Blood and interstitial fluid sampling device

• US 7,666,150 B2
• Filed: 04/29/2004
• Issued: 02/23/2010
• Est. Priority Date: 05/17/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Sanchez, Michael S., Roe, Jeffrey N., Radwanski, Ryszard, Grage, Henry M., Douglas, Joel S.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Szmal; Brian
• Application Number:
  US10/835,094
• Publication Number:
  US 20050010134A1
• Time in Patent Office: 2,126 Days
• Field of Search: 600/573, 600/583, 600/584, 600/578, 606181-183, 604/239, 604/272, 356/246, 356/249, 250/576
• 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 2010/008 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
• 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 5/150083 by vibration, e.g. ultrasound
• 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 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• 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 5/150984 Microneedles or microblades
• 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 5/15136 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 5/15194 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 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. A tissue penetration sampling device for collecting blood from the skin of a patient, the device comprising:

a sampling module having a sampling site, the sampling site having a sample input port,

a sample reservoir in fluid communication with the sample input port,

a tissue penetrating member maintained within the sampling module, the tissue penetrating member having a tip adjacent the sample input port, and

a driver coupled to the tissue penetrating member to drive the tip through the opening to penetrate the skin when the driver is actuated,

the device being configured to provide actuation of the driver, penetration of the skin, application of an electric current to the skin to stimulate blood flow, collection of the blood, and movement of the blood to the sample reservoir.

2. The tissue penetration sampling device of claim 1, further comprising at least one electrode adapted to contact the skin and deliver the electric current to the skin.

3. The tissue penetration sampling device of claim 2, wherein at least one electrode is a stimulator ring.

4. The tissue penetration sampling device of claim 3, wherein the stimulator ring oscillates.

5. The tissue penetration sampling device of claim 2, wherein at least one electrode is a guard, and wherein the tissue penetrating member has a retracted position and the guard is adapted to contact the skin while preventing the tissue penetrating member from contacting the skin in the retracted position.

6. The tissue penetration sampling device of claim 5, further comprising a stimulator ring adapted to contact the skin and oscillate.

7. The tissue penetration sampling device of claim 2, wherein the sample reservoir is an at least one electrode.

8. The tissue penetration sampling device of claim 2, wherein the tissue penetrating member is an at least one electrode.

9. The tissue penetration sampling device of claim 1, wherein the device is configured to provide low voltage DC current to the skin.

10. The tissue penetration sampling device of claim 9, wherein the DC voltage is in the range of one (1) millivolt to twelve (12) volts.

11. The tissue penetration sampling device of claim 9, wherein the DC current is pulsed.

12. The tissue penetration sampling device of claim 1, wherein the device is configured to provide low voltage AC current to the skin.

13. A method of penetrating a target tissue, comprising:

providing a tissue penetrating system with a penetrating member, and an analyte detecting member coupled to a sample chamber;

advancing the penetrating member through the target tissue;

withdrawing the penetrating member from the target tissue;

drawing an adjustable sample of body fluid from the target tissue; and

receiving the volume of body fluid in the sample chamber.

14. The method of claim 13, further comprising:

drawing three (3) microliters (μ

L) of body fluid.

15. The method of claim 13, further comprising:

drawing eight (8) microliters (μ

L) of body fluid.

16. A skin penetrating system, comprising:

a housing member;

a penetrating member positioned in the housing member and adapted to penetrate the target tissue at a penetration site when extended from a retracted position to an extended position;

a skin stimulating member coupled to the housing member and adapted to oscillate and enhance body fluid flow to the penetration site;

a tissue pressure applicator coupled to the housing member and adapted to contact the skin and inhibit the penetrating member from contacting the skin when in the retracted position; and

a vacuum source to provide a low pressure environment to draw fluid from a wound created by the penetrating member in the tissue.

17. A method of sampling, comprising:

providing a sampling module having a tissue piercing member disposed within a lancet channel, a sample reservoir and an orifice on a surface of the sampling module in fluid communication with the sample reservoir;

coupling the tissue piercing member of the sampling module to a driver;

activating a tissue penetrating cycle;

penetrating the target tissue with the tissue piercing member to obtain a sample of blood;

vibrating the tissue piercing member inside the target tissue;

collecting said sample of blood through the orifice; and

wherein said vibrating is from thirty (30) cycles per minute up to one thousand (1000) cycles per minute.

18. A method of sampling, comprising:

providing a sampling module having a tissue piercing member disposed within a lancet channel, a sample reservoir and an orifice on a surface of the sampling module in fluid communication with the sample reservoir;

coupling the tissue piercing member of the sampling module to a driver;

activating a tissue penetrating cycle;

penetrating the target tissue with the tissue piercing member to obtain a sample of blood;

vibrating the tissue piercing member inside the target tissue;

collecting said sample of blood through the orifice; and

wherein said vibrating moves the tissue piercing member up to two (2) to three (3) millimeters per cycle.

19. A method of sampling, comprising:

providing a sampling module having a tissue piercing member disposed within a lancet channel, a sample reservoir and an orifice on a surface of the sampling module in fluid communication with the sample reservoir;

coupling the tissue piercing member of the sampling module to a driver;

activating a tissue penetrating cycle;

penetrating the target tissue with the tissue piercing member to obtain a sample of blood;

vibrating the tissue piercing member inside the target tissue;

collecting said sample of blood through the orifice; and

wherein said vibrating moves the tissue piercing member less than one and one-half (1.5) millimeters per cycle.

20. The method of claim 19 wherein said vibrating moves the tissue piercing member about one-half (0.5) millimeters per cycle.

21. A skin penetrating system, comprising:

a housing member;

a penetrating member positioned in the housing member and adapted to penetrate the target tissue at a penetration site when extended from a retracted position to an extended position;

a skin stimulating member coupled to the housing member and adapted to oscillate and enhance body fluid flow to the penetration site;

a tissue pressure applicator coupled to the housing member and adapted to contact the skin and inhibit the penetrating member from contacting the skin when in the retracted position; and

wherein the skin stimulating member kneads the area using a horizontal motion.

22. The skin penetrating system of claim 21, wherein the skin stimulating member oscillates in the range of two (2) cycles per minute to two hundred (200) cycles per minute.

23. The skin penetrating system of claim 21, wherein the skin stimulating member oscillates at a rate of sixty (60) cycles per minute.

24. A skin penetrating system, comprising:

a housing member;

a penetrating member positioned in the housing member and adapted to penetrate the target tissue at a penetration site when extended from a retracted position to an extended position;

a skin stimulating member coupled to the housing member and adapted to oscillate and enhance body fluid flow to the penetration site;

a tissue pressure applicator coupled to the housing member and adapted to contact the skin and inhibit the penetrating member from contacting the skin when in the retracted position; and

wherein the skin stimulating member oscillates at an ultrasonic frequency as high as forty thousand (40,000) Hertz.

25. A skin penetrating system, comprising:

a housing member;

a penetrating member positioned in the housing member and adapted to penetrate the target tissue at a penetration site when extended from a retracted position to an extended position;

a skin stimulating member coupled to the housing member and adapted to oscillate and enhance body fluid flow to the penetration site;

a tissue pressure applicator coupled to the housing member and adapted to contact the skin and inhibit the penetrating member from contacting the skin when in the retracted position; and

wherein the skin stimulating member oscillates in the range of two (2) cycles per minute to one thousand (1000) cycles per minute.

26. A skin penetrating system, comprising:

a housing member;

a penetrating member positioned in the housing member and adapted to penetrate the target tissue at a penetration site when extended from a retracted position to an extended position;

a skin stimulating member coupled to the housing member and adapted to oscillate and enhance body fluid flow to the penetration site;

a tissue pressure applicator coupled to the housing member and adapted to contact the skin and inhibit the penetrating member from contacting the skin when in the retracted position; and

wherein the skin stimulating member oscillates in the range of ten (10) cycles per minute to four hundred (400) cycles per minute.

27. A skin penetrating system, comprising:

a housing member;

a penetrating member positioned in the housing member and adapted to penetrate the target tissue at a penetration site when extended from a retracted position to an extended position;

a skin stimulating member coupled to the housing member and adapted to oscillate and enhance body fluid flow to the penetration site;

a tissue pressure applicator coupled to the housing member and adapted to contact the skin and inhibit the penetrating member from contacting the skin when in the retracted position; and

wherein the skin stimulating member oscillates in the range of twenty (20) cycles per minute to two hundred (200) cycles per minute.

28. A skin penetrating system, comprising:

a housing member;

a penetrating member positioned in the housing member and adapted to penetrate the target tissue at a penetration site when extended from a retracted position to an extended position;

a skin stimulating member coupled to the housing member and adapted to oscillate and enhance body fluid flow to the penetration site;

a tissue pressure applicator coupled to the housing member and adapted to contact the skin and inhibit the penetrating member from contacting the skin when in the retracted position; and

wherein the skin stimulating member oscillates from one-twentieth (0.05) of a millimeter to eight (8) millimeters.

29. The skin penetrating system of claim 28, wherein the skin stimulating member oscillates from one (1) millimeter to five (5) millimeters.