摘要
It is difficult to weld the material and structure of implantable neuro-stimulator such as pure medical titanium and irregular outside shield by conventional arc welding methods.Currently there are few reports on the neuro stimulator sealing technology,and none of them have simultaneously considered the quality control methods.In order to develop the sealing procedure and quality control methods,an investigation of applying Nd：YAG laser welding to implantable neuro-stimulator components is carried out.Firstly,the automatic Nd：YAG laser welding system equipped with proper fixture configuration is introduced.A special fixture structure is illustrated and the key point for the device is to reduce the fit-up gap between the two shields.Then,a novel welding process technique is proposed to satisfy the engineering requirements.The optimized process parameters for titanium shell,feedthrough and fastener are provided and concluded by an orthogonal experiment.Finally,different quality control measures such as visual inspection,X-ray detecting and leakage testing,are presented on the final products.The results show that the Nd：YAG laser welding applied on the implanted neuro-stimulator under optimized parameters can prevent welding defects and improve the weld joints quality.Combination of various quality control methods will guarantee the sealing performance and mechanical properties of the products.It is confirmed that the processing procedure and quality methods can not only resolve the process technology on welding ultra-thin structure of medical device,but also provide the reference for other implantable device.
It is difficult to weld the material and structure of implantable neuro-stimulator such as pure medical titanium and irregular outside shield by conventional arc welding methods.Currently there are few reports on the neuro stimulator sealing technology,and none of them have simultaneously considered the quality control methods.In order to develop the sealing procedure and quality control methods,an investigation of applying Nd：YAG laser welding to implantable neuro-stimulator components is carried out.Firstly,the automatic Nd：YAG laser welding system equipped with proper fixture configuration is introduced.A special fixture structure is illustrated and the key point for the device is to reduce the fit-up gap between the two shields.Then,a novel welding process technique is proposed to satisfy the engineering requirements.The optimized process parameters for titanium shell,feedthrough and fastener are provided and concluded by an orthogonal experiment.Finally,different quality control measures such as visual inspection,X-ray detecting and leakage testing,are presented on the final products.The results show that the Nd：YAG laser welding applied on the implanted neuro-stimulator under optimized parameters can prevent welding defects and improve the weld joints quality.Combination of various quality control methods will guarantee the sealing performance and mechanical properties of the products.It is confirmed that the processing procedure and quality methods can not only resolve the process technology on welding ultra-thin structure of medical device,but also provide the reference for other implantable device.
基金
supported by National Key Technology R&D Program during the 11th Five-Year Plan Period (Grant No. 2006BAI03A18)
