Measuring chamber for an optical sensor for determining a concentration of a substance in the tissue fluid of a mammal

• US 9,808,187 B2
• Filed: 11/30/2012
• Issued: 11/07/2017
• Est. Priority Date: 12/02/2011
• Status: Expired due to Fees

• Current Assignee: Schildtec GmbH
• Original Assignee: Schildtec GmbH
• Inventors: Freitag, Hans-Joachim
• Primary Examiner(s): Winakur, Erik
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US14/362,365
• Publication Number:
  US 20140350363A1
• Time in Patent Office: 1,803 Days
• CPC Class Codes: A61B 5/1451 for 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14558 by polarisation
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01N 2021/0346 Capillary cells; Microcells
• CPC Class Codes: G01N 2021/0385 Diffusing membrane; Semipermeable membrane
• CPC Class Codes: G01N 2021/0392 Nonplanar windows
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A measuring chamber device for an optically operating sensor for determining a concentration of a substance that is contained in tissue fluid of a mammal. The measuring chamber device has a measuring chamber filled with a liquid measuring medium and a wall with better diffusion permeability for the substance than for other constituents of the tissue fluid. A transmitter device for emitting optical radiation into the measuring chamber, and a receiver device for receiving optical radiation that has passed through the measuring chamber are also provided.

Claims

1. A measurement chamber device for an optical sensor for measuring the concentration of a substance in the interstitial liquid of a mammal, wherein the measurement chamber device comprises:

a measurement chamber, wherein the measurement chamber is filled with a measurement liquid and comprises a wall, the wall including at least one wall section enabling a better diffusion of the substance than of other components of the interstitial liquid, the measurement chamber, further including a first measurement chamber window section receiving a transmitter unit for emitting optical radiation into the measurement chamber and a second measurement chamber window section receiving a receiver unit for detecting optical radiation transmitted through the measurement chamber, the measurement chamber device further comprising a sterilization envelope which encloses the wall section of the measurement chamber but does not block the optical radiation at the measurement chamber window sections, the sterilization envelope defining a pair of openings in opposing walls thereof corresponding to the measurement chamber windows, wherein each of the pair of openings is sealingly coupled to the measurement chamber around the first measurement chamber window section and the second measurement chamber window section, respectively, wherein the sterilization envelope is filled with measurement liquid to bathe the wall section in measurement liquid, and wherein the sterilization envelope is selectively removable before use of the measurement chamber.

2. The measurement chamber device of claim 1, wherein the sterilization envelope comprises a sheet having an opening thread to remove the enclosing envelope.

3. The measurement chamber device of claim 1, wherein the measurement chamber window sections are glued to the wall and extend into the measurement chamber and cover sections of the wall, at which sections a diffusion permeability of the wall is reduced due to the gluing.

4. The measurement chamber device of claim 1, wherein a mounting portion is provided proximate at least one of the first measurement chamber window section or the second measurement chamber section to mount either the transmitter unit or the receiver unit, wherein the at least one mounting portion includes a flange.

5. The measurement chamber device of claim 4, wherein the at least one mounting portion provides a reservoir for an immersion liquid.

6. The measurement chamber device of claim 1, wherein a calibration chamber is provided which contains a calibration liquid and is connected to the sterilization envelope via a liquid connection, wherein the liquid connection is closed initially and can be opened for calibration purposes to mix the measurement liquid with the calibration liquid.

7. The measurement chamber device of claim 1, wherein a mounting and protection device is attached to the first measurement window section.

8. The measurement chamber device of claim 7, wherein the mounting and protection device is an elastic sleeve.

9. The measurement chamber device of claim 7, wherein the mounting and protection device of the measurement chamber device comprises an optically non-transparent material to prevent penetration of interfering light.

10. The measurement chamber device of claim 1, wherein a mounting and protection device is attached to the second measurement window section.

11. The measurement chamber device of claim 1, wherein at least one of the first and second measurement window section comprises a window surface having a convex form at the inside of the measurement chamber to push any gas bubbles in the measurement liquid to the periphery of the measurement chamber window section.

12. The measurement chamber device of claim 1, wherein the first measurement window section is a fiber coupler to connect the transmitter unit by an optical fiber.

13. The measurement chamber device of claim 1, wherein the second measurement window section is a fiber coupler to connect the receiver unit by an optical fiber.

14. The measurement chamber device of claim 1, wherein the sterilization envelope is sealingly coupled to a periphery of the measurement chamber window sections around each of the pair of openings.

15. A module for a sensor for measuring a concentration of a substance, the module comprising a measurement chamber device including a measurement chamber and filled with a measurement liquid, the chamber comprising a wall including at least one wall section enabling a better diffusion of the substance than of other components of the interstitial liquid, the measurement chamber device further comprising a first measurement chamber window section designed to be connected to a transmitter unit for emitting optical radiation into the measurement chamber and a second measurement chamber window section designed to be connected to a receiver unit for detecting optical radiation transmitted through the measurement chamber, wherein the wall and the measurement window sections enclose the measurement liquid, and the device further comprising a sterilization envelope enclosing the wall section of the measurement chamber, wherein the sterilization envelope is filled also with measurement liquid to bathe the wall section in measurement liquid, and wherein the measurement chamber is elongated having a length and a pair of opposing ends, the first measurement chamber window section being located at one end and the second measurement chamber window section being located at the opposing end, the measurement chamber being adapted for transmission of the optical radiation along the length without reflection, the sterilization envelope defining a pair of openings in opposing walls thereof corresponding to the measurement chamber window sections, wherein each of the pair of openings is sealingly coupled to the measurement chamber around the first measurement chamber window section and the second measurement chamber window section respectively.

16. A sensor for measuring a concentration of a substance, the sensor comprising a transmitter unit for emitting optical radiation, a receiver unit for receiving the optical radiation, and a measurement chamber device, the measurement chamber device comprising a measurement chamber and filled with a measurement liquid, the measurement chamber comprising a wall including at least one wall section enabling a better diffusion of the substance than of other components of the interstitial liquid, the measurement chamber further comprising a first measurement chamber window section adapted to receive the transmitter unit, and a second measurement chamber window section receiving the receiver unit, wherein the wall and the measurement window sections enclose the measurement liquid, the measurement chamber device further comprising a sterilization envelope enclosing the wall section of the measurement chamber, the sterilization envelope being filled with measurement liquid to bathe the wall section in measurement liquid, and being selectively removable before use of the measurement chamber, the sterilization envelope defining a pair of openings in opposing walls thereof corresponding to the measurement chamber window sections, wherein each of the pair of openings is sealingly coupled to the measurement chamber around the first measurement chamber window section and the second measurement chamber window section, respectively.

17. The sensor of claim 16, comprising a protection cap to be placed over the receiver unit, the protection cap comprising a flexible portion to connect to the receiver unit.

18. The sensor of claim 17, wherein the protection cap is adapted to be attached independently from the measurement chamber device.

19. The sensor of claim 17, wherein the protection cap comprises an optically non-transparent material to prevent penetration of interfering light.

20. A method for producing a measurement chamber device, the measurement chamber device comprising a measurement chamber having a wall with at least one wall section enabling better diffusion of a substance contained in interstitial liquid than of other substances contained in the interstitial liquid, the measurement chamber further having a first measurement chamber window section and a second measurement chamber window section, the measurement chamber device further including a sterilization envelope enclosing the wall section of the measurement chamber, the sterilization envelope defining a pair of openings in opposing walls thereof corresponding to the measurement chamber windows, each of the pair of openings being sealingly coupled to the measurement chamber around the first measurement chamber window section and the second measurement chamber window section, respectively, the method comprising:

a) enclosing the measurement chamber in the sterilization envelope;

b) filling the measurement chamber and sterilization envelope with the measurement liquid under vacuum conditions and closing a port in the sterilization envelope; and

c) sterilizing the filled unit with ionizing radiation.

21. A method for producing a module for a sensor for measuring a concentration of a substance, the module comprising a measurement chamber device including a measurement chamber, the chamber comprising a wall including at least one wall section enabling a better diffusion of the substance in the interstitial liquid than of other components of the interstitial liquid, the measurement chamber device further comprising a first measurement chamber window section designed to be connected to a transmitter unit for emitting optical radiation into the measurement chamber and a second measurement chamber window section designed to be connected to a receiver unit for detecting optical radiation transmitted through the measurement chamber, the device further comprising a sterilization envelope enclosing the wall section of the measurement chamber, the measurement chamber being elongated having a length and a pair of opposing ends, the first measurement chamber window section being located at one end and the second measurement chamber window section being located at the opposing end, the sterilization envelope defining a pair of openings in opposing walls thereof corresponding to the measurement chamber window sections, wherein each of the pair of openings is sealingly coupled to the measurement chamber around the first measurement chamber window section and the second measurement chamber window section, respectively, the method comprising:

a) enclosing the measurement chamber in the sterilization envelope;

b) filling the measurement chamber and sterilization envelope with the measurement liquid under vacuum conditions and closing a port in the sterilization envelope;

c) sterilizing the measurement chamber and sterilization envelope with ionizing radiation; and

d) connecting the transmitter unit to the measurement window section, and sterilizing the transmitter unit by surface sterilization.

22. A method for producing a sensor for measuring a concentration of a substance, the sensor comprising a transmitter unit for emitting optical radiation, a receiver unit for receiving the optical radiation, and a measurement chamber device, the measurement chamber device comprising a measurement chamber and filled with a measurement liquid, the measurement chamber comprising a wall including at least one wall section enabling a better diffusion of the substance than of other components of the interstitial liquid, the measurement chamber further comprising a first measurement chamber window section adapted to receive the transmitter unit, and a second measurement chamber window section receiving the receiver unit, the measurement chamber device further comprising a sterilization envelope enclosing the wall section of the measurement chamber, the sterilization envelope being selectively removable before use of the measurement chamber, the sterilization envelope defining a pair of openings in opposing walls thereof corresponding to the measurement chamber window sections, wherein each of the pair of openings is sealingly coupled to the measurement chamber around the first measurement chamber window section and the second measurement chamber window section, respectively, the method comprising:

a) enclosing the measurement chamber in the sterilization envelope;

b) connecting a calibration chamber containing a calibration liquid to the sterilization envelope via a liquid connection, the liquid connection being selectively openable and closable;

c) filling the measurement chamber and sterilization envelope with the measurement liquid under vacuum conditions and closing a port in the sterilization envelope;

d) sterilizing the measurement chamber and sterilization envelope with ionizing radiation;

e) connecting the receiver unit to the second measurement chamber window section and connecting the transmitter unit to the first measurement window section; and

f) calibrating the sensor by performing a first measurement with the liquid connection closed, subsequently opening the liquid connection to mix the measurement liquid with the calibration liquid, and performing a second measurement with the measurement liquid being mixed with the calibration liquid.