Intramedullary Fixation Device for Hammertoe Correction

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Solution Overview

Problem

Current surgical methods for hammertoe correction, such as using K-wires, often result in non-unions, migration, and pin tract infections due to inadequate fixation and stability, particularly in the phalanges of the toes.

Innovation Solution

A surgical technique involving an intramedullary fixation device with a smaller diameter head (less than 2.5 mm) that anchors in subchondral bone, providing increased pull-out resistance and stability by spanning multiple joints, and a method for intraoperative trimming to accommodate varying intramedullary canal sizes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If K-wire fixation is used for hammertoe correction, then the procedure is simple and easy to perform, but fixation stability is insufficient leading to non-unions, migration, and pin tract infections

Engineering Contradiction:
Improveease of surgical procedureVSAvoidfixation stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The fixation device is segmented into multiple functional zones: a first head portion for anchoring in subchondral bone, a body portion for intramedullary placement, and a second head portion for distal anchoring. This segmentation allows each portion to perform its specific function optimally, providing stable fixation while maintaining surgical simplicity

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The fixation device transitions from conventional two-dimensional cortical bone fixation to three-dimensional intramedullary canal anchoring with subchondral bone engagement. By utilizing the intramedullary space and anchoring in the dense subchondral bone, the device achieves superior fixation stability while remaining easy to implant

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Strength

If a larger diameter fixation device is used to increase pull-out resistance, then fixation strength is improved, but the device cannot pass through narrower intramedullary canals

Engineering Contradiction:
Improvepull-out resistanceVSAvoidadaptability to canal size variation
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The fixation device features a tapered geometry with a smaller diameter body portion that passes through the intramedullary canal and a larger diameter first head portion that anchors in the dense subchondral bone. This local quality variation allows the device to navigate narrow canals while achieving superior pull-out resistance through strategic anchoring in the stronger subchondral bone

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The device utilizes the parameter change in bone density from cancellous to subchondral bone to achieve fixation. By anchoring the first head portion in the denser subchondral bone, the device achieves high pull-out resistance without requiring a uniformly large diameter throughout its length, thus maintaining adaptability to various canal sizes

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If fixation device anchors only in cancellous bone, then insertion is easier, but pull-out resistance is insufficient leading to migration

Engineering Contradiction:
Improveease of insertionVSAvoidpull-out resistance
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The surgical technique involves preliminary preparation of the intramedullary canal to receive the fixation device, followed by strategic positioning of the first head portion into the subchondral bone. This preliminary action ensures proper alignment and facilitates easy insertion while achieving the goal of strong anchoring in subchondral bone to prevent migration

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS9717543B2Methods and implants for treating hammertoe and other deformities
Publication Date: 2017.08.01 ARROWHEAD MEDICAL DEVICES TECHNOLOGIES LLC
  • US9717543B2 patent drawing
  • US9717543B2 patent drawing
  • US9717543B2 patent drawing

AI summary

Surgical methods and fixation devices for bone fixation and stabilization on a patient include exposing at least a portion of a first phalanx and a second phalanx at a joint of a patient; creating a passage in an intramedullary canal of the first phalanx; inserting a first head portion of a fixation device along the passage in the intramedullary canal in a translating manner past the cancellous bone in the phalanx until the head portion engages the subchondral bone at a base of the first phalanx, the fixation device having an opposing second head portion extending out of the passage from the first phalanx; and introducing the second phalanx onto the second head portion so that the second head portion anchors in the second phalanx.