Lancet-integrated mounter and method of making the same

• US 7,250,056 B2
• Filed: 06/10/2002
• Issued: 07/31/2007
• Est. Priority Date: 06/11/2001
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Hamamoto, Katsumi
• Primary Examiner(s): Dawson; Glenn K.
• Application Number:
  US10/479,528
• Publication Number:
  US 20040158271A1
• Time in Patent Office: 1,877 Days
• Field of Search: None
• US Class Current: 606/181
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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 5/15123 comprising magnets or solenoids
• 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

Abstract

A mounter (3) integrally provided with a lancing element (47B) and analyzer includes a lancing member (47) provided with the lancing element (47B), a first member (4) including an accommodation portion (40) for holding the lancing member (47), and a second member (5) formed separately from the first member (4) for holding the analyzer (6). The accommodation portion (40) includes an accommodation space (43) communicable with the outside through a first opening (43a) and a second opening (43b). The lancing member (47) is held and hermetically sealed in the accommodation space (43) by closing the first opening (43a) and the second opening (43b) with a first seal member (44a) and a second seal member (44b).

Claims

1. A lancet-integrated mounter comprising:

a lancing member including a lancing element and being forwardly movable for lancing, a first member including an accommodation portion for holding the lancing member, an analyzer to which body fluid is supplied, and a second member spaced from the accommodation portion in a forward direction of the lancing member and formed separately from the first member for holding the analyzer;

the accommodation portion including an accommodation space communicatable with an outside through a first opening and a second opening;

the lancing member being held and hermetically sealed in the accommodation space by closing the first opening and the second opening with a first seal member and a second seal member, the analyzer being held by the second member outside the sealed accommodation space.

2. The lancet-integrated mounter according to claim 1, wherein the lancing member moves from an idling position to a lancing position upon receiving an external force to cause the lancing element to project from the accommodation portion.

3. The lancet-integrated mounter according to claim 2, wherein the first seal member is adapted to be formed with a hole in exerting the external force to the lancing member, and

the lancing element forms a hole in the second seal member during the movement of the lancing member from the idling position to the lancing position.

4. The lancet-integrated mounter according to claim 2, wherein the accommodation portion is provided with an engagement portion for holding the lancing member at the idling position.

5. The lancet-integrated mounter according to claim 4, wherein the accommodation portion is provided with a stopper for controlling movement of the lancing member at the lancing position.

6. The lancet-integrated mounter according to claim 5, wherein the lancing member at the lancing position is secured between the engagement portion and the stopper.

7. The lancet-integrated mounter according to claim 1, wherein the first member further includes a holder portion for holding the second member, and a support portion for supporting the accommodation portion at a higher position than the holder portion.

8. The lancet-integrated mounter according to claim 7, wherein the accommodation portion, the holder portion and the support portion are integrally formed as one piece.

9. The lancet-integrated mounter according to claim 7, wherein the accommodation portion is formed separately from the holder portion and the support portion, the accommodation portion being removable from the holder portion and the support portion.

10. The lancet-integrated mounter according to claim 7, wherein the support portion is elastic, and

the support portion flexes to move the accommodation portion downward when an external force in the downward direction is exerted to the accommodation portion and elastically restores the accommodation portion to an original position when the external force is removed.

11. The lancet-integrated mounter according to claim 10, wherein the support portion comprises a plurality of band portions or linear portions.

12. The lancet-integrated mounter according to claim 1, wherein the analyzer is formed with a cutout for allowing movement of the lancing element.

13. The lancet-integrated mounter according to claim 1, wherein the analyzer is fixed at a position higher than a bottom surface of the second member.

14. The lancet-integrated mounter according to claim 1, wherein the analyzer is a biosensor retaining oxidoreductase.

15. A method of making a lancet-integrated mounter, the method comprising the steps of:

forming a lancing member having a lancing element;

forming an analyzer to which body fluid is introduced;

forming a first member including an accommodation portion having an accommodation space, the accommodation space being communicatable with an outside through a first opening and a second opening;

forming a second member separately from the first member;

setting the analyzer to be held by the second member;

setting the lancing member to be held in the accommodation space;

sealing the first opening and the second opening with a first seal member and a second seal member for enclosing the lancing member in the accommodation space;

sterilizing the lancing member together with the first member after the sealing step; and

fitting the second member holding the analyzer to the first member after the sterilizing step.

16. The method of making a lancet-integrated mounter according to claim 15, wherein the sealing step comprises attaching the first seal member and the second seal member to the accommodation portion by ultrasonic welding.

17. The method of making a lancet-integrated mounter according to claim 16, wherein the first seal member and the second seal member comprise a thin metal film or a resin sheet.

18. The method of making a lancet-integrated mounter according to claim 15, wherein the analyzer is a biosensor retaining oxidoreductase.

19. The method of making a lancet-integrated mounter according to claim 15, wherein the sterilizing step is performed by irradiating the first member with gamma rays or electron rays.

20. A lancet-integrated mounter comprising:

a lancing member including a lancing element, a first member including an accommodation portion for holding the lancing member, an analyzer to which body fluid is supplied, and a second member formed separately from the first member for holding the analyzer;

the accommodation portion including an accommodation space communicatable with an outside through a first opening and a second opening;

the lancing member being held and hermetically sealed in the accommodation space by closing the first opening and the second opening with a first seal member and a second seal member;

wherein the first member further includes a holder portion for holding the second member, and a support portion for supporting the accommodation portion at a higher position than the holder portion.

21. A lancet-integrated mounter comprising:

a lancing member including a lancing element, a first member including an accommodation portion for holding the lancing member, an analyzer to which body fluid is supplied, and a second member formed separately from the first member for holding the analyzer;

the accommodation portion including an accommodation space communicatable with an outside through a first opening and a second opening;

the lancing member being held and hermetically sealed in the accommodation space by closing the first opening and the second opening with a first seal member and a second seal member;

wherein the analyzer is formed with a cutout for allowing movement of the lancing element.