Sealed Stapling Reload Assembly for Reusable Adaptor Protection
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Solution Overview
Problem
Surgical stapling devices face challenges in preventing fluid ingress into reusable components during sterilization, making the process more difficult and time-consuming due to contaminants entering the adaptor assembly.
Innovation Solution
A sealed configuration in the reload assembly of the surgical stapling device, including a shell housing, staple cartridge, first seal, staple actuator, and knife carrier, which provides fluid seals to prevent contaminants from entering, allowing for easier cleaning and reuse of the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the adaptor assembly is designed to allow component exchange, then versatility and ease of operation are improved, but fluid ingress and contamination risk increase
Solution Approach 1:
The reload assembly is designed as a disposable component that is replaced rather than sterilized, eliminating the need for complex sterilization processes while maintaining component exchange capability. This resolves the contradiction by making the exchangeable component single-use, so fluid ingress during sterilization becomes irrelevant.
Solution Approach 2:
Seals are incorporated at the interface between the reload assembly and adaptor assembly to prevent fluid ingress while allowing for component exchange. The seals create a fluid barrier that maintains versatility without compromising contamination prevention.
2Reliability
If reusable components are designed for sterilization, then reliability is improved, but cleaning complexity and time consumption increase
Solution Approach 1:
The reload assembly is designed as a disposable component that is discarded after single use, eliminating the need for sterilization entirely. This resolves the contradiction by removing the sterilization requirement, thus eliminating time consumption while maintaining reliability through single-use sterility.
3Ease of manufacture
If the reload assembly is designed as disposable, then ease of manufacture and cleaning are improved, but device complexity increases
Solution Approach 1:
The stapling device is divided into reusable (adaptor assembly) and disposable (reload assembly) segments. This segmentation allows the disposable portion to be manufactured and cleaned simply, while the reusable portion maintains necessary complexity for controlled exchange, resolving the contradiction through functional separation.
Solution Approach 2:
The adaptor assembly is designed with universal interfaces that can accommodate different reload assemblies, allowing the complex reusable portion to serve multiple functions while the simple disposable portion maintains ease of manufacture. This multi-functionality resolves the contradiction by concentrating complexity where it is most beneficial.
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 sealed configuration effectively prevents fluid ingress, simplifying the cleaning process, reducing the reliance on clinicians for assembly and disassembly, and reducing the complexity and cost of the device while maintaining its functionality.
Implementation Method 1
The first seal is disposed within the cavity and defines a staple actuator opening and a knife carrier opening. The staple actuator includes a proximal leg extending proximally therefrom and through the staple actuator opening of the first seal to provide a fluid seal therebetween. The knife carrier includes a proximal body portion extending proximally therefrom and through the knife carrier opening of the first seal to provide a fluid seal therebetween.
Implementation Method 2
The reload assembly further includes a second seal operably coupled to an inner annular surface of the bushing such that a fluid seal is formed between the bushing and a trocar when a trocar is positioned therethrough.
Data Source
AI summary
A stapling device includes a handle assembly, an adaptor assembly extending from the handle assembly, and a reload assembly supported on a distal end portion of the adaptor assembly. The reload assembly includes a shell housing, a staple cartridge, a first seal, a staple actuator, and a knife carrier. The first seal is disposed within a cavity of the shell housing and defines a staple actuator opening and a knife carrier opening. The staple actuator includes a proximal leg extending proximally therefrom and through the staple actuator opening of the first seal to provide a fluid seal therebetween. The knife carrier includes a proximal body portion extending proximally therefrom and through the knife carrier opening of the first seal to provide a fluid seal therebetween.