Abstract:
A device for irradiating blood is provided, the device including a chamber having an elongate configuration defining a hollow interior, the chamber formed of reflective material, a tubular cassette sized and shaped to be received in the interior of the chamber, the tubular cassette having an inside diameter sized and shaped to receive a reflective core having an elongate configuration with an exterior diameter smaller than the interior diameter of the cassette to provide a space for receiving and holding blood stationary, and an array of light-emitting members arranged on the chamber for emitting light of at least one wavelength into the interior of the chamber for irradiating and treating the blood inside the cassette.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 10/570,524, filed Nov. 14, 2006, which is a National Stage of PCT/US2004/028003, filed Aug. 27, 2004, and claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 60/592,063, filed Jul. 29, 2004 and U.S. Provisional Application No. 60/500,366, filed Sep. 4, 2003, where these applications are incorporated herein by reference in their entireties. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention relates generally to a method of irradiating blood and to an irradiation chamber wherein blood is irradiated with various wavelengths of light for the purpose of altering its immunologic status, and more particularly to a chamber of this type in which a stationary fixed amount of blood is measured and displayed for even exposure to a light source of very low heat output, low intensity, and rapid activation and deactivation. 
         [0004]    This invention shall also relate to a light source specifically designed to couple with the chamber for the purpose of irradiating the blood contained within it, and which has a light source. 
         [0005]    2. Description of the Related Art 
         [0006]    The irradiation of blood as a means to alter its immunologic status has been researched since its inception by Knott in 1928. This has always included the extraction of blood and passing it continuously through a chamber while it is irradiated, usually with ultraviolet light. This light is of low intensity in the Knott device. In other methods activating chemicals are used, and higher intensity light is used with devices for clearing the blood of pathogens for blood banking. Chambers for this purpose need to have baffles or be constructed of tubing such that the blood can churn within the chamber so that the greatest amount of blood is exposed to the UV light. This construction was required because of the lack of availability of an ultraviolet light source that was of low heat output and that could be rapidly turned on and off. 
         [0007]    Of prior art interest in regard to such treatment is the blood irradiation chamber disclosed in an article by E.K. Knott in the August 1948 issue (Vol. LXXVI-No. 5) of the American Journal of Surgery, entitled “Development of Ultraviolet Blood Irradiation.” In the disclosed device, extracorporal blood is pumped through a quartz chamber two inches in diameter and one inch in thickness. This chamber contains baffles so that the blood is churned to expose as many elements to the mercury-vapor lamp source as possible. Patents that show Knott-type blood chambers include U.S. Pat. Nos. 1,683,877; 2,309,124; 2,308,516; 2,314,281; and 6,312,593. 
         [0008]    The failing of the Knott-type devices is that they have light sources that are hot, noisy, and require warm up before use. This makes placebo treatments difficult to accomplish, thus limiting research. This also leads to inaccuracy in calculating dosing for research purposes. 
         [0009]    Another failing of the prior devices is that blood is moved through an exposure chamber during exposure to the light source. Moving volumes lead to inaccuracy when dosages are calculated. 
         [0010]    Another failing of the prior devices is that they utilize baffles to churn the blood within their chamber, resulting in uncertainty as to whether all elements in the blood have been properly exposed. Unequal exposure leads to inaccuracy when dosing is calculated. 
       BRIEF SUMMARY OF THE INVENTION 
       [0011]    In view of the foregoing, the disclosed embodiments of the present invention provide for a chamber whereby light can equally irradiate a stationary quantified amount of blood extracorporally, and a light source coupled to the chamber whereby the chamber can be safely irradiated with a light generator that can be quickly activated and deactivated while remaining cool and quiet enough to permit placebo treatment. 
         [0012]    In accordance with another embodiment of the invention, a chamber is provided that is configured to be easily sterilized and reused by the same patient/subject. 
         [0013]    In accordance with another embodiment of the invention, control over the light source is provided whereby its duration, intensity, and wavelength can be easily and quickly adjusted. 
         [0014]    In accordance with one embodiment of the invention, a device for subjecting a stationary quantity of blood to light for the purpose of altering the immune function of the patient is provided. The device includes a chamber formed by a window of a quartz plate and a back formed of hard plastic having an inlet port and an outlet port that communicate with the chamber, including a stopcock valve adjacent the outlet port to retain blood in the chamber and to selectively permit the entry of fluids into the chamber when treated blood exits the chamber back to the patient via the inlet port; and a housing for directing light from a light source to the chamber, the housing including a holder made of plastic having a slot to receive the chamber, a clamp to hold the chamber in the housing, and a mounting with a light source board at an end opposite the holder, and a reflective inner surface to reflect light from the light source to the chamber. 
         [0015]    In accordance with another aspect of the foregoing embodiment of the invention, the light source board includes a printed circuit board having an array of light emitting diodes. Preferably at least one of the diodes in an ultraviolet light emitting diode. 
         [0016]    In accordance with another aspect of the foregoing embodiment of the invention, a microprocessor or computer system is provided that is coupled to the light source to control the lighting of the diodes such that the wavelength of emitted light can be varied or combined to treat various pathological conditions in the blood. 
         [0017]    In accordance with another aspect of the invention, a method of treating a measured and stationary amount of blood from a patient is provided. The method includes receiving blood intravenously from a patient at an inlet port of a chamber by force of the intravenous blood pressure; filling the chamber with the patient&#39;s blood from the inlet port at the bottom of the chamber to a valve at an outlet port at the top of the chamber; exposing the blood in the chamber to a light source for the purpose of altering the immune function of the blood of the patient; opening the valve at the outlet port to introduce fluids into the chamber through the outlet port with sufficient force to return the blood back to the patient intravenously and flushing the chamber with the fluid; and repeating the foregoing steps as desired. 
         [0018]    In accordance with another embodiment of the invention, a device for irradiating blood is provided that includes an elongate reflective chamber, preferably of a circular cross-sectional configuration, although it may have other configurations, such as octagonal, hexagonal, pentagonal, or the like. The chamber has a hollow interior to which access is provided by an access panel hingedly attached as part of the chamber wall. An elongate tube sized and shaped to be received in the interior of the chamber is provided, the tube having an inside diameter and a reflective core, preferably hollow, placed therein having an exterior diameter that is smaller than the interior diameter of the tube to provide a space for holding the blood stationary; and an array of light-emitting members mounted on the chamber for providing irradiating light of one or more wavelengths to the interior of the chamber for irradiating the blood. Ideally, the tube and the hollow reflective core also have circular cross-sectional configurations to provide maximum reflectivity. 
         [0019]    As will be readily appreciated from the foregoing, the tube with hollow core, referred to as a cassette, is disposable to provide safety to healthcare providers. It is also detachable from the blood withdrawing apparatus attached to the patient so as to reduce the risk or eliminate the risk of electrocution to the patient. In addition, the designs of the present invention maintain the blood in a fixed or stationary condition during irradiation. LEDs provide instant cooler light and the ability to select wavelengths. A computer program provides control to the LEDs, allowing double-blind studies and the transmission of data back to a computer. Energy usage is low enough to enable portability for disaster relief and field hospitals. The device is safer because light cannot escape from the unit and damage the eyes. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0020]    For a better understanding of the invention, as well as features and advantages thereof, reference is made to the accompanying drawings wherein; 
           [0021]      FIG. 1  is an exploded side view illustration of a blood treatment system that includes an irradiation chamber coupled with its light source in accordance with the present invention; 
           [0022]      FIG. 2  is a side view of a chamber; 
           [0023]      FIG. 3  is a side view of a chamber holder; 
           [0024]      FIG. 4  is a side view of a housing; 
           [0025]      FIG. 5  is a side view of a light source board; 
           [0026]      FIG. 6  is a front view of the chamber of the present invention; 
           [0027]      FIG. 7  is a front view of the holder of the present invention; 
           [0028]      FIG. 8  is a side view of another embodiment of the invention; 
           [0029]      FIG. 9  is a cross-sectional view taken along lines  9 - 9  of the embodiment of  FIG. 8 ; and 
           [0030]      FIG. 10  is an alternative embodiment of the design of  FIGS. 8 and 9 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0031]    Referring first to  FIG. 1 , shown therein is a system  10  for treating immune problems of a patient by affecting the immune elements within a portion of the patient&#39;s blood. The system  10  includes an irradiation chamber  12  formed in accordance with the invention and a source  14  of light radiation. An inlet port  16  is formed on the chamber  12  and is coupled by a tube  18  to a hypodermic needle  20  that is inserted into the arm of a patient for withdrawing blood from the patient and returning it after treatment. 
         [0032]    The blood of the patient enters into the chamber  12  by gravity feed and the inherent pressure of the blood stream, whereupon it is stopped with a stopcock  22  when the chamber  12  is full. The blood in the chamber  12  is exposed to light emanating from the light source  14  to alter the immune status of the fixed amount of measured blood within the chamber  12 . After exposure, the blood is then returned to the patient in a reverse direction via the same pathway. The stopcock  22  is turned to allow fluid from a hung  23  bag or bottle to enter into the chamber  12 , thus forcing the blood back into the patient and rinsing the chamber  12  of blood. 
         [0033]    As illustrated in  FIG. 2 , the chamber  12  has a back plate  24  that is composed of hard plastic. This back plate  24  has a Luer-type male fitting  26  for connecting the tube  18  from the patient at its lower rear area, and another Luer-type female fitting  28  is located at an upper rear area of the back plate  24  for connecting the stopcock  22  and a tube  27  to the intravenous-type fluids to be delivered to the patient after the blood in the chamber  12  is exposed to the UV light. 
         [0034]    The chamber  12  has a gasket  30  formed of semisoft plastic, preferably 2 mm thick, and which has an area  32  free within it, preferably 20.0 centimeters by 25.0 centimeters. This free area  32 , when a window plate  34  of quartz or other material is applied, forms a 100.0 cubic centimeter vessel  36  (shown in  FIG. 6 ) for measuring the blood to be exposed to the UV light. The plate  34  and the gasket  30  are held to the back plate  24  with a frame  38  of hard plastic through which small screws  39  are fastened into the back plate  24  of the chamber  12 . 
         [0035]    A chamber holder  40  is illustrated in  FIG. 3  and is configured to hold the chamber  12  against a housing  42  for the light source  14 . Preferably, the holder  40  is composed of hard plastic. The chamber  12  is placed into a slot  44  in a lower portion of the holder when a camming clamp is raised. The clamp  46  is hinged to the holder  40  (See  FIG. 7 ), and when lowered into position over the chamber  12 , by its wedge shape and its weight it holds the chamber  12  against a frame  41  of the holder  40 . The holder  40 , being attached to one end of the light housing  42 , thus holds the chamber  42  in place for blood exposure to the light source  14  at the other end of the housing  42 . 
         [0036]    The housing  42  illustrated in  FIG. 4  bears the chamber  12  and chamber holder  40  at one end and the light source  14  at the other end. The chamber  12  is composed of reflective metal sheet  48  on one surface, that surface faced into the center of the housing  42  when the metal sheet  48  is bent to form the rectangular tube-shaped housing. The length of the rectangular tube thus formed is determined by the spread of light from the light source board  14 , thus aiming to maximize the exposure of the blood in the chamber  12  to the light sent from the light source  14 . 
         [0037]    The light source  14  is mounted to a light source board  50 , illustrated in  FIG. 5 , formed of a printed circuit type board containing an array of light emitting diodes  52 . In one embodiment of the invention, light source boards  50  will have ultraviolet light emitting diodes  52 . However, other arrays can contain a mixture of various wavelength light emitting diodes as the invention is tailored to treat various diseases more specifically. The board  50  has a USB connection  54  whereby it may be connected to an external computer of conventional configuration via a cable  56  for powering the light source  14  and controlling the array of light emitting diodes  52 . 
         [0038]      FIGS. 8 and 9  illustrate another embodiment of the invention wherein a device  60  for irradiating blood is provided. The device  60  includes a reflective chamber  62  having in this embodiment a circular cross-sectional configuration. Ideally, the chamber  62  is formed from a reflective stainless steel wall  64  having an access panel  66  mounted via a hinge  68  thereon. The access panel  66  opens to provide access to an interior  70  through a longitudinal opening  72 . The device  60  further includes a quartz tube  74  having a hollow reflective core  78 , preferably formed of plastic, that also has a circular cross sectional configuration sized and shaped to be received inside the reflective chamber  62 . End caps  76  are placed on each end of the quartz tube to support the quartz tube inside the chamber  62  and to retain blood in a space  75  between the core  78  and the tube  74 . 
         [0039]    A plurality of LED arrays  80  are attached to the outside of the chamber  62 , each having a cover (not shown). Corrugated low-voltage sheathing (not shown) will pass wires to the array. The LED arrays  80  include at least one ultraviolet LED. An opening is formed in the chamber  62  at each LED location to admit light into the chamber  62 . 
         [0040]    An alternative embodiment of the design shown in  FIGS. 8 and 9  is illustrated in  FIG. 10  in which the device  90  has a reflective chamber  72  with an octagonal cross-sectional configuration. An interior-mounted quartz tube  94  having a circular cross-sectional configuration is shown positioned inside the chamber  92 . In this embodiment irradiation is provided by the LED arrays  98  arranged around the exterior of the chamber  92 . Blood to be treated will be held stationary in a space  95  between the quartz tube  94  and the core  96 . 
         [0041]    This tubular design will use components that are readily commercially available, hence making them extremely inexpensive by comparison to custom-made components. In addition, this gives the device disposable characteristics, thus improving contamination safety for the health care team involved in handling and irradiating the blood. 
         [0042]    The advantage of these further embodiments, as with the first embodiment described above, is that the blood remains fixed or stationary within the vessel in which it is irradiated. The light source is LED, which provides instant cooler light and the ability to select wavelengths. A computer program is provided that controls the operation of the unit, allowing double-blind studies, and data can be transmitted back to a computer for processing. The program controls intensity, timing, duration, wavelengths of light emission and other data to be stored or transmitted to a processor for further processing. Energy usage from the LEDs is low enough to allow portable units for disaster relief and field hospitals. Safety is enhanced because light cannot escape from the unit and damage eyes. 
         [0043]    In operation, the space between the hollow core and the quartz tube is filled with blood, then disconnected from the patient and the tube is placed inside the irradiation chamber ( 62 ,  92 ). This offers greater safety to the patient by eliminating the chance of electrocution. Alternatively, valves and hoses may be used as in the first embodiment to couple to the patient and to the tube  74 , as described above in the first embodiment. 
         [0044]    Ideally, the quartz tube has a 30 millimeter interior diameter and contains a 20 millimeter cylindrical core of solid plastic that is reflective, the purpose of which is merely to take up space inside the quartz tube and to provide another reflective surface. The size of the inner reflective core may be altered to produce tubular cassettes of varying volumes. 
         [0045]    From the foregoing it will be appreciated that, although specific embodiments of the invention have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention. Accordingly, the invention is not limited except as by the appended claims and the equivalents thereof. 
         [0046]    All of the above U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications and non-patent publications referred to in this specification and/or listed in the Application Data Sheet, are incorporated herein by reference, in their entirety.