The future of the medical tubing sector is highly dynamic, not least because there are a variety of pressures on organizations within this area to provide solutions that are not only of the highest quality but also deliver cost savings throughout the product life cycle. This is mainly driven by the global healthcare market, which continues to demand products and solutions that push the boundaries of what is possible at a highly competitive price.

Take the catheter market as a prime example of these challenges. In the world of neurovascular interventions and other complicated procedures, catheter manufacturers are being pushed for solutions that not only deliver complex treatments more efficiently but also provide cost savings at every turn. In what is becoming a highly cost-conscious marketplace, solutions including peelable heat shrink tubing (PHST) products that enable catheter manufacturers to advance efficiencies through streamlining their workflows, and multi-filar active catheter solutions that provide increased signals into formerly inaccessible areas of the body, will go from being nice-to-have to becoming critical requirements in the future. In effect, today’s innovations are tomorrow’s essentials.

Developments in the PHST market

Developments in the PHST market are continuing all the time, making it an extremely exciting area to be involved in. Not only does this solution address healthcare customers’ unmet needs, but it also paves the way for progressively smaller catheter-based procedures — an ongoing requirement for medical device manufacturers.

For example, ultra-small PHST is designed to be the perfect tubing for laminating jacket coating to tiny guide wires, such as 0.011 and 0.014 in. These miniature guidewires are used in the navigation of vessels to reach a lesion or vessel segment within, for example, the brain or heart. High-shrink ratio PHST (2:1) on the other hand is ideal for processes where tapered microcatheter shafts are used or where tolerance take-up is an issue.

Since companies no longer want to use the process of skiving the heat shrink material from the catheter due to the damage it causes to the underlying construct, PHST can help them produce the final product more rapidly with improved yields and lower inspection levels while being more ergonomically safe.

Newer innovations are adding to PHST’s wider capabilities. For example, a 2.5:1 PHST has been designed that equips catheter manufacturers with the highest shrink ratio currently possible in peelable fluorinated ethylene propylene (FEP).

This tubing enables catheter manufacturers to save time and money through a reduced number of shrink processes. Additionally, thanks to PHST’s take-up, it allows the use of cost-effective, lower tolerance, baseline materials in the manufacturing process, and enables the ability to reflow these materials easily into a single smooth construct quickly and efficiently. This results in a reduced total cost of ownership for the catheter manufacturer, which in turn increases the margin available and provides a reinvestment opportunity.

Ultra-small peelable heat shrink tubing is designed for laminating jacket coating to tiny guide wires, such as 0.011 and 0.014 in. (Credit: Junkosha)

There are a number of applications where this new high-ratio PHST technology could enable better processes and cost savings, including neurovascular catheters that have tapered diameters for the floppy distal segments and proximal sections with larger diameters for pushable support. Because these catheters are mainly braid reinforced proximally and coil reinforced distally, there is a requirement for a PHST solution that can accommodate in a single step the compression required to provide significant bond strength of the materials.

In addition to enabling new processes for manufacturers in their development of innovative products, the faster and more forceful recovery of the 2.5:1 PHST products help reduce or eliminate air entrapment, which can be an unwanted cause of bubbles and associated product defects such as fish eyes, voids, and insufficient strength of bonded layers.

The Move Toward Miniaturization

The move toward miniaturization, from a medical tubing perspective, is picking up pace, with medical device manufacturers demanding catheter options that can readily penetrate harder-to-reach places. Added to this is the requirement for increasingly sophisticated catheters that can send diagnostic signals into the body or provide therapy — in other words, active catheters.

Active catheters are being enabled by technologies such as multi-filar — a new fine wire and cable solution designed using precision engineered PTFE lamination technology. The solution provides multiple signals through an ultra-small shaft, enabling a new generation of small, flexible and intelligent catheters to push the boundaries of current medical procedures.

Single-strand configurations are joined into a multi-filar assembly that can be utilized in electrophysiology catheters for applying pacing and recording protocols from inside the heart and ablation and balloon ablation catheters for atrial fibrillation as well as cardiac mapping. The multi-filar technique also allows for easier assembly of the signal or power wires into the final medical device, making the manufacturing process simpler and more cost-effective.

Alongside active catheters, further innovations that are changing OEM’s perceptions around what is possible include solutions such as mapping catheters, which are used during cardiac and electrophysiological therapies. Mapping catheters are an innovation that help physicians to discover and evaluate the electroanatomic layout of the heart and surrounding area.

High-shrink ratio peelable heat shrink tubing (2:1) is ideal for processes where tapered microcatheter shafts are used or where tolerance take-up is an issue. (Credit: Junkosha)

Overall, the trend toward miniaturization of catheters covers a wide spectrum of applications, including neurovascular delivery of devices such as coils and stents for stroke or aneurysm therapies, and even signals/energy to help support treatments such as neuro-modulation or neurostimulation in the case of research for treatment of Parkinson’s disease.

What Next?

The tubing market is forecasted to see considerable growth in the coming years. There is also evidence of new innovations driving the sector to not only keep up with the pace of change but to keep ahead of the everyday challenges of price, quality and the push for smaller applications.

The future of the medical tubing industry will continue to be an interesting area, not only because organizations in this market face a variety of pressures from the wider supply chain, but also the need to provide cost-effective, high-quality products in less time. This is mainly driven by the global healthcare sector, which continues to demand products and solutions that break through the boundaries at a highly competitive price point.

As we head into 2020, there are numerous challenges the medical tubing and catheter markets face every day in the U.S. and European markets, including:

  • Stringent regulation across all levels of healthcare.

  • The need to not only make procedures less invasive for patients but also that can enable a wider variety of procedures across harder to reach parts of the body.

  • The increasing cost of healthcare, especially in the United States, which places a huge strain on those looking to innovate and provide the best possible outcomes across the sector.

  • The need to streamline workflows and processes, especially for catheter manufacturers, to enable vital cost savings and a reduction in total cost of ownership.

One of the biggest challenges for organizations in this area is to keep innovating the highest quality tubing at the best price to meet customers’ unmet needs in the future. With the push for smaller procedures increasing every year, it is a critical requirement for tubing manufacturers to enable catheters to complete these tasks efficiently and cost-effectively.

Although these various challenges differ around the world, they all require one thing — innovations. These are needed to not only improve patient outcomes but to provide clinicians and other end users with technologies that make their lives easier, reduce costs and save them time. For this reason, continuous innovation must be at the heart of the healthcare sector’s requirements. Without this, the unmet needs will continue to be just that, unmet.

This article was written by Joe Rowan, President and CEO for USA & Europe of Junkosha, Tokyo, Japan. For more information, visit here .


Medical Design Briefs Magazine

This article first appeared in the April, 2020 issue of Medical Design Briefs Magazine.

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