# US 12,109,389 B2 · Fluid path assembly for a drug delivery device

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- Number: US 12,109,389 B2
- Document ID: US12109389B2
- Status: Granted
- Kind: B2
- Application number: 17/256,240
- Filed: 2019-07-12
- Published: 2021-07-29
- Granted: 2024-10-08
- Earliest claimed: 2018-07-31
- Assignees: Amgen Inc.
- Applicants: Amgen Inc.
- Inventors: Matthew Wayne Janke; Sudeshna Dutta Ray; Scott R. Gibson; Daniel Eduardo Groszmann; Wael Mismar; Mehran Mojarrad; Robert Allen Dees; Paul Daniel Faucher
- Web page: https://patentgrep.com/patent/US12109389B2

## CPC

- A61M 5/1452: {pressurised by means of pistons}
- A61M 39/10: Tube connectors or tube couplings
- A61M 5/1626: {Needle protectors therefor (in combination with syringes A61M5/3202; protectors for sharps A61B50/3001)}
- A61M 39/221: {Frangible or pierceable closures within tubing (A61M39/14 takes precedence; frangible closures for containers A61J1/14)}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
- A61M 2005/1585: {Needle inserters}
- A61M 2039/1072: {with a septum present in the connector}
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- 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

Fluid path assemblies for drug delivery devices and methods of establishing a fluid flow path for drug delivery devices are described that include a needle shield valve member that couples to a reservoir having a needle mounted thereto. The needle shield valve member includes an internal barrier that protects the needle and/or contains a drug within the reservoir until activation of the drug delivery device. Upon activation, there is relative movement between the reservoir and needle shield valve member until the needle pierces the barrier to establish a fluid flow path from the reservoir through the needle shield valve member.

## Claims

### Claim 1

A fluid path assembly for a drug delivery device, the fluid path assembly comprising:
a reservoir having a sidewall defining an interior for containing a drug and a neck at a first end;
a needle fixed within the neck of the reservoir with a first end extending forwardly from the reservoir and a second end fluidly connected to the interior of the reservoir, the needle prevented from moving relative to the neck;
a needle shield valve member having a body defining an inlet coupled to the reservoir, an outlet, and a barrier extending between the inlet and the outlet to prevent fluid flow through the body, wherein at least one of the reservoir and the needle shield valve member is movable between a first position where the needle is embedded within or spaced from the barrier and a second position where the needle extends through the barrier to establish a fluid path from the interior of the reservoir to the outlet of the body.

### Claim 2 (depends on 1)

The fluid path assembly of claim 1, wherein the reservoir is movable between the first position and the second position.

### Claim 3 (depends on 1)

The fluid path assembly of claim 1, wherein the needle is embedded within the barrier in the first position.

### Claim 4 (depends on 1)

The fluid path assembly of claim 1, wherein the reservoir includes a flange extending outwardly around the first end of the sidewall; and the inlet of the needle shield valve member includes a first internal groove to engage the flange in the first position and a second internal groove to engage the flange in the second position.

### Claim 5 (depends on 1)

The fluid path assembly of claim 1, wherein the body of the needle shield valve member has an axis of the outlet disposed at a ninety degree angle or less with respect to an axis of the inlet.

### Claim 6 (depends on 1)

The fluid path assembly of claim 1, wherein the body of the needle shield valve member comprises a material permeable by a sterilization gas.

### Claim 7 (depends on 1)

The fluid path assembly of claim 1, wherein the first end of the sidewall includes an end wall tapering to the neck; and further comprising a stopper disposed within the interior of the reservoir, the stopper includes a forward surface having a contour complementary to the end wall.

### Claim 8 (depends on 1)

The fluid path assembly of claim 1, wherein the body of the needle shield valve member has a single piece construction.

### Claim 9 (depends on 1)

The fluid path assembly of claim 1, wherein the outlet of the body includes a reduced width needle reception portion, a conduit reception portion, and a shoulder extending between the conduit reception portion and the needle reception portion.

### Claim 10 (depends on 9)

The fluid path assembly of claim 9, further comprising a conduit disposed within the outlet to abut the shoulder.

### Claim 11 (depends on 1)

The fluid path assembly of claim 1, further comprising a needle shield cover surrounding at least a portion of the body of the needle shield valve member.

### Claim 12 (depends on 11)

The fluid path assembly of claim 11, wherein the needle shield cover includes a body having a length greater than that of the body of the needle shield valve member.

### Claim 13 (depends on 1)

The fluid path assembly of claim 1, further comprising a drive mechanism configured to move at least one of the reservoir and the needle shield valve member from the first position to the second position.

### Claim 14 (depends on 13)

The fluid path assembly of claim 13 in combination with a drug delivery device, the drug delivery device comprising:
a housing;
a needle insertion mechanism; and
a plunger drive mechanism configured to selectively drive the stopper through the container to thereby force the drug from the reservoir with the reservoir in the second position.

### Claim 15

A method of establishing a fluid flow path in a drug delivery device including a reservoir having a sidewall defining an interior for containing a drug and a first end, a needle fixed within the first end of the reservoir with a first end extending forwardly from the reservoir and a second end fluidly connected to the interior of the reservoir, and a needle shield valve member having a body defining an inlet coupled to the reservoir, an outlet, and a barrier extending between the inlet and the outlet to prevent fluid flow through the body, wherein the needle is prevented from moving relative to the neck, the method comprising:
coupling the reservoir to the inlet of the body in a first position so that a tip of the needle is embedded within or spaced from the barrier;
moving at least one of the reservoir and the needle shield valve member to a second position so that the tip of the needle extends through the barrier to establish a fluid flow path from the interior of the reservoir to the outlet of the body.

### Claim 16 (depends on 15)

The method of claim 15, wherein coupling the reservoir to the inlet of the body in the first position comprises embedding the tip of the needle within the barrier.

### Claim 17 (depends on 15)

The method of claim 15, wherein the reservoir includes a neck at the first end and a flange extending outwardly around the neck; and the inlet of the needle shield valve member includes first and second internal grooves, and
wherein coupling the reservoir to the inlet of the body in the first position comprises disposing the flange within the first internal groove; and moving at least one of the reservoir and the needle shield valve member to the second position comprises moving the flange to the second internal groove.

### Claim 18 (depends on 15)

The method of claim 15, further comprising sterilizing the reservoir, needle, and needle shield valve member.

### Claim 19 (depends on 15)

The method of claim 15, further comprising inserting a conduit into the outlet of the needle shield valve member until the conduit abuts a shoulder extending between a conduit reception portion and a needle reception portion of the outlet.

### Claim 20 (depends on 15)

The method of claim 15, further comprising driving a stopper through the reservoir to dispense a drug through the needle and into the outlet of the needle shield valve member, comprising engaging a tapering end wall of the first end of the reservoir with a forward surface of the stopper having a contour complementary to the end wall such that hold up volume of the drug within the reservoir is limited to drug remaining in the needle.