Endometrial Brush Biopsy with Cervical Stop Depth Control
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Solution Overview
Problem
Existing biopsy devices for the uterus, such as the Tao Brush and Pipelle, risk unnecessary tissue damage due to arbitrary or estimated insertion depth, leading to potential complications and discomfort during endometrial sampling.
Innovation Solution
A biopsy device with a cervical stop to limit insertion depth and a combination of a brush for abrasive sampling and suction for fluid collection, allowing precise control over the brush exposure and vacuum creation, minimizing tissue damage and discomfort.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the brush is inserted to the fundus of the uterus using arbitrary or estimated depth, then the endometrial sampling is achieved, but unnecessary tissue damage and patient discomfort occur
Solution Approach 1:
A cervical stop component is introduced as an intermediary element between the brush and the uterus. This stop physically limits the insertion depth by contacting the cervical os, preventing the brush from advancing beyond the desired depth into the uterine cavity. The intermediary structure ensures precise depth control without requiring operator estimation or arbitrary measurement.
2Quantity of substance
If the brush is extended fully to sample the endometrium, then adequate tissue collection is achieved, but trauma to the uterine fundus occurs
Solution Approach 1:
The device segments the sampling function from the insertion function. The cervical stop remains stationary at the cervical os, while only the brush portion extends into the uterus to the limited depth allowed by the stop. This segmentation allows the brush to collect adequate tissue samples within the safe depth boundary, separating the sampling action from the potentially traumatic full insertion.
3Force
If the inner sleeve provides only centering without interference fit, then the guidewire is centered, but vacuum suction is not generated
Solution Approach 1:
The inner sleeve is designed to combine two functions: centering the guidewire and generating vacuum suction. By providing an interference fit rather than just centering, the sleeve creates frictional engagement that generates vacuum force when retracted. This merging of functions eliminates the need for separate centering and vacuum generation mechanisms.
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 ensures accurate and gentle tissue sampling by controlling insertion depth and combining abrasive and suction methods, reducing pain and discomfort while ensuring a reliable specimen collection.
Implementation Method 1
a displaceable structure within the sheath, to form a coaxial structure; the displaceable structure having a first end extending from a proximal end of the sheath and second end configured to, in a first state, extend from a distal end of the sheath, and in a second state, to be retracted into the distal end of the sheath
Implementation Method 2
The device ensures accurate and gentle tissue sampling by controlling insertion depth and combining abrasive and suction methods
Implementation Method 3
a cellular sampling structure, preceded by a suction element
Data Source
AI summary
A biopsy device, comprising a flexible coaxial structure, comprising a wire within a sheath, the wire being adapted to be displaced with respect to the sheath along the coaxial axis by a force applied at a proximal end; a disruptor, at a distal end of the obturator, adapted to disrupt a tissue surface to free cells therefrom, having a first position covered within the sheath and a second position freely extending beyond the sheath; an element, on an exterior of the sheath, configured to limit a depth of insertion of the sheath into a body orifice.