Twisted Anchoring Member Visibility in Implantable Medical Devices

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Solution Overview

Problem

Existing implantable medical devices, such as leadless pacemakers, face challenges in securely anchoring to cardiac tissue without damaging it, and visualizing the anchoring members during implantation is difficult due to their small dimensions and orientation-dependent visibility.

Innovation Solution

The implantable medical device features anchoring members formed as twisted flat strips with a twist angle, enhancing visibility through altered orientations and dimensions, and potentially incorporating radiopaque materials or coatings for improved visualization during procedures like tug tests.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If anchoring members are made small in dimension, then tissue damage is reduced, but visibility during implantation deteriorates

Engineering Contradiction:

Improvetissue damageVSAvoidvisibility of anchoring members

Core Design Contradiction:

Object-affected harmful factorsVSDifficulty of detecting and measuring

Solution Approach 1:

The anchoring members are made radiopaque so they appear bright white on fluoroscopic images, fundamentally changing their visual properties from invisible to highly visible. This allows small anchoring members to be tracked during implantation without increasing their physical size or tissue damage risk.

Inventive Principle:

Principle #32Color changes

Solution Approach 2:

The solution moves from optical visibility (human eye) to radiographic visibility (X-ray imaging). By making the anchoring members radiopaque, they become detectable in the fluoroscopic dimension, solving the visibility problem without affecting their small physical dimensions that minimize tissue damage.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

2Difficulty of detecting and measuring

If anchoring members are twisted to improve visibility, then visibility during implantation is improved, but manufacturing complexity increases

Engineering Contradiction:

Improvevisibility of anchoring membersVSAvoidmanufacturing complexity

Core Design Contradiction:

Difficulty of detecting and measuringVSDevice complexity

Solution Approach 1:

The flat strip is twisted by a specific twist angle (e.g., 90 degrees) to change its orientation and maximize visibility on fluoroscopic images. This parameter change in the geometry of the anchoring member provides consistent visual feedback during implantation while remaining manufacturable through standard forming processes.

Inventive Principle:

Principle #35Parameter changes

3Difficulty of detecting and measuring

If anchoring members are made radiopaque, then visibility during fluoroscopy is improved, but device complexity increases

Engineering Contradiction:

Improvevisibility during fluoroscopyVSAvoiddevice complexity

Core Design Contradiction:

Difficulty of detecting and measuringVSDevice complexity

Solution Approach 1:

The anchoring members are made from composite materials or materials with radiopaque properties (such as certain alloys or polymers with radiopaque fillers). This allows the anchoring members to be visible on fluoroscopic images while maintaining their mechanical functionality and anchoring performance.

Inventive Principle:

Principle #40Composite materials

Data Source

PatentUS11285331B2Implantable medical device comprising an anchoring device

Publication Date: 2022.03.29 BIOTRONIK SE & CO KG

AI summary

An implantable medical device includes a housing having a proximal end and a distal end. The implantable medical device is placeable on cardiac tissue in the region of the distal end. An anchoring device is fixedly attached to the housing in the region of the distal end. The anchoring device includes at least one anchoring member. The at least one anchoring member includes a first end and a second end opposite the first end. The second end is disposed on the housing. The at least one anchoring member longitudinally extends between the first end and the second end along an axis of extension and is formed by a flat strip which is twisted by a twist angle about the axis of extension between the first end and the second end. A method for manufacturing an implantable medical device is also provided.