Intrauterine Pressure Catheter with Shape Memory Stiffener
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Solution Overview
Problem
Current intrauterine pressure monitoring devices are uncomfortable, cumbersome, and prone to measurement errors due to stiff materials and potential misplacement during insertion, leading to hygiene issues and inaccurate data collection.
Innovation Solution
A pressure-monitoring catheter with a flexible biocompatible elastomeric material and a shape memory stiffener, featuring a compliant tip and a gas-filled pressure-monitoring lumen, which minimizes discomfort and ensures accurate pressure measurements by maintaining a linear configuration for easy insertion and reducing the likelihood of misplacement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If intrauterine pressure monitoring devices are inserted to obtain accurate measurements, then measurement precision is improved, but patient comfort deteriorates and device reliability worsens due to discomfort, cumbersome operation, and potential misplacement
Solution Approach 1:
The catheter employs a flexible biocompatible elastomeric material for the catheter body, allowing it to conform to the uterine cavity shape and reduce patient discomfort. The flexible tip specifically adapts to the cervix curvature, facilitating easier insertion while maintaining measurement accuracy through direct uterine pressure contact.
Solution Approach 2:
The shape memory stiffener dynamically adjusts the catheter's structural properties: it maintains a linear configuration during insertion to guide the catheter straight into the uterus, then transitions to a curved configuration when cooled by body temperature to conform to the uterine cavity, thereby improving both ease of operation and measurement reliability.
2Strength
If stiff materials are used in intrauterine devices to maintain structural integrity, then device strength is improved, but ease of operation deteriorates due to discomfort during insertion and potential misplacement
Solution Approach 1:
The catheter combines flexible biocompatible elastomeric material with a shape memory stiffener to create a composite structure that exhibits both flexibility for comfort and structural integrity for reliable operation. This composite design allows the catheter to be soft enough for comfortable insertion yet strong enough to maintain its position and function accurately.
Solution Approach 2:
The shape memory stiffener changes its physical parameters (rigidity and shape) in response to temperature changes. During insertion, the stiffener is in a rigid linear state providing structural support; upon contact with body temperature, it transitions to a flexible curved state that conforms to the uterus, resolving the contradiction between strength and ease of operation.
3Ease of operation
If the catheter is made flexible to improve comfort and reduce misplacement, then ease of operation is improved, but measurement precision may deteriorate due to potential loss of structural stability
Solution Approach 1:
The flexible biocompatible elastomeric material and flexible tip enable comfortable insertion and proper positioning within the uterine cavity, while the gas-filled lumen maintains structural stability for accurate pressure measurements by providing a stable transmission medium that is not affected by the catheter's flexibility.
Solution Approach 2:
The gas-filled pressure-monitoring lumen uses gas as the pressure transmission medium, which maintains structural integrity and measurement precision even when the catheter material is flexible. The gas column provides a stable, compressible medium for accurate pressure transmission from the uterine cavity to the monitoring system.
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 catheter provides more comfortable and accurate intrauterine pressure monitoring with reduced discomfort and improved hygiene, while maintaining the ability to detect pressures within the desired range, enhancing the assessment of uterine contractions and fetal health during labor.
Implementation Method 1
A pressure-monitoring catheter is provided having a flexible biocompatible elastomeric material and a shape memory stiffener
Implementation Method 2
A gas-filled membrane (e.g., a balloon) is formed on the outer surface of the catheter near a distal end of the catheter. The gas-filled membrane is in fluid communication with the gas-filled pressure-monitoring lumen. Changes in pressure against the gas-filled membrane will result in changes in pressure of the gas within the gas-filled pressure-monitoring lumen.
Data Source
AI summary
An intrauterine pressure-sensing catheter for detecting pressure changes within the uterus of a patient is disclosed having a tube with a primary lumen extending from a proximal end to a distal end of the elongate tube. A monitor lumen is positioned within the elongate tube between the primary lumen and a wall of the elongate tube and extends from a proximal end of the elongate tube to a distal end of the elongate tube. A pressure-compliant balloon is disposed about an exterior of the elongate tube adjacent a distal end tip. A sleeve is slidably mounted on an exterior of the elongate tube and disposed over the pressure-compliant balloon during insertion of the pressure-sensing catheter within the patient. The distal end tip is configured to prevent movement of the sleeve over the tip and is further configured to provide a zone of protection for the pressure-compliant balloon.