Drug storage and dispensing devices and systems comprising the same

• US 20070186923A1
• Filed: 01/05/2007
• Published: 08/16/2007
• Est. Priority Date: 01/06/2006
• Status: Active Grant

• Current Assignee: AcelRx Pharmaceuticals Incorporated
• Original Assignee: AcelRx Pharmaceuticals Incorporated
• Inventors: Schreck, Thomas, Rampersaud, Charles, Retailleau, Sascha, Kolosi, William, Poutiatine, Andrew
• Granted Patent: US 8,357,114 B2
• Time in Patent Office: Days
• US Class Current: 128/200.140
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 7/0038 Straws
• CPC Class Codes: A61J 7/0053 Syringes, pipettes or oral dispensers
• CPC Class Codes: A61J 7/0076 Medicament distribution means with pill counting devices A61J7/02; with time indication A61J7/04; containers or packages with special means for dispensing contents B65D83/00
• CPC Class Codes: A61J 7/02 Pill counting devices
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61J 7/0445 for preventing drug dispensing during a predetermined time period
• 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 15/0081 Locking means
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/609 Biometric patient identification means
• CPC Class Codes: A61M 2209/086 : Docking stations
• CPC Class Codes: A61M 31/007 : Injectors for solid bodies, e.g. suppositories
• CPC Class Codes: B65D 83/0418 : the articles being substantially flat and stacked one upon the other and the dispensing-closing device sliding the article to be dispensed along the flat side of the next article
• CPC Class Codes: G01C 9/02 : Details
• CPC Class Codes: G07C 9/22 : in combination with an identity check of the pass holder
• CPC Class Codes: G07F 17/0092 : for assembling and dispensing of pharmaceutical articles medical dispensers for private use, A61J7/00
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: H01Q 1/2208 : associated with components used in interrogation type services, i.e. in systems for information exchange between an interrogator/reader and a tag/transponder, e.g. in Radio Frequency Identification [RFID] systems methods or arrangements for sensing record carriers, e.g. for reading patterns G06K7/00; record carrier for use with machines and with at least a part designed to carry digital markings G06K19/00

Abstract

Drug storage and dispensing devices for dispensing a drug dosage form to a patient are disclosed. The dispensing device has a programmable lock-out feature for locking the dispensing device and is capable of detecting the identity of a user. The invention further provides a method for the treatment of subject, by administering to the subject a drug dosage form using a dispensing device of the invention.

Claims

1. A dispensing device for administration of a drug dosage form to a specific patient, comprising:

a housing having a dispensing end;

a cartridge assembly within the housing, the cartridge assembly being configured to dispense at least one drug dosage form from the dispensing end; and

a patient identification reader configured to identify the specific patient prior to dispensing the drug dosage form.

2. The dispensing device of claim 1, wherein the cartridge assembly includes at least one dispensing cartridge configured to hold at least one drug dosage form.

3. The cartridge assembly of claim 2, wherein the dispensing cartridge may hold the drug dosage form in a stack, a row, a circular disk, a circular-arc disk, a strip, ribbon, tape, helix, or an array or combination of any of the above.

4. The cartridge assembly of claim 2, wherein the dispensing cartridge comprises a cartridge tube, a plunger, a spring, and a cap.

5. The cartridge assembly of claim 2, wherein the dispensing cartridge comprises a disk cartridge.

6. The cartridge assembly of claim 2, wherein the cartridge assembly includes a smart cartridge recognition system.

7. The cartridge assembly of claim 6, wherein the cartridge recognition system is capable of recognizing a type or size of the dispensing cartridge.

8. The cartridge assembly of claim 6, wherein the cartridge recognition system is capable of recognizing a type or amount of drug dosage forms within the dispensing cartridge.

9. The cartridge assembly of claim 6, wherein the cartridge recognition system may be achieved by means of a physical keyed feature on the cartridge;

a bar code on the cartridge;

a magnetic tag on the cartridge;

an RFID tag on the cartridge;

an electronic microchip on the cartridge;

or by detecting some other mechanical, physical, or other feature of the dispensing cartridge.

10. The dispensing device of claim 1, wherein the cartridge assembly forcibly expels the drug dosage form by means of a spring, compressed air, or other mechanism.

11. The dispensing device of claim 1, wherein the cartridge assembly includes a dispensing mechanism for advancing and dispensing the drug dosage form.

12. The dispensing device of claim 11, wherein the dispensing mechanism is selected from the group consisting of mechanical actuation, electromechanical actuation, spring loaded actuation, pneumatic actuation, hydraulic actuation, magnetic actuation, gravitational force actuation, thermal actuation, combustive actuation, phase change expansion or contraction actuation, sonic actuation, and absorbent actuation.

13. The dispensing device of claim 11, wherein the dispensing mechanism includes a pusher/slider, a push rack, pinions, and a channel in the housing and a spring, wherein when the pusher/slider is slid in the channel it engages the push rack and pinions which pushes the drug dosage form upward into the channel by the force provided by the spring on the rack, and the pusher/slider contacts the drug dosage form and dispenses the drug dosage form from the end of the channel.

14. The dispensing device of claim 11, wherein the dispensing mechanism includes a tape and a roller, the tape being configured to hold dosage forms to one surface of the tape with an adhesive, wherein the tape is rolled on the roller such that the surface with the dosage forms adhered to it forms a convex shape, causing the dosage forms to peel off of the adhesive.

15. The dispensing device of claim 14, wherein the dispensing mechanism further includes a peeler blade to assist in removing the dosage form from the adhesive.

16. The dispensing device of claim 11, wherein the dispensing mechanism includes an activation button, a motor, a cam, a desiccant agent, seals, a delivery sensor, and a spring.

17. The dispensing device of claim 12, wherein the dispensing mechanism is actuated manually.

18. The dispensing device of claim 12, wherein the dispensing mechanism is actuated electromechanically.

19. The dispensing device of claim 1, wherein the patient identification means is selected from the group consisting of a fingerprint reader, an optical retinal reader, voice recognition, face recognition system, RFID, Wi-Fi, and DNA detection.

20. The dispensing device of claim 19, wherein the patient identification means is a radio frequency identification (RFID) reader configured to couple with a matching RFID tag on the patient to be identified.

21. The dispensing device of claim 20, wherein for the dispensing device to be unlocked, said RFID reader on said dispensing device must match an RFID tag on the patient.

22. The dispensing device of claim 1, further comprising a replaceable tip proximate the dispensing end.

23. The dispensing device of claim 1, wherein the dispensing end is configured to reduce saliva influx/ingress into the dispensing device by inclusion of seals, wipers, absorbents, adsorbents, desiccants, ejection type devices, air gaps, or combinations thereof, or any other means of minimizing saliva ingress in the device design.

24. The dispensing device of claim 1, wherein the housing is sized to be hand-held.

25. the dispensing device of claim 1, further comprising a graphic display including selected from the group consisting of an alpha-numeric display, a graphical display, an LCD display and an LED display.

26. The dispensing device of claim 1, further comprising a user interface.

27. The dispensing device of claim 1, wherein said dispenser or said cartridge assembly further comprises a dose counter.

28. The dispensing device of claim 1, further comprises an indicator means for notifying the patient when it is time to administer the drug dosage form.

29. The dispensing device of claim 28, wherein the indicator means further provides notification of a potentially dangerous or non-efficacious dosing situation.

30. The dispensing device of claim 1, further comprising an LED display, light, sound or tactile indicator that is activated when the drug dosage form is dispensed.

31. The dispensing device of claim 1, further comprising a memory means for storing dose delivery information.

32. The dispensing device of claim 1, further comprising an interface for bidirectional exchange of information with another device, wherein the other device is a computer.

33. The dispensing device of claim 1, further comprising an antagonist reservoir.

34. The dispensing device t of claim 32, wherein the antagonist reservoir comprises a drug, hormone or other chemical substance inhibiting the function of the drug dosage form.

35. The dispensing device of claim 32, wherein the antagonist reservoir allows the antagonist and the drug dosage form to combine in the event of a system or power failure, device damage or tampering, or system shutdown.

36. The dispensing device of claim 1, further comprising a lock-out feature configured to prevent dispensing of a drug dosage form.

37. The dispensing device of claim 35, wherein the lock-out feature is a programmable lock-out feature.

38. The dispensing device of claim 35, wherein the lock-out feature is a timed lock out with an initial lock-out period selected from the group consisting of from about 1 to about 60 minutes, from about 3 to about 40 minutes and from about 5 to about 30 minutes.

39. The dispensing device of claim 35, wherein the lock-out feature prevents dispensing of a drug dosage form if a dispensing cartridge is not loaded, locked-in, and activated.

40. The dispensing device of claim 38, wherein said lock-out feature is a smart lockout based on dosing history and drug pharmacokinetics.

41. The dispensing device of claim 35, wherein said lock-out feature is based on a trigger, sensor input or other input.

42. The dispensing device of claim 40, wherein said trigger or other input is selected from the group consisting of body temperature, respiratory rate, blood pressure, heart rate, blood chemistry, saliva chemistry, breath chemistry, time of day, date, temperature, humidity and global position.

43. The dispensing device of claim 35, wherein the lock-out feature includes a radio frequency identification (RFID) reader configured to couple with a matching RFID tag on the select patient prior to un-locking the dispensing device.

44. The dispensing device of claim 35, wherein the lock-out feature is selected from the group consisting of a movable pushrod, a non-returning pushrod, an electro-mechanical regulator, an optical sensor pair, a magnetic clutch, a lockout on actuator, a rack and pinion, a safety button latch, a solenoid, a collect on shaft, a keyed hubs, a movable coupling, and cams.

45. The dispensing device of claim 35, wherein the lock-out feature includes setting a lock-out interval between dosing.

46. The dispensing device of claim 43, wherein the lock-out interval is selected from the group consisting of:

a fixed time interval, a predetermined time interval, a predetermined variable time interval, a time interval determined by an algorithm and a variable time interval communicated to the device from a remote computer or docking station.

47. The dispensing device of claim 1, further comprising an external communication means.

48. The dispensing device of claim 45, wherein the communication means includes a bidirectional communication link between the dispensing device and a local or remote computer system, wherein the computer system provides a signal that allows the dispensing device to dispense the drug dosage form.

49. The dispensing device of claim 45, wherein the communication means includes an interface for bidirectional exchange of information with another device.

50. The dispensing device of claim 47, wherein the bidirectional exchange of information is processed through either a wired or wireless mode.

51. The dispensing device of claim 45, wherein the communication means is wireless and information is transmitted from the dispensing device to a computer network or another device via the wireless network.

52. The dispensing device of claim 45, wherein the communication means includes transmitting information about drug delivery history from the dispensing device to another device.

53. The dispensing device of claim 1, further comprising an anti-theft means for deterring theft by an unauthorized person of the dispensing device.

54. The dispensing device of claim 51, wherein the anti-theft means includes

a wireless proximity detection means to detect when the dispensing device is removed from a predetermined proximity to a person, object, or physical location.

55. The dispensing device of claim 51, wherein said anti-theft means is a tethered or locked dispensing device.

56. The dispensing device of claim 1, further comprising a detecting means for detecting the identity of a healthcare professional, wherein the detecting means must be proximal to the dispensing device for operation, so as to prevent accidental or intentional tampering, abuse, or access to the drug dosage form by an unauthorized individual.

57. The dispensing device of claim 1, further comprising a dispensing sensor proximate the dispensing end and configured to sense the dispensing of the drug dosage form from the dispensing end.

58. The dispensing device of claim 1, further comprising a microprocessor having memory, wherein the microprocessor is coupled to the cartridge assembly and the patient identification reader.

59. The dispensing device of claim 56, wherein a microprocessor the herein the memory records the dispensing history of the dispensing device.

60. The dispensing device of claim 1, wherein said dispensing device shuts down after a pre-determined length of time.

61. The dispensing device of claim 1, wherein said dispensing device is operated by a series of steps, comprising:

loading a dosage form into a location;

placing said device in position for dispensing the dosage form;

performing an internal system check; and

dispensing the dosage form, wherein said steps are carried out in sequential order.

62. The dispensing device of claim 1, wherein said dispensing device is operated by a series of steps, comprising:

loading a dosage form into a location;

performing an internal system check;

placing said device in position for dispensing the dosage form; and

dispensing the dosage form, wherein said steps are carried out in sequential order.

63. The dispensing device of claim 1, wherein said dispensing device is operated by a CPU controlled electromechanical series of steps, comprising:

reading a patient dispense request;

checking the time since last dose administration;

checking the patient identification;

dispensing the dosage form, wherein said steps are carried out in sequential order.

64. The dispensing device of claim 1, wherein said dispensing device is operated by a CPU controlled electromechanical series of steps, comprising:

reading a patient dispense request;

checking the time since last dose administration;

checking the patient identification;

performing an internal system check; and

dispensing the dosage form, wherein said steps are carried out in sequential order.

65. The dispensing device of claim 1, wherein said dosage form is administered sublingually.

66. The dispensing device of claim 1, wherein said dispensing device may only be operated following matching with identification of a specific patient.

68. The dispensing device system of claim 65, further comprising a memory means and a user interface.

69. The dispensing device system of claim 65, further comprising:

a recharging station;

a reusable head portion containing the actuator, the PCB, the power supply,

the user identification means, and the communication means and user interface; and

a disposable body portion containing drug dosage cartridge.

70. The dispensing device system of claim 65, further comprising:

a recharging station;

a docking station containing the communication means and user interface;

a reusable head portion containing the actuator, the PCB, the power supply;

the user identification means; and

a disposable body portion containing the drug dosage cartridge.

71. The dispensing device system of claim 65, further comprising:

a recharging station;

a disposable body portion containing the actuator, the PCB, the power supply, the user identification means and the drug dosage cartridge; and

a portable docking fob containing the communication means and user interface.

72. The dispensing device system of claim 65, further comprising:

a docking station containing the communication means and user interface;

a disposable body portion containing the actuator, the PCB, the power supply, the user identification means and the drug dosage cartridge.

73. The dispensing device system of claim 65, further comprising:

a recharging station;

a reusable head portion containing the actuator, the PCB, the power supply, the user identification means;

a disposable body portion containing drug dosage cartridge; and

a portable docking fob containing the communication means and user interface.

75. The method of claim 72, wherein the dispensing of the drug dosage form to an oral mucosal membrane is performed.

76. The method of claim 72, wherein the dispensing of the drug dosage form to the hand is performed.

78. The method of claim 75, wherein the dispensing of the drug dosage form to an oral mucosal membrane is performed.

79. The method of claim 75, wherein the dispensing of the drug dosage form to the hand is performed.

82. The method of claim 79, wherein the steps of disassembly are required by the drug dispenser.

67. A dispensing device system for dispensing a drug dosage form for administration to a specific patient, comprising:

an actuator;

a printed circuit board (PCB);

a power supply;

a user identification means;

a drug dosage cartridge configured to hold drug dosage forms; and

a communication means and user interface.

74. A method of operating a dispensing device for dispensing a drug dosage form for administration to a specific patient, the method comprising the steps of:

loading a tablet cartridge into the dispensing device;

closing and locking the dispensing device;

docking the dispensing device into the PC and programming the dispensing device before initial use;

testing the dispensing device;

pressing any button to wake-up the dispensing device;

identifying input identification;

detecting the identification;

comparing the (a) dispensing request, (b) dispensing history, and (c) programmed prescription; and

if (a), (b) and (c) are consistent with permission to dispense a dosage form from the drug dispensing device of the invention;

displaying dispensing device status and identification which indicates the drug dispensing device is ready;

dispensing a dosage form when the dispense button is pressed; and

locking down the drug dispensing device locks for a preprogrammed time period.

77. A method of operating a dispensing device for dispensing a drug dosage form for administration to a specific patient, the method comprising the steps of:

pressing any button to wake-up the dispensing device;

verifying if a preprogrammed lock-out time is over;

detecting an RFID tag;

visibly verifying the device if a lock-out device is not blocking delivery;

the motor-driven dispensing of a drug dosage form to a patient is performed; and

locking down the dispensing device upon completion of dispensing the dosage form.

80. A method of disassembling a drug dispensing device, the method comprising the steps of:

downloading or recording the dosing history resetting the internal memory; and

recharging the battery.

81. The method of claim 80, wherein the steps of disassembly are required by the drug dispenser.

83. A method of disassembling a drug dispensing device, the method comprising the steps of:

downloading or recording the dosing history

resetting the internal memory

recharging the battery; and

running an internal diagnostic test.

84. The method of claim 83 wherein the steps of disassembly are required by the drug dispenser.