Microsensor needle for pH measurement in tissue

• US 8,095,196 B2
• Filed: 12/19/2006
• Issued: 01/10/2012
• Est. Priority Date: 12/19/2006
• Status: Active Grant

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Inventors: Hacker, Thomas G., Kawanishi, Tetsuro
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US11/642,036
• Publication Number:
  US 20080146902A1
• Time in Patent Office: 1,848 Days
• Field of Search: 600/324, 600/325, 600/339, 600/342, 600/310, 436/68
• US Class Current: 600/342
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14556 by fluorescence A61B5/14555 takes precedence
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: Y10T 29/49879 Spaced wall tube or receptacle

Abstract

A sensor probe for in-situ measurement of pH in a human tissue (e.g., cardiovascular) environment comprises a hollow needle having a tip and a back end. The tip is insertable into the tissue. An optic cable comprises a light conduit surrounded by a cladding. A first end of the light conduit is inserted from the back end of the needle and extends to within a predetermined distance of the tip to define a cavity within the tip. A porous dye layer is contained within the cavity, wherein the dye layer has a response to excitation light delivered through the light conduit that varies according to the pH of the tissue environment. An overcoat layer is deposited on the dye layer, wherein the overcoat layer is ionically permeable and substantially opaque at a light wavelength corresponding to the variable response of the dye layer.

Claims

1. A sensor probe for in-situ measurement of pH in a human tissue environment comprising:

a hollow needle having a tip and a back end, the tip being insertable through tissue into the human tissue environment;

an optic cable comprising a light conduit surrounded by a cladding, wherein a first end of the light conduit not covered by the cladding has an outer diameter substantially conforming to the inner diameter of the hollow needle, is inserted from the back end of the needle, and extends to within a predetermined distance of the tip to define a cavity within the tip, wherein the optic cable is fixed to the hollow needle with the cladding abutting the back end of the needle;

a porous dye layer within the cavity adjacent to the first end of the light conduit, wherein the dye layer has a response to excitation light delivered through the light conduit that varies according to the pH of the human tissue environment; and

an overcoat layer deposited on the dye layer, wherein the overcoat layer is ionically permeable and substantially opaque at a light wavelength corresponding to the variable response of the dye layer.

2. The sensor probe of claim 1 wherein the hollow needle is comprised of stainless steel and is cylindrically shaped.

3. The sensor probe of claim 1 wherein the hollow needle is cylindrically shaped and wherein the tip has a planar profile that is slanted at a predetermined angle with respect to a longitudinal axis of the needle.

4. The sensor probe of claim 3 wherein the first end of the light conduit is slanted to be substantially parallel with the planar profile of the needle tip.

5. The sensor probe of claim 3 wherein the predetermined angle is about 30°

.

6. The sensor probe of claim 1 wherein the porous dye layer fluoresces in response to the excitation light.

7. The sensor probe of claim 1 wherein the overcoat layer is comprised of carbon black.

8. The sensor probe of claim 1 further comprising a plastic housing fixedly mounting the back end of the needle and a portion of the optic cable including the cladding.

9. The sensor probe of claim 8 wherein the plastic housing includes a main body with a stitch-on disk extending from the main body.

10. The sensor probe of claim 8 further comprising a thermistor mounted to the plastic housing and thermally coupled to the hollow needle.

11. A method of manufacturing a sensor probe for in-situ measurement of pH in a human tissue environment, comprising the steps of:

preparing a hollow needle having a slanted tip and a back end, the slanted tip being insertable through tissue into the human tissue environment;

preparing a cladded optic cable by removing the cladding from a first end of a light conduit within the optic cable where the light conduit not covered by the cladding has an outer diameter substantially conforming to the inner diameter of the hollow needle;

attaching a spacing jig onto the slanted tip of the hollow needle wherein the spacing jig has a finger extending from a base, the spacing jig being attached to the needle so that the slanted tip contacts the based and the finger extends into the interior of the hollow needle to define a cavity;

inserting the first end of the light conduit through the back end of the hollow needle to abut the finger of the spacing jig;

fixing the optic cable to the hollow needle with the cladding abutting the back end of the needle;

removing the spacing jig from the hollow needle to expose the cavity;

applying a porous dye layer within the cavity adjacent to the first end of the light conduit, wherein the dye layer has a response to excitation light delivered through the light conduit that varies according to the pH of the human tissue environment; and

applying an overcoat layer on the dye layer, wherein the overcoat layer is ionically permeable and substantially opaque at a light wavelength corresponding to the variable response of the dye layer.

12. The method of claim 11 further comprising the step of:

forming the first end of the light conduit to be slanted at about the same angle as the slanted tip of the hollow needle;

wherein the base of the spacing jig and the finger of the spacing jig have surfaces slanted at about the same angle as the slanted tip of the hollow needle, and wherein the slanted profiles of the tip of the needle and the first end of the light conduit become substantially parallel when the first end of the light conduit abuts the finger of the spacing jig.

13. The method of claim 11 wherein the step of fixing the optic cable to the hollow needle is comprised of gluing a ferrule over the optic cable and the hollow needle.

14. The method of claim 11 further comprising the steps of:

mounting a thermistor in thermal communication with the hollow needle;

connecting wires to the thermistor; and

bundling the wires with the optic cable.

15. The method of claim 14 further comprising the step of:

mounting the hollow needle and thermistor to a plastic housing that includes a main body with a stitch-on disk extending from the main body.

16. The method of claim 11 further comprising the step of:

mounting the back end of the hollow needle to a plastic housing that includes a main body with a stitch-on disk extending from the main body.

17. The method of claim 11 wherein the step of applying a porous dye layer within the cavity comprises:

preparing a dye-labeled cellulose solution;

daubing the dye-labeled cellulose solution into the cavity;

immersing the slanted needle tip into a regeneration bath; and

drying the porous dye layer.

18. The method of claim 11 wherein the step of applying an overcoat layer on the dye layer comprises:

dipping the slanted needle tip into a carbon black solution;

after drying, dipping the slanted needle tip into a triacetin solution; and

drying the overcoat layer.