IP Library Granted Patent US 12688916
Granted Patent B2
US 12688916 · App. 17/244,709 · Granted Jul 21, 2026

Biomarker based nicotine replacement therapy

Inventors: Justin Mellinger (Philadelphia, PA); Ryan Walsh (Downingtown, PA); Sophie Edgar (Hoboken, NJ); Ming Dong (Hoboken, NJ); Curt Binner (Furlong, PA)
Assignee: McNeil AB
G16H20/13A24F40/50A24F47/00A61B5/1118A61M15/06G16H20/10
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Quick Facts
Patent No.
US 12688916
App. No.
17/244,709
Granted
Jul 21, 2026
Kind
B2
Abstract

A device for providing nicotine replacement therapy may be provided. The device may comprise a processor. The processor may be configured to perform one or more actions. A cessation program for a user may be determined. A program intervention event based on a phase of the cessation program may be determined. A marker associated with the user may be determined. A modification to the cessation program may be determined based on the program intervention event.

Claims (82)

1 . A device for providing nicotine replacement therapy, the device comprising:

a motion sensor for generating a first digital signal that indicates one or more motions associated with a user;

a receiver for receiving a second digital signal from a nicotine formulation dispenser, wherein the nicotine formulation dispenser comprises a lockout mechanism; and

a processor, the processor configured to:

determine a nicotine formulation consumption rate associated with the user based on the second digital signal from the nicotine formulation dispenser;

determine a smoking detection event when a carbon monoxide saturation level for the user exceeds a threshold;

determine a rate of cigarette consumption using the smoking detection event;

determine a fidgeting motion using the first digital signal, wherein the fidgeting motion is predictive of the smoking detection event;

determine an anticipated craving time based on the fidgeting motion, the nicotine formulation consumption rate, and the rate of cigarette consumption;

determine an amount of nicotine formulation to reduce a nicotine craving;

determine a modification to a cessation program based on the anticipated craving time;

send a third digital signal to the nicotine formulation dispenser to cause the lockout mechanism to move to an operative position, such that the nicotine formulation dispenser can dispense the amount of nicotine formulation to the user at the anticipated craving time to reduce the nicotine craving; and

send a notification message to the user at the anticipated craving time, wherein the notification message instructs the user to dispense the amount of nicotine formulation from the nicotine formulation dispenser.

2 . The device of claim 1 , wherein the processor is further configured to determine a marker, and wherein the marker comprises at least one of a cigarette count, nicotine data, a user biomarker, or an indicator of user behavior.

3 . The device of claim 1 , wherein the processor is further configured to determine a marker, and wherein the marker is at least one of a heart rate, a resting heart rate, a heart rate variability, a blood pressure, a temperature of the user, a respiration rate, an oxygen saturation, a skin temperature, or a galvanic skin response.

4 . The device of claim 1 , wherein the modification comprises a change to at least one of a rate of reduction of cigarettes, a duration of a phase, a speed at which to reduce cigarettes, a rate of reduction of nicotine replacement therapy, or a speed at which to reduce the nicotine replacement therapy.

5 . The device of claim 4 , wherein the processor is configured to determine the modification to the cessation program based on the anticipated craving time by determining a cessation trend.

6 . A device for providing nicotine replacement therapy, the device comprising:

a motion sensor for generating a first digital signal that indicates one or more motions associated with a user;

a receiver for receiving a second digital signal from a nicotine formulation dispenser, wherein the nicotine formulation dispenser comprises a lockout mechanism;

a processor, the processor configured to:

determine a biomarker associated with a user;

determine a nicotine formulation consumption rate associated with the user based on the second digital signal from the nicotine formulation dispenser;

determine a smoking detection event when a carbon monoxide saturation level for the user exceeds a threshold;

determine a rate of cigarette consumption using the smoking detection event;

determine a fidgeting motion using the first digital signal, wherein the fidgeting motion is predictive of the smoking detection event;

determine an anticipated craving time based on the fidgeting motion, the nicotine formulation consumption rate, and the rate of cigarette consumption;

detect a nicotine craving using the anticipated craving time and the biomarker associated with the user;

determine an amount of nicotine formulation to reduce the nicotine craving;

send a third digital signal to the nicotine formulation dispenser to cause the lockout mechanism to move to an operative position such that the nicotine formulation dispenser can dispense the amount of nicotine formulation to the user at the anticipated craving time to reduce the nicotine craving; and

provide an intervention to the user based on the nicotine craving, wherein the intervention comprises a notification message that instructs the user to dispense the amount of nicotine formulation from the nicotine formulation dispenser at the anticipated craving time.

7 . The device of claim 6 , wherein the biomarker is a first biomarker, and wherein the processor is configured to detect the nicotine craving using the anticipated craving time and the first biomarker associated with the user by:

determining a second biomarker associated with the user;

calculating a predictive value based on the first biomarker and the second biomarker, wherein the predictive value indicates a probability that the user is experiencing the nicotine craving; and

determining that the user is experiencing the nicotine craving when the predictive value exceeds a predictive threshold.

8 . The device of claim 6 , wherein the biomarker is a galvanic skin response, and wherein the processor is configured to detect the nicotine craving using anticipated craving time and the galvanic skin response associated with the user by:

determining a heart rate for the user;

determining a skin temperature for the user; and

detecting the nicotine craving using the galvanic skin response, the heart rate, and the skin temperature.

9 . The device of claim 6 , wherein the notification message further comprises at least one of a behavioral therapy instruction, an indication of an action the user can take to reduce the nicotine craving, or an indication of the biomarker.

10 . The device of claim 6 , wherein the processor is further configured to determine a cessation trend indicated by the biomarker.

11 . A device for providing nicotine replacement therapy, the device comprising:

a motion sensor for generating a first digital signal that indicates one or more motions associated with a user;

a receiver for receiving a second digital signal from a nicotine formulation dispenser, wherein the nicotine formulation dispenser comprises a lockout mechanism; and

a processor, the processor configured to:

determine a nicotine formulation consumption rate associated with the user based on the second digital signal from the nicotine formulation dispenser;

determine a smoking detection event when a carbon monoxide saturation level for the user exceeds a threshold;

determine a rate of cigarette consumption using the smoking detection event;

determine a fidgeting motion using the first digital signal, wherein the fidgeting motion is predictive of the smoking detection event;

determine an anticipated craving time based on the fidgeting motion, the nicotine formulation consumption rate, and the rate of cigarette consumption;

determine a duration for a phase of a cessation program based on the anticipated craving time and the rate of cigarette consumption;

determine an amount of nicotine formulation to reduce a nicotine craving;

determine a modification to a cessation program based on the anticipated craving time, the phase, and the duration;

send a third digital signal to the nicotine formulation dispenser to cause the lockout mechanism to move to an operative position such that the nicotine formulation dispenser can dispense the amount of nicotine formulation to the user at the anticipated craving time to reduce the nicotine craving; and

send a notification message to the user at the anticipated craving time, wherein the notification message instructs the user to dispense the amount of nicotine formulation from the nicotine formulation dispenser.

12 . The device of claim 11 , wherein the processor is further configured to determine a biomarker, and wherein the biomarker is at least one of a heart rate for the user, a skin temperature for the user, or a galvanic skin response for the user.

13 . The device of claim 11 , wherein the phase is a first phase, and wherein the processor is further configured to:

determine an increase to the duration based on at least the cigarette consumption rate;

determine the increase to the duration would exceed a duration threshold; and

assign the user to a second phase of the cessation program.

14 . The device of claim 11 , wherein the phase is a first phase, wherein the duration is a first duration, and wherein the processor is configured to:

assign the user to a second phase of the cessation program when it is determined that a biomarker trend has exceeded a biomarker threshold; and

determine a second duration for the second phase of the cessation program based on at least the cigarette consumption rate.

15 . A device for providing nicotine replacement therapy, the device comprising:

a motion sensor for generating a first digital signal that indicates one or more motions associated with a user;

a receiver for receiving a second digital signal from a nicotine formulation dispenser;

a processor, the processor configured to:

determine a carbon monoxide saturation level for the user;

determine a nicotine formulation consumption rate associated with the user based on the second digital signal from the nicotine formulation dispenser;

determine a smoking detection event when the carbon monoxide saturation level exceeds a threshold;

determine fidgeting motion using the first digital signal, wherein the fidgeting motion is predictive of the smoking detection event;

determine an anticipated craving time based on the fidgeting motion, the nicotine formulation consumption rate, and a rate of cigarette consumption;

determine an amount of nicotine formulation to reduce a nicotine craving;

send a third digital signal to the nicotine formulation dispenser to cause a lockout mechanism to move to an operative position such that the nicotine formulation dispenser can dispense the amount of nicotine formulation to the user at the anticipated craving time to reduce the nicotine craving; and

send a notification message to the user at the anticipated craving time, wherein the notification message instructs the user to dispense the amount of nicotine formulation from the nicotine formulation dispenser.

16 . The device of claim 15 , wherein the processor is further configured to:

determine a phase of a cessation program associated with a user;

determine a duration for a first phase of the cessation program based on the anticipated craving time and the rate of cigarette consumption;

determine a modification to the cessation program based on the phase, the duration, the anticipated craving time, and the smoking detection event;

assign the user to a second phase of the cessation program when it is determined that a nicotine consumption is below a nicotine threshold for the user;

determine a rate of nicotine consumption using the smoking detection event and the nicotine formulation consumption rate; and

determine a second duration for the second phase of the cessation program based on the rate of nicotine consumption.