Laser cut hypotubes are precision-engineered, thin-wallede flexible metal tubes widely used in the production of medical devices such as catheters, endoscopes, and guidewires.
These flexible tubes are manufactured using advanced laser cutting technology, allowing for exceptional dimensional accuracy.
Laser cut hypotubes come in a range of sizes and specifications to meet varying medical needs. Othala Technology offers hypotube sizes from 0.3mm to 20mm in diameter, with wall thickness ranging from 0.06mm to 2mm, helping manufacturers choose the right size for their specific applications using hypotube gauge charts.
| Product Name | Laser Cut Hypotube |
|---|---|
| Application | Endoscopic instruments, catheter shafts, robotic surgical systems |
| Direction | Two, four, 360 degree |
| Material | Stainless Steel 304, 316, Ni-Ti, Cobalt Chrome |
| Hardness | HRC 22-25 (304), HRC 38-46 (17-7PH), HRC 40-50 (MP35N) |
| Diâmetro | 0.3mm to 20mm |
| Material Length | Up to 3m |
| Part Length | 0.2mm to 3mm |
| Kerf Width | 15µm to 30µm |
| Espessura da parede | 0.06mm to 2mm |
| Tolerance | ±0.01mm |
| Manufacturing | Corte a laser |
| Certification | ISO 9001:2015, ISO 13485 |
| Facilities | 5-Axis Laser Cutting Machine |
| Packing | PP bag or tailor-made packing on request |
| Application | Outer Diameter (mm) | Descrição |
|---|---|---|
| Laryngoscope | 4 | Used for visualizing the larynx. |
| Bronchoscope | 5 | Assists in examining the airways and lungs. |
| Gastroscope | 6 – 10 | Enables inspection of the gastrointestinal tract. |
| Ureterorenoscope | 3.5 | Designed for examining the ureter and kidney. |
| Arthroscope | 5 | Utilized in joint surgeries. |
| Percutaneous Nephroscope | 3.5 | Provides access to the kidneys for various procedures. |
| Biliary Endoscope | 4.5 | Used for viewing bile ducts. |
| Colonoscope | 10 – 15 | Essential for colorectal examinations. |
| Cystoscope | 1.8 – 2.8 | Employed to inspect the bladder. |
The choice of material for hypotubes is crucial as it directly influences their strength, flexibility, corrosion resistance, and biocompatibility—key factors for ensuring safe and effective medical applications. Hypotubes are commonly made from biocompatible metals such as stainless steel, nitinol (nickel-titanium alloy), cobalt chrome, or platinum, each offering unique advantages and trade-offs depending on the specific use.
Materials like 304, 316, 17-7PH, MP35N, L605, and Ni-Ti (nickel-titanium alloy) are often selected, with hardness levels ranging from 20 to 50 HRC, to meet the varied demands of different medical applications.
Stainless steel is a preferred choice for hypotubes due to its excellent strength, durability, corrosion resistance, and biocompatibility. Among the various grades, 304 and 316 stainless steel are most commonly used in medical applications.
Both 304 and 316 stainless steels are amenable to cold working to boost strength and dimensional accuracy. Additionally, their excellent machinability and compatibility with laser cutting allow for precise and complex hypotube patterning, essential for modern medical device designs.
The balance of mechanical performance, corrosion resistance, and manufacturability makes stainless steel, particularly grades 304 and 316, a reliable and versatile material for hypotube applications. However, it is less flexible compared to other materials, which may limit its use in devices requiring high flexibility or intricate navigation through tortuous pathways.
Nitinol, a nickel-titanium alloy, is highly valued in hypotube manufacturing for its exceptional flexibility, superelasticity, and unique shape-memory properties. Unlike stainless steel, nitinol can undergo large deformations and return to its original shape, making it ideal for navigating tortuous anatomies in minimally invasive procedures.
Its shape-memory effect allows the material to be heat-treated to “remember” predefined shapes, enabling precise actuation in devices like self-expanding stents and embolic filters. When electropolished, nitinol offers excellent biocompatibility and corrosion resistance, supporting long-term implantation with minimal tissue response.
However, nitinol’s high nickel content may pose allergy risks for sensitive patients, and its complex mechanical behavior often requires specialized fabrication techniques such as laser cutting, thermal setting, and tight process control—leading to higher manufacturing costs compared to stainless steel or titanium.
Despite these challenges, nitinol remains the material of choice for applications demanding superior kink resistance, dynamic flexibility, and reliable shape recovery—such as catheter shafts, guidewires, stents, and orthopedic fixation devices.
Cobalt Chrome (CoCr) alloys are an excellent choice for hypotube applications requiring a balanced combination of rigidity and flexibility. These alloys provide high mechanical strength and exceptional corrosion resistance, ensuring durability in demanding medical conditions. Their inherent biocompatibility makes CoCr especially suitable for applications such as catheter hypotubes, orthopedic implants (e.g., spinal rods or joint replacements), and precision surgical instruments.
However, compared to stainless steel or nitinol, CoCr alloys’ higher hardness introduces specific manufacturing challenges, including the need for specialized machining tools and potentially increased production costs. Despite these limitations, the versatility of CoCr in manufacturing processes like advanced machining and additive manufacturing (3D printing) allows for creating intricate geometries and customized medical solutions tailored to precise clinical needs.
Platinum-coated hypotubes are ideal for specialized medical applications due to their superior biocompatibility, enhanced radiopacity, and long-term corrosion resistance. Their exceptional purity ensures safety and compatibility within the human body, particularly in permanent implants and devices requiring clear imaging visibility.
Additionally, platinum’s excellent electrical conductivity and non-magnetic properties make these hypotubes highly suitable for applications such as pacemaker electrodes, neurostimulation devices, and MRI-compatible vascular implants. However, platinum’s relatively high cost and lower mechanical strength compared to other materials should be considered during selection.
Titanium is occasionally selected for hypotube applications that prioritize lightweight design, enhanced flexibility, and excellent biocompatibility. Its superior strength-to-weight ratio and high corrosion resistance make titanium particularly suited for specialized medical devices, such as minimally invasive surgical tools and lightweight implants.
Although used less frequently than stainless steel or nitinol—primarily due to higher manufacturing costs and machining challenges—titanium is valuable when reduced weight and flexibility are essential without compromising durability.
Engineers should carefully assess clinical demands, manufacturing complexity, and cost-effectiveness to determine if titanium provides the optimal balance of performance and reliability for their specific application.
The manufacturing process of hypotubes includes several key steps:
The selection of high-quality, biocompatible materials is essential for the performance and durability of hypotubes in medical devices. Stainless steel (Grades 304, 316) is commonly chosen for its strength, corrosion resistance, and ease of processing, making it ideal for general applications where mechanical strength and resistance to degradation are critical.
Nitinol (Nickel-Titanium alloy), valued for its superelasticity and shape memory properties, provides exceptional flexibility and kink resistance, making it ideal for applications requiring high flexibility, such as guidewires and stents. Other materials like Cobalt Chrome and copper may also be selected for their specific mechanical properties, such as increased strength or enhanced conductivity, depending on device requirements.
The choice of material must consider factors such as mechanical performance, biocompatibility, cost, and the specific requirements of the medical device. For instance, nitinol may be preferred for applications involving complex body pathways, while stainless steel might be chosen for more straightforward, cost-effective designs. By carefully selecting the most suitable material, the hypotube can achieve optimal performance, reliability, and safety in its intended medical application.
The processing of materials like nitinol is crucial to optimizing their unique properties for medical applications. Heat treatment and annealing involve carefully controlled heating cycles that relieve internal stresses and establish the desired phase transformation temperatures, ensuring that nitinol exhibits superelastic behavior, which allows the material to return to its original shape after deformation.
Cold working processes such as drawing (pulling the material through a die to reduce diameter) and plugging (shaping the material by forcing it through a mold) refine the tube dimensions and increase tensile strength without compromising flexibility. These processes maximize nitinol’s excellent properties, including superelasticity, shape memory, high strength, and corrosion resistance, making it ideal for applications like catheters, stents, and guidewires.
By precisely controlling these manufacturing steps to meet customer specifications, we ensure that the final hypotube performs reliably in complex medical environments, such as navigating tortuous anatomical pathways.
To improve the performance of hypotubes, Othala offers a PTFE (Polytetrafluoroethylene) coating service for stainless steel and nitinol materials. This coating enhances lubricity, significantly reducing friction during device navigation in the body and improving trackability. By providing a smooth, low-friction surface, it reduces wear on the device, leading to longer-lasting and more reliable performance in medical applications.
The PTFE coating process involves precise application methods tailored to customer specifications, ensuring compatibility with various medical devices. This service is available upon request, providing flexibility for manufacturers to meet specific performance and operational requirements.
In modern hypotube manufacturing, five-axis laser cutting machines are used to create precise, intricate patterns, slots, holes, and spirals on the tube surface. Engineers use computer-aided design (CAD) software to develop these patterns, which are then translated into machine instructions via computer-aided manufacturing (CAM) systems. The integration of CAD and CAM ensures that the laser beam follows micron-level precision, achieving customized designs to meet specific strength, flexibility, and functional requirements.
Othala’s programming specialists design programs that control the laser cutting machine, determining the exact dimensions, angles, and patterns required. This precision is critical for producing high-quality hypotubes, enabling them to navigate complex anatomical pathways with reliability and durability. Customization options, such as specific geometric shapes or patterns, can be tailored to meet unique customer specifications, ensuring the final product performs optimally for medical applications.
Laser cutting is a high-precision, non-contact process that uses a focused laser beam to vaporize material and create intricate features on hypotubes. Advanced five-axis machining enables the cutting of complex shapes with micron-level precision, which is essential for manufacturing tubes that must navigate intricate anatomical pathways. This process can create a variety of patterns, including straight cuts, angled slots, and detailed spiral designs, all while minimizing thermal impact to preserve material integrity and avoid burr formation.
At Othala, we use five-axis laser cutting to produce precise spiral patterns on hypotubes, ensuring optimal flexibility and strength. The ability to control such fine details is crucial for medical devices like catheters and guidewires, where precision and reliability are paramount. While the process is highly efficient and effective, it does require careful setup and consideration of material compatibility to achieve the desired results.
Punching is a high-precision machining process used to create holes or indentations in hypotubes. Using a punch and die set, the punch applies force to the material, causing it to deform and create the desired shape. This method is particularly effective for producing rapid, repetitive features with high precision, making it a cost-effective option for high-volume production.
Punching complements laser cutting by providing a quicker alternative for creating consistent and accurate holes or indentations. While it is ideal for certain shapes and materials, punching does have limitations, such as potential wear on the punch and die set and restrictions on material thickness. However, it remains an efficient process for producing precise features required in medical devices, such as fluid passage holes or attachment points.
Riveting is a mechanical fastening process used for joining reusable hypotubes or assemblies, providing secure connections without compromising the flexibility or strength of the tube. Unlike laser-cut hypotubes, which are typically designed for single-use, riveted hypotubes are intended for multiple uses, making them a cost-effective solution for certain medical devices.
The riveting process ensures durability and reliability in the connections, making it ideal for applications that require long-term use. Othala Technology offers expertise in processing riveting hypotubes, enabling the creation of reusable assemblies that maintain high performance throughout their lifecycle.
Passivation is a chemical treatment that removes free iron and surface contaminants from stainless steel, enhancing corrosion resistance by forming a uniform chromium oxide layer.
Typically, hypotubes are immersed in a controlled acid bath (commonly nitric or citric acid), with parameters such as acid type, concentration, temperature, and time carefully regulated. This process complies with standards like ASTM A967, ASTM A380, and AMS 2700E. While highly effective, passivation involves handling hazardous chemicals and requires proper waste management.
Electropolishing is an electrochemical process that smooths the hypotube’s surface by removing microscopic high points, resulting in a bright, clean finish with roughness values as low as 8 RMS. It eliminates burrs, embedded contaminants, and heat tint from previous processes, improving corrosion resistance and reducing bacterial adhesion—critical for medical devices.
Additionally, electrolytic polishing removes surface imperfections, such as burrs and microcracks, improving durability and corrosion resistance to meet ASTM B912 standards. However, it may slightly reduce material thickness and requires precise process control. A follow-up passivation step is often recommended for optimal passive layer formation.
Laser welding is commonly used to join hypotubes to components such as core wires and connectors, providing precise, localized heat input that minimizes thermal distortion and preserves the integrity of thin-walled tubes.
Micro-orbital and resistance welding are ideal for joining small-diameter tubes and creating leak-proof joints in high-throughput applications. These methods are known for their repeatability, low porosity, and consistent weld quality, though they have limited flexibility for complex geometries and may require specialized tooling. Post-weld cleaning and passivation are often necessary to remove heat tint and restore corrosion resistance at the weld site, particularly in stainless steel components used in medical devices.
Ultrasonic cleaning is an effective, non-destructive method for removing contaminants from hypotubes, particularly in medical and high-precision industrial applications. By using high-frequency sound waves (20–40 kHz), it generates microscopic bubbles through cavitation, which implode to create high-pressure jets that dislodge contaminants from both the inner and outer surfaces of the tubes.
Unlike traditional cleaning methods such as manual scrubbing or chemical cleaning, ultrasonic cleaning can reach difficult areas, like tiny crevices and blind holes, which are challenging to clean by other means. It is also non-abrasive, preserving the integrity of the delicate, thin-walled structure of hypotubes.
This process ensures superior cleanliness by removing oils, greases, metal particles, and biological residues, making it ideal for meeting stringent cleanliness standards. Additionally, it minimizes the use of harsh chemicals and can be seamlessly integrated into automated production lines for high-throughput cleaning.
Deburring is a crucial finishing process in hypotube production. This process removes sharp edges, burrs, and metal fragments left from cutting or machining, preventing tissue trauma, vessel damage, and reducing the risk of infection during device insertion.
Various deburring methods are employed depending on the tube material, geometry, and production volume, including mechanical deburring (manual tools, rotary brushes, and abrasive blasting), electrochemical deburring (ECD) for complex geometries, and electrical discharge machining (EDM) for delicate thin-walled tubes. Other methods such as tumbling, ultrasonic, high-pressure water jet, and thermal or chemical deburring offer solutions for specific needs, such as batch processing or fine finishing.
Automated deburring improves consistency and reduces labor, while inspection ensures that edges meet strict quality standards. A well-executed deburring process is essential for the reliability and safety of medical devices.
Quality control is crucial in the production of hypotubes to ensure they meet stringent dimensional, mechanical, and regulatory standards. Othala employs advanced testing equipment, including micrometer calipers, 2D, and 3D measuring instruments, to conduct precise dimensional inspections, verifying tolerances with high accuracy.
Material testing is performed to ensure the mechanical properties and biocompatibility of each hypotube, confirming they meet safety requirements for medical use. Adherence to medical device standards, such as ISO 13485 and ASTM specifications, ensures full compliance and regulatory approval.
Additionally, Othala customizes its quality control procedures to meet specific customer requirements for flexibility, rotational sensitivity, and dimensional accuracy. This thorough approach guarantees that every hypotube performs reliably in critical medical applications, such as catheters and guidewires, where precision, durability, and patient safety are paramount.
Hypotube manufacturing is a complex process that integrates material science, precision engineering, and advanced fabrication techniques. Among these, laser cutting plays a pivotal role, enabling the creation of intricate, micron-scale features with exceptional precision while minimizing thermal damage and preserving material integrity.
This non-contact, high-precision method is particularly effective for processing materials like stainless steel and nitinol, which are commonly used in medical devices. Although laser cutting requires a significant capital investment and careful process control, its long-term cost-effectiveness is evident due to its precision, which reduces the need for post-processing and minimizes material waste.
Compared to alternative manufacturing methods such as EDM or stamping, laser cutting offers greater flexibility in producing customized, high-performance hypotubes that meet stringent medical device standards. While laser cutting may impact the surface finish of the hypotubes, post-processing techniques like polishing can be used to achieve the desired smoothness.
Laser cutting creates intricate, micron-sized features with precision, minimizing thermal damage and preserving material integrity while avoiding mechanical deformation, burrs, and defects. Unlike traditional mechanical cutting methods, which rely on physical contact and may induce stress or distortion, laser cutting uses a focused light beam to vaporize the material. This process involves precise tube fixturing, calibration of laser parameters (wavelength, power, focus), and the use of assist gases (oxygen, nitrogen) to optimize cut quality and speed.
This results in:
Five-axis laser cutting is the industry standard for hypotube manufacturing, offering exceptional precision and versatility. By manipulating both the laser beam and the tube along multiple axes simultaneously, these systems enable the creation of complex, three-dimensional cuts on cylindrical surfaces. This technology is crucial for:
Despite its advantages, five-axis laser cutting demands a significant capital investment and skilled operators to achieve optimal results. Additionally, cutting efficiency may be challenged when working with certain materials or thicker sections. However, compared to traditional mechanical cutting or four-axis systems, the flexibility and precision of five-axis technology enable manufacturers to create more complex and intricate designs, making it particularly suited for critical applications like catheters and stents.
The choice of laser type is critical for cutting delicate hypotubes:
Each laser type offers distinct advantages depending on material and application. Fiber lasers are best for thicker materials, while femtosecond lasers excel in fine, delicate cuts. When selecting the optimal laser, factors such as material compatibility, cost, and scalability should be carefully considered.
Modern laser cutting solutions for hypotubes offer both efficiency and scalability:
By leveraging these advanced laser technologies, manufacturers can produce high-precision hypotubes that meet the rigorous demands of medical and industrial applications.
Various cutting patterns can improve flexibility, torque transmission, and overall performance of hypotubes. Each method is designed to meet specific needs in medical and industrial applications. From Continuous and Interrupted Spiral Cuts to Brickwork and Jigsaw Patterns, the design choice affects both the mechanical properties of the hypotube and its effectiveness for different tasks.
The easiest way to make a tube flexible is by cutting it into a spiral, which allows for different bend radii by altering the pitch. This type of hypotube is referred to as Continuous Spiral Cut Hypotubes. However, a full spiral lacks good torque transmission, as twisting one end has little effect on the other. To improve torque and pushability without significantly reducing flexibility, the spiral can be broken so that the cuts do not go around the entire circumference. These hypotubes, known as Interrupted Spiral Cut Hypotubes.
A different technique for creating flexible hypotubes involves using straight lines that run partially around the circumference. This method provides better pushability and torquability but less flexibility than a pure spiral. To achieve multi-plane flexibility, these lines are rotated, typically by 90 degrees. However, straight lines can cause stainless steel to crack under repeated flexing, especially at the tips where stress is highest. To mitigate this, I-shaped cuts are used, spreading the load and increasing durability, though this also increases manufacturing time and costs.
Brickwork Pattern Cut Hypotubes feature a design characterized by parallel lines of interrupted incisions that resemble the arrangement of stones in a brick wall. This unique pattern not only provides aesthetic appeal but also enhances the functional properties of the hypotube. The interrupted nature of the cuts contributes to improved torque transmission and pushability, as each section can flex independently.
Over the years, various intricate patterns have emerged for flexible tubes, with one standout design being the jigsaw cut, also known as the puzzle cut. In this method, different sections of the tube are entirely separate, connected by two D-shaped socket and ball joints, providing inherent flexibility. Similar to straight lines, movement can be restricted to a single plane. The jigsaw cut offers exceptional flexibility, torque, and pushability, ideally suited for thick wall sections to prevent dislocation. It can also be machined in thinner walls if care is taken.
There are a number of variations in the jigsaw, with some designs using straight edges rather than round. However, they all rely on the same principle and require laser cutting to achieve the highest quality.
Riveting hypotubes, akin to jigsaw-cut hypotubes, feature distinct sections completely separated, initially cut using a five-axis laser machine. However, riveting hypotubes are manually connected using rivets, with each joint section punched, typically in a D-shape. While laser-cut hypotubes are often disposable, riveting hypotubes offer reusability, albeit at a higher cost.
At Othala Technology, we specialize in bespoke cut hypotubes to meet the specific needs of our customers. Our hypotube design services allow for complete customization of materials, dimensions, and patterns to ensure that each product perfectly matches your requirements. We prioritize confidentiality by actively signing non-disclosure agreements with our customers to protect all unique designs and patterns. With our commitment to quality and customization, we deliver solutions that truly meet your expectations.
Thin hypotubes, used in medical devices such as catheters and guidewires, typically have wall thicknesses ranging from 0.001 inches (0.0254 mm) to 0.065 inches (1.65 mm) and require a precise manufacturing process before laser cutting or finishing.
Stainless steel (grades 304 or 316), nitinol, or cobalt chrome may be used depending on the specific application.
A solid billet is heated and passed through a piercing mill, creating a hollow center to form a rough tube with initial dimensions.
The tube is pulled through progressively smaller dies to reduce its diameter and wall thickness, with a plug drawing method maintaining inner diameter consistency.
Lubrication reduces friction, ensuring smooth movement and preventing surface damage.
After drawing, the tube is annealed in vacuum furnaces to relieve internal stresses, restore flexibility, and improve corrosion resistance and surface quality.
The tube undergoes washing, pickling, or passivation to remove contaminants, ensuring a smooth, polished surface necessary for biocompatibility and performance.
For precise dimensional tolerances and superior surface finish, the tube may undergo centerless grinding to improve roundness and accuracy.
Medical applications of hypotubes are essential in various devices.
In fluid delivery and sensing systems, hypotubes are used for fluid delivery, where tight dimensional control is essential, and in instrumentation requiring accurate sensing and flow control in confined spaces.
Hypotubes are also integral to mechanical cable assemblies, initially designed for guidewires and needles, and now widely used as load-bearing connectors in robotics and precision instruments. They serve as compact, strong, and flexible alternatives to traditional mechanical cables, enabling more efficient and reliable assemblies, especially in demanding industrial environments.
A hypotube is a small, flexible, hollow tube, commonly used in medical devices like catheters and endoscopes. It provides maneuverability, kink resistance, and torque transmission, making it ideal for navigating complex pathways.
Hypotubes are typically made using advanced laser cutting techniques, which create intricate patterns on the tube walls, enhancing flexibility while maintaining structural integrity. Materials like stainless steel, Ni-Ti, and Cobalt Chrome are commonly used.
Hypotubes are used in medical procedures such as flexible cystoscopy, endoscopy, and catheter-based interventions. They are also utilized in robotic applications and precision fluid delivery systems in industrial settings.
Hypotubes are often used in catheter shafts, providing the necessary structural support and flexibility to navigate complex anatomical pathways. While catheter shafts offer external strength, hypotubes enable internal flexibility and maneuverability.
Hypotubes are available in diameters ranging from 0.3mm to 20mm, with customizable lengths and wall thicknesses from 0.06mm to 2mm, tailored to meet specific medical and industrial application requirements.
Othala Technology is a prominent hypotube manufacturer, offering a wide range of customizable solutions with a focus on precision and compliance with industry standards like ISO 9001 and ISO 13485. Our expertise in designing complex components makes them a trusted partner in the medical device industry.
