Disposable-retractable finger stick device

• US 5,133,730 A
• Filed: 05/15/1991
• Issued: 07/28/1992
• Est. Priority Date: 05/15/1991
• Status: Expired due to Term

• Current Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Original Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Inventors: Biro, Ladislau, Cusack, Robert F., Mintz, Michael D.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/700,592
• Time in Patent Office: 440 Days
• Field of Search: 606/167, 606/181-183
• US Class Current: 606/182
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15029 for driving devices, i.e. means for driving the piercing element
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 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
• CPC Class Codes: Y10S 29/029 Molding with other step
• CPC Class Codes: Y10T 29/49845 by deforming interlock
• CPC Class Codes: Y10T 29/49861 Sizing mating parts during final positional association
• CPC Class Codes: Y10T 29/49876 by snap fit

Abstract

A finger stick device for making a skin incision includes a blade pivot arm having a first end pivotally coupled to a housing and a second end having an upper sloped surface and a lower surface. A blade is affixed to the second end such that its cutting edge extends away from the lower surface. A resilient bias member when actuated traverses the upper surface and depresses the second end of the blade pivot arm, such that the blade exits the housing and incises the skin. The incising operation is complete upon the bias member traversing the sloped upper surface of the blade pivot arm. Also disclosed herein is a method for manufacturing the finger stick device, in which the bias member and blade pivot arm are molded as a monolithic unit. A blade is attached to the blade pivot arm, and the blade and monolithic unit are inserted into the housing. Further disclosed is an embodiment in which the housing is formed of two uniformly shaped halves, which when joined, provide an internal space for the monolithic unit. In this manner, the two halves are joined with the monolithic unit aligned therebetween so that the housing appears as an integral unit.

Claims

1. Apparatus for implementing a skin incision, comprising:

a blade having a cutting edge;

housing means for housing said blade, said housing means having an exterior surface adapted to be placed flush against the skin and an elongated slot located on said exterior surface;

blade pivoting means, located within said housing means, for pivotally guiding said blade through said elongated slot, said blade pivoting means having a first and second end wherein said first end is pivotally coupled to said housing means and said second end supports said blade, whereby said cutting edge extends from a first surface of said second end toward said elongated slot, said second end having a sloped surface formed thereon opposite said first surface; and

actuatable depressing means, located within said housing means, for engaging and holding said blade pivoting means in a set position, preventing the pivotal movement of said blade pivoting means within said housing, said depressing means being actuated to disengage said blade pivoting means and transverse said sloped surface, displacing said second end of said blade pivoting means toward said elongated slot, such that said cutting edge of said blade emerges from said elongated slot and incises the skin.

2. An apparatus according to claim 1, wherein said depressing means includes an elongated member having a first end that is pivotally coupled to said housing means and a second end that abuts against and displaces said sloped surface of said second end of said blade pivoting means when said depressing means is actuated.

3. An apparatus according to claim 2, wherein said blade pivoting means further includes engaging means for engaging said second end of said elongated member such that said blade is located at said set position entirely within said housing means before said depressing means is actuated.

4. An apparatus according to claim 3, wherein said engaging means includes a detent, located at said second end of said blade pivoting means, for receiving said second end of said elongated member.

5. An apparatus according to claim 3, wherein said blade pivoting means includes a living hinge, located at said first end of said blade pivoting means, and which pivotally couples said first end of said blade pivoting means with respect to said housing.

6. An apparatus according to claim 4, wherein said elongated member is resilient, and wherein said depressing means is actuated by flexing said elongated member to cause said second end of said elongated member to disengage said detent and to traverse said sloped surface of said blade pivoting means at a rate according to the amount of flexure of said elongated member.

7. An apparatus according to claim 6, wherein said depressing means further includes disengaging means for disengaging said second end of said elongated member from said detent according to the amount of flexure of said elongated member.

8. An apparatus according to claim 7, wherein said disengaging means is pawl adjacent to said second end of said elongated member, which pawl contacts said sloped surface of said blade pivoting means when said depressing means is actuated so as to pivot and disengage said second end of said elongated member from said detent, said pawl having a predetermined length to control the amount of lexure of said elongated member.

9. An apparatus according to claim 7, wherein said depressing means further includes flexing means, said flexing means being located external said housing means and entering into said housing means for flexing said elongated member.

10. An apparatus according to claim 9, wherein said flexing means includes a lever arm having one end pivotally coupled to said housing means and a second end that enters through an aperture in said housing means and abuts against said elongated member, whereby moving said lever arm towards said housing means causes said elongated member to flex.

11. An apparatus according to claim 10, wherein said lever arm is L-shaped.

12. An apparatus according to claim 10, wherein said flexing means includes a push button, said push button having one end that enters through said aperture in said housing means and is connected to said elongated member and a second end external said housing means at said aperture, whereby moving said push button towards said housing means causes said elongated member to flex.

13. An apparatus according to claim 10, wherein an end of said housing means opposite said exterior surface is open and receives covering means for covering said open end of said housing means, wherein said first end of said elongated member is pivotally attached to a first end of said covering means, and wherein said one end of said lever arm is pivotally attached to said covering means.

14. An apparatus according to claim 13, further including a reference member having one end attached to a second end of said covering means, and wherein said living hinge pivotally attaches said first end of said blade pivoting means to an opposite end of said reference member, said reference member and said covering means functioning to separate said blade pivoting means and said elongated member by a predetermined distance, that allows said second end of said elongated member to coact with said sloped surface of said blade pivoting means.

15. An apparatus according to claim 14, wherein said lever arm, said blade pivoting means, said elongated member, said covering means and said reference member are integrally formed.

16. An apparatus according to claim 1, wherein said blade pivoting means further includes actuatable retracting means for rapidly retracting said blade, said depressing means actuating said retracting means immediately after traversing said sloped surface of said blade pivoting means, whereby said cutting edge implements a skin incision and then immediately retracts into said housing means.

17. An apparatus according to claim 16, wherein said depressing means further includes locking means for locking said elongated member to said blade pivoting means after said blade retracts into said housing means.

18. An apparatus according to claim 16, wherein said retracting means includes an elongated projection, located intermediate said first and second ends of said blade pivoting means, and wherein said depressing means strikes said elongated projection immediately after traversing said sloped surface and urges said blade pivot means to pivot said blade into said housing means.

19. An apparatus according to claim 1, wherein said blade pivoting means further includes a first living hinge that pivotally couples said first end of said blade pivot means to said housing means, wherein said first living hinge urges said blade pivot means to pivot said cutting edge into said housing means after said depressing means traverses said sloped surface of said blade pivoting means.

20. An apparatus according to claim 18, wherein said second end of said elongated member terminates in a first leg and a second leg, said first leg traversing said sloped surface of said blade pivoting means when said depressing means is actuated, and said second leg coacting with said elongated projection after said first leg traverses said sloped surface.

21. An apparatus according to claim 20, wherein said blade pivoting means further includes engaging means located at said second end of said blade pivoting means for engaging said first leg of said elongated member.

22. An apparatus according to claim 20, wherein said depressing means includes a second living hinge, for coupling said first end of said elongated member to said housing means and for urging said elongated member against said sloped surface of said blade pivoting means, and a notch located on said elongated member for receiving the tip of said sloped surface, which notch receives the tip of said sloped surface after said second leg strikes said elongated projection, whereby said blade is locked entirely in said housing means.

23. Apparatus for implementing a skin incision, comprising:

a blade having a cutting edge;

housing mean for housing said blade, said housing means having a surface adapted to be placed flush against the skin and an elongated slot on said surface;

blade pivoting means, located within said housing means, for pivotally guiding said blade through said elongated slot, said blade pivoting means having a first and second end wherein said first end is pivotally coupled to said housing means and said second end supports said blade, whereby said cutting edge extends from a first surface of said second end toward said elongated slot, said second end having a sloped surface formed thereon, opposite said first surface;

actuatable depressing means, located within said housing means, and when actuated enabling said depressing means to traverse said sloped surface, displacing said second end of said blade pivoting means toward said elongated slot, such that said cutting edge of said blade emerges from said elongated slot and incises the skin; and

retracting means, positioned on said blade pivoting means, for rapidly retracting said second end of said blade pivoting means when coacted by said depressing means immediately after traversing said sloped surface of said second end of said blade pivoting means such that said cutting edge of said blade is retracted from said elongated slot into said housing means.