# US 10,245,377 B2 · Drug delivery systems with sealed and sterile fluid paths and methods of providing the same

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- Number: US 10,245,377 B2
- Document ID: US10245377B2
- Status: Granted
- Kind: B2
- Application number: 15/809,532
- Filed: 2017-11-10
- Published: 2018-05-17
- Granted: 2019-04-02
- Earliest claimed: 2016-11-11
- Assignees: Insulet Corporation
- Applicants: Insulet Corporation
- Inventors: Ian McLaughlin
- Web page: https://patentgrep.com/patent/US10245377B2

## CPC

- A61M 5/16827: {controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths (infusion of multiple fluids without using a controller A61M5/1407)}
- A61L 2/00: Disinfection or sterilisation of materials or objects, in general; Accessories therefor
- A61L 2/087: Particle radiation, e.g. electron-beam, alpha or beta radiation
- A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube
- A61M 5/2466: {by piercing without internal pressure increase (A61M5/2429 takes precedence)}
- A61L 2/07: Steam
- A61L 2/081: Gamma radiation
- A61L 2/082: X-rays
- A61L 2/206: Ethylene oxide
- A61L 2103/23: {Containers other than laboratory or medical, e.g. bottles or mail}
- A61M 5/001: {Apparatus specially adapted for cleaning or sterilising syringes or needles}
- A61M 5/14566: {with a replaceable reservoir for receiving a piston rod of the pump}
- A61M 5/19: having more than one chamber
- A61M 2005/3118: {via the distal end of a syringe, i.e. syringe end for mounting a needle cannula}
- A61M 2005/3132: {having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase}
- A61M 2005/3258: {being compressible or compressed along the needle}
- A61M 2039/1072: {with a septum present in the connector}
- 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)}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

The present disclosure relates generally to the field of drug delivery. In particular, the present disclosure relates to a drug delivery system that includes a sealed and sterile fluid path attached to a drug-loaded container. The disclosure further relates to methods for sterilizing a portion of the drug delivery system without exposing the drug-loaded container to harmful sterilization parameters.

## Claims

### Claim 1

A system, comprising:
a container having a main body and a neck, the container configured to hold a liquid drug;
a cap coupled to the neck, the cap configured to seal an open end of the container;
a fluid path having a first end disposed within the cap and a second end disposed within a cover;
an energy source configured to emit energy; and
a shield positioned adjacent to the container, the shield configured to expose the fluid path to the emitted energy while blocking exposure of the liquid drug to a substantial portion of the emitted energy.

### Claim 2 (depends on 1)

The system of claim 1, wherein the emitted energy is configured to sterilize the fluid path.

### Claim 3 (depends on 2)

The system of claim 2, wherein the emitted energy comprises an electron beam.

### Claim 4 (depends on 3)

The system of claim 3, wherein the shield comprises aluminum.

### Claim 5 (depends on 4)

The system of claim 4, wherein the aluminum shield has a thickness of at least 30 mm.

### Claim 6 (depends on 3)

The system of claim 3, wherein the fluid path comprises a lumen.

### Claim 7 (depends on 3)

The system of claim 3, wherein the liquid drug is sterilized prior to sterilizing the fluid path.

### Claim 8 (depends on 1)

The system of claim 1, wherein the first end of the fluid path comprises a first sharpened tip and the second end of the fluid path comprises a second sharpened tip.

### Claim 9 (depends on 8)

The system of claim 8, wherein the first sharpened tip is configured to pierce the cap and to extend through the cap to couple the first sharpened tip to the liquid drug based on an activation by a user.

### Claim 10 (depends on 9)

The system of claim 9, wherein the cap comprises a first portion configured to extend into a portion of the neck.

### Claim 11 (depends on 10)

The system of claim 10, wherein the cap comprises a second portion configured to overlap an end of the neck.

### Claim 12 (depends on 11)

The system of claim 11, wherein the cap comprises a third portion configured to extend away from the neck and the first portion of the cap.

### Claim 13 (depends on 12)

The system of claim 12, wherein the first sharpened tip is positioned within the first portion of the cap prior to the activation by the user.

### Claim 14 (depends on 12)

The system of claim 12, wherein the first sharpened tip is positioned within the third portion of the cap prior to the activation by the user.

### Claim 15 (depends on 14)

The system of claim 14, wherein the third portion comprises an open chamber.

### Claim 16 (depends on 15)

The system of claim 15, wherein the third portion is configured to collapse when the first sharpened tip pierces the cap upon activation by the user.

### Claim 17 (depends on 11)

The system of claim 11, wherein the cap is coupled to the neck by a crimp component overlapping the second portion of the cap.

### Claim 18 (depends on 9)

The system of claim 9, further comprising a septum positioned between the cap and the liquid drug.

### Claim 19

A method, comprising:
positioning a first end of a fluid path within a container configured to hold a liquid drug;
positioning a second end of the fluid path within a cover;
positioning a shield between an energy source and the container; and
exposing the fluid path to energy emitted by the energy source to sterilize the fluid path while blocking exposure of the liquid drug to a substantial portion of the energy emitted by the energy source.

### Claim 20 (depends on 19)

The method of claim 19, wherein positioning the shield comprising positing an aluminum shield having a thickness of at least 30 mm between the container and the energy source.

### Claim 21 (depends on 19)

The method of claim 19, further comprising sterilizing the liquid drug prior to sterilizing the fluid path.

### Claim 22 (depends on 19)

The method of claim 19, further comprising piercing a cap sealing the container with the first end of the fluid path to couple the liquid drug to the fluid path upon activation by a user.

### Claim 23 (depends on 22)

The method of claim 22, further comprising piercing a septum sealing the container with the first end of the fluid path to couple the liquid drug to the fluid path upon activation by a user.

### Claim 24 (depends on 19)

The method of claim 19, further comprising piercing a plunger sealing the container with the first end of the fluid path to couple the liquid drug to the fluid path upon activation by a user.

### Claim 25 (depends on 19)

The method of claim 19, wherein positioning the shield between the energy source and the container comprises placing the fluid path and the container within a first shield component having an exposure window and coupling a second shield component to the first shield component.