Reproducible lancing for sampling blood

• US 5,871,494 A
• Filed: 12/04/1997
• Issued: 02/16/1999
• 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: Greenstein, Michael, Freeman, Dominique, Lum, Paul, King, David A., Leonard, Leslie Anne, Simons, Tad Decatur
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): BUI, VY Q
• Application Number:
  US08/985,303
• Time in Patent Office: 439 Days
• Field of Search: 606/181, 606/182, 606/183, 606/184, 606/185, 606/186, 604/137, 604/187
• US Class Current: 606/181
• 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 5/150358 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 5/15194 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 analysis apparatus for obtaining blood for analysis from the skin of a patient with a controlled degree of lancing. The apparatus including a cartridge and a driver. The cartridge includes a cartridge case and a lancet. The lancet has a tip and is housed in the cartridge case. The lancet can be driven to extend the tip outside the cartridge case through an opening for lancing the skin of the patient to yield blood. The driver drives the lancet to move the tip distally to lance the skin. The driver is triggerable by the skin which is to be lanced exerting a force exceeding a preset amount against the triggering mechanism of the apparatus, to drive the lancet toward the skin.

Claims

1. A lancing apparatus for obtaining blood for analysis from the skin of a patient with a controlled degree of lancing, comprising:

(a) a cartridge which comprises a cartridge case having a lancing opening and a lancet having a tip, the lancet operatively connected to the cartridge case to allow the lancet to protrude through the lancing opening and move the tip towards the skin for lancing to yield blood; and

(b) a driver for driving the lancet to move the tip distally to lance the skin, the driver being triggerable by said skin exerting a force against the apparatus when said force exceeds a preset amount of preload force;

wherein a spring generates a preload force which needs to be overcome to actuate the driver to drive the lancet towards the skin, the spring resting against an adjuster for adjusting the compression of the spring to vary the preload force.

2. The apparatus according to claim 1 wherein the driver is adjustable to vary the protrusion of the lancet into the skin in lancing.

3. The apparatus according to claim 2 wherein the driver has parts with matching screw threads to adjust the protrusion length of the lancet out of the lancing opening.

4. The apparatus according to claim 1 wherein the cartridge is detachably held in said apparatus such that the cartridge can be removed after obtaining blood from the skin.

5. The apparatus according to claim 1 further comprising, associated with the cartridge case a compartment for receiving blood.

6. The apparatus according to claim 5 comprising, associated with the cartridge case an analytical region for analyzing the property of blood.

7. The apparatus according to claim 6 wherein the analytical region is near the lancing opening for fluid communication between the analytical region and the opening.

8. The apparatus according to claim 6 wherein the analytical region is located distal to the lancet tip before the lancet is extended through the opening.

9. The apparatus according to claim 6 wherein the analytical region encircles the lancing opening on the exterior of the cartridge case.

10. The apparatus according to claim 6 further comprising a display for displaying the analysis result.

11. 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 transferred from a stack of cartridges to be associated with the driver while the other cartridges in the stack are retained on the stack.

12. The apparatus according to claim 1 wherein the cartridge is bar-shaped having a longitudinal axis parallel to which the lancet can extend to lance the skin.

13. The apparatus according to claim 1 further comprising:

a housing having the driver for causing the lancet to extend the lancet tip outside the cartridge case, the cartridge being detachably held in said housing such that the cartridge can be removed after obtaining blood.

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

(a) providing an apparatus having a lancet which has a tip shielded in the apparatus;

(b) adjusting a preload force in the apparatus which needs to be overcome to drive the lancet towards the skin; and

(c) pushing the skin against the apparatus, thereby triggering the apparatus to drive the lancet to extend the lancet tip out of the apparatus when a preset preload force is exceeded.

15. The method according to claim 14 further comprising adjusting the apparatus to vary the depth of protrusion by the lancet into the skin.

16. The method according to claim 14 further comprising extending the lancet through a cartridge which shields the lancet before triggering the apparatus.

17. The method according to claim 16 further comprising receiving blood from lancing in a compartment associated with the cartridge case.

18. The method according to claim 16 further comprising allowing blood from the lanced skin to contact an analytical region associated with the cartridge for analysis.

19. A lancing apparatus for sampling and analyzing blood from the skin of a patient, comprising:

(a) a cartridge having

(i) a cartridge case having a lancing opening through which a lancet can protrude and having a sample compartment near the lancing opening;

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

(b) a housing having a driver for driving the lancet to extend the lancet through the lancing opening, the cartridge being detachably held in said housing such that the cartridge can be removed after sampling blood, the driver having a cocking position which is triggerable when the skin to be lanced exerts on the driver a force exceeding a preset force to release from the cocking position, thereby urging the lancet toward the skin.

20. The apparatus according to claim 19 further comprising an analytical region associated with the cartridge case for analysis of blood.

21. A lancing apparatus for obtaining blood for analysis from the skin of a patient with a controlled degree of lancing, comprising:

(a) a cartridge which comprises a cartridge case having a lancing opening and a lancet having a tip, the lancet operatively connected to the cartridge case to allow the lancet to protrude through the lancing opening and move the tip towards the skin for lancing to yield blood; and

(b) a driver for driving the lancet to move the tip distally to lance the skin, the driver being triggerable by said skin exerting a force against the apparatus when said force exceeds a preset amount of preload force;

wherein the driver has movable parts to adjust the protrusion length of the lancet out of the lancing opening.