Electrode Positioning with Deployable Tissue Attachment
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Solution Overview
Problem
Conventional electrode stimulation devices for temporary bradycardia support lack reliable and safe methods for positioning electrodes within body tissue, particularly in the heart, due to limitations in tissue attachment and deployment mechanisms.
Innovation Solution
The development of an electrical sensing/stimulation apparatus with a deployable/retractable displacement member and tissue attachment mechanism, featuring an elongate lead body with internal lumens, sensing/stimulation electrodes, and atraumatic distal tips, allowing for precise alignment, deployment, and affixation of electrodes within body tissue using bi-directional torque control and expandable elements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional transvenous electrode pacing leads are inserted directly into the right ventricle, then temporary bradycardia support is provided, but the positioning method lacks reliability and safety
Solution Approach 1:
The lead body is divided into distinct functional segments: an elongate lead body for navigation, a deployable displacement member for positioning, and a tissue attachment mechanism for securement. This segmentation allows each component to perform its specific function independently, improving overall positioning reliability without requiring the entire device to be overly complex.
Solution Approach 2:
The tissue attachment mechanism is prepared in a compressed state within the lead body before deployment. This preliminary preparation allows the attachment members to be ready for immediate engagement with tissue upon deployment, ensuring reliable positioning while keeping the device profile low during insertion.
2Stability of the object's composition
If a tissue attachment mechanism is deployed to affix the lead to body tissue, then electrode positioning stability is improved, but tissue trauma increases
Solution Approach 1:
The tissue attachment mechanism uses multiple attachment members distributed at different locations and orientations around the lead body. This local distribution allows the attachment force to be spread across multiple tissue contact points, improving overall positioning stability while reducing the trauma at any single insertion site.
Solution Approach 2:
The tissue attachment mechanism transitions from a compressed low-profile state during insertion to an expanded engaged state during deployment. This dynamic transformation allows the device to minimize tissue disruption during navigation while providing stable attachment when needed, reducing overall tissue trauma.
3Manufacturing precision
If the lead body is made elongate with internal lumens for displacement members, then electrode positioning precision is improved, but device complexity increases
Solution Approach 1:
The displacement members are nested within internal lumens of the lead body, allowing them to be stored in a compact configuration during insertion and then deployed to precise positions. This nesting approach enables precise electrode positioning while maintaining a relatively simple lead body structure during the insertion phase.
Data Source
AI summary
Electrical sensing/stimulation apparatuses for positioning at least one electrode within body tissue are provided. An electrical sensing/stimulation apparatus may comprise an elongate lead body having at least one internal lumen, at least one sensing/stimulation electrode, a deployable/retractable displacement member that moves or biases at least one electrode towards a prescribed direction by the user, a tissue attachment mechanism for affixing the distal segment of the device to body tissue, and an atraumatic distal lead body termination. In a retracted configuration, the attachment mechanism is positioned substantially within the distal segment of the lead body, and in the deployed configuration, the attachment mechanism extends from the axis of the lead body to engage body tissue.