Multiple lancet device

• US 6,660,018 B2
• Filed: 04/30/2001
• Issued: 12/09/2003
• Est. Priority Date: 03/08/1999
• Status: Expired due to Fees

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Agilent Technologies, Inc.
• Inventors: Greenstein, Michael, Freeman, Dominique M, Leonard, Leslie A., Lum, Paul
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/846,139
• Publication Number:
  US 20010027328A1
• Time in Patent Office: 953 Days
• Field of Search: 606/44, 606/116, 606/131, 606/132, 606/167, 606/181, 606/182, 606/183, 606/185, 606/186, 606/187, 606/189, 604/19, 604/22, 604/27, 604/28, 604/46, 604/164.01, 604/187, 604/272-274, 604/540, 604/317, 604/403, 604/411, 600/573, 600/576-579
• US Class Current: 606/181
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• 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 5/150099 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 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A device for puncturing the skin of a patient. The device includes first and second protrusions, each protrusion puncturing the skin when pressed against the skin. The first and second protrusions are arranged such that the first protrusion punctures the skin at a location less than a predetermined distance from the second protrusion. The distance is chosen to be less than the discriminatable distance between distinct pain perception points in the patient, such that the patient perceives a single puncture when the first and second protrusions puncture the skin. In one embodiment of the invention, the device includes a base lip that applies a lateral force to the skin when the base lip is pressed against the skin. In this embodiment, the protrusions are pressed into the skin as the base lip is pressed against the skin.

Claims

1. A device for puncturing the skin of a patient to sample body fluid, said device comprising two or more protrusions including a first protrusion and a second protrusion, each protrusion having a diameter of at least about 200 microns and a separate distal point and puncturing the skin to result in separate puncture wounds when pressed against the skin, at least the first protrusion being arranged such that it punctures the skin at a location at a distance at most 4 mm away from the second protrusion nearest thereto, wherein said device comprises a base assembly associated with said protrusions, said base assembly applying a force having a lateral component to said skin when said base assembly is pressed agains said skin, wherein the protrusions are movable relative to the base assebly.

2. A device according to claim 1 wherein said protrusions are forced into said skin when said base assembly is pressed against said skin.

3. A device according to claim 1 wherein said base assembly comprises a resilient material that is deformed when said base assembly is pressed against said skin.

4. A device according to claim 1 wherein the base assembly includes a border lip surrounding the protrusions such that when pressed against the skin the border lip exerts force on the skin with a component of the force away from the protrusions.

5. A device according to claim 1 wherein said first and second protrusions each comprise a hollow member.

6. A device according to claim 1 wherein each protrusion has a sharp tip off center on the protrusion and a side of each protrusion having the sharp tip on each of the protrusions being arranged to face away from the axis of the lancet device.

7. A device according to claim 6 wherein each protrusion has a beveled end leading to said sharp tip, the bevel of each protrusion facing inwards from the axis of the lancet device.

8. A device according to claim 1 wherein there are three or more protrusions that are hollow to permit fluid flow therein.

9. A device according to claim 1 wherein each protrusion is at most 3 mm away from another of the protrusions in said device.

10. A device for puncturing the skin of a patient to sample body fluid, said device comprising two or more protrusions including a first protrusion and a second protrusion, each protrusion having a diameter of at least about 200 microns and a separte distal point and puncturing the skin to result in separate puncture wounds when pressed against the skin, at least the first protrusion being arranged from the second protrusion nearest thereto, wherein three or more protrusions are hollow to permit fluid flow therein, and wherein said device comprises a chamber in fluid communication with the hollow protrusions, the chamber having an exit having fluid communication to outside the device for access to a suction or capillary force.

11. A device according to claim 10 wherein some of the protrusions are distributed at polygonal vertices equi-distance from the axis and surrounding one or more protrusions nearer to the axis, the polygonal vertices protrusion having a different length from the one or more protrusions nearer to the axis of the lancet device.

12. A device according to claim 11 wherein the protrusions at polygonal vertices surround and are shorter than at least two protrusions that are near the axis of the lancet device.

13. A device according to claim 10 comprising more than three protrusions, and the protrusions are not of equal length.

14. A method of making a lancet device for puncturing the skin of a patient to sample body fluid, comprising:

arranging on a support body two or more protrusions each having a diameter of at least about 200 microns and a separate distal point such that at least one protrusion punctures the skin at a location at a distance D at most 4 mm from another of the protrusions nearest to said one protrusion to result in separate puncture wounds when the protrusions are pressed against the skin;

forming on each protrusion a sharp tip off center on the protrusion; and

arranging the sharp tips of the protrusions to face away from the axis of the lancet device.

15. A method according to claim 14 further comprising attaching a base assembly to said protrusions such that said base assembly has a flare member angled away from the axis of the support body, the flare member applying a force with a lateral component to said skin when said base assembly is pressed against said skin.

16. A method according to claim 14 wherein said protrusions are connected to the base assembly such that the protrusions are forced into said skin when said base assembly is pressed against said skin and wherein said base assembly comprises a resilient material that is deformed when said base assembly is pressed against said skin.

17. A method according to claim 14 comprising forming said base assembly with a resilient material such that the base assembly is deformable when said base assembly is pressed against said skin.

18. A method according to claim 14 further comprising providing on the base assembly a border lip surrounding the protrusions such that when pressed against the skin the border lip exerts force on the skin with a component of the force away from the protrusions.

19. A method according to claim 14 further comprising locating some of the protrusions at polygonal vertices equi-distance from the axis and surrounding one or more of the other protrusions nearer to the axis of the lancet device, the polygonal vertex protrusions having a different length from the one or more protrusions nearer to the axis of the lancet device.

20. A method according to claim 14 wherein each protrusion is at most 3 mm away from another of the protrusions.

21. A method of using a lancet device to puncture the skin of a patient to sample body fluid, comprising:

driving two or more protrusions having a diameter of at least about 200 microns, to puncture the skin such that at least one protrusion punctures the skin at a location a distance D from another of the protrusions nearest thereto when the protrusions are pressed against the skin, said distance D being chosen to be at most 4 mm so as to be less than the discriminatable distance between the distinct pain preception points in the patient, wherein each protrusion has a sharp tip off center on the protrusion such that the side of the protrusion having the sharp tip in each protrusion faces away from the axis of the lancet device when the lancet is being driven into the skin.

22. A method according to claim 21 further comprising pressing a base assembly to push said protrusions to penetrate the skin and to apply a force with a lateral component to said skin to increase tautness of the skin.

23. A method according to claim 21 wherein each protrusion is at most 3 mm away from another of the protrusions.