Slicing disposable blood sampling device

• US 5,527,333 A
• Filed: 09/09/1994
• Issued: 06/18/1996
• Est. Priority Date: 09/09/1994
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Graphic Controls Corporation (Nissha Co., Ltd.)
• Inventors: Hegarty, John M., Rosone, Steven, Field, Gregory T., Nikkels, Ben H.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/303,811
• Time in Patent Office: 648 Days
• Field of Search: 606/181-183, 606/167, 604/136-137, 604/157, 128/770
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• 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 5/15128 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

A disposable blood sampling device for slicing a precise incision of predetermined length and depth in the skin of a patient. The device includes a hollow housing having a top surface with an opening, a front surface, a rear surface, and a bottom surface with an elongated slot adapted to contact the skin of the patient. A trigger is slidably disposed in the opening in the top surface of the housing. A single spring, only, is mounted in the housing in a relaxed, unstressed, and unbiased condition when the device is not actuated. The spring is extended by the trigger when the device is actuated. A cutting blade is coupled to one end of the spring and extends through the elongated slot in the bottom surface of the housing to incise the skin of the patient when the device is actuated. Finally, the device includes a plurality of discrete constraint and restraint elements, positioned in the housing, which collectively form an open guide surface directing the spring, and the blade coupled to the spring, along a predetermined incision path.

Claims

1. A disposable device for slicing a precise incision of predetermined length and depth in the skin of a patient comprising:

a hollow housing having a top surface with an opening, a front surface, a rear surface, and a bottom surface with an elongated slot adapted to contact the skin of the patient;

a trigger slidably disposed in said opening in said top surface of said housing;

a single spring for said device mounted in said housing in a relaxed, unstressed, and unbiased condition when said device is not actuated and extended by said trigger when said device is actuated, said spring having a first end and a second end;

a cutting blade coupled to said second end of said spring and extending through said elongated slot in said bottom surface of said housing to slice the skin of the patient when said device is actuated; and

a plurality of discrete constraint and restraint elements positioned in said housing forming an open guide surface directing said spring, and said blade coupled to said spring, to slice rather than puncture along a predetermined incision path.

2. A device according to claim 1 wherein said housing has a viewport permitting observation of the skin of the patient where the incision will be made.

3. A device according to claim 2 wherein said viewport is an inwardly slanted section of said front surface of said housing, slanting downward toward said elongated slot in said bottom surface of said housing and corresponding in length with said elongated slot.

4. A device according to claim 1 wherein at least a portion of said housing is transparent.

5. A device according to claim 1 wherein said rear surface of said housing has at least one finger indentation and said front surface of said housing has a thumb indentation, said at least one finger indentation and said thumb indentation facilitating handling of said device.

6. A device according to claim 1 wherein said spring has an anchor lug integrally formed on said first end of said spring, said anchor lug mounting said spring in said housing.

7. A device according to claim 6 wherein said housing has a plurality of spring anchor posts limiting said anchor lug of said spring to a single degree of freedom and fixing said anchor lug rotatably in said housing.

8. A device according to claim 1 wherein said spring has a blade lug integrally formed on said second end of said spring, said blade lug having a blade mounting boss onto which said blade is mounted.

9. A device according to claim 1 wherein said spring is resilient plastic.

10. A device according to claim 1 wherein said housing has a spring ramp supporting said spring and upon which said spring slides as said spring extends and retracts.

11. A device according to claim 1 wherein said blade has a cutting edge with a point directed toward said elongated slot in said bottom surface of said housing, said cutting edge angled about thirty degrees from vertical.

12. A device according to claim 11 wherein said blade is surgical grade stainless steel.

13. A device according to claim 1 wherein said spring and said blade are integral and surgical grade stainless steel.

14. A device according to claim 1 wherein said plurality of discrete constraint and restraint elements include:

(a) a stop post positioned in said hollow housing,

(b) a stop positioned on said blade and contacting said stop post to limit horizontal motion of said blade,

(c) a spring restraint positioned in said hollow housing forming a channel between said spring restraint and said bottom surface of said housing, said spring restraint directing the vertical motion of said blade and said channel directing the horizontal motion of said blade, and

(d) a spring restraint follower located on said second end of said spring and opposite said blade and traversing along said spring restraint and through said channel.

15. A device according to claim 14 wherein said blade has a shoulder extending said stop and further limiting horizontal motion of said blade.

16. A device according to claim 1 further comprising means for limiting the sliding of said trigger.

17. A device according to claim 16 wherein said limiting means includes at least one trigger stop post positioned in said hollow housing, said trigger contacting said at least one trigger stop post and lying flush with said top surface of said housing when said trigger is fully depressed in said opening in said top surface of said housing and said device is fully actuated.

18. A device according to claim 1 further comprising means for preventing removal of said trigger from said opening in said top surface of said housing after actuation of said device.

19. A device according to claim 18 wherein said preventing means includes a keeper positioned in said hollow housing.

20. A device according to claim 1 further comprising means for restricting said trigger to a vertical travel path through said opening in said top surface of said housing.

21. A device according to claim 20 wherein said restricting means includes a pair of walls positioned in said hollow housing.

22. A device according to claim 1 wherein said housing has a plurality of ramps supporting said trigger and upon which said trigger slides.

23. A device according to claim 1 further comprising means for precluding inadvertent actuation of said device.

24. A device according to claim 23 wherein said precluding means includes:

(a) a detent post positioned in said hollow housing, and

(b) a flexible leg on said trigger having a first rib resting on top of said detent post before actuation of said device and precluding downward motion of said trigger until a predetermined actuation force is applied to said trigger and said first rib slides around said detent post thereby actuating said device.

25. A device according to claim 1 wherein said spring is a substantially "S" shape having a first loop extending from said first end, an oppositely directed second loop extending from said first loop, a tail extending from said second loop and terminating in said second end, and an elbow disposed between said second loop and said tail.

26. A device according to claim 25 wherein said trigger is a substantially "U" shape having a head upon which actuation force is applied, a longer leg with a left actuator engaging said second loop of said spring and transferring actuation force from said trigger to said spring, and a shorter leg having a right actuator engaging said elbow of said spring and transferring actuation force from said trigger to said spring.

27. A device according to claim 1 further comprising means for automatically retracting said blade into said housing after actuation of said device.

28. A device according to claim 1 further comprising means for prohibiting removal of said trigger from said opening in said top surface of said housing before actuation of said device.

29. A device according to claim 28 wherein said prohibiting means includes:

(a) a detent post positioned in said hollow housing,

(b) a keeper positioned in said hollow housing, and

(c) a flexible leg on said trigger having a second rib lying underneath said detent post and a left actuator lying underneath said keeper, said second rib abutting said detent post and said left actuator abutting said keeper when said trigger is pulled upward.

30. A disposable device for slicing a precise incision of predetermined length and depth in the skin of a patient comprising:

a hollow housing having a top surface with an opening, a front surface, a rear surface, a bottom surface with an elongated slot adapted to contact the skin of the patient, and a plurality of spring anchor posts;

a single, substantially "S"-shaped spring mounted in said housing in a relaxed, unstressed, and unbiased condition when said device is not actuated, said spring having (a) a first end, (b) an anchor lug integrally formed on said first end of said spring, said anchor lug fixed by said spring anchor posts of said housing and mounting said spring in said housing, (c) a second end, (d) a first loop extending from said first end, (e) an oppositely directed second loop extending from said first loop, (f) a tail extending from said second loop and terminating in said second end, and an elbow disposed between said second loop and said tail;

a substantially "U"-shaped trigger slidably disposed in said opening in said top surface of said housing and having a head upon which actuation force is applied, a longer leg with a left actuator engaging said second loop of said spring and transferring actuation force from said trigger to extend said spring, and a shorter leg having a right actuator engaging said elbow of said spring and transferring actuation force from said trigger to extend said spring;

a cutting blade coupled to said second end of said spring and extending through said elongated slot in said bottom surface of said housing to incise the skin of the patient when said device is actuated; and

a plurality of discrete constraint and restraint elements positioned in said housing forming an open guide surface directing said spring, and said blade coupled to said spring, along a predetermined incision path.

31. A device according to claim 30 wherein said housing has a viewport permitting observation of the skin of the patient where the incision will be made.

32. A device according to claim 30 wherein said rear surface of said housing has at least one finger indentation and said front surface of said housing has a thumb indentation, said at least one finger indentation and said thumb indentation facilitating handling of said device.

33. A device according to claim 30 wherein said spring is resilient plastic.

34. A device according to claim 30 wherein said plurality of discrete constraint and restraint elements include:

(a) a stop post positioned in said hollow housing,

(b) a stop positioned on said blade and contacting said stop post to limit horizontal motion of said blade,

(c) a spring restraint positioned in said hollow housing forming a channel between said spring restraint and said bottom surface of said housing, said spring restraint directing the vertical motion of said blade and said channel directing the horizontal motion of said blade, and

(d) a spring restraint follower located on said second end of said spring and opposite said blade and traversing along said spring restraint and through said channel.

35. A device according to claim 30 wherein said hollow housing has at least one trigger stop post, said trigger contacting said at least one trigger stop post and lying flush with said top surface of said housing when said trigger is fully depressed in said opening in said top surface of said housing and said device is fully actuated.

36. A device according to claim 30 wherein said hollow housing has a keeper preventing removal of said trigger from said opening in said top surface of said housing after actuation of said device.

37. A device according to claim 30 wherein said hollow housing has a pair of walls restricting said trigger to a vertical travel path through said opening in said top surface of said housing.

38. A device according to claim 30 wherein said hollow housing has a detent post and said trigger has a flexible leg with a first rib, said first rib resting on top of said detent post before actuation of said device and precluding downward motion of said trigger until a predetermined actuation force is applied to said trigger and said first rib slides around said detent post thereby actuating said device.

39. A device according to claim 30 wherein said hollow housing has a detent post and a keeper and said trigger has a flexible leg with a second rib lying underneath said detent post and a left actuator lying underneath said keeper, said second rib abutting said detent post and said left actuator abutting said keeper when said trigger is pulled upward.

40. A disposable device for slicing a precise incision of predetermined length and depth in the skin of a patient comprising:

a hollow housing having a top surface with an opening, a front surface having a thumb indentation facilitating handling of said device, a rear surface having at least one finger indentation facilitating handling of said device, a bottom surface with an elongated slot adapted to contact the skin of the patient, and a viewport permitting observation of the skin of the patient where the incision will be made;

a trigger slidably disposed in said opening in said top surface of said housing and having a flexible leg with a left actuator, a first rib, and a second rib;

a single, resilient, plastic spring mounted in said housing in a relaxed, unstressed, and unbiased condition when said device is not actuated and extended by said trigger when said device is actuated, said spring having a first end and a second end;

a cutting blade coupled to said second end of said spring and extending through said elongated slot in said bottom surface of said housing to incise the skin of the patient when said device is actuated;

a stop post positioned in said hollow housing;

a stop positioned on said blade and contacting said stop post to limit horizontal motion of said blade;

a spring restraint positioned in said hollow housing forming a channel between said spring restraint and said bottom surface of said housing, said spring restraint directing the vertical motion of said blade and said channel directing the horizontal motion of said blade;

a spring restraint follower located on said second end of said spring and opposite said blade and traversing along said spring restraint and through said channel;

at least one trigger stop post positioned in said hollow housing, said trigger contacting said at least one trigger stop post and lying flush with said top surface of said housing when said trigger is fully depressed in said opening in said top surface of said housing and said device is fully actuated;

a keeper positioned in said hollow housing preventing removal of said trigger from said opening in said top surface of said housing after actuation of said device;

a pair of walls positioned in said hollow housing restricting said trigger to a vertical travel path through said opening in said top surface of said housing;

a detent post positioned in said hollow housing, said first rib of said flexible leg of said trigger resting on top of said detent post before actuation of said device and precluding downward motion of said trigger until a predetermined actuation force is applied to said trigger and said first rib slides around said detent post thereby actuating said device, said second rib of said flexible leg of said trigger lying underneath said detent post and said left actuator of said flexible leg of said trigger lying underneath said keeper with said second rib abutting said detent post and said left actuator abutting said keeper when said trigger is pulled upward.