Dynamic Ligament Fixation Implant with Bioresorbable Coupling

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Solution Overview

Problem

Current methods for syndesmotic injuries, such as rigid screw fixation and tether-based constraints, either restrict joint motion or compromise structural strength, failing to adequately mimic the natural ligament structures and leading to potential bone damage and patient pain.

Innovation Solution

A ligament fixation system comprising an implant with a head member, an anchor member, and a tension member, along with an insertion instrument, allowing for dynamic fixation that mimics the natural ligament structures while enabling motion between the tibia and fibula, using a bioresorbable coupling that transitions from rigid to semi-constrained fixation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If rigid screw fixation is used, then stability and ease of implantation are improved, but joint motion is restricted and risk of bone damage increases

Engineering Contradiction:

Improvefixation stabilityVSAvoidjoint motion

Core Design Contradiction:

Stability of the object's compositionVSEase of operation

Solution Approach 1:

The implant system transitions from rigid screw fixation to dynamic semi-constrained fixation using a tension member and button construct that allows physiologic joint motion while maintaining stability. The system evolves from initial rigid stabilization during healing to gradual restoration of natural joint dynamics.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The fixation system changes the rigidity parameter over time, starting with rigid stabilization and transitioning to semi-constrained motion control. The tension member and button configuration allows the system to adapt its mechanical properties as healing progresses.

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If tether-based constraints are used, then joint motion is allowed, but structural strength is compromised due to unfilled drill holes

Engineering Contradiction:

Improvejoint motionVSAvoidstructural strength

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The tension member acts as an intermediary element that spans the syndesmotic space, providing structural strength while allowing motion. The button construct serves as a mediator that distributes loads and prevents the structural weaknesses associated with traditional drill hole methods.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The implant system combines different material properties and structural configurations - the tension member provides flexible strength while the button construct provides rigid anchorage points, creating a composite fixation system that balances strength and motion capabilities.

Inventive Principle:

Principle #40Composite materials

3Ease of operation

If tethered constraints spanning entire ankle width are used, then joint motion is permitted, but attachment location and distance between tibia and fibula do not mimic intact ligament structures

Engineering Contradiction:

Improvejoint motionVSAvoidanatomical mimicry

Core Design Contradiction:

Ease of operationVSAdaptability or versatility

Solution Approach 1:

The implant system applies fixation locally at the syndesmotic ligament attachment sites rather than spanning the entire ankle width. The button construct is positioned to replicate the specific anatomical location and functional characteristics of the intact syndesmotic ligament.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The implant system replicates the functional characteristics and anatomical positioning of the intact syndesmotic ligament, copying its attachment locations and mechanical behavior to restore natural joint function rather than using a generic spanning construct.

Inventive Principle:

Principle #26Copying

4Ease of manufacture

If rigid screw fixation is used, then simplicity of implantation is achieved, but unpredictable screw failure locations cause bone damage and patient pain

Engineering Contradiction:

Improveimplantation simplicityVSAvoidfixation reliability

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The tension member and button construct serve as intermediary elements that distribute mechanical loads more evenly across the fixation site, reducing stress concentrations that lead to unpredictable screw failures and associated bone damage.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS20250099225A1Ligament fixation system, implants, devices, and methods of use

Publication Date: 2025.03.27 PARAGON 28 INC

AI summary

Devices, systems, implants and methods for achieving ligament fixation are disclosed. An implant includes a head member and an anchor member coupled to the head member. The implant includes tension member that couples the head member to the anchor member. The head member and the anchor member include a cannulation that receives the tension member therein. The implant may include a coupling member positioned between and coupling the head member and the anchor member, the coupling member including a cannulation that receives the tension member therethrough. Insertion instruments for inserting an implant for ligament fixation are also disclosed. Methods of using an implant for achieving ligament fixation are also disclosed.