IP Library Granted Patent US 10,918,321
Granted Patent B2
US 10,918,321 · App. 15/845,503 · Granted Feb 16, 2021

Method for spectrophotometric blood oxygenation monitoring

Inventor: Paul B. Benni (Acton, MA)
Assignee: Edwards Lifesciences Corporation
A61B5/14552A61B5/72A61B5/6814A61B5/6833
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Quick Facts
Patent No.
US 10,918,321
App. No.
15/845,503
Granted
Feb 16, 2021
Kind
B2
Abstract

An apparatus and method for non-invasively determining a blood oxygen parameter value of a subject's tissue is provided. An embodiment of the method includes the steps of: a) providing a spectrophotometric sensor that includes a processing portion and a transducer, b) detecting at least a portion of transmitted light after passage through the subject's tissue and producing initial signal data from the detected light; and c) using the processing portion to: (i) determine a value representative of an attenuation of at least one wavelength of light detected; (ii) determine whether the representative attenuation value is outside a predefined range of attenuation values; and (iii) determine the blood oxygen parameter value using a first interrogation or an alternate interrogation setting.

Claims (33)

1. A method for non-invasively determining a blood oxygen parameter value of a subject's tissue, comprising the steps of:

providing a spectrophotometric sensor that includes a processing portion and at least one transducer, which transducer is operable to transmit light at a first plurality of wavelengths in a range of about 600 nm to about 900 nm into the subject's tissue, and to sense the transmitted light;

detecting at least a portion of the transmitted light after passage through the subject's tissue using the transducer, and producing initial signal data from the light sensed;

using the processing portion to execute instructions stored in a memory device, which instructions cause the processing portion to:

determine a value representative of an intensity attenuation of at least one wavelength of light within the first plurality of wavelengths that is less than about 720 nm using the initial signal data; and

determine whether the representative intensity attenuation value is outside a predefined range of attenuation values; and

determine the blood oxygen parameter value using a subset of the first plurality of predetermined wavelengths, which subset consists of a second plurality of wavelengths in a range of about 720 nm to about 900 nm, if the representative intensity attenuation value is outside the predefined range of attenuation values, or using the first plurality of wavelengths if the representative intensity attenuation value is within the predefined range of attenuation values.

2. A method for non-invasively determining a blood oxygen parameter value of a subject's tissue, comprising the steps of:

providing a spectrophotometric sensor that includes a processing portion and at least one transducer, which transducer is operable to transmit light at a first plurality of wavelengths in a range of about 600 nm to about 900 nm into the subject's tissue, and to sense the transmitted light;

detecting at least a portion of the transmitted light after passage through the subject's tissue using the transducer, and producing initial signal data from the light sensed;

using the processing portion to execute instructions stored in a memory device, which instructions cause the processing portion to:

determine a first value representative of an intensity attenuation of at least one wavelength of light within the first plurality of wavelengths that is less than about 720 nm using the initial signal data;

determine a second value representative of an intensity attenuation of at least one wavelength of light within the first plurality of wavelengths that is greater than about 720 nm using the initial signal data;

determine if the first value representative of said intensity attenuation of at least one wavelength of light within the first plurality of wavelengths that is less than about 720 nm is disproportionate to the second value representative of said intensity attenuation of at least one wavelength of light within the first plurality of wavelengths that is greater than about 720 nm;

determine the blood oxygen parameter value using a subset of the first plurality of predetermined wavelengths, which subset consists of a second plurality of wavelengths in a range of about 720 nm to about 900 nm, if the first value is disproportionate to the second value, or using the first plurality of wavelengths if the first value is proportionate to the second value.

3. The method of claim 2 , wherein the method is performed over a period of time, and wherein the initial signal data is produced once during the period of time.

4. The method of claim 2 , wherein the method is performed over a period of time, and wherein the initial signal data is produced more than once during the period of time.

5. The method of claim 4 , wherein the initial signal data is produced periodically during the period of time.

6. The method of claim 2 , wherein a disproportionate first value relative to said second value is indicative of an altered tissue condition independent of the blood oxygen parameter value.

7. The method of claim 6 , wherein the altered tissue condition includes one or more of a bruise, contusion, scarring, skull fracture, concussion, surgery scarring, infection, tissue discoloration, bone discoloration, dura pigmentation, bone marrow, or forehead hair follicles.

8. The method of claim 2 , wherein said first value is disproportionate to said second value when the respective attenuations do not correspond to predetermined attenuation values.

9. The method of claim 8 , wherein the predetermined attenuation values are representative of attenuation values determined using substantially the same spectrophotometric processes on a normal subject.

10. The method of claim 8 , wherein the predetermined attenuation values are based on empirical data.

11. An apparatus for non-invasively determining a blood oxygen parameter value of a subject's tissue, comprising:

a spectrophotometric sensor that includes at least one processor and at least one transducer, which transducer is operable to transmit light at a first plurality of wavelengths in a range of about 600 nm to about 900 nm into the subject's tissue, and is operable to detect at least a portion of the transmitted light after passage through the subject's tissue, and to produce initial signal data representative of the light sensed;

wherein the at least one processor is in communication with a non-transitory memory storing instructions, which instructions when executed cause the processor to:

determine a first value representative of an intensity attenuation of at least one wavelength of light within the first plurality of wavelengths that is less than about 720 nm using the initial signal data;

determine a second value representative of an intensity attenuation of at least one wavelength of light within the first plurality of wavelengths that is greater than about 720 nm using the initial signal data;

determine if the first value representative of said intensity attenuation of at least one wavelength of light within the first plurality of wavelengths that is less than about 720 nm is disproportionate to the second value representative of said intensity attenuation of at least one wavelength of light within the first plurality of wavelengths that is greater than about 720 nm; and

determine the blood oxygen parameter value using a subset of the first plurality of predetermined wavelengths, which subset consists of a second plurality of wavelengths in a range of about 720 nm to about 900 nm, if the first value is disproportionate to the second value, or using the first plurality of wavelengths if the first value is proportionate to the second value.

12. The apparatus of claim 11 , wherein the instructions when executed cause the processor to produce the initial signal data periodically during a period of time.

13. The apparatus of claim 11 , wherein a disproportionate first value relative to said second value is indicative of an altered tissue condition independent of the blood oxygen parameter value.

14. The apparatus of claim 13 , wherein the altered tissue condition includes one or more of a bruise, contusion, scarring, skull fracture, concussion, surgery scarring, infection, tissue discoloration, bone discoloration, dura pigmentation, bone marrow, or forehead hair follicles.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 25, 2025
From: EDWARDS LIFESCIENCES CORPORATION; EDWARDS LIFESCIENCES LLC; EDWARDS LIFESCIENCES SÀRL; EDWARDS LIFESCIENCES HOLDING B.V.
To: BD SWITZERLAND SARL
Reel/Frame 072920/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 4, 2019
From: CAS MEDICAL SYSTEMS, INC.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 050635/0654 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 18, 2017
From: BENNI, PAUL
To: CAS MEDICAL SYSTEMS, INC.
Reel/Frame 044423/0929 →
Continuity (3)
Continuation 14335458 · Jul 18, 2014
Provisional Application 61847855 · Jul 18, 2013
Related Publication 20180192928A1 · Jul 12, 2018
Cited By (3)
US 12,458,295 US 12,629,067 US 12,648,723