Backflow prevention mechanism for drug delivery device

Patent metadata

Field	Value
Publication number	US-11890450-B2
Application number	US-201916297408-A
Country	US
Kind code	B2
Filing date	Mar 8, 2019
Priority date	Mar 9, 2018
Publication date	Feb 6, 2024
Grant date	Feb 6, 2024

Abstract

A drug delivery device includes a housing defining a shell and an inner volume, a container, a drive mechanism, a needle assembly, a fluid flow connection, and a backflow prevention mechanism. The container has an inner volume to contain a medicament to be administered to a user. The drive mechanism is at least partially disposed within the housing and exerts a force to urge the medicament out the container. The fluid flow connection is coupled to the container and the needle assembly and allows the medicament to flow from the container to the needle assembly to be administered. The backflow prevention mechanism is associated with at least one of the container, the fluid flow connection, or the needle assembly and includes at least one flow restrictor to restrict a fluid from flowing from the needle assembly to the container.

First claim

What is claimed is:

1. A drug delivery device comprising:
a housing defining a shell and an inner volume;
a container at least partially disposed within the housing, the container having an inner volume adapted to contain a medicament to be administered to a user;
a drive mechanism at least partially disposed within the housing, the drive mechanism adapted to exert a force to urge the medicament out the container;
a needle assembly at least partially disposed within the housing, the needle assembly adapted to insert a needle or a trocar into the user's skin and to subsequently retract, thereby leaving a cannula within the user's skin for a period of time at least until the drive mechanism urges the medicament out the container;
a fluid flow connection coupled to the container and the needle assembly, the fluid flow connection adapted to allow the medicament to flow from the container to the needle assembly; and
a backflow prevention mechanism disposed within a coupling region between the container and the needle assembly, the backflow prevention mechanism comprising at least one flow restrictor to restrict a fluid from flowing from the cannula to the container, thereby reducing and/or eliminating clot formation during the period of time at least until the drive mechanism urges the medicament from the container to the needle assembly,
wherein the coupling region includes an upstream portion and a downstream portion, the upstream portion having an upstream diameter larger than the flow restrictor and the downstream portion having a downstream diameter smaller than the flow restrictor.

2. The drug delivery device of claim 1 , wherein the at least one flow restrictor comprises a one-way valve.

3. The drug delivery device of claim 2 , wherein the at least one flow restrictor comprises at least one of:
a slit valve;
an umbrella valve;
a ball valve;
a duckbill valve; or
a flap valve.

4. The drug delivery device of claim 1 , wherein the at least one flow restrictor comprises an air exclusion device.

5. The drug delivery device of claim 1 , wherein the backflow prevention mechanism is disposed at a coupling region at which the fluid flow connection is coupled to the needle assembly.

6. The drug delivery device of claim 5 , wherein the coupling region comprises a ball and reservoir receptacle adapted to seal the needle assembly.

7. The drug delivery device of claim 1 , wherein the fluid flow connection is constructed from a flexible tube.

8. The drug delivery device of claim 7 , wherein the flexible tube is constructed from a polymer material.

9. A backflow prevention mechanism for a drug delivery device, the backflow prevention mechanism disposed within a coupling region between a container and the needle assembly, the backflow prevention mechanism comprising at least one flow restrictor to selectively restrict a fluid from flowing from a cannula to the container over an extended period of time after a needle assembly delivers the cannula within a user's skin, thereby reducing and/or eliminating clot formation,
wherein the coupling region includes an upstream portion and a downstream portion, the upstream portion having an upstream diameter larger than the flow restrictor and the downstream portion having a downstream diameter smaller than the flow restrictor.

10. The backflow prevention mechanism of claim 9 , wherein the at least one flow restrictor comprises a one-way valve.

11. The backflow prevention mechanism of claim 9 , wherein the one-way valve comprises at least one of:
a slit valve;
an umbrella valve;
a ball valve;
a duckbill valve; or
a flap valve.

12. The backflow prevention mechanism of claim 9 , wherein the at least one flow restrictor comprises an air exclusion device.

13. A method of preventing backflow in a drug delivery device having a backflow prevention mechanism, the drug delivery device including housing defining a shell and an inner volume and a container at least partially disposed within the inner volume of the housing and being adapted to contain a medicament to be administered to a user, the method comprising:
at least partially disposing a drive mechanism within the housing, the drive mechanism adapted to exert a force to urge the medicament out of the container;
at least partially disposing a needle assembly within the housing, the needle assembly adapted to insert a needle or a trocar into the user's skin and to subsequently retract, thereby leaving a cannula within the user's skin for a period of time at least until the drive mechanism urges the medicament out the container;
coupling a fluid flow connection to the container and the needle assembly to allow the medicament to flow from the container to the needle assembly; and
disposing a backflow prevention mechanism within a coupling region between the container and the needle assembly, the backflow prevention mechanism comprising at least one flow restrictor that restricts a fluid from flowing from the cannula to the container, thereby reducing and/or eliminating clot formation during the period of time at least until the drive mechanism urges the medicament from the container to the needle assembly.

14. The method of claim 13 , wherein associating the at least one backflow prevention mechanism comprises associating a one way valve with the at least one of the container, the fluid flow connection, or the needle assembly.

15. The method of claim 13 , wherein associating the at least one backflow prevention mechanism comprises associating an air exclusion device with the at least one of the container, the fluid flow connection, or the needle assembly.

16. The method of claim 13 , wherein the backflow prevention mechanism is disposed at a coupling region at which the fluid flow connection is coupled to the needle assembly.

Assignees

• Amgen Inc

Inventors

• Ring Lawrence Scott
• Pirbodaghi Tohid
• Akbari Samin
• Groszmann Daniel Eduardo
• Mojarrad Mehran
• Gordon Mark
• Tikh Mikhail
• Ward Jimmie L
• Gibson Scott R
• Moberg Sheldon B
• Tamsky Joshua
• Faucher Paul
• Lind Jeff

Classifications

• A61M5/16813 Primary

  by controlling the degree of opening of the flow line · CPC title

• A61M5/1413

  Modular systems comprising interconnecting elements · CPC title

• A61M5/14248 Primary

  of the skin patch type · CPC title

• A61M5/158

  Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} · CPC title

• A61M5/16822

  by controlling air intake into infusion reservoir (needle sets with air inlet A61M5/162) · CPC title