Piercing device

• US 20040215224A1
• Filed: 01/15/2004
• Published: 10/28/2004
• Est. Priority Date: 07/19/2001
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Matsumoto, Daisuke, Kasai, Tokuo, Sakata, Tetsuya
• Granted Patent: US 8,016,773 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/150503 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 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

The present invention provides a lancing apparatus (A) which includes a lancet (3) which is movable to advance in a first direction from a deeper portion in a housing (2) toward a front end of a cylindrical member (8) and an analysis component (4) disposed in the cylindrical member (8). The analysis component (4) is movable in a second direction opposite to the first direction upon receiving a force in the second direction. When skin (S) bulges, the analysis component (4) moves in the second direction following the bulging of the skin, whereby blood (b) bleeding from the skin (S) is properly introduced to the analysis component (4).

Claims

1. A lancing apparatus comprising:

a housing integrally or separately formed with a cylindrical member having an open front end,

a lancet disposed in the housing and movable to advance in a first direction from a deeper portion in the housing toward the front end of the cylindrical member, and

an analysis component disposed in the cylindrical member;

wherein the analysis component is movable in a second direction opposite to the first direction upon receiving a force in the second direction.

2. The lancing apparatus according to claim 1, further comprising a negative pressure generator for generating negative pressure in the cylindrical member.

3. The lancing apparatus according to claim 1, wherein the cylindrical member is formed separately from the housing and mounted to the housing to partially project from the housing.

4. The lancing apparatus according to claim 1, further comprising a holder for holding the analysis component, the holder being supported by the cylindrical member via a resilient member capable of expanding and contracting in the first direction and the second direction.

5. The lancing apparatus according to claim 4, wherein the holder is arranged to engage the lancet advancing in the first direction to inhibit further advancement of the lancet.

6. The lancing apparatus according to claim 1, wherein the analysis component includes a surface oriented in the first direction for contacting skin, the skin contacting surface being inclined to extend toward a deeper portion in the housing as it extends closer to a central axis of the cylindrical member.

7. The lancing apparatus according to claim 6, wherein an inclination angle of the analysis component is variable.

8. The lancing apparatus according to claim 7, further comprising a stopper for preventing the analysis component from inclining more than a predetermined angle.

9. The lancing apparatus according to claim 6, wherein the skin contacting surface is adherent.

10. The lancing apparatus according to claim 1, wherein the analysis component comprises a substrate, a reagent disposed on the substrate, a sample introducing portion formed at an edge of the substrate, and a capillary for guiding sample liquid adhering to the sample introducing portion to the reagent layer.

11. The lancing apparatus according to claim 10, wherein the sample introducing portion is defined by a surface which is made hydrophilic.

12. A lancing apparatus comprising:

a housing integrally or separately formed with a cylindrical member having an open front end,

a lancet disposed in the housing and movable to advance in a first direction from a deeper portion in the housing toward the front end of the cylindrical member,

an analysis component disposed in the cylindrical member;

a determiner for determining whether or not a sample is introduced to the analysis component, and

a negative pressure generator for generating negative pressure in the cylindrical member,

wherein the lancing apparatus further comprises a controller for performing control to relieve the negative pressure generated in the cylindrical member when the determiner determines that the sample is not introduced to the analysis component within a predetermined time after the lancing apparatus is advanced toward the front end of the cylindrical member.

13. The lancing apparatus according to claim 12, wherein the analysis component is movable in a second direction opposite to the first direction upon receiving a force in the second direction.

14. The lancing apparatus according to claim 12, further comprising a relief valve for causing an inside of the cylindrical member to communicate with an outside of the housing,

wherein the controller is capable of opening the relief valve to relieve the negative pressure in the cylindrical member.

15. The lancing apparatus according to claim 12, wherein the controller controls the negative pressure generator to regenerate negative pressure in the cylindrical member after negative pressure previously generated in the cylindrical member is relieved.

16. The lancing apparatus according to claim 15,

wherein the advancing movement of the lancet is performed repetitively under control of the controller, and

wherein the lancet advances again under control of the controller when the determiner determines that the sample is not introduced to the analysis component within a predetermined time after negative pressure is regenerated in the cylindrical member.

17. The lancing apparatus according to claim 12, wherein the controller controls the negative pressure generator to further lower a pressure in the cylindrical member after the lancet is advanced and before the negative pressure previously generated in the cylindrical member is relieved.

18. The lancing apparatus according to claim 12, further comprising an analyzer for analyzing the sample introduced to the analysis component and a notifier for notifying analysis results provided by the analyzer.

19. The lancing apparatus according to claim 18, wherein the controller causes the notifier to give a notice when the analysis of the sample by the analyzer is not performed within a predetermined time after the lancet is advanced.

20. The lancing apparatus according to claim 18, further comprising a detector for detecting a pressing force applied to the cylindrical member in a direction opposite to the advancing direction of the lancet, wherein the notifier gives a notice when the pressing force detected by the detector exceeds a predetermined value.