Sealed Stapler Reload Assembly for Fluid Ingress Prevention
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Solution Overview
Problem
Surgical stapling devices face challenges in preventing fluid ingress into reusable components during cleaning, making sterilization difficult and time-consuming, and requiring clinicians to properly assemble and disassemble the device.
Innovation Solution
Incorporating a sealed configuration in the reload assembly of surgical stapling devices, including a first and second seal to prevent fluid ingress, allowing the trocar to be fixed and reducing the complexity of the device while enabling effective cleaning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the reload assembly is designed to allow disassembly for cleaning, then sterilization can be performed, but the device complexity increases and clinicians must properly assemble and disassemble it
Solution Approach 1:
The reload assembly is segmented into a disposable reload component and a reusable adaptor assembly, allowing the contaminable parts to be discarded and the reusable parts to be sterilized separately, simplifying the overall process
Solution Approach 2:
The reload assembly is designed as a disposable component that is discarded after a single use, eliminating the need for complex sterilization procedures while ensuring contamination-free operation
2Reliability
If the adaptor assembly is designed to prevent fluid ingress, then sterilization is simplified, but the device complexity increases
Solution Approach 1:
The reload assembly is designed as a disposable component that is discarded after single use, eliminating the need for complex sterilization procedures and fluid ingress prevention mechanisms in the reusable portions
Solution Approach 2:
The potential contamination source (reload assembly with staple cartridge and knife) is extracted and made disposable, separating it from the reusable adaptor assembly and eliminating the need for complex fluid ingress prevention in the reusable portions
3Loss of time
If the reload assembly is made disposable, then sterilization time is reduced, but the quantity of substance increases due to disposal after single use
Solution Approach 1:
The reload assembly is designed as a disposable component that is discarded after single use, eliminating time-consuming sterilization processes. The cost of the disposable component is offset by the reduced sterilization time and eliminated reprocessing costs
Data Source
Figure 1
Figure 2
Figure 3A
AI summary
A stapling device includes a handle assembly, an adaptor assembly extending from the handle assembly, and a reload assembly (16) supported on a distal end portion of the adaptor assembly. The reload assembly (16) includes a shell housing (110), a staple cartridge (118), a first seal (300), a staple actuator (112), and a knife carrier (114). The first seal (300) is disposed within a cavity of the shell housing (110) and defines a staple actuator opening and a knife carrier opening. The staple actuator (112) includes a proximal leg (113) extending proximally therefrom and through the staple actuator opening of the first seal (300) to provide a fluid seal therebetween. The knife carrier (114) includes a proximal body portion (142) extending proximally therefrom and through the knife carrier opening of the first seal (300) to provide a fluid seal therebetween.