Device and Method for Determining Information Related to a Medical Device

• US 20150306304A1
• Filed: 07/03/2015
• Published: 10/29/2015
• Est. Priority Date: 03/22/2010
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Schabbach, Michael, Kohli, Amit
• Granted Patent: US 10,391,235 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/43 making noise when used correctly
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• 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 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2205/6081 Colour codes
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• 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 5/24 : Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/31 : Details
• CPC Class Codes: A61M 5/31525 : Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/31533 : Dosing mechanisms, i.e. setting a dose administrating mechanisms A61M5/31565
• CPC Class Codes: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 30/20 : for handling medical images, e.g. DICOM, HL7 or PACS

Abstract

The invention relates to an apparatus (2, 3), comprising a mating unit (20-1, 20-2) for releasably attaching the apparatus (2) to a medical device (1) or for releasably receiving at least a part of the medical device (1). The apparatus (2, 3) further comprises one or more optical sensors (25, 26) and/or one or more acoustical sensors (27) for determining information related to a condition and/or use of the medical device (1). The invention further relates to a system comprising such an apparatus (2, 3) and such a medical device (1), to a method (500, 600, 700) and a computer program (61) for determining information related to a condition and/or use of such a medical device (1), and to a computer-readable medium (60) storing such a computer program (61).

Claims

1-42. -42. (canceled)

43. A method of utilizing a supplementary device to determine information related to an injection device, the method comprising the step of

activating a supplementary device;

and further comprising at least one of the following steps

determining a type of medicament contained within the injection device;

determining a currently selected dose;

displaying the currently selected dose;

at least partially monitoring timing of the application sequence,

checking whether an ejection has taken place;

wherein

the step of determining whether an ejection has taken place further comprises the step of differentiating a prime shot from an injection.

44. The method of claim 43 wherein

if it is determined that an ejection has taken place, further comprising the step

transmitting determined data to another device or storing determined data in the memory of the supplementary device.

45. The method of claim 44 further comprising the step of

storing the determined data in a logbook (in the supplementary device or in the another device).

46. The method of claim 44 further comprising the step of the user confirming the determined information as correct before storing the determined data.

47. The method of claim 44 wherein

if it is determined that an ejection has taken place, further comprising the step of

transmitting at least one of the selected dose data and the medicament type data to another device.

48. The method of claim 43 wherein

the step of determining a currently selected dose comprises the steps of:

capturing a sub-image by an optical sensor; and

processing the captured sub-image.

49. The method of claim 48 wherein

the step of processing the captured sub-image comprises the steps of

dividing the captured image by a previously captured background image;

binning of the images to reduce a number of pixels;

normalizing the images to reduce intensity variations in the illumination;

sheering of the captured sub-image and the previously captured background image; and

comparing the captured sub-image and the previously captured background image to a fixed threshold.

50. The method of claim 49 further comprising the step of

determining whether there is a change in the captured sub-image,

wherein the step of determining whether there is a change in the captured sub-image comprises the step of

comparing the currently captured sub-image to the previously captured sub image.

51. The method of claim 50 wherein

if it is determined that there is a change in the captured sub-image, the method further comprising the steps of

capturing a sub-image by an optical sensor;

and

processing the captured sub-image.

52. A method of creating a logbook of selected doses in a supplementary device, the method comprising the steps of

determining a selected dose;

determining whether the selected dose comprises a dose equal to zero;

if the selected dose does not equal zero, the method further comprises the steps of

setting an initial dose value to a value of the determined selected dose;

determining if the initial dose value was previously defined;

if it is determined that the initial dose a supplementary device has been previously defined, the method includes the step of

setting an end dose value to the determined selected dose;

displaying a difference between the value of the initial dose and the value of the end dose,

confirming the difference to be injected; and

storing the difference as a corresponding entry in a logbook as being injected.

53. The method of claim 52 further comprising the step of adding a timestamp to the corresponding entry in the logbook.

54. The method of claim 52 further comprising the step of if the difference to be injected is not confirmed, the method further comprising the step of storing the difference as a corresponding entry in the logbook as being ejected.

55. The method of claim 54 further comprising the step of

adding a timestamp to the corresponding entry in the logbook.

56. The method of claim 54 further comprising the step of

storing information related to performed ejections in the logbook.

57. The method of claim 54 further comprising the step of

storing information required to determine a proposal for a next ejection in the logbook.

58. The method of claim 54 further comprising the step of

storing information that is a basis for a blood glucose monitoring processing in the logbook.

59. The method of claim 54 further comprising the step of

storing information regarding a nature of an ejection in the logbook.

60. A method of utilizing a supplementary device to determine information related to an injection device, the method comprising the step of activating a supplementary device and further comprising at least one step of;

determining a type of medicament contained within the injection device;

determining a currently selected dose;

displaying the currently selected dose.

61. The method of claim 60 further comprising the step of continuously updating the display of the currently selected dose on a display of the supplementary device during dose dialing.

62. The method of claim 60, wherein the steps of determining type of medicament or determining a currently selected dose is based on capturing an image of an information-bearing or information displaying part of the injection device;

and the method further comprising at least one of the steps of

Processing the captured image;

Storing the captured image or the processed image;

providing to another device the captured image or the processed image.