Malleable Needle and Shape Memory Cannula for Nerve Implantation
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Solution Overview
Problem
Current electrical stimulation systems for treating conditions like chronic pain and Parkinson's disease face challenges in accurately implanting medical leads near sensitive nerves like the occipital and trigeminal nerves, due to anatomical variations and the need for precise placement to minimize tissue trauma and ensure effective therapy delivery.
Innovation Solution
A system utilizing a malleable needle and shape memory cannula that adapts to individual anatomical structures, allowing for precise definition of an insertion path and maintaining the cannula's shape after the needle is removed, enabling accurate placement of medical devices such as leads or fluid conduits near target tissue sites.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a rigid needle is used for implantation, then the structural stability is improved, but the adaptability to anatomical variations deteriorates
Solution Approach 1:
The needle is designed with a malleable portion that allows it to change shape dynamically during implantation. The proximal portion remains rigid for stable insertion, while the distal portion can be bent to accommodate anatomical variations, resolving the contradiction between structural stability and adaptability.
Solution Approach 2:
The needle is divided into distinct segments: a rigid proximal portion for structural stability and insertion, and a malleable distal portion for adaptation to anatomical variations. This segmentation allows each part to fulfill its specific function without compromising the other.
2Adaptability or versatility
If the needle is made flexible to adapt to anatomy, then the adaptability is improved, but the manufacturing precision deteriorates
Solution Approach 1:
The needle transitions from a rigid state during manufacturing to a malleable state during use. The malleable portion can be precisely formed during manufacturing to guide the needle along a predetermined path, then softened to allow anatomical adaptation, maintaining both manufacturing precision and adaptability.
Solution Approach 2:
The physical parameters of the needle (rigidity, flexibility) are changed through material selection and thermal processing. The needle material is chosen to have specific transition characteristics that allow it to maintain precision during insertion then adapt to anatomy when heated or manipulated.
3Manufacturing precision
If a straight insertion path is used, then the manufacturing precision is improved, but the adaptability to curved anatomical paths deteriorates
Solution Approach 1:
The needle is designed to transition from a straight configuration during manufacturing and initial insertion to a curved configuration when the malleable portion is bent. This allows the needle to maintain manufacturing precision for the initial path while adapting to curved anatomical paths to reach target sites.
Solution Approach 2:
The needle incorporates a malleable portion that can be bent into curved shapes to follow anatomical pathways. The ability to create controlled curvature in the needle allows it to navigate around anatomical structures while maintaining precise placement capability.
4Stability of the object's composition
If the cannula maintains a fixed shape, then the structural stability is improved, but the ability to conform to tissue paths deteriorates
Solution Approach 1:
The cannula is made from shape memory material whose physical parameters change in response to temperature or other stimuli. The cannula maintains a stable first shape during insertion, then transitions to a second conforming shape when exposed to body temperature or specific conditions, resolving the contradiction between shape stability and tissue conformity.
Solution Approach 2:
The shape memory material in the cannula undergoes a phase transition that allows it to change from a rigid, stable shape during insertion to a flexible, conforming shape when deployed. This phase transition enables the cannula to maintain structural integrity during delivery then adapt to the tissue path afterward.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach enhances the precision and accuracy of implantation, reduces tissue trauma, and ensures effective delivery of electrical stimulation or fluid therapy by accommodating varying anatomical features, thereby improving treatment outcomes.
Implementation Method 1
The cannula comprises a shape memory material, which permits it to change from a first shape to a second shape upon withdrawal of the needle
Data Source
Figure 1A~1B
Figure 2A~2B
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AI summary
The disclosure is directed to a method for implanting a medical device proximate to a target tissue site within an occipital region of a patient, such as proximate to an occipital nerve or a trigeminal nerve. The method comprises introducing an implant tool into a patient to define an insertion path to the target tissue site. The implant tool includes a shape memory cannula and a malleable needle at least partially disposed within an inner lumen of the cannula. The shape of the needle may be changed to accommodate different anatomical structures/features of the patient. Upon withdrawal of the needle from the cannula, the cannula may change shape, thereby changing the shape of the insertion path.