Tamper evident assembly with RFID for syringes

Patent metadata

Field	Value
Publication number	US-12403262-B2
Application number	US-202117235919-A
Country	US
Kind code	B2
Filing date	Apr 20, 2021
Priority date	Nov 28, 2018
Publication date	Sep 2, 2025
Grant date	Sep 2, 2025

Abstract

The present disclosure describes a syringe assembly including a syringe including a Luer connection and a tip, a plunger, a tip cap, a tamper evident cap disposed over the tip cap, a film including a frangible connection, and an RFID tag. The film secures the tamper evident cap to the Luer connection, where the frangible connection can break under a force applied to the tamper evident cap such that the tamper evident cap disengages from the Luer connection when the frangible connection breaks. The RFID tag is disposed on the syringe and has an integrated circuit and an antenna configured to send/receive signals between an RFID reader.

First claim

What is claimed is:

1. A syringe assembly, comprising:
a syringe having a barrel body that extends from a proximal end to a distal end and defines a chamber extending along an axial direction therethrough, a Luer connection at the distal end, and a tip extending from the distal end along the axial direction and defining an outlet in fluid communication with the chamber, wherein the chamber contains a material;
a plunger received within the chamber of the syringe to create a fluid seal within the barrel body;
a tip cap defining a central passage configured to receive a portion of the tip such that the tip cap creates a fluid seal over the outlet;
a tamper evident assembly, comprising:
a tamper evident cap disposed over the tip cap, wherein the tamper evident cap has a main body that defines a proximal end defining an opening, a closed distal end opposite the proximal end along the axial direction, an outer surface, and an inner surface opposite the outer surface that defines a passage extending from the opening of the proximal end and configured to receive the tip cap; and
a film including a frangible connection and configured to secure the tamper evident cap to the Luer connection; and

a radio-frequency identification (RFID) tag configured to receive and store data related to the syringe assembly,
wherein the RFID tag includes an integrated circuit, configured to store electronic information thereon, and an antenna operatively connected to the integrated circuit and configured to receive a signal from an RFID reader to cause transmission of at least part of the electronic information from the integrated circuit, and
wherein the frangible connection is configured to break under a force applied to the tamper evident cap such that the tamper evident cap is configured to disengage from the Luer connection when the frangible connection breaks while maintaining the tip cap over the outlet of the tip following disengagement of the tamper evident cap.

2. The syringe assembly of claim 1 , wherein the film is shrink-wrapped over a portion of the tamper evident cap and at least a portion of the Luer connection.

3. The syringe assembly of claim 1 , wherein the film includes a color-coded portion that comprises a color selected from a plurality of colors that each correspond to a different material.

4. The syringe assembly of claim 3 , wherein the color of the color-coded portion corresponds to the material in accordance with ASTM D4774.

5. The syringe assembly of claim 1 , wherein the film is adhesive-bonded to the tamper evident cap.

6. The syringe assembly of claim 1 , wherein the film is adhesive-bonded to the Luer connection.

7. The syringe assembly of claim 1 , wherein the tamper evident cap includes a plurality of ribs extending radially outwards from the outer surface and configured to secure the film to the tamper evident cap.

8. The syringe assembly of claim 1 , wherein the Luer connection includes a plurality of ribs extending outwards from an outer surface and configured to secure the film to the Luer connection.

9. The syringe assembly of claim 1 , wherein a portion of the main body defines a color-coded portion that comprises a color selected from a plurality of colors that each correspond to a different material.

10. The syringe assembly of claim 1 , wherein the tamper evident cap is spaced in an entirety from the syringe when the tamper evident cap engages the tip cap.

11. The syringe assembly of claim 1 , wherein a portion of the tamper evident cap is in contact with the tip cap.

12. The syringe assembly of claim 11 , wherein the fluid seal over the outlet is not compromised when the tamper evident cap is in contact with the tip cap.

13. The syringe assembly of claim 1 , wherein the material includes an active ingredient that is (a) a therapeutic agent selected from a group consisting of anti-infectives, anesthetics, analgesics, anticoagulants, chemotherapeutics, hormones, antihypertensives, anti-inflammatories, antiemetics, bronchodilators, adrenergics, immunoglobulins, antipsychotics, and antidepressants or (b) a diagnostic agent selected from a group consisting of x-ray, MRI and ultrasound contrast agents, cholecystokinetics, and vasodilators.

14. The syringe assembly of claim 1 , wherein the material includes an active ingredient selected from a group consisting of an opioid, benzodiazepine, α2-adrenergic receptor agonist, beta blocker, morphine, hydromorphone, hydrocodone, oxycodone, oxymorphone, codeine, buprenorphine, naloxone, naltrexone, fentanyl, remifentanil, sufentanil, alfentanil, meperidine, rocuronium, vecuronium, midazolam, lorazepam, diazepam, neostigmine, atropine, glycopyrrolate, dexmedetomidine, cisastracurium, ropivacaine, lidocaine, propofol, ketamine, succinylcholine, moxifloxacin, linezolid, levofloxacin, levetiracetam, vancomycin, cefepime, aztreonam, cefoxitin, ceftriaxone, cefazolin, cefotaxime, ceftazidime, gentamicin, oxacillin, nafcillin, penicillin, cefuroxime, ticarcillin, clavulanic acid, piperacillin, tazobactam, azithromycin, meropenem, ertapenem, tigecycline, micafungin, metronidazole, fluconazole, itraconazole, posaconazole, heparin, enoxaparin, dalteparin, theophylline, acetaminophen (paracetamol), ibuprofen, acetylcysteine, decitabine, azacitidine, docetaxel, pemetrexed, palonosetron, aprepitant, fosaprepitant, famotidine, amiodarone, nitroglycerin, nicardipine, clevidipine, dobutamine, esmolol, labetalol, metroprolol, somatropin, liraglutide, abaloparatide, semaglutide, teriparatide, degarelix, sumatriptan, epinephrine, ephedrine, vasopressin, methotrexate, testosterone, and hydroxyprogesterone.

15. The syringe assembly of claim 1 , wherein the film includes the RFID tag.

16. The syringe assembly of claim 1 , wherein the RFID tag is a passive RFID tag and is configured to receive an electronic signal from the RFID reader to initiate transmission of the at least part of the electronic information.

17. The syringe assembly of claim 1 , wherein the RFID tag is configured to operate at a frequency between 300 MHz and 3000 MHz.

18. The syringe assembly of claim 1 , wherein the electronic information includes at least one of a product identifier, a serial number, a lot number, or an expiration date.

19. The syringe assembly of claim 1 , wherein the RFID tag is disposed on the syringe.

20. The syringe assembly of claim 1 , wherein the proximal end of the tamper evident cap is in contact with the barrel body.

21. The syringe assembly of claim 1 , wherein the tamper evident cap is spaced in an entirety from the tip cap.

22. A tamper evident assembly, comprising:
a tamper evident cap having a main body that defines a proximal end defining an opening, a closed distal end opposite the proximal end along an axial direction, an outer surface, and an inner surface opposite the outer surface that defines a passage extending from the opening of the proximal end and configured to receive a tip cap and a Luer connection of a syringe;
a film including a frangible connection and configured to secure the tamper evident cap to the Luer connection; and
a radio-frequency identification (RFID) tag within the film and configured to receive and store data related to the syringe,
wherein the RFID tag includes an integrated circuit, configured to store electronic information thereon, and an antenna operatively connected to the integrated circuit and configured to receive a signal from an RFID reader to cause transmission of at least part of the electronic informa

Assignees

• Fresenius Kabi Usa Llc

Inventors

• Murray Christopher J
• Ferraro Anthony
• Ju Gang
• Speek Robert

Classifications

• A61M5/5086

  for indicating if defective, used, tampered with or unsterile · CPC title

• G06K19/0723

  the record carrier comprising an arrangement for non-contact communication, e.g. wireless communication circuits on transponder cards, non-contact smart cards or RFIDs · CPC title

• A61M2005/3118

  via the distal end of a syringe, i.e. syringe end for mounting a needle cannula · CPC title

• A61M5/3202

  Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001) · CPC title

• G06K19/07798

  part of the antenna or the integrated circuit being adapted for rupturing or breaking, e.g. record carriers functioning as sealing devices for detecting not-authenticated opening of containers (electronic seals G09F3/03) · CPC title