# US 11,432,904 B2 · RFID tag enabled needle shield

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- Number: US 11,432,904 B2
- Document ID: US11432904B2
- Status: Granted
- Kind: B2
- Application number: 17/095,006
- Filed: 2020-11-11
- Published: 2021-03-11
- Granted: 2022-09-06
- Earliest claimed: 2016-07-11
- Assignees: Shl Medical AG
- Applicants: Shl Medical AG
- Inventors: Markus Bauss; Thomas Dietl
- Web page: https://patentgrep.com/patent/US11432904B2

## 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

A shield assembly for providing a sterile enclosure of an outlet fixedly attached to a container of medicament positioned within a medicament delivery device, the shield assembly comprising:
a rigid sheath configured to fit within, be surrounded by, and operatively engaged with a grabber that is axially fixed to a protective cap connected to a proximal end of a medicament delivery device such that removal of the protective cap from the medicament delivery device causes the grabber to remove the shield assembly from the container of medicament;
a flexible sheath positioned within the rigid sheath and surrounding the outlet of the container of medicament; and
an RFID tag fixedly positioned between the flexible sheath and the rigid sheath and not attached to the protective cap.

### Claim 2 (depends on 1)

The shield assembly of claim 1, wherein the flexible sheath has an outside surface and the rigid sheath has an inside surface, where the RFID tag is positioned between the outside surface and the inside surface.

### Claim 3 (depends on 1)

The shield assembly of claim 1, wherein the flexible sheath abuts the RFID tag positioned on an inside surface of the rigid sheath.

### Claim 4 (depends on 1)

The shield assembly of claim 1, wherein the RFID tag is read-write tag.

### Claim 5 (depends on 4)

The shield assembly of claim 4, where the RFID tag further comprises a read-only memory that contains product identification data.

### Claim 6 (depends on 1)

The shield assembly 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 and the RFID tag.

### Claim 7 (depends on 1)

The shield assembly of claim 1, wherein the RFID tag is fixedly attached to an inside surface of the rigid sheath.

### Claim 8 (depends on 7)

The shield assembly of claim 7 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 9 (depends on 1)

The shield assembly of claim 1, further comprising an antenna in electrical communication with the RFID tag.

### Claim 10 (depends on 9)

The shield assembly of claim 9, wherein the antenna is positioned on an outside surface of the rigid sheath.

### Claim 11 (depends on 1)

The shield assembly of claim 1, wherein the flexible sheath is permanently attached to an inside surface of the rigid sheath.

### Claim 12 (depends on 1)

The shield assembly of claim 1, wherein the flexible sheath has an interior portion comprising a material that forms a sterile and fluid tight seal with the outlet of the container of medicament.

### Claim 13 (depends on 12)

The shield assembly of claim 12, wherein the outlet comprises an injection needle.

### Claim 14 (depends on 1)

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