# US 12,005,240 B2 · Auto-injector

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- Number: US 12,005,240 B2
- Document ID: US12005240B2
- Status: Granted
- Kind: B2
- Application number: 18/413,900
- Filed: 2024-01-16
- Published: 2024-05-09
- Granted: 2024-06-11
- Earliest claimed: 2011-02-18
- Assignees: Sanofi-Aventis Deutschland GmbH
- Applicants: Sanofi-Aventis Deutschland GMBH
- Inventors: Simon Francis Brereton; Thomas Kemp; Rosie Burnell; Matthew Ekman
- Web page: https://patentgrep.com/patent/US12005240B2

## CPC

- A61M 5/3157: {Means providing feedback signals when administration is completed (A61M5/20 takes precedence)}
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- 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 5/326: {Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user}
- A61M 5/46: having means for controlling depth of insertion
- A61M 2005/206
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual 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

An auto-injector for administering a dose of a liquid medicament (M) is present having a tubular chassis telescopable in a tubular case, a carrier subassembly comprising a tubular carrier slidably arranged relative to the chassis inside the case, where the carrier is adapted to contain a syringe with a hollow injection needle. The injector also has a drive spring and a plunger for forwarding load of the drive spring to a stopper of the syringe, wherein the syringe is lockable for joint axial translation with the carrier. A control spring is arranged around the carrier for translating the carrier in a proximal direction (P) for insertion of the needle through the chassis into an injection site.

## Claims

### Claim 1

An auto-injector comprising:
a housing;
a sleeve slidably disposed within the housing and biased in a proximal direction relative to the housing, the sleeve slidable in a distal direction relative to the housing when the sleeve is pressed against an injection site;
a syringe carrier disposed within the housing, the syringe carrier configured to support a syringe within the housing;
a plunger rod comprising a proximal thrust surface with a cylindrical body extending distally from the proximal thrust surface, the cylindrical body defining an opening that extends through a sidewall of the cylindrical body, the plunger rod configured to displace a stopper of the syringe to dispense a medicament from the syringe when the syringe is disposed in the syringe carrier;
a compression drive spring disposed in a distal portion of the housing and having a proximal end engaged to the proximal thrust surface of the plunger rod to bias the plunger rod in the proximal direction relative to the housing;
a first part disposed within the distal portion of the housing and comprising a proximally-extending resilient arm having an enlarged proximal portion releasably held in contact with the opening of the plunger rod to limit proximal movement of the plunger rod relative to first part;
a second part disposed within the distal portion of the housing and comprising an axially-extending member with a protrusion located at a proximal end of the axially-extending member, the protrusion releasably coupled to the plunger rod;
a third part coupled to a distal end of the housing by an engagement between an outward protrusion of the third part and an opening defined by a sidewall of the housing; and
a second compression spring disposed within the distal portion of the housing and having a distal end engaged to the second part to bias the second part in the distal direction toward the third part,
wherein the auto-injector is configured such that upon a predetermined amount of proximal movement of the plunger rod relative to the second part, the second part moves in the distal direction relative to the plunger rod by the second compression spring and impacts the third part to produce an audible indication or a tactile indication.

### Claim 2 (depends on 1)

The auto-injector of claim 1, wherein a proximal portion of the syringe is configured to engage an inward protrusion of the syringe carrier to limit proximal movement of the syringe relative to the syringe carrier when the syringe is disposed in the syringe carrier.

### Claim 3 (depends on 2)

The auto-injector of claim 2, comprising the syringe disposed within the syringe carrier, the syringe comprising a needle fixed to a proximal end of the syringe and the stopper slidably disposed within the syringe, the syringe containing the medicament.

### Claim 4 (depends on 3)

The auto-injector of claim 3, further comprising a protective needle sheath covering the needle.

### Claim 5 (depends on 4)

The auto-injector of claim 4, further comprising a cap removably attached to a proximal end of the housing, the cap comprising an inner sleeve disposed inside the housing and around the protective needle sheath.

### Claim 6 (depends on 5)

The auto-injector of claim 5, wherein the inner sleeve comprises a barb configured to remove the protective needle sheath from the syringe when the cap is removed from the auto-injector.

### Claim 7 (depends on 1)

The auto-injector of claim 1, wherein the third part is coupled to the distal end of the housing such that at least a portion of the third part extends distally beyond the distal end of the housing.

### Claim 8 (depends on 7)

The auto-injector of claim 7, wherein a portion of the first part is disposed in an opening of the second part.

### Claim 9 (depends on 8)

The auto-injector of claim 8, wherein the opening of the second part is on a proximal portion of the second part.

### Claim 10 (depends on 1)

The auto-injector of claim 1, wherein the syringe carrier comprises a resilient arm with a protrusion configured to inwardly deflect upon a predetermined movement of the sleeve relative to the syringe carrier.

### Claim 11 (depends on 1)

The auto-injector of claim 1, wherein the predetermined amount of proximal movement corresponds to an amount of proximal movement in which substantially all the medicament has been dispensed from the syringe.

### Claim 12 (depends on 1)

The auto-injector of claim 1, wherein a ramped engagement between the proximally-extending resilient arm and the opening of the plunger rod biases the proximally-extending resilient arm transversely with respect to the plunger rod.

### Claim 13 (depends on 1)

The auto-injector of claim 1, wherein the protrusion of the second part is releasably coupled to the plunger rod to limit distal movement of the second part relative to the housing.

### Claim 14

An auto-injector comprising:
a housing;
a sleeve slidably disposed within the housing and biased in a proximal direction relative to the housing, the sleeve slidable in a distal direction relative to the housing when the sleeve is pressed against an injection site;
a syringe carrier disposed within the housing, the syringe carrier configured to support a syringe within the housing;
a plunger rod comprising a proximal thrust surface with a cylindrical body extending distally from the proximal thrust surface, the cylindrical body defining an opening that extends through a sidewall of the cylindrical body, the plunger rod configured to displace a stopper of the syringe to dispense a medicament from the syringe when the syringe is disposed in the syringe carrier;
a compression drive spring disposed in a distal portion of the housing and having a proximal end engaged to the proximal thrust surface of the plunger rod to bias the plunger rod in the proximal direction relative to the housing;
a first part disposed within the distal portion of the housing and comprising a proximally-extending resilient arm having an enlarged proximal portion releasably held in contact with the opening of the plunger rod to limit proximal movement of the plunger rod relative to first part;
a second part disposed within the distal portion of the housing and comprising an axially-extending member with a protrusion located at a proximal end of the axially-extending member, the protrusion releasably coupled to the plunger rod;
a second compression spring disposed within the distal portion of the housing and having a distal end engaged to the second part to bias the second part in the distal direction; and
a cylindrical sleeve disposed within the distal portion of the housing and having a cylindrical surface releasably engaged to the enlarged proximal portion of the proximally-extending resilient arm to limit the enlarged proximal portion of the proximally-extending resilient arm from deflecting out of engagement with the opening of the plunger rod,
wherein the auto-injector is configured such that upon a predetermined amount of proximal movement of the plunger rod relative to the second part, the second part moves in the distal direction relative to the plunger rod by the second compression spring causing an audible indication or a tactile indication to be produced.

### Claim 15 (depends on 14)

The auto-injector of claim 14, wherein the cylindrical sleeve is axially movable relative to the proximally-extending resilient arm while maintaining the engagement to the enlarged proximal portion of the proximally-extending resilient arm to limit the proximally-extending resilient arm from deflecting out of engagement with the plunger rod.

### Claim 16 (depends on 15)

The auto-injector of claim 15, wherein the auto-injector is configured such that the proximally-extending resilient arm deflects out of engagement with the opening of the plunger rod upon the cylindrical surface of the cylindrical sleeve moving to a distal side of the enlarged proximal portion of the proximally-extending resilient arm.

### Claim 17 (depends on 14)

The auto-injector of claim 14, wherein the plunger rod and the proximally-extending resilient arm are disposed between the compression drive spring and the cylindrical sleeve.

### Claim 18 (depends on 14)

The auto-injector of claim 14, wherein the predetermined amount of proximal movement corresponds to an amount of proximal movement in which substantially all the medicament has been dispensed from the syringe.

### Claim 19 (depends on 18)

The auto-injector of claim 18, comprising the syringe disposed in the syringe carrier, the syringe containing the medicament.

### Claim 20 (depends on 14)

The auto-injector of claim 14, wherein the protrusion of the second part is releasably coupled to the plunger rod to limit distal movement of the second part relative to the housing.

### Claim 21

An auto-injector comprising:
a housing;
a sleeve slidably disposed within the housing and biased in a proximal direction relative to the housing, the sleeve slidable in a distal direction relative to the housing when the sleeve is pressed against an injection site;
a syringe carrier disposed within the housing, the syringe carrier configured to support a syringe within the housing;
a plunger rod comprising a proximal thrust surface with a cylindrical body extending distally from the proximal thrust surface, the cylindrical body defining an opening that extends through a sidewall of the cylindrical body, the plunger rod configured to displace a stopper of the syringe to dispense a medicament from the syringe when the syringe is disposed in the syringe carrier;
a compression drive spring disposed in a distal portion of the housing and having a proximal end that is engaged with the proximal thrust surface of the plunger rod to bias the plunger rod in the proximal direction relative to the housing;
a first part disposed within the distal portion of the housing and comprising a proximally-extending resilient arm having an enlarged proximal portion releasably held in contact with the opening of the plunger rod to limit proximal movement of the plunger rod relative to the housing;
a second part disposed within the distal portion of the housing and comprising an axially-extending member with a protrusion located at a proximal end of the axially-extending member, the protrusion releasably coupled to the plunger rod; and
a second compression spring disposed within the distal portion of the housing biasing the second part in the distal direction relative to the housing,
wherein the auto-injector is configured such that upon a predetermined amount of proximal movement of the plunger rod relative to the second part, the second part moves in the distal direction relative to the plunger rod by the second compression spring and causes an audible indication or a tactile indication to be produced.

### Claim 22 (depends on 21)

The auto-injector of claim 21, wherein the protrusion of the second part is releasably coupled to the plunger rod to limit distal movement of the second part relative to the housing.

### Claim 23 (depends on 21)

The auto-injector of claim 21, wherein the auto-injector is configured such that the enlarged proximal portion of the proximally-extending resilient arm deflects out of engagement with the opening of the plunger rod upon a cylindrical surface moving to a distal side of the enlarged proximal portion of the proximally-extending resilient arm.

### Claim 24 (depends on 23)

The auto-injector of claim 23, wherein the plunger rod and the proximally-extending resilient arm are disposed between the compression drive spring and the cylindrical surface.

### Claim 25 (depends on 21)

The auto-injector of claim 21, comprising a third part coupled to a distal end of the housing and arranged such that the audible indication or the tactile indication is produced when the second part impacts the third part.

### Claim 26 (depends on 21)

The auto-injector of claim 21, wherein the second part is a noise maker.

### Claim 27

A method comprising:
releasing an enlarged portion of a proximally-extending resilient arm of a first part of an auto-injector out of engagement with an opening defined by a cylindrical body of a plunger rod of the auto-injector causing the plunger rod to move in a proximal direction relative to the first part by a biasing force of a compression drive spring to displace a stopper of a syringe of the auto-injector in the proximal direction towards a needle of the syringe to dispense a medicament of the syringe through the needle, a proximal portion of the syringe engaged with an inward protrusion of a tubular carrier disposed within a housing of the auto-injector to limit proximal movement of the syringe relative to the tubular carrier; and
upon moving the plunger rod by a predetermined amount in the proximal direction relative to a second part of the auto-injector, releasing a releasable coupling between the second part and the plunger rod causing the second part to move in a distal direction by a biasing force of a second compression spring and impact a third part of the auto-injector to produce an audible indication or a tactile indication, an outward protrusion of the third part being attached to a distal end of the housing such that the third part defines a distal end of the auto-injector.

### Claim 28 (depends on 27)

The method of claim 27, wherein the releasable coupling between the second part and the plunger rod is between a protrusion on a proximal end of an axially-extending member of the second part and the plunger rod.

### Claim 29 (depends on 28)

The method of claim 28, wherein releasing the releasable coupling between the protrusion of the second part and the plunger rod is performed when substantially all the medicament has been dispensed from the syringe.

### Claim 30 (depends on 7)

The method of claim 7, wherein the second part impacts a proximal-facing surface of the third part to produce the audible indication or the tactile indication.
