Traverse City Record-Eagle

July 13, 2013

Retired Northport heart surgeon joins artificial pancreas search

BY LORAINE ANDERSON
landerson@record-eagle.com

---- — NORTHPORT — Arne Landè, a retired cardio-vascular surgeon in Northport, says he has a break-through idea for developing a long-sought artificial pancreas for insulin-dependent diabetics.

If approved by the Federal Drug Administration, his small artificial pancreas could dramatically change treatment of diabetes and have a possible economic impact on Northport.

Landè, 81, wants research, development and manufacture of his artificial pancreas device to occur in Northport. He spent many boyhood summers in the village and moved there permanently last year.

The artificial pancreas he envisions will be part of a “sleeve” device to be worn on the forearm that is connected directly to the bloodstream. It will constantly monitor blood glucose levels and automatically inject precise amounts of insulin when needed to control and keep blood sugars balanced.

Landè said Wednesday that he is seeking a chief executive officer to help develop a business plan and a design engineer experienced in the artificial pancreas field to prototype what he calls his “blood-based artificial pancreas.”

“I’ve been thinking about this for 50 years,” Landè said. “Everyone’s assumption is that what I’m suggesting can’t be done, but I think it can because of my background.”

Landè, 81, is no stranger to medical equipment research or blood circulation.

He helped invent the Landè-Edwards membrane blood oygenator as an intern at the University of Minnesota during the late 1960s and early 1970s. The oxygenator was the first commercial artificial lung to be mass produced for heart-lung machines, which are used to circulate the blood outside the body, add oxygen and remove carbon dioxide during open-heart, bypass and other surgeries. About 30,000 were manufactured.

He also developed a prototype for an artificial kidney about the same time for end-stage kidney patients in renal failure. The continuously wearable “hemodializer” was designed to remove the patient’s blood, clean it and put it back into the body. It also incorporated a “sleeve.” Technology, however, wasn’t available then to continue with the project.

Landè already has an approved patent on a portion of the device that dates back to his early work on the artificial kidney. He also has applied for a related U.S. patent and European patents for “blood-based” devices for the pancreas, liver and heart.

“It’s a whole new way of treating people with chronic disease,” he said of his “blood-based” approach. He also claimed that the device will be simpler, quicker, more accurate and a “real-time control of blood glucose.”

Diabetics currently monitor blood sugar levels by pricking their fingers to obtain drops of blood from the subcutaneous tissue directly under the skin. They then determine the amount of insulin needed and inject it.

“Tapping into the subcutaneous tissue is a poor reflection of what’s going on in the bloodstream,” Landè said. “It’s more of an indication of what was going on a half-hour before.”

Lande’s approach would require diabetics to have a surgical procedure known as “in situ debranched vein fistula graft,” or VGF, to obliterate accessory veins in the arm and create a single, fast flowing and durable blood vein. The surgery has been used for years on kidney dialysis patients and would give the monitor direct access to the blood, he said.

He said his artificial pancreas system will not require long years of clinical testing because most of its components are common medical procedures like the VGF, or equipment such as the biostator that already have undergone clinical testing. The biostator is a direct blood-based device that has been used since 1976 to put a “clamp” on blood glucose levels, he said. It uses a simple, thermostat-like algorithm approved by the FDA in 1981.

Landè discussed his idea and design in April at the 2013 Workshop on Innovation Towards an Artificial Pancreas sponsored by the Federal Drug Administration at the National Institutes of Health campus in Bethesda, Md. He also has talked to the Northport Planning Commission, village council and other local groups.

The FDA wants to accelerate research and development of an artificial pancreas system that mimics the pancreas, the six-inch-long organ shaped like a flat pear that is located behind the stomach and surrounded by the small intestine, liver, and spleen.

Almost 26 million children and adults, or 8.3 percent of the U.S. population, suffer from diabetes, according to American Diabetes Association statistics. Another 79 million are pre-diabetic. By 2050, 1 in 3 people in the United States will have diabetes, the association said. Complications include heart disease, stroke, high blood pressure, blindness, kidney disease, nerve system damage and amputation.

Not much, other than the development of insulin pumps, has changed in the treatment of diabetics since the 1920s, when Dr. Frederick Banding and medical student Charles Best discovered insulin in a University of Toronto lab, Landè said.

The modern continuous insulin pump is a device about the size of a beeper. It has a pump reservoir similar to an insulin cartridge, a battery-operated pump, and a computer chip that allows the user to control the exact amount of insulin being delivered. The pump is attached to a thin plastic tube, which has a thin, flexible needle at the end that is inserted under the skin and changed every two days. The pump can be removed for swimming or showering. The amount of insulin is programmed and administered at a constant rate through the needles.

The needles in Lande’s blood-based device would have to be changed twice weekly.