Pre-Shaped Cochlear Implant Lead Coil Design
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Solution Overview
Problem
Cochlear implant lead manipulation during implantation can cause trauma and migration of the stimulation assembly, due to excess lead length and improper securing, which compromises acoustic hearing and requires additional surgical procedures.
Innovation Solution
A pre-shaped medical device with a malleable element that maintains its shape and can be selectively modified to reduce manipulation and secure the lead within the mastoid cavity, featuring a coil shape with a specific number of turns that remains unchanged during and after implantation, facilitating reduced movement and integration within the cochlea.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If excess lead length is used in cochlear implant, then the lead can be manipulated to fit anatomical variations, but the manipulation causes trauma and migration of the stimulation assembly
Solution Approach 1:
The lead is pre-shaped into a coil configuration before implantation, allowing it to be inserted as a pre-formed structure that adapts to the cochlear anatomy without requiring extensive manipulation during the surgical procedure. This preliminary shaping eliminates the need for post-implantation manipulation that causes trauma and migration.
Solution Approach 2:
The lead is configured with a coil shape featuring multiple turns and curves that match the spiral anatomy of the cochlea. This curved, coiled geometry allows the lead to naturally conform to the anatomical variations of different patients without requiring forceful manipulation, thereby preventing trauma and migration while maintaining adaptability.
2Manufacturing precision
If extensive lead manipulation is performed during implantation, then the lead can be positioned accurately, but the manipulation increases the risk of trauma and requires additional surgical procedures
Solution Approach 1:
The lead is pre-shaped and pre-positioned in its final coil configuration before implantation. This preliminary action eliminates the need for extensive manipulation during surgery to achieve proper positioning, thereby reducing surgical time and the risk of trauma while maintaining positioning accuracy.
Solution Approach 2:
The pre-shaped coil lead is designed to self-position and self-conform to the cochlear anatomy upon insertion. The coil structure naturally adapts to the anatomical variations without requiring surgical manipulation, reducing both the time required for positioning and the risk of trauma during the procedure.
3Stability of the object's composition
If the lead is made rigid to maintain its shape, then the lead can be securely positioned, but the lead cannot accommodate anatomical variations
Solution Approach 1:
The lead is designed with a coil structure that combines shape stability with adaptability. The coiled geometry provides sufficient rigidity to maintain its form and prevent migration, while the curved, flexible nature of the coils allows it to accommodate anatomical variations in different patients without requiring manipulation.
Solution Approach 2:
The lead's physical parameters, such as the coil diameter, turn spacing, and material properties, are optimized to provide the right balance between rigidity and flexibility. This parameter optimization allows the lead to maintain its shape for stable positioning while simultaneously adapting to the anatomical variations of different cochlear structures.
Data Source
AI summary
An apparatus includes a container and a medical device configured to be implanted on or within the recipient's body. The medical device is contained within a sealed region of the container prior to implantation of the medical device. The medical device includes at least one housing containing circuitry and a plurality of signal ports spaced from the at least one housing. The plurality of signal ports is configured to be in communication with a portion of the recipient's body. The medical device further includes an elongate assembly extending from the at least one housing and configured to transmit signals between the circuitry and the plurality of signal ports. The assembly has at least one portion having a shape while the medical device is within the sealed region, the shape including at least one loop and/or a plurality of serpentine turns.