Integrated system and method for sampling blood and analysis

• US 5,971,941 A
• Filed: 12/04/1997
• Issued: 10/26/1999
• Est. Priority Date: 12/04/1997
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Hewlett-Packard Company (HP Inc.)
• Inventors: Freeman, Dominique, Leonard, Leslie Anne, Lum, Paul, King, David A., Simons, Tad Decatur, Greenstein, Michael
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US08/985,307
• Time in Patent Office: 691 Days
• Field of Search: 600/573, 600/575, 600/578, 600/583, 600/584, 606/181, 606/182
• US Class Current: 600/573
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• 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 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A blood sampling apparatus for sampling blood from the skin of a patient for analysis. The apparatus includes a cartridge and a housing with a driver. The cartridge has a cartridge case, lancet, and a compartment associated with the cartridge case for receiving blood. The lancet is housed in the cartridge case and operatively connected thereto such that it is drivable to extend outside the cartridge case through a lancing opening for lancing the skin to yield blood. The housing has a driver for urging the lancet to extend outside the cartridge case. During lancing, the cartridge is preferably detachably held in the housing such that the cartridge can be disassociated from the driver after sampling blood.

Claims

1. A blood sampling apparatus for sampling blood from the skin of a patient for analysis, comprising:

(a) a cartridge having

(i) a cartridge case;

(ii) a lancet housed in the cartridge case and operatively connected thereto such that it is drivable to extend outside the cartridge case through a lancing opening for lancing the skin to yield blood;

(iii) associated with the cartridge case a compartment for receiving blood;

(b) a housing having a driver for associating with the lancet to urge the lancet to extend outside the cartridge case, the cartridge being detachably held in said housing such that the cartridge can be disassociated from the driver after sampling blood; and

(c) means for analyzing blood connected with the compartment in the cartridge for blood to flow therefrom to said means for analyzing blood without moving the position of the cartridge in the housing after lancing.

2. The apparatus according to claim 1 further comprising a cassette including a cartridge compartment for detachably housing one or more new cartridges, the cassette being detachably connected to the housing.

3. The apparatus according to claim 2 wherein the housing includes a means for transferring a new cartridge from the cassette to a lancing position without the patient touching the new cartridge.

4. The apparatus according to claim 2 further comprising a second cartridge compartment for receiving one or more spent cartridges.

5. The apparatus according to claim 2 further comprising a calibration cartridge.

6. The apparatus according to claim 2 wherein the cartridge case includes an identification feature visible while the cartridge is in the cassette.

7. The apparatus according to claim 1 wherein the cartridge further comprises a port near to the lancet for receiving blood from the skin after lancing and a channel in communication with the compartment for receiving blood.

8. The apparatus according to claim 1 wherein the cartridge further has a compartment for containing blood, said compartment being visible to the user to observe blood entering therein.

9. The apparatus according to claim 1 further comprising a compressor associated with the housing for processing of data after analyzing the blood.

10. The apparatus according to claim 9 further comprising a display associated with the housing for displaying analysis information.

11. The apparatus according to claim 7 further comprising a finger rest near the port external to the cartridge.

12. The apparatus according to claim 1 further comprising a heating pad for warming a site to be lanced.

13. The apparatus according to claim 1 further comprising a magnifying lens movably and operatively connected to the housing for viewing the skin during blood sampling.

14. The apparatus according to claim 13 wherein the lens has graticule thereon.

15. The apparatus according to claim 1 wherein the lancet has a tip for piercing and the apparatus further comprises a port associated with the compartment for receiving blood and within about 25 mm of the tip of the lancet when the lancet is extended for receiving blood from the skin after lancing, such that less than about 25 mm of movement of the lanced skin relative to the port is needed to expose the port to the lanced skin after lancing.

16. The apparatus according to claim 15 wherein the port is in communication with the compartment via a channel which is capable of drawing blood into the compartment by capillary force.

17. The apparatus according to claim 1 wherein the cartridge includes two surfaces on opposite sides to facilitate stacking cartridges together such that one cartridge can be slid off a stack of cartridges while the other cartridges in the stack are retained.

18. The apparatus according to claim 1 wherein the cartridge further comprises an absorbent surface associated with the cartridge case for wiping blood off the skin.

19. The apparatus according to claim 1 wherein the driver has a spring providing a preload force on the skin which is to be lanced when the skin is pressed against the cartridge, such that the skin pressing harder than a preset value of the preload force will actuate the driver to drive the lancet distally at the skin.

20. The apparatus according to claim 1 wherein the driver has screwthread matching parts adjustable to vary the distance a tip of the lancet is driven outside the cartridge case.

21. The apparatus according to claim 1 further comprising:

a magnifying lens movably and operatively connected to the housing for viewing the skin during blood sampling;

a port associated with the compartment for receiving blood and within about 25 mm of a sharp tip of the lancet when the lancet is extended for receiving blood from the skin after lancing, such that less than about 25 mm of movement of the lanced skin relative to the port is needed to expose the port to the lanced skin after lancing;

a finger rest associated with the housing near the port; and

a cassette detachably connected in the housing, the cassette including a first compartment for detachably housing one or more new cartridges and a second compartment for receiving one or more spent cartridges, the cassette having an opening for dispensing a new cartridge from the cassette to operatively connect with the driver for lancing motion.

22. A method for sampling blood from the skin of a patient, comprising:

(a) providing a lancing apparatus having a detachable cartridge and an analytical region, the cartridge having a lancet with a lancet tip shielded in the cartridge;

(b) driving the lancet to extend the lancet tip out of a cartridge such that the lancet pierces the skin to yield blood;

(c) transferring blood yielded from the skin into the cartridge; and

(d) upon the blood entering the cartridge transferring blood to the analytical region without moving the position of the cartridge in the apparatus.

23. The method according to claim 22 further comprising deploying the cartridge in a support of the lancing apparatus before driving the lancet to lance.

24. The method according to claim 23 further comprising holding a cassette for storing new cartridges in the support to prepare for transferring a new cartridge from the cassette to be deployed in the support for lancing the skin.

25. The method according to claim 22 further comprising, after driving the lancet to pierce the skin, exposing a site of the cartridge to blood resulting from lancing the skin to analyze the blood.

26. The method according to claim 22 further comprising, after transferring blood into the cartridge, processing data of blood analysis by an electronic processor and displaying the result of analysis.

27. The method according to claim 22 further comprising, in transferring blood into the cartridge, exposing a port on the cartridge to blood resulting from lancing the skin, the port being in fluid communication to an analytical compartment for analysis of blood.

28. The method according to claim 27 wherein the port is within about 25 mm from the tip of the lancet after extension thereof for lancing such that less than about 25 mm of movement of the skin relative to the port is needed to expose the port to blood from the skin after lancing.

29. The method according to claim 22 further comprising positioning a magnifying lens adjustably connected to a support housing of the lancing apparatus for viewing the skin for lancing.

30. The method according to claim 23 further comprising, in driving the lancet, pressing the cartridge against the skin to be lanced to trigger the lancing apparatus to drive the lancet towards the skin.

31. The method according to claim 22 further comprising adjusting the extent the lancet tip can be driven out of the cartridge case before driving the lancet.

32. The method according to claim 23 further comprising flowing the blood into the analytical region for analysis after lancing the skin, said analytical region being inside the cartridge.