Lancet assembly

• US 5,755,733 A
• Filed: 07/29/1996
• Issued: 05/26/1998
• Est. Priority Date: 11/29/1994
• Status: Expired due to Term

• Current Assignee: Asahi Polyslider Company, Limited (Izumi-Cosmo Co., Ltd.)
• Original Assignee: Apls Co., Ltd.
• Inventors: Morita, Susumu
• Primary Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/682,706
• Time in Patent Office: 666 Days
• Field of Search: 606/181-185, 128/770-771
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150312 Sterilisation of piercing elements, piercing devices or sampling devices piercing element stocking means, e.g. cartridges, A61B5/15176
• CPC Class Codes: A61B 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• 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 5/150893 by indicating if used, tampered with, unsterile or defective
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

There is provided a blade type lancet assembly of which sterile condition is readily to be kept.

A lancet assembly is composed of a lancet structure and a holder which is combined with the lancet structure, the lancet structure includes a lancet member having a pricking member and an ejector which ejects the lancet member, and an exposed portion of the pricking member is covered with a resin.

Claims

1. A lancet assembly including an ejector assembly, the ejector assembly comprising:

a base member;

a spring member coupled to the base member and extending therefrom; and

at least one flap extending from the base member toward the spring member substantially adjacent the spring member, the flap being separated from the spring member by a gap, said flap acting as an entanglement preventative means whereby said flap substantially prevents foreign objects from becoming entangled with the spring member during handling of the ejector assembly before assembly of the ejector assembly into the lancet assembly.

2. The lancet assembly of claim 1 wherein the base member includes:

a base portion to which said spring member is coupled; and

at least one arm extending upwardly from the base portion substantially parallel the spring member;

wherein the spring member is generally in the form of a wave, and wherein at least one flap has a waved edge disposed substantially adjacent the spring member such that the waved edge of the flap generally follows the waved form of the spring member.

3. The lancet assembly of claim 2 wherein the flap is integrally formed with the arm.

4. The lancet assembly of claim 1 wherein the base member is a U-shaped structure which includes:

a base portion; and

two arms upwardly extending from the base portion substantially parallel to and disposed along opposite sides of the spring member;

wherein the spring member has a generally wave-like contour, and wherein the at least one flap has a waved edge disposed between one of said arms and said spring member substantially adjacent the spring member such that the waved edge of the flap generally follows the wave-like contour of the spring member.

5. The lancet assembly of claim 1 wherein the base member includes:

a base portion; and

at least one arm extending upwardly from the base portion substantially parallel the spring member;

wherein the spring member is in the form of a coil, and the at least one flap has a substantially straight edge disposed substantially adjacent the spring member.

6. The lancet assembly of claim 5 wherein the flap is integrally formed with the arm.

7. A lancet assembly including a lancet structure and a holder for at least partially enclosing the lancet structure, the lancet structure comprising:

a lancet member;

a blade coupled to the lancet member;

an ejector operable to move the lancet member relative to the holder to extend the blade from the holder in an ejection direction;

a molded resin cover covering an exposed portion of the blade; and

a notch in the resin cover at a position at which the resin cover is breakable to expose the exposed portion of the blade when the resin cover is pulled in the ejection direction, the notch being of a depth such that it does not interfere with the sterility of the blade.

8. The lancet assembly of claim 7 wherein the notch is molded.

9. The lancet assembly of claim 8 wherein the notch is further cut into the cover after the resin cover is molded.

10. The lancet assembly of claim 7 wherein the notch is cut into the cover after the resin cover is molded.

11. The lancet assembly of claim 7 wherein said notch is narrow slit.

12. A method for assembling a lancet assembly having a lancet structure and a holder having a cavity, the lancet structure including an ejector, a lancet body, a sterile pricking member and a cover over the pricking member, the lancet assembly having an ejection axis along which the pricking member is ejected through the holder during use, said method comprising the steps of:

holding the holder, inserting the lancet structure into the holder substantially along the ejection axis such that a portion of the cover over the sterile pricking member extends partially through an ejection opening in a wall of the holder.

13. The method as claimed in claim 12 wherein the ejector, lancet body, and cover over the pricking member are formed as a unitary lancet structure and the step of inserting the lancet structure includes inserting the unitary lancet structure into the holder.

14. The method as claimed in claim 12 further including the step of coupling the covered pricking member to the lancet body.

15. The method as claimed in claim 14 wherein the coupling step includes sliding a male portion of the covered pricking member into a female portion of the lancet body in a direction substantially perpendicular to the ejection axis prior to the step of inserting the lancet structure into the holder.

16. The method as claimed in claim 14 wherein the step of inserting the lancet structure includes the steps of inserting the coupled lancet body and covered pricking member into the holder in the direction of the ejection axis, inserting the ejector into the holder, and coupling the ejector to the lancet body.

17. The method as claimed in claim 12 wherein the lancet body and the covered pricking member are formed as a unitary lancet member, and the step of inserting the lancet structure includes the steps of inserting the unitary lancet member into the holder in the direction of the ejection axis, inserting the ejector into the holder, and coupling the ejector to the lancet body.

18. The method as claimed in claim 12 wherein the step of holding the holder comprises substantially sandwiching the holder within a first assembly tool, the method further comprising the steps of substantially sandwiching the lancet structure within a second assembly tool, aligning the lancet structure with the holder, and releasing the lancet structure from the second assembly tool to insert the lancet structure into the holder.

19. The method as claimed in claim 18 wherein the step of sandwiching the lancet structure includes the step of sandwiching the lancet structure between first and second halves of the second assembly tool, and the step of releasing the lancet structure includes the step of separating the first and second halves of the second assembly tool.

20. The method as claimed in claim 12 wherein the step of holding the holder comprises substantially sandwiching the holder within a first assembly tool, the method further comprising the steps of substantially sandwiching the lancet body and covered pricking member within a second assembly tool, substantially sandwiching the ejector within a third assembly tool, aligning the lancet body and covered pricking member with the holder, and releasing the lancer body and covered pricking member from the second assembly tool to insert the lancet body and covered pricking member into the holder, aligning the ejector with the lancet body, covered pricking member, and holder, and releasing the ejector from the third assembly tool.

21. The method as claimed in claim 20 wherein the step of sandwiching the lancet holder and covered pricking member includes the step of sandwiching the lancet body and covered pricking member between first and second halves of the second assembly tool, and the step of releasing the lancet body and covered pricking member includes the step of separating the first and second halves of the second assembly tool.

22. The method as claimed in claim 20 wherein the step of sandwiching the ejector includes the step of sandwiching the ejector between first and second halves of the third assembly tool, and the step of releasing the ejector includes the step of separating the first and second halves of the third assembly tool.

23. The method as claimed in claim 21 wherein the step of sandwiching the ejector includes the step of sandwiching the ejector between first and second halves of the third assembly tool, and the step of releasing the ejector includes the step of separating the first and second halves of the third assembly tool.

24. The method as claimed in claim 18 further comprising the steps of automatically feeding the holder to the first assembly tool and automatically feeding the lancet assembly to the second tool.

25. The method as claimed in claim 20 further comprising the steps of automatically feeding the holder to the first assembly tool and automatically feeding the lancet assembly to the second tool.