His Bundle Pacing Lead Tine Fixation Mechanism
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Solution Overview
Problem
Current medical lead designs for stimulating the bundle of His in the heart often result in inaccurate mapping and tissue damage due to reliance on non-contact sensing or helical electrodes that require repeated penetration and removal, leading to inefficiencies and potential damage.
Innovation Solution
A device with a tine assembly that self-biases from a linear to a curved configuration for active fixation, allowing for precise and secure attachment to cardiac tissue, reducing tissue damage and improving mapping accuracy by using a rotatable shaft to transition the tines between configurations for deployment and retraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If non-contact sensing or helical electrodes are used for mapping, then the lead can be positioned, but mapping accuracy deteriorates and tissue damage increases due to repeated penetration and removal
Solution Approach 1:
The tine assembly is designed to be dynamically configurable between a linear configuration for insertion and a curved configuration for fixation. The tines can be rotated from a straight state (easy insertion) to a curved state (secure anchoring), allowing the same structure to serve both mapping/insertion and fixation functions without repeated tissue penetration
Solution Approach 2:
The fixation device is segmented into multiple tines that can independently curve and engage with tissue. This segmentation allows the load to be distributed across multiple engagement points rather than requiring a single large penetration, reducing localized tissue damage while maintaining secure fixation
2Productivity
If helical electrodes require repeated penetration and removal, then mapping can be performed, but productivity deteriorates due to inefficiencies
Solution Approach 1:
The tine assembly transitions from a linear configuration during insertion/mapping to a curved configuration during fixation. This dynamic transformation eliminates the need to remove and reinsert the lead for fixation, as the tines automatically curve to engage tissue once positioned, significantly reducing procedural time
Solution Approach 2:
The tines are pre-configured in a linear state for easy insertion, and upon insertion, automatically transition to a curved fixation state. This preliminary preparation of the fixation mechanism eliminates the need for subsequent fixation steps requiring repeated access, improving overall productivity
3Reliability
If tines are designed to self-bias from linear to curved configuration, then fixation security is improved, but device complexity increases due to the rotatable shaft mechanism
Solution Approach 1:
The tine assembly is designed to self-bias from a linear to a curved configuration through its own elastic properties when the rotatable shaft is rotated. The tines automatically curve to engage tissue without requiring external fixation mechanisms or complex actuation systems, simplifying the overall device while maintaining secure fixation
Solution Approach 2:
The tines utilize shape memory or elastic deformation to change their configuration from linear to curved based on the rotational input. This parameter change (shape transformation) is achieved through the rotatable shaft's mechanical action, which converts rotational motion into the desired curvature change of the tines for secure tissue engagement
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device enables faster, less invasive mapping and secure fixation of the lead at the bundle of His, minimizing tissue damage and ensuring accurate placement for efficient pacing with higher current density.
Implementation Method 1
The tine assembly includes at least one tine configured to self-bias from a linear configuration within the housing to a curved configuration outside of the housing
Data Source
AI summary
A device for the active fixation of an implantable medical lead includes a housing, a tine assembly, an electrode, and a rotatable shaft. The housing includes a proximal end for connecting to the lead and a distal end opposite the proximal end. The housing defines a housing lumen extending between the proximal end and a recess adjacent to the distal end. The tine assembly is disposed within the housing lumen and includes at least one tine configured to self-bias from a linear configuration within the housing to a curved configuration outside of the housing. The electrode assembly is disposed at the distal end of the housing and includes a plurality of electrodes. The rotatable shaft extends through the housing lumen and is configured to engage the tine assembly such that rotation of the shaft transitions the at least one tine between the linear configuration and the curved configuration.