1.Overview Male erectile dysfunction (erectiledysfunction, ED) is commonly known as “impotence” in China and “sexual impotence” (impotence) in Western countries, but the latter two names have a certain pejorative meaning and do not describe the essence of the disease. The definition of ED is the definition of the NIH Congress in 1993, which can fundamentally explain the essence of the disease and is more easily accepted by both doctors and patients from the psychological point of view, therefore, this definition has been widely adopted by academic circles. Its formulation is: ED is the inability of the penis to achieve and maintain an adequate erection for satisfactory sexual intercourse for at least 6 months. According to the Massachusetts Male Aging Study (MMAS), the prevalence of ED in American men aged 40-70 years was (52±1.3)%, and it is estimated that 25 million American men suffer from various degrees of ED. The epidemiological survey data showed that the prevalence of erectile dysfunction was 73.1% (1157/1582). And August 27-31, 2004 held the “Chinese Medical Association’s Fifth National Male Academic Conference”, hosted by the People’s Hospital of Peking University, supported by more than a dozen hospitals across the country, China’s first “ED patient clinical needs and treatment satisfaction survey report” shows that: China’s 40-70-year-old men are generally facing the problem of ED Trouble, in the sample surveyed, as many as 52.5% of men over 40 years of age endure the torment of ED disease. And more than 9 out of every 10 ED patients believe that the disease has an impact on their masculinity and self-confidence. The current treatment for ED is three lines of treatment: (1) first-line treatment: oral medications (such as sildenafil, vardenafil and tildenafil, etc.), vacuum negative pressure suction devices and psychosexual therapy. (2) Second-line treatment: intracavernous penile injection and intraurethral drug delivery. (3) Third-line treatment: penile prosthesis (also called penile support) implantation. It is a viable remedy for patients who have failed with first- and second-line treatments or who wish to be permanently relieved of their troubles. In 1936, Bogoras applied rib cartilage as a scaffold to perform penile reconstructive surgery, but the use was limited due to osteolysis, infection and prolapse. 1952, Goodwin and Scott applied acrylic In 1966, Beheri reported the use of two rod-shaped polyethylene prostheses implanted into the penile corpus cavernosum with significant results. As the procedure became more widespread and prosthetic materials were refined, it was gradually discovered that the best material for prosthesis fabrication was medical silicone rubber and that the most appropriate location for implantation was within the penile corpus cavernosum. At present, the commonly used types of penile prosthesis are mainly semi-rigid penile prosthesis and expandable penile prosthesis two categories. Semi-rigid penile prosthesis is represented by silver-core silicone prosthesis; after implantation, the penis can be bent and fixed in the desired position. It is easy to implant, inexpensive, and has few complications. However, after implantation, the perineum is bulged, which is detrimental to the appearance. Expandable penile prostheses include two-piece and three-piece penile prostheses. In particular, the advent of the three-piece penile prosthesis has revolutionized the surgical treatment of ED. The three-piece penile prosthesis has improved in terms of hardness, extension and flexion, softness and concealment, achieving the closest appearance to a natural erection, the best concealment and the highest satisfaction, and is by far the most successful penile prosthesis. Foreign research on penile prosthesis started earlier and the technology is more mature, especially the key technology of expandable penile prosthesis has been monopolized by two American companies, AMS and Mentor. However, foreign penile prostheses are designed according to the physiological characteristics of the penis in Europe and the United States, and are expensive in China, which is not conducive to the promotion and application in China. Therefore, the development of China’s independent intellectual property rights of expandable penile prosthesis, for the number of ED patients is very alarming in China, has a very important significance. 3, domestic expandable penile prosthesis Domestic expandable penile prosthesis by Shanghai Yihong Technology Engineering Co., Ltd. and Shanghai Second Medical University Affiliated Renji Hospital, Shanghai Institute of Male Science jointly developed and produced, the development of controlled liquid pump has been awarded a national utility model patent. The main material used is medical-grade silicone rubber, which has the characteristics of high expansion coefficient, better flexibility, high safety performance, non-toxicity and good tissue compatibility. The penile prosthesis is composed of a pump, a reservior and two fluid-filled cylinders, which are connected by a catheter and a connector, commonly known as a three-piece set. The two fluid-filled cylinders are implanted into the penile corpus cavernosum through a urological incision at the penile-scrotal junction, a median suprapubic incision or a transverse subpubic incision, with the fluid capsule placed in the retropubic symphysis and the fluid pump valve placed in the scrotum to simulate the process of erection and weakness of the penis and enable the patient to regain the ability to have sex. The penile prosthesis is pressurized by filling the cylinder with water to support the erection of the penis, and the process of filling is controlled by the fluid pump valve. The fluid pump valve consists of a hydraulic pump, a control button, a pressure check valve, an inhalation valve and an inhalation chamber. Before sexual intercourse, squeeze the hydraulic pump in the liquid pump valve in the scrotum 3 to 5 times, under the pressure, the pressure check valve is opened and the inhalation valve is closed, the liquid will enter the cylinder from the liquid capsule through the pressure check valve, the penis can be thickened and hardened and erected, so that the implantee can complete satisfactory sexual intercourse. After sexual intercourse, the pressure check valve and the inhalation valve will be opened at the same time by pressing the control button in the hydraulic pump, and the liquid in the cylinder will flow back to the capsule under the effect of negative pressure, and the penis will return to the weak state. Since the surgery does not damage the dorsal nerve of the penis, the patient can also have ejaculation and orgasm during sexual intercourse without affecting fertility and urinary function, and there is no difference in the appearance of the original penis after surgery. Through clever design, Shanghai Yihong Technology Engineering Co., Ltd. makes full use of the characteristics of rubber products, using only one spring in two sets of valves instead of the usual two, which both increases the inhalation chamber and simplifies the structure of the inhalation valve. Making full use of the positive and negative pressure difference, the liquid cannot flow back into the bladder when the hydraulic pump is working, and the liquid in the bladder can be quickly replenished to the hydraulic pump under the action of negative pressure after the hydraulic pump is finished, providing sufficient and reliable liquid source for the next operation, thus speeding up the erection of the penis and reducing the incidence of mechanical failure. And it makes it easier to release air when connecting the components together with a connecting conduit and connector. The design of the cylinder is also unique to Ehon’s products. The cylinder consists of three layers: the outer and inner layers are silicon film, and the middle layer is an innovative elastic webbing. The thickness of this webbing is only about 0.15mm, which is the first of its kind in China and thinner than traditional webbing, making it able to withstand pressure and overcome the shortcomings of disorderly expansion of rubber products. Compared with foreign products, the expandable penile prosthesis of Shanghai Yihong Technology Engineering Co. (1) The price is cheap, only 1/3 of the price of similar foreign products. (2) The power of the pump is large, and the speed of the water is about 2.5 times faster than foreign products. It makes the erection of the penis faster and reduces the pressure pain on the scrotum when pressing. (3) The combination of pump and valve is more reasonable. Unlike foreign products that put the hydraulic pump on the top of the liquid pump valve, the product of Shanghai Yihong Technology Engineering Co., Ltd. puts the hydraulic pump on the bottom of the liquid pump valve, which is more convenient for patients to use. The safety and effectiveness of the penile prosthesis is of great concern. After the Shanghai Chemical Products Quality Supervision and Inspection Center Rubber Products Station and the State Drug Administration (SDA) designated testing agency Jinan Medical Device Quality Supervision and Inspection Center for full performance testing, it was found that the cylindrical body of Yihong’s expandable penile prosthesis can withstand a pressure of more than 100Kpa, much higher than the natural pressure of the penis; and in the 300 times / Min rubber flexing test machine by 30,000 times The cylinder can withstand more than 100Kpa pressure, which is much higher than the natural pressure of penis. Its main component, liquid pump valve, has not failed after 500,000 times of fatigue test. Because of the reliable performance of the domestic expandable penile prosthesis, it has been approved by the State Food and Drug Administration for production and clinical use. Zhu Xuanwen et al. applied the intracavernous implantation of penile prosthesis produced by Shanghai Yihong Company to treat 9 patients with ED, and all of them were successful after 6-month follow-up. The success rate was 93.4%, and only 3 cases had postoperative complications. 1 case had the cylinder on one side penetrated from the urethra, and the wound healed after removing the cylinder on that side and keeping the cylinder on the other side. 1 case had the fluid capsule prolapsed from the posterior hiatus of the pubic symphysis to the subcutis, and the inguinal incision was reset again. 1 case had delayed healing of the scrotal incision after surgery in a diabetic patient. There was no 1 case of serious infection and the prosthesis was removed, which is comparable to the performance of similar products abroad. 4, Summary Although the current oral phosphodiesterase 5 inhibitors (such as sildenafil, etc.) in the treatment of ED has achieved certain results, but for patients who are ineffective by first-line and second-line treatment or hope to permanently relieve the trouble, penile prosthesis implantation is the best choice, has a very broad application prospects. The localization of penile prosthesis marks that China’s research in this field has reached the international advanced level, and will play a very good role in promoting the development of male medicine in China.