Sterile Wound Therapy Pump Assembly With Integrated Leak Detection
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Solution Overview
Problem
Existing wound treatment technologies face challenges in maintaining a sterile environment during negative pressure wound therapy, particularly in operating rooms, and there is a need for efficient leak detection and control mechanisms to ensure consistent treatment efficacy.
Innovation Solution
A sterile pump kit and dressing system with integrated leak detection and control mechanisms, including a canisterless pump assembly and a controller to monitor duty cycles and pressure levels, ensuring consistent negative pressure application and minimizing exposure to contaminants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a sterile pump kit is used to maintain sterile environment during negative pressure wound therapy, then infection risk is reduced, but device complexity increases
Solution Approach 1:
The system is divided into separate sterile and non-sterile components. The pump assembly can be sterilized independently and connected to the wound dressing through a sterile barrier, allowing the sterile field to be maintained without requiring the entire system to be sterile. This segmentation enables infection risk reduction while managing device complexity through modular design.
Solution Approach 2:
A sterile barrier or drape is introduced as an intermediary between the non-sterile pump components and the sterile wound dressing. This intermediary maintains the sterile field during negative pressure therapy by preventing contamination from the pump assembly, thereby reducing infection risk without requiring complete sterilization of the entire device.
2Reliability
If integrated leak detection and control mechanisms are implemented, then treatment efficacy is ensured, but device complexity increases
Solution Approach 1:
The system incorporates sensors that continuously monitor negative pressure levels and provide feedback to the control mechanism. When leaks are detected through pressure changes, the system automatically responds by adjusting pump operation or alerting the user, ensuring treatment efficacy without requiring complex manual monitoring systems.
Solution Approach 2:
The leak detection system utilizes the existing negative pressure field itself to detect leaks, rather than requiring separate complex detection mechanisms. The pressure sensors monitor the integrity of the sealed environment using the therapeutic negative pressure already present in the system, enabling reliable leak detection while minimizing additional device complexity.
3Productivity
If immediate initiation of negative pressure wound therapy is enabled in sterile environment, then wound healing is enhanced, but ease of operation decreases
Solution Approach 1:
The pump assembly is pre-sterilized and packaged in a sterile container that can be directly connected to the wound dressing in the operating room. This preliminary preparation of sterile components allows immediate initiation of negative pressure therapy during surgery without requiring time-consuming sterilization procedures, thereby enhancing wound healing rate while maintaining ease of operation through pre-packaged sterile kits.
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 system allows for immediate initiation of negative pressure wound therapy in a sterile environment, reducing infection risk and ensuring consistent treatment by detecting and responding to leaks, thereby enhancing wound healing.
Implementation Method 1
a one-way flow valve in fluid communication with the pump and supported by the housing. Some embodiments of the one-way flow valve can be configured to substantially prevent a flow of gas through the flow pathway in a direction of flow away from the pump
Implementation Method 2
Topical negative pressure (TNP) therapy, sometimes referred to as vacuum assisted closure, negative pressure wound therapy, or reduced pressure wound therapy
Data Source
AI summary
Some embodiments comprise a pump assembly for reduced pressure wound therapy, comprising a housing, a flow pathway through the pump, one or more valves in communication with the flow pathway, a pump supported within or by the housing, and a one-way flow valve in fluid communication with the pump. The pump assembly can have a pressure sensor in communication with the flow pathway through the pump, and at least one switch or button supported by the housing, the at least one switch or button being accessible to a user and being in communication with the controller. The one-way flow valve can be configured to substantially prevent a flow of gas through the one-way flow valve in a direction of flow away from the pump. The pump assembly can have a controller supported within or by the housing, the controller being configured to control an operation of the pump. The pump has been sterilized following the assembly of the pump such that an inside and an outside of the housing, the flow pathway, the one or more valves, the pump, the controller, the battery compartment, and the at least one switch or button have been sterilized.