Injection device, a preassembled dose setting and injection mechanism for an injection device, and a method of assembling an injection device

• US 6,692,472 B2
• Filed: 05/01/2001
• Issued: 02/17/2004
• Est. Priority Date: 05/04/2000
• Status: Expired due to Term

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Miller, Thomas Dedenroth, Hansen, Steffen
• Primary Examiner(s): Huson, Gregory L.
• Assistant Examiner(s): HUYNH, KHOA D
• Application Number:
  US09/846,798
• Publication Number:
  US 20020007154A1
• Time in Patent Office: 1,022 Days
• Field of Search: 604/211, 604/224, 604/207, 604/208, 604/209, 604/210
• US Class Current: 604/211
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2005/3152 including gearings to multiply or attenuate the piston displacing force
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3146 Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/31535 Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
• CPC Class Codes: A61M 5/31541 Means preventing setting of a dose beyond the amount remaining in the cartridge
• CPC Class Codes: A61M 5/3155 by rotational movement of dose setting member, e.g. during setting or filling of a syringe
• CPC Class Codes: A61M 5/31558 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/3156 using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
• CPC Class Codes: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button
• CPC Class Codes: A61M 5/31595 Pre-defined multi-dose administration by repeated overcoming of means blocking the free advancing movement of piston rod, e.g. by tearing or de-blocking

Abstract

An injection device made up from a housing, a dose setting and injection mechanism, a dose setting member and an injection button is described. The dose setting and injection mechanism is made as a preassembled unit insertable into the housing. Both the dose setting member and the injection button is thereafter connected to the preassembled dose setting and injection mechanism inside the boundaries of the housing, while being accessible for a user from outside the housing. The same preassembled dose setting and injection mechanism can fit into a large variety of different houses making production of different variants of an injection device somewhat easier.

Claims

1. A dose setting and injecting mechanism for use with injection devices having housings, the mechanism comprising:

a. piston rod;

b. a piston rod drive means for driving the piston rod, the piston rod drive means being operatively coupled to the piston rod;

c. a dose setting means for setting prescribed; and

d. an injection means for activating the piston rod drive means to drive the piston;

wherein;

the piston rod, piston rod drive means, the dose setting means, and the injection means are operably connected to form a complete operating module that does not require structural assistance from an injection device'"'"'s housing to function.

2. The dose setting and injection mechanism of claim 1, further comprising a means for connecting the mechanism to an injection button and a means for connecting the mechanism to a dose setting member.

3. The dose setting and injection mechanism of claim 2, wherein the dose setting member and injection button are located on the outside on an injection device housing and wherein the connecting means are located internally within the injection device housing.

4. An injection device comprising:

a. a housing having an interior and exterior;

b. a cartridge having a movable piston;

c. an injection button for allowing a user to inject a dose, the injection button having at least a portion that is accessible from the exterior of the housing;

d. a dose setting member mounted to the housing and being accessible from the exterior of the housing

e. a pre-assembled dose setting and injecting mechanism comprising;

i. a piston rod;

ii. a piston rod drive means that is operatively coupled to the piston rod;

iii. a dose setting means for setting a prescribed dose and for controlling the drive of the piston rod drive means;

iv. an injection means for activating the piston rod drive means;

wherein;

the individual parts comprising the dose setting and injection mechanism, including parts i-iv, are pre-assembled as a functional module that does not require the housing for structure or operation; and

f. a means for securing the dose setting and injecting mechanism in the housing and operably coupling the mechanism to the injection button and dose setting member.

5. A method for assembling an injection device having a housing, a dose setting member exterior to the housing and an injection button exterior to the housing, the method comprising the steps of:

pre-assembling a dose setting and injection mechanism as a complete operable module that does not require housing from an injection device for structure;

inserting the pre-assembled dose setting and injection mechanism into the housing;

connecting the dose setting member to the pre-assembled mechanism; and

connecting the injection button to the pre-assembled mechanism.

6. The method of claim 5, further comprising testing the pre-assembled mechanism prior to inserting it in the housing.

7. A complete testable dose setting and injecting mechanism for use with injection devices having housings, the mechanism comprising:

a. piston rod;

b. a piston rod drive means for driving the piston rod, the piston rod drive means being operatively coupled to the piston rod;

c. a dose setting means for setting prescribed; and

d. an injection means for activating the piston rod drive means to drive the piston;

wherein;

the piston rod, piston rod drive means, the dose setting means, and the injection means are operably connected to form a complete operating testable module that is testable apart from and prior to being inserted into an injection device housing.

8. A method for manufacturing an injection device comprising:

a. constructing an injection device housing having an injection button mounted therein, the injection button being accessible on the exterior of the housing;

b. manufacturing and preassemblying a dose setting and injection mechanism that are testable apart from the device housing; and

c. inserting the dose setting and injection mechanism into the housing, whereby the dose setting and injection mechanism is operably coupled to the injection button.

9. The method of claim 8, wherein after step (b) but prior to step (c), the dose setting and injection mechanism is tested.

10. An injection device comprising:

a housing;

an injection button;

a selectively insertable and removable dose setting and injection mechanism that is operable and capable of being tested apart from the housing.