WO2004000114B1 - Perfusion monitor and system, including specifically configured oximeter probes and covers for oximeter probes - Google Patents

Perfusion monitor and system, including specifically configured oximeter probes and covers for oximeter probes

Info

Publication number
WO2004000114B1
WO2004000114B1 PCT/US2003/019294 US0319294W WO2004000114B1 WO 2004000114 B1 WO2004000114 B1 WO 2004000114B1 US 0319294 W US0319294 W US 0319294W WO 2004000114 B1 WO2004000114 B1 WO 2004000114B1
Authority
WO
WIPO (PCT)
Prior art keywords
light
probe
site
extensions
signals
Prior art date
Application number
PCT/US2003/019294
Other languages
French (fr)
Other versions
WO2004000114A1 (en
Inventor
Richard Melker
Joseph A Layon
George Worley
Robert Nappo
Original Assignee
Univ Florida
Richard Melker
Joseph A Layon
George Worley
Robert Nappo
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US10/176,310 external-priority patent/US6909912B2/en
Priority to PCT/US2003/019294 priority Critical patent/WO2004000114A1/en
Priority to EP12165281.2A priority patent/EP2481352B1/en
Priority to EP12165265.5A priority patent/EP2489306B1/en
Priority to JP2004515926A priority patent/JP4704037B2/en
Priority to AU2003247555A priority patent/AU2003247555A1/en
Priority to CA2489808A priority patent/CA2489808C/en
Priority to EP03761126A priority patent/EP1513443B1/en
Application filed by Univ Florida, Richard Melker, Joseph A Layon, George Worley, Robert Nappo filed Critical Univ Florida
Priority to US10/749,471 priority patent/US7024235B2/en
Publication of WO2004000114A1 publication Critical patent/WO2004000114A1/en
Priority to US10/751,308 priority patent/US7127278B2/en
Publication of WO2004000114B1 publication Critical patent/WO2004000114B1/en
Priority to US11/535,295 priority patent/US8755857B2/en
Priority to US13/191,594 priority patent/US20120078069A1/en
Priority to US14/097,672 priority patent/US9668661B2/en
Priority to US15/638,804 priority patent/US10925500B2/en

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Classifications

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    • A61M2230/432—Composition of exhalation 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. The present invention also relates to a combined nasal pulse oximeter probe/nasal cannula. The present invention also relates to other devices that combine a pulse oximeter probe with a device supplying oxygen or other oxygen-containing gas to a person in need thereof. In certain embodiments, an additional limitation of a control means to adjust the flow rate of such gas is provided, where such control is directed by the blood oxygen saturation data obtained from the pulse oximeter probe.

Claims

AMENDED CLAIMS
[received by the International Bureau on 30 December 2003 (30.12.03); original claims 1-29 replaced by new claims 1-46 (11 pages)]
+ STATEMENT
Claims
What is claimed is:
1. A prqbe for measurement of pulse-based differences in light absαrbence across the vascularized tissue of a lip or a cheek αf a patient, comprising: a, a resilient probe frame having an inner face and an outer face, said frame comprising a proximal arm connecting at one end to a cable and at the other end to a bridging section of said frame, said bridging section connecting the proximal arm to one end of a distal arm of said frame, wherein a portion of said distal arm is at a determined distance from an opposing portion of said proximal arm; b, a first pad positioned over at least two light-generating structures that emit light at at least two different wavelength bands known to differentiate oxygenated from non-oxygenated hemoglobin, on the inner face of said portion of the distal arm or of the proximal arm; c. a second pad positioned over at least one light-detecting structure that detects lighi transmitted from said first pad, on the inner face of the arm opposing the first pad; and d. first individual conductors for energizing said at least two light-generating structures, connecting said structures to a monitoring system for light signal production and modulation, and second individual conductors connecting said at least one light-detecting structure to said monitoring system to convey signals of light detected by said at least one light-detecting structure, said first and said second individual conductors passing within said resilient probe frame and thereafter through a cable for carrying said first and said second individual conductors to said monitoring system.
2. The probe of claim 1 , additionally comprising a boot to seal the junction between said probe frame and said cable,
3. The probe of claim 2, wherein said first and second pads are dome-shaped and spaced apart to conform to the thickness of the lip or cheek tissue of a patient.
66 4- The probe of claim 2, wherein said probe frame is hook-shaped, and is sized to engage both sides of the lip or cheek tissue of an average pediatric patient between said first and second pads.
5. The probe of claim 2, wherein said probe frame is hook-shaped, and is sized to engage both sides of the Up oτ cheek tissue of an average adult patient between said first and second pads.
6. The probe of claim 2, wherein said resilient probe frame is hook-shaped and comprises material having a resiliency and memory to retain after a transient deflection the angular and dimensional relationships between ihe at least two lighi- generating structures and die opposingly at least one light-detecting structure.
7. The probe of claim 6, wherein said resilient hook-shaped probe frame is of such resiliency that the force required to move the distal end outwardly 0.25 inch is between about 1,250 to 1,550 grams of force.
8. The probe of claim 6, wherein said resilient hook-shaped probe frame is of such resiliency that the force required to move the distal end outwardly 0,25 inch is between about 150 to 1,250 grams of force.
9. The probe of claim 6, wherein said resilient hook-shaped probe frame is of such resiliency that the force required to move the distal end outwardly 0.25 inch is between about 1,550 to 3,500 grams offeree.
10. The probe of claim 6. wherein said resilient hook-shaped probe frame is of such resiliency that the force requited to move the distal end outwardly 0.25 inch is between about 3,550 to 5,550 grams of force.
11. The probe of claim 1 or 6, additionally comprising a plastic covering sleeve configured to slidably fit over said probe, slidabiy engaging from the end of the distal arm and covering said proximal arm, wherein said covering sleeve is comprised of thin flexible material permitting light transmission at the areas
67 covering said at least two light-generating components and said at least one light- detecting component.
, The probe of claim 2, additionally comprising a plastic covering sleeve configured to slidabjy fit over said probe, slidably engaging from the end of the distal arm and covering said proximal arm and said boot, wherein said covering sleeve is comprised of thin flexible material permitting light transmission at the areas covering said at least two light-generating components and said at least one light- detecting component.
, A probe to measure pulse-based differences in Hght absorbence by die vasculari ed tissue of the septum of the nose of a patient in need thereof, comprising: a. a housing from which emanates two extensions, each said extension sufficiently sized and spaced to enter one πares of ihe nose, and each said extension sufficiently flexible to deflect from the wall of the septum; b. at least two light-generating components that emit light at at kast two different wavelength bands, positioned on the inside face of one of the two extensions; c. at least one light-detecting component that detects light transmitted from said at least two light-generating components, positioned on the inside face of the other of the two extensions; and d. first individual conductors for energizing said at least two light-generating components, connecting said components to a monitoring system for light signal production and modulation, and second individual conductors connecting said at least one light-detecting component to said monitoring system to convey signals of light detected by said at least one light-detecting component, said first and said second individual conductors passing within said housing and thereafter through a cable for carrying said first and said second individual conductors to said monitoring system.
, The probe of claim 13, wherein said at least two light-generating components and said at least one light-detecting component do not protrude from the respective inner sides of said extensions.
68
15. The probe of claim 1 , wherein each of said extensions comprises an inward angle of inflection between about 10 and about 27 degrees.
16. The probe of claim 13, wherein each of said extensions comprises an inward angle of inflection between about 10 and about 20 degrees.
17. The probe of claim 13, wherein each of said extensions comprises an inward angle of inflection of about 15 degrees.
18. The probe of claim 13, wherein each of said extensions comprises an inward angle of inflection, said angle of inflection being sufficient to place said at least two light- generating components and said at least one light-detecting component adjacent to iesselbach's plexus.
] 9, The probe of claim 13, additionally comprising a plastic covering sleeve configured to slidabjy fit over said probe, comprising: a. a first section configured io slide over one of said extensions; b. a second section configured to slide over the other of said extensions; and c. a joining section connecting said first and second sections, and further configured to cover said housing from which emanates said extensions, wherein said covering sleeve is comprised of thin flexible material permitting light transmission at the areas covering said at least two light-generating components and said at least one light-detectin component.
20, The probe of claim 13, additionally comprising a cannula to supply oxygen to said patient and a sampling apparatus to obtain exhaled gases for determination of carbon dioxide content.
21 , A probe to measure pulse-based dif erences in light absorbence by the vasc iarized tissue of the septum of the nose of a patient in need thereof, integral with a cannula to supply oxygen or oxygen-rich gas into the nose, comprising: a. a housing from which emanates two extensions, each said extension sufficiently sized and spaced to enter one nares of the nose, and each said extension sufficiently flexible to deflect from the wall of the septum, wherein
69 one or both extensions are fashioned to provide one or more passages for transport of said oxygen or oxygen-rich gas into the nose; b. at least two light-generating components that emit light at at least two different wavelength bands, positioned on the inside face of one of the two extensions; c. at least one light-detecting component that detects light transmitted from said at least two light-generating components, positioned on the inside face of the other of the two extensions; and d. first individual conductors tor energizing said at least two light-generating components, connecting said components to a monitoring system for light signal production and modulation, and second individual conductors connecting said at least one light-detecting component to said monitoring system to convey signals of light detected by said at least one light-deiecting component, said first and said second individual conductors passing within said housing and thereafter through a cable for carrying said first and said second individual conductors to said monitoring system.
22. The apparams of claim 21 , additionally comprising aϊ least one additional sensor to aid in the study of sleep apnea, said at least one additional sensor selected from the group consisting of air flow, air pressure, end tidal carbon dioxide and respiration pattern recognition.
23. The apparams of claim 21 , wherein each extension is substantially longer than wide.
24. A monitoring system comprising the apparatus of claim 21 , wherein said monitoring system to which said light signals from said apparatus are sent is programmed to send control signals to a valve that controls the supply of oxygen or oxygen-rich gas into the nose via said cannula. and wherein such control signals are determined at least in part by the pulse oximeter data from said pulse oximetry probe.
70 5 , The probe of claim 2 , addi ionally comprising a cannula to supply oxygen to said patient and a sampling apparatus to obtain exhaled gases for determination of carbon dioxide content.
6, The probe of claim 21, wherein said extensions are constructed with plastic to have 60-90 durometev flexibility, and to not simultaneously press into respective sides of said septum where are positioned said at least two light-generating components and said at least one light-detecting component.
7, The probe of claim 26, wherein said at least two I ϊght-generatϊng components and said at least one light-detecting component do not protrude from the respective inner sides of said extensions,
S, A pulse oximetry probe to measure pulse-based differences in light absorbence by the vascularized tissue of a tongue of a patient, comprising: a. a first substantially flat arm which toward a first end has an extension for joining with a second substantially flat arm, and which toward a second end has a first protruding hemispherical pad housing at least two light-generating structures that emit Hght at at least two different wavelength bands known to differentiate oxygenated from non-oxygenated hemoglobin; b. said second substantially flat arm which toward a first end has an extension for joining with said first substantially flat arm, and which toward a second end has a second protruding hemispherical pad, housing at least one light- detecting structure that detects light transmitted from said first arm's pad, positioned on the inner face of the arm opposing the first pad; c. conductors leading from said at least two light-generating structures 3n said at least one light-detecting structure, and through a cable directed away from said probe; d . means for hingedty joining said first substantially flat arm and said second substantially flat arm at said respective extensions; and e. means tor tensioning said first substantially flat arm and said second substantially flat arm around a section of the tongue of a patient.
71
9. A method for analyzing pulse oximeter probe signals from at least two sites on a Jiving 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-get 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 a\ 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.
30. The method of claim 29 wherein said central source site is selected from the group consisting of cheek, nasal septum, alar nares, and tongue.
31. The method of claim 29 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.
32. The method of claim 29 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.
33. The method of claim 29, additionally comprising estimating the blood pressure of said living vertebrate through analysis of pulse time delay between said at least two sites.
34. The method of claim 33, additionally comprising comparing the signals 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.
35. 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 repeating steps b and c to obtain 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.
36. The apparatus of claim 35, additionally comprising means for estimating blood pressure through analysis of pulse time delay between said at least two sites.
73 , An oximeter monitor system foτ 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 at least two pulse oximeter probes; b. input circuitry to receive signals from said at least two pulse oximeter probes positioned ai 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 source site; and d. a read-ont device to provide results to a user of said system.
, The oximeter monitor system of claim 37, 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.
, The oximeter monitor system of claim 37, wherein said central source site is the septum of the nose, and wherein said pulse oximeter probe at said central source
74 site additionally comprises a cannula for the supply of oxygen or oxygen-rich air into said nose,
, The oximeter monitor system of claim 39, additionally comprising a valve adjusted by control signals received from said oximeter monitor system, whereby programming of said oximeter monitoring system provides for a greater opening of said valve, and greater supply of oxygen or oxygen-rich gas, under specified conditions that include analysis of pulse oximeter signals from one or more of said at least two pulse oximeter probes.
, A pulse oximetry probe to measure pulse-based differences in light absorbence by the vascularized tissue of the septum of the nose of a user in need thereof, integral with a cannula to supply oxygen or oxygen-rich gas into the nose, comprising: a. a housing from which emanates two extensions, each extension sufficiently sized and spaced to enter one nares of the nose and contact one side of the septum, whereby one or both extensions additionally are fashioned to provide, one or more passages tor transport of oxygen or oxygen-rich gas into the nose; b. at least two light-generating structures that emit light at at least two different wavelength bands, positioned on the inside face of one of the two extensions; c. at least one light-detecting structure that detects light transmitted from said at least two light-generating structures, positioned on the inside face of the other of the two extensions; and d. first individual conductors for energizing said at least two light-generating structures, connecting said structures to a monitoring system for light signal production and modulation, and second individual conductors connecting said at least one light-detecting structure to said monitoring system to convey signals of light detected by said at least one light-detecting structure, said first and said second individual conductors passing within said housing and thereafter through a cable for carrying said first and said second individual conductors to said monitoring system.
, A system comprising the apparatus of claim 41, wherein said monitoring system to which said light signals from said apparams are sent is programmed to send control
75 signals 10 a valve that controls the supply of oxygen or oxygen-rich gas into the nose via said cannula, and wherein such control signals are determined at least in part by the pulse oximeter data from said pulse oximetry probe.
43. The apparatus of claim 41 , additions lly comprising at least one additional sensor to aid in the s dy of sleep apnea, said at least one additional sensor selected from the group consisting of air flow, air pressure, end tidal carbon dioxide and respiration pattern recognition.
44. The apparatus of claim 13 or 41, wherein each extension is substantially longer than wide.
45. The method of claim 29, wherein said presence of impaired peripheral perfusion is related to decreased peripheral circulation caused by a condition selected from the group consisting of atherosclerosis, aynaud's disease, Buerger's disease, chronic obstructive pulmonary disease, embolic occlusive disease, and progressive diabetes.
46. The method of claim 29, wherein said presence of impaired peripheral perfusion is related to lower circulation \a the limbs of sa d living vertebrate, caused by an acute condition selected from the group consisting of shock, trauma, and mechanical injury.
76
PCT/US2003/019294 2002-06-20 2003-06-19 Perfusion monitor and system, including specifically configured oximeter probes and covers for oximeter probes WO2004000114A1 (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
PCT/US2003/019294 WO2004000114A1 (en) 2002-06-20 2003-06-19 Perfusion monitor and system, including specifically configured oximeter probes and covers for oximeter probes
EP12165281.2A EP2481352B1 (en) 2002-06-20 2003-06-19 Perfusion monitor and system, including specifically configured oximeter probes and covers for oximeter probes
EP12165265.5A EP2489306B1 (en) 2002-06-20 2003-06-19 Perfusion monitor and system, including specifically configured oximeter probes and covers for oximeter probes
JP2004515926A JP4704037B2 (en) 2002-06-20 2003-06-19 Using a novel non-invasive perfusion monitor and system, specially configured oximeter probes, methods of their use, and probe cover, and integrated nasal pulse oximeter probe / cannula device, novel pulse oximetry sensor Closed loop oxygen controller and integrated pulse oximeter probe / breathing apparatus
AU2003247555A AU2003247555A1 (en) 2002-06-20 2003-06-19 Perfusion monitor and system, including specifically configured oximeter probes and covers for oximeter probes
CA2489808A CA2489808C (en) 2002-06-20 2003-06-19 Perfusion monitor and system, including specifically configured oximeter probes and covers for oximeter probes
EP03761126A EP1513443B1 (en) 2002-06-20 2003-06-19 Perfusion monitor and system, including specifically configured oximeter probes and covers for oximeter probes
US10/749,471 US7024235B2 (en) 2002-06-20 2003-12-30 Specially configured nasal pulse oximeter/photoplethysmography probes, and combined nasal probe/cannula, selectively with sampler for capnography, and covering sleeves for same
US10/751,308 US7127278B2 (en) 2002-06-20 2004-01-02 Specially configured lip/cheek pulse oximeter/photoplethysmography probes, selectively with sampler for capnography, and covering sleeves for same
US11/535,295 US8755857B2 (en) 2002-06-20 2006-09-26 Optimized gas supply using photoplethysmography
US13/191,594 US20120078069A1 (en) 2002-06-20 2011-07-27 Blood Flow Monitoring
US14/097,672 US9668661B2 (en) 2002-06-20 2013-12-05 Devices, systems and methods for plethysmographic monitoring at the nose
US15/638,804 US10925500B2 (en) 2002-06-20 2017-06-30 Devices, systems and methods for plethysmographic monitoring at the nose

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US10/176,310 2002-06-20
US10/176,310 US6909912B2 (en) 2002-06-20 2002-06-20 Non-invasive perfusion monitor and system, specially configured oximeter probes, methods of using same, and covers for probes
PCT/US2003/019294 WO2004000114A1 (en) 2002-06-20 2003-06-19 Perfusion monitor and system, including specifically configured oximeter probes and covers for oximeter probes

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US10/176,310 Continuation-In-Part US6909912B2 (en) 2002-06-20 2002-06-20 Non-invasive perfusion monitor and system, specially configured oximeter probes, methods of using same, and covers for probes
US10/176,310 Continuation US6909912B2 (en) 2002-06-20 2002-06-20 Non-invasive perfusion monitor and system, specially configured oximeter probes, methods of using same, and covers for probes

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US10/749,471 Continuation-In-Part US7024235B2 (en) 2002-06-20 2003-12-30 Specially configured nasal pulse oximeter/photoplethysmography probes, and combined nasal probe/cannula, selectively with sampler for capnography, and covering sleeves for same
US10/751,308 Continuation-In-Part US7127278B2 (en) 2002-06-20 2004-01-02 Specially configured lip/cheek pulse oximeter/photoplethysmography probes, selectively with sampler for capnography, and covering sleeves for same

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EP2489306B1 (en) 2015-11-04
CA2489808A1 (en) 2003-12-31
EP1513443A4 (en) 2009-05-13
AU2003247555A1 (en) 2004-01-06
EP2489306A3 (en) 2012-11-21
EP2481352B1 (en) 2014-01-15
WO2004000114A1 (en) 2003-12-31
EP2481352A1 (en) 2012-08-01
EP2489306A2 (en) 2012-08-22
CA2489808C (en) 2016-04-19
EP1513443B1 (en) 2012-10-03
EP1513443A1 (en) 2005-03-16

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