Bioabsorbable Coated Lead Retention Means for Medical Devices

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Solution Overview

Problem

Medical leads used for delivering therapy within the body often face dislodgement issues due to lack of effective retention mechanisms, which can hinder the prolonged delivery of electrical stimulation or fluid infusion therapies.

Innovation Solution

The implementation of retention means along the lead body, such as projections or textured surfaces, that engage with the vessel wall to prevent rearward motion while allowing forward insertion and repositioning, utilizing biocompatible materials like silicone and polyurethane, and potentially bioabsorbable components for chronic implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If retention means are added to prevent lead dislodgement, then lead stability is improved, but lead extraction difficulty increases

Engineering Contradiction:
Improvelead stabilityVSAvoidlead extraction difficulty
Core Design Contradiction:
ReliabilityVSEase of repair

Solution Approach 1:

The patent applies preliminary action by forming a bioabsorbable coating on the retention means before implantation. This coating temporarily prevents tissue ingrowth during the critical healing period, then gradually degrades over time to facilitate easier lead extraction if needed, while still providing initial retention stability

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the physical-chemical parameters of the retention means surface by applying a bioabsorbable coating that transitions from a retention-providing state to a degradation state. This parameter change allows the device to provide strong initial retention while enabling future extraction by reducing tissue adhesion strength over time

Inventive Principle:
Principle #35Parameter changes

2Reliability

If retention means with aggressive engagement features are used, then lead retention is improved, but tissue damage increases

Engineering Contradiction:
Improvelead retentionVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the surface parameters of the retention means by applying a bioabsorbable coating that provides initial retention through friction and mechanical engagement, then gradually degrades to reduce tissue damage and inflammation over time, allowing the body to heal around the retained lead

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent converts the potentially harmful effect of aggressive retention features causing tissue damage into a beneficial process by using a bioabsorbable coating that initially provides strong retention, then systematically degrades to allow tissue healing and reduce chronic inflammation, turning the retention mechanism into a temporary support structure

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

3Reliability

If permanent retention structures are implanted, then lead stability is improved, but long-term tissue inflammation increases

Engineering Contradiction:
Improvelead stabilityVSAvoidchronic inflammation duration
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent changes the temporal parameters of the retention means by using a bioabsorbable coating that provides initial retention stability, then systematically degrades over weeks to months, transforming the retention mechanism from a permanent foreign body into a temporary support structure that allows tissue healing and reduces chronic inflammation

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies discarding and recovering by designing the retention means with a bioabsorbable coating that intentionally degrades and is absorbed by the body over time. This allows the lead to be initially retained securely, then gradually releases the retention function as tissue heals and encapsulates the lead, reducing long-term inflammation from permanent foreign material

Inventive Principle:
Principle #34Discarding and recovering

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 retention means effectively secure the lead in place, ensuring stable therapy delivery by preventing dislodgement and facilitating easy extraction upon tissue encapsulation, while being biocompatible and non-toxic.

Implementation Method 1

projections or textured surfaces, that engage with the vessel wall to prevent rearward motion

Methodology Applied
Scientific EffectFriction: Friction

Implementation Method 2

engage with the vessel wall to prevent rearward motion while allowing forward insertion

Methodology Applied
Scientific EffectNormal force: Force

Data Source

PatentUS7933661B2Lead retention means
Publication Date: 2011.04.26 MEDTRONIC INC
  • US7933661B2 patent drawing
  • US7933661B2 patent drawing
  • US7933661B2 patent drawing

AI summary

A coiled member of a medical device extends along a length of an elongate body of the device. A surface of the coiled member extends at an angle, with respect to a longitudinal axis of the body, from a first edge to a second edge, toward the proximal end of the body, such that the first edge of the surface is disposed in close proximity to the body and the second edge of the surface is spaced apart from the body.