BLOOD AND INTERSTITIAL FLUID SAMPLING DEVICE

• US 20100331731A1
• Filed: 07/29/2010
• Published: 12/30/2010
• Est. Priority Date: 05/17/1996
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Radwanski, Ryszard, Grage, Henry M., Douglas, Joel S., Sanchez, Michael S.
• Application Number:
  US12/845,832
• Publication Number:
  US 20100331731A1
• 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, 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. In one configuration, the lancing needle may be withdrawn very slightly from the point of maximum penetration to create an opening in which blood can pool before being suctioned through to device.

Claims

1. An apparatus for obtaining a sample of body fluid, comprising:

a skin piercing member; and

a drive mechanism connected to the skin piercing member;

wherein the drive mechanism is adapted to extend the skin piercing member to a point of maximum penetration beneath a skin surface and withdraw the skin piercing member from the point of maximum penetration while maintaining the skin piercing member beneath the skin surface to create an opening in which body fluid can pool.

2. The apparatus of claim 1, further comprising:

a double stop system, wherein a first stop defines the point of maximum penetration and a second stop defines the point where the skin piercing member creates the opening in which body fluid can pool.

3. The apparatus of claim 1, wherein the skin piercing member includes a fluid passage, the apparatus further comprising:

a suction mechanism adapted to create suction to draw body fluid through the fluid passage.

4. The apparatus of claim 1, further comprising:

a sample collection chamber connected to the drive mechanism, wherein the drive mechanism is reusable and the sample collection chamber is disposable.

5. The apparatus of claim 1, wherein the skin piercing member is disposable and the drive mechanism is reusable.

6. The apparatus of claim 1, wherein the point of maximum penetration is at a depth of 0.3 to 0.6 millimeters below the skin surface.

7. The apparatus of claim 1, further comprising:

a penetration depth adjustment mechanism adapted to adjust the depth to which the skin piercing member penetrates beneath the skin surface.

8. The apparatus of claim 1, further comprising:

a needle guard connected to the drive mechanism, the needle guard adapted to contact the skin surface and inhibit the skin piercing member from contacting the skin while the skin piercing member is in a retracted position.

9. A method, comprising:

extending a skin piercing member of a fluid sampling device to a point of maximum penetration beneath a skin surface with a drive mechanism; and

withdrawing the skin piercing member from the point of maximum penetration with the drive mechanism while maintaining the skin piercing member beneath the skin surface and forming an opening between the skin piercing member and the skin in which body fluid can pool.

10. The method of claim 9, further comprising:

moving fluid from the opening between the skin piercing member and the skin through a passage in the skin piercing member.

11. The method of claim 9, further comprising:

forming a vacuum; and

drawing fluid from the opening between the skin piercing member and the skin using the vacuum.

12. The method of claim 9, further comprising:

moving fluid from the opening between the skin piercing member and the skin to a sample collection chamber connected to the drive mechanism.

13. The method of claim 9, wherein said extending results in the skin piercing member reaching a maximum depth of 0.3 to 0.6 millimeters below the skin surface.

14. The method of claim 9, further comprising:

limiting the point of maximum penetration beneath the skin surface to a value that can be adjusted.

15. The method of claim 9, wherein said extending includes extending the skin piercing member beyond a needle guard, the needle guard being adapted to contact the skin surface.

16. An apparatus, comprising:

a reusable fluid sampling device including a drive mechanism; and

a disposable member detachably mounted to the drive mechanism and adapted to be replaced after use, the disposable member including a skin piercing member with a fluid passageway, the skin piercing member being adapted to penetrate a skin surface;

wherein the drive mechanism extends the skin piercing member to a point of maximum penetration beneath the skin surface and, while maintaining the skin piercing member in the wound, pulls the skin piercing member back to permit body fluid accumulation; and

wherein the fluid passageway is adapted to draw fluid from the accumulated body fluid.

17. The apparatus of claim 17, wherein the point of maximum penetration is at a depth of 0.3 to 0.6 millimeters below the skin surface.

18. The apparatus of claim 17, wherein the reusable fluid sampling device includes a suction mechanism in communication with the fluid passageway, the suction mechanism adapted to draw accumulated body fluid through the fluid passageway.

19. The apparatus of claim 19, wherein the suction mechanism includes a syringe with a plunger.

20. The apparatus of claim 19, further comprising:

a penetration depth adjustment mechanism adapted to adjust the depth to which the skin piercing member penetrates beneath the skin surface.