Sternal Closure System with Reinforcing Members

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Solution Overview

Problem

Existing methods for closing a dissected sternum after surgery are often painful, prone to complications, and difficult to reopen for subsequent procedures, as they can cause damage to the bone and require complex removal of fixation devices.

Innovation Solution

A system using first and second reinforcing members with holes and closure members to securely hold the sternum portions together, minimizing bone contact and allowing for easy re-entry, featuring adjustable lengths and curvature to fit the sternum's anatomy, and potentially biodegradable materials for reduced patient discomfort and easier subsequent surgeries.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If traditional sternum closure methods are used, then the sternum can be closed, but the patient experiences pain and complications, and re-entry is difficult

Engineering Contradiction:

Improveease of re-entryVSAvoidpatient pain and complications

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The closure system is divided into separate components: individual fasteners that can be independently applied to different locations along the sternum, and separate reinforcing members that can be positioned at specific sites. This segmentation allows for targeted closure without requiring complex overall restructuring, facilitating easier re-entry while reducing patient discomfort.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Reinforcing members serve as intermediary elements between the fasteners and the sternum bone. These intermediaries distribute the mechanical stress from the closure fasteners across a broader area, preventing direct concentration of force on the bone that would cause pain and complications, while still achieving effective closure.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Strength

If traditional fixation devices are used, then the sternum portions can be held together, but the devices cause damage to the bone and require complex removal

Engineering Contradiction:

Improveclosure strengthVSAvoidease of removal

Core Design Contradiction:

StrengthVSEase of manufacture

Solution Approach 1:

The fasteners are designed as temporary, disposable components that serve their closure function during healing and then can be easily removed or allowed to degrade. This eliminates the need for complex removal procedures while maintaining sufficient strength during the critical healing period, and reduces long-term complications from permanent implant removal.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The system utilizes biodegradable materials whose mechanical properties change over time - providing high strength initially for closure and bone healing, then gradually degrading to facilitate easy removal without surgical intervention. This parameter change allows the same component to satisfy both strength and ease of removal requirements at different time points.

Inventive Principle:

Principle #35Parameter changes

3Reliability

If reinforcing members are added to the closure system, then the risk of sternal dehiscence is reduced, but the device complexity increases

Engineering Contradiction:

Improverisk of sternal dehiscenceVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

Reinforcing members are applied locally at specific high-risk areas of the sternum rather than requiring complete circumferential reinforcement. This localized approach provides sufficient protection against dehiscence at critical sites while minimizing the overall number of components and reducing device complexity.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The reinforcing members are integrated with the fastener system such that they work together as a unified closure mechanism. The fasteners provide the closing force while the reinforcing members distribute and amplify this force, creating a synergistic effect that enhances reliability without requiring separate independent systems.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS8992530B2Method and system for longitudinal closure of dissected sternums

Publication Date: 2015.03.31 CHARLOTTE MECKLENBURG HOSPITAL AUTHORITY

AI summary

Systems, devices, and methods for longitudinal closure of a dissected sternum are provided. The system includes first and second reinforcing members, fasteners, and closure members. Each reinforcing member is configured to be placed on an outer surface of a respective sternum portion, such that each reinforcing member is longitudinally disposed on an opposite side of a sternum opening with respect to the other reinforcing member. Fasteners may be placed in holes defined in the reinforcing members to secure a respective reinforcing member to a corresponding sternum portion. The closure members, which may be sternal closing wires, may then be wrapped around the sternum portions and the reinforcing members transversely to close the sternum opening. The system provides for a low installed profile, enhancing patient comfort and facilitating healing, and also provides for quick and easy access to the thoracic cavity for re-do sternotomies, if needed.