Ligament Fixation Implant with Compression Cap and Breakaway Anchor

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Solution Overview

Problem

Current methods for ligament fixation in syndesmotic injuries, such as rigid screw fixation and tether-based constraints, either restrict joint motion or compromise structural strength, leading to inadequate healing and potential bone damage.

Innovation Solution

A ligament fixation system comprising an implant with a compression cap, an anchor member, and a breakaway portion that allows for temporary rigid fixation followed by physiologic motion, enabling controlled compression and eventual separation to facilitate healing without damaging native bone.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If rigid screw fixation is used, then stability and simplicity of implantation are improved, but joint motion is completely restricted and unpredictable screw failure can damage bone

Engineering Contradiction:

Improvefixation stabilityVSAvoidjoint motion range

Core Design Contradiction:

Stability of the object's compositionVSEase of operation

Solution Approach 1:

The implant transitions from a static rigid screw to a dynamic system with a breakaway portion that allows controlled motion. The breakaway portion initially provides rigid stabilization during healing, then fails in a controlled manner to allow physiologic joint motion, resolving the contradiction between stability and motion range.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The implant is divided into distinct segments including a breakaway portion, end members, and an anchor member. This segmentation allows the breakaway portion to fail independently while leaving the anchor member intact in the bone, providing controlled failure mode that prevents bone damage while allowing motion.

Inventive Principle:

Principle #1Segmentation

2Ease of operation

If tethered constraints spanning the entire width of the ankle are used, then joint motion is allowed, but structural strength decreases due to drilling holes that remain unfilled

Engineering Contradiction:

Improvejoint motion rangeVSAvoidstructural strength

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The implant is inserted through a pilot hole that is subsequently filled by the anchor member and end members. This preliminary action of creating the hole followed by filling it with structural material maintains bone integrity and structural strength while still allowing the tether to permit joint motion.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The implant combines different materials and structures - the tether portion allows motion while the anchor member and end members provide rigid structural support in the bone. This composite approach allows simultaneous achievement of motion capability and structural strength.

Inventive Principle:

Principle #40Composite materials

3Reliability

If rigid fixation is used to stabilize the joint, then healing is supported, but the patient's range of motion is limited and screw failure can cause bone damage

Engineering Contradiction:

Improvehealing supportVSAvoidbone damage risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The implant's mechanical properties change over time through controlled failure of the breakaway portion. Initially, the breakaway portion provides rigid fixation with high stability for healing. After healing, the breakaway fails and the implant transitions to a more flexible configuration, changing the mechanical parameters to allow motion and reduce bone damage risk.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The breakaway portion is designed as a temporary, sacrificial element that is intentionally made to fail after serving its purpose during healing. This disposable component protects the permanent anchor member and bone from damage by absorbing excessive forces and failing in a controlled manner.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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 system provides stable fixation for healing while allowing physiologic motion post-healing, reducing the risk of bone damage and improving structural strength by mimicking natural ligament structures.

Implementation Method 1

inserting the cap member over the end member to compress the first bone and the second bone

Methodology Applied

Scientific EffectCompression: Compression

Data Source

PatentUS20240050138A1Ligament fixation system, implants, and devices with a compression cap, and methods of use

Publication Date: 2024.02.15 PARAGON 28 INC

AI summary

Implants, devices, systems, and methods for achieving ligament fixation are disclosed. An implant comprises a cap member comprising an internally threaded opening extending from a first end thereof, an anchor portion comprising a first end that defines a tip of the implant and external threads, and a coupling portion extending between the cap member and the anchor portion. The coupling portion of the implant includes an externally threaded portion threadably coupled within the internally threaded opening of the cap member. The cap member of the implant is longitudinally moveable along the coupling portion. Insertion instruments for inserting an implant for ligament fixation are also disclosed. Methods of using an implant for achieving ligament fixation are also disclosed.