Medical Device and Method of Assembly

• US 20130012871A1
• Filed: 12/16/2010
• Published: 01/10/2013
• Est. Priority Date: 12/17/2009
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Pommereu, Christian
• Granted Patent: US 9,463,279 B2
• Time in Patent Office: Days
• US Class Current: 604/111
• 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 5/3146 Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31561 using freely adjustable volume steps
• CPC Class Codes: A61M 5/31575 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button
• CPC Class Codes: G06T 1/00 General purpose image data processing
• CPC Class Codes: Y10T 29/49769 Using optical instrument [excludes mere human eyeballing]
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The present invention relates to a medical device for administering a medicinal product to a patient comprising at least one component (2, 8, 10, 12, 14, 15, 16, 17, 18, 20, 22, 24, 26, 28) comprising a material having an additive embedded therein, wherein the additive is adapted to provide a visually perceptible signal when exposed to electromagnetic radiation. The invention is particularly intended for drug delivery devices, such as e.g. of pen-type injectors. With the visually perceptible signal embedded in the at least one component, visually controlled assembly of such devices can be improved. Additionally the invention provides an effective means antagonize counterfeiting of drugs and of medical devices.

Claims

1. Medical device for administering a medicinal product to a patient comprising at least one component (2, 8, 10, 12, 14, 15, 16, 17, 18, 20, 22, 24, 26, 28) comprising a material having an additive embedded in the bulk of said component, wherein the additive is adapted to provide a visually perceptible signal when exposed to electromagnetic radiation.

2. Medical device according to claim 1, wherein the material comprises an injection molded thermoplastic material and wherein the additive comprises at least one dye being substantially homogeneously distributed in the material.

3. Medical device according to any one of the preceding claims, wherein the additive is fluorescent in response to a first spectral range of the electromagnetic radiation.

4. Medical device according to any one of the preceding claims, wherein the additive is photochromic with respect to a second spectral range of the electromagnetic radiation.

5. Medical device according to any one of the preceding claims, wherein the additive is substantially absorptive or reflective with respect to a third spectral range of the electromagnetic radiation.

6. Medical device according to any one of the preceding claims 3 to 5, wherein first, second and/or third spectral ranges have a spectral width (FWHM) of less than 100 nm, preferably less than 50 nm, most preferably less than 10 or less than 5 nm.

7. Medical device according to any one of the preceding claims, wherein the first, second and/or third spectral ranges are in the infrared-, visible-, UV- or X-ray spectral range.

8. Medical device according to any one of the preceding claims, wherein the additive irreversibly changes at least one visually perceptible property once exposed to a predetermined amount of radiation of a given spectral range.

9. Medical device according to any one of the preceding claims 1 or 3 to 8, wherein the material is configured as a lubricant.

10. Medical device according to any one of the preceding claims and being configure as a drug delivery device, preferably as an inhaler or an injection device.

11. Medical device according to claim 10 and comprising

a housing (15),

a drive mechanism (10),

a cartridge holder (2) adapted to receive a cartridge (8) filled with a medicinal product and having a piston (16) slidably disposed therein,

wherein the drive mechanism (10) is to be operably engaged with the piston (16) of the cartridge (8) by way of a piston rod (18) for dispensing of a dose of the medicinal product and wherein further

the housing (15), the drive mechanism (10), the piston rod (18), the cartridge holder (2) and/or a separately added lubricant are designed as the at least one component having the additive embedded therein.

12. Method of assembly of a drug delivery device adapted for dispensing of a dose of a medicinal product, wherein the device comprises at least one or several of the following components:

a housing (15), a drive mechanism (10), a cartridge holder (2) adapted to receive a cartridge (8) filled with the medicinal product, wherein the cartridge (8) comprises a piston (16) slidably disposed therein, and wherein the drive mechanism (10) is to be operably engaged with the piston (16) of the cartridge (8) by means of a piston rod (18) for dispensing of a dose of the medicinal product, the method of assembly comprises the steps of;

embedding of at least one additive in at least one component (2, 8, 10, 12, 14, 15, 16, 17, 18, 20, 22, 24, 26, 28) of the drug delivery device, wherein the additive is adapted to provide a visually perceptible signal when exposed to electromagnetic radiation,

exposing the component to said electromagnetic radiation,

detecting a visually perceptible response of the additive for determining of an absolute or relative position and/or orientation of the component (2, 8, 10, 12, 14, 15, 16, 17, 18, 20, 22, 24, 26, 28) and

assembling the at least one component (2, 8, 10, 12, 14, 15, 16, 17, 18, 20, 22, 24, 26, 28) with another component (2, 8, 10, 12, 14, 15, 16, 17, 18, 20, 22, 24, 26, 28) of the drug delivery device.

13. The method according to claim 12, wherein presence, position and/or orientation of the at least one component (2, 8, 10, 12, 14, 15, 16, 17, 18, 20, 22, 24, 26, 28) is determined by means of processing of an image in which the component is contrast-enhanced.

14. A method of labelling of a medical device with a certificate of authenticity comprising the steps of:

embedding of an additive in the bulk of at least one component (2, 8, 10, 12, 14, 15, 16, 17, 18, 20, 22, 24, 26, 28) of the medical device, wherein the additive is adapted to provide a visually perceptible signal when exposed to electromagnetic radiation of a predefined, selected and limited spectral range,

exposing the component (2, 8, 10, 12, 14, 15, 16, 17, 18, 20, 22, 24, 26, 28) to electromagnetic radiation of said spectral range and

detecting and/or analyzing electromagnetic radiation reflected, transmitted or scattered by the component.

15. The method according to claim 14, wherein the width (FWHM) of the spectral range is less than 100 nm, preferably less than 50 nm, most preferably less than 10 or less than 5 nm.

16. A method of visualizing an unusability of a medical device comprising the steps of:

selecting of an additive adapted to change at least one visually perceptible property when exposed to electromagnetic radiation of a predefined wavelength for at least a predefined period of time and

embedding of the additive in the bulk of at least one component of the medical device.