Blood and interstitial fluid sampling device

• US 20020082522A1
• Filed: 11/20/2001
• Published: 06/27/2002
• 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: Douglas, Joel S., Roe, Jeffrey N., Radwanski, Ryszard, Grage, Henry M., Sanchez, Michael S.
• Granted Patent: US 6,793,633 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 2010/008 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 (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

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 receiving the sample from the needle;

means for retracting the needle from the skin; and

means for drawing the sample of fluid which accumulates on the surface of the skin into the sample container upon needle retraction.

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

a skin stimulation member for contacting and massaging the skin;

an oscillation system for oscillating the skin stimulation member; and

a spring and actuator member adapted for activating the oscillation system upon retraction of the needle from the skin.

7. A device according to claim 6 further comprising a spring and actuator member adapted for activating the oscillation system upon retraction of the needle from the skin.

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

a housing member suitable for hand held use and adapted to contain a member or system for piercing the skin;

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.

9. A device according to claim 8 wherein the system for piercing the skin comprises laser system or a fluid under pressure directed to pierce the skin.

10. A device according to claim 8 wherein the member for piercing the skin comprises a needle positioned adjacent the end of the tube and driving member for urging the needle into the skin and a second member for retracting the needle from the skin.

11. A device according to claim 10 wherein the tube is a multichambered tube containing in one chamber a needle and adapted for receiving the sample in a second chamber.

12. A device according to claims 8, 9, 10 or 11 comprising a pump system for pulling the fluid sample into the tube.

15. A device according to claim 14 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.

16. A device according to claim 15 wherein the stimulation member is adapted to increase the opening of the wound and enhance fluid flow from the wound.

17. A device according to claim 15 wherein the stimulation member is adapted to stroke the skin toward the wound to enhance fluid flow from the wound.

20. A needle according to claim 19 wherein the spade portion is angled toward the center line of the tube.

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

one chamber in the tube containing a needle adapted for piercing the skin; and

a second chamber in the tube adapted for receiving a sample of fluid from the pierced skin.

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

a housing member suitable for 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 a massaging the skin near the wound to stimulate the flow of fluid to and out of the wound.

18. A device according to claim 2, 6 or 14 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.

30. A device according to claims 2, 6 or 14 wherein the stimulation member or system comprises a flat spiral spring, ultrasonic action, piezoelectric action, heating, friction or vibration.

19. A needle for piercing the skin comprising a hollow tube having a pointed spade protrusion extending substantially longitudinally from a portion of one side of the end of the tube.

21. A needle having an angled or beveled tip for piercing the skin comprising a hollow tube wherein the longitudinal passageway in the tube is eccentrically located in the tube.

22. 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.

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; and

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.

2. A device according to claim 1 comprising a skin stimulation member for contacting and massaging the skin;

a skin stimulation member for contacting and massaging the skin;

an oscillation system for oscillating the skin stimulation member; and

a spring and actuator member adapted for activating the oscillation system upon retraction of the needle from the skin.

3. A device according to claim 2 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 providing accurate depth control of needle penetration.

4. A device according to claims 1, 2 or 3 comprising:

an actuator system for cyclic movement of the needle in the vertical or horizontal direction while the needle is inserted into the skin.

23. The device of claim 22 further comprising electrodes positioned in the collection tube for connection to a sensor to sense the presence and amount of fluid within the collection tube.

24. A device according to claims 1, 5, 8, 13, 14, 20 or 22 further comprising:

an integral test unit for testing the sample.

25. A device of claims 1, 5, 8, 13, 14, or 22 adapted to receive a test device unit which absorbs the sample from the wound site.

27. A device according to claim 26 further comprising a test strip on which the fluid sample is deposited from the capillary tube.

33. A device according to claim 4 wherein the activator system comprises ultrasonic, piezoelectric, mechanical or electrical action.

34. A device according to claims 1, 5, 8, 13, 14 or 22 further comprising a system for injecting a material into the skin.

35. A device according to claims 1, 5, 13, 14 or 22 further comprising suction means for pulling a sample into the needle, tube or chamber.

36. A device according to claims 1, 5, 8, 13, 25, 22, 28, 29 or 31 wherein the needle, the system for piercing the skin or lancet member is adapted to pierce the skin at an angle less than 90°

.

37. A device according to claim 36 adapted to stimulate the skin prior to or during the peircing the skin.

38. A device according to claims 1, 5, 8, 13, 14, 22, 28, 29 or 31 wherein the portion of the device which pierces the skin and the portion of the device which collects or contains the sample are disposable units.

39. A device according to claims 1, 5, 8, 13, 14, 22, 28, 29 or 31 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.

40. A device according to claims 1, 5, 8, 13, 14 or 22 further comprising a system for imposing an electric potential across the skin from a point distant from the wound in the skin to a point near or in the wound in the skin.

41. A device according to claims 1, 5, 8, 13, 14 or 22 comprising a system to measure the volume of the sample collected.

42. A device according to claim 41 wherein the measuring system is adapted to stop the sample collection at a predetermined volume of sample.

43. A device according to claims 1, 5, 8, 13, 14, 22 or 26 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.

24-1. A device according to claim 23 wherein the test unit comprises a calorimetric test unit or an electrochemical test unit.

26. 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.

28. 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.

29. 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.

31. A lancing device for piercing the skin comprising multiple lancing members formed from needles or barbs.

32. 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.

44. 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.

46. A method according to claim 45 comprising inserting a device to pierce the skin and oscillating the device in the wound.

47. A method according to claim 46 comprising partially retracting the device and collecting the sample while the device is partially inserted in the wound.

45. A method for collection a sample of a body fluid comprising:

mechanically massaging a skin area;

piercing the skin to create a wound;

mechanically massaging a skin area adjacent the wound; and

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