Precision depth control lancing tip

• US 7,736,322 B2
• Filed: 12/23/2003
• Issued: 06/15/2010
• Est. Priority Date: 12/27/2002
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Forster, Richard, Sachsenweger, Peter, Kuhr, Hans-Juergen, Hannant, Matt, Hildebrandt, Wilhelm, Roe, Steven N., Weiss, Thomas, Wiegel, Chris
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): TOWA, RENE T
• Application Number:
  US10/744,167
• Publication Number:
  US 20040236251A1
• Time in Patent Office: 2,366 Days
• Field of Search: 600573-583, 606181-182, 606139-144, 606147-148
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• 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 5/1519 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 bodily fluid sampling device is operable to lance with a precise depth and express fluid from both fingertip and alternate sites. In one form, the device is operable to adjust the penetration depth of the lancet into the skin. The bodily fluid sampling device includes a lancet adapted to form an incision in skin. A skin contacting member has an orifice through which the lancet extends when lancing the skin. The orifice has a first opening size that is sized to flatten the skin around the lancet during lancing. The orifice has a second opening size that is larger than the first opening size after the incision is formed to express fluid from the incision.

Claims

1. A method, comprising:

lancing an incision in skin with a lancet of a sampling device;

controlling penetration depth of the lancet by flattening skin around the lancet with a lancet opening of the device during said lancing;

expressing fluid from the incision by pressing an expression opening of the sampling device around the incision, wherein the expression opening is larger than the lancet opening;

wherein the sampling device includes a housing and a ball member that has the expression opening and the lancet opening rotatably coupled to the housing; and

rotating the expression opening in position to express fluid after said lancing.

2. The method of claim 1, wherein:

the ball member is rotatably coupled to the housing through one or more pivot pins; and

said rotating the expression opening includes rotating the ball member about the one or more pivot pins.

3. The method of claim 2, wherein:

the lancet opening is at most 2.5 mm in diameter; and

said lancing the incision includes extending the lancet through the lancet opening that is at most 2.5 mm in diameter.

4. The method of claim 3, wherein said expressing includes pressing the expression opening around the incision that is at least 7.0 mm in diameter.

5. The method of claim 2, wherein said expressing includes pressing the expression opening around the incision that is at least 7.0 mm in diameter.

6. The method of claim 2, wherein:

the lancet opening is at most 2.5 mm in diameter; and

said lancing the incision includes extending the lancet through the lancet opening that is at most 2.5 mm in diameter.

7. The method of claim 6, wherein said expressing includes pressing the expression opening around the incision that is at least 7.0 mm in diameter.

8. The method of claim 1, wherein said expressing includes pressing the expression opening around the incision that is at least 7.0 mm in diameter.

9. A method, comprising:

providing a sampling device that includes a lancet and a lancet opening that is sized to generally flatten skin around the lancet during lancing, wherein the sampling device has an expression opening that is sized larger than the lancet opening to express fluid;

placing the lancet opening against the skin to generally flatten the skin;

forming an incision in the skin with the lancet by extending the lancet through the lancet opening after said placing of the lancet opening against the skin;

adjusting the sampling device so that the expression opening is able to express the fluid after said forming the incision;

expressing the fluid from the incision by pressing the expression opening around the incision;

the sampling device includes a ball that has the lancet opening and the expression opening; and

said adjusting includes rotating the ball so that the expression opening is positioned to express the fluid.

10. The method of claim 9, wherein:

the lancet opening is at most 2.5 mm in diameter; and

said forming the incision includes extending the lancet through the lancet opening that is at most 2.5 mm in diameter.

11. The method of claim 10, wherein:

the expression opening is at least 7.0 mm in diameter; and

said expressing includes pressing the expression opening around the incision that is at least 7.0 mm in diameter.

12. The method of claim 11, wherein:

the ball is rotatably coupled to the sampling device through one or more pivot pins; and

said adjusting includes rotating the ball about the one or more pivot pins.

13. The method of claim 10, wherein:

the ball is rotatably coupled to the sampling device through one or more pivot pins; and

said adjusting includes rotating the ball about the one or more pivot pins.

14. The method of claim 9, wherein:

the expression opening is at least 7.0 mm in diameter; and

said expressing includes pressing the expression opening around the incision that is at least 7.0 mm in diameter.

15. The method of claim 14, wherein:

the ball is rotatably coupled to the sampling device through one or more pivot pins; and

said adjusting includes rotating the ball about the one or more pivot pins.

16. The method of claim 9, wherein:

the ball is rotatably coupled to the sampling device through one or more pivot pins; and

said adjusting includes rotating the ball about the one or more pivot pins.

17. A method, comprising:

rotating a ball member of a lancing device to a first position where a first opening in the ball member faces skin;

placing the ball member in the first position against the skin;

cutting an incision in skin by extending a lancet through the first opening in the ball member;

rotating the ball member to a second position where a second opening in the ball member faces the skin, the second opening being larger than the first opening; and

expressing fluid from the incision by pressing the second opening against the skin around the incision with the ball member in the second position.

18. The method of claim 17, in which said expressing includes pressing the second opening against the skin that is at least 7.0 mm in diameter.

19. The method of claim 18, in which said cutting includes extending the lancet through the first opening that is at most 2.5 mm in diameter.

20. The method of claim 19, wherein:

the ball member is rotatably coupled to the lancing device through one or more pivot pins; and

said rotating the ball member includes rotating the ball member about the one or more pivot pins.

21. The method of claim 18, wherein:

the ball member is rotatably coupled to the lancing device through one or more pivot pins; and

said rotating the ball member includes rotating the ball member about the one or more pivot pins.

22. The method of claim 17, in which said cutting includes extending the lancet through the first opening that is at most 2.5 mm in diameter.

23. The method of claim 22, wherein:

the ball member is rotatably coupled to the lancing device through one or more pivot pins; and

said rotating the ball member includes rotating the ball member about the one or more pivot pins.

24. The method of claim 17, wherein:

the ball member is rotatably coupled to the lancing device through one or more pivot pins; and

said rotating the ball member includes rotating the ball member about the one or more pivot pins.