Completely artificial heart: not far from your chest
Release date: 2017-01-06
From an engineering point of view, the human heart is a miracle. In the heart of the adult chest, the myocardium pulsates nearly 100,000 times a day. After the aorta pumps blood, blood is transferred to the body through the artery, including the branches and toes of the brain.
Due to the complex physiological structure of the heart, biomedical engineers need to spend a long time building a mechanical replica, using artificial hearts to keep heart failure patients alive. Since the 1950s, ambitious researchers have attempted to build artificial hearts, but there have been frequent obstacles. Now, the four companies think they have found the right technology and they are trying to prove it. Clinical trials and animal trials have finally proven the reliability of permanent artificial hearts and are ready for clinical use in 2017.
Currently, only about 5.7 million people in the United States are diagnosed with heart failure, meaning that their heart will gradually become unable to pump blood effectively. Some patients with severe illnesses have joined the waiting list for heart transplants, but many patients are waiting to die because of the scarcity of the donated heart.
The artificial heart from the SynCardia system in Arizona, USA, has been approved by the US regulatory authorities as a “transplant bridge.†The company is now recruiting patients for clinical trials to test the device as a permanent replacement. SynGardia CEO Michael Garippa said the trial has a small range of only 28 patients. Previously, more than 1,600 patients who had placed artificial hearts for a short period of time proved that the SynCardia heart was safe.
The picture is the Syncardia system. The Syncardia heart has been used as a solution in the clinic, waiting for patients who need to be transplanted. Now I am testing whether the heart of Syncardia can be permanently replaced.
Garippa believes that the SynCardia heart is durable based on the simplicity of the device. He said: "There is no electronic component in the patient's body." SynCardia's heart has two plastic chambers to mimic the heart. Each plastic chamber is divided into two parts by a membrane, one part being the ventricle with air and the other part being the atrium with blood. A patient with a SynCardia heart carries a 6 kg air compressor that connects the tubing through the abdomen, delivering air to the two ventricles, pushing their membranes to push the blood out of the other side of the atrium. The compressor operates at a steady rate of 120 times per minute, but with a loud sound. "This is not a normal life, but it is more vigorous than the heartbeat of heart failure patients," Garippa said.
A French company called Carmat wants to make artificial hearts better. “Our system is very quiet,†says Piet Jansen, chief medical officer at Carmat. Like the SynCardia device, the Carmat heart has two artificial chambers that are pumped outward through the diaphragm. The Carmat heart uses an implanted pump that replaces compressed air with hydraulic fluid to drive the diaphragm. Although Carmat's heart is larger, heavier and more complex than SynCardia's device, it has a sensor that calculates the patient's heart rate based on the patient's level of motion and changes the heart rate through a microprocessor. Carmat's designer I am proud of the design. The wires need to be connected from the patient's back to the neck to connect a 3 kg battery pack.
Carmat's first feasibility study seems to be tortuous: two of the four patients died within three months. Industry analyst Andrew Thompson, who recently wrote a report on artificial heart, said that these patients are extremely weak, and that their death is not a malfunction of the device, it is because of the patient's body.
European regulators have approved the main clinical trials Carmat launched in August this year. The regulator will approve the company's next experiment, and Carmat surgeons expect to implant the device into about 20 patients by the end of 2017, and hope that in 2018, the artificial heart will be certified as a permanent replacement for Europeans. Device.
The other two companies have not yet entered the clinical trial phase. The technical methods adopted by the two companies are considered by experts to have more development prospects. Both companies refuse to use the membrane to push the blood, but instead use a centrifugal pump with a rotating function to push the blood forward through the rotation of the fan blades, transporting a constant blood flow through the artery. Based on technology developed by the Cleveland Clinic, Cleveland Heart's artificial heart was implanted in two calves in 201, and a 90-day trial was conducted. The calf is still alive and healthy. In Texas, a company called Bivacor is currently working with the Texas Heart Institute to conduct a 90-day study in the calf. The two companies are still adjusting their designs to humans for experimentation.
Gianluca Torregrossa is a cardiac surgeon who has implanted SynCardia equipment and documented the progress of artificial heart research. He is eager to observe the two companies Carmat and Bivacor. Torregrossa said that the two companies' "continuous flow" design is even better, and if the two companies have fewer moving parts, there will be a better future.
When it comes to clinical trials, all technologies must prove themselves in very difficult situations. Syncarpia's Garippa said: "Doctors don't want to refer patients to science projects unless they have no choice. If the technique is suitable for these patients, it can be proven to be a reliable artificial heart. The 2017 trial It is finally possible to prove the miracle created by mankind. This is an engineering miracle, not a biological miracle.
Source: Lei Feng Net
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