Orthopedic Implant Insertion Using Insulating Restraining Block

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Solution Overview

Problem

Existing methods for constraining, protecting, insulating, and inserting orthopedic implants, particularly shape memory materials like nitinol, face challenges such as premature shape change due to operating room temperatures, difficulty in inserting without damaging, and improper positioning during surgical procedures, as existing solutions fail to provide adequate insulation, protection, and anatomical alignment.

Innovation Solution

A method and apparatus involving a restraining block with an impact surface and a base block that constrains and insulates the implant, allowing for easy insertion and anatomical positioning, using a medical instrument to engage and deform the block for secure attachment, preventing over-insertion and protecting the implant from damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If shape memory implants are held by forceps and exposed to air during surgery, then the implant can be easily manipulated, but the implant is susceptible to premature shape change from operating room temperatures

Engineering Contradiction:
Improvemanipulation easeVSAvoidshape stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent introduces an intermediary device (restraining block with insulating material) that mediates between the implant and the warm operating room environment. The insulating material acts as a thermal barrier, allowing the implant to be manipulated while preventing premature shape change by blocking heat transfer from the surrounding air.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If the implant is struck with a mallet to insert it into hard bone, then the implant can be inserted, but the implant can be deformed or its biocompatible surface finish damaged

Engineering Contradiction:
Improveinsertion capabilityVSAvoidsurface finish integrity
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The patent segments the implantation process into two distinct phases: (1) constrained insertion phase where the implant is held in a restraining block that protects it during initial placement, and (2) expansion phase where the implant is released to expand within the bone. This segmentation allows controlled insertion without direct mallet impact on the implant surface, preserving the biocompatible coating.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The restraining block serves as a protective cushion that absorbs impact forces during insertion. The block is designed to receive controlled impacts and transmit only the necessary force to advance the implant, while the cushioning material protects the implant's surface finish from direct damage.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Productivity

If an intramedullary implant with a bend or curve is subjected to linear impacting force, then the implant can be inserted, but the implant might be deformed or damaged

Engineering Contradiction:
Improveinsertion capabilityVSAvoidstructural integrity
Core Design Contradiction:
ProductivityVSStrength

Solution Approach 1:

The patent employs a dynamic restraining block that can deform elastically under impact forces. The block is designed with compliant features that allow it to flex and adapt to the curved shape of the implant during insertion, distributing forces evenly and preventing stress concentration that could damage the implant's structural integrity.

Inventive Principle:
Principle #15Dynamics

4Ease of operation

If the implant is placed into one bone first, then it can be inserted sequentially, but it can be dislodged and moved out of position by inserting into a second bone

Engineering Contradiction:
Improvesequential insertionVSAvoidpositioning accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent merges the positioning and insertion functions into a single integrated process. The restraining block maintains precise anatomical positioning of the implant while it is being inserted into the first bone, and this positioning is maintained throughout the insertion into the second bone. The block acts as a stable reference frame that prevents dislodgement and ensures accurate final positioning.

Inventive Principle:
Principle #5Merging (Combining)

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 constrains, insulates, and positions orthopedic implants, preventing premature shape change and damage during insertion, ensuring accurate anatomical placement and secure fixation of bones during orthopedic procedures.

Implementation Method 1

Implants made from shape memory materials, such as nitinol, are particularly suited for this approach because they can be inserted into the two bones, expand upon warming by the body, and thus fixate bones to one another.

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS9775659B2Method and system for storing and inserting an implant
Publication Date: 2017.10.03 BIOMEDICAL ENTERPRISES INC
  • US9775659B2 patent drawing
  • US9775659B2 patent drawing
  • US9775659B2 patent drawing

AI summary

An implant storage and insertion system for a shape memory orthopedic implant allows the implant to be constrained in a deformed state, protected, insulated, held for insertion, and properly positioned in bone. The implant storage and insertion system includes a restraining block having an impact surface. The restraining block engages an implant at a first end, and further a medical instrument engages the restraining block and positions the restraining block at a bone such that the impact surface may be impacted to insert a second end of the implant into the bone.