Medical injection system comprising a medical injection device and a dose limiter module

• US 9,604,007 B2
• Filed: 11/08/2012
• Issued: 03/28/2017
• Est. Priority Date: 11/08/2011
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Kjeldsen, Bastian Gaardsvig, Mouridsen, Brian
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): DARB, HAMZA A.
• Application Number:
  US14/355,460
• Publication Number:
  US 20140257195A1
• Time in Patent Office: 1,601 Days
• Field of Search: 604207-212
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/3154 limiting maximum permissible 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 5/31553 without axial movement of dose setting member

Abstract

The present invention relates to a medical injection system comprising a medical injection device (100) of the type comprising a rotatable dose setting member (160). The system further comprises a dose limiter module (200) adapted for being releasably coupled to the injection device (100). The dose limiter module (200) comprises a dose limiter base (201) and a limiter (240) arranged relative to the dose limiter base (201) so that their relative position is adjustable to set an adjusted dose limiting position. When the dose limiter module (200) is coupled to the injection device (100), the limiter (240) cooperates with the dose setting member (160) to define a blocking means for preventing rotation of the dose setting member (160) beyond the adjusted dose limiting position. The dose limiter module (200) further comprises a user operable lock (210,212,232,223,243) configured for operation between a locked state and an unlocked state to respectively prevent and enable modification of the adjusted dose limiting position, the lock (210,212,232,223,243) being configured for maintaining the lock in the locked state at least when the dose limiter module (200) is not coupled with the injection device (100).

Claims

1. A medical injection system comprising an injection device and a dose limiter module,

wherein the injection device is configured for setting and injecting set doses of a drug from a reservoir and comprising a housing and a rotatable dose setting member, and wherein the injection device is configured so that during dose setting, the dose setting member is rotated in a first rotational direction from a first rotational position to a second rotational position in accordance with a size of a dose to be injected, and during dose injection, the dose setting member is rotated counter to said first rotational direction back to said first rotational position,

wherein the dose limiter module is adapted for being releasably coupled to the injection device to define a coupled state where the dose limiter module is attached to the injection device and to define a decoupled state where the dose limiter module is detached from the injection device, the dose limiter module comprising:

a dose limiter base,

a limiter arranged relative to the dose limiter base so that a relative position between the limiter and the dose limiter base is adjustable to set an adjusted dose limiting position of the drug from the reservoir,

wherein, in the coupled state, the limiter cooperates with the dose setting member to define a blocking structure for preventing rotation of the dose setting member beyond the adjusted dose limiting position when the dose setting member is rotated in the first rotational direction, and

wherein the dose limiter module comprises a user operable lock configured for operation between a locked state and an unlocked state to respectively prevent and enable adjustment of the position of the limiter relative to the dose limiter base, the lock being configured for maintaining the lock in the locked state at least when the dose limiter module is in the decoupled state.

2. The medical injection system as defined in claim 1, wherein the lock is so configured that, when the dose limiter module is in the coupled state, the lock is shiftable into an unlocked state of the lock to enable adjustment of the position of the limiter relative to the dose limiter base.

3. The medical injection system as defined in claim 1, wherein the lock comprises a lock operating structure that upon user operation shifts the lock from the locked state to the unlocked state to enable movement of the limiter relative to dose limiter base.

4. The medical injection system as defined in claim 1, wherein the limiter comprises a first thread that engages a thread associated with the dose limiter base and wherein a position of the limiter relative to the dose limiter base is adjusted by relative rotation between the limiter and the dose limiter base.

5. The medical injection system as defined in claim 1, wherein the dose limiter module is so configured that when the dose limiter module is in the coupled state, a position of the limiter relative to the dose limiter base is adjustable by structure of the dose setting member of the injection device.

6. The medical injection system as defined in claim 1, wherein the limiter and the dose limiter base are so configured that the limiter is movable between a minimum dose limiting position and a maximum dose limiting position and wherein the dose limiter module further comprises a spring adapted to act upon the limiter for urging the limiter towards the minimum dose limiting position so that when the limiter is positioned away from the minimum dose limiting position the limiter moves automatically towards the minimum dose limiting position when the lock is shifted to the unlocked state.

7. The medical injection system as defined in claim 6, wherein when in the coupled state, the limiter moves automatically into abutment with a track follower, when the lock is shifted to the unlocked state.

8. The medical injection system as defined in claim 1, wherein, when the dose limiter module is in the coupled state, the module and the injection device defines:

a first member that, at least in the locked state, is non-rotatably mounted relative to the dose limiter base, the first member defining a generally cylindrical surface defining a first track surface,

a second member that rotates around a central axis and that follows rotation of the dose setting member, the second member defining a generally cylindrical surface defining a second track surface, and

a track follower arranged between the first member and the second member, the track follower defining a first geometry for engaging the first track surface of the first member and a second geometry for engaging the second track surface of the second member,

wherein the first track surface is defined as one of a thread or a longitudinal track for engagement with the first geometry of the track follower, and wherein the second track surface is defined as another one of a thread or a longitudinal track for engagement with the second geometry of the track follower so that the track follower moves along the central axis when the dose setting member is rotated, and

wherein the limiter forms a part of said blocking structure for blocking rotation of the dose setting member in the first rotational direction by blocking axial movement of the track follower in accordance with the adjusted dose limiting position of the limiter relative to the dose limiter base.

9. The medical injection system as defined in claim 8, wherein the limiter defines said first member.

10. The medical injection system as defined in claim 8, wherein the dose limiter module defines the track follower and the second member so that when the dose limiter module is in the decoupled state, the track follower and the second member forms part of the dose limiter module.

11. The medical injection system as defined in claim 1, wherein, when the dose limiter module is in the coupled state, the module and the injection device defines:

a first member that, at least in the locked state, is non-rotatably mounted relative to the dose limiter base the first member defining a cylindrical surface defining a first thread

a second member that rotates around a central axis and that follows rotation of the dose setting member, the second member defining a cylindrical surface having a second thread, and

a track follower arranged between the first member and the second member, the track follower defining a first geometry for engaging the first thread of the first member and a second geometry for engaging the second thread of the second member,

wherein a pitch of the first thread is different to a pitch of a second thread so that the track follower rotates around the central axis and moves along the central axis when the dose setting member is rotated, and

wherein the limiter forms a part of said blocking structure for blocking rotation of the dose setting member in the first rotational direction by blocking axial movement of the track follower in accordance with the adjusted dose limiting position of the limiter relative to the dose limiter base.

12. The medical injection system as defined in claim 1, wherein the injection device includes a rotational dose element that defines a helical thread engaging a helical thread associated with the housing of the injection device, the rotational dose element being adapted to rotate with the dose setting member and wherein the limiter of the dose limiter module, when the dose limiter module is in the coupled state, is adapted to engage said rotational dose element for preventing rotation of the dose setting member beyond the adjusted dose limiting position when the dose setting member is rotated in the first rotational direction.

13. The medical injection system as defined in claim 12, wherein a dose dial scale defines said rotational dose element.

14. The medical injection system as defined in claim 12, wherein the rotational dose element defines one or more rotational blocking surfaces and wherein the limiter defines corresponding one or more rotational counter blocking surfaces and wherein the one or more rotational blocking surfaces engage respective ones of the one or more counter blocking surfaces for preventing rotation of the dose setting member beyond the adjusted dose limiting position when the dose setting member is rotated in the first rotational direction.

15. The medical injection system as defined in claim 1, wherein the limiter and the dose limiter base are adapted for relative rotation over an angle exceeding 360 degrees.