Patent promises to place smart scalpels in surgeons’ hands

Jan. 30, 2003 — A Pittsburgh company believes it is close to carving out a unique piece of the MEMS market with its first patent.

Verimetra Inc. says its U.S. patent for embedding sensors on cutting tools will help it commercialize smart surgical devices and, down the road, other consumer and industrial applications.

“The patent gives us a level of confidence we did not have before,” said Michele Migliuolo, the 2-year-old firm’s president and chief executive. “There’s greater credibility with customers and investors — you have a reasonable expectation of protection.”

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Migliuolo described Verimetra’s new intellectual property as both broad and seminal: It contains nearly 60 claims that cover the concept of embedding a MEMS-based sensor as close as possible to the edge of a metal cutting tool. And while there are plenty of microsystems in medicine — blood pressure sensors, endoscopes, pacemakers — Verimetra says its patent stakes a sole claim in MEMS sensors for cutting tools.

One patent attorney who specializes in small tech IP said Verimetra’s claim appears to be justified.

“From the first blush, I think that could be a powerful patent,” said Kelly Kordzik, chairman of the nanotechnology practice at the Texas-based law firm of Winstead Sechrest & Minick. Kordzik also has prepared and prosecuted patents related to MEMS.

“Anyone who is going to be manufacturing and selling a cutting instrument that has some type of sensor technology integrated with that cutting blade is going to have to be concerned about this patent,” Kordzik said.

The patent gives Verimetra more credibility as the company negotiates with medical device makers interested in licensing the technology. Some manufacturers are testing Verimetra’s prototypes and Migliuolo said at least one firm, which he would not identify, is incorporating the sensors into an eye-surgery tool that it hopes to have on the market by year’s end.

Verimetra says MEMS-laden scalpels, needles and drills would give surgeons an unprecedented level of control or even the flexibility to perform entirely new procedures. Verimetra’s suite of tools incorporate sensing and measuring devices to track and record information during surgery. The sensors, for instance, can tell how close a scalpel is to a blood vessel and shut the tool down if it veers too close.

In addition to ophthalmic surgeries, Migliuolo said, the company will focus the next several months on commercializing the technology for three other specialties: orthopedic, dental and cardiac. For instance, temperature sensors could be placed in drills to make sure the jawbone doesn’t overheat during a dental implant surgery.

Verimetra also expects to receive a grant this spring from the Pittsburgh Life Sciences Greenhouse in collaboration with Carnegie-Mellon University’s Robotics Institute and Children’s Hospital of Pittsburgh to develop MEMS-based ultrasound devices for surgical navigation during fetal heart surgery. Prototype testing could begin this summer, Migliuolo said.

He said success in the medical realm could be a springboard into industries such as tool-wear sensors on manufacturing equipment or even temperature sensors in the blades of a food processor to keep the food from overheating and spoiling.

For most of its initial applications, the company said, it can avoid lengthy review by the U.S. Food & Drug Administration because the basic form and function of an already-approved tool does not change with the integration of sensors. “It feels exactly the same as the tool you used yesterday, only it’s smart,” Migliuolo said.

The key, he said, is working with toolmakers on defining materials and sealing techniques once sensors are embedded so they add no risk to the patient. If Verimetra’s sensor fails, the surgeon can go back to using the scalpel or gripper as it was originally designed.

Kordzik said his only concerns deal with potential limitations in the language of the patent, which refers to embedding the sensor within the recess of the blade on a semiconductor substrate. He said he recognizes the value of embedding the sensor in medical tools, but said he would have liked to have seen a claim in the patent that didn’t require a recess in the blade. That might keep others from developing exterior sensors on cutting tools for nonmedical applications.

Kordzik also said Verimetra also could be limiting future applications by not including a claim for sensors that do not require a semiconductor substrate. In nanotechnology, for instance, nanoparticles could be engineered to sense pressure and generate an electrical signal that is transmitted up the blade to a processing system.

“Someone might be able to improve upon this and not be within the bounds of the patent,” he said.

Migliuolo said he doesn’t believe either will be a limiting factor.

“Verimetra is about real sensors on real tools,” he said. “If nano is ever able to do that, good for nano. But the reality is that’s a very elegant goal to hope for. … I’m too busy building a business in the short term to have to worry about will be commercialized five to 10 years down the line.”

As for the ultimate goal — acceptance by end users — he believes the best bet is to show the value of sensor-enabled tools to surgeons and their equipment suppliers. “When the surgeon really sees it’s not vaporware, you can see he gets excited,” he said. “We say, ‘Now, who is your supplier?'”

The “Data Knife” concept from Verimetra incorporates sensing and data gathering capabilities on the edge of various surgical tools.

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