Lancet system

• US 9,005,232 B2
• Filed: 02/03/2014
• Issued: 04/14/2015
• 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): MILES, JONATHAN WADE
• Application Number:
  US14/171,473
• Publication Number:
  US 20140228873A1
• Time in Patent Office: 435 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 lancing device capable of retaining a lancet and, when actuated, urging the lancet forward to puncture a skin surface of a user, the lancing device having an exit opening; and

(b) the lancet for use with the lancing device, the 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, wherein the distal end of the needle bearing portion 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 of the pedestal circumscribe the distal surface of the needle bearing portion and have a length of at least 1.0 millimeter, and wherein the distal surface of the needle bearing portion extends through an exit opening of a 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;

(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.

2. The lancing system of claim 1, 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.

3. The lancing system of claim 1, wherein the distal surface of the needle bearing portion has an area of up to 12 square millimeters.

4. The lancing system of claim 1, wherein the distal surface of the needle bearing portion has a surface area of at least about 0.5 square millimeter.

5. The lancing system of claim 1, wherein the distal surface of the needle bearing portion has a surface area of between about 0.8 square mm and 3 square mm.

6. The lancing system of claim 1, wherein said distal surface of the needle bearing portion is substantially flat.

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

8. The lancing system of claim 1, wherein the longitudinal extent of the needle is between about 0.3 millimeters and about 1.0 millimeters.

9. The lancing system of claim 1, wherein the longitudinal extent of the needle is between 0.5 and 0.75 millimeters.

10. The lancing system of claim 1, wherein the needle is a 36 gauge needle.

11. The lancing system of claim 1, wherein the longitudinal extent of the exterior portion of the needle is less than about 1.0 millimeter.

12. The lancing system of claim 1, wherein the needle has a diameter of less than about 0.2 millimeter.

13. The lancing system of claim 1, wherein the lancing device further comprises a depth adjustment mechanism.

14. A method for puncturing skin of a subject with a lancet, said skin comprising an epidermis and a dermis having a papillary layer and a reticular layer, comprising:

(a) providing a lancing system comprising;

(i) a lancet comprising;

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, wherein the distal end of the needle bearing portion 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 of the pedestal circumscribe the distal surface of the needle bearing portion and have a length of at least 1.0 millimeter, and wherein the distal surface of the needle bearing portion extends through an exit opening of a 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;

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

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

(ii) 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;

(b) puncturing the subject'"'"'s skin with the lancet such that the distal surface of the needle bearing portion of the lancet presses against the skin and the needle is fully embedded in the skin; and

(c) withdrawing the needle from the skin,

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

15. The method of claim 14, wherein the longitudinal extent of the exterior portion of the needle of the lancet is less than about 1.0 millimeter.

16. The method of claim 14, wherein the needle of the lancet has a diameter of less than about 0.2 millimeter.