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• W2138304348 abstract "Free flap surgery—the isolation of vascularized tissue from one location for implantation at a second location—is widely used in the reconstructive microsurgery to replace large tissue defects of the head and neck, breast, etc. It is complex, often requires extended periods in the operating room, and invariably involves periods of tissue ischemia during flap harvest and implantation.In 1986, Ostrup and Berggren first described the use of a sutureless anastomotic device designed to create end-to-end anastomoses of microvessels in the 0.8 mm–3.0 mm diameter range that dramatically reduced the time required to create microvascular anastomoses while maintaining patency rates of 98% in both arteries and veins [1]. This device, first manufactured and sold by 3M as the Unilink® System, is now manufactured and sold by Synovis MCA, a division of Baxter International. The Microvascular Anastomotic COUPLER® (COUPLER) is widely used in free tissue transfer, with published patency rates of 95–100% [2].Notwithstanding these advances, complications—most notably flap failure due to vascular occlusion—can still occur and, if untreated will result in flap ischemia, and possible loss. Fortunately, complications generally occur within 48 h of operation [3] and with intervention the salvage rate is 33–57% [4]. For this reason, postoperative monitoring is important and can provide both the patient and hospital staff peace of mind.The gold standard for monitoring flap viability has been clinical observation (i.e., color, temperature, swelling, capillary refill time) [5]. These methods, while useful are subjective and prone to error. Doppler ultrasound technology was first applied to the measurement of small vessel blood flow in the late 1960s and high-frequency (20 MHz) Doppler ultrasound is now recognized as an effective tool for measuring blood flow intra-operatively as well as postoperatively. However, proper placement and orientation of implantable Doppler probes have been a challenge [6–9].In the device described here, a team of engineers and scientists at Synovis Life Technologies, Inc. (St. Paul, MN, USA) sought to overcome the limitations of current technology by combining two existent technologies in an innovative way. By integrating a high-frequency Doppler ultrasonic probe into the COUPLER, reliable intra-operative and postoperative monitoring would be possible while maintaining the benefits of the COUPLER itself. To this end, the design team added a molded feature to the existing device a.k.a. the “scabbard” that holds a small Doppler probe at a 60 deg relative to flow and is connected to external electronics via a very thin percutaneous lead (Fig. 1). This angle has been set to maximize signal quality and keeps the probe from reorienting itself in relation to the vessel. The Doppler probe is encapsulated in a water insoluble coating which prevents body fluids from penetrating the probe and disrupting the signal. The tolerances are such that the probe is held in position via friction with a retention force that is high enough to limit accidental dislodgement during placement but is low enough to ensure that the anastomosis is not disturbed postoperatively by normal tension on the lead. The Doppler probe is designed to remain in place during the normal postoperative observation period after which time it can be easily removed without the need for reoperation. We describe here the results of a pivotal preclinical study designed to evaluate the flow monitoring capabilities of the Flow COUPLER™ system as well as the impact probe removal has on vessel patency.A preclinical study was performed under good laboratory practices conditions at NAMSA, Brooklyn Park, MN, USA. Twenty six New Zealand White Rabbits each received two Flow COUPLER™ devices, one each on the left and right jugular veins. All animals were heparinized with 200 units/kg IV prior to implant. Each vessel was isolated and then clamped proximal and distal to the anastomotic site using microvascular clamps. The vessel was transected and then anastomosed using a Flow COUPLER™ (Fig. 2). The percutaneous lead was tunneled subcutaneously approximately 5 cm caudal to the incision and externalized. Audible Doppler probe signal measurements were taken immediately following the surgical procedure as well as on day 1, 3, 5, 7, 10, and 14 days postoperatively. All signal measurements were recorded as either present or not present.At time points 3, 7, or 14 days, following final signal measurements, a subset of the animals were sedated by IM injection of ketamine (20–70 mg/kg) and xylazine (3–5 mg/kg). The Doppler probe was removed from the Flow COUPLER™ by application of firm and steady withdrawal force to the externalized probe wire until the Doppler probe was removed entirely from the body. Seven days following probe removal, animals were sedated again by IM injection, and either intubated or masked with isoflurane. The left and right internal jugular veins were isolated proximal to the implant sites and the animals were administered 200 units/kg heparin intravenously. To verify vessel patency, an appropriately sized JELCO® IV catheter was placed in each vessel and an antegrade venogram was performed with a 50:50 OPTIRAY™ 350:saline solution. All anastomosis sites were recorded as patent or not patent.Device implantation was largely uneventful. It was found through experimentation that the final angle of the probe lead could be anticipated and controlled by the placement of the anastomotic instrument during surgery and this aided in probe lead routing, externalization, and stability after surgical site closure. Probe signal was facilitated by irrigation with saline to ensure fluid contact between the tip of the Doppler probe and the vessel wall. Cutaneous fixation of the probe lead was aided by a suture sleeve incorporated into the lead itself.The reliability of all implanted probes was assessed via Doppler signal monitoring of blood flow at scheduled intervals postimplantation. As seen in Table 1, all probes produced a Doppler signal at all time-points tested.Seven days following probe removal, the patency of each anastomosis was verified using antegrade venography. Patency was confirmed in all vessels (100%) following probe removal.Key criteria for this system included (1) retain the benefits of the existing COUPLER® microanastomic device (2) incorporate a Doppler probe at a fixed position and angle relative to the vessel and to blood flow, (3) remain functional and inert when in contact with body fluids, (4) provide accurate Doppler readings, and (5) do so without impact on vessel patency. The device described here met these criteria. The incorporation of a Doppler probe did not negatively impact anastomotic device handling or deployment. All Doppler probes were functional for a period of at least 14 days postimplantation. Vessel patency was not disturbed postsurgery or following removal of the probe after healing (14 days).Since its commercial launch in 2010 the clinical experience with the flow coupler has been largely positive as reported by Um et al. [10]. The combination of two well established technologies—a unique sutureless anastomotic device and high-frequency Doppler ultrasonic velocimetry—has produced an innovative system that permits real-time monitoring of free flap blood flow directly at the site of anastomosis." @default.
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• W2138304348 date "2014-04-28" @default.
• W2138304348 modified "2023-09-26" @default.
• W2138304348 title "Innovative Sutureless Microvascular Anastomotic Device With Embedded Doppler Flow Monitor1" @default.
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• W2138304348 doi "https://doi.org/10.1115/1.4027018" @default.
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