# US 11,992,653 B2 · Drug delivery insertion apparatuses and system

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- Number: US 11,992,653 B2
- Document ID: US11992653B2
- Status: Granted
- Kind: B2
- Application number: 16/515,749
- Filed: 2019-07-18
- Published: 2020-01-23
- Granted: 2024-05-28
- Earliest claimed: 2018-07-18
- Assignees: Insulet Corporation
- Applicants: Insulet Corporation
- Inventors: Jason O'Connor; Ian McLaughlin; Daniel Allis; David Nazzaro
- Web page: https://patentgrep.com/patent/US11992653B2

## CPC

- A61M 5/14566: {with a replaceable reservoir for receiving a piston rod of the pump}
- A61M 5/1408: {in parallel, e.g. by manifolds or with sequencing valves}
- A61M 5/14248: {of the skin patch type}
- A61M 5/1582: {Multi-lumen needles}
- A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube
- A61M 5/16881: {Regulating valves}
- A61M 5/1413: {Modular systems comprising interconnecting elements}
- A61M 5/16877: {Passive flow controllers; Devices for setting a flow rate (clamp-type valves A61M39/28)}
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/3114: {Filling or refilling}
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/583: by visual feedback
- A61M 2209/045: for filling, e.g. for filling reservoirs
- 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)}

## Abstract

Disclosed are examples for a system for drug delivery and components thereof. The system may include an on-body pump device and a secondary unit. The on-body pump device may include a reservoir and a fluid pathway. The reservoir may be configured to hold a liquid drug. The secondary unit may be removably coupled to the on-body pump device. The secondary unit may be configured to receive a prefilled cartridge containing a liquid drug, expel the liquid drug from the prefilled cartridge, and deliver the liquid drug to the reservoir of the on-body pump device via the fluid pathway. Examples of variations to the secondary unit are also disclosed.

## Claims

### Claim 1

A system, comprising:
an on-body pump device comprising a reservoir, a pump mechanism, and a fluid pathway, wherein the reservoir is configured to hold fluid and the on-body pump device is configured to be attached to skin of a user; and
a secondary unit removably coupled to the on-body pump device,
the secondary unit including an opening and further including a variable fill mechanism, wherein the opening is configured to receive a prefilled cartridge having a plunger and containing a liquid drug, and the variable fill mechanism including:
a travel pin operable to engage the plunger of the prefilled cartridge and move as the prefilled cartridge is inserted in the opening:
an indicator rod, wherein the travel pin is further configured to engage the indicator rod, wherein the indicator rod is configured to move as the prefilled cartridge is inserted in the opening, and
a gear operable to move a visual indicator of the indicator rod corresponding to a fill volume of the liquid drug within the reservoir;
wherein the secondary unit, while coupled to the on-body pump device is configured to:
expel the fill volume of liquid drug from the prefilled cartridge, and
deliver the liquid drug to the reservoir of the on-body pump device via the fluid pathway.

### Claim 2 (depends on 1)

The system of claim 1, wherein the on-body pump device further comprises a needle and a needle insertion mechanism, wherein:
the needle is coupled to the fluid pathway, and
the needle insertion mechanism is operable to insert the needle into the skin of a user to enable delivery of the liquid drug.

### Claim 3 (depends on 2)

The system of claim 2, further comprising:
a first interlock operable to prevent operation of the needle insertion mechanism until the reservoir is filled with a desired volume of the liquid drug.

### Claim 4 (depends on 1)

The system of claim 1, wherein the secondary unit further comprises:
a first dial operable to select a basal rate for delivery of a basal dosage of the liquid drug; and
a second dial operable to select a bolus increment for delivery of a bolus dosage of the liquid drug.

### Claim 5 (depends on 1)

The system of claim 1, wherein the secondary unit further comprises:
an opening configured to receive the prefilled cartridge, the opening having:
a cartridge stop configured to contact the plunger of the prefilled cartridge, and
a fill needle configured to pierce the plunger of the prefilled cartridge.

### Claim 6 (depends on 1)

The system of claim 1, wherein the on-body pump device further comprises:
an introducing needle device operable to insert a needle coupled to the reservoir into skin of a user.

### Claim 7 (depends on 1)

The system of claim 1, wherein the secondary unit further comprises:
a first opening configured to receive a first prefilled cartridge; and
a second opening configured to receive a second prefilled cartridge, wherein the first opening includes a first fill needle, and the second opening includes a second fill needle.

### Claim 8 (depends on 7)

The system of claim 7, wherein the reservoir further comprises:
a first reservoir compartment and a second reservoir compartment, wherein:
the first reservoir compartment is fluidly coupled to the first fill needle within the first opening, and
the second reservoir compartment is fluidly coupled the second fill needle within the second opening.

### Claim 9

An on-body pump device, comprising:
a first reservoir configured to hold a first fluid;
a second reservoir configured to hold a second fluid;
a first pump mechanism fluidly coupled to the first reservoir, the first pump mechanism operable to pump the first fluid from the first reservoir;
a second pump mechanism fluidly coupled to the second reservoir, the second pump mechanism operable to pump the second fluid from the second reservoir;
a flow regulator valve fluidly coupled to the first pump mechanism and the second pump mechanism, wherein the flow regulator valve includes:
a first flow channel and a second flow channel,
an inner valve coupled to the first flow channel operable to deliver the first fluid at a first variable flow rate,
an outer valve coupled to the second flow channel operable to deliver the first fluid at a second variable flow rate independent of the first flow rate, and
a gear system configured to independently set a first flow rate of the first fluid from the first pump mechanism relative to a second flow rate of the second fluid from the second pump mechanism; and
a cannula fluidly coupled to the flow regulator valve.

### Claim 10 (depends on 9)

The on-body pump device of claim 9, wherein the cannula is a multi-lumen cannula, comprising a first port configured to deliver the first fluid from the first reservoir and a second port configured to deliver the second fluid from the second reservoir.

### Claim 11 (depends on 10)

The on-body pump device of claim 10, wherein:
the first flow channel of the flow regulator valve is fluidly coupled to the first port of the multi-lumen cannula, and
the second flow channel of the flow regulator valve is fluidly coupled to the second port of the multi-lumen cannula.

### Claim 12 (depends on 9)

The on-body pump device of claim 9, further comprising:
a septum for receiving a secondary unit, the septum configured to enable delivery of the first fluid and the second fluid to the first reservoir and second reservoir, respectively.

### Claim 13

A secondary unit, comprising:
an opening configured to receive a prefilled cartridge containing a liquid drug, wherein a fill needle and a cartridge stop are within the opening;
a variable fill mechanism operable to extract a volume of the liquid drug from a prefilled cartridge inserted in the opening, wherein the volume is variable based on a volume setting mechanism; and
a needle insertion mechanism configured to actuate an introducing needle of an on-body pump device,
wherein the variable fill mechanism includes:
a needle operable to extract a volume of the liquid drug from the prefilled cartridge when received in the opening;
a variable fill rod operable to contact the prefilled cartridge and move as the prefilled cartridge is inserted farther in the opening,
an indicator rod configured to move as the prefilled cartridge is inserted farther in the opening, and
a gear operable to move a visual indicator of the indicator rod corresponding to a fill volume of the liquid drug within the reservoir;
wherein the fill needle is configured to pierce a septum of the on-body pump device to deliver the fill volume of liquid drug to the on-body pump device while the on-body pump device is attached to skin of a user.

### Claim 14 (depends on 13)

The secondary unit of claim 13, wherein the needle insertion mechanism comprises:
an insertion mechanism button at a surface of the secondary unit, wherein the insertion mechanism button is operable to actuate the introducing needle;
an insertion spring responsive to actuation of the insertion mechanism button; and
a member coupled to the insertion spring, wherein the member is configured to interact with an insertion mechanism septum of the on-body pump device.

### Claim 15 (depends on 13)

The secondary unit of claim 13, wherein the variable fill mechanism further comprises:
a visual indicator movable along a volume scale shown on a visual amount indicator component;
a travel stop having an inclined plane;
a travel pin operable to engage a plunger and move as the prefilled cartridge is inserted in the opening, the travel pin configured to travel and intersect with the travel stop; and
a spring-loaded component operable to prevent the indicator rod from returning to a prior position.

### Claim 16 (depends on 13)

The secondary unit of claim 13, further comprising:
a release button that enables the secondary unit to be removed from the on-body pump device.

### Claim 17 (depends on 13)

The secondary unit of claim 13, further comprising:
a settings dial configured to set or adjust an amount of the liquid drug for delivery into the on-body pump device.

### Claim 18 (depends on 1)

The system of claim 1, wherein the secondary unit further comprises:
a needle insertion mechanism configured to actuate an introducing needle of the on-body pump device.

### Claim 19 (depends on 13)

The secondary unit of claim 13, wherein the needle insertion mechanism further comprises:
a spring, and
the needle insertion mechanism is further configured to use the spring when actuating the introducing needle of the on-body pump device.

### Claim 20 (depends on 13)

The secondary unit of claim 13, wherein the variable fill mechanism further comprises a dial, wherein the gear is connected to the dial.