Method and apparatus for sampling bodily fluid

• US 7,758,516 B2
• Filed: 02/14/2006
• Issued: 07/20/2010
• Est. Priority Date: 09/26/2001
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Perez, Edward P.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SMITH, FANGEMONIQUE A
• Application Number:
  US11/353,849
• Publication Number:
  US 20070060845A1
• Time in Patent Office: 1,617 Days
• Field of Search: 600/573, 600/583, 600/578, 600/584, 606/181, 606/182, 606/183
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• 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 5/150236 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 5/150396 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 5/15113 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 5/1519 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

Bodily fluid is sampled by causing a lancet mounted in a housing to be displaced toward a skin surface. A vacuum mechanism disposed on the housing is utilized to create a suction in the area to be incised causing bodily fluid to pool. The vacuum mechanism may then be deactivated thereby releasing the vacuum force on the skin, or repeatedly activated and deactivated. After the vacuum device has been utilized, the lancet is advanced to form an incision. The vacuum device may be activated, activated and deactivated, or repeatedly activated and deactivated after forming the incision. The sample may be withdrawn from the incision through a capillary tube.

Claims

1. A method of expressing bodily fluid from an incision in the skin, the method comprising:

disposing a testing device against the skin at a bodily fluid sampling location, the testing device including a distal end portion forming a seal with the skin, a vacuum source communicating with the distal end portion of the testing device, and a lancing device;

activating the vacuum source;

creating a vacuum in the distal end portion of the testing device adjacent to the sampling location;

drawing the skin into the distal end portion of the testing device and to a drawn-in position;

deactivating the vacuum source after said activating;

releasing the vacuum in the distal end portion of the testing device adjacent to the sampling location after said creating;

releasing the skin from the drawn-in position in the distal end portion, said releasing the skin occurring after said drawing and in response to said releasing the vacuum;

forming an incision in the skin with the lancing device, wherein said forming occurs after said activating, after said deactivating and after said releasing.

2. The method according to claim 1, further comprising reactivating the vacuum source after said forming an incision.

3. The method according to claim 2, further comprising additionally deactivating the vacuum source after said reactivating.

4. The method according to claim 1, further comprising collecting the bodily fluid for testing.

5. The method according to claim 4, wherein the testing device further includes a test strip, and wherein said collecting deposits bodily fluid onto the test strip.

6. The method according to claim 5, wherein the test strip is electrochemical.

7. The method according to claim 5, further comprising determining the level of glucose in the bodily fluid, and displaying the level on a display included on the testing device.

8. The method according to claim 1, wherein the testing device further includes a stimulating device disposed about the distal end portion of the testing device, the method further comprising stimulating the area of the skin to be lanced with the stimulating device to pucker the skin.

9. The method according to claim 1, wherein the lancing device is solid and contains no holes.

10. The method according to claim 1, further comprising maintaining the testing device against the skin at the bodily fluid sampling location during said activating, said creating, said drawing, said deactivating, said releasing the vacuum, said releasing the skin and said forming.

15. The method according to claim 8, wherein the stimulating includes applying a vibratory force to the target tissue.

16. The method according to claim 15, wherein the stimulating includes applying an ultrasonic vibratory force to the target tissue.

17. The method according to claim 1, further comprising applying a heat force to the bodily fluid sampling location with the testing device.

11. A method of obtaining a sample of capillary whole blood from a target tissue, comprising:

providing a penetrating system that includes a tissue stabilizing member, a tissue stimulation member, and a vacuum source;

drawing the target tissue into the tissue stabilizing member and to a drawn-in position with the vacuum source;

releasing the vacuum source after said drawing;

releasing the target tissue from the drawn-in position within the tissue stabilizing member, said releasing the target tissue occurring after said releasing the vacuum and in response to said releasing the vacuum;

applying skin stimulation to the target tissue with the tissue stabilizing member;

introducing a penetrating member through the target tissue to form an incision after said releasing the target tissue; and

collecting blood from the incision in the penetrating system.

12. The method of claim 11, wherein the skin stimulation is a vibratory motion applied to the target tissue.

13. The method of claim 11, wherein the skin stimulation increases blood circulation at the target tissue.

14. The method of claim 11, wherein the skin stimulation is a heat force applied to the target tissue.