山东STAPLER

The stapler is used in a large number of therapeutic items. The early concept of stapler dates back to the 14th century BC, when the Arab doctor Albucasis used giant ants to sew the mouth. Put the giant ant on the edge of the wound, make the giant ant bite the wound, and then remove the body of the giant ant, leaving the head to suture the wound. It can be said that this is the initial suture device. With the development of manufacturing industry, tubular stapler, linear stapler, anorectal (hemorrhoid) stapler, linear cutting stapler and arc cutting stapler have also been born.

The intended uses of our common staplers are as follows:

1. Tubular stapler: It is mainly used to create anastomotic stoma in digestive tract reconstruction surgery.

2. Anorectal (hemorrhoid) stapler: used for selective resection of mucosa on the dentate line.

3. Linear stapler: mainly used for the closure of stumps or incisions in digestive tract reconstruction and organ resection.

4. Straight cutting stapler: mainly used for creating anastomosis and closing stumps or incisions in digestive tract reconstruction and other organ resection operations.

5. Arc cutting stapler: mainly used for creating anastomosis and closing stump or incision during digestive tract reconstruction and organ resection.

As the stapler is very convenient, it has been popularized and grown savagely. However, the stapler has also caused many accidents, nearly 10000 serious injuries and hundreds of deaths.

Qualified staplers should meet the following requirements:

(1) The stapler shall be flexible to open and close without clamping stagnation

(2) The components and body frame of stapler shall be able to be assembled and disassembled smoothly; All moving parts shall be able to push smoothly without jamming and loosening; The assembly loader body shall be firm, and the fitting pin shall not fall off or deform.

(3) The security mechanism (release button, closing handle) of stapler shall be flexible and safe to use. The spring shall be flexible enough to return quickly when the handle is released.

Due to the frequent occurrence of accidents, it is proposed to reclassify surgical staplers as high-risk medical devices, and to conduct pre marketing review and performance effect research on the devices. Now all surgical tissue binding equipment may be classified as Class II equipment, which means that pre marketing review and pre marketing notification are required. For MIM metal powder injection molding manufacturers, this means the products produced, A short period of time cannot be popularized. For medical manufacturers, it may take a year for a product to be reviewed before it goes on the market and to be notified before it is approved to go on the market, and it will take countless times of experimental work. After all, medical devices are used to cure patients and save people, so it is not allowed to be careless. Assuming that the product quality problems occurred in the use of medical device staplers, the fines will be very harsh.

Medical devices pay attention to the appearance. After the production of MIM metal powder injection molding, they must be manually polished and mirror treated. Even a product is precision machined. More attention is paid to the quality requirements. Many medical devices are broken during use. The strength of medical devices is enhanced through processes such as heat treatment and product curing to make them reach the ideal standard.