# US 2016/0354552 A1 · Needle Safety Device and Drug Delivery Device

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- Number: US 2016/0354552 A1
- Document ID: US20160354552A1
- Status: Published application
- Kind: A1
- Application number: 15/104,865
- Filed: 2014-12-18
- Published: 2016-12-08
- Earliest claimed: 2013-12-20
- Applicants: Sanofi-Aventis Deutschland GMBH
- Inventors: Moritz KEIM; Winfried HUTHMACHER; Peter NOBER
- Web page: https://patentgrep.com/patent/US20160354552A1

## CPC

- A61M 5/3204: {Needle cap removers, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices}
- A61M 5/3245: {Constructional features thereof, e.g. to improve manipulation or functioning}
- 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 5/3271: {with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position}
- A61M 5/3272: {having projections following labyrinth paths}
- A61M 2005/3267: {Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body}
- 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 invention refers to a needle safety device (4) for a drug delivery device (1) comprising a needle cap remover (8) adapted to capture a needle cap (6) by a positive and/or non-positive connection, wherein the needle cap remover (8) comprises a top end (8.3), a needle shield (7) adapted to cover a needle (5) of the drug delivery device (2) before and after injection, wherein the needle shield (7) comprises a needle shield end (7.4) adapted to engage an injection site, and at least one blocking pin (9) which inwardly extends from the top end (8.3) and/or the needle shield end (7.4) into the needle cap remover (8) and/or into the needle shield (7).

## Claims

### Claim at position 1

1-10. (canceled)

### Claim 11

A needle safety device for a drug delivery device, comprising:
a needle cap remover adapted to capture a needle cap by at least one of a positive connection and a non-positive connection, wherein the needle cap remover comprises a top end;
a needle shield adapted to cover a needle of the drug delivery device before and after injection, wherein the needle shield comprises a needle shield end adapted to engage an injection site;
at least one blocking pin which inwardly extends from the top end into at least one of the needle cap remover and the needle shield; and
a guiding arrangement comprising a guide track and a corresponding flexible guide arm, wherein one of the guiding track and the guide arm is arranged at a housing and the other of the guiding track and the guide arm is arranged at the needle shield,
wherein the at least one blocking pin is adapted to obstruct the guiding arrangement such that the guide arm is inhibited from moving into the guide track, thereby blocking the guiding arrangement.

### Claim 12 (depends on 11)

The needle safety device according to claim 11, wherein the at least one blocking pin comprises at least two oppositely disposed blocking pins.

### Claim 13 (depends on 11)

The needle safety device according to claim 11, wherein the at least one blocking pin is integral to the needle cap remover.

### Claim 14 (depends on 11)

The needle safety device according to claim 11, wherein the at least one blocking pin is carried through at least one of the top end and the needle shield end, and an outside end of the at least one blocking pin is adapted to form a button.

### Claim 15 (depends on 14)

The needle safety device according to claim 14, wherein the button is formed as a protruding button.

### Claim 16 (depends on 15)

The needle safety device according to claim 15, wherein the at least one blocking pin comprises a recess adapted to a shape of a guide arm of the needle shield.

### Claim 17 (depends on 14)

The needle safety device according to claim 14, wherein the button is formed as flat button.

### Claim 18 (depends on 14)

The needle safety device according to claim 14, wherein a gripping portion is arranged at a top end of the needle cap remover.

### Claim 19 (depends on 11)

The needle safety device according to claim 11, wherein the at least one blocking pin comprises a locking hook adapted to lock the at least one blocking pin in a distal direction.

### Claim 20

A drug delivery device comprising:
a housing;
a needle safety device mounted to the housing of the drug delivery device, the needle safety device comprising
a needle cap remover adapted to capture a needle cap by at least one of a positive connection and a non-positive connection, wherein the needle cap remover comprises a top end;
a needle shield adapted to cover a needle of the drug delivery device before and after injection, wherein the needle shield comprises a needle shield end adapted to engage an injection site;
at least one blocking pin which inwardly extends from the top end into at least one of the needle cap remover and the needle shield; and
a guiding arrangement comprising a guide track and a corresponding flexible guide arm, wherein one of the guiding track and the guide arm is arranged at a housing and the other of the guiding track and the guide arm is arranged at the needle shield,
wherein the at least one blocking pin is adapted to obstruct the guiding arrangement such that the guide arm is inhibited from moving into the guide track, thereby blocking the guiding arrangement.

### Claim 21 (depends on 20)

The drug delivery device of claim 20, wherein the drug delivery device is an autoinjector or an injection pen.

### Claim 22 (depends on 20)

The drug delivery device of claim 20, further comprising a medicament container comprising a medicament having at least one pharmaceutically active compound.

### Claim 23

A method of operating a drug delivery device, the method comprising:
removing a needle cap from the drug delivery device;
releasing at least one blocking pin from a guiding arrangement of the drug delivery device to enable a needle shield of the drug delivery device to retract; and
pushing a distal end of the drug delivery device against an injection site to cause the needle shield to retract, thereby activating the drug delivery device for injection of a medicament.

### Claim 24 (depends on 23)

The method of claim 23, wherein removing the needle cap comprises removing the at least one blocking pin from the guiding arrangement of the drug delivery device.

### Claim 25 (depends on 23)

The method of claim 23, wherein pushing the distal end of the drug delivery device against the injection site comprises:
pushing the at least one blocking pin against the injection site to release the at least one blocking pin from the guiding arrangement to enable the needle shield to retract, and then pushing the needle shield against the injection site to activate the drug delivery device.

### Claim 26 (depends on 25)

The method of claim 25, further comprising, after pushing the distal end of the drug delivery device against the injection site, releasing the distal end of the drug delivery device from the injection site such that a locking hook of the at least one blocking pin locks the at least one blocking pin to inhibit movement of the needle shield.

### Claim 27 (depends on 23)

The method of claim 23, wherein releasing the at least one blocking pin comprises, after removing the needle cap from the drug delivery device, removing a blocking component from the drug delivery device, wherein the blocking component comprises the at least one blocking pin.

### Claim 28 (depends on 23)

The method of claim 23, wherein releasing the at least one blocking pin from the guiding arrangement comprises releasing the at least one blocking pin from the guiding arrangement such that a guide arm of the guiding arrangement is movable into a guide track of the guiding arrangement, thereby enabling the needle shield to retract.

### Claim 29 (depends on 28)

The method of claim 28, wherein releasing the at least one blocking pin from the guiding arrangement comprises causing the guide arm of the guide arrangement to slide into a recess of the at least one blocking pin such that the guide arm of the guide arrangement is movable into the guide track.

### Claim 30 (depends on 28)

The method of claim 28, wherein pushing the distal end of the drug delivery device against the injection site causes the needle shield to retract relative to a housing of the drug delivery device, wherein one of the guide track and the guide arm is arranged at a housing and the other of the guide track and the guide arm is arranged at the needle shield.
