Pacifier for infants

Abstract

The invention relates to a pacifier (1) for infants, comprising a mouthpiece (2) to be received in the oral cavity and a shield (3) which is connected to the mouthpiece (2) and which is designed to be arranged outside the oral cavity, and comprising an optical sensor device for determining a blood oxygen content, which optical sensor device comprises a light source (51) associated with the mouthpiece (2) or the shield (3) and a light receiver (52) associated with the mouthpiece (2) or the shield (3), wherein the light receiver (52) is arranged at a distance from the light source (51).

Description

[0001] Pacifiers for infants

[0002] The invention relates to a pacifier for infants, with a mouthpiece for insertion into the oral cavity and a shield connected to the mouthpiece and designed for placement outside the oral cavity.

[0003] DE 9 307 871 Ul off fenbart a pacifier with a sensor in the teat and an LCD digital display device as well as with a microelectronic evaluation device which is housed within the pacifier plate, wherein the sensor is designed as a thermocouple or temperature-dependent resistor and is used to determine the body temperature of an infant.

[0004] The purpose of the invention is to provide a pacifier for infants with which one or more vital functions of the infant can be determined.

[0005] This problem is solved by a pacifier for infants, comprising a mouthpiece for insertion into the mouth and a shield connected to the mouthpiece and designed for placement outside the mouth, by integrating an optical sensor device for determining blood oxygen levels into the pacifier. This sensor device includes a light source and a light receiver associated with the mouthpiece or shield, the light receiver being positioned at a distance from the light source. The pacifier thus has a design closely resembling that of commercially available pacifiers without any sensor function, making the exchange between a commercially available pacifier without a sensor function and the pacifier according to the invention with the integrated optical sensor device virtually imperceptible to the infant.

[0006] Aside from its use for infants, geometrically adapted versions of the pacifier are also available for toddlers and children. The following descriptions of the pacifier's features always refer to its use with infants; however, these features apply equally to toddlers and children.

[0007] To determine the infant's blood oxygen level, the pacifier includes an optical sensor device designed to perform optical absorption measurements on a part of the infant's body, specifically the upper gum and / or upper lip, or the lower gum and / or lower lip. For this absorption measurement, a light source and a light receiver positioned at a distance from the light source are provided. Depending on the body part being measured, these components can be located either in the mouthpiece, both in the shield, or distributed between the mouthpiece and the shield. The optical measuring path, determined by the light source and the light receiver, can be configured for either transmission or reflection measurements.In transmission measurement, the light source and the light receiver are positioned on opposite sides of the body part, so that the optical path runs through the body part. In reflection measurement, the light source and the light receiver are positioned on the same side of the body part, with the light rays being reflected predominantly from that side of the body part.

[0008] During the determination of blood oxygen levels, the heart rate can also be measured. Heart rate is a particularly important parameter in pediatrics, as changes towards a critical patient condition in infants and young children often initially manifest as a decreasing heart rate before a reduction in blood oxygen saturation occurs.

[0009] The optical method for determining blood oxygen content is known in principle. By way of example, DE 60 023 030 T2 discloses a pulse oximeter sensor comprising a reusable and a disposable part. The reusable part of the sensor includes the relatively durable and expensive components of the transmitter, detector, and connector. The disposable part of the sensor is formed by a relatively inexpensive adhesive tape with which the sensor is attached to a measurement site, usually a patient's finger or toe. The disposable part of the sensor is connected to the reusable part in such a way that the disposable part can be easily replaced when the adhesive is used up or the tape is soiled or excessively worn.

[0010] However, in the invented pacifier, unlike the known prior art, where blood oxygen levels are measured on a finger of the human hand, the absorption measurement is performed in the infant's mouth. This allows for a synergistic effect, as the vast majority of infants already use a pacifier, and the absorption measurement in the infant's mouth using the invented pacifier does not cause any additional stimuli that could lead to undesirable stress for the infant.

[0011] Preferred areas of application for the invented calming pacifier are found particularly in pediatric emergency departments, in the inpatient care of infants, in postoperative monitoring (recovery room), at pediatricians' offices, in pre-hospital emergency medical care (rescue services), in the home care of infants and children with pre-existing conditions, and at midwives' offices.

[0012] The supply of electrical energy to the light source and the reception of electrical sensor signals from the light receiver can be provided via wired or wireless means.

[0013] In the wired version, the pacifier is connected via a cable to a power supply and evaluation unit, which can be positioned separately and thus spatially distant from the pacifier. Such a wired connection is particularly suitable if the infant already requires other cables or tubes, as is often the case in intensive care.

[0014] In the wireless version, the light source can be equipped with an electromagnetic wave receiver, and the light receiver with an electromagnetic wave transmitter and receiver. This allows for energy transfer to the light source and feedback of sensor signals from the light receiver without a physical connection between the pacifier and a power supply and evaluation unit. This type of pacifier is also suitable for clinical use, as the wireless energy and signal transmission between the power supply and evaluation unit and the pacifier requires a technological complexity that is only acceptable in exceptional cases for private use.With the ongoing development of wireless coupling methods, it can be assumed that, at least in a short range of 1 to 10 m, energy coupling into the light source and signal extraction from the light receiver can be achieved, for example, via a wireless network (wireless LAN - WLAN) or directly via a mobile phone. An advantage here is that the determination of blood oxygen content can be carried out cyclically at a repetition rate of several seconds, so that energy coupling and signal extraction between individual measurement cycles can be performed even with low energy densities and using small, local energy storage devices such as capacitors assigned to the light source and / or the light receiver.

[0015] For determining blood oxygen content, it is advantageous if the light source and the light receiver are each aligned at least substantially parallel to an optical axis defined by the distance between the light source and the light receiver. It is assumed that the light source is a light-emitting diode (LED) and has a typically conical or lobe-shaped emission characteristic, with a spatial direction in which maximum emission occurs also referred to as the principal axis, and this principal axis preferably aligned with the light receiver. By way of example, the light receiver has a conical reception characteristic, with a central axis, describing an incidence direction on the light receiver at which the light receiver exhibits its maximum sensitivity, preferably aligned with the light source.

[0016] Advantageous further developments of the invention are the subject of the dependent claims.

[0017] It is advantageous if the light source and the light receiver are electrically connected to an evaluation unit arranged in the shield, which includes an energy storage device. This results in a completely self-sufficient system in which no additional energy input or signal output is required. Rather, the evaluation unit is configured to supply electrical energy from the energy storage device, which can be a capacitor, accumulator, or battery, to the light source. Furthermore, the evaluation unit is configured to receive and evaluate sensor signals from the light receiver in order to determine the blood oxygen content. Preferably, the evaluation unit includes a digital circuit section to enable digital processing of the sensor signals from the light receiver.Additionally, the evaluation unit may include an analog circuit section with which, for example, analog signal levels provided by the light receiver can be processed, amplified, and optionally filtered before analog-to-digital conversion. It is particularly preferred that the evaluation unit be implemented as a printed circuit board with analog and digital components and include a microcontroller configured to execute a stored computer program, wherein the computer program includes, among other things, commands for controlling the light source and algorithms for evaluating sensor signals from the received light.

[0018] With such a self-contained pacifier, care procedures such as dressing, undressing, and personal hygiene are made easier, as there is no need to consider any wiring. Furthermore, the infant can move freely or be moved during the measurement. There is also no sensation of a foreign object, as most infants are accustomed to using a pacifier.

[0019] It is advantageous if the light source and the light receiver are arranged in the mouthpiece. With such an arrangement of light source and light receiver, ambient light, which can interfere with the determination of blood oxygen content, is largely shielded, since the absorption measurement takes place in the largely closed oral cavity. It is particularly preferred that the light source and the light receiver are oriented such that the posterior surface of the upper or lower chewing surface of the infant, facing the pharynx, can be used for the absorption measurement.

[0020] Alternatively, the light source and the light receiver are arranged within the shield. This allows for short electrical cable lengths between the evaluation unit and the light source and the light receiver. Preferably, the light source and / or the light receiver are directly integrated into the electrical circuit of the evaluation unit. Particularly preferred is the orientation of the light source and the light receiver such that the outer surface of the infant's upper or lower lip can be used for absorption measurement.

[0021] Preferably, the shield features a rod-shaped mouthpiece holder for attaching the mouthpiece, and the mouthpiece has a recess adapted to the mouthpiece holder. This creates an interface that allows for easy replacement of the mouthpiece. Thus, the mouthpiece can be disposed of after single or multiple uses, or it can be reused as a normal pacifier with an otherwise non-functional, rigid insert, which also has a shield. The shield with the attached mouthpiece holder, on the other hand, is designed for permanent reuse. Preferably, the rod-shaped mouthpiece holder and the mouthpiece are designed to fit together such that the mouthpiece completely encloses the mouthpiece holder, and there is no contact between the infant's mouth and the mouthpiece holder during use of the pacifier.Preferably, the mouthpiece carrier extends along an axis of extension, in particular a straight line, from the shield and has cross-sections in cross-sectional planes oriented transversely to this axis of extension or straight line, which prevent undesired rotation between the mouthpiece and the mouthpiece carrier. Non-circular cross-sections, such as oval, rectangular, square, or polygonal cross-sections, are particularly suitable for this purpose. In a further development of the invention, the light source is arranged in the mouthpiece carrier and the light receiver is arranged in the shield.This ensures that, when the pacifier is used as intended, it is highly likely that either at least the (upper or lower) gum or at least the (upper or lower) lip of the infant is positioned in the optical path between the light source and the light receiver, thus allowing a determination of the blood oxygen content to always be carried out.

[0022] In a further embodiment of the invention, the mouthpiece is made of a rubber-elastic material that exhibits an optical transmission greater than 85 percent, particularly for light in a wavelength range of 640 to 680 nanometers and / or in a wavelength range of 920 to 960 nanometers. The mouthpiece is preferably made of a material whose haptic properties closely resemble those of materials used in commercially available pacifiers without integrated sensors.For example, the mouthpiece is made of a silicone material that is particularly crystal clear and that has an advantageous optical transmission greater than 85 percent, at least for the two different electromagnetic waves provided by the light source, which are located in the wavelength ranges of 640 nanometers to 680 nanometers and 920 nanometers to 960 nanometers.

[0023] It is advantageous if the mouthpiece covers the back of the shield facing the rod-shaped mouthpiece holder. This ensures, firstly, that the mouthpiece cannot be swallowed even if it unintentionally detaches from the mouthpiece holder, as the mouthpiece itself has an area that is geometrically similar to the shield of the pacifier. Secondly, this ensures a significant decoupling of the mouthpiece, which is in direct contact with the infant's mouth during normal use, from the shield and the attached mouthpiece holder, thus facilitating compliance with hygiene regulations when the pacifier is reused.

[0024] Preferably, an operating device and a display device are arranged on an outer surface of the shield facing away from the mouthpiece. The operating device can, for example, be designed as a pressure switch with which the optical sensor device can be switched on and / or off. Furthermore, the operating device can be used to select different operating modes and / or to set specific parameters for carrying out the absorption measurement. The display device can be implemented as a segment display or as a matrix display, in particular as a liquid crystal display (LCD display) or as an (organic) light-emitting diode display (LED display) and serves to display the determined blood oxygen content. In addition, further information can be displayed with the display device, such as a pulse rate or a time course of the blood oxygen content.In particular, the display device may be designed to operate in different modes. For example, a critical blood oxygen level may be indicated by increased brightness, enhanced contrast, or a larger font size on the display. Conversely, if the blood oxygen level is not critical, an energy-saving mode may be activated, such as switching off the backlight or reducing the contrast. Additionally, the display device may include an audible alarm that sounds, particularly in the event of a critical blood oxygen level or a measurement error, such as when the pacifier is no longer in the mouth.

[0025] In an advantageous further development of the invention, an optical fiber is arranged between a surface of the shield or mouthpiece and the light receiver. The optical fiber bridges the gap between the light receiver and a surface of the shield or mouthpiece, which, for example, allows the light receiver to be mounted directly on a printed circuit board belonging to the evaluation unit. The optical fiber can be made of a plastic material, for example. A flexible plastic material is particularly preferred.

[0026] An advantageous embodiment of the invention is shown in the drawing. This shows:

[0027] Figure 1 shows a strictly schematic front view of a pacifier.

[0028] Figure 2 shows a right-hand view of the pacifier according to Figure 1.

[0029] Figure 3 shows a left-hand view of the pacifier according to Figure 1, and Figure 4 shows a strictly schematic horizontal section through the pacifier according to Figure 1.

[0030] A pacifier 1, shown schematically in Figures 1 to 4, is dimensioned similarly to a commercially available pacifier without sensor functions (not shown). The pacifier 1 comprises a mouthpiece 2 made of a rubber-elastic material, which is attached to a shield 3, also referred to as the base. When the pacifier 1 is used as intended, the mouthpiece 2 is placed in the infant's mouth. The shield 3, on the other hand, is dimensioned such that it reliably remains outside the infant's mouth and cannot be placed inside.

[0031] In the illustration of Figure 1, an upper chewing ridge 31, a lower chewing ridge 32, an upper lip 33 and a lower lip 34 of an otherwise not shown infant are shown in a strictly schematic, dashed representation to illustrate the arrangement of the pacifier 1 during its intended use.

[0032] This shows that a distal area 9 of the mouthpiece 2 projects into the pharyngeal cavity 35, while a proximal area 10 of the mouthpiece 2 is typically accommodated between the upper chewing ridge 31 and the lower chewing ridge 32, so that the upper lip 33 and the lower lip 34 lie directly against a protective wall 11, which is an integral and one-piece part of the mouthpiece 2 and adjoins the proximal area 10 of the mouthpiece 2.

[0033] By way of example, the protective wall is dimensioned such that it completely covers the back side 5 of the shield 3 and thereby provides protection for the shield 3. As can be seen in Figures 1 and 4, both the back side 5 of the shield 3 and the protective wall 11 are curved in two perpendicular directions to each other in order to ensure the best possible fit to the geometry of the infant's mouth area.

[0034] Furthermore, it can be seen from Figures 1 and 4 that a rod-shaped mouthpiece carrier 66 extends from the rear side 5 of the shield 3 along an axis of extension 67 with a rectangular cross-section, and is received in a correspondingly shaped recess 12 of the mouthpiece 2. By way of example, it is provided that the recess 12 is adapted to the mouthpiece carrier 66 in such a way that a friction-fit connection between the mouthpiece 2 and the shield 3 is ensured.

[0035] Figures 1 and 4 also show the positioning of a light source 51 and a light receiver 52, which form an optical measuring path in which, during intended use of the pacifier 1, the upper gum 31 and the upper lip 33 of the infant are positioned. For this purpose, the light source 51 is housed in the mouthpiece carrier 66 and is designed to provide light rays (not shown) in a vertical upward direction, as shown in Figure 1. Furthermore, the light receiver 52 is integrated into the back 5 of the shield 3 and is positioned away from the plane of section shown in Figure 1, so that, during intended use, the measuring path between the light source 51 and the light receiver 52 always passes through the upper gum 31 and the upper lip 33 of the infant.As can be seen in Figure 4, a cavity 67 is formed in the shield 3, which serves to accommodate an evaluation unit 63 (shown only schematically) and an energy storage device 64. The evaluation unit 63 can be implemented as a printed circuit board with electrical and electronic components and may include a microprocessor (not shown) on which a computer program runs, which can be used to control the various functions of the calming suction device 1. The energy storage device 64 is shown purely as an example and is designed to supply the evaluation unit 63 with electrical energy. The energy storage device 64 can be supplied with electrical energy externally either via a charging socket (not shown) or via an inductive charging device (also not shown).

[0036] The evaluation unit 63 is electrically connected to the light source 51 via a supply line 53. Furthermore, the evaluation unit 63 is connected via a sensor line 54 to the light receiver 52, which is concealed in Figure 4 by the curved rear side 5 of the sign 3. In addition, the evaluation unit 63 is connected via a display line 55 to a display unit 6, which is arranged on a front side 4 of the sign 3 and is, for illustrative purposes only, designed as a light-emitting diode matrix display.

[0037] Furthermore, the evaluation unit 63 is connected via a control line 56 to a control button located next to the display unit 6 on the front 4.

[0038] Additionally, the evaluation unit 63 may be connected via a communication line 57 to a communication module 65, which may be, for example, an integrated circuit designed for wireless communication with a mobile device (not shown), in particular a mobile phone, and which may, for example, use the Bluetooth communication protocol. Alternatively, the communication module 65 may be designed for WLAN communication.

[0039] The operation of the pacifier 1 can be described as follows: In a first step, the pacifier 1 is activated by pressing the operating button 7, which initially switches the evaluation unit 63 from an energy-saving state to an activation state. In the activation state, the evaluation unit 63 supplies electrical energy to the light source 51 to cause alternating emission of light waves in the wavelength ranges of 640 nanometers to 680 nanometers and 920 nanometers to 960 nanometers, wherein it is preferably provided that in each of the two wavelength ranges, light beams with exactly a single wavelength (monochromatic light) are emitted.Furthermore, in the activation state, a sensor signal provided by the light receiver 52 is evaluated in the evaluation unit 63 in order to be able to draw a conclusion about the blood oxygen content based on the absorption properties for the two different wavelength ranges.

[0040] If the pacifier 1, after activation of the light source 51 and evaluation of the sensor signals from the light receiver 52, is not placed in the mouth of an infant as intended with the mouthpiece 2, the evaluation unit 63 issues an error message to the display unit 6 via the display line 55. As soon as the pacifier 1 is placed in the mouth of an infant as intended with the mouthpiece, the light receiver 52 can detect the light absorption of the light radiation emitted by the light source 51 in the two wavelength ranges and provide corresponding sensor signals to the evaluation unit 63. In this case, the evaluation unit 63 calculates the blood oxygen content from the sensor signals received by the light receiver 52 and displays the determined value on the display unit 6 via the display line 55.

[0041] Additionally, the evaluation unit 63 may provide the determined blood oxygen content value to the communication module 65 via the communication line 57. The communication module 65, via a wireless data connection to an end device (not shown), in particular a mobile phone, can display the blood oxygen content on the respective end device. For example, a standard mobile phone is used as the end device, running specific computer software (application or app) designed to display the blood oxygen content value provided by the evaluation unit 63 via the communication module 65.

[0042] Preferably, the evaluation unit 63 stores one or more limit values ​​for blood oxygen levels and is configured to trigger corresponding displays on the display unit 6 when these limit values ​​are exceeded or fallen below. These displays may, in particular, be alarm messages that appear when the blood oxygen level falls below a predefined threshold. Additionally, the evaluation unit 63 may activate an acoustic signal generator, either integrated into the display unit 6 or implemented separately (not shown), to emit an acoustic alarm signal when a predefined threshold is undershot.Additionally or alternatively, it may be provided that the evaluation unit 63 can also trigger an alarm signal output in an end device that is wirelessly disconnected from the pacifier 1 via the communication module 65.

[0043] Furthermore, it can be provided that a heart rate, which can be determined in the usual manner in connection with the blood oxygen content, is displayed on the display unit 6. It is particularly preferred that a perfusion index determined by the evaluation unit 63 is displayed at least temporarily on the display unit 6. The perfusion index is a numerical value that corresponds to the pulsatile blood flow at the sensor position. It is a relative value that varies from patient to patient and depending on the sensor position. This variation depends on whether the light emitted by the light source is absorbed by bone, connective tissue, and skin, or by the pulsating blood. A constant and a variable signal component, as well as the ratio of these two signal components, can be calculated and output as a percentage of perfusion or as a perfusion index.For values ​​above 4%, the measurement is considered reliable.

Claims

Claims 1. Pacifier (1) for infants, with a mouthpiece (2) for ingestion in the oral cavity and a shield (3) connected to the mouthpiece (2) and designed for arrangement outside the oral cavity, as well as an optical sensor device for determining a blood oxygen content, comprising a light source (51) associated with the mouthpiece (2) or the shield (3) and a sensor connected to the mouthpiece (2) or the shield (3) comprises associated light receiver (52), wherein the light receiver (52) is arranged spaced apart from the light source (51).

2. Pacifier (1) according to claim 1, characterized in that the light source (51) and the light receiver (52) are electrically connected to an evaluation device (63) which is arranged in the shield (3) and which comprises an energy storage device (64).

3. Pacifier (1) according to claim 2, characterized in that the light source (51) and the light receiver (52) are arranged in the mouthpiece (2).

4. Pacifier (1) according to claim 2, characterized in that the light source (51) and the light receiver (52) are arranged in the shield (3).

5. Pacifier (1) according to claim 2, characterized in that a rod-shaped mouthpiece carrier (66) for attaching the mouthpiece (3) is formed on the shield (3) and that the mouthpiece (3) is provided with a recess (12) which is adapted to the mouthpiece carrier (66).

6. Pacifier (1) according to claim 5, characterized in that the light source (51) is arranged in the mouthpiece carrier (66) and that the light receiver (52) is arranged in the shield (3).

7. Pacifier (1) according to claim 5 or 6, characterized in that the mouthpiece (2) is made of a rubber-elastic material which has an optical transmission greater than 85 percent, in particular for light in a wavelength range of 640 nanometers to 680 nanometers and / or in a wavelength range of 920 nanometers to 960 nanometers.

8. Pacifier (1) according to claim 4, 5 or 6, characterized in that the mouthpiece (2) covers a rear side (5) of the shield (3) facing the rod-shaped mouthpiece carrier (66).

9. Pacifier (1) according to claim 1, characterized in that an operating device (7) and a display device (6) are arranged on an outer surface of the shield (3) facing away from the mouthpiece (2).

10. Pacifier (1) according to claim 1, characterized in that an optical waveguide is arranged between a surface of the shield (3) or the mouthpiece (2) and the light receiver (52).

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