Polyester is the first material used in the manufacture of artificial blood vessels. Medical polyester, like medical sutures, has been proven to be safe for long-term use in the human body. Its biggest problem is that it has poor anticoagulant properties and requires anticoagulant pretreatment and bio-coating.
ePTFE is an expanded form of PTFE, commonly known as the king of plastics. It is equivalent to a new product made from PTFE using a special process. In comparison, ePTFE performs very well in terms of anticoagulation, has good biocompatibility in the human body, and has a very mild rejection reaction. In addition, it is not easy to degrade like polyester, and can be used for a long time in the human body without frequent replacement. Compared with polyester, it does not require anticoagulation pretreatment and biological coating. These conveniences make it widely praised in clinical practice.
Are the new generation of artificial blood vessels star materials really flawless? There is no such thing as safe and perfect in the world. It is impossible for medical devices to be as good as the tissues and organs grown by the human body.
The shortcomings of ePTFE have been summarized in international research papers. It is always inferior to the elasticity of human blood vessels. It is softer but not as soft as the human body, which causes blood to flow in it for a long time. Over time, it is easier to form blood clots at the anastomosis, causing blockage.
Such instrument materials are very challenging for the surgeon's technical level.
If a surgeon has excellent skills, he or she may be able to help the patient handle the anastomosis of the artificial blood vessel better, so that the probability of blockage is low, and even if it occurs, the time point will be delayed. If the surgeon's skills are average, the consequences are self-evident.
Can we expect all surgeons to have superb skills?
Impossible. The supply and demand for exceptionally good surgeons has always been imbalanced.
It is like inventing a smart phone. It must have a fool-proof operation so that most people can use it. If it is made complicated and only programmers can use it, it will become something that is not for the general public and will not be able to be sold.
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In the medical materials market, it becomes: the medical surgical materials created must meet the technical level of most surgeons, rather than the technical level of the big guys.
If you simply use the technical level of a big shot to make medical equipment, it is doomed to fail to be promoted, and even clinical trials will not pass, because the results of the clinical trials will be terrible. For example, there is an indicator in the clinical trial of this artificial blood vessel, called the long-term vascular patency rate. The surgery performed by a big shot may make this indicator of this material perform well, reaching 80% to 90% after six months, while surgeons with average technical level can only reach 40% to 50% and fail.
The test results should be based on the general technical level of surgeons. Seeing this clinical trial value, all clinicians and researchers are overwhelmed.
In summary, ePTFE has its shortcomings, but since it has been recognized in the production of artificial blood vessels internationally, the proportion of defects should be kept within a controllable range and should not exceed it.
Now it becomes a matter of choosing one or the other. Either the material is not good, or there are some indescribable contradictions between the surgical technology and the new product?
The teachers at the conference table looked serious and asked each other whether they should first determine whether these problematic cases were widespread in various hospitals.
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