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EP-4297828-B1 - SELF-ASPIRATING SYRINGE SYSTEMS, CARTRIDGES, AND METHODS

EP4297828B1EP 4297828 B1EP4297828 B1EP 4297828B1EP-4297828-B1

Inventors

  • CHELLQUIST, Eric Magnus

Dates

Publication Date
20260513
Application Date
20220224

Claims (15)

  1. A cartridge (100) for receiving an injectable drug, comprising: a body (106) comprising: a proximal end portion (108) comprising a proximal opening (110); a distal end portion (112) comprising a distal opening (114); a bore (104) coupling the proximal opening (110) and the distal opening (114); a pierceable septum (116) coupled to the distal opening (114); a plunger (120) movably carried within the bore (104); a volume disposed in the bore (104) between the pierceable septum (116) and the plunger (120), the volume having a reduced pressure, the reduced pressure being less than atmospheric pressure; characterised in that a stopper (122) is detachably coupled to the proximal opening (110), wherein the plunger (120) is configured to couple to an actuating rod (142) upon detachment of the stopper (122) from the body (106).
  2. The cartridge (100) of claim 0, wherein the volume comprises a gas having the reduced pressure.
  3. The cartridge (100) of any one of claims 1-2, further comprising a seal (118) coupled to the distal end portion (112) and covering the pierceable septum (116).
  4. The cartridge (100) of any one of claims 1-3, further comprising a nut (124) detachably coupled to the proximal end portion (108) and securing the stopper (122) between the nut (124) and the plunger (120).
  5. A syringe system for delivering an injectable drug to a subject, comprising: a cartridge (100) according to claim 1, the syringe system further comprising a vial (126) carrying the injectable drug; a transfer device configured to deliver the injectable drug from the vial (126) to the bore (104) of the cartridge (100); and a delivery needle (140) configured to be coupled to the distal end portion (112) of the cartridge (100) and deliver the injectable drug from the cartridge (100) to the subject, wherein the syringe system further comprises an actuating rod (142) configured to couple to the plunger (120).
  6. The syringe system of claim 5, further comprising a distal seal (118) coupled to the distal end portion (112) and covering the pierceable septum (116).
  7. The syringe system of any one of claim 5-6, wherein the transfer device comprises a transfer cannula (138) configured to pierce the pierceable septum (116).
  8. The syringe system of any one of claims 5-7, wherein the transfer device comprises a flexible conduit (144).
  9. A method of manufacturing a cartridge (100) according to claim 1, the cartridge (100) configured to receive an injectable drug, the method comprising: providing a body (106) comprising a distal opening (114), a proximal opening (110), and bore (104) extending between the distal opening (114) and the proximal opening (110); positioning a plunger (120) in the bore (104); coupling a stopper (122) to the proximal opening (110); reducing a pressure in the bore to less than atmospheric pressure; and sealing the distal opening (114), characterised in that : the stopper (122) is detachably coupled to the proximal opening (110); and the plunger (120) is configured to couple to an actuating rod (142) upon detachment of the stopper (122) from the body (106).
  10. The method of claim 9, further comprising, prior to reducing the pressure in the bore (104), partially inserting a septum (116) into the distal opening (114) such that the bore (104) remains in fluid communication with an external environment of the body (106).
  11. The method of claim 10, wherein: sealing the distal opening (114) comprises further inserting the septum (116) into the distal opening (114) and covering the septum (116) with a seal; and/or the method further comprises coupling a nut (124) to the body (106) and over the stopper (122).
  12. The method of any one of claims 10-11, wherein reducing the pressure in the bore (104) comprises positioning the body (106) in a pressure reduction chamber (150).
  13. The method of claim 12, further comprising, while the body (106) is positioned in the pressure reduction chamber (150), inserting a septum (116) into the distal opening (114) to inhibit fluid communication between the bore (104) and the pressure reduction chamber (150), and optionally further comprising removing the body (106) from the pressure reduction chamber (150), and wherein sealing the distal opening (114) comprises, after removing the body (106) from the pressure reduction chamber (150), covering the septum (116) with a seal.
  14. A method of delivering a injectable drug from an internal chamber of a vial (126) to the internal bore (104) of a cartridge (100) according to claim 1, the internal bore (104) initially having a reduced pressure volume, the method comprising: venting the internal chamber (130) of the vial (126) such that the injectable drug is exposed to atmospheric pressure; coupling a transfer device to the vial (126); coupling the transfer device to the cartridge (100), the transfer device thereby facilitating fluid communication between the internal chamber (130) of the vial (126) and the internal bore (104) of the cartridge (100); and permitting the injectable drug to flow from the internal chamber (130) of the vial (126), through the transfer device, and into the internal bore (104) of the cartridge (100).
  15. The method of claim 14, wherein: coupling the transfer device to the vial (126) comprises piercing a septum (132) of the vial (126) with a needle of the transfer device; coupling the transfer device to the cartridge (100) comprises piercing a septum (116) of the cartridge (100) with a needle of the transfer device; and/or after permitting the injectable drug to flow into the internal bore (104) of the cartridge (100), the method further comprises: decoupling the transfer device from the cartridge (100); coupling a needle to the cartridge (100); and delivering the injectable drug to a subject via the needle.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional Application No. 63/153,420, filed February 25, 2021. BACKGROUND The present disclosure relates to syringe systems for delivering injectable drugs to subjects, and, in particular, self-aspirating syringe systems and cartridges having reduced-pressure volumes that facilitate self-aspiration. Injectable drugs are commonly provided in multiple-dose or single-dose vials, and such agents are dispensed from the vials to hypodermic syringes for subsequent delivery to patients. More specifically, this process typically begins by holding the syringe with the needle pointing upwardly. The syringe's plunger is then retracted to fill the syringe with air, specifically a volume of air equal to the volume of the injectable drug to be administered to a patient. The needle of the syringe is then inserted through a stopper coupled to the opening of a vial, and the plunger is advanced to deliver the air from the syringe to the vial. Next, the vial and the syringe are inverted, and the needle's tip is held in the injectable drug. The plunger is then retracted to fill the syringe with the injectable drug, and the needle is removed from the vial. The syringe is then ready to deliver the injectable drug to a patient. For some individuals, such as diabetics, the above process is relatively difficult or inconvenient. In other settings, such as high-throughput contract pharmacies, the above process is overly time consuming. Accordingly, it would be desirable to provide improved syringe systems. EP1825878A1 discloses an assembly for administering to a patient a dose of active material, e.g. a radio active substance containing fluid and/or a contrast medium fluid for imaging purposes. The assembly comprises a container, having a ejection side with an exit and a control side; and a plunger movable from the proximal to the distal side of the container to eject the dose, which is pre-filled in the container, from the exit. Further, the assembly comprises a conduit configuration, which is connectable to the exit of the container and to the patient. The plunger in the assembly comprises a passage for a flushing fluid, which passage is normally closed and selectively opened. For selectively opening the passage the assembly comprises an opener, which is arrangable at the exit to act on the plunger to open the passage with the plunger moved to a position in proximity of the exit. US2015013827A1 discloses a reservoir for a drug delivery system is provided, wherein the reservoir comprises a cavity, the cavity being filled with a dose of a fluid drug such that the dose of the drug occupies 95% or more of the cavity, wherein the dose volume is less than 5 ml. Furthermore, a method for filling a reservoir for a drug delivery system is provided. SUMMARY The scope of the invention is defined in the appended claims. According to an embodiment of the present disclosure, a cartridge is configured to receive an injectable drug. The cartridge includes a body, and the body includes a proximal end portion having a proximal opening, a distal end portion having a distal opening, and a bore coupling the proximal opening and the distal opening. The cartridge further includes a pierceable septum coupled to the distal opening and a plunger movably carried within the bore. A volume is disposed in the bore between the pierceable septum and the plunger. The volume has a reduced pressure, and the reduced pressure is less than atmospheric pressure. A stopper is detachably coupled to the distal opening. According to another embodiment of the present disclosure, a syringe system is configured for delivering an injectable drug to a subject. The syringe system includes a cartridge, a vial, a transfer device, and a delivery needle. The cartridge includes a body having a bore, a plunger movably carried within the bore, and a volume disposed in the bore. The volume has a reduced pressure, and the reduced pressure is less than atmospheric pressure. The vial carries the injectable drug. The transfer device is configured to deliver the injectable drug from the vial to the bore of the cartridge. The delivery needle is configured to be coupled to the distal end portion of the cartridge and deliver the injectable drug from the cartridge to the subject. According to yet another embodiment of the present disclosure, a method of manufacturing a cartridge, the cartridge being configured to receive an injectable drug, includes: providing a body including a distal opening, a proximal opening, and bore extending between the distal opening and the proximal opening; positioning a plunger in the bore; coupling a stopper to the proximal opening; reducing a pressure in the bore to less than atmospheric pressure; and sealing the distal opening. According to yet another embodiment of the present disclosure, a method of delivering an injectable drug from an internal chamber of a vial to an internal bo