# US 11,110,228 B2 · Component for an injection device, system, and method

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- Number: US 11,110,228 B2
- Document ID: US11110228B2
- Status: Granted
- Kind: B2
- Application number: 15/775,506
- Filed: 2016-11-21
- Published: 2018-12-20
- Granted: 2021-09-07
- Earliest claimed: 2015-11-27
- Assignees: Sanofi-Aventis Deutschland GmbH
- Applicants: Sanofi-Aventis Deutschland GmbH
- Inventors: Stephan Riedel; Peter Scharf
- Web page: https://patentgrep.com/patent/US11110228B2

## CPC

- A61M 5/3204: {Needle cap removers, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices}
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- A61M 2005/312: {comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2207/00: Methods of manufacture, assembly or production
- 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

A component for an injection device is a combined needle shield and cap component that comprises a unitary compressible body moulded from rubber. The unitary compressible body has formed therein a cavity for shielding a needle, the cavity having an opening at a first end of the component and extending axially within the component. It also has formed thereon a grip arrangement comprising one or more shape features that permit gripping by a user of the component so as to facilitate the application of force by the user along the longitudinal axis of the component. The combined needle shield and cap component has a proximal end configured to be partly insertable into a body of an injection device. The outer surface of the compressible body has a step profile at a location between the proximal end of the compressible body, which is configured to be inserted into the injection device, and an adjacent part of the compressible body, which is configured to remain outside of injection device, wherein the proximal end of the compressible body has a smaller diameter than the adjacent part of the compressible body.

## Claims

### Claim 1

A component for an injection device comprising:
a unitary compressible body moulded from rubber, wherein the unitary compressible body:
has formed therein a cavity for shielding a needle, the cavity having an opening at a first end of the component and extending axially within the component;
has formed thereon a grip arrangement comprising one or more shape features that permit gripping by a user of the component so as to facilitate the application of force by the user along a longitudinal axis of the component; and
has a proximal end configured to be partly insertable into a body of an injection device,
wherein an outer surface of the compressible body has a step profile at a location between the proximal end of the compressible body and an adjacent part of the compressible body, wherein a distal end of the compressible body is configured to be inserted into the injection device and the adjacent part of the compressible body is configured to remain outside of the injection device, wherein the proximal end of the compressible body has a smaller diameter than the adjacent part of the compressible body,
wherein an outer diameter of the proximal end of the compressible body is greater than an internal diameter of the injection device into which the compressible body is insertable when the compressible body is in an uncompressed state.

### Claim 2 (depends on 1)

A component as claimed in claim 1, wherein an outer diameter of a proximal portion of the component is greater than 1 cm when the component is in an uncompressed state.

### Claim 3 (depends on 1)

A component as claimed in claim 1, wherein the grip arrangement comprises a surface that faces at least partially in a proximal direction relative to the longitudinal axis of the component.

### Claim 4 (depends on 1)

A component as claimed in claim 1, wherein the grip arrangement comprises a head portion located distally from a neck portion.

### Claim 5 (depends on 1)

A component as claimed in claim 1, wherein the cavity is tapered.

### Claim 6 (depends on 1)

A component as claimed in claim 1, wherein the unitary compressible body comprises a needle holder cavity for tightly abutting a needle holder of the injection device, the needle holder cavity extending axially from the opening at the first end of the component and being shaped to coincide with a shape of the needle holder of the injection device; and
wherein the cavity for shielding the needle adjoins the needle holder cavity and extends axially within the component.

### Claim 7 (depends on 1)

An injection device including the component according to claim 1, the component configured to close an end of the injection device.

### Claim 8 (depends on 7)

An injection device according to claim 7, including medicament.

### Claim 9 (depends on 8)

An injection device according to claim 8 comprising a cartridge at least partly full of medicament.

### Claim 10

A system comprising an injection device and a combined needle shield and cap component closing an end of the injection device, wherein the combined needle shield and cap component comprises:
a unitary compressible body moulded from rubber having formed therein a cavity for shielding a needle, the cavity having an opening at a first end of the combined needle shield and cap component and extending axially within the combined needle shield and cap component, the compressible body having formed thereon a grip arrangement comprising one or more shape features that permit gripping by a user of the combined needle shield and cap component so as to facilitate the application of force by the user in a distal direction along a longitudinal axis of the combined needle shield and cap component,
wherein a proximal end of the compressible body is located within a body of the injection device at the end of the injection device,
wherein an outer surface of the compressible body has a step profile at a location between the proximal end of the compressible body and an adjacent part of the compressible body, the location coinciding with an end of the body of the injection device with the adjacent part of the compressible body being external to the body of the injection device, and
wherein the proximal end of the compressible body has a smaller diameter than the adjacent part of the compressible body,
wherein an outer diameter of the proximal end of the compressible body is greater than an internal diameter of the injection device into which the compressible body is insertable when the compressible body is in an uncompressed state.

### Claim 11 (depends on 10)

A system as claimed in claim 10, wherein an outer diameter of a proximal portion of the combined needle shield and cap component is greater than 1 cm when the combined needle shield and cap component is in an uncompressed state.

### Claim 12 (depends on 10)

A system as claimed in claim 10, wherein the grip arrangement comprises a surface that faces at least partially in a proximal direction relative to the longitudinal axis of the combined needle shield and cap component.

### Claim 13 (depends on 10)

A system as claimed in claim 10, wherein the grip arrangement comprises a head portion located distally from a neck portion.

### Claim 14 (depends on 10)

A system as claimed in claim 10, wherein the cavity is tapered.

### Claim 15 (depends on 10)

A system as claimed in claim 10, wherein the unitary compressible body comprises a needle holder cavity for tightly abutting a needle holder of the injection device, the needle holder cavity extending axially from the opening at the first end of the combined needle shield and cap component and being shaped to coincide with a shape of the needle holder of the injection device; and
wherein the cavity for shielding the needle adjoins the needle holder cavity and extends axially within the combined needle shield and cap component.

### Claim 16 (depends on 10)

A system according to claim 10, wherein the injection device includes medicament.

### Claim 17 (depends on 10)

A system according to claim 10, wherein the injection device comprises a cartridge at least partly full of medicament.

### Claim 18

A method comprising:
inserting a sheath containing a combined needle shield and cap component into a housing or a syringe carrier of an injection device, wherein the combined needle shield and cap component:
comprises a unitary compressible body moulded from rubber;
has a larger outer diameter than an inner diameter of the sheath when the combined needle shield and cap component is uncompressed, such that the combined needle shield and cap component is compressed whilst inside the sheath;
has formed therein a cavity for shielding a needle, the cavity having an opening at a first end of the combined needle shield and cap component and extending axially within the combined needle shield and cap component;
has formed thereon a grip arrangement comprising one or more shape features that permit gripping by a user of the combined needle shield and cap component so as to facilitate the application of force by the user along a longitudinal axis of the combined needle shield and cap component;
has a proximal end configured to be partly insertable into a body of the injection device; and
includes a step profile on an outer surface of the compressible body at a location between the proximal end of the compressible body and an adjacent part of the compressible body, wherein the proximal end of the compressible body is configured to be inserted into the injection device and the adjacent part of the compressible body is configured to remain outside of the injection device, wherein the proximal end of the compressible body has a smaller diameter than the adjacent part of the compressible body; and
removing the sheath whilst leaving the combined needle shield and cap component in the housing so that the combined needle shield and cap component expands and engages with one or more inner walls of the housing or syringe carrier.

### Claim 19 (depends on 18)

A method as claimed in claim 18 wherein the injection device contains a cartridge at least partly filled with medicament and having a needle assembly provided thereon, wherein the needle forming part of the needle assembly is provided within the cavity of the combined needle shield and cap component.

### Claim 20 (depends on 18)

A method as claimed in claim 18 wherein an inner surface of the sheath is a low friction surface.
