Domestic Pacemaker Surgery

  What is a pacemaker? A pacemaker is a small, delicate microelectronic device consisting of a pulse generator, an electrode and an extension lead, all implanted in the body. The implanted components do not interfere with the patient’s daily life. Since the pacemaker is adjustable, each patient is equipped with a programmable controller to adjust the parameters within the safety limits set by the physician for a more comfortable treatment.  1. Implantable part Neurostimulator: A device like a pacemaker, consisting of a battery and a microcircuit system. It is implanted under the skin near the clavicle and can generate an electrical signal via an extension cord to a target site deep within the brain. Its dimensions are similar to a stopwatch — 6 cm wide, 5.5 cm long, and 1 cm thick. The neurostimulator weighs approximately 42 grams, or less than 1.5 ounces.  Brain stimulator leads: Each lead consists of four thin insulated coils and four 1.5 mm electrodes at the tip. The leads are implanted in the subthalamic nucleus (STN) or pale globus pallidus (GPi) of the brain in patients with Parkinson’s disease or in the ventral interhemispheric nucleus (VIM) in patients with Parkinson’s disease or spontaneous tremor. This lead uses one electrode or a multi-electrode combination to deliver the stimulus.  2. Patient-operated part Patient programmable controller: The patient places this small, grippable controller on top of the neurostimulator and presses a button on it to control the neurostimulator on and off, to detect the on/off status of the system, and to check the battery status.  3. Physician-operated part Clinicians can use this instrument to check the working status of the neurostimulator in a non-invasive way, and adjust the appropriate stimulation parameters according to the condition and response, as well as to know the battery usage.  The domestically produced brain pacemaker was launched not long ago amidst the eager expectation of more than 2 million Parkinson’s disease patients nationwide. The localization of the pacemaker has broken the technological monopoly of the United States and made it possible for Chinese patients with Parkinson’s disease to enjoy this high-tech achievement with high reliability and low price.  The brain pacemaker is a major technological breakthrough in brain science at the end of the 20th century, and is the first choice of surgical therapy for the treatment of mid- to late-stage Parkinson’s disease. Currently, 100,000 patients worldwide have been implanted with pacemakers. The quality of life of the vast majority of these patients has improved substantially after surgery. In China, 5,000 patients have already used a pacemaker. This is because at that time this technology was monopolized by the United States, and the high monopoly caused high profits, the light instrument needs more than 200,000 yuan, plus the cost of surgery, a time to 250,000 to 260,000 yuan, and then 3 to 5 years, also have to spend about 150,000 yuan to replace the battery. The total cost of domestic pacemakers can be reduced to about 150,000 yuan, and the cost of battery replacement will also be significantly reduced. There is also a rechargeable pacemaker, which can be charged wirelessly outside the body and does not require battery replacement within 10 years.  In addition to the price advantage, domestic pacemakers are also comparable to foreign products in terms of highly reliable efficacy and quality. With the support of the Ministry of Science and Technology and other national departments, a research team composed of outstanding talents from multiple disciplines, including electronics, software, materials, manufacturing, reliability engineering, and medicine, from the School of Aerospace of Tsinghua University, has gone through a long and arduous road of research since 2000. “If our family members are ill, do we have the confidence to choose the brain pacemaker we developed?” In every step of the work, they asked themselves this question countless times, striving for perfection in all their work.  The application of aerospace high technology, which guarantees high reliability, to brain pacemakers is one of the characteristics of domestic pacemakers. They have done a lot of technical innovation by applying the technology accumulated in the fields of microsatellite and manned spaceflight. For example, the internal software of the pacemaker can be updated wirelessly, which greatly improves the reliability of the software and facilitates the detection of problems and timely solutions. They have also achieved significant innovations in integration, design, manufacturing, reliability, and power consumption control, especially in stimulator software replanting and in vitro charging.  From each tiny part to the whole pacemaker manufacturing process, they have a strict quality inspection system to ensure the high quality and quality of their products. They have conducted strict temperature, pressure and shock tests on the product according to the human internal environment and activities; after that, they conducted thorough and reliable tests on experimental rabbits and experimental monkeys for about 4 years to prove the safety, efficacy and reliability of the domestic brain pacemaker, and finally, the product was officially put into human clinical trials, and nearly 100 volunteers joined the clinical trials one after another in the past 3 years to obtain satisfactory results . They went from a sad face before the operation to a smiling face after the operation, the family members went from anxiety at the beginning to relief later, and the clinicians went from doubts at the beginning to heartfelt praise at the end. So far, the longest post-operative follow-up period has reached 42 months, the instrument is safe and stable, and the patient’s symptoms have been reduced by 60% to 90%. Experts in the industry have commented that the performance indexes of domestic brain pacemakers have reached the level of similar foreign products and can meet the requirements of clinical application.