Retention Mechanism for Implantable Lead Anchoring
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Solution Overview
Problem
The subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation procedure involves multiple incisions and suturing, which increases procedure time, risks infection, and leaves visible scars, necessitating a simplification of the method for securing leads without sutures.
Innovation Solution
A retention device with an elongate body and securing mechanisms that expand from a compressed state to anchor the lead to tissue, reducing the need for suturing and minimizing tissue trauma, allowing for single or reduced incision implantation methods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If suture loops and suturing steps are used to secure the lead, then the lead can be firmly attached to the fascia, but the procedure time increases and the complexity of the implantation procedure increases
Solution Approach 1:
The patent removes the suture loops and suturing steps from the implantation procedure. Instead of using external sutures to secure the lead to the fascia, the invention uses an expansion mechanism that anchors the lead directly to the tissue through mechanical expansion, eliminating the need for separate suturing operations and thereby reducing procedure time while maintaining secure attachment
Solution Approach 2:
The lead securing mechanism performs its own attachment function through self-expansion. The expansion mechanism is deployed and automatically anchors itself to the surrounding tissue without requiring external suturing assistance. This self-service capability eliminates the need for additional suturing steps and reduces overall procedure time
2Ease of operation
If multiple incisions are made during implantation, then the lead can be properly positioned and secured, but the risk of infection increases and visible scars are left
Solution Approach 1:
The expansion mechanism serves multiple functions: it anchors the lead to the tissue, provides structural support, and secures the lead in position. This multi-functionality allows the lead to be properly positioned and secured through a single incision, eliminating the need for multiple incisions and thereby reducing infection risk and visible scarring
3Reliability
If suture loops are used to secure the lead, then the lead can be firmly attached, but the device complexity and number of components increase
Solution Approach 1:
The patent merges the lead body and the expansion mechanism into a single integrated structure. The expansion mechanism is incorporated directly into the lead, eliminating the need for separate suture loops and external securing components. This integration maintains firm attachment security while reducing the overall number of components and device complexity
Data Source
AI summary
Retention devices for use with an implantable medical device (IMD) are disclosed. An illustrative retention device may comprise an elongate body including a bore configured to receive and substantially surround an implantable lead of the IMD and an outer surface configured to receive a suture. The retention device may also include a securing mechanism configured to push against tissue of the patient.