Viscoelastic Polymer Medical Securement Device
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current medical article securement systems, such as those using sutures or rigid clips, can cause discomfort, infection, and are costly, while tape-based securement methods provide inconsistent and low securement force, making them inadequate for long-term medical device attachment.
Innovation Solution
A viscoelastic polymer film with specific mechanical properties, including a glass transition temperature between 15 °C and 45 °C, a tan δ max of at least 0.4, and a tensile storage modulus of at least 10 MPa at 30 °C, is used to create a securement device with a conformable and adhesive backing, incorporating a formed bend and notch for medical articles, offering both rigidity and conformability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If rigid components (clip or injection-molded clamp) are used for securement, then securement force and reliability are improved, but cost increases and conformability to skin decreases
Solution Approach 1:
The patent applies parameter changes by selecting a viscoelastic polymer with specific mechanical properties: tensile storage modulus E' of at least 10 MPa at 30°C, loss factor tan δ max of at least 0.4, and glass transition temperature Tg of at least 15°C and no greater than 45°C. These parameter specifications enable the polymer to provide rigid-like securement force while maintaining conformability and reducing manufacturing cost compared to traditional rigid clips.
Solution Approach 2:
The securement device uses a composite structure combining a viscoelastic polymer film with an adhesive layer. This composite material approach allows the device to exhibit both the conformability of flexible materials and the securement reliability of rigid structures, while avoiding the high costs associated with molded plastic devices.
2Force
If rigid components (clip or injection-molded clamp) are used for securement, then securement force is improved, but conformability to skin decreases
Solution Approach 1:
The viscoelastic polymer's mechanical parameters are specifically controlled to achieve optimal balance: the tensile storage modulus E' of at least 10 MPa provides sufficient securement force, while the glass transition temperature Tg of 15-45°C ensures the material remains soft and conformable to skin contours at body temperature.
Solution Approach 2:
The patent employs a flexible viscoelastic polymer film instead of rigid structures. This thin film can conform to the contours of the patient's skin and the medical device while still providing adequate securement force through its controlled mechanical properties.
3Ease of manufacture
If tape-based securement is used, then cost and ease of use are improved, but securement force and consistency decrease
Solution Approach 1:
The viscoelastic polymer is engineered with specific mechanical parameters (tensile storage modulus E' ≥ 10 MPa, loss factor tan δ max ≥ 0.4) that provide securement force significantly exceeding that of conventional tapes, while maintaining cost-effectiveness and ease of use.
Solution Approach 2:
The viscoelastic nature of the polymer allows it to dynamically adapt to movement and deformation, maintaining consistent securement force over time and through patient motion, unlike static tape materials that degrade in performance.
4Ease of operation
If tape-based securement is used, then ease of use and low cost are improved, but securement reliability and consistency decrease
Solution Approach 1:
By controlling the viscoelastic parameters (tan δ max ≥ 0.4, E' ≥ 10 MPa), the polymer provides reliable and consistent securement performance that maintains adherence over extended periods, eliminating the need for frequent replacement while keeping the device simple to apply.
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 viscoelastic polymer film provides reliable and consistent securement of medical articles, preventing debonding and edge lift, while maintaining ease of use and low cost, thus addressing the limitations of existing methods.
Implementation Method 1
a viscoelastic polymer film having a first major surface and a second major surface opposite the first major surface, the polymer film having a thickness of at least 0.1 mm, a glass transition temperature, Tg, of at least 15 °C and no greater than 45 °C, a tan δ max of at least 0.4, and a tensile storage modulus E' of at least 10 MPa at 30 °C, 1 Hz when tested according to Dynamic Mechanical_analysis
Data Source
Figure 1~3
Figure 4~5
Figure 6
AI summary
Medical article securement systems comprising a viscoelastic polymer and optionally a base layer for securing a medical article to the body of a patient, and particularly, for securing various catheter systems, tubes, or other elongated medical devices to the body of a patient and methods of making and using such.