Balloon Catheter Design and Manufacturing

Balloon catheters are widely used in a range of minimally invasive medical procedures, both therapeutic and diagnostic. These include delivering stents, opening blockages, and dilating vessels. Being very specialized, non invasive medical devices of high precision, balloon catheters production requires extensive know how. In this article, we discuss the design considerations, as well as take a look at manufacturing overview of balloon catheters.

Application Considerations

Balloon Catheter Types

The primary driver for balloon catheter design is its intended use of application. Amongst the various factors to consider during the design phase are the type of balloon, the required type of catheter, as well as key device performance characteristics. Depending on the use case, there are three major types of balloon catheters, which are: Over The Wire (OTW), Rapid Exchange (RX), and Fixed Wire (FW). Each type offers its own advantages, depending on how each catheter type is guided by the physician through the desired path.

Balloon Catheter Applications

Today high-pressure balloons can have thinner walls, higher strength,  smaller profiles and can be utilized in a wide range of minimally invasive procedures. They can be produced in a wide range of diameters, lengths, and shapes. 

Enhancements in balloon design and technology provide increased flexibility to designers of medical devices, making the development of new and improved devices possible. As a result, high-pressure balloons are used in a variety of diagnostic and therapeutic procedures: 

  • Cardiology, multi-point instead of just single point ablation
  • Urology, the combination of temperature sensors provide the ability to test for Piezoelectricity
  • ENT, the opening of sinuses can be done using a balloon integrated catheter
  • Neurology and Gynecology have specialized balloon catheter uses today, such as combining examination with slow-release drugs delivered through a balloon catheter using a tilting motion

Balloon Catheter Design Considerations

There are some key performance characteristics that highly influence balloon catheter design. The first is the time required to inflate and deflate the balloon (inflation/deflation time), which should be minimized as much as possible. 

In order to achieve this, catheter manufacturers try to design the balloon in a way that maximizes the inner area of the inflation balloon. 

Second key characteristic is the catheter’s tracking ability to advance through the desired path and reach the treatment area. This is important for complex anatomy, eg. in neurological balloon catheter applications. 

Lastly, the insertion profile is another critical balloon catheter characteristic. It denotes the size of the incision required to insert the catheter into the patient. Smaller insertion profiles are of course preferable, since they facilitate quicker patient recovery and easier healing process.

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Manufacturing of Balloon Catheters

Why Assemble on a Balloon Catheter?

Balloon catheters occupy the volume of the natural geometric shape of a physiological region or cavity. This makes them by far the least invasive and most patient friendly operating and treatment method. Moreover, balloon catheters provide an ideal platform for deploying flexible circuit combinations, thereby enabling the development of new and innovative operation methods.

Specialized Materials & Manufacturing Techniques 

The materials and manufacturing techniques used in balloon catheter production are far too many to mention here, the most important however are:

  • Application of hydrophilic materials that offer lubricity, so that friction during catheter insertion is reduced
  • Use of radiopaque materials in certain catheter segments, for improved catheter visibility during usage
  • Utilization of materials with varying hardnesses, for accurate catheter flexibility control
  • Specialized metal braiding techniques and patterns, to offer the physician precise catheter torque manipulation
  • Specialized balloon forming techniques to achieve a desired shape or burst pressure levels to ensure safe and efficient balloon operation

Micro Assembly

Balloon catheters have detailed moving parts with specialized functionality. Depending on the assembly needs of the device, catheter manufacturers may need to operate micro-assembly lines. Utilizing a variety of visual aids including microscopes, highly trained and skilled operators perform detailed parts assembly. The result is consistent and reliable fabrication of detailed parts.

Embedded Electronics

An array of electronics may be used to augment balloon catheters operation and increase their efficiency. These may include electrodes, EKG sensors, unipolar or ablation electrodes, impedance based contact sensors, and thermistors, to name a few. So a big part of balloon catheter manufacturing involves embedded and stretchable electronics.

Your Balloon Catheter Partner

At Quasar, we have accumulated  the ability to execute complex balloon catheter assemblies, mounting elements on or inside the balloon. If you are considering developing a balloon catheter or seeking a solution to a specific challenge with your existing balloon catheter Contact us to discover how you can benefit from our know-how and experience. 

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