Disposable lancet and lancing cap combination for increased hygiene

• US 20050283094A1
• Filed: 06/21/2004
• Published: 12/22/2005
• Est. Priority Date: 06/21/2004
• 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., Thym, Detlef
• Granted Patent: US 7,766,845 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15192 comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing

Abstract

A body fluid testing device includes a test strip, an incision forming member, and a housing. The test strip includes an expression surface. In addition, the test strip is attached to the housing to form a cavity, and the cavity slidably receives the incision forming member. The body fluid testing device is positioned over the incision site where the incision forming member makes an incision. The user presses the expression surface against the skin to express body fluid. The cavity collects body fluid via capillary action, and the test strip analyzes the body fluid.

Claims

1. A body fluid sampling device, comprising:

a disposable cartridge including

an incision forming member configured to be actuated to form an incision in skin,

a test strip for testing body fluid from the incision, the test strip having an expression surface configured to express the body fluid from the incision when pressed against the skin, and

a housing coupled to the test strip, the housing and the test strip defining a cavity configured to draw the body fluid onto the test strip via capillary action, wherein the incision forming member is slidably disposed in the cavity.

2. The body fluid testing device of claim 1, further including an actuation mechanism.

3. The body fluid testing device of claim 2, wherein:

the disposable cartridge is detachably coupled to the actuation mechanism to permit disposal and replacement of the cartridge; and

the incision forming member is actuated by the actuation mechanism.

4. The body fluid testing device of claim 2, wherein:

the housing includes an opening;

the incision forming member includes a tab to slidably engage with the opening; and

wherein the tab actuates the incision forming member when the tab is engaged by the actuation mechanism to form the incision.

5. The body fluid testing device of claim 2, wherein the actuation mechanism is operable to retract the incision forming member into the cavity to draw fluid from the incision into the cavity.

6. The body fluid testing device of claim 1, further including a retraction mechanism;

and

the incision forming member is detachably coupled to the retraction mechanism to permit retraction of the incision forming member.

7. The body fluid testing device of claim 1, wherein the incision forming member includes a needle.

8. The body fluid testing device of claim 1, wherein:

the housing has a half-pipe shape; and

the incision forming member has a half-cylindrical shape.

9. The body fluid testing device of claim 1 wherein the expression surface is coated with a hydrophilic material.

10. The body fluid testing device of claim 1 wherein the incision forming member is coated with a hydrophilic material.

11. The body fluid testing device of claim 1, wherein the housing includes one or more connectors to connect with the incision forming member.

12. The body fluid testing device of claim 11, wherein the connectors are made of a flexible material.

13. The body fluid testing device of claim 1, wherein the connectors are configured to disconnect from the incision forming member.

14. The body fluid testing device of claim 1, further comprising:

a cap covering the incision forming member to protect the sterility of the incision forming member; and

wherein the incision forming member, the test strip, and the housing are configured to receive the cap.

15. The body fluid testing device of claim 1, wherein the test strip is configured to produce a signal to analyze the body fluid from the incision.

16. The body fluid testing device of claim 15, wherein the test strip has a capillary active surface to transport the body fluid into the test strip.

17. A body fluid testing device, comprising:

an actuation member; and

a disposable cartridge detachably coupled to the actuation member, the cartridge including

an incision forming member configured to be actuated by the actuation member to form an incision in skin,

a test means;

a housing coupled to the test means, wherein the test means and housing define a cavity; and

wherein the cartridge has an expression surface configured to express fluid when pressed against the skin.

18. The body fluid testing device of claim 17, wherein:

the incision forming member is slidably received within the cavity.

19. The body fluid testing device of claim 17, wherein:

the incision forming member includes an end to engage with the actuation member;

wherein the actuation member actuates the incision forming member when the end is engaged to form an incision with the incision forming member;

the test means is a test strip configured to draw bodily fluid from the incision; and

the test strip analyzes the fluid.

20. The body fluid testing device of claim 19, wherein:

the test strip is coated with a hydrophilic material.

21. The body fluid testing device of claim 17, further comprising:

a cap covering the incision forming member to ensure a hygienic disposal of the cartridge; and

wherein the housing and the incision forming member are configured to receive the cap.

22. The body fluid testing device of claim 17, wherein the housing includes one or more connectors to connect with the incision forming member.

23. The body fluid testing device of claim 22, wherein the connectors are configured to disconnect from the incision forming member.

24. The body fluid testing device of claim 17, wherein:

the housing has a rectangular shape; and

the incision forming member has a rectangular shape.

25. The body fluid testing device of claim 17, further including an adhesive cover to couple the housing to the test means.

26. A body fluid testing device, comprising:

an actuation mechanism; and

a disposable cartridge detachably coupled to the actuation mechanism to permit disposal and replacement of the cartridge, the cartridge including

a housing with an extension member configured to contact skin;

a test strip configured to attach to the housing;

wherein the test strip and extension member define a passageway sized and arranged to draw fluid via capillary action from an incision in skin;

an incision forming member configured to form the incision in skin; and

wherein the incision forming member is at least partially received within the passageway.

27. The body fluid testing device of claim 26, wherein the test strip is attached to the housing with a snap-in mechanism.

28. The body fluid testing device of claim 26, wherein the test strip is attached to the housing with an adhesive cover.

29. The body fluid testing device of claim 26, wherein the test strip is coated with a hydrophilic material.

30. The body fluid testing device of claim 26, wherein:

the housing includes an opening;

the incision forming member includes a tab to slidably engage with the opening;

wherein the tab actuates the incision forming member when the tab is engaged by the actuation mechanism to form an incision with the incision forming member;

the passageway draws fluid via capillary action; and

the test strip analyzes the fluid.

31. The body fluid testing device of claim 26, further including a front portion of the incision forming member

32. The body fluid testing device of claim 26, where the test strip is configured to measure glucose in blood.

33. A method, comprising:

forming an incision in skin with an incision forming member of a disposable cartridge, wherein the disposable cartridge includes a test strip and a housing that define a cavity in which the incision forming member is slidably disposed;

expressing body fluid from the incision by pressing an expression surface of the disposable cartridge against the skin;

drawing the body fluid from the incision into the cavity; and

testing the body fluid in the cavity with the test strip.

34. The method of claim 33, further comprising disposing of the disposable cartridge after said testing.

35. The method of claim 33, further comprising:

retracting the incision forming member within the cavity; and

drawing fluid into the cavity by capillary action.

36. The method of claim 34, further comprising:

covering the disposable cartridge with a cap.