Blood Testing Apparatus Having a Rotatable Cartridge with Multiple Lancing Elements and Testing Means

• US 20090005664A1
• Filed: 04/23/2008
• Published: 01/01/2009
• Est. Priority Date: 11/21/2000
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: MALOWANIEC, Krzysztof D., WURSTER, Thomas, DIEKMANN, Christoph, FREEMAN, Dominique
• Granted Patent: US 8,641,644 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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 5/1513 comprising linear sliding guides 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 5/15161 Characterized by propelling the piercing element in a radial 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
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: G01N 33/96 involving blood or serum control standard

Abstract

A blood testing apparatus has a test member and a laser source configured to produce a wound from which blood flows. The laser source produces at least a cutting wavelength, and a coagulation wavelength. Electronics for analysis and a display are provided. The test member, laser source, electronics and display form a glucose monitoring system that is integrated in a single apparatus.

Claims

1. Blood testing apparatus with a blood extraction device (8) having a lancing element (12), with a membrane-like test means defining a measurement field, with an evaluation device (38) comprising electronics for analysis and with a display device (44), which form a complete system to be manipulated as a single apparatus, characterized in that a plurality of test means (30) can be inserted into the apparatus which are moveable into an operating position in which they can interact with the evaluation device (38) to perform several measurements in succession, that the blood extraction device (8) also has a plurality of lancing elements (12), and that when a particular test means (30) is positioned in the operating position, a lancing element (12) can be urged through the test means (30) and can pierce the skin surface of a user, said skin being placed against the apparatus at a lancing position aligned with the operating position, so that blood emanating from the skin surface can impinge directly on the test means (30).

2. Blood testing apparatus from claim 1, wherein the lancing element (12) remains in the test means (30) following the lancing procedure and can be removed with said test means from the operating position in order to position a new test means there.

3. Blood testing apparatus from claim 1 or 2, wherein the lancing element (12) is manageably conjoined to the test means (30) and can be inserted together with said test means into the apparatus and can be deployed to the operating position.

4. Blood testing apparatus from claim 1, 2 or 3 wherein spent lancing elements (12) and test means (30) can be ejected or can be brought to a storage and disposal position.

5. Blood testing apparatus from one of the preceding claims, wherein the test means (30) are disposed on a carrier (32) which is moveable with respect to a housing body (4) and can be inserted with said carrier into the housing body (4) of the apparatus.

6. Blood testing apparatus from claim 5, wherein the test means (30) are disposed on the carrier (32) such that the particular surface normal of the test means runs in the radial direction.

7. Blood testing apparatus from claim 5 or 6, wherein the carrier (32) has a annular configuration and can be rotated about the center of the ring.

8. Blood testing apparatus from claim 5, 6 or 7, wherein the lancing device is housed within the annulus.

9. Blood testing apparatus from one of the preceding claims, wherein the lancing means (12) are disposed on a carrier (32) rotatable with respect to the housing body (4) and can be inserted with said carrier into the housing body (4) of the apparatus.

10. Blood testing apparatus from claim 9, wherein the lancing elements (12) and the test means (30) are disposed on the same carrier (32).

11. Blood testing apparatus from one of the preceding claims, wherein the apparatus has an essentially circular disc-shaped outer contour.

12. Blood testing apparatus from one of the preceding claims, wherein the apparatus has oppositely located a lancing position (28) against which to place the skin surface to be lanced and a release position to initiate the lancing procedure by manual actuation of a release button (14).

13. Blood testing apparatus from claim 12, wherein the apparatus can be held by a user holding the apparatus at the lancing position (28) and the release button (14) with two fingers.

14. Blood testing apparatus from one or more of the preceding claims, characterized by a safety mechanism which permits initiation of the lancing procedure only when the apparatus is manipulated correctly.

15. Blood testing apparatus from claim 12, 13 or 14, wherein the release button (14) is ergonomically shaped to be grasped by the thumb of a user.

16. Blood testing apparatus from claim 12, 13, 14 or 15, wherein the release button (14) has a pressure point which must be overcome in order to release the lancing device.

17. Blood testing apparatus from one or more of the preceding claims, wherein the number of test means to be manipulated as a unit is 5 to 75, preferably 14-28.

18. Blood testing apparatus from one or more of the preceding claims, wherein the carrier (32) comprises a first housing section (56) for the test means (30) and a second housing section (68) for the lancing elements (12), which can inserted one into the other.

19. Blood testing apparatus from one or more of the preceding claims, wherein the carrier has a central recess (60) which has the drive mechanism (10) and an electric-motor propulsion means (52) for the carrier (32) and/or the drive mechanism (10).

20. Blood testing apparatus from one or more of the preceding claims, wherein the carrier (32) has a spring means (69) to retract a lancing element (12) from the skin surface of the user.