Phototherapy of jaundiced newborns using garments containing semiconductor light-emitting devices

• US 6,596,016 B1
• Filed: 04/19/2000
• Issued: 07/22/2003
• Est. Priority Date: 03/27/1997
• Status: Expired due to Term

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Vreman, Hendrik J., Stevenson, David K., Seidman, Daniel S.
• Primary Examiner(s): Shay, David M.
• Application Number:
  US09/551,946
• Time in Patent Office: 1,189 Days
• Field of Search: 607/88, 607/91, 290/5, 290/6, 128/903, 128/904, 600/310, 600/315
• US Class Current: 607/88
• CPC Class Codes: A61N 2005/0645 Applicators worn by the patient
• CPC Class Codes: A61N 2005/0652 Arrays of diodes
• CPC Class Codes: A61N 5/0621 Hyperbilirubinemia, jaundice treatment
• CPC Class Codes: Y10S 128/903 Radio telemetry
• CPC Class Codes: Y10S 128/904 Telephone telemetry
• CPC Class Codes: Y10S 2/906 Head covering or protector

Abstract

A phototherapy garment contains a flexible backing material, a transparent liner, and a flexible printed circuit sheet containing surface-mounted light-emitting diodes (LEDs) positioned between the backing material and the liner. An infant is placed inside the garment so that the LEDs illuminate a large portion of the infant'"'"'s skin for phototherapy. The LEDs preferably emit high-intensity blue light, suitable for treatment of neonatal hyperbilirubinemia or Crigler-Najjar syndrome. The LEDs are arranged in a densely packed array facing the liner and emit uniform, high intensity light. A power supply, which may be portable, supplies adjustable power to the LEDs, preferably pulsed with a duty cycle of approximately 10%, and preferably to overdrive the LEDs to maximize light output. A two-way communications device incorporated into the garment allows a physician or computer to control the garment remotely and gather relevant information periodically or continuously. The garment may also contain a feedback system with skin bilirubin sensors, so that the intensity level and duration of light therapy can be based on bilirubin in the skin, which is a reflection of the newborn'"'"'s serum bilirubin concentration. The garment can be of any type, including sacs, hats, sweaters, jackets, and rompers, and is lightweight and portable, allowing an infant to be treated at home, in the hospital, or when in transit. The garment provides high light intensity over a larger surface area of the newborn than allowed with existing techniques, thus providing very efficient phototherapy.

Claims

1. A phototherapy garment comprising:

a) a flexible shell having an inside surface and an outside surface;

b) a liner sealed to said inside surface of said flexible shell and defining a pocket between said shell and said liner;

c) a flexible printed circuit sheet having a printed circuit and a plurality of surface-mounted light-emitting diodes electrically connected to said printed circuit, said printed circuit sheet being secured inside said pocket with said light-emitting diodes facing said liner, wherein said liner is substantially transparent to an emission wave length of said light-emitting diodes; and

d) a power supply in electrical communication with said printed circuit, wherein said power supply intermittently provides power to said light-emitting diodes at a predetermined frequency and with a predetermined duty cycle.

2. The garment of claim 1 wherein said garment is selected from the group consisting of a hat, a sweater, a jacket, a romper, and a sac.

3. The garment of claim 1 wherein said duty cycle is less than 50%.

4. The garment of claim 1 wherein said duty cycle is approximately 10%.

5. A phototherapy garment comprising:

a) a flexible backing material having an inside surface, an outside surface, and an edge;

b) a liner sealed to said inside surface of said backing material and defining a pocket between said backing material and said liner;

c) a printed circuit sheet having a printed circuit and a plurality of surface-mounted light-emitting diodes electrically connected to said printed circuit, said printed circuit sheet being secured inside said pocket with said light-emitting diodes facing said liner, wherein said liner is substantially transparent to an emission wavelength of said light-emitting diodes; and

d) a power supply in electrical communication with said printed circuit, wherein said power supply intermittently provides power to said light-emitting diodes at a predetermined frequency and with a predetermined duty cycle.

6. The garment of claim 5 wherein said printed circuit sheet is a flexible printed circuit sheet.

7. The garment of claim 5 wherein said power supply comprises a portable power supply.

8. The garment of claim 5 wherein said power supply comprises means for supplying power intermittently to said light-emitting diodes.

9. The garment of claim 5 wherein said power supply comprises means for overdriving said light-emitting diodes.

10. The garment of claim 5 wherein said flexible printed circuit sheet covers a majority of said inside surface of said backing material.

11. The garment of claim 5 wherein two adjacent portions of said edge of said backing material are joined together to define an interior space surrounded by said liner, and wherein a neonate is positioned in said interior space.

12. The garment of claim 5 wherein said backing material, said liner, and said flexible printed circuit sheet have removed portions to allow heat removal through said removed portions.

13. The garment of claim 5 wherein said duty cycle is less than 50%.

14. The garment of claim 5 wherein said duty cycle is approximately 10%.

15. The garment of claim 5 further comprising a communications device in electrical communication with said light-emitting diodes.

16. The garment of claim 15 wherein said communications device is a two-way communications device.

17. The garment of claim 15 wherein said communications device is a wireless communications device.

18. The garment of claim 5 further comprising a skin sensor secured to said liner.

19. The garment of claim 18 wherein said skin sensor detects skin reflectance.

20. The garment of claim 18 wherein said skin sensor detects a property chosen from the group consisting of skin temperature, oxygen saturation, glucose blood level, and perspiration.

21. The garment of claim 5 wherein said light-emitting diodes are arranged in a two-dimensional array.

22. The garment of claim 21 wherein said array is densely packed, whereby said light-emitting diodes generate substantially uniform light.

23. The garment of claim 22 wherein said array has a density of approximately 16 light-emitting diodes per square inch.

24. The garment of claim 5 wherein said garment has an irradiance of greater than 30 μ

W/cm²/nm.

25. The garment of claim 24 wherein said garment has an irradiance of greater than 100 μ

W/cm²/nm.

26. The garment of claim 5 wherein said light-emitting diodes emit light of a wavelength suitable for treating hyperbilirubinemia in neonates.

27. The garment of claim 26 wherein said wavelength is between 420 and 500 nm.

28. The garment of claim 27 wherein said wavelength is between 440 and 470 nm.

29. A method of treating a neonate for hyperbilirubinemia comprising the steps of:

a) providing a garment having a plurality of surface-mounted light-emitting diodes that emit light at a wavelength suitable for treating hyperbilirubinemia;

b) covering a skin region of said neonate with said garment such that said light-emitting diodes face said skin region;

c) intermittently providing sufficient power at a predetermined frequency and with a predetermined duty cycle to said light-emitting diodes to activate said light-emitting diodes.

30. The method of claim 29 wherein said garment is selected from the group consisting of a hat, a sweater, a jacket, a romper, and a sac.

31. The method of claim 29 further comprising the steps of measuring a serum bilirubin concentration of said neonate, and using said serum bilirubin concentration to control said activation of said light-emitting diodes.

32. The method of claim 29 further comprising controlling said activation of said light-emitting diodes from a remote location.

33. The method of claim 29 wherein said skin region has a circumference and said garment covers a majority of said circumference.

34. The method of claim 29 where in said duty cycle is less than 50%.

35. The method of claim 29 wherein said duty cycle is approximately 10%.

36. A method of treating a patient for Crigler-Najjar syndrome comprising the steps of:

a) providing a garment having a plurality of surface-mounted light-emitting diodes that emit light at a wavelength suitable for bilirubin conversion;

b) covering a skin region of said patient with said garment such that said light-emitting diodes are facing said skin region; and

c) intermittently providing sufficient power at a predetermined frequency and with a predetermined duty cycle to said light-emitting diodes to activate said light-emitting diodes.

37. The garment of claim 36 wherein said duty cycle is less than 50%.

38. The garment of claim 36 wherein said duty cycle is approximately 10%.