Deflectable Catheter Navigation via Dynamic Shape Change
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Solution Overview
Problem
Current lead removal devices face challenges in navigating tortuous anatomy and efficiently extracting leads with scar tissue, increasing procedure time and risk due to the lack of mechanisms for navigating through the body's vessels.
Innovation Solution
A deflectable catheter system comprising a housing, orienting member, actuator, and elongate members that can change configuration from straight to curved, allowing for navigation and rotation within bodily passages to facilitate lead removal by advancing and retracting the catheter system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a traditional lead removal device with sheath and dissecting blade is used, then the lead can be extracted, but the device cannot navigate through tortuous anatomy, increasing procedure time and risk
Solution Approach 1:
The catheter system employs elongate members that can dynamically change their configuration between straight and curved states. The first elongate member can be actuated to deflect at different angles, allowing the catheter to adapt to tortuous anatomical paths during navigation while maintaining the ability to straighten for lead extraction
Solution Approach 2:
The catheter is divided into multiple elongate members (first elongate member, second elongate member) that can be independently controlled and positioned. This segmentation allows each segment to navigate specific anatomical curves while the entire system can be coordinated to reach the target vessel
2Reliability
If a traditional lead removal device is used, then lead extraction is possible, but the lack of navigation mechanism increases procedural risk
Solution Approach 1:
The second elongate member is disposed within the lumen of the first elongate member, creating a nested configuration. This allows the system to maintain a compact profile during navigation while providing the functionality of multiple controllable segments, reducing overall device complexity compared to having fully independent catheters
Solution Approach 2:
The catheter system integrates multiple functions into a single device: navigation through tortuous anatomy, positioning at the lead site, and facilitating lead extraction. The elongate members serve both as navigation tools and as structural support for the extraction mechanism
3Adaptability or versatility
If the first elongate member is made deflectable to navigate anatomy, then navigability improves, but the mechanism increases device complexity
Solution Approach 1:
The first elongate member incorporates a flexible structure that can be actuated to deflect. The member includes a lumen and can be constructed with flexible materials that allow bending and curvature changes when force is applied through the wire member, providing navigability without complex mechanical joints
4Measurement precision
If the second elongate member is made rotatable relative to the first, then positioning precision improves, but the control mechanism becomes more complex
Solution Approach 1:
The wire member acts as an intermediary control element that transmits force from the actuator to the first elongate member. By manipulating the wire member, the operator can control the deflection and positioning of the elongate members, providing precise control through a simple pull-wire mechanism rather than complex mechanical actuators
Data Source
Figure 1~1A
Figure 2
Figure 3~5
AI summary
Example deflectable catheter systems are described. An example deflectable catheter system includes a housing, an orienting member, an actuator, a first elongate member, a second elongate member, and a wire member. The housing defines a passageway. The orienting member is attached to the housing. The actuator is attached to the orienting member and is moveable between an actuator first position and an actuator second position. The first elongate member is attached to the orienting member and defines a lumen. The first elongate member is moveable between a first, substantially straight configuration when the actuator is in the actuator first position and a second, curved configuration when the actuator is in the actuator second position. The second elongate member is disposed through the passageway of the housing and extends through the lumen defined by the first elongate member. The second elongate member is rotatable relative to the first elongate member.