IP Library Granted Patent US 12,233,246
Granted Patent B2
US 12,233,246 · App. 17/366,231 · Granted Feb 25, 2025

Dose detection system module for a medication delivery device

Inventors: Benjamin David Bauer (Indianapolis, IN); Timothy Mark Blum (Columbus, OH); Roy Howard Byerly (Indianapolis, IN); Andrea Concu (Milan, IT); Marco Cortinovis (Seriate, IT); Paolo Degan (Ranica, IT); Jared Alden Judson (Medford, MA); Rossano Claudio Massari (Lissone, IT); Giorgio Maria Sardo (Milan, IT)
Assignee: ELI LILLY AND COMPANY
A61M5/31528A61M5/31551A61M5/31568A61M5/31585A61M5/31593A61M2205/3306A61M2205/3317A61M2205/3327
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Quick Facts
Patent No.
US 12,233,246
App. No.
17/366,231
Granted
Feb 25, 2025
Kind
B2
Abstract

Dose detection systems for medication delivery devices are described. One is a module for removable attachment to a dose button of a medication delivery device. A device with a dose detection system is also disclosed. The module includes a processor and at least one measurement sensor operably coupled to the processor and configured to detect the positon of a sensed component within the delivery device. Medication identification system may also be provided with an identification sensor and a light guide member.

Claims (33)

1. A dose detection module to attach to a dose actuator of a medication delivery device, the dose actuator having a cylindrical button sidewall that a user can use to set a dose, and an axial surface, the device comprising a sensed component rotatable during dose dispensing, said module comprising:

a housing;

a plurality of attachment arms configured to removably attach to the cylindrical button sidewall of the dose actuator; and

an electronics assembly contained in the housing, comprising a processor, and at least one measurement sensor operably coupled to the processor, wherein the at least one measurement sensor is configured to detect angular position and/or rotational movement of the sensed component to generate position signals, wherein the electronics assembly includes an identification sensor operably coupled to the processor, and a light guide member configured to provide an optical path for the identification sensor,

wherein, when the dose detection module is attached to the cylindrical button sidewall of the dose actuator, the identification sensor is disposed facing the axial surface of the dose actuator, the light guide member is disposed between the identification sensor and the axial surface of the dose actuator, the identification sensor configured to detect an indicia from the axial surface, the indicia being information associated with a type of the medication delivery device or a medication contained with the medication delivery device.

2. The module of claim 1 , wherein the identification sensor is configured to emit light and/or detect color of said dose actuator after reflection of light from the dose actuator.

3. The module of claim 2 , wherein the identification sensor comprises a RGB light source configured to emit RGB light to said dose actuator and a color sensor configured to detect color of said dose actuator after reflection of RGB light from the dose actuator.

4. The module of claim 1 , wherein the light guide member includes a light guide post proximally extending through an opening of a housing wall.

5. The module of claim 4 , wherein the identification sensor is disposed over the light guide post, the light guide post providing the optical path for the identification sensor from a distal surface of the housing wall that is in abutment against the axial surface of the dose actuator.

6. The module of claim 4 , wherein the light guide post proximally extends through the opening of the housing wall beyond the at least one measurement sensor, wherein the electronics assembly includes a first circuit board segment having the at least one measurement sensor and a second circuit board segment located proximal to the first circuit board segment, wherein the second circuit board segment has the identification sensor.

7. The module of claim 4 , wherein the light guide member is fixedly secured to the housing wall, and the identification sensor is positioned to detect a center or a near-center of the axial surface of the dose actuator.

8. The module of claim 4 , wherein the light guide member includes one or more attachment posts radially spaced from the light guide post, the housing wall including one or more attachment apertures, each of the one or more attachment apertures receiving a corresponding one of the one or more attachment posts.

9. The module of claim 8 , wherein the light guide post proximally extends through the opening of the housing wall beyond the at least one measurement sensor, wherein the identification sensor is disposed over the light guide post and axially spaced therefrom.

10. The module of claim 1 , further comprising a switch system configured to permit an increase of power to the electronics assembly, wherein the housing includes a proximal wall and a module housing sidewall, the proximal wall axially movable relative to the module housing sidewall to activate the switch system by a force less than a force required for dose delivery from actuation of the device.

11. The module of claim 1 , wherein the housing includes a light guide indicator, the electronics assembly including a light indicator element operably coupled to the processor to emit light at the light guide indicator.

12. The module of claim 1 , wherein the attachment arms extend beyond a distal wall of the housing, the attachment arms being angularly spaced from one another, each of the arms having a bearing portion to be received into a corresponding recesses formed in the cylindrical button sidewall of the dose actuator.

13. The module of claim 12 , wherein the bearing portion of each of the attachment arms extend radially inward from an interior surface of the respective attachment arm, wherein the bearing portion is configured to be placed against or in close proximity to a radial lip of the dose actuator.

14. The module of claim 13 , wherein the bearing portion of each of the attachment arms includes a distal facing angled end to slidably engage the radial lip during attachment of the module to the dose actuator, and an angled surface to slidably engage the radial lip during detachment of the module from the dose actuator.

15. The module of claim 14 , wherein an attachment force applied to the module to attach the module to the dose actuator is less than a detachment force applied to the module to remove the module from the dose actuator.

16. The module of claim 14 , wherein when the module is attached to the dose actuator the module is configured to rotate relative to the dose actuator at a predetermined torque applied to the module.

17. The module of claim 1 , wherein the at least one measurement sensor is axially and rotatably locked with the sensed component during dose setting, and rotatably fixed relative to the sensed component that rotates during dose dispensing.

18. A dose delivery system, comprising:

a medication delivery device having a dose actuator coupled to a device body, a reservoir containing a medication, and an end of the body configured to receive a needle, a sensed component rotatable during dose dispensing, wherein the dose actuator has a cylindrical button sidewall and an axial surface; and

a dose detection module removably attachable to the dose actuator, the dose detection module having a housing, a plurality of attachment arms configured to couple to the cylindrical button sidewall of the dose actuator, and an electronics assembly contained in the housing, comprising a processor, and at least one measurement sensor operably coupled to the processor, wherein the at least one measurement sensor is configured to detect angular position and/or rotational movement of the sensed component to generate position signals, wherein the electronics assembly includes an identification sensor operably coupled to the processor,

wherein, when the dose detection module is attached to the dose actuator, the identification sensor is disposed facing the axial surface of the dose actuator, a light guide member is disposed between the identification sensor and an axial surface of the dose actuator, the light guide member is configured to provide an optical path for the identification sensor, the identification sensor configured to detect an indicia from the axial surface, the indicia being information associated with a type of the medication delivery device or a medication contained with the medication delivery device.

19. The system of claim 18 , wherein the identification sensor comprises a RGB light source configured to emit RGB light to said dose actuator and a color sensor configured to detect color of said dose actuator after reflection of RGB light from the dose actuator.

20. The system of claim 19 , wherein the light guide member comprises a light guide post proximally extending through an opening of a housing wall of said housing beyond the at least one measurement sensor, wherein the identification sensor is disposed over the light guide post and axially spaced therefrom.

21. The system of claim 18 , wherein the dose actuator comprises a radial lip, wherein the attachment arms extend beyond the housing wall of the housing, the attachment arms being equi-angularly spaced from one another, each of the arms having a bearing portion slidably engage the radial lip during attachment of the dose detection module to the dose actuator of the medication delivery device, and slidably engage the radial lip during detachment of the dose detection module from the dose actuator of the medication delivery device.

22. The system of claim 21 , wherein the dose actuator comprises a plurality of recesses, each recess sized to receive a portion of the bearing portion of the attachment arm, wherein when the bearing portion is received into the recess, an axially bearing surface of the bearing portion is placed against or in close proximity to an underside of the radial lip.

23. The system of claim 21 , wherein the attachment arms are integrally formed with a housing wall of said housing.

24. The system of claim 21 , wherein each of the attachment arms is formed having a J-shape.

25. The system of claim 21 , wherein each of the attachment arms has a proximally extending bearing portion.

26. The system of claim 18 , wherein the dose detection module further comprises a presence switch system that is activated when the dose detection module is attached to the dose actuator.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 16, 2021
From: BLUM, TIMOTHY MARK
To: BATTELLE MEMORIAL INSTITUTE
Reel/Frame 056878/0571 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 16, 2021
From: DEGAN, PAOLO; CORTINOVIS, MARCO; CONCU, ANDREA; MASSARI, ROSSANO CLAUDIO; SARDO, GIORGIO MARIA; VERGANI, MARCO
To: FLEXTRONICS DESIGN S.R.L.
Reel/Frame 056878/0711 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 16, 2021
From: JUDSON, JARED ALDEN
To: JUDSON ENGINEERING LLC
Reel/Frame 056878/0789 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 16, 2021
From: BAUER, BENJAMIN DAVID; BYERLY, ROY HOWARD; BATTELLE MEMORIAL INSTITUTE; JUDSON ENGINEERING LLC; FLEXTRONICS DESIGN S.R.L.
To: ELI LILLY AND COMPANY
Reel/Frame 056878/0934 →
Continuity (4)
Continuation 16603900
Provisional Application 62779652 · Dec 14, 2018
Provisional Application 62633655 · Feb 22, 2018
Related Publication 20210330888A1 · Oct 28, 2021
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