Method and apparatus for sampling bodily fluid

• US 20040267160A9
• Filed: 09/25/2002
• Published: 12/30/2004
• Est. Priority Date: 09/26/2001
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Perez, Edward
• Application Number:
  US10/254,314
• Publication Number:
  US 20040059256A1
• 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 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 syringe mounted in a housing to be displaced toward a skin surface. A suction element disposed on the housing is utilized to creates a suction in the area to be incised causing bodily fluid to pool. Additionally, the suction mechanism may be utilized to create a suction in the tube for drawing in bodily fluid through the piercing element and into the tube. The syringe remains in the resulting incision while the surrounding body tissue is stimulated by a stimulator ring to urge bodily fluid toward the incision. Simultaneously, the syringe may be moved relative to the incision to keep the incision open. Such movement of the syringe may comprise reciprocation in the longitudinal or lateral directions, or both. Alternatively, the movement of the syringe may comprise rotation about a longitudinal center line of the syringe, with the pointed end of the syringe being in the shape of one-half of a cone segment. The suction may then be applied to the area being incised to promote further pooling of bodily fluid. After the bodily fluid has been pooled, suction may be created in a collection tube disposed in communication with the syringe, to draw bodily fluid inwardly through the syringe.

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 location from which the bodily fluid sample is to be taken, the testing device including a distal end portion forming a seal with the skin;

activating a vacuum source communicating with the distal end portion of the testing device and drawing the skin in the area into the distal end portion of the testing device;

deactivating the vacuum source;

forming an incision in the skin with a hollow piercing element; and

collecting the bodily fluid for testing using the hollow piercing element.

2. The method according to claim 1, wherein the testing device includes the vacuum source.

3. The method according to claim 1, wherein the vacuum source is applied before forming the incision.

4. The method according to claim 1, wherein the vacuum source is applied after the forming the incision.

5. The method according to claim 1, wherein the vacuum source is applied before and after the forming the incision.

6. The method according to claim 1, wherein the step of deactivating the vacuum source further includes releasing the vacuum between the testing device and the area of the skin to be lanced.

7. The method according to claim 1, wherein the testing device further includes a hollow fluid transport member having one end in fluid communication with the hollow piercing element and a second end in fluid communication with a test strip.

8. The method according to claim 7, wherein the vacuum source creates a vacuum in the hollow fluid transport member.

9. The method according to claim 7, wherein the test strip is chemical based.

10. The method according to claim 7, wherein the test strip is electrochemical.

11. The method according to claim 1, wherein the method further includes drawing the sample of bodily fluid from the incision to a test strip, determining the level of glucose in the bodily fluid, and displaying the level on a display included on the testing device.

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

13. The method according to claim 1, wherein the method further includes vibrating the hollow piercing element after forming the incision.

14. The method according to claim 1, wherein the method further includes rotating the hollow piercing element after forming the incision.

15. The method according to claim 5, wherein the testing device further includes a stimulating device disposed about the distal end of the testing device, wherein the method further includes oscillating the stimulating to cause the area of the skin to be lanced to pucker, said method further including oscillating the hollow piercing element after forming the incision.

16. A hand-held apparatus for extracting bodily fluid from an incision in the skin, comprising:

a body having a distal end, the distal end being positionable against the skin surrounding an incision location;

a suction means coupled with said body for applying a suction to the distal end of said body;

a cutting member connected with said body and movable between a first position displaced from the skin and a second position extending into the skin at an incision location; and

a fluid extraction member positioned to receive bodily fluid from the incision location.

17. The invention of claim 16 wherein said suction means is for applying the suction prior to said cutting member contacting the skin.

18. The invention of claim 17 wherein said suction means is further for releasing the suction prior to said cutting member contacting the skin.

19. The invention of claim 16 wherein said suction means is for applying the suction after said cutting member contacts the skin.

20. The invention of claim 19 wherein said suction member is for first applying the suction and then subsequently releasing the suction.

21. The invention of claim 16 wherein said body further includes means for vibrating said cutting member after contacting the skin.

22. The invention of claim 16 wherein said body includes means for rotating said cutting member after contacting the skin.

23. The invention of claim 16 wherein said suction means is for applying the suction to said fluid extraction member.

24. The invention of claim 16 in which said body further includes a testing member wherein said fluid extraction member is configured to deposit extracted fluid onto said testing member.

25. The invention of claim 16 wherein said cutting member is hollow.

26. The invention of claim 16 wherein said body further includes means for oscillating the distal end.

27. The invention of claim 21 in which said body further includes a testing member, said fluid extraction member being configured to deposit extracted fluid onto said testing member, said body further including means for oscillating the distal end.

28. The invention of claim 21 wherein said cutting member is hollow and is in fluid communication with said fluid extraction member, said suction means being for applying suction to said fluid extraction member, said body further including means for oscillating the distal end.