LED blue light area light source for medical equipment and wearable device

Abstract

The present disclosure relates to the technical field of smart wear, in particular to a LED blue light surface light source for medical equipment for fading neonatal jaundice and a wearable device, the surface light source comprises a light source assembly and an envelope structure, the envelope structure is arranged on the outer side of the light source assembly and is used for sealing the light source assembly; the light source assembly comprises a circuit board, blue light LED lamp beads and a cover plate; the circuit board is a single-sided flexible circuit board, a plurality of blue light LED lamp beads are in communication with the conductive layer on the front surface of the single-sided flexible circuit board; the cover plate is the same as the single-sided flexible circuit board in shape and comprises a plurality of through holes, the connecting surface of the cover plate is connected with the front surface of the single-sided flexible circuit board, and the through holes are sleeved on the blue light LED lamp beads. In the technical scheme of the embodiment of the present disclosure, the light therapy environment position is not limited, and the light therapy can be completed at home, without separating the mother and the baby, the light therapy operation is convenient and fast, the light leakage is not easy to occur, and the safety for the baby, the family and the nursing staff is higher.

Description

Technical Field

[0001] This disclosure relates to the field of smart wearable device technology, and in particular to an LED blue light surface light source and wearable device for medical devices used to reduce neonatal jaundice. Background Technology

[0002] Jaundice can be visible to the naked eye when the bilirubin level in a newborn's blood exceeds 5-7 mg / dl. More than two-thirds of full-term or near-term newborns may develop jaundice in the early postnatal period. When the bilirubin level exceeds the 95th percentile, it can be defined as hyperbilirubinemia.

[0003] When the serum total bilirubin level (TSB) is >20 mg / dL, the infant must be admitted to the neonatal intensive care unit (NICU) for treatment. This type of infant accounts for less than 1 / 10 of all children with hyperbilirubinemia and is defined as severe or worse.

[0004] Infants with mild to moderate hyperbilirubinemia (below severe level) must receive intervention, with blue light phototherapy being the most commonly used, effective, and safe method. Studies indicate that the prevalence of neonatal hyperbilirubinemia in my country is 13.6%. In medical institutions that do not yet have the capacity for close monitoring of bilirubin levels, newborns in high- to medium-risk areas require phototherapy.

[0005] Currently, most newborns are discharged from the hospital within 72 hours of birth, with their bilirubin levels peaking between days 4 and 6 and regressing within two weeks. Premature infants reach their peak bilirubin level between days 5 and 7, which can be delayed up to four weeks. Therefore, bilirubin monitoring is essential for newborns discharged at home, and appropriate phototherapy should be administered if bilirubin levels are abnormal.

[0006] During phototherapy treatment, hospitalization primarily involves phototherapy equipment, including phototherapy boxes, fluorescent lamps, LED lamps, and fiber optic blankets. The first three (phototherapy boxes, fluorescent lamps, LED lamps, and fiber optic blankets) offer good therapeutic effects but require separation of mother and infant, demand high levels of nursing care, and are prone to side effects such as diarrhea. Fiber optic blankets are less effective and are best used in combination with the first three. After discharge, limited personnel make follow-up of newborns difficult, and the capabilities of community general practitioners are often lacking. Consequently, when newborns develop severe jaundice, they are typically referred to specialized medical institutions. The dangers of moderate and mild hyperbilirubinemia are often overlooked, with most cases resolving spontaneously. The resulting damage is often underestimated due to its delayed manifestation or difficulty in detection.

[0007] Further explanation is needed: The biggest advantage of mainstream medical phototherapy boxes, fluorescent lamps, and LED lamps is their definite curative effect, effective for severe and above hyperbilirubinemia; however, their disadvantages include: infants wearing eye masks may experience anxiety due to separation from their mothers, easily tearing off the eye masks and causing blue light damage to their eyes, as well as side effects such as crying, diarrhea, and rashes; it can also cause anxiety in postpartum mothers, which is not conducive to postpartum recovery, breastfeeding, and the establishment of parent-child relationships; at the same time, nursing staff need to feed newborns, clean up excrement, and soothe them during treatment, which is a heavy workload, and they are passively exposed to blue light for a long time, which poses a significant potential danger; and they cannot enter the mother-infant rooming-in ward or home. Summary of the Invention

[0008] To address at least the above-mentioned technical problems in the prior art, this disclosure provides an LED blue light surface light source for medical devices and a wearable device.

[0009] One embodiment of this disclosure provides an LED blue light surface light source for medical devices, used to emit blue light for phototherapy, including a light source assembly and a sealing structure. The sealing structure is sleeved on the outside of the light source assembly to seal it. The light source assembly includes a circuit board, blue LED beads, and a cover plate. The circuit board is a single-sided flexible circuit board, and multiple blue LED beads are connected to the conductive layer on the front side of the single-sided flexible circuit board. The cover plate has the same shape as the single-sided flexible circuit board and includes multiple through holes. The connecting surface of the cover plate is connected to the front side of the single-sided flexible circuit board, and the through holes are sleeved on the blue LED beads.

[0010] In some embodiments, the conductive layer of the single-sided flexible circuit board is rolled copper; the thickness of the single-sided flexible circuit board is less than 0.1 mm.

[0011] In some embodiments, the light source assembly includes multiple LED groups, each LED group including at least two blue LEDs; the multiple LED groups are connected in parallel, and the multiple blue LEDs in each LED group are connected in series; the thickness of the blue LEDs is less than 0.5 mm, and the arrangement density of the blue LEDs on the single-sided flexible circuit board is not less than 3 per square centimeter.

[0012] In some embodiments, the cover plate is made of transparent thermoplastic polyurethane elastomer; after the cover plate is connected to the single-sided flexible circuit board, the surface height of the cover plate is not higher than the end of the blue LED lamp bead.

[0013] In some embodiments, the envelope structure includes a transparent top film and a non-transparent bottom film, the edges of the top film and the bottom film are welded to form a sealed envelope structure; the top film and the bottom film are made of thermoplastic polyurethane elastomer, the thickness of the top film is less than the thickness of the bottom film, and the thickness of the top film and the bottom film is not greater than 0.1 mm.

[0014] In some embodiments, the light source assembly further includes an input / output interface connected to the single-sided flexible circuit board; an opening is provided on the top film or the bottom film, the end of the input / output interface extends through the opening out of the envelope structure, and a sealing structure is provided between the input / output interface and the opening.

[0015] In some embodiments, before the input / output interface is sealed to the opening, a vacuum operation is performed to press the enclosure structure and the light source assembly into a single structure.

[0016] In some embodiments, the phototherapy intensity of the light source assembly should be 12.86–25.73 μW / (cm²). 2 The effective wavelength range of the blue LED beads is 420–520 nm.

[0017] One aspect of this disclosure is to provide a wearable device, including the aforementioned LED blue light surface light source for medical devices.

[0018] In some embodiments, the light source assembly has a defined unfolded area that covers at least the user's torso.

[0019] This disclosure provides an LED blue light surface light source and wearable device for medical devices. The thickness of the surface light source is controllable. When used for phototherapy, the wearable device can be worn on a child's body. The blue light emitted by the blue LED beads in the light source assembly is used to perform phototherapy on children with jaundice. The technical solution of this disclosure is not limited by the location of the phototherapy environment; it can be performed at home without separating the mother and child. The phototherapy operation is convenient and quick, and there is little risk of light leakage, making it safer for children, family members, and caregivers. Attached Figure Description

[0020] The above and other objects, features, and advantages of this disclosure will become readily apparent from the following detailed description of exemplary embodiments, taken in conjunction with the accompanying drawings. Several embodiments of this disclosure are illustrated in the drawings by way of example and not limitation, in which:

[0021] In the accompanying drawings, the same or corresponding reference numerals indicate the same or corresponding parts.

[0022] Figure 1This is a front view of an LED blue light surface light source for medical devices according to an embodiment of the present disclosure;

[0023] Figure 2 This is a partial cross-sectional view of an LED blue light surface light source for medical devices according to an embodiment of the present disclosure.

[0024] In the picture:

[0025] 1: Light source assembly; 2: Encapsulation structure;

[0026] 11: Circuit board; 12: Blue LED beads; 13: Cover plate; 14: Input / output interface;

[0027] 21: Top membrane; 22: Bottom membrane. Detailed Implementation

[0028] To make the objectives, features, and advantages of this disclosure more apparent and understandable, the technical solutions in the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this disclosure, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

[0029] like Figure 1 and Figure 2 As shown, this embodiment of the present disclosure provides an LED blue light surface light source for medical devices, used to emit blue light for phototherapy. It includes a light source assembly 1 and a sealing structure 2. The sealing structure 2 is sleeved on the outside of the light source assembly 1 to seal the light source assembly 1. The light source assembly 1 includes a circuit board 11, blue LED beads 12, and a cover plate 13. The circuit board 11 is a single-sided flexible circuit board 11, and multiple blue LED beads 12 are connected to the conductive layer on the front side of the single-sided flexible circuit board 11. The cover plate 13 has the same shape as the single-sided flexible circuit board 11 and includes multiple through holes. The connecting surface of the cover plate 13 is connected to the front side of the single-sided flexible circuit board 11, and the through holes are sleeved on the blue LED beads 12.

[0030] The surface light source provided in this embodiment can be worn on the newborn for blue light irradiation therapy when used for phototherapy of neonatal jaundice. Therefore, in addition to meeting basic phototherapy requirements, it is also necessary to prevent blue light leakage into the surrounding environment to avoid harm to the newborn, caregivers, and medical personnel. Furthermore, the surface light source needs to be thin, flexible, easy to operate, portable, comfortable to wear, and not easily damaged. The following provides a detailed description of each part of the LED blue light surface light source.

[0031] Continue to refer to Figure 1 and Figure 2In some embodiments, the conductive layer of the single-sided flexible circuit board 11 is rolled copper; the thickness of the single-sided flexible circuit board 11 is less than 0.1 mm. The overall thickness of the LED blue light surface light source provided in this disclosure embodiment is controlled below 1 mm, preferably below 0.8 mm. Therefore, it is necessary to strictly limit the thickness dimensions of each component of the LED blue light surface light source.

[0032] For example, the thickness of the rolled copper is 18 μm, and the front side of the single-sided flexible circuit board 11 is a white polyimide film with a thickness of less than 30 μm. Preferably, the total thickness of the single-sided flexible circuit board 11 is less than 0.07 mm.

[0033] In some embodiments, the light source assembly 1 includes multiple LED groups, each LED group including at least two blue LEDs 12; the multiple LED groups are connected in parallel, and the multiple blue LEDs 12 within each LED group are connected in series. For example, each LED group includes two blue LEDs 12 connected in series. Based on the above-described arrangement of the blue LEDs 12, the failure of individual LEDs will not cause a large number of LEDs in a row to go out. That is, if a large number of LEDs do not go out in a row, the assembly can still continue to be used, with minimal impact on the phototherapy effect; at the same time, it can reduce hazards such as radiation, static electricity, and heat.

[0034] In some embodiments, the thickness of the blue LED bead 12 is less than 0.5 mm, preferably less than 0.4 mm, wherein the outer diameter of the blue LED bead 12 is less than 2 mm, preferably less than 1.5 mm; according to the above design requirements and referring to the manufacturing capabilities of the LED chip and packaging industry, an 8×11mil chip packaged 0603-0.4T LED bead can be selected as the basic light-emitting unit for phototherapy.

[0035] In some embodiments, the blue LED beads 12 are arranged at a density of not less than 3 per square centimeter on the single-sided flexible circuit board 11. For example, the bead arrangement density is 4 beads / cm². 2 Increasing the operating current can enhance the luminous intensity of a single blue LED bead 12, but the heat generation increases faster (according to the LED bead's current-voltage curve), and it also increases the risk of electromagnetic radiation and static electricity. Therefore, the lowest operating current (1mA per bead) is preferred. Using this density of surface mount soldering can achieve the light irradiation level of conventional treatment intensity at the lowest operating current.

[0036] In some embodiments, the cover plate 13 is made of transparent thermoplastic polyurethane elastomer; after the cover plate 13 is connected to the single-sided flexible circuit board 11, the surface height of the cover plate 13 is not higher than the end of the blue LED bead 12.

[0037] For example, the surface of the cover plate 13 is flush with the end of the blue LED beads 12. The cover plate 13 is made of transparent thin sheet of polyester or polyether thermoplastic polyurethane elastomer (TPU) with a thickness of 0.4mm to 0.45mm. Holes are drilled using a CNC drilling machine according to the positions of the blue LED beads 12 arranged on the single-sided flexible circuit board 11, and the cover plate 13 is cut to the same size and shape as the single-sided flexible circuit board 11. When the cover plate 13 is connected to the single-sided flexible circuit board 11, the through-holes formed by the drilling operation cover the blue LED beads 12, filling the gap between the blue LED beads 12 and the single-sided flexible circuit board 11. The cover plate 13 provides some support and protection for the single-sided flexible circuit board 11 without affecting its bending performance.

[0038] In this embodiment, the cover plate 13 is made of TPU material, which has superior flexibility, light transmittance and other excellent physicochemical properties compared to silicone, PVC and other plastics. It should be noted that after the single-sided flexible circuit board 11 is covered with the porous TPU cover plate 13, the resulting whole retains the characteristics of being light, thin and soft, while also enhancing the mechanical strength that neither of the two materials possesses when they exist alone, thereby improving the tear resistance of the edge portion of the single-sided flexible circuit board 11.

[0039] In some embodiments, the envelope structure 2 includes a transparent top film 21 and a non-transparent bottom film 22, the edges of the top film 21 and the bottom film 22 are welded to form a sealed envelope structure 2; the top film 21 and the bottom film 22 are made of thermoplastic polyurethane elastomer, the thickness of the top film 21 is less than the thickness of the bottom film 22, and the thickness of the top film 21 and the bottom film 22 is not greater than 0.1 mm.

[0040] For example, the non-transparent bottom film 22 is made of 0.08mm thick black TPU film, and the transparent top film 21 is made of 0.05mm thick TPU film with a light transmittance greater than 90%. The bottom film 22 and the top film 21 are laser-welded to form a sheath structure 2. An opening is left at one end of the sheath structure 2, the light source assembly 1 is placed inside the sheath, and then the opening is sealed using laser welding. For example, the width of the laser welding line is less than 2mm. For example, the sealing strength requirement for the sheath structure 2 is that it should remain watertight even when submerged at a depth of 50cm for more than 8 hours. The excellent watertightness of the sheath structure 2 makes it safer and more reliable for newborns to use. At the same time, the sheath structure 2 also protects internal components and reduces the risk of damage to them.

[0041] In this embodiment of the disclosure, when the cover plate 13 and the enclosure structure 2 are damaged, they can be remanufactured, thereby extending the service life of the LED blue light surface light source for medical devices.

[0042] In some embodiments, the light source assembly 1 further includes an input / output interface 14, which is connected to a single-sided flexible circuit board 11; an opening is provided on the top film 21 or the bottom film 22, the end of the input / output interface 14 passes through the opening and exits through the cover structure 2, and a sealing structure is provided between the input / output interface 14 and the opening.

[0043] For example, the input / output interface 14 can be any common interface, such as a Type-C interface or a Micro USB interface. Alternatively, the input / output interface 14 can have a custom structure. For example, in this embodiment of the disclosure, a non-standard sized Type-C interface is chosen, which satisfies the characteristics of no front or back, resistance to plugging and unplugging, and small and lightweight design. It also avoids connecting existing devices on the market to the input / output interface 14, thus preventing connection errors.

[0044] For example, in this embodiment of the present disclosure, when the input / output interface 14 is installed, a polyimide film (0.2 mm thick) and a stainless steel sheet (0.2 mm thick) are attached to the surface-mount soldered input / output interface 14. The female connector of the input / output interface 14 is directly reinforced with a stainless steel sheet. The stainless steel sheet overlaps the polyimide film by 2 mm to avoid easy breakage at the joint.

[0045] In some embodiments, before sealing the input / output interface 14 with the opening, a vacuum operation is performed to press the sleeve structure 2 and the light source assembly 1 into a single structure. A silicone strip and sealing clips are used to seal the input / output interface 14 with the opening. The required sealing strength between the input / output interface 14 and the opening is such that the entire sleeve structure 2 remains watertight even when submerged at a depth of 50cm for at least 8 hours.

[0046] In some embodiments, the phototherapy intensity of the light source assembly 1 should be 12.86–25.73 μW / (cm²). 2 The effective wavelength range of the blue LED lamp bead 12 is 420-520nm.

[0047] According to phototherapy standards, the phototherapy intensity of a traditional phototherapy box is 6–12 μW / (cm²). 2 In this embodiment, the phototherapy intensity of the light source assembly 1 should be 12.86–25.73 μW / (cm²). 2 The effective wavelength range for phototherapy is 420–520 nm, preferably 430–490 nm. Based on this, the light irradiance in this embodiment is 1.29–2.57 mW / cm². 2 It is valid.

[0048] This disclosure provides a wearable device including the aforementioned LED blue light surface light source for medical devices. The light source assembly 1 has a defined unfolded area, covering at least the user's torso.

[0049] For example, a universal LED blue light source can be manufactured, which is compatible with most newborns and has high versatility. For instance, a newborn weighing 3.5 kg can be selected, and their trunk geometric parameters can be measured, including chest circumference, abdominal circumference (2cm below the navel), shoulder width, distance from armpit to shoulder top, posterior iliac crest circumference, and the vertical distance from the posterior iliac crest circumference to the sacrum. Based on this information, a wearable device can be manufactured.

[0050] Since the phototherapy effect is related to the area of ​​illumination, the larger the area of ​​the wearable device, the better. Referring to the areas covered by phototherapy boxes during phototherapy for newborns, the coverage area of ​​the LED blue light source is determined to be the newborn's torso. Specifically, the chest above the armpit line is excluded due to the risk of mechanical compression near the neck, and the abdomen 2cm below the navel is too close to the vulva, posing a risk if blue light leakage occurs. Therefore, considering the above design, the total coverage area of ​​the wearable device provided in this embodiment is 688cm². 2 about.

[0051] For example, the body surface area of ​​newborn infants (m²) 2 ) = weight (kg) × 0.035 + 0.1, therefore, the body surface area of ​​a newborn with a birth weight of 3.5 kg is 2225 cm². 2 Approximately 750 cm²; newborns undergoing phototherapy in the phototherapy box must wear eye shields and diapers, with the coverage area measured to be greater than 750 cm². 2 Therefore, the effective light-receiving area for newborns is 1475 cm². 2 Therefore, 688 / 1475 = 46.6%, and the coverage rate of the LED blue light surface light source is about 46%. Based on the setting of phototherapy intensity and effective wavelength range, the blood circulation speed in the human body is very fast. For example, the blood flow to the uterus during full-term pregnancy can reach 450-650ml / min. That is, with the coverage area of ​​the surface light source, the newborn's entire blood can flow through more than once within 20 minutes.

[0052] For example, the wearable device includes multiple areas. Area A contains 63 × 38 = 2394 LEDs, Area B contains 20 × 12 = 240 LEDs, and Area C contains 30 × 5 = 150 LEDs. The total number of LEDs is 2394 + 240 + 150 = 2784, which is the total number of blue LEDs.

[0053] This disclosure provides an LED blue light surface light source and wearable device for medical devices. The thickness of the surface light source is controllable. When used for phototherapy, the wearable device can be worn on the body of an infant. Blue light is emitted by the blue LED beads 12 in the light source assembly 1 to perform phototherapy on infants with jaundice. The technical solution of this disclosure is not limited by the location of the phototherapy environment; it can be performed at home without separating the mother and infant. The phototherapy operation is convenient and quick, and there is little risk of light leakage, making it safer for infants, family members, and caregivers.

[0054] In the description of this specification, references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this disclosure. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of those different embodiments or examples.

[0055] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this disclosure, "a plurality of" means two or more, unless otherwise explicitly specified.

[0056] The above are merely specific embodiments of this disclosure, but the scope of protection of this disclosure is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this disclosure should be included within the scope of protection of this disclosure. Therefore, the scope of protection of this disclosure should be determined by the scope of the claims.

Claims

1. A wearable device, characterized in that, The device includes a medical device LED blue light surface light source for emitting blue light for phototherapy. Based on the geometric parameters of the newborn's torso, a wearable device is manufactured so that the area covered by the medical device LED blue light surface light source is the newborn's torso. The LED blue light surface light source for medical devices includes a light source assembly (1) and a cover structure (2). The cover structure (2) is sleeved on the outside of the light source assembly (1) to seal the light source assembly (1). The light source assembly (1) includes a circuit board (11), blue LED beads (12), and a cover plate (13). The circuit board (11) is a single-sided flexible circuit board. Multiple blue LED beads (12) are connected to the conductive layer on the front side of the single-sided flexible circuit board. The conductive layer of the single-sided flexible circuit board is rolled copper. The thickness of the blue LED beads (12) is less than 0.5 mm and the outer diameter is less than 2 mm. The arrangement density of the blue LED beads (12) on the circuit board (11) is not less than 3 per square centimeter. The front side of the single-sided flexible circuit board is a white polyimide film. The cover plate (13) has the same shape as the single-sided flexible circuit board and includes multiple through holes. The connecting surface of the cover plate (13) is connected to the front side of the single-sided flexible circuit board. The through holes are sleeved on the blue LED beads (12). The material of the cover plate (13) is transparent thermoplastic polyurethane elastomer. The envelope structure (2) includes a transparent top film (21) and a non-transparent bottom film (22). The edges of the top film (21) and the bottom film (22) are welded to form a sealed envelope structure (2). The top film (21) and the bottom film (22) are made of thermoplastic polyurethane elastomer. The thickness of the top film (21) is less than the thickness of the bottom film (22), and the thickness of the top film (21) and the bottom film (22) is not greater than 0.1 mm. The LED blue light surface light source can be formed into a wearable device that can be worn on a child's body, and the overall thickness of the LED blue light surface light source is less than 1 mm.

2. The wearable device according to claim 1, characterized in that, The thickness of the single-sided flexible circuit board is less than 0.1 mm.

3. The wearable device according to claim 2, characterized in that, The light source assembly (1) includes multiple LED groups, each LED group including at least two blue LEDs (12); the multiple LED groups are connected in parallel, and the multiple blue LEDs (12) in each LED group are connected in series; The thickness of the blue LED bead (12) is less than 0.5 mm, and the arrangement density of the blue LED bead (12) on the single-sided flexible circuit board is not less than 3 per square centimeter.

4. The wearable device according to claim 2, characterized in that, After the cover plate (13) is connected to the single-sided flexible circuit board, the surface height of the cover plate (13) is not higher than the end of the blue LED lamp bead (12).

5. The wearable device according to claim 1, characterized in that, The light source assembly (1) also includes an input / output interface (14), which is connected to the single-sided flexible circuit board; An opening is provided on the top membrane (21) or the bottom membrane (22), and the end of the input / output interface (14) passes through the opening to exit the cover structure (2), and a sealing structure is provided between the input / output interface (14) and the opening.

6. The wearable device according to claim 5, characterized in that, Before the input / output interface (14) is sealed with the opening, the sealing structure (2) and the light source assembly (1) are pressed into a single structure by a vacuuming operation.

7. The wearable device according to any one of claims 1 to 6, characterized in that, The light intensity of the light source component (1) should be 12.86~25.73μW / (cm²•nm), and the effective wavelength range of the blue LED beads (12) should be 420~520nm.

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