Distal Tip Anchor Fixation Mechanism for Medical Lead Implantation
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Solution Overview
Problem
The implantation of medical leads with distal tip anchors is challenging due to obstruction during passage through introducers and subcutaneous tissue, leading to ineffective anchoring and potential migration of the lead, which hinders proper stimulation.
Innovation Solution
A tool with a fixation mechanism that restrains and releases the distal tip anchor, allowing for secure implantation by maintaining the anchor in a fixed position during tunneling and releasing it at the stimulation site, utilizing a movable body or elongated flexible body to facilitate passage and anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a distal tip anchor is added to the medical lead to improve anchoring effectiveness, then the lead stability is improved, but the ease of implantation deteriorates because the anchor obstructs passage through the introducer and subcutaneous tissue
Solution Approach 1:
The distal tip anchor is designed with dynamic characteristics, allowing it to change shape or configuration during implantation. The anchor can be compressed or folded to a smaller profile for passage through the introducer, then expanded or deployed at the target site to provide effective anchoring. This dynamic transformation resolves the contradiction between ease of implantation and lead stability.
Solution Approach 2:
The distal tip anchor is nested within or integrated into the lead body in a compact configuration during the implantation process. The anchor is contained within the introducer along with the lead, minimizing obstruction during passage. Once at the target site, the anchor is deployed from its nested state to provide the required anchoring function, thus resolving the contradiction between compact implantation profile and effective anchoring.
2Reliability
If the distal tip anchor is made larger to improve anchoring effectiveness, then the lead stability is improved, but the ability to pass through the introducer and subcutaneous tissue deteriorates
Solution Approach 1:
The anchor employs dynamic size transformation, maintaining a compact size during implantation that allows easy passage through the introducer and subcutaneous tissue. Upon deployment at the target site, the anchor expands or unfolds to its larger operational size, providing effective anchoring. This dynamic size change resolves the contradiction between anchor size and passage ability.
Solution Approach 2:
The distal tip anchor is segmented into multiple components or sections that can be collapsed or folded together during implantation to reduce overall size. At the target site, these segments are deployed or unfolded to create the larger anchor structure needed for effective anchoring. This segmentation allows the anchor to transition between small (for passage) and large (for anchoring) states, resolving the size contradiction.
Data Source
AI summary
Medical leads include distal tip anchors that are retained by fixation mechanisms of implantation tools. The fixation mechanism may include a fixed body that has features retaining the distal tip anchor. The fixation mechanism may include a movable body that can apply tension to the distal tip anchor to force the distal tip anchor to be released from the features of the fixed body. The movable body may include an axial portion that is received by an axial hole of the fixed body to allow for axial movement of the movable body to release the distal tip anchor. The fixation mechanism may instead include an elongated flexible body that passes through the distal tip anchor and is attached to the fixed body. Tension applied to the elongated body creates a releasing motion of the distal tip anchor to free the distal tip anchor from the features of the fixed body.


