Expandable Tissue Thickness Compensator for Surgical Staplers
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Solution Overview
Problem
Current surgical stapling devices face challenges in effectively compensating for varying tissue thicknesses, which can lead to inconsistent staple formation and reduced efficacy in tissue closure.
Innovation Solution
The development of a surgical stapler with an adjustable anvil and a compressible tissue thickness compensator, which aligns staples within a staple cartridge to accommodate different tissue thicknesses, ensuring consistent staple formation and improved tissue closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed anvil is used in surgical stapling devices, then the device structure is simple, but it cannot accommodate varying tissue thicknesses leading to inconsistent staple formation
Solution Approach 1:
The anvil is made adjustable with multiple position settings that allow it to move closer to or farther from the staple cartridge. This dynamic adjustment capability enables the anvil to accommodate varying tissue thicknesses while maintaining consistent staple formation, resolving the contradiction between adaptability and structural simplicity.
Solution Approach 2:
The anvil adjustment mechanism is segmented into discrete position settings, allowing selective positioning based on tissue thickness requirements. This segmentation provides adaptability for different surgical scenarios while keeping the adjustment mechanism relatively simple and manageable.
2Manufacturing precision
If tissue thickness compensation is not implemented, then the device structure remains simple, but staple formation consistency deteriorates across different tissue thicknesses
Solution Approach 1:
A compressible tissue thickness compensator is introduced as an intermediary element between the anvil and the tissue. This compensator absorbs thickness variations through compression, ensuring consistent staple formation across different tissue thicknesses while adding minimal structural complexity to the overall device.
Solution Approach 2:
The compensator material properties are designed to change under compression, allowing it to adapt to different tissue thicknesses. This parameter change approach enables consistent staple formation without requiring complex mechanical adjustment mechanisms.
3Adaptability or versatility
If the anvil is positioned far from the tissue to accommodate thick tissue, then thick tissue can be stapled, but staple formation quality deteriorates for thin tissue
Solution Approach 1:
The adjustable anvil allows dynamic repositioning based on actual tissue thickness encountered during surgery. For thin tissue, the anvil can be positioned closer to maintain optimal staple formation quality, while for thick tissue it can be positioned farther away, thus resolving the contradiction between adaptability and staple quality.
Solution Approach 2:
The anvil position can be locally optimized for each specific tissue thickness scenario. This local quality adjustment ensures that staple formation conditions are optimized for the specific tissue being stapled, whether thin or thick, thereby maintaining high staple quality across different tissue types.
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 solution enables consistent staple formation across varying tissue thicknesses, enhancing the efficacy of tissue closure and reducing the risk of tissue damage or incomplete sealing.
Implementation Method 1
a compressible tissue thickness compensator, which aligns staples within a staple cartridge to accommodate different tissue thicknesses
Implementation Method 2
The patch may be coated and/or impregnated with materials, such as, precursors, that will form a hydrogel in situ. These hydrogels may further promote hemostasis and/or assist in adhering the patch to tissue.
Data Source
Figure 1
Figure 1A
Figure 1B~1E
AI summary
A tissue thickness compensator (70010, 70130, 70150, 70182) may generally comprise a biocompatible material, a first component (70010A), and a second component (70010B), wherein the first component and second component form a reaction product to expand the tissue thickness compensator. The first component may comprise a first hydrogel precursor, the second component may comprise a second hydrogel precursor, and the reaction product may comprise a hydrogel. The reaction product may be formed in vivo and/or in situ by contacting the first component and the second component. The first component and/or second component may be encapsulated and configured to release the components when rupturcd. The reaction product may comprise a fluid-swcllablc composition. Articles of manufacture comprising the tissue thickness compensator and methods of making and using the tissue thickness compensator are also described.