Junkosha's peelable heat-shrinkable tube technology Junflon is expected to save time and improve the process in catheter manufacturing. Provided by Pure Light.
The following is how the peelable tube technology promotes the advancement of catheterization.
The future of the medical catheter industry is interesting, especially because organizations in this field are under pressure to provide cost-effective and highest-quality products in a shorter period of time. This is mainly driven by the global healthcare market, which continues to require products and solutions that push the limits at very competitive price points.
Take the catheter market as an example to illustrate these challenges. In the field of neurovascular technology, clinicians are pushing solutions that enable them to perform complex operations more effectively, which not only reduces the cost of time and money, but also provides patients with higher quality care. All technologies, including delivery of stents, coils, and in some cases even the delivery of signals/treatments through catheters, will change from "dispensable" to mainstream technology in the next few years.
The peelable heat shrinkable tubing (PHST) market is an exciting area. Not only does it address the unmet needs of healthcare customers, but it also paves the way for the gradual reduction of catheter-based surgery-a continuing need for medical device manufacturers.
PHST ultimately reduces the total cost of ownership (TCO) for catheter manufacturers. Since companies no longer need to use the process of scraping heat-shrinkable materials from the ducts, PHST can help them produce the final product faster, increase output and reduce inspection levels, while being more ergonomic.
The peelable heat shrink process requires a very specific set of tasks, usually using a mandrel, etched PTFE liner (EPL), braided sleeve, Pebax tube, PHST and laminator. After the EPL liner is stretched onto the mandrel and knotted at both ends, the catheter manufacturer should place it in a vertical laminator with a heating chuck at the top and a weight at the bottom to achieve consistent heating and Stretching amount. At this stage, an important consideration for catheter manufacturers is the tensile strength of the EPL. Generally speaking, high tensile strength is required, and many manufacturers have proprietary processes to develop this strength.
After the first stage is completed, the etched PTFE lined mandrel is removed from the laminator, and the metal braided sleeve is first placed on the liner (this provides the surgeon with tortuosity to help bend the catheter around the body to help Reach the vessel or section), then the Pebax tube, and finally the PHST. The next stage is to put all of this in a laminator, where PHST can reflow all the materials used in a continuous, strong tube. The catheter manufacturer can easily peel off the PHST, neck the mandrel and pull it out.
PHST's latest innovation is based on the needs of medical technology manufacturers, who require tubes that work on micro-guide wires to navigate blood vessels that can reach lesions or vascular segments in the brain or heart. This technology requires ultra-small PHST and high shrinkage. The ultra-small PHST tube is suitable for laminating the sheath coating to the tiny guide wires (e.g. 0.011 inch and 0.014 inch). PHST showed that the inner diameter after recovery was as low as 0.009 inches. In manufacturing processes where tapered microcatheter shafts are used or there are tolerance tightening issues, a high shrinkage ratio PHST (2:1) can be used.
One of the main advantages of PHST is that it can reduce the scrap rate and shorten the assembly time. Just open a slit at one end to start, PHST can be easily peeled along its entire length without additional tools, so it saves a lot of time when removing fluorinated ethylene propylene heat shrinkable tubing (FEP-HST). In addition, it improves In order to increase the productivity of catheter manufacturers, they can easily remove the PHST without damaging the catheter or guide wire, allowing the same catheter to be used more frequently.
The trend of miniaturization of catheters covers a wide range of applications, including neurovascular delivery of devices such as coils and stents for stroke or aneurysm treatment. The technology also enables signals/energy to help support treatments such as neuromodulation or neurostimulation, such as the potential treatment of Parkinson's disease.
In addition to miniaturization, another trend of medical device manufacturers is to develop catheters that can send diagnostic signals into the body or provide treatment. These are called "active" catheters.
Active catheters are designed to provide channels for the transmission of signals or energy, such as intravascular ultrasound. The feature of this technology is diagnostic applications, such as intravenous examination of atherosclerosis, in which case fatty substances gather along the arterial wall and the signal is returned to the data collection device at the distal end. Therapeutic applications include pulsed ultrasound to remove plaque, and transcranial MRI-guided HIFU (High Intensity Focused Ultrasound) system for non-invasive treatment of various brain diseases, such as brain cancer and Parkinson’s disease (thermo ultrasound) and stroke (mechanical Ultrasound) using microbubbles).
Peripheral arterial disease, in which plaque accumulates in the arteries of the legs and other parts to prevent blood flow, is usually treated with balloon angioplasty and stents. A new device pioneered by Shockwave Medical combines lithotripsy (sonic wave decomposition of calcium, commonly used to treat kidney stones) with angioplasty balloon catheters.
The miniaturization of catheters and the increasing popularity of active catheters are challenging the global medical device industry to produce solutions that enhance its use in previously inaccessible body parts. New tools such as PHST are cost-effective in reducing scrap rates, while also increasing output by reducing assembly time.
Joe Rowan is Junkosha's President and CEO of the United States and Europe. Junkosha was established in Japan in 1954 and is a pioneer in the application of complex fluoropolymer technology in the field of medical devices and microwave interconnection. Junkosha has three operations in Japan, including its headquarters, and sites in the United States, the United Kingdom, and China.
The views expressed in this blog post are only those of the author and do not necessarily reflect the views of MedicalDesignandOutsourcing.com or its employees.
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