Product Assembly Expertise | Minnesota MedTec

Assembly Expertise can make a significant difference in production times and end-product quality.

Minnesota MedTec offers your company a wide variety of product assembly options to suit your specific applications and needs.

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Braided Delivery Systems
Sheaths
Balloon Catheters
Cables
Dilators
Loaders
Catheters
Prototyping
Packaging
Sterilization
Bar Coded Mfg. Inventory
Automated Label Printing

Braided Delivery Systems

Minnesota Medtec produces delivery systems which are designed for specific purposes.

Most of the delivery systems we product have at least a two components that must be produced independently but must function as a unit when it is complete. In many cases a customer will come to us and tell us the requirements of their product and we put together all of the specifications for them.

Tooling is generally available for most catheters systems but special items may be needed for specific unique product needs.

Sheaths

Minnesota MedTec are experts in manufacturing sheaths.

Sheaths are available in many varieties, shapes, and sizes. Sheath sizes are designed using a variety of ISO regulations but vary based on specific needs of customers.

Some customers declare the french size designation to be the ID of a sheath and others declare it to be the OD based on the use. For example, some advertise that a 6 fr. sheath is one that passes a six french catheter (actual dimensions can vary based on the product passing through the space) while others are more interested in the outside diameter of the catheter so they advertise that the catheter OD is six french.

What is a french anyway? A french is a third of a mm and is used originally as most catheters weren’t round. The doctors were concerned of how much space the catheters took up in bodies. Vessels and ducts are able to conform to oval objects so the physicians would roll the catheters on a french scale to determine the amount of space the catheter takes up so they know what size vessels they can fit the device into. Standard French sizes eventually took hold as the processing methods became available to produce round catheters. Don’t listen to Wikipedia.

At Minnesota MedTec we produce sheaths with coils, 16 carrier braid, 32 carrier braid, extruded, split-able, reflowed, centerless ground and many other methods and a variety of materials. Just complete the quote form and we will give send you the prices.

Balloon Catheters

Balloon catheters are manufactured in our certified class 10,000 controlled environments. Most drawings and processes are already established for Nylon and PU balloons. Some designs are made using adhesive bonded components and some of them are designed to use heat bonds based on the products performance requirements.

Balloons have very unique requirements based on the specific products performance requirements.

Volume tested balloons are used using volume sources such as syringes and usually have a larger expansion ratios so the user can start with a small crossing profile and inflate the balloons to large sizes to fill the areas required such a a balloon to measure the size of a heart defect or to implant an expandable valve.

These balloons have unique expansions ratios (generally over 20% from its starting size up to 4000%) and can be adjusted based on the processing method for blowing or casting to minimize or maximize the tensile modulus of the balloons as needed in the procedure.

Pressure tested balloons are generally used during angioplasty procedures or procedures that require high pressures and low elongation.

Some customers generalize these balloons into two categories ( compliant and non-compliant). All balloons are compliant to some extent when using a variety of pressures which increases at body temperature.

Distension (balloon expansion) is generally measured using the OD of final size (generally the OD @ maximum rated pressure or burst) minus the OD of blown size divided by the OD of the blown size.

Burst pressures can be determined using stress analysis and material tensile stress calculations to determine the required wall thicknesses to withstand the inflation pressures based on families of stress levels.

Cables

Minnesota MedTec has special processes to produce unique delivery cables and handle assemblies generally used to introduce components into vessels and enable the user to disconnect the cable when in use by simply unscrewing the device at the end of the cable.

The miniature screws and couplings have been used in 100’s of thousands of cases without any failures. Most of the cables are laser welded to coils with a center core that can be adjust in stiffness based on the needs of the customer.

Dilators

Minnesota MedTec has been making dilators for more than 20 years and has used this experience to to assist customers in specifying the perfect dilator for almost any application.

We have a large base of knowledge using a variety of materials for dilators. The materials, wall thicknesses, and tolerances are very important aspects for our customers dilators. Dilators must be advanced over a guide-wire and through the desired sheath or auxiliary component and provide a smooth introduction into vessels to its specified location easily. We prefer using polyethylene based materials for dilators because the low coefficient of friction and the hardness/wall thickness can be adjusted by the mixing HDPE and LDPE to the desired result.

Our dilators must have very smooth finishes using our proprietary sizing die technology during our extrusion process that shapes the outside diameter and applies the surface finish of the part to the desired size and smoothness. In some applications, we are required to make the surfaces with a mat finish.

We stock many sizes, lengths, and can provide them with hubs molded onto them for most applications.

Loaders

Information coming soon.

Catheters

Deflecting Tip Catheters

Using our patented device handle, Minnesota Medtec is able to produce deflecting tipped catheters with a variety of deflecting radiuses. We can even provide deflection with two different curves in one catheter for very difficult access locations.

Deflection catheters from 3 to 14 fr.

Coil Reinforced Catheters

During the past 20 years, Minnesota MedTec have had opportunity to insert coils into the walls of our catheters as well as braid.

Coils have a unique ability to support catheters shafts for kink resistance better then braid. Braid act just like the wall of a standard tube with compression on the inside radius of the tube and it stretches on the other side just like a standard tube. However, with a braid it does offer additional force required to kink a tube.

Coils inserted into catheter walls don’t have the same restrictions as from the braid and permits the catheter to elongate on the larger radius side of the tube and supports the tube better as it is deflected. A combination of both will allow for a torqueable shaft and a kink resistant distal segment that remains open while bent.

Coils can be inserted into a catheter on a continuous bases or in segments based on customer needs however there are some limitations for them.

Radiopaque Tipped Catheters

Radiopaque markers are used with catheters to visualize locations and components using radiologic techniques. Some of these techniques require very strong highly visible platinum, gold, or tungsten marker bands for visualization.

At Minnesota MedTec we use a variety of materials to aid in the visualization of products under x-rays and fluoroscopes. The standard materials are plastic resins filled with Barium, Bismuth, or tungsten braid to enable practitioners to see the entire shafts of products. In many cases we must use Tungsten materials extruded into plastics and coated with virgin plastic covers to make a safe and highly visible specific location on the catheters shaft.

The design choices are yours but the plastic processing is our expertise. We can even make these catheters with wall thicknesses as low as .005″ wall thicknesses.

Prototyping

Prototypes are free if its a standard product for us and you are a qualified prospect. We are a fully integrated company with extrusion, balloons, braiding, reflow, tooling, and assembly in house for your convenience.

At Minnesota MedTec our goal is to manufacture catheters not design them as the design process adds significant costs because of the burdensome long term regulatory processes and design control processes. The design is best left to you, our customer, but we can help you by informing you to the processes and polymer processing possibilities.

If needed, we can supply the design control process, FDA approvals, CE mark etc.

Packaging

Minnesota MedTec can offer our customers with cleanrooms packaging for just about any type of packaging desired. Some of the packaging requires tooling specific to your needs at additional costs may be required. We have Validated heat sealers with nitrogen back filling for Tyvek pouches as well as standard heat sealers for polybags and vapor barriers.

If desired, we can send parts out for packaging test and shelf life testing as needed.

Sterilization

One of the largest endeavors for product development is the sterilization and the sterilization validation process.

Minnesota MedTec will work with you through your desired process and include the sterilization process into our travelers as needed.

With the onset of virtual medical device companies, we are able to assist and manage all of your needs.

Bar Coded Mfg. Inventory

We believe in continuous improvement.

Bar coded manufacturing inventory is just one of our systems to help eliminate human errors from improperly made products and labels. The regulatory bodies consider labeling to be a very significant issue and no mistakes can be allowed.

When we receive an order from our customer, we verify all of the materials needed are in stock and are correct using our digital inventory system. Our system automatically generates the codes for the materials and labels to minimize any possible mistakes. Our travelers are also generated automatically from the documented processes and on the product prints.

Automated Label Printing

Automatic label printing is completed from the start of your order.

When our customers place their orders, MMTI creates a traveler that our employees use to document the steps and tests need to create the products. Using shipping addresses already qualified in the system, it eliminates human errors and creates an efficient system for packaging, labeling, certifying, and shipping.