Steerable Catheters

Catheters

When it comes to designing, developing, and manufacturing high quality, predictable, steerable catheters, Midwest Interventional Systems can’t be beat. By leveraging our experience in managing complex steerable delivery systems from concept through commercialization, we help guide our clients through the development, ultimately getting them to market faster and within budget. We start our approach to steerable catheter design by defining design outputs, which include:

Bend angles

Bend diameters

Planes of deflection

Dimensional specifications

Steerable structural heart delivery systems - Transcatheter mitral valve and tricuspid valve delivery systems, Left atrial appendage closure delivery systems

Steerable ablation catheters

Robotically controlled steerable catheter systems

Steerable microcatheters

These outputs are driven by the anatomy and the approach. We have direct experience in designing and developing steerable systems for applications such as:

When it comes to designing, developing, and manufacturing high quality, predictable, steerable catheters, Midwest Interventional Systems can’t be beat. By leveraging our experience in managing complex steerable delivery systems from concept through commercialization, we help guide our clients through the development, ultimately getting them to market faster and within budget. We start our approach to steerable catheter design by defining design outputs, which include:

Bend angles

Bend diameters

Planes of deflection

These outputs are driven by the anatomy and the approach. We have direct experience in designing and developing steerable systems for applications such as:

Dimensional specifications

Steerable structural heart delivery systems - Transcatheter mitral valve and tricuspid valve delivery systems, Left atrial appendage closure delivery systems

Steerable ablation catheters

Robotically controlled steerable catheter systems

When it comes to designing, developing, and manufacturing high quality, predictable, steerable catheters, Midwest Interventional Systems can’t be beat. By leveraging our experience in managing complex steerable delivery systems from concept through commercialization, we help guide our clients through the development, ultimately getting them to market faster and within budget. We start our approach to steerable catheter design by defining design outputs, which include:

Bend angles

Bend diameters

Planes of deflection

Dimensional specifications

Steerable structural heart delivery systems - Transcatheter mitral valve and tricuspid valve delivery systems, Left atrial appendage closure delivery systems

Steerable ablation catheters

These outputs are driven by the anatomy and the approach. We have direct experience in designing and developing steerable systems for applications such as:

When it comes to designing, developing, and manufacturing high quality, predictable, steerable catheters, Midwest Interventional Systems can’t be beat. By leveraging our experience in managing complex steerable delivery systems from concept through commercialization, we help guide our clients through the development, ultimately getting them to market faster and within budget. We start our approach to steerable catheter design by defining design outputs, which include:

Bend angles

Bend diameters

Planes of deflection

Dimensional specifications

Steerable structural heart delivery systems - Transcatheter mitral valve and tricuspid valve delivery systems, Left atrial appendage closure delivery systems

Steerable ablation catheters

These outputs are driven by the anatomy and the approach. We have direct experience in designing and developing steerable systems for applications such as:

Robotically controlled steerable catheter systems

Steerable microcatheters

When it comes to designing, developing, and manufacturing high quality, predictable, steerable catheters, Midwest Interventional Systems can’t be beat. By leveraging our experience in managing complex steerable delivery systems from concept through commercialization, we help guide our clients through the development, ultimately getting them to market faster and within budget. We start our approach to steerable catheter design by defining design outputs, which include:

Bend angles

Bend diameters

Planes of deflection

Dimensional specifications

These outputs are driven by the anatomy and the approach. We have direct experience in designing and developing steerable systems for applications such as:

Steerable structural heart delivery systems - Transcatheter mitral valve and tricuspid valve delivery systems, Left atrial appendage closure delivery systems

Steerable ablation catheters

Robotically controlled steerable catheter systems

Steerable microcatheters

Steerable Catheter Design Process

Mandrels

The first component to consider in steerable catheter design does not actually make it into the final product – this component is the processing mandrel. Depending on the design requirements for the inner lumen of the steerable shaft, the following must be considered:

Thermal properties during reflow/lamination

Surface treatments

Geometry considerations - mandrel grooving, radius considerations

Liners

The next component MIS evaluates in the design process is the liner material for the main lumen and pull wire lumens for the catheter. Liners are lubricious material that line the inner diameter of lumens to reduce frictional forces from passing other instruments, catheters, devices, and in the case of steerables, pull wires through these lumens. There are a number of options for liner material to incorporate into the delivery system, and they ultimately depend on the application. Common liner materials typically consist of:

Film cast or ram extruded and etched PTFE

FEP, etched

Polyimide

Standard thermoplastic extrusions with lubricious additives

Reinforcement

The next layer to a steerable catheter delivery system is either a lamination aid or a reinforcement layer. The reinforcement layer plays a critical role in the overall device torqueability, achievable bend angles and bend diameters, kink resistance, and pushability. Depending on the application of the device, performance requirements, and other interacting devices, MIS engineers have a plethora of options in their catheter reinforcement toolbox, including, but not limited to:

Braid Reinforcement

Round and flat wire

Single, dual, tri, & quad start wire

Variable pitch braiding

Material: 304 & 316 Stainless steel, nitinol, tungsten, UHMWPE, etc.

Braid pattern and number of carriers

Coil Reinforcement

Round and flat wire

Clockwise and counterclockwise winding

Single or multilayered

Material: 304 & 316 Stainless steel, nitinol, tungsten, UHMWPE, etc.

Variable pitch coiling

-Braid/Coil Hybrid
-Laser cut hypotubes and polymers

Pull Ring & Wire Assembly

At the distal end of the reinforcement segment of a catheter, it is common to abut a steering assembly. Most commonly this includes a pull ring and pull wire assembly; however, there are other technologies like magnets and coaxial steering mechanisms that can be employed. For the majority of steerable systems, a pull ring and attached pull wire will be employed and act as a critical component which drives the articulation of the overall catheter system. Several items that we consider during pull wire and ring development are:

Ring and wire material selection

Round or flat pull wire design

Welding

Pull ring design

Pull wire to ring tensile

Force to deflect the overall system

Jacket

The final layer in constructing a steerable delivery system is the jacket, or medical extrusion. The extrusions provide coverage over the reinforcement layer of the catheter and are also critical to the device torqueability, flexibility, compression and elongation resistance. MIS will help in developing a number of specifications surrounding these jackets, which include:

Material selection – Polyamides, thermoplastic elastomers (TPEs), and thermoplastic urethanes (TPUs)

Selective durometer placement and material transition considerations

Hydrophilic coating

Catheter distal tip forming

Single and multilumen extrusion design

Contact us today to discuss how we can help determine the optimal approach to design your articulating catheter, and partnering with you on the development of your delivery system.

When it comes to designing, developing, and manufacturing high quality, predictable, steerable catheters, Midwest Interventional Systems can’t be beat. By leveraging our experience in managing complex steerable delivery systems from concept through commercialization, we help guide our clients through the development, ultimately getting them to market faster and within budget. We start our approach to steerable catheter design by defining design outputs, which include:

Bend angles

Bend diameters

Planes of deflection

Dimensional specifications

These outputs are driven by the anatomy and the approach. We have direct experience in designing and developing steerable systems for applications such as:

Steerable structural heart delivery systems - Transcatheter mitral valve and tricuspid valve delivery systems, Left atrial appendage closure delivery systems

Steerable ablation catheters

Robotically controlled steerable catheter systems

Steerable microcatheters

Microcatheter Design Process

Mandrels/Beading

Mandrel and processing aid selection is critical in microcatheter design. Depending on the design requirements for the inner lumen of the microcatheter, there are several features that must be considered:

Thermal properties during reflow/lamination

Surface treatments

Coatings

Geometry considerations - mandrel grooving, radius considerations, tapered mandrels

Radial compression

Liners

The next component MIS evaluates in the design process is the liner material for the main lumen of the catheter. Liners are lubricious material that line the inner diameter of lumens to reduce frictional forces from passing other instruments, catheters, devices. There are a number of options for liner material to incorporate into the delivery system, and they ultimately depend on the application. Common liner materials typically consist of:

Film cast or ram extruded and etched PTFE

FEP, etched

Polyimide

Standard thermoplastic extrusions with lubricious additives

Liner thicknesses for microcatheters can vary, but we have experience in working with liners that have a single wall thickness as low as 0.0005”.

Reinforcement

The next layer to a microcatheter delivery system is typically a reinforcement layer. The reinforcement layer plays a critical role in the overall device torquability, achievable bend angles and bend diameters, kink resistance, and pushability. Depending on the application of the device, performance requirements, and other interacting devices, MIS engineers have a plethora of options in their catheter reinforcement toolbox, including, but not limited to:

Braid Reinforcement

Round and flat wire

Single, dual, tri, & quad start wire

Variable pitch braiding

Material: 304 & 316 Stainless steel, nitinol, tungsten, UHMWPE, etc.

Braid pattern and number of carriers

Coil Reinforcement

Round and flat wire

Clockwise and counterclockwise winding

Single or multilayered

Material: 304 & 316 Stainless steel, nitinol, tungsten, UHMWPE, etc.

Variable pitch coiling

Braid/Coil Hybrid

Braided and coiled hybrid designs are commonplace in microcatheter design. A proximal braided portion provides pushability and torquability, while a coiled distal section allows for a tighter bend radius to be achieved while minimizing lumen ovalization. Important system considerations need to be taken into account, particularly at the junction of the braid and coil segments, and our experienced team can provide guidance in these areas.

Jacket

The final layer in constructing a microcatheter is the jacket, or medical extrusion. The extrusions provide coverage over the reinforcement layer of the catheter and are also critical to the device torqueability, flexibility, compression and elongation resistance. MIS will help in developing a number of specifications surrounding these jackets, which include:

Material selection – Polyamides, thermoplastic elastomers (TPEs), and thermoplastic urethanes (TPUs)

Selective durometer placement and material transition considerations

Hydrophilic coating

Catheter distal tip forming

Contact us today to discuss how we can help determine the optimal approach to design and develop your custom microcatheter.

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