Dialysis Autoconnect Mechanism for Sterile Fluid Integration
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Solution Overview
Problem
Dialysis patients face difficulties in connecting dialysis fluid bags to treatment machines due to the required force and dexterity, leading to potential contamination and infection risks.
Innovation Solution
A dialysis cassette with a frame, pump chamber, flexible membranes, and ports with integral spikes, along with an autoconnect device that automates the connection process by rotating fingers to grasp and remove caps, reducing the need for manual force and preserving sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual connection of dialysis fluid bags is used, then patient autonomy is maintained, but the force required and dexterity needed create contamination and infection risks
Solution Approach 1:
The system performs the connection operation automatically without requiring manual intervention. The autoconnect device engages the spike with the membrane seal and advances the connector through the membrane, eliminating the need for the patient to manually apply force during the connection process, thereby reducing contamination risk while maintaining patient autonomy.
Solution Approach 2:
The manual mechanical connection process is replaced with an automated mechanical system. The autoconnect device uses a motorized or spring-assisted mechanism to advance the connector through the membrane seal, substituting the manual force application with an automated mechanical system that reduces contamination risk.
2Ease of operation
If automated connection is implemented, then connection force and contamination risk are reduced, but device complexity increases
Solution Approach 1:
The autoconnect device is integrated with the dialysis machine, merging the connection function into the existing system. This integration shares mechanical components, control systems, and housing, thereby reducing the overall complexity increase that would result from a completely separate automated connection device.
Solution Approach 2:
The connector is pre-assembled with the spike and membrane seal components in a sterile, pre-sterilized configuration. This preliminary assembly eliminates the need for complex real-time assembly operations during the connection process, reducing the complexity of the automated system while maintaining connection ease.
3Reliability
If manual cap removal is used, then device simplicity is maintained, but sterility is compromised due to touching
Solution Approach 1:
The system automatically removes the cap from the connector without requiring manual intervention. The autoconnect device engages with the cap and removes it automatically, eliminating the need for the patient or operator to touch the cap, thereby preserving sterility while maintaining reasonable system complexity.
Solution Approach 2:
The autoconnect device acts as an intermediary between the user and the sterile components. It performs the cap removal operation automatically, serving as a sterile barrier that prevents direct human contact with the cap and connector, thereby preserving sterility without requiring complex sterile technique procedures.
4Productivity
If force is applied to connect fluid bags, then connection is achieved, but contamination and infection risks increase
Solution Approach 1:
The system performs the connection operation automatically without requiring manual intervention. The autoconnect device engages the spike with the membrane seal and advances the connector through the membrane, eliminating the need for the patient to manually apply force during the connection process, thereby reducing contamination risk while maintaining patient autonomy.
Solution Approach 2:
The manual mechanical connection process is replaced with an automated mechanical system. The autoconnect device uses a motorized or spring-assisted mechanism to advance the connector through the membrane seal, substituting the manual force application with an automated mechanical system that reduces contamination risk.
Data Source
AI summary
A dialysis system includes a dialysis machine comprising a motorized autoconnection mechanism, a fluid supply line connected to a source of dialysis fluid, and a cassette for use with the dialysis machine. The cassette includes a frame, a pump chamber within the frame, a first set of valves for routing the dialysis fluid from the fluid supply line to the pump chamber, and a second set of valves for routing the dialysis fluid from the pump chamber to a patient line. The cassette also includes a plurality of ports communicating with the first and second set of valves. Each port includes an integral spike. The motorized autoconnection mechanism is configured to move the fluid supply line and the patient line automatically so as to be spiked open respectively by the plurality of ports of the cassette.