Intelligent inhaler providing feedback to both patient and medical professional

• US 5,363,842 A
• Filed: 12/20/1991
• Issued: 11/15/1994
• Est. Priority Date: 12/20/1991
• Status: Expired due to Term

• Current Assignee: Aradigm Corporation
• Original Assignee: Circadian, Inc.
• Inventors: Lanpher, Gregory B., Mishelevich, David J., Long, James, Lanpher, Ted W.
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): Lewis, Aaron J.
• Application Number:
  US07/811,398
• Time in Patent Office: 1,061 Days
• Field of Search: 128/200.14, 128/200.23, 128/203.12, 128/204.21, 128/204.23, 128/725, 128/205.23
• US Class Current: 128/200.14
• CPC Class Codes: A61B 8/0875 for diagnosis of bone A61B5/4504 takes precedence
• CPC Class Codes: A61J 7/0481 working on a schedule basis
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2016/0042 in the expiratory circuit
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The present invention detects how much air is inhaled through the inhaler with what time course (including such derived measurements as how much volume is inspired within the bounds of a given flow range) as well as certain events such as the triggering of the release of aerosol. The system can be set up to compare the resultant time course to either (a) a standard target envelope (e.g., one or more of flow, volume, and time) for that patient programmed into the intelligent inhalation device by a healthcare professional. Based on the comparison, the success or failure of effective inhaler actuation and aerosol inspiration can be signaled to the patient (e.g., visually or through sound) and may be recorded with a time and date stamp for later decoding and evaluation of the invention, the device would also possess the ability to signal the patient to continue post-inspiratory breath holding for use in interpreting the success of medication delivery.

Claims

1. A portable hand-held inhaler device comprising:

a housing adapted to be hand-held by a user;

a canister of inhaled medication received within the housing;

delivery means incorporated in said housing for delivering a desired unit dose of said inhaled medication from said canister;

electronic sensor means incorporated in said housing for measurement of air flow through said delivery means;

microprocessor means incorporated in said housing, comprising means for storage of data including relative time of activation of said delivery means, and for storing data representative of duration and pattern of inspiration through said delivery means for each activation event;

said microprocessor means further comprising means for performing logical operations or interpretative calculations upon said data;

signaling means responsive to said microprocessor means for providing feedback to said user, said feedback expressing to the user whether the delivery of medication has been done correctly;

motion sensor means for detecting if said medicine canister is shaken prior to each activation event and for producing an output signal representative of the magnitude and duration of the shaking to said microprocessor means; and

means responsive to said motion sensor means for signaling the user that the canister of medication was not shaken prior to activation.

2. A hand-held inhaler device comprising:

a housing adapted to be hand-held by a user;

delivery means incorporated in said housing for delivering, upon activation, a desired unit dose of inhaled medication from an associated canister received in said housing;

electronic sensor means responsive to activation of said delivery means, incorporated in said housing for measuring flow of air through said medication delivery means and for producing output signals representative thereof for each activation event;

microprocessor means incorporated in said housing for storage of data including relative time of activation of said delivery means, and for storing data representative of duration and pattern of inspiration through said medication delivery means, said microprocessor being adapted to record data pertaining to each medication delivery event to thereby provide a record of medication delivery for compliance monitoring;

means operatively connected with said microprocessor for performing logical operations to optimize the patient'"'"'s use of said delivery means in response to interpretative calculations upon said data;

signaling means responsive to said means for performing logical operations, for providing feedback to a user, wherein said feedback expresses to the user success in inhaled medication delivery and provides one or more recommendations for improved patent inhalation in subsequent doses; and

wherein said means for performing logical operations further comprises a motion sensor means for detecting of said medicine canister is shaken prior to each medication delivery event.

3. An apparatus according to claim 2, wherein the microprocessor means further comprises means for storing a target envelope pattern representing the time course of an effective inspiration for comparison to measured inspiration patterns, whereby said comparison is used to govern feedback provided to the user.

4. An apparatus according to claim 3 wherein said canister of inhaled medication comprises a reservoir integral with said housing and adapted for storing a quantity of airborne medication.

5. The apparatus of claim 3 wherein said feedback further comprises means for displaying a target inspiration pattern as a function of time.

6. The apparatus of claim 5 wherein said feedback further comprises means for displaying a comparison of a patient'"'"'s actual inhalation pattern with a prescribed target pattern.

7. An apparatus according to claim 2 further comprising:

computer monitoring means communicating electronically with said microprocessor means of said hand-held inhaler for retrieving and processing said stored data representative of duration and pattern of inspiration, said computer monitoring means further comprising a means for displaying said stored data for compliance review by a healthcare professional.

8. The apparatus as in claim 7 wherein said computer monitoring means further comprises means for processing data input from at least one of the following sources:

diagnostic instruments, diagnostic tests, clinical records, clinical observations, and professional opinions.

9. An apparatus according to claim 2 wherein the microprocessor means incorporated in said inhaler housing further comprises means for reprogramming said signaling means to vary the desired dose of medication inhaled by the patient in response to said logical operations or interpretive calculations upon said data.

10. An apparatus according to claim 9 further comprising means for reprogramming the signaling means to vary the timing of frequency of delivery of medication.

11. An apparatus according to claim 2 wherein said microprocessor further comprises wireless transmission means for transmitting output signals representative of said stored data to a remotely located computer means for compliance monitoring.

12. An apparatus according to claim 11 wherein said wireless transmission means comprises input means responsive to remotely generated signals for reprogramming said microprocessor means to vary the time interval for delivering a desired unit dose of said medication.

13. An apparatus according to claim 12 responsive to a remotely generated input signal indicative of the times prescribed for delivery of said dosage of medicine, wherein said means for indicating comprises at least one of the following:

indicator lights, auditory tones and vibration.

14. An apparatus according to claim 2 wherein said microprocessor comprises data communication means for transmitting said data along a communication path to a spatially remote control means for compliance monitoring and said data communication means includes means for receiving remotely generated signals from said remote control means for reprogramming said microprocessor to vary the desired dose of said inhaled medication.

15. An apparatus according to claim 2 wherein said signaling means further comprises interactive feedback means for interrogating a patient regarding exposure to an event affecting inhalation such as exposure to allergens and breathing irritants, and further comprising switch means adapted to receive a yes or no answer from said patient in response to said means for interrogating and for recording said answer as data to be stored in said microprocessor.

16. An apparatus according to claim 2 wherein said signaling means further comprises interactive feedback means for providing immediate feedback to the patient as to success or failure of an inhalation action, including a message as to what correction is appropriate.

17. An apparatus according to claim 2 wherein said interactive feedback message comprises a message such as at least one of the following:

"clean inhaler", "rinse mouth", "avoid pets", and "avoid cold."

18. An apparatus according to claim 2 wherein said canister of inhaled medication comprises a reservoir of airborne medication disposed externally from said hand-held inhaler, including conduit means for communicating said airborne medication with said hand-held inhaler delivery means.

19. An apparatus according to claim 2 wherein said delivery means comprises a spacer having a first end integral with said hand-held inhaler and having a second end adapted for delivering said medication into a user'"'"'s mouth.

20. An apparatus according to claim 2 wherein said delivery means further comprises a spacer separated from said hand-held inhaler and interposed between said handheld inhaler and said user, said spacer having a first end communicating with said hand-held inhaler through a conduit, and having a second end adapted for delivering a desired dose of inhaled medication into a user'"'"'s mouth.

21. An apparatus according to claim 2 wherein said microprocessor further comprises output means communicating electronically along a communication path with a remotely located digital computer for transmitting signals representative of said stored data for remote compliance monitoring;

and

said microprocessor further comprising input means for receiving input signals from said remotely located digital computer for reprogramming said microprocessor means to vary the desired dose of medication inhaled by the patient.

22. An apparatus according to claim 2 further comprising at least one of auditory, visual and vibratory alarm means for notifying a user when to take said medication.

23. An apparatus according to claim 2 wherein said means for performing logical operations or interpretive calculations upon data comprise means for processing selected spirometric measured values such as peak flow to provide feedback of a user'"'"'s therapeutic response.

24. An apparatus according to claim 2 further comprising sensor means responsive to a user'"'"'s shaking of the inhaler for turning on said delivery means for subsequent activation by a user.

25. A portable hand-held inhaler device comprising:

a housing adapted to be hand-held by a user;

a canister of inhaled medication received within the housing;

delivery means incorporated in said housing for delivering a desired unit dose of said inhaled medication from said canister;

electronic sensor means incorporated in said housing for measurement of air flow through said delivery means;

microprocessor means incorporated in said housing, comprising means for storage of data, including relative time of activation of said delivery means, and for storing data representative of measured duration and pattern of inspiration through said delivery means for each activation event;

said microprocessor means further comprising means for performing logical operations or interpretive calculations upon said data;

signaling means incorporated in said housing responsive to said microprocessor means for providing feedback to said user, said feedback expressing to the user whether the delivery of medication has been done correctly; and

wherein said signalling means further comprises means for interrogating a patient concerning factors relating to patient status such as symptoms or exposures.

26. A portable hand-held inhaler device comprising:

a housing adapted to be hand-held by a user;

a canister of inhaled medication received within the housing;

delivery means incorporated in said housing for delivering a desired unit dose of said inhaled medication from said canister;

electronic sensor means incorporated in said housing for measurement of air flow through said delivery means;

microprocessor means incorporated in said housing, comprising means for storage of data, including relative time of activation of said delivery means, and for storing data representative of measured duration and pattern of inspiration through said delivery means for each activation event;

said microprocessor means further comprising means for performing logical operations or interpretive calculations upon said data;

signaling means incorporated in said housing, responsive to said microprocessor means for providing feedback to said user, said feedback expressing to the user whether the delivery of medication has been done correctly;

wherein said microprocessor further comprises wireless transmission means for transmitting output signals representative of said stored data to a remotely located computer means for compliance monitoring.

27. A portable hand-held inhaler device comprising:

a housing adapted to be hand-held by a user;

a canister of inhaled medication received within the housing;

delivery means incorporated in said housing for delivering a desired unit dose of said inhaled medication from said canister;

electronic sensor means incorporated in said housing for measurement of air flow through said delivery means;

microprocessor means incorporated in said housing, comprising means for storage of data, including relative time of activation of said delivery means, and for storing data representative of measured duration and pattern of inspiration through said delivery means for each activation event;

said microprocessor means further comprising means for performing logical operations or interpretive calculations upon said data;

signaling means incorporated in said housing, responsive to said microprocessor means for providing feedback to said user, said feedback expressing to the user whether the delivery of medication has been done correctly;

wireless transmission means comprising input means responsive to remotely generated signals for reprogramming said microprocessor to vary the time interval for delivering a desired unit dose of said medication; and

wherein said signalling means is responsive to said remotely generated input signals for indicating a time prescribed for delivery of said dosage of medicine, said means for indicating comprising at least one of the following;

indicator lights, auditory tones and vibration.

28. A portable hand-held inhaler device comprising:

a housing adapted to be hand-held by a user;

a container of inhaled medication received within the housing;

delivery means incorporated in said housing for delivering a desired unit dose of said inhaled medication from said container;

electronic sensor means incorporated in said housing for measurement of air flow through said delivery means;

microprocessor means incorporated in said housing, comprising means for storage of data, including relative time of activation of said delivery means, and for storing data representative of measured duration and pattern of inspiration through said delivery means for each activation event;

said microprocessor means further comprising means for performing logical operations or interpretive calculations upon said data;

signaling means incorporated in said housing responsive to said microprocessor means for providing feedback to said user, said feedback expressing to the user whether the delivery of medication has been done correctly;

reprogramming means responsive to said measurement from said electronic sensor means for reprogramming the signalling means to vary the timing of frequency of delivery of medication.

29. A method for administering an air borne medication by a digital computer communicating with a microprocessor incorporated in a portable hand-held inhaler, comprising the steps of:

measuring the values of at least the time, date and inspiration pattern for each use of said inhaler by a patient;

storing said measured values in a microprocessor means incorporated in said portable inhaler;

displaying said measured values in a display unit incorporated in said inhaler for providing interactive feedback with the patient;

retrieving said measured values by wireless communication into a remotely located computer for providing remote compliance monitoring;

visually displaying said measured values on a display unit of said remotely located computer to permit evaluation of a therapeutic effect of said medication upon the patient.

30. A method for administering an air borne medication through a digital computer communicating with a microprocessor incorporated in a portable and hand-held inhaler, comprising the steps of:

measuring the values of at least the time, date and inspiration pattern for each use of said inhaler by a patient;

storing said measured values in a microprocessor means incorporated in said portable inhaler;

displaying said measured values in a display unit incorporated in said inhaler for providing interactive feedback with the patient;

retrieving said measured values along a communication path into a remotely located computer for providing remote compliance monitoring;

visually displaying said measured values on a display unit of said remotely located computer to permit evaluation of a therapeutic effect of said medication upon the patient;

interrogating a patient through the display unit in the inhaler concerning factors affecting inhalation such as exposure to allergens, breathing irritants or the like;

receiving a yes or no answer from the patient in response to the step of interrogating through a switch on the inhaler; and

recording the patient'"'"'s answer as data to be stored in the microprocessor.

31. The method of claim 30 wherein the step of visually displaying said measured values includes the step of further processing of selected spirometric measured values in said remotely located computer means to provide feedback of a patient'"'"'s therapeutic response.

32. The method of claim 31 wherein said step of further processing comprises the step of displaying a target inspiration pattern on said display unit as a function of time.

33. The method of claim 32 wherein said step of further processing comprises the step of displaying a comparison of a patient'"'"'s actual inhalation pattern with a prescribed target pattern.