Download this article in .PDF format
This file type includes high resolution graphics and schematics when applicable.

When it comes to surgical technologies, the collective wish list of clinical users is as wide ranging as the niche areas in which the innovations are used. That’s the theme of a recent survey in which more than 100 surgeons were interviewed by researchers at Sagentia Ltd, a UK-based technical advisory and product development company with offices in Boston.

Sagentia Medical Technology Advisory Manager Gillian Davies explains that the survey was conducted to gain information on what surgeons desire from the surgical instruments, devices, and equipment on which they rely. What follows is an overview of their wants and some of the breakthroughs that are effectively fulfilling their needs.

Want: Ease of use

TissuGlu surgical adhesive created by Pittsburgh-based Cohera Medical, Inc. , is a lysine-derived urethane adhesive with a unique chemical composition that cures in the presence of moisture, eliminating the need for surgical drains. CEO Patrick Daly says, "Most surgeons use closed suction drains to drain fluid after large flap procedures such as mastectomies, tummy tucks, and lymph node dissections. Our product is like spot welding the area with evenly spaced drops of glue. Our technology is effective because it allows for natural tissue contact and quicker healing, eliminating need for drains.

"TissuGlu is contained in an easy-to-use applicator that has a proprietary rotating head and is stored at room temperature," Daly continues. "A nurse takes it out of the box and hands it to the doctor who slides one lever, clicks a trigger, and applies the glue. Once done, the doctor simply throws the device away."

The Rail 4D technology by K2M, Inc., Leesburg, Va., was inspired by structural I-beam geometry and provides an alternative to the traditional round spinal rods. It is a top-loading, low-profile system, which has proved helpful in addressing difficult surgical maneuvers during complex spinal surgery.

"We focus on scoliosis and minimally invasive surgery," says CEO Eric Major. "We are doing everything we can to make these surgeries less invasive and the recovery faster."

Major says another of KRM’s simplified and flexible technologies is its Serengeti system, which enables one-step, percutaneous placement of the screw and retractor, providing direct visualization and improved access for rod introduction.

Want: Pain management

Several breakthrough technologies are addressing post-operative and chronic pain, including the ON-Q, a single-use, disposable pump that continuously delivers regulated, targeted pain relief. Developed by I-Flow, LLC, a subsidiary of Kimberly-Clark, the innovation may be used for up to five days following a variety of surgical procedures. A ball is filled with local anesthetic that infuses over time, through a catheter, depending on the configuration. There are no electronic components, only a flow restrictor on the tubing.

According to Price St. Hilaire, I-Flow executive and global marketing director, "The best part is that patients treated with ON-Q experience a faster recovery and go home an average of 1.1 days sooner than those treated with narcotics alone."

Taking on the task of chronic pain relief, Eric Grigsby is a private-practice physician, clinician, and founder of Neurovations, which does clinical research and innovation.

"An exciting product currently being tested on patients at our facility in a clinical trial is for Spinal Modulation Company, which developed the Axium Spinal Cord Stimulator System."

This treatment places a small electrode on the spinal small root ganglion or SRG. It stimulates the SRG for chronic pain control without narcotics. "It’s a very promising strategy and has had the CE mark in Europe for about 18 months," says Grigsby. "It’s a challenge to find and pinpoint the right stimulation for the right area that needs pain relief. However, through the spine we can reach almost the entire body."

Grigsby is also working with Myo Science, which has a focused cold therapy using a very tiny 22-gauge needle. "It freezes the nerve that goes to the middle of the knee and the knee cap and makes the joint numb for about 3 to 4 months. This can be done in a doctor’s office."

Want: Early diagnoses

Even though colonoscopy is the gold standard in screening procedures for catching colorectal cancer, many cases are still not discovered early enough. EndoChoice merged with Israel-based Peer Medical and purchased a scope manufacturer, RMS Endoskopie-Technik in Hamburg, Germany, to develop Fuse, an endoscope that provides a 330° view of the colon, rather than the 150° to 170° field of view that traditional endoscopes provide.

"A team of engineers figured out how to get three cameras onto a flexible endoscope without making the endoscope larger; current methods only use one camera," says Doug Ladd, chief marketing officer for EndoChoice. "One of our engineers realized that by folding flexible circuits and putting them into the end of an endoscope, it used less power and got the imaging platform into a smaller space. Another innovation was using LED lighting as opposed to fiber bundle lighting. Our Israeli technologists discovered that the LED lighting would fit onto this new platform of a bent, flex circuit. Not only did they make it smaller, they got rid of the fiber bundle."

"The most recent study indicated that the traditional forward-view colonoscopes missed 42% of the adenomas in patients. Fortunately, these adenomas were then found using the Fuse endoscope system."

Schott’s Lighting and Imaging division, Southbridge, Mass., formed a team to improve fiber optic leached fiber bundles specifically designed for small diameter endoscopes, with an outer diameter of the shaft less than 3 mm.

"These are primarily used in ureteroscopes," says Vijay Shanbhag, medical sales manager for the division. "This procedure can be uncomfortable [and what we provide] helps the doctor to view more, which means less time for the procedure while reducing the need to re-scope."

Made at the Schott plant in Germany, Shanbhag says the fibers provide "better transmission, slightly higher numerical aperture, and better autoclavability. The fibers are also RoHS-compliant."

Better tubes and couplings

Existing products are being modified to meet demand for innovations that meet the niche needs of clinicians. Such needs included better connections. Twist Lock couplings by Ventura, Calif.-based LinkTech are meeting this need.

"The new couplings are our smallest quick connects yet," says Hector Cordero, design engineer. That claim is significant, given that the company manufactures more than 1,800 standard quick couplings. The Twist Lock ‘Easy Grip Barrels’ that provide an ergonomic handle to ensure a nonslip, secure grip for achieving reliable connections. An audible click when connected seals the deal.

Cordero says that producing connectors is always challenging. For the Twist Lock couplings, the barrel had to be symmetrical for it to function properly and molding the product gave them some issues. "We have to make sure they have a symmetrical interface. When we design new products, we thoroughly test them for performance by using a pressure decay monitor and other various instruments. Then we send out samples to customers and ask for their confirmation feedback, this assures our designs meet the end customers’ needs."

The Kimberly-Clark Health Care division’s innovation in respiratory health is the KimVent Microcuff endotracheal tube.

"What’s unique about this endotracheal tube, either pediatric or adult, is the cuff. Our new cuff is made of polyurethane, while other cuffs are made with polyvinylchloride (PVC)," says Michael Wells, respiratory health product manager.

Polyurethane is a much thinner and stronger material. It’s only 10-µ to 20-µ thick while PVC cuffs are around 50-µ to 80-µ thick.

"The thicker PVC cuff can fold in on itself," says Wells. "The cuff is is supposed to block all secretions, blood, and other contaminants, but if the cuff folds in on itself, it allows all of these micro-aspirates into the lungs, which can lead to ventilator-associated pneumonia."

The biggest design challenge was finding a way to attach the cuff to standard tubing, says Nuno Azeredo, associate marketing director. "We had to develop an entirely new process to attach cuffs made of polyurethane to tubing. It took almost a year to find the right adhesive. Then it required rigorous testing in terms of FDA requirements for biocompatibility."

Simplifying successes

While the products and technologies discussed in this article may cover a wide range of specialties, they share one common characteristic: a clear and specific benefit to the clinician.

Simply put, that spells success for surgical device and equipment innovators.

Download this article in .PDF format
This file type includes high resolution graphics and schematics when applicable.