Pico-Cylinder
INSPIRATION
Picocyl’s story began in early 2012 at an innovative medical delivery device company. This company planned to commercialize various self-powered, single-use, handheld medical devices based on so-called “micro”-gas-filled cylinders for power source platforms. The medical device company recognized that springs did not have the energy profile, and that batteries were too expensive and required to much space, for delivering high-viscosity drugs and implantables for the human body. Gas-filled cylinders were the perfect component solution. Consistent with other projects and the company’s business model of using off-the-shelf components, a global sourcing activity was initiated. The sourcing journey began at MD&M West in Anaheim, CA with the identification of a several potential component providers. The potential component providers, located in Europe, Asia and North America were surveyed by the company’s sourcing team. They discovered that all available potential manufacturing sources were focused on industrial and automotive markets, with no regard and no understanding of medical device quality standards. The lack of a gas-filled cylinder manufacturer with capabilities and processes designed for medical applications became the inspiration to do it themselves.
THE CHALLENGE
The company’s project team had high standards for the gas-filled cylinders since these platforms could be used for life-critical applications – the gas-filled cylinders needed to perform 100% of the time. Additionally, the cylinders needed to be smaller than “micro”; the company’s team needed “pico” size cylinders. The available sources used industrial grade steel and were plated after the gas filling, making it extremely expensive, if not impossible to verify the required amount of gas in the cylinder to meet device specifications. After a year of searching, the company disappointedly concluded that if the projects were to continue, they would need to invest in not only designing the gas-filled cylinders and actuators, but also create a new manufacturing plant with new processes and custom designed automation for supplying the needed gas-filled cylinders. In late 2014, the seed for Picocyl was planted.
INNOVATIVE THINKING
The Picocyl design team and early founders met the challenge and engineered the world’s first “pico”-sized stainless-steel cylinder with a patented low-force Breakaway Septum cap and precision-matched actuator mechanism. Our solution centered around providing the right amount of stored energy for the task and the minimum gas actuation force necessary. Our goal was to deliver the smallest, most capable medical-grade power source to allow the surgical device designers to produce the most ergonomic and effective device available.
In early 2017, a new building was constructed from the ground up, with a state-of-the-art class 8 cleanroom for the sole purpose of manufacturing Pico-Cylinders for the medical industry. Proprietary manufacturing processes and custom automated equipment were created and validated to enable the first manufacturing plant in the world to provide a source for medical device gas-filled cylinders.
REQUIREMENTS
Low Puncture Force
Low puncture force (<80N) so that the Pico-Cylinder can be activated by a simple push of a lever by a finger or thumb which led to the development of the patented cap that breaks away with a blunt pin as opposed to the traditional cylinder that uses a sharpened puncture pin to shear a soft metal diaphragm. The force required for the traditional cylinder can be 4x what was required for the Pico-Cylinder.
Sealing
An elongated cylindrical sealing surface that allows a simple o-ring to seal on the neck of the canister for >2mm of stroke.
Traceability
Traceability is enabled by permanent laser marking of the cylinder during the filling process. Both a QR code and human readable text is used to contain the critical information of total mass, part number, lot number and serial number as required.
Gas Mass Measurement
The ability to measure the mass of the gas over the shelf life of the cylinder through the elimination of an external plating for corrosion protection. Traditional cylinders are made of mild steel that is then zinc plated following the filling and welding of the cylinders to close them. The variation in plating weight is often more than the mass of the gas inside the cylinder. This becomes more pronounced as the cylinders become smaller and therefore the mass of the gas becomes smaller. In the traditional cylinder, once it is filled, it is impossible to know what the mass of the gas is inside. Pico-Cylinders are made of stainless steel which has excellent corrosion protection. Since there is no added weight of plating, the total mass of the cylinder remains the same over the life of the product as long as there are no leaks. Checking for gas loss is as simple as weighing the cylinder and comparing it to its original fill weight that is laser marked on the cylinder.
High Burst Pressure
High burst pressures of >50 MPa (7250 psi) are required to ensure shipping and handling safety with both liquified CO2 and pure gases over a wide variety of shipping temperatures. This is accomplished by innovation in the cap configuration, the welding of the cap to the canister, the selection of high strength stainless steels, and rigorous FEA analysis and testing to ensure that the burst pressure is maintained with very high process capability.
Leak-Free Performance
Leak-free performance over the shelf life of the product. Since these are designed for life-critical medical devices, it is crucial that the cylinders maintain their gas mass over the life of the product. The leak integrity is enabled by the unique patented Breakaway Septum design that ensures that is only thin in the sections that will allow for the breakaway action of the septum and is thick in all other sections. The forming process also creates metal flow across the thin perimeter to provide improved grain structure that reduces inclusions and grain irregularities that would promote leakage.
LIFECYCLE JOURNEY
INTENTIONAL DESIGN
Pico-PinFunctionality
The biggest challenges for single-use, handheld medical device innovation has always been ergonomics and performance. Historically, available power sources have been too bulky, and too expensive with unnecessary features and functionality for single-use medical devices. This resulted in oversized, heavy, handheld devices that are not user friendly. Picocyl products provide high-performance, high-reliability options for device design in a convenient, easy-to-use form factor, that were previously not available to the medical device industry. Our Pico-Cylinders are filled with the optimum amount of pressurized gas to power your device to get the job done. No more, no less. It’s that simple. Furthermore, we know how to release the gas reliably and integrate the sub-system with your medical device through proven packaging techniques. With the smallest possible package of stored energy, right sized for your medical application, our application engineers can support your design tasks to develop effective, self-powered medical devices that maximize performance, ergonomics and ease of use.
Performance
Picocyl products provide a better alternative to devices operated manually, or powered by springs or batteries. Made of medical-grade stainless steel, our gas filled Pico-Cylinders are the only medical device components of their kind in the global market. Our Breakaway Septum Pico-Cylinders offer safe and reliable gas release for medical devices. Gas release is achieved by driving a Pico-Pin into the Breakaway Septum integrated into the Pico-Cylinder cap. The septum preferentially tears around the perimeter to “open-the-hatch” and release the gas. The diameter of the septum is larger than the Pico-Pin diameter, ensuring unobstructed gas release. Picocyl’s Pico-Pins are manufactured with proven high-volume automated manufacturing processes to ensure consistency and improve reliability. Our Valve-Release Pico-Cylinders are an alternative to our Breakaway Septum Pico-Cylinders, by incorporating a spring-loaded valve to allow for partial gas release and reclosure to maintain the internally stored gas until its next use. Multi-use powered devices or multi-use gas delivery applications are ideal for Valve-Release pico-Cylinders.
Consistency
Pico-Cylinders are precisely filled with high-purity gases to customizable volume and pressure specifications using our proprietary gas-filling and welding technology. To ensure component integrity, each Pico-Cylinder is 100% verified for fill weight, and laser marked for identification & traceability. Our 5th-generation, proprietary automated gas-filling and welding equipment was custom designed for the medical industry with annual capacities from hundreds of thousands to tens of millions of units per year. All Pico-Cylinders can be labeled with QR codes and/or human-readable information, including part identification, lot numbers and gross mass. Additionally, Picocyl can provide custom inspection equipment to ensure cylinders are received at your business as expected.
Quality
Picocyl is an ISO 13485:2016 certified company, with competencies in the design and development, manufacturing and distribution of gas-filled cylinders for gas-powered assembly modules for delivery systems for medical applications. All Picocyl components are manufactured in a state-of-the-art certified ISO Class 8 cleanroom. Our manufacturing environment ensures a clean, safe and contaminant-free product. At Picocyl, we consider our product to be a critical component of our customer’s devices. For this reason, after the automated gas filling and welding process, each Pico-Cylinder undergoes three additional 100% leak-free verification process steps to confirm seal integrity and to ensure performance over its entire shelf life.
Sustainability
Picocyl is an environmental conscious company and has actively designed our products and processes in an environmentally conscious manner. The stainless steel used in all of Picocyl’s products is made from RoHS compliant materials. Additionally, Picocyl has invested in automation to de-gas any out of specification cylinders so that the steel can be recycled. For some applications, Picocyl fills cylinders with “greenhouse” gases. For these products, Picocyl captures 100% of the exhaust / waste gases and sends the gas to companies that reuse the gases in industrial applications or disposes of the gas responsibly. Picocyl can also design a program to support the recycling of your device, partnering with Colorado based recycling and e-recycling businesses.
Manufacturability
Through years of strategic partnering, Picocyl has developed relationships with industry leading companies for deep drawing, metal stamping, plastic injection molding, custom automation and testing equipment. Picocyl’s proprietary gas filling and welding automation is currently in its 5th generation, with each new generation leveraging the previous generations lessons-learned and real-world data for continuous improvement.
