RF Guidewire Sheath Mechanism to Limit Adjacent Tissue Damage
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Solution Overview
Problem
Existing ablation procedures, such as RF and cryoablation, indiscriminately damage healthy tissue like the esophagus, phrenic nerve cells, and coronary arteries due to uncontrolled energy delivery, and perforation devices risk damaging adjacent tissue during procedures.
Innovation Solution
A perforation device with a passive electrode sheathing design featuring a movable insulation sheath that covers and exposes the electrode selectively, combined with a spacer and radiopaque coil, to protect adjacent tissue from damage during tissue piercing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If RF energy is continuously delivered to the tip electrode during advancement, then tissue piercing is achieved, but adjacent tissue is damaged
Solution Approach 1:
The insulation sheath is designed to be movable rather than fixed, allowing it to dynamically change position between covering and exposing the electrode. During advancement, the sheath covers the electrode to prevent damage, and during piercing, it retracts to expose the electrode for energy delivery, thus resolving the contradiction between continuous energy delivery and tissue protection
Solution Approach 2:
The insulation sheath is pre-positioned to cover the electrode before energy delivery occurs. This preliminary protective action is taken before the harmful effect (energy delivery) can cause damage to adjacent tissue, allowing safe advancement and positioning without unintended tissue destruction
2Reliability
If the electrode is always exposed for energy delivery, then ablation function is maintained, but cross-back damage occurs
Solution Approach 1:
The insulation sheath transitions from a static covering to a dynamic component that can retract and advance. When the device is advanced through tissue, the sheath covers the electrode to prevent cross-back damage. When energy delivery is required, the sheath retracts to expose the electrode, maintaining ablation function while preventing harmful effects during advancement
Solution Approach 2:
The harmful function of continuous energy delivery is extracted and separated from the advancement process. The insulation sheath acts as a barrier that removes the electrode from the harmful energy field during advancement, allowing the electrode to be exposed only when needed for its intended ablation function
3Ease of manufacture
If a fixed insulation design is used, then manufacturing is simple, but tissue protection is insufficient
Solution Approach 1:
The insulation sheath is designed with dynamic capabilities including a compressible portion that can be compressed to retract and expose the electrode, and an expansion mechanism that allows it to expand and cover the electrode during advancement. This dynamic design provides adequate tissue protection while remaining manufacturable using standard medical device fabrication techniques
4Object-affected harmful factors
If the sheath covers the electrode during advancement, then tissue damage is prevented, but energy delivery is blocked
Solution Approach 1:
The insulation sheath is designed with a compressible portion that can be compressed to retract and expose the electrode for energy delivery, while maintaining its protective covering function during advancement. This dynamic reconfiguration allows the sheath to switch between protection mode and energy delivery mode, resolving the contradiction between preventing tissue damage and enabling energy delivery
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 minimizes cross-back and through-and-through tissue damage by ensuring the electrode is covered when not in use, enhancing safety during procedures like transseptal access.
Implementation Method 1
A movable insulation sheath is configured to move from a first position to a second position, wherein the first position covers the at least one electrode and the second position exposes the at least one electrode
Implementation Method 2
The at least one electrode is configured to receive energy for piercing a target tissue
Implementation Method 3
A radiopaque coil is located in the distal portion
Data Source
AI summary
A perforation device having a passive electrode sheathing design includes an elongate body having a proximal portion including a proximal end and a distal portion including a distal end. At least one electrode is located at the distal end. The at least one electrode is configured to receive energy for piercing a target tissue. At least one conductor extends from the proximal end to the at least one electrode. The at least one conductor is configured to electrically connect the at least one electrode to a control system. A movable insulation sheath is configured to move from a first position to a second position, wherein the first position covers the at least one electrode and the second position exposes the at least one electrode.