Surgical stapler: Demand supports development value

Business News Agency January 12th The current annual sales of surgical staplers in the United States are as high as US$2 billion. It is expected that this number will reach US$2.28 billion in 2011 and has become an important medical device branch in the world.

Staplers are the most widely used office supplies in the world and have been developed and used for more than a century. With a stapler, single-page documents, text data, etc. can be bound into a book, which is easy for people to search and read, and is not easily lost. Inspired by the stapler, European Hungarian Humer Hulti, a brain-wearing surgeon, came up with the whimsical idea: Exploring and developing a medical device product similar to a stapler for suturing wounds, thereby greatly reducing the number of doctors. Stitch the time of the wound. He put this idea into practice and eventually developed a medical stapler like a stapler in 1908. The aircraft weighs 3.6 kilograms and can be used for suturing the skin after general surgery as a replacement for hand-stitched wounds. Dr. Hulti was thus hailed by the international medical community as "the father of surgical suturing devices." According to reports, staples used in early-stage surgical staplers were mostly made of stainless steel nails. Later, European companies developed titanium nails, plastic nails made of inert polymer materials, and high-flexible metals. Wound suture deduction and so on (in foreign countries will be classified as surgical staples category). Since the medical community already has suture instruments such as gut (and later silk), why should we develop a surgical suture device?

Widely used in Europe and America

The European Physicians Association summarizes the advantages of surgical staplers as follows:

The first is that it is easy to use and saves the time for suturing wounds, thereby greatly reducing the work intensity of doctors.

The second is the use of surgical suturing devices for certain special organs, such as large bowel resection lesions, hernia surgery and groin surgery, etc., after surgery to do a convenient and strong joint surgery. These special organs are in a state of regular movement (such as the intestines will peristrate, the groin is in the joint of the thigh and abdomen, vulnerable to thigh movement), such as the use of conventional gut string suture, the wound will be easy to crack accidentally , thereby affecting the healing of the wound.

The third is that special organs such as heartbroken organs sutured with a surgical suturing device are very tight and do not leak blood (blood water) or contents of the intestinal tract, resulting in contamination of abdominal organs, causing inflammation and other unexpected events.

In Western developed countries, surgical staplers are now used in general surgery, laryngology, thoracic surgery, and other surgeries instead of artificially stitched wounds.

Although the Hungarian doctor developed the world’s first prototype of a practical surgical suturing instrument as early as 1908, it was not until the early 1960s that this new invention was left unattended and was unexplored because of the European medical community. He was skeptical and considered it impractical. In 1964, Leon Hirsch, an American entrepreneur, made bold improvements to the inventions of Hungarian doctors and introduced a utility model surgical suture device (Auto Suture). However, even if its invention was advanced and practical, it was not until the late 1970s that the American Society of Surgeons suspected that it would recommend the use of the device to replace the artificial suture wound in order to test its applicability and safety. In 1977, a universal surgical stapler (trade name Ethicon) developed by the well-known American Medical Device Manufacturer (USSC) was successfully listed in the country, and it is on the US market due to its advantages of easy operation and easy maintenance. It became popular and has been widely used in the US surgical community. In 1998, USSC was merged with Johnson & Johnson Pharmaceuticals. The best-selling stapler was renamed Covidien.

It is necessary to explain that not only steel nails, but also sutures such as catgut or silk thread can be used for the medical suturing device. Doctors use different specifications of steel nails or sutures depending on the patient's organs or parts. As for surgical sutures, there are many different specifications and materials for steel nails. Such as bending nails, round nails and other special nails, and special nails for throat surgery. Nowadays, the use of surgical suturing devices by the medical profession in Europe and the United States has become very popular. Not only general surgery but also abdominal surgery, laryngo surgery, thoracic surgery, and plastic surgery can be used to perform suture stitching. The application of advanced endoscopes such as laparoscopes and laryngoscopes based on fiber optics lays the technical foundation for the popularization and application of surgical staplers. In the endoscope plus TV open surgery, the suturing device can not play the role of manual suture. With the aid of a television screen and a stitcher, surgeons can perform a variety of complex surgical procedures.

New market prospects can be expected

The surgical staplers used in the 1990s generally used steel metal nails. Therefore, after the wounds healed, a second operation must be performed to remove the steel nails in the patient's abdominal cavity. This means that the patient has to open the knife twice and suffer more pain. . After 2007, foreign medical device manufacturers developed new device products such as “absorbable sutures or surgical plastic nails” that could be absorbed by human tissues. This avoided the patient’s pain of opening the knife twice. According to reports, such sutures or plastic nails that can be absorbed by the body are made of a polymer material called "polyglycolic acid." Its stiffness and softness are in line with medical regulations. What's more, the material will automatically decompose into carbon dioxide and water within a certain period of time, so it will not harm the human body. However, in fact, the nails for surgical staplers used so far are still titanium steel nails. Because of its high strength, small size, and inertness to human organ tissue, it is not likely to cause infection. The only drawback of titanium steel nails is that it can cause allergic reactions to a small number of patients because titanium steel is mixed with trace amounts of nickel. The latter will It causes skin itching and rash, but titanium itself does not cause allergies. In spite of this, titanium steel nails also have the advantage that, when using a medical diagnostic imaging machine such as CT or MRI for scanning examinations, the degree of healing of the sutured parts of the organs can be clearly observed, making it easy for doctors to make correct judgments. The use of plastic nails is difficult to achieve this effect.

According to a report released last year by a famous American consulting company, Frost & Sullivan, the current US sales of surgical stapler products (including sutures and other suture instruments) are as high as US$2 billion, and this number is expected to reach US$2.28 billion in 2011. . Stitching equipment products has become an important branch of medical equipment. Although not sold in the United States, Europe's surgical suture devices are also worth about 1 billion euros. The market growth of surgical suture devices in other countries and regions in the world is also very impressive. But overall, except for industrialized countries such as Japan, Singapore, and South Korea, the combined sales of surgical suture devices in other countries totaled only several hundred million US dollars.

According to reports, surgical staplers developed and marketed abroad are classified into: linear staplers (ie, staplers using conventional gut and silk sutures), circular staplers (applicable to cavity surgery), and linear cutting staplers. The purse-string suturing device, skin fascia suture device, laryngeal suturing device, thoracoscope-specific suturing device, and other special suturing devices.

Domestic market to be developed

Since 1976, China started to develop new products of domestic surgical suturers, which are not much later than foreign countries. However, because of the disadvantages of the operation and use of surgical suturing devices that were developed early in the country and the inconvenience of maintenance, it is difficult to achieve large scale in the domestic clinical medical community. Promotion and application.

Since the 1990s, with the rapid development of China's national economy, major hospitals in coastal cities have directly imported a number of advanced surgical stapler products from the United States and other developed countries for clinical use, including thoracoscopic staplers, Special specifications such as the throat stapler and surgical stapler products. Under the impetus of imported products, coupled with the huge demand in the domestic market, the production of surgical staplers in China began to increase. At present, more than a dozen companies including Shanghai, Changzhou, Jiangsu, and Suzhou are producing surgical stapler products. It is estimated that the annual sales of the products will amount to several hundred million yuan. However, compared with surgical stapler products produced by developed countries, domestic staplers still have many shortcomings (especially in terms of technical performance).

There are vast rural areas in China, and the total number of township hospitals is as many as several hundred thousand. The township hospital doctors are eager to have medical devices that are easy to operate, easy to maintain, and moderately priced. If domestic manufacturers can develop these products as soon as possible, there will be a broad market prospect.