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我是一位製程工程師,我對鍋爐、焚化爐、纖維過濾器和旋風式系統等知之甚詳,但我也罹患馬凡氏症候群,這是一種遺傳疾病。1992年,我參加一項基因研究計畫,恐懼地發現,如你們在投影片中所見,我的升主動脈直徑已超出正常範圍,即底端的綠線部份。正常人的介於3.2和3.6公分之間,我的已擴張到4.4公分。如你們所見,我的主動脈逐漸擴張,情況逐漸惡化到必須動手術的程度。
這種手術非常可怕-麻醉,打開胸腔,置入人工心臟,連接心肺機,使體溫下降到攝氏18度左右,停止心跳,切掉主動脈,以塑膠瓣膜和塑膠主動脈取代。最重要的是,你必須接受終生抗凝血療法,通常使用華法林(抗凝血劑)。一想到這種手術就令人退縮,想到得終身使用華法林實在令人恐懼不已。
所以我對自己說,我是一名工程師,我在研發部門工作,這只不過是管線問題,我可以處理這一點,這是我可以改變的,所以我著手徹底改變主動脈擴張的治療方式。這個計畫的目標很簡單,馬凡氏症候群患者唯一真正出問題的地方是升主動脈,它缺少一些拉伸強度,所以療法的可能性在於將血管外圍包覆起來,使它保持穩定,正常運作。如果高壓軟管或高壓液體管線稍微凸起,只要在它外圍纏一些膠帶即可,理論上就是這麼簡單-雖然不曾實際用於血管上。對我來說,支撐血管外部的最大好處是,我可以保留身體所有部位,所有內皮組織和瓣膜,不需使用任何抗凝血療法。
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以下為系統擷取之英文原文
I'm a process engineer. I know all about boilers and incinerators and fabric filters and cyclones and things like that, but I also have Marfan syndrome. This is an inherited disorder. And in 1992 I participated in a genetic study and found to my horror, as you can see from the slide, that my ascending aorta was not in the normal range, the green line at the bottom. Everyone in here will be between 3.2 and 3.6 cm. I was already up at 4.4. And as you can see, my aorta dilated progressively, and I got closer and closer to the point where surgery was going to be necessary.
The surgery on offer was pretty gruesome -- anesthetize you, open your chest, put you on an artificial heart and lung machine, drop your body temperature to about 18 centigrade,stop your heart, cut the aorta out, replace it with a plastic valve and a plastic aorta, and, most importantly, commit you to a lifetime of anticoagulation therapy, normally warfarin.The thought of the surgery was not attractive. The thought of the warfarin was really quite frightening.
So I said to myself, I'm an engineer, I'm in R and D, this is just a plumbing problem. I can do this. I can change this. So I set out to change the entire treatment for aortic dilation. The project aim is really quite simple. The only real problem with the ascending aorta in people with Marfan syndrome is it lacks some tensile strength. So the possibility exists to simply externally wrap the pipe. And it would remain stable and operate quite happily. If your high-pressure hose pipe, or your high-pressure hydraulic line, bulges a little, you just wrap some tape around the outside of it. It really is that simple in concept, though not in execution. The great advantage of an external support for me was that I could retain all of my own bits, all of my own endothelium and valves, and not need any anticoagulation therapy.
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所以,我們從何處開始著手?好,這是我心臟的橫切面,你們可以看見中間那個裝置,那個小結構正在收縮,那是左心室正將血液擠入主動脈瓣膜-你們可以看見主動脈瓣膜的兩片瓣葉正在運作-向上伸入升主動脈。這個部份,即升主動脈會逐漸擴張,最後爆裂,這當然是致命的。我們先將來自核磁共振和電腦斷層掃描的影像進行組織,藉此製作病人的主動脈模型。
這是我的主動脈模型,我口袋裡有實物,如果有人想把玩一下,請隨意。你們可以看到,這是相當複雜的結構,底部是特殊的三葉形,其中包含主動脈瓣膜,然後向上收縮成圓柱形,逐漸變細而彎曲,所以-這是一種相當難製作的結構,影片中是我主動脈的CAD(電腦繪圖)模型,這是後期發展出的CAD模型之一。我們反覆琢磨,逐步改善模型,當我們研究出適合的模型後,將它做成實體塑膠模型,如你們所見,使用快速成型技術,這是另一種工程技術。然後我們根據這個模型,分毫不差地訂做出一種多孔網眼布,它的外型與模型一致,能相當完美地包覆主動脈,因此這確實是完全個人化的醫療方式,每一位患者的植入物都是量身訂做的。
一旦做出成品,植入非常容易。John Pepper,上帝保佑,他是心臟和胸腔外科教授,從未做過像這樣的手術。他植入第一個裝置,不甚滿意,於是將它取出,再植入第二個。我在手術臺上躺了四個半小時後,大功告成,心滿意足地出院。所以植入手術其實是最容易的部分。
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So where do we start? Well this is a sagittal slice through me. You could see in the middle that device, that little structure, squeezing out. Now that's a left ventricle pushing blood up through the aortic valve -- you can see two of the leaflets of the aortic valve working there -- up into the ascending aorta. And it's that part, the ascending aorta, which dilates and ultimately bursts, which, of course, is fatal. We started by organizing image acquisition from magnetic resonance imaging machines and CT imaging machines from which to make a model of the patient's aorta.
This is a model of my aorta. I've got a real one in my pocket, if anyone would like to look at it and play with it. You can see, it's quite a complex structure. It has a funny trilobal shape at the bottom, which contains the aortic valve. It then comes back into a round form and then tapers and curves off. So it's quite a difficult structure to produce. This, like I say, is a CAD model of me, and this is one of the later CAD models. We went through an iterative process of producing better and better models. When we produced that model we turn it into a solid plastic model, as you can see, using a rapid prototyping technique, another engineering technique. We then use that former to manufacture a perfectly bespokeporous textile mesh, which takes the shape of the former and perfectly fits the aorta. So this is absolutely personalized medicine at its best really. Every patient we do has an absolutely bespoke implant.
Once you've made it, the installation's quite easy. John Pepper, bless his heart, professor of cardiothoracic surgery -- never done it before in his life -- he put the first one in, didn't like it, took it out, put the second one in. Happy, away I went. Four and a half hours on the table and everything was done. So the surgical implantation actually was the easiest part.
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如果你將我們的新療法與現有技術比較-即所謂的複合式主動脈根部置換術,這是兩者之間令人驚訝的差異,我想這張圖表能讓你們一目了然。植入我們的裝置需耗費兩小時,現有療法則須耗費六小時。現有療法需要,如我說過的,使用心肺體外循環機,及使整個身體降溫,這兩項我們都不需要。我們在心臟跳動的情況下進行手術,醫生將身體切開,在心臟跳動的情況下處理主動脈,整個過程中身體都維持原來溫度,不需侵入血液循環系統,所以這確實相當棒。
但對我來說,最棒的部分絕對是不需使用抗凝血療法。我不需服用任何藥物,除非我自己選擇吸毒。(笑聲)。事實上,對長期使用華法林的人來說,生活品質必定會受到嚴重影響,更糟的是,它必定會使壽命縮短。同樣地,如果選擇植入人工瓣膜,每當接受侵入性治療時,就得同時進行抗生素療法,甚至連看個牙醫都得服用抗生素,以防瓣膜受到感染。同樣地,這些我都不需要,所以我相當自在。我的主動脈已修復,我再也不需要擔心它了,這可說是我的重生。
回到這場演講的主題:跨學科研究。為何一位通常與鍋爐為伍的製程工程師,最後會去製造某種使自己生命改觀的醫療裝置?好,答案是跨學科團隊合作。這是團隊核心成員的名單,如你們所見,其中不只有醫療和工程這兩門主要學科的技術人員,也有來自這兩門學科的各類專家。John Pepper是實際為我動手術的心臟外科醫生,但其他人則在不同方面有所貢獻,例如醫療放射學家Raad Mohiaddin。我們必須取得品質良好的影像來製作CAD模型,目前Warren Thornton仍為我們製作所有CAD模型,他必須藉由相當難分析的輸入資料,編寫特定的CAD代碼來製作模型。
但過程中也有一些障礙、一些問題,專業術語就是個大問題。我認為現場沒人能同時理解投影片中這四個術語;你們當中的工程師瞭解快速成型和CAD的意義,如果你們當中有任何醫療人員,將會瞭解前兩個術語的意義;但現場沒有任何人同時瞭解這四個字的意義。理解術語的意義非常重要,當我們使用某個特定術語時,必須確保團隊中每個人都理解其真正意義。
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If you compare our new treatment to the existing alternative, the so-called composite aortic root graft, there are one of two startling comparisons, which I'm sure will be clear to all of you. Two hours to install one of our devices compared to six hours for the existing treatment. The existing treatment requires, as I've said, the heart and lung bypass machine and it requires a total body cooling. We don't need any of that; we work on a beating heart. He opens you up, he accesses the aorta while your heart is beating, all at the right temperature. No breaking into your circulatory system. So it really is great.
But for me, absolutely the best point is there is no anticoagulation therapy required. I don't take any drugs at all other than recreational ones that I would choose to take. (Laughter)And in fact, if you speak to people who are on long-term warfarin, it is a serious compromise to your quality of life. And even worse, it inevitably foreshortens your life.Likewise, if you have the artificial valve option, you're committed to antibiotic therapywhenever you have any intrusive medical treatment at all. Even trips to the dentist require that you take antibiotics, in case you get an internal infection on the valve. Again, I don't have any of that, so I'm entirely free. My aorta is fixed, I haven't got to worry about it, which is a rebirth for me.
Back to the theme of the presentation: In multidisciplinary research, how on earth does a process engineer used to working with boilers end up producing a medical device which transforms his own life? Well the answer to that is a multidisciplinary team. This is a list of the core team. And as you can see, there are not only two principal technical disciplines there, medicine and engineering, but also there are various specialists from within those two disciplines. John Pepper there was the cardiac surgeon who did the actual work on me, but everyone else there had to contribute one way or another. Raad Mohiaddin, medical radiologist: We had to get good quality images from which to make the CAD model. Warren Thornton, who still does all our CAD models for us, had to write a bespoke piece of CAD code to produce this model from this really rather difficult input data set.
There are some barriers to this though. There are some problems with it. Jargon is a big one. I would think no one in this room understands those four first jargon points there.The engineers amongst you will recognize rapid prototyping and CAD. The medics amongst you, if there are any, will recognize the first two. But there will be nobody else in this room that understands all of those four words. Taking the jargon out was very important to ensure that everyone in the team understood exactly what was meant when a particular phrase was used.
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各領域的習慣用法也相當有趣。我們拍攝了許多我身體的橫切面影像,然後用這些影像建立一個CAD模型。我們製作出第一個CAD模型,但負責製作塑膠模型的外科醫生無法完全理解這個模型,然後我們發現它其實是真正主動脈的鏡像。它是鏡像的原因是,在現實世界中,我們總是俯視平面圖,房屋、街道或地圖的平面圖;在醫學界,他們習慣仰視平面圖,所以這些橫切影像全都會變成反向。所以我們必須注意各學科的慣用方式,每個人都必須理解各學科對此是否有既定的設定。
體制上的障礙是計畫中另一件令我們相當頭痛的事。布朗普頓醫院受帝國大學醫學院管轄,這兩個機構間的關係不佳,存在一些嚴重問題。我與帝國醫學院和布朗普頓醫院均有合作,使這項計畫產生一些嚴重的問題-實在不應該存在的問題。
研究和倫理委員會:如果你想在手術方面做任何創新,你必須得到當地研究和倫理機構許可,我想在波蘭也一樣,對授權進行新手術的做法應該大同小異。我們不僅有這方面的官僚問題,也有專業領域的嫉妒問題。有些研究和倫理委員會的人不希望看到John Pepper再次成功,因為他實在太成功了,這讓我們產生一些額外問題。
官僚主義問題:當你研究出一種新療法後,必須將一份說明文件發送給全國所有醫院。英國有國家臨床卓越研究院(NICE),毫無疑問,波蘭也有類似機構。我們必須通過NICE的審查。現在在網路上,我們有很棒的臨床指南,因此任何對此感興趣的醫院都可上網閱讀NICE的報告,與我們聯繫,然後自行進行這種手術。
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Our disciplinary conventions were funny as well. We took a lot of horizontal slice images through me, produced those slices and then used those to build a CAD model. And the very first CAD model we made, the surgeons were playing with the plastic model, couldn't quite figure it out. And then we realized that it was actually a mirror image of the real aorta.And it was a mirror image because in the real world we always look down on plans, plans of houses or streets or maps. In the medical world they look up at plans. So the horizontal images were all an inversion. So one needs to be careful with disciplinary conventions.Everyone needs to understand what is assumed and what is not assumed.
Institutional barriers were another serious headache in the project. The Brompton Hospital was taken over by Imperial College's School of Medicine, and there are some seriously bad relationship problems between the two organizations. I was working with Imperial and the Brompton, and this generated some serious problems with the project,really problems that shouldn't exist.
Research and ethics committee: If you want to do anything new in surgery, you have to get a license from your local research and ethics. I'm sure it's the same in Poland. There will be some form of equivalent, which licenses new types of surgery. We didn't only have the bureaucratic problems associated with that, was also had professional jealousies. There were people on the research and ethics committee who really didn't want to see John Pepper succeed again, because he's so successful. And they made extra problems for us.
Bureaucratic problems: Ultimately when you have a new treatment you have to have a guidance note going out for all of the hospitals in the country. In the U.K. we have the National Institute for Clinical Excellence, NICE. You'll have an equivalent in Poland, no doubt. We had to get past the NICE problem. We now have a great clinical guidance out on the Net. So any of the hospitals interested can come along, read the NICE report get in touch with us and then get doing it themselves.
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資金障礙:這是另一項需要考慮的大問題,以下觀點也是個大問題:當我們第一次接觸資助這類研究的英國慈善機構之一時,基本上他們將它視為一項工程提案,他們不瞭解這個計畫。他們是醫生,自視甚高,認為這必定是無稽之談,將它冷凍起來,所以最後我只好去找私人投資者,放棄尋求公部門的資助。但大多數研發工作需要機構的資助,例如波蘭科學院或工程和物理科學研究委員會之類的,你必須得到那些人的認可。
當你試圖進行跨學科工作時,術語是個大問題。因為在工程領域,大家都明白CAD和R.P.(快速成型)-在醫療領域則不然。我認為審核資金的官僚們確實得更積極些,他們真的得開始與其他人溝通,必須擁有多一點想像力-如果這不是過分的要求-但很可能是。
我創造了一個語詞:「阻礙性保守主義」。太多醫學界的人不願改變,特別是當一位空降這個領域的工程師為他們帶來答案時。他們不想改變,他們只想墨守成規。事實上,英國有許多外科醫生依然等著我們的病人出什麼狀況,讓他們可以說,「啊,我就說嘛,這種手術不好。」事實上,我們為30位病人動過這種手術,我接受這種手術已有7年半時間,所有術後病例累積使用的時間已有90年,還沒發現任何問題。英國依然有人這麼說,「嗯,主動脈根部包覆手術,是啊,你知道,它不可能有效。」
這確實是個問題,確實是個問題。我敢肯定,現場各位多少都遇過各領域中的自大傢伙,包括醫療人員、醫生和外科醫生等,主要是因為這是醫生自我保護的方式,「是啊,我當然能照顧好我的病人。」我認為這不是好現象,但這是我個人的看法。
當然,自我意識同樣是個大問題。如果你在一個跨學科小組工作,你必須讓組員擁有懷疑的權力,你必須表達對他們的支持。心臟與胸腔外科教授Tom Treasure,相當傑出的傢伙,很容易就能給予他尊重。而他給予我的尊重呢?就略有不同了。這些是所有的壞消息。好消息是,其中的好處多得令人難以置信。翻譯那個字,我打賭他們辦不到。
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Funding barriers: Another big area to be concerned with. A big problem with understanding one of those perspectives: When we first approached one of the big U.K. charitable organizations that funds this kind of stuff, what they were looking at was essentially an engineering proposal. They didn't understand it; they were doctors, they were next to God. It must be rubbish. They binned it. So in the end I went to private investors and I just gave up on it. But most R and D is going to be institutionally funded, by the Polish Academy of Sciences or the Engineering and Physical Sciences Research Council or whatever, and you need to get past those people.
Jargon is a huge problem when you're trying to work across disciplines, because in an engineering world, we all understand CAD and R.P. -- not in the medical world. I suppose ultimately the funding bureaucrats have really got to get their act together. They've really got to start talking to each other, and they've got to exercise a bit of imagination, if that's not too much to ask -- which it probably is.
I've coined a phrase "obstructive conservatism." So many people in the medical world don't want to change, particularly not when some jumped-up engineer has come along with the answer. They don't want to change. They simply want to do whatever they've done before. And in fact, there are many surgeons in the U.K. still waiting for one of our patientsto have some sort of episode, so that they can say, "Ah, I told you that was no good." We've actually got 30 patients. I'm at seven and a half years. We've got 90 post-op patient years between us, and we haven't had a single problem. And still, there are people in the U.K. saying, "Yeah, that external aortic root, yeah, it'll never work, you know."
It really is a problem. It really is a problem. I'm sure everyone in this room has come across arrogance amongst medics, doctors, surgeons at some point. The middle point is simply the way that the doctors protect themselves. "Yeah, well of course, I'm looking after my patient." I think it's not good, but there you are, that's my view.
Egos, of course, again, a huge problem If you're working in a multidisciplinary team,you've got to give your guys the benefit of the doubt. You've got to express support for them. Tom Treasure, professor of cardiothoracic surgery: incredible guy. Dead easy to give him respect. Him giving me respect? Slightly different. That's all the bad news. The good news is the benefits are stonkingly huge. Translate that one. I bet they can't.
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當你有一組擁有不同專業訓練、不同專業經驗的人,他們不僅擁有不同的知識基礎,也能從不同角度觀察一切事物,如果你可以讓那些人聚在一起,讓他們發表想法,瞭解對方,結果可能相當壯觀。你可以找到新的解決方案,相當新穎的解決方案,之前從未有人想過的方法,非常迅速、容易,你可以簡化大量工作,只要善用這個你所擁有的廣大知識庫。結果是,這是對技術及知識一個完全不同的運用方式。
這一切所產生的結果是,你可以用令人難以置信的少數預算得到令人難以置信的快速進展,我不好意思告訴大家,從我的想法到將這個裝置植入我體內,整個過程的成本有多低廉。我不打算告訴你們它的成本,因為我懷疑,或許美國的標準手術療法,單是為一位病人進行手術的成本就比實現我的夢想還多。
這就是我想說的。演講時間還剩3分鐘,Heather應該會很喜歡我。如果有任何疑問,請稍後上前來跟我討論,很榮幸能跟大家彼此交流,非常感謝。
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When you have a group of people who have had a different professional training, a different professional experience, they not only have a different knowledge base, but they have a different perspective on everything. And if you can bring those guys together and you can get them talking and understanding each other, the results can be spectacular.You can find novel solutions, really novel solutions, that have never been looked at beforevery, very quickly and easily. You can shortcut huge amounts of work simply by using the extended knowledge base you have. And as a result, it's an entirely different use of the technology and the knowledge around you.
The result of all this is that you can get incredibly quick progress on incredibly small budgets. I'm so embarrassed at how cheap it was to get from my idea to me being implanted that I'm not prepared to tell you what it cost. Because I suspect there areabsolutely standard surgical treatments probably in the USA which cost more for a one-off patient than the cost of us getting from my dream to my reality.