Leadless Cardiac Stimulation Hook Assembly for Endocardial Fixation
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Solution Overview
Problem
Existing cardiac stimulation technologies, such as pacemakers and implantable defibrillators, face challenges with lead-related complications, limited accessibility, and difficulty in securing electrodes to complex tissue structures like the endocardial wall, which hinders effective multisite stimulation.
Innovation Solution
The development of implantable stimulation assemblies with tissue engagement mechanisms, including a hook mechanism and acoustic energy conversion, allows for secure electrode placement and stimulation on complex cardiac tissue without the need for leads, using a receiver-stimulator that converts acoustic energy to electrical energy for effective cardiac pacing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If lead wires are used to deliver electrical stimulation, then electrical energy can be delivered to target tissue, but complications due to infection, lead failure, and electrode dislodgement occur
Solution Approach 1:
The patent removes the lead wire component from the stimulation system by using a leadless electrode design. The electrode is delivered directly to the target tissue site through a catheter and secured in place, eliminating the need for lead wires that connect external pulse generators to internal electrodes. This extraction of the problematic lead wire component directly resolves the contradiction by maintaining stimulation delivery while eliminating infection and lead failure risks.
Solution Approach 2:
The patent introduces a delivery catheter as an intermediary tool that enables direct placement of the electrode at the target tissue site. The catheter serves as a temporary mediator during the implantation process, allowing the electrode to be positioned and secured without requiring lead wires for delivery or connection. After implantation, the catheter is removed, leaving only the secure electrode in place.
2Reliability
If anchor mechanism is pushed into complex tissue structure, then electrode can be secured to tissue, but improper securing occurs due to complex trabeculae, papillary muscles, and chordae
Solution Approach 1:
The patent employs a dynamic anchoring mechanism that can transition between different states during deployment. The anchor is initially in a compressed or retracted state for delivery, then transitions to an expanded or deployed state upon reaching the target tissue. This dynamic transformation allows the anchor to adapt to the complex three-dimensional structure of cardiac tissue, ensuring proper engagement with trabeculae, papillary muscles, or chordae regardless of the specific tissue architecture encountered.
Solution Approach 2:
The patent utilizes parameter changes in the anchor mechanism, such as changes in shape, volume, or structural configuration, to enable effective anchoring in complex tissue. The anchor may change from a compact delivery configuration to an expanded secured configuration, altering its physical parameters to optimize engagement with the target tissue structure. This parameter transformation allows the same device to effectively secure to various complex tissue architectures without requiring different devices for each tissue type.
3Adaptability or versatility
If lead wires are required for stimulation, then electrical delivery is possible, but number of accessible locations and ability for multisite stimulation are limited
Solution Approach 1:
The patent divides the stimulation system into multiple independent leadless electrodes that can be separately delivered and positioned at different target sites. Each electrode functions as an independent stimulation unit, eliminating the need for a single complex lead wire system to reach multiple locations. This segmentation allows for straightforward multisite stimulation by simply deploying additional independent electrodes at different cardiac locations, significantly enhancing adaptability while reducing overall system complexity.
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
This solution provides stable and effective cardiac stimulation by securely engaging electrodes with complex endocardial tissue, reducing complications and enhancing the ability for multisite stimulation, thereby improving treatment outcomes for cardiac conditions.
Implementation Method 1
a receiver-stimulator that converts acoustic energy to electrical energy for effective cardiac pacing
Data Source
AI summary
The present technology is generally directed to medical implants, such as stimulation assemblies for stimulating heart tissue. In some embodiments, a stimulation assembly includes a body, circuitry positioned at least partially within the body, an electrode coupled to the body, and a hook mechanism coupled to the body. The stimulation assembly can be implanted at cardiac tissue of a patient such that the electrode electrically contacts the tissue. The circuitry can be configured to receive acoustic energy and convert the acoustic energy to electrical energy, and the electrode can deliver the electrical energy to the tissue to stimulate the tissue. The hook mechanism can be configured to engage the tissue to pull the tissue and the electrode toward and into engagement with one another.