Device and method for removing liquid from endogenic tissue and determining the concentrations of substance in said liquid

• US 6,969,351 B2
• Filed: 01/10/2001
• Issued: 11/29/2005
• Est. Priority Date: 01/27/2000
• Status: Expired due to Fees

• Current Assignee: Meinhard Knoll
• Original Assignee: Meinhard Knoll
• Inventors: Knoll, Meinhard
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): Kremer, Matthew J
• Application Number:
  US10/182,123
• Publication Number:
  US 20030109807A1
• Time in Patent Office: 1,784 Days
• Field of Search: 600/316, 600/365, 600/573, 600/578, 600/583, 600/584, 600/309
• US Class Current: 600/309
• 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 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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

The present invention relates to a device for removing liquid from endogenic tissue and determining concentrations of substances in this liquid, in which a hollow chamber (3), which is placeable in direct contact on the skin (1) covering the tissue with at least one contact opening (3.1) disposed on a contact surface (3.2) and the hollow chamber (3) is connected to a low pressure-producing element (P) via a channel (4.1).

Claims

1. A method for removing liquid from endogenic tissue and determining concentrations of substances in this liquid, comprising:

placing a device on a skin surface, the device having at least one contact opening configured on at least one hollow chamber in a contact surface,

setting a low pressure at the hollow chamber and, forming a liquid reservoir underneath the skin surface,

collecting the liquid in the liquid reservoir,

subsequently flowing the liquid from the liquid reservoir out of the tissue and guiding the liquid with suction forces occasioned by low pressure to a sensor or a sensor system, which is disposed on the channel or is integrated in the wall of the hollow chamber, and

monitoring a lymph flow by determining the number of drops per unit of time, which are sucked into a capillary body.

2. The method according to claim 1, comprising setting a pressure in the hollow chamber, which is 0.05 to 1 bar below the ambient pressure, for the formation of the liquid reservoir and the transportation of the liquid.

3. The method according to claim 1, comprising transporting the liquid with a volume flow of at least 0.01 μ

l/min to the sensor or to the sensor system.

4. The method according to claim 1, comprising continually conveying the liquid.

5. The method according to claim 1, further comprising penetrating at least an uppermost skin layer lying above the liquid reservoir after formation of the liquid reservoir with the help of a penetration element disposed in the hollow chamber or guidable through the contact opening of the hollow chamber in the direction of the skin.

6. A device for removing liquid from endogenic tissue and determining concentrations of substances in this liquid, comprising:

at least one hollow chamber having at least one contact opening disposed on a contact surface, the hollow chamber being placeable in direct contact on the skin covering the tissue, and the hollow chamber being connected to a low pressure-producing element via a channel, and

a sensor or sensor system disposed on the channel, and/or a sensor or sensor system being integratable into a wall of the hollow chamber;

wherein the device comprises two parts, wherein one part is present with an element producing low pressure and a second part is present with at least one sensor; and

wherein both parts are interchangeable.

7. The device according to claim 6, wherein the sensor or the sensor system is disposed on the device such that it is in contact with the liquid.

8. The device according to claim 6, wherein the contact opening has an inner width of from 0.01 to 10 mm.

9. The device according to claim 6, further comprising a penetration element disposed on the hollow chamber in the direction of the skin.

10. The device according to claim 9, wherein the penetration element comprises at least a blade, a lancet, a needle, or a pin.

11. The device according to claim 9, wherein the contact opening includes an external edge, the external edge of the contact opening being configured as a second penetration element.

12. The device according to claim 6, wherein the contact opening is surrounded in a liquid-impermeable manner when placed in position on the skin.

13. The device according to claim 6, further comprising an adhesive, the adhesive being applied at least around the contact opening on the contact surface, and/or on other external edges.

14. The device according to claim 6, including a plurality of sensors or sensor systems, the plurality of sensors or sensor systems being disposed one behind the other in a transportation direction of the liquid.

15. The device according to claim 6, further comprising a membrane, the membrane being disposed between the hollow chamber and the channel.

16. The device according to claim 6, wherein the low pressure-producing element comprises at least a vacuum chamber.

17. The device according to claim 6, wherein at least one capillary body is disposed in the vacuum chamber, in or connected to the channel.

18. The device according to claim 6, wherein a membrane is disposed between electrodes and which are separated from each other, said membrane separating the electrodes from the liquid transported through the channel.

19. The device according to claim 6, wherein electrodes for the sensor or sensor system are formed from platinum or Ag/AgCl.

20. A device for removing liquid from endogenic tissue and determining concentrations of substances in this liquid, comprising:

at least one hollow chamber having at least one contact opening disposed on a contact surface, the hollow chamber being placeable in direct contact on the skin covering the tissue, and the hollow chamber being connected to a low pressure-producing element via a first channel, and a penetration element disposed in the hollow chamber in the direction of the skin,

a gas-permeable membrane and a further channel, the gas-permeable membrane being disposed between the hollow chamber and the further channel, the further channel being connected to the low pressure-producing element,

wherein

a sensor or a sensor system is disposed on the first channel.

21. A device for removing liquid from endogenic tissue and determining concentrations of substances in this liquid, comprising:

at least one hollow chamber having at least one contact opening disposed on a contact surface, the hollow chamber being placeable in direct contact on the skin covering the tissue, and the hollow chamber being connected to a low pressure-producing element via a channel, and a penetration element disposed in the hollow chamber in the direction of the skin,

wherein

a sensor or a sensor system is disposed on the channel, and wherein a plurality of contact openings is present on one or more hollow chambers.

22. A device for removing liquid from endogenic tissue and determining concentrations of substances in this liquid, comprising:

at least one hollow chamber having at least one contact opening disposed on a contact surface, the hollow chamber being placeable in direct contact on the skin covering the tissue, and the hollow chamber being connected to a low pressure-producing element via a channel, and a penetration element disposed in the hollow chamber in the direction of the skin,

an anode and a cathode, the anode being adapted for contact with skin and the cathode being adapted for contact with a lymph, the anode and the cathode being configured on the contact surface,

wherein

a sensor or a sensor system is disposed on the channel.

23. A device for removing liquid from endogenic tissue and determining concentrations of substances in this liquid, comprising:

at least one hollow chamber having at least one contact opening disposed on a contact surface, the hollow chamber being placeable in direct contact on the skin covering the tissue, and the hollow chamber being connected to a low pressure-producing element via a channel, and a penetration element disposed in the hollow chamber in the direction of the skin,

wherein

a sensor or a sensor system is disposed on the channel, and wherein the device is formed from a plurality of plate-shaped elements, which are connected to each other, and the hollow chamber and the channel are configured and a plate-shaped element is the carrier of the sensor or of the sensor system.

24. A device for removing liquid from endogenic tissue and determining concentrations of substances in this liquid, comprising:

at least one hollow chamber having at least one contact opening disposed on a contact surface, the hollow chamber being placeable in direct contact on the skin covering the tissue, and the hollow chamber being connected to a low pressure-producing element via a channel, and a penetration element disposed in the hollow chamber in the direction of the skin,

wherein

a sensor or a sensor system is disposed on the channel, and wherein the sensor system is configured as a plate-shaped element in which at least one containment is introduced, the containment tapering from the surface of the plate-shaped element in the direction of a surface oriented towards the channel, an oppositely-situated surface in which the containment is coated with electrodes and, in the containments, a membrane material is contained, the membrane surfaces of which, oriented in the direction of the channel, are in contact with the liquid transported through the channel.

25. A device for removing liquid from endogenic tissue and determining concentrations of substances in this liquid, comprising:

at least one hollow chamber having at least one contact opening disposed on a contact surface, the hollow chamber being placeable in direct contact on the skin covering the tissue, and the hollow chamber being connected to a low pressure-producing element via a channel, and a penetration element disposed in the hollow chamber in the direction of the skin,

wherein

a sensor or a sensor system is disposed on the channel, and wherein the device determines glucose concentrations in the lymph of humans.

26. A device for removing liquid from endogenic tissue and determining concentrations of substances in this liquid, comprising:

at least one hollow chamber having at least one contact opening disposed on a contact surface, the hollow chamber being placeable in direct contact on the skin covering the tissue, and the hollow chamber being connected to a low pressure-producing element via a channel, and

a sensor or sensor system disposed on the channel, and/or a sensor or sensor system being integratable into a wall of the hollow chamber;

wherein the sensor system is configured as a plate-shaped element in which at least one containment is introduced, the containment tapering from the surface on the plate-shaped element in the direction of a surface oriented towards the channel, an oppositely-situated surface in which the containment is coated with electrodes and, in the containments, a membrane material is contained, the membrane surfaces of which, oriented in the direction of the channel, are in contact wit the liquid transported through the channel.

27. A method for removing liquid from endogenic tissue and determining concentrations of substances in this liquid, comprising:

placing a device on a skin surface, the device having at least one contact opening configured on at least one hollow chamber in a contact surface,

setting a low pressure in the hollow chamber and, forming a liquid reservoir underneath the skin surface,

collecting the liquid in the liquid reservoir,

subsequently flowing the liquid from the liquid reservoir out of the tissue and guiding the liquid with suction forces occasioned by low pressure to a sensor or a sensor system, which is disposed on the channel or is integrated in the wall of the hollow chamber, and

measuring a complex electrical resistance between a penetration element and an electrode in contact with the surface of the skin.

28. The method according to claim 27, further comprising penetrating at least an uppermost skin layer lying above the liquid reservoir after formation of the liquid reservoir with the help of a penetration element disposed in the hollow chamber or guidable through the contact opening of the hollow chamber in the direction of the skin.