Device and method for variable speed lancet

• US 7,258,693 B2
• Filed: 04/21/2003
• Issued: 08/21/2007
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Freeman, Dominique M.
• Primary Examiner(s): Hayes; Michael J.
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/420,535
• Publication Number:
  US 20040010279A1
• Time in Patent Office: 1,583 Days
• Field of Search: 606/167, 606/172, 606/181, 606/182, 606/183, 600/573, 600/576, 600577-579, 600/583, 128/898
• US Class Current: 606/181
• 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 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc

Abstract

A method of penetrating tissue is provided. The method comprises using a lancet driver to advance a lancet into the tissue; advancing the lancet at a first desired velocity in a first layer of tissue; advancing the lancet at a second desired velocity in a second layer of tissue; and advancing the lancet at a third desired velocity in a third layer of tissue. In one embodiment, the method may including using a processor having logic for controlling velocity of the lancet in each layer of tissue.

Claims

1. A method of penetrating tissue comprising:

using a lancet driver to advance a lancet into said tissue;

advancing said lancet at a first desired velocity in a first layer of tissue;

advancing said lancet at a second desired velocity in a second layer of tissue;

advancing said lancet at a third desired velocity in a third layer of tissue; and

creating a wound in the tissue;

wherein at least two of the first, the second, the third velocity being different; and

wherein the first, the second and the third layer are different tissue layer.

2. The method of claim 1 further comprising using a processor having logic for controlling velocity of the lancet in each layer of tissue.

3. The method of claim 2 wherein said lancet achieves a lancet velocity between about 4 to 10 m/s while in at least one of the layers of tissue.

4. The method of claim 2 wherein said lancet achieves a penetration depth, as measured from a surface of the tissue, of between about 0.5 to about 2.0 mm.

5. The method of claim 2 wherein said second desired velocity is sufficient to minimize nerve stimulation while maintaining cutting efficiency.

6. The method of claim 2 wherein said second velocity is the same as the first velocity.

7. The method of claim 2 wherein said first velocity is at least partially determined based on hydration of the stratum corneum.

8. The method of claim 2 wherein said second velocity is at least partially determined based on hydration of the stratum corneum.

9. The method of claim 2 wherein a four edge algorithm is used to control lancet velocity.

10. The method of claim 2 wherein there are at least 30 different decision points to change lancet velocity during penetration.

11. The method of claim 2 wherein there are at least 30 different decision points to change lancet velocity prior to the lancet reaching a stopped position in the tissue.

12. The method of claim 2 further comprising using a first detection algorithm on a lancet inbound phase and a second detection algorithm on a lancet outbound phase.

13. The method of claim 2 controlling lancet velocity to within 1% at a speed of 5 m/s.

14. The method of claim 2 lancing according to regional velocity profiles based on variation of cell type.

15. The method of claim 2 lancing according to regional velocity, said velocity base on changes of regional cell types and the resistance they provide.

16. The method of claim 2 lancing according to regional velocity profiles based on location to pain sensors.

17. The method of claim 2 wherein position and velocity are determined based on cell population and distribution in the different zones of tissue.

18. The method of claim 2 wherein said lancet has a maximum velocity through a stratum corneum, has a velocity in the epidermis sufficient to reduce shock waves to pain sensor in dermis, and a velocity through in the dermis sufficient for efficient cutting of blood vessels without stimulating pain sensors.

19. The method of claim 1 wherein said penetrating member achieves a penetrating member velocity between about 4 to 10 m/s while in at least one of the layers of tissue.

20. The method of claim 1 wherein said penetrating member achieves a penetration depth, as measured from a surface of the tissue, of between about 0.5 to about 2.0 mm.

21. The method of claim 1 wherein said penetrating member is sufficient to minimize nerve stimulation while maintaining cutting efficiency.

22. The method of claim 1 wherein said second velocity is the same as the first velocity.

23. The method of claim 1 wherein said first velocity is at least partially determined based on hydration of the stratum corneum.

24. The method of claim 1 wherein said second velocity is at least partially determined based on hydration of the stratum corneum.

25. The method of claim 1 wherein a four edge algorithm is used to control penetrating member velocity.

26. The method of claim 1 wherein there are at least 30 different decision points to change penetrating member velocity during penetration.

27. The method of claim 1 wherein there are at least 30 different decision points to change penetrating member velocity prior to reaching.

28. The method of claim 1 further comprising using a first detection algorithm on a penetrating member inbound phase and a second detection algorithm on a penetrating member outbound phase.

29. The method of claim 1 controlling penetrating member velocity to within 1% at a speed of 5 m/s.

30. The method of claim 1 lancing according to regional velocity profiles based on variation of cell type.

31. The method of claim 1 lancing according to regional velocity, said velocity based on changes of regional cell types and the resistance they provide.

32. The method of claim 1 lancing according to regional velocity profiles based on location to pain sensors.

33. The method of claim 1 wherein position and velocity are determined based on cell population and distribution in the different zones of tissue.

34. The method of claim 1 wherein said penetrating member has a maximum velocity through a stratum corneum, has a velocity in the epidermis sufficient to reduce shock waves to pain sensor in dermis, and a velocity through in the dermis sufficient for efficient cutting of blood vessels without stimulating pain sensors.