Disposable lancet and lancing cap combination for increased hygiene

• US 7,766,845 B2
• Filed: 06/21/2004
• Issued: 08/03/2010
• Est. Priority Date: 06/21/2004
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Thym, Detlef, Roe, Jeffrey N.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US10/872,945
• Publication Number:
  US 20050283094A1
• Time in Patent Office: 2,234 Days
• Field of Search: 600/573, 600/576, 600/583, 600/584, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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. An apparatus, comprising:

a disposable body fluid testing cartridge including

an incision forming member for forming an incision in skin, the incision forming member having a tab that extends laterally from the incision forming member for controlling movement of the incision forming member as the incision forming member is extended and retracted during formation of the incision,

a housing defining a side opening through which the tab extends for controlling penetration depth of the incision forming member into the skin,

connectors attaching the incision forming member to the housing to form one molded body, the connectors being flexible to facilitate folding of the incision forming member against the housing, wherein the connectors are positioned to align the tab of the incision forming member with the opening in the housing as the incision forming member and housing are folded together about the connectors,

the incision forming member and the housing being folded together with the connectors being bent,

the tab of the incision forming member extending laterally through the opening of the housing, the opening of the housing configured to limit movement of the tab,

a test strip attached to the housing for analyzing body fluid from the incision in the skin, the test strip having an expression surface configured to express the body fluid from the incision when pressed against the skin,

wherein the housing has a first cavity wall and the test strip has a second cavity wall, the first cavity wall of the housing and the second cavity wall of the test strip defining a capillary cavity configured to draw body fluid onto the test strip via capillary action,

the incision forming member being slidably disposed within said capillary cavity; and

an actuation mechanism coupled to the tab of the incision forming member for extending and retracting the incision forming member during formation of the incision, the actuation mechanism coupled to the exterior of the housing to engage the tab being extended through the opening.

2. The apparatus of claim 1, wherein the connectors are configured to permit movement of the incision forming member relative to the housing.

3. The apparatus of claim 1, wherein the connectors are severed to permit movement of the incision forming member relative to the housing.

4. The apparatus of claim 1, wherein the housing that in part defines the capillary cavity has a half-pipe shape to simplify manufacturing.

5. The apparatus of claim 4, wherein the housing has a pair of edges defined by the half-pipe shape and the test strip is coupled to the pair of edges of the housing.

6. The body fluid testing device of claim 1, wherein the expression surface is coated with a hydrophilic material to promote fluid collection.

7. The apparatus of claim 1, wherein the housing includes an extension configured to contact skin, the extension including the first cavity wall.

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

9. The body fluid testing device of claim 1, wherein the incision forming member is coated with a hydrophilic material to promote fluid collection.

10. 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.

11. An apparatus, comprising:

a disposable body fluid testing cartridge including

an incision forming member for forming an incision in skin,

a housing for receiving the incision forming member,

connectors molded with the incision forming member and the housing to form one body, the connectors being flexible to facilitate folding of the incision forming member against the housing,

the incision forming member and the housing being folded together with the connectors being bent,

a test strip attached to the housing for analyzing body fluid from the incision in the skin, the test strip having an expression surface configured to express the body fluid from the incision when pressed against the skin,

wherein the housing has a first cavity wall and the test strip has a second cavity wall, the first cavity wall of the housing and the second cavity wall of the test strip defining a capillary cavity configured to draw body fluid onto the test strip via capillary action,

the incision forming member being slidably disposed within said capillary cavity,

wherein the housing defines a guide opening along one side,

wherein the incision forming member having a tab extending laterally through the guide opening in the housing, the guide opening of the housing configured to limit movement of the tab,

wherein the connectors are positioned to align the tab of the incision forming member with the guide opening in the housing, and

an actuation mechanism coupled to the tab of the incision forming member for extending and retracting the incision forming member during formation of the incision, the actuation mechanism coupled to the exterior of the housing to engage the tab through the guide opening.

12. The apparatus of claim 11, wherein the connectors are configured to disconnect from the incision forming member to permit movement of the incision forming member relative to the housing.

13. The apparatus of claim 11, wherein the connectors are configured to permit movement of the incision forming member relative to the housing.

14. The apparatus of claim 11, 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. An apparatus, comprising:

a disposable body fluid testing cartridge including

an incision forming member for forming an incision in skin,

a housing defining a side, guide opening for guiding the incision forming member during penetration into the skin,

a tab extending laterally from the incision forming member through the guide opening in the housing for controlling penetration depth of the incision forming member as the incision forming member is extended and retracted during formation of the incision, the guide opening configured to limit movement of the incision forming member,

a test strip attached to the housing for analyzing body fluid from the incision in the skin, the test strip having an expression surface configured to express the body fluid from the incision when pressed against the skin,

wherein the housing has a first cavity wall and the test strip has a second cavity wall, the first cavity wall of the housing and the second cavity wall of the test strip defining a capillary cavity configured to draw body fluid onto the test strip via capillary action,

the incision forming member being slidably disposed within said capillary cavity, and

an actuation mechanism coupled to the tab of the incision forming member for extending and retracting the incision forming member during formation of the incision, the actuation mechanism coupled to the exterior of the housing to engage the tab through the guide opening.

16. The apparatus of claim 15, wherein the incision forming member and the housing are molded to form one body.

17. The apparatus of claim 15, further comprising:

connectors attaching the incision forming member to the housing, the connectors being flexible to facilitate folding of the incision forming member against the housing, wherein the connectors are positioned to align the tab of the incision forming member with the opening in the housing as the incision forming member and housing are folded together about the connectors.