Strain-Relieved Pacing Element for Deep Septal Penetration Control
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Solution Overview
Problem
Existing pacing leads are not well suited for deep septal pacing, particularly left bundle branch area pacing, as they lack the ability to control penetration into the target tissue and are susceptible to buckling, requiring multiple attempts for accurate placement.
Innovation Solution
A biostimulator with a strain-relieved pacing element that includes a flexible conductor surrounded by a strain relief with decreasing stiffness distally, allowing it to penetrate the septal wall without buckling and facilitate precise deployment at the left bundle branch.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If existing pacing leads are used for deep septal pacing, then the leads are susceptible to buckling and lack control over penetration, but this requires multiple attempts for accurate placement and increases procedure time
Solution Approach 1:
The pacing lead incorporates a strain relief section with varying stiffness properties - stiffer proximal section for support and more flexible distal section for controlled penetration. This parameter change in mechanical properties enables precise depth control during septal wall penetration while preventing buckling, reducing the number of placement attempts needed
Solution Approach 2:
The pacing lead is divided into distinct segments: a proximal stiff section providing structural support, a strain relief section with gradient stiffness for controlled flexibility, and a distal flexible section for tip navigation. This segmentation allows each section to perform its specific function - the stiffer proximal section prevents buckling while the flexible distal section enables precise penetration control
2Reliability
If existing pacing leads are used for deep septal pacing, then the leads are susceptible to buckling, but this prevents reliable penetration into the target tissue
Solution Approach 1:
The strain relief section features a stiffness gradient that transitions from stiffer proximal regions to more flexible distal regions. This parameter change enables the lead to maintain overall structural stability while allowing the distal tip to flex and penetrate reliably into the deep septal target tissue without buckling the entire lead structure
3Measurement precision
If excessive penetration attempts are made with existing leads, then the target region may not be engaged accurately, but this increases tissue damage
Solution Approach 1:
The pacing lead design provides tactile feedback through its strain relief section during penetration attempts. The varying stiffness gives the operator sensory information about tissue engagement depth and resistance, enabling accurate determination of target region engagement with fewer attempts and reduced tissue damage
Data Source
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AI summary
A biostimulator (100) includes a housing (202) having a longitudinal axis (204) and containing an electronics compartment (206). The biostimulator (100) includes a fixation element (106) coupled to the housing (202). The fixation element (106) extends about the longitudinal axis (204). The biostimulator (100) includes a pacing element (108) coupled to the housing (202). The pacing element (108) includes a strain relief (410) surrounding a flexible conductor (406) distal to the fixation element (106). A stiffness of the strain relief (410) decreases in a distal direction. Other embodiments are also described and claimed.