Multilayered optical sensing patch and retaining plug therefor

• US 20080286155A1
• Filed: 05/16/2008
• Published: 11/20/2008
• Est. Priority Date: 05/15/2007
• Status: Active Grant

• Current Assignee: Polestar Technologies Inc.
• Original Assignee: Polestar Technologies Inc.
• Inventors: Kane, James A.
• Granted Patent: US 8,313,710 B2
• Time in Patent Office: Days
• US Class Current: 422/82.08
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 21/77 by observing the effect on a chemical indicator
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence

Abstract

A multilayered optical sensing patch, for the measurement of conditions, such as pH, oxygen level, etc, within containers, is provided. The multilayered optical sensing patch of the present invention is comprised of a heat sealable polymer substrate layer, and a polymeric sensing membrane later attached thereto. The polymer sensing membrane layer is formed of a porous polymer support membrane, and an optical sensing composition (comprising a reactive indicator) covalently bonded thereto. The heat sealable polymer substrate layer is capable of being securely bonded to the inner layer of bioreactor bags, as well as the porous polymer support substrate layer. Further, the porous polymer support membrane layer provides a firm supporting structure for the polymeric sensing layer, thereby protecting the optical sensing composition disposed therein from degradation/damage.

Claims

1. A multilayered optical sensing patch comprising:

(a) a heat sealable polymer substrate layer; and

(b) a polymeric sensing membrane layer attached to said heat sealable polymer substrate layer, said polymeric sensing membrane layer comprised of;

(i) a porous polymer support membrane layer having a plurality of pores disposed therein; and

(ii) an optical sensing composition comprising a reactive indicator capable of covalently bonding to chemical groups on the porous polymer support membrane.

2. The multilayered optical sensing patch of claim 1, wherein the reactive indicator of the optical sensing composition comprises a fluorescent or calorimetric sensing composition for the detection or measurement of oxygen, pH, carbon dioxide, ammonia, alkali and alkaline-earth metal ions, nutrients such as glucose, or metabolites such as lactate, acetate.

3. The multilayered optical sensing patch of claim 1, wherein the reactive indicator comprises one or more of isothiocyanates, isocyanates, succinimidyl esters, sulfonyl chloride, and vinyl sulfoesters.

4. The multilayered optical sensing patch of claim 3, wherein the reactive indicator is one or more of acetylated 8-hydroxypyrene-1,3,6-trisulfonyl chloride, fluorescein isothiocyanate, Oregon Green®

isothiocyanate, Oregon Greene 488 carboxylic acid, succinimidyl ester (5 or 6 isomer), 5-(and

     6)-carboxy SNAFL®

-1, succinimidyl ester, and 5-(and

     6)-carboxy SNAFL®

-1, succinimidyl ester.

5. The multilayered optical sensing patch of claim 1, wherein the heat sealable polymer substrate layer is comprised of one or more of a polyether, polyamide, polyvinyl or polyolefin.

6. The multilayered optical sensing patch of claim 1, wherein the heat sealable polymer substrate has an optical transparency of 50% or greater over the spectral range of interest.

7. The multilayered optical sensing patch of claim 1, wherein the porous polymer support membrane is comprised of nylon, polyester, cellulous acetate, or nitrocellulous.

8. The multilayered optical sensing patch of claim 1, wherein the porous polymer support membrane has a pore size of from about 0.1 to about 20 μ

m.

9. The multilayered optical sensing patch of claim 1, wherein the porous polymer support membrane has an onset melt temperature of 200 degrees centigrade or greater.

10. The multilayered optical sensing patch of claim 1, wherein the porous polymer support membrane is attached to the heat sealable polymer membrane at an interpenetrating interfacial region, said interfacial region being formed by percolation of the heat sealable polymer membrane into the pores of the porous polymer support membrane during heating.

11. The multilayered optical sensing patch of claim 1, wherein the optical sensing composition is directly chemically bonded to the porous polymer support membrane, by covalently bonding of the reactive indicator directly to active (free) amines or hydroxyl groups on the porous polymer support membrane.

12. The multilayered optical sensing patch of claim 2, wherein the optical sensing composition is directly chemically bonded to the porous polymer support membrane, by covalently bonding of the reactive indicator directly to active (free) amines or hydroxyl groups on the porous polymer support membrane.

13. The multilayered optical sensing patch of claim 3, wherein the optical sensing composition is directly chemically bonded to the porous polymer support membrane, by covalently bonding of the reactive indicator directly to active (free) amines on the porous polymer support membrane.

14. The multilayered optical sensing patch of claim 1, wherein the heat sealable polymer substrate is polyethylene, the porous polymer support membrane is a microporous nylon, and the optical sensing composition is comprised of particles, said particles being covalently bonded to microporous nylon.

15. A method of manufacturing the multilayered optical sensing patch of claim 1, comprising the steps of:

(a) soaking the porous polymer support membrane in a pH buffer composition, dimethyl formamide, or triethylamine in water solution;

(b) placing the porous polymer support membrane in a solution comprising the reactive indicator, and allowing the porous polymer support membrane to soak in the solution for a time period sufficient to allow the reactive indicator to covalently bond to the free amines on the porous polymer support membrane;

(d) removing any unbound reactive indicator from the polymer sensing membrane layer by decanting the solution and/or rinsing the solution from the porous polymer support membrane; and

(e) laminating the heat sealable polymer substrate film to the porous polymer support membrane layer, having pores therein, using a combination of heat and pressure.

16. An optical sensing patch retaining plug comprising:

a plug body having a plug face;

an optical sensing patch in communication with the plug face; and

a fiber optic insertion channel disposed within said plug body, said fiber optic insertion channel being disposed adjacent to the optical sensing patch,

wherein at least a portion of the plug face not in communication with the optical sensing patch may be welded to a bioreactor bag or other container of interest.

17. The optical sensing patch retaining plug of claim 16, wherein the plug body is comprised of heat sealable material.

18. The optical sensing patch retaining plug of claim 16, wherein the heat sealable material is comprised of one or more of polypropylene, low density polyethylene, linear low density polyethylene, ethyl vinyl acetate, hydrolyzed ethylene vinyl acetate, low vinyl acetate ethylene-vinyl acetate copolymer, polyvinylidene fluoride, styrene butadiene copolymers, ionomers, acid copolymers, thermoplastic elastomers, and plastomers.

19. The optical sensing patch retaining plug of claim 16, wherein the fiber optic insertion channel comprises a means for securedly retaining a fiber optic device therein.

20. The optical sensing patch retaining plug of claim 19, wherein the means for securedly retaining a fiber optic device comprises threaded members, compression fit retaining devices and/or adhesives.