Torqueable Polymer Sheath for Pacing Lead Extraction

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current pacing lead extraction techniques face challenges such as ineffective mechanical sheaths that struggle with tortuous paths and hard tissues, and expensive laser systems that are unaffordable for many treatment centers, leading to complications and high costs.

Innovation Solution

A torqueable and flexible polymer sheath with a durable, radiopaque tip and braided composite construction, equipped with a separating mechanism that can strip, dilate, or cut adherent tissue using a cutting tip, allowing for effective pacing lead extraction under reduced force and minimizing the risk of lead breakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If metal sheaths are used to strip scar tissue from implanted leads, then tissue separation capability is improved, but ability to traverse tortuous lead paths deteriorates

Engineering Contradiction:

Improvetissue separation capabilityVSAvoidability to traverse tortuous lead paths

Core Design Contradiction:

StrengthVSAdaptability or versatility

Solution Approach 1:

The sheath is divided into multiple sections with varying properties: a proximal stiff section for structural support and a distal flexible section for navigating tortuous paths. This segmentation allows the sheath to combine the tissue-cutting effectiveness of metal with the path-following capability of flexible materials.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The sheath employs a composite construction combining metal components for tissue separation with flexible polymer sections for navigating curved paths. This composite approach integrates the advantages of both materials while mitigating their individual disadvantages.

Inventive Principle:

Principle #40Composite materials

2Adaptability or versatility

If plastic sheaths are used to access distal lead locations, then ability to traverse tortuous paths is improved, but torque properties and radiopacity deteriorate

Engineering Contradiction:

Improveability to access distal lead locationsVSAvoidtorque properties

Core Design Contradiction:

Adaptability or versatilityVSEase of operation

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Inventive Principle:

Principle #40Composite materials

3Adaptability or versatility

If plastic sheaths are used to access distal lead locations, then ability to traverse tortuous paths is improved, but penetration into hard tissue deteriorates

Engineering Contradiction:

Improveability to access distal lead locationsVSAvoidpenetration into hard tissue

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Inventive Principle:

Principle #40Composite materials

4Strength

If laser devices are used to cut scar tissue away from the lead, then tissue separation effectiveness is improved, but cost deteriorates

Engineering Contradiction:

Improvetissue separation effectivenessVSAvoidcost

Core Design Contradiction:

StrengthVSEase of manufacture

Solution Approach 1:

The invention replaces the laser energy-based tissue separation system with a mechanical cutting system. The sheath incorporates a cutting tip that mechanically separates tissue through rotation and contact, eliminating the need for expensive laser equipment while achieving effective tissue separation.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

5Strength

If longitudinal forces are applied during dilation techniques, then tissue separation is improved, but lead breakage risk increases

Engineering Contradiction:

Improvetissue separationVSAvoidlead breakage risk

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The sheath incorporates a cutting tip that rotates during the tissue separation process, converting a static pushing force into a dynamic cutting action. This rotational movement allows tissue separation with reduced longitudinal force application, minimizing the risk of lead breakage.

Inventive Principle:

Principle #15Dynamics

Data Source

PatentEP1935348B1Tissue separating systems

Publication Date: 2013.09.04 SPECTRANETICS CORP

Figure 1~1C
Figure 2A~2B
Figure 3~4

AI summary

Systems and methods for separating an object such as a pacing lead from a patient tissue involve a flexible and torqueable shaft having an internal lumen sized to receive the object, and a hard separating mechanism for separating the object from the tissue. Typically the shaft and separating mechanism are advanced along or toward the object, and the separating mechanism is contacted with the tissue. The shaft is rotated to effect separation between the object and the tissue. The systems and methods are well suited for use in cardiac pacing or defibrillator lead explant procedures.