# US 12,005,226 B1 · Modular wearable medicament delivery device and method of use thereof

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- Number: US 12,005,226 B1
- Document ID: US12005226B1
- Status: Granted
- Kind: B1
- Application number: 17/697,554
- Filed: 2022-03-17
- Granted: 2024-06-11
- Earliest claimed: 2021-02-18
- Assignees: Fresenius Kabi Deutschland GmbH
- Applicants: Fresenius Kabi Deutschland GmbH
- Inventors: Sharon D. West; Justin E. Bechstein
- Web page: https://patentgrep.com/patent/US12005226B1

## CPC

- A61M 5/14248: {of the skin patch type}
- A61M 5/1413: {Modular systems comprising interconnecting elements}
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/1726: {the body parameters being measured at, or proximate to, the infusion site}
- A61M 2205/3327: Measuring
- A61M 2230/201: Glucose concentration
- A61M 2230/208: pH-value
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- A61M 2230/50: Temperature
- 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 medicament delivery device and method of use thereof. The device includes a sensor module and an injector module. The injector module is adapted to (i) be coupled to the sensor module during injection of a cannula and a needle into subcutaneous tissue and during delivery of the medicament and (ii) be removed from the sensor module after the delivery of the medicament.

## Claims

### Claim 1

A medicament delivery device comprising:
a sensor module comprising:
a sensor housing, and
at least one sensor disposed in the sensor housing; and
an injector module comprising:
an injector module housing,
a reservoir disposed in the injector module housing, the reservoir adapted to be filled with a medicament to be delivered to a patient,
a cannula adapted to (i) fluidically connect with the reservoir and (ii) pass into a subcutaneous tissue,
a needle initially disposed in a lumen defined by the cannula and adapted to pass into the subcutaneous tissue, and
a coupling mechanism adapted to couple the injector module to the sensor module, the coupling mechanism comprising a latch,
wherein the injector module is adapted to (i) be coupled to the sensor module during injection of the cannula and the needle into the subcutaneous tissue and during delivery of the medicament and (ii) be removed from the sensor module after the delivery of the medicament.

### Claim 2 (depends on 1)

The medicament delivery device of claim 1, wherein the at least one sensor comprises at least one of a temperature sensor, an accelerometer, a gyroscope, a pulse oximeter, a blood pressure sensor, a hydration sensor, a pH sensor, glucose sensor, or a UV exposure sensor.

### Claim 3 (depends on 1)

The medicament delivery device of claim 1, wherein the at least one sensor is disposed on a bottom surface of the sensor module and is configured to be in contact with the skin surface when the adhesive patch is connected thereto.

### Claim 4 (depends on 1)

The medicament delivery device of claim 1, wherein the sensor module defines a recess adapted to mate with the latch.

### Claim 5 (depends on 1)

The medicament delivery device of claim 1, wherein the coupling mechanism comprises a push button adapted to move the latch between an engaged position and a disengaged position.

### Claim 6 (depends on 5)

The medicament delivery device of claim 5, wherein the push button extends through a portion of the injector module housing.

### Claim 7 (depends on 1)

The medicament delivery device of claim 1, wherein the sensor housing of the sensor module defines a needle port.

### Claim 8 (depends on 7)

The medicament delivery device of claim 7, wherein the cannula is further adapted to pass through the needle port of the sensor module.

### Claim 9 (depends on 7)

The medicament delivery device of claim 7, wherein the needle is further adapted to pass through the needle port.

### Claim 10

A method for delivering a medicament, the method comprising:
connecting to a skin surface a medicament delivery device comprising an injector module coupled to a sensor module comprising at least one sensor, wherein (i) the injector module comprises a reservoir containing the medicament, and (ii) the injector module comprises a coupling mechanism adapted to couple the injector module to the sensor module, the coupling mechanism comprising a latch;
delivering the medicament from the injector module into a subcutaneous tissue; and
after delivery of the medicament, removing the injector module from the sensor module.

### Claim 11 (depends on 10)

The method of claim 10, wherein the injector module further comprises a cannula in fluidic communication with the reservoir, and delivering the medicament comprises passing the cannula into the subcutaneous tissue.

### Claim 12 (depends on 11)

The method of claim 11, further comprising leaving the cannula in the subcutaneous tissue after delivery of the medicament.

### Claim 13 (depends on 11)

The method of claim 11, wherein the injector module further comprises a needle disposed in a lumen in the cannula, and delivering the medicament comprises piercing the skin surface with the needle prior to passing the cannula into the subcutaneous tissue.

### Claim 14 (depends on 10)

The method of claim 10, further comprising monitoring a biometric parameter with the sensor module.

### Claim 15 (depends on 14)

The method of claim 14, wherein the biometric parameter is monitored after the injector module is removed.

### Claim 16 (depends on 14)

The method of claim 14, wherein the biometric parameter comprises at least one of temperature, oxygen level, blood pressure, hydration, pH, glucose, or UV exposure.

### Claim 17 (depends on 10)

The method of claim 10, wherein the sensor module defines a recess adapted to mate with the latch.

### Claim 18 (depends on 10)

The method of claim 10, wherein the coupling mechanism comprises a push button adapted to move the latch between an engaged position and a disengaged position.

### Claim 19 (depends on 10)

The method of claim 10, wherein the medicament comprises pegfilgrastim.
