# US 11,439,765 B2 · Variable fill drug delivery device

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,439,765 B2
- Document ID: US11439765B2
- Status: Granted
- Kind: B2
- Application number: 16/524,647
- Filed: 2019-07-29
- Published: 2019-11-14
- Granted: 2022-09-13
- Earliest claimed: 2016-08-14
- Assignees: Insulet Corporation
- Applicants: Insulet Corporation
- Inventors: David Nazzaro
- Web page: https://patentgrep.com/patent/US11439765B2

## CPC

- A61M 5/16886: {for measuring fluid flow rate, i.e. flowmeters}
- A61M 5/31568: {Means keeping track of the total dose administered, e.g. since the cartridge was inserted}
- A61M 5/14248: {of the skin patch type}
- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/1454: {spring-actuated, e.g. by a clockwork}
- A61M 5/1684: {by detecting the amount of infusate remaining, e.g. signalling end of infusion}
- A61M 5/2033: {Spring-loaded one-shot injectors with or without automatic needle insertion (multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287)}
- G01F 13/00: Apparatus for measuring by volume and delivering fluids or fluent solid materials, not provided for in the preceding groups
- A61M 5/1685: {by detection of position of a floating member}
- A61M 5/3129: {Syringe barrels (A61M5/3205, A61M5/50 take precedence)}
- A61M 5/3155: {by rotational movement of dose setting member, e.g. during setting or filling of a syringe}
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/14533: {cam actuated}
- A61M 2005/2073: {preventing premature release, e.g. by making use of a safety lock}
- A61M 2005/31518: {designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members}
- A61M 2202/0468: non-physiological
- A61M 2205/3306: Optical measuring means
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/3389: Continuous level detection (A61M2205/3393 takes precedence)
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual feedback
- A61M 2205/584: having a color code
- G01F 11/029: {provided with electric controlling means (G01F11/022 and G01F11/024 take precedence)}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G01F: MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME

## 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

### Claim 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 including:
a flexure beam housing, wherein the flexure beam housing is configured to attach to the plunger by at least one plunger latch; and
a clutch spring positioned around a base of a fixed thrust component and coupled to the flexure beam housing, 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, and
the infusion engine is configured to:
retain the plunger prior to activation of the variable fill drug delivery device,
release the plunger after activation of the variable fill drug delivery device, and
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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

The variable fill drug delivery device of claim 1, wherein the at least one plunger latch includes a first plunger latch attached to a first depending tab portion of a first arm of the plunger and a second plunger latch attached to a second depending tab portion of a second arm of the plunger.

### Claim 4 (depends on 3)

The variable fill drug delivery device of claim 3, 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.

### Claim 5 (depends on 4)

The variable fill drug delivery device of claim 4, 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.

### Claim 6 (depends on 5)

The variable fill drug delivery device of claim 5, wherein the release coupler is coupled to the fixed thrust component.

### Claim 7 (depends on 4)

The variable fill drug delivery device of claim 4, wherein the infusion engine further comprises a first compression spring positioned around the first and second arms of the flexure beam housing.

### Claim 8 (depends on 7)

The variable fill drug delivery device of claim 7, 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.

### Claim 9 (depends on 8)

The variable fill drug delivery device of claim 8, wherein the spring cap is positioned over the first and second arms of the plunger.

### Claim 10 (depends on 1)

The variable fill drug delivery device of claim 1, wherein the fixed thrust component comprises a base and a spline shaft extending from the base, wherein a release coupler is coupled to the spline shaft of the fixed thrust component and the spline shaft forming a slip joint.

### Claim 11 (depends on 10)

The variable fill drug delivery device of claim 10, wherein the base of the fixed thrust component is coupled to a release component.

### Claim 12 (depends on 1)

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

### Claim 13

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 including:
a flexure beam housing including a first arm and a second arm;
a first compression spring positioned around the first arm and the second arm of the flexure beam housing; and
a clutch spring positioned around a base of a fixed thrust component and coupled to the flexure beam housing, 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, and
the infusion engine is configured to:
retain the plunger prior to activation of the variable fill drug delivery device,
release the plunger after activation of the variable fill drug delivery device, and
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.

### Claim 14 (depends on 13)

The variable fill drug delivery device of claim 13, wherein the infusion engine further comprises:
a second compression spring positioned around a spring cap.

### Claim 15 (depends on 14)

The variable fill drug delivery device of claim 14, wherein an end of the second compression spring is adjacent to the plunger and positioned over the end of the spring cap.

### Claim 16 (depends on 13)

The variable fill drug delivery device of claim 13, further comprising:
a release component configured to rotate when the variable fill drug delivery device is activated.

### Claim 17 (depends on 16)

The variable fill drug delivery device of claim 16, wherein:
the fixed thrust component is configured to rotate about a central axis of the fixed thrust component when the release component rotates.

### Claim 18 (depends on 13)

The variable fill drug delivery device of claim 13, further comprising:
a release coupler configured to rotate with a spline shaft of the fixed thrust component.

### Claim 19 (depends on 18)

The variable fill drug delivery device of claim 18, 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.

### Claim 20

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 including:
a flexure beam housing;
a clutch spring positioned around a base of a fixed thrust component and coupled to the flexure beam housing, wherein:
a release coupler is coupled to a spline shaft of the fixed thrust component, wherein the release coupler and the spline shaft form a slip joint,
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, and
the infusion engine is configured to:
retain the plunger prior to activation of the variable fill drug delivery device,
release the plunger after activation of the variable fill drug delivery device, and
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.