Blood and interstitial fluid sampling device

• US 7,828,749 B2
• Filed: 11/22/2006
• Issued: 11/09/2010
• Est. Priority Date: 05/17/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Radwanski, Ryszard, Grage, Henry M., Douglas, Joel S., Sanchez, Michael S.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/562,496
• Publication Number:
  US 20070093728A1
• Time in Patent Office: 1,448 Days
• Field of Search: 600/573, 600/583, 600/584, 606181-183, 204/403.11, 204/403.14, 422/82.01, 435/287.9, 435/817
• 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, comprising:

a main body having an opening where the main body is configured to be placed against tissue;

a lancing member configured to extend through the opening of the main body to cut an incision in the tissue;

a test strip disposed at the opening of the main body to directly collect and analyze the body fluid from the incision;

the main body including a slot; and

the test strip being fitted in the slot in the main body.

2. The device of claim 1, further comprising:

a stimulation ring received around the opening of the main body, the stimulator ring being configured to oscillate against the tissue for pumping the body fluid from the incision.

3. The device of claim 2, further comprising:

a motor configured to oscillate the stimulation ring, wherein the motor is configured to oscillate the stimulation ring at a frequency from 5 to 1000 cycles per minute.

4. The device of claim 3, wherein the stimulation ring is configured to oscillate in a range of 1 to 5 mm.

5. The device of claim 2, wherein the stimulation ring and the main body have a slot in which the test strip is received.

6. The device of claim 5, further comprising:

a secondary motion spring; and

a secondary motion trigger configured to release the secondary motion spring to lower the test strip onto the body fluid.

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

8. An integrated device, comprising:

a main body having an opening where the main body is configured to be placed against tissue;

a lancing member configured to extend through the opening of the main body to cut an incision in the tissue;

a test strip disposed at the opening of the main body to directly collect and analyze the body fluid from the incision; and

a stimulation ring received around the opening of the main body, the stimulator ring being configured to oscillate against the tissue for pumping the body fluid from the incision.

9. The device of claim 8, further comprising:

a motor configured to oscillate the stimulation ring, wherein the motor is configured to oscillate the stimulation ring at a frequency from 5 to 1000 cycles per minute.

10. The device of claim 9, wherein the stimulation ring is configured to oscillate in a range of 1 to 5 mm.

11. The device of claim 8, wherein the stimulation ring and the main body have a slot in which the test strip is received.

12. The device of claim 11, further comprising:

a secondary motion spring; and

a secondary motion trigger configured to release the secondary motion spring to lower the test strip onto the body fluid.

13. The device of claim 8, wherein the test strip is configured to electrochemically analyze the sample.