Inhalation device with a dose-timer, an actuator mechanism, and patient compliance monitoring means

• US 5,284,133 A
• Filed: 07/23/1992
• Issued: 02/08/1994
• Est. Priority Date: 07/23/1992
• Status: Expired due to Fees

• Current Assignee: Armstrong Pharmaceuticals, Inc. (Amphastar Pharmaceuticals Incorporated)
• Original Assignee: Armstrong Pharmaceuticals, Inc. (Amphastar Pharmaceuticals Incorporated)
• Inventors: Burns, James S., Marshak, Daniel R.
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): Asher, Kimberly L.
• Application Number:
  US07/919,030
• Time in Patent Office: 565 Days
• Field of Search: 128/200.14-200.24, 128/202.22, 128/203.12-203.15, 128/419 G, 128/724, 128/203.24, 604/54, 604/239, 222/23, 222/36-38, 222/645, 222/644, 222/649, 222/635
• US Class Current: 128/200.23
• CPC Class Codes: A61M 15/0066 with means for varying the dose size
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• 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 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient

Abstract

An inhalation device is provided with a mechanism to assure patient compliance with a drug dosage regimen. The control mechanism includes a controller (24), a timer (26), an actuator (28) and a signalling device (30). The controller (24) is programmed or preset with a time and dosage schedule for the drug to be delivered. For example, the controller (24) may be programmed to allow for two puffs from an MDI every eight hours. The actuator (28) operates in conjunction with the timer (26) and prevents the inhalation device from being actuated after the programmed dosage has been administered at the prescribed interval. The actuator (28) could be an electronically controlled valve (58) or pawl (66) arrangement or other suitable mechanism. The signaling device (30) provides an audible, visual or tactile sensation during the time period prescribed for administration of the drug so that the patient is reminded to inhale his or her medicine at the prescribed time intervals. The history of actuation, non-actuation, and improper attempts at actuation can all be recorded and analyzed off-site at a later by a physician, pharmacist, or other authorized health care professional.

Claims

1. A patient compliance system, comprising:

a drug delivery means;

a controller connected to said drug delivery means programmed or preset with dose and time of dose information for a drug being delivered by said drug delivery means, said dose and time of dose information setting forth a number of actuations of said drug delivery means to be provided at prescribed intervals;

a timer connected to said controller for tracking the time between actuations of said drug delivery means;

an actuator connected to said drug delivery means and said controller for actuating said drug delivery means, said actuator including means for preventing actuation of said drug delivery means when a patient attempts to actuate the drug delivery means at non-prescribed intervals or when a patient tries to exceed said number of actuations at said prescribed intervals;

means, coupled to said controller, for recording a time and number of actuations of said drug delivery means, said recording means being actuated by said actuator; and

means for verifying that a patient is properly positioned to inhale drug from said drug delivery means,

said verifying means comprising means for simultaneously sensing a patients mouth in close contact and around said drug delivery means, a drop in pressure in said drug delivery means and an actuation of said drug delivery means by said actuator.

2. A patient compliance system as recited in claim 1 further comprising a signalling device connected to said controller for signalling a prescribed interval for administration of said drug.

3. A patient compliance system as recited in claim 1 wherein said drug delivery means is a metered dose inhaler.

4. A patient compliance system as recited in claim 1 wherein said drug delivery means is a nebulizer.

5. A patient compliance system as recited in claim 1 wherein said drug delivery means is a powdered drug inhaler.

6. A patient compliance system as recited in claim 1 wherein said means for preventing actuation comprises locking means which includes a valve operated by said controller.

7. A patient compliance system as recited in claim 1 wherein said drug delivery means is a metered dose inhaler and wherein said actuator comprises a mechanical means for restraining a pressurized canister in said metered dose inhaler.

8. A patient compliance system as recited in claim 1 wherein said controller has a means for interacting with at least one of a plurality of interchangeable chips, each with different dose and time of dose information.

9. A patient compliance system according to claim 1, wherein said verifying means comprises means for sensing lips of a patient surrounding said drug delivery means and said lip sensing means is operable when said actuator is actuated by said patient.

10. A patient compliance system according to claim 9, wherein said lip sensing means comprises first and second electrical contacts coupled to said controller.

11. A patient compliance system according to claim 1, wherein said verifying means comprises a pressure transducer coupled to said controller and operable when said actuator is actuated by said patient.

12. A patient compliance system according to claim 1, wherein said verifying means comprises means for sensing lips of a patient surrounding said drug delivery means and a pressure transducer coupled to said controller and operable when said actuator is actuated by said patient, said verifying means being operable when said actuator is actuated by said patient.

13. A patient compliance system, comprising:

a drug delivery means;

a controller connected to said drug delivery means programmed or preset with dose and time of dose information for a drug being delivered by said drug delivery means, said dose and time of dose information setting forth a number of actuations of said drug delivery means to be provided at prescribed intervals;

a timer connected to said controller for tracking the time between actuations of said drug delivery means;

an actuator connected to said drug delivery means and said controller, said actuator preventing actuation of said drug delivery means when a patient attempts to actuate the drug delivery means at non-prescribed intervals or when a patient tries to exceed said number of actuations at said prescribed intervals;

means for recording a time and number of actuations of said drug delivery means, and

means for recording a time and number of attempted unprescribed actuations of said drug delivery means.

14. A patient compliance system, comprising:

a drug delivery means;

a controller connected to said drug delivery means programmed or preset with dose and time of dose information for a drug being delivered by said drug delivery means, said dose and time of dose information setting forth a number of actuations of said drug delivery means to be provided at prescribed intervals;

a timer connected to said controller for tracking the time between actuations of said drug delivery means;

an actuator connected to said drug delivery means and said controller for actuating said drug delivery means, said actuator including means for preventing actuation of said drug delivery means when a patient attempts to actuate the drug delivery means at non-prescribed intervals or when a patient tries to exceed said number of actuations at said prescribed intervals; and

means for recording a time and number of attempted unprescribed actuations of said drug delivery means.

15. A patient compliance system as recited in claim 14 further comprising a means for recording a time and number of actuations of said drug delivery means.

16. A patient compliance system as recited in claim 14 further comprising a means for verifying a patient is positioned properly to inhale drug from said drug delivery means.