MSI Balloon & Stent Equipment

Machine Solutions Inc. (MSI) is the leading process and testing equipment supplier to device manufacturers worldwide. The proprietary MSI segmental compression mechanism provides an even, repeatable radial compression that has been proven for stent crimping, stent loading, catheter balloon folding, and marker band swaging applications. We offer the most advanced, automated and integrated solutions to the medical device manufacturing industry.

Manufacturing

·       Stent Crimping

·       Balloon Pleating & Folding

·       Marker Band Swaging

·       Heart Valve Crimping Tools

·       Catheter Laser Bonding

·       Tube Processing

·       Catheter Laminating

·       Device Performance Testing

For a timely response, go to Online enquiry or contact us at +1 905 770 5108 or info@hngmedical.com.

Automated Stent Crimping-SC775S/875S 

The MSI SC775S/875S stent crimping equipment maximizes operator efficiency and streamlines product handling through automation, process control, and feedback. This equipment is intended for medium- to high-volume manufacturing of balloon-expandable stents and balloon-expandable stent graft products. The SC775S/875S integrates the proprietary MSI segmental compression mechanism with PLC control and touch screen user interface. Data acquisition collects and stores cycle data for quality purposes.

The SC775S/875S stent crimping equipment features multi-stage profiles with crimp-to-force and crimp-to-diameter movements, which is especially important for minimizing recoil associated with cobalt-chromium stents. Staged interrupts allow for in-process inspection and re-sheathing, and synchronized balloon vacuum and inflation can increase stent retention. Process alarm windows ensure the crimping process remains in control.

Features

·       Supports optional features such as barcode scanning, leak detection, and laser micrometer

·       Servo motor provides precision diameter control

·       Includes crimp-to-force and crimp-to-diameter operating modes

·       Improves stent retention and stent profiles

·       Includes multi-stage profiles with synchronized balloon pressure and process interrupts

·       Acquires and stores cycle data for quality purposes

Specification Data

Remarks:*0-0.100” diameter, 0-100lbs crimp force.

Balloon Catheter Pleating and Folding-FFS475S/575S 

The MSI FFS475S/575S is engineered and manufactured to pleat and fold balloon catheters to the lowest possible profile. This machine base provides accurate and repeatable results while reducing cycle times and reject rates. Small balloon profiles are achieved by designing each proprietary thermal Wavepleat™ head to the exact balloon specifications they are intended to process. MSI uses the most advanced machining practices to ensure the tightest tolerances in the industry.

This new, improved balloon catheter pleating and folding equipment focuses on a more user-friendly design while maintaining the capabilities and robustness of our current models. We have improved upon our current FFS775S/875S platforms by integrating all machine controls into the PLC/HMI to ensure ease of operation and maintenance, while providing a more cost-effective package.

The FFS475S/575S models are designed to be compatible with our current pleat and fold head designs. The two platforms can accommodate a variety of head lengths, making the FFS475/575 our most versatile pleat and fold machine base.

Features

·       Produces low profiles and high yields

·       Tightest dimensional tolerances in the industry

·       Reduced operator dependency

·       Product-specific profiles that allow for quick, easy set-up during lot changes

·       Thermal Wavepleat™ and fold heads

·       Accommodates a range of interchangeable head lengths

·       Force and diameter calibration performed by the user without removing the heads

Specification Data

Balloon Pleating and Folding

·       MSI Technology revolutionized balloon folding method across the industry

·       Patented “curved wings” ensures high yields

·       Uniform and repeatable balloon pleating and folding optimizes balloon profile

·       Custom designed equipment for each customer

DEB Balloon Folding 

·       Protects drug coatings during pleat and fold process

·       Successful installation and duplication in high volume production environments

·       Ensures desired drug dosage

·       Eliminate dependence on skilled operators 

·       Significant reduction in cycle time

Automated Stent Loading with CrimpPulse™ Technology-SE1900S 

The MSI SE1900S self-expanding stent loading equipment expands on industry-proven stent loading technology by making the process more repeatable and easier for operators to set up. The addition of patent-pending CrimpPulse™ technology reduces friction during loading, making it possible for manufactures to process longer-length and difficult-to-load stents.

The SE1900S is PLC controlled with a touch screen user interface. The system can network with local and server based data management and can integrate with other systems. These capabilities make the SE1900S an excellent choice for high volume manufacturers looking for advanced process control and integration with current MES systems.

Features

·       PLC controlled

·       Three element, quick change design

·       Automated handling system

·       Swages a wide range of materials

·       Low maintenance, space-saving design

·       No lubrication required

·       Clean room ready

Stent Loading 

·       Platforms for crimping and loading self expanding devices into delivery systems

·       Patented CrimpPulse™ technology to reduce loading forces

·       Product offerings for R&D to high volume manufacturing

High Force Rotary Swaging with Band Positioning-SW655S 

The SW655S platform combines MSI’s proprietary element swaging technology and patented marker band positioning capability into a single machine. The automated equipment eliminates the inconsistent results of manual processing, increases throughput, and produces higher-tolerance parts. The optional pick-and-place system allows this machine to run without any operator support.

The PC interface with the PLC control system allows the user to quickly change, set up, or develop profiles for a variety of product sizes. This system meets your manufacturing requirements by processing up to full-length catheters and subassemblies The segmental compression preswaging mechanism allows the unit to position and preswage products of various sizes without tooling changes.

MSI’s patented element swaging technology improves the repeatability of process results. The mechanism continuously swages down to a fixed diameter.  There is no need to adjust shims to achieve the desired results. The machine can process hundreds of thousands of cycles without geometrical changes or maintenance. Resulting products feature surpassingly smooth band finish and guidewire lumen integrity. The swaging mechanism doesn’t use any greases or lubricants, so it cn be installed in a clean room environment. The SW655S equipment produces highly repeatable results in an efficient, operator-free process that provides immediate benefits to the user.

Features

·       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

Automated High Force Rotary Swaging with PLC Control-SW255S 

The MSI SW255S integrates our proprietary Element swaging technology into a PLC-controlled automated handling system. Process controls include traverse speed, traverse distance, swage head rotation speed and the number of swage cycles. The robust Element technology swages a wide range of metal band materials down to a smooth, embedded final diameter.

The SW255S is ideal for R&D or manufacturing in a clean room environment. it features an automated handling system that advances product into the swage elements for a uniform, repeatable final swage diameter. This swaging process is upgradable to our automated machine platforms, allowing manufacturers to increase production volumes without redundant validation.

MSI SW255S-400 with our infinite travel distance roller system option will allow you to swage long travel band to band spacing distances eliminating the need to reposition the catheter during the swaging process marker band. This feature will allow for consistent accurate band spacing results. The roller system works very similarly to what comes on our automated platforms and provides a nice alternative to our traditional V block system with its simplistic design and feed capabilities.

Features

·       PLC controlled

·       Three element, quick change design

·       Automated handling system

·       Swages a wide range of materials

·       Low maintenance, space-saving design

·       No lubrication required

·       Clean room ready

Heart Valve Crimping Tools

·       Designed for crimping balloon expandable and self expanding heart valves in a lab and at patient bedside.

·       Durable base unit configurations and single use disposable units.

·       Custom configurations available for single use device applications.

    HV200                                                                  HV500                                                                           HV950

    Durable Crimping Tool                                      Disposable Crimping Tool                                          Durable Crimping Tool with Quill

  ·       Multi-use design                                                ·       Low cost, disposable, single procedure tool                 ·       Stainless steel push quill

  ·       Easily disassembled                                          ·       Designed and configured for specific device                ·       Screw advancement of quill

       and reassembled for cleaning

Interventional Device Testing Equipment (IDTE)

The interventional device testing equipment (IDTE) from MSI quantitatively tests, compares and records performance features of interventional devices. This equipment is ideal for testing catheters, guidewires, stent delivery systems, colonoscopes, endoscopes, and scope tools. IDTE’s PC controls and versatile test configurations allow for simple and repeatable test setups and instantaneous feedback on device design changes, there by reducing design timelines. Test results can be used for regulatory submissions, competitive product testing and R&D device evaluation.

The IDTE was designed with several international testing standards in mind. These include: ASTM F2394-07 for preconditioning of the stent on the deployment system prior to retention testing, ISO Standard 25539-1:2003(E) Titled “Cardiovascular Implants – Endovascular Devices” and ISO/TS15539:2000(E) Titled “Cardiovascular Implants Endovascular Prostheses”. While still adhering to published guidance standards, the IDTE allows users to distinguish their products from competitors by creating and testing in extremely challenging conditions.

Standard test methods include

·       Track force

·       Lesion crossability force

·       Push efficiency

·       Catheter-guide wire compatability

·       Flexibility/kink force

·       Bifurcation “kissing” stent force

·       Torque strength

·       Rotational response  

·       Torque to failure

·       Tip stiffness

·       Insertion force measurement

Stent Securement Testing-SR1000 

·       Guide-type securement test

·       Proximal or distal displacement

·       Video assist and capture of test

·       PC control and data capture