# US 12,179,000 B2 · Audible indicator

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- Number: US 12,179,000 B2
- Document ID: US12179000B2
- Status: Granted
- Kind: B2
- Application number: 17/148,296
- Filed: 2021-01-13
- Published: 2021-05-06
- Granted: 2024-12-31
- Earliest claimed: 2015-06-03
- Assignees: Sanofi-Aventis Deutschland GmbH
- Applicants: Sanofi-Aventis Deutschland GmbH
- Inventors: Carsten Mosebach; Thomas Mark Kemp; Louise Hodgson; William Timmis
- Web page: https://patentgrep.com/patent/US12179000B2

## CPC

- A61M 5/2033: {Spring-loaded one-shot injectors with or without automatic needle insertion (multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287)}
- A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
- A61M 5/3157: {Means providing feedback signals when administration is completed (A61M5/20 takes precedence)}
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- A61M 2205/43: making noise when used correctly
- A61M 2205/581: by audible feedback
- 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)}

## Abstract

The disclosure relates to an audible indicator for use with a drug delivery device comprising a bistable resilient force member capable of residing in two states. In a biased state, the resilient force member is biased and stores energy In a relaxed state, the resilient force member is relaxed. The resilient force member releases the stored energy when transitioning from the biased state into the relaxed state, thereby generating an audible signal.

## Claims

### Claim 1

An audible indicator for use with a drug delivery device, comprising:
a resilient force member configured to reside in two or more states having two or more different conformations,
wherein in a relaxed state, the resilient force member is configured to be relaxed in a first conformation,
wherein in a biased state, the resilient force member is configured to be biased to store energy in a second conformation different from the first conformation,
wherein the resilient force member is configured to release stored energy to generate an audible signal when changing from the biased state into the relaxed state due to a transition from the second conformation to the first conformation, and
wherein the resilient force member includes a leaf spring having a longitudinal axis, wherein the resilient force member is bent by a certain angle about the longitudinal axis forming two angled wing-shaped sections.

### Claim 2 (depends on 1)

The audible indicator according to claim 1, wherein the leaf spring has a rectangular shape, a square shape or an oval shape.

### Claim 3 (depends on 1)

The audible indicator according to claim 1, wherein the resilient force member is configured to be supported in the biased state in order to prevent transition into the relaxed state.

### Claim 4 (depends on 1)

The audible indicator according to claim 1, wherein the audible indicator is capable of producing an audible signal with a volume of at least 100 dB.

### Claim 5 (depends on 1)

The audible indicator according to claim 1, wherein the audible indicator is adapted to indicate completion of medicament delivery,
wherein the resilient force member includes a leaf spring comprising one or more wing-shaped sections adapted to store energy on one or more outer edges or in a central region of the one or more wing-shaped sections,
wherein the resilient force member is configured to change from the biased state into the relaxed state, when the one or more wing-shaped sections pivot about a certain angle.

### Claim 6 (depends on 1)

The audible indicator according to claim 1, wherein the resilient force member is a bistable resilient force member.

### Claim 7 (depends on 1)

The audible indicator according to claim 1, wherein the resilient force member is configured to be changed from the biased state by a movement of a plunger.

### Claim 8 (depends on 7)

The audible indicator according to claim 7, wherein the resilient force member is configured to be changed from the biased state into the relaxed state by the movement of the plunger towards a distal position at an end of a medicament delivery process.

### Claim 9 (depends on 1)

The audible indicator according to claim 1, wherein the resilient force member is configured such that a conversion from the biased state into the relaxed state causes the resilient force member to generate an audible signal.

### Claim 10 (depends on 9)

The audible indicator according to claim 9, wherein the resilient force member is configured to generate the audible signal without hitting any component of an autoinjector.

### Claim 11 (depends on 10)

The audible indicator according to claim 10, wherein the audible indicator is configured such that the audible signal indicates that a medicament delivery process is finished and/or that a full dose was spent.

### Claim 12

An audible indicator for use with a drug delivery device, comprising:
a resilient force member configured to reside in two or more states having two or more different conformations,
wherein in a relaxed state, the resilient force member is configured to be relaxed in a first conformation,
wherein in a biased state, the resilient force member is configured to be biased to store energy in a second conformation different from the first conformation,
wherein the resilient force member is configured to release stored energy to generate an audible signal when changing from the biased state into the relaxed state due to a transition from the second conformation to the first conformation,
wherein the resilient force member is configured such that a conversion from the biased state into the relaxed state causes the resilient force member to generate an audible signal,
wherein the resilient force member is configured to generate the audible signal without hitting any component of an autoinjector,
wherein the audible indicator is configured such that the audible signal indicates that a medicament delivery process is finished and/or that a full dose was spent, and
wherein the resilient force member comprises or is made of spring steel.

### Claim 13

An autoinjector, comprising: a case; a needle shroud telescopically coupled to the case and movable between a first extended position relative to the case in which a needle is covered and a retracted position relative to the case in which the needle is exposed; and an audible indicator comprising: a resilient force member configured to reside in two or more states having two or more different conformations, wherein in a relaxed state, the resilient force member is configured to be relaxed in a first conformation, wherein in a biased state, the resilient force member is configured to be biased to store energy in a second conformation due to an elastic deformation of the resilient force member, the second conformation being different from the first conformation, wherein the resilient force member is configured to release stored energy to generate an audible signal when changing from the biased state into the relaxed state due to a transition from the second conformation to the first conformation, wherein in the relaxed state, a longitudinal axis extending in a direction of a greatest length of the resilient force member is (i) parallel to a longitudinal axis of the autoinjector and/or (ii) parallel to a longitudinal axis of a plunger of the autoinjector which serves for forwarding a force of a drive spring, and wherein the longitudinal axis of the autoinjector and/or the longitudinal axis of the plunger extends along a direction in which the needle shroud is telescopically movable relative to the case.

### Claim 14 (depends on 13)

The autoinjector according to claim 13, comprising:
a retaining element,
wherein the retaining element is configured to support the resilient force member in the biased state in order to prevent transition into the relaxed state,
wherein the case is a rear case that comprises at least two support arms and the retaining element, and
wherein the at least two support arms and the retaining element project distally.

### Claim 15 (depends on 13)

The autoinjector according to claim 13, wherein the resilient force member is a bistable resilient force member.

### Claim 16 (depends on 13)

The autoinjector according to claim 13, wherein the resilient force member is a monostable resilient force member.

### Claim 17 (depends on 13)

The autoinjector according to claim 13, comprising a drive spring configured to provide a force for administering an injection of a drug.

### Claim 18 (depends on 13)

The autoinjector according to claim 13, comprising a retaining element on the case, the retaining element configured to support the resilient force member in the biased state on a distal end or on a distal end portion of the resilient force member.

### Claim 19 (depends on 13)

The autoinjector according to claim 13, comprising a plunger release mechanism for preventing release of the plunger prior to retraction of the needle shroud.

### Claim 20 (depends on 13)

The autoinjector according to claim 13, wherein a main axis of the resilient force member is parallel to the longitudinal axis of the autoinjector and/or parallel to the longitudinal axis of the plunger when the resilient force member is in the relaxed state.

### Claim 21 (depends on 20)

The autoinjector according to claim 20, comprising a medicament container containing a medicament, wherein the needle is attached to the medicament container.

### Claim 22

A method of delivering a drug from an autoinjector into a subject, the method comprising: moving a needle shroud of the autoinjector between a first extended position relative to a case of the autoinjector in which a needle is covered and a retracted position relative to the case in which the needle is exposed; delivering the drug from the autoinjector into the subject through the needle; and changing a resilient force member of an audible indicator of the autoinjector from a biased state in which the resilient force member stores energy in a first conformation due to an elastic deformation of the resilient force member to a relaxed state in which the resilient force member has a second conformation thereby releasing stored energy of the resilient force member to generate an audible signal, the second conformation being different from the first conformation, wherein in the relaxed state, a longitudinal axis extending in a direction of a greatest length of the resilient force member is (i) parallel to a longitudinal axis of the autoinjector and/or (ii) parallel to a longitudinal axis of a plunger of the autoinjector which serves for forwarding a force of a drive spring, and wherein the longitudinal axis of the autoinjector and/or the longitudinal axis of the plunger extends along a direction in which the needle shroud is telescopically movable relative to the case.

### Claim 23 (depends on 22)

The method of claim 22, wherein the drug comprises dupilumab or alirocumab.

### Claim 24 (depends on 23)

The method of claim 23, wherein the drug comprises small interfering RNA.
