Some medical devices include multiple single-use tubes that are needed to supply or remove fluids, gases, suction, and/or power for the same application. A paratube bonds these multiple tubes together into a single structure which makes them much easier to manage and identify.
Tekni-Plex Healthcare is a pioneer in the field of paratubing and has technology to tightly control the tolerances on the bond strength between tubing. Having a tight process window on the tube to tube bond is the key factor to limiting process risks associated with a paratube configuration.
Our application areas of expertise include arterial drills, neurovascular applications, wound management, laprascopic surgey, ophthomology, and biopsy devices.
Tight Process Controls
There are various methods and processes for bonding tubes together and they offer varying levels of product consistency. Tekni-Plex Healthcare is able to tightly control not only the peel strength consistency but also the inner diameter and outer diameter of each individual tube line.
Ensuring consistent and stable bond strength along with tight dimensional and concentricity specifications is a tricky process and can cause many downstream application problems when done incorrectly. Below are a few of the more common problems seen from inexperienced solutions providers.
Bond strength between tubes of more than 1.5 pounds can lead to the partial tearing of a tube wall. This can add to the risk of a fluid leak or lack of suction in the application due to an insufficient fitting attachment.
Non-uniform bonding between tubes can lead to chatter marks or void spaces on an individual tube. This can lead to process leaks because of insufficient solvent bonding to a fitting.
Bond strength between two tubes of less than 0.22 pounds of pull force can lead to random tube separation and an entire assembly falling apart prior to application use. This is usually rejected by a medical professional or clinician prior to use and can lead to increased costs and is detrimental to a company’s image.
Excessive pull force required to separate a tube can lead to tube distortion and concentricity issues. This could lead to process leaks during final application use.
Uneven tube separation can lead to an inconsistent tube outer diameter with “thin wall spots” which adds to rejects during assembly and can cause process leaks.
Uneven tube separation can lead to an inconsistent tube outer diameter with “thick wall spots” which adds to rejects during assembly and can cause process leaks.
The individual tubes inside the paratube can be engineered and customized to exact specifications. Customization options include:
- Configurations with up to 8 tubes bonded together.
- Colors, stripes, and texture can be added so that each tube can be identified easily and quickly for accurate installation onto the device. Up to 8 different colors can be used on the same paratube design.
- Each tube can be made of its own unique compound engineered to accommodate the fluid, gas, or suction it’s meant to deliver.
- The tube ends can be separated to ensure efficient and secure bonding into the connecting ports or luers.
Paratubing Validation Services
The Tekni-Plex Healthcare validation approach has been used to satisfy FDA validation requirements in other device components. The robust approach for validation is supported by an ISO 13485 quality system for traceability and reproducibility when moving into production. The validation incorporates operation qualification (OQ) and production qualification (PQ) to document and prove the critical parameter range for production, and then simulate production runs. The validation can be tuned to customer requirements according to their risk assessment. It also incorporates measurement systems analysis to satisfy measurement capability regulations, and in addition features current-part comparisons to ensure there is no change in quality or appearance to the customer’s production floor or end users.