Release date: 2014-07-23
Author: Wen Yi
Artificial cardiac pacemakers are a major contribution of modern biomedical engineering to humans, and patients with severe arrhythmia who have failed in the past for medical treatment have been treated, greatly reducing the mortality rate of cardiovascular disease.
In 1932, American chest surgeon Hyman invented the first electric pulse generator driven by a clockwork. The two needles can be used to puncture the atrium to make the heart beat. He named the artificial pacemaker (Artificial Pacemaker). ). In 1960, American Greatbatch created an implantable pacemaker. In the 1970s, a dual-chamber pacemaker (DVI) that better matched the pace of the room and a versatile pacemaker (DDD) that could treat various bradycardias were developed. In the 1980s, in addition to the improvement of lightweight and miniaturization, pacemakers also showed the functions of program control and telemetry. In the 1990s, anti-tachycardia pacing and frequency adaptive pacemakers (DDDR) emerged. At present, higher performance dual-chamber/double-atrial synchronous three-chamber pacemakers, as well as pacemakers with defibrillation capabilities, have also been widely used in clinical practice.
Implantable cardioverter defibrillator ICD
A pacemaker with defibrillation is much more complicated than a normal pacemaker. Implantable Cardiover Defibrillator - ICD (Implantable Cardioverter Defibrillator) is a device that automatically detects ventricular tachycardia, slows ventricular fibrillation and performs shift control and shock cardioversion. The most effective means of dying. ICD's requirements for manufacturing technology are very high, and currently only a few companies around the world can produce. At present, the world's four major producers, Medtronic, St. Jude, Boston Science, and Germany's Baiduo force, basically monopolize the world market.
The price of ICD is very high, and the average price of the product is around 10~150,000 yuan. Due to economic reasons, the implantation rate of ICD in Chinese patients with heart disease is very low. Compared with the United States, the ICD implantation rate in the United States is 450 units per million people, compared with less than one in China. ICD needs to be backed by mature semiconductor development, design, integration and manufacturing technologies. There are no domestic companies that can produce ICDs in China. For a long time, the development of our semiconductor industry has lagged behind and we are heavily dependent on imports. In 2012, China’s semiconductor imports exceeded US$200 billion, and the amount of semiconductor imports has now exceeded the amount of oil imports. In recent years, the state has raised the development of the semiconductor industry to the height of the national strategy, and introduced a series of policies and provided substantial financial support to support the development of the domestic semiconductor industry. It is foreseeable that in the near future, there will be domestic ICD products.
In recent years, the all-subcutaneous implantable cardioverter defibrillator (S-ICD) has opened up a new field of sudden cardiac death prevention. More than 2,000 patients in Europe, New Zealand and the United States have successfully implanted S-ICD. The traditional transvenous cardioversion cardioverter defibrillator (ICD) requires the electrode lead to be implanted directly into the heart, while the S-ICD system is completely subcutaneous, eliminating the need to place the lead on the heart and thus not touching the heart. Or blood vessels.
Wireless pacemaker
Although millions of people around the world have implantable pacemakers, this pacemaker is not without any problems. Although the pacemaker is small in size, the surgeon has to cut the patient's heart to install the device, then connect it to the line, and then direct electrical stimulation to the heart muscle. These tiny wires may break, or the heart will cause a heartbeat when the wire moves, and it can cause a malfunction in severe cases. This situation may change soon.
In 2013, St. Jude of the United States announced a wholly-owned acquisition of Nanostim, which has the only approved leadless cardiac pacemaker. As early as 2011, St. Jude invested US$123 million as an investor in Nanostim and acquired the exclusive option to acquire the latter. St. Jude immediately announced the acquisition after Nanostim's leadless pacemaker received CE certification. In addition to reducing complications, wireless pacemakers have the advantages of less trauma, easy implantation, and compatibility with MRI, which is the future development of pacing technology.
Medtronic also announced shortly that it has successfully implanted its latest ultra-small pacemaker for the first US citizen. Medtronic claims that the product is the world's smallest pacemaker, the size of a vitamin-only drug, which is one-tenth the size of a traditional pacemaker. The surgeon delivers the instrument to the heart site and attaches it to the heart wall through a catheter inserted into the femoral vein. The electrodes at the end of the pacemaker conduct electrical pulses to the heart, and this process does not require wires.
Figure 1: Micro-wireless pacemaker released by Medtronic
Micro-wireless pacemakers are now being used in human trials, and St. Jude's products have been approved for clinical use in Europe. The battery of the pacemaker can maintain a full load for 8 to 10 years. It is worth mentioning that the miniature wireless cardiac pacemaker combines both pacing and monitoring functions. It is equipped with sensors that monitor the heart's physiological data in real time, including heart rate and blood pressure. If the heart does not need help at this time, the pacemaker will automatically go to sleep until the heart lacks energy again, it will start working.
Source: Medical Device Innovation Network
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