Amateur Medicine (2 Case Studies)

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http://www.bbc.co.uk/news/health-24524027

20 November 2013 Last updated at 01:25 GMT

The engineer who fixed his own heart and others too

By Smitha MundasadHealth reporter, BBC News

As an engineer, Tal Golesworthy is no stranger to taking things apart, figuring out what the trouble is and putting them back together with the problem solved.

But for more than 30 years, he lived with a life-threatening issue that was less easy to fix.

That is, until he took an idea from the garden, combined it with some basic procedures borrowed from the aeronautical industry and came up with a "beautifully simple" solution to treat his own heart condition.

He then managed to convince surgeons to put it into him.

And nine years since his operation, the 57 year old engineer from Gloucestershire in the UK, has managed to help over 40 people with similar conditions.

Andrew Ellis, a keen footballer, has benefited from Mr Golesworthy’s inventiveness.

At just 27 years old, Mr Ellis said it was daunting to put himself through an experimental medical procedure experienced by so few, but he was glad he did.

Five years after his surgery, he remains fit and healthy and "feels like someone without a heart condition".

Mr Golesworthy, is now calling on surgeons across Europe to start a trial and test his device against more conventional therapy.

Like Mr Ellis, Tal Golesworthy has Marfan syndrome – a disorder in which the body’s connective tissues are faulty. These tissues normally act as scaffolding for the major organs, ensuring they are kept in shape and in place. But people with severe forms of the syndrome can have problems with their eyes, joints and particularly their hearts.

‘Crude and simple’

As the heart pumps blood around the body, the aorta – the main vessel from the heart – stretches to accommodate the blood-flow. In most people it relaxes back to normal size, but for people with Marfan syndrome it can fail to recover, gradually enlarging over time.

From an early age, Mr Golesworthy was fully aware he was living with the risk his aorta could one day stretch so much it would burst. And during a regular check-up in 2000, he was told the time had come to consider pre-emptive surgery.

But he was "unimpressed" with the options available to him. Traditional surgery is lengthy and complex and includes replacing the stretched segment of the aorta with an artificial graft. Sometimes surgeons also have to put metal valves inside the heart to replace ones that are cut out.

But having metal in his heart would mean Mr Golesworthy would have to take blood-thinning medication for the rest of his life to ensure a smooth blood-flow. And this medication carries the risk of bleeding from even a minor fall.

As an active person and keen skier, this was a side-effect Mr Golesworthy was unwilling to tolerate.

He says: "I didn’t want to have to live my life in a cotton wool cocoon and I thought I might be able to come up with something less intrusive and complex that didn’t require a part of my heart to be taken away."

So he engineered himself a solution.

His thinking was straightforward.

He says: "If the hose-pipe is bulging, I must get some insulation tape and wrap it round the outside of the hose-pipe to stop it bulging.

"It’s that crude and simple, and we have all done it in our gardens."

Persuading surgeons he might be able to improve upon their techniques was not easy. But he managed to convince Prof Tom Treasure, then at Guy’s Hospital London, and Prof John Pepper, of the Royal Brompton Hospital, London, that they may be able to learn a thing or two from engineering techniques.

‘Tailor-made’

The process took a growing team three years to perfect. The result would be a personalised sleeve that is stitched snugly around the enlarged vessel, providing structural support and preventing it from growing any bigger.

The sleeve is made of a medical-grade mesh, using material that has been used to suture wounds for many years.

The team hypothesised that by putting the sleeve on the outside – rather than the inside – of the aorta, they would reduce the complexity of the surgery needed, there would be no need for anti-clotting drugs and there would be less time under the knife.

And four years on from its inception, they were ready for the next big step – Mr Golesworthy would be the first guinea pig for his device.

Although they had had several dry runs of the operation, he remembers it as the scariest day of his life.

He says: "I have spent my entire professional life project-managing various projects but of course this one was completely different. It was me that was going to be on the slab at the end of it."

The two-hour operation was carried out at the Royal Brompton Hospital. Nine years on, Mr Golesworthy’s aorta has not grown in size.

"All of a sudden my aorta is now fixed, I began to breathe easy and sleep well and relax in a way that I hadn’t done for years and years before," he says.

Mr Golesworthy says his motivation at the beginning of this project was entirely selfish, but the team has now been able to offer the tailor-made sleeves to more than 40 patients in London, the John Radcliffe Hospital, Oxford and the Leuven University Hospital in Belgium.

Andrew Ellis who had his procedure at the Royal Brompton Hospital, London, knew cardiac surgery was on the cards for a long time.

His biological father had died with the condition in his early twenties so he was acutely aware of the risks of not having treatment. But like Mr Golesworthy, Mr Ellis wasn’t keen on long and intrusive surgery or life-long medication.

He had the procedure using Mr Golewsorthy’s device in 2007. Five years later, his latest scan showed his aorta had not grown in size.

"Tal’s invention has taken away the looming threat of a major operation that was hanging over me for so long," he said.

‘True place’

Like any other surgery however, it is not without risk. For the majority it has worked well so far, but one person died of complications during the operation.

Prof Graham Cooper, consultant cardiac surgeon at Sheffield Teaching Hospital NHS Trust, who was not involved in the project, says: "Mr Golesworthy is a brilliant engineer and is very far-sighted. It is a real achievement to get such innovation into the NHS.

"But we have been doing the traditional operation for over 20 years and it is proven to be very safe and effective we know it stops people from dying.

"This new operation may have some advantages – it may mean patients have less time in hospital and under go a less complex procedure – but it will still be a long time before we have the data to compare different approaches. We need a robust trial of all the options available before we know its true place."

Mr Golesworthy says the next step must be just that. He has recently put a call out in the European Heart Journal to bring together researchers in the field and put his device to the test.

The process

  • Several computerised tomography (CT) and magnetic resonance imaging (MRI) scans of Mr Golesworthy’s heart were taken
  • Computer aided design software and 3D printing was used to convert these images into a physical model of Mr Golesworthy’s aorta
  • Placing this 3D replica in a solution of medically approved polymers enabled the team to mould the bespoke sleeve

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http://www.nytimes.com/2013/11/14/health/new-tool-to-ease-difficult-births-a-plastic-bag.html

November 13, 2013

Car Mechanic Dreams Up a Tool to Ease Births

By DONALD G. McNEIL Jr.

The idea came to Jorge Odón as he slept. Somehow, he said, his unconscious made the leap from a YouTube video he had just seen on extracting a lost cork from a wine bottle to the realization that the same parlor trick could save a baby stuck in the birth canal.

Mr. Odón, 59, an Argentine car mechanic, built his first prototype in his kitchen, using a glass jar for a womb, his daughter’s doll for the trapped baby, and a fabric bag and sleeve sewn by his wife as his lifesaving device.

Unlikely as it seems, the idea that took shape on his counter has won the enthusiastic endorsement of the World Health Organization and major donors, and an American medical technology company has just licensed it for production.

With the Odón Device, an attendant slips a plastic bag inside a lubricated plastic sleeve around the head, inflates it to grip the head and pulls the bag until the baby emerges.

Doctors say it has enormous potential to save babies in poor countries, and perhaps to reduce cesarean section births in rich ones.

“This is very exciting,” said Dr. Mario Merialdi, the W.H.O.’s chief coordinator for improving maternal and perinatal health and an early champion of the Odón Device. “This critical moment of life is one in which there’s been very little advancement for years.”

About 10 percent of the 137 million births worldwide each year have potentially serious complications, Dr. Merialdi said. About 5.6 million babies are stillborn or die quickly, and about 260,000 women die in childbirth. Obstructed labor, which can occur when a baby’s head is too large or an exhausted mother’s contractions stop, is a major factor.

In wealthy countries, fetal distress results in a rush to the operating room. In poor, rural clinics, Dr. Merialdi said, “if the baby doesn’t come out, the woman is on her own.”

The current options in those cases are forceps — large, rounded pliers — or suction cups attached to the baby’s scalp. In untrained hands, either can cause hemorrhages, crush the baby’s head or twist its spine.

Although more testing is planned on the Odón Device, doctors said it appeared to be safe for midwives with minimal training to use.

Along the way, it has won research grants from the United States Agency for International Development and from Grand Challenges Canada. “We’ve given out $32 million for 61 different innovations, and this one is the farthest along,” said Dr. Peter A. Singer, the chief executive of Grand Challenges Canada.

The device will be manufactured by Becton, Dickinson and Company, or BD, of Franklin Lakes, N.J., which is better known for making syringes.

“My first reaction, as soon as I saw it, was positive,” said Gary M. Cohen, the company’s executive vice president for global health. It was at the World Economic Forum in Davos, Switzerland, that Dr. Merialdi asked him to consider taking it on.

“Many inventions get to the prototype stage, but that’s maybe 15 percent of what needs to be done,” Mr. Cohen said. “There’s finalizing the design for manufacture, quality control, the regulatory work and clinical studies. Absent that, they don’t see the light of day.”

So far, the device has been safety-tested only on 30 Argentine women, all of whom were in hospitals, had given birth before and were in normal labor.

“I was glad they asked me, because it was for a good cause,” said Luciana Valle, a kindergarten teacher who was 31 two years ago when her son, Matteo, was one of the first babies extracted with the device. Because Matteo weighed almost nine pounds, “it really helped,” she said in a telephone interview. “His head came out on my second push.”

The W.H.O. will now oversee tests on 100 more women in normal labor in China, India and South Africa, and then on 170 women in obstructed labor.

In a telephone interview from of his idea.

He tinkers at his garage, but his previous inventions were car parts. Seven years ago, he said, employees were imitating a video showing that a cork pushed into an empty bottle can be retrieved by inserting a plastic grocery bag, blowing until it surrounds the cork, and drawing it out.

That night, he won a dinner bet on it.

At 4 a.m., he woke his wife and told her the idea that had just come to him. (His own children were born without problems, he said, but he has an aunt who suffered nerve damage from birth.)

His wife, he recalled, “said I was crazy and went back to sleep.”

The next morning, a somewhat skeptical friend introduced him to an obstetrician. “You can imagine these two guys in suits in a waiting room full of pregnant ladies,” he said.

The doctor was encouraging, so he kept working. Polyethylene replaced the bag his wife had sewn, and the jar was replaced by a plastic uterus.

With the help of a cousin, Mr. Odón met the chief of obstetrics at a major hospital in Buenos Aires. The chief had a friend at the W.H.O., who knew Dr. Merialdi, who, at a 2008 medical conference in Argentina, granted Mr. Odón 10 minutes during a coffee break.

The meeting instead lasted two hours. At the end, Dr. Merialdi declared the idea “fantastic” and arranged for testing at the Des Moines University simulation lab, which has mannequins more true-to-life than a doll and a jar.

Since then, Mr. Odón has continued to refine the device, patenting each change so he will eventually earn royalties on it.

“My daughter said, ‘And now I can have my doll back,’ ” he said.

It is too early to know what BD will charge, Mr. Cohen said, but each device should cost less than $50 to make. While the company expects to profit on all sales, it will charge poor countries less.

Dr. Merialdi said he endorsed a modest profit motive because he had seen other lifesaving ideas languish for lack of it. He cited magnesium sulfate injections, which can prevent fataleclampsia, and corticosteroids, which speed lung development in premature infants.

“But first, this problem needed someone like Jorge,” he said. “An obstetrician would have tried to improve the forceps or the vacuum extractor, but obstructed labor needed a mechanic. And 10 years ago, this would not have been possible. Without YouTube, he never would have seen the video.”

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