in open heart surgery or a nose job, he says.
In the operating room, blood is drawn from the patient, put into the hourglass-shaped AFC, and spun into layers through the filter. Platelet-poor plasma (PPP) and platelet-rich plasma (PRP) are separated out. When water is taken out of PPP, the result is a concentrated protein called fibrinogen, which helps with blood clotting. The PRP contains white blood cells (disease fighters) in addition to platelets. Platelets contain growth factors that the body uses to signal other areas that “we’ve got a problem,” Kyle says.
In knee surgery, PRP is applied in and around deep soft tissue closures, and PPP is applied to the bone ends. “Using the patient’s own body’s concentrated fluid helps prime the bone cuts for optimal healing once the implant is in place,” Kyle says. Each AFC kit is optimized for specific procedures, and surgeons decide what cellular materials to use and how to apply it.
“In knee and hip surgeries, this therapy has been shown to achieve a four fold decrease in postoperative wound drainage,” Kyle says. Too much drainage can cause swelling or infection. One study on animals looked at the strength of bone graft material after 14 days and found a 40 to 60 percent increase in strength compared to surgeries without regenerative cell therapy.
Using the AFC system also keeps fluids in a safe, enclosed environment. Current medical practice has personnel spraying the PPP or PRP fluid into a cup from outside the sterile field. Then another person draws the fluid up into a syringe and administers it to the patient. “We think that’s not optimal,” Kyle says. “These fluids have delicate cells in them. We want to minimize the trauma [to them] to increase the efficacy of the cells once they hit the body. Through our transfer device, we’re able to reduce the fluid tumbling and/or trauma to the cells.”