Portable phototherapy system and methods of using the same
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- KIDTECH
- Filing Date
- 2025-11-26
- Publication Date
- 2026-06-04
Smart Images

Figure US2025057297_04062026_PF_FP_ABST
Abstract
Description
Attorney Docket No.: KDTC-002 / 01WO 353043-2007PORTABLE PHOTOTHERAPY SYSTEM AND METHODS OF USING THE SAMECross-Reference to Related Applications
[0001] This application claims priority to U.S. Provisional Application No. 63 / 725,809, filed November 27, 2024, entitled “Portable Phototherapy System and Methods of Using the Same,” the disclosure of which is hereby incorporated by reference in its entirety.Technical Field
[0002] Embodiments herein relate to a garment including a phototherapy system for providing phototherapy to a patient and methods of using the same.Background
[0003] Phototherapy is the delivery of light to a patient and can be used to treat a variety of diseases. For example, phototherapy can be used to reduce the appearance of psoriasis and eczema symptoms. Phototherapy can be safe for all ages and therefore is also a common treatment for newborn jaundice. However, there are common issues with conventional phototherapy treatment systems for infants such as dehydration, hypothermia, requirement of eye protector, lack of parent-child bonding, interruption of feeding during treatment, and / or interruption of treatment during feeding.Summary
[0004] In some embodiments, an apparatus comprises a garment shell configured to be worn by an infant, the garment shell including: a first portion including a back section and a pair of side extensions, the back section configured to cover a back of the infant, the pair of side extensions extending from the back section and configured to wrap around sides of the infant; a second portion configured to extend under a bottom of the infant and to be secured to the pair of side extensions; and a pocket disposed on an inner surface of the first portion, the pocket defining a space in which a light panel is configured to be removably disposed, the light panel including a plurality of light sources configured to emit light at a predetermined wavelengthAttorney Docket No.: KDTC-002 / 01WO 353043-2007 and intensity to deliver light therapy to the infant, the garment shell configured to keep a front portion of the infant exposed such that the front portion of the infant can directly contact skin of an adult while the infant receives the light therapy.
[0005] In some embodiments, an apparatus comprises a flexible circuit board; a plurality of light sources coupled to the flexible circuit board, the plurality of light sources including a plurality of sets of light sources, the plurality of sets of light sources configured to be independently activated via the flexible circuit board; and a protective shell coupled to the flexible circuit board and the plurality of light sources and configured to at least partially enclose the plurality of light sources, the protective shell including a plurality of openings extending through the protective shell, the plurality of openings configured to allow dissipation of heat generated by the plurality of light sources, the plurality of light sources configured to be disposed near a surface of skin of an infant and emit light on the surface of the skin of the infant.
[0006] In some embodiments a system comprises a light panel configured to be disposed in a garment for an infant, the light panel including a first set of light sources and a second set of light sources configured to emit light as part of a light therapy session to treating a disease in the infant; one or more sensors; and a controller operatively coupled to the light panel, the one or more sensors, and an external device, the controller configured to: receive, from the external device, information associated with a light therapy session; send a signal to the light panel to cause at least one of the first set of light sources or the second set of light sources to emit light based on the information associated with the light therapy session; monitor, via the one or more sensors, one or more signals including at least one of a biosignal of the infant or a signal associated with the garment; and selectively adjust an output of the first set of light sources and the second set of light sources based on the one or more signals.
[0007] In some embodiments, an apparatus comprises a bassinet for holding an infant receiving light therapy via a garment, the bassinet including a bottom surface and one or more sidewalls, the bassinet including an open top and breathable material on at least a portion of at least one of the bottom surface or the one or more sidewalls, the bassinet configured to allow air flow around the infant to allow heat dissipation of heat generated by the garment.
[0008] In some embodiments, an apparatus, comprises a support surface configured to support an infant receiving light therapy via a garment, the support surface configured to be coupled toAttorney Docket No.: KDTC-002 / 01WO 353043-2007 a bassinet and extend over an opening of the bassinet to support the infant in the bassinet, the support surface including a breathable material and configured to be spaced a distance from a bottom of the bassinet when clipped onto the bassinet to allow air flow around the infant to facilitate heat dissipation of heat generated by the garment.Brief Description of the Drawings
[0009] FIG. 1 is a schematic block diagram of a system for delivering phototherapy to a patient, according to embodiments.
[0010] FIG. 2 is a schematic block diagram of a light panel for delivering light to skin of a patient, according to embodiments.
[0011] FIG. 3 is a schematic block diagram of a garment shell configured to hold a light panel for delivering phototherapy to an infant wearing the garment shell, according to embodiments.
[0012] FIG. 4 shows a garment shell worn by an infant and configured to hold a light panel to provide phototherapy to the infant, according to embodiments.
[0013] FIGS. 5A-5B show a front view and a back view, respectively, of a garment shell configured to hold a light panel for delivering phototherapy to an infant, according to embodiments. FIG. 5C is a photograph of the garment shell showing a pocket in which the light panel is configured to be removably disposed, according to embodiments.
[0014] FIGS. 6A-6B show a front side and a back side, respectively, of a garment shell configured to hold a light panel for delivering phototherapy to an infant, according to embodiments.
[0015] FIG. 7 shows a schematic diagram of a light panel including a plurality of light sources and a protective shell, according to embodiments.
[0016] FIG. 8 is an exploded view of a light panel including a plurality of light sources and a protective shell, according to embodiments.
[0017] FIGS. 9A-9B show different configurations of light panels, according to embodiments.Attorney Docket No.: KDTC-002 / 01WO 353043-2007
[0018] FIGS. 10A-10B show different configurations of light panels, according to embodiments.
[0019] FIG. 11 shows a protective shell configured to be coupled to a light panel, the protective shell including a light absorber, according to embodiments.
[0020] FIG. 12A is a diagram of a protective shell that includes cut outs disposed over the light sources, according to embodiments. FIG. 12B is a diagram of a protective shell that includes cut outs disposed between adjacent light sources, according to embodiments.
[0021] FIG. 13 is a diagram of a light panel having a shape that corresponds to a pocket of a garment shell, according to embodiments.
[0022] FIGS. 14A-14C show examples of a user interface for controlling a light panel of a phototherapy system, according to embodiments.
[0023] FIG. 15 is a flow chart diagram of method for delivering phototherapy using a phototherapy system, according to embodiments.
[0024] FIGS. 16A-16B show an open configuration and a closed configuration, respectively, of a garment shell configured to hold a light panel for delivering therapy to an infant, according to an embodiment.
[0025] FIGS. 17A-17B show the garment shell of FIGS. 16A-16B worn by an infant, according to an embodiment.
[0026] FIG. 18A shows a garment shell coupled to a controller configured to control a light panel for delivery phototherapy, according to an embodiment.
[0027] FIG. 18B shows a garment shell wirelessly coupled to a controller configured to control a light panel for delivering phototherapy, according to an embodiment.
[0028] FIG. 19 is a diagram for an occupancy sensor in an open configuration, according to an embodiment.
[0029] FIGS. 20A-20B are images of an occupancy sensor in an open configuration and a closed configuration, respectively, according to an embodimentAttorney Docket No.: KDTC-002 / 01WO 353043-2007
[0030] FIG. 21 shows a pair of openings disposed in a garment shell for delivery phototherapy and configured to receive a portion of an occupancy sensor, according to an embodiment.
[0031] FIG. 22A shows a garment including a shield portion on a left of a garment to prevent light leakage towards a face of the infant versus no shield portion on right of the garment, according to embodiments.
[0032] FIG. 22B delineates a portion of the garment that can include the shield portion, according to embodiments.
[0033] FIG. 23 shows a light panel including a plurality of light sources and defining a plurality of openings therethrough, according to embodiments.
[0034] FIGS. 24A-24B show a close-up view of an opening of a plurality of openings defined in a light panel, according to embodiments.
[0035] FIGS. 25A-25B show a three-dimensional view of an opening of the plurality of openings of a light panel, according to embodiments.
[0036] FIGS. 26A-26D show a bassinet for holding an infant, according to embodiments.
[0037] FIG. 27 shows a bassinet for holding an infant, according to embodiments.
[0038] FIG. 28 shows a support surface configured to clip to the bassinet to support the infant in the bassinet, according to embodiments.Detailed Description
[0039] Phototherapy (also referred to as light therapy) can be used to treat a variety of different conditions including skin diseases such as psoriasis, eczema, vitiligo, mycosis fungoides and can also be used to treat jaundice. According to American Association of Pediatrics (AAP) and several other publications, about 60% of the infants born in United States of America (USA) each year become clinically jaundiced or with hyperbilirubinemia. Jaundice or hyperbilirubinemia is the result of increased production and reduced elimination of bilirubin from the newborn. For some infants, if it is not treated, the bilirubin level continues to increaseAttorney Docket No.: KDTC-002 / 01WO 353043-2007 to a dangerous level. Excessive level of bilirubin leads to brain disorder which is known as Kernicterus and Bilirubin Induced Neurological Disorder (BIND) and can be fatal.
[0040] When the body is exposed to light having certain parameters (e.g., wavelength and intensity), the body can transform unconjugated bilirubin into compounds that are more easily excreted by the body through urine and feces. Effectiveness of phototherapy depends on four main factors, which are (1) irradiance or light intensity, (2) color or wavelength of the light, (3) skin coverage or exposed area, and (4) time or duration of exposure.
[0041] Conventional systems for delivering phototherapy to infants suffer from drawbacks including negative side effects on the newborn (e.g., hypothermia, dehydration, risk of eye damage, etc.), lack of portability, lack of comfortability, bulkiness of light source, low irradiance levels of light source, and / or limited light coverage on the infant’s skin. For example, existing methods for administering phototherapy for treating hyperbilirubinemia in newborns include positioning the newborn, fully nude and wearing eye patches to protect the eyes, under lights (e.g., blue fluorescent light). Not only are these systems bulky and non-portable, but the blue fluorescent light source does not produce enough heat to the infant. Therefore, the infant can develop hypothermia. To prevent hypothermia, more fluorescent lights of other wavelengths can be added to the system to produce enough heat; however, this can lead to the infant becoming dehydrated. In phototherapy systems using other light sources, other challenges exist such as tradeoffs between adequate irradiance of the light panel, portability of the system, comfortability of the system, and light coverage. For example, phototherapy systems that have irradiance suitable for treating jaundice in infants may suffer from low coverage on the skin. Alternatively, phototherapy systems that are less bulky and / or are not stationary may not produce suitable irradiance levels.
[0042] In contrast, the embodiments described herein relate to a phototherapy system including a light panel configured to be removably disposed in a garment shell. In some embodiments, the garment can be a swaddle configured to receive an infant. The light panel may include a plurality of light sources (e.g., light emitting diodes (LEDs), organic light emitting diodes (OLEDs), fiber optic cables, etc.). The garment may be configured to position and / or orient the light panel over a portion of the infant’s body. In some embodiments, the garment may include a pocket in which the light panel can be removably disposed. The pocket may include a transparent material such that light emitted from the panel can contact the skinAttorney Docket No.: KDTC-002 / 01WO 353043-2007 of the infant. In some embodiments, the garment may include a second pocket configured to hold a power source (e.g., a portable and / or rechargeable battery) and / or a controller. In some embodiments, the garment shell may be configured to hold a portable power source and controller such that the phototherapy system is fully portable. In some embodiments, the phototherapy system described herein may allow the infant to breastfeed while receiving light therapy and promote parent-child bonding.
[0043] Embodiments described herein can include a light panel configured to produce a suitable level of irradiance for treating jaundice while also being light weight (e.g., less than about 12 ounces while having a coverage area of up to about 1300 cm2(centimeters squared), comfortable for the infant, and operational on levels of power that can be provided by a small battery pack to not disturb the infant. The phototherapy system described herein may include a light panel including a plurality of LEDs arranged in an ordered formation and coupled to a circuit board. The light panel and / or the circuit board may be disposed in a protective shell. The protective shell may include a plurality of cut outs (e.g., indentations, spaces, openings, through holes, pockets, etc.), which can reduce an overall weight of the light panel. In some embodiments, each of the plurality of cut outs can act as a convex lens to the skin. For example, a surface closer to the skin that defines the cut outs may be convex. The protective shell can protect the light panel and associated circuitry from being exposed to damaging materials such as liquid and / or protect the infant from the circuitry of the light panel. In some embodiments, the protective shell can act as a light guide, guiding light from the light source towards the skin of the infant, thereby reducing stray light (e.g., light that does not reach the infant’s skin). In some embodiments, the protective shell may include, and the silicone may act as a light guide for light emitted from a light source.
[0044] Additionally, embodiments described herein relate to a phototherapy system including a controller configured to control light delivered by the light panel in response to at least one of user input or data collected. In some embodiments, the phototherapy system may include one or more sensors operatively coupled to the light panel and the controller. The controller may be configured to receive information including at least one of data from the sensors or a user input (e.g., from an external device) and adjust an output of the light panel in response to the information received. In some embodiments, the controller may be configured to lower an irradiance level of the light sources and / or turn off the light panel. In some embodiments, the controller may automatically (e.g., without user input) adjust the output of the light panel.Attorney Docket No.: KDTC-002 / 01WO 353043-2007
[0045] The phototherapy system described herein can use LEDs, OLEDs and / or fiberoptics for distributing the appropriate light over a large area of the infant’s body. The phototherapy system is effective, inexpensive, lightweight, baby-friendly, durable, and easy to set up and use. The phototherapy system can consume relatively low power from a rechargeable battery and can be used outside of a hospital or during travel. The phototherapy system can minimize discomfort to babies and caregivers and can output light at one or more predetermined wavelength range for treating an associated condition (e.g., jaundice). The phototherapy system may include a real-time monitoring system (RTMS), a controller, a communication system, and one or more user interfaces (UIs). Thus, the phototherapy system can communicate with users and other devices and systems and enables quick response from the users (e.g., remotely). The phototherapy system delivers phototherapy that causes little to no side effects of hypothermia, dehydration, or rash etc. and requires no eye protector. The ability for the phototherapy system to provide suitable light therapy while having low power consumption enables the operation with a battery, so feeding and holding of the infant does not impact treatment, thereby promoting parent-child bonding.Overview:
[0046] FIG. 1 is a schematic block diagram of a phototherapy system 1000 for delivering phototherapy to a patient 102, according to embodiments. As shown, the phototherapy system 1000 includes a garment shell 100 (e.g., a swaddle, gown, shirt, dress, vest, bib, harness, jumpsuit, etc.). In some embodiments, the garment shell 100 may be configured to enable skin- to-skin contact between the patient 102 (e.g., the infant / newborn) and an adult (e.g., the parent). In some embodiments, the garment 100 may be reusable and / or washable between uses. The garment shell 100 may be configured to be opened such that the patient 102 (e.g., an infant / newborn) can be disposed inside the garment shell 100. For example, the garment shell 100 may include a fastener (e.g., a zipper, VELCRO®, buttons, straps, clips, etc.) extending along a front side of the garment shell 100 and configured to open the garment shell 100 such that the patient 102 can be disposed inside and / or so that the garment shell 100 can be disposed around the patient 102. The fastener can include a two-way zipper which allows opening the garment 100 from the top and / or the bottom (e.g., for easy diaper change for infants without interrupting treatment). For example, the user may unzip from a top end (e.g., near the head of the infant) towards a bottom end (e.g., near the feet of the infant) of the garment shell 100 and / or unzip from the bottom end towards the top end of the garment shell 100.Attorney Docket No.: KDTC-002 / 01WO 353043-2007
[0047] In some embodiments, the garment shell 100 includes a breathable section 130 disposed on and / or forming a portion thereof. In some embodiments, the breathable section 130 may include a breathable fabric such as, for example, a mesh, a fabric with openings, a lightweight fabric, etc. The breathable section 130 may be configured to allow a release of light and / or heat emitted by the light panel. In some embodiments, the garment shell 100 may further include an active heat dissipation mechanism such as a fan, blower, cooling material, etc. The active heat dissipation mechanism may be configured to move hot air out of the inside of the garment 100 and move cool air into the inside of the garment 100. In some embodiments, the garment 100 may optionally include a movable section (e.g., a movable flap). The movable flap may be attached to a side of the garment 100, for example. The movable flap may have a first configuration in which the movable flap does not cover the breathable section 130, and a second configuration in which the movable flap covers the breathable section 130 to block light emitted by the light panel 110 from existing the breathable section 130. The garment 100 may further includes a pair of arm holes and a neck hole such that the infant can wear the garment 100. In some embodiments, the bottom end of the garment 100 (e.g., the swaddle) may be closed. Further details of the garment 100 are described in FIG. 3 below.
[0048] The phototherapy system 1000 may include a light panel 110 (i.e., a light producing panel assembly (LPPA)) configured to be removably disposed in at least a portion of the garment shell 100. In some embodiments, the garment shell 100 may include one or more pockets on an inner surface and / or on an outer surface of thereof. For example, the garment shell 100 may include a first pocket on an inner surface thereof, the first pocket defining a space in which the light panel 110 may be at least temporarily disposed. The light panel 110 may be formed in or include a shape that corresponds to the space of the first pocket. In some embodiments, the first pocket may be configured such that the light panel 110 may be aligned over and / or covering a target area of the patient 102 when the light panel 110 is disposed in the first pocket. For example, the first pocket may be configured such that the light panel 110 is positioned over or near a portion of a torso of the patient 102 (e.g., a back and / or a chest of the patient 102). In some embodiments, the light panel 110 may be positioned to emit light on the upper body in 360 degrees and to emit light on a full back side of the lower body. In some embodiments, the light panel 110 and / or the garment 100 may be configured such that light emitted from the light panel 110 may cover or contact at least 1% to 100% of the infant’s body. The light panel 110 may include a plurality of light sources (e.g., LEDs, OLEDs, fiber optics,Attorney Docket No.: KDTC-002 / 01WO 353043-2007 etc.) configured to emit light towards the skin of the patient 102 when the light panel 110 is disposed in the garment shell 100 (e.g., the first pocket of the garment shell 100).
[0049] In some embodiments, the plurality of light sources may be in an ordered configuration (e.g., a grid, a staggered grid, a repetitive pattern, etc.). The plurality of light sources may be coupled to a circuit board configured to electrically connect (e.g., at the correct polarity) the light sources to the power supply 145 and / or to the controller 150. The circuit board may be configured to control output of the light sources 112 in response to signals from the power supply 145 and / or controller 150. In some embodiments, electrical connections of the phototherapy system 1000 may include heat dissipation components such as copper traces, copper coins and / or graphene film attached to one or both sides of the electrical connections or electrical circuits. In some embodiments, electrical connections in the light panel 110 may include the heat dissipation components. The electrical circuits of the phototherapy system 1000 may all include electrical connectors compatible with medical requirements for treatment.
[0050] The light panel 110 may further include a protective shell configured to be disposed on and / or around a portion of the light sources 112 and the circuit board 116. The protective shell may be disposed on one or both sides of the light sources and circuit board and may be configured to protect the electronics from damaging materials and / or to protect the patient from the electronics. In some embodiments, the protective shell may include a plurality of cut outs. In some embodiments, the light panel 110 may be configured such that a space is maintained between the light panel 110 and a chest of the infant. For example, the light panel 110 may create a tent shape such that at least a portion of the light panel 110 is lifted off of the chest of the infant. Therefore, little to no weight from the light panel 110 may press on the chest of the infant, promoting more safe and comfortable conditions during the phototherapy session. Further details of the light panel 110 are described in FIG. 2 below.
[0051] The phototherapy system 1000 may further include the controller 150, the power source 145, and may optionally include one or more sensors 140, a communication interface 152, a memory 154, and one or more external devices 180. In some embodiments, the garment shell 100 may include one or more pockets defining a space configured to at least temporarily receive the controller 150 and / or the power source 145 (and / or the memory 154, the communication interface 152). For example, the garment shell 100 may include a second pocket defining a space for both the controller 150 and power source 145. In this way, the phototherapy systemAttorney Docket No.: KDTC-002 / 01WO 353043-20071000 may be fully mobile and / or portable. In some embodiments, the garment shell 100 may include different pockets for the power source 145 and the controller 150. In some embodiments, the battery source 145, the controller 150, and the light panel 110 may all be disposed in the same pocket.
[0052] In some embodiments, the power source 145 may be operatively coupled to the light panel 110 and configured to provide power to the light panel 110. In some embodiments, the power source 145 may be any suitable power source such as a portable battery, a rechargeable battery, or a power cord coupled to a wall plug, for example. In some embodiments, the power source 145 may be a portable and rechargeable battery. The power source 145 may be light weight and low volume such that the power source 145 fits comfortably in the garment shell 100 and does not disturb the patient 102 while worn. In some embodiments, the power source 145 may be configured to provide constant power to the phototherapy system 1000. In some embodiments, the power source 145 may be a battery couplable to a cord and wall plug that may be configured to provide constant power to the phototherapy system 1000. In some embodiments, the power source may be a battery couplable to a cord and wall plug, the battery configured to provide power to the phototherapy system 1000 when not connected to the wall plug. In some embodiments, the power source 145 may be a rechargeable battery, and the rechargeable battery may provide between about 1 hour to about 3 hours of power when fully charged. In some embodiments, the power source 145 may provide power that is about equal to three times a length of an average breastfeeding time for the infant.
[0053] The sensor(s) 140 may be configured to monitor at least one of a biosignal of the patient 102 and / or a signal related to an environment inside the garment 100. For example, the sensor(s) 140 may be configured to monitor at least one of a location of the garment 100, a temperature inside the garment 100, a temperature of the light panel 110, a humidity inside the garment, and / or a bilirubin level of the patient 102. The sensor(s) 140 can include at least one of a temperature sensor, a humidity sensor, wetness sensor, a light intensity sensor, a global position system (GPS) sensor, a sound detector, a motion detector, an accelerometer, an occupancy sensor, and / or a bilirubin meter. In some embodiments, the signals the sensor(s) 140 collect may be safety parameters to promote safe operating of the phototherapy system 100 for treating an infant. In some embodiments, the sensor(s) 140 may be included in the light panel 110. In some embodiments, the sensor(s) 140 may be integrated into the garment 100 (e.g., sewn into a portion of the garment 100). In some embodiments, the sensor(s) 140 may beAttorney Docket No.: KDTC-002 / 01WO 353043-2007 integrated into a circuit board (e.g., the FBC 216) of the light panel 110. In some embodiments, the sensor(s) 140 may be configured to be coupled to a skin of the patient 102. In some embodiments, the sensor(s) may include one or more proximity sensors (e.g., infrared sensors) configured to measure one or more signals corresponding to a distance between the light panel and a skin of the infant. In some embodiments, the proximity sensors may be used to determine whether the infant is disposed in the garment based on the distance determined between the light panel and the skin. In some embodiments, the sensor(s) 140 may communicate the data collected to the controller 150 for analysis, storage, and / or communication to the external device 180. In some embodiments, the sensor(s) may be configured to continuously monitor the signals. In some embodiments, the sensor(s) may be configured to monitor the signals periodically and / or at predetermined time intervals.
[0054] In some embodiments, the controller 150 may be operably coupled to the light panel 110, the power source 145, the sensor(s) 140, and / or the external device(s) 180. The controller 150 may be configured to receive information associated with a light therapy session. For example, the controller 150 may receive information from at least one of the external device(s) 180, the sensor(s) 140, and / or directly from the light panel 110. The information can include, but is not limited to, a biosignal of the patient 102 such as bilirubin levels (e.g., collected by the sensor(s) 140), patient history of the patient 102, user input (e.g., from the external device(s) 180), output parameters of the light panel, a duration of time the light panel has been active, and / or a prescription (e.g., time and intensity of light) for the light therapy. The controller 150 may be configured to adjust an output of the light panel 110 based on the information received. In some embodiments, the controller 150 may adjust the irradiance of the light sources 110 by changing a current delivered to the light panel 110. In some embodiments, the information the controller 150 monitors may correspond to the one or more safety parameters for delivery safe phototherapy to infants. In some embodiments, the controller 150 may be configured to detect when the one or more safety parameters crosses a predetermined threshold and / or falls outside of a predetermined range. In some embodiments, a safety parameter may have a predetermined range and if the measured signal falls outside of that range, the controller 150 may adjust the output of the light panel 110, and / or alert (e.g., using sounds, text messages, flashing light, buzzing, instructions, dialogue windows, etc.) the user via the external device 180. In some embodiments, the controller 150 may cause the external device 180 to display a message informing the user that the light panel 110 has been automatically shut off and / or an intensityAttorney Docket No.: KDTC-002 / 01WO 353043-2007 of the light source has been reduced. In some embodiments, the controller 150 may alert and / or display a message to the user when switching on (e.g., automatically) the light panel 110 based on the parameters set by the user (e.g., on the external device 180). In some embodiments, the controller 150 can turn off (e.g., automatically) the light panel 110 based on treatment cycles the user has input on a user interface (e.g., on the external device 180). In some embodiments, the user can also configure the phototherapy system 1000 to only send alerts and display messages, so the users can manually turn on and / or off the light panel 110. In some embodiments, the controller 150 may be configured to cause the external device 180 to alert the user when a power level of the phototherapy system 1000 is low. In some embodiments, the controller may be configured to turn on and / or off (e.g., automatically) based on a signal from the sensor(s) (e.g., the occupancy sensor). For example, when the distance exceeds the second predetermined threshold, the controller may automatically turn off the light panel. In some embodiments, the controller may be configured to adjust an intensity of light emitted from the light panel based on the one or more signals collected by the one or more sensors.
[0055] In some embodiments, a minimum threshold of the intensity of light from the light sources 112 at the surface of the skin of the patient 102 may be at least about 15 pW / cm2 / nm (microwatts per centimeter square per nanometer) or at least about 30 pW / cm2 / nm. In some embodiments, a predetermined upper threshold of a temperature level inside the garment 100 is about 40 degrees Celsius (C). In some embodiments, a predetermined upper threshold of a temperature emitted by the light panel 110 is between about 38 degrees C and about 40 degrees C. In some embodiments, a predetermined range of humidity level inside the garment 100 is between about 10% and about 90%, inclusive of all ranges and subranges therebetween. In some embodiments, a duration of time of the phototherapy session may be in a range of about 5 minutes to about 24 hours, inclusive of all ranges and subranges therebetween. In some embodiments, the duration of time of the phototherapy session may be in a range of about 45 minutes to about 3 hours, inclusive of all ranges and subranges therebetween. In some embodiments, the duration of the phototherapy session may correspond to an amount of time the infant is normally fed such that the phototherapy session can be completed during feeding. In some embodiments, the duration of the phototherapy session may depend on user input and / or a prescription.
[0056] In some embodiments, the controller 150 may be configured to receive, from the external device 180, information associated with the light therapy session (e.g., a duration ofAttorney Docket No.: KDTC-002 / 01WO 353043-2007 the session, an intensity and / or wavelength of the light for session, one or more safety parameter ranges, etc.). The controller 150 may be configured to send a signal to the light panel 110 to cause the light panel 110 to emit light based on the information associated with the light therapy session. In some embodiments, the controller 150 may be configured to monitor, via the sensor(s) 140, one or more signals including at least one of the biosignal of the patient 102 or a signal related to the environment inside the garment 100. In some embodiments, the controller 150 may be configured to determine or detect whether the one or more signals crosses a predetermined threshold and / or falls outside of a predetermined range. The controller 150 may be configured to adjust the output of the light panel 110 in response to at least one of the one or more signals crossing the predetermined threshold and / or falling outside of the predetermined range. For example, the controller 150 may drop the light intensity output from the light panel 110 to below a certain value in response to a signal crossing the predetermined threshold. In some embodiments, the controller 150 and / or a circuit board coupled to the light panel 110 may include electrical circuits to power the light panel 110 according to one or more light panel parameters such as for example, constant voltage and / or pulsed at a higher voltage, frequencies, and / or duty cycles to produce a desired light output.
[0057] In some embodiments, the plurality of light sources of the light panel 110 can include a plurality of sets (or groupings) of light sources configured to be independently (e.g., selectively) controlled. In some embodiments, the sets of light sources are grouped together spatially on the light panel 110. In some embodiments, the light panel can include a plurality of sets of light sources distributed across the light panel 110. In some embodiments, the system 1000 can include a light panel assembly including a plurality of light panels. The plurality of panels can be physically separated, as described below in FIG. 23. In some embodiments, light panel can include a first set of light sources and a second set of light sources. In some embodiments, the first set of light sources can be configured to align with the back of the infant when the light panel 110 is disposed in the garment shell 100. For example, the first set of light sources can be configured to be disposed on a central section of the light panel 110. In some embodiments, the second set of light sources can be configured to be disposed on one or both extensions (e.g., extensions 1710b, 1710c shown in FIG. 13) of the light panel 110 extending from the central portion (e.g., the extension configured to wrap around the side of the infant to the front of the infant). In some embodiments, the first set of light sources and the second set of light sources can be independently activated and / or turned off to control an amount of lightAttorney Docket No.: KDTC-002 / 01WO 353043-2007 and / or heat emitted from the light panel 110. In some embodiments, each extension can include a separate set of light sources that are independently controlled. In some embodiments, the extensions can include a set of light sources that are controlled together.
[0058] In some embodiments, each set of light sources can be coupled to the controller 150. In some embodiments, the controller 150 can be operatively coupled to one or more switches. The one or more switches can cause the controller 150 to send signals to a respective set of light sources of the plurality of light sources (e.g., to activate the set of light sources, to adjust an output of the set of light sources, and / or to turn off the set of light sources). In some embodiments, the plurality of light sources can be coupled to a plurality of controllers, and each controller can control a respective set of light sources. In some embodiments, the controller can be configured to adjust an output of the first set of light sources or the second set of light sources based on the signals measured by the sensor 140. For example, the sensor 140 can be configured to monitor a signal including at least one of a biosignal of the infant or a signal associated with the garment 100 (e.g., a temperature around the light panel 110), and the controller 150 can be configured to adjust (e.g., independently) an output of a set of light sources of the plurality of light sources. In some embodiments, the controller 150 can be configured to turn off the first set of light sources while keeping the second set of light sources activated. Therefore, the infant can receive continuous light exposure without the light panel 110 generating heat above a predetermined threshold (e.g., a safety threshold). In some embodiments, the controller 150 can be configured to cycle through the plurality of sets of light sources. In some embodiments, the controller 150 can be configured to turn off the first set of light sources (e.g., aligned with the back of the infant) when the infant is laying on their back, while the second set of light sources (e.g., on the extensions of the light panel) remain activated. The selective activation of different sets of light sources can allow for heat generated by the light panel to dissipate.
[0059] The controller 150 may include one or more processors, and the processors may be configured to carry out functions, processes, and / or modules for operation of the phototherapy system 1000. The processor(s) of the controller 150 can be any suitable processing device(s) configured to run and / or execute a set of instructions or code. For example, the processors can be and / or can include one or more data processors, image processors, physics processing units, digital signal processors (DSP), analog signal processors, mixed-signal processors, machine learning processors, finite state machines (FSM), compression processors (e.g., dataAttorney Docket No.: KDTC-002 / 01WO 353043-2007 compression to reduce data rate and / or memory requirements), encryption processors (e.g., for secure wireless data and / or power transfer), and / or the like. The processors can be, for example, a general-purpose processor, central processing unit (CPU), microprocessor, microcontroller, Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a processor board, a virtual processor, and / or the like. The processors can be configured to run and / or execute or implement software application processes and / or other modules, processes and / or functions related to controlling the output of the light panel 110 and / or monitoring biosignals of the patient 102. The underlying device technologies may be provided in a variety of component types, for example, metal-oxide semiconductor field-effect transistor (MOSFET) technologies like complementary metal-oxide semiconductor (CMOS), bipolar technologies like generative adversarial network (GAN), polymer technologies (e.g., silicon-conjugated polymer and metal-conjugated polymer-metal structures), mixed analog and digital, and / or the like.
[0060] In some embodiments, the controller 150 may be coupled to a memory 154 for storing information (e.g., information related to the phototherapy session such as a duration of the session, the bioisgnals, and / or information about an environment of the phototherapy system 1000). Additionally or alternatively, the controller 150 may be configured to send all information to the external device(s) 180 for storage. In other words, the controller 150 may not store information onboard. The memory 154 can be any suitable memory device(s) configured to store data, information, computer code or instructions (such as those described herein), and / or the like. The memory may store (1) phototherapy session information such as duration, intensity, patient identifying information, etc.); (2) data collected from the sensor(s); (3) and / or any other information related to functioning of the system 1000. In some embodiments, the memory can be and / or can include one or more of a random access memory (RAM), static RAM (SRAM), dynamic RAM (DRAM), a memory buffer, an erasable programmable read-only memory (EPROM), an electrically erasable read-only memory (EEPROM), a read-only memory (ROM), flash memory, volatile memory, non-volatile memory, combinations thereof, and the like. In some embodiments, the memory may also be configured to at least temporarily store sensor(s) data, for example, until the data is transmitted to the external device(s) 180.
[0061] In some embodiments, the controller 150 may be configured to send information related to the light panel 110, the power source 145, and / or the sensor(s) 140 to the externalAttorney Docket No.: KDTC-002 / 01WO 353043-2007 device(s) 180. In some embodiments, at least one of the controller 150 and the external device(s) 180 may be configured to process and / or analyze data such as, for example, biosginal data, location data, temperature data, and / or humidity data. In some embodiments, the controller 150 may process and / or analyze the data and in real-time or near real-time and control the light panel 110 in response to the processed and / or analyzed data. For example, the controller 150 may receive sensor data including a raw signal associated with a bilirubin level of the patient 102, and the controller 150 may be configured to process and / or analyze the raw signal and determine the bilirubin level of the patient 102. The processor 150 may then reduce and / or increase an intensity of the light output from the light panel 110 based on the bilirubin level. In some embodiments, the processor 150 may turn off and / or stop (e.g., automatically or without user input) the light panel from outputting light based on at least one of the sensor data (e.g., bilirubin levels), a user input, and / or a prescription for the light therapy. In some embodiments, the external device 180 may be configured to at least partially process and / or analyze sensor data for the sensor(s) 140 and send the processed data to the controller 150 to control the light panel 110.
[0062] In some embodiments, the controller 150 and / or the power source 145 may include a display configured to display information to the user. In some embodiments, the controller 150 and / or the power source 145 may include one or more input / output (I / O) devices configured to receive user inputs directly from the user.
[0063] The external device 180 can include any suitable compute device such as, for example, one or more user device(s), a physician device, a server, and / or a database. The external device 180 may include a phone, a tablet, a laptop computer, a desktop computer, or any other suitable compute device. In some embodiments, the external device(s) 180 may include a user interface configured to display information related to the phototherapy sessions to the user and / or receive user input for controlling the led panel 110. In some embodiments, the external device(s) 180 may include a display such that the controller 150 can cause the external device(s) 180 to display information related to the phototherapy and / or the patient. For example, the controller 150 may be configured to send information related to an intensity and / or wavelength of the light output from the light panel 110 such that the display displays this information to the user. In some embodiments, the external device 180 may be configured to run an application on a touch screen, a website running remotely, and / or execute remote procedure call services. In some embodiments, the external device 180 (e.g., via the user interface) may be configured toAttorney Docket No.: KDTC-002 / 01WO 353043-2007 display the monitoring information, alert users, and take the commands from the users to control the light panel 110 operation status and set up light panel parameters.
[0064] In some embodiments, users can be locally and / or remotely connected to the phototherapy system 1000. For example, the controller 150 and the external device(s) 180 may be configured to communicate remotely. For example, the phototherapy system 1000 may include the communication interface 152 configured to communicate wirelessly (e.g., via Bluetooth, Wi-Fi, cellular such as 3G, 4G, 5G, etc., 802.1 IX Zigbee, etc.). In some embodiments, the communication interface 152 can include one or more satellite, WI-FI, Bluetooth, or cellular antenna.). In some embodiments, the communication interface 152 may include one or more senders, receivers, and / or double-direction transportation channels. The senders and the receivers can exchange data through the double-direction transportation channels. In some embodiments, the senders can be receivers and the receivers can be senders. In some embodiments, the senders and the receivers can be anything the transportation channels connect to, including the light panel 110, the controller 150, the external device 180, and / or a data server or other medical devices. In some embodiments, the communication interface 152 may be modularized to allow easy extension of new features. The communication interface 152 may be integrated into the controller 150 and / or a separate hardware component. In some embodiments, the communication interface 152 may communicate some or all information between the controller 150 and the light panel 110 and / or the controller 150 and the external device 180.
[0065] FIG. 2 is a schematic block diagram of a light panel 210 for delivering light to skin of a patient 202, according to embodiments. In some embodiments, the light panel 210 may include a plurality of light sources 212 (e.g., LEDs, OLEDs, fiber optics) coupled to a circuit board (e.g., a flexible circuit board (FCB)) 216. In some embodiments, the light source(s) 212 may be arranged in an ordered configuration (e.g., a grid configuration, a zig-zag configuration, a repetitive pattern, etc.). In some embodiments, the light sources 212 (e.g., when disposed in a pocket of the garment) may be configured to be disposed near a surface of the skin of the patient 202 and emit light on the surface of the skin of the patient 202. In some embodiments, the light sources 212 (e.g., LEDs) may have a viewing angle and / or be spaced from one another such that an intensity of light emitted from the light sources 212 is above a predetermined threshold at the surface of the skin of the patient 202. In some embodiments, the light sources 212 may be spaced from one another such that no gaps in illumination exist at a side of theAttorney Docket No.: KDTC-002 / 01WO 353043-2007 protective shell 220 closest to the patient 202 and / or on the surface of the skin of the patient 202. For example, the light source 212 can be LEDs that are set apart (e.g., spaced) from one another such that the light projected by each LED on a surface that is a predefined distance away overlaps or extends from the light projected by its adjacent LEDs on that surface. In the case of LEDs having predefined viewing angles, the LEDs can be set at a predetermined distance from one another based on the viewing angle and a predetermined distance to the surface. In some embodiments, the viewing angle and the distance between the light sources 212 may be configured such that a light intensity is substantially evenly distributed across the surface of the skin of the patient 202.
[0066] In some embodiments, the light panel 210 may include about 10 light sources to about 2000 light sources, inclusive of all ranges and subranges therebetween. In some embodiments, the viewing angle of each light source 212 may be in a range of about 0 degrees to about 180 degrees, inclusive of all ranges and subranges therebetween. In some embodiments, the viewing angle of each light source 212 may be in a range of about 60 degrees to about 130 degrees, inclusive of all ranges and subranges therebetween. In some embodiments, it may be desirable to have a larger viewing angle such that each light source can project light over a larger area, and so that less light sources may need to be used to project light over a larger surface area. In some embodiments, a distance between adjacent light sources 212 may be in a range of about 2 mm to about 20 mm, inclusive of all ranges and subranges therebetween. As described above, in some embodiments, this distance may be set based on the viewing angle of the light sources 210 and / or a predetermined distance to a surface that the light is projected toward. Additionally, as described below, the light sources 210 may be disposed in a protective shell 220. When disposed in a protective shell 220, the shell may allow for transmission of light, such that light projected by the light sources 210 can reach a target surface (e.g., the skin of an infant). Additionally, to ensure that light is distributed across the skin of the infant, it may be desirable to have light sources 210 that collectively can project light across the thickness of the protective shell 220 to each point of the outer surface or edge of the protective shell 220. The light that projects outward from the edge of the protective shell 220 can then be configured to provide an even distribution of light. Further details of such an arrangement are described with respect to FIG. 7.
[0067] The plurality of light sources 212 and / or the FCB 212 may be disposed in a protective shell 220. In some embodiments, the protective shell 220 may include one or more portions orAttorney Docket No.: KDTC-002 / 01WO 353043-2007 layers. In some embodiments, the protective shell may include single or multiple protection layers that cover the light sources 212 of the panel to protect the light sources 212 from fire and fluids such as urine, food, feces, etc. In some embodiments, the protective shell 220 may be waterproof or liquid proof. In some embodiments, the protective shell 220 may include a first portion or layer configured to be disposed on a first side of the light source(s) 212 (e.g., the light emitting side) and / or a first side of the FCB 216. The first portion or layer of the protective shell 220 may protect the light source(s) 212 from damage (e.g., liquids such as sweat or urine or physical damage from force applied to the light source(s) 212). In some embodiments, the protective shell 220 may include a second portion or layer configured to be disposed on a second side of the light sources 212 (e.g., the non-emitting side) and / or a second side of the FCB 216 such that the protective shell 220 envelopes the light source(s) 212 and / or the FCB 216. In some embodiments, the first portion may be joined (e.g., sealed, affixed) to the second portion to form the shell to protect an internal environment of the shell from the external environment. In some embodiments, the protective shell 220 may act as a light guide to guide light from the light source(s) 212 to the skin of the patient 202. In some embodiment, the protective layer 220 may reduce stray light, e.g., by having surfaces that block light from straying outside of the desired target area or reflect light back toward the desired target area.
[0068] The protective shell 220 may include a transparent material such that light can pass through the protective shell 220 towards the patient 202. In some embodiments, at least a portion of the protective shell 220 covering the light sources 212 (e.g., a side of the light sources facing the patient 202) may have transparent material. In some embodiments, the protective shell 220 may be flexible such that the protective shell 220 can at least partially conform to the garment and / or the body of the patient 220. In some embodiments, the protective shell 220 can include any suitable material such as, for example, silicone, polyvinyl chloride (PVC), high medical grade transparent silicone, or a suitable combination thereof. In some embodiments, a protection level of the protective shell 220 material may be IP65. The material of the protective shell 220 may be a medical grade material. In some embodiments, the protective shell 220 may include materials which are compatible with standard cleaning and disinfectant fluids.
[0069] In some embodiments, the protective shell 220 may include a light-reflective layer, the light-reflective layer disposed on the second side of the light sources 212 and / or the second side of the FCB 216 such that stray light from the plurality of light sources 212 is reflected back to the surface of the skin of the patient. In some embodiments, the protective shell 200Attorney Docket No.: KDTC-002 / 01WO 353043-2007 may include a light-absorbing layer, the light-absorbing layer disposed on the second side of the FCB 216 such that stray light from the plurality of light sources 212 is absorbed. In some embodiments, the light-absorbing layer may include an opaque material that absorbs light. In some embodiments, the light-absorbing layer may include a material that is dark in color (e.g., dark blue, black, etc.). In some embodiments, the light-reflective layer may include a reflective material (e.g., silver / chrome).
[0070] In some embodiments, the protective shell 220 may include a plurality of cut outs 222 (e.g., indentations, spaces, openings, through holes, pockets, etc.). For example, the protective shell 200 may define the plurality of cut outs 222 between at least some adjacent light sources 212 of the plurality of light sources 212. In some embodiments, the first layer of the protective shell 220 may define a first portion of the cut outs 222 and the second layer of the protective shell 220 may define a second portion of the cut outs 222. In some embodiments, the first portion and the second portion may be configured to align to define an inner volume when the first layer and the second layer are adjoined. In some embodiments, only the first layer and / or only the second layer of the protective layer may define cut outs 222. In some embodiments, the cut outs 222 may be through holes (e.g., an absence of material) that extend from a first surface of the protective shell 220 to a second surface of the protective shell 220 such that the protective shell 220 is openwork or forms a lattice structure. In some embodiments, the protective shell 220 may include a plurality of indentations. In some embodiments, the cut outs 222 may be in one or more layers of the protective shell 220.
[0071] In some embodiments, the cut outs 222 may include any suitable shape such as, for example, a circle, an oval, a square, a rectangle, a diamond, a polygon, an abnormal shape, etc. In some embodiments, the indentations form an oval (e.g., an ellipsoid or a semi-ellipsoid).
[0072] In some embodiments, the light panel can include a plurality of openings (e.g., through holes) extending through the light panel 210. In some embodiments, the light panel 210 can include the openings in addition to or instead of the plurality of cut outs. In some embodiments, the plurality of openings can extend from a first side of the light panel to a second side of the panel. The plurality of openings can be configured to extend through all layers of the light panel. In some embodiments, the plurality of openings can be configured to allow heat dissipation of heat generated by the plurality of light sources of the light panel. In some embodiments, the plurality of openings can be disposed between light sources. In someAttorney Docket No.: KDTC-002 / 01WO 353043-2007 embodiments, the plurality of openings can be disposed outside of a viewing angle of the light sources. In some embodiments, the light panel 210 can include a plurality of cut outs 222 in the protective shell 220 and a plurality of openings extending through the protective shell 220.
[0073] In some embodiments, at each opening of the plurality of openings, the protective shell can include an overmolded portion to hold together layers of the light panel 210, as described further in FIGS. 24A-24B. For example, a material of the protective shell may seal an inner surface of each opening of the plurality of openings (e.g., to prevent separation between the plurality of layers of the light panel).
[0074] In some embodiments, a total thickness of the protective shell 220 may be in a range of about 2 mm (millimeters) to about 10 mm, inclusive of all ranges and subranges therebetween. In some embodiments, a total thickness of each cut out 222 may be in a range of about 0.5 mm to about 9.5 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the cut outs 222 may define an inner volume, and the inner volume of the cut outs 222 may be in a range of about 0.5 mm3to about 5 cm3, inclusive of all ranges and subranges therebetween. In some embodiments, a maximum cross-sectional area of the cut outs 222 may be in range of about 0.5 mm2to about 15cm2, inclusive of all ranges and subranges therebetween. In some embodiments, a total weight of the protective shell 220 with the cut outs 222 may be in a range of about 0.1 g (grams) to about 1 kg (kilogram), inclusive of all ranges and subranges therebetween. In some embodiments, the cut outs 222 may reduce a total weight of the protective shell 220 up to about 50%, about 60%, about 70%, about 80%, about 90%, about 95%. In some embodiments, the cut outs 222 may reduce a total weight of the protective shell 220 by about 95%. In some embodiments, the cut outs 222 may reduce a total weight of the light panel 210 by about X%. The reduced weight of the light panel 210 may reduce a pressure or force the light panel 210 exerts on a chest of an infant.
[0075] In some embodiments the cut outs 222 may be disposed over the light sources 212 such that light passes through the cut outs 222. In some embodiments, the cut outs 222 may be disposed between, adjacent, and / or above the light sources 212 such that the cut outs 222 are positioned outside of a light cone defined by the viewing angle of the light sources 212 and / or other path of light of the light sources. Alternatively, the cut outs 222 may intervene with a light path of the light sources 212, thereby changing a light distribution of light emitted from each light source 212. In some embodiments, the cut outs 222 may act like a converging lens.Attorney Docket No.: KDTC-002 / 01WO 353043-2007In some embodiments, the inner volume of the cut outs 222 may have a different refractive index than a refractive index of the protective shell material such an angle of light changes as the light moves through the cut outs 222. In some embodiments, the cut outs 222 (e.g., indentations) may be fully contained in the protective shell 220 meaning that an outer surface of the protective shell 220 feels smooth.
[0076] In some embodiments, the light panel 210 may be configured to emit light in a range of 0 pW / cm2 / nm to about 100 pW / cm2 / nm, inclusive of all ranges and subranges therebetween. In some embodiments, the light panel 210 may emit light at least 30 pW / cm2 / nm across an entire surface area of the light panel 210. In some embodiments, a wavelength of light emitted from the light panel 210 may be in a range of about 450 nm to about 500 nm, inclusive of all ranges and subranges therebetween. In some embodiments, a wavelength of light emitted from the light panel 210 may be in a range of about 465 nm to about 475 nm, inclusive of all ranges and subranges therebetween. In some embodiments, a surface area (e.g., an area of the patient) that the light panel 210 may be configured to emit light onto may be about 10 cm2, 50 cm2, 100 cm2, 200 cm2, 300 cm2, 400 cm2, 500 cm2, 600 cm2, 700 cm2, 800 cm2, 900 cm2, 1000 cm2, 1100 cm2, 1200 cm2, 1300 cm2, 1400 cm2, 1500 cm2, 1600 cm2, 1700 cm2, 1800 cm2, 1900 cm2. In some embodiments, the surface area may be up to 1300 cm2. In some embodiments, the light panel 210 may be configured to run using between about 5 mW to about 100 mW of power. In some embodiments, the light panel 210 may be configured to run using between about 50 mW to about 100 mW of power. In some embodiments, the light panel 210 may have about 10,000 to about 100,000 hours of lifetime.
[0077] In some embodiments, the light panel 210 may have any suitable configuration. For example, the light panel 210 may include a fiberoptic light source panel made of a single piece or assembled by several pieces to distribute the light. In some embodiments, the fiberoptic light source panel may be a flexible woven fiberoptic light source panel. In such embodiments, the fiberoptic panel may include a single layer or multiple layers, which can be assembled from a single piece or assembled from several pieces, to distribute the light. In some embodiments, the light panel 210 may include a plurality of LEDS couple to a flexible fiberoptic panel (FFP) to produce light with a predetermined wavelength and intensity and distribute light over a large surface area (e.g., greater than 1000 cm2). In some embodiments, the LEDs may be the light sources of the optical fibers which are coupled to the LEDs. In some embodiments, the optical fibers may be disposed in plastic shells. In some embodiments, the LED light sources may beAttorney Docket No.: KDTC-002 / 01WO 353043-2007 disposed outside of the garment shell. In some embodiments, the LEDs may be configured to produce light in opposing directions at opposite sides of the fiberoptic segment to increase light intensity. In some embodiments, the light panel 210 may include a plurality of pixels assembled by several LEDs. In some embodiments, the LEDs may be positioned to form a shape integrated into a single piece with or without a fiberoptic panel. In some embodiments, the light panel 210 may include a plurality of OLEDs and / or multiple pixels assembled by several OLEDs in any shape. The light panel 210 may be integrated into one piece with or without a fiberoptic panel. In some embodiments, the light panel 210 may include a plurality of portions coupled together to produce light with a predetermined wavelength and intensity and to distribute light over a large surface area. In some embodiments, the light panel 210 can be configured to include flexible arrays, meshes, sheets, or discrete devices. The light panel 210 may be structurally and / or functionally similar to the light panel 110, and therefore, certain details of the light panel 210 are not described in FIG. 2.
[0078] FIG. 3 is a schematic block diagram of a garment shell 300 configured to hold a light panel 310 for delivering phototherapy to an infant wearing the garment shell, according to embodiments. In some embodiments, the garment shell 300 may include a first fastener (e.g., a zipper) extending along the front side of the garment shell 300. The first fastener may be configured to be manipulated (e.g., unzipped, unclipped, unbuttoned, etc.) to open the garment shell 300 such that the infant can be disposed inside the garment shell 300. In some embodiments, the garment shell 300 may include any suitable material such as cotton, wool, polyester, linen, etc. In some embodiments, the garment shell 300 may include cotton. In some embodiments, a fabric of at least a portion of the garment shell 300 may be double-layered (e.g., to more effectively prevent light from escaping through the fabric than single layer). In some embodiments, at least a portion of the garment shell 300 may include double-layered cotton. In some embodiments, the garment shell 300 may be configured as one size or may be come in different sizes to fit to all body sizes and / or different age infants. In some embodiments, the garment shell 300 may be a swaddle. The garment shell 300, light panel 310, and breathable section 330 may be structurally and / or functionally similar to the garment shell 100, light panel 110, 210, and / or breathable section 130, and therefore, certain details of the garment shell 300 are not described in FIG. 3.
[0079] As shown, the garment shell 300 may include a first pocket (e.g., pocket 1) 304 disposed on or sewn to an inner surface of the garment shell 300. The first pocket may defineAttorney Docket No.: KDTC-002 / 01WO 353043-2007 a space in which a light panel is configured to be removably disposed. In some embodiments, the space of the first pocket may extend from a backside of the garment shell 300 to a front side of the garment shell 300. In some embodiments, the space may be configured such that the light panel covers a back of the infant and / or a portion of a front of the infant. In some embodiments, a first portion of the light panel 310 may cover a portion of the back of the infant and a second portion of the light panel 310 may cover a portion of the chest of the infant. Alternatively or additionally, the first pocket 304 may be configured such that the light panel covers the back of the infant and the sides of the infant, leaving a front portion of the infant (e.g., the chest and / or upper abdomen) exposed. In this way, the garment shell may enable skin- to-skin contact between the infant and the parent. In some embodiments, the first pocket 304 may include a transparent material such that light from the light panel 310 can shine through the transparent material towards the infant. In some embodiments, the first pocket 304 may include a mesh material. In some embodiments, the first pocket 304 may include a fabric such as polyester. In some embodiments, the first pocket 304 may include a second fastener (e.g., a zipper). In some embodiments, the second fastener may be accessible from a front and / or a back side of the garment 300. In some embodiments, the second fastener may be accessible from the back side of the garment 300. In some embodiments, the second fastener may be configured to be opened (e.g., unzipped) such that the light panel 310 can be disposed in the space.
[0080] In some embodiments, the garment shell 300 may include a second pocket (e.g., pocket 2) 305 defining a space configured to receive one or more additional components of the phototherapy system. For example, the second pocket 305 may be configured to receive the controller 350, the power source 345, and / or at least some of the sensor(s) 340. In some embodiments, the second pocket 305 may include a third fastener (e.g., a zipper) configured to open and close the second pocket 305. In some embodiments, the second pocket 305 may be disposed on a back side of the garment shell 300 and / or near a bottom of the garment shell 300.
[0081] In some embodiments, the garment shell 300 may further include a breathable section 330 (e.g., a mesh, lace, breathable fabric, one or more openings defined in a fabric, etc.) on at least a portion of the garment shell 300. The breathable section 330 may allow light or heat that is emitted by the light panel to exit the garment shell 300. In some embodiments, the breathable section 330 may at least partially align with a stomach and / or a bottom half of the infant when the infant is in the garment shell 300. In some embodiments, the breathable section 330 mayAttorney Docket No.: KDTC-002 / 01WO 353043-2007 be configured to align with at least a portion of the light panel 310 when the light panel 310 is disposed in the garment shell 300. In some embodiments, the garment shell 300 may include an active heat dissipation mechanism (e.g., a fan, a blower, a cooling material, etc.).
[0082] In some embodiments, the garment shell 300 may further include a protective flap 332. The protective flap 332 may be configured to selectively cover the breathable section 330. For example, the protective flap 332 may be movable between a first configuration in which the protective flap 332 does not cover the breathable portion 330, and a second configuration in which the protective flap 332 covers the breathable portion 330. In some embodiments, the protective flap 332 may be moved by a user (e.g., mother) between the first configuration and the second configuration. In some embodiments, the protective flap 332 may be coupled to and / or sewn to on side of the garment shell 300 such that the protective flap 332 can be moved over the breathable section 330. In some embodiments, the protective flap 332 may prevent light from escaping the garment shell 300. In some embodiments, the protective flap 332 may prevent light from shining toward the user holding the infant. In some embodiments, the protective flap 332 may include a material such as cotton (e.g., double-layered cotton). In some embodiments, the garment shell 300 may include a main body, the breathable section 330, and the protective flap 332. The main body and the protective flap 332 may include a first material and the breathable section 330 may include a second material that is different from the first material. In some embodiments, the first material may include cotton (e.g., double-layered cotton) and the second material may include a polyester (e.g., a mesh polyester). In some embodiments, the main body of the garment shell 300 may define a first space in which the infant is disposed and the first pocket 304 may define a second space separate from the first space in which the light panel is disposed.
[0083] In some embodiments, the garment shell 300 may further include a pair of arm holes 306. The pair of arm holes may define openings that are adjustable in size. For example, the arm holes 306 may each include zippers configured to loosen and / or tighten the arm holes 306. In some embodiments, the arm holes 306 may be configured to fit snug around the arms of the infant such that light does not escape the garment shell 300. For example, an outer edge of each arm hole 306 may be configured to abut the arm of the infant to prevent light from escaping through the arm hole 306. In some embodiments, the garment shell 300 may further include a neck hole 308 through which the infant’s head may be disposed. In some embodiments, the neck hole 308 may be coupled to a light shielding collar (hereinafter, “collar”) 311 configuredAttorney Docket No.: KDTC-002 / 01WO 353043-2007 to prevent light from escaping the garment shell 300 through the neck hole 308. In some embodiments, the collar 311 may protect the eyes and / or brain of the infant from being exposed to light. In some embodiments, the collar 311 may allow the infant to not wear protective glasses during phototherapy. In some embodiments, the collar may include an adjustable member such as, for example, a drawstring, a VELCRO®, an elastic band etc. to seal the light inside the garment shell 300.
[0084] FIG. 4 shows a phototherapy system including a garment shell 400 worn by an infant 402 and configured to hold a light panel to provide phototherapy to the infant 402, according to embodiments. As shown, the garment shell 400 may be a swaddle including a closed bottom. The garment shell 400 may include a pair of arm holes 406 through which the infant’s 402 arms may be disposed. Each arm hole 406 includes an adjustable portion (e.g., a zipper, drawstring, VELCRO®, etc.) such that the arm holes 406 can be adjusted to fit snug around the infant’s arms and prevent light from escaping the garment shell 400 through the arm holes 406. As shown, the arm holes 406 may each be zipped along a length of the arm holes 406 to decrease and / or increase a diameter of an opening defined by the arm hole 406. The garment shell 400 may further include a neck hole 408 through which the infant’s 402 head can be disposed. The neck hole 408 is coupled to a collar 411 including an adjustable portion such that the collar 411 can adjusted to prevent light from escaping the garment shell 400 and shining towards the infant’s face.
[0085] The garment shell 400 includes a first fastener 403 (e.g., zipper) extending along a length of the garment shell 400 and configured to open the garment shell 400 such that the infant 402 can be disposed inside. In some embodiments, the first fastener 403 may be on a front side of the garment shell 400. In some embodiments, the first fastener 403 may be on a back side of the garment shell 400. The garment shell 400 may further include a second fastener 407 (e.g., zipper) extending around at least a portion of a torso of the infant 402. The second fastener 407 may be coupled to a first pocket (not shown) disposed inside the garment shell 400. The second fastener 407 may be configured to open the first pocket such that a user can access the first pocket and dispose a light panel for delivering photo therapy into the first pocket.
[0086] As shown, the garment shell 400 further includes a breathable section 430 configured to allow light and / or heat to move out of the garment shell 400 and / or to allow cool air to moveAttorney Docket No.: KDTC-002 / 01WO 353043-2007 into the garment shell 400. The breathable section 430 may cover a lower half of the front side of the infant 402. The garment shell 400 may include a protective flap 432 configured to be moved to cover at least a portion of the breathable section 430. As shown, the protective flap 432 is in an open configuration (e.g., a first configuration) and can be transitioned to the closed configuration by the user. The phototherapy system and garment shell 400 may be structurally and / or functionally similar to the phototherapy system 1000 and garment shells 100, 300, and therefore certain aspects of the garment shell 400 are not described herein.
[0087] FIGS. 5A-5B show a front view and a back view, respectively, of a garment shell 500 configured to hold a light panel for delivery phototherapy to an infant, according to embodiments. As shown in FIG. 5A, the garment shell 500 includes a first fastener 503, a second fastener 507 coupled to a first pocket (not shown), a breathable section 530, a pair of arm holes 506, and a neck hole coupled to a collar 511. The garment shell 500 may be structurally and / or functionally similar to the garment shells 100, 300, 400, and therefore certain details of the garment shell 500 are not described herein.
[0088] The garment shell 500 may include sensor(s) 540 coupled to and / or sewn into a portion of the garment shell 500. As shown, the sensor(s) 540 is disposed on a chest portion of the garment shell 500 and / or a on a back portion of the garment shell 500. FIGS. 5A-5B shows an outline 510 corresponding to an upper boundary of the light panel inside a first pocket disposed in the garment shell 500. As shown, the light panel is configured to cover at least a chest of the infant.
[0089] As shown in FIG. 5B, the garment shell 500 further includes a second pocket 505 disposed on the back side of the garment shell 500. The second pocket 505 includes a zipper 509 configured to open and / or close the second pocket 505. The second pocket may be configured to receive the controller and / or the power supply 545. The power supply 545 may be configured to supply power to the light panel via one or more electrical connectors 556, 558 (e.g., a cable, wire, conductive trace, conductive thread, adapters, outlets, etc.). In some embodiments, the one or more electrical connectors 556, 558 may be sewn into the fabric of the garment shell 500. The garment shell 500 may include a first electrical connector 556 (e.g., an adapter) configured to connect the battery 545 and / or controller to a second electrical connector 558 (e.g., a cable, wire, conductive thread, etc.).Attorney Docket No.: KDTC-002 / 01WO 353043-2007
[0090] FIG. 5C is a photograph of the garment shell 500 showing the first pocket 504 in which the light panel is configured to be removably disposed, according to embodiments. As shown, the first pocket 504 includes a portion of fabric 514 (e.g., transparent fabric) sewn to an inner surface of a main body of the garment shell 500 such that the portion of fabric and the inner surface of the main body define a space therebetween. In some embodiments, the main body of the garment shell 500 and a first side of the portion of fabric 514 may define a first space in which the infant is disposed and the main body of the garment shell 500 and a second side of the portion of fabric 512 opposite the first side may define a second space separate from the first space in which the light panel is disposed. The first pocket 504 can include the fastener 507 to open and / or close the first pocket. As shown, the fastener 507 can be accessible to the user from inside the garment shell 500. The
[0091] FIGS. 6A-6B show a front side and a back side, respectively, of a garment shell 600 configured to hold a light panel for delivery phototherapy to an infant, according to embodiments. As shown in FIG. 6A, the garment shell 600 includes a first fastener 503 configured to open and / or close the garment shell 600 such that the infant can be disposed inside. The first fastener 603 may open a main body of the garment shell 600, which defines a first space in which the infant can be disposed. The garment shell 600 further includes a breathable section 630 forming a portion of a front side of the main body of the garment shell 600. As shown in FIG. 6B, the garment shell 600 further includes a first pocket 604 defining a second space physically separate from the first space. In some embodiments, the light panel is configured to be removably disposed in the second space defined by the first pocket 604. The first pocket 604 may include a portion formed from a transparent material such that light can shine through the transparent material into the first space in which the infant is disposed. The garment shell 600 further includes a second pocket 605 defining a third space configured to receive one or more electrical components. For example, the second pocket 605 may be configured to receive at least one of a power source and / or a controller. The second pocket 605 includes a second fastener 609 configured to open and / or close the second pocket. As shown, the second pocket 605 can be disposed on a lower back side of the garment shell 500. The garment shell 600 may further include a pair of arm holes 606 including an adjustable portion or fastener to change a size of the arm holes 606 (e.g., a zipper). The garment shell 600 may be structurally and / or functionally similar to the garment shells 100, 300, 400, 500 and therefore certain details of the garment shell 600 are not described herein.Attorney Docket No.: KDTC-002 / 01WO 353043-2007
[0092] FIG. 7 shows a schematic diagram of a cross-sectional side view of a light panel 710 including a plurality of light sources 712 and a protective shell 720, according to embodiments. As shown, the light sources 712 (LED’s) may be coupled to and / or disposed on a circuit board 716. The light sources 712 may include a distance D between adjacent light sources. In some embodiment, the protective shell 720 may have a thickness T. In some embodiments, the protective shell 720 may include one or more cut outs 722 disposed between the light sources 712. In some embodiments, the cut outs 722 may be in plane with the light sources 712. Alternatively, or additionally, the cut outs 722 can be in a different plane or extend into a different plane from the light sources 712. For example, the cut outs 722 can extend lower than the light sources, but remain outside of a light cone of the light sources 712. The cut outs 722 may be positioned such that the cut outs 722 are not disposed within a light cone of the light sources 712. As shown, the cut outs 722 may be semi-ovals (or semi-ellipsoids), however, it should be appreciated the cut outs 722 can have any suitable shape. In some embodiments, the circuit board 716 may transect the cut outs 722. The light sources 712 may each include a viewing angle a. In some embodiments, the distance D and the viewing angle a may be related by the equation: The distance D and the viewing angle a may be configured suchthat a total surface area at the edge of the protective shell 720 is illuminated (e.g., within the light cone). In some embodiments, the distance D and the viewing angle a may be configured such that greater than 80%, greater than 90%, greater than 95% of the total surface area at the edge of the protective shell 720 is illuminated. In some embodiments, the distance D may be about 1.5 cm to about 5 cm, inclusive of all ranges and subranges therebetween. In some embodiments, the viewing angle a may be about 100 degrees to 150 degrees, inclusive of all ranges and subranges therebetween. In some embodiments, the thickness T of the protective shell 720 may be in a range of about 0.5 mm to about 15 mm, inclusive of all ranges and subranges therebetween. The light source 712 shown in the dashed line may be optional because a total surface at the edge of the protective shell is illuminated by the other light sources 712 in the light panel 720. In some embodiments, the distance D, the thickness T, and the viewing angle a can be adjusted to evenly distribute the light emitted from the light panel. For example, these parameters may be adjusted such that an intensity of light is substantially evenly distributed (e.g., within 1%) of a desired value across the edge of the protective shell 720. The light panel 710 may be structurally and / or functionally similar to the light panels 110, 210, and therefore certain details of the light panel 710 are not described herein in FIG. 7.Attorney Docket No.: KDTC-002 / 01WO 353043-2007
[0093] FIG. 8 is an exploded view of a light panel 810 including a plurality of light sources 812 and a protective shell 820a, 820b, according to embodiments. As shown, the light panel 810 includes a plurality of light sources 812 arranged in an ordered configuration (e.g., a grid configuration). The light sources 812 include one or more traces and / or a circuit board 816 connecting them. In some embodiments, the protective shell may include a first layer 820a defining a first set of indentations 822a (e.g., oval indentations). The light sources 812 and the circuit board 816 may be disposed on a second layer 820b of the protective shell. The second layer 820b may define a second set of indentations 822b between each of the light sources 812. A position and / or a shape of the first set of indentations 822a may correspond to a position and / or shape of the second set of indentations 822b. For example, the first set of indentations 822a may align with the second set of indentations 822b such that the first and second set of indentations form a sphere and / or an ellipsoid defining an inner volume containing air. In some embodiments, the indentations may function as a convergent lens to converge light emitted by the light sources 812, thereby increasing an irradiance of the light. While FIG. 8 shows the protective shell as having a first layer 820a and a second layer 820b each including indentations 822a, 822b, it should be appreciated that the protective shell may only include one protective layer and / or only one protective layer may include indentations. The light panel 810 may be structurally and / or functionally similar to the light panels 110, 210, 710 and therefore certain details of the light panel 810 are not described herein in FIG. 8.
[0094] FIGS. 9A-9B show different configurations of light panels 910, 1010, according to embodiments. As shown in FIG. 9A, the light panel 910 forms a grid defining a plurality of square openings. At least some of the intersection points of the grid may include a light source 912. Each of the light sources 912 may be electrically connected and / or physically connected by the connectors (e.g., bands) 916. For example, each band 916 may include a conductive trace, a wire, a cable, etc. configured to electrically connected adjacent light sources 912. As shown, the light panel 910 forms a rectangle shape, although it should be appreciated the light panel 910 can form any suitable shape.
[0095] As shown in FIG. 9B, the light panel 1010 forms a grid defining a plurality of square openings. At least some of the intersection points of the grid may include a light source 1012. Each of the light sources 1012 may be electrically connected and / or physically connected by the bands 1016. For example, each band 1016 may include a conductive trace, a wire, a cable, etc. configured to electrically connected adjacent light sources 1012. As shown, the light panelAttorney Docket No.: KDTC-002 / 01WO 353043-20071010 forms a rectangle shape including a pair of projections. In some embodiments, the projections, extensions, or flaps of the light panel 1010 may be configured to wrap around from a back side of the infant towards a front side of the infant, e.g., when the light panel 1010 is disposed in a garment for delivery light therapy. The light panels 910, 1010 may be structurally and / or functionally similar to the light panels 110, 210, 710, 810, and therefore certain details of the light panels 910, 1010 are not described herein in FIGS. 9A-9B.
[0096] FIGS. 10A-10B show different configurations of light panels 1110, 1210, according to embodiments. As shown, the light panel 1110 forms a staggered grid configuration in which the light sources 1110 may be staggered. As shown, a first set of connectors 1121 may be physical connections and a second set of connectors 1116 may include electrical connections and / or include circuitry. For example, the first set of connectors 1121 may include silicone, and the second set of connectors 1016 may include circuits covered in silicone. The second set of connectors 1116 may provide data and / or power to and from the light sources 1112. In some embodiments, the second set of connectors 1016 may be configured to extend along a first direction (e.g., parallel to one another) and the first set of connectors 1121 may extend along a second and a third direction. For example, the first set of connectors 1121 may be arranged such that the light panel 1110 define a plurality of chevron-like shapes.
[0097] As shown in FIG. 10B, the light panel 1210 forms a staggered grid like configuration in which the light sources 1212 may be staggered. The light panel includes a first set of connectors 1221 that are physical connectors and a second set of connectors 1216 that include electrical connections and / or circuitry. In some embodiments, the first set of connectors 1221 may zig-zag. The zig-zag formation may provide stronger physical connections and can support a heavier weight of the light panel 1210. The zig-zag pattern may additionally increase irradiance of the light sources because the zig-zagging may increase overlap in light emitted between light sources. For LED design they want to make the light distribution more even. The light panels 1110, 1210 may both define openings (in other words they are open work panels). The light panels 110 may be structurally and / or functionally similar to the light panels 110, 210, 710, 810, 910, 1010, and therefore certain details of the light panel 1210, 1210 are not described herein in FIGS. 10A-10B.
[0098] FIG. 11 shows a protective shell 1320 configured to be coupled to a light panel, the protective shell 1320 including a light absorber 1318, according to embodiments. As shown,Attorney Docket No.: KDTC-002 / 01WO 353043-2007 the protective shell 1320 defines a plurality of cut outs 1322. The cut outs 1322 may extend from a first side of the protective shell 1320 through a second side of the protective shell 1320. As shown, the protective shell 1320 be openwork (e.g., form a lattice). The light absorber 1318 may not define openings. As shown, the light absorber 1318 is a solid piece of material. The light absorber may include an opaque or dark material such that light can be absorbed. In some embodiments, the light sources may be disposed along the edges of the cut outs 1322. In some embodiments, the light sources may be disposed at the intersection points of the openwork. In some embodiments, the light sources may be disposed along the edges of the openwork.
[0099] FIG. 12A is a diagram of a protective shell 1420 that includes cut outs 1422 disposed over the light sources 1412. As shown, the cut outs 1422 include a cross-sectional shape that is a circle. These cut outs 1422 may be disposed on an outer surface of the protective shell 1420 facing the skin of the infant and convex towards the skin of the infant (e.g., protrude towards the infant’s skin). Therefore, this design may be uncomfortable to the infant because of the protrusion towards the chest of the infant. In contrast, FIG. 12B is a diagram of a protective shell 1620 that includes cut outs 1622 disposed between adjacent light sources 1612 and on an inner surface of the protective shell 1620, according to embodiments. As shown, the light sources 1412 can be arranged in an ordered pattern, and the cut outs 1622 may disposed therebetween. As shown, the cut outs 1622 may be oval (or have an oval cross-section). The cut outs 1622 may be contained within the protective shell 1620 such that a surface of the protective shell facing the chest of the infant is flat and / or smooth. This design may be more comfortable for the infant, as there are no protrusions pressing on the infant’s chest. The protective shells 1420, 1620 may be structurally and / or functionally similar to any of the protective shells described herein, and therefore are not described in further detail in FIGS. 12A-12B.
[0100] FIG. 13 is a diagram of a light panel 1700 having a shape that corresponds to a pocket of a garment shell, according to embodiments. The light panel 1710 may include a plurality of light sources and a plurality of connections 1716 connecting the light sources (e.g., physically and / or electrically). As shown, the connections 1716 may be zig-zag connections to increase a strength of the physical connection and / or support a heavier weight and / or to increase irradiance of the light panel 1710. The light panel 1710 may include a central section 1710a with a first extension (e.g., flap, projection, etc.) 1710b and a second extension 1710c extending laterally therefrom. The central section 1710a may be configured to align with a back of theAttorney Docket No.: KDTC-002 / 01WO 353043-2007 patient, and the extensions 1710b, 1710c may each be configured to wrap around the patient and cover a portion of the chest of the patient.
[0101] FIGS. 14A-14B show examples of a user interface 1890 (e.g., executable on an external device) for controlling a light panel of a phototherapy system, according to embodiments. As shown in FIG. 14A, the user interface 1890 may present information related to: (1) the patient identification (ID) 1891, the practitioner ID 1893 of the practitioner associated with the patient, the garment ID 1895 of the garment associated with the patient, treatment parameters 1892a, 1892b, 1892c, including sensor data from sessions, and / or notes 1897 from sessions. For example, the user interface 1890 can show the light intensity 1892a delivered during a selected session, an upper temperature threshold 1892b used during the selected session, and / or a lower temperature threshold 1892c used during the selected session. The user interface 1890 may be configured such that the user can select icons for more information. In some embodiments, the user interface 1890 may be configured to receive user inputs. User inputs can include selections of parameters for the light therapy session (e.g., duration, intensity), notes related to a session, and / or inputs to stop or start power to the light panel.
[0102] As shown in FIG. 14B, the user interface 1890 may allow the user to select a date, and the user interface 1890 may display a session log including a plurality of session summaries 1898a, 1898b, 1898c. The session summaries 1898a- 1898c may include information related to the light therapy session(s) delivered on the date. As shown in FIG. 14C, the user interface may be configured to display a profile page for the patient including, for example, the patient ID 1891, information related to the patient 1894, notes related to the patient 1896, and / or a prescription 1895 associated with the patient for light therapy sessions. The user interface may provide an easy way for the caretaker of the infant to manage the phototherapy treatment using the phototherapy system. The user interface can allow real time or near real-time updates to be displayed to the user, thereby enabling the user to safely monitor the delivery of phototherapy sessions.
[0103] FIG. 15 is a flow chart diagram of method 1500 for delivery phototherapy using a phototherapy system, according to embodiments. Although method 1500 is described herein with respect to phototherapy system 1000, it should be appreciated that method 1500 is applicable for any phototherapy system described herein. The method 1500 may includeAttorney Docket No.: KDTC-002 / 01WO 353043-2007 receiving information associated with a light therapy session from an external device 180, at 1510. The information may include at least one of a duration of the session, a predetermined light intensity to be administered, a bilirubin level of the patient, a session history of the patient, etc. In some embodiments, a controller and / or an external device 180 coupled to the controller 150 may be configured to receive the information associated with the light therapy system 1000. In some embodiments, the information associated with the light therapy session may be a user input. At 1512, the method includes sending a signal to a light panel 110 (e.g., an LED panel) to cause the light panel 110 to emit light based on the information associated with the light therapy session. For example, the controller 150 may send a signal (e.g., voltage and / or current signal) such that the light panel 110 emits may light at the predetermined light intensity and / or for the predetermined amount of time. In some embodiments, a user can adjust parameters of the light therapy session (e.g., via the user interface). At 1514, the method includes monitoring one or more signals including at least one of a biosignal of an infant 102 or a signal related to an environment of a garment 100 in which the infant 102 is disposed. For example, the controller 150 may be configured to monitor (e.g., via the sensors 140) a temperature inside the garment 100 and / or a bilirubin level of the infant 102. The method may optionally include determining the one or more signals crosses a predetermined threshold, at 1516 (e.g., to keep the temperature below a predetermined threshold and / or the light intensity within a predetermined range). In some embodiments, the controller 150 may additionally or alternatively be configured to receive, before or during the light therapy session, information associated with a user input (e.g., from the external device) and / or the controller 150 may receive the user input directly.
[0104] The method 1518, may include adjusting an output of the light panel 110 in response to at least one of the one or more signals crossing the predetermined threshold or a user input. In some embodiments, if the at least one of the one or more signals crosses the predetermined threshold, the method may include increasing and / or decreasing an intensity of light or turning off the light panel 110. For example, if the temperature increases above the predetermined threshold (e.g., 40 degrees C), the method may include reducing the light intensity emitted by the light panel 110 and / or turning off the light panel 110. In some embodiments, the controller 150 may automatically adjust the output. In some embodiments, the user may manually adjust the output. In some embodiments, the method 1500 may optionally include alerting the user (e.g., via the external device 180) that a signal crossed a respective predetermined threshold.Attorney Docket No.: KDTC-002 / 01WO 353043-2007The method 1500 may further include storing information related to the light therapy session in a memory (e.g., on the controller 150 and / or on the external device 180.) In some embodiments, the information related to the light therapy session stored may inform future session. The method 1500 described herein, allows a user to remotely monitor and / or easily administer light therapy to an infant and to receive real-time and / or near real-time updates associated with the light therapy.Skin-to-Skin Garment:
[0105] In some embodiments, a garment shell for delivering phototherapy to an infant may be configured to facilitate skin-to-skin contact between the infant and adult (e.g., the parent) during a phototherapy session. Skin-to-skin contact may promote healthy development in infants, and may be especially important for neonatals. Therefore, it is desirable to enable skin- to-skin contact during phototherapy sessions. FIG. 16A shows an open configuration of a garment shell (e.g., “garment”) 1900 configured to facilitate skin-to-skin contact between an infant and an adult, according to an embodiment. FIG. 16B shows the garment 1900 in the closed configuration, according to an embodiment. In some embodiments, the garment 1900 in the closed configuration may only partially cover the infant (e.g., may leave one or more portions of the infant exposed) such that the infant can make skin-to-skin contact with the adult during the therapy session. For example, the garment 1900 in the closed configuration may form a shape such as a harness, overalls, a kangaroo baby carrier, or the like. In some embodiments, the garment 1900 in the closed configuration may be configured such that a chest, arms, and / or legs of the infant may be exposed such that the chest, arms, and / or legs of the infant can directly contact the skin of the adult / parent, as shown in FIGS. 17A-17B.
[0106] As shown in FIGS. 16A-17B, the garment includes a first portion 1900a configured to cover a back and sides of the infant (e.g., under the arms) and a second portion 1900b configured to extend under a bottom of the infant and to be secured to the first portion 1900a. The first portion 1900a may include extensions configured to wrap around the sides of the infant and fasten to the second portion 1900b. The garment 1900 may include one or more fasteners 1907a, 1907b configured to secure the garment 1900 in the closed configuration. For example, the extensions can each include fasteners 1907a (e.g., buttons, VELCRO®, adhesive, snap-fit mechanism, etc.) configured be coupled to a fastener 1907b (e.g., complementary buttons, VELCRO®, adhesive, snap-fit, etc.) to secure the extensions of the first portion 1900aAttorney Docket No.: KDTC-002 / 01WO 353043-2007 to an end of the second portion 1900b. When the first portion 1900a is secured to the second portion 1900b, the garment shell 1900 may define leg holes 1908 through which the legs of the infant may be disposed, as shown in FIG. 16B. In some embodiments, the second portion 1900b may be configured to provide support to a portion of the infant (e.g., the hips) when the infant is being carried in the garment 1900.
[0107] As shown in FIGS. 16A-16B, the garment 1900 may include a pocket 1910 configured to receive a light panel for delivering phototherapy to the infant. The light panel may be structurally and / or functionally similar to any of the light panels described herein, and therefore, certain details of the light panel are not described in further detail with respect to FIGS. 16A-18B. The pocket 1910 may be disposed on an inner surface of the garment 1900 and extend across the back of the garment shell 1900 to the sides (e.g., the extensions) of the garment 1900 such that when the light panel is disposed in the pocket 1910, the light panel aligns with or contacts the back and the sides of the infant. In some embodiment, the pocket 1910 may have a first opening through which the light panel is configured to be disposed, and may optionally include a second opening through which a cord configured to connect to a controller and / or power source may extend. The surface 1904 of the pocket 1910 may include a material configured to allow light to pass therethrough (e.g., a mesh, a translucent material, a transparent material, etc.). The second portion 1900b may not receive any light panel. The light panel may be configured to be disposed in the pocket 1910 such that light is emitted onto the back and the sides of the infant when the infant wears the garment 1900. In some embodiments, the light panel may have a smaller area than the first portion 1900a of the garment 1900. In some embodiments, the outer perimeter or edges of the garment 1900 can be configured to seal the light generated by the light panel inside the garment 1900. In some embodiments, the garment 1900 may be configured to form a snug fit with the infant to seal light within the garment and prevent light from straying away from the skin of the infant, as shown in FIGS. 17A-17B. For example, the first portion 1900a may be configured to directly contact the skin of the infant such that a majority or all of the light emitted from the panel is directed to the skin of the patient (e.g., infant) wearing the garment 1900 and not to a skin of the adult / parent. As shown, the garment shell 1900 covers the back and sides of the infant and a lower portion of a front side of the infant.
[0108] The garment may include straps 1906 configured to extend up and over the shoulders of the infant to secure the garment 1900 to the infant. As shown in FIGS. 17A-17B, the strapsAttorney Docket No.: KDTC-002 / 01WO 353043-20071906 may extend from the second portion 1900b of the garment 1900 to a top end of the first portion 1900a of the garment 1900. In some embodiments, the straps may include a material configured to be flexible, soft, and / or non-irritating to the skin of the infant. In some embodiments, the material may be transparent or semi-transparent. The material of the straps 1906 may be stretchable or include elastic. In some embodiments, the material of the straps 1906 may be configured to secure the straps 1906 and / or the garment 1900 in place, e.g., by being slip resistant or having grip. For example, the straps 1906 may include a material that gently grips the skin of the infant or prevents or resists slipping across the skin. The material of the straps 1906 may be any suitable material such as, for example, rubber, cotton, polyester, latex, nylon, or a suitable combination thereof. In some embodiments, the straps 1906 may include gauze (e.g., loosely woven material). In some embodiments, the straps 1906 may include or be formed of different material(s) than the first portion 1900a and the second portion 1900b of the garment 1900. In some embodiments, the first portion 1900a and the second portion 1900b of the garment 1900 may include or be formed of cotton (e.g., double-layered cotton). In some embodiments, the materials of the garment shell (e.g., the straps 1906 and the first and second portions 1900a, 1900b of the garment 1900) may include or be formed of a biocompatible material.
[0109] In some embodiments, the first portion 1900a and the second portion 1900b of the garment 1900 may include a material configured to hold a weight of the infant. The garment shell can be configured to be secured to the caregiver, and the garment shell can be configured to support a weight of the infant when the infant wears the garment shell and the garment shell is secured to the caregiver. In some embodiments, the garment 1900 may be coupleable to a securement member (not shown) configured to secure the infant and the garment 1900 to a torso of the adult. For example, the garment 1900 may be coupled to an outer shell, fabric, or strap(s) configured to secure the garment shell 1900 to the adult, e.g., as in the case of a kangaroo baby carrier.
[0110] FIG. 18A shows the garment shell 1900 coupled to a controller 1950. The garment shell may include a light panel disposed in the pocket 1910 thereof. As shown, the controller 1950 is coupled via a wire connector 1945 configured to exit from the pocket 1910 of the garment shell 1900. In some embodiments, the controller 1950 may be structurally and / or functionally similar to the controller 150, and therefore, certain details of the controller 1950 are not described herein with respect to FIG. 18 A. FIG. 18B shows a garment shell 2000Attorney Docket No.: KDTC-002 / 01WO 353043-2007 wirelessly coupled to a controller 2050. The garment shell 2000 may be structurally and / or functionally similar to the garment shell 100, 300, 1900, and therefore, certain aspects of the garment shell 2000 are not described herein with respect to FIG. 18B. The controller 2050 may include a communication interface configured to wirelessly couple to a communication interface integrated into the light panel. In some embodiments, the controller 2050 may be configured to be kept outside of the garment shell and wirelessly control function of the light panel disposed in a pocket 2010 defined by the garment 2000. Certain aspects of the garment shells 1900, 2000 may be similar to any of the garment shells described herein, and therefore, certain aspects of the garment shells, 1900, 2000 are not described in further detail herein with respect to FIGS . 16 A- 18B .Occupancy Sensing:
[0111] In some embodiments, a garment shell for delivering phototherapy to an infant may include an occupancy sensor or connector configured to detect when an infant is disposed in the garment shell and / or the garment shell is secured on or around the infant (e.g., baby sensing, occupancy detection, baby-in-swaddle detection, etc.). FIG. 19 shows a schematic diagram of an occupancy sensor 2130 configured to be coupled to the garment shell (and the light panel disposed thereon) to detect when the infant is wearing or secured in the garment shell. In some embodiments, the occupancy sensor 2130 may be implemented as a connector that can form a circuit when the garment is zipped up or otherwise enclosed around the infant. For example, the connector can include first and second portions that can engage with one another to form a circuit or electrical pathway. When the garment is zipped up and the connector is connected, the connector can enable power and / or signals to be sent to a light panel in the garment, e.g., by establishing a connection between the power source (e.g., power source 145) and / or controller (e.g., controller 150) and the light panel disposed in the garment. By establishing this connection, the connector can enable the light panel to be activated and controlled to deliver the phototherapy. For example, the connector can be configured to couple and decouple the light panel from the power source and / or controller to automatically result in the light panel turning on and off, respectively. In some embodiments, establishing the connection can also cause a signal indicating the infant is secured in the garment shell to be sent to the controller, which can result in the activation of the light panel. For example, the occupancy sensor 2130 may include an open configuration in which the circuit is open and a closed configuration in which the circuit is closed such that current can flow through the circuit to indicate the garmentAttorney Docket No.: KDTC-002 / 01WO 353043-2007 is secured around the infant and / or to power the light panel. In some embodiments, the occupancy sensor 2130 may be coupleable (e.g., electrically connected) to the light panel when the light panel is disposed in the garment. In some embodiments, the controller operatively coupled to the occupancy sensor 2130 may be configured to detect the current flowing through the circuit to determine the garment is secured on the infant, and in turn enable the light panel to be activated and / or to activate the light panel (e.g., automatically).
[0112] As shown, the occupancy sensor 2130 may include a first portion including a first electrical connector 2136a, a first elongate member (e.g., wire, cord, etc.) 2134a, and a first clasp 2132a (e.g., button, plug, electrical contact, connector, etc.). The occupancy sensor 2130 may further include a second portion including a second electrical connector 2136, a second elongate member 2134b, and a second clasp 2132b. In some embodiments, the first elongate member 2134a and the second elongate member 2134b may include an electrical connection (e.g., a wire, cable, etc.). The second clasp 2132b may include an extension (e.g., a pin, male banana connector, etc.) configured to be coupled a portion of the first clasp 2132a and / or disposed in an opening or cavity (e.g., female banana connector) defined by the first clasp 2132a. In some embodiments, the first portion may be electrically connected to electronics in the light panel via the first electrical connector 2136a, and the second portion of the occupancy sensor 2130 may be electrically connected to electronics in the light panel via the second electrical connector 2136b. In this way, the first portion and the second portion of the occupancy sensor 2130 and a portion of the light panel may be configured to collectively form a circuit. In some embodiments, the first portion and the second portion may be configured to be coupled to one another or to contact one another (e.g., via the first and second clasp 2132a, 2132b) to transition the occupancy sensor to the closed configuration (e.g., close the circuit) to signal the garment is secured on or around the infant, and enable the light panel to be activated and / or to automatically activate the light panel.
[0113] FIG. 20A shows a first clasp 2232a and a second clasp 2232b of an occupancy sensor in an open configuration (decoupled configuration). The first clasp 2232a and the second clasp 2232b in the open configuration may break a circuit of the occupancy sensor such that no current can flow therethrough. The lack of current through the occupancy sensor indicates the garment shell is not secured on the infant. As shown, the second clasp 2232b includes an extension 2233 configured to be disposed in a cavity defined by the first clasp 2232a to couple the first and second clasp 2232a, 2232b and transition the occupancy sensor to the closedAttorney Docket No.: KDTC-002 / 01WO 353043-2007 configuration. In some embodiments, the first and second clasps 2232a, 2232b may include a banana clasp, a pin and socket connector, a plug, or the like. FIG. 20B shows the first and second clasps 2232a, 2232b coupled to one another such that the occupancy sensor is in the closed configuration and current can flow therethrough.
[0114] FIG. 21 shows a pair of openings 2330 defined in a front portion of the garment 2300 through which a portion of the elongate members and the first and second clasps of an occupancy sensor are configured to extend such that the first and second clasps of the occupancy sensor can be coupled together. In some embodiments, occupancy sensor / connector can be desirably placed on the garment such that a user would need to decouple the connector to remove the infant from the garment. Therefore, the sensor can ensure that any light that is being generated by the garment is deactivated when a user opens the garment and removes the infant from the garment. For example, the occupancy sensor may be configured to extend across one or more fasteners of the garment such that the user has to couple and decouple the occupancy sensor when taking the infant in and out of the garment.
[0115] In some embodiments, the garment 2300 may include a first channel extending from a first opening from the pair of openings 2330 toward a first end of the light panel and a second channel extending from a second opening from the pair of openings 2330 toward a second end of the light panel. The first and second channel may be configured to receive the first portion and the second portion of the occupancy sensor, respectively. In some embodiments, the openings 2330 may open to an internal volume of the garment such that the elongate portion of the occupancy sensor extends within the internal volume of the garment to the light panel. The elongate portions of the occupancy sensor may be configured to extend through the channel such that the first and second clasps extend through the pair of openings 2330 to an outside of the garment. In this way, the clasping portion of the occupancy sensor may be disposed outside of the garment and can be configured to be clasped outside of the garment (e.g., over fastener of the garment, over a portion of the infant (e.g., a chest, an abdomen, etc.)). For example, once the infant is disposed inside the garment and the garment is fastened (e.g., via a zipper, VELCRO®, etc.), the clasps may be coupled to one another (e.g., by a user) across the fastener such that the occupancy sensor transitions to the closed configuration. Additionally, when the infant is taken out of the garment, the first and second clasps may be decoupled, thereby opening the circuit such that no current flows therethrough such that the light panel may be prevented from being activated. The controller may be configured to detectAttorney Docket No.: KDTC-002 / 01WO 353043-2007 current flow through the circuit to determine the baby is in the garment shell, and the controller may be configured to detect the break in current to determine that the infant is not secured in the garment. In some embodiments, the circuit in the closed configuration may enable the light panel to receive power from the power source such that the light panel can be activated.
[0116] FIG. 22 A shows the garment comparing a first portion (e.g., a shield portion) 2962 on the left side of the garment to a second portion 2960 with no shielding on the right side of the garment, according to embodiments. As shown, the shield portion 2962 blocks or shields light from passing through the garment to protect the face and eyes of the infant. In some embodiments, the shield portion 2962 of the garment shell can include an additional layer of material or fabric and can be located near a head of the infant (e.g., a shoulder area of the garment). In some embodiments, the shield portion 2962 of the garment can include one or more additional layers of material (e.g., two layers, three layers, four layers, etc.). In some embodiments, the garment can include double-layered cotton, and the shield portion 2962 can include one or more additional layers of cotton. In some embodiments, the shield portion 2962 of the garment shell can include a fabric with a thickness above a threshold to prevent light from passing through the material. In some embodiments, the thickness of the material of the shield portion 2962 can be greater than a thickness of the material in the rest of the garment shell such that the shield portion blocks lights while the rest of the garment shell is breathable. Although the shield portion 2962 is shown on one side of the garment, it should be appreciated that the shield portion 2962 can be disposed on both sides of the garment (e.g., across the shoulder portion of the garment). FIG. 22B delineates an example portion of the garment suitable for including the shield portion (e.g., the additional layer of material). As shown, the portion of the garment shell above the line 2961 can include the shield portion.
[0117] FIG. 23 shows a light panel 2410 including a plurality of light sources 2412 and defining a plurality of openings 2423 therethrough, according to embodiments. In some embodiments, the light panel 2410 can include a plurality of light sources 2412 arranged in an organized manner. The light panel 2410 may include a central section 2410a with a first extension (e.g., flap, projection, etc.) 2410b and a second extension 2410c extending laterally therefrom. The central section 2410a may be configured to align with a back of the infant, and the extensions 2410b, 2410c may each be configured to wrap around the infant and cover a portion of the sides of the infant, the stomach of the infant, and / or the chest of the infant. In some embodiments, the light panel 2410 can be configured to fit into a swaddle garment. InAttorney Docket No.: KDTC-002 / 01WO 353043-2007 some embodiments, the light panel 2410 can be configured to fit into a kangaroo carrier garment (e.g., overall, harness, etc.)
[0118] In some embodiments, the light panel 2410 can include a flexible circuit board (not shown) coupled to the plurality of light sources 2412. In some embodiments, the plurality of light sources 2412 and the flexible circuit board can be coupled together to form a light emitting assembly (e.g., the plurality of light sources and / or the flexible circuit board). In some embodiments, the protective shell 2420 can be configured to at least partially enclose the light emitting assembly. In some embodiments, the light panel 2410 can include a plurality of layers. In some embodiments, the protective shell 2420 can include a plurality of layers. For example, the protective shell 2420 can include a first layer disposed on a first side of the light emitting assembly and the protective shell 2420 can include a second layer disposed on a second side of the light emitting assembly. Therefore, the light panel 2410 can include a third layer including the light emitting assembly (e.g., the plurality of light sources 2410 and the flexible circuit board).
[0119] In some embodiments, the light panel 2410 can define a plurality of openings (e.g., holes, apertures, through holes, etc.) 2423 extending from a first side of the light panel 2410 to a second side of the light panel 2410. The plurality of openings 2423 can be configured to extend through all layers of the light panel 2410. In some embodiments, the plurality of openings 2423 can be configured to allow heat dissipation of heat generated by the plurality of light sources 2412 of the light panel 2410. In some embodiments, the plurality of openings 2423 can be disposed between light sources 2412. In some embodiments, the plurality of openings 2423 can be disposed outside of a viewing angle of the light sources 2412. In some embodiments, the light panel 2410 can define the plurality of openings 2423 in addition to or instead of the plurality of cut outs 2422 (e.g., similar to any of the cut outs described herein such as the cut outs 222 described with respect to FIG. 2). In some embodiments, the light panel 2410 can include a plurality of cut outs 2422 in the protective shell 2420 (e.g., but not extending through all the layers of the protective shell 2420) and a plurality of openings extending through the protective shell 2420. In some embodiments, the light panel 2410 can include any suitable number of openings 2423 such as between about 1 opening to about 1000 openings, inclusive of all values and subranges therebetween.Attorney Docket No.: KDTC-002 / 01WO 353043-2007
[0120] In some embodiments, the plurality of light sources 2423 can include a plurality of sets (or groupings) of light sources configured to be independently (e.g., selectively) controlled. In some embodiments, the sets of light sources are grouped into sections of the light panel. In some embodiments, the light panel can be a light panel assembly that include sections that are physically separate from one another. For example, the light panel can include three separate sections (e.g., a central section and two side extension sections). The separate sections can improve how easily the light panel fits inside the swaddle. In some embodiments, the light panel 2410 can include a plurality of sets of light sources distributed across the light panel 2410. In some embodiments, light panel 2410 can include a first set of light sources and a second set of light sources. In some embodiments, the first set of light sources can be configured to align with the back of the infant when the light panel is disposed in the garment. For example, the first set of light sources can be configured to be disposed on the central section 2410a of the light panel. In some embodiments, the second set of light sources can be configured to be disposed on one or both of the extensions 2410b, 2410c. In some embodiments, the first set of light sources and the second set of light sources can be independently activated or turned off to control an amount of light and / or heat emitted from the light panel 2410. In some embodiments, each extension 2410b, 2410c can include a separate set of light sources that are independently controlled. In some embodiments, the extensions can include a set of light sources that are controlled together.
[0121] In some embodiments, the plurality of light sources are coupled to a controller (not shown). In some embodiments, the controller can be operatively coupled to one or more switches. The one or more switches can cause the controller to control a respective set of light sources of the plurality of light sources. In some embodiments, the plurality of light sources can be coupled to a plurality of controllers, and each controller can control a respective set of light sources. In some embodiments, the light panel 2410 can be operatively coupled to a sensor configured to measure signals corresponding to a light intensity emitted from the light panel 2410, a temperature around the light panel 2410, and / or a humidity around the light panel 2410 (e.g., inside the garment). In some embodiments, the controller can be configured to adjust an output of the first set of light sources or the second set of light sources based on the signals measured by the sensor. For example, the sensor can be configured to monitor a signal including at least one of a biosignal of the infant or a signal associated with the garment (e.g., a temperature around the light panel 2410), and the controller can be configured to adjust (e.g.,Attorney Docket No.: KDTC-002 / 01WO 353043-2007 independently) an output of a set of light emitters of the plurality of light emitters. In some embodiments, the controller can be configured to turn off at least one of the first set of light sources or the second set of light sources. In some embodiments, the controller can be configured to turn off the first set of light sources or the second set of light sources in response to the signal crossing a predetermined threshold (e.g., the predetermined temperature or light intensity thresholds described above). In some embodiments, the controller can be configured to turn off the first set of light emitters while keeping the second set of light emitters activated. Therefore, the infant can receive continuous light exposure without the light panel 2410generating heat above a predetermined threshold (e.g., a safety threshold). In some embodiments, the controller can be configured to cycle through the plurality of sets of light sources.
[0122] In some embodiments, the controller can be configured to turn off the first set of light sources (e.g., aligned with the back of the infant) when the infant is laying on their back, while the second set of light sources (e.g., on the extensions of the light panel) remain activated. The selective activation of different sets of light sources can allow for heat generated by the light panel to dissipate.
[0123] In some embodiments, at each opening of the plurality of openings 2423, the protective shell 2420 can include an overmolded portion to hold together layers of the light panel, as described further in FIGS. 24A-24B. For example, a material of the protective shell 2420 may seal an inner surface of each opening of the plurality of openings (e.g., to prevent separation between the plurality of layers of the light panel). The light panel 2410 can be structurally and / or functionally similar to the light panel 110, 210, 310, 710, 1710, and therefore, certain details of the light panel 4510 are not described herein with respect to FIG. 23.
[0124] FIGS. 24A-24B show a close-up view of an opening 2523 of a plurality of openings defined in a first layer 2510 of a light panel, according to embodiments. The light panel can include an opening 2523 extending through all layers of the light panel 2510 (e.g., a first protective shell layer, a second protective shell layer, and / or a flexible circuit). In some embodiments, each opening 2423 can each have an outer diameter XI in a range between about 3 mm and about 10, inclusive of all values and subranges therebetween. In some embodiments, the plurality of openings can have an outer diameter XI in a range between about 5 mm andAttorney Docket No.: KDTC-002 / 01WO 353043-2007 about 6 mm, inclusive of all values and subranges therebetween. In some embodiments, each opening 2423 can have an inner diameter X2 in a range between about 1 mm and about 8 mm, inclusive of all values and subranges therebetween. In some embodiments, the inner diameter X2 can be in a range between about 3 mm and about 5 mm, inclusive of all values and subranges therebetween. In some embodiments, dimensions of the openings of the light panel can vary depending on a size of the garment (e.g., smaller garment may have smaller dimensions).
[0125] The material of the protective shell of the light panel can form a seal along an inner surface of the opening 2523 to hold the layers of the light panel together. In some embodiments, a portion of the material of a first layer 2510 of the protective shell can extend beyond a first surface 2519 of the first layer 2510 of the protective shell. For example, the first layer 2510 of the protective shell can have a raised portion 2527 (e.g., overmold, overhang, etc.) around the opening 2523. In some embodiments, the raised can include a groove 2529 circumferentially around the raised portion 2527 such that the raised portion forms a lip (e.g., flange, rim, etc.) 2527. Therefore, the raised portion 2527 can form a dovetail. In some embodiments, the groove 2529 have a width Y1 between about 0.1 mm and about 0.5 mm, inclusive of all values and subranges therebetween. In some embodiments, the lip (e.g., the portion above the groove) can have a height Y2 in a range between about 0.1 mm and about 0.5 mm, inclusive of all values and subranges therebetween. In some embodiments, the raised portion 2527 (e.g., the dovetail) can act as a fastener configured to hold the layers of the light panel together. For example, the first layer 2510 of the protective shell can include the dovetail, and the second layer of the protective shell can include a geometry configured to receive the dovetail such that the first layer and the second layer of the protective shell are held together (e.g., with the flexible circuit therebetween). In some embodiments, the protective shell of the light panel 2510 can be formed from a mold, and the mold can be configured such that a material of the protective shell is molded into a shape in which the inner surface of the opening is sealed (or substantially sealed). For example, the mold can be configured such that the material of the protective shell is molded into a shape in which the opening forms the raised portion 2527 that couples a second layer of the protective shell thereto such that an inner surface along the opening 2623 is sealed or closed.
[0126] FIGS. 25A-25B show a three-dimensional view of an opening 2623 of the plurality of openings of a layer of a light panel 2610, according to embodiments. As shown, the opening 2623 includes a raised portion 2627 that extends beyond a surface of the protective shell (e.g., the polymer such as silicone). In some embodiments, the portion that extends beyond theAttorney Docket No.: KDTC-002 / 01WO 353043-2007 surface can include a groove therein and form a lip. The raised portion 2627 can be configured to hold the layers of the light panel together (e.g., can fasten to a second layer of the protective shell).
[0127] FIGS. 26A-26D show a bassinet 2700 (e.g., crib, carrier, etc.) for holding an infant, according to embodiments. In some embodiments, the bassinet 2700 can be for holding an infant receiving light therapy via a garment (e.g., any of the garments described herein). The bassinet 2700 can a body including a bottom surface 2720 and one or more sidewalls 2710. In some embodiments, the bassinet 2700 can include an open top. The bassinet 2700 can include a breathable material on at least a portion of the bottom surface 2720 and / or at least a portion on the one or more sidewalls 2710 of the bassinet 2700. The breathable portion can be configured to allow air flow (shown with arrows in FIGS. 26C-26D) around the infant to facilitate heat dissipation of heat generated by the garment. In some embodiments, the breathable material can include a mesh. As shown, a portion of the sidewalls 2710 can be formed from mesh. In some embodiments, ends 2712 of the sidewall 2710 of the bassinet (e.g., near where a head or feet of the infant would be located) can include a solid material. In some embodiments, the bassinet can include support members 2715 (e.g., feet, legs, etc.) configured to hold the body of the bassinet 2700 off the ground. In some embodiments, a bottom surface of the bassinet 2700 can have a portion 2720 that is breathable and one or more portions 2722 that are solid (or less breathable), as shown in FIG. 26C. In some embodiments, a central portion of the bottom surface can include breathable material (e.g., mesh). In some embodiments, an entire bottom surface of the bassinet 2700 can include the breathable material.
[0128] In some embodiments, the bassinet 2700 can be operatively coupled to a controller. The controller can be operatively coupled the garment and or one or more sensors disposed on the bassinet. In some embodiments, the bassinet 2700 can include a sensor coupled thereto, the sensor configured to measure signals associated with an environment in the bassinet. In some embodiments, the controller can be configured to receive signals associated with the environment in the bassinet 2700 and control one or more external devices based on the signals / For example, the bassinet 2700 can be coupled to or disposed near one or more active sources of air flow. In some embodiments, the one or more active sources of air flow can include at least one of a fan or a cooling surface. In some embodiments, the one or more active sources of air flow can be configured to blow air through the crib and / or around the infant (e.g., underneath the infant). In some embodiments, the bassinet 2700 can be coupled to a source ofAttorney Docket No.: KDTC-002 / 01WO 353043-2007 humidity (e.g., a humidifier). In some embodiments, the controller can be configured to send a signal to control the one or more active sources of air flow and / or the humidifier based on the signals measured by the sensor. For example, the controller can monitor a temperature within the bassinet (or the garment) and can be configured to turn on the one or more active sources of air flow if the temperature increases above a threshold. In some embodiments, the sensor can be configured to measure a humidity in the bassinet 2700, and the controller can be configured to activate the humidifier if the humidity drops below a threshold to prevent dehydration of the infant.
[0129] FIG. 27 shows a bassinet 2800 for holding an infant receiving light therapy, according to embodiments. In some embodiments, the bassinet 2800 can be for holding an infant receiving light therapy via a garment (e.g., any of the garments described herein). The bassinet 2800 can a body including a bottom surface 2820 and one or more sidewalls 2810. In some embodiments, the bassinet 2800 can include an open top. The bassinet 2800 can include a breathable material on at least a portion of the one or more sidewalls 2810 of the bassinet 2800. The breathable portion can be configured to allow air flow around the infant to facilitate heat dissipation of heat generated by the garment. In some embodiments, the breathable material can include a mesh. As shown, a portion of the sidewalls 2810 can be formed from mesh. In some embodiments, the bottom 2820 of the bassinet 2800 can be a solid surface (e.g., without mesh). In some embodiments, the bottom 2820 of the bassinet can include a double layered cotton. In some embodiments, the bassinet 2800 can include support members 2815 (e.g., feet, legs, etc.) configured to hold the body of the bassinet 2800 off the ground. The bassinet 2800 can be structurally and / or functionally similar to the bassinet 2700 of FIGS. 26A-26D, and therefore, certain details of the bassinet 2800 are not described herein with respect to FIG. 27.
[0130] FIG. 28 shows a support surface 2850 (e.g., hammock) configured to clip to the bassinet 2800 to support the infant in the bassinet, according to embodiments. In some embodiments, the support surface 2850 can be configured to be coupled to any bassinet 2800 or crib (e.g., the bassinets described herein). In some embodiments, the support surface 2850 configured to support an infant receiving light therapy via a garment, the support surface 2850 configured to couple to (e.g., clip onto) a bassinet 2800 and extend over an opening of the bassinet 2800 to support the infant in the bassinet 2800. The support surface 2850 cam include a breathable material configured to allow air flow therethrough. The support surface 2850, when couple to the bassinet 2800, can be configured to be spaced a distance from a bottomAttorney Docket No.: KDTC-002 / 01WO 353043-2007 surface 2820 of the bassinet 2800 to allow air flow around the infant, thereby facilitating heat dissipation of heat generated by the garment. In some embodiments, the support surface 2850 can have dimensions corresponding to the bassinet 2800 such that the support surface 2850 can extend across the opening of the bassinet 2800. In some embodiments, the support surface 2850 can have adjustable dimensions such that the support surface 2850 can be coupled to different bassinets or cribs. In some embodiments, the support surface 2850 can include one or more fasteners 2861 configured to fasten to an edge of the bassinet 2800, as shown in FIG. 28. In some embodiments, the one or more fasteners 2861 can clip to or be coupled to a top surface of the bassinet 2800. In some embodiments, a portion 2852 of the support surface 2850 can include the breathable material (or mesh). For example, a central portion 2852 of the support surface 2850 (e.g., where the infant is to be positioned) can include the breathable material. In some embodiments, an outer portion 2862 (e.g., perimeter) of the support surface can be formed from a material having sufficient structural support to support a weight of the infant. In some embodiments, the support surface 2860 can include a sensor configured to measure one or more signals associated with an environment around the infant and / or in the bassinet. In some embodiments, the support surface 2860 can be fastened within an inner volume of the bassinet but spaced from the bottom surface of the bassinet 2800. In this way, the support surface 2850 can allow air flow around (e.g., underneath) the infant while the sidewalls of the bassinet 2800 hold the infant within the bassinet 2800. In some embodiments, the sidewalls of the basinet 2800 can have coupling portions at a predetermined height along the sidewall configured to couple to the support surface (e.g., the fasteners of the support surface).
[0131] In some embodiments, a kit comprises a garment shell configured to removably receive a light panel to provide light therapy to an infant, and a bassinet configured to allow dissipation of heat generated by the light panel. In some embodiments, a kit comprises a basinet and a support surface configured to be coupled to the bassinet and support an infant thereon, the support surface including breathable material to allow dissipation of heat generated by delivery of a light therapy to the infant. In some embodiments, a kit comprises a garment shell configured to removably receive a light panel to provide light therapy to an infant, a bassinet including breathable material, and a support surface configured to be coupled to the bassinet and support an infant thereon, the support surface including breathable material. In some embodiments, the garment shell of the kits can be similar to or the same as any of the garment shells described herein. The light panel of the kits can be similar to or the same as any of theAttorney Docket No.: KDTC-002 / 01WO 353043-2007 light panels described herein. In some embodiments, the bassinet of the kits can be similar to or the same as any of the bassinets described herein.
[0132] Alternatively or additionally, one or more fasteners of the garment can operate as the occupancy sensor. In some embodiments, one or more portions of the garment itself may be configured to include electrical contact points electrically connected to the light panel. For example, one or more buttons on the neck portion of the garment may include conductive material and be electrically coupled to the electronics of the light panel such that when the buttons are coupled together, a closed circuit is formed, and the light panel can be activated (e.g., may be automatically activated in response to the buttons being coupled). In some embodiments, any one of the fasteners on the garment may include a conductive material configured to form a circuit with the light panel when the fasteners are coupled together such that light panel can be activated.
[0133] In some embodiments, the garment may include one or more proximity sensors (e.g., infrared sensors) configured to measure one or more signals corresponding to a distance between the light panel and a skin of the infant. In some embodiments, the one or more proximity sensors may be disposed on a side of the light panel configured to face the skin of the infant and may be operatively coupled to the controller of the phototherapy system. In some embodiments, the proximity sensors may be used to determine whether the infant is disposed in the garment based on the distance determined between the light panel and the skin. In some embodiments, the controller may be configured to determine that the infant is in the garment when the distance between the light panel and the skin falls below a first predetermined threshold. In some embodiments, the controller may be configured to determine that the infant is not inside the garment and / or has been removed from the garment when the distance between the light panel and the skin of the infant exceeds a second predetermined threshold. In some embodiments, the controller may be configured to turn on and / or off (e.g., automatically) based on the distance between the light panel and the skin. For example, when the distance exceeds the second predetermined threshold, the controller may automatically turn off the light panel. In some embodiments, the controller may be configured to adjust an intensity of light emitted from the light panel based on the one or more signals collected by the proximity sensors (e.g., based on the distance between the infant and the light panel).Attorney Docket No.: KDTC-002 / 01WO 353043-2007
[0134] Various concepts may be embodied as one or more methods, of which at least one example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments. Put differently, it is to be understood that such features may not necessarily be limited to a particular order of execution, but rather, any number of threads, processes, services, servers, and / or the like that may execute serially, asynchronously, concurrently, in parallel, simultaneously, synchronously, and / or the like in a manner consistent with the disclosure. As such, some of these features may be mutually contradictory, in that they cannot be simultaneously present in a single embodiment. Similarly, some features are applicable to one aspect of the innovations, and inapplicable to others.
[0135] In addition, the disclosure may include other innovations not presently described. Applicant reserves all rights in such innovations, including the right to embodiment such innovations, file additional applications, continuations, continuations-in-part, divisionals, and / or the like thereof. As such, it should be understood that advantages, embodiments, examples, functional, features, logical, operational, organizational, structural, topological, and / or other aspects of the disclosure are not to be considered limitations on the disclosure as defined by the embodiments or limitations on equivalents to the embodiments. Depending on the particular desires and / or characteristics of an individual and / or enterprise user, database configuration and / or relational model, data type, data transmission and / or network framework, syntax structure, and / or the like, various embodiments of the technology disclosed herein may be implemented in a manner that enables a great deal of flexibility and customization as described herein.
[0136] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.
[0137] As used herein, in particular embodiments, the terms “about” or “approximately” when preceding a numerical value indicates the value plus or minus a range of 10%. Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lowerAttorney Docket No.: KDTC-002 / 01WO 353043-2007 limit of that range and any other stated or intervening value in that stated range is encompassed within the disclosure. That the upper and lower limits of these smaller ranges can independently be included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.
[0138] The phrase “and / or,” as used herein in the specification and in the embodiments, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and / or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
[0139] As used herein in the specification and in the embodiments, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the embodiments, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e., “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the embodiments, shall have its ordinary meaning as used in the field of patent law.
[0140] As used herein in the specification and in the embodiments, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarilyAttorney Docket No.: KDTC-002 / 01WO 353043-2007 including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and / or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.
[0141] In the embodiments, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of’ and “consisting essentially of’ shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.
[0142] While specific embodiments of the present disclosure have been outlined above, many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the embodiments set forth herein are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the disclosure. Where methods and steps described above indicate certain events occurring in a certain order, those of ordinary skill in the art having the benefit of this disclosure would recognize that the ordering of certain steps may be modified and such modification are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. The embodiments have been particularly shown and described, but it will be understood that various changes in form and details may be made.
Claims
Attorney Docket No.: KDTC-002 / 01WO 353043-2007Claims1. An apparatus, comprising: a garment shell configured to be worn by an infant, the garment shell including: a first portion including a back section and a pair of side extensions, the back section configured to cover a back of the infant, the pair of side extensions extending from the back section and configured to wrap around sides of the infant; a second portion configured to extend under a bottom of the infant and to be secured to the pair of side extensions; and a pocket disposed on an inner surface of the first portion, the pocket defining a space in which a light panel is configured to be removably disposed, the light panel including a plurality of light sources configured to emit light at a predetermined wavelength and intensity to deliver light therapy to the infant, the garment shell configured to keep a front portion of the infant exposed such that the front portion of the infant can directly contact skin of an adult while the infant receives the light therapy.
2. The apparatus of claim 1, wherein the garment shell, when worn by the infant, keeps at least one of arms, legs, or a chest of the infant exposed.
3. The apparatus of claim 1, wherein the garment shell, when the second portion is secured to the pair of side extensions, defines a pair of leg holes.
4. The apparatus of claim 1, wherein the garment shell further includes a pair of straps, each strap from the pair of straps having a first end coupled to the back section and a second end coupling to a respective side extension, the pair of straps configured, when the infant wears the garment shell, to extend over a chest of the infant.
5. The apparatus of claim 4, wherein the pair of straps include stretchable material.Attorney Docket No.: KDTC-002 / 01WO 353043-20076. The apparatus of claim 1, wherein the garment shell is configured to be secured to the adult, the garment shell configured to support a weight of the infant when the infant wears the garment shell and the garment shell is secured to the adult.
7. The apparatus of claim 1, wherein the light panel includes one or more sensors coupled thereto, the one or more sensors configured to monitor at least one of a biosignal of the infant or a signal associated with the garment shell.
8. The apparatus of claim 7, wherein the biosignal of the infant may include a bilirubin level of the infant.
9. The apparatus of claim 7, wherein the signal associated with the garment shell includes at least one of a location of the garment shell, a temperature inside the garment shell, a temperature of the light panel, or a humidity inside the garment shell.
10. The apparatus of claim 1, wherein a portion of the pocket includes a transparent material such that light emitted from the light panel reaches skin of the infant when the infant wears the garment shell.
11. The apparatus of claim 1, wherein the plurality of light sources includes light emitting diodes (LEDs).
12. The apparatus of claim 1, wherein light panel includes: a flexible circuit board; and a protective shell configured to enclose the plurality of light sources and the flexible circuit board, the protective shell including a plurality of openings extending through the protective shell, the plurality of openings configured to allow dissipation of heat generated by the plurality of light sources.
13. The apparatus of claim 1, wherein the plurality of light sources includes a first set of light sources and a second set of light sources, the first set of light sources and the second set of light sources being independently controlled.Attorney Docket No.: KDTC-002 / 01WO 353043-200714. The apparatus of claim 13, wherein the first set of light sources aligns with the back section of the garment shell, and the second set of light sources aligns with the pair of side extensions of the garment shell.
15. An apparatus, comprising: a flexible circuit board; a plurality of light sources coupled to the flexible circuit board, the plurality of light sources including a plurality of sets of light sources, the plurality of sets of light sources configured to be independently activated via the flexible circuit board; and a protective shell coupled to the flexible circuit board and the plurality of light sources and configured to at least partially enclose the plurality of light sources, the protective shell including a plurality of openings extending through the protective shell, the plurality of openings configured to allow dissipation of heat generated by the plurality of light sources, the plurality of light sources configured to be disposed near a surface of skin of an infant and emit light on the surface of the skin of the infant.
16. The apparatus of claim 15, wherein the protective shell further includes a plurality of cut outs disposed between at least some adjacent light sources of the plurality of light sources.
17. The apparatus of claim 16, wherein the plurality of cut outs reduces a total weight of the protective shell.
18. The apparatus of claim 15, wherein a viewing angle of each light sources of the plurality of light sources is in a range between 0 degrees and 180 degrees.
19. The apparatus of claim 15, wherein the protective shell including a first layer and a second layer joined together, the first layer being disposed on a first side of the plurality of light sources and the second layer disposed on a second side of the plurality of light sources opposite the first side, the first layer and the second layer sealed together at an inner surface of each opening of the plurality of openings.Attorney Docket No.: KDTC-002 / 01WO 353043-200720. The apparatus of claim 15, wherein at least a portion of the protective shell is transparent.
21. The apparatus of claim 15, wherein the apparatus is configured to be disposed in a garment that is fully portable, the flexible circuit board is coupled to a controller and one or more batteries each configured to be disposed in a portion of the garment.
22. The apparatus of claim 21, wherein the apparatus further includes: a sensor configured to measure one or more signals associated with the garment, the controller is configured to: determine if the one or more signals crosses a predetermined threshold; and turn off at least one of a first set of light sources or a second set of light sources in response to the one or more signals crossing the predetermined threshold.
23. The apparatus of claim 22, wherein the one or more signals includes a temperature near the apparatus or an intensity of light.
24. The apparatus of claim 15, wherein the plurality of light sources includes light emitting diodes (LEDs).
25. A system, comprising: a light panel configured to be disposed in a garment for an infant, the light panel including a first set of light sources and a second set of light sources configured to emit light as part of a light therapy session to treating a disease in the infant; one or more sensors; and a controller operatively coupled to the light panel, the one or more sensors, and an external device, the controller configured to: receive, from the external device, information associated with a light therapy session; send a signal to the light panel to cause at least one of the first set of light sources or the second set of light sources to emit light based on the information associated with the light therapy session;Attorney Docket No.: KDTC-002 / 01WO 353043-2007 monitor, via the one or more sensors, one or more signals including at least one of a biosignal of the infant or a signal associated with the garment; and selectively adjust an output of the first set of light sources and the second set of light sources based on the one or more signals.
26. The system of claim 25, wherein the information associated with the light therapy sessions includes at least one of a wavelength of light, an intensity of light, or a duration of the light therapy session.
27. The system of claim 25, wherein the controller is further configured to: determine if the one or more signals crosses a predetermined threshold; and turn off at least one of the first set of light sources or the second set of light sources in response to the one or more signals crossing the predetermined threshold.
28. The system of claim 27, wherein the signal associated with the garment includes at least one of a location of the garment, a temperature inside the garment, a temperature of the light panel, an amount of time the light panel has been emitting light, or a humidity inside the garment.
29. The system of claim 28, wherein disease is jaundice, and the biosignal of the infant includes a bilirubin level.
30. The system of claim 29, wherein the controller is configured to adjust an intensity of the light emitted from at least one of the first set of light sources or the second set of light sources according to the bilirubin level.
31. The system of claim 25, wherein the light panel includes an LED panel.
32. An apparatus, comprising: a bassinet for holding an infant receiving light therapy via a garment, the bassinet including a bottom surface and one or more sidewalls, the bassinet including an open top and breathable material on at least a portion of at least one of the bottom surface or the one orAttorney Docket No.: KDTC-002 / 01WO 353043-2007 more sidewalls, the bassinet configured to allow air flow around the infant to allow heat dissipation of heat generated by the garment.
33. The apparatus of claim 32, further comprising: a sensor coupled to the bassinet and configured to measure signals associated with an environment in the bassinet; and a controller operatively coupled to the sensor, the controller configured to receive the signals associated with the environment in the bassinet and control one or more external devices based on the signals.
34. The apparatus of claim 33, further comprising: one or more active sources of air flow operatively coupled to the bassinet.
35. The apparatus of claim 34, wherein the controller is configured to send a signal to control the one or more active sources of air flow based on the signals measured by the sensor.
36. The apparatus of claim 34, wherein the one or more active sources of air flow includes at least one of a fan or a cooling surface.
37. The apparatus of claim 32, wherein the breathable material is a mesh.
38. An apparatus, comprising: a support surface configured to support an infant receiving light therapy via a garment, the support surface configured to be coupled to a bassinet and extend over an opening of the bassinet to support the infant in the bassinet, the support surface including a breathable material and configured to be spaced a distance from a bottom of the bassinet when clipped onto the bassinet to allow air flow around the infant to facilitate heat dissipation of heat generated by the garment.
39. The apparatus of claim 38, wherein the breathable material is a mesh.Attorney Docket No.: KDTC-002 / 01WO 353043-200740. The apparatus of claim 38, wherein the bassinet includes a bottom surface and one or more sidewalls, the bassinet including an open top and breathable material on at least a portion of at least one of the bottom surface or the one or more sidewalls, the bassinet configured to allow air flow around the infant to allow heat dissipation of heat generated by the garment.