Contained Morcellation Guard for Safe Tissue Removal
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Solution Overview
Problem
Existing surgical methods for removing large tissue specimens through small incisions or body orifices, such as during hysterectomies or myomectomies, risk spreading malignant tissue and increasing patient mortality due to the use of open morcellation, which is now discouraged by the FDA.
Innovation Solution
A system comprising a containment bag and guard that allows for safe and controlled morcellation within a closed system, using a guard to protect the bag and surrounding tissue from accidental incisions and a cap to maintain pneumoperitoneum, enabling the specimen to be morcellated and removed in a controlled environment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If open morcellation is used to reduce tissue size for removal through small incisions, then the specimen can be removed through minimal access, but malignant tissue may spread and patient mortality increases
Solution Approach 1:
A containment bag is introduced as an intermediary device between the morcellator blade and the surrounding tissue environment. The bag captures all morcellated tissue pieces during the cutting process, preventing malignant cells from dispersing into the abdominal cavity while still allowing the morcellation procedure to proceed through a small incision.
Solution Approach 2:
The containment bag is constructed from flexible, puncture-resistant material that can withstand the morcellation process. The bag's flexible nature allows it to be inserted through a small incision, expanded to contain the specimen, and manipulated during the procedure while maintaining containment of tissue pieces.
2Reliability
If a containment bag is used to prevent tissue spread during morcellation, then patient safety is improved, but the device complexity increases
Solution Approach 1:
The guard and cap are merged with the containment bag system to create an integrated solution. The guard attaches to the morcellator and the cap seals the bag opening, forming a cohesive system that maintains pneumoperitoneum while preventing tissue escape, thereby managing complexity through functional integration.
Solution Approach 2:
The harmful function of tissue dispersion is extracted and isolated by placing it within the containment bag. The bag separates the morcellation process from the surrounding surgical environment, containing only the necessary elements (specimen, blade, and captured tissue) while excluding the risk of malignant cell spread.
3Reliability
If a guard is used to protect the containment bag from accidental incisions, then tissue containment integrity is maintained, but the device complexity increases
Solution Approach 1:
The guard serves as a protective barrier positioned between the morcellator blade and the containment bag. It provides beforehand protection against accidental incisions or punctures that could compromise the containment system, ensuring the bag's integrity is maintained throughout the procedure.
4Reliability
If a cap is used to maintain pneumoperitoneum during morcellation, then surgical conditions are improved, but the device complexity increases
Solution Approach 1:
The cap extracts and seals the opening of the containment bag, creating a closed system that maintains pneumoperitoneum. By sealing the bag opening, the cap prevents gas escape and maintains the inflated state necessary for proper surgical visualization and working conditions.
Data Source
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AI summary
Systems and methods for preventing the seeding of cancerous cells during morcellation of a tissue specimen inside a patient's body and removal of the tissue specimen from inside the patient through a minimally-invasive body opening to outside the patient are provided. One system includes a cut-resistant tissue guard removably insertable into a containment bag. The tissue specimen is isolated and contained within the containment bag and the guard is configured to protect the containment bag and surrounding tissue from incidental contact with sharp instrumentation used during morcellation and extraction of the tissue specimen. The guard is adjustable for easy insertion and removal and configured to securely anchor to the body opening. Protection-focused and containment-based systems for tissue removal are provided that enable minimally invasive procedures to be performed safely and efficiently.