# US 12,222,253 B2 · Medicament delivery device development evaluation system

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- Number: US 12,222,253 B2
- Document ID: US12222253B2
- Status: Granted
- Kind: B2
- Application number: 17/437,786
- Filed: 2020-02-13
- Published: 2022-05-19
- Granted: 2025-02-11
- Earliest claimed: 2019-03-13
- Assignees: Shl Medical AG
- Applicants: Shl Medical AG
- Inventors: Chun Chang; Chia Cheng Lin; Sheng-wei Lin; Hsueh-Yi Chen; Yiju Chen; Wen-Sheng Chien
- Web page: https://patentgrep.com/patent/US12222253B2

## CPC

- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- G01L 1/22: using resistance strain gauges
- G01L 5/1627: of strain gauges (using piezoresistors G01L5/162)
- G01P 15/00: Measuring acceleration; Measuring deceleration; Measuring shock, i.e. sudden change of acceleration
- A61M 2205/332: Force measuring means
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/70: with testing or calibration facilities
- 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)}
- G01L: MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE (weighing G01G)
- G01P: MEASURING LINEAR OR ANGULAR SPEED, ACCELERATION, DECELERATION, OR SHOCK; INDICATING PRESENCE, ABSENCE, OR DIRECTION, OF MOVEMENT (measuring or recording blood flow A61B5/02, A61B8/06; monitoring speed or deceleration of electrically-propelled vehicles B60L3/00; vehicle lighting systems adapted to indicate speed B60Q1/54; determining position or course in navigation, measuring ground distance in geodesy or surveying G01C; combined measuring devices for measuring two or more variables of movement G01C23/00; measuring velocity of sound G01H; measuring velocity of light G01J7/00; measuring direction or velocity of solid objects by reception or emission of radiowaves or other waves and based on propagation effects, e.g. Doppler effect, propagation time, direction of propagation, G01S; measuring speed of nuclear radiation G01T; measuring acceleration of gravity G01V; {measuring or recording the speed of trains B61L23/00; speed indicators incorporated in motor vehicles B60K35/00; measuring frequency or phase G01R; traffic control G08G})

## Abstract

A medicament delivery device development evaluation system is presented having a dummy medicament delivery device comprising at least one force sensor configured to detect an external force applied to the dummy medicament delivery device, processing circuitry configured to receive force measurements from the force sensor, and a storage medium configured to store the force measurements received by the processing circuitry.

## Claims

### Claim 1

A medicament delivery device development evaluation system comprising:
a dummy medicament delivery device comprising a plurality of modular units including a main body module and alternative modules, each configured to be detachable to the main body module, wherein each alternative module of the alternative modules differs from a remainder of the alternative modules, and wherein the main body module comprises one or more force sensors configured to detect an external force applied to the dummy medicament delivery device;
processing circuitry configured to receive force measurements from the one or more force sensors, wherein the processing circuitry is configured to compare the force measurements to corresponding reference ranges in order to determine whether the force measurements are within the corresponding reference ranges; and
a storage medium configured to store the force measurements received by the processing circuitry.

### Claim 2 (depends on 1)

The medicament delivery device development evaluation system as claimed in claim 1, wherein the one or more force sensors include a rotation force sensor and a linear force sensor.

### Claim 3 (depends on 1)

The medicament delivery device development evaluation system as claimed in claim 1, comprising a plurality of different dummy medicament delivery devices, each dummy medicament delivery device including one or more force sensors configured to detect an external force applied to the respective dummy medicament delivery device.

### Claim 4 (depends on 1)

The medicament delivery device development evaluation system as claimed in claim 1, wherein the alternative modules are of the same module type configured to be detachably assembled with the main body module.

### Claim 5 (depends on 4)

The medicament delivery device development evaluation system as claimed in claim 4, wherein the one or more force sensors are configured to detect a force applied to the main body module or to the alternative module by movement of an alternative module, assembled with the main body module, relative to the main body module, and wherein the processing circuitry is configured to receive a force measurement from the one or more force sensors, and the storage medium is configured to store the force measurements.

### Claim 6 (depends on 5)

The medicament delivery device development evaluation system as claimed in claim 5, wherein one module type is a cap, wherein the one or more force sensors includes a rotation force sensor configured to detect a rotational force applied to the main body module or the cap by rotation of the cap relative to the main body module.

### Claim 7 (depends on 6)

The medicament delivery device development evaluation system as claimed in claim 6, wherein the one or more force sensors includes a linear force sensor configured to detect a linear force applied to the main body module or to the cap when the cap is pulled off the main body module.

### Claim 8 (depends on 5)

The medicament delivery device development evaluation system as claimed in claim 5, wherein one module type is an activation button, wherein the one or more force sensors includes a linear force sensor is configured to detect a linear force applied to the activation button.

### Claim 9 (depends on 4)

The medicament delivery device development evaluation system as claimed in claim 4, wherein each alternative module includes one or more additional force sensors.

### Claim 10 (depends on 1)

The medicament delivery device development evaluation system as claimed in claim 1, comprising a display device configured to display the force measurements stored in the storage medium.

### Claim 11 (depends on 10)

The medicament delivery device development evaluation system as claimed in claim 10, wherein the display device is configured to display reference ranges for each of the force measurements stored in the storage medium.

### Claim 12 (depends on 11)

The medicament delivery device development evaluation system as claimed in claim 11, wherein each reference range extends between a maximum allowed force value and a minimum allowed force value for the corresponding force measurement.

### Claim 13 (depends on 12)

The medicament delivery device development evaluation system as claimed in claim 12, wherein each maximum allowed force value and the minimum allowed force value are determined by a standard.

### Claim 14 (depends on 1)

The medicament delivery device development evaluation system as claimed in claim 1, wherein the dummy medicament delivery device is a dummy injector, a dummy inhaler or a dummy eye-dispenser.

### Claim 15

A medicament delivery device development evaluation system comprising:
a dummy medicament delivery device comprising a plurality of modular units including a main body module and alternative modules, each configured to be detachable to the main body module, wherein each alternative module of the alternative modules differs from a remainder of the alternative modules;
a rotational force sensor and a linear force sensor both of which is configured to detect an external force applied to the dummy medicament delivery device;
processing circuitry configured to receive rotational force measurements from the rotational force sensor and receive linear force measurements from the linear force sensor, wherein the processing circuitry is configured to compare the rotational force measurements and the linear force measurements to corresponding reference ranges in order to determine whether the rotational force measurements and linear force measurements are within the corresponding reference ranges; and
a storage medium configured to store the force measurements received by the processing circuitry.

### Claim 16 (depends on 15)

The medicament delivery device development evaluation system as claimed in claim 15, wherein one of the modular units is configured as a cap such that the rotation force sensor detects a rotational force applied to the main body module or to the cap by rotation of the cap relative to the main body module.

### Claim 17 (depends on 15)

The medicament delivery device development evaluation system as claimed in claim 15, wherein one of the modular units is configured as an activation button such that the linear force sensor detects a linear force applied to the main body module or to the cap when the cap is pulled off the main body module.

### Claim 18 (depends on 15)

The medicament delivery device development evaluation system as claimed in claim 15 further comprises a display device that displays the force measurements stored in the storage medium.

### Claim 19 (depends on 18)

The medicament delivery device development evaluation system as claimed in claim 18, wherein the display shows reference ranges for each of the force measurements stored in the storage medium, a maximum allowed force value, and a minimum allowed force value.
