Lancet device with skin movement control and ballistic preload

• US 6,306,152 B1
• Filed: 03/08/1999
• Issued: 10/23/2001
• Est. Priority Date: 03/08/1999
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Agilent Technologies, Inc.
• Inventors: Lum, Paul, Verdonk, Edward D.
• Primary Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/264,598
• Time in Patent Office: 960 Days
• Field of Search: 606/181, 606/182, 606/183, 606/184, 600/573, 600/838, 600/578, 600/576, 604/68, 604/130, 604/134-175, 604/57, 604/64, 604/187-199, 604/239, 604/243, 604/264, 604/274, 604/272
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• 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

Abstract

A device for puncturing the skin of a patient. The device includes a lancet for puncturing the skin and a skin stabilizer associated with the lancet for stabilizing the skin to reduce its freedom of movement when the lancet strikes it. The skin stabilizer has an opening through which the lancet can pass to puncture the skin. The skin stabilizer applies pressure on the skin around the opening. The application of pressure, in additional to reducing the freedom of movement of the skin directly held by the skin stabilizer, also increases the tautness of the skin in the opening prior to the lancet penetrating the skin. The opening is not substantially larger than the size of the lancet.

Claims

1. A device for puncturing the skin of a patient, comprising:

(a) lancet for puncturing the skin;

(b) skin stabilizer associated with the lancet, the skin stabilizer having an opening through which the lancet can pass to puncture the skin, the opening having a size about the size of the lancet to larger than the size of the lancet to a small degree, the skin stabilizer applying pressure around the opening to press on the skin to stabilize the skin by reducing its ability to move and increasing tautness of skin in the opening prior to the lancet penetrating the skin; and

(c) driver mechanism to propel the skin stabilizer to contact the skin.

2. A device according to claim 1 wherein the skin stabilizer comprises a barrel having an annular forward end for applying pressure on the skin, the annular forward end provides the opening.

3. A device according to claim 2 wherein the skin stabilizer comprises a cylindrical barrel with a bore in which the lancet can slide, the barrel'"'"'s forward end when applied to the skin stabilizes the skin.

4. A device according to claim 1 wherein the skin stabilizer comprises a plurality of legs, arranged in a ring-like fashion, which when applied to the skin increases the skin'"'"'s tautness radially inward of the legs.

5. A device according to claim 1 wherein the skin stabilizer includes a flaring border lip surrounding the opening such that when the border lip is pressed against the skin the border lip exerts force on the skin with a component of the force directing radially outward from the opening.

6. A device according to claim 1 wherein the opening has a longest linear dimension and the lancet has a longest linear dimension of cross section and wherein the longest linear dimension of the opening is larger than the size of the lancet by less than three times the longest linear dimension of cross section of the lancet.

7. A device according to claim 1 wherein the lancet has a cross section and a cross-sectional area and the opening has an area and wherein the cross section of the lancet is disk-shaped and the area of the opening is larger than the size of the lancet by less than 5 times the cross-sectional area of the lancet.

8. A device according to claim 1 wherein said mechanism is a driver for driving the skin stabilizer and the lancet, and wherein the lancet is slidably connected to the skin stabilizer such that when they are driven together toward the skin, if the skin stabilizer is stopped by the skin, the lancet will continue its forward motion for a sufficient distance with sufficient force to penetrate the skin to cause bleeding.

9. A device according to claim 8 further comprising a spring which can be retained in a compressed form for release to propel the skin stabilizer and the lancet toward the skin for lancing.

10. A device according to claim 8 wherein the driver comprises a spring for propelling the skin stabilizer and the lancet and wherein the lancet is rigidly connected to a mass sufficiently heavy that when the skin stabilizer is stopped by the skin after propulsion the lancet and the mass will have sufficient momentum to penetrate the skin to a sufficient depth to cause bleeding.

11. A device according to claim 1 further comprising a means anchored to the stabilizer for preventing the skin stabilizer from sliding off the skin when the skin stabilizer is applied to the skin.

12. A method of using a lancet device to puncture the skin of a patient, comprising:

(a) using a driver mechanism to mechanically propel a skin stabilizer to stabilize the skin to reduce its freedom of movement by putting pressure on the skin at one or more locations surrounding a central area not in contact with the stabilizer when the stabilizer is applied to the skin; and

(b) puncturing the skin with a lancet at the central area thereafter, wherein the central area which is not in contact with the skin stabilizer is not substantially larger than the cross-sectional size of the lancet.

13. A method according to claim 12 further comprising applying a cylindrical skin stabilizer to press on the skin in an annular form around the lancet to stabilize the skin.

14. A method according to claim 12 further comprising applying pressure on a plurality of points arranged in a ring-shape around the lancet to stabilize the skin.

15. A method according to claim 12 further comprising applying to the skin a force having a lateral component directing radially outward to increase the tautness of the skin before the lancet penetrates the skin.

16. A method according to claim 12 further comprising mechanically propelling the skin stabilizer and the lancet toward the skin and wherein the skin stabilizer is stoppable by the skin without penetration whereas the lancet will continue to move forward after the skin stabilizer has been stopped.

17. A method according to claim 12 comprising using sufficient mass to provide sufficient momentum to the lancet such that the lancet will penetrate the skin by momentum to a sufficient depth to cause the skin to bleed.

18. A method of using a puncturing device to puncture an object with a stretchable surface layer, comprising:

(a) using a driver mechanism to mechanically propel a stabilizer to contact and stabilize one or more areas of the surface layer to reduce its freedom of movement, the one or more areas encircling a central area not in contact with the stabilizer; and

(b) puncturing the surface layer at the central area with a shaft having a sharp end thereafter, wherein the central area which is not in contact with the stabilizer is not substantially larger than the cross-sectional size of the shaft.

19. A method according to claim 18 further comprising mechanically propelling a stabilizer and the shaft toward the surface layer, wherein the stabilizer is stoppable by the surface layer without penetration, whereas the shaft will continue to move toward the object by momentum to penetrate the surface layer to a predetermined depth before stopping.

20. A device for puncturing the skin of a patient, said device comprising:

(a) lancet for puncturing the skin, the lancet having a mass associated therewith;

(b) skin stabilizer associated with the lancet, the skin stabilizer having an opening through which the lancet can pass to puncture the skin, the skin stabilizer, when applied on the skins, applying pressure around the opening to press on the skin to increase tautness thereof prior to the lancet penetrating the skin, the lancet being movably connected to the skin stabilizer, the skin stabilizer being stoppable by the skin without penetration when driven toward the skin by a driver, the lancet having sufficient mass to continue by momentum to move forward to penetrate the skin sufficiently to cause bleeding after the skin stabilizer has stopped; and

(c) spring-actuated driver associated with the skin stabilizer and the lancet for propelling the skin stabilizer and the lancet toward the skin.