Granted Patent B1

US 12,357,539 · App. 18/666,320 · Granted Jul 15, 2025

Inventors: Haiming Wu (Weston, MA); Danial Ferreira (Woodbridge, CT)

Assignee: Genzyme Corporation

A61J1/2065A61J1/2013A61J1/2055

Abstract

Claims (35)

1. A vial adapter for connecting to an injection vial, the injection vial comprising a barrel and a barrel head with an outlet, wherein the outlet is sealed by a pierceable stopper and wherein the pierceable stopper comprises an inside surface, the vial adapter comprising:

an adapter body comprising a top wall and a sidewall, the sidewall projecting from the top wall in a longitudinal direction to form a receptacle with a distal side of the top wall, wherein the receptacle is configured to receive at least a portion of the barrel head; and

a movable part comprising a base part and an elongated fluid channel extending through the top wall along the longitudinal direction, the elongated fluid channel comprising a proximal channel section merging into a mechanical connector and comprising a distal channel section with a channel aperture,

wherein the movable part is adjustably movable relative to the adapter body along the longitudinal direction to align the channel aperture with the inside surface of the pierceable stopper,

wherein when the channel aperture is aligned with the inside surface of the pierceable stopper, the channel aperture is flush with a distally-facing side of the inside surface, and

wherein the elongated fluid channel comprises an elongated channel sidewall and a channel projection, the channel projection (i) is longitudinally aligned with the channel aperture, (ii) comprises a proximally facing abutment face configured to abut the inside surface of the pierceable stopper, (iii) extends laterally from the elongated fluid channel, and (iv) protrudes laterally from the elongated channel sidewall.

2. The vial adapter according to claim 1 , wherein the adapter body comprises a longitudinally extending guiding structure with a guiding receptacle, in which the movable part is movably guided in the longitudinal direction.

3. The vial adapter according to claim 2 , wherein the guiding receptacle comprises a receptacle sidewall and wherein the base part of the movable part comprises a base part sidewall with an outside surface, wherein at least one section of the outside surface is complementary shaped to the receptacle sidewall.

4. The vial adapter according to claim 2 , wherein the base part of the movable part is in longitudinal sliding engagement with the guiding receptacle.

5. The vial adapter according to claim 3 , wherein the receptacle sidewall comprises a through recess, and wherein the movable part comprises a lateral projection extending radially through the through recess.

6. The vial adapter according to claim 2 , wherein the guiding receptacle comprises a bottom facing in a longitudinal proximal direction, and wherein the movable part comprises an abutment face facing in a longitudinal distal direction.

7. The vial adapter according to claim 6 , comprising a biasing element arranged between the bottom of the guiding receptacle and the abutment face of the movable part, wherein the biasing element is configured to apply a biasing force between the adapter body and the movable part to increase a longitudinal distance between the abutment face and the bottom.

8. The vial adapter according to claim 1 , comprising a spike comprising a tipped end facing in a distal direction and configured to penetrate the pierceable stopper.

9. The vial adapter according to claim 1 , wherein the movable part comprises an elongated cannula, through which the elongated fluid channel extends longitudinally.

10. An injection kit for administering a liquid medicament, the injection kit comprising:

an injection vial comprising a barrel to accommodate a liquid medicament and comprising a barrel head with an outlet, wherein the outlet is sealed by a pierceable stopper and wherein the pierceable stopper comprises an inside surface, and

a vial adapter comprising:

an adapter body comprising a top wall and a sidewall, the sidewall projecting from the top wall in a longitudinal direction to form a receptacle with a distal side of the top wall, wherein the receptacle is configured to receive at least a portion of the barrel head; and

a movable part comprising a base part and an elongated fluid channel extending through the top wall along the longitudinal direction, the elongated fluid channel comprising a proximal channel section merging into a mechanical connector and comprising a distal channel section with a channel aperture, wherein the movable part is adjustably movable relative to the adapter body along the longitudinal direction to align the channel aperture with the inside surface of the pierceable stopper, wherein when the channel aperture is aligned with the inside surface of the pierceable stopper, the channel aperture is flush with a distally-facing side of the inside surface, and

wherein the elongated fluid channel comprises an elongated channel sidewall and a channel projection, the channel projection (i) is longitudinally aligned with the channel aperture, (ii) comprises a proximally facing abutment face configured to abut longitudinally with the distally-facing side of the inside surface of the pierceable stopper, (iii) extends laterally from an interior of the elongated fluid channel, and (iv) protrudes laterally from the elongated channel sidewall.

11. A method of withdrawing a liquid medicament contained in an injection vial, the method comprising:

engaging a vial adapter with a barrel head of a barrel of the injection vial, wherein the vial adapter comprises an adapter body and a movable part, the movable part comprising an elongated fluid channel comprising a distal channel section with a channel aperture;

penetrating a pierceable stopper of the injection vial in longitudinal distal direction, thereby urging the elongated fluid channel of the vial adapter through the pierceable stopper, wherein the pierceable stopper seals an outlet of the barrel head;

aligning the channel aperture of the elongated fluid channel with an inside surface of the pierceable stopper so that the channel aperture is flush with a distally-facing side of the inside surface by adjustably moving the movable part relative to a base part of the movable part in a longitudinal direction, and

engaging a proximally facing abutment face of a channel projection of the elongated fluid channel with the inside surface of the pierceable stopper, wherein the channel projection (i) is longitudinally aligned with the channel aperture, (ii) extends from the elongated fluid channel, and (iii) protrudes from an elongated channel sidewall of the elongated fluid channel.

12. The method according to claim 11 , wherein the adapter body of the vial adapter is at least one of engaged, fastened, or fixed to the barrel head of the barrel of the injection vial without penetrating the pierceable stopper.

13. The method according to claim 11 , wherein the pierceable stopper is penetrated by moving or urging the movable part of the vial adapter relative to the adapter body in the longitudinal direction.

14. The method according to claim 11 , wherein a liquid substance located inside the injection vial is completely or almost completely withdrawn from an interior of the injection vial via the channel aperture.

15. A method of administering an injectable medicament, the method comprising:

using a vial adapter for connecting to an injection vial that comprises a barrel and a barrel head with an outlet, wherein the outlet is sealed by a pierceable stopper and wherein the pierceable stopper comprises an inside surface, and wherein the vial adapter comprises

an adapter body comprising a top wall and a sidewall, the sidewall projecting from the top wall in a longitudinal direction to form a receptacle with a distal side of the top wall, wherein the receptacle is configured to receive at least a portion of the barrel head; and

a movable part comprising a base part and an elongated fluid channel extending through the top wall along the longitudinal direction, the elongated fluid channel comprising a proximal channel section merging into a mechanical connector and comprising a distal channel section with a channel aperture,

wherein the elongated fluid channel comprises an elongated channel sidewall and a channel projection, the channel projection (i) is longitudinally aligned with the channel aperture, (ii) comprises a proximally facing abutment face, (iii) extends laterally from the elongated fluid channel, and (iv) protrudes laterally from the elongated channel sidewall,

wherein the movable part is adjustably movable relative to the adapter body along the longitudinal direction to align the channel aperture with the inside surface of the pierceable stopper and to abut the proximally facing abutment face of the channel projection with the inside surface of the pierceable stopper, and

wherein when the channel aperture is aligned with the inside surface of the pierceable stopper, the channel aperture is flush with a distally-facing side of the inside surface.

Assignments (3)

References Cited (82)

Cited By (1)

US 12,661,305