US7047054B2 — Laser diode optical transducer assembly for non-i…

Claim 1

Independent Claim 256 words

A near infrared spectrophotometric (NIRS) monitoring assembly for noninvasive monitoring of blood oxygenation levels in a subject's body, said assembly comprising: a) at least one flexible housing having a window and which can be attached directly to a subject's body; b) a plurality of laser light sources which are operatively associated with said housing, each of said light sources being operative to emit a near infrared light signal of a different wavelength, which light signals are transmitted through said housing window; c) a photodiode assembly which can be attached directly to the subject's body and which is operably connected to said light sources, said photodiode assembly being operative to measure light intensity values emanating from light emitted by said light sources and passing through the subject's body; and d) a laser safety interlock system designed to disable laser operation in case of assembly dislodgment from the patient's body, said safety interlock comprising: I) means for monitoring ambient light and emitted laser light; and II) means for processing signals received by said photodiode assembly so as to determine secure assembly attachment to the subject's body: i) by monitoring ambient light conditions and disabling laser operation when ambient light levels are greater than a predetermined level; ii) by monitoring laser output and disabling laser operation when laser output is outside of a predetermined range; and iii) by monitoring changes in detected laser output over a predetermined measuring period and disabling laser operation if changes in laser output are above or below predetermined levels during a predetermined measuring period.

Claim 2

Dependent Claim 256 words

A near infrared spectrophotometric (NIRS) monitoring assembly for noninvasive monitoring of blood oxygenation levels in a subject's body, said assembly comprising: a) at least one flexible housing having a window and which can be attached directly to a subject's body; b) a plurality of laser light sources which are operatively associated with said housing, each of said light sources being operative to emit a near infrared light signal of a different wavelength, which light signals are transmitted through said housing window; c) a photodiode assembly which can be attached directly to the subject's body and which is operably connected to said light sources, said photodiode assembly being operative to measure light intensity values emanating from light emitted by said light sources and passing through the subject's body; and d) a laser safety interlock system designed to disable laser operation in case of assembly dislodgment from the patient's body, said safety interlock comprising: I) means for monitoring ambient light and emitted laser light; and II) means for processing signals received by said photodiode assembly so as to determine secure assembly attachment to the subject's body: i) by monitoring ambient light conditions and disabling laser operation when ambient light levels are greater than a predetermined level; ii) by monitoring laser output and disabling laser operation when laser output is outside of a predetermined range; and iii) by monitoring changes in detected laser output over a predetermined measuring period and disabling laser operation if changes in laser output are above or below predetermined levels during a predetermined measuring period.

Claim 3

Dependent Claim 55 words

The assembly of claim 1 , wherein said laser safety interlock system includes a laser start up sequence upon initial attachment of said assembly to the subject's body to determine secure assembly attachment, wherein the ambient light level is monitored and verified to be below a predetermined level prior to allowing laser operation to begin.

Claim 4

Dependent Claim 232 words

A near infrared spectrophotometric (NIRS) monitoring assembly for noninvasive monitoring of blood oxygenation levels in a subject's body, said assembly comprising: a) at least one flexible housing having a window which housing can be attached directly to a subject's body; b) a plurality of light sources which are operably associated with said housing, each of said light sources being operable to emit a near infrared light signal of a different wavelength, which light signals are transmitted through said housing window; c) a photodiode assembly which can be attached directly to the subject's body and which is operatively connected to said light sources, said photodiode assembly being operative to measure light intensity values emanating from light emitted by said light sources and passing through the subject's body; and d) a processor which controls actuation of said light sources and which processes light intensity signals from said photodiode assembly; and e) a connector housing assembly interposed between said processor and said light sources and photodiode assembly, said connector housing assembly including light source power driver controls connected to said processor and connected to said light sources, and an encoding calibration mechanism connected to said processor for supplying essential NIRS operating calibrating information to said processor whereby the following information is encoded: i) light sources-to-photodiode assembly separation distance; ii) light source wavelengths; and iii) coefficients relating to change in light source wavelengths over temperature changes.

Claim 5

Dependent Claim 232 words

A near infrared spectrophotometric (NIRS) monitoring assembly for noninvasive monitoring of blood oxygenation levels in a subject's body, said assembly comprising: a) at least one flexible housing having a window which housing can be attached directly to a subject's body; b) a plurality of light sources which are operably associated with said housing, each of said light sources being operable to emit a near infrared light signal of a different wavelength, which light signals are transmitted through said housing window; c) a photodiode assembly which can be attached directly to the subject's body and which is operatively connected to said light sources, said photodiode assembly being operative to measure light intensity values emanating from light emitted by said light sources and passing through the subject's body; and d) a processor which controls actuation of said light sources and which processes light intensity signals from said photodiode assembly; and e) a connector housing assembly interposed between said processor and said light sources and photodiode assembly, said connector housing assembly including light source power driver controls connected to said processor and connected to said light sources, and an encoding calibration mechanism connected to said processor for supplying essential NIRS operating calibrating information to said processor whereby the following information is encoded: i) light sources-to-photodiode assembly separation distance; ii) light source wavelengths; and iii) coefficients relating to change in light source wavelengths over temperature changes.

Claim 6

Dependent Claim 31 words

The assembly of claim 3 wherein coefficients indicating the relationship of laser diode automatic power control feedback, monitor current, and corresponding laser output power output are encoded in said calibration mechanism.

Claim 7

Dependent Claim 46 words

The assembly of claim 4 further comprising additional encoded coefficients in said calibration mechanism which indicate types of NIRS monitoring assemblies which are specifically intended to be used on different particular types of biological tissue, on different particular subject body parts, or on particular subject species.

Claim 8

Dependent Claim 37 words

The assembly of claim 5 wherein the calibration parameters are encoded by the use of encoding devices selected from the group consisting of: resistors of predetermined values; programmable read only memory devices; bar codes; and combinations thereof.

Claim 9

Dependent Claim 364 words

A near infrared spectrophotometric (NIRS) monitoring assembly for noninvasive monitoring of blood oxygenation levels in a subject's brain, said assembly comprising: a) a flexible housing which can be attached directly to a subject's head, said housing having a first part which traverses the subject's forehead; b) a plurality of light sources which are operatively associated with said first part of said housing, each of said light sources being operative to emit near infrared light signals of different wavelengths, which light signals are transmitted through a window in said housing; c) a photodiode assembly which is operatively associated with said first part of said housing and with said light sources, said photodiode assembly having a light sensitive surface and being operative to measure light intensity values emanating from light emitted by said light sources and passing through the subject's brain; d) a fiber optic guide assembly connected to said light sources; e) an electrical signal-transmitting cable assembly connected to said photodiode assembly for transmitting electrical signals therefrom, said fiber optic guide assembly and said electrical signal-transmitting cable assembly being oriented relative to said housing so that both said fiber optic guide assembly and said cable assembly pass over the subject's crown when said housing is attached to the subject's forehead; f) an ambient electromagnetic interference (EMI) shield surrounding said photodiode assembly, said EMI shield including an electrically conductive optically transparent material electrically interfaced to an electrically conductive capsule which covers all surfaces of said photodiode assembly which are not covered by said electrically conductive optically transparent material, said electrically conductive optically transparent material and said capsule allowing measurement of light intensity values emitted by said light sources while preventing ambient EMI from influencing operation of said NIRS monitoring assembly; and g) a transparent rigid optical spacer of predetermined thickness, placed over said electrically conductive optically transparent material, interposed between said photodiode assembly and a surface of the NIRS monitoring assembly that abuts the subject's skin when the assembly is attached to the subject's head, said spacer being operative to further attenuate EMI from influencing operation of said NIRS monitoring assembly, by reducing the capacitive coupling between the photodiode light sensitive surface and the subject's head.

Claim 10

Dependent Claim 364 words

A near infrared spectrophotometric (NIRS) monitoring assembly for noninvasive monitoring of blood oxygenation levels in a subject's brain, said assembly comprising: a) a flexible housing which can be attached directly to a subject's head, said housing having a first part which traverses the subject's forehead; b) a plurality of light sources which are operatively associated with said first part of said housing, each of said light sources being operative to emit near infrared light signals of different wavelengths, which light signals are transmitted through a window in said housing; c) a photodiode assembly which is operatively associated with said first part of said housing and with said light sources, said photodiode assembly having a light sensitive surface and being operative to measure light intensity values emanating from light emitted by said light sources and passing through the subject's brain; d) a fiber optic guide assembly connected to said light sources; e) an electrical signal-transmitting cable assembly connected to said photodiode assembly for transmitting electrical signals therefrom, said fiber optic guide assembly and said electrical signal-transmitting cable assembly being oriented relative to said housing so that both said fiber optic guide assembly and said cable assembly pass over the subject's crown when said housing is attached to the subject's forehead; f) an ambient electromagnetic interference (EMI) shield surrounding said photodiode assembly, said EMI shield including an electrically conductive optically transparent material electrically interfaced to an electrically conductive capsule which covers all surfaces of said photodiode assembly which are not covered by said electrically conductive optically transparent material, said electrically conductive optically transparent material and said capsule allowing measurement of light intensity values emitted by said light sources while preventing ambient EMI from influencing operation of said NIRS monitoring assembly; and g) a transparent rigid optical spacer of predetermined thickness, placed over said electrically conductive optically transparent material, interposed between said photodiode assembly and a surface of the NIRS monitoring assembly that abuts the subject's skin when the assembly is attached to the subject's head, said spacer being operative to further attenuate EMI from influencing operation of said NIRS monitoring assembly, by reducing the capacitive coupling between the photodiode light sensitive surface and the subject's head.

Claim 11

Dependent Claim 323 words

A near infrared spectrophotometric (NIRS) monitoring assembly for noninvasive monitoring of blood oxygenation levels in a subject's brain, said assembly comprising: a) a flexible housing which can be attached directly to a subject's head, said housing having a first part which traverses the subject's forehead; b) a plurality of light sources which are operatively associated with said first leg part of said housing, each of said light sources being operative to emit near infrared light signals of different wavelengths, which light signals are transmitted through a window in said housing; c) a photodiode assembly which is operatively associated with said first leg part of said housing and with said light sources, said photodiode assembly having a light sensitive surface and being operative to measure light intensity values emanating from light emitted by said light sources and passing through the subject's brain; d) a fiber optic guide assembly connected to said light sources; and e) an electrical signal-transmitting cable assembly connected to said photodiode assembly for transmitting electrical signals therefrom, said fiber optic guide assembly and said electrical signal-transmitting cable assembly being oriented relative to said housing so that both said fiber optic guide assembly and said cable assembly pass over the subject's crown when said housing is attached to the subject's forehead; and f) a laser safety interlock system designed to disable laser operation in case of assembly dislodgment from the patient's head, said safety interlock system comprising means for monitoring: I) ambient light; II) emitted laser light; III) output by said photodiode assembly; and IV) processing signals received by said photodiode assembly; so as to determine secure assembly attachment to the subject's head and i) disabling laser operation when ambient light levels are greater than a predetermined level; ii) disabling laser operation when laser output is outside of a predetermined range; and iii) disabling laser operation if changes in laser output are above or below predetermined levels during a predetermined measuring period.

Claim 12

Dependent Claim 323 words

A near infrared spectrophotometric (NIRS) monitoring assembly for noninvasive monitoring of blood oxygenation levels in a subject's brain, said assembly comprising: a) a flexible housing which can be attached directly to a subject's head, said housing having a first part which traverses the subject's forehead; b) a plurality of light sources which are operatively associated with said first leg part of said housing, each of said light sources being operative to emit near infrared light signals of different wavelengths, which light signals are transmitted through a window in said housing; c) a photodiode assembly which is operatively associated with said first leg part of said housing and with said light sources, said photodiode assembly having a light sensitive surface and being operative to measure light intensity values emanating from light emitted by said light sources and passing through the subject's brain; d) a fiber optic guide assembly connected to said light sources; and e) an electrical signal-transmitting cable assembly connected to said photodiode assembly for transmitting electrical signals therefrom, said fiber optic guide assembly and said electrical signal-transmitting cable assembly being oriented relative to said housing so that both said fiber optic guide assembly and said cable assembly pass over the subject's crown when said housing is attached to the subject's forehead; and f) a laser safety interlock system designed to disable laser operation in case of assembly dislodgment from the patient's head, said safety interlock system comprising means for monitoring: I) ambient light; II) emitted laser light; III) output by said photodiode assembly; and IV) processing signals received by said photodiode assembly; so as to determine secure assembly attachment to the subject's head and i) disabling laser operation when ambient light levels are greater than a predetermined level; ii) disabling laser operation when laser output is outside of a predetermined range; and iii) disabling laser operation if changes in laser output are above or below predetermined levels during a predetermined measuring period.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2009-05-15	2009-11-14	2010-05-16	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2013-05-15	2013-11-14	2014-05-16	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2017-05-15	2017-11-14	2018-05-16	$7700.00	Window Closed / Lapsed

Laser diode optical transducer assembly for non-invasive spectrophotometric blood oxygenation monitoring

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