BODY FLUID LANCING, ACQUIRING, AND TESTING CARTRIDGE DESIGN

• US 20110077554A1
• Filed: 09/28/2009
• Published: 03/31/2011
• Est. Priority Date: 09/28/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Roe, Steven N., Frey, Stephan-Michael
• Granted Patent: US 8,961,431 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150435 Specific design of proximal end
• 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 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• 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 5/15146 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 5/15151 Each piercing element being stocked in a separate isolated 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
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

A lancet wheel having a rim with a plurality of lancets extending radially inward from the rim is dropped in a circular frame having a plurality of spokes forming a plurality of chambers for facilitating drop-in assembly of the modular lancet wheel with the frame. A test ring having a plurality of test sections is assembled on the frame such that one test section is located adjacent each lancet to form an integrated cartridge. Each lancet includes a lancet tip defining a capillary groove sized to collect a body fluid sample from the incision via capillary action. The lancet tip exits the chamber to form the incision in skin, the capillary groove collects the body fluid sample, the lancet tip retracts into the chamber, and a portion of the lancet contacts the test section to transfer the sample from the capillary groove to the test section to analyze the sample.

Claims

1. 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.

2. The apparatus of claim 1, 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.

3. The apparatus of claim 2, 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.

4. The apparatus of claim 3, 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.

5. The apparatus of claim 2, 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.

6. The apparatus of claim 1, 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.

7. The apparatus of claim 1, 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.

8. The apparatus of claim 1, further comprising:

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

9. The apparatus of claim 1, 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.

10. The apparatus of claim 9, 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.

11. The apparatus of claim 2, 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.

12. The apparatus of claim 1, 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.

13. The apparatus of claim 1, wherein each of the lancet tips are configured to contact a test section and to deposit a body fluid sample on the test section.

14. 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.

15. The method of claim 14, 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.

16. The method of claim 15, 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.

17. The method of claim 15, 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.

18. The method of claim 14, further comprising:

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

19. The method of claim 14, 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.

20. 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.

21. The method of claim 20, 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.

22. The method of claim 20, further comprising:

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

23. The method of claim 20, further comprising:

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

24. 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 the penetration depth of the lancet tip is determined.

25. The apparatus of claim 24, 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.

26. The apparatus of claim 25, 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.

27. The apparatus of claim 25, 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.

28. The apparatus of claim 25, 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.

29. 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.

30. The apparatus of claim 29, 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.

31. The apparatus of claim 32, 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.

32. The apparatus of claim 29, 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.

33. The apparatus of claim 29, wherein the frame includes a plurality of ledges and each of the plurality of ledges defines a notch configured to receive the lancet tip.

34. The apparatus of claim 32, 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.

35. 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.

36. The method of claim 35, 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.

37. The method of claim 36, 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.

38. 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.