Lancet system

• US 8,647,356 B2
• Filed: 07/21/2008
• Issued: 02/11/2014
• Est. Priority Date: 07/21/2007
• Status: Active Grant

• Current Assignee: Stanley I. Kim
• Original Assignee: Stanley I. Kim
• Inventors: Kim, Stanley I.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US12/452,314
• Publication Number:
  US 20100121368A1
• Time in Patent Office: 2,031 Days
• Field of Search: 606/181, 606/182, 606/183, 604/136, 604/137, 604/138, 604/139, 600/583
• US Class Current: 606/181
• 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 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 smaller 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, the lancing device having an exit opening,

wherein the distal surface of the needle bearing portion protrudes out of the exit opening of the lancing device and contacts the skin surface of the skin 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'"'"'s skin,

wherein the distal surface of the needle bearing portion 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, and

wherein protrusion of the needle and the distal surface of the needle bearing portion from the exit opening is limited by contact between an outer surface of the needle bearing portion and an interior surface of the lancing device.

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 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 about 0.3 millimeter 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 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, and a needle,

the 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 being sized to pass through the exit opening, wherein the needle 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 of the needle bearing portion and of said needle through said exit opening upon actuation of said trigger, carrying said distal surface to a skin surface and said needle into the skin surface, thereby producing a predictable depth of penetration of the user'"'"'s skin, and

wherein protrusion of the needle and the distal surface of the needle bearing portion from the exit opening is limited by contact between the outer surface of the needle bearing portion and the interior surface of the lancing device.

12. The lancing system of claim 11 further comprising:

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

13. The lancing system of claim 11 further comprising:

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

14. 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 smaller 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 passes through the exit opening of the lancing device and contacts 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, and

wherein protrusion of the needle and the distal surface of the needle bearing portion from the exit opening is limited by contact between an outer surface of the needle bearing portion and an interior surface of the lancing device.