Premature infant care system
The neonatal care unit addresses challenges in skin-to-skin care for premature infants by providing a regulated environment with integrated life support and monitoring, enhancing thermoregulation and promoting developmental benefits.
Patent Information
- Application Number
- JP2023521822
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-10-11
- Filing Date
- 2021-10-10
- Publication Date
- 2025-12-02
- Estimated Expiration
- 2041-10-10
AI Technical Summary
Skin-to-skin holding of premature infants poses challenges in maintaining environmental parameters such as temperature and humidity, providing continuous life support, and monitoring connectivity, which are crucial for their development and care.
A neonatal care unit with a hood and sealing skirt that fits over a caregiver's torso, allowing a premature infant to be housed in a regulated environment for skin-to-skin contact, featuring temperature control, humidity regulation, and integrated life support and monitoring systems.
Provides a controlled environment for premature infants, enhancing thermoregulation, reducing heat loss, and ensuring continuous medical support while allowing extended skin-to-skin contact, thereby promoting brain and motor development.
Smart Images

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Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to UK Patent Application No. 2016124.6, filed October 11, 2020, entitled "PREMATURE INFANT CARE SYSTEM," which is incorporated herein by reference in its entirety.
[0002] Some embodiments of the present invention relate generally to the field of newborn care, and more particularly to a newborn care unit for use during skin-to-skin care. [Background technology]
[0003] Preterm infants often require hospitalization and may require care in a neonatal intensive care unit (NICU). Skin-to-skin holding has been reported as a valuable intervention for preterm infants. Current understanding of the influence of parental bodies on preterm infant development suggests that the physical cradling of the parent's chest and arms during skin-to-skin holding has a significant impact on the newborn's brain development and the caregiving process. Recent studies have reported that the long-term effects of skin-to-skin holding include larger head circumference at 1 year of age and significant improvements in motor and cognitive development. Summary of the Invention [Problem to be solved by the invention]
[0004] However, skin-to-skin holding of premature infants poses challenges with regard to actually transferring the infant, maintaining and controlling environmental parameters such as temperature and humidity, and providing continuous life support and monitoring connectivity.
[0005] The above examples of the related art and its associated limitations are intended to be illustrative and not exhaustive. Other limitations of the related art will become apparent to those skilled in the art upon reading this specification and studying the drawings.
[0006] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools, and methods that are intended to be exemplary and explanatory, and not limiting in scope. [Means for solving the problem]
[0007] In one embodiment, a neonatal care unit is provided that includes: a hood defining a space therein, the hood having a bottom opening, and the hood being sized to accommodate a neonate; a sealing skirt extending along at least a portion of a periphery of the bottom opening and configured to engage in sealing engagement with at least a portion of a front torso region of a human; at least one access opening disposed in a side wall of the hood and sized to allow passage of a neonate; at least two arm ports disposed in the side wall and sized to allow passage of a hand; and at least one port configured to allow passage of a medical conduit.
[0008] In one embodiment, a method is also provided that includes providing a neonatal care unit comprising: a hood defining a space therein, the hood having a bottom opening, the hood being sized to accommodate a neonate; a sealing skirt extending along at least a portion of a periphery of the bottom opening and configured to engage in sealing engagement with at least a portion of a front torso region of a human; at least one access opening disposed in a side wall of the hood and sized to allow passage of a neonate therethrough; at least two arm ports disposed in the side wall and sized to allow passage of a hand therethrough; and at least one port configured to allow passage of a medical conduit therethrough; positioning the neonatal care unit over the front torso region of the human such that the sealing skirt engages in sealing engagement with at least a portion of the front torso region; positioning the neonate into the interior space through the access opening; and passing the at least one medical conduit through the at least one port.
[0009] In some embodiments, the hood is made of a clear polymer.
[0010] In some embodiments, the hood is sized to fit within the front torso region such that the entire periphery of the sealing skirt engages the front torso region.
[0011] In some embodiments, the hood has a two-layer construction.
[0012] In some embodiments, the sealing skirt extends over at least 85% of the length of the periphery.
[0013] In some embodiments, the sealing skirt is made of an elastic material.
[0014] In some embodiments, the sealing skirt is an inflatable sealing skirt.
[0015] In some embodiments, the access opening comprises a door that can be opened and closed, and a periphery of the door comprises a sealing element that engages in sealing engagement with the periphery of the access opening. In some embodiments, the placing comprises (i) opening the door, (ii) placing the neonate into the interior space through the access opening, and (iii) closing the door.
[0016] In some embodiments, the door is disposed in a side wall at the distal end of the hood.
[0017] In some embodiments, the door has a two-layer construction.
[0018] In some embodiments, at least two arm ports are located on opposite sides of the hood.
[0019] In some embodiments, each of the at least two arm ports comprises a sealing membrane configured to at least partially sealingly engage a periphery of an arm entering the arm port.
[0020] In some embodiments, the medical conduit is one of a tube, a cable, a connector, a wire, a liquid carrier, a gas carrier, an electrical wire, a monitoring cable, a viewing cable, and a data cable.
[0021] In some embodiments, the medical conduit is associated with at least one medical monitoring device configured to measure one of ambient air temperature, body temperature, air humidity, neonatal respiration, neonatal cardiac function, neonatal blood oxygenation, neonatal brain activity, neonatal blood pressure, and neonatal cardiopulmonary activity.
[0022] In some embodiments, the medical conduit is associated with at least one of an intravenous pump, a supplemental oxygen system, a continuous positive airway pressure system, a feeding tube, an umbilical artery catheter, a fluid transport device, a hemofiltration system, and a hemodialysis system.
[0023] In some embodiments, the medical conduit is associated with at least one of ventilation, air conditioning, air humidification, and air heating.
[0024] In some embodiments, the neonatal care unit further comprises a heating element and a control unit configured to operate the heating element to heat the interior space to a particular temperature.
[0025] In some embodiments, the neonatal care unit further comprises one or more straps configured to extend around the torso and operably connect using a fastening means. In some embodiments, the method further comprises extending one or more straps around the torso and operably connecting the straps using a fastening means.
[0026] In some embodiments, the neonatal care unit further comprises an infrared reflective coating applied to the interior surface of the hood other than the access opening, the at least two arm ports, and the at least one port.
[0027] In some embodiments, the neonatal care unit further comprises an infrared reflective cover disposed over the hood and configured to cover an exterior surface of the hood other than the access opening, the at least two arm ports, and the at least one port. In some embodiments, the method further comprises disposing the cover over the hood.
[0028] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed description.
[0029] Exemplary embodiments are illustrated in the referenced drawings, in which dimensions of components and features shown have generally been chosen for convenience and clarity of presentation and are not necessarily drawn to scale. The drawings are listed below. [Brief explanation of the drawings]
[0030] [Figure 1] 1 illustrates a neonatal care unit of the present disclosure, according to some embodiments of the present invention. [Figure 2] FIG. 1 is a side view of an exemplary neonatal care unit, according to some embodiments of the present invention. [Figure 3] FIG. 1 is a perspective view of another exemplary neonatal care unit, according to some embodiments of the present invention. [Figure 4] FIG. 10 is another perspective view of a neonatal care unit, according to some embodiments of the present invention. [Figure 5] 1 is a flowchart of a method of caring for a newborn baby, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION
[0031] A neonatal care unit for premature, preterm, and / or low birth weight infants and an associated method of providing the neonatal care unit are disclosed.
[0032] In some embodiments, the care unit provides a compact newborn care capsule that can be placed in proximity to the body of a caregiver (e.g., a parent) to provide extended skin-to-skin care in a controlled environment, in a NICU, or outside of a traditional NICU. In some embodiments, the care unit is a portable, open-bottom unit configured for placement in substantial sealing engagement around the bare torso or chest of a caregiver to provide a controlled environment for skin-to-skin care to a newborn housed therein. In some embodiments, the care unit provides a regulated environment particularly suited for the continuous care of premature infants.
[0033] As mentioned above, skin-to-skin holding has been reported as a valuable intervention for preterm infants. Current understanding of the influence of parental bodies on preterm infant development suggests that the physical cradling of the parent's chest and arms during skin-to-skin holding has a significant impact on the newborn's brain development and the caregiving process. Recent studies have reported that the long-term effects of skin-to-skin holding include larger head circumference at 1 year of age and significant improvements in motor and cognitive development.
[0034] The benefits of skin-to-skin holding are widely considered a valuable intervention for preterm infants. However, simply holding preterm infants outside of a controlled environment care unit can pose certain challenges and risks for preterm infants, specifically with regard to heat and moisture regulation, which can pose some significant disadvantages compared to term infants.
[0035] Preterm infants have little insulating subcutaneous fat compared with full-term infants, making them much more susceptible to heat loss. Furthermore, preterm infants' skin is very thin, resulting in significant transepidermal water loss and evaporative heat loss. Infants up to 26 weeks of age completely lack the thin stratum corneum, making their skin permeable to water. Furthermore, preterm infants have a greater surface area-to-volume ratio, which can result in excessive evaporative heat loss. Due to the lack of insulating subcutaneous fat, heat is more easily lost from the internal organs to the skin, resulting in a more rapid drop in internal temperature. In very preterm infants, such as those born between 25 and 27 weeks of age, evaporative heat loss may be the most important mode of heat loss, possibly for more than 10 days after birth. Furthermore, preterm infants may have blood vessels located closer to the skin, increasing the rate of heat loss.
[0036] In addition to being at increased risk for heat loss, preterm infants may have poor thermoregulatory mechanisms and may have much more limited heat production than term infants. Preterm infants may lack the shivering mechanism used to maintain body temperature. Additionally, term infants' response to the rapid temperature fluctuations at birth includes increased spontaneous muscle activity, which may be minimal in very preterm infants. Brown fat available for non-shivering heat production may be significantly more limited in preterm infants, and thus calories intended for natural growth are more diverted toward heat production.
[0037] Therefore, protecting infants from heat loss and providing adequate thermoregulation are among the most important goals in the NICU. Improved thermoregulation increases the chances of survival for preterm infants, reduces the infant's need for metabolic work to generate heat using energy intended for growth and development, and eliminates the problems and complications associated with rewarming chilled infants.
[0038] In utero, the primary route of amniotic fluid absorption by the fetus is through the fetal skin and its diffusion into the fetal circulation. This route of water absorption is commonly referred to as the intramembranous route. The amniotic fluid is constantly absorbed by the fetus, mostly excreted and circulated back into the amniotic sac. In preterm birth, immature skin may be exposed to the harsh, dry environment of the nursery, where the intramembranous route of amniotic fluid absorption may be halted or even reversed through significant evaporative loss. Specifically, the skin of infants born between 23 and 26 weeks of gestation is generally extremely immature and may be ineffective as an epidermal moisture barrier. This can lead to disturbances in thermoregulation, water balance, and impaired skin integrity. Therefore, preterm infants born before approximately 30 weeks of gestation may experience up to 15 times the water loss of full-term infants due to their immature stratum corneum.
[0039] Thus, a potential advantage of the present disclosure is to provide a regulated, protected, insulated, portable capsule in which a newborn can be housed in close proximity to the caregiver's naked body, thereby providing extended skin-to-skin care without risk to the newborn. The care unit exhibits a simple, cost-effective construction and may provide a practical solution for use in developed as well as emerging countries.
[0040] 1 illustrates a neonatal care unit 100 of the present disclosure. Unit 100 is generally shown as an open-bottom capsule or hood that is placed over the upper body region (e.g., chest) of a caregiver, for example, while lying in bed or in a reclining position. Unit 100 may provide a conditioned environment suitable for the care of premature infants, including, but not limited to, temperature control, humidity control, air circulation control, respiratory support, and other and / or additional life support and / or monitoring equipment and connections.
[0041] In some embodiments, unit 100 is open-bottomed so that the newborn contained therein can experience direct skin-to-skin contact with the caregiver upon whose body unit 100 is placed, while the care unit forms a protective capsule that surrounds the newborn and engages in a peripheral sealing engagement with the caregiver's body. In some embodiments, the bottom periphery of unit 100 comprises an at least partial sealing element, e.g., a sealing skirt (shown in FIGS. 2, 3, and 4), for at least partially sealing the bottom periphery of unit 100 against the caregiver's body area to protect the interior of care unit 100 from the ambient environment and enable necessary or desired environmental parameters within unit 100 to be maintained within desired ranges of values that may be necessary to support the life and health of the newborn.
[0042] FIG. 2 is a side view and FIG. 3 is a perspective view of a neonatal care unit 100 according to some embodiments of the present disclosure.
[0043] In some embodiments, the neonatal care unit 100 comprises a hood 102, resembling a cover or capsule, defining side walls, a top, and a bottom opening A. The hood 102 may be designed and sized to contain a neonate within it. In some embodiments, the hood 102 is a compact hood sized to fit snugly around the neonate and contain the neonate within a minimal interior volume, for example, such that the neonate's umbilical stump may extend beyond the opening in the hood 102. Thus, the stump may be accessed from the exterior of the hood 102 for insertion of a catheter, such as a peripherally inserted central catheter (PICC line), and / or any other suitable medical tubing. In this manner, venous access may be established and the neonate may be provided with IV medications, fluids, and / or nutrition without having to access the interior of the hood 102 and potentially disrupt the regulated environment therein.
[0044] In some embodiments, the hood 102 has a bottom perimeter 102a sized to fit and engage the caregiver's upper body (e.g., chest) region. In some embodiments, the bottom perimeter 102a of the hood 102 defines a generally flat plane. In some embodiments, the bottom perimeter 102a may be contoured to generally follow the contours of a human chest region. In some embodiments, multiple perimeter contours of the hood 102 may be used to accommodate, for example, a female or male user.
[0045] In some embodiments, the hood 102 may be an oval or oblong hood, a box, a dome, a curved shape, a prismatic shape, or any similar shape. The hood 102 may be sized to accommodate various sizes of neonates, as well as one or more appliance units, as described in more detail below. In some embodiments, the hood 102 has a length of 25-45 cm, a width of 15-30 cm, and a height of 15-20 cm.
[0046] Hood 102 may have materials and structures configured to isolate the neonate from the surrounding environment and maintain a regulated internal temperature, humidity, oxygen concentration, etc. In some embodiments, hood 102 facilitates retaining and maintaining a regulated environment within care unit 100 and physically protects the neonate from the external environment.
[0047] In some embodiments, the hood 102 is constructed of an impermeable, transparent material to allow observation of the newborn from at least two directions by the treating nurse and the holding parent. In some embodiments, the hood 102 can be rigid, semi-rigid, or flexible. In some embodiments, portions of the hood 102 can be rigid, semi-rigid, and / or flexible. In some embodiments, any suitable synthetic resin or polymer can be used to construct the hood 102. In some embodiments, the hood 102 can be made of a thermoplastic or thermosetting polymer using an injection molding process. In some embodiments, the hood 102 has a double-layer structure to promote thermal insulation, with a thin layer of, for example, a specific gas between two layers of material. In some embodiments, the hood 102 is made of a composite material. For example, the hood 102 can be made of a medical-grade polymer, such as medical-grade polycarbonate, that complies with ISO 10993.
[0048] In some embodiments, the hood 102 includes a sealing skirt 104 attached along at least a portion of the length of its bottom periphery 102a. In some embodiments, the skirt 104 can be configured to at least partially seal a gap formed between the bottom periphery of the hood 102 and the contours of the caregiver's body. In some embodiments, the sealing skirt 104 is configured to provide a sufficient seal between the hood and the caregiver's body so that the environment within the hood can be maintained and controlled. For example, the sealing skirt 104 can provide a sufficient seal to maintain and control the temperature, humidity, and / or airflow within the hood. As described later herein, the temperature, humidity, and / or airflow can be monitored and controlled based on the monitored parameters.
[0049] In some embodiments, the skirt 104 may include a peripheral skirt that depends generally downwardly and / or radially from the bottom peripheral edge 102a. The skirt 104 may include a unitary, continuous skirt that surrounds the entire bottom peripheral edge 102a. However, in some embodiments, the skirt 104 may include two or more individual skirt sections or strips, each extending over a portion of the bottom peripheral edge 102a. In some embodiments, the skirt 104 may be made of any suitable flexible, sealing material, such as a thermoplastic elastomer, silicone rubber, or the like, and may conform to the contours of the caregiver's body when the unit 100 is placed over the caregiver's upper body region, as seen in FIG. 1 . In some embodiments, the skirt 104 and / or portions thereof may be overmolded onto the bottom edge 102a. In other embodiments, the skirt 104 may be attached to the bottom edge 102a, for example, inserted into a corresponding slot defined in the bottom edge 102a. In other embodiments, the skirt 104 may be welded to the bottom edge 102a, for example, by ultrasonic welding. In other embodiments, the skirt 104 may be adhered to the bottom edge 102a, for example, using any suitable adhesive. In some embodiments, the skirt 104 may extend continuously or intermittently over at least 85% of the length of the bottom edge 102a. In some embodiments, the sealing skirt 104 may be an inflatable sealing skirt. In such cases, the sealing skirt 104 may include one or more inflation / deflation openings for the introduction / withdrawal of an inflation medium (e.g., gas, liquid, etc.). In a non-limiting example, the sealing skirt 104 may include medical-grade polycarbonate. In another non-limiting example, the sealing skirt 104 may include a medical-grade silicone sheet.
[0050] In some embodiments, the skirt 104 is included in a garment worn by a caregiver (e.g., a parent) holding the newborn. Such a garment may include a strip / sleeve connected to the skirt 104 and configured to attach the skirt to the caregiver's body. In some embodiments, the garment including the skirt 104 has a hole substantially the size of the bottom opening A, allowing the skirt 104 to cover the bottom periphery 102a of the hood 102 while leaving the caregiver's torso uncovered and allowing direct skin-to-skin contact with the infant. In some embodiments, the hood 102 may include one or more connectors for connecting the hood (e.g., periphery 102a) to the skirt 104 included in the garment. The connectors may include any suitable means for connecting the skirt to the hood. In some embodiments, the garment may be made from an elastic material (e.g., a silicone-based elastomer or any other elastomer or elastic fabric), and the hole in the garment may have a circumference substantially smaller (e.g., 10% smaller) than the circumference of the bottom opening A. Thus, when the peripheral edge 102a of the hood 102 is inserted into the hole in the skirt 104, the skirt may slightly gelatinize to provide a sufficient seal between the caregiver's body and the hood.
[0051] In some embodiments, the hood 102 may include at least one access door 106 that resides within an opening 108 in a side wall of the hood 102. In some embodiments, the door 106 may reside in a side region of the side wall of the hood 102. In other embodiments, as seen in FIG. 3, the door 106 may reside in a distal end region of the hood 102, the distal end defining the region of the hood 102 that is farthest from the caregiver's head when the care unit 100 is in use as shown in FIG. 1.
[0052] In some embodiments, door 106 can be opened and closed to provide access to the interior of hood 102, for example, to load a neonate housed within hood 102. In some embodiments, door 106 has a dual-layer construction. In some embodiments, the periphery of door 106 includes a sealing element (e.g., a hook-and-loop fastener) to ensure an airtight seal of opening 108 when door 106 is closed. In a non-limiting example, door 106 is made from polyvinyl chloride coated on the inside with a clear medical sticker.
[0053] In some embodiments, the hood 102 includes one or more arm ports 110 in its side walls for accessing and manipulating the newborn from various positions while maintaining the protection of the hood 102 to the newborn. In some embodiments, a pair of arm ports 110 may be present, for example, on a first side of the side wall of the hood 102, or each port of the pair may be present on both sides, as shown in Figures 2 and 3. In some embodiments, the arm ports 110 may allow a caregiver and / or medical professional to place their arm into the care unit 100 for the purpose of performing various procedures, medical care, and / or physical examinations on the newborn.
[0054] In some embodiments, the hood 102 includes one or more strips or straps for securing the newborn to the caregiver's body. The one or more strips may include an adjustable fastener that allows for adjustment of the length of the strap and fastening of the newborn to the caregiver's body.
[0055] In some embodiments, arm port 110 may be provided with a sealing membrane 111 configured to at least partially sealingly engage the periphery of an arm entering arm port 110. In some embodiments, sealing membrane 111 may be an elastic membrane provided with a plurality of slits to allow passage of the hand and forearm and for sealingly engaging the periphery. In some embodiments, when hood 102 has a two-layer structure, each arm port 110 may include two sealing membranes 111, each corresponding to one layer of hood 102.
[0056] In some embodiments, the hood 102 may be provided with one or more ports 114 configured to allow passage of conduits or leads, such as infusion or monitoring conduits 116. For example, one conduit 116 may provide oxygen-enriched air to the hood 102. In some embodiments, the ports 114 may be provided with sealed joints as known in the art. In some embodiments, at least one of the ports 114 may be in close proximity to the access door 106.
[0057] In some embodiments, the hood 102 may include a conduit 116 having a short tube with a mouthpiece that allows the caregiver to blow humidified air into the hood 102. The air provided by the caregiver is naturally moist.
[0058] In some embodiments, hood 102 may be provided with one or more connections 120 to allow connection and passage of one or more medical measurement and monitoring systems (including sensors and / or monitors) for temperature, respiration, cardiac function, oxygenation, brain activity, for example, an ECG (electrocardiography) monitor, a blood pressure monitor, a cardiopulmonary monitor, a pulse oximeter, etc. In some embodiments, connection 120 includes a communication port, an electrical port, a fluid connector, etc.
[0059] In some embodiments, the care unit 100, e.g., the hood 102, may be provided with one or more openings, ports, and / or connections 120 for engaging life support equipment with the care unit 100, e.g., tubing 122. The tubing 122 may be selected from medical tubing, electrical wires, communication wires (e.g., fiber optics), and may be configured to connect the care unit 100 with any necessary devices, conduits, fluid sources, needles, sensors, monitors, etc., used by medical personnel in connection with the neonate. Such equipment may include all tubing, cables, connectors, wires, liquid carriers, gas carriers, electrical wires, monitoring cables, viewing cables, data cables, etc., that may be used in connection with the maintenance or monitoring of life support equipment, medical equipment, or the physical environment associated with the care unit 100.
[0060] In some embodiments, medical devices and systems used in combination with the care unit 100 include, for example: IV (intravenous) pumps, oxygen supplemental systems via head hoods or nasal cannulae, continuous positive airway pressure systems, feeding tubes, umbilical artery catheters, fluid transfer devices, hemofiltration systems, hemodialysis systems, Medical measurement and monitoring systems (including sensors and / or monitors) for temperature, respiration, cardiac function, oxygenation, and brain activity, such as ECG (electrocardiography) monitors, blood pressure monitors, cardiopulmonary monitors, and pulse oximeters; and Environmental control systems such as ventilators, air conditioners, humidifiers, thermostats, air conditioning systems, silencers, vibration dampers, etc. may include:
[0061] For example, in some embodiments, the care unit 100, e.g., the hood 102, may be continuously provided with air circulation and distribution, e.g., through conduits 116 connected to the hood 102 through ports 114. In some embodiments, the air circulation may be provided by a ventilation unit, e.g., a fan, blower, compressor, pump, air streamer, propeller, ventilator, etc., connected to ventilate the neonate with a continuous flow of filtered, oxygenated, conditioned, and humidified air. In some embodiments, the care unit 100 may be provided with a gas line circuit for administering a medicated gas mixture to the neonate within the hood 102. In some embodiments, an oxygen line may be connected to the care unit 100, e.g., through ports 114 or connections 120.
[0062] In some embodiments, the care unit 100 may be provided with one or more sensors configured to measure one or more parameters associated with the care unit 100, such as at least one of air temperature, neonatology temperature, air humidity, air composition, oxygen level, CO2 concentration, pressure, light, movement, and sound. In some embodiments, the care unit 100 may be configured to provide an indication regarding the measured parameters, for example, when one or more measured parameters deviate from a predetermined value or range of values. In some embodiments, such an indication may be visual or audible, such as sounding an alarm or flashing a warning light. In some embodiments, such an indication (e.g., from ambient sensors and / or infant-associated sensors) may automatically vary air flow, air humidity and temperature, or open or close ventilation ports to restore the variables to a desired range in a closed-loop manner.
[0063] In some embodiments, the care unit 100 may include a heat unit (not shown) configured to generate and maintain a temperature within the hood 102 at a predetermined level or range of levels. In some embodiments, the heat unit may be an electric heater with controls configured to vary the heat output of the heater to heat the air within the hood 102 and / or the walls of the hood 102 to a selected temperature. In other embodiments, the heat unit may be comprised of an infrared heater, a water / oil heating radiator, a coil heater, a quartz tube air heater, a condenser-type heater, or the like. In some embodiments, circulation of hot humidified air may be provided through the port 114 by the conduit 116. In some embodiments, circulation of hot humidified air may be provided by hot humidified air used for non-invasive respiratory support of infants. In some embodiments, humidification may be provided by a tube with a mouthpiece that allows a caregiver to blow humidified air into the hood.
[0064] 4 illustrates an embodiment of the present disclosure in which the interior of the hood 102 may be at least partially provided with an infrared-reflective coating 128 configured to reflect IR radiation, e.g., body heat from the caregiver and / or neonate, toward the interior of the hood 102, thus reducing heat transfer from the interior of the hood 102 to the surrounding environment and mitigating heat loss from the neonate housed within the hood. In some embodiments, the IR-reflective coating 128 covers interior areas of the hood 102 other than the openings and ports, e.g., opening 108, arm port 110, port 114, and / or connection 120. In some embodiments, the care unit 100 may include one or more reflective coatings 128 disposed on one or more of the walls of the hood 102, as shown. In some embodiments, the reflective coating 128 may cover at least 80% of the surface of the hood 102, or the covering may cover only one or two walls of the hood 102. In some embodiments, the reflective coating 128 may include a polymer sheet coated with an IR-reflective pigment. Alternatively, IR-reflective pigments may be coated directly onto the walls / coverings of the hood 102. In some embodiments, the IR-reflective coating 128 may be transparent in the visible spectrum. For example, the IR-reflective coating 128 may include a multilayer film including three thin layers of dielectric material / metal material / dielectric material. In yet another example, the IR-reflective coating 128 may include two polymer layers with refractive indices differing by at least about 0.03, and the polymer layers may have optical thicknesses of about 0.09 μm to 0.45 μm.
[0065] Alternatively, in some embodiments, an IR reflective cover (not shown) is provided that is disposed over hood 102 and configured to reflect IR radiation emitted from hood 102. In some embodiments, the reflective cover extends over the exterior surface of hood 102, except for the openings and ports, such as opening 108, arm port 110, port 114, and / or connection 120. In some embodiments, the IR reflective cover may comprise substantially the same material as IR reflective coating 128 described previously herein.
[0066] In some embodiments, the reflective coating and / or reflective cover may be configured to focus reflected IR radiation around the position of the newborn within the hood 102 when in use.
[0067] 3 and 4, in some embodiments, the care unit 100 includes one or more means for securing the care unit 100 to the caregiver to prevent movement and slippage of the care unit 100 when the care unit 100 is in use and positioned on the caregiver's body region. For example, in some embodiments, the care unit 100 may include one or more straps 130 configured to extend around the caregiver's torso and operably connect using the securing means.
[0068] Reference is now made to Figure 5, which is a flowchart of a method for caring for a neonate, according to some embodiments of the present invention. In step 510, a neonate care unit for caring for a neonate, such as the neonate care unit 100 disclosed herein above, may be provided. In step 520, the neonate care unit 100 may be placed on the anterior torso region of a person such that the sealing skirt (e.g., sealing skirt 104) engages in sealing engagement with at least a portion of the anterior torso region. In step 530, a neonate is placed within the interior space of the neonate care unit 100. The neonate is placed into the interior space of the device through an access opening, such as door 106. In step 540, at least one medical conduit (e.g., conduits 116 and / or 122) may be passed through at least one port included in the neonate care unit 100.
[0069] In some embodiments, the method may further include monitoring at least one parameter of the neonate using at least one sensor included in the neonate care unit. For example, the sensor included in the neonate care unit 100 may monitor at least one of ambient air temperature, body temperature, air humidity, neonate respiration, neonate cardiac function, neonate blood oxygenation, neonate brain activity, neonate blood pressure, and neonate cardiopulmonary activity. In some embodiments, the at least one monitored parameter may be used by a controller associated with the neonate care unit 100 to control the delivery of at least one of medication, heat, humidity, nutrition, and ventilation ports. The controller may receive signals from at least one of the sensors (e.g., hood ambient sensor and / or neonate monitoring sensor) and automatically vary at least one of operating parameters, such as the heating unit, ventilation ports, air supply pump, nutrition / blood supply pump / valve, and humidity level. For example, if the measured temperature and humidity are lower than required thresholds, hot humidified air may be provided. In another example, if the neonate's saturation level is below 90, a direct supply of oxygen-enriched air and / or oxygen may be provided.
[0070] In some embodiments, the monitoring parameters may allow caregivers and / or medical personnel to monitor the vital signs of a newborn while skin-to-skin under the newborn care unit 100 .
[0071] Throughout this application, various embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, the description of a range such as 1 to 6 should be considered to have specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numerical values within that range, e.g., 1, 2, 3, 4, 5, and 6. This is true regardless of the broadness of the range.
[0072] Whenever a range of numerical values is given herein, it is intended to include any recited numbers (fractional or integer) within the range given. The phrases range from a first recited number to a second recited number and range from a first recited number to a second recited number are used interchangeably herein and are intended to include the first recited number and the second recited number, and all fractional and integer numbers therebetween.
[0073] In the description and claims of this application, the words "comprise," "include," and "have," and their forms, do not necessarily limit the members in a list with which the words may be associated. Furthermore, in the event of a conflict between this application and any document incorporated by reference, it is intended that the present application control.
[0074] The description of various embodiments of the present invention has been presented for purposes of illustration, but is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the spirit and scope of the described embodiments. The terms used herein have been selected to best explain the principles, practical applications, or technical improvements of the embodiments over technologies found in the market, or to enable others skilled in the art to understand the embodiments disclosed herein.
Claims
1. 1. A neonatal care unit comprising: a hood defining an interior space and having a bottom opening defined by a bottom periphery of a sidewall of the hood, the hood being sized to accommodate a newborn, the opening configured to allow complete skin-to-skin contact between the newborn and a caregiver; a sealing skirt extending along at least a portion of the periphery of the bottom opening and configured to engage in sealing engagement with at least a portion of the person's front torso region; at least one access opening disposed in a sidewall of the hood and sized to allow passage of the neonate; at least two arm ports disposed in the side walls and sized to receive hands therethrough; at least one port configured to allow passage of a medical conduit; A neonatal care unit equipped with:
2. 10. The neonatal care unit of claim 1, wherein the hood is one of: made of a transparent polymer; and having one or more transparent windows that allow viewing from one or more directions.
3. 2. The neonatal care unit of claim 1, wherein the hood is sized to fit within the front torso region such that the entire periphery of the sealing skirt engages the front torso region.
4. The neonatal care unit of claim 1 , wherein the hood has a two-layer structure.
5. The neonatal care unit of claim 1 , wherein the sealing skirt extends over at least 85% of the length of the perimeter.
6. The neonatal care unit of claim 1 , wherein the sealing skirt is made of an elastic material.
7. The neonatal care unit of claim 1 , wherein the sealing skirt is an inflatable sealing skirt.
8. 10. The neonatal care unit of claim 1, wherein the access opening comprises a door that can be opened and closed, a periphery of the door comprising a sealing element that engages in sealing engagement with a periphery of the access opening.
9. The neonatal care unit of claim 8 , wherein the door is located in the side wall at the distal end of the hood.
10. 10. The neonatal care unit of claim 1, wherein each of the at least two arm ports comprises a sealing membrane configured to at least partially sealingly engage a periphery of an arm entering the arm port.
11. 10. The neonatal care unit of claim 1, wherein the medical conduit is one of a tube, a cable, a connector, a wire, a liquid carrier, a gas carrier, an electrical wire, a monitoring cable, a viewing cable, and a data cable.
12. 10. The neonatal care unit of claim 1, wherein the medical conduit is associated with at least one medical monitoring device configured to measure one of ambient air temperature, body temperature, air humidity, neonatal respiration, neonatal cardiac function, neonatal blood oxygenation, neonatal brain activity, neonatal blood pressure, and neonatal cardiopulmonary activity.
13. 10. The neonatal care unit of claim 1, wherein the medical conduit is associated with at least one of an intravenous pump, a supplemental oxygen system, a continuous positive airway pressure system, a feeding tube, an umbilical artery catheter, a fluid transport device, a hemofiltration system, and a hemodialysis system.
14. The neonatal care unit of claim 1 , wherein the medical conduit is associated with at least one of ventilation, air conditioning, air humidification, and air heating.
15. 10. The neonatal care unit of claim 1, further comprising one or more sensors configured to monitor at least one of ambient air temperature, body temperature, air humidity, neonatal respiration, neonatal cardiac function, neonatal blood oxygenation, neonatal brain activity, neonatal blood pressure, and neonatal cardiopulmonary activity.
16. 16. The neonatal care unit of claim 15, further comprising a controller configured to control the provision of at least one of medication, heat, humidity, nutrition, and ventilation based on one or more signals received from the one or more sensors.
17. The neonatal care unit of claim 1 further comprising a heating element.
18. 10. The neonatal care unit of claim 1, further comprising one or more straps extending around the torso and configured to be operably connected using a fastening means.
19. The neonatal care unit of claim 1 , wherein the sealing skirt is included in a garment configured to be worn by a caregiver.
20. 10. The neonatal care unit of claim 1, further comprising an infrared reflective coating applied to an interior surface of the hood other than the access opening, the at least two arm ports, and the at least one port.
21. 21. The neonatal care unit of claim 20, wherein the infrared reflective coating is transparent to visible light.
22. 10. The neonatal care unit of claim 1, further comprising an infrared reflective cover positioned over the hood and configured to cover an exterior surface of the hood other than the access opening, the at least two arm ports, and the at least one port.
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