# US 10,864,059 B2 · RFID tag enabled needle shield

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- Number: US 10,864,059 B2
- Document ID: US10864059B2
- Status: Granted
- Kind: B2
- Application number: 16/871,893
- Filed: 2020-05-11
- Published: 2020-08-27
- Granted: 2020-12-15
- Earliest claimed: 2016-07-11
- Assignees: Shl Medical AG
- Applicants: Shl Medical AG
- Inventors: Markus Bauss; Thomas Dietl
- Web page: https://patentgrep.com/patent/US10864059B2

## CPC

- A61B 90/98: using electromagnetic means, e.g. transponders
- A61M 5/31: Details
- A61M 5/3129: {Syringe barrels (A61M5/3205, A61M5/50 take 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 5/3204: {Needle cap removers, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices}
- A61M 5/326: {Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user}
- G06K 19/07749: {the record carrier being capable of non-contact communication, e.g. constructional details of the antenna of a non-contact smart card}
- G16H 20/17: delivered via infusion or injection
- A61M 39/20: Closure caps or plugs for connectors or open ends of tubes
- A61M 2005/3131: {specially adapted for improving sealing or sliding}
- A61M 2205/60: with identification means
- A61M 2205/6054: Magnetic identification systems
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}
- G06K: GRAPHICAL DATA READING (image or video recognition or understanding G06V); PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

The present invention relates to an RDID tag enabled needle shield assembly that provides a sterile enclosure of an injection needle and that can be fixedly attached to a pre-filled syringe for administering an injection of medicament to a patient after removal of the needle shield assembly. The RFID tag is fixedly attached to the needle shield through co-molding or another form of permanent attachment. The present invention also relates to a method of tracking the life cycle of a medicament injection device where the RFID tag enabled needle shield assembly is attached to an injection needle that is connected to a syringe barrel that is part of an injection device. Data is written to or read from the RFID tag during the entire life cycle of the injection device, including assembly, packaging, storing, distribution and use.

## Claims

### Claim 1

An injection device for administering medicament comprising:
a housing;
a protective cap comprising a grabber;
a syringe positioned with the housing and having an attached injection needle having a sharp end; and
a needle shield assembly comprising;
a rigid sheath configured to fit within, be surrounded by, and operatively engaged with the grabber when the protective cap is connected to the housing such that removal of the protective cap from the housing causes the grabber to remove the needle shield assembly from the pre-filled syringe;
a flexible sheath positioned within the rigid sheath, where the flexible sheath has an interior portion removably connected to the sharp end of the injection needle to form a sterile and fluid tight seal; and
an RFID tag fixedly attached to only to the rigid sheath or to the flexible sheath and not to the protective cap.

### Claim 2 (depends on 1)

The injection device of claim 1, wherein the RFID tag is a read-write tag.

### Claim 3 (depends on 1)

The injection device of claim 1, wherein the RFID tag further comprises a read-only memory that contains product identification data.

### Claim 4 (depends on 1)

The injection device of claim 1, wherein the rigid sheath is attached to the flexible sheath such that axial movement of rigid sheath causes axial movement of the flexible sheath.

### Claim 5 (depends on 1)

The injection device of claim 1, wherein the RFID tag is fixedly attached to the rigid sheath.

### Claim 6 (depends on 1)

The injection device of claim 1, wherein the RFID tag is fixedly attached by one of a snap fit, an inlay, co-molded, an adhesive, lamination, paid, a press fit or a combination thereof.

### Claim 7 (depends on 1)

The injection device of claim 1 further comprising an antenna in electrical communication with the RFID tag.

### Claim 8 (depends on 1)

The injection device of claim 1 further comprising a needle cover remover configured to remove the needle shield assembly before administering an injection of the medicament through the needle.

### Claim 9 (depends on 1)

The injection device of claim 1 further comprising a dose delivery mechanism having attached a second RFID tag that is configured to exchange information with the RFID tag attached to the needle shield assembly.

### Claim 10 (depends on 1)

The injection device of claim 1 is a pen-type injector.

### Claim 11 (depends on 1)

The injection device of claim 1 is an auto-injector and the syringe is pre-filled with a medicament.

### Claim 12 (depends on 1)

The injection device of claim 1 further comprises a power unit.

### Claim 13 (depends on 12)

The injection device of claim 12, wherein the power unit comprises a hollow plunger.

### Claim 14 (depends on 13)

The injection device of claim 13, wherein the power unit further comprises a compression spring positioned within the hollow plunger.

### Claim 15 (depends on 1)

A system comprising:
the injection device of claim 1; and
a device accessory that is configured to read data from the RFID tag.

### Claim 16 (depends on 15)

The system of claim 15, wherein the device accessory is removably attached to an outside surface of the injection device.

### Claim 17 (depends on 16)

The system of claim 16, wherein the device accessory is reusable on more than one injection device.

### Claim 18 (depends on 15)

The system of claim 15, wherein the housing further comprises a second RFID tag.

### Claim 19 (depends on 15)

The system of claim 15, wherein the device accessory further comprises a third RFID tag.

### Claim 20 (depends on 15)

The system of claim 15, wherein the device accessory is configured to communicate with an external source to transmit data related to functioning of the injection device.
