Expandable Anchoring Electrode Lead for Cardiac Tissue Fixation
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Solution Overview
Problem
Conventional systems for temporary bradycardia support, which involve transvenous electrode pacing leads inserted into the right ventricle, face challenges in securely positioning and maintaining electrodes for effective heart rate regulation, particularly for patients with reversible causes of bradycardia that do not require permanent pacemaker implantation.
Innovation Solution
A device comprising an elongate lead body with an electrode array, anchoring elements, and a displacement mechanism that navigates through the cardiovascular system to securely position the electrode array against the intraventricular septum, using expandable anchoring elements and an atraumatic tip to minimize tissue damage, and a handle with actuation mechanisms for deploying and verifying the anchoring elements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If transvenous electrode pacing leads are inserted directly into the right ventricle, then temporary bradycardia support is provided, but secure positioning and maintenance of the electrode is difficult
Solution Approach 1:
The lead incorporates an expandable displacement mechanism that transitions from a compressed delivery state to an expanded deployed state, enabling dynamic adaptation to tissue geometry and achieving secure positioning without complex manual manipulation
Solution Approach 2:
The displacement mechanism acts as an intermediary between the lead body and cardiac tissue, providing a controlled interface that facilitates reliable positioning through expandable structures that engage with the intraventricular septum
2Stability of the object's composition
If anchoring elements are used to secure the electrode, then fixation stability is improved, but tissue damage may increase
Solution Approach 1:
The lead employs an atraumatic tip with flexible, biocompatible material that conforms to tissue surfaces, providing secure fixation while minimizing mechanical damage and irritation to the cardiac tissue
Solution Approach 2:
The anchoring elements transition from a retracted configuration during delivery to an extended configuration upon deployment, enabling stable fixation only when needed while reducing tissue interaction during insertion and removal
3Ease of operation
If the lead body is made flexible for navigation through the cardiovascular system, then ease of navigation is improved, but positioning precision against the intraventricular septum deteriorates
Solution Approach 1:
The lead body transitions from a flexible compressed state during navigation to a stabilized expanded state during positioning, with the displacement mechanism providing rigid support that ensures precise engagement with the intraventricular septum
Solution Approach 2:
The lead is pre-formed with a specific geometry and the displacement mechanism is pre-positioned to automatically engage with the intraventricular septum upon expansion, eliminating the need for complex manual positioning adjustments
Data Source
AI summary
A device for positioning an electrode in tissue includes: a lead body having a distal portion; an electrode array coupled to the lead distal portion; an anchoring element having an anchor tip and being operable in a first configuration in which the anchor tip is retracted within the lead and in a second configuration in which the anchor tip is extended outside the lead and configured to fixate within the tissue; and a displacement mechanism that is actuated to bias the electrode array or the anchoring element toward the tissue. A method for positioning an electrode in tissue includes: navigating, to the tissue, a lead with an electrode array, an anchoring element with a distal anchor tip, and a displacement mechanism; biasing the electrode array and anchoring element towards the tissue with the displacement mechanism; and deploying the anchoring element, and verifying fixation of the anchor tip within the tissue.