Balloon Catheter Tactile Feedback for Wireless Electrode Placement
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Solution Overview
Problem
Current cardiac pacing technologies face challenges with lead-based systems, including complications from infection, lead failure, and limited accessibility for multisite stimulation due to the need for lead wires, and lack tactile feedback during wireless electrode implantation, requiring additional imaging techniques like fluoroscopy and echocardiography for precise positioning.
Innovation Solution
A delivery system with an elongate sheath and a balloon coupled to a pressure sensor, which provides tactile and visual feedback by detecting contact with the endocardial wall through pressure variations, allowing for accurate placement of wireless stimulation electrodes without the need for external imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If lead wire systems are used for cardiac stimulation, then electrical stimulation can be delivered to cardiac tissue, but complications from infection, lead failure, and limited accessibility occur
Solution Approach 1:
The patent extracts and removes the lead wire component from the stimulation system, replacing it with a wireless electrode that can be directly implanted into the heart chamber. This eliminates the foreign body (lead wire) that causes infections and failures, while maintaining the electrical stimulation function through a different delivery mechanism.
Solution Approach 2:
The patent replaces the mechanical lead wire system with a wireless electrical stimulation system. Instead of using physical leads to transmit signals, the system uses wireless transmission to deliver electrical stimulation, eliminating the mechanical components that are prone to failure and infection.
2Power
If lead wires are required for stimulation, then electrical energy can be transmitted to tissue, but the number of accessible locations and multisite stimulation capability are limited
Solution Approach 1:
The patent removes the lead wire constraint that limits accessibility, allowing the electrode to be directly implanted at multiple locations in the heart chamber without being tethered by lead wires. This enables multisite stimulation and access to locations that were previously difficult to reach.
Solution Approach 2:
The patent divides the stimulation system into separate functional components: the wireless electrode can be independently positioned at different sites, and the control system can manage multiple sites separately. This segmentation allows for flexible multisite stimulation without the constraints of a single lead wire path.
3Reliability
If wireless stimulation electrodes are delivered via catheter, then lead wire complications are eliminated, but visualizing and determining catheter position relative to target location becomes difficult
Solution Approach 1:
The patent incorporates tactile feedback mechanisms that allow the operator to sense when the catheter is in contact with the target tissue. This feedback system provides real-time information about catheter position and contact status, eliminating the need for external imaging techniques and enabling precise positioning without visual assistance.
Solution Approach 2:
The system provides its own positioning information through integrated sensors and feedback mechanisms, making the catheter self-identifying regarding its position relative to target tissue. This eliminates the need for external imaging services and allows the operator to independently determine accurate positioning.
4Ease of manufacture
If conventional delivery systems are used for wireless electrodes, then implantation can be performed, but tactile feedback is lacking and additional imaging techniques are required
Solution Approach 1:
The patent integrates tactile feedback sensors into the delivery system that provide real-time information about contact with target tissue. This feedback mechanism eliminates the need for external imaging techniques, simplifying the overall system while maintaining ease of implantation through direct tactile guidance.
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
Enables precise and effective implantation of wireless stimulation electrodes, reducing the risk of improper placement and increasing the likelihood of successful stimulation therapy by providing real-time feedback and eliminating the need for complex imaging procedures.
Implementation Method 1
a pressure sensor configured to detect contact with the endocardial wall through pressure variations
Data Source
AI summary
The present technology is generally directed to delivery systems for medical implants, such as electrode assemblies for stimulating heart tissue. In some embodiments, a delivery system for a medical implant includes an elongate sheath having a distal portion and a balloon coupled to the distal portion of the sheath. The delivery system can further include a fluid circuit configured to be in fluid communication with the balloon and having a pressure source and a pressure sensor. The pressure source can move the balloon between an inflated configuration and a deflated configuration, and the pressure sensor can sense a pressure within the balloon. The sensed pressure can be monitored to determine (i) that the balloon is in contact with heart tissue of a heart, (ii), a motion profile of the heart tissue, and/or (iii) blood flow characteristics within the heart.