Variable fill drug delivery device

• US 10,441,723 B2
• Filed: 08/14/2017
• Issued: 10/15/2019
• Est. Priority Date: 08/14/2016
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Nazzaro, David
• Primary Examiner(s): Stigell, Theodore J
• Application Number:
  US15/676,289
• Publication Number:
  US 20180043089A1
• Time in Patent Office: 792 Days
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14533 cam actuated
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• CPC Class Codes: A61M 5/1685 by detection of position of a floating member
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/3129 : Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3155 : by rotational movement of dose setting member, e.g. during setting or filling of a syringe
• CPC Class Codes: A61M 5/31568 : Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: G01F 11/029 : provided with electric controlling means G01F11/022 and G01F11/024 take precedence
• CPC Class Codes: G01F 13/00 : Apparatus for measuring by volume and delivering fluids or fluent solid materials, not provided for in the preceding groups

Abstract

Variable fill drug delivery devices for delivering a therapeutic agent to a patient are provided. A variable fill drug delivery device includes a drug container to store a variable amount (or user-selectable amount) of a therapeutic agent. A plunger of the variable fill drug delivery device is positioned in the drug container. An infusion engine of the variable fill device is coupled to the plunger. The infusion engine retains the plunger prior to activation of the variable fill drug delivery device and releases the plunger after activation of the variable fill drug delivery device. After activation, the infusion engine drives the plunger from a first position within the drug container to a second position within the drug container to expel the variable amount of the therapeutic agent from the drug container for delivery to a patient.

Claims

1. A variable fill drug delivery device, comprising:

a container configured to store a user-selectable amount of a therapeutic agent;

a plunger positioned in the container; and

an infusion engine coupled to the plunger, the infusion engine configured to retain the plunger prior to activation of the variable fill drug delivery device, the infusion engine configured to release the plunger after activation of the variable fill drug delivery device and to drive the plunger from a first position within the container to a second position within the container to expel the user-selectable amount of the therapeutic agent from the container for delivery to a patient,

wherein the infusion engine comprises a flexure beam housing attached to the plunger by a first plunger latch and a second plunger latch,

wherein the first plunger latch is attached to a first depending tab portion of a first arm of the plunger and the second plunger latch is attached to a second depending tab portion of a second arm of the plunger,

wherein the first plunger latch is positioned at an end of a first arm of the flexure beam housing and the second plunger latch is positioned at an end of a second arm of the flexure beam housing,

wherein the infusion engine further comprises a release coupler positioned between the first and second arms of the flexure beam housing, an end of the release coupler attached to the plunger,

wherein the release coupler is coupled to a fixed thrust component,

wherein the fixed thrust component comprises a base and a spline shaft extending from the base, wherein the release coupler is coupled to the spline shaft of the fixed thrust component, the release coupler and the spline shaft forming a slip joint,

wherein the base of the fixed thrust component is coupled to a release component,

wherein the infusion engine further comprises a clutch spring positioned around the base of the fixed thrust component and coupled to the flexure beam housing,

wherein the infusion engine further comprises a first compression spring positioned around the first and second arms of the flexure beam housing.

2. The variable fill drug delivery device of claim 1, wherein the infusion engine further comprises a spring cap positioned around a portion of the first compression spring, an end of the spring cap adjacent to the plunger.

3. The variable fill drug delivery device of claim 2, wherein the spring cap is positioned over the first and second arms of the plunger.

4. The variable fill drug delivery device of claim 3, wherein the infusion engine further comprises a second compression spring positioned around the spring cap.

5. The variable fill drug delivery device of claim 4, wherein an end of the second compression spring is adjacent to the plunger and positioned over the end of the spring cap.

6. The variable fill drug delivery device of claim 5, wherein the release component is configured to rotate when the variable fill drug delivery device is activated.

7. The variable fill drug delivery device of claim 6, wherein the fixed thrust component is configured to rotate about a central axis of the fixed thrust component when the release component rotates.

8. The variable fill drug delivery device of claim 7, wherein the release coupler is configured to rotate with the spline shaft of the fixed thrust member.

9. The variable fill drug delivery device of claim 8, wherein the first plunger latch is configured to disengage from the first depending tab portion of the first arm of the plunger and the second plunger latch is configured to detach from the second depending tab portion of the second arm of the plunger to release the plunger when the release coupler rotates.

10. The variable fill drug delivery device of claim 9, wherein the release coupler is shaped to have a first length in a first direction and a second length in a second direction perpendicular to the first direction, wherein the first length is larger than the second length.

11. The variable fill drug delivery device of claim 9, wherein the release coupler is configured to not press against the first and second arms of the flexure beam housing after rotating.

12. The variable fill drug delivery device of claim 11, wherein the first and second compression springs are configured to expand when the first plunger latch is disengaged from the first depending tab portion of the first arm of the plunger and the second plunger latch is disengaged from the second depending tab portion of the second arm of the plunger.

13. The variable fill drug delivery device of claim 12, wherein the first and second compression springs are configured to drive the plunger from the first position within the container to the second position within the container as the first and second compressions springs expand.

14. The variable fill drug delivery device of claim 13, wherein the first and second compressions springs are arranged in series.

15. The variable fill drug delivery device of claim 13, wherein the first and second compressions springs have substantially the same spring constant values.

16. The variable fill drug delivery device of claim 13, wherein the expelled user-selectable amount of the therapeutic agent is provided to a needle.

17. The variable fill drug delivery device of claim 1, wherein the user-selectable amount of the therapeutic agent is less than a total fixed amount of the therapeutic agent that the container is configured to store.

18. The variable fill drug delivery device of claim 1, wherein the clutch spring is configured to attach to the base of the fixed thrust component after the container is filled with the user-selectable amount of the therapeutic agent.

19. The variable fill drug delivery device of claim 1, wherein the clutch spring is configured to attach to the base of the fixed thrust component after the patient engages a first user interaction component.

20. The variable fill drug delivery device of claim 1, wherein the clutch spring is configured to attach to the base of the fixed thrust component after an on-body interlock of the variable fill drug delivery device is engaged.

21. The variable fill drug delivery device of claim 1, wherein the clutch spring is a radial torsion spring.