IP Library Granted Patent US 12,318,594
Granted Patent B2
US 12,318,594 · App. 17/408,523 · Granted Jun 3, 2025

On-body interlock for drug delivery device

Inventors: David Nazzaro (Groveland, MA); Ian McLaughlin (Groton, MA); Simon Kozin (Lexington, MA); Maureen McCaffrey (Arlington, MA); Jackie Mac (Malden, MA); Alexander Doudoumopoulos (Boxborough, MA); Bhavin Patel (Franklin Park, NJ)
Assignee: INSULET CORPORATION
A61M5/31593A61M5/14248A61M5/28A61M5/31531A61M5/32A61M2005/2474A61M2005/3142A61M2005/31518A61M5/42A61M37/00
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Quick Facts
Patent No.
US 12,318,594
App. No.
17/408,523
Granted
Jun 3, 2025
Kind
B2
Abstract

A wearable drug delivery device that can deliver a liquid drug stored in a container to a patient is provided. The container can be a prefilled cartridge that can be loaded into the drug delivery device by the patient or that can be preloaded within the drug delivery device when provided to the patient. A sealed end of the container is pierced to couple the stored liquid drug to a needle conduit that is coupled to a needle insertion component that provides access to the patient. A drive system of the drug delivery device can expel the liquid drug from the cartridge to the patient through the needle conduit. The drive system can be controlled to provide the liquid drug to the patient in a single dose or over multiple doses.

Claims (94)

1. A drug delivery device, comprising:

a housing;

a container configured to store a liquid drug;

a needle insertion component configured to insert and retract a needle into skin of a user when triggered;

a drive component configured to expel a portion of the liquid drug from the container, wherein the drive component is coupled to a plunger;

a conduit configured through the plunger and operable to transfer the expelled portion of the liquid drug from the container and through the plunger;

two external buttons on an outside of the housing configured to interact with the drive component; and

an on-body interlock configured to contact skin of the user and disposed at a bottom portion of the drug delivery device, wherein the on-body interlock is a button or a switch operable to retract into the drug delivery device when the bottom portion is coupled to the user and is operable to prevent triggering of the needle insertion component and to prevent delivery of the liquid drug to the user.

2. The drug delivery device of claim 1 , wherein the on-body interlock is operable to extend from the bottom portion out of the drug delivery device.

3. The drug delivery device of claim 1 , wherein the on-body interlock is configured to be biased to extend from the bottom portion when the bottom portion is uncoupled from the user.

4. The drug delivery device of claim 1 , further comprising an adhesive component positioned on the bottom portion and configured to attach the drug delivery device to the user.

5. The drug delivery device of claim 1 , wherein the two external buttons on the outside of the housing are located on opposite sides of the housing.

6. A drug delivery device, comprising:

a housing;

a container configured to store a liquid drug;

a needle insertion component configured to insert and retract a needle into skin of a user when triggered;

a drive component configured to expel a portion of the liquid drug from the container, wherein the drive component is coupled to a plunger;

a conduit configured through the plunger and operable to transfer the expelled portion of the liquid drug from the container and through the plunger;

two external buttons on an outside of the housing configured to interact with the drive component; and

an on-body interlock configured to contact skin of the user and disposed at a bottom portion of the drug delivery device, wherein the on-body interlock is operable to prevent triggering of the needle insertion component and to prevent delivery of the liquid drug to the user, and the on-body interlock is a pivoting component that is operable to:

extend outside the bottom portion of the drug delivery device, and

retract inside of the drug delivery device in response to an applied force.

7. A drug delivery device, comprising:

a housing;

a container configured to store a liquid drug;

a needle insertion component configured to insert and retract a needle into skin of a user when triggered;

a drive component configured to expel a portion of the liquid drug from the container, wherein the drive component is coupled to a plunger;

a conduit configured through the plunger and operable to transfer the expelled portion of the liquid drug from the container and through the plunger;

two external buttons on an outside of the housing configured to interact with the drive component; and

an on-body interlock configured to contact skin of the user and disposed at a bottom portion of the drug delivery device, wherein the on-body interlock is operable to prevent triggering of the needle insertion component and to prevent delivery of the liquid drug to the user, wherein

the drug delivery device is operable to:

in response to the on-body interlock being depressed, activation of the drug delivery device is enabled.

8. The drug delivery device of claim 7 , wherein the on-body interlock is a push rod.

9. A drug delivery device, comprising:

a housing;

a bottom portion configured to be disposed on skin of a user;

a container configured to store a liquid drug;

a needle insertion component configured to extend a needle through an opening in the bottom portion;

a drive component configured to expel a portion of the liquid drug from the container, wherein the drive component is coupled to a plunger;

a conduit configured through the plunger and operable to transfer the expelled portion of the liquid drug from the container and through the plunger;

two external buttons on an outside of the housing configured to interact with the drive component; and

an on-body interlock disposed at the bottom portion of the drug delivery device and operable to enable activation of the drug delivery device when the bottom portion is placed on the skin of the user, wherein the opening for the needle of the needle insertion component is spaced away and separate from the on-body interlock, and the on-body interlock is biased to extend out of the bottom portion of the drug delivery device.

10. The drug delivery device of claim 9 , wherein the on-body interlock is a push rod.

11. The drug delivery device of claim 9 , further comprising an adhesive component positioned on the bottom portion and configured to attach the drug delivery device to the user.

12. The drug delivery device of claim 11 , wherein the adhesive component comprises at least one of a strip or pad.

13. A drug delivery device, comprising:

a housing;

a bottom portion configured to be disposed on skin of a user;

a container configured to store a liquid drug;

a needle insertion component configured to extend a needle through an opening in the bottom portion;

a drive component configured to expel a portion of the liquid drug from the container, wherein the drive component is coupled to a plunger;

a conduit configured through the plunger and operable to transfer the expelled portion of the liquid drug from the container and through the plunger;

two external buttons on an outside of the housing configured to interact with the drive component; and

an on-body interlock disposed at the bottom portion of the drug delivery device and operable to enable activation of the drug delivery device when the bottom portion is placed on the skin of the user, wherein the opening for the needle of the needle insertion component is spaced away and separate from the on-body interlock, and the drug delivery device is in an idle state when the on-body interlock is extended through the bottom portion of the drug delivery device.

14. A drug delivery device, comprising:

a housing;

a bottom portion configured to be disposed on skin of a user;

a container configured to store a liquid drug;

a needle insertion component configured to extend a needle through an opening in the bottom portion;

a drive component configured to expel a portion of the liquid drug from the container, wherein the drive component is coupled to a plunger;

a conduit configured through the plunger and operable to transfer the expelled portion of the liquid drug from the container and through the plunger;

two external buttons on an outside of the housing configured to interact with the drive component; and

an on-body interlock disposed at the bottom portion of the drug delivery device and operable to enable activation of the drug delivery device when the bottom portion is placed on the skin of the user, wherein the opening for the needle of the needle insertion component is spaced away and separate from the on-body interlock, and the on-body interlock retracts inside the drug delivery device in response to coupling to a user.

15. The drug delivery device of claim 14 , wherein the on-body interlock is a button or a switch.

16. A drug delivery device, comprising:

a housing;

a bottom portion configured to be disposed on skin of a user;

a container configured to store a liquid drug;

a needle insertion component configured to extend a needle through an opening in the bottom portion;

a drive component configured to expel a portion of the liquid drug from the container, wherein the drive component is coupled to a plunger;

a conduit configured through the plunger and operable to transfer the expelled portion of the liquid drug from the container and through the plunger;

two external buttons on an outside of the housing configured to interact with the drive component; and

an on-body interlock disposed at the bottom portion of the drug delivery device and operable to enable activation of the drug delivery device when the bottom portion is placed on the skin of the user, wherein the opening for the needle of the needle insertion component is spaced away and separate from the on-body interlock, and the on-body interlock is a pivoting component biased to extend outside of the drug delivery device and operable to pivot into the drug delivery device when depressed.

17. A drug delivery device, comprising:

a housing;

a bottom portion configured to be disposed on skin of a user;

a container configured to store a liquid drug;

a needle insertion component configured to extend a needle through an opening in the bottom portion;

a drive component configured to expel a portion of the liquid drug from the container, wherein the drive component is coupled to a plunger;

a conduit configured through the plunger and operable to transfer the expelled portion of the liquid drug from the container and through the plunger;

two external buttons on an outside of the housing configured to interact with the drive component; and

an on-body interlock disposed at the bottom portion of the drug delivery device and operable to enable activation of the drug delivery device when the bottom portion is placed on the skin of the user and in response to the on-body interlock being depressed activation of the drug delivery is enabled,

wherein the opening for the needle of the needle insertion component is spaced away and separate from the on-body interlock.

18. The drug delivery device of claim 17 , wherein the on-body interlock is a push rod, a button, or a switch.

19. The drug delivery device of claim 17 , further comprising an adhesive component positioned on the bottom portion and configured to attach the drug delivery device to the user.

20. A drug delivery device, comprising:

a housing;

a bottom portion configured to be disposed on skin of a user;

a container configured to store a liquid drug;

a needle insertion component configured to extend a needle through an opening in the bottom portion;

a drive component configured to expel a portion of the liquid drug from the container, wherein the drive component is coupled to a plunger;

a conduit configured through the plunger and operable to transfer the expelled portion of the liquid drug from the container and through the plunger;

two external buttons on an outside of the housing configured to interact with the drive component; and

an on-body interlock disposed at the bottom portion of the drug delivery device and operable to enable activation of the drug delivery device when the bottom portion is placed on the skin of the user, wherein the opening for the needle of the needle insertion component is spaced away and separate from the on-body interlock, and when the on-body interlock extends from the bottom of the drug delivery device activation of the drug delivery is prevented.

Assignments (2)
SECURITY AGREEMENT SUPPLEMENT FOR INTELLECTUAL PROPERTY Recorded Nov 16, 2022
From: INSULET CORPORATION
To: MORGAN STANLEY SENIOR FUNDING, INC., AS COLLATERAL AGENT
Reel/Frame 061951/0977 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 23, 2021
From: NAZZARO, DAVID; MCLAUGHLIN, IAN; KOZIN, SIMON; MCCAFFREY, MAUREEN; MAC, JACKIE; DOUDOUMOPOULOS, ALEXANDER; PATEL, BHAVIN
To: INSULET CORPORATION
Reel/Frame 057251/0349 →
Cited By (1)
US 12,527,912