Smart Plasma Scalpel Provides Bloodless Orthopedic Surgery

Jerome Canady, MD, Founder and CEO of US Medical Innovations, LLC, of Takoma Park, MD, trained as a multi-organ transplant surgeon at Yale University and at the University of Pittsburgh. Dr. Canady has a long record of involvement in the creation of new plasma devices and technologies for surgery. At the outset of this journey the following question occurred to Dr. Canady, “Why can’t we take the plasma devices which are used for open surgery, and design something to go through an endoscope, and use it to zap polyps or tumors?” His response was to do just that, leading to the creation of his first invention—an endoscopic plasma device, created during his third year as a Surgical Resident in Pittsburgh in 1990.

Much later, as a post-doctorate fellow at Yale in immunology and transplant surgery, he designed all types of devices for this area. He opened his own company, US Medical Innovations in 2010. This led to the development of the Canady Hybrid Plasma™ Scalpel (“CHPS”), the first smart multifunctional hybrid plasma device in the world.

He laughed as he described the technology and the stunning visuals it evokes, being similar to the light sabers used in the Star Wars film series. “It’s the same technology found in neon lights or a plasma TV. But, now we can control plasma for surgery; for killing tumors, for killing cancer. This plasma is distinct from other plasmas because it is cold plasma. Normal cautery devices function at up to 200 degrees F, while Canady’s Scalpel operates at less than 98 degrees F. It cuts through the tissue and it seals the vessels at the same time. This creates relatively bloodless, or at most, surgical procedures with minimal blood,” he said.

The product received FDA approval in November of 2011. The very first surgical procedure it was used for was to remove breast tumors. Canady said that Dr. Robert DeWitty, a surgical oncologist from Washington DC, used it at Providence Hospital for a mastectomy and had absolutely no blood loss. He told his colleagues at Providence who were doing joint replacements and from there, it just exploded. Even plastic surgeons have begun using the Canady devices all across the USA.

“Plastic surgeons love it in particular because it leaves almost no scarring,” said Canady. “Initially I designed the device for liver surgery because I was a liver transplant surgeon. However, when the orthopedic surgeons tried it out, that’s when it really started to grow. One surgeon told another about it and it went off the Richter Scale.”

From the period of just a few doctors using it in 2012, it took off all through 2013. Today some of the most cutting-edge joint replacement surgeons in the country are using it. For knee and hip replacements, there is virtually no blood loss. “They don’t have to use any other type of device, and we’ve heard reports that some total knee replacement surgeons are even considering a same-day knee replacement procedure that would allow patient to leave the hospital in less than 24 hours with the help of this device. If a patient has a knee replacement at 9 AM, he/she may have full 90 degree flexion of the knee by 2 PM that same day,” said Canady. “Furthermore, the device doesn’t burn the tissue. It cuts through the tissue like a knife going through warm butter. And it also eliminates bleeding and coagulating as it cuts. In the past, orthopedic surgeons put a tourniquet on the patient to stop the bleeding while they were doing these joint replacements. Unfortunately, tourniquets also stop the blood from circulating efficiently, so once the tourniquet is removed, all the bad blood that was being held back, suddenly spurts up to the replaced joint, which is one reason joint replacement patients experience so much pain and swelling, which slows recovery.”

As for US Medical Innovations, Canady said that the company’s family of devices is moving into all areas, including cranioplasties (brain surgeries). The next area will be to start using it in pediatrics on heart patients with congenital heart conditions. “Standard surgical procedures are very precarious in infants and young children. They typically use a saw to open up the chest, but with this, they will be able to cut through the sternum of a child without damaging the heart and with little or no blood loss.”

Another area that is prime for this type of surgical technology is the area of inoperable tumors—those that simply cannot be removed using any type of known surgical procedures. Patients are written off to just go home and die. But with this procedure, a previously ‘inoperable’, stage 4 cancer can be removed with minimal blood loss. After surgery with this device, Dr. Canady has proposed a follow-up treatment with the next generation of cold plasma devices he is developing, which he believes would eradicate any remnant cancerous cells from the patient’s system. These two technologies taken together could offer new hope to patients who were previously issued the equivalent of a death sentence, as the inoperable now becomes operable.

Canady says that he believes that plasma will be the future of all surgery. He notes: “There was an old Star Trek episode where the crew went back in time to earth in the 20th century. Sulu was hit by a car and rushed to a hospital operating room. They were getting ready to take the drill and start cutting into him and Bones yelled, ‘My God man! What are you doing? This is barbaric.’ Then he pulls out his phaser tool and buzzes it over Sulu and fixes everything. That’s what this is about. It is here right now. We now have access to this hybrid plasma technology where they can remove tumors that are entwined in blood vessels or embedded in vital organs so deeply that the patient would immediately bleed to death if normal surgery was attempted. The future is now!”

Getting a Leg Up on Sports Orthopedics

Swiftwick, Brentwood, TN, manufactures highly innovative compression socks and liner socks for amputees. While this technology is for all types of sport and medical use, it truly shines when used by more athletic amputees.

“We have been producing sport compression socks for a long time,” said Mark A. Cleveland, CEO. “Now we have medical compression socks that are manufactured using FDA compliant production processes so a doctor can prescribe a compression regimen as part of a recovery or post-surgical treatment.”

Swiftwick’s move the sport compression business for amputees came about when Cleveland’s friend, an active young man who lived with an amputation below his right knee after a car accident, was complaining about sweat build up in his prosthetic leg. The challenges he faced when working out included having to stop when training or even in the middle of a race, because his limb liner material would lose its grip on his skin from excessive sweat build up. The inconvenience and discomfort was obvious.

Another friend, a double-amputee, was running a 10K. He was just finishing the 10K when one of his legs flew off because he lost the connection between the skin and the urethane liner due to sweat build up. He fell, broke his collar bone and was carried off in an ambulance.

It became evident to Cleveland, from these two experiences, that a new technology was needed. “We developed seam-free technology for maximum comfort and quickly recognized that new materials would be required to address this challenge,” he explained. “The amputee’s distal end suffers from many issues, including torque and weight related forces and various skin conditions like hyperhidrosis—simply   because the good Lord intended that you have feet, not have the bone stopping right there. Trials soon proved our strategy to manage the moisture was working. We also deployed our advanced antimicrobial technology to support skin health.”

This technology had exceptional results. Amputees no longer had to stop three miles into their training run to take off their appendage and dump out excess sweat, then clean up and put the socket back on before they could continue their training.

“The Para-Olympic athletes of 2012 took to it immediately. Some 50 world records and medals were earned by those athletes since that time because their training plan could be adjusted, leading to improved performance,” said Cleveland.

When the Swiftwick Valor® liner product was first offered, the prosthetic industry wasn’t eager to embrace it. The existing products previously attempting to address this challenge disappointed the community so completely the concept was almost entirely rejected. As a result, most traditional approaches were to not put anything between the skin and the liner interface for the prosthesis. But grass roots campaigning from happy, active customers changed that mind set and the Valor liner product was in demand.

This product was appropriate for the relatively fit athlete who was a below the knee amputee or had a certain profile of residual limb. But, demand rapidly emerged from those who have above the knee amputations and those who were over-weight, but wanted to get active. “Unfortunately, the larger volume of their residual limb was just too much for our first product to address,” Cleveland said.

Leg volumes change with muscular atrophy or water retention. The profile of a one residual limb compared to another is very different. Swelling also has to be accounted for and managed. There needed to be a product that would be sized to the required length, but would also have a much more flexible expansion capability.

To do this required developing a whole new technology, from the material in the liner sock to discovering manufacturing machinery adjustments that could produce the end product. The compressive material could not be like Spandex that expands to the point where it just can’t be pulled any further. “Our first Valor product used Spandex which has a natural limit in being able to expand without being too tight. We had to develop a new expandable elastomeric technology with a flat modulus property for constant compression, less sensitive to volume,” said Cleveland.

Working with partners to develop a revolutionary formulation was only half the challenge. How do you make new, expansive products when all the machines in the industry are designed to only work with well-established, well-understood elastic materials like Spandex? “The elastic content is drawn into your machine with a specific pre-tensioning that everyone understands and everyone knows how to work with it.” Cleveland explains, “That doesn’t work with our new product, Flexival, so everything had to change.”

The company had to change the mind-frame of the supply chain, experiment with mechanical teams who slowed down machine operations, and changed processes to find the perfect machine settings and new ways to feed new materials.

The cross section profile of most elastic materials is similar to the profile of a micro rubber band—flat and wide. When fed into a machine a flat, wide textile can twist. Every time it twists that could change the compression value. “The Flexival cross section is circular. In our industry it’s referred to as a continuous filament, melt spun fiber. It has unique physical characteristics that offer 50% thinner fibers for the same power. It’s closer to the look and feel of a fishing line. It has a great feel to the hand. It doesn’t flip or twist like Spandex can – so it winds up being more consistent and smooth. We are able to get the same power level of a 120 denier spandex, using a 120 denier Flexival, with 40% less mass. It is thinner and lighter but has the same power.”

With their new products, made of this new material, many medical compression needs can be met and all types of amputees, regardless of where they need to attach their limb and regardless of their body mass or activity level, can access the benefit of liners that will fit their limb and prosthesis perfectly and wick away sweat.

Conclusion

Coming from two completely different focus points, both of these companies are innovators in their own fields and both are making the world a bit better for both physicians and patients.