Triangular Fixation Member for Implantable Medical Devices

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Solution Overview

Problem

Implantable medical devices require reliable fixation mechanisms to maintain stable positioning within the body without causing tissue trauma, while also allowing for temporary or permanent placement and easy removal without adverse consequences.

Innovation Solution

The development of a fixation member for implantable medical devices, such as elongated leads and fluid delivery catheters, featuring a triangular shape with a tapered distal tip and a resilient, biostable polymeric material that promotes tissue ingrowth and stability, coupled with a delivery tool for deployment and release, ensuring secure positioning and easy retrieval.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a robust fixation mechanism is used for permanent implantation, then the device stability is improved, but the tissue trauma increases

Engineering Contradiction:

Improvedevice stabilityVSAvoidtissue trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The fixation member is designed with dynamic characteristics that allow it to adapt to body movements and tensions. The resilient polymeric material enables the fixation member to flex and conform to tissue motion, maintaining stable fixation while reducing stress concentration and tissue damage over time.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The invention changes the material parameters from rigid (metallic helices or tines) to resilient and biostable polymeric materials. This parameter change allows the fixation member to maintain mechanical strength for reliable fixation while providing flexibility to reduce tissue trauma and adapt to physiological movements.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If a robust fixation mechanism is used for permanent implantation, then the device stability is improved, but the ease of removal deteriorates

Engineering Contradiction:

Improvedevice stabilityVSAvoidease of removal

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The resilient polymeric fixation member is designed to be temporarily embedded in tissue and then recovered (removed) when needed. The material properties allow it to maintain fixation during the implantation period while enabling clean removal without significant tissue damage or difficulty, fulfilling both permanent stability and easy retrieval requirements.

Inventive Principle:

Principle #34Discarding and recovering

3Reliability

If a fixation member is designed for secure positioning, then the device stability is improved, but the tissue trauma increases

Engineering Contradiction:

Improvedevice stabilityVSAvoidtissue trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The fixation member utilizes resilient and biostable polymeric materials that combine the properties of flexibility and structural integrity. This composite material approach allows the fixation member to securely position the medical device while being biocompatible and gentle on surrounding tissues, reducing trauma compared to traditional rigid materials.

Inventive Principle:

Principle #40Composite materials

Data Source

PatentUS7904179B2Implantable medical device system with fixation member

Publication Date: 2011.03.08 MEDTRONIC INC

AI summary

A fixation device for a subcutaneous implantable medical device includes a deformable tip portion that reduces in width when coupled with a fixation tool such that implantation of the implantable medical device through tissue is facilitated. Upon release from the fixation tool, the fixation device returns to its initial shape and stably secures the position of the implantable medical device.