Research And Design Of Lead Lead Fixation For Deep Brain Stimulation

Deep brain stimulation is a treatment for functional neurological diseases.It is performed by implanting a deep brain stimulator(clinically known as a "brain pacemaker")into the human body.It is generally composed of a pulse generator,an extension wire and an electrode wire.The pulse generator is implanted subcutaneously to generate electrical pulse stimulation signals and an electrode wire.Implanted into the patient's brain,the target nuclei discharge in the brain,by stimulating signals to suppress abnormal nerve signals causing symptoms of the disease,so that patients can be treated.The treatment has been controlled by American companies since its inception.In 2013,the CFDA approved the sale of domestic brain pacemakers,ending the monopoly on imported products.Accuracy of lead placement is the key to the success of this procedure.If the lead is displaced,it will require reoperation,which will bring additional pain and economic pressure to the patient.Therefore,the fixation of lead has become an important research topic.The use of lead fixing devices is the main current lead fixation technology,but also the use of titanium plate or bone cement and other uncommon means.In this paper,these fixing methods are analyzed in detail,and the design scheme of the third generation lead fixing device is proposed.The new design scheme is optimized on the basis of the second-generation products.The core implant parts are still designed with the second-generation product.The base is fixed with bone screws.The size of the base is smaller than before.The operation is simpler and more reliable.The clamping of the electrode is still two-stage.The first-stage clamping ensures the implant lead in the vertical position,the second stage clamping completely fixed the lead.And the first stage clamping adopts the automatic clamping mode.The third generation lead fixing device is designed in detail.The clamping part is the most important part of the product.Using the good toughness,elasticity and processing energy of polymer materials,the fixing structure and clamping structure are realized in one part,and then a U-spring is designed to provide more stable clamping force for the clamping structure..In addition to these implants,special placement and removal tools are designed,all of which are disposable.After implanting the lead fixing device into the body,the higher the skull is,the greater the scalp tension is.In addition,the design of the profile radian has different effects on stress concentration.This paper simulates the design model,compares the influence of several typical lead fixing device on skin tension,and designs the new electricity.The size and radian of the lead fixing device are more suitable for implanting into the human body.Finally,the design verification prototype is manufactured with the designed three-dimensional model,and the displacement caused by the fixed lead is tested with the verification prototype,and the locking force of the two-stage electrode clamping is tested.At the same time,the second-generation and the first-generation products are tested under the same conditions.It has better performance.