Products for the Medical Markets
- UV Curing Adhesives
- Cyanoacrylate Adhesives assembly
- Cyanoacrylate Adhesives for Wound and Tissue
We partner with Cyberbond, an ISO 13485 certified manufacturer of adhesives for the medical industry. Below is some information via Cyberbond’s website:
Medical Adhesive Requirements
Because of the extensive testing all medical instruments undergo before they are put into use, manufacturers find it advantageous to select adhesives they already know to be compatible for use with the human body. Several different standards exist to provide this assurance, most notably USP (United States Pharmacopia) Class VI and ISO 10993.
Many Cyberbond cyanoacrylates and UV-curables are certified to both standards. We have recently emphasized ISO 10993, which is in more widespread use internationally.
The 10993 standard encompasses a variety of different tests, each of which covers a different aspect of biocompatibility. Generally, manufacturers have one of the tests in mind when designing a medical device; Cyberbond has many adhesives that have passed the following:
• ISO 10993-5: Test for In-Vitro Cytotoxicity
An agar diffusion test checks to see if the tested cyanoacrylate or UV-curable will destroy a cell culture.
• ISO 10993-10: Tests for Irritation and Sensitization
Injections of the tested adhesive are administered intradermally to live test subjects to determine—through observation of vascular dilation—whether the adhesive will cause inflammation of the skin (erythema) or an accumulation of liquids (edema).
• ISO 10993-11: Tests for Systemic Toxicity
Injections of the tested adhesive are administered intravenously into the abdominal cavity. The test is passed only if no biological reaction is observed.
- Tack-free bond
Adhesives used as coatings, or in other applications where they are not encapsulated within the device, are generally required to present a tack-free outer surface.
- Sterilization processes
Even if an adhesive is certified as biocompatible, it must be capable of withstanding the sterilization required to render the rest of the device safe for use. Depending on a variety of factors, including device type and manufacturer preference, there are several different methods of sterilization to choose from.
Disposable devices are typically sterilized in one of the following ways:
• ETO (Ethylene Oxide)
Parts are treated for several hours with a gas that penetrates packaging and kills micro-organisms. ETO is used for heat-sensitive parts that cannot withstand high-temperature sterilization methods. Very often, the ETO process is repeated twice; this is referred to as 2x ETO. Cyberbond products withstand this treatment.
• Gamma Radiation
Parts are treated with gamma rays, killing micro-organisms even through packaging.
Cyberbond products withstand this treatment.
Multi-use medical devices are typically sterilized in the following way:
• Autoclave Sterilization
Parts are put into an autoclave, which is a specialized type of pressure cooker. Inside, the heat, steam and pressure work together to sterilize the parts. Standard CAs and UVs do not withstand this procedure.
Medical Adhesive Applications
- Biopsy and Infusion Needles
Biopsy and infusion needles are typically potting applications, where a metal needle is surrounded by adhesive in a recess in a plastic housing. Alternatively, as in the case of the bite-wing cannula pictured in green at left, adhesive is applied to a needle, which is inserted into a tight-fitting housing. In both applications, sealing is as important as strength–blood and fluids must not be allowed to penetrate the bond. Adhesive strength in these applications is usually evaluated by means of a simple tensile test.
Dissimilar substrates are the primary challenge of needle bonding. Needles are almost always stainless steel, where the plastic housing could be any of a variety of substrates, including polycarbonate, nylon, ABS, or more exotic molded plastics. This creates a challenge from the standpoint of requiring an adhesive that has affinity for multiple substrates.
Cyberbond is proud to offer several adhesive solutions with such affinity. Among our Cyberlite UV-curable acrylates, our U306 is 10993-5 tested and bonds well to both stainless and several different plastics. From our cyanoacrylate range, our 2008, 2028, and 2240-05 have all shown excellent results, and all are tested for biocompatibility.
- Tube/Hub Bonding
Tube/hub applications are straightforward in that they require the terminus of a length of flexible tubing to be bonded within a rigid plastic hub.
Though tube/hub bonding is not difficult to understand, it requires an adhesive to bond a variety of challenging substrates, and often times to accommodate an extremely tight fit between tube and hub. Traditionally, manufacturers have designed this tight fit to facilitate sealing and prevent foreign bodies from penetrating or leaking from the hub. In such cases, solvents were typically the adhesive of choice, as their low viscosity lubricated the fit between tube and hub.
The benefit of Cyberbond products in tube/hub applications is that, unlike solvents, our adhesives do not attack plastic, allowing for a stronger bond. Additionally, our 2008 and 2028 cyanoacrylates, as well as our U301 and U304 UV-curables, provide excellent adhesion on the exotic extruded plastics increasingly used to replace PVC-based tubing.
- Balloon Catheters
Balloon catheter applications involve small-diameter tubing that has been divided internally to allow it to deliver both air and treatment solutions simultaneously. This tubing is bonded to either end (the “cuff”) of an inflatable balloon or “sleeve.” As with needle bonding, sealing and strength are of equal importance, as air must not be allowed to exit the sleeve. In addition, balloon bonds are usually required to resist moisture at body temperatures.
Materials in balloon catheter bonding tend to present the greatest challenge to adhesion, especially as manufacturers move away from phthalate-based tubing. PET balloons w/ Pellethane tubing are typical. Combined with the need to resist water/moisture, balloon catheter applications can present difficulties that only an experienced and technically proficient adhesive manufacturer can overcome.
Cyberbond has employed our U301 and U304 medical-grade UV-curables in balloon catheter applications, as both work effectively across an array of different substrates.
ISO 10993 Approvals
Cyberbond’s experience in the medical device market means that we’ve had the opportunity to certify many formulas to various ISO 10993 standards for biocompatibility. These are listed below, along with the specific tests they have passed:
Tests for Cytotoxicity
Tests for Irritation and Sensitization
Tests for Systematic Toxicity
Experience shows us that some products are particularly well-suited to certain applications—for example, 2008 is perfect for tight-tolerance needle bonding; 2028 or 2077 work better for wider gaps. Lower-viscosity UV-curables like U301 and U305 offer unique advantages for interference-fit tube bonding with their lubricity, allowing parts to be mated easily and cured on demand.