Surgical Instrument Loading Unit Authentication Under Fluid Exposure
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Solution Overview
Problem
Powered surgical instruments face reliability issues due to malfunctions caused by fluid exposure compromising the communication between the chip and handle assembly, leading to instability or inoperability during endoscopic procedures.
Innovation Solution
A surgical instrument with a microcontroller and handle interface, featuring a shipping bracket with a microchip that stores authentication and identification data, ensuring secure communication and preventing component movement during shipping and handling, thus maintaining operational integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the microchip is integrated into the loading unit body, then communication with the handle assembly can be established, but the microchip is exposed to fluids (blood, bile, irrigation solutions) which compromises its functionality
Solution Approach 1:
The patent divides the loading unit into two functional parts: the loading unit body (with staple cartridge and anvil) and a separate shipping bracket. The microchip is integrated into the shipping bracket rather than the loading unit body, creating spatial separation between the sensitive electronic component and the fluid-exposed surgical components. This segmentation protects the microchip from fluid exposure while maintaining communication capability with the handle assembly through the bracket interface.
Solution Approach 2:
The shipping bracket acts as an intermediary component that bridges the loading unit and the handle assembly. It provides a protected environment for the microchip while establishing the electrical connection needed for authentication and communication. The bracket serves as a mediator that allows the microchip to communicate with the handle without being directly exposed to the surgical environment's fluids.
2Ease of operation
If the loading unit allows free movement during shipping, then handling is easier, but components may move inadvertently causing damage or misalignment
Solution Approach 1:
The shipping bracket is designed to be attached to the loading unit before shipping and handling operations. It preliminarily secures the staple cartridge and anvil in fixed positions relative to each other, preventing inadvertent movement during transportation and storage. The bracket's engagement features with the loading unit body establish stable component positioning in advance of the actual surgical use.
3Adaptability or versatility
If multiple loading units with different specifications are used with the same handle assembly, then versatility is improved, but authentication and compatibility verification become more complex
Solution Approach 1:
Each loading unit's microchip contains authentication data and specifications that automatically identify the loading unit type when coupled with the handle assembly. The handle assembly's microcontroller automatically reads and verifies this information, enabling the system to self-configure for the specific loading unit without requiring manual intervention or complex external verification procedures. This self-service approach simplifies the authentication process despite supporting multiple loading unit varieties.
Data Source
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AI summary
A surgical instrument includes a handle having a handle frame, a microcontroller having at least one program and memory, and a handle interface supported by the handle frame and in electrical communication with the microcontroller. The instrument further includes a loading unit having a body configured for operative coupling to the handle frame of the handle, and an end effector coupled to a distal end of the body and configured to perform a surgical task. A bracket is mounted to the loading unit and includes a microchip having at least one of authentication data and identification data relating to the loading unit.