Drug delivery device, method of manufacture, and method of use

Patent metadata

Field	Value
Publication number	US-2019022306-A1
Application number	US-201716071873-A
Country	US
Kind code	A1
Filing date	Feb 13, 2017
Priority date	Feb 12, 2016
Publication date	Jan 24, 2019
Grant date	—

Abstract

Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.

First claim

1 . A wearable drug delivery device comprising:
a housing; a container disposed in the main housing, the container including a barrel and a plunger seal moveable through the barrel; a drug disposed in the barrel, the drug comprising at least one of a Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) specific antibody or a granulocyte colony-stimulating factor (G-CSF); a cannula having an internal passage and configured to be operably connected in fluid communication with the container to deliver the drug to a patient during use of the wearable drug delivery device; an introducer needle initially disposed in the cannula and configured for introducing the cannula into the patient's skin; a drive mechanism disposed in the main housing and including an energy source selectively activatable to move the plunger seal through the barrel: an insertion mechanism including:
an insertion biasing member initially retained in an insertion biasing member energized state, the insertion biasing member being configured to move the introducer needle and the cannula into the patient's skin as the insertion biasing member de-energizes, and
a first retainer moveable between: (i) a first retainer retaining position, where the first retainer retains the insertion biasing member in the insertion biasing member energized state, and (ii) a first retainer releasing position, where the first retainer allows the insertion biasing member to de-energize;
a button disposed at an exterior surface of the main housing and manually displaceable by a user; and a trigger assembly configured to, in response to displacement of the button by the user: (i) activate the energy source to move the plunger seal through the barrel, and (ii) move the first retainer from the first retainer retaining position to the first retainer releasing position.

2 . (canceled)

3 . The wearable drug delivery device of claim 1 , the trigger assembly including a first control arm and a second control arm, the first control arm being configured to activate the energy source in response to displacement of the button by the user, and the second control arm being configured to move the first retainer from the first retainer retaining position to the first retainer releasing position in response to displacement of the button by the user.

4 . The wearable drug delivery device of claim 3 , comprising:
a pierceable seal controlling access to an interior of the barrel of the container; a container access needle configured to pierce the pierceable seal to establish fluid communication between the container and the cannula during use of the wearable drug delivery device; and a connection hub connected to the container access needle and moveable relative to the container between: (i) a connection hub first position, where the container access needle is spaced apart from the first pierceable seal, and (ii) a connection hub second position, where the container access needle pierces the pierceable seal.

5 . The wearable drug delivery device of claim 4 , the first control arm including main body and a first and a second protrusion extending from opposite sides of the main body, the first protrusion being configured to move the connection hub from the connection hub first position to the connection hub second position in response to displacement of the button by the user, the second protrusion being configured to move the first retainer from the first retainer retaining position to the first retainer releasing position in response to displacement of the button by the user.

6 . The wearable drug delivery device of 4 , wherein displacement of the button by the user causes the trigger assembly to, simultaneously: (i) activate the energy source to move the plunger seal through the barrel, (ii) move the first retainer from the first retainer retaining position to the first retainer releasing position, and (iii) move the connection hub from the connection hub first position to the connection hub second position.

7 . The wearable drug delivery device of claim 3 , the trigger assembly including:
a first spring disposed between the button and the first control arm; a second spring arranged in series with the first spring and disposed between the first control arm and the housing; wherein the second spring has a greater stiffness than the first spring such that, in response to initial displacement of the button by the user, initial compression of the first spring is greater than initial compression of the second spring.

8 . (canceled)

9 . (canceled)

10 . (canceled)

11 . The wearable drug delivery device of claim 1 , comprising:
a window covering an opening in the housing; and the housing including an upper housing portion and a lower housing portion, wherein the window is configured to connect the upper housing portion to the lower housing portion.

12 . (canceled)

13 . The wearable drug delivery device of claim 1 , the insertion mechanism comprising:
a retraction biasing member initially retained in a retraction biasing member energized state, the retraction biasing member being configured to withdraw the retraction biasing member from the patient as the retraction biasing member de-energizes; a second retainer moveable between: (i) a second retainer retaining position, where the second retainer retains the retraction biasing member in the retraction biasing member energized state, and (ii) a second retainer releasing position, where the second retainer allows the retraction biasing member to de-energize; and the second retainer including a flexible clip, wherein the flexible clip undergoes elastic deformation when the second retainer moves from the second retainer retaining position to the second retainer releasing position.

14 . The wearable drug delivery device of claim 1 , comprising:
a tubular conduit configured to be operably connected in fluid communication with the container access needle during use of the wearable drug delivery device; and a manifold connecting the tubular conduit and the cannula, the insertion biasing member causing the manifold and at least a portion of the tubular conduit to move relative to the housing as the insertion biasing member de-energizes.

15 . The wearable drug delivery device of claim 1 , comprising:
an electrically-powered element; a battery configured to supply the electrically-powered element with electricity; an adhesive applied to an exterior surface of the main housing; and an adhesive liner covering the adhesive, wherein removal of the adhesive liner from the adhesive causes the battery to supply the electrically-powered element with electricity.

16 . The wearable drug delivery device of claim 14 , comprising a heating element disposed adjacent to the tubular conduit and configured to warm the drug as the drug flows through the tubular conduit during delivery.

17 . (canceled)

18 . A support system for a patient, the system comprising:
the wearable drug delivery device according to claim 1 ; the wearable drug delivery device including a first communication module configured to transmit a report representative of at least one of a condition or an operational state of the drug delivery device; and an external computing device comprising:
a second communication module configured to receive the report;
a processor;
a memory coupled to the processor and configured to store non-transitory, computer-executable instructions that, when executed by the processor, cause the processor to:
associate the patient with the at least one support group;
st

Assignees

• Amgen Inc

Inventors

• Gibson Scott R
• Moberg Sheldon B
• Taha Basel Hasan
• Boyaval Margaux Frances
• Destefano Mark A
• Love John C
• Hanson Ian B
• Bente Iv Paul F
• Clemente Matthew J
• Ramaswamy Rajan
• Codd Daniel S
• Beaver Scott
• Bokelman Kevin L
• O'Connor Sean M
• Decker Robert
• Shetty Gautam N
• Agard Ryan M
• Ciccarelli Nicholas J
• Davenport Daniel

Classifications

• A61M2005/2481

  comprising means for biasing the ampoule out of the ampoule holder · CPC title

• A61M5/315

  Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod {or piston}; Appliances on the rod for facilitating dosing {; Dosing mechanisms} · CPC title

• A61M2205/35

  Communication · CPC title

• A61M2205/3368

  Temperature · CPC title

• A61M5/14566

  with a replaceable reservoir for receiving a piston rod of the pump · CPC title