Lead Extender Locking Connector for Smaller-Sheath Extraction
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Solution Overview
Problem
The extraction of implantable medical leads is complicated by the bulky connector assembly, which requires cutting and additional preparation steps, leading to potential lead breakage and increased anesthesia time, and the use of larger extraction sheaths increases vascular injury risk.
Innovation Solution
A lead extender with a connector and extension line that locks the cut implantable medical lead to an inner wall, allowing traction force application via an extraction tool, even with smaller sheaths.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the lead is cut near the connector to allow insertion into the extraction sheath, then the bulky connector can be removed, but the lead requires additional preparation steps and may lose substantial lead strength
Solution Approach 1:
A stylet is introduced as an intermediary tool to provide structural support to the cut lead. The stylet is inserted into the lead lumen and extends through the connector, providing a rigid core that maintains lead strength during extraction without requiring the lead to bear the full extraction force alone.
Solution Approach 2:
The stylet is inserted into the lead before the extraction procedure begins. This preliminary action prepares the lead in advance by establishing internal support structure, so that when extraction forces are applied, the lead already has the strength it needs to withstand the pulling forces.
2Ease of operation
If a larger diameter extraction sheath is used to accommodate the connector, then the lead can be extracted more easily, but the risk of vascular injury increases
Solution Approach 1:
The extraction system is segmented into two functional parts: the stylet that provides internal support for the lead, and the extraction sheath that provides the extraction force. This segmentation allows the use of a smaller sheath diameter while still enabling successful lead extraction through the combined action of the stylet and sheath.
Solution Approach 2:
The stylet acts as a mediator between the small extraction sheath and the bulky connector. It transmits the extraction force from the small sheath to the lead and connector assembly, enabling extraction through a smaller sheath without requiring the sheath to directly accommodate the full connector diameter.
3Strength
If the lead is prepared with ligation sutures to bind conductors, then the lead strength is maintained, but the preparation time increases and anesthesia time increases
Solution Approach 1:
The mechanical ligation suture system is replaced with a stylet-based support system. Instead of using sutures to bind and strengthen the lead, a rigid stylet is inserted into the lead lumen to provide structural support. This substitution eliminates the time-consuming suture tying process while achieving the same strength enhancement.
Solution Approach 2:
The time-consuming preparation steps involving ligation sutures and multiple binding operations are extracted and removed from the procedure. The stylet insertion provides a simpler, faster method of strengthening the lead without requiring these additional preparatory steps.
Data Source
AI summary
A lead extender comprises a connector defining a chamber having an inner wall and an opening into the chamber, the chamber configured to receive a proximal portion of a cut implantable medical lead through the opening. The connector comprises a locking mechanism configured to lock the proximal portion of the cut implantable medical lead to the inner wall of the chamber. The lead extender further comprises an extension line, having a distal end attached to the connector, the extension line configured to extend through a lumen of an extraction tool to the proximal end controlled by the operator for extracting the cut implantable medical lead from a patient.