Apparatus for verifying the identity of a final fluid product for medical or pharmaceutical use

• US 8,881,980 B2
• Filed: 08/04/2009
• Issued: 11/11/2014
• Est. Priority Date: 08/04/2009
• Status: Active Grant

• Current Assignee: Pharmed S.A.M.
• Original Assignee: Stepra Ltd.
• Inventors: Magill, Conan
• Primary Examiner(s): Mikels, Matthew
• Application Number:
  US13/387,848
• Publication Number:
  US 20120125998A1
• Time in Patent Office: 1,925 Days
• Field of Search: 235/375, 235/380, 235/383, 235/435, 235/439, 235/454, 235/462
• US Class Current: 235/385
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: G01N 21/25 Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
• CPC Class Codes: G01N 21/33 using ultraviolet light G01N21/39 takes precedence
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 21/65 Raman scattering
• CPC Class Codes: G01N 2201/0221 Portable; cableless; compact; hand-held

Abstract

An apparatus (22) for verifying a final product being packaged in a final container (28), includes an optical spectroscopy analysis unit including a device for holding the final container (28), and a probe, characterized in that the holding device includes a clamping system including a reference platform (32) for supporting and positioning the final container (28) in a determined position with respect to the probe (P) and a clamping bar (36), the holding device being adapted to receive any form of final containers such as syringes, vials or Intravenous bags. In addition, a software for managing and characterizing optical signals from a drug product to confirm that the drug was correctly prepared prior to administration is described.

Claims

1. An apparatus (22) for verifying the identity of a final fluid product for medical or pharmaceutical use, said final product being packaged in a final container (28), said apparatus comprising at least an optical spectroscopy analysis unit adapted to determine at least one property of the final product and for issuing at least a verifying signal corresponding to said property, said unit comprising

a device for holding said final container (28);

a probe (P) associated with a source of light located and configured so as to emit and direct light through the wall (39) of the final container (28) and the final product and comprising a light sensor located so as to receive said directed light after the light has passed through the final product, said sensor providing light sensor signals to be used for the generation of said verifying signal corresponding to said property;

characterized in that said holding device comprises;

a clamping system comprising a reference platform (32) for supporting and positioning the final container (28) in a determined position with respect to the probe (P) and a clamping bar (36) which is moveable with respect to the reference platform (32) for pressing the outer wall (39) of the final container (28) in contact with said reference platform (32), said reference platform (32) being capable of receiving light from said light source, said holding device being adapted to receive any form of final containers such as syringes, vials or intravenous bags, and

characterized in that the clamping bar (36) is pivotally mounted with respect to the reference platform (32), around an axis of rotation (A-A) which is perpendicular to the plane of the reference platform, and characterized in that the clamping bar (36) can pivot between an offset rest angular position for placing the final container (28) on the reference platform (32), and a clamping work angular position in which the clamping (36) bar extends in registration with a facing portion of the wall of the final container.

2. An apparatus according to claim 1, characterized in that the reference platform (32) comprises at least one through hole (54) for the passage of said directed light, and characterized in that said probe (P) is moveable with respect to the reference platform (32) in order that a terminal end (62) of the probe (P) is occupying a determined position with respect to a facing portion of the wall (39) of the final container (28) bearing against the reference platform (32) in the zone of the through hole (54).

3. An apparatus according to claim 2, characterized in that the probe (P) is urged elastically (70) towards the wall of the final container in order to occupy said determined position.

4. An apparatus according to claim 1, characterized in that the clamping bar (36) is urged elastically (28) against the wall of the final container.

5. An apparatus according to claim 1, characterized in that the clamping bar (36) is slidably mounted with respect to the reference platform (32), along a direction (A-A) which is perpendicular to the plane of the reference platform (32).

6. An apparatus according to claim 1, characterized in that the clamping system comprises a device (48, 52) for angularly locking the clamping bar (36) in its clamping work angular position.

7. An apparatus according to claim 1, characterized in that a moveable safety mask (56) is provided which is pivotally linked with the clamping bar (36) and which, when the clamping bar is not in its work angular position, extends on the way of the emitted light.

8. An apparatus according to claim 1, characterized in that the holding device is mounted on a weighing unit (60) in order to determine, directly or indirectly, the weight of the quantity of final product contained in the final container, in order to permit verifying and validating medications prior to their administration by allowing a user to validate the medication administered, in composition and quantity—

dosage.

9. An apparatus according to claim 1, characterized in that it comprises a housing having a closed upper part containing at least said holding device and any final container in position for verification.

10. An apparatus according to claim 9, characterized in that the upper part of the housing is equipped with a movable lid (24), and in that the lid is associated with a safety arrangement for interrupting the emission of light by said light source when the lid is not in its closed position.

11. An apparatus according to claim 1 that is configured as a portable, stand alone apparatus having a body comprising a handle (100) by which the user, or a robot arm, may hold it, and an activation element (102).

12. A portable apparatus according to claim 11, characterized in that said probe (P) is supported by said body.

13. A portable apparatus according to claim 12, characterized in that said reference platform (32) is integrated to said body and, and in that said clamping bar (36) is slidably mounted with respect to the reference platform.

14. A portable apparatus according to claim 12, characterized in that it comprises a pair of jaws (108, 110) which are pivotally mounted on said body, in that one of said jaws ensures the function of a reference platform, and in that the other one of said jaws has the function of a clamping bar.

15. An apparatus according to claim 1, characterized in that it includes a device for scanning a barcode, or another readable identifier, associated with a patient and/or associated with the final container.

16. An apparatus according to claim 1, characterized in that it includes a device for marking the verified final container.

17. An apparatus according to claim 1, characterized in that it includes means for displacing the final container with respect to the probe for providing several various light sensor signals for the generation of the said signal corresponding to said property.

18. An apparatus according to claim 1, characterized in that said analysing unit is using the Raman effect in order to obtain a Raman spectrum of the final product.