Integrated Tube Sheath for Straight Cochlear Implant Insertion
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Solution Overview
Problem
Existing implantable medical devices face challenges in maintaining the structural integrity and minimizing trauma during implantation, particularly with pre-curved stimulation assemblies like cochlear implants, due to the need for a balance between flexibility and stiffness to navigate the cochlea without causing damage.
Innovation Solution
The integration of a slideably engaged, elongate tube sheath around the stimulation assembly, which remains implanted post-insertion, provides structural support during implantation and maintains the assembly's straight configuration, using materials like silicone to minimize trauma and preserve auditory function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a pre-curved stimulation assembly is used to navigate the cochlea, then the ability to follow the cochlear curvature is improved, but the structural integrity and stability during insertion deteriorate
Solution Approach 1:
The system is divided into two functional segments: a flexible pre-curved stimulation assembly for navigating the cochlea and a rigid straightening sheath for maintaining structural integrity during insertion. The sheath can be removed after insertion, leaving only the stimulation assembly in place.
Solution Approach 2:
A straightening sheath acts as an intermediary device that provides temporary structural support during the insertion process. The sheath engages with the stimulation assembly to maintain its straight configuration, then is removed after successful placement in the cochlea.
2Ease of operation
If the stimulation assembly is made flexible to navigate the cochlea, then the ease of insertion is improved, but the structural support and stability deteriorate
Solution Approach 1:
The system transitions from a static flexible assembly to a dynamic configuration where a rigid sheath is temporarily applied during insertion, then removed after placement. This allows the assembly to be rigid when needed for structural support and flexible when needed for navigation.
Solution Approach 2:
The effective stiffness parameter of the insertion system is changed by adding the rigid sheath during insertion and removing it afterward. This allows the system to have high stiffness during insertion for structural support, then transition to the natural flexible state for cochlear navigation.
3Stability of the object's composition
If a separate straightening sheath is used during insertion, then the structural integrity during insertion is improved, but the device complexity increases
Solution Approach 1:
The straightening sheath is integrated with the stimulation assembly as a combined package. The sheath is pre-attached to the assembly in a nested configuration, allowing them to be handled as a single unit during insertion and simplifying the overall device structure.
Solution Approach 2:
The stimulation assembly is nested within the straightening sheath in a compact configuration. The flexible assembly fits inside the rigid sheath, allowing both components to be stored and handled together while maintaining their individual functions.
Data Source
Figure 1A~1B
Figure 1C
Figure 1D
AI summary
Presented herein are integrated tube sheaths (tube sheaths) for implantable stimulation assemblies. An integrated tube sheath is configured to be disposed around, and is slideably engaged with, an outer surface of an associated stimulation assembly. The integrated tube sheath is configured to retain the stimulation assembly in a straight arrangement for implantation of the stimulation assembly into a recipient. Following implantation of the stimulation assembly, the integrated tube sheath is configured to remain implanted in the recipient.