Splittable Lead Introducer with Non-Cylindrical Locking Fixture
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Solution Overview
Problem
Conventional lead introducers for implantable stimulation systems often result in lead movement during removal, compromising the precise positioning of electrodes, especially in complex lead arrangements, and some introducers are less stiff, prolonging insertion duration.
Innovation Solution
A two-component lead introducer with a combined needle/sheath and stylet, featuring a splittable sheath and hub design with a non-cylindrical locking fixture, allows for lateral release of the lead without sliding, reducing complexity and maintaining precise positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a conventional lead introducer is used, then the lead can be inserted into the patient, but the lead moves during removal compromising precise positioning
Solution Approach 1:
The introducer is divided into separate components: a needle component and a sheath component. The needle can be removed independently from the sheath, allowing the lead to remain positioned in the sheath without moving during removal operations. This segmentation prevents lead displacement while maintaining insertion precision.
Solution Approach 2:
The needle is nested within the sheath during insertion, with the needle defining a channel through which the lead passes. The sheath surrounds and protects the lead during insertion, then the needle is removed while the lead remains positioned within the sheath. This nested arrangement ensures stable lead placement without movement during the removal process.
2Ease of operation
If a less stiff introducer is used, then the insertion process is simpler, but the insertion duration is prolonged
Solution Approach 1:
The introducer system allows dynamic adjustment of stiffness during the procedure. The needle component provides initial stiffness for rapid insertion, then can be removed to allow simpler manipulation of the lead within the sheath. This dynamic configuration enables both rapid insertion and operational simplicity without compromising either objective.
3Adaptability or versatility
If a complex lead arrangement is used, then more therapeutic options are available, but lead movement during removal compromises positioning
Solution Approach 1:
The introducer is segmented into needle and sheath components that can be separated. Complex lead arrangements with multiple electrodes can be positioned within the sheath without risk of movement during removal, as the needle is removed independently while the lead remains constrained within the sheath. This maintains positioning precision for complex configurations.
Solution Approach 2:
Complex lead arrangements are nested within the sheath during insertion and positioning. The sheath provides continuous protection and positioning for the entire lead array, preventing electrode displacement even in complex multi-electrode configurations. The needle can then be removed without affecting lead positioning.
Data Source
AI summary
A lead introducer includes a combined needle/sheath having a splittable sheath configured to split along the length of the splittable sheath, a splittable hub coupled to the proximal end region of the splittable sheath and configured to split into a first portion and a second portion, a needle defining a channel extending along the length of the needle for delivery of a lead through the needle, where the needle is not bonded to the splittable hub and the splittable sheath, and a non-cylindrical locking fixture attached to, or part of, a proximal end region of the needle, where the splittable hub includes a cavity having a shape complementary to the non-cylindrical locking fixture of the needle to hold the needle within the splittable hub and restrict rotation of the needle relative to the splittable hub. Another lead introducer includes a splittable hub and splittable needle attached to the splittable hub.