A novel, pencil-sized device now provides surgeons with an alternative to traditional methods of suturing arteries. The Arterial Everter, Medical Category winner of the 2017 “Create the Future” Design Contest, will reduce operation times, according to the technology’s inventor.
The Arterial Everter supports the improvement of a process known as arterial microvascular anastomosis, a medical procedure used in many tissue-transfer applications. Anastomosis connects small blood vessels measuring less than four millimeters in diameter.
A Medical GEM
Frequently, veins or arteries are stitched together using sutures. Another joining option, however, calls for the Synovis GEM Coupler, an implantable anastomosis product from the Birmingham, AL-based medical device manufacturer Synovis Micro.
The GEM Coupler consists of two rings, each with protruding pins. In an operation, two vessels are placed through a ring, folded back, and impaled on the pins. The two rings are then pressed together, forming a secure connection: a successful anastomosis.
Synovis’s GEM Coupler joins veins in about 5 minutes; the less flexible arteries, however, have proven to be a more time-consuming challenge. An artery has a thicker, more muscular wall, and can therefore "pop off" the coupler pins as a surgeon tries to fold the vessel over.
As a result, surgeons and residents must undergo extensive additional training prior to operating on a patient in need of tissue transfer.
Jeff Plott, research fellow at the University of Michigan and an inventor of the "Create the Future”-winning Arterial Everter, believes his device will enable a more rapid anastomosis of arteries.
What is the Arterial Everter?
The process of dilation gently expands a vessel’s diameter, making a vein or artery easier to manipulate.
The handheld Arterial Everter facilitates the simultaneous dilation and impaling of the artery onto the pins of the GEM Coupler. The device’s sloping sides dilate the vessel as it is pushed into the artery.
As a user moves forward with the device, the artery is pushed into the pins. The pins then pass through the artery and into the everter, ensuring that the artery is securely fixed to the coupler pins.
After each end of the artery is secured to the coupler ring, the rings are clamped together, forming the secure connection. Since all the pins are secured into the vessel at the same time, the artery does not "pop off."
Getting Up to Speed
Compared to manual suturing, the average time to perform the anastomosis was significantly less when using the everter and GEM coupler combination, says Plott, who tested the technology on a live porcine model.
By using the everter with the GEM Flow Coupler, a variation of the standard GEM device, surgeons can additionally monitor the anastomosis procedure. The Flow Coupler’s Doppler reading provides valuable information on the movement of blood through a vessel.
“With this active monitoring, doctors will be able to know immediately if there is an issue with the blood flow, so they can go back in and fix the problem before further complications arise,” says Plott.
The Path to ‘Create the Future’
The development of the Arterial Everter began at the University of Michigan, as plastic surgeons required a device that could quickly connect small arteries. With the need identified, the project was brought to an engineering senior design team at U of M where Plott served as the engineering mentor to the project.
After the semester’s student team designed and prototyped many ideas, Plott then took over the engineering on the project, bringing the device through another 14 design iterations before landing on the final “Create the Future”-winning device seen today.
“We are now in the late stages of licensing the everter to a major medical device company who will handle the FDA filing and bring the product to market,” says Plott. “We expect this process to take about 1 to 2 years.”
The Arterial Everter took first prize in the Medical category of the 2017 "Create the Future” Design Contest. Winners of the competition were announced on October 4.
What do you think? Share your thoughts below.
- See all of the winners from this year’s ‘Create the Future’ Design Contest.
- Visit our official Medical Design Briefs
- Also: A Pulse Sensor Measures Artery Health.