Blood and interstitial fluid sampling device

• US 6,332,871 B1
• Filed: 05/10/1999
• Issued: 12/25/2001
• Est. Priority Date: 05/17/1996
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Radwanski, Ryszard, Grage, Henry M., Douglas, Joel S., Sanchez, Michael S.
• Primary Examiner(s): Lacyk, John P.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/180,839
• Time in Patent Office: 960 Days
• Field of Search: 600/586, 600/556
• 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 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 5/150076 by heating
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150091 by electricity
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/150236 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 5/150358 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150977 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 5/15136 : 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, drive mechanism, kneading or vibration mechanism, optional suction system, 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 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 device for obtaining a sample of body fluid through the skin comprising:

a housing member suitable for use and adapted to contain a needle for piercing the skin;

a spring member in the housing for urging the needle to protrude from the end of the housing sufficient to penetrate the skin;

a plunger member for retracting the needle against the spring tension and a trigger member to engage the plunger to hold the needle retracted until released by the trigger;

a stop member to limit the depth of needle penetration of the skin when released by the trigger;

a sample container communicating with the needle for receiving the sample from the needle;

a second spring for retracting the needle from the skin and a suction cam and plunger activated upon the retraction of the needle for drawing the sample of fluid which accumulates on the surface of the skin into the sample container; and

a skin stimulation member constructed for contacting and stimulating the skin by at least one of mechanical action, piezoelectric action, ultrasonic action, electrical action, and thermal action.

2. A device according to claim 1 comprising:

an actuator to deploy the stimulation member in the down position before needle penetration of the skin for holding the skin taut; and

for a stop member providing accurate depth control of needle penetration.

3. A device according to claim 1 further comprising a system for injecting a material into the skin.

4. A device according to claim 2 wherein the skin stimulation member is adapted to stimulate the skin prior to or during the piercing of the skin.

21. A device according to claim 1 wherein the portion of the device which pierces the skin is adapted to oscillate while inserted into the skin which oscillation is by vertical, horizontal, rotation or cyclic movement.

5. A device for obtaining a sample of body fluid through the skin comprising:

a housing member adapted to contain a needle for piercing the skin;

a drive means in the housing for urging the needle to protrude from the end of the housing sufficient to penetrate the skin;

a stop member to limit the depth of needle penetration into the skin by the device means;

a sample container communicating with the needle for retrieving the sample from the needle;

means for retracting the needle from the skin;

means for drawing the sample of fluid which accumulates on the surface of the skin into the sample container; and

means for stimulating the surface of the skin by at least one of mechanical action, piezoelectric action, electrical action, and thermal action.

6. A device according to claim 5 further comprising a skin stimulation member for contacting and massaging the skin adjacent to the point of needle penetration.

7. A device according to claim 6 further comprising a system for injecting a material into the skin.

8. A device for obtaining a sample of body fluid through the skin comprising:

a housing member suitable for hand held use;

a system for piercing the skin comprising a laser system or a fluid under pressure;

a sample collection tube positioned to collect a sample of fluid emerging from the pierced skin; and

an actuator for causing the member or system to pierce the skin.

22. A device according to claim 8 wherein the sample container or sample collection tube comprises a material having an affinity for the sample fluid sufficiently high to collect the fluid sample from the surface of the skin but sufficiently low to allow the fluid sample to wick from the container or tube when placed in contact with a test strip or device having an affinity for the fluid sample higher than that of the container or tube.

9. A device for collecting a sample of body fluid from a wound in the skin comprising:

a housing member suitable for hand-held use containing a chamber for collecting a sample of fluid emerging from the wound; and

a skin stimulation member movably positioned at the end of the housing member for contacting and massaging the skin near the wound to stimulate the flow of fluid to and out of the wound.

10. A device according to claim 9 wherein a stimulation member is positioned between the chamber and the housing and is adapted to telescopically extend from the housing to contact the skin and pump the body fluid to the wound.

11. A device according to claim 9 wherein the stimulation member comprises a polygon, square, circular or annular shape, a paddle or squeegee member, a system for employing a fluid under pressure to contact and stimulate the skin, or a fluid contained in a flexible membrane for contacting and stimulating the skin.

12. A needle for piercing the skin comprising a hollow tube having a center line, and a pointed spade protrusion extending substantially longitudinally from a portion of one side of the end of the tube and angled toward the center line of the tube.

13. A device for use in a body fluid sampling device for obtaining a sample through the skin comprising:

a standoff member adapted for contacting the skin;

a sample collection tube positioned in the standoff member for receiving the fluid sample;

a lancet member movably positioned in the standoff member adjacent to the tube for piercing the skin; and

electrodes positioned in the standoff member adapted for connection to a sensor to sense the presence of fluid within the standoff member.

14. A device according to claim 13 further comprising:

an integral test unit for testing the sample.

15. A device of claim 13 adapted to receive a test device unit which absorbs the sample from the wound site.

16. A body fluid collection device comprising a capillary tube flared on one end for contacting the skin and having a suction member positioned on the opposite end.

17. A device according to claim 16 further comprising a test strip on which the fluid sample is deposited from the capillary tube.

26. The device according to claim 16, further comprising a bulb-shaped member at the opposite end.

27. The device according to claim 16, wherein the tube is modified with a surfactant to increase its ability to wick up the body fluid.

18. A device for use in a body fluid sampling device for obtaining a sample through the skin comprising:

an elongated holder member having a plurality of passageways extending longitudinally through the member; and

lancet members positioned in said passageways and adapted for creating a plurality of wounds in the skin when contacted with the skin.

19. A device for use in a body fluid sampling device for obtaining a sample through the skin comprising:

a plate member having a plurality of sharp protrusion extending from one side of the plate member adapted for creating a plurality of wounds in the skin when contacted with the skin.

20. A method of collecting a sample of body fluid which includes piercing the skin;

mechanically stimulating the wound created by piercing the skin;

collecting the sample which results from the stimulating; and

dispensing the sample.

23. A method of collecting a sample of body fluid comprising:

piercing the skin with a hypodermic needle;

withdrawing the needle from the skin;

massaging an area adjacent the wound; and

collecting a sample of fluid from the surface of the skin into the hypodermic needle.

25. A method according to claim 23 comprising inserting a device to pierce the skin and oscillating the device in the wound.

24. A method for collecting a sample body fluid comprising:

mechanically massaging a skin area;

piercing the skin area to create a wound;

mechanically massaging the skin area adjacent the wound; and

collecting a fluid sample from the wound or the surface of the skin.

28. A device for obtaining a sample of body fluid through the skin comprising:

a housing member containing means for lancing the skin;

a stop member; and

a heated stimulation member adapted to contact the skin and stimulate blood flow.

29. The device of claim 28, wherein the stimulation member is in the form of a polygon, circle or annular shaped ring.