WO1999016308A1 - Dispositif et technique d'irradiation du sang avec la lumiere solaire et de la lumiere a spectre continu - Google Patents

Dispositif et technique d'irradiation du sang avec la lumiere solaire et de la lumiere a spectre continu Download PDF

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Publication number
WO1999016308A1
WO1999016308A1 PCT/US1998/019292 US9819292W WO9916308A1 WO 1999016308 A1 WO1999016308 A1 WO 1999016308A1 US 9819292 W US9819292 W US 9819292W WO 9916308 A1 WO9916308 A1 WO 9916308A1
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WIPO (PCT)
Prior art keywords
blood
sample
biological fluid
full spectrum
solar
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PCT/US1998/019292
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English (en)
Inventor
Kenneth James Dillon
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Kenneth James Dillon
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Kenneth James Dillon filed Critical Kenneth James Dillon
Publication of WO1999016308A1 publication Critical patent/WO1999016308A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods

Definitions

  • This invention relates generally to a method of irradiating the blood with solar and/or full spectrum radiation, and specifically to a device that uses solar and/or full spectrum radiation to stimulate the irradiated blood cells for the treatment of infectious, inflammatory, circulatory, and other disorders.
  • the present device provides a low cost method that avoids the drawbacks of previous blood irradiation therapies.
  • the activated blood cells resulting from such therapy were found to achieve a beneficial effect by various mechanisms including oxygenation of the blood, destruction of microorganisms, normalization of the components of the blood via the effects of the secondary radiation emitted from the irradiated blood cells, suppression of inflammation, improvement of microcirculation, and stimulation of hematopoiesis. Accordingly, UBI was used by many American practitioners until the 1950s when it was set aside presumably in favor of antibiotics and vaccines. In recent years, interest in such therapy has revived, as exemplified by the device disclosed in United States Patent No. 5,459,322, which provides an apparatus for exposing a blood sample to ultraviolet radiation. Similar devices came to be used in Central Europe.
  • LBI Low- Intensity Lasers and Irradiation in the Millimeter Range, (1994), p. 148).
  • LBI via transdermal irradiation of a vein with an infrared laser of a longer wavelength (830 nm vs. the normal 632.8 nm) provided measurable results while avoiding the invasiveness of an IV needle and waveguide as the longer wavelength permitted deeper penetration in order to irradiate the blood more effectively.
  • the results were not nearly as good as with intravenous LBI (Ibid., pp. 140-3).
  • photopheresis is a combination of UBI and chemotherapy in which the secondary radiation triggers the photoactive drug previously taken up by the target cells.
  • photopheresis uses less irradiation and more chemotherapy than UBI.
  • the substances used are generally psoralens, which occur in nature but are used in chemotherapeutic concentrations that can have more toxic effects than other forms of Bl (Edelson, R., New England Journal of Medicine. 316: 297-303, "Treatment of Cutaneous T-Cell Lymphoma by Extracorporeai Photochemotherapy” (1991)).
  • Photopheresis has the advantage that it is approved by the FDA for the treatment of cutaneous T-cell lymphoma and is currently in clinical trials for other indications. Examples may be found in United States Patent No. 5,426,116 and 5,593,823. Its use ranges from inactivation of pathogens in blood using photoactivation and psoralens as found in U.S. Patent No. 5,593,823 to a method of treating atherosclerosis as in US. Patent No. 5,426,116.
  • the basic technique uses low- intensity fluorescent sources of UV-A and is employed in many major medical centers.
  • UV-A wavelengths might explain this deviation from the equivalence between solar and artificial UV irradiation that established action spectra ordain, but it is equally possible that such aspects of solar irradiation as coherence length, polarization, and magnetic field are involved.
  • the present invention also provides a device that is totally portable such that it may be used in the field while ensuring even, thorough irradiation.
  • the present invention comprises an apparatus and method for the solar and full spectrum irradiation of blood cells.
  • a full spectrum light source is pivotally mounted on a support above a rotatable transfusion bag holder that can be rotated by means of knobs as on a typewriter.
  • the cage Underneath the cage is a metal reflector that is attached on both sides of the device to the pivot point so that it can be turned in an arc and held in place by friction.
  • the cage is opened to insert a transfusion bag with blood, then closed with a latch.
  • the full spectrum light then irradiates the blood as the knob is turned in order to expose all the cells evenly and avoid coagulation.
  • the transfusion bag is removed in order to return the blood to the body.
  • a measurement of solar irradiation intensity is made with an incident light meter in order to calculate the correct exposure time for a therapeutic dose.
  • the full spectrum light is rotated out of the way, the transfusion bag is inserted, the reflector is rotated to face the sun, and a knob is turned until the therapeutic dose is received.
  • the full spectrum light 1 consists of an ultraviolet fluorescent tube 2 and a visible and infrared fluorescent tube 3, as well as a shade 4 with an inside reflective surface.
  • the full spectrum light 1 can be folded out of the way during the solar mode by turning it on its pivot 5.
  • the metal base 6 has two triangular sides 7 and 8 between which is inserted a cage 9 turned by a knob 10.
  • the cage 9 has a latch 11 that permits it to be opened to insert the transfusion bag 12.
  • the central portion of the cage has indentations 13 and 14 on both sides to squeeze the transfusion bag 12 and prevent it from sliding during cranking.
  • a metal reflector 15 with polished inner surface 16 is attached to the sides 7 and 8 at pivot 5 so as to rotate in order to aim it to reflect solar irradiation in the solar mode.
  • a sliding drawer (not shown) in the base 6 contains storage space for an incident light meter and other items.
  • the base 6 also contains the ballast (not shown) for the full spectrum light 1.
  • a switch 17 operates the light.
  • a preferred embodiment of the apparatus and method in the treatment of a patient of 70 kg with an infectious disease is to decide first whether to use the solar mode or the full spectrum mode, in keeping with the medical condition, availability of sunlight, and patient's wishes.
  • the full spectrum mode of the current invention is high in precision, especially since it will ordinarily be administered indoors where the temperature, which can affect the output of the fluorescent lights, can be controlled.
  • Various UBI devices and the solar mode of the current invention are less precise, but the potential for superior efficacy and lower toxicity of the solar mode of the current invention offsets its lower precision.
  • Bl therapy relies more on the practitioner's judgment and evaluation of the patient's condition than do chemotherapies dosed according to standard protocol. Bl's therapeutic effect can much more closely correspond to the frequency and intervals at which the treatment is repeated than to the precise dose.
  • the device should be set up on a table outdoors.
  • the intensity of solar irradiation is measured with an incident light meter, and the full spectrum mode's standard therapeutic dose is divided by this intensity to yield the number of minutes for a therapeutic dose at that intensity of solar irradiation.
  • the therapeutic dose is determined by iterative testing of various levels beginning with very low ones. A typical low level to begin with would be 1 minute exposure.
  • An endpoint indicator of when a too high level is being reached is as described in the Knott technique. Specifically, when the blood is reinfused into the patient and the patient flushes, then the high endpoint has been reached and should not be exceeded.
  • 175 ml of blood (2.5 ml per kg) is withdrawn from the antecubital vein into a 200-ml capacity transparent, polypropylene transfusion bag.
  • the bag and needle hull are capped with sterile caps; according to the judgment of the nurse, saline solution may first be injected into needle, bag, or both in order to lessen the chance of coagulation. Then the bag is placed into the cage 9, the latch 11 is closed, the full spectrum light 1 is rotated out of the way, the device is aimed at the sun, and the reflector 15 is rotated in order to obtain maximum reflection into the blood.
  • the reflector reduces the amount of time required to achieve a full dose, with the added benefit of reducing the time in which coagulation of the blood is an issue.
  • the patient or the nurse slowly turns the knob 10 to rotate the cage 9 in order to ensure a gentle turbulence of the blood cells. This will provide an even and thorough irradiation of all cells, avoid damaging overexposure of any individual cells, and minimize the danger of coagulation.
  • the transfusion bag is removed from the device and the blood is reinfused through the vein.
  • the method and apparatus of the present invention make possible batch processing of blood contained in transfusion bags, which in turn conveys major benefits unavailable in past devices.
  • the transfusion bag should be transparent, preferably of polypropylene or some other material that permits passage of UV rays.
  • the bag should be as thin as possible to permit the least blockage or distortion of solar and full spectrum irradiation.
  • the inside of the bag should be rounded like a pouch to deny the blood any corner or edge in which to coagulate.
  • the bag should be optimally 200 ml in volume, though any size between 100 ml and 400 ml is also acceptable. Larger amounts can exceed the known limit at which Bl therapy is very low in toxicity and should be used only in emergencies such as fulminating conditions. In these cases, several transfusion bags in a row can be used. Smaller bags--10-50 ml-may be employed in the treatment of infants and children.
  • transfusion bag will permit better transmission of irradiation than through devices using glass or quartz barriers because the plastic can be made very thin and because there will be no film buildup from use to use, which would necessitate cleaning or degrade the passage of irradiation.
  • the use of a disposable transfusion bag also prevents transmission of infection and obviates the need for bulky disposable cuvettes.
  • the relatively low cost of the transfusion bag makes the present invention more affordable in countries with limited resources and lessens the likelihood that the transfusion bags will be reused, thereby transmitting infections.
  • the needle should have a large bore-16 gauge is appropriate-in order to lessen the chances of coagulation.
  • the tubing should also have a large bore for the same reason.
  • the transfusion bag As soon as the blood is returned to the vein, the transfusion bag, tubing, and needle are disposed of. If, despite precautions, coagulation should occur, the transfusion bag is immediately disposed of and a new one is used for newly drawn blood.
  • the small doses ( ⁇ 200 ml) mean that the loss of blood in any such incident is minimal.
  • Any commercially available standard incident light meter can be used to measure solar irradiation.
  • the light meter may also be integrated into the device.
  • the different intensities of solar irradiation at different latitudes, times of day and year, and levels of cloud coverage will mean that the duration of the treatment in solar mode can vary considerably. Unless there is changing cloud cover, the intensity of solar irradiation can be assumed to be fixed for the relatively brief time that the blood is exposed. Blood cells are highly reactive to irradiation of any kind, and can be presumed to be even more reactive to solar irradiation than to other kinds. Thus the duration of therapy will be much shorter than would permit significant changes in the intensity of solar irradiation or the location of the sun.
  • the solar mode of the present invention can operate under light cloud cover. Photons absorbed through clouds, from skylight, from ambient light, and from reflection will all activate blood cells, though it is thought that direct solar irradiation from a clear sky will have the best effect.
  • the device will save money because the energy will be free and because there will be no need to replace fluorescent tubes.
  • the present invention can be employed solely in the solar mode, with consequent savings in energy and fluorescent tubes. This approach would reduce environmental waste and be suitable for patients who desire only natural therapy, not available with current devices. It would then also be possible to use the device in remote settings outside of the range of electricity.
  • the reflector 15 In the full spectrum mode, the reflector 15 is rotated to the bottom of its arc and the full spectrum light 1 is moved to the top of its arc. In order to lessen fluctuation of the UV portion of the full spectrum light 1 , it is best to turn it on 5 minutes before irradiating the blood.
  • the reflector should be a concave 30-45 degree section of a circle, not a parabola because that might focus the reflected rays so much that they would damage the blood cells.
  • the shortest full spectrum lights currently available are 15 inches in length. If the device is smaller, it is best to provide two or three complementary fluorescent tubes side by side.
  • One arrangement for a smaller device with current lighting technology would be to have two tubes-one for UV and blue, the other for the remaining colors and infrared.
  • Another arrangement would be three tubes-one for UV, one for visible light with a blue high point, and one for red and infrared.
  • This approach has the added benefit of avoiding the early burnout of the UV portion of current full spectrum lights that makes it necessary to discard them after perhaps 1 ,000 hours of usage if one desires a UV component, thereby wasting the capacity of their visible and infrared portions to burn for 15,000 hours.
  • the UV tube can be exchanged as frequently as necessary, perhaps every 1 ,000 hours, while the other tubes can serve their entire lives.
  • the therapeutic dose in the full spectrum mode can be calibrated either with reference to the very precise therapeutic doses of low-intensity lasers used for LBI or by an iterative testing of various levels beginning with very low ones.
  • the standard therapeutic dose (length of irradiation) is administered to 2 to 3 ml of blood per kilogram, which is at the low end of the traditional American "Knott technique" and at the high end of the amount commonly irradiated in Russia.
  • 1 to 2 treatments should suffice.
  • 6 to 8 treatments might be required over the course of two months.
  • the device and method according to the present invention can be employed for a very wide range of indications including the suppression of graft versus host disease, treatment of burns and nonhealing wounds, and in veterinary medicine.
  • the device may be used for the irradiation of fractions of blood and of other fluids, including samples obtained from donors.
  • UV-A and visible/infrared bulbs to comprise the full spectrum light minimizes any potential for injury to the operator that might arise in the use of powerful UV-B and UV-C bulbs. Still, the light shade 4 can be made deeper to ensure that no radiant energy - no matter how mild - strikes the operator.
  • Bl is much lower in intensity and far less concentrated on a specific target than present day x-ray treatments.
  • the relatively rapid turnover of the blood cell population also reduces the impact of Bl.
  • the UV radiation from the Russian UBI device is much less ionizing; in UV-A devices, none of it is. None of the currently used LBI devices emits ionizing radiation.

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Abstract

Technique et dispositif permettant d'irradier un échantillon, tel que du sang, avec la lumière solaire et/ou de la lumière à spectre continu. Le dispositif permet d'irradier uniformément et totalement un échantillon tel que du sang, en extracorporel, sans anticoagulants coûteux. L'invention peut être utilisée pour traiter les pathologies infectieuses, inflammatoires et circulatoires.
PCT/US1998/019292 1997-09-29 1998-09-17 Dispositif et technique d'irradiation du sang avec la lumiere solaire et de la lumiere a spectre continu WO1999016308A1 (fr)

Applications Claiming Priority (2)

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US93981997A 1997-09-29 1997-09-29
US08/939,819 1997-09-29

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WO1999016308A1 true WO1999016308A1 (fr) 1999-04-08

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6212255B1 (en) * 1998-09-02 2001-04-03 Randol E. Kirk System for X-ray irradiation of blood
EP2859915A1 (fr) 2013-10-10 2015-04-15 Wojewodzki Szpital Specjalistyczny we Wroclawiu Dispositif de photobiomodulation sanguine pendant la circulation extracorporelle
WO2017035874A1 (fr) * 2015-09-06 2017-03-09 江苏摩科特医疗科技有限公司 Irradiateur de sang

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995002325A1 (fr) * 1993-07-12 1995-01-26 Baxter International Inc. Appareil et procede d'inactivation des contaminants viraux des liquides biologiques
US5798523A (en) * 1996-07-19 1998-08-25 Theratechnologies Inc. Irradiating apparatus using a scanning light source for photodynamic treatment

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995002325A1 (fr) * 1993-07-12 1995-01-26 Baxter International Inc. Appareil et procede d'inactivation des contaminants viraux des liquides biologiques
US5798523A (en) * 1996-07-19 1998-08-25 Theratechnologies Inc. Irradiating apparatus using a scanning light source for photodynamic treatment

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DATABASE BIOSIS, AN 80:179168, DURDEYEV et al., "Dynamics of Densimetric Blood Indexes Under the Effect of Concentrated Sunlight"; & IZV. AKAD. NAUK TURKM. SSR SER. BIOL. NAUK, 1978, No. 6, pages 81-83. *
SELVAAG E., "Photohemolysis Due to Oral Antidiabetic Drugs", JOURNAL OF TOXICOLOGY - CUTANEOUS AND OCULAR TOXICOLOGY, 1997, Vol. 16, No. 4, pages 217-226. *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6212255B1 (en) * 1998-09-02 2001-04-03 Randol E. Kirk System for X-ray irradiation of blood
EP2859915A1 (fr) 2013-10-10 2015-04-15 Wojewodzki Szpital Specjalistyczny we Wroclawiu Dispositif de photobiomodulation sanguine pendant la circulation extracorporelle
WO2017035874A1 (fr) * 2015-09-06 2017-03-09 江苏摩科特医疗科技有限公司 Irradiateur de sang

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