인공 심장: 심장 기술의 발전과 도전 과제

내구성이 뛰어난 무선 인공 심장을 개발하는 것은 전 세계 주요 사망 원인인 심부전을 퇴치하는 데 매우 중요하며, 잠재적으로 심부전을 줄일 수 있습니다.

### 영구적인 인공 심장을 위한 탐구
* ❤ 심혈관 질환, 특히 심부전은 전 세계적으로 주요 사망 원인이며, **궁극적인 목표는 실용적이고 영구적인 종합 인공 심장**을 개발하는 것입니다.
* 📈 모든 기술은 **시그모이드 채택 곡선**을 따르며, 지난 10년 동안에야 **10년 이상 지속될 가능성**이 있는 디바이스가 개발되었습니다.
* 💉 현재 심부전 치료의 표준은 **심장이식**이지만, 전 세계적으로 매년 약 100만 건의 **심장이식 요청**이 있을 정도로 기증 심장이 심각하게 부족한 상황입니다.
* 🏥 최초의 인공 심장은 **1969년에 임상적으로 사용**되었으며, 이후 현재 이식용 브릿지 장치로 승인된 **SynCardia 및 Carmat**와 같은 장치로 발전했습니다.
* 🔧 기존 인공 심장의 가장 큰 문제는 **지속적으로 구부려야 하기 때**문에 장치가 마모되는 장기적인 내구성입니다.
* 🌀 바이오바코어는 자기부상 회전 디스크를 사용하여 폐와 신체에 혈액을 공급하는 **회전식 인공 심장**을 개발하여 내구성이 오래 지속될 수 있는 가능성을 제시했습니다.
* 🔋 현재 인공 심장의 중요한 문제 중 하나는 환자의 피부를 통해 심장에 연결된 **서류가방 크기의 전원 팩**이 필요하다는 점이며, **배터리 수명 연장 및 무선 충전**과 같은 발전은 환자의 삶의 질을 개선하는 데 매우 중요합니다.
* 🌟 다양한 기술 발전의 융합은 외부 전선 없이 **오랫동안 지속되는 인공 심장의 개발에 대한 희망**을 가져와 전 세계 심부전 환자들의 전망을 변화시킬 수 있습니다.

Cardiovascular disease, and specifically heart failure, is the number one cause of death in men and women across just about every demographic. If we had a patient with a bad heart, and we could take their heart out and replace it with a machine, we'd do it all the time. For the last half-century, scientists have been working tirelessly to create a machine that can accurately mimic the function of a beating human heart, envisioning devices they hope will one day rid us of the number one cause of death in the world. Every technology goes through a sigmoidal adoption curve. 5% of people are doing it, then 10, then 15, then suddenly it saturates and goes vertical. And only now in the last decade or so have we had the technology to make devices that potentially could last a decade or more. If we had a practical, permanent, total artificial heart, it would be one of the biggest accomplishments in modern medicine.

When it comes to heart failure, there's currently only one gold standard of treatment: replacing the failing heart with a healthy donor. And while there are nearly 6,000 heart transplants done annually, there are about a million requests for donor hearts each year, 600,000 of which are in the U.S. alone. So the main limitation to heart transplantation is having a donor heart that we can place in a patient who's destined to die from heart failure. Dr. William Cohn is a heart surgeon at the Texas Heart Institute and an innovator in artificial heart technology. And if you think about it, it's gotta be a healthy heart from a patient who's died in such way that it didn't affect their heart. And that doesn't happen that frequently. So to be able to save the lives of all these patients that are dying of heart failure, we need something other than a transplanted heart. Your heart's just a pump.

Every cell in your body needs
nutrition, needs oxygen. It gets that through the blood that goes through every
blood vessel in your body. The heart is the pump
that makes the blood move. So a heart is a very simple
device by some metrics, but incredibly complex by others. So a lot of scientists looked at the heart function
and tried to mimic it. The really first artificial heart was designed by a guy
named Domingo Liotta, brilliant Argentinian
scientist who was working at the Cleveland clinic. Then came down to work with Michael DeBakey, pioneering heart surgeon in Houston. And they developed a device that DeBakey had implanted in seven cows. The longest went about 12 hours. While DeBakey was in Washington DC asking for additional funding, his then partner, Denton Cooley, implanted it in a desperate ill human
patient, Haskell Karp. April 4th, 1969, that was the world's first clinical use.

of a total artificial heart. The possibility has been established as a reality. The fact that Mr. Karp has regained organ function in terms of cerebral function and kidney function indicates that it's a mechanical heart is a feasibility. Unfortunately, the valves that they'd put in this version of the heart were breaking up the blood. The broken up blood was causing the kidneys to fail, and after 64 hours on the device, they did an emergency transplant and tragically 36 hours later died of an infection. But it showed us that that type of thing was possible. The heart had bladders that filled and emptied with compressed air that drove the blood forward. One way valves made it so that when the bladders collapsed, blood poured into the device. When the bladders filled, it went out through the great vessels. Based on that technology, that device continued to evolve and evolved into what we now have, the SynCardia device, which is the world's first approved device.

just like the one implanted in 1969, but much better membranes,
much better valves, much better material, and
manufacturing techniques. Now we've just heard
that the Carmat device has been approved for
commercial sale in Europe, and that's great. That's a step forward, but it's still approved for temporary use. SynCardia and Carmat are the only approved artificial hearts in the world right now. But they're currently
approved only as bridge to transplant devices, temporary hearts that work
to keep patients alive until a real donor
heart becomes available. The longest an artificial
heart has ever lasted in a patient is 1,374 days,
or roughly four years, the real limitation being
long-term durability. Think about it now. If your heart is beating
80 times a minute, that's 132,000 times in a day, that's 42 million times in a year. So the challenge with
all the artificial hearts that have been developed
so far is, it wears out.

Anything that has to flex over and over again to make it so it never fails, I think this is a tall order. The durability factor has led other groups to rethink their approach to how an artificial heart mimics our own. BiVACOR, a startup from Brisbane, Australia that's headquartered in Houston Texas, has come up with a device that hardly resembles a human heart at all. Their radical new approach has helped them to raise more than $20 million and has won over industry heavy hitters like Dr. Cohn, who serves as their chief medical officer. My name is Daniel Timms, I'm a mechanical engineer with a PhD in biomedical engineering. During my PhD, I invented the BiVACOR device and have been developing that device ever since. The artificial heart that we're creating is what's called a rotary total artificial heart, which has a spinning disc, which is magnetically levitated within a cavity to pump the blood to both the lungs.

and to the body simultaneously. It's a similar process to a
fan, where your ceiling fan will spin and air will come
down at a constant flow rate. Instead of air, we're pumping blood. But it's very similar
impellers, effectively, that's inside the artificial heart. And so that approach
is radically different from utilizing compressing sacks. A spinning disc that is
magnetically levitated, meaning that there's no touchdown of any of those moving parts, can
affectively last forever. BiVACOR's artificial heart works off of rapidly spinning pump technology, developed by scientists
Rob Jarvik and Rich Wampler in the mid-1980s. In their device, small turbines sat
outside unhealthy hearts to assist with blood flow
to a single ventricle. Timms' device builds on that idea by using a spinning disc, or impeller, to push and regulate the flow
of blood to both ventricles. The impeller inside

it's a single disc with veins
on one side to pump the blood to the body, and veins on the other side to pump the blood to the lungs. And they look different because
the requirements of pressure are different in the body and the lungs. The magnetic levitation system interfaces with two ring-shaped magnets. That magnetic bearing detects this radar, and if the radar moves further away, coils will energize to bring it closer. And if it gets too close,
they'll de-energize. And we'll do that 2000 times
a second to read the position and then keep the disc levitated
well away from the casing, therefore eliminating any
of the mechanical wear. BiVACOR is currently testing its device in this system that circulates liquids to replicate the functions
of the human body. There's one big question, though, that they won't be able to
answer before human trials: whether BiVACOR patients
will have a pulse.

While we tend to think of the pulse as fundamental to the heart's function, BiVACOR's device can actually propel blood in a continuous stream, which works fine in the lab and in animal trials. But no one knows exactly what its effects would be on the human body. So Timms is exploring other options as well. Right now, the device is operating in a continuous flow mode. But then we want to introduce pulsatility into that system. So we can turn on pulsatility in that regard. You'll see this device is running in a pulsatile mode, once every second. And we are reproducing that pulsatility by taking the spinning disc and rapidly spinning it up and down, up and down once a second. And that reproduces that pulsatile outflow, now that we can observe. What we then have the ability for this device to do is even change that beat rate. And where alternatively the patient is exercising.

and there might be a higher
beat rate required there. And this is at a 90 beats per minute now. Resting and sleeping, and so that pulse rate will be lower. Eventually, BiVACOR intends for these changes in heart rate to be automatic based on blood
pressure changes that occur when a patient moves from one type of physical activity to another. This is a project that I've worked on now for almost two decades. During my undergraduate
studies, around about that time, my father had heart failure. In the early days, the whole goal was to try to make
something, a little naively, to help his failing circulation. We decided that we'd do some of the work in our garage or in our home. My father was a plumber. So he was very adept
with circulation systems. So what we decided to
do was make a prototype of this device. So this is one of the very
first prototype iterations of the BiVACOR device.

So you'll see here, we have an ability to put in different horseshoe magnets. On this side is where the motor can fit inside. Then of course we look inside the pump and we can see one of the very first impeller designs that was actually made by my dad. He machined this on a mini lathe, right next to the TV. So he could work on the mini lathe while watching TV. Although we are now creating a device and obviously not in time for him, there's many other people out with heart failure. And not only does it touch the patient with the heart failure, but their immediate family, which is something that my mum and myself have been dealing with now for now 15 years since that time. So that really catalyzed the motivation and the passion really to get this into those patients that need it. BiVACOR is currently working with the FDA, undergoing durability and animal studies.

They're also poised for their first human implant to take place in 2022. Meanwhile, France-based Carmat received approval from the EU at the end of 2020 and has started manufacturing its hearts for commercial sale. Hopes are high that Carmat's heart will prove longer lasting than earlier artificial hearts, and the company intends for its product to eventually become a permanent replacement, not just a stopgap. As promising as these technologies are, one big remaining downside is the briefcase-sized power packs that have to stay permanently connected to the hearts through the patient's skin. Advancements like extending battery life and replacing cable drive lines with wireless charging technology would have to be realized before an artificial heart patient's freedom is truly on par with a healthy transplant recipient. You could argue that we're still in this low phase. We haven't gone vertical yet because there are four or 5,000 pumps implanted a year, but 400,000 people dying of heart failure.

It's a whole bunch of technical forces that are converging on
having an artificial heart that lasts a long time,
that doesn't have a wire through the skin. And then, maybe heart failure won't be the number one
cause of death in the world.

Permanent Artificial Hearts Are Closer Than You Think

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과학자들은 전 세계 주요 사망 원인을 해결하기 위해 50년 이상 인간 심장의 기능을 효과적으로 복제할 수 있는 기계를 만들기 위해 노력해 왔습니다.

심장 이식의 가장 큰 한계는 매년 약 백만 건의 심장 기증 요청이 있을 정도로 수요가 많음에도 불구하고 건강한 기증 심장이 부족하다는 점입니다.

1969년 4월 4일, 인공 심장이 인간 환자에게 처음으로 임상적으로 사용되면서 인공 심장 기술 개발의 중요한 이정표가 마련되었습니다.

첫 번째 버전의 인공 심장은 가능성을 보였지만 내구성에 문제가 있었기 때문에 SynCardia와 Carmat 장치가 개발되었습니다.

이러한 인공 심장은 현재 실제 심장을 이식할 수 있을 때까지 임시 해결책으로 승인되었습니다.

인공 심장의 주요 과제는 장기적인 내구성으로, BiVACOR는 회전 디스크가 있는 회전형 인공 심장을 사용하는 근본적인 새로운 접근 방식을 개발했습니다.

바이오바코어 인공심장: 심장 기술의 혁신

BiVACOR의 인공 심장은 자기 부상 회전 디스크를 사용하여 혈액을 펌핑하며 장기적인 내구성을 목표로 합니다.

이 장치는 혈류가 지속적으로 흐르기 때문에 인체의 자연 기능에 미치는 영향에 대한 의문이 제기되고 있습니다.

또한 보다 자연스러운 혈류를 재현하기 위해 맥동성을 도입하는 방안을 모색하고 있으며 운동 중을 포함하여 박동수를 조절하는 기능도 연구하고 있습니다.

바이오바코어 심장 장치: 개인적인 여정

20년에 걸쳐 진행된 프로젝트인 BiVACOR 심장 장치는 환자의 활동량에 따라 심박수를 자동으로 조절하는 것을 목표로 합니다.

이 장치의 프로토타입은 아버지의 심부전으로 인해 연구자와 아버지가 차고에서 직접 만들었습니다.

BiVACOR 기기는 현재 FDA 승인을 위한 내구성 및 동물 실험을 진행하며 테스트 단계에 있습니다.

프랑스에 본사를 둔 Carmat는 유럽연합의 승인을 받아 현재 상업용 인공 심장을 생산하고 있습니다.

이 회사는 장기적인 솔루션이 되는 제품을 목표로 배터리 수명을 연장하고 무선 충전을 구현하기 위해 노력하고 있습니다.

이 회사의 목표는 인공 심장을 이식에 대한 실용적인 대안으로 만들고 심부전으로 인한 사망자 수를 줄이는 것입니다.