Body fluid composition measuring apparatus

• US 7,207,952 B2
• Filed: 07/26/2001
• Issued: 04/24/2007
• Est. Priority Date: 07/26/2000
• Status: Expired due to Fees

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: Sonoda, Kouichi, Takinami, Masao, Yaguchi, Yoshiaki
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): Szmal; Brian
• Application Number:
  US10/333,582
• Publication Number:
  US 20030109808A1
• Time in Patent Office: 2,098 Days
• Field of Search: 600/573, 600575-578, 600/583, 600/584, 422/56, 422/82.05, 422 99-101, 204/403.01, 435/14, 436/180, 436/148, 436/169, 436/177
• US Class Current: 600/584
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• 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 5/150099 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 5/15142 Devices intended for single use, i.e. disposable
• 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
• CPC Class Codes: A61B 5/417 the bone marrow

Abstract

A body fluid component measuring apparatus capable of accurately measuring a specific component in a body fluid for a short time includes, in a main body, a measuring device for detecting the sampling of a body fluid and measuring a component of the sampled body fluid, and a pump and an electromagnetic valve which constitute an evacuating mechanism. When the sampling of blood is detected, the pump is stopped to release the evacuation state. Another apparatus according to a second aspect includes a pressure detecting means and a notifying device. A puncturing device is operated only when it is decided on the basis of a result of detection by a sensor, that the housing is in an evacuation state, and after the sampling is detected, the evacuation is released and information is notified. A further apparatus according to a third aspect includes a pressure adjusting means for fluctuating the pressure.

Claims

1. A combination of a body fluid component measuring apparatus and a chip adapted to be mounted thereto, said chip comprising a chip housing, a puncture needle and a strip of test paper disposed on said chip housing, said chip housing possessing a contact portion at a tip side thereof, and said contact portion internally possessing a tip opening, said body fluid component measuring apparatus comprising:

a touch portion to which an epidermis to be punctured is touched;

a housing space for holding said chip;

puncturing means for operating said puncture needle when said chip is mounted to said apparatus so as to puncture the epidermis touched to said touch portion;

evacuating means for evacuating a puncture site of the epidermis to be punctured by said puncture needle as well as the housing space;

measuring means for measuring an amount of a specific component of a body fluid sampled from the puncture site and diffused in said test paper;

body fluid sampling detecting means for detecting the sampling of the body fluid; and

evacuation releasing means for releasing or relieving the evacuation state of at least said housing space;

wherein when the sampling of the body fluid is detected by said body fluid sampling detecting means, the evacuation state of at least said housing space is released or relieved, and then the amount of the specific component in the sampled body fluid is measured by said measuring means.

2. The combination of the body fluid component measuring apparatus and the chip according to claim 1, wherein the measurement of the amount of the specific component in the body fluid requires a specific component in atmospheric air.

3. The combination of the body fluid component measuring apparatus and the chip according to claim 1, wherein said evacuation releasing means has a flow passage for communicating said housing space to the outside and a valve for opening/closing said flow passage.

4. The combination of the body fluid component measuring apparatus and the chip according to claim 1, wherein said evacuation releasing means has a flow passage for communicating said housing space to the outside, and at least part of said flow passage has a portion in which an air passing resistance is relatively high.

5. The combination of the body fluid component measuring apparatus and the chip according to claim 1, wherein a component forming at least part of said measuring means also forms at least part of said body fluid sampling detecting means.

6. The combination of the body fluid component measuring apparatus and the chip according to claim 1, the body fluid component measuring apparatus further comprising an apparatus housing which houses said puncturing means, said housing space being provided at said apparatus housing wherein said evacuating means brings said housing space in said housing into an evacuation state.

7. The combination of the body fluid component measuring apparatus and the chip according to claim 6, wherein said evacuation releasing means releases or relives the evacuation state of said housing space in said apparatus housing.

8. The combination of the body fluid component measuring apparatus and the chip apparatus according to claim 1, wherein the operation of said puncturing means and the operation of said evacuating means are allowed to be nearly simultaneously started.

9. The combination of the body fluid component measuring apparatus and the chip according to claim 1, wherein said test paper is specialized for measurement of a blood sugar level.

10. The combination of the body fluid component measuring apparatus and the chip according to claim 1, the body fluid component measuring apparatus further comprising:

pressure detecting means for detecting the pressure in said housing space; and

notifying means for notifying specific information;

wherein upon operation of said evacuating means to evacuate said housing space, a notice based on the information from said pressure detecting means is outputted by said notifying means.

11. The combination of the body fluid component measuring apparatus and the chip according to claim 1, the body fluid component measuring apparatus further comprising:

pressure adjusting means for adjusting the pressure in said housing space;

wherein at the time of sampling the body fluid from the puncture site, said housing space is evacuated by said pressure adjusting means with the pressure fluctuated with elapsed time.

12. A combination of a body fluid component measuring apparatus and a chip adapted to be mounted thereto for sampling a body fluid via an epidermis and measuring a component of the body fluid,

said chip comprising:

a housing;

a puncture needle; and

a strip of test paper disposed on said housing;

said housing possessing a contact portion at a tip side thereof, and said contact portion internally possessing a tip opening,

said body fluid component measuring apparatus comprising;

a touch portion to which the epidermis is touched;

a housing space for holding said chip air-tightly sealed with the epidermis touched to said touch portion;

evacuating means for evacuating said space;

measuring means for measuring an amount and/or a property of a specific component in the body fluid sampled in said space;

pressure detecting means for detecting the pressure in said space; and

notifying means for notifying specific information;

wherein upon operation of said evacuating means to evacuate said space, a notice based on the information from said pressure detecting means is outputted by said notifying means.

13. The combination of the body fluid component measuring apparatus and the chip according to claim 12, wherein said body fluid component measuring apparatus comprises puncturing means for operating said puncture needle when said chip is mounted to said apparatus so as to puncture the epidermis touched to said touch portion.

14. A combination of a body fluid component measuring apparatus and a chip adapted to be mounted thereto, said chip comprising a housing, a puncture needle and a strip of test paper disposed on said housing, said housing possessing a contact portion at a tip side hereof, and said contact portion internally possessing a tip opening, said body fluid component measuring apparatus comprising:

a touch portion to which an epidermis is touched;

puncturing means for operating said puncture needle when said chip is mounted to said apparatus so as to puncture the epidermis touched to said touch portion;

evacuating means for evacuating the puncture site of the epidermis to be punctured by said puncture needle as well as a housing space of said body fluid component measuring apparatus;

pressure detecting means for detecting the pressure in said housing space;

measuring means for measuring an amount of a specific component in the body fluid sampled from the puncture site; and

notifying means for notifying specific information;

wherein upon operation of said evacuating means to evacuate said housing space, a notice based on the information from said pressure detecting means is outputted by said notifying means.

15. The combination of the body fluid component measuring apparatus and the chip according to claim 14, wherein when the evacuation state of said housing space is detected by said pressure detecting means, said puncture needle is operated by said puncturing means.

16. The combination of the body fluid component measuring apparatus and the chip according to claim 15, the body fluid component measuring apparatus further comprising:

operation starting means including an electrical drive source, said means being used for starting the operation of said puncturing means by drive of said drive source;

wherein the evacuation state of said housing space is detected by said pressure detecting means, the operation of said puncturing means is started by said operation starting means and said puncture needle is operated by said puncturing means.

17. The combination of the body fluid component measuring apparatus and the chip according to claim 14, wherein said puncturing means has a plunger and an urging member for urging said plunger in the direction toward the touch portion.

18. The combination of the body fluid component measuring apparatus and the chip according to claim 17, wherein said plunger has a locking portion for restricting the movement of said plunger in the direction toward the touch portion, and when the locking of said locking portion is released in the state that the plunger remains urged by said urging member, said plunger is moved in the direction toward the touch portion to allow said puncture needle to puncture the epidermis.

19. The combination of the body fluid component measuring apparatus and the chip according to claim 18, further comprising operation starting means including an electrical drive source, said means being used for releasing the locking of said locking portion by drive of said drive source;

wherein when the evacuation state of said housing space is detected by said pressure detecting means, the locking of said locking portion is released by said operation starting means.

20. The combination of the body fluid component measuring apparatus and the chip according to claim 14, wherein when the evacuation state of said housing space is detected by said pressure detecting means, the evacuation state is once released, and then the puncture is performed and the puncture site of the finger punctured by said puncture needle as well as said housing space for housing said puncture needle are evacuated.

21. A body fluid component measuring apparatus used with a chip mounted thereto, said chip including a puncture needle, said apparatus comprising:

a touch portion to which an epidermis to be punctured is touched;

puncturing means for operating said puncture needle so as to puncture the epidermis touched to said touch portion;

evacuating means for evacuating the puncture site of the epidermis to be punctured by said puncture needle as well as a housing space for housing said puncture needle;

pressure detecting means for detecting the pressure in said housing space;

measuring means for measuring an amount of a specific component in the body fluid sampled from the puncture site; and

notifying means for notifying specific information;

wherein when said evacuating means is operated and the pressure in said housing space as determined by the detecting means is not sufficiently reduced, a notice about an error is outputted by said notifying means.

22. The combination of the body fluid component measuring apparatus and the chip according to claim 21, wherein when an evacuation state of said housing space is detected by said pressure detecting means, said puncture needle is operated by said puncturing means.

23. The combination of the body fluid component measuring apparatus and the chip according to claim 22, the body fluid component measuring apparatus further comprising:

operation starting means including an electrical drive source, said means being used for starting the operation of said puncturing means by drive of said drive source;

wherein the evacuation state of said housing space is detected by said pressure detecting means, the operation of said puncturing means is started by said operation starting means and said puncture needle is operated by said puncturing means.

24. The combination of the body fluid component measuring apparatus and the chip according to claim 21, wherein said puncturing means has a plunger and an urging member for urging said plunger in the direction toward the touch portion.

25. The combination of the body fluid component measuring apparatus and the chip according to claim 24, wherein said plunger has a locking portion for restricting the movement of said plunger in the direction toward the touch portion, and when the locking of said locking portion is released in the state that the plunger remains urged by said urging member, said plunger is moved in the direction toward the touch portion to allow said puncture needed to puncture the epidermis.

26. The combination of the body fluid component measuring apparatus and the chip according to claim 25, the body fluid component measuring apparatus further comprising operation starting means including an electrical drive source, said means being used for releasing the locking of said locking portion by drive of said drive source;

wherein when the evacuation state of said housing space is detected by said pressure detecting means, the locking of said locking portion is released by said operation starting means.

27. The combination of the body fluid component measuring apparatus and the chip according to claim 21, wherein when an evacuation state of said housing space is detected by said pressure detecting means, the evacuation state is once released, and then the puncture is performed and the puncture site of the finger punctured by said puncture needle as well as said housing space are evacuated.

28. A body fluid component measuring apparatus used with a chip mounted thereto, said chip including a puncture needle, said apparatus comprising:

a touch portion to which an epidermis to be punctured is touched;

puncturing means for operating said puncture needle so as to puncture the epidermis touched to said touch portion;

evacuating means for evacuating a puncture site of the epidermis to be punctured by said puncture needle as well as a housing space for housing said puncture needle;

pressure detecting means for detecting the pressure in said housing space;

measuring means for measuring an amount of a specific component in a body fluid sampled from the puncture site;

notifying means for notifying specific information;

wherein when said evacuating means is operated and the pressure in said housing space as determined by the detecting means is not sufficiently reduced, a notice to correct the position of the epidermis touched to said touch portion is outputted by said notifying means, and when the evacuation state of said housing space is not detected by said pressure detecting means even after a specific time has elapsed, a notice about an error is outputted by said notifying means.

29. A combination of a body fluid component measuring apparatus and a chip adapted to be mounted thereto, said chip comprising a housing, a puncture needle and a strip of test paper disposed on said housing, said housing possessing a contact portion at a tip side thereof, and said contact portion internally possessing a tip opening, said body fluid component measuring apparatus comprising:

a touch portion to which an epidermis to be punctured is touched;

puncturing means for operating said puncture needle when said chip is mounted to said apparatus so as to puncture the epidermis touched to said touch portion;

evacuating means for evacuating a puncture site of the epidermis to be punctured by said puncture needle as well as a housing space for housing said chip;

pressure detecting means for detecting the pressure in said housing space; and

measuring means for measuring an amount of a specific component in a body fluid sampled from the puncture site;

wherein, when said evacuating means is operated and the pressure in said housing space as determined by the detecting means is sufficiently reduced, said puncture needle is operated by said puncturing means.

30. A combination of a body fluid component measuring apparatus and a chip adapted to be mounted thereto for sampling a body fluid via an epidermis and measuring a component of the body fluid,

said chip comprising:

a housing;

a puncture needle; and

a strip of test paper disposed on said housing;

said housing possessing a contact portion at a tip side thereof, and said contact portion internally possessing a tip opening,

said body fluid component measuring apparatus comprising;

a touch portion to which the epidermis is touched;

a housing space for holding said chip air-tightly sealed by the epidermis touched to said touch portion;

pressure adjusting means for adjusting the pressure in said space; and

measuring means for measuring an amount and/or a property of a specific component of the body fluid sampled in said space;

wherein at the time of sampling the body fluid in said space via the epidermis, said space is evacuated by said pressure adjusting means with the pressure fluctuated with elapsed time.

31. The combination of the body fluid component measuring apparatus and the chip according to claim 30, wherein said body fluid component measuring apparatus comprises puncturing means for operating said puncture needle when said chip is mounted to said apparatus so as to puncture the epidermis touched to said touch portion.

32. A combination of a body fluid component measuring apparatus and a chip adopted to be mounted thereto, said chip comprising a puncture needle, said body fluid component measuring apparatus comprising:

a touch portion to which an epidermis to be punctured is touched;

puncturing means for operating said puncture needle when said chip is mounted to said apparatus so as to puncture the epidermis touched to said touch portion;

pressure adjusting means for adjusting the pressure in a housing space for housing said chip; and

measuring means for measuring an amount of a specific component in a body fluid sampled from the puncture site;

wherein at the time of sampling the body fluid from the puncture site, at least one cycle of reducing the pressure in said housing space once to a first pressure lower than atmospheric pressure and then gradually increasing the pressure in said housing space is performed by said pressure adjusting means with the pressure fluctuated with elapsed time.

33. The combination of the body fluid component measuring apparatus and the chip according to claim 32, the body fluid component measuring apparatus further comprising:

pressure detecting means for detecting the pressure in said housing space;

wherein the pressure in said housing space is adjusted, on the basis of information from said pressure detecting means, by said pressure adjusting means.

34. The combination of the body fluid component measuring apparatus and the chip according to claim 32, wherein at the time of sampling the body fluid, the pressure in said housing space is alternately changed, by said pressure adjusting means, between a first pressure lower than atmospheric pressure and a second pressure higher than the first pressure.

35. The combination of the body fluid component measuring apparatus and the chip according to claim 34, wherein said second pressure is equal to or less than atmospheric pressure.

36. The combination of the body fluid component measuring apparatus and the chip according to claim 34, wherein a difference between said second pressure and said first pressure is in a range of 100 to 600 mmHg.

37. The combination of the body fluid component measuring apparatus and the chip according to claim 32, wherein a period of the pressure fluctuation is in a range of 1 to 30 sec.

38. The combination of the body fluid component measuring apparatus and the chip according to claim 32, wherein said first pressure is in a range of 100 to 600 mmHg.