Staple Cartridge Deformable Feature Tissue Retention
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Solution Overview
Problem
Existing surgical stapling instruments face challenges in ensuring a leak-proof anastomosis during end-to-end anastomosis procedures, particularly due to the formation of flap regions that can compromise the integrity of the anastomosis over time.
Innovation Solution
The development of alternative staple cartridges with features such as malleable elements, elastic buttresses, and shape memory characteristics that are integrated into the staple cartridges to ensure that all staples and tissue are positioned within the cutting line of the circular stapler, preventing flap regions and ensuring a secure, leak-proof anastomosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional staple cartridges are used without additional retention features, then the stapling operation is simpler, but flap regions form that compromise anastomosis integrity over time
Solution Approach 1:
The staple cartridge is segmented into distinct functional zones: a deformable feature (such as a malleable element or elastic buttress) that engages outer portions of tissue, and a staple deployment mechanism that secures inner portions. This segmentation allows the deformable feature to prevent flap region formation while the staple mechanism provides secure attachment, resolving the contradiction between reliability and complexity.
Solution Approach 2:
The deformable feature is positioned and configured in advance within the staple cartridge to engage and retain outer portions of the tissue before stapling occurs. This preliminary action prevents the formation of flap regions that would otherwise compromise anastomosis integrity over time, while maintaining a relatively simple overall cartridge structure.
2Reliability
If all tissue is positioned within the cutting line using deformable features, then leak-proof anastomosis is achieved, but the staple cartridge manufacturing becomes more complex
Solution Approach 1:
The deformable feature utilizes changes in material properties (such as elasticity or malleability) to achieve tissue retention. By selecting materials with appropriate mechanical parameters, the feature can be formed using standard manufacturing processes, balancing the need for complex functionality with ease of manufacture.
Solution Approach 2:
The deformable feature is constructed as a flexible element (such as an elastic buttress or malleable barrier) that can be integrated into the staple cartridge using conventional fabrication techniques. This flexible structure effectively positions tissue within the cutting line to prevent leaks while maintaining manufacturing simplicity.
3Reliability
If malleable elements are added to retain tissue, then flap regions are prevented, but the device complexity increases
Solution Approach 1:
The malleable element is merged with the staple cartridge structure as an integrated component rather than a separate attachment. This combining of functions reduces the number of discrete parts and simplifies the overall device complexity while maintaining the reliability benefits of flap region prevention.
Solution Approach 2:
The malleable element serves multiple functions: it retains outer portions of tissue, prevents flap region formation, and works in conjunction with the staple mechanism to ensure secure attachment. This multi-functionality reduces the need for additional components, thereby limiting the increase in device complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The proposed solution effectively prevents the formation of flap regions, ensuring that all staples are positioned radially inward of the cut line, thereby maintaining the integrity of the anastomosis and preventing leaks, even in the long term.
Implementation Method 1
a deformable feature, wherein the deformable feature is configured to be coupled to tissue in response to actuation of the staple cartridge, wherein the deformable feature is configured to retain at least one outer portion of stapled tissue
Implementation Method 2
shape memory characteristics that are integrated into the staple cartridges to ensure that all staples and tissue are positioned within the cutting line
Data Source
AI summary
An apparatus includes a staple cartridge including a plurality of staples and a deck defining a plurality of openings. Each opening of the plurality of openings is associated with a corresponding staple of the plurality of staples, such that each staple is configured to pass through a corresponding opening of the plurality of openings. The apparatus further includes a deformable feature configured to be coupled to tissue in response to actuation of the staple cartridge. The deformable feature is configured to retain at least one outer portion of stapled tissue in an inwardly directed position relative to an inner portion of stapled tissue.