Pulse Systems provides contract manufacturing services to the medical device industry for precision laser machining and processing of thin-wall tubular metal components, sub-assemblies, and implants. Among the breadth of services we offer are:

• Laser Cutting
• Electropolishing
• Nitinol Shape Setting / Heat Treating
• Corrosion Testing / Passivation
• Microblasting
• Laser Welding
• Cleanroom Assembly
• Stent Manufacturing
• CNC Machining

We participate with our customers in the entire product life cycle, from rapid turnaround for low-volume engineering prototypes all the way through cost-effective volume production in 100,000+ quantities.

Our ISO 9001:2008 Certified and ISO 13485:2003 certified manufacturing facility is located in Concord, California.

Laser Cutting

Laser machining is the core competency of our business. We have developed specific programming methodologies that enable us to efficiently laser cut designs that our competition cannot process. Whether your design is an intricate, tight tolerance, fragile part or a tube with a few features with wide tolerances, you can be assured we can make cost effective parts in prototype and production quantities.

• Cut tolerance of +/-0.00002
• Kerf width: down to .0005"
• Wall thickness: 0.002" to 0.025"
• Tubing diameter range: 0.008" – 0.700" OD

Material Capabilities:

• Stainless Steel
• Nitinol (NiTi)
• Cobalt Chromium
• Titanium
• Tantalum
• Platinum
• Gold
• Silver
• Brass
• Copper
• Hastelloy
• Magnesium
• Elgiloy
• Please contact us regarding other materials

Electropolishing

Permanently implantable medical devices such as stents and filters use electropolishing as a critical final surface finishing step.

While mechanical processes may polish and chemical processes may passivate, electropolishing does both. When electropolishing, the metal work piece is connected to the positive terminal of a DC power supply and immersed in a temperature controlled bath of electrolyte. The negative terminal of the power supply is attached to a separate electrode in the bath. When voltage is applied, current flows through the bath removing material from the work piece. It is this material removal that polishes the work piece.

The imperfections inherent to micromachining nitinol may negatively affect the performance and reduce the service life of a particular device. Subsequently, electropolishing is often critical to the functionality of the final Nitinol device. In nitinol this process removes surface imperfections while creating a thin uniform titanium oxide layer (TiO₂) that improves biocompatibility and reduces corrosion. The nearly nickel-free TiO₂ layer of electropolished Nitinol has been shown to be an excellent source of corrosion protection.

Electropolishing benefits stainless steel parts in ways similar to nitinol, but the mechanisms are different. Instead of a titanium oxide layer being formed, the corrosion improvements come from the removal of free iron from the surface of the material.

Our experienced engineers understand that there are different electropolishing requirements for different medical devices. We work with our customers on their unique electropolishing needs, which range from minimal material removal to micro-polished surfaces. Minimal material removal may refer to as little as 10% material removal, while micro-polishing the surface of a part may exceed 40% material removal. However, both of these values may vary greatly depending on the type of material and geometric configuration of the device. Please contact Pulse Systems and let our experienced engineers work with you on your specific needs.

Materials:

• Nitinol, Stainless Steel, Cobalt Chromium

Tolerance:

• Exceptional repeatability and predictability

Benefits:

• Removes slag, machining artifacts, and heat affected zones (HAZ) that result from thermo-cutting processes (e.g., laser, and EDM machining)
• Eliminates surface irregularities
• Rounds sharp edges
• Improves performance characteristics of Nitinol parts
• Dramatically enhances corrosion resistance
• Improves surface reflectivity and brightness
• Provides the most superior form of passivation of Stainless Steels and Nitinol
• Removes metallic and non-metallic inclusions introduced by manufacturing

Laser Welding

The process of laser welding is the joining of two metal parts using infrared laser energy. The parts are fixtured so that they can be fused together in a non-contact manner.

This process does not use filler metals and is done in an inert atmosphere, so that impurities are not introduced into the finished assembly. Laser welding is a very effective method for joining thin-walled tubular components used in medical devices.

• Computerized 4-axis Nd:YAG laser welding workstations
• Component assembly fixturing
• Weld types: spot, seam, butt, lap, circumferential, penetration
• Minimum spot size: .004"
• Welding of similar & dissimilar metals
  • Stainless to Platinum, Gold, Tantalum, or Copper
  • Copper to Nickel Chromium alloys
  • Nitinol to Tantalum o Stainless to Nitinol (limited strength)
• Cleanroom environment

Microblasting

The defining term in microblasting is micro—very small. The technology is used to clean, texture, deburr, or otherwise process very small parts and hard-to-reach areas with extreme accuracy. Microblasting is used to remove both the oxide layer and the remelt that occurs during laser cutting.

View large images

The microblasting equipment utilizes a very fine dry-abrasive powder which is propelled by compressed air through a small nozzle onto the surface to be processed. A variety of media types and sizes are available to provide the desired surface roughness.

• Ideal for overmolding and bonding applications
• Yields superior adhesion characteristics
• Various degrees of surface abrasion available
• Part deburring
• Surface preparation for electropolishing
• Can be used for quick turn prototypes compared to other finishes

Shape Setting / Heat Treating

Shape Setting refers to the process of forming a Nitinol device into its final geometric configuration when it is unconstrained and in its austenitic phase.

In order for a device to reach its functional geometric configuration, it is necessary to form the material into a new "memory" shape. To do so, the Nitinol device under goes heat treatment while being firmly constrained into its new shape in a fixture or on a mandrel. The heating methods can vary depending on the application.

At Pulse, we have various proven Shape Setting processes for different unique applications. Please contact Pulse Systems and let our experienced engineers work with you on your specific needs.

• Large expansion ratio
• Radial and complex shape setting capabilities
• Furnace and fluidized bath treatments
• Active Af testing: bend, crush and recovery testing of Nitinol

Cleanroom Assembly

Pulse Systems offers cleanroom assembly as a value-added service to our customers. Within our cleanroom facility, we can provide a wide range of mechanical assembly capabilities such as laser welding, microjoining, crimping, and bonding.

We offer tooling and fixture design and fabrication to facilitate start-up and expansion of your production.

With our in-house testing capability we can furnish tensile testing of completed assemblies. In conjunction with our assembly services, we can perform turn-key material outsourcing, handling of consigned materials.

After 10 years in the business of supporting hundreds of companies like yours, Pulse Systems is known by its customers for Quality, Service, Technology, Value, and Teamwork.

Quality

There can be no compromises when it comes to product quality. In the medical device industry, the quality of your product is only as good as the quality standards under which it was produced. At Pulse Systems, we accept nothing less than exceptional quality and conformance to your requirements.

Service

We understand that in business, time is money. By producing your prototypes quickly, and by meeting your growing production schedules, we increase your opportunity for success. We also understand that we need to keep you well-informed about the status of your jobs.

Technology

We have built our core competency in precision laser machining and related processing services to serve our customers' needs for those capabilities. We continuously expand our technical infrastructure so that you can concentrate your efforts on product design and development while we focus on these highly specialized manufacturing technologies.

Value

We take pride in providing value to our customers by delivering quality solutions for challenging problems in a timely and cost-effective manner. Through the efforts of our highly motivated team of employees, we have built a successful enterprise that will continue to grow to serve your needs in the future.

Teamwork

Over the years we have helped our customers grow from entrepreneurial start-up ventures to highly successful public companies. We are in business today because we have cooperatively built good working relations and common understanding of the product requirements with our customers.

Laser Cutting Guidelines

Determine cut width (laser Kerf width)

• + Larger kerf = faster cutting = less $
• + Smaller kerf = slower cutting = more $$$

Thin wall (.002" - .005") | .0005" - .001" Kerf
Normal Wall (.006" - .009") | .001" - .002" Kerf
Thick Wall (.010" - .025") | .0015" - .004" Kerf

Tubing Limitations

• + Wall = .002" - .025"
• + Diameter = .008" - .700" OD
• + Tubing Length: We can accommodate most tubing lengths over 4" but prefer lengths 54" and higher

Calculating yield from raw material

(Supplied Tubing Length - 6") / (Part Length + .015") = Maximum Part Yield Per Tubing Length

NG:YAG Laser limitations

• + Holes cut in tubing create a slight taper effect (fig. 1*)
• + Cuts are made "normal" to surface of tube (fig. 2)
• + Laser cannot cut "off-axis" (fig. 3)
• + Material rotates under fixed laser beam

Flat or "unrolled" drawing formats (fig. 4**)

• + DWG
• + DXF
• + PDF (for quoting purposes only. Pulse cannot program from PDF files)
• + SLDDRW (tubing should be created with longitudinal slit so part can be unrolled)

* Important: specify on drawing which diameter (ID or OD) is more critical to maintain for thru-hole measurements.
** Example of 2D flat or "unrolled" drawing file.