Transdermal Intraosseous Device with Roughness Gradient

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Solution Overview

Problem

Existing external fixation devices for amputation or trauma face challenges with infection at the interface between prosthetic devices and soft tissue, as they often attach to soft tissue rather than bone, leading to potential bone resorption and complications.

Innovation Solution

A transdermal intraosseous device with a transdermal adapter and bone fixator featuring a porous metal dome-shaped structure and controlled roughness gradient surface treatments to enhance dermal tissue adhesion and prevent infection, utilizing a dermal transition structure with blasting and acid-etching treatments for improved contact with the dermis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a metal portion extends beyond the cut surface of the bone for soft tissue attachment, then the prosthetic device can be supported, but the interface between the prosthetic device and soft tissue becomes a source of infection

Engineering Contradiction:
Improveprosthetic device supportVSAvoidinfection risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent applies porous metal coating on the bone fixator surface to promote osseointegration. The porous structure allows bone ingrowth and creates a biological bond between the implant and bone, eliminating the need for soft tissue attachment to metal surfaces and thereby reducing infection risk at the prosthetic-soft tissue interface

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The patent changes the surface properties of the bone fixator by controlling roughness parameters through blasting and acid-etching treatments. These surface modifications enhance dermal tissue adhesion and promote epithelial migration away from the implant surface, preventing epithelial downgrowth and reducing infection susceptibility

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If the fixation device attaches to soft tissue rather than bone, then the prosthetic device can be supported, but bone resorption occurs over time

Engineering Contradiction:
Improveprosthetic device supportVSAvoidbone strength
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The porous metal coating promotes direct bone-to-implant contact and osseointegration, transferring mechanical loads from the prosthetic device to the bone through a biological bond. This eliminates the soft tissue attachment mechanism that causes bone resorption and maintains long-term bone strength

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The patent uses composite surface treatments combining porous metal coating with controlled roughness gradients (blasting and acid-etching) to create a multi-functional interface that simultaneously promotes osseointegration and dermal tissue adhesion, preventing both bone resorption and epithelial downgrowth

Inventive Principle:
Principle #40Composite materials

3Ease of manufacture

If a smooth surface is used for the transdermal adapter, then manufacturing is easier, but dermal tissue adhesion is insufficient and infection risk increases

Engineering Contradiction:
Improveadapter manufacturingVSAvoiddermal tissue adhesion
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent systematically modifies surface roughness parameters through controlled blasting and acid-etching treatments to create an optimal roughness gradient. This gradient promotes dermal tissue adhesion and epithelial migration while remaining manufacturable, balancing production simplicity with biological performance

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies different surface treatments to different regions of the transdermal adapter: the dermal transition structure has controlled roughness gradients for tissue adhesion, while other areas maintain smoother surfaces for ease of manufacture. The porous metal coating is applied selectively to the bone fixator surface where osseointegration is needed

Inventive Principle:
Principle #3Local quality

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 solution effectively reduces the risk of infection by promoting dermal tissue adhesion and preventing epithelial downgrowth, while allowing for stable anchoring and osseointegration, thereby reducing bone loss and enhancing prosthetic device stability.

Implementation Method 1

A dermal transition structure is configured to include a controlled roughness gradient from the external shaft to the dome-shaped portion and configured for use in infection control at a dermis layer of the patient

Methodology Applied
Scientific EffectSurface roughness gradient:

Implementation Method 2

The first transitional surface treatment layer is roughened by blasting for contact with the dermis

Methodology Applied
Scientific EffectBlasting treatment:

Implementation Method 3

The second transitional surface treatment layer is roughened by a combination of blasting treatment and acid-etching treatment for contact with the dermis

Methodology Applied
Scientific EffectAcid etching:

Implementation Method 4

The dermal transition structure includes a porous metal dome-shaped structure surrounding and overlaying the dome-shaped portion of the transdermal adapter

Methodology Applied
Scientific EffectPorous metal structure: Porosity

Implementation Method 5

configured to include a controlled roughness gradient from the external shaft to the dome-shaped portion and configured for use in infection control at a dermis layer of the patient

Methodology Applied
Scientific EffectRoughness gradient:

Data Source

PatentUS10166125B2Transdermal intraosseous device
Publication Date: 2019.01.01 BIOMET MFG LLC
  • US10166125B2 patent drawing
  • US10166125B2 patent drawing
  • US10166125B2 patent drawing

AI summary

A transdermal intraosseous device includes a transdermal adapter for an external prosthetic device for a bone of a patient and a bone fixator including a distal portion coupled to the transdermal adapter and a proximal portion for anchoring into the bone. The transdermal adapter includes a dome-shaped portion for transcutaneous implantation and an external shaft extending from the dome-shaped portion. A dermal transition structure is configured to include a controlled roughness gradient from the external shaft to the dome-shaped portion and configured for use in infection control at a dermis layer of the patient.