Body fluid sampling device

• US 20030018300A1
• Filed: 09/19/2002
• Published: 01/23/2003
• Est. Priority Date: 11/21/1997
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Radwanski, Ryszard, Duchon, Brent G., Douglas, Joel S.
• Granted Patent: US 6,969,359 B2
• Time in Patent Office: Days
• US Class Current: 604/164.01
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/150503 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 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/1519 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

Body fluid is sampled from a skin incision by placing a ring against the skin and repeatedly applying an elastic pressing force to the ring, whereby a stimulator surface of the ring depresses a ring of skin and body tissue in surrounding relationship to the incision to force body fluid from the incision. The stimulator surface is inclined at an angle of 10 to 65 degrees; a width of the stimulator surface is from 5 mm to 20 mm, and an inner diameter of the stimulator surface is no less than 6.0 mm.

Claims

1. A sampling device for sampling a bodily fluid through an incision in a skin surface, comprising:

a housing; and

a stimulator member attached to the housing, the stimulator member being adapted to contact the skin surface around the incision and express a drop of the bodily fluid from the incision, the stimulator member defining an interior opening having a dimension of at least 6.0 mm to minimize smearing of the drop by contact between the drop and the stimulator member.

2. The device of claim 1, wherein the dimension of the interior opening is not greater than 12.0 mm.

3. The device of claim 1, wherein the stimulator member has an annular shape defining a circular interior opening.

4. The device of claim 3, wherein the stimulator member has an exterior radius and an interior radius, and the difference between the exterior radius and the interior radius is from 5 to 20 mm.

5. The device of claim 1, further including a lancing device attached to the housing, the lancing device being movable relative to the housing to extend from the housing a sufficient distance to lance the skin surface.

6. The device of claim 5, wherein the lancing device is positioned in the housing to extend through the interior opening.

7. The device of claim 1, further comprising means for forming the incision in the skin surface.

8. The device of claim 1, further comprising a second skin contacting member configured to contact the skin surface.

9. The device of claim 8, wherein the stimulator member and the second skin contacting member are coaxially oriented.

10. The device of claim 8, wherein the second skin contacting member is positioned radially outward from the stimulator member.

11. The device of claim 8, wherein:

the housing extends along a longitudinal axis;

the stimulator member has a first position relative the second skin contacting member in which the second skin contacting member extends longitudinally outward from the stimulator member and a second position in which the stimulator member extends longitudinally outward from the second skin contacting member.

12. The device of claim 11, wherein both the stimulator member and the second skin contacting member are ring shaped and co-axially oriented with respect to one another.

13. The device of claim 11, wherein the second skin contacting member is longitudinally movable relative to the housing.

14. The device of claim 11, further comprising:

a first force transmitting member positioned between the second skin contacting member and the housing; and

a second force transmitting member positioned between the stimulator member and the second skin contacting member.

15. The device of claim 14, wherein:

the first force transmitting member includes an outer spring; and

the second force transmitting member includes a sleeve spring.

16. The device of claim 14, wherein the first force transmitting member and the second force transmitting member are constructed and arranged to relieve pressure applied by the stimulator member against the skin surface and to allow fresh bodily fluid to flow toward the incision while the second skin contacting member remains in contact with the skin surface upon movement of the housing away from the skin surface.

17. The device of claim 14, wherein the first force transmitting member and the second force transmitting member are constructed and arranged to extend the stimulator member to the second position and engage the skin surface upon movement of the housing toward the skin surface.

18. The device of claim 14, wherein both the stimulator member and the second skin contacting member are ring shaped and co-axially oriented with respect to one another.

19. The device of claim 14, wherein the second skin contacting member is longitudinally movable relative to the housing.

20. The device of claim 19, wherein the stimulator member is slidable relative to the housing.

21. The device of claim 8, further comprising:

a first force transmitting member positioned between the second skin contacting member and the housing; and

a second force transmitting member positioned between the stimulator member and the second skin contacting member.

22. The device of claim 21, wherein the first force transmitting member and the second force transmitting member are constructed and arranged to relieve pressure applied by the stimulator member against the skin surface and to allow fresh bodily fluid to flow toward the incision while the second skin contacting member remains in contact with the skin surface upon movement of the housing away from the skin surface.

23. The device of claim 21, wherein the first force transmitting member and the second force transmitting member are constructed and arranged to extend the stimulator member to engage the skin surface upon movement of the housing toward the skin surface.

24. The device of claim 1, further comprising:

a lancet to form the incision in the skin surface;

a spring provided in the housing to move the lancet towards the skin surface;

means for cocking the lancet; and

means for releasing the lancet automatically upon pressing the device against the skin.

25. The device of claim 1, further comprising means for releasing the lancet automatically upon pressing the device against the skin.

26. The device of claim 25, wherein the means for releasing the lancet releases the lancet upon movement of the stimulator member in a rearward direction.

27. The device of claim 25, further comprising:

a second skin contacting member configured to contact the skin;

wherein the housing extends along a longitudinal axis; and

wherein the stimulator member has a first position relative the second skin contacting member in which the second skin contacting member extends longitudinally outward from the stimulator member and a second position in which the stimulator member extends longitudinally outward from the second skin contacting member.

28. The device of claim 27, wherein the means for releasing the lancet releases the lancet when the stimulator member is in the second position.

29. The device of claim 1, wherein the stimulator member is movable relative to the housing.

30. The device of claim 29, wherein the stimulator member is slidable relative to the housing.

31. The device of claim 29, further comprising a force transmitting member provided between the stimulator member and the housing.

32. The device of claim 1, further comprising:

an outer member surrounding the stimulator member and adapted to contact the skin surface.

33. The device of claim 32, wherein both the stimulator member and the outer member are ring shaped and co-axially oriented with respect to one another.

34. The device of claim 32, wherein:

the housing extends along a longitudinal axis;

the stimulator member has a first position relative the outer member in which the outer member extends longitudinally outward from the stimulator member and a second position in which the stimulator member extends longitudinally outward of the outer member.

35. The device of claim 34, wherein both the stimulator member and the outer member are ring shaped and co-axially oriented with respect to one another.

36. The device of claim 34, wherein the outer member is longitudinally movable relative to the housing.

37. The device of claim 32, further comprising:

an adapter received in the housing;

a carrier received in the adapted to carry a lancet;

a carrier spring seated between the carrier and the stimulator member to retract the carrier after lancing;

an outer spring seated between the outer member and the adapter to bias the outer member against the skin surface;

a sleeve in which the housing is received;

a sleeve spring seated between the sleeve and the housing to retract the stimulator from the skin surface upon release of forward force on the sleeve to relieve pressure applied by the stimulator member against the skin surface and to allow fresh bodily fluid to flow toward the incision while the outer member remains in contact with the skin surface.

38. The device of claim 38, further comprising the lancet carried in the carrier.

40. The method of claim 39, wherein:

the stimulator includes an outer member surrounding the stimulator member; and

said expressing includes

contacting the skin with the outer member,

moving the housing away from the skin to relieve pressure applied by the stimulator member against the skin to allow fresh bodily fluid to flow toward the opening in the skin, and

maintaining contact between the outer member and the skin during said moving the housing away from the skin.

41. The method of claim 40, wherein said expressing includes:

pressing the stimulator member against the skin a second time after said moving the housing away from the skin.

39. A method of obtaining a body fluid sample, comprising:

providing a device including a housing, a lancing device movable relative to the housing to lance skin and a stimulator member attached to the housing to contact the skin, the stimulator member defining an interior opening having a dimension of at least 6.0 mm;

lancing the skin with the lancing device to create an opening in the skin; and

expressing fluid from the opening in the skin by pressing the stimulator member against the skin.

42. A method of obtaining a bodily fluid sample, comprising:

providing a device including a housing, a lancing device movable relative to the housing to lance skin, a stimulator member attached to the housing to contact the skin and an outer member surrounding the stimulator member;

forming an incision in the skin with the lancing device;

contacting the skin with the outer member;

pressing the stimulator member against the skin to express bodily fluid from the incision;

relieving pressure applied by the stimulator member against the skin to allow fresh bodily fluid to flow toward the opening in the skin, and

maintaining contact between the outer member and the skin during said relieving pressure.