Laser Hermetic Sealing In Medical Devices

We possess extensive expertise in precision welding for implantable medical devices, including cardiac pacemakers, brain-computer interfaces, cochlear implants, capsule endoscopes, and particularly neuromodulation devices. The effectiveness of hermetic sealing not only determines product performance but is intrinsically linked to patient safety and clinical outcomes, necessitating exceptionally stringent sealing standards. Additionally, the inherent properties of stainless steel and titanium—core materials in most medical devices—introduce significant challenges to hermetic welding processes.

By conducting welding within glovebox-maintained water-oxygen-free inert gas atmospheres or vacuum environments, we achieve dual objectives: eliminating welding defects while ensuring ultralow water-oxygen levels (<1 ppm) and particulate cleanliness (ISO Class 5 equivalent). This controlled approach is critical for implantable devices, where biocompatibility and long-term stability directly impact therapeutic success.

Related Equipment
Pacemaker
Medical Devices hermetic sealing case

  • Material

    titanium alloy

  • Weld seam inspection

    The weld seam is uniform and flat, without cracks, pores, oxidation blackening, etc

  • Helium Leak Test

    Detection results of helium mass spectrometer leak detector：1*10-12Pa·m³/s

  • Other requirements

    Strictly control the water oxygen content

Our Quality Management
Standardized process flow
  • Material testing
  • Welding pretreatment
  • Fixture positioning
  • Seal welding
  • Hermetic testing
Triple reliability verification

  • process monitoring

    Real time closed-loop control of welding energy; CCD monitoring system for molten pool morphology

  • Testing methods

    Metallographic analysis (weld penetration and defect detection); Helium mass spectrometry leak detection (sensitivity 5 × 10 ⁻13 Pa · m ³/s)

  • Environment Simulation

    Temperature shock test (-55 ℃) ↔+ 125 ℃ 1000 cycles); 85% RH humidity aging test (2000 hours)

Following standards
  • ASTM B209 Standard for Aluminum and Aluminum Alloy Plates
  • EN 485-2 Aluminum Welding Applicability Certification
  • AMS 2681E Aerospace Laser Welding Process Specification
  • MIL-STD-883 Method 1014 Sealing Test
  • GJB 548B-2005 Reliability of Microelectronic Devices
  • NADCAP Welding AC7114 Aerospace Special Process Certification
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