Tamper evident cap for syringes

Patent metadata

Field	Value
Publication number	US-11964142-B2
Application number	US-202016850396-A
Country	US
Kind code	B2
Filing date	Apr 16, 2020
Priority date	Nov 28, 2018
Publication date	Apr 23, 2024
Grant date	Apr 23, 2024

Abstract

A syringe assembly includes a syringe and a tamper evident cap disposed over a Luer connection of the syringe, the tamper evident cap having a main body that defines a proximal end defining an opening, a 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 to receive a tip cap and the Luer connection, where the tamper evident cap is spaced from the tip cap. The main body further defines a frangible connection between the proximal and distal ends of the main body. The frangible connection can break under a force applied to the distal end of the tamper evident cap such that the proximal end of the tamper evident cap remains engaged with the syringe when the frangible connection breaks.

First claim

What is claimed is:

1. A method of filling a syringe with a material, the method comprising:
receiving a syringe having a barrel body extending from a distal end to an open proximal end, the distal end having a luer connection defining an outlet, the barrel body defining a chamber that extends along an axial direction therethrough, wherein a tip cap is over the outlet to create a fluid seal over the outlet;
filling the chamber with the material through the open proximal end;
disposing a plunger within the chamber at the open proximal end; and
applying a tamper evident cap over the luer connection and the tip cap, such that the tamper evident cap is spaced in an entirety from the tip cap and is in contact with the barrel body.

2. The method of claim 1 , wherein the tamper evident cap has a main body defining a proximal end defining an opening and a distal end opposite the proximal end along the axial direction, the method further comprising:
shrink-wrapping a film over the proximal end of the tamper evident cap and at least a portion of the barrel body.

3. The method of claim 2 , wherein the film is configured to secure the proximal end of the tamper evident cap to the syringe when a frangible connection breaks.

4. The method of claim 2 , 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.

5. The method of claim 4 , wherein the color of the color-coded portion comprises corresponds to the material in accordance with ASTM D4774.

6. The method of claim 1 , wherein applying the tamper evident cap includes creating an interference fit directly between the barrel body and the tamper evident cap.

7. The method of claim 1 , wherein the tamper evident cap is applied over the luer connection and the tip cap after disposing the plunger within the chamber.

8. The method of claim 1 , wherein the tamper evident cap is spaced in an entirety from the tip cap so that the fluid seal over the outlet is not compromised when the tamper evident cap is applied over the luer connection and the tip cap.

9. The method 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.

10. The method 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.

11. The method of claim 1 , wherein the tamper evident cap is in direct contact with the barrel body.

12. A method of filling a syringe with a material, the method comprising:
receiving a syringe having a barrel body extending from a distal end to an open proximal end, the distal end having a luer connection defining an outlet, the barrel body defining a chamber that extends along an axial direction therethrough, wherein a tip cap is placed over the outlet to create a fluid seal over the outlet;
filling the chamber with the material through the open proximal end;
disposing a plunger within the chamber at the open proximal end;
applying a tamper evident cap over the luer connection and the tip cap, such that the tamper evident cap is spaced in an entirety from the tip cap; and
shrink-wrapping a film over at least a portion of the tamper evident cap and at least a portion of the barrel body.

13. The method of claim 12 , wherein:
the tamper evident cap has a main body defining a proximal end defining an opening and a distal end opposite the proximal end along the axial direction, and
shrink-wrapping the film over at least the portion of the tamper evident cap and at least the portion of the barrel body comprises shrink-wrapping the film over the proximal end of the tamper evident cap and at least the portion of the barrel body.

14. The method of claim 12 , 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.

15. The method of claim 12 , wherein the tamper evident cap is in direct contact with the barrel body to create an interference fit between the barrel body and the tamper evident cap after being applied over the luer connection and the tip cap.

16. The method of claim 12 , wherein the tamper evident cap is applied over the luer connection and the tip cap after disposing the plunger within the chamber.

17. The method of claim 12 , wherein the tamper evident cap is spaced in an entirety from the tip cap so that the fluid seal over the outlet is not compromised when the tamper evident cap is applied over the luer connection and the tip cap.

18. The method of claim 12 , 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.

19. The method of claim 12 , 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, m

Assignees

• Fresenius Kabi Usa Llc

Inventors

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

Classifications

• A61M5/5086 Primary

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

• A61J1/2096

  Combination of a vial and a syringe for transferring or mixing their contents · CPC title

• A61M5/3134

  characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula · CPC title

• B65B3/003

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title

• A61M2005/3104

  Caps for syringes without needle · CPC title