Lancet apparatus and methods

• US 5,776,157 A
• Filed: 10/02/1996
• Issued: 07/07/1998
• Est. Priority Date: 10/02/1996
• Status: Expired due to Term

• Current Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Farnes, Tim L., Thorne, Gale H., Thorne, Gale H. Jr., Owen, Charles V., Stout, Gary H.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): MULCARE, NANCY C
• Application Number:
  US08/720,699
• Time in Patent Office: 643 Days
• Field of Search: 606/181, 606/182, 606/183, 128/760, 128/762, 128/771, 204/206, 206/569-571
• US Class Current: 606/182
• 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 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/15128 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
• CPC Class Codes: A61B 5/15155 Piercing elements which are specially shaped or are provided with fittings or attachments to facilitate nesting, stacking or joining together end-to-end or side-by-side
• CPC Class Codes: A61B 5/15165 Piercing elements stocked in or on a strip

Abstract

A one-time-use, self-powered, disposable lancet apparatus packaged both as strips comprising a plurality of lancets and as individually packaged lancets. A novel lancet blade design comprises means for attaching each blade in a loader stack for an automated assembly machine. Individually packaged lancets are disclosed in both one-step and two-step embodiments. In each case, every lancet comprises a self-contained package which houses a powered lancet blade before use and a spent blade after use to assure safety from inadvertent sticks both before and after a lancing procedure.

Claims

1. A one-time-use, disposable lancet actuating apparatus which is triggered to discharge a lancet tip from a lancet housing and to retract the lancet tip into the lancet housing for safe disposal, said apparatus comprising:

the lancet housing comprising at least one frangible part;

a lancet blade disposed within the lancet housing and comprising the lancet tip;

means for storing energy which is also disposed within the lancet housing and which is adapted to be selectively released from a state of high potential energy to provide a unidirectional angular form of kinetic energy, said energy storing means comprising means for driving said blade linearly outward from and inward into said lancet housing as a result of said angular form of kinetic energy and for communicating with a catch which further communicates with a triggerable release;

said lancet housing further comprising a hub which in an initial state is an integral and is a frangibly releasible part of said lancet housing, said hub comprising a frangibly releasing section the catch and a base which communicates through said frangibly releasing section to the rest of said lancet housing as a part of said triggerable release and which communicates through the hub to the catch for said communicating means; and

said frangibly releasing section comprising a pair of concentric grooves, at least one of said grooves circumscribing said base, said grooves in combination defining a region, interposed between said grooves, in which substantially all segments of said lancet housing which frange when the base of the hub is placed under stress and separated from the rest of the lancet housing are disposed.

2. A one-time-use, disposable lancet actuating apparatus according to claim 1, wherein said lancet housing comprises an orifice through which the lancet tips travels outwardly and inwardly.

3. A one-time-use, disposable lancet actuating apparatus according to claim 2, wherein said lancet housing further comprises a shroud disposed about said orifice, said shroud comprising a raised surface which acts to contain flow of fluid resulting from action of the lancet.

4. A one-time-use, disposable lancet actuating apparatus according to claim 1, wherein said lancet housing comprises a linear strip comprising a plurality of frangibly connected lancet devices.

5. A one-time-use, disposable lancet actuating apparatus according to claim 1, wherein said lancet housing comprises only a single lancet device.

6. A one-time-use, disposable lancet actuating apparatus according to claim 1, wherein said apparatus comprises two housing parts, said lancet housing and a second housing, said lancet housing disposed as an inner housing slidably disposed inside said second housing, said lancet and second housings being moved one relative to the other to form said triggerable release for frangibly separating the hub from the lancet housing.

7. A one-time-use, disposable lancet actuating apparatus according to claim 6, wherein said lancet and second housings, in combination, comprise means for moving said lancet housing relative to said second housing in a direction which is transverse to direction of linear movement of said lancet tip.

8. A one-time-use, disposable lancet actuating apparatus according to claim 6, wherein said lancet and second housings, in combination, comprise means for moving said lancet housing relative to said second housing in a line of movement substantially parallel to direction of linear movement of said lancet tip.

9. A one-time-use, disposable lancet actuating apparatus which is triggered to discharge a lancet tip from a lancet housing and retract the lancet tip into the lancet housing for safe disposal, said apparatus comprising:

at least one lancet housing frangibly joined to a blank, said blank comprising a closure over a portion of said lancet housing which comprises an orifice through which said lancet tip is discharged and retracted, said orifice being opened when the blank is removed from the lancet housing prior to, and in preparation for, use of the apparatus in a medical procedure;

the lancet housing comprising a top part securely affixed to a bottom part;

a lancet blade disposed within the lancet housing and comprising the lancet tip;

means for storing energy which is selectively released from a state of high potential energy to provide a unidirectional angular form of kinetic energy, said energy storing means comprising means for driving said blade linearly outward from and inward into said lancet housing as a result of said angular form of kinetic energy and for communicating with a catch which further communicates with a triggerable release;

inwardly and a shroud disposed as an interface between said lancet housing and said blank, said shroud being disposed about said orifice after the blanks removed and comprising an arcuately a raised surface disposed in said bottom part and a complementary raised surface disposed in said top part which in combination act to contain flow of fluid resulting from action of the lancet.

10. A one-time-use, disposable lancet actuating apparatus according to claim 9 wherein each of said raised surface comprises an edge which is affixed to a frangible portion of said housing and, when displaced from the frangible portion comprises an internal surface which is not contaminated by material externally disposed to said housing before displacing the frangible portion.

11. A one-time-use, disposable lancet actuating apparatus according to claim 9 wherein said lancet housing comprises a linear strip comprising a plurality of frangibly connected lancet housings and associated blanks.

12. A one-time-use, disposable lancet actuating apparatus according to claim 9 wherein said lancet housing comprises only a single lancet device.

13. A one-time-use, disposable lancet actuating apparatus according to claim 9 wherein said apparatus comprises two housing parts, said lancet housing and a second housing, said lancet housing disposed as an inner housing slidably disposed inside said second housing, said lancet and second housings being moved one relative to the other to form said triggerable release for frangibly separating a hub part from the rest of the lancet housing.

14. A one-time-use, disposable lancet actuating apparatus according to claim 13 wherein said lancet and second housings, in combination, comprise means for moving said lancet housing relative to said second housing in a direction which is transverse to direction of linear movement of said lancet tip.

15. A one-time-use, disposable lancet actuating apparatus according to claim 13 wherein said lancet and second housings, in combination, comprise means for moving said lancet housing relative to said second housing in a line of movement substantially parallel to direction of linear movement of said lancet tip.