FIELD: medicine.
SUBSTANCE: present invention relates to methods of making medical devices, more specifically to methods for making frames for use inside human and other mammalian organs, including intravascular, medical devices made from materials with shape memory effect, and can be used in the manufacture of nitinol frames of an occluder, a heart valve, a stent retriever, a peripheral stent and other similar products, which are applicable for implantation, prosthetics and short-term contact with the human or other mammal body. Described is a method of making a nitinol framework of an intraorgan medical device, according to which a model of a nitinol framework is constructed; preparing the nitinol workpiece for its thermal treatment; thermal treatment of the nitinol workpiece is carried out at least once to obtain a nitinol framework, wherein number of heat treatments is selected proceeding from the following criteria: deformation of nitinol workpiece is not more than 10% at each heat treatment and total time during which nitinol workpiece is held at annealing temperature is not more than 100 minutes. Heat treatment of the nitinol workpiece is carried out in such a way that the nitinol workpiece is heated to an annealing temperature; holding nitinol workpiece at annealing temperature; annealed nitinol workpiece is cooled. Annealing temperature is selected in range from 350 to 550°C and the time during which the nitinol workpiece is held at an annealing temperature in range of 5–100 minutes such that when the annealing temperature is increased, said time is reduced. After thermal treatment of the nitinol workpiece to obtain a frame, it is chemically etched and then electrically polished.
EFFECT: increased wear resistance of the nitinol frame of the intraorgan medical device with low injuries of patient’s body tissues during its implantation, prosthetics and short-term contact with the patient’s body; biocompatibility of said frame with patient's body tissues; self-expansion of the nitinol frame of the above medical device with its increased radial rigidity.
20 cl, 5 ex
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Authors
Dates
2024-08-07—Published
2023-12-13—Filed