Assembly having lancet and means for collecting and detecting body fluid

• US 6,315,738 B1
• Filed: 12/30/1999
• Issued: 11/13/2001
• Est. Priority Date: 01/04/1999
• Status: Expired due to Term

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: Morikawa, Naoki, Sonoda, Kouichi, Nishikawa, Hisao, Takinami, Masao
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/475,125
• Time in Patent Office: 684 Days
• Field of Search: 600/573, 600/576, 600/578, 600/579, 600/583, 600/584, 606/181, 606/182
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150587 by friction fit
• CPC Class Codes: A61B 5/15061 by material engagement, e.g. welding, bonding
• 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 5/1519 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

An assembly to be detachably mounted on a body fluid monitoring system is provided. The assembly has a lancet and a device for collecting and detecting a body fluid. The lancet has a puncture needle. In this assembly, the puncture needle is maintained in sterilized conditions until its use, and the sterilization can be conducted with no adverse effects on the detection device. A readily sterilizable lancet unit and a body fluid-collecting and detecting unit adapted for use in such an assembly as well as a body fluid-monitoring system including such an assembly are also provided. The assembly comprises a first housing having a sleeve which movably accommodates the lancet in its interior, and a second housing having the body fluid detection device. The first housing and the second housing share an opening. The lancet is sterilized before the assembly. The body fluid-collecting and detecting section has a body fluid guide on the periphery of the inlet.

Claims

1. An assembly having a lancet and body fluid collection and detection means for collecting and detecting a body fluid wherein said assembly is to be detachably mounted on a body fluid-monitoring system having a lancing means and said assembly comprises:

a lancet section comprising

a lancet having a puncture needle on a distal end of the lancet and a connector on a proximal end of the lancet for connection to said lancing means of the body fluid-monitoring system, and a first housing having a sleeve which movably accommodates said lancet in an interior of the sleeve, and which has a first opening on a distal end of the sleeve to enable projection of the needle into an exterior of the sleeve and the proximal opening to enable connection of said connector with said lancing means of the body fluid-monitoring system, and

wherein said lancet before the lancing is secured in said sleeve at a position near the proximal opening to gas-tightly seal said sleeve;

a body fluid-collecting and detecting section comprising the body fluid detection means and a second housing having a second opening for introducing the body fluid into said detection means;

a first seal member for sealing said first opening; and

wherein said first housing is gas-tightly sealed with both said first seal member for sealing said first opening and said lancet for sealing said proximal opening; and

said first housing and said second housing are fixedly integrated with each other such that said first opening of said first housing and said second opening of said second housing together define a distal opening to enable the projection of said puncture needle to the exterior of said assembly, and the assembly comprised of the lancet section and the body fluid-collection and detection section being a one-piece assembly.

2. An assembly according to claim 1 produced by sterilizing said lancet section having said puncture needle accommodated in said first housing with said first opening and said proximal opening sealed;

and assembling the sterilized lancet section with said body fluid-collecting and detecting section to constitute a one-piece assembly.

3. An assembly according to claim 2 wherein the entire assembly after assembling is covered with a protective shield.

4. An assembly according to claim 2 wherein said puncture needle remains sterilized until said first seal member is removed from said first opening.

5. An assembly according to claim 1 wherein the entire assembly after assembling is covered with a protective shield.

6. An assembly according to claim 5 wherein said first seal member is connected to said protective shield and said first seal member is removed from said first opening simultaneously with removal of said protective shield.

7. An assembly according to claim 1 wherein said first housing has a detachment preventing means for preventing detachment of said lancet after use.

8. An assembly according to claim 7 wherein said detachment-preventing means also serves the function of sealing said proximal opening of said sleeve.

9. An assembly according to claim 1 wherein said second housing is defined with a flow path for guiding the body fluid from said distal opening to said body fluid detection means by capillary action, and an inlet port for guiding said body fluid into said flow path.

10. An assembly according to claim 9 wherein said flow path in the second housing comprises a plurality of flow path sections between which corners are defined at an angle, and a projection having a tip, said projection protruding into the flow path is provided on each corner so that the tip of the projection contacts with meniscus of the body fluid formed at the corner.

11. An assembly according to claim 9 wherein said inlet port has a body fluid guide formed along a periphery of the inlet port.

12. An assembly according to claim 11 wherein said body fluid guide comprises two or more guide members and said guide members are projections formed on the periphery of said inlet port.

13. An assembly according to claim 11 wherein said body fluid guide is located inside of said second opening.

14. An assembly according to claim 11 wherein said body fluid guide has a constitution comprising two side members and a lower plate member.

15. An assembly according to claim 14 wherein said lower plate member has a downwardly extending projection on a distal section thereof.

16. An assembly according to claim 15, said second housing having a bottom face, wherein said body fluid guide members are designed such that a width between said side members increases from the side of said inlet to the side of a distal end, and surface tension of said body fluid is lower in an interior space enclosed with said fluid guide members than in an interior of said flow path, and the distal ends of said side members are mounted at an angle less than 90°

to the bottom face of said second housing.

17. An assembly according to claim 11, said body fluid guide having a tip, wherein said puncture needle passes near the tip of said body fluid guide or between side members of said body fluid guide during puncture.

18. An assembly according to claim 1 wherein said second housing has a sleeve in an interior of the second housing to fittingly receive at least a part of the sleeve of the first housing, and said sleeve of the second housing has an opening in a body of the sleeve;

and

a detection area of the body fluid detection means is secured to an exterior surface of said sleeve of the second housing.

19. A body fluid-monitoring system comprising a main body of the body fluid-monitoring system and the assembly of claim 1, wherein said main body includes:

lancing means having a recess at a distal end,

means for measuring the target component in the body fluid, and

holder means for detachably holding the assembled housings of the assembly, and

said assembly is held by said holder means, and the connector of said lancet is fitted into said recess formed in the distal end of said lancing means.

20. A body fluid-collecting and detecting unit for detecting a target component of a body fluid comprising:

a housing having a bottom face;

an inlet port for the body fluid;

a test strip which enables measurement of the target component in the body fluid;

a flow path for guiding the body fluid from said inlet port to said test strip by capillary action;

a body fluid guide formed along the periphery of the inlet port, wherein said body fluid guide comprises two or more side members and a lower plate member, and

wherein said body fluid guide is designed such that a width between said side members increases from the side of said inlet to the side of a distal end, and surface tension of said body fluid is lower in an interior space enclosed with said guide members than in an interior of said flow path, and the distal ends of said side members are mounted at an angle less than 90°

to the bottom face of said housing.

21. An assembly having a lancet and body fluid collection and detection means for collecting and detecting a body fluid wherein said assembly is to be detachably mounted on a body fluid-monitoring system having a lancing means and said assembly comprises:

a lancet section comprising

a lancet having a puncture needle on a distal end of the lancet and a connector on a proximal end of the lancet for connection to said lancing means of the body fluid-monitoring system, and a first housing having a sleeve which movably accommodates said lancet in an interior of the sleeve, and which has a first opening on a distal end of the sleeve to enable projection of the needle into an exterior of the sleeve and a proximal opening to enable connection of said connector with said lancing means of the body fluid-monitoring system, and

wherein said lancet before the lancing is secured in said sleeve at a position near the proximal opening to gas-tightly seal said sleeve;

a body fluid-collecting and detecting section comprising the body fluid detection means and a second housing having a second opening for introducing the body fluid into said detection means;

a first seal member for sealing said first opening and a second seal member for sealing said proximal opening; and

wherein said first housing is gas-tightly sealed with both said first seal member for sealing said first opening and said second seal member for sealing said proximal opening; and

said first housing and said second housing are fixedly integrated with each other such that said first opening of said first housing and said second opening of said second housing together define a distal opening to enable the projection of said puncture needle to the exterior of said assembly, the assembly comprised of the lancet section and the body fluid-collecting and detecting section being a one-piece assembly.