Resilient Scaffold for Leadless Pacemaker Electrode
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Solution Overview
Problem
Leadless cardiac pacemakers face challenges in effectively pacing the atrial tissue due to its thin and deformable nature, leading to inconsistent contact and scarring issues that impede the delivery of electrical impulses.
Innovation Solution
A biostimulator with an electrode mounted on a resilient scaffold that supports the electrode away from the fixation element, allowing for flexible coupling with the atrial walls, ensuring optimal pacing performance by maintaining contact and reducing scarring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a rigid electrode is used in a leadless cardiac pacemaker, then the electrode can be firmly supported at the nose of the device, but it cannot maintain consistent contact with the thin and deformable atrial tissue, leading to poor pacing performance
Solution Approach 1:
The patent applies the dynamics principle by transitioning from a rigid electrode support system to a flexible, dynamic one. The foam material allows the electrode to move and adapt with the deformable atrial tissue, maintaining consistent contact during cardiac cycles while providing adequate support for electrical stimulation delivery.
Solution Approach 2:
The patent implements this principle by using a foam material that acts as a flexible intermediary between the rigid pacemaker housing and the soft atrial tissue. This flexible material conformally contacts the tissue surface, ensuring reliable electrical contact despite tissue deformation and movement.
2Device complexity
If the electrode is rigidly supported at the nose of the leadless pacemaker, then the structure is simple, but the electrode bounces in and out of contact with the tissue as the heart beats, causing ineffective pacing
Solution Approach 1:
The foam material serves as a flexible interface layer between the rigid pacemaker body and the soft atrial tissue. This flexible material absorbs mechanical discrepancies and maintains conformal contact during cardiac motion, ensuring reliable electrode-tissue coupling without complicating the overall device structure.
Solution Approach 2:
The patent changes the mechanical parameters of the electrode support system by introducing a foam material with specific elastic properties. This material provides both mechanical support and compliance, allowing the electrode to maintain consistent contact with the deformable tissue while keeping the mounting structure relatively simple.
3Strength
If a fixation element is placed adjacent to the electrode, then the device can be securely anchored to the tissue, but scarring from the anchor site impedes electrical impulse delivery
Solution Approach 1:
The patent applies segmentation by spatially separating the fixation element and electrode functions. The fixation element is positioned at one location to provide secure anchoring, while the electrode is positioned at a different location to deliver electrical impulses, preventing scarring from interfering with electrical conduction pathways.
Solution Approach 2:
The foam material acts as an intermediary between the fixation element and the electrode-tissue interface. This flexible material allows the fixation element to be securely anchored while maintaining proper spacing and mechanical coupling for the electrode to effectively deliver electrical impulses without interference from anchor-site scarring.
Data Source
AI summary
A biostimulator, such as a leadless cardiac pacemaker, including a fixation element and an electrode mounted on a resilient scaffold, is described. The fixation element and the resilient scaffold are coupled to a housing of the biostimulator. The resilient scaffold can support the electrode against a target tissue at a location that is radially offset from a location where the fixation element anchors the housing to the target tissue. A flexibility of the resilient scaffold allows the electrode to conform to a shape and movement of the target tissue when the housing is rigidly fixed to the target tissue by the fixation element. The resiliently supported electrode that is radially offset from the anchor point can reliably pace the target tissue without piercing the target tissue. Other embodiments are also described and claimed.