Analysis system for automatic skin prick analysis

• US 8,251,922 B2
• Filed: 04/07/2010
• Issued: 08/28/2012
• Est. Priority Date: 10/08/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Meacham, George Bevan Kirby, Haar, Hans-Peter
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M
• Application Number:
  US12/755,839
• Publication Number:
  US 20110092855A1
• Time in Patent Office: 874 Days
• Field of Search: 600/583, 600/584, 606181-183
• US Class Current: 600/584
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Analysis system for automatically performing a skin prick analysis by pricking the skin for producing a sample of body liquid and detecting an analyte contained in the sample. The analysis system comprises a magazine with a plurality of compartments each containing a lancing element and an analysis element, and a reusable hand-held instrument having a drive assembly. The drive assembly is adapted for driving at least the following movements by manually generated mechanical force: a coupling movement by which one of the lancing elements is coupled to the drive assembly; a puncturing and sample collection movement of one of the lancing elements contained in the magazine and coupled to the drive assembly; and a remaganizing movement by which the test element is transported back into the compartment of the magazine.

Claims

1. An analysis system for automatically performing a skin prick analysis by pricking the skin for producing a sample of body liquid and detecting an analyte contained in the sample, the analysis system comprising:

a magazine with a plurality of compartments each containing a test element comprising a lancing element and an analysis element, the lancing element having a pricking tip for performing a skin prick and a sample transfer capillary for transfer of sample liquid to the analysis element, the analysis element comprising

a reagent system which reacts with the analyte contained in the sample causing a measurable change of a measurement quantity characteristic for the desired analytical result, and

a reusable hand-held instrument having a housing and a drive assembly for driving movements of parts inside the housing for the analysis, wherein the drive assembly drives at least the following movements by a manually generated mechanical force;

a coupling movement by which one of the lancing elements in a compartment of the magazine and located in a piercing position is coupled to the drive assembly;

a puncturing and sample collection movement of one of the lancing elements contained in the magazine and coupled to the drive assembly, the puncturing and sample collection movement includes a forward movement phase in a puncturing direction until the pricking tip reaches a point of maximum displacement and, after the point of maximum displacement, a reverse movement phase opposite to the puncturing direction during which reverse movement phase the speed is reduced as compared to the forward movement for allowing suctioning of sample into the sample transfer capillary;

a remaganizing movement by which the test element is transported back into the compartment of the magazine.

2. The analysis system of claim 1, wherein the drive assembly drives by a manually generated mechanical force an indexing movement of the magazine for transporting a compartment containing an unused test element to the piercing position.

3. The analysis system of claim 1, further comprising,

test elements which are integral lancing and analysis elements including a lancing portion with the lancing element and an analysis portion with the analysis element, the analysis portion of the test elements comprise a reaction site containing the reagent system, wherein the lancing element is in permanent fluid communication with the reaction site of the analysis element, a capillary channel leading to the reaction site for transporting sample liquid by capillary forces to the reagent system.

4. The analysis system of claim 3, wherein the analysis portion of the test element comprises an optical wave guide having a distal end arranged at the reaction site for carrying out an optical measurement.

5. The analysis system of claim 4, wherein at least a part of the reagents of the reagent system are fixed at a distal end face of the optical wave guide.

6. The analysis system of claim 1, wherein the analysis elements are separate from the lancing elements and fixed in the compartments of the magazine and the sample liquid is transferred inside the compartment from the lancing element to the analysis element as a result of a movement of the lancing element, which movement is driven by the drive assembly by manually generated force and brings the lancing element to a sample transfer position in which it contacts the analysis element for sample transfer.

7. The analysis system of claim 6, wherein the measurement quantity characteristic of the desired analytical result is an optically measurable quantity and the system comprises an optical measurement device for measuring the optically measurable measurement quantity, and wherein a light detector of the optical measurement device is located in registry with the piercing position such that the change of an optical measurement quantity of an analysis element fixed in a compartment located in the piercing position can be measured thereby.

8. The analysis system of claim 1, wherein the magazine is a drum magazine.

9. The analysis system of claim 1, wherein the compartments of the magazine comprise at least one barrier to preserve sterility of elements contained therein and to exclude environmental contaminants, the at least one barrier includes at least one of,

a foil barrier covering an opening of the compartment, and

a tapered plug seal between the test element and a wall of the compartment.

10. The analysis system of claim 9, wherein the instrument comprises a foil opener for opening a foil barrier of the compartment, such that the opening of the foil barrier takes place independently of the lancing element, a movement required for opening of the foil barrier being driven by the drive assembly by manually generated force.

11. The analysis system of claim 1, wherein manually generated force is applied to the drive assembly by a reciprocating movement of an actuator, the reciprocating movement of the actuator comprising a rearward movement from a home position against the puncturing direction to an extended position and a forward movement in the puncturing direction towards the home position, and the re-usable hand-held instrument is stored with the actuator in the home position.

12. The analysis system of claim 11, wherein each of the rearward and forward movements of the actuator provide mechanical energy for at least one of the coupling movement, the puncturing and sample collection movement and the remaganizing movement.

13. The analysis system of claim 1, wherein the drive assembly comprises a cam controller having two cam drive mechanisms, each cam drive mechanism includes a cam rotor with a cam and a cam follower engaging the cam, such that a first part of the movement of the lancing element is determined by a relative movement between the cam follower and the cam of one of the cam drive mechanisms and a second part of the movement of the lancing element is determined by a relative movement of the cam follower and the cam of the other cam drive mechanism.

14. The analysis system of claim 13, wherein distance of the two cams is adjustable in the axial direction of the rotors for adjustment of the rearward phase of the movement of the lancing element.

15. The analysis system of claim 1, wherein the volume of the housing of the re-usable hand-held instrument is approximately 80 cm³.

16. The analysis system of claim 1, wherein the volume of the housing of the re-usable hand-held instrument is approximately 50 cm³.

17. The analysis system of claim 1, wherein the weight of the re-usable handheld instrument with a magazine inserted therein is approximately 60 g.

18. The analysis system of claim 1, wherein the weight of the re-usable handheld instrument with a magazine inserted therein is approximately 40 g.

19. The analysis system of claim 1, wherein a measurement of the measurable quantity characteristic of the desired analytical result is performed after the remaganizing movement.