Removable Power Pack Architecture for Sterile Surgical Staplers
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Solution Overview
Problem
Surgical staplers face challenges with contamination risks, high costs, and damage to electronic components due to sterilization, especially in reusable powered models, leading to increased costs and reduced lifespan.
Innovation Solution
A fully enclosed and removable power pack for surgical staplers that prevents contact with patient fluids, allowing reuse without sterilization, and includes motors and encoders for precise control of firing and articulation mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If surgical staplers are made reusable with electronic components, then cost effectiveness improves, but the electronic components are damaged by sterilization processes
Solution Approach 1:
The surgical stapler is divided into two separate parts: a reusable handle assembly containing electronic components and a disposable cartridge containing the staples and anvil. This segmentation allows the handle to be reused without sterilization while the cartridge is disposed of after single use, resolving the contradiction between reusability and sterilization damage to electronics.
Solution Approach 2:
The cartridge is designed as a disposable component that is discarded after a single use, eliminating the need to sterilize electronic components. The low cost of the disposable cartridge enables multiple surgeries using the same handle assembly, improving cost effectiveness while preserving electronic component functionality.
2Reliability
If surgical staplers are disposed after each use, then contamination risks are eliminated, but the cost increases due to discarding expensive electronic components
Solution Approach 1:
By separating the stapler into a reusable handle and disposable cartridge, the system maintains contamination prevention through single-use disposal of the cartridge while preserving expensive electronic components in the handle for repeated use, thereby reducing overall cost.
Solution Approach 2:
The disposable cartridge serves as a single-use component that prevents contamination transmission, while the reusable handle with expensive electronics is not subjected to sterilization, reducing the overall cost per procedure.
3Reliability
If sterilization processes are applied to powered staplers, then contamination risks are reduced, but the lifespan of the stapler is shortened
Solution Approach 1:
The stapler is segmented into a reusable handle and disposable cartridge, allowing the handle to avoid sterilization processes that would damage electronic components and shorten lifespan, while the cartridge is disposed of to maintain contamination control.
Solution Approach 2:
The disposable cartridge eliminates the need for sterilization of the handle assembly, preserving the lifespan of electronic components while maintaining contamination control through single-use disposal of the cartridge.
4Device complexity
If manual actuation is used, then device complexity is reduced, but high forces are required to fire staples through tissue
Solution Approach 1:
The manual mechanical actuation system is replaced with an electric motor-driven system in the handle assembly. The motor provides the necessary force to fire staples through tissue without requiring high manual forces from the user, while the overall device remains relatively simple in design.
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
Reduces sterilization time and costs, extends the lifespan of the stapler, and ensures reliable operation by maintaining the power pack in a sterile environment, while enabling efficient and cost-effective multiple uses.
Implementation Method 1
an encoder is positioned within the power pack to detect movement of the rotatable screw to determine a firing position of the firing mechanism
Data Source
AI summary
A surgical fastener applier having a housing containing a compartment therein, an elongated member extending distally from the housing and first and second jaws. A firing mechanism is positioned within the housing movable to a second position to effect firing of fasteners. A power pack is removably loadable into the compartment, the power pack having one or both of a) a first motor and a first engagement member removably engageable with the firing mechanism when the power pack is loaded into the compartment to effect movement of the firing mechanism; and b) a second motor and a second engagement member removably engageable with an articulating mechanism in the housing of the surgical fastener applier to effect movement of an articulation mechanism to effect articulation. One or both of a firing position and an articulation position are tracked during the surgical procedure. Sensors are provided to detect select parameters and instrument functions.