Medical Lead Positioning with Constrained Self-Expanding Fixation
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Solution Overview
Problem
Existing medical lead implantation systems struggle to perform 'trolling' or test electrical signal application when self-expanding fixation elements are distal to electrodes, as the fixation elements deploy prematurely, making lead repositioning difficult or impossible.
Innovation Solution
The system includes an introducer and lead with positional markings that allow for test electrical signals to be applied without deploying fixation elements, enabling precise placement of the distal electrode and subsequent deployment of fixation elements for secure implantation, using either positional markings on the lead or a conductive member with a non-conductive distal end to facilitate proper lead placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fixation elements are disposed on the lead distal to the electrodes, then the lead can be securely anchored in tissue, but the ability to perform trolling and reposition the lead is lost when fixation elements deploy prematurely
Solution Approach 1:
The introducer device is used to preliminarily constrain the fixation elements in a compressed state during lead insertion and positioning. This allows the lead to be advanced to the desired location and tested with electrical signals before the fixation elements are deployed. The introducer acts as a temporary constraint that is removed only when proper positioning is confirmed, thereby preserving repositioning capability until the optimal placement is achieved.
Solution Approach 2:
The introducer device serves as an intermediary between the operator and the fixation elements. It temporarily mediates the interaction by compressing and holding the fixation elements in a non-deployed state during insertion and positioning. This intermediary constraint allows the lead to be manipulated and repositioned freely until the introducer is removed, at which point the fixation elements are free to deploy and anchor the lead securely.
2Ease of operation
If the lead is extended distally beyond the introducer to apply test electrical signals, then trolling can be performed, but the fixation elements will be deployed and lead repositioning will be compromised
Solution Approach 1:
The introducer device preliminarily constrains the fixation elements in a compressed state before they are needed for anchoring. This preliminary constraint allows the lead to be extended beyond the introducer for test signal application without triggering fixation element deployment. The constraint is maintained throughout the trolling process and only released when proper lead positioning is confirmed, thereby preserving both test signal capability and position adjustability.
3Reliability
If fixation elements are deployed during initial test stimulation, then the lead is anchored in place, but the ability to reposition the lead is lost
Solution Approach 1:
The introducer device acts as an intermediary constraint that prevents premature fixation element deployment during test stimulation. By compressing the fixation elements within the introducer, it allows the lead to be positioned and tested without triggering anchoring. The introducer is then removed only after proper positioning is confirmed, at which point the fixation elements are free to deploy and anchor the lead securely, thereby maintaining process flexibility while ensuring reliable anchoring.
Data Source
AI summary
Leads having distal electrodes may be used in application of test stimulation for purposes of implanting a lead having a fixation element distal to an electrode array. The fixation element is proximal the distal electrode. Accordingly, the distal electrode may be advanced beyond a distal end of an introducer while the fixation element may be retained in a retracted configuration by the introducer. If the test signals applied by the distal electrode indicate that the distal electrode is in the desired location of the patient, a series of markings on the lead may be used to facilitate placement of the electrode array at the location previously occupied by the distal electrode; i.e. the desired location of the patient. The electrodes of the electrode array may then be used to provide therapy to the patient.