Paddle Lead Ridge Design for Secure Suture Anchoring
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Solution Overview
Problem
Existing implantable pulse generator leads lack reliable anchoring mechanisms, leading to inconsistent or unintended tissue stimulation due to inadequate securement, which can result in ineffective therapy delivery.
Innovation Solution
The development of a paddle lead with a thicker ridge surrounding a thinner main panel, designed to be securely sutured to anatomical structures, where the ridge prevents tear propagation and ensures stable anchoring, thereby focusing electrical stimulation on targeted tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a thin main panel is used for the paddle lead, then the lead body remains flexible and implantable, but the lead lacks sufficient strength to resist tearing during suturing and implantation
Solution Approach 1:
The paddle lead incorporates a ridge with increased thickness specifically at the suturing location, while the rest of the main panel maintains its thin profile. This localized thickening provides enhanced tear resistance precisely where sutures are applied, without compromising the overall flexibility of the lead body for implantation.
Solution Approach 2:
The paddle lead is segmented into distinct regions: a thin main panel for flexibility, a thicker ridge for strength during suturing, and electrodes for functionality. This segmentation allows each region to be optimized for its specific function without compromising the others.
2Strength
If a thick ridge is added to the paddle lead to prevent tear propagation, then the lead gains improved structural integrity, but the overall device complexity increases
Solution Approach 1:
The ridge is merged with the main panel to form a unitary structure, eliminating the need for separate reinforcement components. This integration achieves enhanced tear propagation resistance while minimizing additional structural complexity, as the ridge and main panel are manufactured as a single piece.
3Reliability
If the paddle lead is secured firmly to tissue, then reliable chronic therapy delivery is achieved, but the risk of tear propagation during implantation increases
Solution Approach 1:
The thicker ridge is designed beforehand to intercept and block tear propagation before it can compromise the entire lead structure during the implantation process. This preemptive structural feature ensures that even if tearing initiates at the suture site, the ridge prevents catastrophic failure, maintaining anchoring reliability.
Data Source
AI summary
Various embodiments concern an implantable paddle lead. The paddle can be attached to a distal portion of an elongate lead body. The paddle can comprise a main panel and a ridge that peripherally surrounds the main panel. The main panel can comprise a first face and a second face opposite the first face. One or more electrodes can be exposed on the first face but not exposed on the second face. The paddles can be sutured to anatomical structures. The sutures can be threaded through the main panel but not through the ridge. The paddle can be thicker along the ridge than along the main panel.