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OrganOx medical device
Ask people: “When was the first organ transplant?” and they may well say Dr Christiaan Barnard’s successful heart swap operation in 1967.
But transplants started long before that, and a kidney transplant in 1953 was the pioneer. The first liver transplant was conducted in 1963, by American surgeon Dr Thomas Starzl.
The bugbear of organ swaps is tissue rejection, the body seeing the new organ as foreign, and invoking the immune system to attack it.
Immunosuppressants such as cyclosporin emerged in the 1980s to minimise such attacks and prolong patients’ lives.
Liver transplants pose a far greater risk than kidney or heart operations. Should the new kidney or heart fail to ‘take’, the patient can be kept alive by dialysis, or an artificial heart but there are no artificial livers.
Either a new organ is found immediately, or the recipient will die. As a result, liver surgeons are very selective in choosing organs and livers suffer a high discard rate.
There are more than 30,000 patients on the liver transplant waiting list in Europe and the USA who will die without a transplant. But there are only about 12,000 liver transplants a year in these countries, and 20 per cent of patients die while on the waiting list.
Now, Oxford University spin-out company OrganOx has developed a sophisticated device that can not only preserve a retrieved liver for up to 24 hours before transplantation, but also minimise damage to the organ, both before and during transplant surgery.
Chief executive Dr Les Russell (pictured) is highly experienced with medical devices and described how the OrganOx technology offers a paradigm shift in methodology.
“Currently, livers are removed, prepared and stored using low temperatures. The liver is a warm organ and can be damaged by chilling it down and then warming it up during the transplant.
“Our device mimics the body, keeps it warm and active once retrieval is complete, monitors condition and feeds it vital fluids like oxygenated blood and nutrients automatically.”
Even using the OrganOx device, the organ retrieval process remains the same.
The body cavity is chilled and the liver removed to a cold saline bath where it is flushed and fitted with cannulas — small needles for removal or delivery of fluids.
To connect immediately to the OrganOx system, special cannulas — “like Hozelock connectors,” according to Dr Russell — are inserted. Instead of then being placed in an icebox for transportation, the liver is connected to OrganOx’s self-contained and transportable trolley and the power switched on. The trolley can use mains power, vehicle or aircraft power, or its own batteries when being wheeled about.
The device increases the availability of livers from non-heart-beating donors.
At present, 95 per cent of donor organs come from patients declared brain dead, whose relatives agree the donation and that life support should be turned off.
Non-heart-beating patients have functioning brains but are cardiac dead. Once donation has been agreed with relatives, life support is terminated. The patient is monitored until vital signs are extinct, and then for a further period in case of what is called the Lazarus syndrome — spontaneous restarting of the heart.
The period between turning off life support and actual death varies, with young people tending to die more quickly.
But with the body gradually shutting down, the flow of oxygenated blood to the liver diminishes. This is known as warm ischaemia.
If ischaemia goes on too long, the liver will be unsuitable for transplant. Where the organ is suitable for donation, the OrganOx system will keep it in better condition.
Another key point is that the liver is monitored to the point of transplant and what may look an unsuitable organ is actually functioning extremely well.
For example, livers from obese patients can suffer from steatosis or fatty deposits. Surgeons may well discard such organs on a visual inspection but with the OrganOx monitoring, outwardly unsuitable organs can show excellent characteristics.
The aim is to substantially increase the number of non-heart-beating donors.
It took Dr Russell some time to devise a viable business model. With only 650 liver transplants a year in the UK, just seven transplant centres and each device being expensive, pure sales of the device would have been unsustainable.
Instead, the device will be sold to the centres at relatively low or no cost, and an income stream derived from the many consumables involved.
Development is entirely outsourced to Team Developments in Cambridge with almost all components bought from top-class manufacturers.
Dr Russell is the only employee and works closely with the inventors, Professor Peter Friend, the University’s Professor of Transplantation, and Professor Constantin Coussios, Professor of Biomedical Engineering.
The company has just secured second funding of £2.75m from both existing shareholders, such as Oxford University and Technikos, and also a prestigious new one, the Royal Society.
Once clinical trials are complete and European health and safety regulations complied with, the product is scheduled for launch in Europe in 2013.
Dr Russell added: “The current numbers on the waiting list are far too high. With our device, substantial inroads can be achieved.”