Blackfin designs patient-adjustable prosthetic socket

LOVELAND — Sometimes, it takes just one.

The medical need of one patient, a woman wanting to restore her activity in watersports, was enough to launch a new company that builds equipment to alleviate concerns of numerous amputee patients who wear prosthesis equipment.

Blackfin Biomechatronics LLC, a startup by prosthetics industry veteran Clint Accinni, has created an adjustable limb socket. The product, which in the coming couple of months will begin its entry into the health care market, is one of four winners of BizWest’s IQ (Innovation Quotient) Awards, which were unveiled in May. 

The issue for the majority of amputees, Accinni said, is that the remaining part of their limbs after amputation doesn’t stay the same size during the day.

For an amputee, arteries and other blood vessels are severed, which creates a fluid return problem. The limb starts out in the morning one size but gets smaller during the day, thus creating a need to tighten the socket so that it doesn’t slip or rub on the limb.

“It’s like starting the day wearing a size 10 shoe and ending the day needing a size eight,” he said. 

Accinni worked previously with a company that used vacuum systems to tighten sockets; the vacuum system would suck air out of the socket causing it to snug up to the remaining limb.

“But that didn’t work for people who are active in watersports or other activities. A mechanical volume adjustment was needed,” he said.

The patient he referred to had lost feet and fingers as an end result of meningitis, which caused toxic shock, loss of blood flow and finally resulted in amputation.

She wanted to return to activities such as wakesurfing. Accinni devised a socket that includes a dial on its side that permits the user to gradually tighten the socket as the limb reduces in size during the day. Because the woman had limited dexterity because of finger loss, the dial can be operated with the palm or side of the hand. 

Accinni’s design was turned over to a design engineer to fine tune the device. The design is fed into a 3d printer to produce the final product.

“This is a major game changer to improve quality of life,” he said.

While most sockets today have no ability to adjust, Accinni expects that within five years 70% to 80% will be adjustable. That’s the market the new company is hoping to capture.

While numbers of amputees will surge during times of war when traumatic injuries are common, other causes of amputation are more prevalent, he said. Diabetes and vascular disease account for a significant share of the 2.5 million amputee cases in the country, he said.

He will market his new device to the limited number of suppliers of prosthetic devices, and work with hospital systems for awareness of the product. 

Medicare has created a new payment code for the devices in the past few weeks, which will help users as they seek insurance payments, he said.

Blackfin also plans to open a medical clinic to work in parallel with the manufacturing company. Typically, after a surgeon removes a limb, a patient needs to wait five or six weeks before physical therapists and prosthetists can fit the socket. Physical therapy continues after the fitting to help patients adjust.

Blackfin, which has just two employees, will add 15 or 20 within a year, plus an additional five to work in the clinic.

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