Tissue Thickness Compensator for Surgical Stapler
Solution Overview
Problem
Existing surgical stapling instruments face challenges in effectively handling varying tissue thicknesses and ensuring consistent staple formation across different tissue types, particularly when thicker tissues are involved.
Innovation Solution
The development of a staple cartridge with integrated tissue thickness compensators and a surgical stapler designed to accommodate varying tissue thicknesses, featuring components such as collapsible and compressible structures, protective layers, and alignment matrices to ensure proper staple deployment and formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a standard surgical stapler is used, then the device structure remains simple, but it cannot effectively handle varying tissue thicknesses and ensure consistent staple formation
Solution Approach 1:
The patent applies parameter changes by incorporating a compressible tissue thickness compensator that can be compressed to different degrees depending on tissue thickness. This allows the stapler to adapt its compression force and staple formation parameters dynamically, ensuring consistent staple formation across varying tissue thicknesses without requiring multiple different stapler designs.
Solution Approach 2:
The patent implements dynamics through the compressible tissue thickness compensator that can dynamically adjust its compression level during the stapling process. The compensator transitions from an uncompressed state to a compressed state, allowing the device to adapt to different tissue thicknesses in real-time, thereby maintaining staple formation consistency while handling variable tissue conditions.
2Reliability
If tissue thickness compensators are integrated into the staple cartridge, then consistent staple formation across varying tissue thicknesses is achieved, but the device complexity increases
Solution Approach 1:
The patent applies universality by designing the compressible tissue thickness compensator to serve multiple functions simultaneously: it compensates for varying tissue thicknesses, provides consistent compression force, supports the stapling process, and ensures reliable tissue capture. This multi-functional component improves reliability across different tissue types while adding only one integrated structure rather than multiple separate mechanisms.
3Manufacturing precision
If the staple cartridge includes collapsible and compressible structures, then proper staple deployment is ensured across different tissue types, but the manufacturing complexity increases
Solution Approach 1:
The patent applies flexible shells and thin films through the use of a compressible tissue thickness compensator made from flexible, compressible material. This allows the compensator to be molded into the required shape and integrated into the staple cartridge as a single piece or pre-assembled component, simplifying the manufacturing process compared to rigid, multi-part mechanisms while still providing the necessary compliance and compression capability for consistent staple deployment.
Data Source
Figure 1
Figure 1A
Figure 1B~1E
AI summary
A two-part tissue thickness compensator assembly can include a first tissue thickness compensator configured to be positioned relative to an anvil of a surgical stapler, a second tissue thickness compensator configured to be positioned relative to a staple cartridge of the surgical stapler, and a hinge connecting the first tissue thickness compensator to the second tissue thickness compensator. The first and/or second tissue thickness compensators may include additional engagement features, such as a raised ridge that engages a slot in the anvil and/or the staple cartridge. In certain embodiments, the first and/or second tissue thickness compensators may include an encasement that contains a suitable biologic agent. An end effector assembly may be provided for attachment to a surgical instrument that includes, for example, a staple cartridge, an anvil, a first tissue thickness compensator positioned on the anvil, and a second tissue thickness compensator positioned on the staple cartridge.