Balloon Catheter Equipment & Expertise
Machine Solutions provides the full spectrum of equipment solutions needed to produce the world’s best balloon catheters. From concept to production, our equipment can meet the product specification and production demands of all customers. This includes machinery for balloon forming, balloon bonding, balloon folding, necking, cutting, coating, testing, mold production and more.
Machine Solutions is proud to be the one-stop shop for all balloon catheter manufacturing processes. Our equipment experts are ready to advise engineers on the best solution to meet their process needs.
MSI’s revolutionary folding method and equipment is used to manufacture most approved balloon catheters on the market today. The patented Wavepleat™ design reduces cycle times and minimizes fold diameters by optimizing curvature for the balloon material. Automated machines are equipped to maximize throughput or process drug eluting balloons. All of our equipment uses best in class materials to ensure quality control and repeatable results with data acquisition and networking capabilities.
Balloon forming is the keystone process for balloon catheter manufacturing. The electrically heated stretch blow molding process enables the production of various very accurate and repeatable high-quality balloons with tight tolerances in an extensive variety of sizes and shapes. BW-TEC offers a variety of balloon forming machines ranging from 1-up to 4-up systems. Equipment offerings come in vertical, horizontal and soft split mold configurations. All of BW-TEC balloon forming equipment is designed for the production of high-quality polymer balloons for angioplasty and other medical applications.
- Space saving vertical configurations
- Multi-part process with 4-up machines
- Soft balloon split mold machines for large diameter urethane balloons
- Balloon necking machine designed to neck down balloon tubes
- Balloon mold diameters: Ø 1.5 – 40 mm
- Balloon mold length: 6– 350 mm
Tube necking machines are designed to create the parasin required for the balloon forming process. The tubing is pulled through a heated sizing die to reduce the diameter in preparation for the balloon forming process the final diameter of the tube can be changed by adjusting the following parameters: die diameter, temperature, speed and sensor position.
Marker Band Swaging
Marker bands are swaged under the balloon tapers so that the balloon location can be identified using fluoroscopy. MSI specializes in marker band swaging technology that produces superior marker band appearance. Using high-tolerance machining techniques and unique fixed diameter tooling designs, MSI’s superior marker band swaging equipment ensures less variability than competitors. With over 10 years of experience, our seasoned engineers have the ability to design marker band swaging equipment to fit your specific needs with a wide range of materials and sizes.
Other beneficial features:
- Free sample processing to prove capability prior to purchase
- Entry-level price point
- Ability to add automation features to accommodate high-volume manufacturing
- Standard quality inspection and software documentation
Once formed the balloon is attached to the catheter tubing using hot air, hot dies or laser. Laser bonding creates short, soft and flexible welding-connections of the balloon to the catheter tubing. A CO2 laser provides the most precise heating method to manufacture catheters. Laser energy can be focused to a spot size of less than 0.5mm making short, soft and flexible welding-connections. The end result is precisely reproducible. Applications include proximal/distal balloon bonds, soft tip attachment and other catheter/tube bonding processes.
MSI’s mandrel straightening equipment is designed to recycle bent or bowed mandrels through an automated process. All of our mandrel straightener machines are designed to reduce material costs, reduce operator dependence with automatic, pick-and-place product handling, and process multiple mandrel diameters without tooling changes.
Our mandrel straightening product features include:
- Recycle bent or bowed mandrels
- Reduce material costs
- Reduce operator dependence with automatic, pick-and-place product handling
- Process multiple mandrel diameters without tooling changes
- Process bare or coated stainless steel mandrels
Drug Coated Balloon Folding
MSI’s drug-eluting balloon pleating and folding equipment is the industry’s first and only system specifically designed for processing DEB/DCB products. The FFS1075S expands upon industry-proven balloon folding technology with the addition of integrated PTFE film, which protects balloon coatings from damage and eliminates the potential for cross contamination, which can occur with conventional pleat/fold methods.
- Reduces folded profile and sheathing force
- Protects drug coatings from damage and cross contamination
- Reduces cycle time and operator handling
- Eliminates twisting of pleats
- Creates equal-length pleats for uniform deployment
Vertical Balloon Forming
Vertical orientation provides a small footprint for an optimal use of production floor space in the balloon forming process. Customers may start with a single machine and add on machines as additional capacity is required. The machine is equipped with a PLC control, a PC with touch screen and the BW-TEC HMI. All process parameters for individual products can be stored in separate recipes.
Automated Catheter Manufacturing Workstation
The “Workcell” is an automated platform designed to improve the quality, speed and cost of multiple balloon catheter and stent delivery production processes. Catheters are oriented vertically to significantly reduce floor space required. It is estimated that the standard configuration of these machines would require over 25 linear meters of manufacturing floor space. The Workcell can squeeze all of these processes into 2m2 machine.
- Single operator can run multiple production processes
- Parallel processes run simultaneously to optimize takt time and production output
- Vertical product handling reduces equipment footprint
- Integrate quality inspections without impact on takt time
- Automated product handling increases consistency of finished product
- Customize configuration to meet the needs of your unique process
Marker Band Swaging with Automated Positioning
MSI’s Automated Marker Band Swaging Equipment automatically positions and swages marker bands within tight manufacturing tolerances. Intended for high volume PTCA and PTA length product manufacturing, the pick and place loading option allows
for continuous, automated processing. The profile driven swagers include integrated PLC control system with touch screen interface for easy process development and quick product change over.
- Eliminates need for operator to manually load swaging machine and position bands
- Improve product positioning repeatability (±0.15mm accuracy product- and distance- dependent)
- Supports fast, easy change to different product sizes
- Swages a wide range of marker band materials
- Cleanroom ready
- Requires no lubrication or shims
- MSI provides functional and software inspection check lists to support validation activities
Protect Heat Sensitive Catheter Balloons
The Beahm Balloon Bonder 520-B Leverages long proven split-die technology as the system protects heat sensitive catheter balloons during the welding and bonding processes by encasing the balloon in a pneumatically actuated cavity immediately adjacent to the weld area. The equipment further enhances protection as the die heads are retracted during the loading and unloading process of the component. The 520-B balloon bonder is also ideal for the protection of heat sensitive materials of non-balloon type catheters such as electrical components and coils.