Colorectal Cell Sampling Device with Invertible Membrane
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Solution Overview
Problem
Current methods for colorectal cancer screening lack invasiveness, simplicity, and cost-effectiveness while being insufficiently sensitive and specific, with challenges in obtaining reliable samples of exfoliated cells from stool due to contamination, material loss, and standardization issues.
Innovation Solution
A colorectal cell sampling device with a flexible membrane that expands to contact the mucosal surface, allowing pressurization to collect cells without contamination, featuring a closable interior cavity and means for precise pressure control, enabling direct sampling from the rectal mucosa.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If flexible colonoscopy/sigmoidoscopy is used for CRC screening, then diagnostic precision is improved, but invasiveness and cost increase making it impractical for routine screening
Solution Approach 1:
The invention extracts only the essential diagnostic function from colonoscopy by collecting exfoliated cells that can be analyzed outside the body, eliminating the need for invasive visual examination while preserving diagnostic capability through cell analysis
Solution Approach 2:
The invention uses exfoliated cells as an intermediary between the colorectal mucosa and diagnostic analysis, allowing indirect sampling that avoids direct invasive examination while still providing diagnostic information about tumour presence
2Ease of operation
If faecal occult blood testing is used for CRC screening, then simplicity and low cost are improved, but sensitivity and specificity deteriorate producing unacceptably high false negative and false positive rates
Solution Approach 1:
The invention creates a cellular copy of the colorectal mucosa surface by collecting exfoliated cells, which preserves diagnostic information better than faecal blood tests while maintaining simplicity and low cost of operation
Solution Approach 2:
The invention changes the diagnostic parameter from detecting blood presence to analyzing cellular morphology and characteristics, thereby improving sensitivity and specificity while keeping the test simple and affordable
3Measurement precision
If colonic lavage procedure is used to obtain exfoliated cells, then sample quality is improved, but invasiveness and complexity increase similar to sigmoidoscopy/colonoscopy
Solution Approach 1:
The invention utilizes the body's natural cell exfoliation process to provide the sample, eliminating the need for complex lavage procedures while still obtaining sufficient exfoliated cells for analysis
4Quantity of substance
If density gradient centrifugation is used to isolate colonocytes from faeces, then cell recovery is improved, but contamination with faecal matter and bacteria increases
Solution Approach 1:
The invention converts the natural exfoliation process that occurs in the presence of faeces into a benefit by collecting cells directly from the mucosal surface where they exfoliate, then immediately processing them to avoid faecal contamination rather than trying to isolate them from contaminated faecal material
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 device provides a non-invasive, cost-effective method for obtaining high-quality exfoliated cell samples with reduced contamination and improved standardization, enhancing patient acceptance and screening efficiency.
Implementation Method 1
pressurisation of the interior cavity to at least a first elevated pressure causes the membrane to emit from the distal end of said insertion member
Implementation Method 2
pressurisation of the interior cavity to a second reduced pressure causes the membrane to invert and return to the interior cavity of said insertion member
Data Source
AI summary
A device for collection of exfoliated cells from the rectal mucosa comprises a hollow, cylindrical body having an inflatable and invertible flexible membrane attached to one end thereof. Applying positive pressure to inflate the membrane after the device is inserted, preferably through a rectal access tube, into the rectum causes exfoliated cells to be collected on the surface of the membrane. Before removal of the device, negative pressure is applied and the membrane, along with the collected sample of exfoliated cells, is deflated, inverted and withdrawn into the body of the device, thereby avoiding contact of the collected sample with body surfaces or the rectal access tube as the device is removed from the rectum.