How to assemble medical devices

Abstract

This disclosure provides, in general terms, a method for assembling a medical device. The method comprises forming a first assembly, the first assembly comprising a body, a needle mechanism, and a sterile connector operably connected to a portion of the needle mechanism and configured to accept a cartridge. The needle mechanism and the sterile connector form a fluid path assembly, which is mounted on the body forming the first assembly. The method further comprises forming a second assembly and combining the first and second assemblies. The second assembly comprises a base end and a translation mechanism, the translation mechanism configured to engage with a cartridge.

Claims

1. A method for assembling medical devices, To form a first assembly, wherein the first assembly is The main unit and Needle mechanism, Includes a sterile connector operably connected to a part of the needle mechanism and configured to accept a cartridge, The needle mechanism and the sterilization connector form a fluid path assembly that connects to the main body. To form a second assembly, wherein the second assembly is It includes a base end and a translation mechanism, the translation mechanism being configured to engage with the cartridge, The method comprising combining the first assembly and the second assembly.

2. The method according to claim 1, further comprising loading the cartridge into the first assembly before combining the first assembly with the second assembly.

3. The method according to claim 2, wherein the cartridge is filled with a drug while it is being loaded into the first assembly.

4. The method according to claim 2, wherein the cartridge is filled with water or empty during loading into the first assembly.

5. The method according to claim 1, wherein the main body includes a base, a chassis, a circuit board configured as a controller, and a start switch movable relative to the base.

6. The method according to claim 1, wherein the needle mechanism includes a carrier, a shuttle movably coupled to the carrier, a driver movably coupled to the carrier, a biasing member configured to apply a biasing force to the shuttle, and a fluid conduit coupled to the driver.

7. The aforementioned translation mechanism, An actuator coupled to the base end, The method according to claim 1, comprising a lead screw assembly.

8. The method according to claim 7, wherein the lead screw assembly includes a first screw, a second screw screwwise engaged with the first screw, and a third screw screwwise engaged with the second screw.

9. The process further includes loading the cartridge into the first assembly before combining the first assembly with the second assembly, The method according to claim 8, wherein the first screw is configured to engage with the cartridge when the first assembly and the second assembly are combined.

10. After combining the first assembly and the second assembly, the adhesive patch is bonded to the tissue engagement surface of the medical device, The method according to claim 1, further comprising sealing the medical device in a package after combining the first assembly and the second assembly.

11. The method according to claim 10, wherein the package includes a seal configured to indicate evidence of tampering.

12. Forming the first assembly is The method according to claim 1, comprising imaging one or more components of the first assembly to identify a defect.

13. Forming the first assembly is Bending the flexible part of the printed circuit board assembly, The method according to claim 1, comprising bonding the printed circuit board assembly to the main body.

14. A method for assembling medical devices, To form a first assembly, wherein the first assembly is A main body comprising a base, chassis, a circuit board configured as a controller, and a movable activation switch relative to the base, A needle mechanism having a carrier, a shuttle movably coupled to the carrier, a driver movably coupled to the carrier, a bias configured to apply a biasing force to the shuttle, and a fluid conduit coupled to the driver, Includes a sterile connector operably connected to a portion of the fluid conduit and configured to accept a cartridge, The needle mechanism and the sterilization connector form a fluid path assembly that connects to the base of the main body. To form a second assembly, wherein the second assembly is The assembly includes a base end, an actuator connected to the base end, and a lead screw assembly having a first screw, a second screw screwable into the first screw, and a third screw screwable into the second screw. The lead screw assembly is coupled to the actuator and forms a parallel movement mechanism, and the parallel movement mechanism is configured to engage with the cartridge. The method comprising combining the first assembly and the second assembly.

15. The method according to claim 14, further comprising loading the cartridge into the first assembly before combining the first assembly with the second assembly.

16. After combining the first assembly and the second assembly, the adhesive patch is bonded to the tissue engagement surface of the medical device, The method according to claim 14, further comprising sealing the medical device in a package after combining the first assembly and the second assembly.

17. Forming the first assembly is The method according to claim 14, comprising imaging one or more components of the first assembly to identify a defect.

18. A method for assembling a first assembly of a medical device, To form a needle mechanism having a carrier, a shuttle movably coupled to the carrier, a driver movably coupled to the carrier, a biasing member communicating with the shuttle and the driver, and a fluid conduit coupled to the driver, To form a sterile connector configured to accept a cartridge, The needle mechanism is coupled to the sterilization connector to form a fluid path assembly, The fluid path assembly is coupled to the base of the first assembly, The method comprising coupling a printed circuit board assembly to the base of the first assembly.

19. The method according to claim 18, further comprising imaging one or more components of the first assembly in order to identify a defect.

20. The method according to claim 18, further comprising bending a flexible portion of a printed circuit board assembly.

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