{"id":1184,"date":"2013-06-12T10:10:55","date_gmt":"2013-06-12T00:10:55","guid":{"rendered":"http:\/\/legoeng.local\/?p=1184"},"modified":"2021-04-23T20:45:12","modified_gmt":"2021-04-23T10:45:12","slug":"real-world-engineering-using-the-nxt-to-break-apart-blood-clots","status":"publish","type":"post","link":"http:\/\/legoeng.local\/real-world-engineering-using-the-nxt-to-break-apart-blood-clots\/","title":{"rendered":"Real World Engineering: Using the NXT to break apart blood clots"},"content":{"rendered":"
OmniSonics Medical Technologies, Inc. is a medical device start-up corporation located in Wilmington, Massachusetts, and was established in 1997. OmniSonics has developed a product that can be used in the treatment of\u00a0vascular occlusive conditions\u00a0such as blood clots. Blood clots, also known as “thrombus,” can block blood supply to the heart, brain, lungs, or limbs or cause heart attack, stroke or limb pain. Traditionally blood clots are treated with medication or interventional means (i.e. catheter based or surgical procedures). OmniSonics has created a treatment of blood clots that is not highly invasive and does not rely on medication.<\/p>\n
OmniSonics’ products are based on their patented OmniWave Technology. OmniWave technology is the first that uses\u00a0ultrasonic vibrations\u00a0along a small wire to treat vascular occlusive conditions. This is done by inserting a wire, or “waveguide,” with a small diameter into an affected artery or vein. The other end of the wire is attached to a hand piece that helps the doctor guide the end that has been inserted into the vessel. The hand piece contains a\u00a0piezo-electronic transducer. The transducer causes the wire to vibrate ultrasonically. The proximal part of the wire (that part that is closest to the hand piece) vibrates longitudinally (i.e. in the direction of the wire). This motion is converted to transverse waves (vibration that moves in the direction normal to the axis of the wire) at the distal end of wire (the part farthest from the hand piece). This ultrasonic vibration causes the blood clot to break apart and dissolve, allowing the clot to be carried away with the blood flow and absorbed into the body.<\/p>\n
It is crucial that the wire vibrates at the proper frequency and does not fracture or break while treating the clot. In order to ensure these criteria, extensive testing must occur. Steve Forcucci, a principal mechanical engineer at OmniSonics, explains that OmniSonics must follow the Federal Drug Administration\u2019s (FDA) regulations since the isolate<\/a> will be used on human beings. This requires extensive testing to prove product safety and efficacy. OmniSonics has recently received FDA approval of their Omniwave System for use in periperal vasculature. The safety benchmark, as determined by the FDA, was met and OmniSonics will soon begin a small limited market study for use in humans.<\/p>\n Testing both durability and efficacy of the wire before moving to human subjects is necessary to provide confidence that the wire is strong enough and that it will not break. To ensure its durability, OmniSonics has developed an endurance rig (See Figures 1 & 3) to test the wire. The wire is run through a hypo tube (See Figure 2) and into a fixture that bends the wire at 180 degrees. An automated device, that contains the transducer, slides the wire into the tube and the results appear on a computer. This configuration allows the working end of the wire to follow a curved path to simulate use in a curved vessel.\u00a0 The curvature can be adjusted to study the effects of changing the curve’s radius.<\/p>\n