Pre-curved Catheter Tube Shape Setting via Heat Sterilization
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Solution Overview
Problem
Existing catheter assemblies do not effectively maintain a pre-curved configuration during insertion, which is desirable for optimal positioning within a patient, as they tend to revert to their original shape after removal from packaging.
Innovation Solution
A catheter assembly with a tube constraint that temporarily holds the catheter tube in a curved configuration during a heat sterilization process, such as ethylene oxide sterilization, to permanently set the curve, allowing for a pre-curved catheter tube that maintains its shape post-release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If a catheter tube is packaged in a straight configuration, then it is easy to store and transport, but it reverts to its original shape after removal from packaging and cannot maintain the desired curved configuration during insertion
Solution Approach 1:
The catheter tube is pre-formed into the desired curved configuration using a form or mandrel before final packaging. This preliminary shaping action ensures the catheter maintains its intended geometry during insertion, eliminating the need for manual manipulation and improving positional stability at the insertion site
Solution Approach 2:
The patent utilizes thermal processing parameters to permanently set the curved configuration of the catheter tube. By controlling temperature, time, and pressure during the forming process, the tube material's properties are temporarily altered to allow shaping, then cooled to lock in the desired curved geometry
2Ease of operation
If a catheter tube is manually manipulated into position during insertion, then it can be positioned, but it requires significant operator skill and time, increasing procedural complexity
Solution Approach 1:
The catheter tube is pre-formed into the desired curved configuration before sterilization and packaging. This preliminary action eliminates the need for manual manipulation during insertion, making the procedure easier to perform while reducing operator skill requirements and procedural time
Solution Approach 2:
The patent replaces manual mechanical manipulation with a thermally-driven forming process during manufacturing. The curved configuration is permanently set through controlled thermal processing, substituting the need for operator skill-based manual positioning with an automated manufacturing process
3Reliability
If heat sterilization is applied to a catheter tube, then it achieves sterilization, but the tube may deform or lose its desired configuration
Solution Approach 1:
The catheter tube is formed into its desired curved configuration before the heat sterilization process. The forming is done at controlled temperatures and pressures that create a stable configuration, which then serves as the basis for subsequent sterilization without deformation
Solution Approach 2:
The patent carefully controls the thermal parameters during both forming and sterilization processes. By adjusting temperature, time, and pressure parameters, the tube material undergoes temporary property changes during forming, then stabilizes to maintain its configuration through the sterilization heat treatment
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 solution ensures that the catheter tube is permanently formed in a pre-curved configuration, enhancing its positional stability and usability within medical applications by utilizing heat sterilization procedures commonly used in medical device sanitation.
Implementation Method 1
The heating procedure may include heat sterilization procedures commonly used to sterilize medical devices prior to use
Data Source
AI summary
A pre-curved catheter tube of a catheter assembly or other elongate medical device and methods for forming such a device using a heating procedure is disclosed. Pre-curving of the catheter tube is desirable to impart to the catheter assembly a desired positional configuration when the catheter assembly is inserted into a patient. The heating procedure may include heat sterilization procedures commonly used to sterilize medical devices prior to use. One method for curving a catheter tube of a catheter assembly includes constraining the catheter tube into a curved configuration using the tube constraint, heating the catheter tube in the curved configuration for a predetermined time at a predetermined temperature, and releasing the catheter tube from the tube constraint after the heating is complete.