SYSTEM FOR ADMINISTERING A MEDICAMENT

• US 20170068799A1
• Filed: 09/18/2014
• Published: 03/09/2017
• Est. Priority Date: 09/26/2013
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Companion Medical, Inc. (Medtronic Plc)
• Inventors: Mensinger, Michael Robert, Saint, Sean
• Granted Patent: US 10,754,927 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: A61M 5/31571 Means preventing accidental administration for automatic syringes A61M5/20
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Provided is a system for delivering and recording a dose of a medicament to a patient. Also provided is a method of administering a medicament to a patient. Additionally provided is a method of tracking usage of a medicament by a patient through a pen.

Claims

1. A system for delivering and recording a dose of a medicament to a patient, the system comprising a pen, the pen comprising

a body comprising a vial of the medicament;

a mechanism capable of dispensing the medicament;

a first sensor capable of determining that the pen is being used;

a second sensor capable of detecting the size of the dose being delivered;

a processor capable of processing dose information;

a power source that powers the processor;

a memory capable of storing dose information; and

a wireless transmitter capable of communicating with a separate companion device and/or directly to an internet service.

2. The system of claim 1, wherein the mechanism can be manually operated.

3. The system of claim 1, further comprising a first mechanism to select a dose to be administered.

5. The system of claim 1, wherein the medicament is insulin.

6. The system of claim 1, wherein the medicament is an infertility treatment, a pain medication, a multiple sclerosis treatment or a rheumatoid arthritis treatment.

7. The system of claim 1, further comprising software capable of receiving and processing data transmitted by the wireless transmitter when the software is loaded onto the companion device.

9. The system of claim 1, where the first sensor comprises an electromechanical switch operatively coupled to the cap of the pen.

10. The system of claim 1, wherein the first sensor is an electromechanical rotary sensor.

16. The system of claim 1, wherein the dose information that can be stored in the memory includes dose size and time information.

18. The system of claim 1, wherein a time of dispensing the medicament is stored with each dose and synchronized by the companion device.

19. The system of claim 1, wherein the first sensor determines that the pen is being used, the second sensor detects the size of the dose being delivered, and the transmitter automatically communicates with the companion device without input by the patient when the dose is delivered.

20. The system of claim 1, wherein the first sensor and the second sensor are the same sensor.

21. The system of claim 1, wherein the companion device is one or more of:

a cloud-based server, a mobile electronic device or a smartphone.

26. The system of claim 1, wherein the pen and/or the companion device further provides a visual, auditory or vibratory warning to prevent accidental double dosing upon a determination that a dose has too recently been given.

27. The system of claim 1, wherein the pen provides a mechanical lockout if a dose has too recently been given to prevent double dosing.

28. The system of claim 27, wherein the pen allows user override for back to back doses.

29. The system of claim 1, wherein the pen provides a mechanical maximum dose limit equal to or greater than a calculated dose from the companion device.

36. The system of claim 28, wherein the companion device determines when a dose would be unsafe to give, transmits the determination to the pen and the pen prevents the dose administration unless the patient overrides the prevention of the dose administration.

38. The system of claim 1, wherein the companion device provides a visual, auditory or vibratory alert when a dose is missed.

39. The system of claim 7, wherein the software is capable of transmitting dose information to a computer.

40. The system of claim 39, wherein the dose information in the computer is accessible by a physician and/or an insurance company.

67. The system of claim 1, wherein the processor is configured to remain in a low power mode until activated at a programmable interval to conduct communications with an external device.

68. The system of claim 1, wherein the companion device is configured to display an estimate of current insulin active in a patient'"'"'s body.

4. (canceled)

8. (canceled)

11-15. -15. (canceled)

17. (canceled)

22-25. -25. (canceled)

30-35. -35. (canceled)

37. (canceled)

41-47. -47. (canceled)

48. A method of tracking usage of a medicament by a patient through a pen, wherein the medicament is administered from the pen in a plurality of boluses over time, the method comprising

recording information about the medicament administration and storing the information on a companion device,

wherein the information comprises the quantity and time of each administered bolus of the medicament.

49. The method of claim 48, wherein the medicament is insulin.

50. The method of claim 48, wherein the medicament is an infertility treatment, a pain medication, a multiple sclerosis treatment or a rheumatoid arthritis treatment.

52. The method of claim 48, wherein the companion device is a mobile electronic device.

53. The method of claim 48, wherein the information can be entered into the companion device manually.

61. The method of claim 52, wherein the administration of the calculated dose can be remotely approved by a third party.

62. The method of claim 48, wherein the pen has a screen capable of displaying information recorded or calculated on the companion device and transmitted to the pen.

63. The method of claim 48, wherein the companion device can generate a report of the information recorded or calculated on the companion device, wherein the report can be electronically transferred, printed, emailed to a specified address, and/or uploaded to a remote server.

64. The method of claim 63, wherein the companion device has a contact list that can be used to select a contact for transmittal of the report.

65. The method of claim 48, where the information can be viewed real time remotely by a second companion device via sharing of the data over a server.

66. The method of claim 48, wherein the pen and companion device comprises a body comprising a vial of the medicament;

a mechanism capable of dispensing the medicament;

a first sensor capable of determining that the pen is being used;

a second sensor capable of detecting the size of the dose being delivered;

a processor capable of processing dose information;

a power source that powers the processor;

a memory capable of storing dose information; and

a wireless transmitter capable of communicating with a separate companion device and/or directly to an internet service.

51. (canceled)

54-60. -60. (canceled)