Over the last 13 years -- one, three, 13 years -- I've been part of an exceptional team at InSightec in Israel and partners around the world for taking this idea, this concept, noninvasive surgery, from the research lab to routine clinical use. And this is what I'll tell you about. 13 years -- for some of you, you can empathize with that number. For me, today, on this date, it's like a second bar mitzvah experience.
在过去的13年里- 1,3,13年- 我作为以色列InSightech里一个优秀团队里的一员 协同世界各地的同道之士 将一个新构想,一个理念 ——非侵入性手术 从研究实验室带进日常临床应用 这将是我要谈论的话题 13年- 在座各位当中有些人会对这个数字产生共鸣 对我来说 就像第二次成年礼一样
(Laughter)
(笑声)
So this dream is really enabled by the convergence of two known technologies. One is the focused ultrasound, and the other one is the vision-enabled magnetic resonance imaging. So let's first talk about focused ultrasound. And I hold in my hand a tissue-mimicking phantom. It is made out of silicon. It is transparent, made just for you. So you see, it's all intact, completely transparent. I'll take you now to the acoustic lab. You see the phantom within the aquarium. This is a setup I put in a physics lab. On the right-hand side, you see an ultrasonic transducer. So the ultrasonic transducer emits basically an ultrasonic beam that focuses inside the phantom. Okay, when you hear the click, this is when the energy starts to emit and you see a little lesion form inside the phantom. Okay, so everything around it is whole and intact. It's just a lesion formed inside. So think about, this is in your brain. We need to reach a target inside the brain. We can do it without harming any tissue. So this is, I think, the first kosher Hippocratic surgical system.
这个梦想的 实现是 两项现存技术 结合的结果 一个是聚焦超声 另一个是 可视化磁共振成像技术 首先来谈谈聚焦超声 我手里是 一个组织模型 由硅材料制成 透明的,便于大家观察 显而易见,它是完整的 完全透明的 现在我们来到声学实验室 可以看到玻璃缸里的透视图 这是我在物理实验室里的装置 在右边 是一台超声传感器 当超声传感器 对着模型内部 发射出一束超声波束 你听见咔嗒声 就是能量要发射了 然后你能看见模型内部 出现了小小的损坏 而周围一切 都完好无损 损伤完全从内部形成 试想一下,如果这是你的大脑 我们要击中大脑内部的一处目标 我们可以在不伤及任何组织的情况下办到 我想 这是第一个符合犹太戒律的希波克拉底手术系统
(Laughter)
(笑声)
Okay, so let's talk a little bit about ultrasound, the force of ultrasound. You know all about imaging, right, ultrasound imaging. And you know also about lithotripsy -- breaking kidney stones. But ultrasound can be shaped to be anything in between, because it's a mechanical force. Basically, it's a force acting on a tissue that it transverses. So you can change the intensity, the frequency, the duration, the pulse shape of the ultrasound to create anything from an airbrush to a hammer. And I am going to show you multiple applications in the medical field that can be enabled just by focusing, physically focusing.
接下来谈谈超声波 超声波的力量 大家都知道超声波成像 还有体外震波碎石术 可以震碎肾结石 但超声波可以成为 两者间的任何形态 因为它是一种机械力 它横穿组织时对其 产生作用力 所以可以通过改变超声波的强度、频率 波长和脉冲波形 来创造出从喷枪到铁锤的 任何东西 接下来我要展示的是 通过聚焦超声波 只用物理聚焦 在医疗领域中的 多种应用
So this idea of harnessing focused ultrasound to treat lesions in the brain is not new at all. When I was born, this idea was already conceived by pioneers such as the Fry brothers and Lars Leksell, who is know actually as the inventor of the gammaknife. But you may not know that he tried to perform lobotomies in the brain, noninvasively, with focused ultrasound in the '50s. He failed, so he then invented the gammaknife. And it makes you ponder why those pioneers failed. And there was something fundamental that they were missing. They were missing the vision. It wasn't until the invention of the MR and really the integration of MR with focused ultrasound that we could get the feedback -- both the anatomical and the physiological in order to have a completely noninvasive, closed-loop surgical procedure.
使用聚焦超声波 来治疗脑损伤 并不是新理念 这个构想早在我出生之前 就已经形成了,比如弗莱兄弟 和拉尔斯・莱克塞尔 后者因 发明伽玛刀而闻名 但大家可能不知道 早在五十年代他 尝试利用聚焦超声波 进行非侵入式前脑白质切断术 没有成功 于是他发明了伽玛刀 于是你会思索 为什么这些先辈都没有成功 因为一些关键的东西 未被发现和使用 他们缺少成像技术 直到磁共振成像的发明 直到磁共振成像 与聚焦超声波的合二为一 我们才能在解剖学 和生理学上得到肯定答案 才可以执行完全无侵入、完全体内 进行的手术
So this is how it looks, you know, the operating room of the future today. This is an MR suite with a focused ultrasound system. And I will give you several examples. So the first one is in the brain. One of the neurological conditions that can be treated with focused ultrasound are movement disorders, like Parkinson's or essential tremor. What is typical to those conditions, to essential tremor for example, is inability to drink or eat cereal or soup without spilling everything all over you, or write legibly so people can understand it, and be really independent in your life without the help of others.
这就是今天看到的未来 手术室的样子 这是配有聚焦超声波系统的磁成像成套设备 我会给大家看一些例子 第一个位于大脑内部 可以通过聚焦超声波治疗的 一个神经性病症是 运动障碍 比如帕金森氏症或者原发性颤抖症 这类疾病的典型症状就是 比如原发性颤抖症 就是吃麦片 或喝汤的时候 会把汤洒得到处都是 或者写的字没人能识别 必须依赖别人的帮助 才能生活
So I'd like you to meet John. John is a retired professor of history from Virginia. So he suffered from essential tremor for many years. And medication didn't help him anymore. And many of those patients refused to undergo surgery to have people cut into their brain. And about four or five months ago, he underwent an experimental procedure. It is approved under an FDAIDE at the University of Virginia in Charlottesville using focused ultrasound to ablate a point in his thalamus. And this is his handwriting. "On June 20th," if you can read it, "2011." This is his handwriting on the morning of the treatment before going into the MR So now I'll take you through [what] a typical procedure like that looks like, [what] noninvasive surgery looks like.
让我介绍一下 约翰 约翰是一位退休的历史教授 来自维吉尼亚 患原发性颤抖症多年 药物治疗再无成效 许多类似的病人拒绝手术 因为需要开颅 大概四五个月前 他接受了一个实验性治疗 这个治疗在夏洛特斯维尔的弗吉尼亚大学获得了 美国食品药物管理监督局的 临床实验医疗器材许可 使用聚焦超声 切除他视丘里的一个点 这是他的字迹 如果大家看得请的话, “6月20日” “2011年” 这是他的字迹 接受磁共振治疗前的 之前写下的 接下来我要带各位了解一下 典型的手术流程 非侵入性手术的过程
So we put the patient on the MR table. We attach a transducer, in this case, to the brain, but if it will be a different organ, it will be a different transducer attached to the patient. And the physician will then take a regular MR scan. And the objective of that? I don't have a pointer here, but you see the green, sort of rectangle or trapezoid? This is the sort of general area of the treatment. It's a safety boundary around the target. It's a target in the thalamus. So once those pictures are acquired and the physician has drawn all the necessary safety limits and so on, he selects basically a point -- you see the round point in the middle where the cursor is -- and he presses this blue button called "sonicate." We call this instance of injecting the energy, we call it sonication. The only handwork the physician does here is moving a mouse. This is the only device he needs in this treatment.
我们将病人平置于磁共振的手术台上 装上传感器,这里是针对大脑的 如果是其他的器官 就会用其他不一样的传感器 医生会 先进行常规磁共振扫描 扫描对象呢? 我手头没有指示棒 不过你看到这些绿色的类似矩形或梯形的部分吗? 这可以说是治疗的大致区域 这是目标周围的 安全区域 这是视丘中的手术对象 只要获取这些图片 并且医生也划出了 所有必要的安全限制范围等等, 他就会选取一个点- 就是正中间,箭头所指的那个圆点- 然后他按下这个叫“声处理”的按钮 我们把注射能量这一步 叫做声波降解法 医生唯一的体力活就是 移动鼠标 鼠标是他在治疗过程中唯一需要的设备
So he presses "sonicate," and this is what happens. You see the transducer, the light blue. There's water in between the skull and the transducer. And it does this burst of energy. It elevates the temperature. We first need to verify that we are on target. So the first sonication is at lower energy. It doesn't do any damage, but it elevates the temperature by a few degrees. And one of the unique capabilities that we leverage with the MR is the ability to measure temperature noninvasively. This is really a unique capability of the MR. It is not being used in regular diagnostic imaging. But here we can get both the anatomical imaging and the temperature maps in real time. And you can see the points there on the graph. The temperature was raised to 43 degrees C temporarily. This doesn't cause any damage. But the point is we are right on target. So once the physician verifies that the focus spot is on the target he has chosen, then we move to perform a full-energy ablation like you see here. And you see the temperature rises to like 55 to 60 degrees C. If you do it for more than a second, it's enough to basically destroy the proteins of the cells.
他按下“声处理”,接下来 请看传感器,就是淡蓝的部分 头颅和传感器之间是水 传感器释放出能量 提高温度 我们首先得确认 是否命中目标 因此第一次超声波降解 发射能量较低 不会产生任何伤害 只会把温度提高 几度而已 磁共振的一个 独特功能就是 非侵入性温度测量 这是磁共振的特有功能 一般不会用于 常规的造影诊断 但我们可以使用它 取得实时的解剖影像和温度走势图 可以看到图像上的这些点 温度被暂时提升 至43摄氏度 这不会造成任何伤害 但重点是我们命中目标了 一旦医生确定 聚焦点击中选定目标 下一步便是 高能切除 如图所示 温度上升到 55到66摄氏度 如果这种状态持续超过一秒 基本上就足够摧毁 细胞中的蛋白质了
This is the outcome from a patient perspective -- same day after the treatment. This is an immediate relief. (Applause) Thank you. John is one of [about] a dozen very heroic, courageous people who volunteered for the study. And you have to understand what is in people's mind when they are willing to take the risk. And this is a quote from John after he wrote it. He said, "Miraculous." And his wife said, "This is the happiest moment of my life." And you wonder why. I mean, one of the messages I like to carry over is, what about defending quality of life? I mean, those people lose their independence. They are dependent on others. And John today is fully independent. He returned to a normal life routine. And he also plays golf, like you do in Virginia when you are retired. Okay, so you can see here the spot. It's like three millimeters in the middle of the brain. There's no damage outside. He suffers from no neurodeficit. There's no recovery needed, no nothing. He's back to his normal life.
这是病人眼中的术后结果- 治疗结束的当天 症状立刻消失了 (掌声) 谢谢 约翰是众多 有胆量和勇气参加这项研究的 志愿者之一 需要知道的是 当他们决定冒这个险时 他们心里想的是什么 约翰写下这些之后 他说:“太神奇了!” 他的妻子说:“这是我一生中最开心的时刻。“ 也许你不理解 我想说的是 为什么我们要维护生活的质量? 这些人失去独立生活的能力 他们要依赖于别人 而约翰现在完全不用依靠别人了 他恢复了正常人的生活 他会去打高尔夫球 就像很多人在 维吉尼亚的退休生活 好,请看这里的雾状物 在大脑中间大约3毫米处 没有任何外部损伤 他没有任何神经损伤 没有康复期 什么都不用 他直接恢复到正常生活
Let's move now to a more painful subject. Pain is something that can make your life miserable. And people are suffering from all kinds of pain like neuropathic pain, lower-back pain and cancer pain from bone metastases, when the metastases get to your bones, sometimes they are very painful. All those I've indicated have already been shown to be successfully treated by focused ultrasound relieving the pain, again, very fast. And I would like to tell you about PJ. He's a 78 year-old farmer who suffered from -- how should I say it? -- it's called pain in the butt. He had metastases in his right buttock, and he couldn't sit even with medication. He had to forgo all the farm activities. He was treated with radiation therapy, state-of-the-art radiation therapy, but it didn't help. Many patients like that favor radiation therapy.
下面我们要 谈论一个痛苦的话题 疼痛可以让 生活变得很悲惨 人们承受着各种各样的痛苦 比如神经痛、腰痛 骨转移带来的癌症疼痛 当癌细胞转移进入你的骨髓 有时候会非常非常痛 我谈到的这些痛症 都已经被证实 可以通过聚焦超声技术 非常快速地治愈 可以一下子消除疼痛 下面我想介绍一下 PJ 他是个农民 78岁了 他的疼痛 来自臀部 他的癌细胞转移到了臀部右侧 即使有药物治疗 他也无法坐下 他停止了任何劳作 接受了放射治疗 最先进的放射治疗 但毫无帮助 很多病人倾向于放射治疗
And again, he volunteered to a pivotal study that we ran worldwide, also in the U.S. And his wife actually took him. They drove like three hours from their farm to the hospital. He had to sit on a cushion, stand still, not move, because it was very painful. He took the treatment, and on the way back, he drove the truck by himself. So again, this is an immediate relief. And you have to understand what those people feel and what their family experiences when it happens. He returned again to his daily routine on the farm. He rides his tractor. He rides his horse to their mountain cabin regularly. And he has been very happy.
但他决定参与 我们这个在世界范围内 进行的重大研究项目 当然也包括美国 是他的妻子带他来的 他们从农场开了 大概三个小时的车 他得坐在一个垫子上 一动都不能动 不然就会很痛 他接受了治疗 回家路上 他就能自己开卡车了 这再次证明 治疗瞬间就消除了疼痛瞬间 你可以体会 当病痛解除时 这些病人和 他们家人的感受 他又开始了 每天在农场的劳作 他开着他拖拉机 骑着马定期去山间小屋 从此一直都很开心
But now, you ask me, but what about war, the war on cancer? Show us some primary cancer. What can be done there? So I have good news and bad news. The good news: there's a lot that can be done. And it has been shown actually outside of the U.S. And doing that in the U.S. is very painful. I don't see, without this nation taking it as some collective will or something that is a national goal to make that happen, it will not happen. And it's not just because of regulation; it's because of the amount of money needed under the current evidence-based medicine and the size of trials and so on to make it happen.
但现在你会问我 那么对癌症的宣战呢? 我们要看看对于那些首要癌症 这个研究能做些什么呢? 我这儿有好消息,也有坏消息 好消息是:我们能做的有很多 这点美国以外地区已经得到证实 但是在美国的话 非常棘手 似乎没有全民为之请愿 或视其为国民目标来推进 事情就没法办成 我不这样认为 这不仅是制度法规的问题 还有现行的实证医学体系下 要投入的巨额资金以及 临床试验的规模等等 都成为实现目标的阻碍
So the first two applications are breast cancer and prostate cancer. They were the first to be treated by focused ultrasound. And we have better-than-surgery results in breasts. But I have a message for the men here. We heard here yesterday Quyen talking about the adverse event trait in prostate cancer. There is a unique opportunity now with focused ultrasound guided by MR, because we can actually think about prostate lumpectomy -- treating just the focal lesion and not removing the whole gland, and by that, avoiding all the issues with potency and incontinence. Well, there are other cancer tumors in the abdomen -- quite lethal, very lethal actually -- pancreas, liver, kidney. The challenge there with a breathing and awake patient -- and in all our treatments, the patient is awake and conscious and speaks with the physician -- is you have to teach the MR some tricks how to do it in real time. And this will take time. This will take two years.
研究的首要两项应用 是乳腺癌和前列腺癌 这两种是癌症中首先使用聚焦超声波治疗的 乳腺癌的治疗结果显示比手术效果更好 不过有个消息提供给在场男士 听说吉兰昨天在这里 探讨了前列腺癌治疗的 不良症状 通过使用磁共振成像和聚焦超声波技术 我们有一个全新的治疗前景 因为我们可以考虑 前列腺肿瘤切除- 治疗局部病变 而不用切除整个腺体 这样就避免了 性功能丧失和尿失禁问题 其他的一些出现在腹腔的癌症- 相当致命,可以说很致命 胰脏,肝脏,肾脏里的 治疗的困难是- 病人是完全清醒的 在我们所有的治疗中 病人完全清醒 可以和医生交谈- 困难就是我们得让磁共振成像 实现实时成像 这不容易 我们花了两年做到
But I have now a message to the ladies. And this is, in 2004, the FDA has approved MR-guided focused ultrasounds for the treatment of symptomatic uterine fibroids. Women suffer from that disease. All those tumors have heavy bleeding during periods, abdominal pressure, back pain, frequent urination. And sometimes, they cannot even conceive and become pregnant because of the fibroid. This is Frances. She was diagnosed with a grapefruit-sized fibroid. This is a big fibroid. She was offered a hysterectomy, but this is an inconceivable proposition for someone who wants to keep her pregnancy option. So she elected to undergo a focused ultrasound procedure in 2008. And in 2010, she became a first-time mother to a healthy baby. So new life was born.
现在有一个带给女士们的消息 2004年 美国食品药物管理局已经批准了磁共振成像引导聚焦超声波技术 应用于子宫肌瘤的临床治疗 女性常受此病痛折磨 肿瘤会导致 经期大量出血 腹部张痛 背痛 尿频 有时甚至会导致 无法受孕 这位女性住在法国 她被诊断出长有一个柚子大小的子宫肌瘤 这是很大的子宫肌瘤 医生建议她切除子宫 但对于期望怀孕的人来说 这是无法接受的选择 她在2008年选择了接受 聚焦超声波治疗 2010年她成了一个健康宝宝的妈妈 就这样一个新生命诞生了
(Applause)
(掌声)
So in conclusion, I'd like to leave you with actually four messages. One is, think about the amount of suffering that is saved from patients undergoing noninvasive surgery, and also the economical and emotional burden removed from their families and communities and the society at large -- and I think also from their physicians, by the way. And the other thing I would like you to think about is the new type of relationship between physician and patients when you have a patient on the table [who] is awake and can even monitor the treatment. In all our treatments, the patient holds a stop sonication button. He can stop the surgery at any moment.
最后 我想要给各位留下四个信息 首先试想一下 非侵入式手术 可以让多少病人脱离苦海 可以帮助他们的家人、社区 还有社会减轻多少 经济和情感上的负担- 我想应该也减轻了医生的负担 另外请想象一下 医患之间形成了 一种新的关系 当病人躺着手术台上 他是完全清醒的甚至可以监督治疗 在我们的治疗中 病人握着一个解除手术的按钮 病人可以随时中止手术
And with that note, I would like to thank you for listening.
带着这些讯息, 最后我想感谢各位的聆听
(Applause)
(掌声)