Device and method for determining information related to a medical device

• US 10,391,235 B2
• Filed: 07/03/2015
• Issued: 08/27/2019
• 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
• Primary Examiner(s): Vu, Quynh-Nhu H.
• Application Number:
  US14/791,293
• Publication Number:
  US 20150306304A1
• Time in Patent Office: 1,516 Days
• 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. A method of utilizing a supplementary device to determine information related to an injection device, the method comprising:

activating a supplementary device; and

determining whether an ejection has taken place, wherein determining whether the ejection has taken place comprises differentiating a prime shot from an actual injection based upon ejection sounds sensed by an acoustic sensor, and wherein a first ejection sound produced when performing the prime shot is differentiated acoustically from a second ejection sound produced by the actual injection.

2. The method of claim 1, further comprising in response to determining that the ejection has taken place, generating determined data and transmitting the determined data to another device or storing determined data in a memory of the supplementary device.

3. The method of claim 2, further comprising storing the determined data in a logbook.

4. The method of claim 2, further comprising receiving a user input confirming the determined data as correct before storing the determined data.

5. The method of claim 2, further comprising

in response to determining that the ejection has taken place,

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

6. The method of claim 1 further comprising determining a currently selected dose, wherein determining the currently selected dose comprises:

capturing a sub-image by an optical sensor; and

processing the sub-image.

7. The method of claim 6 wherein

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

dividing the image by a previously captured background image;

binning of the sub-image to reduce a number of pixels;

normalizing the sub-image to reduce intensity variations in the illumination;

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

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

8. The method of claim 7 further comprising the step of

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

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

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

9. The method of claim 8 wherein, if it is determined that there is a change in the sub-image, the method further comprises the steps of:

capturing the sub-image by an optical sensor; and

processing the sub-image.