# US 10,117,996 B2 · State changing appliance for a drug delivery device

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- Number: US 10,117,996 B2
- Document ID: US10117996B2
- Status: Granted
- Kind: B2
- Application number: 14/653,408
- Filed: 2013-12-20
- Published: 2015-12-03
- Granted: 2018-11-06
- Earliest claimed: 2012-12-21
- Assignees: Novo Nordisk A/S
- Applicants: Novo Nordisk A/S
- Inventors: Mads Schenstroem Stefansen
- Web page: https://patentgrep.com/patent/US10117996B2

## CPC

- A61M 5/31525: {Dosing (burettes, pipettes B01L3/02)}
- A61M 5/31536: {Blocking means to immobilize a selected dose, e.g. to administer equal doses}
- A61M 5/31575: {using scaling up or down transmissions, e.g. gearbox}
- A61M 2005/3154: {limiting maximum permissible dose}
- F04C 2270/0421: Controlled or regulated
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- F04C: ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS (engines F03C); ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS

## Abstract

A system comprising a state changing appliance and a drug delivery device, the state changing appliance comprising first interface means for rotationally locking to a first exterior portion of the drug delivery device, second interface means for rotationally locking to a second exterior portion of the drug delivery device, the first exterior portion and the second exterior portion being angularly displaceable relative to one another from a first relative position to a second relative position, which second relative position defines a set dose to be expelled by the drug delivery device, and limiter means for limiting a relative angular displacement between the first interface means and the second interface means.

## Claims

### Claim 1

A system comprising a drug delivery device of the type capable of displaying a set dose of drug to be expelled therefrom, and a state changing appliance structured for detachable attachment to the drug delivery device,
wherein the drug delivery device comprises:
a first exterior portion, and
a second exterior portion, the first exterior portion and the second exterior portion being capable of undergoing relative angular displacement from a first relative position defining a first state of the drug delivery device to a second relative position defining a second state of the drug delivery device, and
wherein the state changing appliance comprises:
a first coupling structure configured for rotational fixation with respect to the first exterior portion, wherein the first coupling structure is configured to engage with the first exterior portion in a first rotational interlocking connection, and wherein one of the first coupling structure and the first exterior portion comprises a plurality of circumferentially spaced apart first interface structures and the other of the first coupling structure and the first exterior portion comprises a first dedicated geometry adapted for engagement or abutment with one or more of the plurality of circumferentially spaced apart first interface structures,
a second coupling structure configured for rotational fixation with respect to the second exterior portion, the first coupling structure and the second coupling structure being capable of undergoing relative angular displacement, and the second coupling structure is configured to engage with the second exterior portion in a second rotational interlocking connection at a plurality of relative angular orientations of the state changing appliance and the drug delivery device, and wherein one of the second coupling structure and the second exterior portion comprises a plurality of circumferentially spaced apart second interface structures and the other of the second coupling structure and the second exterior portion comprises a second dedicated geometry adapted for engagement or abutment with one or more of the plurality of circumferentially spaced apart second interface structures, and
a limiter mechanism adapted to define a maximum for the relative angular displacement between the first coupling structure and the second coupling structure.

### Claim 2 (depends on 1)

A system according to claim 1, wherein the drug delivery device further comprises a housing and a dose dial rotatable relative to the housing to set a dose to be delivered from the drug delivery device, and wherein the first exterior portion is rotationally fixed with respect to the housing and the second exterior portion is rotationally fixed with respect to the dose dial.

### Claim 3 (depends on 1)

A system according to claim 1, wherein the state changing appliance further comprises a tubular shell body being open at one end and having a hollow interior, the hollow interior being structured to accommodate a portion of the drug delivery device, when the state changing appliance is attached to the drug delivery device.

### Claim 4 (depends on 3)

A system according to claim 3, wherein the drug delivery device comprises a drug reservoir having a drug outlet, and wherein a portion of the shell body covers the drug outlet when the state changing appliance is attached to the drug delivery device.

### Claim 5 (depends on 1)

A system according to claim 1, wherein the limiter mechanism comprises a position indicator rotationally locked with respect to the first coupling structure, a first abutment surface defining a first extreme position of the position indicator, and a second abutment surface angularly spaced apart from the first abutment surface and defining a second extreme position of the position indicator, at least one of the first abutment surface and the second abutment surface being rotationally coupled with the second coupling structure.

### Claim 6 (depends on 5)

A system according to claim 5, wherein the state changing appliance is switchable between a non-programmable state in which the first abutment surface and the second abutment surface are rotationally locked relative to one another and a programmable state in which the first abutment surface and the second abutment surface are capable of relative rotational motion.

### Claim 7 (depends on 6)

A system according to claim 6, wherein the first abutment surface is arranged on a first dose defining structure and the second abutment surface is arranged on a second dose defining structure, the first dose defining structure comprising a first engagement structure and the second dose defining structure comprising a second engagement structure, and wherein the first dose defining structure and the second dose defining structure are arranged concentrically about a longitudinal axis and are capable of relative axial displacement between a first relative axial position in which the first engagement structure interfaces with the second engagement structure to prevent relative angular displacement between the first dose defining structure and the second dose defining structure and a second relative axial position in which the first engagement structure and the second engagement structure are disengaged, thereby allowing relative angular displacement between the first dose defining structure and the second dose defining structure.

### Claim 8 (depends on 7)

A system according to claim 7, wherein the state changing appliance further comprises a user operable state defining button activatable to switch the first dose defining structure and the second dose defining structure between the first relative axial position and the second relative axial position.

### Claim 9 (depends on 7)

A system according to claim 7, wherein the first abutment surface and the second abutment surface are biased towards one another.

### Claim 10 (depends on 7)

A system according to claim 7, wherein the position indicator shifts from a dormant state to a functioning state in response to an attachment of the state changing appliance to the drug delivery device, and wherein in the functioning state, before reaching the second extreme position, the position indicator is prevented from returning to the dormant state by an engagement with at least one of the first dose defining structure and the second dose defining structure.

### Claim 11 (depends on 10)

A system according to claim 10, wherein the position indicator is biased towards the dormant state, and wherein when in the second extreme position the position indicator shifts from the functioning state to the dormant state in response to a detachment of the state changing appliance from the drug delivery device.

### Claim 12 (depends on 10)

A system according to claim 10, wherein the first abutment surface and the position indicator are biased towards one another by a biasing torque, and wherein the engagement between the position indicator and the at least one of the first dose defining structure and the second dose defining structure is adapted to resist the biasing torque.

### Claim 13 (depends on 12)

A system according to claim 12, wherein the engagement between the position indicator and the at least one of the first dose defining structure and the second dose defining structure comprises an interface provided with ratchet teeth circumferentially distributed along a radially extending surface, and wherein adjacent teeth are separated a distance which correlates with a dose dial increment of the drug delivery device.

### Claim 14 (depends on 5)

A system according to claim 5, wherein the at least one of the first abutment surface and the second abutment surface is rotationally coupled with the second coupling structure via a gear mechanism reducing the ratio of relative angular displacement between the first abutment surface and the position indicator to relative angular displacement between the first coupling structure and the second coupling structure.

### Claim 15 (depends on 14)

A system according to claim 14, further comprising a tubular shell body being open at one end and having a hollow interior, the hollow interior being structured to accommodate a portion of the drug delivery device, when the state changing appliance is attached to the drug delivery device, and wherein the shell body carries the second coupling structure and has a central gear in the hollow interior, wherein the first abutment surface is rotationally coupled with the second coupling structure via at least one spur gear meshing with the central gear and an internal gear of the first dose defining structure.

### Claim 16 (depends on 1)

A state changing appliance for use in a system according to claim 1.

### Claim 17 (depends on 1)

A drug delivery device for use in a system according to claim 1.