# US 9,750,898 B2 · Medicated module with interlock

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- Number: US 9,750,898 B2
- Document ID: US9750898B2
- Status: Granted
- Kind: B2
- Application number: 13/882,696
- Filed: 2011-10-31
- Published: 2013-08-29
- Granted: 2017-09-05
- Earliest claimed: 2010-11-03
- Assignees: Sanofi-Aventis Deutschland GmbH
- Applicants: James Alexander Davies; John David Cross; Malcom Stanley Boyd; Steven Wimpenny; Daniel Thomas De Sausmarez Lintell; Simon Lewis Bilton; Naceur Rekaya
- Inventors: James Alexander Davies; John David Cross; Malcom Stanley Boyd; Steven Wimpenny; Daniel Thomas De Sausmarez Lintell; Simon Lewis Bilton; Naceur Rekaya
- Web page: https://patentgrep.com/patent/US9750898B2

## CPC

- A61M 5/50: having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile {(retractable needles or needle protectors with means for preventing re-use A61M5/321)}
- A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
- A61M 5/32: Needles; Details of needles pertaining to their connection with syringe or hub (infusion needles A61M5/158); Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M 5/326: {Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user}
- A61M 5/3294: {comprising means for injection of two or more media, e.g. by mixing}
- A61M 2005/1787: {Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid}
- A61M 2005/3142: {Modular constructions, e.g. supplied in separate pieces to be assembled by end-user}
- A61M 2205/583: by visual feedback
- 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

A medicated module attachable to a drug delivery device comprising a connecting body configured for attachment to the drug delivery device. A first needle held within a first needle hub of the connecting body and a second needle fixed within a second needle hub of the connecting body. A recess within the connecting body defining a reservoir. The reservoir containing at least one dose of a medicament and configured for fluid communication with the first needle. The connecting body further comprises a lockout feature that prevents the medicated module from being reconnected to the drug delivery device after the medicated module has been connected to the drug delivery device a first time.

## Claims

### Claim 1

A medicated module attachable to a drug delivery device, said medicated module comprising:
a connecting body configured for attachment to said drug delivery device;
a first needle fixed within a first needle hub of said connecting body;
a second needle fixed within a second needle hub of said connecting body; and
a recess within said connecting body defining a reservoir, said reservoir containing at least one dose of a medicament, said reservoir configured for fluid communication with said first needle,
wherein said connecting body further comprises a lockout feature that prevents said medicated module from being reconnected to said drug delivery device after said medicated module has been connected to said drug delivery device a first time and subsequently removed, and
wherein said lockout feature comprises a locking ring, said locking ring is rotated after said medicated module is attached to said drug delivery device so as to lock out said medicated module from being reconnected to said drug delivery device.

### Claim 2 (depends on 1)

The medicated module of claim 1, further comprising:
a needle guard operatively coupled to said connecting body; and
a biasing element positioned between said connecting body and said needle guard.

### Claim 3 (depends on 2)

The medicated module of claim 2, wherein when a dose of said medicament is injected by said medicated module, said needle guard moves in a proximal direction against a force created by said biasing element.

### Claim 4 (depends on 2)

The medicated module of claim 2, wherein said needle guard is locked from moving in a proximal direction until said medicated module is connected to said drug delivery device.

### Claim 5 (depends on 1)

The medicated module of claim 1, wherein when said medicated module is attached to said drug delivery device, said first needle pierces a drug delivery device reservoir.

### Claim 6 (depends on 1)

The medicated module of claim 1, further comprising a bellows containing a priming fluid in fluid communication with a proximal end of said second needle.

### Claim 7 (depends on 6)

The medicated module of claim 6, wherein said bellows is in fluid communication with a distal end of said first needle.

### Claim 8 (depends on 1)

A drug delivery system comprising:
a medicated module according to claim 1; and
a drug delivery device comprising a dose setting mechanism, a reservoir holder coupled to the dose setting mechanism, wherein a distal end of the reservoir holder is configured for attaching the medicated module,
wherein the system comprises a mechanical logic feature configured for (i) allowing a first use of the medicated module, (ii) allowing a subsequent use of the medicated module, wherein the second use occurs prior to the medicated module being detached from the drug delivery device, and (iii) preventing subsequent uses of the medicated module once removed.

### Claim 9 (depends on 8)

The drug delivery system of claim 8, wherein the mechanical logic feature is further configured to, after allowing the use of the medicated module, prevent a subsequent use of a second medicated module different than the medicated module.

### Claim 10 (depends on 9)

The drug delivery system of claim 9:
wherein the mechanical logic feature is part of the drug delivery device,
wherein the mechanical logic feature of the drug delivery device comprises (i) a fixed alignment feature and (ii) a plurality of coded features,
wherein a corresponding mechanical logic feature of the medicated module comprises (i) a corresponding fixed alignment feature and (ii) at least one corresponding coded feature that corresponds to the each of the plurality of coded features of the mechanical logic feature of the drug delivery device, wherein the at least one corresponding coded feature is disposed on an outer wall of a core mechanism of the medicated module, and
wherein the interaction of the plurality of coded features of the mechanical logic feature of the drug delivery device and the corresponding coding features serves to change a state of the drug delivery device from unused to used.

### Claim 11 (depends on 8)

The drug delivery system of claim 8, wherein at least part of the mechanical logic feature is part of the drug delivery device.
