INCUBATOR WITH A NOISE MUFFLING MECHANISM AND METHOD THEREOF

FIELD OF THE INVENTION

The present invention generally pertains to a medical device, preferably a neonate incubator, with a noise muffling mechanism and to method thereof.

BACKGROUND OF THE INVENTION

The medical environment is characterized by many noise generating elements. The major benefits of making a quiet medical product are that soothing sounds, or absence thereof, lead to greater patient acceptance, patient compliance and, and reduces health risks for both the patient and the medical/technical personal. Further, a quiet medical environment lowers the disturbances to the medical staff, leading to less mistakes in caregiving.

The effect on the patient from the noisy surroundings can range from disturbing to harmful depending on the noise generating device. Patients may experience discomfort, anxiety, and temporary to permanent hearing damage. Acoustic noise may pose a particular problem to specific patient groups. For example, patients with psychiatric disorders may become confused or suffer from increased anxiety because of exposure to loud noise. Sedated patients may experience discomfort in association with high noise levels.

Neonates and babies are another group of patients that are especially sensitive to sound disturbances. As reviewed in Ranganna R., Bustani P., “Reducing noise on the neonatal unit”, Infant, 2011; 7(1):25-28, noise can have a harmful effect on the heart rate and oxygen saturations of the neonate. Further noise changes the sleep and awake cycles of the neonates therefore alters feeding patterns.

The sound levels, especially at low frequencies, within a modern incubator may reach levels that are likely to be harmful to the developing newborn. Much of the noise is at low frequencies and thus difficult to reduce by conventional means. Therefore, advanced forms of noise control are needed to address, see e.g., Marik et al., Pediatr Crit Care Med. 2012 November; 13(6):685-9. The noise in an incubator can result for example from the circulation of air, and/or engines, pumps, and ventilators supporting various life supporting mechanisms. Many noises are even amplified within an incubator, such as the noise generated by CPAP (continuous positive airway pressure) because of the closed space.

In addition, various noise types corrupts infants analyzing devices, such as Electrocardiography (ECG). As described in J. Mahil and T. Sree Renga Raja “Hybrid swarm algorithm for the suppression of incubator interference in premature infants ECG”, J. Applied Sciences, Engineering and Technology 6 (16):2931-2935, 2013, where a learning algorithm is described for interference noise cancelling techniques for filtering the ECG signal.

Another example of a noise generating medical device is a Magnetic Resonance Imaging device. An MRI utilizes strong magnetic fields and radio waves to form images of the body. The MRI's magnetic field is created by running electrical current through an electromagnet. An MRI is noisy because when the current is switched on, the force on the coil comprising the electromagnet goes from zero to huge in just milliseconds, causing the coil to expand slightly, which makes a loud “click.” When the MRI generates an image, the current is switched on and off rapidly. The result is a rapid-fire clicking noise, which is amplified by the enclosed space in which the patient lies. Other noise sources in the MRI facility are Patient comfort fans and cryogen reclamation systems associated with superconducting magnets of MR systems. Acoustic noise produced by these subsidiary systems is considerably less than that caused by gradient magnetic fields, but contributes to the overall discomfort of the patient. RF hearing is another noise generated by the magnetic resonance device during scanning. This occurs when the human head is subjected to pulsed radiofrequency (RF) radiation at certain frequencies, an audible sound perceived as a click, buzz, chirp, or knocking noise may be heard. This acoustic phenomenon is referred to as “RF hearing”, “RF sound” or “microwave hearing”, believed to originate from thermo-elastic expansion over a brief time period in the tissues of the head. With specific reference to the operation of MR scanners, RF hearing has been found to be associated with frequencies ranging from 2.4- to 170-MHz, as is usually masked by other noise generating means.

Various types of acoustic noise are produced during the operation of an MR system. Problems associated with acoustic noise for patients and healthcare professionals include annoyance, verbal communication difficulties, heightened anxiety, temporary hearing loss and, also, the potential for permanent hearing impairment. Currently, patients are given headphones and ear plugs in order to illuminate at least partially their acoustic noise exposure. These passive means of noise protection may have the limitation of hampering verbal communication with patients during the operation of the MR system. Additionally, standard earplugs are often too large for the ear canal of adolescents and infants Importantly, passive noise control devices provide non-uniform noise attenuation over the hearing range. While high frequencies may be well attenuated, attenuation is often poor at low frequencies. This is problematic because, for certain pulse sequences, the low frequency range is where the peak MR imaging-related acoustic noise is generated. Active noise cancellation means are known in the art to significantly reduce in the level of acoustic noise. This is achieved by introducing “anti-phase noise” to a particular source that interferes destructively with the noise source and built into headphones. The anti-noise system involves a continuous feedback loop with continuous sampling of the sounds in the noise environment so that the surrounding noise is attenuated. These mechanisms require adaptation to each different noise generating device and pose another device to be installed over the patient, in an already complicated and tensioned environment.

It is thus still a long felt need to provide an effective, safe, medical environment for patients within a medical device, eliminating the need for the patient to be further connected to additional devices, and mechanisms during medical examinations with a noise generating device. This device will effectively reduce equipment derived noise and sound reverberation and/or reflection. Further the device disclosed in the present invention can function to reduce the transfer of sound to the patient accommodating volume.

SUMMARY OF THE INVENTION

The present invention provides a noise-attenuating neonate incubator (NANI) comprising sound attenuating module (SAM) configured to decrease the sound amplitude ratio at time, t_i, (AmpRat_ti) to a critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) or less, wherein the sound attenuating module (SAM) comprises: (a) at least one sound sensor in communication with the CRM, configured for continuously sampling the sound amplitude ratio at time t_i(AmpRat_ti) within the incubator; (b) at least one CRM for storing the critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) and, the sound amplitude ratio at time, t_i, (AmpRat_ti); and, (c) at least one sound attenuator in communication with the CRM for decreasing the sound amplitude ratio at time, (AmpRat_ti), if AmpRat_ti>AmpR_QVΔt, such that AmpRat_ti<AmpRat_QVΔt; wherein the critical amplitude ratio value of the sound measured over a predetermined time, Δt, AmpRat_QVΔt<about 178.8_Δt. It is another object of the current invention to disclose the NANI defined in any of the above, wherein the sensor is further in communication with a selected from a group consisting of: at least one indicator, at least one user interface, at least one alarm system, at least one CPU, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the CRM is configured to control the sound attenuator according to a selected from a group consisting of: parameters received by means of at least one sensor, parameters inputted through a user interface, parameters received from neonate medical equipment, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the sound attenuator comprises an active sound masking system, configured to emit at least one acoustical sound signal, by means of at least one acoustical sound-speaker.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein at least one acoustical sound signal is selected from a group consisting of: white noise, pink noise, grey noise, brownian noise, blue noise, violet noise, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the sound attenuator comprises a reactive acoustical device, configured to cancel or reduce the noise by means of a destructive interference generated by a selected from a group consisting of: at least one transducer, at least one speaker, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM is configured to differentiate at least one predefined sound from background noise, and attenuate a selected from a group consisting of: the background noise, at least one predefined noise, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the CRM is configured to store at least one sound characteristic selected from a group consisting of: sound levels, tone, overtone composition, reverberations, sound frequency, sound wavelength, sound wave amplitude, sound wave speed, sound wave direction, sound wave energy, sound wave phase, sound wave shape, sound wave envelope, sound timbre, and any combination thereof.

The present invention provides a noise-attenuating neonate incubator (NANI) comprising sound attenuating module (SAM) configured to decrease the sound's amplitude ratio at time, (AmpRat_ti) to a critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) or less.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM is configured to attenuate the noise in a predefined sound characteristic.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM is configured to attenuate the noise by a selected from a group consisting of: reduce the sound levels, reduce sound reflections, reduce sound reverberation, create sound diffusion, mask sound, cancel sound, change the sound signature, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM is configured to change at least one sound characteristic selected from a group consisting of: sound levels, tone, overtone composition, reverberations, sound frequency, sound wavelength, sound wave amplitude, sound wave speed, sound wave direction, sound wave energy, sound wave phase, sound wave shape, sound wave envelope, sound timbre, and any combination thereof, thereby generating a different sound signature.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the sound signature is selected from a group consisting of: configurable by the user, predefined, automatically adjustable in reference to the neonate's life parameters, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM comprising at least one means selected from group consisting of: active sound attenuating means, passive sound attenuating means, hybrid sound attenuating means, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein at least one passive sound attenuating means is selected from a group consisting of: at least one sound absorptive material, at least one resonator, at least one sound shield, at least one bass trap, at least one sound baffle, at least one diffuser, at least one insulation padding, at least one sound reflector, at least one sound muffler (SM), and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM comprising at least one sound muffler (SM) comprising at least one cylindered conduit, having at least one length (l) and at least one width (w); the cylinder comprising at least one air inlet, and at least one air outlet; further wherein the SM is configured such as that sound exiting at least one air outlet is of a different sound signature than sound entering at least one air inlet.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SM comprises at least a first cylinder, and at least a second cylinder, connected therebetween, the connection comprises at least one opening configured to permit a fluid communication therebetween.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein at least one cylinder width (w) is selected from a group consisting of: width (w) is equal along the length (l), is differential along the length (l) or any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SM comprises a plurality of n cylinders, having the length (l)_{1- . . . n}and the width (w)_{1- . . . n}of the each cylinder, are selected from a group consisting of: (l)₁=(l)_n, (l)₁>(l)_n, (l)₁<(l)_n, (l)₁≠(l)_n, (w)₁=(w)_n, (w)₁>(w)_n, (w)₁<(w)_n, (w)₁≠(w)_n, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM comprises at least one insulation padding configured to insulate the neonate placement within the NANI; further wherein the insulation comprises at least one opening configured to permit access to within the NANI.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein at least a portion of the insulation comprises a material selected from a group consisting of: thermo insulating material, sealing material, foam material, fire retardant materials, at least partially transparent material and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM comprises at least one sound shield comprising at least a portion of a material selected from a group consisting of: at least one insulating material, at least one sealing material, at least one sound absorbent material, at least one vibration absorbing material, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM is a modular component reversibly attachable to the incubator.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM comprises at least one sound reflector configured to direct the noise to a selected from a group consisting of: at least one absorptive surface, at least one sound diffuser, at least one sound baffle, at least one reflective surface, at least one resonator, at least one sound shield, a location directed away from the neonate, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein at least a portion of the SAM comprises n layers; further wherein each of the n layers comprising an inner side towards the neonate, and an opposite outer side facing away from the neonate.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein each of the n layers comprising a predefined Noise Reduction Coefficient (NRC) value, Sound Transmission Class (STC) value, or both; further wherein the NRC value, STC value, or both, can be equal or different for the each of one of n layers.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein at least 2 of the n layers comprising a Noise Reduction Coefficient (NRC) value for each of the n layers; where each of the layers comprising at least one sound level S [dB] measured on the layer outer side, and at least one first sound level S₁[dB], measured on the layer inner side, having a dS₁- . . . dSn, wherein dS of the SAM equals S₁-Sn, and S₁-Sn<S₁.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein at least 2 of the n layers comprising a Sound transmission class (STC) value for each of the n layers; where each of the layers comprising at least one sound level S [dB] measured on the layer outer side, and at least one first sound level S₁[dB], measured the layer inner side, having a dS₁- . . . dSn, wherein dS of the SAM equals S₁-Sn, and S₁-Sn<S₁.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM further comprising: (a) a space, S₁, between at least one of n layers to the incubator, a space S_nbetween each of the n layers, or both; (a) STC₁(sound transmission class) value, measured for the layers_1-n; and, (c) mobilization means, connected to at least one of the n layers, configured to mobilize at least one of the n layers, having a space S_1a, between at least one of n layers to the incubator, a space S_nabetween each of the n layers, or both, and STC₂value measured for the layers_1-n; where S₁<S_1a, S_n<S_na, or both, and where STC₁<STC₂.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the incubator further comprises at least one conduit having at least one SAM configured to muffle the sound passing through the conduit.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM, the incubator, or both are made of MRI safe materials.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the incubator further comprises at least one sensor selected from a group consisting of: sound level sensor, sound frequency sensor, sound direction sensor, sound amplitude sensor, sound tone sensor, sound speed sensor, sensor configured to sense life parameters of the neonate, and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM is configured to reduce reverberation of sound, reflections of sound, or both within the inner volume, by means of at least one selected from a group consisting of; absorptive material, a sound baffle, a sound diffuser, an active sound cancellation device and any combination thereof.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the NANI further comprises at least one air inlet, air outlet, or both, configured for the entry and/or exit of air; further wherein at least one air inlet, outlet, or both further comprises at least one SAM.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the NANI is at least temporarily accommodated in a cart comprising a mobile base, interconnected to the incubator by at least one support pillar.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the cart further comprises at least one SAM.

It is another object of the current invention to disclose the NANI defined in any of the above, wherein the SAM is connected to a selected from a group consisting of the incubator, the cart base, the pillar, and any combination thereof.

The present invention provides a method for sound attenuating a neonate incubator, characterized by: (a) obtaining a noise-attenuating neonate incubator (NANI) comprising at least one sound attenuating module (SAM) configured to decrease the sound's amplitude ratio at time, t_i. (AmpRat_ti) to a critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) or less; (b) accommodating the neonate in the NANI; and, (c) attenuating the noise by at least one SAM, thereby changing the sound signature.

It is another object of the current invention to disclose the method as defined in any of the above, additionally comprising the following steps: (a) obtaining the SAM further comprising: at least one CRM, at least one sound sensor in communication with the CRM, at least one sound attenuator in communication with the CRM; (b) storing the critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) and, the sound amplitude ratio at time, t_i(AmpRat_ti); and, by means of the CRM; (c) continuously sampling the sound amplitude ratio at time, AmpRat_tiwithin the NANI, by means of at least one sound sensor; and, (d) decreasing the sound amplitude ratio at time, (AmpRat_ti), if AmpRat_ti>AmpR_QVΔt, such that AmpRat_ti<AmpRat_QVΔt; wherein the critical amplitude ratio value of the sound measured over a predetermined time, Δt, AmpRat_QVΔt<about 178.8_Δt, by means of the sound attenuator. It is another object of the current invention to disclose the method as defined in any of the above, additionally comprising the step of further relaying information from the sensor to a selected from a group consisting of: at least one indicator, at least one user interface, at least one alarm system, at least one CPU, and any combination thereof.

It is another object of the current invention to disclose the method as defined in any of the above, additionally comprising the step of controlling the sound attenuator by means of the CRM according to a selected from a group consisting of: parameters received by means of at least one sensor, parameters inputted through a user interface, parameters received from neonate medical equipment, and any combination thereof.

The present invention provides a standard of care for sound attenuating an incubator, comprising steps of: (a) obtaining a noise-attenuating neonate incubator (NANI) comprising at least one sound attenuating module (SAM) configured to decrease the sound's amplitude ratio at time, t_i, (AmpRat_ti) to a critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) or less; (b) accommodating the neonate in the incubator; and, (c) attenuating the noise by at least one SAM, thereby changing the sound signature, further wherein at least one of the following is held true: (a) the noise level in the incubator is below 45 Decibels; (b) the noise level in the incubator is below 60 Decibels; (c) the amount of audible related complications of neonates when utilizing the incubator is b times lower than the average value of audible complications of neonates; b is equal or greater than 1.05; (d) the average value of salivary cortisol level index from noise derived stress of patient when utilizing the incubator during MRI is n times lower than the average value during MRI; n is equal or greater than 1.05; (e) the incubator remains stable when tilted 10° in normal use, and when tilted 20° during transportation; (f) the incubator does not tip over when the encountered with a force of 100 N or less; (g) the radiated electromagnetic fields in the inner volume of the incubator, comprising electrical equipment system will be at a level up to 3 V/m for the frequency range of the collateral standard for EMC (electromagnetic compatibility); further the electrical equipment is performing its intended function as specified by the manufacturer or fail without creating a safety harm at a level up to 10 V/m for the frequency range of the collateral standard for EMC; and, (h) the average number of insurable claims of a selected from a group consisting of: manufacturer, handler, user, operator, medical care personal, medical facility, medical facility management or any combination thereof when utilizing the incubator is v times lower than patient MRI associated insurable claims; v is equal or greater than 1.05.

BRIEF DESCRIPTION OF THE FIGURES

In order to understand the invention and to see how it may be implemented in practice, a few preferred embodiments will now be described, by way of non-limiting example only, with reference to be accompanying drawings, in which:

FIG. 1 illustrates a neonate residing in an incubator is a noisy environment;

FIG. 2a-e schematically illustrates in an out of scale manner embodiments of a the location of a sound attenuating module in connection with an incubator;

FIG. 3a-f schematically illustrates in an out of scale manner different embodiments of a passive SAM;

FIG. 4a-d schematically illustrates in an out of scale manner different embodiments of an active SAM;

FIG. 5 schematically illustrates an incubator/medical device with a ventilating system with noise muffling mechanisms;

FIG. 6 schematically illustrates in an out of scale manner, an incubator as part of a cart comprising a ventilating system at the incubators base, and noise muffling mechanisms;

FIG. 7a is a schematic diagram describing a an incubator comprising a ventilating system configured to stream air through at least one sound muffler;

FIG. 7b is a schematic diagram describing a cart comprising an incubator connected to a ventilating system through at least one sound muffler; and,

FIG. 8a-e are schematic diagrams describing a neonate's disturbance parameter as a function of amplitude, frequency, and duration of sound interruption.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description is provided so as to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide an apparatus and methods for reducing noise in medical devices.

The present invention pertains to a neonate incubator comprising a sound attenuator for attenuating noise. The present invention further pertains to a neonate incubator comprising an active sound attenuator for attenuating the noise. It is in the scope of the present invention that the active sound attenuator is in addition to a passive sound attenuator, or that the active sound attenuator is combined with a passive sound attenuator.

The present invention also pertains to a neonate incubator comprising a passive sound attenuator for attenuating the noise. It is in the scope of the present invention that the passive sound attenuator is in addition to an active sound attenuator, or that the passive sound attenuator is combined with an active sound attenuator.

The essence of the present invention is to provide an incubator, comprising an inner environment adapted to at least temporarily accommodate a patient, and a surrounding environment comprising at least one noise generator, the incubator is characterized by comprising at least one sound attenuating means configured to attenuate the noise within the inner environment, generated by the at least one noise generator.

It is further is the scope of the invention to provide a medical device configured to be accommodate by a neonate, comprising at least one sound attenuator selected from a group consisting of: an active sound attenuator, a passive sound attenuator, a hybrid sound attenuator, and any combination thereof. The term “medical device” interchangeably refers hereinafter to any apparatus, device, or mechanism, configured to at least partially accommodate a patient, during the patient's stay in a health caring facility and/or during examination, testing, imaging, operating, treating of the patient. This medical device can be such as any magnetic resonance imaging device, incubator, transport incubator, any transportable incubator, cart, CT scanner, X-ray device, ultrasonography device, elastography, fluoroscopy device, photoacoustic imaging device, thermography device, functional near-infrared spectroscopy, medical photography device and nuclear medicine functional imaging device, positron emission tomography (PET) device, operating table, treatment table, medical transport device, and any combination thereof.

The term ‘transport incubator’ interchangeably refers hereinafter to any incubator, immobilized incubator, transportable incubator, a portable incubator and any combination thereof. It is in the scope of the invention an immobilized permanently placed incubator or a portable one configured for accommodating neonates when under care.

The term ‘magnetic resonance imaging device’ (MRD), specifically applies hereinafter to any Magnetic Resonance Imaging (MRI) device, any Nuclear Magnetic Resonance (NMR) spectroscope, any Electron Spin Resonance (ESR) spectroscope, any Nuclear Quadruple Resonance (NQR), any Laser magnetic resonance device, any Quantum Rotational field magnetic resonance device (cyclotron), and any combination thereof. The term, in this invention, also applies to any other analyzing and imaging instruments comprising a volume of interest, such as computerized tomography (CT), ultrasound (US) etc. The MRD hereby disclosed is optionally a portable MRI device, such as the ASPECT-MR Ltd commercially available devices, or a commercially available non-portable device. Additionally or alternatively, the MRD is self-fastening cage surrounding a magnetic resonance device as depicted in U.S. Pat. No. 7,719,279 B2, filed 27/May/2008 titled: “SELF-FASTENING CAGE SURROUNDING A MAGNETIC RESONANCE DEVICE AND METHODS THEREOF”, of which is hereby incorporated by reference in its entirety.

The term “cart” refers hereinafter to any apparatus used for transporting the cart. This includes any transport device or any small vehicle pushed or pulled by manually, automatically or both. More specifically the term relates to a structure able to hold the incubator having mobility providing elements such as one or a plurality of a wheel, roller, sliding blade, rotating belt, etc. For example, trolley, handcart, pushcart, electric cart, wagon, barrow, rickshaw, ruck, wagon, barrow, buggy, dolly, carriage, float, cab, dray, gig, gurney, handcart, palanquin, pushcart, tumbrel, wheelbarrow, curricle, etc.

The term “incubator” interchangeably refers hereinafter to a special unit specializing in the care of ill or premature newborn infants. This includes a stationary incubator, a moveable incubator, a transport incubator, a disposable incubator, a healthcare facility incubator, portable incubator, an intensive care incubator, an incubator intended for home use, an incubator for imaging a neonate, a treatment incubator, a modular incubator, an isolating incubator and any combination thereof. The neonatal incubator is a box-like enclosure in which an infant can be kept in a controlled environment for observation and care. The incubator usually includes observation means to the accommodated neonate, and openings for the passage of life support equipment, and the handler's hands. At least partially enclosed environment formed within the incubator is at least partially isolated from the external environment conditions such as noise, vibration, drift, temperature, light, gas concentrations, humidity, microorganisms, etc., and/or regulated to reach life supporting parameters defined by medical personal. The incubator can contain, or be connected to life supporting equipment. The internal environment can be controlled by environment control systems such as temperature regulating, ventilating, humidifying, lighting, moving, noise reduction systems, vibration reducing systems, etc.

The term “MRI-safe” interchangeably refers herein to any material that, when used in the magnetic resonance environment, will present no additional risk to the patient and not significantly affect the quality of the diagnostic information. The material is completely non-magnetic, non-electrically conductive, and non-RF reactive, eliminating all of the primary potential threats during an MRI procedure.

The term “human hearing” interchangeably refers herein to any sound received by the human ear, with the typical frequency range for normal hearing being between 20-Hz to 20,000-Hz. The logarithmic decibel scale, dB, is used when referring to sound power.

The term “decibels” or “dB”, interchangeably refers herein to the unit used to express the ratio between two values of such as an amplitude. If sound power ratios are x and amplitude ratios Ix then dB equivalents 10 log 10×. As depicted in Wikipedia, when referring to measurements of field amplitude, it is usual to consider the ratio of the squares of Ai (measured amplitude) and Ao (reference amplitude). This is because in most applications power is proportional to the square of amplitude, and it is desirable for the two decibel formulations to give the same result in such typical cases. Thus, the following definition is used:

$L_{dB} = 10 \log_{10} (\frac{A_{1}^{2}}{A_{0}^{2}}) = 20 \log_{10} (\frac{A_{1}}{A_{0}}) .$

A change in power ratio by a factor of 10 is a change of 10 dB. The decibel is commonly used in acoustics as a unit of sound pressure, for a reference pressure of 20 micropascals in air and 1 micropascal in water. The reference pressure in air is set at the typical threshold of perception of an average human and there are common comparisons used to illustrate different levels of sound pressure. Sound pressure is a field quantity, therefore the field version of the unit definition is used:

$L_{p} = 20 \log_{10} (\frac{p_{rms}}{p_{ref}}) dB$

where p_refis equal to the standard reference sound pressure level of 20 micropascals in air or 1 micropascal in water.

On the decibel scale, the smallest audible sound (near total silence) is 0 dB. Here are some common sounds and their decibel ratings as known in the art: Near total silence—0 dB, A whisper—about 15 dB, Normal conversation—about 40-60 dB, A lawnmower—90 dB about, A car horn—about 110 dB, A rock concert or a jet engine—about 110-150 dB, A gunshot or firecracker—140 dB. It is known in the art that any sound above 85 dB can cause hearing loss, and the loss is related both to the power of the sound as well as the length of exposure. Eight hours of 90-dB sound can cause damage to your ears; any exposure to 140-dB sound causes immediate damage (and causes actual pain).

According to one embodiment of the invention, the passive sound attenuator, the active sound attenuator, or both together, are configured to maintain the sound levels at 45 dB or lower.

The present invention provides a noise-attenuating neonate incubator (NANI) comprising sound attenuating module (SAM) configured to decrease the sound amplitude ratio at time, t_i, (AmpRat_ti) to a critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) or less, wherein the sound attenuating module (SAM) comprises: (a) at least one sound sensor in communication with the CRM, configured for continuously sampling the sound amplitude ratio at time t_i(AmpRat_ti) within the incubator; (b) at least one CRM for storing the critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) and, the sound amplitude ratio at time, t_i, (AmpRat_ti); and, (c) at least one sound attenuator in communication with the CRM for decreasing the sound amplitude ratio at time, (AmpRat_ti), if AmpRat_ti>AmpR_QVΔt, such that AmpRat_ti<AmpRat_QVΔt; wherein the critical amplitude ratio value of the sound measured over a predetermined time, Δt, AmpRat_QVΔt<about 178.8_Δt. The term “AmpRat_ti” interchangeably refers herein to a value of the amplitude ratio of the sound measured in a specific point in time, t_ifor counts per unit of time. The unit for frequency is hertz (Hz), 1 Hz means that an event repeats once per second. The period, usually denoted by T, is the duration of one cycle, and is the reciprocal of the frequency 1:

$T = \frac{1}{f} .$

As the human hearing ranges between 20-20000 Hz, the minimal time between two maximal amplitudes can be calculated to be 50 microsecond and the maximum as 0.05 second. Therefore, as a non-limiting example the time lapse can be such as equal or greater than 50 microseconds. Additionally or alternatively, it is known in the art of signal processing that sampling of a signal usually pertains sampling at least two time lapses of a signal. In signal processing, sampling is the reduction of a continuous signal to a discrete signal. A common example is the conversion of a sound wave to a sequence of samples. A sample refers to a value or set of values at a point in time and/or space. Sampling in order to create a sample is called a sampling event. The signal sampled can be monotone or comprise a plurality of tones. The value of 50 microseconds is the minimum lapse between two amplitude peaks of a signal wave in the range of human hearing, and any tone combination will necessarily be this value or higher.

Additionally or alternatively, the sampling frequency (sampling rate) for audio sampling, when it is necessary to capture audio covering the entire 20-20,000 Hz range of human hearing, audio waveforms are typically sampled at 44.1 kHz, 48 kHz, 88.2 kHz, or 96 kHz. (as depicted in Wikipedia). It is known in the art according to the Nyquist theorem that it is required to sample a given signal at approximately double-rate of its highest frequency. Sampling rates higher than about 50 kHz to 60 kHz cannot supply more usable information for human listeners. Therefore the minimum sampling rate for the SAM according to one embodiment of the invention is 40 kHz. Higher Sampling rate will provide a high resolution for determining the characteristics of the signal sampled.

The term “AmpR_QVΔt” interchangeably refers herein to a critical amplitude ratio value of the sound measured over a predetermined time, Δt, during this time a plurality of sampling events can be preformed. This value is predetermined, additionally or alternatively, this value can be configured by the user. Additionally or alternatively, the CRM is configured to change the AmpR_QVΔtin real time by adjusting the sound attenuation to the responses of the neonate.

The term “wave shape” is the actual shape of the wave. Some different types of waves are: sine waves, which are pure tones—they have no harmonics. Square waves and triangle waves both have only odd harmonics, but the different levels of their harmonics distinguish them from one another. Sawtooth waves have both even and odd harmonics. It is the unique combination of the fundamental and the harmonics that gives a sound its timbre (the tone color, or the quality, of a sound). Timbre is also defined by the sound envelope. The Envelope is kind of a combination of amplitude and wavelength—it describes the individual parts of a sound, broken down into ADSR (Attack, Decay, Sustain, Release). Attack—How a sound is started after the sound source begins to vibrate; Decay—the initial dying off after the attack; Sustain—when the sound remains relatively constant after the initial decay; Release—the time period and manner in which a sound fades to nothing, (http://www.audioduct.com/Lessons).

The term “sound wave phase” refers herein to the time relationship between 2 waves. In-Phase—the waves are working together; (compression and rarefaction occur in both waves at the same time.) This increases the amplitude. If 2 waves are totally in-phase, then amplitude is increased by 3 dB. Out-of-Phase—the waves are working against each other (compression is occurring in one wave while rarefaction is occurring in in the other. If the waves are completely out of phase) (180°, there will be extreme cancellation.

It is in the scope of the invention to additionally or alternatively sample at least one sound characteristic selected from a group consisting of: sound levels [dB], sound frequency [Hz], duration of cycle [sec], tone combination within the sound signal, wavelength [feet or meters], velocity [feet per sec or meter per sec], Wave shape, Envelope, Timbre, Phase, and any combination thereof.

Means for sampling a signal/noise are such as: recording by analog means such as records, tapes and etc., A Digital audio that uses pulse-code modulation and digital signals for sound reproduction. This includes analog-to-digital conversion (ADC), digital-to-analog conversion (DAC), storage, and transmission.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the CRM is configured for one or more sampling events creating one or more sample values; Further wherein the sample one or more values are analyzed to determine the sound signature.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the CRM is configured for sampling the amplitude ratio of a signal between the time point t and t₁=l>t+50 microseconds, thereby determining AmpRat_ti.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the CRM is configured for calculating the average of at least two sampling events to determine AmpRat_ti.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein AmpR_tiis measured at least one specific time interval. As a non-limiting example, the amplitude ratio is measured continuously or at any time interval such as: 50 microseconds, 50 microsecond+X [microseconds], where X is any integer.

According to another embodiment of the invention the sampling frequency is =l>40000 Hz.

The term “sound” interchangeably refers herein to any audible acoustic waves, as depicted in Wikipedia, sound is a vibration that propagates as a typically audible mechanical wave of pressure and displacement, through a medium such as air or water, when intercepted by any human, animal or any mechanical device or receiver. It is in the scope of the present invention that sound can be characterized by at least one of the following parameters: sound levels (can be measured in as sound pressure or in decibels [dB], overtone composition, reverberations, sound frequency [Hz], sound wavelength [feet or meters], tone, sound wave amplitude, sound wave velocity [meters per sec. or feet per sec], sound wave direction, timbre, sound wave phase, sound wave shape, sound envelope, and, sound wave energy [joules]. Any of the aforementioned characteristics can be used to define a sound signature.

It is further in the scope of the present invention that the sound attenuating means generate a sound signature different than the sound generated by any noise generator. Therefor the sound attenuating means can completely attenuate the sound generated by the noise generator such that it is not auditable within the limits of the human hearing, additionally or alternatively, the sound can be attenuated completely, or attenuated in at least one of the sound characteristics, therefor creating a new sound signature.

The term “noise” interchangeably refers herein to any unwanted sound defined in terms of frequency spectrum (in Hz), intensity (in dB), and time duration. Noise can be steady-state, intermittent, impulsive, or explosive. Transient hearing loss may occur following exposure to loud noise, resulting in a temporary threshold shift (i.e., a shift in the audible threshold). This term further includes harmonious and/or non-harmonious sounds, intended and/or unintended such as: a melody, tapping, banging, chirping, squeaking, blast, buzz, cacophony, clamor, commotion, crash, echo, cry, explosion, roar, babel, bang, bellow, blare, boom, caterwauling, clang, clatter, detonation, din, discord, disquiet, disquietude, drumming, eruption, jangle, lamentation, outcry, pandemonium, peal, racket, knocking, shot, shouting, squawk, stridency, thud, uproar, yell, music, or any combination thereof including a single or plurality of each.

Noise tends to be enhanced by decreases in section thickness, field of view, repetition time, and echo time Furthermore, noise characteristics have a spatial dependence. For example, noise levels can vary by as much as 10 dB as a function of patient position within a defined space such as the bore of a magnetic resonance system or within an incubator. The presence and size of the patient may also affect the level of acoustic noise. Airborne sound travels through the air and can transmit through a material, assembly or partition. Sound can also pass under doorways, through ventilation, over, under, around, and through obstructions. When sound reaches a room where it is unwanted, it becomes noise. Further noise can be prolonged and multiplied by reverberations and reflections.

Additionally or alternatively the noise can originate from at least one of the following: a medical device operation, a incubator in communication with a motor, noise derived of an attached medical device, life support equipment, a venting mechanism, a thermo regulating system, an air filtering system, a humidifier, rapid alterations of currents within magnetic resonance coils, an external alarm, external speech sounds, closing or opening of the incubator, handling of equipment in the incubator vicinity, and etc.

The term “sound attenuation means” interchangeably refers herein to any means configured for attenuating or muffling general and specific sounds, including noise. These means include: passive sound attenuators, active sound attenuators, and hybrid sound attenuators.

The term “passive sound attenuators” or “passive acoustic attenuators” interchangeably refer herein to such as resonators designed for specific frequencies, sound absorptive materials and linings, insulation padding, sound shields, bass traps, diffusers, sound baffles, resonators, and any combination thereof. Passive sound absorptive materials that are used can be incorporated in connection with the incubator (from within, on top, at least partly enveloping the incubator, along at least a portion of the incubator inner volume and etc.), adjacent to the noise generator, connected to at least one other sound attenuating means such as active sound attenuating means, and any combination thereof, having at least a portion of the sound energy dissipated within the medium itself as sound travels through them. Absorbing materials can be such as porous materials commonly formed of matted or spun fibers. Common porous absorbers allow air to flow into a cellular structure where sound energy is converted to heat. These may include a thick layer of cloth or carpet, spray-applied cellulose, aerated plaster, fibrous mineral wool and glass fiber, open-cell foam, and felted or cast porous ceiling tile. Resonators can also absorb sound, this is created by holes or slots connected to an enclosed volume of trapped air. Further, any acoustic insulation materials can be employed. Thickness plays an important role in sound absorption by porous materials. Other absorbers are panel absorbers. Typically, panel absorbers are non-rigid, non-porous materials which are placed over an airspace that vibrates in a flexural mode in response to sound pressure exerted by adjacent air molecules for example thin wood paneling over framing, lightweight impervious ceilings and floors, glazing and other large surfaces capable of resonating in response to sound.

The term ‘passive attenuation means’ refers also to a passive pad-like acoustic sealing, configured to insulate the inner environment from its surrounding environment; to a passive acoustic diffuser; to passive absorptive acoustical surfaces (such as acoustic foams, rags etc), configured to reduce the acoustic noise by absorbing the sound energy, when sound waves collide with the same (as opposed to reflecting the energy); where part of the absorbed energy is transformed into heat and part is transmitted and to combination thereof.

It is further well in the scope of the invention wherein the term ‘passive attenuation means’ also refers to means and methods for:

(a) Sound insulation: prevent the transmission of noise by the introduction of a mass barrier such as brick, thick glass, concrete, metal etc;
(b) Sound absorption: a porous material which acts as a ‘noise sponge’ by converting the sound energy into heat within the material; such as decoupled lead-based tiles, open cell foams and fiberglass;
(c) Vibration damping: applicable for large vibrating surfaces. The damping mechanism works by extracting the vibration energy from the thin sheet and dissipating it as heat; such as sound deadened steel; and
(d) Vibration isolation: prevents transmission of vibration energy from a source to a receiver by introducing a flexible element or a physical break; such as springs, rubber mounts, cork etc.

The term “Acoustic insulation material” or “sound insulation padding” interchangeably refers herein to any material with the ability to absorb sound, act as a barrier of sound, or both. This can refer in a non-limiting manner to materials such as: cork, wool, cotton, Eel grass, fiber glass, glass wool, wood, paper, Cobalt Quilt, sugarcane, hydrated Calcium sulphate, POP, Coir, plastic, PVC, perforated metal, Mineral fiber board, or Micore, Thermocole, Polyurethane, Jute, Mylar film, melamine, rubber, rock wool, cellulose, polystyrene, polyethylene, polyester, metal any of these materials when recycled, and etc. Further the acoustic material can be in one or more forms such as a sheet, fabric, tile, blanket, foam, rug, carpet, drape, curtain, panel, board, any casted shape, rod, block, beads, straw like, gravel like particles, Fabric can be wrapped around substrates to create what is referred to as a “pre-fabricated panel”, and any combination thereof. Additionally or alternatively, the insulation material can be at least partially constructed from Composite foams, these are acoustical foams that are made by layering different facings or foams together to create enhanced performance for specific application types. Composite foams can meet more than one acoustical requirements at the same time such as providing both sound blocking and sound absorbing capabilities. These can be open or closed cell foams. Additionally or alternatively all the aforementioned materials can be at least partly porous. Additionally or alternatively, all the aforementioned materials can be combined with fire resistant materials.

The term “resonators” interchangeably refers herein to a structure configured to typically act to absorb sound in a narrow frequency range. Resonators include some perforated materials and materials that have openings (holes and slots). Such as a Helmholtz resonator, which has the shape of a bottle. The resonant frequency is governed by the size of the opening, the length of the neck and the volume of air trapped in the chamber. Typically, perforated materials only absorb the mid-frequency range unless special care is taken in designing the facing to be as acoustically transparent as possible.

The term “Bass Traps” interchangeably refers herein to acoustic energy absorbers which are designed to damp low frequency sound energy with the goal of attaining a flatter low frequency (LF) room response by reducing LF resonances in rooms. Similar to other acoustically absorptive devices, they function by turning sound energy into heat through friction. There are generally two types of bass traps: resonating absorbers and porous absorbers. By their nature resonating absorbers tend toward narrow band action [absorb only a narrow range of sound frequencies] and porous absorbers tend toward broadband action [absorbing sound all the way across the audible band—low, mid, and high frequencies], though both types can be altered to be either more narrow, or more broad in their absorptive action. Examples of resonating type bass traps include Helmholtz resonators, and devices based on diaphragmic elements or membranes which are free to vibrate in sympathy with the room's air when sound occurs. Resonating type bass traps achieve absorption of sound by sympathetic vibration of some free element of the device with the air volume of the room. Such free elements in a resonating device can come in many forms such as the air volume captured inside a Helmholtz resonator—or a thin wooden panel held only by its edges [a style of diaphragmic absorber]. Resonating absorbers can be made from just about any material that can either form a stiff walled vessel [a glass bottle for example] or any membrane stiff enough to be susceptible to being induced to vibrations by impinging sound.

It is in the scope of the invention wherein the term “diffusion” refers to the efficacy by which sound energy is spread evenly in a given environment. A perfectly diffusive sound space is, as defined in Wikipedia, one that has certain key acoustic properties which are the same anywhere in the space. A non-diffuse sound space would have considerably different reverberation time as the listener moved around the room. Virtually all spaces are non-diffuse. Spaces which are highly non-diffuse are ones where the acoustic absorption is unevenly distributed around the space, or where two different acoustic volumes are coupled. The diffusiveness of a sound field can be measured by taking reverberation time measurements at a large number of points in the room, then taking the standard deviation on these decay times. Alternately, the spatial distribution of the sound can be examined. Small sound spaces generally have very poor diffusion characteristics at low frequencies due to room modes.

Still in the scope of the invention, “diffusors”, and “diffusers” are interchangeably used herein to define means to treat sound aberrations within a medical device, such as echoes. As depicted in Wikidepia, diffusers are an excellent alternative or complement to sound absorption because they do not remove sound energy, but can be used to effectively reduce distinct echoes and reflections while still leaving a live sounding space. Compared to a reflective surface, which will cause most of the energy to be reflected off at an angle equal to the angle of incidence, a diffusor will cause the sound energy to be radiated in many directions, hence leading to a more diffusive acoustic space. It is also important that a diffusor spreads reflections in time as well as spatially. Diffusors can aid sound diffusion, but this is not why they are used in many cases; they are more often used to remove coloration and echoes. The term ‘diffusers’ also relates to MLS Diffusors, 1000 Hz Quadratic-Residue Diffusor, Primitive-Root Diffusors, Optimized Diffusors, Two Dimensional (“Hemispherical”) Diffusors etc.

The term “sound baffle” interchangeably refers herein to a construction or device which reduces the strength (level) of airborne sound, as measured in dB (decibels). Sound baffles are a fundamental tool of noise mitigation, for the practice of minimizing noise or reverberation. An important type of sound baffle is a noise barrier/sound shield. Sound baffles are also applied to walls and ceilings in building interiors to absorb sound energy and thus lessen reverberation. These include, as non-limiting examples, wave baffles, fabric coated baffles, curtain baffles, panel baffles and etc.

The term “active sound attenuator” or “active sound controlling devices” interchangeably refer herein to any device or mechanism that involves the investment of energy in order to attenuate sound. As a non-limiting example, Active noise control (ANC), also known as noise cancellation, or active noise reduction (ANR), is a method for reducing unwanted sound by the addition of a second sound specifically designed to cancel the first. For example a device that creates destructive interferences using a secondary source of noise such as using actuator loudspeakers. As depicted in Wikipedia, since sound is a pressure wave, which consists of a compression phase and a rarefaction phase, it can be effected by another wave. A noise-cancellation speaker emits a sound wave with the same amplitude but with inverted phase (also known as antiphase) to the original sound. The waves combine to form a new wave, in a process called interference, and effectively cancel each other out—an effect which is called phase cancellation. Some active sound controlling devices use active feedback mechanisms utilizing information received from sound sensors in various locations, and respond to the specific frequency and sound level received. An active sound control mechanism can be efficiently employed in a system whose generated sound characteristics such as amplitude, frequency, speed, sound levels, and etc., can be calculated. Another mean of active sound attenuation can be a sound masking system. Other means for active noise control involve the use of analog circuits or digital signal processing. Adaptive algorithms are designed to analyze the waveform of the background aural or nonaural noise, then based on the specific algorithm generate a signal that will either phase shift or invert the polarity of the original signal. This inverted signal (in antiphase) is then amplified and a transducer creates a sound wave directly proportional to the amplitude of the original waveform, creating destructive interference. This effectively reduces the volume of the perceivable noise.

According to another embodiment of the invention the sound attenuation module comprises at least one noise-cancellation speaker. Additionally or alternatively, the speaker comprises at least one of the following features: (a) the noise cancelling speaker or the sound masking speaker is co-located with the sound source to be attenuated; (b) the noise cancelling speaker or the sound masking speaker is configured to emit about the same audio power level as the source of noise.

According to another embodiment of the invention the sound attenuating module comprises at least one transducer configured to emit a cancellation signal. Additionally or alternatively, at least one transducer is located adjacent to the noise source, at the inner environment of the incubator, near the neonates head, or in any combination thereof. Alternatively, at least one transducer is located where sound attenuation is wanted.

According to another embodiment of the invention the sound attenuating module comprises a plurality of signal generating speakers configured to effectively cancel or reduce sound, and a plurality of sound sensors providing feedback at of the sound characteristics of a plurality of locations in a defined space; further wherein the plurality of speaker and sensors is in communication with a CPU, a CRM or both configured to reactively control the sound reduction or cancellation according to predefined parameters and feedback received by the sensors. This is especially beneficial as the three-dimensional wave fronts of the unwanted sound and the cancellation signal could match and create alternating zones of constructive and destructive interference, reducing noise in some spots while doubling noise in others. Further unexpected sound reflections and reverberations can alter sound cancellation or reduction, emphasizing the need for a feedback mechanism. Additionally or alternatively, the sound attenuation module further comprises passive sound attenuation means configured to operate together with active sound attenuators to achieve the sound attenuation desired.

The term “sound masking” interchangeably refers herein to the addition of natural or artificial sound (such as white noise or pink noise) into an environment to cover up unwanted sound by using auditory masking. As depicted in Wikipedia, this is in contrast to the technique of active noise control. Sound masking reduces or eliminates awareness of pre-existing sounds in a given area and can make a work environment more comfortable, while creating speech privacy so workers can better concentrate and be more productive. Sound masking can also be used in the outdoors to restore a more natural ambient environment. Sound masking is a similar process of covering a distracting sound with a more soothing or less intrusive sound. The masking must reduce the difference between the steady background level and the transient levels associated with both speech and other sounds. Motivation and productivity are improved when this is accomplished. The masking sound itself must not change rapidly and should be as meaningless as possible. As a non-limiting example, masking can be obtained by the generation of an acoustic noise signal such as: white noise, pink noise, blue noise, gray noise, brownian noise, violet noise, a repetitive noise derived in nature (such as the sound of waves), music, speech, and any combination thereof. Additionally or alternatively, the noise signal can be repeated over a predefined amount of time or be administered intermittently, continuously, or in any pattern or combination of the different kinds.

The term “hybrid sound attenuation means” interchangeably refer herein to means or systems that employ both active and passive elements to achieve sound reduction, and adaptive-passive systems that use passive devices whose parameters can be varied in order to achieve optimal noise attenuation over a band of operating frequencies, such as a tunable Helmholtz resonator. As a non-limiting example, disclosed in the art is “Air transparent soundproof window”, arXiv: 1307.0301 [cond-mat.mtrl-sci]arxiv.org/abs/1307.0301, http://phys.org/news/2013-07-materials-scientists-window-mutes-air.html#jCp describing a screen that although passable to air, lowers the sound transmitted by up to 35 dB, by designing specific chambers and holes configured to capture and attenuate sound, consisting of a three-dimensional array of diffraction-type resonators with many holes centered at each individual resonator. Further, the researchers note that changing the size of the hole allows for muting different frequencies.

It is further within the scope of the invention an incubator, comprising an envelope fitting for housing a neonate, comprising at least one air flow opening, the opening comprising at least one resonator configured to attenuate sound. Additionally or alternatively, the envelope comprises volume having height represented by h, and is measured preferably in millimeters. The value of h can be constant or variable throughout the medical device. In at least a portion of this volume resonators and attenuators can be implemented. Further this volume can be filled with sound absorptive material situated around the perforations.

The term “sound shield” refers herein after to any sound barriers or sound reflection panel, sound absorbing panel, screens, baffle, or any combination thereof, single or a plurality of, configured to lowering the sound reaching the patient.

The term “reverberation” interchangeably refers herein to a prolongation of the sound in the room caused by continued multiple reflections is called reverberation. This can happen in an at least partially enclosed space during the time it takes a sound to become inaudible and stop emitting energy. When room surfaces are highly reflective, sound continues to reflect or reverberate. The effect of this condition is described as a live space with a long reverberation time. A high reverberation time will cause a build-up of the noise level in a space.

The term “reflection” interchangeably refers herein to a phenomenon that sound reflects back from at least one surface or object before reaching the receiver. These reflections can have unwanted or even disastrous consequences. Reflective corners or peaked ceilings can create a “megaphone” effect potentially causing annoying reflections and loud spaces. Reflective parallel surfaces lend themselves to a unique acoustical problem called standing waves, creating a “fluttering” of sound between the two surfaces. The standing waves can produce natural resonances that can be heard as a pleasant sensation or an annoying one. Reflections can be attributed to the shape of the space as well as the material on the surfaces. Domes and concave surfaces cause reflections to be focused rather than dispersed which can cause annoying sound reflections. Absorptive surface treatments can help to eliminate both reverberation and reflection problems.

The term “NRC” or “Noise Reduction Coefficient” interchangeably refers herein to a characteristic of a material/product presenting the average absorption across four octave band center frequencies. (250 Hz, 500 Hz, 1000 Hz, 2000 Hz.). It can be roughly estimate that a product with an NRC 0.75 will absorb about 75% of the sound energy that hits it. The highest level is NRC 1.0. Substantially this is the average of the mid frequency absorption rate, rounded to the near 5%, and does not include the high and low frequencies.

The term “STC” or “Sound Transmission Class” interchangeably refers herein to a number rating of the transmission loss properties of a material and/or product. It is a single-number rating of a material's or an assembly's ability to resist airborne sound transfer at the frequencies 125-4000 Hz. Substantially, this refers to a material's barrier ability qualities. In general, a material/product with higher STC rating blocks more noise from transmitting through a partition. STC is highly dependent on the construction of the partition. A partition's STC can be increased by: adding mass, increasing or adding air space, adding absorptive material within the partition, and likewise. A partition is given an STC rating by measuring its Transmission Loss over a range of 16 different frequencies between 125-4000 Hz. The STC rating does not assess the low frequency sound transfer. Doors, windows, walls, floors, etc. are tested to determine how much noise passes through.

The term “about” interchangeably refers herein to a divergence of up to plus or minus 20% around a given value.

The term “patient placement” interchangeably refers herein to any location within the inner volume of the medical device configured to accept a patient, e.g. neonate. Additionally or alternatively, this location can comprise a bed, a restraint, a mattress, concave shape, pillow, ergonomic shape, belts, straps, flat surface, at least partially flexible surface, a disposable portion, a sterilizable portion, confinement means, and any combination thereof.

The term “fluid communication” refers hereinafter to a communication between two objects that allow flow of matter (gas, fluid or solid) at least one direction between them.

The term “venting module” refers hereinafter to a module that circulates air and distributes it either evenly or in a defined direction. More specifically the term relates to a fan, a jet, a blower, a compressor, a pump, air streamer, propeller, ventilator, thermantidote, axial-flow fans, centrifugal fan, cross-flow fan, airflow generated using the Coand{hacek over (a)} effect, etc.

The term “neonate” interchangeably refers herein after to: patient, newborn, baby, infant, toddler, child, adolescent, adult, elderly, patient, individual, subject, inmate, sufferer, outpatient, case, client, etc.; further this term refers to person, animal, or sample, as a whole, or a portion thereof.

The term “neonate disturbance parameter” interchangeably refers herein to any parameter known in the art as signifying a neonate unfavorable reaction. As a -limiting example, this can be an acceleration or deceleration of the neonate heart rate (as depicted in Willlams et. al, 2009, and in Schulman et al. 1969) a rise in blood pressure (as depicted in Jurkovicova and Aghova et al, 1989), a change in the breathing pattern, (as depicted in Wharrad and Davis et al, 1997, and Long et al, 1980), or different oxygen saturation (as depicted in Zahr and Balian et al, 1995); excess movement or a reduction in the movement of the neonate in reference to a normal average, a change in brain patterns, crying more than a normal average, an interruption or change in sleeping patterns or eating patterns, and etc. Additionally or alternatively, the Anderson Behavioral Scale can be used to assess behavioral and sleep states as depicted in Anderson et al, 1990, further techniques like magnetic imaging, EEG, as depicted in Huotilainnen et al 2003, Cheour et al, 1998, 2002), have been shown to be reliable measurements for the reaction of neonates.

The term “transparent material” interchangeably refers hereinafter to materials such as, poly-methyl methacrylate, thermoplastic polyurethane, polyethylene, polyethylene terephthalate, isophthalic acid modified polyethylene terephthalate, glycol modified polyethylene terephthalate, polypropylene, polystyrene, acrylic, polyacetate, cellulose acetate, polycarbonate, nylon, glass, polyvinyl chloride, etc. Further in some embodiments at least a portion of this material is imbedded with non-transparent materials for means of strength and/or conductivity such as metallic wires.

The term “sensor” interchangeably refers hereinafter to any device that receives a signal or stimulus (heat, pressure, light, motion, sound, humidity etc.) and responds to it in a distinctive manner. This manner can be such as inducing the action/inaction of other devices, inducing the action/inaction of indicators (visual, auditable or sensible), inducing the display of the input received by the sensor, inducing the data storage/analysis of input in a central processing unit, etc.

The term “life supporting equipment” interchangeably refers hereinafter to any element that provides an environmental condition, a medical condition or monitoring of an environmental or medical condition thereof that assists in sustaining the life of a neonate and/or bettering their physical and physiological wellbeing. This element can be: (a) any medical equipment: all devices, tubes, connectors, wires, liquid carriers, needles, sensors, monitors, etc., that are used by medical personal in association with the patient. This equipment is such as bilirubin light, an IV (intravenous) pump, oxygen supplementation systems by head hood or nasal cannula, continuous positive airway pressure system, a feeding tube, an umbilical artery catheter, a fluid transport device, hemofiltration system, hemodialysis system, MRI contras solution injection, imaging the neonate etc.; (b) medical measurement and observation systems (including sensors and/or monitors) of temperature, respiration, cardiac function, oxygenation, brain activity such as ECG (electrocardiography) monitor, blood pressure monitor, cardio-respiratory monitor, pulse oximeter; and (c) environmental control systems such as ventilator, air conditioner, humidifier, temperature regulator, climate control systems, noise muffling device, vibration muffling device, etc. and any combination thereof.

The term “medical equipment tubing” interchangeably refers hereinafter to all tubes, cables, connectors, wires, liquid carriers, gas carriers, electrical wires, monitoring cables, viewing cables, data cables, etc., that is used in connection to life support equipment, medical equipment or physical environment maintenance or monitoring.

The term “life parameters” interchangeably refers herein to any measurable value or parameter of the neonate that can be used as an indicator of life or/and well-being. This parameter can be detected from afar by a viewing system, monitoring system, ultrasound technology, medical equipment, camera from afar, or by physically touching the neonate by a connected sensor. This parameter is such as temperature, cardiovascular activity (heart rate, blood pressure, breathing rate, and etc.), blood oxygenation, movement, brain activity, and etc.

The term “CPU”, central processing unit, interchangeably refers hereinafter to the hardware within a computer that carries out the instructions of a computer program by performing the basic arithmetical, logical, and input/output operations of the system. In the embodiments of the invention the CPU can be connected to: at least one CRM, a user interface, at least one sensor, at least one indicator, at least one venting module, at least one temperature regulating vent, at least one air filter, at least one sound filter, at least one humidifier, at least one air circulating mechanism, life supporting equipment, a control panel, a monitoring device, a viewing or filming device, and etc., at last one engine configured to convert electrical power into movement of such as a vent, a baffle, a recline-able neonate restraint means, sealing of at least one opening in the incubator, or and etc., thus providing the user monitoring and/or control over various aspects of the invention.

The term “Computer readable media”, (CRM), interchangeably refers hereinafter to, a medium capable of storing data in a format readable by a mechanical device (automated data medium rather than human readable). Examples of machine-readable media include magnetic media such as magnetic disks, cards, tapes, and drums, punched cards and paper tapes, optical disks, barcodes and magnetic ink characters. Common machine-readable technologies include magnetic recording, processing waveforms, and barcodes. Any information retrievable by any form of energy can be machine-readable.

The term “plurality” interchangeably refers herein to one and/or more than one.

According to one embodiment of the invention a noise-attenuating neonate incubator (NANI) comprising sound attenuating module (SAM) configured to decrease AmpR_tito AmpR_QVΔtor less. The NANI can comprise one or more SAM. Each SAM can hold one or more sound attenuators, the sound attenuators can attenuate sound or at least change the sound signature by passive sound attenuating means such as: insulation padding, sound shield, sound baffle, sound diffuser, sound absorber, bass trap, resonator and etc. The passive sound attenuation means can also appear at least partially in the form of a layered construction. Another option for the SAM is to comprise active and passive sound attenuators utilizing active or passive attenuating means. Another option is only active attenuating means.

According to another embodiment of the invention, a noise-attenuating neonate incubator (NANI) comprising sound attenuating module (SAM) configured to decrease the sound amplitude ratio at time, (AmpRat_ti) to a critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) or less, wherein the sound attenuating module (SAM) comprises: (a) at least one sound sensor in communication with the CRM, configured for continuously sampling the sound amplitude ratio at time t_i(AmpRat_ti) within the incubator; (b) at least one CRM for storing the critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) and, the sound amplitude ratio at time, t_i, (AmpRat_ti); and, (c) at least one sound attenuator in communication with the CRM for decreasing the sound amplitude ratio at time, t_i, (AmpRat_ti), if AmpRat_ti>AmpR_QVΔt, such that AmpRat_ti<AmpRat_QVΔt; wherein the critical amplitude ratio value of the sound measured over a predetermined time, Δt, AmpRat_QVΔt<about 178.8_Δt.

It is known in the art that amplitude ratio of 178.8 is equivalent to about 45 dB.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM is configured to decrease AmpR_tito AmpR_QVΔtor less.

Additionally or alternatively, any sound characteristic is measured and/or stored by the CRM such as: sound levels, tone, overtone composition, reverberations, sound frequency, sound wavelength, sound wave amplitude, sound wave speed, sound wave direction, sound wave energy, sound wave phase, sound wave shape, sound wave envelope, sound timbre, and etc. Additionally or alternatively, the CRM is configured to differentiate background noise from a specific predefined noise, and attenuate only the desired noise.

According to another embodiment of the invention the SAM is configured to attenuate any sound level over a selected from a group consisting of 45 dB, 50 dB, 60 dB, and any combination thereof.

According to another embodiment of the invention, the SAM is configured to attenuate any sound level over a selected from a group consisting of: 100_ΔtAmpR, 178.8 AmpR_Δt, 316.2 AmpR_Δt, 1000 AmpR_Δt, or any combination thereof.

According to another embodiment of the invention, the SAM is configured to modify the sound within the incubator such that it is of at least one different sound characteristic selected from a group consisting of: sound levels, tone, overtone composition, reverberations, sound frequency, sound wavelength, sound wave amplitude, sound wave speed, sound wave direction, sound wave energy, sound wave phase, sound wave shape, sound wave envelope, sound timbre, and any combination thereof.

According to another embodiment of the invention the SAM is configured to attenuate any sound level over a predefined level, that lasts for over 50 microseconds, over 1 millisecond, over 0.1 second, over 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 10 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds, 2 minutes, 3 minutes, 4 minutes, 5 minutes, above 5 minutes, and any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the sensor is further in communication with a selected from a group consisting of: at least one indicator, at least one user interface, at least one alarm system, at least one CPU, and any combination thereof. Additionally or alternatively the CPU in connection with the CRM can be configured to generate a status report to describing the sound within the incubator, or the physical state of the system. Further the CPU can be configured to trigger an alarm system according to preset parameters of sound sensed by at least one sensor. In an embodiment the CRM can be remotely controlled by a cellular phone, a remote computer, a remote control, and etc.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the CRM is configured to control the sound attenuator according to a selected from a group consisting of: parameters received by means of at least one sensor, parameters inputted through a user interface, parameters received from neonate medical equipment, and any combination thereof. Additionally or alternatively, the CRM is able to control the output of the sound attenuator according to specific sound levels and sound frequencies.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the CRM is configured to differentiate the sound attenuation of predefined hours. As an example, the sound attenuation can be of different sound signature during the night and day, during feeding hours, during physical examination and etc.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the CRM is configured to record and store a history of sound and the reaction of the neonate. Additionally or alternatively, the CRM is configured to attenuate at least one sound characteristic correlated with the most neonate disturbances.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the sound attenuator comprises an active sound masking system, configured to emit at least one acoustical sound signal, by means of at least one acoustical sound-speaker. According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least one acoustical sound signal is selected from a group consisting of: white noise, pink noise, grey noise, brownian noise, blue noise, violet noise, and any combination thereof. According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the sound attenuator comprises a reactive acoustical device, configured to cancel the noise by means of a destructive interference generator.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM is configured to attenuate the noise by a selected from a group consisting of: reduce the sound levels, reduce sound reflections, reduce sound reverberation, create sound diffusion, mask sound, cancel sound, change the sound signature, and any combination thereof. According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM is configured to change at least one sound characteristic selected from a group consisting of: sound levels, tone, overtone composition, reverberations, sound frequency, sound wavelength, sound wave amplitude, sound wave speed, sound wave direction, sound wave energy, sound wave phase, sound wave shape, sound wave envelope, sound timbre, thereby generating a different sound signature.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the sound signature is selected from a group consisting of: configurable by the user, predefined, automatically adjustable in reference to the neonate's life parameters, and any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM comprising at least one means selected from group consisting of: active sound attenuating means, passive sound attenuating means, hybrid sound attenuating means, and any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least one passive sound attenuating means is selected from a group consisting of: at least one sound absorptive material, at least one resonator, at least one sound shield, at least one bass trap, at least one sound baffle, at least one diffuser, at least one insulation padding, at least one sound reflector, at least one sound muffler (SM), and any combination thereof. According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM comprises at least one sound shield comprising at least a portion of a material selected from a group consisting of: at least one insulating material, at least one sealing material, at least one sound absorbent material, at least one vibration absorbing material, and any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM comprises at least one insulation padding configured to insulate the neonate placement within the NANI; further wherein the insulation comprises at least one opening configured to permit access to within the NANI.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least a portion of the insulation comprises a material selected from a group consisting of: thermo insulating material, sealing material, foam material, fire retardant materials, at least partially transparent material and any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least a portion of the insulation comprises means for shielding at least a portion of the incubator from a selected from a group consisting of: magnetism, electromagnetic interference, physical damage and any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least a portion of the insulation comprises at least one conduit having at least one first aperture into the incubator and at least one aperture to the external environment, fitted for the passage of tubing within; further wherein the conduit is configured to attenuate the passage of frequencies selected from a group consisting of: 0 to about 1000 MHz, 0 to about 500 MHz, 0 to about 200 MHz and any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM is a modular component reversibly attachable to the incubator.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM comprises at least one sound reflector configured to direct the noise to a selected from a group consisting of: at least one absorptive surface, at least one sound diffuser, at least one sound baffle, at least one reflective surface, at least one resonator, at least one sound shield, a location directed away from the neonate, and any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the incubator further comprises at least one conduit having at least one SAM configured to muffle the sound passing through the conduit.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM, the incubator, or both are made of MRI safe materials.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the incubator further comprises at least one sensor selected from a group consisting of: sound level sensor, sound frequency sensor, sound direction sensor, sound amplitude sensor, sound tone sensor, sound speed sensor, sensor configured to sense life parameters of the neonate, and any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM is configured to reduce reverberation of sound, reflections of sound, or both within the inner volume, by means of at least one selected from a group consisting of; absorptive material, a sound baffle, a sound diffuser, an active sound cancellation device and any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the incubator further comprises at least one air inlet, air outlet, or both, configured for the entry and/or exit of air; further wherein at least one air inlet, outlet, or both further comprises at least one SAM.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the incubator is at least temporarily accommodated in a cart comprising at least one SAM.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM comprises hybrid sound attenuating means comprising active and passive sound attenuating means combined in at least one sound attenuator.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the sound attenuating means is configured to reduce reverberation of sound, reflections of sound, or both within the inner volume, by means of at least one selected from a group consisting of; absorptive material, a sound baffle, a sound diffuser, an active sound cancellation device and any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the sound attenuating means are placed within the incubator, outside the incubator, on top the incubator, remotely from the patient, adjacent to the patient, aside the incubator, remote from the incubator, and in any combination thereof.

According to one embodiment of the invention, MLS Diffusors are used. Maximum length sequence based diffusors are made of strips of material with two different depths. The placement of these strips follows an MLS. The width of the strips is smaller than or equal to half the wavelength of the frequency where the maximum scattering effect is desired. In ideal situations small vertical walls should be placed between lower stripes, improving the scattering effect in the case of tangential sound incidence. The bandwidth of these devices is rather limited, one octave above the design frequency they behave like a flat surface.

According to another embodiment of the invention, Quadratic-Residue Diffusors are used. According to another embodiment of the invention, 1000 Hz Quadratic-Residue Diffusors are used. MLS based diffusors are superior to geometrical diffusors in many respects; they have limited bandwidth. The new goal was to find a new surface geometry that would combine the excellent diffusion characteristics of MLS designs with wider bandwidth. Quadratic-Residue Diffusors can be designed to diffuse sound in either one or two directions.

According to another embodiment of the invention, Primitive-Root Diffusors are used. They are based on a number theoretic sequence. Although they produce a notch in the scattering response, in reality the notch is over too narrow a bandwidth to be useful. In terms of performance, they are very similar to Quadratic-Residue Diffusors.

According to another embodiment of the invention, Optimized Diffusors are used. By using numerical optimization, it is possible to increase the number of theoretical designs, especially for diffusors with a small number of wells per period. But the big advantage of optimization is that arbitrary shapes can be used which can blend better with architectural forms.

According to another embodiment of the invention, Two Dimensional (“Hemispherical”) Diffusors are used. Those are designed, like most diffusors, to create “a big sound in a small room,” unlike other diffusors, two dimensional diffusors scatter sound in a hemispherical pattern. This is done by the creation of a grid, whose cavities have wells of varying depth, according to the matrix addition of two quadratic sequences equal or proportionate to those of a regular diffusor. These diffusors are very helpful for controlling the direction of the diffusion, particularly in studios and control rooms.

Reference is now made to FIG. 1, illustrating in a non-limiting, out of scale schematic manner a neonate (1) residing within an incubator (100). The neonate is subject to sounds/noise originating from the outside (10) or from within (11). The neonate is also subject to reverberations and reflective of sound (12) within the incubator. These sounds can cause distress or even harm the neonate (1).

Reference is now made to FIG. 2a-e, illustrating in a non-limiting, out of scale schematic manner an incubator (100) configured to be accommodated by a neonate (1), the incubator comprising at least one SAM, sound attenuating module, (150). The sound attenuating module can be passive, active or a combination thereof. In FIG. 2a the SAM (150) is connected to the ceiling of the incubator (100) from within, and can be a passive sound attenuating means such as a baffle, a diffuser, a resonator; or active as a reactive, predefined or both. FIG. 2b shows more than one SAM (150a, 150b) in connection with the incubator (100) housing at least temporarily the neonate (1). 150a is a suspended along the inner wall of the incubator, and can cover at least apportion of the incubator inner wall. 150b is an embodiment of the sound attenuating module placed ontop the incubator (100). FIG. 2c shows a SAM (150a) in a configuration having at least a portion thereof outside the incubator (100), and at least a portion thereof within the incubator (100). Another embodiment is a SAM embedded within the incubator wall and at least partially accessible from outside the incubator (100). FIG. 2d shows another embodiment where the SAM (150) is embedded at least in part within the incubator wall and accessible at least partially through the incubator front face. FIG. 2e describes yet another embodiment where the noise muffling/sound attenuating device/SAM is located in a remote location without physical connection with the incubator. This embodiment is possible utilizing active sound attenuation means, comprising at least one transducer configured to generate a disruptive signal to the sound, a masking system configured to provide sound parallel to the noise such as white, pink, grey, brownian, blue violet noise. The attenuating mask in an embodiment be a melody, music, or any sound generated for this purpose.

Reference is now made to FIG. 3a-d, illustrating in a non-limiting, out of scale schematic manner different embodiments of the invention, shown in a section viewed from the incubator face (FIG. 2e 44), along the ‘A’ dashed line (FIG. 2e). FIG. 3a shows an incubator (100) with passive sound attenuating means (110) comprising at least a portion of insulation padding, and an active sound attenuation module (150). The incubator further harbors at least one diffuser (170) allowing the diffusion of sound within the incubator. FIG. 3b shows an incubator (100) having at least one SAM (150) and at least one sound generating speaker (155) generating a sound mask. FIG. 3c shows the face of the incubator (100), having insulation padding completely covering and sealing the inner environment of the incubator. Further, the incubator is openable and/or closable by a door (220) attach on such as a hinge (200), pivot point, axis turning point, joint and etc. The door further comprises at least one conduit (300) attenuating the passage of RF frequencies that can disrupt the reading or an imager such as an MRI, or disrupt any electrical mechanisms and circuits while allowing the passage of life support tubing (310) from the external environment to within the incubator (100). FIG. 3d shows an open incubator (100) from the face side (44FIG. 2e), further comprising an insulating layer covering at least a portion of the inner envelope, configured to passively attenuate sound, and fitted to accommodate a neonate. The incubator further comprises at least one resonator (185), and at least one sound shield (180), configured to attenuate sound. The resonator can be a passive or hybrid sound attenuator. In an embodiment the incubator comprises a bass trap or any active or passive means configured to attenuate the low frequency sounds, such as the sounds emitted by an incubator motor (as disclosed in Seleny and Streczyn 1969, that found that the noise emitted by the incubator motor is of maximal energy at 125 Hz).

Reference is made to FIG. 3e schematically illustrating in a non-limiting, out of scale manner an embodiment of the invention. In this embodiment the incubator (100) comprises a plurality of layers (110, 111, 112). Additionally or alternatively, each layer can be of different size, materials and over all sound attenuating quality. According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least a portion of the SAM comprises n layers; further wherein each of the n layers comprising an inner side towards the neonate, and an opposite outer side facing away from the neonate.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein each of the n layers comprising a predefined Noise Reduction Coefficient (NRC) value, Sound Transmission Class (STC) value, or both; further wherein the NRC value, STC value, or both, can be equal or different for the each of one of n layers.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least 2 of the n layers comprising a Noise Reduction Coefficient (NRC) value for each of the n layers; where each of the layers comprising at least one sound level S [dB] measured on the layer outer side, and at least one first sound level S₁[dB], measured on the layer inner side, having a dS₁- . . . dSn, wherein dS of the SAM equals S₁-Sn, and S₁-Sn<S₁.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least 2 of the n layers comprising a Sound transmission class (STC) value for each of the n layers; where each of the layers comprising at least one sound level S [dB] measured on the layer outer side, and at least one first sound level S₁[dB], measured the layer inner side, having a dS₁- . . . dSn, wherein dS of the SAM equals S₁-Sn, and S₁-Sn<S₁.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM further comprising: (a) a space, S₁, between at least one of n layers to the incubator, a space S_nbetween each of the n layers, or both; (b) STC₁(sound transmission class) value, measured for the layers_1-n; and, (c) mobilization means, connected to at least one of the n layers, configured to mobilize at least one of the n layers, having a space S_1a, between at least one of n layers to the incubator, a space S_nabetween each of the n layers, or both, and STC₂value measured for the layers_1-n, where S₁<S_1a, S_n<S_na, or both, and where STC₁<STC₂.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least one of the n layers is reversibly connectable to the incubator, the one of n layers, or both.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least one of n layers comprises at least one passive sound attenuating means configured to a selected from a group consisting of: reduce reverberation, reduce reflection, reduce sound levels, or any combination thereof, of the sound within the inner environment generated by the sound generator.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least one layer comprises at least a portion of a selected from a group consisting of: an electrical isolating material, electrically conductive material configured to closes conductive circle, disposable material, at least partially transparent material, fire resisting material, MRI safe material, sterilizable material, and any combination thereof.

Reference is made to FIG. 3f schematically illustrating in a non-limiting, out of scale manner an embodiment of the invention. In this embodiment, various layer types are shown (115, 116). These layers can be of porous material, solid material, flexible vibration absorbing material, fire resistive material, and etc. The layers each cover at least a portion of the incubator inner walls.

Reference is now made to FIG. 4a-d, schematically illustrating in a non-limiting, out of scale manner, different embodiments of an active SAM. FIG. 4a shows a neonate (l), accommodated within an incubator (100). The incubator (100) comprises at least one sound attenuating module (150) comprising at least one sound sensor (160), and at least one transducer (168) configured to emit a destructive signal configured to cancel or at least reduce the sound reaching the neonate's (l) ears. The SAM further comprises at least one CRM in communication with at least one sensor and at least one transducer. Additionally or alternatively, the SAM (150) is in wired or wireless communication with an acoustic sound speaker (152) in a different location than the 168, (e.g. on the ceiling, the wall, the floor, of the inner environment of the incubator) configured to generate sound for masking the noise within the incubator. Additionally or alternatively, the SAM is further connected to at least one another transducer (151) that together with the first one (168) is configured to destruct a sound effects from the three dimensional qualities of the noise colliding with the destructive signal. Additionally or alternatively, the SAM is connected to at least one power source such as electrical line, a battery, a generator, and etc. FIG. 4b shows a SAM (150) comprising a CRM (162), at least one speaker, and at least one sensor (160) on a reversibly connectable panel. Further the incubator (100) comprises at least one passive sound attenuating means such as insulation or sealing material. FIG. 4c illustrates an embodiment of a CRM (162) comprising a processor (164). The CRM (162) is in communication with a plurality of sensors (160) dispersed in various location within the incubator (100), and at least one sound attenuator (152) configured to attenuate the sound sensed by the sound sensors (160) and predefined by the user as disruptive. This embodiment represents a reactive sound attenuation means that refers directly to the specific noise reaching the inner enclosure of the incubator (100). In an embodiment, the CRM is configured to differentiate the background sound from specific sound disturbing for neonates and attenuate only the disturbing sound by generating a specific destructive signal. FIG. 4d illustrates at least one SAM (150) comprising at least one sound attenuating means (152). Additionally or alternatively, the incubator further comprises at least one sensor such as a sound sensor, a sensor sensing the neonate life parameters, and/or a viewing device. Additionally or alternatively, the SAM further comprises a user interface (comprising a screen, keys, buttons, scroll, mouse, and such) configured to allow programming of the SAM via the CRM.

Reference is now made to FIG. 5, illustrating in a non-limiting, out of scale schematic manner an medical device that can be embodied as an incubator (100), an imaging device, a treatment device and as such, having an inner portion (2) where patient is imagined. In this medical device with a noise muffling mechanism, passive and active means are provided to reduce as a non limiting example the MRI-noise (gradient noise), and outside noise (hospital noise). A passive pad-like acoustic sealing (10) is affixed to MRI's opening, configured to insulate the inner environment from its surrounding environment. A further a passive absorptive acoustical surface (11) is located in the inner environment. Moreover, an active acoustical sound-speaker, located adjacent to the patient (12a) and adjacent to MRI's gradient-oriented noise generator (12b). The sound speakers emit white acoustical noise such the noise is filtered and masked. Additionally or alternatively, one or more a reactive acoustical device (can be presented by 12a and/or 12b), are configured to cancel MRI's surrounding acoustical noise by destructive interference. Additionally or alternatively, an air ventilating mechanism (14) is configured to facilitated the effective air flow (2) through (3) the MRI away from the patients ears such that acoustical noise is deflected away form the patients ears of the device.

Reference is now made to FIG. 6, similarly illustrating in a non-limiting, out of scale schematic manner an infant's incubator (200) comprising a passive absorptive acoustical surface (11) is located in the inner environment. Additionally or alternatively, an active acoustical sound-speaker/a reactive acoustical device located adjacent to the patient (101). Additionally or alternatively, an air ventilating mechanism (14) comprising a fan (heater and humidifier as an option) is configured to facilitated the effective air flow (2) through in incubator away from the patient such that acoustical noise is deflected away from the patient of the device. The sound generated by the air flow and/or the ventilation system can be attenuated by at least one sound attenuating module (12) comprising active sound attenuating means. Additionally or alternatively, the ventilating system is located at the column (201) supporting the upper tray of the cart comprising the incubator, in this embodiment additional sound attenuating mechanisms are added adjacent to the vent, and air inlets and outlets.

Reference is now made to FIG. 7a, schematically illustrating in a non-limiting, out of scale manner an embodiment of the invention. A neonate incubator (102) configured by means of size shape and material to accommodate a neonate (1). The incubator includes a ventilating system comprising at least one thermo-regulating vent (14) in fluid communication with the incubator base through at least one sound attenuating module, SAM, configured to change at least one parameter of the sound signature reaching the neonate. The SAM is configured such that it allows air to enter the incubator through ports (190a, 190b) from a compartment (160c) below the incubator floor through air inlets (175).

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the medical device further comprises an air ventilating mechanism, configured to facilitated effective air flow through the medical device away from the patients ears such that the acoustical noise is deflected away from the patients ears.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the ventilating mechanism further comprises at least one air inlet, air outlet, or both, configured for the entry and/or exit of air; further wherein the at least one air inlet, outlet, or both further comprises at least one SAM.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the ventilating mechanism further comprises at least one vent configured to stream air through the at least one air inlet towards the inner environment; further wherein the ventilating mechanism further comprises at least one SAM configured to attenuate noise generated by the vent.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SAM comprising at least one sound muffler (SM) comprising at least one cylindered conduit, having at least one length (l) and at least one width (w); the cylinder comprising at least one air inlet, and at least one air outlet; further wherein the SM is configured such as that sound exiting at least one air outlet is of a different sound signature than sound entering at least one air inlet.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SM comprises at least a first cylinder, and at least a second cylinder, connected therebetween, the connection comprises at least one opening configured to permit a fluid communication therebetween.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein at least one cylinder width (w) is selected from a group consisting of: width (w) is equal along the length (l), is differential along the length (l) or any combination thereof.

According to another embodiment of the invention, a NANI as defined above is disclosed, wherein the SM comprises a plurality of n cylinders, where the length (l)_{1- . . . n}and the width (w)_{1- . . . n}of the each cylinder, are selected from a group consisting of: (l)₁=(l)_n, (l)₁>(l)_n, (l)₁<(l)_n, (l)₁≠(l)_n, (w)₁=(w)_n, (w)₁>(w)_n, (w)₁<(w)_n, (w)₁≠(w)_n, and any combination thereof.

Reference is now made to FIG. 7b, similarly illustrating in a non-limiting, out of scale schematic manner an infant's incubator (103) situated in a cart having at least one mobile base (500) connected by at least one pillar (400). The cart comprises at least one ventilating system situated within the pillar (400) and/or within the cart base (500). The ventilating system comprises at least one vent (14) in fluid communication with at least one sound muffler, SM, (151a, 151b), configured to have at least one air inlet to receive a stream of air from the vent, and at least one air outlet to distribute air to the incubator. The SM is configured to change at least one sound characteristic of the sound generated by the vent and entering the incubator, through a compartment on the bottom of the incubator (160b). Additionally or alternatively, the air leaving the incubator can also pass through at least one SM configured to change the sound signature thereby creating a less noisy environment. Additionally or alternatively, the SM and ventilating system are at least partially made of MRI safe materials.

According to another embodiment of the invention, the incubator is connected to a cart comprising at least one mobile base, interconnected by at least one support pillar; further wherein the cart is configured by means of size and shape to be at least partly inserted into an MRD having an open bore; further wherein the incubator and cart are configured such that the cart effectively shuts the MRD bore when inserted; further wherein at least a portion of the cart and at least a portion of the incubator are made of MRI—safe materials. Additionally or alternatively, all components of the incubator, cart, SAM and/or ventilation system that are inserted into the MRD bore are made of MRI safe materials.

Reference is now made to FIG. 8a, schematically illustrating in a non-limiting, out of scale manner a diagram representing the neonate disturbance parameter as a function of the sound levels over time. The dashed line ‘A’ represents the disturbance of a neonate, according to the Anderson Behavioral Scale, exposed to noise in relatively high levels over time, without a sound attenuation module. It is shown that the disturbance grows over time. When using a reactive sound attenuation module, the neonate disturbance parameter decreases as the system detects the disturbance and generates masking sound and/or a destructive signal effectively lowering the sound levels reaching the neonate to under 45 dB.

Reference is now made to FIG. 8b, schematically illustrating in a non-limiting, out of scale manner a diagram representing the neonate disturbance parameter, according to the Anderson Behavioral Scale (as a non-limiting example), as a function of the sound amplitude ratio over time. The dashed line (A) shows the disturbance of the neonate rising over time in reference to the rise in the sound amplitude ratio. The line (B) shows only a minimal rise in the disturbance of the neonate when utilizing at least one SAM having at least one passive sound attenuation means.

Reference is now made to FIG. 8c, schematically illustrating in a non-limiting, out of scale manner a diagram representing the neonate disturbance parameter, according to the Anderson Behavioral Scale (as a non-limiting example), as a function of the sound frequency over time. The dashed line ‘A’ represents the disturbance of a neonate exposed to noise in relatively high frequencies over time, without a sound attenuation module. It is shown that the disturbance grows over time. When using a reactive sound attenuation module, the neonate disturbance parameter decreases as the system detects the disturbance and generates masking sound and/or a destructive signal effectively lowering the sound frequencies reaching the neonate to a predefined parameter (as a non-limiting example—under 1600 Hz, under 1000 Hz, under 600 Hz, 800-1200 Hz, 600-1500 Hz, 1000-2000 Hz, 200-2000 Hz, 100-800 Hz, 1-100 Hz, 1200-1500 Hz, 2000-300 Hz, 2000-3000 Hz, 3000-4000 Hz, 4000-20000 Hz, 20 Hz-20000 Hz, 20-15000 Hz; and any combination thereof; additionally or alternatively, the system can change the sound signature reaching the neonate to filter out low frequency sounds, and leave the high frequency sounds, or filter out all frequencies out of a predefined range, as a non-limiting example, leave only frequencies between 800-1200 Hz, 600-1500 Hz, 1000-2000 Hz, 200-2000 Hz, 100-800 Hz, 1-100 Hz, 1200-1500 Hz, 2000-300 Hz, 2000-3000 Hz, 3000-4000 Hz, 4000-20000 Hz, 20 Hz-20000 Hz, 20-15000 Hz and any combination thereof, Additionally or alternatively or eliminate at least one frequency, and allow at least one frequency.

Reference is now made to FIG. 8d, schematically illustrating in a non-limiting, out of scale manner a diagram representing the neonate disturbance parameter, according to the Anderson Behavioral Scale (as a non-limiting example), as a function of the sound level in dB over time. The dashed line (A) shows the disturbance of the neonate rising over time in reference to the rise in the sound levels. The line (B) shows only a minimal rise in the disturbance of the neonate when utilizing at least one SAM having at least one passive sound attenuation means.

Reference is now made to FIG. 8e, schematically illustrating in a non-limiting, out of scale manner a diagram representing the neonate disturbance parameter, according to the Anderson Behavioral Scale (as a non-limiting example), as a function of generation of a disturbing sound over time. The dashed line (A) shows the disturbance of the neonate rising over time in reference to accumulation of exposure time to the disturbance. The line (B) shows only a minimal rise in the disturbance of the neonate when utilizing at least one SAM having at least one sound attenuation means configured to change the sound signature reaching the neonate.

According to one embodiment of the invention, a method for sound attenuating a neonate incubator, characterized by: (a) obtaining a noise-attenuating neonate incubator (NANI) comprising at least one sound attenuating module (SAM) configured to decrease the sound's amplitude ratio at time, t_i, (AmpRah_ti) to a critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) or less; (b) accommodating the neonate in the NANI; and, (c) attenuating the noise by at least one SAM, thereby changing the sound signature.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the following steps: (a) obtaining the SAM further comprising: at least one CRM, at least one sound sensor in communication with the CRM, at least one sound attenuator in communication with the CRM; (b) storing the critical amplitude ratio value of the sound measured over a predetermined time, Δt, (AmpR_QVΔt) and, the sound amplitude ratio at time, t_i, (AmpRat_ti); and, by means of the CRM; (c) continuously sampling the sound amplitude ratio at time, t_i, AmpRat_tiwithin the NANI, by means of at least one sound sensor; and, (d) decreasing the sound amplitude ratio at time, t_i, (AmpRat_ti), if AmpRat_ti>AmpR_QVΔt, such that AmpRat_ti<AmpRat_QVΔt; wherein the critical amplitude ratio value of the sound measured over a predetermined time, Δt, AmpRat_QVΔt<about 178.8_Δt, by means of the sound attenuator.

As known in the art, amplitude ration of 178.8 is equivalent to about 45 dB.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of further relaying information from the sensor to a selected from a group consisting of: at least one indicator, at least one user interface, at least one alarm system, at least one CPU, and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of controlling the sound attenuator by means of the CRM according to a selected from a group consisting of: parameters received by means of at least one sensor, parameters inputted through a user interface, parameters received from neonate medical equipment, and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the steps of: (a) configuring the CRM for one or more sampling events creating one or more sample values; (b) sampling at least one signal thereby creating at least one sample value; and, (c) analyzing at least one sample comprising one or more values, to determine the sound signature.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of configuring the CRM for sampling the amplitude ratio of a signal between the time point t and t₁= or > from t+50 microseconds, thereby determining AmpRat_ti.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of calculating the average of at least two sampling events to determine AmpRat_tiby means of the CRM.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of obtaining the sound attenuator comprising an active sound masking system having at least one acoustical sound speaker, and emitting at least one acoustical sound signal, by means of the speaker.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of emitting at least one acoustical sound signal selected from a group consisting of: white noise, pink noise, grey noise, brownian noise, blue noise, violet noise, and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of obtaining the sound attenuator comprising a reactive acoustical device, configured for cancelling the noise by means of a destructive interference generator, and generating a destructive interference, thereby at least partly destructing the noise.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of configuring the SAM to attenuate the noise by a selected from a group consisting of: reducing the sound levels, reducing sound reflections, reducing sound reverberation, creating sound diffusion, masking sound, cancelling sound, changing the sound signature, and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of changing at least one sound characteristic selected from a group consisting of: sound levels, tone, overtone composition, reverberations, sound frequency, sound wavelength, sound wave amplitude, sound wave speed, sound wave direction, sound wave energy, sound wave phase, sound wave shape, sound wave envelope, sound timbre, and any combination thereof, by the SAM, thereby generating a different sound signature.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising at least one of the following steps: (a) configuring the sound signature by the user in real time; (b) predefining the sound signature by the user; and, (c) automatically adjusting the sound signature in reference to the neonate's life parameters.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of obtaining the SAM comprising at least one means selected from group consisting of: active sound attenuating means, passive sound attenuating means, hybrid sound attenuating means, and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising at least one of the following steps: (a) actively attenuating the noise by the active sound attenuating means; and, (b) passively attenuating the noise by the passive sound attenuating means.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of selecting at least one passive sound attenuating means from a group consisting of: at least one sound absorptive material, at least one resonator, at least one sound shield, at least one bass trap, at least one sound baffle, at least one diffuser, at least one insulation padding, at least one sound reflector, at least one sound muffler (SM), and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of selecting the SAM comprises at least one sound shield comprising at least a portion of a material selected from a group consisting of: at least one insulating material, at least one sealing material, at least one sound absorbent material, at least one vibration absorbing material, and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the steps of: (a) obtaining the SAM comprising at least one sound muffler (SM) comprising at least one cylindered conduit, having at least one length (l) and at least one width (w); the cylinder comprising at least one air inlet, and at least one air outlet; (b) configuring the SM such that sound exiting at least one air outlet is of a different sound signature than sound entering at least one air inlet, (c) Thereby changing the sound signature.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of obtaining the SM additionally comprising at least a first cylinder, and at least a second cylinder, connected therebetween, the connection comprises at least one opening configured to permit a fluid communication therebetween.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of obtaining at least one cylinder width (w) is selected from a group consisting of: width (w) is equal along the length (l), is differential along the length (l) or any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of obtaining the SM comprising a plurality of n cylinders, having the length (l)_{1- . . . n}and the width (w)_{1- . . . n}of the each cylinder, are selected from a group consisting of: (l)₁=(l)_n, (l)₁>(l)_n, (l)₁<(l)_n, (l)₁≠(l)_n, (w)₁=(w)_n, (w)₁>(w)_n, (w)₁<(w)_n, (w)₁≠(w)_n, and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the steps of: (a) obtaining the SAM comprising at least one insulation padding, and at least one opening in the insulation; (b) insulating the NANI by means of the insulation; (c) accessing the NANI and the neonate residing within by means of the opening.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step obtaining at least a portion of the insulation comprising a material selected from a group consisting of: thermo insulating material, sealing material, foam material, fire retardant materials, at least partially transparent material and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the steps of: (a) obtaining at least a portion of the insulation comprising at least a portion of shielding means; and, (b) shielding at least a portion of the incubator from a selected from a group consisting of: magnetism, electromagnetic interference, physical damage and any combination thereof, by the shielding means.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the steps of: (a) obtaining at least a portion of the insulation comprising at least one conduit having at least one first aperture into the incubator and at least one aperture to the external environment, fitted for the passage of tubing within; and, (b) attenuating the passage of frequencies selected from a group consisting of: 0 to about 1000 MHz, 0 to about 500 MHz, 0 to about 200 MHz and any combination thereof, by means of the conduit.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the steps of: (a) obtaining the SAM configured to reversibly attach and detach to the incubator; and, (b) reversibly attach and detach the SAM to the NANI.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the steps of: (a) obtaining the SAM comprises at least one sound reflector; (b) reflecting at least partially the noise to a selected from a group consisting of: at least one absorptive surface, at least one sound diffuser, at least one sound baffle, at least one reflective surface, at least one resonator, at least one sound shield, a location directed away from the neonate, and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of obtaining at least a portion of the SAM comprising n layers; each of the n layers comprising an inner side towards the neonate, and an opposite outer side facing away from the neonate.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the steps of: (a) selecting each of the n layers comprising a predefined Noise Reduction Coefficient (NRC) value, Sound Transmission Class (STC) value, or both; and, (b) selecting the NRC value, STC value, or both, to be equal or different for the each of one of n layers.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of selecting at least 2 of the n layers comprising a Noise Reduction Coefficient (NRC) value for each of the n layers; where each of the layers comprising at least one sound level S [dB] measured on the layer outer side, and at least one first sound level S₁[dB], measured on the layer inner side, having a dS₁- . . . dSn, and dS of the SAM equals S₁-Sn, and S₁-Sn<S₁.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of selecting at least 2 of the n layers comprising a Sound transmission class (STC) value for each of the n layers; where each of the layers comprising at least one sound level S [dB] measured on the layer outer side, and at least one first sound level S₁[dB], measured the layer inner side, having a dS₁- . . . dSn, and dS of the SAM equals S₁-Sn, and S₁-Sn<S₁.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the steps of: (a) obtaining the SAM further comprising: (i) a space, S₁, between at least one of n layers to the incubator, a space S_nbetween each of the n layers, or both; (ii) STC₁(sound transmission class) value, measured for the layers_1-n; and, (iii) mobilization means, connected to at least one of the n layers, configured to mobilize at least one of the n layers, having a space S_1a, between at least one of n layers to the incubator, a space S_nabetween each of the n layers, or both, and STC₂value measured for the layers_1-n; and, (b) mobilizing at least one layer such that S₁<S_1a, S_n<S_na, or both, and STC₁<STC₂.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of reversibly connecting at least one of the n layers to the incubator, the one of n layers, or both.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of obtaining at least one of n layers comprises at least one passive sound attenuating means configured to a selected from a group consisting of: reducing reverberation, reducing reflection, reducing levels, and any combination thereof, of the noise within the NANI.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of selecting at least one layer comprising at least a portion of a selected from a group consisting of: an electrical isolating material, electrically conductive material configured to closes conductive circle, disposable material, at least partially transparent material, fire resisting material, MRI safe material, sterilizable material, and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of obtaining the NANI further comprising at least one conduit having at least one SAM, and muffling the noise passing through the conduit into the NANI.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of obtaining the SAM made of MRI safe materials.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the steps of: (a) obtaining the incubator further comprises at least one sensor selected from a group consisting of: sound level sensor, sound frequency sensor, sound direction sensor, sound amplitude sensor, sound tone sensor, sound speed sensor, sensor configured to sense life parameters of the neonate, and any combination thereof; (b) sensing by means of the sensor;

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of configuring the SAM to reducing reverberation of sound, reflections of sound, or both within the NANI, by means of at least one selected from a group consisting of; absorptive material, a sound baffle, a sound diffuser, an active sound cancellation device and any combination thereof.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of obtaining the NANI further comprising at least one air inlet, air outlet, or both, configured for the entry and/or exit of air; and connecting to at least one air inlet, outlet, or both further at least one SAM.

According to another embodiment of the invention, a method as defined above is disclosed, additionally comprising the step of at least temporarily accommodating the NANI in a cart comprising at least one SAM.

According to one embodiment of the invention a standard of care for sound attenuating an incubator, comprising steps of: (a) obtaining a noise-attenuating neonate incubator comprising sound attenuating module (SAM) configured to decrease AmpR_tito AmpR_QVΔtor less; (b) accommodating the neonate in the incubator; and, (c) attenuating the noise by at least one SAM, thereby changing the sound signature, further wherein at least one of the following is held true: (a) the noise level in the incubator is below 45 Decibels; (b) the noise level in the incubator is below 60 Decibels; (c) the amount of audible related complications of neonates when utilizing the incubator is b times lower than the average value of audible complications of neonates; b is equal or greater than 1.05; (d) the average value of salivary cortisol level index from noise derived stress of patient when utilizing the incubator during MRI is n times lower than the average value during MRI; n is equal or greater than 1.05; (e) the incubator will remain stable when tilted 10° in normal use and when tilted 20° during transportation; (f) the incubator will not tip over when the force is 100 N or less; (g) the radiated electromagnetic fields in the inner volume of the incubator, comprising electrical equipment system will be at a level up to 3 V/m for the frequency range of the collateral standard for EMC (electromagnetic compatibility); further the electrical equipment is performing its intended function as specified by the manufacturer or fail without creating a safety harm at a level up to 10 V/m for the frequency range of the collateral standard for EMC; and, (h) the average number of insurable claims of a selected from a group consisting of: manufacturer, handler, user, operator, medical care personal, medical facility, medical facility management or any combination thereof when utilizing the incubator is v times lower than patient MRI associated insurable claims; v is equal or greater than 1.05.

According to one embodiment of the invention, sound parameters are assessed to meet the noise criterion curves of NC-noise criteria (L. Beranek (ed.), “Noise reduction”, McGraw-Hill, New York, 1960), NR-noise rating (C. Kosten, G. van Os, “Community reaction criteria for external noise in the control of noise”, NPL symposium no. 12, HMO, London 373, 1962), RC-room criteria′(M. Crocker (ed.), “Encyclopedia of Acoustics, J. Wiley & Sons, New York, 3, 1166-1170, 1997 and NCB-balanced noise criteria (D. Egan, “Architectural Acoustics”, McGrow-Hill, New York, 1988).

According to one embodiment of the invention an ANTI, (100) having all means for standing all applied regulations, especially the following standards and sections thereof: ANSI/AAMI/IEC 60601-2-19:2009 Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators. This standard applies to the basic safety and essential performance of baby incubators. This standard can also be applied to baby incubators used for compensation or alleviation of disease, injury or disability. More specifically this especially applies to sections 201.2 Normative references; 201.4 General requirements; 201.8 Protection against electrical HAZARDS from ME EQUIPMENT; 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS; 201.10 Protection against unwanted and excessive radiation HAZARDS; 201.11 Protection against excessive temperatures and other HAZARDS; 201.12 Accuracy of controls and instruments and protection against hazardous outputs; 201.13 HAZARDOUS SITUATIONS and fault conditions; 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS); 201.15 Construction of ME EQUIPMENT; 201.16 ME SYSTEMS; 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS; 202 Electromagnetic compatibility—Requirements and tests; 210 Requirements for the development of physiologic closed-loop controllers 201.3.201; FIG. 201.101—INFANT SKIN TEMPERATURE measurement; FIG. 201.102—Variation of INCUBATOR TEMPERATURE; all incorporated herein in its entirely as a reference.

Additionally or alternatively the medical device enclosed inner volume, configured to at least temporarily accommodate at least a portion of the patient is configured to meet the noise criteria and/or comprises all means for standing at least one of the applied regulations and in any combination thereof, especially the following standards and sections thereof: ANSI/AAMI/IEC 60601-2-20:2009 Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators; and more specifically to section 201.3.201; AIR CONTROLLED TRANSPORT INCUBATOR in which the air temperature is automatically controlled by an air temperature sensor close to a value set by the OPERATOR; 201.3.202 AVERAGE TEMPERATURE average of temperature readings taken at regular intervals at any specified point in the COMPARTMENT achieved during STEADY TEMPERATURE CONDITION; 201.3.203 AVERAGE TRANSPORT INCUBATOR TEMPERATURE average of the INFANT TRANSPORT INCUBATOR TEMPERATURE readings taken at regular intervals achieved during STEADY TEMPERATURE CONDITION; 201.3.204 BABY CONTROLLED TRANSPORT INCUBATOR AIR CONTROLLED TRANSPORT INCUBATOR which has the additional capability of automatically controlling the INCUBATOR air temperature in order to maintain the temperature as measured by a SKIN TEMPERATURE SENSOR according to the CONTROL TEMPERATURE set by the OPERATOR NOTE An INFANT TRANSPORT INCUBATOR operating as a BABY CONTROLLED INCUBATOR is a PHYSIOLOGIC CLOSED-LOOP CONTROLLER as defined in IEC 60601-1-10; 201.3.205 COMPARTMENT environmentally-controlled enclosure intended to contain an INFANT and with transparent section(s) which allows for viewing of the INFANT; 201.3.206 CONTROL TEMPERATURE, temperature selected at the temperature control; 201.3.207 INFANT PATIENT up to the age of three months and a weight less than 10 kg; 201.3.208 INFANT TRANSPORT INCUBATOR, TRANSPORTABLE ME EQUIPMENT that is equipped with a COMPARTMENT and a TRANSPORTABLE electrical power source with the means to control the environment of the INFANT primarily by heated air within the COMPARTMENT; 201.3.209 SKIN TEMPERATURE, temperature of the skin of the INFANT at a point on which the SKIN TEMPERATURE SENSOR is placed; 201.3.210 SKIN TEMPERATURE SENSOR sensing device intended to measure the INFANT'S SKIN TEMPERATURE, noise levels accepted for a neonate were taken from “Acceptable noise levels for neonates in the neonatal intensive care unit” Knutson, A. J. et al., Washington University School of Medicine”, 2013, all incorporated herein in its entirely as a reference.

Number	Date	Country
61872793	Sep 2013	US
61879154	Sep 2013	US
61893959	Oct 2013	US
61902236	Nov 2013	US
61902314	Nov 2013	US

INCUBATOR WITH A NOISE MUFFLING MECHANISM AND METHOD THEREOF

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