Lancet cartridge for sampling blood

• US 6,071,294 A
• Filed: 12/04/1997
• Issued: 06/06/2000
• Est. Priority Date: 12/04/1997
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Agilent Technologies, Inc.
• Inventors: Greenstein, Michael, Lum, Paul, Freeman, Dominique, King, David A., Leonard, Leslie Anne, Simons, Tad Decatur
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/985,384
• Time in Patent Office: 915 Days
• Field of Search: 606/167, 606/181, 606/182, 600/583, 600/565, 600/584, 600/564
• US Class Current: 606/181
• 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 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• 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 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• 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 cartridge for sampling and analyzing blood from the skin of a patient. The cartridge has a cartridge case, a lancet, and associated with the cartridge case an analytical region for analyzing the property of blood. The lancet has a tip for lancing the skin and is housed in the cartridge case. The lancet is operatively connected to the cartridge case such that the lancet can be pushed to extend its tip outside the cartridge case for lancing the skin to yield blood. The blood from the lancing wound is transferred to the analytical region and be analyzed.

Claims

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

(a) a cartridge case having an opening through which an actuator can extend from outside the cartridge case thereinto, wherein the cartridge case includes two surfaces on opposite sides to facilitate stacking cartridges together such that one cartridge can be slid off from a stack of cartridges onto a supporting surface such that the one cartridge can be retained thereon while the lancet is actuated to extend the lancet tip outside the cartridge case for lancing;

(b) a lancet having a tip for lancing the skin, housed in the cartridge case, the lancet being drivable by the actuator to transmit force to the lancet, thereby extending the lancet tip outside the cartridge case for lancing;

(c) a spring inside the cartridge case associated with the lancet for applying a force to urge the lancet into the cartridge case when the lancet tip is extended outside the cartridge case; and

(d) associated with the cartridge case, a compartment for receiving blood.

2. The cartridge according to claim 1 wherein the compartment includes an analytical region for analyzing the property of blood.

3. The cartridge according to claim 2 wherein the cartridge further comprises a reagent for interacting with blood to analyze the property of blood.

4. The cartridge according to claim 2 wherein the analytical region has a protective cover.

5. The cartridge according to claim 2 wherein the analytical region is proximate to the lancing opening for fluid communication between the analytical region and the opening.

6. The cartridge according to claim 1 further comprising a port associated with the cartridge case 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 relative movement of the lanced skin to the cartridge is needed to expose the port to the lanced skin, the port being in communication with the compartment via a channel which is capable of drawing blood therethrough by capillary forces.

7. The cartridge according to claim 1 wherein the cartridge further comprises an indicator mark on the cartridge case identifying a characteristic of the cartridge for visual identification.

8. The cartridge according to claim 1 wherein the cartridge further comprises an absorbent surface for wiping blood off the skin.

9. The cartridge according to claim 1 wherein the cartridge has no detachable cover shielding the lancet and wherein the cartridge case shields the lancet from being touched by the patient before being driven to extend, the lancet being returnable into the cartridge case after lancing the skin.

10. The cartridge according to claim 1 wherein the cartridge has at least a bar-shaped portion suitable for inserting into a bar-shaped storage slot and being expelled therefrom to associate with a driver or driving the lancet.

11. The cartridge according to claim 8 wherein the cartridge is disposable and is detachably held on the supporting surface for lancing.

12. The cartridge according to claim 1 wherein the compartment is optically accessible so its content or a portion thereof is visible to a user.

13. A blood sampling apparatus for sampling blood from the skin of a patient, comprising a cartridge which comprises:

(a) a cartridge case having a lancing opening through which a lancet can extend therethrough and an opening for an actuator to extend from outside thereinto to urge the lancet toward the skin, wherein the cartridge case includes two surfaces on opposite sides to facilitate stacking cartridges together such that one cartridge can be slid off from a stack of cartridges onto a supporting surface such that the one cartridge can be retained thereon while the lancet is actuated to extend the lancet tip outside the cartridge case for lancing;

(b) the lancet having a tip, housed in the cartridge case and operatively connected thereto such that the tip can be urged to extend through the lancing opening from the cartridge case for lancing the skin to yield blood, the lancet being returnable into the cartridge case by a spring in the cartridge case after lancing for safe disposal; and

(c) an analytical region associated with the cartridge case and within about 25 mm of the tip of the lancet when the lancet is extended for receiving and analyzing blood from the skin after lancing, such that less than about 25 mm of relative movement of the lanced skin to the cartridge is needed to expose the analytical region to the lanced skin after lancing.

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

(a) moving a cartridge from a stack of cartridges onto a support to be held thereon, the cartridge having a lancet having a tip and being shielded in the cartridge,

(b) driving the lancet in the cartridge with an actuator extending from outside into the cartridge to extend the lancet tip out of a cartridge such that the lancet pierces the skin to yield blood;

(c) urging the lancet back into the cartridge after lancing; and

(d) depositing the blood yielded from skin to a compartment associated with the cartridge from which the lancet tip is extended.

15. The method according to claim 14, wherein the compartment has an analytical region for analysis of the blood.

16. The method according to claim 15, further including the step of exposing a site of the compartment to blood resulting from lancing the skin, wherein the site has a chemical reactive to blood.

17. The method according to claim 14 further comprising detachably holding the cartridge in a reusable driver for driving the lancet in the cartridge to lance the skin and further comprising detaching the cartridge from the driver for disposing the cartridge after use.

18. The method according to claim 14 wherein less than about 25 mm of movement of the lanced skin relative to the compartment is needed to expose an inlet of the compartment to blood from the lanced skin.

19. The method according to claim 17 further comprising deploying a cartridge in the driver before lancing and removing the cartridge after lancing, wherein the process from deploying to removing the cartridge is performed without requiring a protective shield covering the lancet tip to be detached from or attached to the cartridge.

20. The method according to claim 14 further comprising exposing a port on the cartridge to blood resulting from lancing the skin, wherein blood from the port can pass through a channel by capillary forces to the compartment.

21. The method according to claim 14, wherein the compartment has an inlet port proximate to the opening such that less than about 5 mm of relative movement of the cartridge to the lanced skin is needed to expose the inlet port to blood from the lanced skin.

22. The method according to claim 14, further comprising wiping blood off the skin on an absorbent surface on the cartridge.

23. A cartridge for sampling blood from the skin of a patient, comprising:

(a) a cartridge case;

(b) associated with the cartridge case, an absorbent surface for wiping blood off the skin; and

(c) associated with the cartridge case, a compartment for receiving blood.

24. The cartridge according to claim 23 further comprising an opening in fluid communication with the compartment for blood intake from exterior and a cover covering the opening to shield the opening from contamination.

25. The cartridge according to claim 23 further comprising a site containing chemicals for non-combustional exothermic reaction.

30. The cartridge according to claim 23, further comprising a lancet having a tip, housed in the cartridge case, for lancing the skin when the tip is extended outside the cartridge case.

26. A cartridge for sampling blood from the skin of a patient, comprising:

(a) a cartridge case;

(b) a lancet having a tip for lancing the skin, housed in the cartridge case; and

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

wherein the cartridge has at least a bar-shaped portion suitable for inserting into a bar-shaped storage slot and being expelled therefrom to associate with a driver for driving the lancet.

27. A cartridge for sampling blood from the skin of a patient, comprising:

(a) a cartridge case, including two surfaces on opposite sides thereof to facilitate stacking cartridges together in a stack such that one cartridge can be slid off the stack while the other cartridges in the stack are retained;

(b) a lancet having a tip for lancing the skin, housed in the cartridge case; and

(c) associated with the cartridge case, a compartment for receiving blood.

28. The cartridge according to claim 27, wherein the cartridge can be slid from a stack of cartridges onto a supporting surface such that the cartridge can be retained thereon while the lancet is actuated to extend the lancet tip outside the cartridge case for lancing.

29. A disposable cartridge for sampling blood from the skin of a patient, comprising:

(a) a cartridge case, wherein the cartridge case includes two surfaces on opposite sides to facilitate stacking cartridges together such that one cartridge can be slid off from a stack of cartridges onto a supporting surface such that the one cartridge can be retained thereon while the lancet is actuated to extend the lancet tip outside the cartridge case for lancing;

(b) a lancet having a tip for lancing the skin, housed in the cartridge case, a spring associated with the lancet in the cartridge case for applying a force to urge the lancet tip back into the cartridge when the lancet tip is extended outside the cartridge case; and

(c) associated with the cartridge case, a compartment for receiving blood.

31. A cartridge for sampling blood from the skin of a patient, comprising:

(a) a cartridge case having an opening through which an actuator can extend from outside the cartridge case thereinto and a port associated with the cartridge case 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 relative movement of the lanced skin to the cartridge is needed to expose the port to the lanced skin, the port being in communication with the compartment via a channel which is capable of drawing blood therethrough by capillary forces;

(b) a lancet having a tip for lancing the skin, housed in the cartridge case, the lancet being drivable by the actuator to transmit force to the lancet, thereby extending the lancet tip outside the cartridge case for lancing;

(c) a spring inside the cartridge case associated with the lancet for applying a force to urge the lancet into the cartridge case when the lancet tip is extended outside the lancet case; and

(d) associated with the cartridge case, a compartment for receiving blood.

32. The cartridge according to claim 31, wherein the port is at an opening through which the lancet extends through the cartridge case.