Implant intervention medical instrument key parameter extraction and evaluation method based on axiom design

Abstract

The invention provides an implant intervention medical instrument key parameter extraction and evaluation method based on axiom design. The evaluation method starts from the specific clinical use purpose of the implant interventional medical instrument to be evaluated and the anatomical structure constraint of the implantation position; user requirements are defined in a user domain, various properties including biomechanical properties, material properties and biological properties, structural design parameters and material design parameters are decomposed and refined in a functional domain,and ethical constraints are formed. The change conditions of various performance indexes of the implantable interventional medical instrument under the influence of different design parameters are obtained through testing methods such as mechanical testing, material science testing and biocompatibility testing; on the basis, a design matrix capable of quantitatively reflecting the change relationbetween the design parameters and the performance of the implantable interventional medical instrument is obtained, the design of the implantable interventional medical instrument is evaluated from the perspectives of the information amount and the coupling degree, and the evaluation result can provide a basis for optimization of the design of the implantable interventional medical instrument.

Description

technical field [0001] The invention belongs to the technical field of implant medical device design, and in particular relates to a method for extracting and evaluating key parameters of implant medical devices based on axiom design. Background technique [0002] As an important branch of medical devices, implant-interventional medical devices are widely used in the medical industry and play an irreplaceable role in clinical operations and rehabilitation. Since this type of medical device has long-term interaction with the complex anatomical structure and physiological environment in the body after being implanted in the human body, it is necessary to comprehensively evaluate the short-term and long-term effects after implantation during the research and development process. Intervention in the research and development of medical devices has brought certain difficulties. At present, in the process of designing and evaluating implant-interventional medical devices, R&D pers...

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Problems solved by technology

[0004] However, it is very difficult to apply the axiomatic design theory to the design evaluation of medical devices. This is mainly reflected in the fact that medical devices have strict safety and reliability requirements, and there are many risk factors. At the same time, they are a high-tech Application-intensive and multidisciplinary technical fields, which undoubtedly increase the complexity of evaluating the design of implanted medical devices

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