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1. WO2020112797 - CAPUCHON INVIOLABLE POUR SERINGUES

Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

[ EN ]

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, and a Luer connection 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 Luer connection such that the tip cap creates a fluid seal over the outlet; and

a tamper evident cap disposed over the Luer connection, 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 configured to receive the tip cap and the Luer connection, wherein the tamper evident cap is spaced in an entirety from the tip cap, the main body further defining a frangible connection between the proximal and distal ends of the main body,

wherein the frangible connection is configured to break under a force applied to the distal end of the tamper evident cap such that the proximal end of the tamper evident cap is configured to remain engaged with the syringe when the frangible connection breaks.

2. The syringe assembly of claim 1, further comprising:

a film shrink-wrapped over the proximal end of the tamper evident cap and at least a portion of the syringe.

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

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

6. The syringe assembly of claim 2, wherein the film is adhesive-bonded to the tamper evident cap.

7. The syringe assembly of claim 2, wherein the film is adhesive-bonded to the syringe.

8. The syringe assembly of claim 2, wherein the proximal end of the main body includes a plurality of external ribs extending radially outwards from the outer surface and configured to secure the film to the tamper evident cap.

9. The syringe assembly of claim 1, wherein the proximal end of the main body includes a plurality of internal ribs extending radially inwards from the inner surface and configured to form an interference fit with the Luer connection.

10. 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.

11. The syringe assembly of claim 1, wherein the frangible connection comprises a plurality of frangible bridges positioned circumferentially around the main body.

12. The syringe assembly of claim 1, wherein the proximal end of the main body is attached to the syringe via a sonic weld.

13. The syringe assembly of claim 1, wherein the distal end comprises a distal wall.

14. The syringe assembly of claim 13, wherein the distal wall closes the distal end of the tamper evident cap.

15. The syringe assembly of claim 1, wherein the fluid seal over the outlet is not compromised when the tamper evident cap is disposed over the Luer connection or when the frangible connection is broken.

16. 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.

17. The syringe assembly of claim 1, wherein the material includes an active ingredient selected from a group consisting of an opioid, benzodiazepine, a2-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.

18. A method of filling a syringe with a material, the method comprising:

receiving a syringe having a barrel body extending from a distal end having a Luer connection defining an outlet to an open proximal end, 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; 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.

19. The method of claim 18, 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 syringe.

20. The method of claim 19, wherein the film is configured to secure the proximal end of the tamper evident cap to the syringe when a frangible connection breaks.

21. The method of claim 19, 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.

22. The method of claim 21, wherein the color of the color-coded portion comprises corresponds to the material in accordance with ASTM D4774.

23. The method of claim 18, wherein applying the tamper evident cap includes creating an interference fit between the Luer connection and the tamper evident cap.

24. A tamper evident cap, comprising:

a main body having a proximal end defining an opening and a distal end opposite the proximal end along an axial direction, wherein the main body defines an outer surface and an inner surface opposite the outer surface, the inner surface defining a passage configured to receive a tip cap and a Luer connection of a syringe such that a portion of the inner surface is configured to engage with the Luer connection, the main body further defining a frangible connection between the proximal end and the distal end,

wherein the frangible connection is configured to break under a force applied to the distal end such that, when the distal end is decoupled from the proximal end, the proximal end is configured to remain engaged with the Luer connection.