中国国际医疗器械设计与制造技术展览会(Medtec China)2021

Dedicated to design & manufacturing for medical device

August 31-September 2 2022 | SWEECC H1&H2

The Journey Toward Intelligent Catheters

2022-06-02

The journey toward intelligent catheters is an important one, not only from the clinician’s perspective, but also from the patient’s. Their development is necessary to accelerate the shift from costly, burdensome surgical treatments toward cost-effective and patient-friendly, minimally invasive interventions. In order treat a wide range of patients and types of disease, it is crucial to have smaller and more flexible, high signal capacity catheters at the surgery team’s disposal.

This type of tool will provide surgeons with the high-quality imaging to precisely identify patient anatomy to help maximize the safety and efficacy of the procedure. Decreasing size and increasing the flexibility of these catheters will help physicians more effectively navigate demanding patient anatomy, resulting in efficient and accurate devices or therapeutic delivery. Together, these advancements result in tangible, direct benefits for the patients, such as greater access to safer, less-invasive procedures, with quicker recovery times.

Intelligent catheters, with new diagnostic and therapeutic capabilities, enables the development of new, advanced therapies for diseases that are currently treated by complex surgical procedures. This will not only allow for more individuals to be treated, but will minimize risks, improving quality of life and reducing death rates for these patients.

Intelligent catheters will allow a wider range of functions to be integrated into single, small devices in a cost-effective and industrially feasible manner. Since catheter-based procedures are typically done on an outpatient basis, they do not require an expensive OR suite or recovery in a hospital bed, helping to ease the gap in availability of surgical treatments across different demographics or countries.

To this end, solutions such as multi-filar cables and multi-channel transmission cables (MCT) represent a breakthrough in the design of medical device cables that take us one step closer on the journey to the next generation of these important devices.


MULTI-FILAR ACTIVE CATHETER SOLUTION

The innovation behind the multi-filar active cables is a significant breakthrough. Multi-filar cables can have a capacity of up to 60 lines — depending on AWG size or pitch — and are designed to provide not only increased functionality but also more signals into formerly inaccessible areas of the body. Using Junkosha’s precision-engineered PTFE lamination technology, 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, 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 overall manufacturing process simpler and more cost-effective.

The process of manufacturing multi-filar wires is complicated. Junkosha has perfected this process by being able to accommodate the specific requirements for the final product design. For example, each individual strand can be color coded in the material, in accordance with specific industry standards or to make connection operations more simplified in downstream operations. The bond strength between the individual strands can be adjusted to maximize strength for challenging assembly conditions or optimized for difficult separation processes. Multi-filar configurations allow for joining dissimilar single strand alloys together in one package. This flexibility in alloy selection is perfectly suited for applications like thermocouples — microcables that need a high strength member for load bearing or assembly operations and electrochemical process cells.

MULTI-CHANNEL TRANSMISSION CABLES

Multi-channel transmission (MCT) cables are a further milestone toward intelligent catheters. MCT represents a significant improvement on existing shielded twisted pair, coaxial, and flexible printed circuit technology and enables new data-rich signals to be utilized in therapies such as intracardiac echocardiogram, ultrasound endoscopy, and intervascular ultrasound (IVUS).

Existing catheters use shielded twisted pair or coaxial constructs to support signals along the device. This established technology has driven advances in catheter design and facilitated the delivery of many essential interventional, intervascular diagnostics, and therapies. However, the progress toward miniaturization and flexibility has been hampered by the standard coaxial approach which comprises a core conductor, insulation and a shield wire. Physics and electromagnetics have prevented the development of smaller cables and has inhibited catheter flexibility.

In contrast, the new MCT cable design includes four times the amount of signal lines per individual cable, while at the same time preserving signal to noise performance. This is possible thanks to the company’s patented shielding/grounding design. Whereas the traditional catheter requires two coaxial cables to run in parallel carrying two individual signal streams, MCT enables multiples of four signals to be brought together in one cable, thereby significantly increasing the signal capacity per unit diameter.

Early prototypes have achieved a 32 percent reduction in the size of the cable, a critical factor in the attainment of future procedures within narrower vessels. The MCT approach also provides a greater degree of flexibility compared to the existing approaches. This flexibility promises major advances in the scope of medical procedures, especially within endoscopy. Overall, this innovation addresses the mutually exclusive needs of small size and signal integrity simultaneously. This in turn unlocks opportunities for catheter manufacturers to deliver valuable, previously unrealized options, to clinicians.

As the requirement for smaller and smaller devices increases for a wider variety of therapies, so the need for innovations like the MCT solution become paramount to enable them. It is essential to continue to push the boundaries of what is possible on this journey to miniaturization, all the while unlocking opportunities for catheter manufacturers to deliver improved solutions.

LOOKING AHEAD

The pace of change in the medical device sector is increasing continuously. An example of this is the development of mapping catheters, which are used during cardiac and electrophysiological therapies. Mapping catheters are an innovation that help physicians to discover and evaluate the electroanatomical layout of the heart and surrounding area. Previously believed to be impossible, catheter-based solutions are now available to accurately pinpoint problems within blood vessels and the heart. Interventional procedures utilizing intelligent catheters rather than high-risk surgery will allow medical teams all over the world to decrease the risk to all patients, decrease recovery times, and to develop new therapies to heal diseases that until now have been impossible to treat.

As the demand for complex catheter-based procedures increases, the need for innovations such as the multi-filar cables and the multi-channel transmission cables become paramount to enable them. Solutions such as these are continually pushing the boundaries of what is possible with minimally invasive devices and intelligent catheters, unlocking opportunities for OEMs to deliver improved patient outcomes, quicker recovery times, and lower costs of care.

These solutions will be key to expanding the capabilities of medical teams around the world, helping reach maximum levels of medical quality and patient care, even in areas where, traditionally, medical resources have been scarce.

This article was written by Kevin LaDow, Medical Product Manager USA West, Junkosha USA Inc.