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In the growing medical equipment industry, the application of pressure-sensitive adhesive tape is everywhere. Pressure sensitive adhesive tape is often the main or even key part of the products used in surgery, wound, incontinence care, monitoring, diagnosis and other aspects. The performance of the final product is also closely related to the performance of pressure-sensitive adhesive tape. Therefore, in the design of medical products, how to select the pressure-sensitive adhesive tape with proper function and excellent performance has become an important topic concerned by the corresponding R & D personnel. This paper briefly summarizes the characteristics of medical pressure-sensitive tape, and introduces the key points of selecting pressure-sensitive tape in the design process from the practical application of three common medical products: disposable surgical towel, ECG electrode and blood glucose test paper.
First, the characteristics of pressure-sensitive adhesive so-called pressure-sensitive adhesive refers to a kind of adhesive sensitive to pressure. The adhesive can be formed by applying a certain amount of pressure to the bonding surface through hands or fingers. The pressure-sensitive adhesive tape is a kind of adhesive tape which is coated on the strip material (such as film, non-woven fabric, foam, etc.) and has pressure-sensitive property after drying. Generally, pressure-sensitive adhesive tape is composed of base material, adhesive layer, release paper, uncoiler, etc.
Compared with other adhesive methods, pressure-sensitive adhesive tape has a series of advantages as follows:
1. The use of pressure-sensitive adhesive tape does not need heating, solvent modulation, mechanical reinforcement and other tedious processes, convenient and fast.
2. Pressure sensitive adhesive tape is easy to store, and the adhesive layer will not dry solid for a long time, so it is also called adhesive.
3. In most cases, the pressure-sensitive adhesive tape can be peeled from the adhered surface without damage, which is also an important advantage of the pressure-sensitive adhesive tape. Because of these unique advantages, pressure-sensitive adhesive tape is widely used in medical products, especially in disposable medical products.
Second, simply list some common applications
• disposable surgical towel;
• wound care products, including transparent dressing, functional dressing, infusion patch, pocket making, etc;
• monitoring products - such as ECG electrode, EEG electrode, blood oxygen probe, etc;
• in vitro diagnostic products - test strips for blood glucose, cholesterol, bilirubin, lipids, etc;
• paste products for external use.
There are some special requirements for pressure-sensitive adhesive tape used in medical products, which need to be considered and realized in the research and development process of pressure-sensitive adhesive tape.
Third, unique medical tape
(1) Safety for medical products, especially those directly or indirectly contacting human body, its safety is mainly reflected in environmental protection, biocompatibility, production process stability and traceability. For the key process parameters, the process capability index (CPK) is usually required to be more than 1.33, and the relevant information such as raw material batch, operators, equipment parameters used for any batch of products can be traced through the lot number, so as to investigate and improve the problems.
(2) The function of functional pressure-sensitive adhesive tape, in short, is to stick well.
For medical pressure-sensitive adhesive tape, there are three main points:
1. Whether the adhesive to the material is enough: when the adhesive tape needs to paste the material to the skin (for example, when it is used for the surgical towel), the adhesive tape shall be able to firmly stick to the skin surface.
2. Whether the adhesion to the skin is appropriate: because most medical adhesive tapes need to be pasted on the skin, they should have appropriate viscosity, rather than the stronger the better the viscosity. 3M clinical research department evaluates the strength and applicability of the adhesive tape to the skin by testing the peel strength of the tape on the skin. (as shown in the figure)
3. Whether it can adapt to the corresponding sterilization methods: different sterilization methods have different effects on product performance. Selecting the materials suitable for the sterilization methods of products is an important part of product design.
(3) With the improvement of medical level, the comfort of comfort medical products has been paid more and more attention by medical staff and patients. For medical products using pressure-sensitive adhesive tape, whether there is pain when they are torn off, whether there is residual adhesive left, how compliant and elastic they are, and whether they are glued or not, are the direct feelings of patients, which are the specific embodiment of the comfort of the tape. How to transform these items into quantifiable and testable indexes is an important task for medical tape manufacturers.
Fourth, selection of pressure-sensitive tapes for different medical supplies
(1) The first one is the application of double-sided tape
The front side of the double-sided tape (roll open side) is pasted on the surgical towel material. When it is used in the operating room, the release paper is removed and the back side is pasted on the patient's skin to form a fixation. In addition to fixing the surgical towel, the adhesive tape can also prevent the microorganism in the non sterile area of the skin from moving to the surgical site, so as to avoid the wound infection caused thereby. The second application is to apply single-sided film tape to the surgical site. Doctors can cut the tape and skin directly for operation, which is generally called surgical film. It can effectively prevent the microorganisms in the deep skin around the surgical incision from migrating to the skin surface, and then entering the incision, causing infection.
Selection requirements:
Good stickiness to surgical towel material
Good skin viscosity, especially wet viscosity
Easy to tear off from the skin without damage and residual glue
Good compliance (skin fit)
With certain shear strength
Proper unwinding force and parting force
(2) For the electrode pasted in a short time, the medical adhesive tape with good initial viscosity should be used instead of the air permeability. For electrode products used in dynamic electrocardiogram, the adhesion and permeability of backing tape is more important. On the one hand, it can ensure that the electrode can be pasted firmly and accurately

 

2020-02-13 10:09
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