Lancet-integrated sensor, measurer for lancet-integrated sensor, and cartridge

• US 7,691,071 B2
• Filed: 01/21/2002
• Issued: 04/06/2010
• Est. Priority Date: 01/19/2001
• Status: Active Grant

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Inventors: Tokuno, Yoshinobu, Kojima, Shinichi
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US10/222,000
• Publication Number:
  US 20030144608A1
• Time in Patent Office: 2,997 Days
• Field of Search: 600/583, 600/576, 600/347, 600/365, 606/167, 606/181, 606/182, 606/185, 604/6.15, 604/6.16, 604/117, 604/136
• US Class Current: 600/583
• 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 5/0006 ECG or EEG signals
• 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 5/150259 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150725 removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• 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 sensor and a lancet are integrated with each other. A thin strip-shaped sensor and a lancet are integrated so that the lancet moves in parallel, along a longitudinal direction of the sensor. A measuring device to which an integrated lancet and sensor is attached is provided with a function of driving the attached lancet.

Claims

1. A lancet-integrated sensor comprising:

a lancet having a strip-shaped connector and a needle part attached at an end of said connector so as to extend in a direction along the longitudinal direction of said connector for lancing skin of a subject to extract bodily fluid of the subject; and

a sensor for analyzing the bodily fluid extracted by said needle part lancing the skin, said sensor including a sensor body having two thin plates bonded together such that said sensor body has a shape of a long and thin strip, with at least one of said two thin plates having a concave portion such that defined within said sensor body is a space and a port at one end of said sensor body in the longitudinal direction of said sensor body, and with said lancet extending through and being confined within said space such that said needle part is positioned so as to be passed through said port and said space,

wherein said sensor includes electrodes having a reagent layer that are positioned so as to be exposed to said port such that bodily fluid drawn into said space through said port by capillary action can reach said electrodes,

wherein said lancet and said sensor are constructed and arranged such that when bodily fluid is brought into contact with said sensor body after the bodily fluid has been extracted by said needle part lancing the skin upon passing through said port and said space in response to said lancet being driven longitudinally of said sensor body by an external driving device, the bodily fluid is drawn into said space through said port by capillary action, and

wherein an end of said lancet, opposite to the end of said connector at which said needle part is attached, comprises a projecting part that projects from said sensor body, said projecting part having an end portion which can be grasped by the external driving device of an external measurement apparatus, and the external driving device of the external measurement apparatus being engaged with said projecting part so that said lancet can be reciprocally driven along the longitudinal direction of said sensor body.

2. The lancet-integrated sensor according to claim 1, wherein

said connector includes projections extending from opposite sides thereof, respectively, and

said concave portion defines abutment surfaces for contacting said projections so as limit an amount of travel of said lancet within said sensor body.

3. The lancet-integrated sensor according to claim 2, wherein

said electrodes are on one of said two thin plates.

4. The lancet-integrated sensor according to claim 3, wherein

said concave portion is in one of said two thin plates, and

said electrodes are on the other of said two thin plates.

5. The lancet-integrated sensor according to claim 1, wherein

said electrodes are on one of said two thin plates.

6. The lancet-integrated sensor according to claim 5, wherein

said concave portion is in one of said two thin plates, and

said electrodes are on the other of said two thin plates.

7. The lancet-integrated sensor according to claim 1, further comprising:

a connection terminal to be connected with an external measurement device for electrically measuring the characteristics of the bodily fluid extracted by said needle part lancing the skin.

8. The lancet-integrated sensor according to claim 1, further comprising:

a detachable protection cover for covering said needle part, wherein said detachable protection cover is to be removed from said needle part when said needle part is to be exposed from said sensor body for lancing the skin.

9. The lancet-integrated sensor according to claim 8, wherein

said detachable protection cover has a tube part for housing said needle part, and a wide grip part for facilitating removal of said detachable protection cover from said needle part, with said tube part being positioned between said wide grip part and said sensor body when said needle part is housed within said tube part.

10. The lancet-integrated sensor according to claim 9, wherein

said tube part has a space in which a front end portion of said sensor body can be housed.

11. The lancet-integrated sensor according to claim 8, wherein

said wide grip part is constructed and arranged to be held while the lancet-integrated sensor is attached to an external measuring device, and while said end of said connector is engaged with the external driving device.

12. The lancet-integrated sensor according to claim 1, wherein

said connector is made of resin.

13. The lancet-integrated sensor according to claim 1, further comprising:

a holder, covering a periphery of said sensor body, for holding said lancet and said sensor.

14. The lancet-integrated sensor according to claim 13, wherein

said holder is made of a transparent material.

15. The lancet-integrated sensor according to claim 1, wherein

said space is long and narrow.

16. The lancet-integrated sensor according to claim 1, wherein

said lancet and said sensor are constructed and arranged such that when said needle part lances the skin a tip of said needle part projects from said sensor body.

17. The lancet-integrated sensor according to claim 1, further comprising:

a cavity for collecting the bodily fluid extracted by said needle part lancing the skin, said cavity being separate from said space.

18. The lancet-integrated sensor according to claim 1, wherein

said space serves as a cavity for collecting the bodily fluid extracted by said needle part lancing the skin.

19. The lancet-integrated sensor according to claim 1, further comprising:

a cavity for collecting the bodily fluid extracted by said needle part lancing the skin, said cavity having an inlet for this extracted bodily fluid at an end of said sensor body from which a tip of said needle projects.

20. The lancet-integrated sensor according to claim 1, wherein

the lancet-integrated sensor is disposable, and is to be discarded after the bodily fluid which has been extracted by said needle part lancing the skin is collected in the lancet-integrated sensor and a reaction between the bodily fluid and a reagent in the lancet-integrated sensor is analyzed by an external assay device.

21. The lancet-integrated sensor according to claim 1, wherein

said connector includes projections extending from opposite sides thereof, respectively, and

said concave portion defines abutment surfaces for contacting said projections so as limit an amount of travel of said lancet within said sensor body.