Precision depth control lancing tip

• US 20040236251A1
• Filed: 12/23/2003
• Published: 11/25/2004
• Est. Priority Date: 12/27/2002
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hildebrandt, Wilhelm, Roe, Steven N., Weiss, Thomas, Wiegel, Chris, Forster, Richard, Sachsenweger, Peter, Kuhr, Hans-Juergen, Hannant, Matt
• Granted Patent: US 7,736,322 B2
• Time in Patent Office: Days
• 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 body fluid sampling device, comprising:

a lancet to form an incision in skin;

a first member configured to contact the skin during lancing, the first member defining a lancet opening through which the lancet extends during lancing, the lancet opening being sized to generally flatten the skin around the lancet during lancing; and

a second member coupled to the first member, the second member defining an expression opening that is sized larger than the lancet opening to express fluid from the incision.

2. The device of claim 1, further comprising:

wherein the first member includes a reference tube;

wherein the second member includes a housing that includes an expression flange; and

a deformable membrane coupled between the first member and the expression flange.

3. The device of claim 1, wherein the first member includes a lancing cap and the second member includes an expression cap detachably coupled over the lancing cap.

4. The device of claim 1, wherein the first member includes a housing and the second member includes a flip cap pivotally coupled to the housing.

5. The device of claim 1, wherein the first member includes a pivot member and the second member includes a housing, the pivot member being unshaped and pivotally coupled to the housing.

6. The device of claim 1, wherein the first member includes a petal member with petals that define the lancet opening and the second member includes a petal cartridge in which the petal member is disposed.

7. The device of claim 1, wherein the first member includes an inner cap and the second member includes an outer cap coupled to the inner cap in an extendable fashion.

8. The device of claim 1, wherein the first member includes a detachable insert and the second member includes a housing, the insert being detachably coupled to the housing.

9. The device of claim 1, wherein the lancet opening is at most 2.5 mm in diameter.

10. The device of claim 1, wherein the expression opening is at least 7.0 mm in diameter.

11. A body fluid sampling device, comprising:

a housing;

a lancet disposed in the housing to lance skin; and

a member coupled to the housing, the member defining a lancet opening sized to flatten the skin around the lancet during lancing, the member defining an expression opening that is sized larger than the lancet opening to express fluid from alternate sites.

12. The device of claim 11, wherein the member includes a cap extendably coupled to the housing to adjust penetration depth of the lancet, the cap defining a fingertip cavity around the lancet opening that is shaped to receive a fingertip, the cap including an expression ridge that surrounds the fingertip cavity.

13. The device of claim 11, wherein the member includes a ball member rotatably coupled to the housing.

14. The device of claim 11, wherein the housing includes an inner cap and the member includes an outer cap rotatably coupled to the inner cap.

15. The device of claim 14, wherein the inner cap has grooves and the outer cap has ridges that engage the grooves.

16. The device of claim 11, wherein the housing includes a base cap and the member includes a plate pivotally coupled to the base cap.

17. The device of claim 11, wherein the member includes a slide member slidably coupled to the housing.

18. The device of claim 17, wherein the slide member L-shaped.

19. The device of claim 17, further comprising:

wherein the housing includes an inner cap that defines a slide groove in which the slide member is slidably disposed; and

an outer cap cover the inner cap and the slide member.

20. A body fluid sampling device, comprising:

means for rupturing skin; and

means for providing a first opening size to flatten the skin during rupturing; and

means for providing a second opening size larger than the first opening size to express fluid.

21. The device of claim 20, wherein the means for rupturing the skin includes a lancet.

22. The device of claim 20, wherein the means for providing the first opening size includes a flip cap.

23. The device of claim 20, wherein the means for providing the first opening size includes a ball member.

24. The device of claim 20, wherein the means for providing the second opening size includes a housing.

25. The device of claim 20, wherein the means for providing the second opening size includes a slide member.

26. 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; and

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.

27. The method of claim 26, further comprising:

wherein the sampling device includes a housing and a flip cap pivotally coupled to the housing, the flip cap defines the lancet opening and the housing defines the expression opening; and

pivoting the flip cap away from the expression opening in the housing before said expressing.

28. The method of claim 26, further comprising:

wherein the sampling device includes a housing an a ball member that defines 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.

29. The method of claim 26, further comprising:

collecting the fluid from the incision; and

analyzing the fluid.

30. 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;

adjusting the sampling device so that the expression opening is able to express the fluid;

forming an incision in the skin with the lancet; and

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

31. The method of claim 30, wherein said adjusting the sampling device occurs before said forming the incision.

32. The method of claim 30, wherein said adjusting the sampling device occurs after said forming the incision.

33. The method of claim 30, wherein:

the sampling device includes a housing that defines the expression opening and a flip cap that is able to cover the expression opening; and

said adjusting the sampling device includes flipping the flip cap to expose the expression opening.

34. The method of claim 30, wherein:

the sampling device includes a ball that defines 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.