Lancet device for forming incision

• US 7,879,058 B2
• Filed: 04/22/2005
• Issued: 02/01/2011
• Est. Priority Date: 04/26/2004
• Status: Active Grant

• Current Assignee: Asahi Polyslider Company, Limited (Izumi-Cosmo Co., Ltd.)
• Original Assignee: Asahi Polyslider Company, Limited (Izumi-Cosmo Co., Ltd.)
• Inventors: Ikeda, Yoshiaki
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Tanner; Jocelin C
• Application Number:
  US11/587,539
• Publication Number:
  US 20070225741A1
• Time in Patent Office: 2,111 Days
• Field of Search: 606167-185, 600/583
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150465 Specific design of proximal end
• CPC Class Codes: A61B 5/150564 Protectors removed by pulling or pushing
• 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 5/150717 manually removed
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

An incision device capable of preventing inadvertent firing, and including a covered attached to the device. The incision device comprises a housing, and a lancet guide assembly having lancet guides and a lancet body. The lancet body further comprises a lancet blade. The lancet blade is covered by a removable protective cover having a stopper which prevents a trigger arm from being moved so as to fire the lancet blade.

Claims

1. An incision device for forming an incision, the incision device comprising:

(1) a housing including a first opening;

(2) a lancet guide assembly including a lancet body and a lancet guide, the lancet body being mounted within the housing for pivotal movement and comprising a lancet blade covered by a removable protective cover, and the lancet guide being provided for guiding the lancet blade through an arcuate cutting stroke;

(3) a trigger mechanism including a trigger arm mounted in the housing for pivotal movement between a ready-to-fire position and a firing position, the trigger arm having a trigger actuating element; and

(4) a spring element arranged within the housing so as to be in an unbiased condition when the trigger arm is in the ready-to-fire position and so as to be biased by engaging a catch arranged in the housing as the trigger arm pivots towards the firing position,

wherein the housing and lancet guide assembly are configured such that during the cutting stroke, the lancet blade extends through the first opening in the housing when the lancet body is pivoted between an unfired position and a fired position;

wherein the trigger mechanism and the spring element are configured such that the spring element in the biased condition is released from the catch arranged in the housing when the trigger arm reaches the firing position;

wherein the spring element is arranged such that when released from the catch the spring element exerts a force on the lancet body which pivots the lancet body from the unfired position to the fired position and thereby moves the lancet blade through the cutting stroke; and

wherein the removable protective cover comprises a stopper which prevents the trigger arm from moving to reach the firing position when the protective cover covers the lancet blade by directly contacting the trigger actuating element.

2. The incision device according to claim 1 wherein each of the trigger mechanism and the lancet body are arranged independently in the housing.

3. The incision device according to claim 1 wherein each of the lancet body and the trigger arm pivots respectively.

4. The incision device according to claim 3 wherein the lancet body pivots about a first pivot axis at an end of the lancet body and a first bearing portion arranged in the housing which corresponds to the first pivot axis, and

wherein the trigger arm pivots about a second pivot axis at an end of the trigger arm and a second bearing portion arranged in the housing which corresponds to the second pivot axis.

5. The incision device according to claim 1 wherein the trigger mechanism and the lancet body are integrally formed by a connecting portion located between them, and a notch is provided between the trigger mechanism and the connecting portion and a notch is provided between the connecting portion and the lancet body, the notches being configured to substantially allow pivot movements of the trigger mechanism and the lancet body.

6. The incision device according to claim 1 wherein the spring element is connected to the trigger arm.

7. The incision device according to claim 1 wherein the spring element has a resiliently compressible generally V-shaped configuration, an end of the spring element being connected to the trigger actuating element of the trigger arm and a free end of the spring element being engaged with the catch when the trigger arm is in the ready-to-fire position such that movement of the trigger arm from the ready-to-fire position to the firing position compresses the spring element.

8. The incision device according to claim 7 wherein the spring element is configured such that the free end of the spring element strikes and then comes over the lancet body when the biased spring element is released.

9. The incision device according to claim 1 wherein the trigger arm is configured such that when the trigger arm reaches the firing position, the trigger arm abuts against the spring element and releases the spring element from the catch.

10. The incision device according to claim 9 wherein the spring element includes a cam surface, and the trigger arm includes a cam surface which complementarily engages the cam surface of the spring element so as to release the spring element from the catch when the trigger arm reaches the firing position.

11. The incision device according to claim 1 wherein the housing includes a guide groove, and

wherein the lancet guide comprises a projecting lug carried by the lancet body which complementarily engages the guide groove.

12. The incision device according to claim 1 wherein the lancet guide assembly is configured such that the lancet blade is arranged entirely within the housing when the lancet body is in the unfired position and when the lancet body is in the fired position.

13. The incision device according to claim 1 wherein the lancet blade is carried on the lancet guide assembly by a blade holder included on the lancet body.

14. The incision device according to claim 1 wherein the trigger arm is configured such that it cannot return to the ready-to-fire position after it has been pivoted to the firing position.

15. The incision device according to claim 1 wherein the removable protective cover of the lancet guide assembly is a snap-off or pull-off removable protective cover.

16. The incision device according to claim 1 wherein the removable protective cover includes a flange portion which covers a skin-engaging portion of the housing, and

wherein the stopper is a protrusion which extends into the housing from the flange portion.

17. The incision device according to claim 1 wherein the lancet body includes an expandable section which permits linear expansion of the lancet body when the lancet body is pivoted between the unfired position and the fired position.

18. The incision device according to claim 17 wherein the expandable section has a bilaterally symmetrical shape.

19. The incision device according to claim 18 wherein the expandable section has an oval-shape.

20. The incision device according to claim 1, wherein said housing further includes a second opening,

wherein the stopper of the removable protective cover extends through the second opening when the lancet blade is covered by the removable protective cover, and

wherein the first opening is spaced apart from the second opening.

21. The incision device according to claim 1, wherein the trigger mechanism is configured such that the trigger actuating element contacts the spring element when the trigger arm is pivoted to the firing position so as to release the spring arm from the catch, and

wherein the removable protective cover is configured such that the stopper blocks a pivoting path of the trigger arm such that the trigger actuating element directly contacts the stopper and is prevented from reaching the spring element when the removable protective cover covers the lancet blade.

22. The incision device according to claim 1, wherein the housing includes an edge portion, and wherein the trigger arm includes a ridge which engages the edge portion when the trigger arm reaches the firing position so as to prevent the trigger arm from returning to the ready-to-fire position.

23. An incision device for forming an incision, the incision device comprising:

(1) a housing including a first opening;

(2) a lancet guide assembly including a lancet body and a lancet guide, the lancet body being mounted within the housing for pivotal movement and comprising a lancet blade covered by a removable protective cover, and the lancet guide being provided for guiding the lancet blade through an arcuate cutting stroke;

(3) a trigger mechanism including a trigger arm mounted in the housing for pivotal movement between a ready-to-fire position and a firing position; and

(4) a spring element arranged within the housing so as to be in an unbiased condition when the trigger arm is in the ready-to-fire position and so as to be biased by engaging a catch arranged in the housing as the trigger arm pivots towards the firing position,

wherein the housing and lancet guide assembly are configured such that during the cutting stroke, the lancet blade extends through the first opening in the housing when the lancet body is pivoted between an unfired position and a fired position;

wherein the trigger mechanism and the spring element are configured such that the spring element in the biased condition is released from the catch arranged in the housing when the trigger arm reaches the firing position;

wherein the spring element is arranged such that when released from the catch the spring element exerts a force on the lancet body which pivots the lancet body from the unfired position to the fired position and thereby moves the lancet blade through the cutting stroke;

wherein the removable protective cover comprises a stopper which prevents the trigger arm from moving to reach the firing position when the protective cover covers the lancet blade; and

wherein the housing includes an edge portion, and wherein the trigger arm includes a ridge which engages the edge portion when the trigger arm reaches the firing position so as to prevent the trigger arm from returning to the ready-to-fire position.