Specially configured lip/cheek pulse oximeter/photoplethysmography probes, selectively with sampler for capnography, and covering sleeves for same

• US 7,127,278 B2
• Filed: 01/02/2004
• Issued: 10/24/2006
• 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 Services, Inc., University of Florida Research Foundation, Incorporated (State University System of Florida)
• Inventors: Melker, Richard J., Worley, George, Gravenstein, Joachim S.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/751,308
• Publication Number:
  US 20040260161A1
• Time in Patent Office: 1,026 Days
• Field of Search: 600/310, 600322-323, 600/340, 600/344
• US Class Current: 600/340
• 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 novel lip/cheek probes for detection of pulse-based differences in light absorbence across the vascularized tissue of a lip or cheek of a patient. These probes are fabricated to provide signals to estimate arterial oxygen saturation, and/or to obtain other photoplethysmographic data. The present invention also relates to a combined probe/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, and to sampling means for exhaled carbon dioxide in combination with the novel lip/cheek probes. 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

1. A probe for measurement of pulse-based differences in light absorbence across the vascularized tissue of a lip or a cheek of 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 light 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 said 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.

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 lip or 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 the at least two light-generating structures and the 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 of force.

10. 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 3,550 to 5,550 grams of force.

11. The probe of claim 1, additionally comprising a plastic covering sleeve configured to slidably fit over said probe, slidably 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 covering said at least two light-generating components and said at least one light-detecting component.

12. The probe of claim 2, additionally comprising a plastic covering sleeve configured to slidably 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.

13. The probe of claim 6, additionally comprising a plastic covering sleeve configured to slidably fit over said probe, slidably 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 covering said at least two light-generating components and said at least one light-detecting component.

14. A probe for measurement of pulse-based differences in light absorbence across the vascularized tissue of a lip or a cheek of 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 light transmitted from said first pad, on the inner face of the arm opposing the first pad;

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 said cable for carrying said first and said second individual conductors to said monitoring system; and

e. a means for attaching an associated device selected from the group consisting of a capnography sampler and a cannula device for the supply of oxygen or oxygen-rich gas,

wherein said means for attaching provides for reversible and adjustable engagement of said associated device.

15. The probe of claim 14, wherein said means for attaching is along the outer face of said proximal arm.

16. The probe of claim 14, additionally comprising a boot to seal the junction between said probe frame and said cable, wherein said boot comprises means for attaching.

17. A probe for measurement of pulse-based differences in light absorbence across the vascularized tissue of a lip or a cheek of 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 comprising at least two light-generating structures that emit light at at least two different wavelength bands known to differentiate oxygenated from non-oxygenated hemoglobin, positioned on the inner face of said portion of the distal arm or of the proximal arm;

c. a second pad comprising at least one light-detecting structure that detects light transmitted from said first pad, positioned on the inner face of the arm opposing the first pad;

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 said cable for carrying said first and said second individual conductors to said monitoring system; and

e. integrally attached at least one member of the group consisting of a capnography sampler and a cannula device for the supply of oxygen or oxygen-rich gas.