BODY FLUID LANCING, ACQUIRING, AND TESTING CARTRIDGE DESIGN

• US 20100174211A1
• Filed: 01/28/2010
• Published: 07/08/2010
• Est. Priority Date: 09/17/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Braendle, Hansjoerg, Roe, Steven N., Frey, Stephan-Michael, List, Hans, Hoerauf, Christian
• Granted Patent: US 9,186,097 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150175 Adjustment of penetration depth
• 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 5/150419 comprising means for capillary action
• 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 5/150526 Curved or bent needles
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15132 comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A disposable device for analyzing body fluid especially for blood sugar tests includes a container which can be inserted into a measuring apparatus, a sampling member provided in the container to pierce skin of a body part and sample body fluid, and a test member for receiving body fluid obtained by the skin-piercing. In one form, the test member is fixed in a retaining chamber of the container, and the sampling member is configured in the same retaining chamber such that it is separated at a distance from the test member in an initial state and is in contact with the test member to transfer body fluid in a transfer state after the skin-piercing.

Claims

1. A disposable device for analyzing body fluid especially for blood sugar tests comprising a container which can be inserted into a measuring apparatus, a sampling member provided in the container to pierce skin of a body part and sample body fluid, and a test member for receiving body fluid obtained by the skin-piercing, wherein the test member is fixed in a retaining chamber of the container, and the sampling member is configured in the same retaining chamber such that it is separated at a distance from the test member in an initial state and is in contact with the test member to transfer body fluid in a transfer state after the skin-piercing.

2. The device according to claim 1, wherein the sampling member is actuated to carry out a piercing movement outwards and backwards into the container, and the test member is arranged stationary inside the container.

3. The device according to claim 1, wherein the sampling member is

separated from the test member by means of a spacer which can be put out of function during the skin-piercing.

4. The device according to claim 3, wherein the spacer extents over a

distance in direction of a piercing movement of the sampling member in order to provide a free space between the sampling member and the test member.

5. The device according to claim 3, wherein the spacer is removable

by an actuator configured to actuate piercing movement of the sampling member.

6. The device according to claim 3, wherein the spacer is formed, preferably with a predetermined breaking point, at a wall of the container defining the retaining chamber, and that the spacer is cut off the wall to achieve the transfer phase.

7. The device according to claim 3, wherein the spacer is connected to the sampling member, and a stopper of the container is removable such the spacer is inoperable in the transfer state.

8. The device according to claim 1, wherein the sampling member is urged against the test member by means of a resilient element.

9. The device according to claim 1, wherein the sampling member is deflected against a restoring force of the resilient element during the skin-piercing.

10. The device according to claim 9, wherein the sampling member has a flexible bending link forming the resilient element.

11. The device according to claim 1, wherein the sampling member is formed as a hooked needle, and a spring-arm of the hooked needle is pre-tensioned against the test member.

12. The device according to claim 1, in which the sampling member has a tip to pierce the skin and a capillary structure to uptake body fluid, wherein the capillary structure is in fluidic connection with the test element during the transfer phase.

13. The device according to claim 1, wherein the sampling member comprises a pointed piercing arm, and a laterally open channel is extending along the piercing arm preferably having a bent section that can be contacted with the test member.

14. The device according to claim 1, wherein the sampling member has an engagement slot to receive an actuator rod for driving a piercing movement.

15. The device according to claim 1, wherein the test member is formed as a reagent pad having a reactive layer which is sensitive to an analyte in the body fluid, and that the flat-material pad is attached to a wall of the container defining the retaining chamber.

16. The device according to claim 1, wherein the test member is configured to be mounted in the container as a unit separate from the sampling member.

17. The device according to claim 1, wherein the container is sealed against the environment by a sealing foil, and at least a piercing part of the sampling member is penetrated through the sealing foil to allow the skin-piercing.

18. The device according to claim 1, wherein the container includes a wall structure which defines the retaining chamber and comprises a desiccant material.

19. The device according to claim 1, wherein the container is formed as a magazine to contain a plurality of sampling members and test members preferably arranged in pairs in respective retaining chambers.

20. The device according to claim 1, wherein the container comprises a disk-like configuration and contains a plurality of sampling members formed as a lancet wheel, and the sampling members are actuated through a side face of the disk.

21. The device according to claim 1, wherein the lancet wheel is formed in one piece preferably by etching or cutting a metallic sheet material.

22. The device according to claim 1, wherein the container includes a hub to engage a rotary drive for successive rotary positioning of the sampling members with respect to a sampling port of the apparatus constructed to receive the body part.

23. A process for analyzing body fluid especially for blood sugar tests in which a container is inserted into a measuring apparatus, a sampling member provided in the container is actuated to pierce skin of a body part and sample body fluid, and body fluid obtained by the skin-piercing is transferred to a test member, wherein the test member is maintained stationary in a retaining chamber of the container, and the sampling member is disposed at a distance from the test member in an initial state and is brought in contact with the test member to transfer body fluid in a transfer state after the skin-piercing.

24. An apparatus, comprising:

an integrated cartridge having drop-in assembly of components, including

a lancet wheel having a lancet rim with a plurality of lancets extending radially inward from the lancet rim, each of the lancets having a leg portion and a lancet tip extending substantially transverse to the leg portion; and

a frame having an egg crate shape with a plurality of chambers to facilitate drop-in assembly of the lancet wheel onto the frame.

25. The apparatus of claim 24, further comprising:

a test ring having a continuous strip of chemistry, the test ring being sectionable into a plurality of test sections; and

wherein the plurality of chambers are configured to section the test ring into the plurality of test sections and each of the lancets is positioned next to one test section.

26. The apparatus of claim 25, wherein each of the lancets has a contact portion to contact a test section and to deposit a body fluid sample on the test section, and the leg portion is resilient to move between a first position wherein the lancet tip forms an incision and a second position wherein the contact portion contacts the test section.

27. The apparatus of claim 26, further comprising:

wherein the frame defines a plurality of windows sized to receive the contact portion of the lancet; and

a plurality of cover barriers positioned between the lancet rim and the test ring to cover the plurality of windows, each of the cover barriers defining a slot sized to receive the contact portion of the lancet, the plurality of cover barriers movable between a first position wherein the cover barriers cover the windows and a second position wherein the slots align over the windows to expose the test section under the cover barriers and allow the contact portion of the lancet to contact the test section.

28. The apparatus of claim 25, further comprising:

a first sterility sheet configured to cover the plurality of chambers and the plurality of lancet tips;

wherein the frame includes a plurality of openings sized to receive a driver; and

a second sterility sheet configured to cover the plurality of openings and the plurality of chambers, wherein the test ring, the first sterility sheet, and the second sterility sheet maintain the sterility of unused lancets and the humidity of unused test sections.

29. The apparatus of claim 24, wherein the lancet tip is configured to form an incision in skin and the lancet tip includes a capillary groove configured to collect the body fluid sample via capillary action.

30. The apparatus of claim 24, further comprising:

a meter, the meter having the integrated cartridge stored in the meter; and

a driver configured to engage the leg portion of the lancet to rotate the lancet to form an incision in skin with the lancet tip.

31. The apparatus of claim 24, further comprising:

a plurality of wedges made of a desiccant material, wherein one of the wedges is positioned in each chamber of the frame.

32. The apparatus of claim 24, further comprising:

a test ring having a continuous strip of chemistry, the test ring being sectionable into a plurality of test sections,

wherein the plurality of chambers are configured to section the test ring into the plurality of test sections and each of the lancets is positioned next to one test section, and

a test ring frame defining a plurality of windows configured to receive the test ring and to facilitate viewing of the plurality of test sections through the plurality of windows.

33. The apparatus of claim 32, further comprising:

wherein the test ring frame defines a plurality of tester openings sized to receive a lancet tip of the lancet,

a first sterility sheet configured to cover the plurality of tester openings and the plurality of lancet tips; and

a second sterility sheet configured to cover the plurality of chambers of the frame, wherein the test ring, the first sterility sheet, and the second sterility sheet maintain the sterility of unused lancets and the humidity of unused test sections.

34. The apparatus of claim 25, wherein each of the lancets has a lancet tip to contact a test section and to deposit a body fluid sample on the test section, and the leg portion is resilient to move between a first position wherein the lancet tip forms an incision and a second position wherein the lancet tip contacts the test section.

35. The apparatus of claim 24, wherein the frame includes a plurality of slats, and

a pair of the plurality of slats are positioned in each of the plurality of chambers to restrain the lancet prior to a lancing event and after the lancing event.

36. The apparatus of claim 24, wherein each of the lancet tips are configured to contact a test section and to deposit a body fluid sample on the test section.

37. A method, comprising:

assembling an integrated disposable cartridge, wherein said assembling includes

dropping a lancet wheel into a circular frame, the lancet wheel having a rim with a plurality of radially inwardly extending lancets, the frame having a plurality of spokes defining a plurality of chambers, and

positioning each of the lancets in one of the chambers.

38. The method of claim 37, wherein said assembling further includes:

attaching a test ring having a continuous strip of chemistry onto the frame; and

sectioning the test ring into a plurality of test sections by the plurality of spokes, each of the test sections positioned under one of the lancets.

39. The method of claim 38, wherein said assembling further includes:

positioning a plurality of movable cover barriers between the plurality of lancets and the plurality of test sections to eliminate contact between the lancet and the test section until the lancet and the corresponding cover barrier are actuated, wherein each of the cover barriers defines a window to expose a portion of the test section for contact by the lancet.

40. The method of claim 38, further comprising:

wherein each of the lancets has a lancet tip and a resilient leg portion;

forming an incision in tissue with one of the lancet tips wherein the leg portion is in a first position; and

transferring a body fluid sample from the lancet tip to the test section wherein the leg portion is in a second position.

41. The method of claim 37, further comprising:

loading the integrated disposable cartridge into a meter configured to actuate the plurality of lancets.

42. The method of claim 37, further comprising:

dropping a desiccant wheel into the circular frame, the desiccant wheel having a rim with a plurality of wedges, and

positioning each of the wedges in one of the chambers.

43. A method, comprising:

providing an integrated disposable cartridge including a frame, a lancet wheel having a plurality of lancets extending radially inward from a rim, and a test ring having a plurality of test sections, wherein the plurality of lancets contact the plurality of test sections;

forming an incision in tissue with one of the lancets by rotating the lancet away from the plurality of test sections;

collecting a body fluid sample with a capillary groove on the lancet;

withdrawing the lancet from the incision in tissue by rotating the lancet towards the plurality of test sections; and

transferring the body fluid sample from the capillary groove on the lancet to one of the test sections by contacting the test section with the lancet to release the body fluid sample.

44. The method of claim 43, further comprising:

wherein the rotating the lancet away from the plurality of test sections includes moving a driver towards the lancet in a horizontal direction relative to the frame to contact the lancet; and

wherein the rotating the lancet towards the plurality of test sections includes moving the driver away from the lancet in a horizontal direction relative to the frame.

45. The method of claim 43, further comprising:

indexing the frame to an unused lancet after transferring the body fluid sample in the capillary groove to the test section.

46. The method of claim 43, further comprising:

forming a second incision in skin with the lancet to obtain an adequate amount of body fluid sample.

47. An apparatus, comprising:

a microsampler wheel including

a base, a plurality of lancets, and a plurality of ribs, wherein the plurality of ribs and the plurality of lancets extend radially outward from the base, and the plurality of ribs and the plurality of lancets alternate with each other,

each of the lancets having a curved lancet tip configured to form an incision in skin,

each of the lancets configured to rotate about the base while forming the incision, the curvature of the rotation of the lancet is similar to the curvature of the lancet tip, and

each of the plurality of ribs is positioned as a reference surface from which a penetration depth of the lancet tip is determined.

48. The apparatus of claim 47, further comprising:

wherein each of the plurality of lancets includes a leg portion, a first leg member, and a second leg member;

the leg portion is attached to the base, the leg portion extends from the base to the first leg member and the leg portion forms a first angle with the base, the first angle being acute;

the first leg member spans between the leg portion and the second leg member, the first leg member forms a second angle with the leg portion, the second angle being obtuse;

the second leg member spans between the first leg member and the lancet tip, wherein the lancet tip defines a capillary groove; and

a plurality of test sections, each of the test sections positioned adjacent one of the lancets.

49. The apparatus of claim 48, wherein:

the capillary groove is located on a front face of the lancet tip and extends into the second leg member; and

each of the test sections is positioned adjacent the second leg member.

50. The apparatus of claim 48, wherein:

the capillary groove is located on a rear face of the lancet tip; and

each of the test sections is positioned adjacent the rear face of the lancet tip.

51. The apparatus of claim 48, wherein:

the capillary groove is located on a rear face of the lancet tip;

a second capillary groove is located on the lancet tip, the second capillary groove extends from the rear face of the lancet tip to the front face of the lancet tip to transfer the body fluid sample from the rear face to the front face of the lancet tip; and

each of the test sections is positioned adjacent the front face of the lancet tip.

52. An apparatus, comprising:

an integrated cartridge having drop-in assembly of components, including

a lancet wheel having a lancet rim with a plurality of lancets extending radially inward from the lancet rim, each of the lancets having means for transferring a body fluid sample to a test element, and

a frame having means for facilitating drop-in assembly of the lancet wheel onto the frame.

53. The apparatus of claim 52, wherein the means for transferring the body fluid sample includes the lancet having a contact portion to contact the test element and deposit the body fluid sample on the test element.

54. The apparatus of claim 52, wherein the means for transferring the body fluid sample includes the lancet having a lancet tip to contact the test element and deposit the body fluid sample on the test element.

55. The apparatus of claim 52, wherein the means for facilitating drop-in assembly of the lancet wheel onto the frame include the frame having an egg crate shape with a plurality of chambers.

56. The apparatus of claim 52, wherein the frame includes a plurality of ledges and each of the plurality of ledges defines a notch configured to receive a lancet tip.

57. The apparatus of claim 55, wherein the frame includes a plurality of slats and a pair of the plurality of slats are positioned in each of the plurality of chambers to restrain one of the plurality of lancets.

58. A method, comprising:

actuating a first mechanism to rotate a reference member about a base member to contact skin and form a reference surface, the reference member attached to the base member, wherein penetration depth of a lancet tip is measured relative to the reference surface; and

actuating a second mechanism to travel along the reference member and a lancet to rotate the lancet about the base member, the lancet attached to the base member, wherein the lancet having a lancet tip forms an incision in the skin.

59. The method of claim 58, further comprising:

the actuating the first mechanism includes pressing a first cylinder against the reference member; and

the actuating the second mechanism includes moving a second cylinder along the reference member and the lancet.

60. The method of claim 59, wherein the pressing the first cylinder includes rotating the first cylinder to pump the reference member against the skin and express bodily fluid to the incision in the skin.

61. An apparatus, comprising:

an integrated cartridge having drop-in assembly of components, including

a lancet wheel having a plurality of lancets, each of the lancets having a leg portion and a lancet tip extending substantially transverse to the leg portion, and

a frame having a plurality of chambers to facilitate drop-in assembly of the lancet wheel onto the frame;

a test ring having a continuous strip of chemistry, the test ring being sectionable into a plurality of test sections, wherein the plurality of chambers are configured to section the test ring into the plurality of test sections and each of the lancets is positioned next to one test section; and

wherein each of the lancet tips is configured to contact a test section and to deposit a body fluid sample on the test section, and the leg portion is resilient to move between a first position wherein the lancet tip forms an incision and a second position wherein the lancet tip contacts the test section.