Body-fluid inspection device

• US 6,261,245 B1
• Filed: 01/22/1999
• Issued: 07/17/2001
• Est. Priority Date: 01/22/1998
• Status: Expired due to Term

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: Kawai, Eiji, Sonoda, Kouichi, Nishikawa, Hisao, Takinami, Masao
• Primary Examiner(s): Lacyk, John P.
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/236,009
• Time in Patent Office: 907 Days
• Field of Search: 600/573, 600/576, 600/577, 600/578, 600/583, 600/584, 661/81
• US Class Current: 600/576
• 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 5/150022 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 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/15113 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 5/15186 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

A body-fluid inspection device, which sticks a skin so as to obtain a fine amount of body fluids and measures ingredients of the body fluids, includes a casing having an opening, a sticking device having a sticking needle that is allowed to protrude from the opening of the casing, and a suction device which places at least portion of a space inside the casing in a reduced-pressure state. Also included are a reduced-pressure releasing device for releasing the space inside the casing from the reduced-pressure state, a chip which is detachably attached to the opening of the casing and is provided with test paper for absorbing the body fluids that have been sucked by the body-fluid suction device, a measuring device for measuring ingredients of the body fluids that have been absorbed by the test paper, and a display device for displaying results of measurements made by the measuring device. The display device is placed on one portion of a surface of the casing. The sticking, the suction and the measuring devices are installed inside the casing.

Claims

1. A body-fluid inspection device which sticks a skin so as to obtain a fine amount of body fluids and measures ingredients of the body fluids, comprising:

a casing having an opening;

sticking means having a sticking needle that is allowed to protrude from the opening of the casing;

suction means which places at least a portion of a space inside the casing in a reduced-pressure state for sucking body fluids from a wound produced by the sticking means;

reduced-pressure releasing means for releasing the space inside the casing from the reduced-pressure state, the reduced-pressure releasing means being provided with a vent hole which allows the inside and the outside of the casing to communicate with each other and an opening and closing means for opening and closing the vent hole;

a chip which is detachably attached to the opening of the casing, and provided with test paper for absorbing the body fluids that have been sucked by the suction means;

measuring means for measuring ingredients of the body fluids that have been absorbed by the test paper; and

display means for displaying results of measurements made by the measuring means, the display means being placed on one portion of a surface of the casing,

wherein the sticking means, the suction means and the measuring means are installed inside the casing.

2. The body-fluid inspection device according to claim 1, further comprising evacuation means which, when the casing becomes a pressurized state at the time of sticking, releases an amount of air corresponding to the excessive pressure.

3. The body-fluid inspection device according to claim 2, wherein the opening and closing means comprises a wedge member, the evacuation means is constituted by a non-return valve that is installed in the vent hole so as to stop a force directed into the casing, and the wedge member allows the non-return valve to be opened and closed in the reverse direction.

4. The body-fluid inspection device according to claim 1, further comprising connecting means provided with a seal member for connecting the casing and the chip in an air-sealed state, the connecting means being installed in the opening of the casing.

5. The body-fluid inspection device according to claim 1, further comprising body-fluid guide means for guiding the body fluids that have been sucked to the test paper by capillary phenomenon, the body-fluid guide means being installed in the chip.

6. The body-fluid inspection device according to claim 1, further comprising release means for removing the chip, the release means being installed at the opening of the casing.

7. The body-fluid inspection device according to claim 1, wherein the sticking means comprises adjusting means for adjusting the depth of sticking by the sticking needle.

8. The body-fluid inspection device according to claim 1, which comprises:

a housing having an opening at the tip end thereof;

sticking means including a sticking plunger that is allowed to shift toward the tip end inside the housing with the sticking needle being attached thereto, and a first pressing means for pressing the sticking plunger toward the tip end;

suction means including a suction plunger that is provided with a seal member having an air-sealed property and that brings the housing to a reduced-pressure state upon shifting toward the base end, and a second pressing means for pressing the suction plunger toward the base end;

air-releasing means for releasing the housing which is in a reduced-pressure state to the atmospheric pressure; and

operation means for carrying out at least a sticking process by the sticking needle and a pressure-reducing process inside the housing by an operation of the suction plunger, successively in this order or at the same time.

9. The body-fluid inspection device according to claim 1, which comprises:

a housing having an opening at the tip end thereof;

sticking means including a sticking plunger that is allowed to shift toward the tip end inside the housing with the sticking needle being attached thereto, and a first pressing means for pressing the sticking plunger toward the tip end;

suction means including a suction plunger that is provided with a seal member having an air-sealed property and that brings the housing to a reduced-pressure state upon shifting toward the base end, and a second pressing means for pressing the suction plunger toward the base end;

air-releasing means for releasing the housing which is in a reduced-pressure state to the atmospheric pressure; and

operation means which carries out a sticking process by the sticking needle and a pressure-reducing process inside the housing by an operation of the suction plunger, successively in this order or at the same time, and then allows the housing to be released to the atmospheric pressure.

10. The body-fluid inspection device according to claim 1, which comprises:

a housing having a tip end that is opened;

a plunger to which a lancet having a sticking needle extending toward the tip end is attached, the plunger being allowed to slide inside the housing;

a stopper connected in the rear end direction of the plunger;

an adjustment mechanism which contacts the stopper; and

a sticking-use spring for shifting the lancet, the plunger and the stopper toward the tip end of the housing, the sticking-use spring being connected to the plunger or the stopper,

wherein;

an engaging section is provided in the inner face of the housing;

a stopping section is formed in at least one of the lancet, the plunger and the stopper, the stopping section being allowed to engage the engaging section so as to stop the lancet, the plunger and the stopper at a first position; and

after the lancet, the plunger and the stopper have shifted toward the tip end from the first position by the spring that is released from the engagement between the engaging section and the stopping section, the stopper comes into contact with the adjustment mechanism so that the shift of the lancet, the plunger and the stopper is stopped at a second position.

25. The body-fluid inspection device according to claim 1, further comprising evacuation means which, when the casing becomes a pressurized state at the time of sticking, releases an amount of air corresponding to the excessive pressure.

11. A sticking tool comprising:

a housing having an opening at the tip end thereof;

a sticking plunger that is allowed to shift toward the tip end inside the housing with the sticking needle being attached thereto;

first pressing means for pressing the sticking plunger toward the tip end;

a suction plunger that is provided with a seal member having an air-sealing property and that brings the housing to a reduced-pressure state upon shifting toward the base end;

second pressing means for pressing the suction plunger toward the base end;

air-releasing means for releasing the housing which is in a reduced-pressure state to the atmospheric pressure; and

operation means for carrying out at least a sticking process by the sticking needle and a pressure-reducing process inside the housing by an operation of the suction plunger, successively in this order or at the same time.

13. The sticking tool according to claim 11, wherein the sticking plunger has a first stopping section for making an engagement with the housing, and is allowed to shift toward the tip end by releasing the engagement of the first stopping section while being pressed by the first pressing means, so as to carry out a sticking operation.

14. The sticking tool according to claim 13, wherein the suction plunger has a second stopping section for making an engagement with the housing, and is allowed to shift toward the base end by releasing the engagement of the second stopping section while being pressed by the second pressing means, so as to carry out a suction operation inside the housing.

15. The sticking tool according to claim 14, wherein the operation means is provided with an operation button which carries out the releasing of the first stopping section and the releasing of the second stopping section in this order or at the same time.

16. The sticking tool according to claim 11, wherein the air-releasing means is automatically allowed to operate when the suction plunger has arrived at or approaches a limit position of shift on the base-end side.

17. The sticking tool according to claim 14, wherein the operation means has an operation button which carries out the releasing of the first stopping section and the releasing of the second stopping section in this order or at the same time, and then allows the air-releasing means to operate.

18. The sticking tool according to claim 15, further comprising a first protrusion and a second protrusion that respectively engage the first stopping section and the second stopping section, and a pressing member that is elastically deformed in accordance with the operation of the operation button.

19. The sticking tool according to claim 11, wherein the suction plunger is provided with a gasket which slides while being in contact with the inner face of the housing in an air-sealed state.

20. The sticking tool according to claim 11, wherein the air-releasing means is constituted by an air-releasing valve.

21. The sticking tool according to claim 20, wherein the air-releasing valve is provided with a vent opening, a seal member made of an elastic member capable of sealing the vent opening and an opening and closing mechanism for opening and closing the vent opening by deforming or shifting the seal member.

22. The sticking tool according to claim 20, wherein the air-releasing valve has a function as a relief valve for releasing air corresponding to an excessive pressure when the housing is in a pressurized state.

23. The sticking tool according to claim 11, further comprising an adjustment mechanism for adjusting the depth of sticking made by the sticking needle.

24. The sticking tool according to claim 11, wherein an operation direction in which the sticking plunger is shifted so as to carry out a sticking operation and a shifting direction of the sticking plunger are different from each other.

28. The sticking tool according to claim 17, further comprising a first protrusion and a second protrusion that respectively engage the first stopping section and the second stopping section, and a pressing member that is elastically deformed in accordance with the operation of the operation button.

31. The sticking tool according to claim 21, wherein the air-releasing valve has a function as a relief valve for releasing air corresponding to an excessive pressure when the housing is in a pressurized state.

12. A sticking tool comprising:

a housing having an opening at the tip end thereof;

a sticking plunger that is allowed to shift toward the tip end inside the housing with the sticking needle being attached thereto;

first pressing means for pressing the sticking plunger toward the tip end;

a suction plunger that is provided with a seal member having an air-sealing property and that brings the housing to a reduced-pressure state upon shifting toward the base end;

second pressing means for pressing the suction plunger toward the base end;

air-releasing means for releasing the housing which is in a reduced-pressure state to the atmospheric pressure; and

operation means which carries out a sticking process by the sticking needle and a pressure-reducing process inside the housing by an operation of the suction plunger, successively in this order or at the same time, and then allows the housing to be released to the atmospheric pressure.

26. The sticking tool according to claim 12, wherein the sticking plunger has a first stopping section for making an engagement with the housing, and is allowed to shift toward the tip end by releasing the engagement of the first stopping section while being pressed by the first pressing means, so as to carry out a sticking operation.

27. The sticking tool according to claim 12, wherein the air-releasing means is automatically allowed to operate when the suction plunger has arrived at or approaches a limit position of shift on the base-end side.

29. The sticking tool according to claim 12, wherein the suction plunger is provided with a gasket which slides while being in contact with the inner face of the housing in an air-sealed state.

30. The sticking tool according to claim 12, wherein the air-releasing means is constituted by an air-releasing valve.

32. The sticking tool according to claim 12, further comprising an adjustment mechanism for adjusting the depth of sticking made by the sticking needle .

33. The sticking tool according to claim 12, wherein an operation direction in which the sticking plunger is shifted so as to carry out a sticking operation and a shifting direction of the sticking plunger are different from each other.