Modular Circular Stapler Anvil for Precise Staple Pocket Forming
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Solution Overview
Problem
Existing surgical stapling instruments face challenges in providing a secure and leak-proof anastomosis between sections of the digestive tract, particularly in maintaining precise alignment and deformation of staples for effective tissue sealing.
Innovation Solution
The design of a circular stapling instrument with a modular anvil system, where the anvil head and shank are formed using metal injection molding and subsequent machining processes, such as coining or electrochemical machining, to create staple forming pockets that deform staples consistently and securely, ensuring precise alignment and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional manufacturing methods are used for the anvil, then manufacturing simplicity is maintained, but manufacturing precision and consistency of staple forming pockets are insufficient
Solution Approach 1:
The anvil is divided into two separately manufactured components (head and shank) that are precision-machined and then coupled together. This segmentation allows each component to be manufactured with high precision using specialized processes (MIM for head, machining for shank) rather than attempting to manufacture the entire anvil as a single piece, thereby resolving the contradiction between manufacturing precision and ease of manufacture.
Solution Approach 2:
The head and shank are coupled together through precision machining and assembly to form a complete anvil assembly. This merging of separately manufactured high-precision components creates a final product that achieves superior manufacturing precision while maintaining reasonable ease of manufacture through modular construction.
2Reliability
If conventional anvil design is used, then device simplicity is maintained, but reliability of tissue sealing and leak-proof anastomosis is insufficient
Solution Approach 1:
The anvil is segmented into a head portion containing the staple forming pockets and a shank portion for structural support and coupling. This segmentation allows the critical sealing function to be concentrated in the precision-machined head with optimized staple forming pockets, while the shank provides structural integrity, thereby improving reliability without excessive complexity.
Solution Approach 2:
Different regions of the anvil are given different qualities and functions: the head is precision-machined with specific staple forming pocket geometries for reliable sealing, while the shank is designed for structural support and coupling. This local differentiation of quality and function improves sealing effectiveness while maintaining overall system manageability.
Data Source
AI summary
A method is used to manufacture an anvil of a surgical circular stapler. The anvil includes a head and a shank extending proximally from the head. The method includes forming the head of a surgical circular stapler using a metal injection molding process. The method also includes forming an annular array of staple forming pockets in the head. The method also includes machining the shank of the surgical circular stapler. The method also includes coupling together the head and the shank of the surgical circular stapler that were separately manufactured.