Installation body for body fluid sampling apparatus and method of manufacturing the apparatus

• US 20040209350A1
• Filed: 02/02/2004
• Published: 10/21/2004
• Est. Priority Date: 08/03/2001
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Sakata, Tetsuya
• Granted Patent: US 8,323,212 B2
• Time in Patent Office: Days
• US Class Current: 435/287.1
• 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/150519 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 5/150541 Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• 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 5/15125 comprising a vacuum or compressed fluids
• 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

Abstract

The present invention relates to an attachment (X) for body fluid sampling device, comprising: a lancing member (21) including a lancing needle (28); an analyzing implement (5) for obtaining information on a target component in body fluid; and an attachment main body (1) holding the lancing member (21) and the analyzing implement (5). The attachment main body (X) includes a movable member (3) movable with the analyzing implement (5) longitudinally of the lancing needle (28). The attachment main body (1) includes for example, a holder (2) for holding the lancing member (21). The holder (2) has an inner space (22) for movement of the lancing needle (28). The lancing needle (28) is held preferably as sealed in the inner space (22).

Claims

1. An attachment for body fluid sampling device, comprising:

a lancing member including a lancing needle;

an analyzing implement for obtaining information on a target component in body fluid; and

an attachment main body holding the lancing member and the analyzing implement,

wherein the attachment main body includes a movable member movable with the analyzing implement longitudinally of the lancing needle.

2. The attachment according to claim 1, wherein

the attachment main body includes a holder for holding the lancing member,

the holder having an inner space for movement of the lancing member,

the lancing needle being held as sealed in the inner space.

3. The attachment according to claim 2, wherein

the holder includes an opening for the inner space to communicate with outside,

the inner space being sealed by a seal on the opening.

4. The attachment according to claim 1, further comprising a cap co-holding the analyzing implement with the movable member,

wherein removal of the cap leaves the analyzing implement held by the movable member.

5. The attachment according to claim 4, wherein

the movable member includes first holding means for holding the analyzing implement,

the cap including second holding means for holding the analyzing implement,

the first holding means having a greater holding force for holding the analyzing implement than the second holding means.

6. The attachment according to claim 5, wherein the first holding means has a plurality of hook-like engagers.

7. The attachment according to claim 5, wherein

the analyzing implement includes a through hole,

the second holding means includes an engager having a diameter grater than that of the through hole, for insertion through the through hole.

8. The attachment according to claim 1, wherein the analyzing implement includes a substrate, and a first and a second electrodes formed on the substrate, the analyzing implement being held by the movable member, with part of the first and the second electrodes extending sideways of the movable member.

9. The attachment according to claim 1, wherein

the lancing member is integral with the holder via a weak portion,

the lancing member moves relatively to the holder upon a longitudinal load onto the lancing member.

10. A method of making an attachment for body fluid sampling device, comprising:

a sealing step of sealing a lancing needle held by an attachment main body;

a sterilizing step of sterilizing the attachment main body which holds the lancing needle; and

an analyzing implement mounting step of mounting an analyzing implement in the sterilized attachment main body.

11. The method according to claim 10, wherein the analyzing implement mounting step is performed by attaching a cap which holds the analyzing implement to the attachment main body.

12. The method according to claim 10, wherein

the attachment main body includes an inner space communicating with outside via an opening,

the sealing step being performed by sealing the opening with a seal.

13. The method according to claim 12, wherein the seal is fixed to the attachment main body by ultrasonic fusing in the sealing step.

14. The method according to claim 10, wherein the sealing step includes formation of a holder holding the lancing needle, and integration thereafter of the holder with a movable member, the movable member having holding means for holding the analyzing implement and being movable back and forth relatively to the holder.