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EP0352610A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Fiber-optic physiological probes

Assignee: Abbott Laboratories
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Filing: 1989-07-19
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Granted: —
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Expires: 2009-07-19
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Abstract

Abstract Fiber-optic sensors suitable for monitoring physiological analyte concentration. An analyte-permeable matrix is disposed in the light path defined by the axial core at one end of an optical fiber segment. The matrix contains an indicator molecule covalently linked to a polymer, preferably methyl methacrylate/methacrylamidopropyltrimethylammonium chloride, N-vinyl­pyrrolidone/p-aminostyrene, methyl methacrylate/hydroxymethyl methacrylate, methyl methacrylate/N-vinylpyrrolidone, or methyl methacrylate/acrylic acid. In representative embodiments, the polymer is approximately 94:6 mole/mole percent of either methyl methacrylate/methacrylamidopropyltrimethylammonium chloride or N-vinylpyrrolidone/p-aminostyrene copolymer. Drift-free performance is obtained with such sensors having analyte-permeable matrices of significantly less than about 70 microns in thickness. The indicator molecule may be covalently linked to the polymer through an aminoarylalkylamine, such as 4-(aminophenyl)-ethylamine or 4-(aminophenyl)-propylamine. The indicator molecule may be an absorptive molecule, such as phenol red or carboxynaphthophthalein (hydrogen ion analyte), in which case the indicator molecule may be covalently linked to the polymer through either an azo-amide or an amidyl-amide linkage. The indicator molecule may be a luminescent molecule, such as carboxynaphthofluorescein (hydrogen ion analyte) or an oxygen-quenchable porphyrin derivative. The sensor may have a reflector disposed in the light path distal with respect to the optical fiber segment to the analyte-permeable matrix. Suitable reflectors include gold foil or films of titanium dioxide, zinc oxide, or barium sulfate. A pCO₂ sensor is configured with a gas-permeable but ion-­impermeable membrane encapsulating an analyte-permeable matrix that includes a base having a pKa ranging from about 6.0 to about 7.8. The outer membrane may be a silicone, polycarbonate, or urethane. The base may be an inorganic salt, such as bicarbonate, in which case the analyte-permeable matrix should include an antioxidant. Alternatively, the base may be a polymeric base containing, e.g., 2-vinylpyridine, 4-vinylpyridine, histamine, 1-vinylimidazole, or 4-vinylimadazole. Gas-permeability is afforded to the matrix by a minor component of hydrophilic polymer such as polyethylene glycol. A plurality of the pH, pO₂, and pCO₂ sensors may be disposed together in substantially coterminal array to make a multi-variable probe, which may also include a thermocouple wire.

Inventors

  • 👤 Lokanathan M. Lyer
  • 👤 Kenneth S. Lyon
  • 👤 Jeffrey B. Yim

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 14:41
CPC Classifications
G; G01; G01N; G01N21/00; G01N21/75; G01N21/77; G01N21/7703; A; A61; A61B; A61B5/00; A61B5/145; A61B5/14539; A61B5/1455; A61B5/1459; G01N21/62; G01N21/63; G01N21/64; G01N21/6428; G01N21/01; G01N21/03; G01N2021/0385; G01N2021/6434; G01N2021/7706; G01N2021/772; G01N2021/7769; G01N2021/7786; G01N21/78; G01N21/783; G01N21/80; G01N21/84; G01N21/85; G01N21/8507

Claims Analysis

Total Claims: 13
Claim 1
Independent Claim 82 words
A fiber-optic sensor suitable for monitoring physiological analyte concentration, comprising an analyte-permeable matrix disposed in the light path defined by the axial core at one end of an optical fiber segment, the analyte-permeable matrix comprising an indicator molecule covalently linked to a polymer, the indicator molecule capable of responding to the analyte in an optically detectable manner, and the polymer being a copolymer selected from the group consisting of methyl methacrylate/methacrylamidopropyltrimethylam­monium chloride, N-vinylpyrrolidone/p-aminostyrene, methyl methacrylate/­hydroxymethyl methacrylate, methyl methacrylate/N-vinylpyrrolidone, and methyl methacrylate/acrylic acid.
Claim 2
Dependent Claim 82 words
A fiber-optic sensor suitable for monitoring physiological analyte concentration, comprising an analyte-permeable matrix disposed in the light path defined by the axial core at one end of an optical fiber segment, the analyte-permeable matrix comprising an indicator molecule covalently linked to a polymer, the indicator molecule capable of responding to the analyte in an optically detectable manner, and the polymer being a copolymer selected from the group consisting of methyl methacrylate/methacrylamidopropyltrimethylam­monium chloride, N-vinylpyrrolidone/p-aminostyrene, methyl methacrylate/­hydroxymethyl methacrylate, methyl methacrylate/N-vinylpyrrolidone, and methyl methacrylate/acrylic acid.
Claim 3
Dependent Claim 36 words
The fiber-optic sensor of Claim 1, wherein the polymer is formulated in the range of from about 60:40 to about 80:20 wt/wt percent of N-­vinylpyrrolidone/p-aminostyrene copolymer or about 94:6 mole/mole percent of methyl methacrylate/methacrylamidopropyltrimethylammonium chloride copolymer.
Claim 4
Dependent Claim 28 words
The fiber-optic sensor of Claim 1, wherein the indicator molecule is covalently linked to the polymer through an aminoarylalkylamine selected from the group consisting of 4-(aminophenyl)-ethylamine and 4-(aminophenyl)­propylamine.
Claim 5
Dependent Claim 38 words
The fiber-optic sensor of Claim 1, wherein the analyte is selected from the group consisting of hydrogen ion, oxygen and carbon dioxide, and the indicator molecule is selected from the group consisting of phenol red, carboxynaphthophthalein and carboxynaphthofluorescein.
Claim 6
Dependent Claim 27 words
The fiber-optic sensor of Claim 1, further comprising a reflector disposed in the light path distal with respect to the optical fiber segment to the analyte-permeable matrix.
Claim 7
Dependent Claim 33 words
The fiber-optic sensor of Claim 1, further comprising a gas-permeable but ion-impermeable membrane encapsulating the analyte-permeable matrix, the analyte-permeable matrix comprising a base having a pKa ranging from about 6.0 to about 7.8.
Claim 8
Dependent Claim 59 words
The fiber-optic sensor of Claim 6, wherein the gas-permeable but ion-impermeable membrane comprises a resin selected from the group consisting of silicones, polycarbonates, and urethanes; the base comprises an inorganic salt or a polymeric base selected from the group consisting of monomers, homopolymers, and copolymers of 2-vinylpyridine, 4-vinylpyridine, 1-vinylimidazole, and 4-vinylimidizole; wherein the analyte-permeable matrix further comprises an antioxidant.
Claim 9
Dependent Claim 32 words
A multi-variable probe, comprising a plurality of fiber-optic sensors according to Claims 1, 2, 3, 4, 5, 6, or 7, the analyte-permeable matrices of said sensors being disposed in substantially coterminal array.
Claim 10
Independent Claim 80 words
A method of manufacturing a fiber-optic sensor suitable for monitoring physiological analyte concentration, comprising the steps of: casting a polymer film of substantially uniform thickness, the polymer film being permeable to an analyte in solution and comprising a covalently-linked or admixed indicator molecule capable of responding to the analyte in an optically detectable manner; cutting the film to produce a disc-shaped indicator matrix of substantially uniform thickness; and, affixing the indicator matrix to one end of an optical fiber segment.
Claim 11
Independent Claim 80 words
A method of manufacturing a fiber-optic sensor suitable for monitoring physiological analyte concentration, comprising the steps of: casting a polymer film of substantially uniform thickness, the polymer film being permeable to an analyte in solution and comprising a covalently-linked or admixed indicator molecule capable of responding to the analyte in an optically detectable manner; cutting the film to produce a disc-shaped indicator matrix of substantially uniform thickness; and, affixing the indicator matrix to one end of an optical fiber segment.
Claim 12
Independent Claim 90 words
A method of monitoring analyte concentration in a fluid, comprising the steps of: contacting a fluid with a fiber-optic sensor according to Claims 1, 2, 3, 4, 5, 6, or 7; irradiating the analyte-permeable matrix through the optical fiber segment at a first wavelength band corresponding to a region of analyte-dependent absorbance by the indicator molecule; measuring absorbance by or emission from the analyte-permeable matrix at a predetermined second wavelength band; and, determining the concentration of the analyte in the fluid as a function of the measured absorbance or emission.
Claim 13
Dependent Claim 40 words
The method of Claim 10, wherein the fiber-optic sensor is inserted through a catheter into a patient's bloodstream so that the analyte-permeable matrix projects from about 0.5 to about 1.5 mm beyond the end of the catheter into the bloodstream.

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