Conductive Fixation Clip for Implantable Medical Device

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Solution Overview

Problem

Existing electrical stimulation systems face challenges in maintaining the position of implantable medical leads near target tissue sites, leading to potential migration and unintended nerve damage, which can reduce the effectiveness of therapy and cause inflammation.

Innovation Solution

An actively deployable fixation clip is integrated with the implantable medical device, capable of changing shape from an undeployed to a deployed state to securely engage with surrounding tissue, thereby fixing the position of the lead proximate to the target tissue site and potentially serving as an electrode for delivering stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a stimulation lead is implanted to deliver electrical stimulation therapy, then the lead can provide therapeutic stimulation to the target tissue site, but the lead may migrate from the target site causing reduced therapy effectiveness and potential nerve damage

Engineering Contradiction:

Improvelead position stabilityVSAvoidlead migration

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The fixation clip is pre-formed in a compressed configuration that is retained within an introducer during implantation. Once the lead is positioned at the target site, the clip is released and automatically expands to its deployed configuration, engaging with surrounding tissue to secure the lead before any migration can occur.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The fixation system is divided into separate components: the fixation clip, the introducer, and the stimulation lead. This segmentation allows the clip to be independently deployed and activated after lead positioning, providing a dedicated fixation mechanism that addresses lead stability without interfering with the stimulation function.

Inventive Principle:

Principle #1Segmentation

2Adaptability or versatility

If the fixation clip is made electrically conductive to serve as an electrode, then it can deliver additional stimulation therapy, but it increases the complexity of the device design

Engineering Contradiction:

Improvefixation clip functionalityVSAvoidfixation clip structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The fixation clip is designed to perform multiple functions: it provides mechanical fixation to secure the lead, and when made from electrically conductive material, it also serves as an additional electrode for delivering stimulation therapy. This multi-functionality is achieved without adding separate components, as the same clip structure fulfills both fixation and stimulation roles.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The fixation and stimulation functions are merged into a single component. The fixation clip incorporates both the mechanical fixation features (compressible structure for tissue engagement) and the electrical stimulation features (conductive material with electrode configuration), eliminating the need for separate fixation and electrode components.

Inventive Principle:

Principle #5Merging (Combining)

3Reliability

If the fixation clip is deployed immediately upon implantation, then the lead position is secured, but the clip cannot be repositioned if initial placement is incorrect

Engineering Contradiction:

Improvelead fixation securityVSAvoidlead repositionability

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The fixation clip remains in a compressed, non-deployed state during the implantation process while retained within the introducer. This allows the surgeon to position the lead at the target site and verify correct placement before the clip is released and deployed. Once deployed, the clip provides secure fixation, but the delayed activation ensures repositionability during the implantation procedure.

Inventive Principle:

Principle #10Preliminary action

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 fixation clip effectively prevents lead migration, maintains optimal positioning of electrodes, reduces the risk of nerve damage, and ensures reliable and consistent delivery of electrical stimulation therapy.

Implementation Method 1

The fixation element is actively deployable from a first shape to a second shape to resist substantial movement of the implantable medical device from the target tissue site

Methodology Applied

Scientific EffectShape memory: Shape Memory Alloy

Implementation Method 2

The fixation element comprises an electrically conductive portion configured to at least one of deliver electrical stimulation to a target tissue site within a patient

Methodology Applied

Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS7765012B2Implantable medical device including a conductive fixation element

Publication Date: 2010.07.27 MEDTRONIC INC

AI summary

A system comprises an implantable medical device and an actively deployable clip attached to the implantable medical device to restrict movement of the implantable medical device once the clip is deployed within a body of a patient. The clip includes an electrically conductive portion. The implantable medical device may be implanted proximate to any suitable tissue site within the patient, and in one embodiment, the implantable medical device is implanted proximate to an occipital nerve or a trigeminal nerve of the patient.