# US 11,439,756 B2 · Flow communication unit with preservative

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- Number: US 11,439,756 B2
- Document ID: US11439756B2
- Status: Granted
- Kind: B2
- Application number: 16/641,883
- Filed: 2018-08-20
- Published: 2020-08-06
- Granted: 2022-09-13
- Earliest claimed: 2017-08-30
- Assignees: Novo Nordisk A/S
- Applicants: Novo Nordisk A/S
- Inventors: Vera Pinto Glenting; Joern Drustrup; Henrik Bengtsson; Jonas Kildegaard Pedersen
- Web page: https://patentgrep.com/patent/US11439756B2

## CPC

- A61M 5/2459: {upon internal pressure increase, e.g. pierced or burst (A61M5/2429 takes precedence)}
- A61M 5/001: {Apparatus specially adapted for cleaning or sterilising syringes or needles}
- A61M 5/2448: {comprising means for injection of two or more media, e.g. by mixing}
- A61M 5/345: {Adaptors positioned between needle hub and syringe nozzle}
- A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube
- A61M 5/3297: {Needles arranged coaxially}
- A61M 39/162: {with antiseptic agent incorporated within the connector}
- A61M 2005/312: {comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting}
- A61M 2205/3337: Controlling, regulating pressure or flow by means of a valve by-passing a pump
- 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 assembly includes a sealed drug reservoir unit, a subcutaneous flow conducting device in the form of a needle unit or an infusion set, and a flow communication unit. The flow communication unit includes a proximal hollow needle adapted to penetrate a needle-penetrable septum of the reservoir, a first flow-way inflow communication with the proximal needle and comprising a pressure-controlled valve, a second flow-way in flow communication with the first flow-way, an amount of preservative arranged to react with a substance received by the second flow-way, and distal flow communication structure adapted to provide flow communication between the second flow-way and the needle unit. The valve is controlled to open when the reservoir is pressurized, the preservative being provided to react with substances introduced to the second flow way via the needle unit.

## Claims

### Claim 1

An assembly comprising (a) a cartridge with a drug-filled interior, (b) a flow conducting device, and (c) a flow communication unit adapted to provide flow communication between the cartridge and the flow conducting device,
(a) the drug-filled cartridge comprising:
an outlet sealed by a needle-penetrable septum,
(b) the flow conducting device comprising:
a hollow tubular structure with a skin-piercing distal end, and
a proximal flow inlet,
(c) the flow communication unit comprising:
a proximal hollow needle adapted to penetrate the needle-penetrable septum,
a first flow way in flow communication with the proximal needle and comprising pressure-controlled valve structure,
a second flow way in flow communication with the first flow way,
an amount of preservative arranged to react with a substance received by the second flow way, and
distal flow communication structure adapted to provide flow communication between the second flow way and a flow conducting device flow inlet,
a tubular conduit comprising a distal portion with an open end, the tubular conduit forming the second flow way, and
a preservative unit comprising the amount of preservative and having a first axial position in which the tubular conduit distal portion is embedded in preservative, and a second axial position in which the tubular conduit distal portion protrudes distally from the preservative unit,
wherein the preservative unit is moved from the first position to the second position when the flow conducting device is connected to the flow communication unit, the tubular conduit distal portion thereby providing the distal flow communication structure,
whereby:
a combined flow way can be established between the cartridge interior and the hollow tubular structure via at least two of the proximal needle, the first flow way, and second flow way, when the cartridge, the flow communication unit and the flow conducting device are connected to each other,
the valve structure is controlled to open when the cartridge interior is pressurized, and
the preservative can react with a substance introduced to the second flow way via the hollow tubular structure with the skin-piercing distal end.

### Claim 2 (depends on 1)

The assembly as in claim 1, wherein the flow conducting device is a needle unit, wherein the hollow tubular structure is a hollow expelling needle with the skin-piercing distal end.

### Claim 3 (depends on 2)

The assembly as in claim 2, wherein the preservative unit comprises biasing structure moving the preservative unit from the second position to the first position when the needle unit is disconnected from the flow communication unit.

### Claim 4 (depends on 2)

The assembly as in claim 2, wherein:
the needle unit comprises the hollow tubular structure comprising a proximal portion with an open end forming the proximal flow inlet, and
the second flow way is adapted to receive the tubular conduit proximal portion when the needle unit is connected to the flow communication unit.

### Claim 5 (depends on 1)

The assembly as in claim 1, wherein the preservative unit comprises a reservoir with the amount of preservative.

### Claim 6 (depends on 5)

The assembly as in claim 5, wherein the reservoir comprises a needle-penetrable septum portion adapted to be penetrated by the hollow conduit distal portion when the preservative unit is moved from the first position to the second position.

### Claim 7

An assembly comprising (a) a cartridge with a drug-filled interior, (b) a flow conducting device, and (c) a flow communication unit adapted to provide flow communication between the cartridge and the flow conducting device,
(a) the drug-filled cartridge comprising:
an outlet sealed by a needle-penetrable septum,
(b) the flow conducting device comprising:
a hollow tubular structure with a skin-piercing distal end, and
a proximal flow inlet,
(c) the flow communication unit comprising:
a proximal hollow needle adapted to penetrate the needle-penetrable septum,
a first flow way in flow communication with the proximal needle and comprising pressure-controlled valve structure,
a second flow way in flow communication with the first flow way,
an amount of preservative arranged to react with a substance received by the second flow way, and
distal flow communication structure adapted to provide flow communication between the second flow way and a flow conducting device flow inlet,
whereby:
a combined flow way can be established between the cartridge interior and the hollow tubular structure via at least two of the proximal needle, the first flow way, and second flow way, when the cartridge, the flow communication unit and the flow conducting device are connected to each other,
the valve structure is controlled to open when the cartridge interior is pressurized, and
the preservative can react with a substance introduced to the second flow way via the hollow tubular structure with a skin-piercing distal end; wherein the flow conducting device is a needle unit, wherein the hollow tubular structure is a hollow expelling needle with the skin-piercing distal end; wherein: the needle unit comprises the hollow tubular structure comprising a proximal portion with an open end forming the proximal flow inlet, and
the second flow way is adapted to receive the tubular conduit proximal portion when the needle unit is connected to the flow communication unit;
wherein: the second flow way is in the form of a conduit comprising an amount of preservative, the conduit being closed by a septum adapted to be penetrated by the tubular conduit proximal portion when the needle unit is connected to the flow communication unit.

### Claim 8 (depends on 7)

The assembly as in claim 7, wherein the flow communication unit comprises:
a reservoir with the amount of preservative,
a preservative flow communication between the conduit and the reservoir,
wherein the preservative flow communication is operated between an initial open state and an operational closed state when the needle unit is connected to the flow communication unit.

### Claim 9 (depends on 8)

The assembly as in claim 8, wherein:
the flow communication unit comprises a septum structured to flex and move axially from an initial distal position to a proximal operational position to thereby close the preservative flow communication when the needle unit is connected to the flow communication unit.

### Claim 10

A flow communication unit comprising:
a proximal hollow needle adapted to penetrate a needle-penetrable septum,
a first flow way in flow communication with the proximal needle and comprising pressure-controlled valve structure,
a second flow way in flow communication with the first flow way,
an amount of preservative arranged to react with a substance received by the second flow way, and
distal flow communication structure adapted to provide flow communication between the second flow way and a flow conducting device flow inlet,
a tubular conduit comprising a distal portion with an open end, the tubular conduit forming the second flow way, and
a preservative unit comprising the amount of preservative and having a first axial position in which the tubular conduit distal portion is embedded in preservative, and a second axial position in which the tubular conduit distal portion protrudes distally from the preservative unit,
wherein the preservative unit is moved from the first position to the second position when the needle unit is connected to the flow communication unit, the tubular conduit distal portion thereby providing the distal flow communication structure,
wherein the valve structure is controlled to open when the proximal hollow needle is pressurized.

### Claim 11 (depends on 10)

The flow communication unit as in claim 10, wherein the flow conducting device flow inlet is a needle unit flow inlet.

### Claim 12 (depends on 11)

The flow communication unit as in claim 11, wherein the preservative unit comprises a reservoir with the amount of preservative, the reservoir comprising a needle-penetrable septum portion adapted to be penetrated by the hollow conduit distal portion when the preservative unit is moved from the first to the second position.

### Claim 13 (depends on 12)

The flow communication unit as in claim 12, wherein the second flow way is in the form of a conduit comprising an amount of fluid preservative, the conduit being sealed by a needle-penetrable septum.