Lead Removal Stylet Vibration for Tissue-Bound Cardiac Leads
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Solution Overview
Problem
Existing methods for removing cardiac leads are complicated by tissue growths that attach to the lead, posing a risk of perforation and often require invasive cutting devices that can clog the pathway, while leaving the lead in place is not a preferred solution due to obstruction and infection risks.
Innovation Solution
A lead removal stylet (LRS) is inserted into the lead and vibrated at binding sites to dislodge tissue, using automated or manual control to detect and disrupt binding, allowing for safe removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If simple traction is used to remove the lead, then the removal process is simple, but the lead cannot be removed due to tissue growths binding it
Solution Approach 1:
The patent applies mechanical vibration through a lead removal stylet that vibrates at high frequency to disrupt the binding tissue between the lead and surrounding body tissue. The vibration mechanically breaks the fibrous tissue attachments, allowing the lead to be freed without requiring cutting devices or leaving it in place. This resolves the contradiction by making removal feasible (improving reliability) while maintaining a relatively simple procedural approach (preserving ease of operation).
2Reliability
If cutting devices are used to remove tissue attachments, then the lead can be freed from binding tissue, but tissue buildup clogs the pathway
Solution Approach 1:
The patent extracts the tissue disruption function from cutting devices and implements it through vibration-based mechanical disruption. The stylet vibrates to fragment and dislodge binding tissue into small particles that can be cleared through the pathway, rather than creating large tissue chunks that would clog the sheath. This resolves the contradiction by achieving reliable lead removal while preventing pathway clogging through the mechanism of tissue fragmentation rather than excision.
Solution Approach 2:
The patent replaces the cutting mechanical system with a vibration-based mechanical system. Instead of using blades or sheaths that cut and dislodge large tissue pieces, the system uses high-frequency vibration to mechanically fragment tissue into smaller particles. This substitution resolves the contradiction by maintaining the ability to free the lead from binding tissue while eliminating the clogging problem associated with cutting devices.
3Object-affected harmful factors
If the lead is left in position, then removal complications are avoided, but blood flow obstruction and infection risk increase
Solution Approach 1:
The patent uses mechanical vibration to safely remove the lead by disrupting binding tissue without causing perforation. The controlled vibration applied through the stylet systematically breaks down tissue attachments along the lead's path, allowing complete removal rather than leaving it in place. This resolves the contradiction by eliminating both the perforation risk (by avoiding forceful traction) and the long-term harmful effects of leaving the lead in situ (obstruction and infection).
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 LRS effectively dislodges tissue attachments, reducing the risk of perforation and obstruction, and enabling safe extraction of cardiac leads.
Implementation Method 1
The LRS is moved through the lead's internal lumen and the LRS tip is extensively vibrated at tissue binding sites to dislodge the binding tissue
Implementation Method 2
an implant that includes a transducer element that couples inductively to an alternating magnetic field
Implementation Method 3
the transducer element is an integral part of the implant... application of ultrasonic fluctuations
Data Source
Figure 1A
Figure 1B
Figure 1C~1D
AI summary
A method for extracting a lead from a patient comprising: providing a lead removal stylet; inserting the stylet into the lead; locking the stylet to a position inside the lead; and vibrating the stylet with tissue disrupting vibration to cause the lead to vibrate and to disconnect from binding tissue.