Sterile Amniotic Fluid Collection via Blunt Needle and Stopcock
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Solution Overview
Problem
Current methods for obtaining amniotic fluid, such as amniocentesis, pose risks and pain to pregnant women and are insufficient for large-scale harvesting of biomolecules or culturing stem cells, lacking a safe and efficient means for sterile collection before a Caesarean section.
Innovation Solution
A method involving a blunt tip needle connected to a three-way stopcock and sterile tubing, with a Luer lock syringe and collection container, allowing for sterile collection of amniotic fluid using low suction and filtration to obtain biomolecules and stem cells, minimizing risks and pain through ultrasound guidance during an elective C-section.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If amniocentesis (transabdominal amniotic fluid collection) is performed by inserting a needle through the abdomen into the uterus, then amniotic fluid can be collected for diagnostic testing, but the procedure entails risks of complications and medical accidents, causing pain and anxiety to the pregnant woman
Solution Approach 1:
The patent performs amniotic fluid collection during an elective Caesarean section before the uterus is incised, allowing collection to occur in advance of any surgical intervention that might compromise sterility or safety. This preliminary collection avoids the risks associated with post-incision collection while still providing adequate fluid for therapeutic product development
Solution Approach 2:
The patent uses a sterile collection system with a three-way stopcock and sterile tubing as an intermediary between the amniotic sac and collection container, allowing fluid extraction without direct needle insertion into the maternal abdomen. This intermediary system maintains sterility while minimizing direct contact and associated risks
2Quantity of substance
If a small amount of amniotic fluid is collected during amniocentesis, then diagnostic testing can be performed, but the amount is insufficient for large-scale harvesting of biomolecules or culturing of stem cells
Solution Approach 1:
The patent collects a larger volume of amniotic fluid than the minimal amount required for diagnostic testing, obtaining sufficient fluid for both diagnostic purposes and large-scale biomolecule harvesting. This excessive collection ensures adequate material for therapeutic product development without requiring multiple procedures
Solution Approach 2:
The collected amniotic fluid serves multiple functions simultaneously: it provides material for diagnostic testing, stem cell culture, and biomolecule harvesting. This multi-functional approach maximizes the utility of the collected fluid, allowing both diagnostic and therapeutic applications from a single collection event
3Reliability
If amniotic fluid is collected during an elective Caesarean section, then sterile collection with minimal risk can be achieved, but the procedure requires coordination with surgical timing and protocol
Solution Approach 1:
The collection system is divided into separate sterile components including a needle, three-way stopcock, sterile tubing, and collection container. This segmentation allows each component to be independently sterilized and assembled in a controlled manner, maintaining overall sterility while simplifying the assembly process during surgery
Solution Approach 2:
The three-way stopcock serves as an intermediary device that coordinates between the surgical team and the collection system, allowing controlled connection and disconnection of sterile components without compromising the sterile field. This intermediary simplifies the coordination required during the surgical procedure
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
This method significantly reduces risks and pain by enabling the sterile collection of amniotic fluid with biomolecules and stem cells, providing a safer and more efficient means for research and therapeutic product development, achieving high sterility and minimal risk to the mother and fetus.
Implementation Method 1
The amniotic fluid is collected sterilely through the blunt tip needle and sterile tubing into a collection container
Data Source
AI summary
Provided herein is a pre-Caesarean method for collecting amniotic fluid from a patient. A needle is inserted into the incision site for the future C-section, which may be under ultrasound guidance, through which the amniotic fluid is drawn under a low level suction and, optionally, gravity to a sterile collection container. The method encompasses filtering and/or irradiating the amniotic fluid to collect biomolecules of interest such as growth factors and/or stem cells. Also provided is the sterile amniotic fluid or filtrates thereof collected by the method described herein.