Cut-Resistant Mesh Guard for Contained Tissue Removal
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Solution Overview
Problem
Existing tissue removal methods, particularly morcellation, risk spreading malignant tissue during procedures like hysterectomies and myomectomies, posing a significant threat to patient safety due to the dispersion of tumor cells.
Innovation Solution
A cut-resistant mesh guard with a tubular shape and flanges at both ends is used to create a protected pathway through body openings, anchoring at the tissue margins and guiding tissue extraction while preventing damage to surrounding tissues and containment systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If morcellation is performed to reduce tissue size for removal through small incisions, then the tissue can be removed through the incision, but malignant tissue may be spread and cancer upstaged
Solution Approach 1:
A containment bag is introduced as an intermediary device between the morcellation process and the surrounding environment. The bag encapsulates the tissue during cutting and removal, preventing tumor cells from dispersing into the abdominal cavity while still allowing the surgeon to perform morcellation and extract tissue through the small incision.
Solution Approach 2:
The containment bag is deployed before the morcellation process begins, creating a protective barrier in advance. This preliminary protective action prevents the harmful effect of tumor cell dispersion before it can occur during the tissue reduction and extraction process.
2Ease of operation
If the targeted tissue is too large to be removed in whole through the small incision, then morcellation is performed to reduce size, but pieces of tissue may be cut off and left behind in the patient
Solution Approach 1:
The containment bag acts as a mediator that collects all tissue pieces during morcellation and extraction. Even small fragments cut during the reduction process are captured within the bag, ensuring complete tissue removal and preventing any pieces from being left behind in the patient's body cavity.
3Productivity
If open power morcellation is used without a bag, then the procedure is simpler and faster, but errant pieces may disperse and seed tumor cells
Solution Approach 1:
The containment bag is positioned at the incision site to capture all tissue fragments during rapid morcellation. This allows the surgeon to perform open power morcellation at full speed while the bag simultaneously prevents errant pieces from dispersing and seeding tumor cells in the abdominal cavity.
Solution Approach 2:
The containment bag is deployed beforehand to create a protective containment zone. This prior protective measure cushions against the harmful effect of tumor cell dispersion, allowing the surgeon to proceed with rapid open morcellation without fear of cell seeding.
4Reliability
If a containment bag is used during morcellation, then tumor cell dispersion is prevented, but the device complexity increases
Solution Approach 1:
The containment bag is constructed from a flexible, thin-walled material that is simple in design yet effective in function. This flexible shell approach provides reliable tumor cell containment while adding minimal complexity to the overall morcellation system, as the bag can be easily manipulated and positioned during the procedure.
Data Source
AI summary
A guard for providing a cut-resistant pathway through a body orifice or incision to circumferentially protect tissue at the margin is provided. The guard is made of flexible, cut-resistant mesh material having a plurality of interwoven thermosoftening filaments. The guard has a central lumen and at least one flared end. The flared end, which serves to anchor the guard in the body opening, is deformable into a reduced configuration to facilitate its insertion and removal. The layer of mesh stretches laterally to increase the diameter of the central lumen. The flexibility and expandability of the guard allows the guard to conform to body openings of different sizes. The guard may include a drawstring to cinch the flared distal end from the proximal end. The guard is thermoset with the flared distal end that is biased to spring back to its normal, undeformed configuration when released from a deformed configuration.