Lancet Assembly and Pricking Device

• US 20090143810A1
• Filed: 09/25/2006
• Published: 06/04/2009
• Est. Priority Date: 09/29/2005
• Status: Active Grant

• Current Assignee: Izumi-Cosmo Co., Ltd.
• Original Assignee: Izumi-Cosmo Co., Ltd.
• Inventors: Abe, Teruyuki, Seki, Kazuharu, Kitamura, Yoritaka
• Granted Patent: US 8,246,645 B2
• Time in Patent Office: Days
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• 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 5/150564 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 5/150725 removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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

Abstract

A lancet assembly that enables it to prick with smaller number of steps and be disposed safely. The lancet assembly comprising a lancet and a lancet holder that houses the lancet, wherein

• • the lancet comprises a lancet body, a lancet cap and a pricking component, the pricking component is situated in both of the lancet body and the lancet cap, the tip of the pricking component is covered with the lancet cap, and the lancet cap and the lancet body are integrally connected together by a bridging component;
  • when the lancet cap is pressed in the pricking direction with the lancet body attached to the lancet holder, the bridging component is broken so that the lancet cap is separated from the lancet body; and thereafter
  • when the separated lancet cap is pressed further in the pricking direction, the separated lancet cap moves to a position that is off the pricking pathway of the pricking component.

Claims

1. A lancet assembly comprising a lancet and a lancet holder that houses the lancet, wherein

the lancet comprises a lancet body, a lancet cap and a pricking component in which the lancet body and the lancet cap are made of resin and the pricking component is made of metal, the pricking component is situated in both of the lancet body and the lancet cap, the tip of the pricking component is covered with the lancet cap, and the lancet cap and the lancet body are integrally connected together by a bridging component;

when the lancet cap is pressed in the pricking direction with the lancet body attached to the lancet holder, the bridging component is broken so that the lancet cap is separated from the lancet body, and thereby the tip of the pricking component is exposed while the pricking component remains situated in the lancet body; and

when the separated lancet cap is pressed further in the pricking direction, the separated lancet cap moves to a position that is off the pricking pathway of the pricking component.

2. The lancet assembly according to claim 1, wherein the lancet holder has, on its inner wall, a guide for guiding the lancet body along the pricking direction, and the lancet body has a guided component that slots into the guide of the lancet holder;

and

a protrusion A on the guided component and a protrusion B within the guide are in contact with each other, and thereby the lancet body is secured to the lancet holder.

3. The lancet assembly according to claim 1, wherein the bridging component has a notch.

4. The lancet assembly according to claim 1, wherein the lancet is housed in the lancet holder so that the lancet does not protrude from the lancet holder;

and

the lancet holder has an opening on each of its end faces whereas the lancet holder has no openings on its side faces.

5. The lancet assembly according to claim 4, wherein the lancet holder has a pricking opening on one end face thereof;

and

the pricking opening has a diameter in a range from 0.5 to 2.0 mm.

6. The lancet assembly according to claim 2, wherein the protrusion A and the protrusion B are in contact with each other such that the one protrusion B is located between the two protrusions A, and thereby the lancet body is secured to the lancet holder.

7. The lancet assembly according to claim 1, wherein the lancet cap comprises a pair of first wing parts extending backward.

8. The lancet assembly according to claim 1, wherein the lancet holder is provided with a slope component for guiding the separated lancet cap to the position that is off the pricking pathway;

and

the lancet cap is provided with a sloped portion that has a shape corresponding to the slope component.

9. The lancet assembly according to claim 1, wherein the lancet cap is capable of engaging with a lancet cap removing part that is provided in an injector for launching the pricking component;

the lancet cap removing part engages with the lancet cap when the lancet assembly with the lancet body secured to the lancet holder is loaded into the injector by inserting the lancet holder into the injector through the front end opening of the injector;

when the lancet holder is further inserted while the lancet cap removing part and the lancet cap is still in engagement, the force for pressing the lancet cap in the pricking direction is generated so that the bridging component is broken and the lancet cap is separated from the lancet body, and thereby the tip of the pricking component is exposed while the pricking component remains situated in the lancet body; and

when the lancet holder is furthermore inserted, the separated lancet cap moves to the position that is off the pricking pathway within the lancet holder.

10. The lancet assembly according to claim 7, wherein the edge of each first wing part of the lancet cap has an engagement portion that is capable of complementarily engaging with the end portion of the lancet cap removing part.

11. The lancet assembly according to claim 9, wherein

the rear end portion of the lancet body has an engagement portion that is capable of engaging with a plunger provided in the injector;

the rear end portion of the lancet body and the front end portion of the plunger engage with each other when the lancet assembly is loaded into the injector by inserting the lancet holder into the injector through the front end opening of the injector, and thereby, when the lancet holder is inserted further, the plunger is retracted so that the force required for launching the pricking component is stored in the plunger.

12. The lancet assembly according to claim 11, wherein

the lancet holder has, on its inner wall, a guide channel for guiding the lancet body along the pricking direction whereas the lancet body has the guided component that slots into the guide channel of the lancet holder;

the protrusion A on the guided component and the protrusion B within the guide channel are in contact with each other so that the lancet body is secured to the lancet holder; and

after the lancet cap is separated from the lancet body upon the loading of the lancet assembly into the injector, the plunger is prevented from being retracted further, so that the lancet body that is in engagement with the plunger is prevented from being further inserted; and

thereafter, when the lancet holder is forced to move further in the direction of insertion, the contact between the protrusion A and the protrusion B ceases, and thereby the lancet body can move along the guide channel in the pricking direction.

13. The lancet assembly according to claim 9, wherein the lancet body has a pair of second wing parts extending forward;

in the lancet assembly that has been ejected from the injector after pricking, the pair of second wing parts is capable of making contact with a stopper surface provided within the lancet holder so that the tip of the pricking component does not protrude from the pricking opening.

14. The lancet assembly according to claim 13, wherein the rear end face of the slope component for guiding the separated lancet cap off the pricking pathway serves as the stopper surface.

15. The lancet assembly according to claim 13, wherein there is a groove in the lancet cap removing part of the injector;

and

when the pricking component is ready to be launched, the pair of second wing parts lies in the groove.

16. The lancet assembly according to claim 15, wherein the groove is bow-shaped.

17. The lancet assembly according to claim 15, wherein

upon pricking, the pair of second wing parts moves along the groove without making contact with the stopper surface.

19. An injector for launching the pricking component, used in combination with the lancet assembly according to claim 1,

the injector comprising:

a plunger that is capable of engaging with the rear end portion of the lancet body, and thus capable of launching the lancet body in the pricking direction;

a lancet cap removing part that is capable of engaging with the lancet cap; and

a trigger lever that is pressed to launch the pricking component, wherein

the lancet assembly can be loaded into the injector by inserting the lancet holder into the injector through the front end opening of the injector;

when the lancet assembly with the lancet body secured to the lancet holder is loaded into the injector, the lancet cap removing part can engage with the lancet cap; and

when the lancet holder is further inserted while the lancet cap removing part and the lancet cap is still in engagement, the force for separating the lancet cap from lancet body or for moving the lancet cap and the lancet body away from each other is generated, and the separated lancet cap can move to the position that is off the pricking pathway of the pricking component.

20. The injector according to claim 19, wherein a spring is provided around the plunger between a flange formed around an intermediate portion of the plunger and a partition provided in an injector housing;

upon the loading of the lancet assembly into the injector, the rear end portion of the lancet body engages with the front end portion of the plunger so that the plunger is retracted, and thereby the spring is compressed;

the flange of the plunger moves to a position located backward relative to a rear stepped portion of the trigger lever, and thereafter the flange of the plunger engages with the rear stepped portion while the compressed spring is maintained.

21. The injector according to claim 13, wherein the lancet cap removing part has a bow-shaped groove;

and

when the lancet cap removing part engages with the lancet cap upon the loading of the lancet assembly into the injector, the pair of second wing parts is placed in the bow-shaped groove.

22. The injector according to claim 19, further comprising a pricking depth adjusting mechanism, the pricking depth adjusting mechanism comprises:

a protrusion that is provided on the rear end portion of the plunger, protruding outwardly from the plunger in the transverse direction thereof; and

a cylindrical component with graduated stepped portions of various heights, wherein

when the plunger moves forward for pricking, the protrusion provided on the rear end portion of the plunger hits the stepped portions of the cylindrical component so that the plunger is unable to move further forward, and

the stepped portions which the protrusion hits can be switched to other stepped portions with different heights by rotating the cylindrical component about its center axis, and thereby the distance over which the plunger can move forward for pricking is changed.

23. The injector according to claim 19, further comprising an ejector;

and

the lancet holder is pressed forward by sliding the ejector forward, and thereby the lancet assembly is ejected from the injector.

24. The lancet assembly according to claim 1, wherein

the lancet is housed in the lancet holder such that a part of the lancet cap protrudes from the lancet holder;

the protruding part of the lancet cap makes contact with the front end portion of an injector for launching the pricking component, when the lancet assembly is loaded into the injector by inserting the lancet holder into the injector through the front end opening of the injector;

when the lancet holder is further inserted while the protruding part of the lancet cap and the front end portion of the injector are still in contact with each other, the force for moving the lancet cap and the lancet body away from each other is generated so that the lancet cap is separated from the lancet body due to the breaking of the bridging component, and thereby the tip of the pricking component is exposed while the pricking component remains situated in the lancet body; and

when the lancet holder is inserted furthermore, the separated lancet cap is guided by opposing side faces of the lancet holder to move to the position that is off the pricking pathway of the pricking component.

25. The lancet assembly according to claim 24, wherein

the lancet cap comprises a pair of separator protrusions extending in a transverse direction and in a symmetrical configuration with respect to the pricking component;

each of the opposing side faces of the lancet holder has an elongated opening as a guide;

each separator protrusion of the lancet cap extends through the elongated opening so that the edge portion of the each separator protrusion protrudes outward from the elongated opening;

when the lancet assembly is loaded into the injector, the edge portion of the each separator protrusion makes contact with the front end portion of the injector;

when the lancet holder is further inserted, the edge portion of the each separator protrusion is pressed forward by the front end portion of the injector while the lancet body is prevented from moving forward, and thereby the force for moving the lancet cap and the lancet body away from each other is generated so that the bridging component is broken; and

when the lancet holder is inserted furthermore, the edge portion of the each separator protrusion moves obliquely forward off the pricking pathway along the elongated opening, and thereby the separated lancet cap together with the separator protrusions is guided to the position that is off the pricking pathway of the pricking component.

26. The lancet assembly according to claim 25, wherein, the each separator protrusion moves obliquely forward with respect to the pricking direction, and then the each separator protrusion moves forward in a direction parallel to the pricking pathway, and thereby the edge portion of the each separator protrusion moves off the pricking pathway.

27. The lancet assembly according to claim 24, wherein

the lancet body comprises a pair of stopper protrusions extending in a transverse direction and in a symmetrical configuration with respect to the pricking component;

and

each stopper protrusion is deformed inwardly by the force exerted thereon upon launching the lancet body, whereas the each stopper protrusion returns to its original shape after the pricking is completed and the tip of the pricking component has been retracted,

as a result, the each stopper protrusion upon pricking does not make contact with a stopper provided on an inner surface of the lancet holder, whereas the each stopper protrusion after pricking can make contact with the stopper and thereby the tip of the pricking component does not protrude from the pricking opening after pricking.

28. The lancet assembly according to claim 24, wherein

the lancet holder has, on its inner wall, a guide channel for guiding the lancet body in the pricking direction, and the lancet body has a guided component that slots into the guide channel of the lancet holder;

a protrusion A on the guided component and a protrusion B within the guide channel make contact with each other so that the lancet body is secured to the lancet holder; and

when the lancet assembly is loaded into the injector, the plunger is prevented from being further retracted after the lancet cap is separated from the lancet body, so that the lancet body engaging with the plunger is prevented from being further inserted into the injector;

and thereafter when the lancet holder is forced to move further in the direction of insertion, the contact between the protrusion A and the protrusion B ceases so that the lancet body can move along the guide channel in the pricking direction.

29. An injector for launching the pricking component, used in combination with the lancet assembly according to claim 24, the injector comprising:

a plunger that is capable of engaging with the rear end portion of the lancet body, and thus capable of launching the lancet body in the pricking direction; and

a trigger lever that is pressed to launch the pricking component, wherein

the lancet holder can be inserted into the injector through the front end opening of the injector while the protruding part of the lancet cap and the front end portion of the injector are still in contact with each other, and thereby the lancet cap is separated from the lancet body, and the separated lancet cap moves forward within the lancet holder to the position that is off the pricking pathway of the pricking component;

a spring is provided around the plunger between a flange formed around an intermediate portion of the plunger and a partition provided in an injector housing;

upon the loading of the lancet assembly into the injector, the rear end portion of the lancet body engages with the front end portion of the plunger so that the plunger is retracted, and thereby the spring is compressed; and

the flange of the plunger moves to a position located backward relative to the rear end portion of the trigger lever, and thereafter the flange of the plunger engages with the rear end portion of the trigger lever while the compressed spring is maintained.

30. The injector according to claim 25, further comprising a hook part on which an inward force is exerted, wherein

when the lancet holder is further inserted after the lancet cap has been separated from the lancet body, the hook part fits with the rear edge of the elongated opening from outside of the lancet holder so as to lock the lancet holder.

31. The injector according to claim 27, further comprising a slider part that extends backward from the front end portion of the injector wherein,

when the lancet holder is inserted backward into the injector through the front end opening of the injector, one stopper protrusion of the lancet body is deformed inwardly by the slider part and retains its deformed state, whereas the other stopper protrusion of the lancet body is deformed inwardly by the front portion of the trigger lever upon pressing the trigger lever inwardly.

32. The injector according to claim 31, wherein

when or after the other stopper protrusion is deformed upon pressing the trigger lever, the rear end of the trigger lever and the flange of the plunger are no longer in engagement.

33. A lancet that constitutes the lancet assembly according to claim 1.

34. A lancet holder that constitutes the lancet assembly according to claim 1.

36. The pricking device according to claim 22, wherein the pricking opening has a diameter in a range from 0.5 to 2.0 mm so that a pricking depth set by the pricking depth adjusting mechanism is less likely to be affected by the force applied to a region to be pricked.

37. A lancet that constitutes the lancet assembly according to claim 24.

38. A lancet holder that constitutes the lancet assembly according to claim 24.

18. A lancet assembly comprising a lancet and a lancet holder that houses the lancet, wherein

the lancet comprises a lancet body, a lancet cap and a pricking component in which the lancet body and the lancet cap are made of resin and the pricking component is made of metal, the pricking component is situated in both of the lancet body and the lancet cap, and the tip of the pricking component is covered with the lancet cap;

when the lancet cap is pressed in the pricking direction with the lancet body secured to the lancet holder, the lancet cap and the lancet body move away from each other, and thereby the tip of the pricking component is exposed while the pricking component remains situated in the lancet body; and

when the separated lancet cap is pressed further in the pricking direction, the separated lancet cap moves to a position that is off the pricking pathway of the pricking component.

35. (canceled)