[01] The present disclosure pertains to systems and methods for providing pulse oximetry to infants, and, in particular, enabling pulse oximetry for non-sedated children by using a modified pacifier.

[02] It is well known that various types of pulse oximetry are available,

including transmission pulse oximetry (alternatively referred to as transillumination pulse oximetry) and reflectance pulse oximetry. It is well known that taking sensor readings from non-sedated infants presents a variety of challenges. It is well that pulse oximetry requires well-perfused tissue.

[03] Accordingly, it is an object of one or more embodiments of the present invention to provide an assembly for pulse oximetry in infants. The assembly comprises a nipple configured to be held in place orally by an infant through application of suction force; a shield connected to the nipple, wherein the shield is configured to seat around the mouth of the infant responsive to suction being applied orally to the nipple by the infant; a first oximeter sensor component configured to emit electromagnetic radiation, and a second oximeter sensor component configured such that responsive to the nipple being in place orally on the infant, the second oximeter sensor receives electromagnetic radiation emitted from the first oximeter sensor component that has passed through facial tissue of the infant, the second oximeter sensor being further configured to generate output signals conveying information related to one or more parameters of the received electromagnetic radiation. The first oximeter sensor component is either disposed within the nipple such that responsive to the nipple being held in place orally by the infant, the first oximeter sensor component is positioned within the mouth of the infant, or carried by the shield extraoraUy while the nipple is in place orally.

[04] It is yet another aspect of one or more embodiments of the present

invention to provide a method for oximetry sensing of a non-sedated infant. The method comprises seating a shield around the mouth of an infant, the shield being connected to a nipple; emitting electromagnetic radiation by a first oximeter sensor component; receiving electromagnetic radiation from the first oximeter sensor component, wherein the received electromagnetic radiation has passed through facial tissue of the infant; and generating output signals conveying information related to one or more parameters of the received electromagnetic radiation. The first oximeter sensor component is either disposed within the nipple, such that, responsive to suction being applied orally to the nipple, the first oximeter sensor component is positioned within the mouth of the infant, or carried by the shield extraorally while the nipple is in place orally.

[05] It is yet another aspect of one or more embodiments to provide a system configured to provide oximetry sensing for an infant. The system comprises first means for holding the system in place orally through application of suction force; second means for seating around the mouth, responsive to suction being applied orally to the first means; emitting means for emitting electromagnetic radiation; receiving means for receiving electromagnetic radiation from the emitting means, wherein the received electromagnetic radiation has passed through facial tissue of the infant; and means for generating output signals conveying information related to one or more parameters of the received electromagnetic radiation. The emitting means is either being disposed within the first means, such that, responsive to suction being applied orally to the first means, the emitting means is positioned within the mouth of the infant, or being carried by the second means extraorally while the first means is in place orally.

[06] These and other objects, features, and characteristics of the present

invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.

[07] FIG. 1 illustrates an oximetry sensor assembly system configured to

provide oximetry sensing for non-sedated infants, according to certain embodiments; [08] FIG. 2 illustrates a cross-sectional view of an oximetry sensor assembly system configured to perform pulse oximetry for non-sedated infants; and

[09] FIG. 3 illustrates a method for providing pulse oximetry for non-sedated infants, according to certain embodiments.

[10] As used herein, the singular form of "a", "an", and "the" include plural references unless the context clearly dictates otherwise. As used herein, the statement that two or more parts or components are "coupled" shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs. As used herein, "directly coupled" means that two elements are directly in contact with each other. As used herein, "fixedly coupled" or "fixed" means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other.

[11] As used herein, the word "unitary" means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a "unitary" component or body. As employed herein, the statement that two or more parts or components "engage" one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components. As employed herein, the term "number" shall mean one or an integer greater than one (i.e., a plurality).

[12] Directional phrases used herein, such as, for example and without

limitation, top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.

[13] FIG. 1 illustrates an oximetry sensor assembly system 10 configured to provide oximetry sensing for non-sedated infants, according to certain embodiments. Oximetry sensor assembly system 10 may be simply referred to herein as system 10.

System 10 is based on the structure of a pacifier, which includes at least a nipple, to be held inside the mouth of an infant 106, and a shield 12 connected and/or coupled to the nipple, configured to seat around the mouth of infant 106 (i.e. around lips 101 of infant 106), when the nipple is held in place orally by infant 106. System 10 may include one or more of a first oximeter sensor component 17a (not shown in FIG. 1), a second oximeter sensor component 14a (not shown in FIG. 1), a sensor support structure 15, a handle 19, and/or other components. By way of illustration, FIG. 2 illustrates a cross-sectional view of an oximeter sensor assembly system 10, including a nipple 11, shield 12, first oximeter sensor component 17a, second oximeter sensor component 14a, and other components.

[14] The size and/or volume of system 10 and/or constituent components

thereof may be adjusted as appropriate for the age of infant 106. For example, a prematurely-born baby may need a smaller nipple than a full-term baby. Nipple 11 may interchangeably be referred to herein as a baglet. Exemplary shapes for nipple 11 include orthodontic, bottle nipple, spherical, conical, thumb-shaped, and/or other shapes conventionally used in pacifiers. Shield 12 may interchangeably be referred to herein as a guard. The shape of shield 12 is not intended to limited to the exemplary illustrations provided herewith. Shield 12 may be any shape that prevents it from being pulled into the mouth of infant 106 from the suction force applied to nipple 11. Shield 12 may include one or more holes 18 (or relief openings) to allow, e.g., for spit to be discharged without undue interference in the operation of system 10.

[15] Referring to FIG. 2, first oximeter sensor component 17a is configured to emit electromagnetic radiation. For example, first oximeter sensor component 17a may include one or more LEDs, bispectral emitters, dual spectral emitters, semiconductor dies, and/or other means for emitting electromagnetic radiation. Second oximeter component 14a is configured to receive electromagnetic radiation, emitted by first oximeter sensor component 17a, that has passed through facial tissue of infant 106. Second oximeter component 14a is further configured to generate output signals conveying information related to one or more parameters of the received electromagnetic radiation. For example, second oximeter sensor component 14a may include one or more photodiodes, photoelectric receivers, semiconductor dies, and/or other means for receiving

electromagnetic radiation. During operation, system 10 typically emits electromagnetic radiation of at least two different wavelengths, for example about 660 nm and about 940 nm). The received electromagnetic radiation can be used to spectrophotometrically determine, e.g., a ratio of oxidized to reduced hemoglobin and/or to determine pulsatility of the blood of the infant. Determining and/or monitoring, e.g. , SpC>2 may be used in screening for certain types of congenital heart disease.

[16] In some embodiments, first oximeter sensor component 17a is disposed within the nipple such that, responsive to the nipple being held in place orally by infant 106, first oximeter sensor component 17a is positioned within the mouth of infant 106. Second oximeter sensor component 14a may be carried by shield 12 extrao rally while the nipple is held in place. In some embodiments, the position of first oximeter sensor component 17a and second oximeter sensor component 14a, as explained above, may be reversed compared to the depiction in FIG. 2: first oximeter sensor component 17a may be carried by shield 12 extraorally while nipple 11 is in place, and second oximeter sensor component 14a may be disposed within nipple 1 1 such that, responsive to the nipple being held in place orally, through the application of suction force and/or oral muscles by infant 106 akin to the way conventional pacifiers are held in place orally, second oximeter sensor component 14a is positioned within the mouth of infant 106.

[17] In some embodiments, a first oximeter sensor component 17b and a second oximeter sensor component 14b are carried by sensor support structure 15, such that one of these two sensor components, during operation, is positioned within the mouth of infant 106. Sensor support structure 15 is carried by, coupled with, and/or connected to system 10, and/or a component thereof, such as, e.g. shield 12. First oximeter sensor component 17b is configured to emit electromagnetic radiation. For example, first oximeter sensor component 17b may include one or more LEDs, bispectral emitters, dual spectral emitters, semiconductor dies, and/or other means for emitting electromagnetic radiation. Second oximeter component 14b is configured to receive electromagnetic radiation, emitted by first oximeter sensor component 17b, that has passed through facial tissue of infant 106, such as, e.g., cheek 104. For example, second oximeter component 14b may include one or more photodiodes, photoelectric receivers, semiconductor dies, and/or other means for receiving electromagnetic radiation. Second oximeter component 14b is further configured to generate output signals conveying information related to one or more parameters of the received electromagnetic radiation. Sensor support structure 15 is configured such that first oximeter sensor component 17b emits electromagnetic radiation through cheek 104 of infant 106, from within the mouth of infant 106. In some embodiments, the position of first oximeter sensor component 17b and second oximeter sensor component 14b, as explained above, may be reversed compared to the depiction in FIG. 2, such that second oximeter sensor component 14b is positioned within the mouth of infant 106.

[18] In some embodiments, nipple 11 and shield 12 are used to carry and/or hold in place a sensor support structure, such as, e.g., sensor support structure 15. Such a sensor support structure may be configured to carry a first and second oximeter sensor component, such that electromagnetic radiation emitted by the first oximeter sensor component is received by the second oximeter sensor component, after passing through facial tissue of infant 106. For example, facial tissue used for pulse oximetry may be one or more of (part of) the nose of an infant, such as a nostril 102, alar tissue 105, the nasal septum, and/or other parts of a nose, (part of) an ear of an infant, such as an earlobe 103, and/or other parts of an (outer) ear, the buccal surface, posterior soft palate, hard palate, lingual surfaces, gums, and/or other well-perfused facial tissue providing readily accessible capillary beds of infant 106 for transillumination pulse oximetry.

[19] Referring to Fig. 1, in some embodiments, system 10 includes a sensor cable 16 configured to transmit output signals generated by an oximeter sensor component, e.g. for processing purposes. Such output signals may be used to determine various parameters related to pulse oximetry, such as, e.g., an SpC>2 parameter of infant 106.

[20] In some embodiments, a first oximeter sensor component 17c, disposed extrao rally during operation of system 10, may be used. First oximeter sensor component 17c is configured to emit electromagnetic radiation. For example, first oximeter sensor component 17c may include one or more LEDs, bispectral emitters, dual spectral emitters, semiconductor dies, lasers, and/or other light sources as appropriate and conventionally used with optical fiber and/or waveguides. Electromagnetic radiation emitted by first oximeter sensor component 17c may be guided into the mouth of infant 106 by an optical fiber 20, electromagnetic waveguide, and/or other conventional means for guiding electromagnetic radiation from a light source (or a plurality of sources) to a location removed from that light source (or sources). Electromagnetic radiation emitted by first oximeter sensor component 17c may be received, e.g., by second oximeter sensor component 14a, second oximeter sensor component 14b, and/or another oximeter sensor component arranged such that the electromagnetic radiation passes through facial tissue of infant 106.

[21] The illustration of first or second oximeter sensor component 17a and 14a including single members in FIG. 2 is not intended to be limiting. The illustration of first or second oximeter sensor component 17b and 14b including single members in FIG. 2 is not intended to be limiting. The illustration of oximeter sensor components at or near particular locations and/or areas of infant 106 is not intended to be limiting. In some embodiments system 10 includes a plurality of sensors operating as described above by generating output signals conveying information related to parameters of the received electromagnetic radiation that has passed through facial tissue of infant 106. Resulting signals or information from any oximeter sensor component may be transmitted, e.g. for processing purposes. This transmission may be wired and/or wireless.

[22] FIG. 3 illustrates a method for providing pulse oximetry for non-sedated infants. The operations of method 300 presented below are intended to be illustrative. In certain embodiments, method 300 may be accomplished with one or more additional operations not described, and/or without one or more of the operations discussed.

Additionally, the order in which the operations of method 300 are illustrated in FIG. 3 and described below is not intended to be limiting.

[23] In certain embodiments, method 300 may be implemented in one or more processing devices and/or assemblies (e.g., a digital processor, an analog processor, a digital circuit designed to process information, an analog circuit designed to process information, a state machine, and/or other mechanisms for electronically processing information, analog processing of information, and/or any combination thereof). The one or more processing devices and/or assemblies may include one or more devices and/or components executing some or all of the operations of method 300, e.g. in response to instructions stored electronically on an electronic storage medium. The one or more processing devices or assemblies may include one or more devices and/or components configured through hardware, firmware, and/or software to be specifically designed for execution of one or more of the operations of method 300.

[24] At an operation 304, a shield is seated around the mouth of an infant, the shield being connected to a nipple. In one embodiment, operation 304 is performed by a shield similar to or substantially the same as shield 12 (shown in FIG. 1 and described above).

[25] At an operation 306, electromagnetic radiation is emitted. In one

embodiment, operation 306 is performed by an oximeter sensor component similar to or substantially the same as first oximeter sensor component 14b (shown in FIG. 2 and described above). The oximeter sensor component is either disposed within the nipple, such that, responsive to suction being applied orally to the nipple, the oximeter sensor component is positioned within the mouth of the infant, or the oximeter sensor component is carried by the shield extraorally while the nipple is in place orally.

[26] At an operation 308, electromagnetic radiation is received from the

oximeter sensor component, wherein the received electromagnetic radiation has passed through facial tissue of the infant. In one embodiment, operation 308 is performed by an oximeter sensor component similar to or substantially the same as second oximeter sensor component 17b (shown in FIG. 1 and described above).

[27] At an operation 310, output signals are generated conveying information related to one or more parameters of the received electromagnetic radiation. In one embodiment, the one or more parameters may relate to SpC>2 of the infant. In one embodiment, operation 310 is performed by an oximeter sensor component similar to or substantially the same as second oximeter sensor component 17b (shown in FIG. 1 and described above). [28] In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word "comprising" or "including" does not exclude the presence of elements or steps other than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.

[29] Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.