METHODS AND APPARATUS FOR SAMPLING AND ANALYZING BODY FLUID

• US 20100222704A1
• Filed: 05/13/2010
• Published: 09/02/2010
• Est. Priority Date: 05/17/1996
• 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 8,123,701 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150213 Venting means
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• 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
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.

Claims

1. A method, comprising:

loading a disposable into a lancing device that includes a lancet and a test strip with a capillary passage that has a capillary opening configured to draw body fluid via capillary action;

placing the lancing device in contact with skin;

firing the disposable towards the skin with the lancing device, wherein during said firing the lancet and the test strip of the disposable move together as a single unit towards the skin;

retracting the disposable away from the incision;

moving the capillary opening of the capillary passage past the lancet to contact the capillary opening with a drop of body fluid from the incision on the surface of the skin;

drawing via capillary action the body fluid from the drop into the capillary passage;

analyzing the body fluid from the incision with the test strip;

unloading the disposable from the lancing device after said analyzing;

discarding the disposable after said loading; and

loading a fresh disposable into the lancing device after said unloading.

2. The method of claim 1, further comprising:

pressing the lancing device further against the skin with force in addition to that applied by said placing to express the body fluid from the incision; and

wherein said pressing includes depressing a ring of the skin around the incision to cause the incision to bulge while spreading apart the incision.

3. The method of claim 2, further comprising:

determining automatically with a drop sensing mechanism in the lancing device whether the drop of the body fluid expressed from the incision is of sufficient size to provide a proper sample.

4. The method of claim 3, further comprising:

energizing an indicator on the lancing device when the drop of the body fluid expressed from the incision is of sufficient size to provide the proper sample.

5. The method of claim 1, wherein said moving the capillary opening includes moving a pusher to engage and move the capillary passage.

6. The method of claim 5, further comprising:

retracting the pusher and the capillary passage.

7. A method, comprising:

loading a disposable into a lancing device, the disposable includes a lancet and a test strip with a capillary passage that has a capillary opening configured to draw body fluid via capillary action, the lancing device includes a sleeve slidably mounted in a housing and a pusher configured to engage the capillary passage;

moving the sleeve relative to the housing to place the sleeve in contact with skin;

firing the disposable towards the skin with the lancing device, wherein during said firing the lancet and the test strip of the disposable move together as a single unit towards the skin;

retracting the disposable away from the incision;

moving the pusher to drive the capillary opening of the capillary passage past the lancet to contact the capillary opening with a drop of body fluid from the incision on the surface of the skin;

drawing via capillary action the body fluid from the drop into the capillary passage;

retracting the pusher and the capillary passage away from skin; and

analyzing the body fluid from the incision with the test strip.

8. The method of claim 7, further comprising:

unloading the disposable from the lancing device after said analyzing;

discarding the disposable after said loading; and

loading a fresh disposable into the lancing device after said unloading.