# US 2021/0330880 A1 · Drug Delivery Device with Container Access System and Related Method of Assembly

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- Number: US 2021/0330880 A1
- Document ID: US20210330880A1
- Status: Published application
- Kind: A1
- Application number: 16/625,208
- Filed: 2018-07-11
- Published: 2021-10-28
- Earliest claimed: 2017-07-25
- Assignees: Amgen Inc.
- Applicants: Amgen Inc.
- Inventors: Sheldon Moberg; Matthew Wayne Janke; Wael Mismar; Alexis Dechelette
- Web page: https://patentgrep.com/patent/US20210330880A1

## CPC

- A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube
- 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 5/2033: {Spring-loaded one-shot injectors with or without automatic needle insertion (multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287)}
- A61M 5/2466: {by piercing without internal pressure increase (A61M5/2429 takes precedence)}
- A61M 5/288: {by piercing without internal pressure increase (A61M5/283 takes precedence)}
- A61M 39/18: Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
- A61M 2005/14252: {with needle insertion means}
- A61M 2207/00: Methods of manufacture, assembly or production
- A61M 2207/10: Device therefor
- 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

Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a container including a wall with an interior surface and a seal member with an end surface. The interior surface of the wall and the end surface of the seal member may define a reservoir filled with a drug. A fluid pathway assembly may be connected to the container and include an overmold member that covers a length of a container access needle and which defines an enclosed space with the seal member. The overmold member may be moveable relative to the seal member to carry the container access needle between a storage position, where a point of the container access needle is disposed exterior to the reservoir, and a delivery position, where the point extends through the end surface of the seal member into the reservoir.

## Claims

### Claim 1

A drug delivery device comprising:
a container including a wall with an interior surface and a seal member with an end surface, the interior surface of the wall and the end surface of the seal member defining a reservoir filled with a drug; and
a fluid pathway assembly connected to the container and including
a container access needle having a point, and
an overmold member covering a length of the container access needle and defining an enclosed space between the overmold member and the seal member, the overmold member being moveable relative to the seal member to carry the container access needle between a storage position, where the point is disposed exterior to the reservoir, and a delivery position, where the point extends through the end surface of the seal member into the reservoir.

### Claim 2 (depends on 1)

The drug delivery device of claim 1, wherein the point of the container access needle is disposed in the enclosed space when the container access needle is disposed in the storage position.

### Claim 3 (depends on 1)

The drug delivery device of claim 1, comprising a recess formed in the seal member and receiving a proximal end of the overmold member, wherein the enclosed space is defined within the recess.

### Claim 4 (depends on 3)

The drug delivery device of claim 3, the recess receiving the proximal end of the overmold member via an interference-fit connection.

### Claim 5 (depends on 4)

The drug delivery device of claim 4, a proximal end of the seal member extending into the container such that at least a portion of the recess is disposed within the container.

### Claim 6 (depends on 1)

The drug delivery device of claim 1, comprising a clip member mounted on the seal member and frictionally engaging the overmold member to resist movement of the overmold member relative to the seal member.

### Claim 7 (depends on 6)

The drug delivery device of claim 6, the clip member having an interior surface defining a through hole, the proximal end of the overmold member extending through the through hole and into the recess.

### Claim 8 (depends on 6)

The drug delivery device of claim 6, the interior surface of the clip member defining a gripping element, the gripping element being received in a corresponding groove formed in the overmold member when the needle is disposed in the storage position.

### Claim at position 9

9-10. (canceled)

### Claim 11 (depends on 1)

The drug delivery device of claim 1, comprising a clip member mounted on the seal member and frictionally engaging the overmold member to resist movement of the overmold member relative to the seal member, the clip member having an interior surface defining a through hole, a proximal end of the overmold member extending partially through the through hole, wherein the enclosed spaced is defined within the through hole.

### Claim 12 (depends on 11)

The drug delivery device of claim 11, comprising an O-ring disposed about the proximal end of the overmold member and sealingly and slidably engaging the interior surface of the clip member.

### Claim 13 (depends on 11)

The drug delivery device of any one of claim 11, the clip member having a proximal end and a distal end, the proximal end including a mounting flange disposed radially outwardly of the distal end and engaging the seal member.

### Claim 14 (depends on 11)

The drug delivery device of claim 11, the interior surface of the clip member defining a gripping element, the gripping element being received in a corresponding groove formed in the overmold member when the needle is disposed in the storage position.

### Claim at position 14

15-16. (canceled)

### Claim 17

A method of assembly comprising:
providing a container having a wall with an interior surface, and a fluid pathway assembly including a container access needle having a point and an overmold member, the overmold member covering a length of the container access needle with the point protruding outwardly from the overmold member;
covering a first opening formed in the wall of the container with a seal member such that an end surface of the seal member and the interior surface of the wall of the container define a reservoir; and
positioning the overmold member to define an enclosed space between the overmold member and the seal member.

### Claim 18 (depends on 17)

The method of claim 17, comprising mounting a clip member on the seal member and frictionally engaging the clip member and the overmold member.

### Claim 19 (depends on 18)

The method of claim 18, wherein frictionally engaging the clip member and the overmold member includes aligning an inwardly protruding gripping element of the clip member with a corresponding groove formed in the overmold member such that the inwardly protruding gripping element is received in the corresponding groove.

### Claim 20 (depends on 17)

The method of claim 17, wherein positioning the overmold member to define an enclosed space between the overmold member and the seal member comprises inserting the overmold member into a recess formed in the seal member.

### Claim 21 (depends on 20)

The method of claim 20, wherein inserting the overmold member into the recess formed in the seal member includes forming an interference-fit connection between the overmold member and the seal member.

### Claim 22 (depends on 18)

The method of claim 18, wherein positioning the overmold member to define an enclosed space between the overmold member and the seal member comprises partially inserting the overmold member through a through hole of the clip member such that a terminal end of the overmold member is disposed within the through hole.

### Claim 23 (depends on 22)

The method of claim 22, wherein positioning the overmold member to define an enclosed space between the overmold member and the seal member comprises sealingly engaging an interior surface of the clip member with an O-ring disposed around the terminal end of the overmold member.

### Claim 24 (depends on 17)

The method of claim 17, comprising filling the reservoir of the container with a drug.

### Claim at position 23

25-28. (canceled)