Lead Implant Fixation Mechanism with Depressed Sleeve
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Solution Overview
Problem
Existing implantable medical electrical lead fixation mechanisms do not provide sufficient holding force to prevent movement of the distal portion carrying electrodes, particularly in configurations requiring enhanced anchoring.
Innovation Solution
The use of a flexible sleeve with uniformly spaced depressions and suture grooves along the outer surface of the lead, where sutures are tightened to deform the sleeve into interlocking engagement with the depressions, enhancing the holding force by creating a secure anchor to the surrounding tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a traditional fixation mechanism is used, then the lead can be implanted, but the holding force is insufficient to prevent movement of the distal portion
Solution Approach 1:
The fixation mechanism is divided into multiple uniformly spaced depressions along the lead body, creating discrete anchoring points. Each depression works independently to provide localized tissue engagement, collectively distributing and increasing the total holding force along the lead's length.
Solution Approach 2:
The depressions create localized regions of enhanced tissue interaction along the lead body. Each depression concentrates the fixation function at specific points rather than distributing it uniformly, allowing the lead to engage tissue more effectively at multiple discrete locations to prevent movement.
2Ease of operation
If the lead is made more flexible for implantation, then ease of insertion improves, but anchoring strength to tissue decreases
Solution Approach 1:
The lead body incorporates segmented depressions that allow the flexible lead to maintain its flexibility for insertion while creating discrete rigid anchoring points. The spaced depressions provide localized structural features for tissue engagement without compromising the overall flexibility of the lead during implantation.
Data Source
Figure 1
Figure 2A
Figure 2B~2C
AI summary
A fixation mechanism of an implantable lead includes a plurality of depressions of an outermost surface of the lead and a relatively flexible sleeve mounted around the outermost surface. The depressions are spaced apart from one another along a length, and each extends circumferentially, wherein a longitudinal center-to-center spacing between each adjacent depression is uniform along the length, and each depression is of substantially the same size. The sleeve has an internal surface in sliding engagement with the outermost surface of the lead, and an external surface, in which suture grooves are formed. A longitudinal center-to-center spacing between adjacent suture grooves may be substantially the same as, or a multiple of, the longitudinal center-to- center spacing between adjacent depressions of the outermost surface of the lead. The sleeve may also include a ridge protruding from the internal surface, aligned with, or offset (by center-to-center spacing of depressions) from, the grooves.