Non-penetrating Fixation Element for Secure Neuromuscular Lead Anchoring
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Solution Overview
Problem
Existing anchoring mechanisms for medical devices like electrical stimulation leads and catheters are prone to dislodgement, especially when implanted in or adjacent to muscle tissue, due to the high mobility of these tissues, leading to ineffective therapy delivery and potential tissue damage.
Innovation Solution
The development of elongated members with fixation elements at the distal region that are designed to contact and secure tissue without penetration, providing bidirectional stabilization and minimizing muscle damage, allowing for secure anchoring using percutaneous techniques or the lead itself, with configurations such as flanges, helical screws, and expandable elements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional anchoring mechanisms (tines, fins, screws) are used to secure leads, then anchoring strength is improved, but tissue damage and dislodgement risk increase due to penetration and muscle mobility
Solution Approach 1:
Instead of penetrating tissue to anchor, the fixation element contacts tissue externally. The smooth surface configuration inverts the conventional approach by using non-penetrating contact to achieve anchoring, thereby preventing tissue damage while maintaining lead security.
Solution Approach 2:
The fixation element with smooth surface acts as a flexible interface between the lead and tissue, conforming to tissue contours without penetration. This flexible contact mechanism provides anchoring strength while avoiding the harmful effects of rigid penetration into mobile muscle tissue.
2Reliability
If fixation elements are placed at proximal distance from electrodes, then anchoring is achieved, but electrode stability deteriorates due to tissue movement relative to target
Solution Approach 1:
The fixation element extends laterally from the lead body in a direction perpendicular to the lead axis, creating a wider footprint that anchors the lead more effectively. This dimensional extension allows the fixation element to be positioned optimally relative to both the electrode and tissue, simultaneously achieving anchoring reliability and electrode stability.
3Ease of operation
If percutaneous approach is used for implantation, then invasiveness is reduced, but anchoring mechanism complexity increases due to deployment constraints
Solution Approach 1:
The fixation element is designed to be self-deploying or self-anchoring through the percutaneous approach, eliminating the need for complex deployment mechanisms. The simple geometric configuration allows the element to automatically engage tissue upon insertion, reducing both invasiveness and mechanism complexity.
4Reliability
If bidirectional stabilization is implemented, then lead dislodgement resistance is improved, but fixation element complexity increases compared to unidirectional tines
Solution Approach 1:
The fixation element employs asymmetric geometry with a smooth surface configuration that provides bidirectional stabilization through its shape rather than through symmetric multi-component structures. This asymmetric design achieves enhanced dislodgement resistance while maintaining simplicity by using a single integrated element.
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
Apparatus for neuromuscular electrical stimulation and methods for anchoring the same are provided. The apparatus may include an elongated member having one or more electrodes disposed at the distal region of the elongated member and at least one fixation element disposed at the distal region of the elongated member. The fixation element may be shaped and sized to be deployed between tissue layers, such as muscle layers, without damaging the tissue layers so as to secure the one or more electrodes in or adjacent to a desired anatomical site within a patient. An additional fixation element may be disposed at the distal region of the elongated member so that tissue, such as a muscle, may be sandwiched between the fixation elements without damaging the tissue.