BLOOD AND INTERSTITIAL FLUID SAMPLING DEVICE

• US 20070093728A1
• Filed: 11/22/2006
• Published: 04/26/2007
• 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: Radwanski, Ryszard, Roe, Jeffrey, Sanchez, Michael, Douglas, Joel, Grage, Henry
• Granted Patent: US 7,828,749 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150076 by heating
• 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 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• 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 5/150396 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15136 by use of radiation, e.g. laser
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15196 : semi-automatically retracted, i.e. in which the retraction of the piercing unit requires a deliberate action by the user such as manual release of spring-biased retraction means
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood

Abstract

A device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from a body. The device comprises a blood collection system including a lancing needle (16), drive mechanism (11), kneading or vibration mechanism (25), optional suction system (7), and sample ejection mechanism. The device is preferably sized to be hand-held in one hand and operable with one hand. The device can optionally contain integral testing or analysis component (83) for receiving the sample and providing testing or analysis indication or readout for the user. A method involves piercing the skin at a rapid rate, kneading the surrounding area by ultrasonic action, piezoelectric or mechanical oscillation to stimulate the blood flow from the wound, drawing the fluid using a pumping system.

Claims

1. An integrated device for obtaining a sample and measuring a chemical concentration, comprising:

a lancing member capable of being deployed and retracted to pierce a location of the skin of a patient to create a wound and a flow of blood from the wound;

a test area proximate the lancing member and configured and arranged to receive a sample of the blood and to measure a chemical concentration of the sample having an appropriately small volume as desired; and

wherein when the skin is pierced and the lancing member is retracted, the sample of blood flows from the wound to the test area without displacement of the device.

2. The device of claim 1, wherein the test area includes a disposable test strip.

3. The device of claim 1, wherein the test area is configured to electrochemically analyze the sample.

4. The device of claim 1, further comprising:

a guide member in which the lancing member is disposed, the guide member being configured to guide the lancing member during deployment and retraction.

5. The device of claim 4, wherein the guide member is a guide tube.

6. The device of claim 1, further comprising:

a firing mechanism positioned to fire the lancing member.

7. An apparatus, comprising:

a reusable sampling device including a firing mechanism; and

a disposable detachably mounted in the sampling device so that the disposable is able to be replaced after use, the disposable including

a lancing member actuatable by the firing mechanism to create a wound in skin by extending from the disposable and retracting along a travel path,

a capillary passage having a greater capillary affinity for body fluid than the skin for collecting the body fluid bled from the wound via capillary action,

the capillary passage extending in a parallel manner relative to the travel path of the lancing member to promote collection of the body fluid, and

the lancing member and capillary passage being coupled together to form a single unit for simultaneous removal from the sampling device and disposal of the lancing member and the capillary passage.

8. The apparatus of claim 7, wherein:

the capillary passage has an opening where the body fluid is drawn from the wound;

the opening is proximate where the lancing member extends from the disposable; and

the capillary passage and the lancing member are positioned in a side-by-side orientation.

9. The apparatus of claim 8, wherein disposable has a cutout between the opening of the capillary passage and the lancing member to promote communication of the body fluid to the capillary passage.

10. The apparatus of claim 8, wherein the disposable include:

a lancet guide tube in which the lancing member is guided; and

a capillary tube defining the capillary passage.

11. The apparatus of claim 10, wherein disposable has a cutout between the lancet guide tube and the capillary tube to promote communication of the body fluid to the capillary passage.

12. The apparatus of claim 7, wherein:

the lancing member is contained within the capillary passage; and

the lancing member is adapted to extend from the capillary passage to cut the wound and retract inside the capillary passage after creating the wound.

14. The apparatus of claim 7, wherein the firing mechanism includes a firing spring configured to fire the lancing member.

15. The apparatus of claim 14, further comprising a return spring located and sized to retract the lancing member.

16. The apparatus of claim 7, wherein the capillary passage is configured to collect the body fluid without displacement of the disposable.

13. The apparatus of 12, wherein:

the disposable includes a capillary tube; and

the lancing member is contained within the capillary tube.

17. A method, comprising:

loading a disposable into a sampling device that has a firing mechanism, wherein the disposable includes a lancing member and a capillary passage that form a single unit, wherein the capillary passage extends in a parallel manner in the disposable relative to the lancing member;

creating a wound in the skin by firing the lancing member of the disposable into the skin with the firing mechanism of the sampling device;

collecting body fluid on the surface of the skin from the wound by drawing the body fluid into the capillary passage via capillary action; and

disposing of the lancing member and the capillary passage simultaneously by removing the disposable from the sampling device.

18. The method of claim 17, wherein said collecting the body fluid includes drawing the body fluid into the capillary passage without displacement of the disposable.

19. The method of claim 17, wherein:

the lancing member and capillary passage are oriented in a side-by-side manner with a cutout opening therebetween; and

said collecting the body fluid includes drawing the body fluid away from the lancing member and into the capillary passage through the cutout opening.

20. The method of claim 17, wherein said creating the incision includes extending the lancing member from the capillary passage.