Multi-layer Tissue Thickness Compensator for Surgical Staplers
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Solution Overview
Problem
Existing surgical stapling instruments face challenges in achieving optimal tissue compression, leading to either excessive compression causing tissue ischemia or necrosis, or insufficient compression resulting in leakage and poor tissue joining, due to the difficulty in selecting the appropriate tissue thickness compensator.
Innovation Solution
A tissue thickness compensator comprising a resilient layer and a sacrificial collapsible layer with specific pressure-compression curves, where the sacrificial layer collapses at high compression to alleviate over-compression, and the resilient layer maintains optimal pressure for tissue healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single-layer tissue thickness compensator is used, then the device complexity is low, but the tissue compression consistency deteriorates due to inability to adapt to varying tissue thicknesses
Solution Approach 1:
The tissue thickness compensator is divided into multiple layers with different compression characteristics. The first layer (resilient layer) and second layer (collapsible layer) each contribute differently to the overall compression behavior, allowing the compensator to adapt to varying tissue thicknesses while maintaining consistent compression forces.
Solution Approach 2:
The compensator combines materials with different mechanical properties in a layered structure. The resilient layer provides elastic recovery while the collapsible layer provides permanent deformation capability, creating a composite structure that achieves both adaptability and compression consistency.
2Reliability
If excessive compression is applied to ensure sufficient tissue joining, then the tissue joining effectiveness is improved, but tissue damage occurs due to ischemia or necrosis
Solution Approach 1:
The compensator structure dynamically adapts its compression characteristics based on the applied load and tissue thickness. The transition from resilient to collapsible layer engagement allows the system to self-regulate compression forces, preventing excessive pressure that would cause tissue damage while ensuring sufficient compression for effective joining.
Solution Approach 2:
The compensator utilizes changes in material compression parameters across different layers. The first layer exhibits elastic parameter changes while the second layer exhibits plastic deformation, allowing the system to control compression forces within a safe and effective range for tissue joining.
3Object-affected harmful factors
If insufficient compression is applied to avoid tissue damage, then the tissue damage risk is reduced, but leakage and poor tissue joining occur
Solution Approach 1:
The layered structure segments the compression function into two stages: initial compression by the resilient layer ensures adequate force for tissue joining without excessive pressure, while the collapsible layer provides additional deformation capacity to adapt to thicker tissues, preventing both insufficient and excessive compression scenarios.
Solution Approach 2:
The resilient layer acts as a cushioning element that engages first during compression, providing controlled initial compression forces that are sufficient for tissue joining while protecting against excessive forces. This preliminary cushioning prevents the need for higher compression forces that would risk tissue damage.
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 multilayer tissue thickness compensator ensures consistent and optimal tissue compression, preventing excessive pressure that can cause tissue damage while ensuring sufficient joining and healing, thereby improving the effectiveness of surgical stapling.
Implementation Method 1
a resilient compensation layer (130) having a first pressure-compression curve
Implementation Method 2
a collapsible compensation layer (120) adjacent said resilient compensation layer, said collapsible compensation layer having a second pressure-compression curve
Data Source
Figure 1A~1C
Figure 2A~2G
Figure 3A~4
AI summary
A fastener cartridge assembly for stapling tissue includes a staple cartridge, fashioned to drive staples through tissue, a plurality of staples and a tissue thickness compensator assembly. The tissue thickness compensator is comprised of a sacrificial compressible layer and a resilient compressible layer. The sacrificial compressible layer is designed such that the resilient compressible layer compresses more easily at low pressures, but the sacrificial compressible layer compresses more easily at high pressures. The resilient compressible layer ensures that thin tissue is compressed when the staples are ejected into the tissue while the sacrificial compressible layer prevents over compression of the tissue. The tissue thickness compensator assembly can therefore be designed to provide a specific deflection-compression curve.