Past and present life of stapler
Suture is an essential and very important link in surgery. Before the 20th century, all the sutures in surgical operations were completed by manual sutures. It was OK to ligate small wounds or small blood vessels. Once encountering operations on internal organs such as esophagus, lung, gastrointestinal, liver, spleen and pancreas, doctors had to spend several or even ten hours on suturing.
Nowadays, many operations still require doctors to use superb "sewing" skills to suture wounds or organs and tissues. But sometimes they can also use a medical "stapler" - stapler to make surgical suture more efficient through mechanized operation, and make many difficult and complex operations easier, and greatly reduce the incidence of surgical complications.
01 Birth of stapler
In 1908, Hungarian doctor H ü mer H ü ltl took inspiration from the stapler and successfully invented a new hemostatic suture tool - stapler. It is assembled from various metal parts, weighing up to 8 pounds, and takes up to 2 hours to assemble. You may not feel much about its Chinese name, but if you move out its English name, Surgical Stapler, will it be more impressive?
Humer Hultl, the father of surgical staplers
Since we got inspiration from the stapler, we must be able to guess the working principle of the stapler immediately. Recall the process of binding paper and replace the paper with tissue in our body, which can roughly restore the working appearance of the stapler.
Of course, if it is exactly the same as the stationery stapler, the stapler is not a great invention. In order to better solve the problem of hemostasis in surgery, Dr. H ü ltl, the inventor of stapler, has some great ideas:
He modified the nail anvil so that the compressed suture can be in the shape of "B", which can not only firmly bind the main blood vessels, but also ensure the blood supply and nutrition of the nailed tissue and the cutting edge; The multi row suture nails designed by him adopt the staggered arrangement method. The trajectory of the suture nails is like two parallel dotted lines, which lock the gap with each other to ensure that all blood vessels passing through the cutting are ligated to avoid leakage at the anastomosis.
"B" type sewing nail
It is worth mentioning that until today these two points have also been used in the design of staplers. Therefore, Hultl is known as the "father of surgical staplers".
The appearance of stapler has greatly improved the efficiency and success rate of some operations, but it has also undergone continuous upgrading: the original stapler can only be sutured, and then people added blades in the nail bin, realizing the function of cutting while sewing; The shape and function of staplers used in different organ surgery have also undergone different evolution.
02 Modern stapler
Basic structure of linear stapler
In 1921, the linear stapler was introduced (Aladar Von Petz, Hungary), simplifying the design of the stapler, replacing the metal wire with nickel silver alloy, and repeatedly filling the staples, making the stapler more portable. In 1934, H Friederich and Neuffer improved the stapler and added a replaceable nail chamber; In 1951, the Research Institute of Experimental Surgical Instruments of the former Soviet Union carried out a systematic research on the suture device, and was in the leading position in this field.
In 1958, stapler got key improvement in the United States
Ravich, an American scholar, introduced the suture technology to the United States after visiting the Soviet Union's Institute of Experimental Surgical Instruments.
In 1967, Locn Hirsch, the founder of American surgical company Auto Suture, and his engineers fundamentally solved the problem of time-consuming assembly of staples and produced a stapler that can be easily used in clinical surgery.
In 1968, the cutting suture device was introduced
American surgical companies have introduced staplers with double sets of double row staples and blades, which can cut tissues at the same time of suturing. They are mostly used for the disconnection of gastrointestinal tissues, or the inversion anastomosis of gastrointestinal and enterointestinal tissues.
In 1978, the tube end stapler (EEA) was introduced
EEA is equipped with double row annular staples and blades. The blades are used to cut off the tissues inside the staples during anastomosis, so as to form end to end anastomoses, and are used for annular anastomosis of cavities with different diameters).
The appearance of tubular end stapler
In 1979, disposable stapler came out
In 1979, American Ethicon Company developed a variety of sutures and staplers, and produced the world's first fully disposable mechanical stapler for single patient. The disposable stapler reduces the probability of cross infection of patients caused by instrument disinfection, reduces the probability of postoperative complications, and also makes the mass production and wide application of staplers a step up.
Since then, various types of sutures for different tissues have come out, providing surgeons with powerful weapons for surgery.
The advent of disposable stapler
Improvement and innovation of sewing nail forming technology
In 2004, Covidien invented the DST sewing nail forming technology. DST is the abbreviation of Directional Staffing Technology, which is translated as "Guided Stitch Molding Technology". Compared with traditional technology, DST technology has made two innovations:
1. Approximate square stud leg:
The square column shaped staples with a cross section similar to a rectangle contact a plane with the nail pusher plate, so as to avoid the offset or distortion of the nail legs when the nail pusher plate moves.
Approximate square stud leg
2. Drop shaped anvil:
The larger nail anvil groove can more effectively guide the perfect shaping of the nail leg.
As a result of the joint action of these two points, no matter the thickness of the tissue to be matched is thin or thick, a perfect B stitch that can be selected without error can be stably pressed out.
In 2012, Tristaple Chuangshi intelligent anastomosis technology came out
When the traditional stapler works, it will strike 2-3 rows of staples of equal height and size on both sides of the cutting path. However, in practical application, due to the difference in tissue thickness, it is inevitable that the sewing nails with equal height will "ignore one thing and lose another". Tight nails may affect blood supply and healing; Loose nails may cause leakage, which is really a dilemma.
To solve this contradiction, Medtronic launched Tri Staple ™ The technology, in short, is the use of three rows of unequal height, ladder shaped sewing nail technology.
Tri-Staple ™ technology
The simple adjustment of the height of the sewing pin brings about a very simple effect. After firing, the nails are tight inside and loose outside. The nails near the knife edge have short legs and are sewn tightly to prevent bleeding; The distal nail leg is high and loosely sewn, which can maintain the circulation of tissue fluid and blood, provide nutrition for the tissue and accelerate the healing.
In addition, the firing time of the staples also has a sequence of three rows from the inside to the outside. With the stepped nail box surface, the staples can be accurately clamped without damaging the tissues. At the same time, during the firing process, the sewing nail always precedes the blade, which also ensures the safety of the organization to the greatest extent.
"Sewing before cutting" technology
In a word, Tri Staple technology, through the unique design of three rows of unequal height and gradual clamping, has achieved the effect of tight anastomosis, adaptive tissue thickness and injury prevention, greatly improving the safety of patients during operation and postoperative healing.
In 2015, the first electric intelligent cutting stapler was born
Electric intelligent cutting stapler
Covidie launched iDrive in 2015 ™ Intelligent platform and mechanical anastomosis require doctors to constantly manipulate the handle to fire the staples in sections. If the firing speed is improper or the operation is shifted, the patient's tissues will be damaged and the safety will not be guaranteed. The iDrive intelligent platform can not only automatically adjust the firing speed, firing at a uniform speed, but also give feedback when the thickness of the clamped tissue is too thick, reminding the doctor to change the position or replace the nail leg of another height, effectively improving the safety of the tissue during the anastomosis process. Not to mention that it is only necessary to simply control the button at the handle to realize the infinite rotation of the nail chamber angle, which greatly facilitates the doctor's operation.
To sum up, after more than a century of development, staplers can be divided into linear staplers, circular staplers, linear cutting staplers, purse string staplers, skin fascia staplers, laparoscopic staplers, and electric intelligent cutting staplers. The future has come to you and me. Let's welcome the early days of the new technology and new equipment era with a more open attitude!
The China Medical Device Market Access Guide is a report drafted by the Medical Device Business Department of CIRS Group, which aims to help companies and individuals who want to sell their medical devices to the People's Republic of China and register their medical device products in NMPA. This guideline describes the key definitions, main regulations, authorities and requirements for the full life cycle of medical devices in China, including pre registration preparation, registration process, testing/inspection, clinical evaluation, quality management system and post registration market management.
Medical treatment is one of the three topics of people's livelihood. As an important supporting point of the medical system, the medical device industry has received more and more attention. When the concept of urbanization is gradually emphasized, the market of medical device industry has been excavated.
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