LANCET SYSTEM

• US 20100121368A1
• Filed: 07/21/2008
• Published: 05/13/2010
• Est. Priority Date: 07/21/2007
• Status: Active Grant

• Current Assignee: Stanley I. Kim
• Original Assignee: Stanley I. Kim
• Inventors: Kim, Stanley I.
• Granted Patent: US 8,647,356 B2
• Time in Patent Office: Days
• US Class Current: 606/182
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150587 by friction fit
• CPC Class Codes: A61B 5/150603 by rotation, e.g. bayonet or screw
• 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 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/150938 by blunting or disabling needle
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• 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 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 : fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Abstract

A lancing system comprising a lancet with a handle portion to and a needle bearing portion, the needle bearing portion retaining a thin needle protected by a safety cap. The safety cap includes first and second chambers, where the first chamber acts as a sheath and the second chamber having a surface positioned to compromise the structure of the needle when the needle bearing portion of the lancet body is inserted into the second chamber.

Claims

1. A lancing system comprising:

(a) a lancet comprising;

(i) a needle bearing portion having a proximal end and a distal end, the proximal end comprising a proximal surface having a first diameter, the distal end comprising a distal surface having a second diameter, the second diameter being small than the first diameter;

(ii) a handle portion attached to the proximal end of the needle bearing portion; and

(iii) a needle having an exterior portion extending from the distal surface of the needle bearing portion, the exterior portion of the needle having a needle proximal end, a needle distal end, and a longitudinal extent between the needle proximal end and the needle distal end, wherein the needle proximal end is in contact with the distal surface of the needle bearing portion; and

(b) a lancing device capable of retaining the lancet and, when actuated, urging it forward to puncture a skin surface of a user and then urging it backward away from the skin surface, the lancing device having an exit opening,

wherein the distal surface of the needle bearing portion is operative to protrude out of the exit opening of the lancing device and apply a compressive force to the skin surface of the user when the longitudinal extent of the needle is fully embedded in the skin surface of the user, thereby producing a predictable depth of penetration of the user.

wherein the distal surface has an area of up to 12 square millimeters and the longitudinal extent of the exterior portion of the needle is less than about 1.0 millimeter.

2. The lancing system of claim 1, wherein the distal end of the needle bearing portion of the lancet comprises a pedestal, the pedestal comprising one or more walls extending axially outwardly from the proximal surface of the needle bearing portion to the distal surface of the needle bearing portion, wherein the one or more walls circumscribe the distal surface.

3. The lancing system of claim 2, wherein the pedestal is cylindrical and has a diameter of between about 1 millimeter and about 3.5 millimeters.

4. The lancing system of claim 3, wherein the pedestal has a diameter of between about 1.5 millimeters and 2.0 millimeters.

5. The lancing system of claim 2, wherein the one or more walls has a length of at least 1.0 millimeters millimeter.

6. The lancing system of claim 1, the distal surface has a surface area of at least about 0.8 square millimeter.

7. The lancing system of claim 1, wherein the longitudinal extent of said exterior portion of said needle is between 0.3 millimeters and about 1.0 millimeter

8. The lancing system of claim 1, wherein said exterior portion of said needle has a diameter of less than about 0.2 millimeter.

9. The lancing system of claim 1, wherein the diameter of the needle bearing portion tapers from a point on the proximal end of the needle bearing portion to the distal end.

10. The lancing system of claim 9, wherein the taper extends from the point on the proximal end of the needle bearing portion to the needle.

11. A lancing system comprising:

(a) a lancet comprising;

(i) a needle bearing portion having a proximal end and a distal end;

(ii) a handle portion attached to the proximal end of the needle bearing portion; and

(iii) a needle having an exterior portion extending from the distal end of the needle bearing portion, the exterior portion of the needle having a needle proximal end, a needle distal end, and a longitudinal extent between the needle proximal end and the needle distal end; and

(b) a safety cap comprising;

(i) a first chamber having a first end and a first opening for receiving at least the needle of the lancet body, wherein the first chamber accommodates the needle when the first end of the cap is removably secured to the lancet; and

(ii) a second chamber having a second opening for receiving the needle bearing portion of the lancet body, the second chamber comprising a surface positioned to contact the needle and compromise the structure of the needle when the needle bearing portion is inserted into the second chamber of the safety cap.

12. The lancing system of claim 11, wherein the second chamber is not sufficiently deep to fully contain the needle when the needle bearing portion is inserted into the second chamber.

13. The lancing system of claim 11, wherein the second chamber comprises an interior surface which is sloped at an angle which is acute with respect to the axial orientation of the needle when the lancet is fully inserted into the second chamber.

14. The lancing system of claim 11, wherein the needle bearing portion of the lancet can be fixedly secured to the second chamber of the safety cap.

15. The lancing system of claim 11, wherein the second chamber of the safety cap comprises one or more projections for engaging one or more receptacles of the needle bearing portion in order to secure the safety cap to the lancet.

16. The lancing system of claim 11, wherein the safety cap further comprises a flange configured to support the safety cap on a support surface, wherein the opening of the second chamber is directed away from the support surface when the flange supports the safety cap on the support surface.

17. The lancing system of claim 11, wherein the first chamber and second chamber are located on opposed ends of the safety cap.

18. The lancing system of claim 17, wherein the second end of the safety cap comprises an indicator to distinguish the second end from the first end of the safety cap.

19. The lancing system of claim 11, wherein the first chamber comprises a sheath for retaining only the needle of the lancet, further comprising a flange extending from the safety cap to the lancet for supporting the safety cap on the lancet.

20. The lancing system of claim 11, wherein the longitudinal extent of the needle is between about 0.3 millimeters and about 1.0 millimeters.

21. The lancing system of claim 11, wherein the needle has a diameter of less than about 0.2 millimeters.

50. The lancing system of claim 11, wherein the first chamber comprises a sheath for retaining only the needle of the lancet,

51. The lancing system of claim 11 further comprising:

a flange extending from the safety cap to the lancet for supporting the safety cap on the lancet.

53. A lancing system of claim 11 wherein the safety cap is removably attached to said lancet.

22. A lancet for use in a lancing device comprising a lancing device wall having an outer distal surface and an interior surface and having an exit opening that perforates the lancing device wall, said lancet comprising:

a handle portion;

a needle bearing portion comprising a distal surface having a surface area of up to twelve square millimeters, a needle bearing portion wall and an outer surface, said needle bearing portion being disposed adjacent to said handle portion; and

a needle comprising an exterior portion that extends about 0.3 millimeter to about 1.0 millimeter from said distal surface

wherein the distal surface of the needle bearing portion is operative to protrude out of the exit opening and apply a compressive force to a skin surface of a user when the exterior portion of the needle is fully embedded in the skin surface of the user, thereby producing a predictable depth of penetration of the user and no pain.

23. The lancet of claim 22 wherein said needle bearing portion wall extends axially outwardly from said distal surface to form a pedestal.

24. The lancet of claim 22 wherein said distal surface has a surface area of less than nine square millimeters.

25. The lancet of claim 24 wherein said distal surface has a surface area is in the range of one half square millimeter to three square millimeters.

26. The lancet of claim 22 wherein said distal surface is substantially flat.

27. The lancet of claim 22 wherein said exterior portion has a longitudinal extent that is less than the thickness of the lancet device wall.

28. The lancet of claim 22 wherein said exterior portion has a longitudinal extent that is about 0.7 millimeter.

29. The lancet of claim 22 wherein said needle is round in cross section and has a diameter in the range of 0.234 millimeter to 0.0813 millimeter.

30. The lancet of claim 22 wherein said needle is a 36 gauge needle.

31. A lancet for use in a lancing device for puncturing the human skin, said human skin comprising an epidermis and a dermis having a papillary layer and a reticular layer, said lancing device comprising a lancing device wall having an outer distal surface and an interior surface and having an exit opening that perforates the lancing device wall, said lancet comprising:

a handle portion;

a needle bearing portion comprising a needle bearing portion wall, an outer surface and a distal surface having a surface area of up to nine square millimeters and that is operative to pass into the exit opening, said needle bearing portion being disposed adjacent to said handle portion; and

a needle that protrudes from said distal surface;

wherein said needle has an exterior portion that has a longitudinal extent that, when in use and said distal surface has passed into the exit opening and is applying a compressive force to the human skin, is long enough to cut blood vessels in said papillary layer and is short enough not to impact pain fibers in the reticular layer, thereby producing a predictable depth of penetration of the user and no pain.

32. The lancet of claim 31 wherein said needle bearing portion wall extends axially outwardly from said distal surface to form a pedestal.

33. The lancet of claim 31 wherein said distal surface has a surface area of less than seven square millimeters.

34. The lancet of claim 31 wherein said distal surface has a surface area is in the range of one half square millimeters to three square millimeters.

35. The lancet of claim 31 wherein said distal surface is substantially flat.

36. The lancet of claim 31 wherein said longitudinal extent is less than the thickness of said lancet device wall.

38. The lancet of claim 31 wherein said longitudinal extent is about 0.7 millimeter.

39. The lancet of claim 31 wherein said needle is round in cross section and has a diameter in the range of 0.234 millimeter to 0.0813 millimeter.

40. The lancet of claim 31 wherein said needle is a 36 gauge needle.

37. The lancet of claim wherein said longitudinal extent is in the range of about 0.3 millimeter to about 1.0 millimeter.

41. A lancet comprising:

a handle portion;

a needle bearing portion comprising a distal surface having a surface area of up to nine square millimeters, said needle bearing portion being disposed adjacent to said handle portion; and

at least one needle that protrudes about 0.3 millimeter to 1.0 millimeter from said distal surface; and

wherein the distal surface of the needle bearing portion is operative to apply a compressive force to a skin surface of a user when the exterior portion of the needle is fully embedded in the skin surface of the user, thereby producing a predictable depth of penetration of the user.

42. A lancet comprising:

a handle portion;

a needle bearing portion comprising a distal surface having a surface area of up to nine square millimeters, said needle bearing portion being mounted on said handle portion; and

at least one needle that protrudes from said distal surface, said at least one needle having a transverse extent of less than about 0.2 millimeter; and

wherein the distal surface of the needle bearing portion is operative to apply a compressive force to a skin surface of a user when the exterior portion of the needle is fully embedded in the skin surface of the user, thereby producing a predictable depth of penetration of the user.

43. A lancet for use in puncturing the human skin, said human skin comprising an epidermis and a dermis having a papillary layer and a reticular layer, said lancet comprising:

a handle portion;

a needle bearing portion comprising a distal surface having a surface area of less than nine square millimeters, said needle bearing portion being disposed on said handle portion; and

a needle that protrudes 0.3 to 1.0 millimeter from said distal surface;

wherein said needle has an exterior portion that, when the lancet is in use and said distal surface is applying a compressive force to the human skin, is long enough to cut blood vessels in said papillary layer and is short enough not to impact pain fibers in the reticular layer, thereby producing a predictable depth of penetration of the user.

44. A lancet for use in puncturing the human skin, said human skin comprising an epidermis and a dermis having a papillary layer and a reticular layer, said lancet comprising:

means for handling the lancet;

means for bearing comprising a distal surface having a surface area of up to nine square millimeters, said means for bearing being disposed adjacent to said means for handling; and

means for puncturing that protrudes from said distal surface;

wherein said means for puncturing, when in use and said distal surface is applying a compressive force to the human skin, is long enough to cut blood vessels in said papillary layer and is short enough not to impact pain fibers in the reticular layer, thereby producing a predictable depth of penetration of the user.

45. A lancing system comprising:

a lancing device comprising a housing which encloses a spring mechanism and a trigger, said housing comprising a lancing device wall having an outer distal surface and an interior surface and having an exit opening that perforates the lancing device wall; and

a lancet mounted in said housing, said lancet comprising;

a handle portion,

a needle bearing portion comprising a needle bearing portion wall, an outer surface and a distal surface, said needle bearing portion being mounted on said handle portion, said distal surface having a surface area in the range of nine square millimeters to twelve square millimeters, and

a needle that protrudes about 0.3 millimeter to about 1.0 millimeter from said distal surface;

wherein said spring mechanism is operative to propel said distal surface and said needle through said exit opening upon actuation of said trigger, carrying said distal surface and said needle into a skin surface, thereby producing a predictable depth of penetration of the user.

46. The lancing system of claim 45 further comprising:

a safety cap having two chambers, a first chamber that is operative to enclose and protecting said needle prior to its use and a second chamber that is operative to enclose said needle after its use.

47. The lancing system of claim 45 further comprising:

means for retracting said lancet into said housing after its use.

48. A method for puncturing the skin with a lancet, said skin comprising an epidermis and a dermis having a papillary layer and a reticular layer and said lancet comprising a needle that extends from a distal surface having a surface area of up to nine square millimeters, said method comprising:

jabbing the needle into the skin until the distal surface is pressing against the skin and the needle is fully embedded in the skin; and

withdrawing the needle from the skin;

thereby consistently and painlessly cutting blood vessels in the papillary layer and not impacting pain nerve fibers in the reticular layer and producing a predictable depth of penetration.

49. A method for puncturing the skin with a lancet, said skin comprising an epidermis and a dermis having a papillary layer and a reticular layer and said lancet comprising a needle that extends from a distal surface having a surface area of up to nine square millimeters, said needle having a length of less than 1.0 millimeter and a diameter of less than 0.234 millimeter, said method comprising:

jabbing the needle into the skin until the distal surface is pressing against the skin and the needle is fully embedded in the skin; and

withdrawing the needle from the skin;

thereby consistently and painlessly cutting blood vessels in the papillary layer and producing a predictable depth of penetration.

52. A lancing system comprising:

(a) a lancet comprising;

(i) a needle bearing portion having a proximal end and a distal end, the proximal end comprising a proximal surface having a first diameter, the distal end comprising a distal surface having a second diameter and having a surface area of up to twelve square millimeters, the second diameter being small than the first diameter;

(ii) a handle portion attached to the proximal end of the needle bearing portion; and

(iii) a needle having an exterior portion extending from the distal surface of the needle bearing portion, the exterior portion of the needle having a needle proximal end, a needle distal end, and a longitudinal extent between the needle proximal end and the needle distal end, wherein the needle proximal end is in contact with the distal surface of the needle bearing portion; and

(b) a lancing device comprising a housing having an exit opening, said lancing device being operative to retain the lancet in the housing, urge it forward to puncture a skin surface when actuated by a user and then retract it back into the housing,

wherein the distal surface of the needle bearing portion is able to pass through the exit opening of the lancing device and contact the skin surface of the user, thereby producing a predictable depth of penetration of the user,

wherein the longitudinal extent of the exterior portion of the needle is less than about 1.0 millimeter and said exterior portion has a diameter that is less than 0.234 millimeters.