Rose-Hulman Ventures Helps Physicians Improve Skin Biopsy Sampling

Cutting edge: Interns at Ventures introduced the use of suction to lift skin to the right level for a uniform biopsy every time.

Rose-Hulman Ventures is creating a new weapon in the war on skin cancer that could save money, time, and lives.

Recently, surgeons and pathologists at the Indiana University School of Medicine conceptualized a medical device to make skin biopsies easier and more uniform. If successful, this could cut the time patients must wait to learn whether skin lesions are cancerous. That, in turn, could decrease time to surgical excision and potentially save lives.

“That’s what motivated us,” says Dr. Luke Gutwein, a fellow in plastic and reconstructive surgery at IU and one of the doctors involved in the project.

Engineers at Ventures innovated a key component to the device; they introduced the prototype to use suction through a vacuum tube to lift the skin to a uniform level before the biopsy is taken, Gutwein says.

Currently, dermatologists do most skin biopsies using a shave biopsy blade that is unable to quantify tissue depth. Consequently, there is often a large variation in the depth of the biopsy provided to laboratories, sometimes leaving pathologists without enough tissue to provide complete results. If biopsies aren’t deep enough, for example, it may be difficult to tell how far a serious skin cancer, such as melanoma, has invaded, Gutwein explains.

“Depth of biopsy is critical,” he says. “If it’s not thick enough, you can compromise care and delay treatment.”

Most biopsies are also performed by dermatologists who have trained extensively to take biopsies that have sufficient depth to yield useful pathology. The device devised by the joint venture should be easy enough to use that a nurse practitioner or physician’s assistant can get a similar biopsy as that from a dermatologist. “Patients could be biopsied by their primary care physician instead of having to wait with cancer for a specialist appointment,” says Gutwein.

Depth perfection: A tiny, disposable blade takes the biopsy at the same depth for each skin sample.

Faced with this, IU doctors got the idea for a handheld device, about the length and thickness of a permanent marker, which any doctor or nurse practitioner can easily use during a routine office visit. The challenge was getting a uniform sample. After consulting with the Indiana University Research and Technology Corp., this spring the IU doctors asked Rose-Hulman Ventures to develop a prototype. After several iterations, the project resulted in a successful working model this summer. The device is simply placed on a patient’s skin and automatically takes a biopsy at a uniform depth.

The prototype includes a small, disposable, rotating blade at the end of a suction tube, explains Barry Davignon, a Rose-Hulman Ventures project manager. A vacuum creates suction through the tube that lifts the patient’s skin just before the blade quickly takes the sample. The prototype went through several improvements before reaching the present version, adds Nathan Stewart, a senior mechanical engineering major at Rose-Hulman who was the main student intern working on the project. There were about 10 different prototypes developed over the spring and summer, he says.

If all goes well, Gutwein believes that the biopsy device, which currently has no official name, could be available for doctors and nurse practitioners to use on their patients within a couple of years.

“I have great hope for it,” he says.