System and method for piercing dermal tissue

• US 20060178573A1
• Filed: 02/03/2004
• Published: 08/10/2006
• Est. Priority Date: 03/06/2003
• Status: Abandoned Application

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: Kermani, Mahyar Z, Sohrab, Borzu
• Application Number:
  US10/511,495
• Publication Number:
  US 20060178573A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• 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 5/150091 by electricity
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• 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 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure

Abstract

A system for piercing dermal tissue includes a skin-piercing element (e.g., an integrated micro-needle and biosensor medical device), at least one electrical contact (e.g., an electrical skin contact) and a meter configured for measuring an electrical characteristic (e.g., resistance and/or impedance) existent between the skin-piercing element and the electrical contact(s) when the system is in use. The electrical contact(s) can be integrated with a pressure/contact ring of the meter to provide a compact and inexpensive system compatible with integrated micro-needle and biosensor medical devices. Also, a method for piercing dermal tissue that includes contacting dermal tissue (e.g., skin) with at least one electrical contact and inserting a skin-piercing element into the dermal tissue while measuring an electrical characteristic existent between the skin-piercing element and the electrical contact(s).

Claims

1. A system for piercing dermal tissue, the system comprising

a skin-piercing element;

at least one electrical contact; and

a meter configured for measuring an electrical characteristic existent between the skin piercing element and the at least one electrical contact when the system is in use.

2. The system of claim 1, wherein the at least one electrical contact is an electrical skin contact.

3. The system of claim 1, wherein the meter is configured to measure an electrical characteristic between the skin-piercing element and the at least one electrical contact that is indicative of dermal tissue penetration by the skin-piercing element.

4. The system of claim 1, wherein the meter is configured to measure an electrical characteristic between the skin-piercing element and the at least one electrical contact that is indicative of a stability of dermal tissue penetration by the skin-piercing element.

5. The system of claim 1, wherein the meter is configured to measure an electrical characteristic between the skin-piercing element and the at least one electrical contact that is indicative of dermal tissue penetration residence time by the skin-piercing element.

6. The system of claim 1, wherein the electrical characteristic is the electrical resistance between the skin-piercing element and the at least one electrical contact.

7. The system of claim 1, wherein the electrical characteristic is the electrical impedance between the skin-piercing element and the at least one electrical contact.

8. The system of claim 1, wherein the at least one electrical contact includes a first electrical contact and a second electrical contact.

9. The system of claim 8, wherein the meter is further configured for measuring an electrical characteristic existent between the first and second electrical contacts.

10. The system of claim 1, wherein the meter includes a pressure/contact ring and the at least one electrical contact is integrated with the pressure/contact ring.

11. The system of claim 1, wherein the skin-piercing element is a micro-needle.

12. The system of claim 11, wherein the micro-needle is a component of an integrated micro-needle and biosensor medical device.

13. A system for piercing dermal tissue, the system comprising

a skin-piercing element;

a first electrical contact;

a second electrical contact; and

a meter configured for measuring an electrical characteristic existent between the skin piercing element and the first and second electrical contacts when the system is in use.

14. The system of claim 13, wherein the electrical characteristic is the electrical impedance between the skin-piercing element and both of the first and second electrical contacts.

15. The system of claim 13, wherein the meter includes a pressure/contact ring and the first and second electrical contacts are integrated with the pressure/contact ring.

16. The system of claim 13, wherein the skin-piercing element is a micro-needle.

17. The system of claim 16, wherein the micro-needle is a component of an integrated micro-needle and biosensor medical device.

18. The system of claim 13, wherein the first electrical contact is a first electrical skin contact and the second electrical contacts is a second electrical skin contact.

19. A method for piercing dermal tissue comprising:

contacting dermal tissue with at least one electrical contact; and

inserting a skin-piercing element into the dermal tissue while measuring an electrical characteristic existent between the skin-piercing element and the at least one electrical contact, thereby penetrating the dermal tissue.

20. The method of claim 19 further including the step of presenting a user with an indicator of a dermal tissue penetration depth of the skin-piercing element, said indicator being based on the measured electrical characteristic.

21. The method of claim 19 further including the step of presenting a user with an indicator of a dermal tissue penetration stability of the skin-piercing element, said indicator being based on the measured electrical characteristic.

22. The method of claim 19 further including the step of presenting a user with an indicator of dermal tissue penetration residence time of the skin-piercing element, said indicator being based on the measured electrical characteristic.

23. The method of claim 19, wherein the inserting step includes inserting a micro-needle skin-piercing element.

24. The method of claim 19, wherein the inserting step includes inserting a micro-needle of an integrated micron-needle and biosensor medical device.

25. The method of claim 19, wherein the inserting step further involves measuring the electrical characteristic prior to contact between the skin-piercing element and the dermal tissue, when the skin-piercing element has contacted the dermal tissue and when the skin-piercing element has penetrated the dermal tissue.

26. The method of claim 19, wherein the measuring is accomplished by applying a current in the range of 1 mA to 10 mA.

27. The method of claim 19, wherein the measuring is accomplished using a potential frequency in the range of 10 KHz to 1 MHz, where the low end of the frequency prevents user discomfort and the high end of the frequency minimizes stray capacitance from being measured.