Portable Organ Perfusion – Airdrive
Airdrive: the Portable Organ Perfusion System
The Airdrive Portable Organ Perfusion System is a Machine Perfusion System in which one donor organ is connected to receives perfusion and cooling from a special Machine Perfusion fluid. The organ is perfused continuously during transport with an oxygenated perfusion fluid by a membrane pump that pumps perfusion fluid from the container, into the organ’s artery and or portal vein. The organ container is placed in an expanded polystyrene transport box for protection and insulation. The temperature of the organ is kept at a level (8 +/- 4 oC) below the outside temperature by means of cool packs inside the transport box. The intended use of the Airdrive Portable Organ Perfusion System is to perfuse and preserve a harvested organ during transport from a donor to the recipient. The device is suitable to transport one human kidney. The organ container has sterile parts which will be in contact with the perfusate fluid and organ. The device is for single use only. The maximum period of use is 14 hours for the kidney.
Use of the Airdrive
The intended users are transplant surgeons, in an operating room. Transplant surgeons connect the organ to the Airdrive’s organ lead(s), and after the usual visual and manual assessment upon arrival also take the organ out of the Airdrive. The preparation of the device is described in the Instructions for Use. In short, the Airdrive is pre-loaded with 4 cool packs to cool the system 1 hour upfront, the dedicated oxygen bottle is opened by simply rotating the tap on top of the bottle. The cover on the sterile section is opened just before the surgeon is ready to place the organ into the organ container (see figure 1).
Figure 1: Preparation of the Airdrive. Left top: Tyvek layer as sterile barrier on the organ container. Right top: removal of the Tyvek layer. Bottom left: Tyvek layer removed, transparent lid (cover) still in place, covering the organ container. Bottom, right: Transparent lid (cover) removed. Organ will be placed in the container.
Special Machine Perfusion fluids are added directly into the container (2 liter for kidney). Then the operator selects the organ, see Figure 2, to initiate the Airdrive. The Airdrive automatically starts the “initiation” in which the Airdrive is automatically pumping the fluid around and excess air can be removed through the bubble trap by attaching a syringe to the luer lock connector at the right hand upper corner of the organ container.
After approximately three minutes the system automatically jumps into “priming” mode during which the surgeon can connect the organ to the organ lead(s) of the device. Make sure that during preparation of the organ connectors on the back table, the organ is actively cooled by sterile ice or packaged ice and fluids. The operator presses again the preferred organ button, see Figure 3. The Airdrive then automatically starts pumping. After the lid (cover) on the inner container is placed (Figure 2), the top part of the outer isolating foam box can be closed and the straps secured. The Airdrive is now ready for transport. During the use of the Airdrive, the flow, pressure and temperature are displayed on the integrated display in the control panel, together with the elapsed running time (Figure 1). By pushing the “-” button on the display, the measured values during the whole running time of the device can be selected. By pushing the “+” button, the operator can return to the present values. There are no more buttons or switches than shown in Figure 1. Between the positioning and the removal of the organ into and from the Airdrive, the Airdrive is transported from the hospital of the donor to the hospital of the recipient. During transport of the Airdrive the transport box remains closed. The person moving the Airdrive has no other task than to keep the device in an upright position and prevent it from rough handling. After the Airdrive has arrived in the hospital of the recipient, and after appropriate matching has taken place the organ will be taken out of the Airdrive in the operating room by a transplant surgeon.
Airdrive ready for transport to the receiving hospital: the (foam) top cover pin place, Airdrive sticker placed.