Drug delivery device and method

Patent metadata

Field	Value
Publication number	US-12390583-B2
Application number	US-202117503106-A
Country	US
Kind code	B2
Filing date	Oct 15, 2021
Priority date	Mar 9, 2015
Publication date	Aug 19, 2025
Grant date	Aug 19, 2025

Abstract

A drive mechanism ( 100 ) for use with a drug container ( 50 ) in a drug pump, the drug container ( 50 ) having a barrel ( 58 ) and a plunger seal ( 60 ), including a tether, an electrical actuator ( 101 ) and a gear interface. Rotation of the gear interface is controlled by the actuator ( 101 ). A gear assembly rotationally engages with the gear interface. The gear assembly includes a main gear and a regulating mechanism. Release of the tether is metered by the gear assembly through the regulating mechanism. A piston ( 110, 1110, 2110 ) is connected to the tether and is disposed in the barrel ( 58 ) and configured to translate axially within the container. A biasing member is disposed at least partially within the barrel ( 58 ) and is retained in an energized state between the piston ( 110, 1110, 2110 ) and drive housing, wherein the release of the tether controls the free expansion of the biasing member from its energized state and the axial translation of the piston ( 110, 1110, 2110 ).

First claim

What is claimed is:

1. A wearable drug delivery device comprising:
an outer housing attachable to a patient;
a drug storage container positioned at least partially within the outer housing;
an insertion mechanism positioned at least partially within the outer housing and including:
an insertion mechanism housing,
a rotational biasing member configured to rotate the insertion mechanism housing, and
a delivery member connected or configured to be connected in fluid communication with the drug storage container and configured for insertion into the patient;

a retainer selectively moveable with respect to the insertion mechanism housing, the retainer having a first position wherein the retainer is operably coupled with the insertion mechanism housing to prevent rotation of the insertion mechanism housing and a second position wherein the retainer is at least temporarily uncoupled from the insertion mechanism housing to allow rotation of the insertion mechanism housing; and
wherein at least a portion of the delivery member is initially disposed within the insertion mechanism housing.

2. The wearable drug delivery device of claim 1 , wherein the delivery member is operably coupled with the insertion mechanism housing such that initial rotation of the insertion mechanism housing causes the delivery member to be inserted into the patient.

3. The wearable drug delivery device of claim 1 , wherein the insertion mechanism housing comprises a protrusion, the protrusion contacting the retainer when the retainer is in the first position and not contacting the retainer when the retainer is in the second position.

4. The wearable drug delivery device of claim 1 , wherein at least a portion of the retainer moves linearly in moving from the first position to the second position.

5. The wearable drug delivery device of claim 1 , comprising a drive mechanism positioned at least partially within the outer housing, the drive mechanism being configured to move a drug out of the drug storage container and into the patient via the delivery member.

6. The wearable drug delivery device of claim 1 , wherein the rotational biasing member comprises a torsion spring.

7. The wearable drug delivery device of claim 1 , wherein the delivery member comprises a needle.

8. The wearable drug delivery device of claim 1 , wherein at least a portion of the rotational biasing member surrounds at least a portion of the insertion mechanism housing.

9. The wearable drug delivery device claim 1 , comprising an adhesive patch disposed on a bottom surface of the outer housing for attaching the outer housing to the patient.

10. The wearable drug delivery device of claim 1 , wherein the outer housing is removably attachable to the patient.

11. The wearable drug delivery device of claim 1 , wherein:
the outer housing comprises a bottom surface removably attachable to the patient;
the rotational biasing member is configured to rotate the insertion mechanism housing about an axis; and
the axis is substantially perpendicular to the bottom surface of the outer housing.

12. The wearable drug delivery device of claim 3 , wherein the protrusion extends outwardly from a cylindrical portion of the insertion mechanism housing.

13. The wearable drug delivery device of claim 4 , wherein the at least a portion of the retainer moves in a direction perpendicular to a rotational axis of the insertion mechanism housing.

14. The wearable drug delivery device of claim 5 , wherein the drive mechanism is configured to move at least a portion of the retainer with respect to the insertion mechanism housing.

15. The wearable drug delivery device of claim 7 , wherein the needle is hollow.

16. A method comprising:
providing a wearable drug delivery device comprising an outer housing, a drug storage container positioned at least partially within the outer housing, an insertion mechanism positioned at least partially within the outer housing, the insertion mechanism including an insertion mechanism housing, a rotational biasing member configured to rotate the insertion mechanism housing, a delivery member configured for insertion into a patient, and a retainer having a first position wherein the retainer is operably coupled with the insertion mechanism housing to prevent rotation of the insertion mechanism housing and a second position wherein the retainer is at least temporarily uncoupled from the insertion mechanism housing to allow rotation of the insertion mechanism housing, wherein at least a portion of the delivery member is initially disposed within the insertion mechanism housing;
positioning the outer housing in contact with the patient;
moving the retainer from the first position to the second position to allow the rotational biasing member to rotate of the insertion mechanism housing, wherein rotation of the insertion mechanism housing causes the delivery member to be inserted at least partially into the patient; and
moving a drug out of the drug storage container into the patient via the delivery member.

17. The method of claim 16 , wherein the insertion mechanism housing comprises a protrusion, the protrusion contacting the retainer when the retainer is in the first position and not contacting the retainer when the retainer is in the second position.

18. The method of claim 16 , wherein:
the outer housing comprises a bottom surface removably attachable to the patient;
the rotational biasing member is configured to rotate the insertion mechanism housing about an axis; and
the axis is substantially perpendicular to the bottom surface of the outer housing.

19. A wearable drug delivery device comprising:
an outer housing attachable to a patient;
a drug storage container positioned at least partially within the outer housing;
an insertion mechanism positioned at least partially within the outer housing and including:
an insertion mechanism housing,
a rotational biasing member configured to rotate the insertion mechanism housing, and
a delivery member connected or configured to be connected in fluid communication with the drug storage container and configured for insertion into the patient;

a retainer selectively moveable with respect to the insertion mechanism housing, the retainer having a first position wherein the retainer is operably coupled with the insertion mechanism housing to prevent rotation of the insertion mechanism housing and a second position wherein the retainer is at least temporarily uncoupled from the insertion mechanism housing to allow rotation of the insertion mechanism housing; and
wherein:
the outer housing comprises a bottom surface removably attachable to the patient,
the rotational biasing member is configured to rotate the insertion mechanism housing about an axis, and
the axis is substantially perpendicular to the bottom surface of the outer housing.

20. A method comprising:
providing a wearable drug delivery device comprising an outer housing, a drug storage container positioned at least partially within the outer housing, an insertion mechanism positioned at least partially within the outer housing, the insertion mechanism including an insertion mechanism housing, a rotational biasing member configured to rotate the insertion mechanism housing, a delivery member configured for insertion into a patient, and a retainer having a first position wherein the retainer is operably coupled with the insertion mechanism housing to prevent rotation of the insertion mechanism housing and a second position wherein the retainer is at l

Assignees

• Amgen Inc

Inventors

• Laurence Lawton
• Bente Iv Paul F
• Destefano Mark A
• Dardani Ian P
• Hanson Ian B

Classifications

• A61M2205/3584

  using modem, internet or Bluetooth® · CPC title

• A61M2205/276

  preventing unwanted use · CPC title

• A61M2005/14506

  mechanically driven, e.g. spring or clockwork · CPC title

• A61M2005/1402

  Priming · CPC title

• A61M5/158

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