Tunneling Tool Dual-Handle Sheath Retention
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Solution Overview
Problem
Current tunneling tools used in implanting therapy delivery elements, such as stimulation leads or catheters, face challenges in securely retaining the outer sheath within the body during the removal of the shaft, due to the interference caused by bends in the tool, which complicates the separation process.
Innovation Solution
A tunneling tool with a malleable elongated shaft and a dual-handle system, where a primary handle is used to remove the shaft while a secondary handle with a locking mechanism retains the sheath in place, allowing for secure positioning and easy separation, utilizing a twisting-lock mechanism to engage and disengage the handles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single-handle tunneling tool is used, then the device structure is simple, but the sheath cannot be securely retained during shaft removal
Solution Approach 1:
The handle is divided into two separate handles: a primary handle for manipulating the shaft and a secondary handle for retaining the sheath. This segmentation allows each handle to perform its specific function independently, ensuring reliable sheath retention during shaft removal without requiring a complex integrated mechanism.
2Adaptability or versatility
If bends are added to the tunneling tool for navigation, then the tool can navigate complex pathways, but the bends interfere with sheath separation
Solution Approach 1:
By separating the shaft and sheath manipulation functions into different handles, the operator can independently control the shaft (with bends for navigation) and the sheath. The secondary handle maintains engagement with the sheath while the primary handle maneuvers the shaft through complex pathways, eliminating interference between navigation bends and sheath separation.
Solution Approach 2:
The secondary handle acts as an intermediary between the operator and the sheath, maintaining continuous engagement with the sheath during shaft manipulation. This intermediary mechanism ensures that sheath separation is not affected by the bends in the shaft used for pathway navigation.
3Reliability
If a locking mechanism is added to secure the sheath, then the sheath retention is improved, but the device complexity increases
Solution Approach 1:
Instead of adding a complex locking mechanism to secure the sheath to the shaft, the design inverts the approach: the secondary handle is designed to engage with the sheath in a manner that naturally maintains retention during shaft removal. The handles can be easily separated after the procedure, providing reliable retention without permanent complex locking structures.
Data Source
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AI summary
A tunneling tool for creating a pathway for implanting a therapy delivery element in a living body. The tunneling tool includes a malleable elongated shaft having a distal end. A sheath having a lumen is slidably positioned over a portion of the shaft. A primary handle secured to proximal end of the shaft permits a user to advance and manipulate the shaft and the sheath in the living body. A secondary handle with an opening is slidably positioned on the shaft between the primary handle and the sheath. The opening has a diameter less than an outside diameter of a proximal end of the sheath. A locking mechanism releasably engages the secondary handle to the primary handle. The sheath is retained in a desired location within the living body by securing the secondary handle relative to the living body as the primary handle is used to remove the shaft from the sheath.