Tamper-Evident Strapping with Self-Locking Rivet for Medical Devices
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Solution Overview
Problem
Existing tamper-evident security straps for medical devices like splints and casts do not allow for adjustable tightness without compromising their integrity, leading to unauthorized removal and potential misuse by patients, which can result in incorrect support or legal issues.
Innovation Solution
An adjustable tamper-evident strapping system with a self-locking rivet mechanism that allows for limited adjustment post-application, preventing unauthorized removal by requiring destruction of the strap for removal, and incorporating a hook and loop system for tensioning, with a sub-strap guiding optimal placement and adjustment range.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the strapping is made secure and tamper-evident with fixed integrity, then unauthorized removal is prevented, but adjustability for managing swelling and comfort is lost
Solution Approach 1:
The strapping system is divided into a main strap with fixed tamper-evident integrity and a separate adjustable sub-strap. The sub-strap can be independently adjusted to accommodate swelling changes while the main strap maintains its security function. This segmentation allows different parts of the system to serve different functions without compromising either.
Solution Approach 2:
The sub-strap incorporates dynamic adjustment capabilities through movable components that allow the strapping tension to be modified. This enables the system to adapt to changing physiological conditions (swelling) while the main strap remains statically secure and tamper-evident.
2Ease of operation
If the strapping allows easy removal and re-use, then patient comfort and convenience are improved, but unauthorized removal and misuse by patients increases
Solution Approach 1:
The strapping is segmented into a main strap that requires destruction to remove (maintaining security) and a sub-strap that can be adjusted (providing ease of operation). This segmentation creates a system where legitimate adjustment is possible but unauthorized removal remains difficult.
Solution Approach 2:
The sub-strap acts as an intermediary element between the main strap and the body. It provides a layer of adjustability and comfort while the main strap maintains the security function. The sub-strap can be adjusted to accommodate patient needs without compromising the integrity of the main strap.
3Reliability
If the strapping is designed to set firmly to provide proper support, then medical effectiveness is improved, but patient ability to remove it without supervision increases
Solution Approach 1:
The support function is divided between the main strap (which sets firmly to provide proper support) and the sub-strap (which can be adjusted). The main strap maintains firm support through its tamper-evident design, while the sub-strap provides adjustability that prevents easy unsupervised removal.
Solution Approach 2:
The system allows parameter changes in the sub-strap tension to accommodate patient needs while maintaining the main strap's firm support characteristics. This enables the system to adapt to patient comfort requirements without compromising the firm support needed for medical effectiveness.
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
Ensures secure and adjustable strapping that prevents unauthorized removal, indicating tampering through visible signs of destruction, while allowing medical professionals to manage swelling and ensure proper support without compromising the strap's integrity.
Implementation Method 1
a sheet of thermoplastic material bonded to a skin contacting fabric layer wherein the thermoplastic sheet is configured to be both flexible and extensible when heated to a softening temperature
Implementation Method 2
incorporating a hook and loop system for tensioning
Data Source
Figure 1~3
Figure 4a~4b
AI summary
A compliance strapping includes a predetermined adjustability, tamper deterring and indicating strapping, adapted, in use, to form an encircling loop. The compliance strapping is passed around an object and for further security the strap can be threaded through lining material or through a wearable article or medical device. The free end (2) of the elongate member is passed through the loop, which may be a D-loop (9) sewn into the strapping, thus forming an encircling loop of strapping. The second end is brought around to close proximity with a region of the strapping which has been passed through the loop and the tamper indicating means (5a,5b) fastened known as the self locking rivet to said region of the strapping. Thus the encircling loop cannot be broken because the region of the strapping with the self locking rivet fastened thereto cannot pass back through the D-loop.