Medical Lead Proximal End Metal Support Stiffness

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Solution Overview

Problem

Medical leads used for conducting electrical energy between tissue and circuitry often face challenges during implantation due to flexibility issues, which can lead to kinking and difficulty in inserting the proximal end into the header of an implantable medical device, potentially causing uncertainty and resistance.

Innovation Solution

The medical leads incorporate a metal support with longitudinal and cross members, encapsulated in polymer fill, providing structural stiffness and mechanical fixation, which facilitates easier insertion and maintains integrity during the implantation procedure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the lead is made flexible to accommodate curved implant paths, then the lead can be easily inserted along curved paths, but the proximal end becomes too flexible and difficult to insert into the header

Engineering Contradiction:

Improveability to follow curved implant pathsVSAvoidease of insertion of proximal end into header

Core Design Contradiction:

Adaptability or versatilityVSEase of operation

Solution Approach 1:

The lead is divided into segments with different mechanical properties: the proximal end contains a metal support structure (longitudinal members and cross members) providing stiffness for header insertion, while the distal end and main body remain flexible for curved implant paths. This segmentation allows each portion to be optimized for its specific function.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The lead structure implements local quality by providing enhanced structural support (metal support with longitudinal and cross members) specifically at the proximal end where stiffness is needed for header insertion, while the rest of the lead maintains flexibility. The polymer fill and metal support are localized to the proximal end region.

Inventive Principle:

Principle #3Local quality

2Ease of operation

If the proximal end is made stiffer to facilitate insertion into the header, then insertion becomes easier, but the lead may kink or bend excessively during implantation

Engineering Contradiction:

Improveease of insertion of proximal end into headerVSAvoidresistance to kinking during implantation

Core Design Contradiction:

Ease of operationVSStability of the object's composition

Solution Approach 1:

The metal support structure is segmented into longitudinal members (providing axial strength and kink resistance) and cross members (providing radial support and preventing excessive bending). This segmentation allows the proximal end to maintain structural integrity while facilitating header insertion.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The proximal end uses a composite structure combining metal support members (for stiffness and strength) with polymer fill material (for flexibility and cushioning). This composite construction provides the necessary axial strength to prevent kinking while allowing controlled flexibility for insertion.

Inventive Principle:

Principle #40Composite materials

3Strength

If a metal support structure is added to the proximal end to provide axial strength, then insertion ease and kink resistance improve, but the device complexity increases

Engineering Contradiction:

Improveaxial strength of proximal endVSAvoidstructural complexity of lead end

Core Design Contradiction:

StrengthVSDevice complexity

Solution Approach 1:

The metal support structure serves multiple functions simultaneously: it provides axial strength for header insertion, prevents kinking during implantation, maintains the geometric configuration of electrical elements, and works with the polymer fill to create a composite structure. This multi-functionality reduces the need for additional separate components.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The metal support structure is nested within the polymer fill material, which itself is contained within the lead body. The longitudinal members and cross members are positioned within the polymer matrix, creating a nested configuration that maximizes structural efficiency while minimizing overall complexity.

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS9138576B2Lead end having inner support

Publication Date: 2015.09.22 MEDTRONIC INC

AI summary

Various embodiments of this disclosure concern a lead end having an inner support. Such a lead can include a first end, a second end, a main body, and a plurality of exposed electrical elements on each of the lead ends. A metal support can be contained within the first end, the metal support comprising a plurality of longitudinal members and a plurality of cross members between the longitudinal members, the metal support having an interior space. The first lead end can further include polymer fill within the interior space of the metal support and encapsulating at least a substantial portion of the metal support, the polymer fill defining at least some of the exterior surface of the first end between the exposed electrical elements of the first end.