# US 11,077,246 B2 · Wearable injector with sterile adhesive patch

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- Number: US 11,077,246 B2
- Document ID: US11077246B2
- Status: Granted
- Kind: B2
- Application number: 16/049,850
- Filed: 2018-07-31
- Published: 2019-03-21
- Granted: 2021-08-03
- Earliest claimed: 2017-08-18
- Assignees: Amgen Inc.
- Applicants: Amgen Inc.
- Inventors: Ali Nekouzadeh; Jerome Olivas; Joshua Merilos; Matthew Wayne Janke; Justin Harris; Marc Orloff; Edward Stapleford Nielsen; Chitra Nadig; Yasaman Damestani; Guojie Song; Bryton De Guia
- Web page: https://patentgrep.com/patent/US11077246B2

## CPC

- A61M 5/14248: {of the skin patch type}
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/14264: {with means for compensating influence from the environment}
- A61M 2205/0205: Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
- A61M 2205/0238: the material being a coating or protective layer
- A61M 2205/50: with microprocessors or computers
- A61M 2205/58: Means for facilitating use, e.g. by people with impaired vision
- A61M 2205/587: Lighting arrangements
- 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

An adhesive patch for a drug delivery device with a bacteria impermeable sterility margin surrounding an edge surface of the adhesive patch is disclosed, as well as a drug delivery device fixed to such an adhesive patch and a method of assembling a drug delivery device with such an adhesive patch. In some arrangements, the sterility margin is attached to or integral with a lower liner on a lower surface of the adhesive patch. In other arrangements, the sterility margin is attached to or integral with an upper liner on an upper surface of the adhesive patch.

## Claims

### Claim 1

A drug delivery device comprising:
a housing having a bottom wall;
an adhesive patch adhered to the bottom wall and having an area contained within an outer perimeter, the area having an upper surface, a lower surface, and an edge surface at the outer perimeter between the upper surface and the lower surface;
a bacteria impermeable lower liner on the lower surface; and
a bacteria impermeable sterility margin surrounding and abutting the edge surface of the adhesive patch,
wherein the outer perimeter of the adhesive patch is pre-cut to separate from the sterility margin.

### Claim 2 (depends on 1)

The drug delivery device of claim 1, wherein the bacteria impermeable sterility margin is attached to or integral with the adhesive patch or the lower liner.

### Claim 3 (depends on 1)

The drug delivery device of claim 1, further comprising a bacteria impermeable upper liner on the upper surface, wherein the sterility margin is optionally attached to or integral with the upper liner.

### Claim 4 (depends on 1)

The drug delivery device of claim 1, wherein the outer perimeter of the adhesive patch is pre-cut in a perforated manner to separate from the sterility margin.

### Claim 5 (depends on 1)

The drug delivery device of claim 1, wherein the housing includes an interior space and a top wall, a container is disposed within the interior space, and the top wall includes a window positioned to allow viewing of the container, the window including a polarized filter that filters out up to and including 50% of light in the visible range.

### Claim 6

An adhesive system for use with a wearable drug delivery device, the system comprising:
an adhesive patch having an outer perimeter, an upper surface, a lower surface, and an edge surface at the outer perimeter and extending between the upper surface and the lower surface;
a bacteria impermeable lower liner on the lower surface; and
a bacteria impermeable sterility margin surrounding and abutting the edge surface of the adhesive patch,
wherein the outer perimeter of the adhesive patch is pre-cut to separate from the sterility margin.

### Claim 7 (depends on 6)

The adhesive system of claim 6, wherein the bacteria impermeable sterility margin is attached to or integral with the adhesive patch or the lower liner.

### Claim 8 (depends on 6)

The adhesive system of claim 6, further comprising a bacteria impermeable upper liner on the upper surface, wherein the sterility margin is optionally attached to or integral with the upper liner.

### Claim 9 (depends on 8)

The adhesive system of claim 8, wherein the upper liner includes a pre-cut first perimeter surrounding a portion of an area of the adhesive patch that is configured to be adhered to a drug delivery device.

### Claim 10 (depends on 6)

The adhesive system of claim 6, further comprising a hole provided in the area to allow passage of a delivery member of the drug delivery device.

### Claim 11 (depends on 6)

The adhesive system of claim 6, wherein the outer perimeter is pre-cut in a perforated manner to separate from the sterility margin.

### Claim 12 (depends on 6)

The adhesive system of claim 6, wherein the sterility margin has a width of at least two millimeters.
