Sternal Osteotomy Guide and Fixation System

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Solution Overview

Problem

Sternal dehiscence and deep sternal wound infection (DSWI) complications following cardiac surgery are significant due to poor wound healing and surgery-related factors, with no effective solutions addressing asymmetric osteotomy or providing improved treatment procedures and apparatus for sternal fixation.

Innovation Solution

A sternal osteotomy guide and fixation system comprising non-bioresorbable intra-sternal shims, tie members with gear racks, and ratcheting brackets, along with a ratchet gun, to provide anteroposterior stability and distribute pressure, reducing the risk of DSWI by allowing for uniform and efficient closure of the sternum.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional wire cerclage closure is used, then the surgical procedure is simple and quick, but sternal stability is insufficient leading to dehiscence and infection in high-risk patients

Engineering Contradiction:
Improvesternal stabilityVSAvoidfixation system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The fixation system is segmented into multiple functional components: intra-sternal shims for anterior stabilization, tie members for compression, and brackets for posterior fixation. This segmentation allows each component to address specific stability requirements while maintaining overall system manageability during surgery.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Intra-sternal shims serve as intermediary elements placed within the sternum to provide anterior stabilization and distribute forces. These shims act as mediators between the tie members and the sternal halves, enabling reliable fixation without requiring complex external hardware.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If asymmetric osteotomy is performed without a guide, then the surgical procedure is faster and simpler, but manufacturing precision and symmetry of the osteotomy are compromised

Engineering Contradiction:
Improveosteotomy symmetryVSAvoidcutting guide complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The cutting guide is designed as a universal device that can be applied to various sternum sizes and patient anatomies. It provides multiple functions: establishing midline alignment, guiding symmetric osteotomy cuts, and ensuring proper positioning of fixation hardware, thereby achieving manufacturing precision without proportionally increasing complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Manufacturing precision

If prolonged surgery time is spent on manual tightening, then uniform compression can be achieved, but productivity and surgical efficiency are reduced

Engineering Contradiction:
Improvecompression uniformityVSAvoidsurgical efficiency
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The ratchet mechanism on the brackets provides self-service functionality by automatically maintaining uniform compression forces once the tie members are tightened. The ratchet prevents backsliding and ensures consistent force distribution across the sternal halves, eliminating the need for prolonged manual adjustment while maintaining compression uniformity.

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS10179011B2Sternal osteotomy guide and sternal fixation system
Publication Date: 2019.01.15 MONTEFIORE MEDICAL CENT INC
  • US10179011B2 patent drawing
  • US10179011B2 patent drawing
  • US10179011B2 patent drawing

AI summary

Systems and methods are described for a sternal osteotomy guide and sternal fixation system.