# US 11,896,810 B2 · Injection monitoring device with delivery signature

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- Number: US 11,896,810 B2
- Document ID: US11896810B2
- Status: Granted
- Kind: B2
- Application number: 18/066,800
- Filed: 2022-12-15
- Published: 2023-12-14
- Granted: 2024-02-13
- Earliest claimed: 2017-12-29
- Assignees: Genentech, Inc.
- Applicants: Genentech, Inc.
- Inventors: Steven N. Roe
- Web page: https://patentgrep.com/patent/US11896810B2

## CPC

- A61M 5/31511: {Piston or piston-rod constructions, e.g. connection of piston with piston-rod (A61M5/5066 takes precedence)}
- A61M 5/3157: {Means providing feedback signals when administration is completed (A61M5/20 takes precedence)}
- A61M 5/31536: {Blocking means to immobilize a selected dose, e.g. to administer equal doses}
- A61M 5/31578: {the piston rod being moved by the axial movement of a component directly in contact with it}
- G16H 20/17: delivered via infusion or injection
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/332: Force measuring means
- A61M 2205/3327: Measuring
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/8206: battery-operated
- 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)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Drug delivery systems and methods of use thereof for recording administration of a drug dose to a subject are provided. Aspects of the invention include a syringe stopper rod comprising a sensor component that is configured to detect a delivery signature, and to transmit a report comprising a drug dose completion signal to a data management component, e.g., a mobile computing device.

## Claims

### Claim 1

A syringe stopper rod comprising:
a sensor comprising a wireless transmitter module;
a deflection component configured to generate a delivery signature in response to a delivery stroke of the syringe stopper rod; and
at least one internal trigger switch contact assembly,
wherein the wireless transmitter module is configured to transmit a report comprising a drug dose completion signal when the sensor detects the delivery signature,
wherein the deflection component comprises:
a plurality of trigger switches that are configured to deflect in an inward direction when compressed by a syringe barrel and make contact with the internal trigger switch contact assembly; and
a circuit board component disposed on the stopper rod and configured to separately detect an inward deflection of each trigger switch.

### Claim 2 (depends on 1)

The syringe stopper rod according to claim 1, wherein the internal trigger switch contact assembly is disposed between a trigger switch and an internal circuit board component.

### Claim 3 (depends on 1)

The syringe stopper rod according to claim 1, wherein the circuit board component comprises a conductive rubber switch pad.

### Claim 4 (depends on 1)

The syringe stopper rod according to claim 1, comprising at least two trigger switches that are disposed on a first side of the stopper rod.

### Claim 5 (depends on 4)

The syringe stopper rod according to claim 4, further comprising one or more centering components disposed on a second side of the stopper rod, opposite the at least two trigger switches.

### Claim 6 (depends on 4)

The syringe stopper rod according to claim 4, wherein the syringe stopper rod comprises at least four trigger switches, wherein at least two trigger switches are disposed on a first side of the syringe stopper rod, and at least two trigger switches are disposed on a second, opposite side of the syringe stopper rod.

### Claim 7 (depends on 6)

The syringe stopper rod according to claim 6, wherein each of the at least two trigger switches on the first side of the syringe stopper rod is disposed at the same longitudinal position along the syringe stopper rod as each of the at least two trigger switches on the second, opposite side of the syringe stopper rod.

### Claim 8 (depends on 6)

The syringe stopper rod according to claim 6, wherein each of the at least two trigger switches on the first side of the syringe stopper rod is disposed at a different longitudinal position along the syringe stopper rod than each of the at least two trigger switches on the second, opposite side of the syringe stopper rod.

### Claim 9 (depends on 1)

The syringe stopper rod according to claim 1, comprising at least two trigger switches, wherein one trigger switch is disposed on a first side of the stopper rod, and one trigger switch is disposed on a second, opposite side of the stopper rod.

### Claim 10 (depends on 9)

The syringe stopper rod according to claim 9, wherein each of the at least two trigger switches is disposed at the same longitudinal position along the syringe stopper rod.

### Claim 11 (depends on 9)

The syringe stopper rod according to claim 9, wherein each of the at least two trigger switches is disposed at a different longitudinal position along the syringe stopper rod.

### Claim 12 (depends on 1)

The syringe stopper rod according to claim 1, wherein the syringe stopper rod comprises a first material, and the trigger switches are integrated into the syringe stopper rod and comprise the first material.

### Claim 13 (depends on 12)

The syringe stopper rod according to claim 12, wherein one or more trigger switches comprise a second material that is different from the first material.

### Claim 14 (depends on 12)

The syringe stopper rod according to claim 12, wherein at least one trigger switch comprises an alignment component.

### Claim 15 (depends on 14)

The syringe stopper rod according to claim 14, wherein the alignment component comprises a semi-circular tab.

### Claim 16 (depends on 1)

The syringe stopper rod according to claim 1, wherein the trigger switches are integrated into an external trigger switch assembly that is separable from the syringe stopper rod.

### Claim 17 (depends on 16)

The syringe stopper rod according to claim 16, wherein the syringe stopper rod comprises a first material, and the external trigger switch assembly comprises a second material that is different from the first material.

### Claim 18 (depends on 16)

The syringe stopper rod according to claim 16, further comprising one or more deflection limiting components configured to limit a deflection range of one or more trigger switches.

### Claim 19 (depends on 18)

The syringe stopper rod according to claim 18, wherein at least one deflection limiting component is disposed on the syringe stopper rod adjacent to each trigger switch.

### Claim 20 (depends on 19)

The syringe stopper rod according to claim 19, wherein the deflection limiting component comprises a semi-circular tab.

### Claim 21 (depends on 1)

The syringe stopper rod according to claim 1, wherein the delivery signature comprises a deflection order of the trigger switches, a deflection duration of each trigger switch, one or more time intervals corresponding to a time between a deflection of a first trigger switch and a deflection of a second trigger switch, or any combination thereof.

### Claim 22 (depends on 1)

The syringe stopper rod according to claim 1, wherein the deflection component comprises a force sensor.

### Claim 23 (depends on 22)

The syringe stopper rod according to claim 22, wherein the force sensor is an absolute force sensor.

### Claim 24 (depends on 22)

The syringe stopper rod according to claim 22, wherein the force sensor is a relative force sensor.

### Claim 25 (depends on 22)

The syringe stopper rod according to claim 22, wherein the deflection component comprises a circuit board sensor component comprising a first inductive sensor coil configured to move toward a first detection target in response to a force applied to the syringe stopper rod by a user.

### Claim 26 (depends on 25)

The syringe stopper rod according to claim 25, wherein the first detection target is disposed on an internal surface of the syringe stopper rod.

### Claim 27 (depends on 25)

The syringe stopper rod according to claim 25, wherein the first detection target is disposed on an external surface of the syringe stopper rod.

### Claim 28 (depends on 25)

The syringe stopper rod according to claim 25, wherein the first detection target is disposed on a thumb pad.

### Claim 29 (depends on 25)

The syringe stopper rod according to claim 25, wherein the first detection target comprises a conductive material.

### Claim 30 (depends on 25)

The syringe stopper rod according to claim 25, wherein the delivery signature comprises an injection force profile applied to the syringe stopper rod by a user.

### Claim 31 (depends on 30)

The syringe stopper rod according to claim 30, wherein the injection force profile comprises a break loose force, a glide force, an end of dose force, or any combination thereof.

### Claim 32 (depends on 31)

The syringe stopper rod according to claim 31, wherein the injection force profile further comprises a first time interval and/or force magnitude associated with the break loose force, a second time interval and/or force magnitude associated with the glide force, and a third time interval and/or force magnitude associate the end of dose force.

### Claim 33 (depends on 32)

The syringe stopper rod according to claim 32, wherein the injection force profile comprises a characteristic shape that is indicative of the delivery stroke.
