Disposable lancet

• US 5,643,306 A
• Filed: 03/22/1996
• Issued: 07/01/1997
• Est. Priority Date: 03/22/1996
• Status: Expired due to Term

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US08/620,565
• Time in Patent Office: 466 Days
• Field of Search: 606/181-185, 128/770
• US Class Current: 606/182
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150488 Details of construction of shaft
• 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

Abstract

Single use disposable lancet devices are disclosed as inexpensive, easy to use, and safe instruments for the piercing or cutting of a patient'"'"'s skin to obtain small amounts of blood for diagnostic purposes. The devices described readily visually indicate, upon casual observance, whether or not they have yet been used. A locking device is further provided to physically prevent re-use of the devices after they have been used once.

Claims

1. A single use disposable lancet device comprising:

a housing;

a spring mechanism pivotally mounted in said housing, said spring mechanism comprising a sharpened end, wherein said spring mechanism is mounted within said housing in a substantially unbiased state; and

an actuator for biasing said spring mechanism, said actuator being movable, with respect to said housing, from an initial position to a biasing position to a locked position, in that order;

said actuator including a locking device which engages said spring mechanism for preventing movement of said actuator from said locked position;

said housing including an opening sized to permit said sharpened end to protrude therethrough exteriorly of said housing upon biasing of said spring mechanism, and said sharpened end retracting back inside of said housing in said locked position; and

said spring mechanism and said sharpened end being mounted within said housing in a substantially unbiased state when said actuator is in said initial position, said spring mechanism being biased by said actuator when said actuator is in said biased position causing said sharpened end to protrude from said housing, and said spring mechanism returning to a substantially unbiased state when said actuator is in said locked position.

2. A single use disposable lancet device as recited in claim 1, further comprising:

a pivot post mounted within said housing;

wherein said spring mechanism is pivotally mounted around said pivot post and is pivotally biased with respect to said pivot post upon biasing by said actuator.

3. A single use disposable lancet device as recited in claim 1, further comprising:

a stop mounted within said housing;

wherein said spring mechanism comprises a second end opposite said sharpened end, said second end being stopped from movement in a predetermined direction by said stop during biasing of said spring mechanism.

4. A single use disposable lancet device as recited in claim 1, wherein said housing comprises two face components joined by a peripheral surface to form a compartment within.

5. A single use disposable lancet device as recited in claim 4, wherein said actuator is mounted substantially centrally of one of said face components.

6. A single use disposable lancet device as recited in claim 4, wherein said actuator is mounted through said peripheral surface.

7. A single use disposable lancet device as recited in claim 4, wherein said housing is substantially disk-shaped with said two face components comprising two substantially circular faces and said peripheral surface joining said circular faces along circumferential edges.

8. A single use disposable lancet device as recited in claim 1, wherein said actuator comprises:

a button actuatable by one or more fingers of a user;

a shaft extending from said button and extending into said housing; and

a biasing portion for contacting and biasing said spring mechanism upon movement of said actuator from said initial position to said biasing position;

wherein said button visibly extends from said housing in said initial position.

9. A single use disposable lancet device as recited in claim 8, wherein said biasing portion comprises a ramped fin extending from said shaft for progressive biasing of said spring mechanism as said button is pushed nearer said housing.

10. A single use disposable lancet device as recited in claim 9, wherein said locking device comprises a notch formed between an end of said ramped fin, said shaft, and said button, wherein, upon fully depressing said button so as to abut said housing, said spring mechanism slides off said ramped fin and into said notch, thereby returning to a substantially unbiased condition and preventing return of said actuator to said initial position;

wherein, when in said initial position, said button extends from said housing so that a user can readily visually identify said initial position and know that the lancet device has yet to be used; and

wherein, when in said locked position, said button is approximate said housing so that a user can readily visually identify said locked position and know that the lancet device has been used and is to be disposed of.

11. A single use disposable lancet device as recited in claim 8, wherein said actuator further comprises:

a flange extending from an end of said shaft opposite an end of said shaft which extends from said button;

wherein said flange abuts said spring mechanism in said initial position and prevents removal of said actuator from said housing.

12. A single use disposable lancet device as recited in claim 8, wherein said biasing portion comprises a taper on an end of said shaft opposite an end of said shaft extending from said button, and an untapered portion of said shaft extending from said taper for progressive biasing of said spring mechanism as said button is pushed nearer said housing.

13. A single use disposable lancet device as recited in claim 12, wherein said locking device comprises a notch formed in said shaft, between said untapered portion and said end of said shaft extending from said button, wherein, upon fully depressing said button so as to abut said housing, said spring mechanism slides off said untapered portion and into said notch, thereby returning to a substantially unbiased condition and preventing return of said actuator to said initial position;

wherein, when in said initial position, a user can readily visually identify said initial position and know that the lancet device has yet to be used; and

wherein, when in said locked position, a user can readily visually identify said locked position and know that the lancet device has been used and is to be disposed of.

14. A single use disposable lancet device as recited in claim 13, wherein said actuator further comprises:

a flange extending from said shaft between said notch and said end of said shaft which extends from said button;

wherein said flange abuts an internal surface of said housing when said actuator is in said initial position and prevents removal of said actuator from said housing.

15. A single use disposable lancet device as recited in claim 12, wherein said locking device comprises a keyway formed through said shaft, between said untapered portion and said end of said shaft extending from said button, wherein, upon fully depressing said button so as to abut said housing, said spring mechanism slides off said untapered portion and into said keyway, thereby returning to a substantially unbiased condition and preventing return of said actuator to said initial position;

wherein, when in said initial position, a user can readily visually identify said initial position and know that the lancet device has yet to be used; and

wherein, when in said locked position, a user can readily visually identify said locked position and know that the lancet device has been used and is to be disposed of.

16. A single use disposable lancet device as recited in claim 15, wherein said actuator further comprises:

a flange extending from said shaft between said keyway and said end of said shaft which extends from said button;

wherein said flange abuts an internal surface of said housing when said actuator is in said initial position and prevents removal of said actuator from said housing.

17. A single use disposable lancet device comprising:

a housing;

a spring mechanism mounted to said housing, said spring mechanism comprising a sharpened end, wherein said spring mechanism is mounted within said housing in a substantially unbiased state;

an actuator for biasing said spring mechanism, wherein said actuator is movable, with respect to said housing, to bias said spring mechanism to extend said sharpened end so as to protrude from said housing;

means for indicating that the lancet device has not been used and that the lancet device has been used, wherein said means for indicating is movable with said actuator to move from indicating that the lancet device has not been used and that the lancet device has been used; and

means for preventing re-use of the lancet device after a single use has been accomplished, wherein said means for preventing engages said actuator upon protrusion of said sharpened end from said housing.

18. A single use disposable lancet device as recited in claim 17, wherein said actuator comprises:

a button actuatable by one or more fingers of a user;

a shaft extending from said button and extending into said housing; and

a biasing portion for contacting and biasing said spring mechanism upon movement of button toward said housing;

wherein said means for indicating that the lancet device has not been used and has been used comprises two positions of said button with respect to said housing wherein said button visibly extends from said housing to show that the lancet device has not been used, and wherein said button visibly contacts said housing to show that the lancet device has been used; and

wherein said means for preventing re-use of the lancet device after a single use has been accomplished comprises a locking mechanism which locks said button in the position wherein said button contacts said housing, thereby preventing retraction of said button and preventing said actuator from biasing said spring mechanism more than one time.

19. A single use disposable lancet device as recited in claim 17, wherein said actuator comprises:

a button actuatable by one or more fingers of a user;

a shaft extending from said button and extending into said housing; and

a biasing portion for contacting and biasing said spring mechanism upon movement of button toward said housing;

wherein said means for indicating that the lancet device has not been used and has been used comprises two positions of said button with respect to said housing wherein said button visibly extends from said housing to show that the lancet device has not been used, and wherein said button is substantially flush with said housing to show that the lancet device has been used; and

wherein said means for preventing re-use of the lancet device after a single use has been accomplished comprises a locking mechanism which locks said button in the position wherein said button contacts said housing, thereby preventing retraction of said button and preventing said actuator from biasing said spring mechanism more than one time.

20. A single use disposable lancet device as recited in claim 18, wherein said button includes an element to prevent actuation of the button.

21. A single use disposable lancet device as recited in claim 19, wherein said button includes an element to prevent actuation of the button.