Non-invasive perfusion monitor and system, specially configured oximeter probes, methods of using same, and covers for probes

• US 6,909,912 B2
• Filed: 06/20/2002
• Issued: 06/21/2005
• Est. Priority Date: 06/20/2002
• Status: Expired due to Term

• Current Assignee: Beta Biomed Services, Inc., University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: Beta Biomed Incorporated, University of Florida (State University System of Florida)
• Inventors: Melker, Richard
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US10/176,310
• Publication Number:
  US 20030236452A1
• Time in Patent Office: 1,097 Days
• Field of Search: 600322-323, 600/324
• US Class Current: 600/323
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2562/247 Hygienic covers, i.e. for covering the sensor or apparatus during use
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/02427 Details of sensor
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/0873 using optical means
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6819 Nose
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/7278 : Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61M 16/0003 : Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/0051 : with alarm devices
• CPC Class Codes: A61M 16/0057 : Pumps therefor
• CPC Class Codes: A61M 16/021 : operated by electrical means A61M16/202 – A61M16/205 take precedence
• CPC Class Codes: A61M 16/0666 : Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0672 : Nasal cannula assemblies for oxygen therapy
• CPC Class Codes: A61M 16/08 : Bellows; Connecting tubes having means for taking samples G01N1/22; Water traps; Patient circuits
• CPC Class Codes: A61M 16/085 : Gas sampling
• CPC Class Codes: A61M 16/20 : Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 2202/0007 : introduced into the body
• CPC Class Codes: A61M 2202/0208 : Oxygen
• CPC Class Codes: A61M 2202/03 : Gases in liquid phase, e.g. cryogenic liquids
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2210/0618 : Nose
• CPC Class Codes: A61M 2210/0625 : Mouth
• CPC Class Codes: A61M 2210/0662 : Ears
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/06 : Heartbeat rate only
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/42 : Rate
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)

Abstract

The present invention relates to a novel non-invasive perfusion/resistance status monitor system and methods of using the same, and more specifically, a vascular perfusion status monitor system receiving and processing signals from at least two pulse oximeter probes, where each of the at least two pulse oximeter probes are situated at advantageously different locations in a patient. Novel pulse oximeter probes are configured to be placed, respectively, across the lip or cheek, across the septum or nares of the nose, and on the tongue. These probes are fabricated to provide signals to estimate arterial oxygen saturation. Conventional oximeter probes also can be configured to function according to the novel methods of determining differences in peripheral blood flow and/or resistance described herein.

Claims

1. A method for analyzing pulse oximeter probe signals from at least two sites on a living vertebrate to determine the presence or absence of, or to monitor changes in, impaired peripheral perfusion, comprising the steps of:

a. removably affixing a first pulse oximeter probe to a central source site located in the head of a patient in need of said method;

b. removably affixing a second pulse oximeter probe to a first peripheral site of interest on said patient;

c. measuring signals from said central source site pulse oximeter and said first peripheral site pulse oximeter,

d. averaging sufficient sequential signals from each site to obtain a statistically reliable average, and from said average calculating a time-set estimate of the arterial blood oxygen saturation, and repeating this averaging to obtain sequential time-set estimates from each site;

e. comparing a time-set estimate of the arterial blood oxygen saturation from the central source site with an estimate, taken at a similar time, of the arterial blood oxygen saturation from the first peripheral site; and

f. determining the presence or absence of, or the time-based changes in, impaired peripheral perfusion proximal to said first peripheral site.

2. The method of claim 1 wherein said central source site is selected from the group consisting of cheek, nasal septum, alar nares, and tongue.

3. The method of claim 1 wherein said first peripheral site is selected from the group consisting of a finger, a toe, and a section of tissue distal from an area of potential damage or disease adversely affecting, suspected or known to have compromised the peripheral vascular resistance and/or peripheral blood perfusion, and/or peripheral vascular disease.

4. The method of claim 1 wherein said monitoring assesses changes over time in oxygenation of tissues proximal to said second pulse oximeter during drug dosing/effectiveness and/or reoxygenation procedures.

5. The method of claim 1, additionally comprising estimating the blood pressure of said living vertebrate through analysis of pulse time delay of said signals between said at least two sites.

6. The method of claim 5, additionally comprising comparing the analysis of said pulse time delay with blood pressure estimates obtained by other means, and applying a factor to enhance the accuracy of said estimating the blood pressure.

7. The method of claim 1, wherein said presence of impaired peripheral perfusion is related to decreased peripheral circulation caused by a condition selected from the group consisting of atherosclerosis, Raynaud'"'"'s disease, Buerger'"'"'s disease, chronic obstructive pulmonary disease, embolic occlusive disease, and progressive diabetes.

8. The method of claim 1, wherein said presence of impaired peripheral perfusion is related to lower circulation to the limbs of said living vertebrate, caused by an acute condition selected from the group consisting of shock, trauma, and mechanical injury.

9. Apparatus for analyzing pulse oximeter probe signals from at least two sites on a living vertebrate, to determine the presence or absence of, or to monitor changes in, impaired peripheral perfusion, comprising:

a. means for receiving pulse oximeter probe signals from at least two sites on a living vertebrate, wherein at least one said site is a central source site and at least one said site is a peripheral site;

b. means for signal averaging sufficient signals from each pulse oximeter probe site to obtain a statistically reliable average;

c. means for calculating a time-set estimate of the arterial blood oxygen saturation based on said statistically reliable average;

d. means for obtaining sequential time-set estimates of arterial blood oxygen saturation from each site;

e. means for comparing a time-set estimate of the arterial blood oxygen saturation from the central source site with an estimate, taken at a similar time, of the arterial blood oxygen saturation from the first peripheral site;

f. means for determining the presence or absence of, or the time-based changes in, impaired peripheral perfusion proximal to said first peripheral site based on the extent to which said first peripheral site has lower oxygen saturation than said central source site; and

g. means for presenting results to a user of said apparatus.

10. The apparatus of claim 9, additionally comprising means for estimating blood pressure through analysis of pulse time delay between said at least two sites.

11. An oximeter monitor system for analyzing pulse oximeter probe signals from at least two sites on a living vertebrate, to determine the presence or absence of, or to monitor changes in, impaired peripheral perfusion, comprising:

a. output circuitry to deliver timed signals to energize light generating components of a least two pulse oximeter probes;

b. input circuitry to receive signals from said at least two pulse oximeter probes positioned at at least two sites on a living vertebrate, wherein at least one said site is a central source site and at least one said site is a peripheral site;

c. a computer loaded with software to

1. provide timed signals to energize said light generating components;

2. average sufficient signals from each pulse oximeter probe site to obtain a statistically reliable average;

3. calculate a time-set estimate of the arterial blood oxygen saturation based on said statistically reliable average;

4. repeat steps 2 and 3 to obtain sequential time-set estimates of arterial blood oxygen saturation from each site;

5. compare a time-set estimate of the arterial blood oxygen saturation from the central source site with an estimate, taken at a similar time, of the arterial blood oxygen saturation from the first peripheral site; and

6. based on developed parameters, determine the presence or absence of, or the time-based changes in, impaired peripheral perfusion proximal to said first peripheral site based on the extent to which said first peripheral site has lower oxygen saturation than said central souree site; and

d. a read-out device to provide results to a user of said system.

12. The oximeter monitor system of claim 11, additionally comprising software in said computer with steps for estimating blood pressure through analysis of pulse time delay between said at least two sites, including means for adjustment of blood pressure estimates based on at least one comparison with a result from a conventional blood pressure measurement of said living vertebrate.