Abstract:
A treatment device and method for treatment of a bio-fluid are disclosed. The device includes a treatment chamber configured to receive bio-fluid to be treated, a light treatment element disposed around at least a portion of the treatment chamber, and a piston mechanism disposed inside the treatment chamber for advancing the bio-fluid inside the treatment chamber toward a constricted location corresponding to the at least the portion of the treatment chamber around which the treatment element is being disposed. Upon passing bio-fluid through the location, the treatment element applies a treatment to the passing bio-fluid.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application relates to U.S. patent application Ser. No. 11/285,959 to Petrie, filed Nov. 22, 2005, and entitled “Blood Irradiation System, Associated Devices and Methods for Irradiating Blood”, now U.S. Pat. No. 7,547,391 B2 and U.S. and U.S. Pat. No. 6,312,593 B1 to Petrie, filed Apr. 23, 1999, issued Nov. 6, 2001, and entitled “Ultraviolet Blood Irradiation Chamber”. The present application incorporates the disclosures of the above applications and patent herein by reference in their entireties. 
       BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    Embodiments of the present invention are directed to devices, systems and methods for treating bio-fluids (e.g., blood and blood products, such as platelets, red cells and plasma) with ultraviolet light, and corresponding related components, systems and methods. 
         [0004]    2. Background 
         [0005]    It has long been recognized and understood that specific wavelengths of ultraviolet radiation have the ability to destroy certain biological and chemical structures. While the sun and most active celestial bodies normally emit all types of UV radiation, portions of the earth&#39;s atmosphere prevent its destructive form of energy from reaching the surface. 
         [0006]    During the last century, scientists and medical practitioners experimented with the use of UV radiation in the treatment of diseases. One such experiment in the late 1930&#39;s involved the development of a rudimentary device designed to expose human blood to a UV lamp, in an effort to kill virus and bacteria. This particular device, while sometimes medically successful with respect to the patients being treated, was an electrical and mechanical failure due to several factors. First and foremost, the UV lamp was difficult to operate; just to get the lamp to strike was a major handling problem. There were numerous interactive controls that required constant re-adjustment to keep the device operating properly. In addition, the lamp had only a short lifespan before it either failed to strike, or produce the necessary therapeutic wavelength of UV. There was also an ongoing general maintenance issue with a water cooling process and a belt drive sequence of included mechanics. In addition, the control of the flow rate of the blood through the system also required constant adjustment and monitoring by a trained operator. Because of the design of the device, blood collection was also difficult. Specifically, gravity was used to draw and collect the blood into an open beaker. The beaker was than moved to a position above the device and allowed to drain through the pump and exposure chamber. 
         [0007]    Although positive therapeutic treatments sometimes resulted when all system components were operating properly, such conditions did not occur often. Moreover, if a mechanical, electrical or lamp problem developed during the course of a clinical procedure, the system provided no visual or audible indications to notify the operator or an automatic fail-safe termination of operation. 
       SUMMARY OF THE INVENTION 
       [0008]    In some embodiments, the present invention is directed to a device that exposes bio-fluids, especially whole blood or blood products, to an Ultraviolet (UV) irradiation energy source for sterilization or chemical reaction during the action of infusion, collection, removal or bulk processing, e.g. in a blood banks, clinics and hospital environments. Some target end products that are sterilized include concentrated red cells and plasma. In some embodiments, the device includes a controlled thin film displacement reactor that enables direct and reflective UV exposure for sterilization or reaction. The reactor and UV source are located in-line either with the intra-venous blood processing lines, collection bags/containers or bulk blood containers. In some embodiments, the present invention relates to a treatment device for treatment of a bio-fluid. The device includes a treatment chamber configured to receive bio-fluid to be treated, a light treatment element disposed around at least a portion of the treatment chamber, and a piston mechanism disposed inside the treatment chamber for advancing the bio-fluid inside the treatment chamber toward a constricted location corresponding to the at least the portion of the treatment chamber around which the treatment element is being disposed. The constricted location has a passage width of about 1 millimeter to about 5 millimeters to permit optimal light penetration through said bio-fluid (as used herein “width” should be taken to mean the narrowest inside cross section through which the bio-fluid flows within the chamber&#39;s constricted location-hence, it could be an inside diameter, or a narrowest cross section of any shape utilized for the constricted location. In some preferred embodiments, the preferred passage width is about 2 to about 4 millimeters. Upon passing of the bio-fluid through the constricted location, the treatment element applies a treatment to the passing bio-fluid. 
         [0009]    In some embodiments, the bio-fluid is blood or one or more blood products, and the treatment element is an ultraviolet (“UV”) lamp, where the treatment is application of UV radiation. 
         [0010]    In some embodiments, the treatment device includes cooling mechanisms disposed along the treatment chamber and wherein the treatment element is configured to be disposed around the cooling mechanism and the treatment chamber. Each the cooling mechanism includes a cooling jacket containing water, where the water is distilled and air-free. Further, the cooling mechanisms are configured to reduce temperature of bio-fluid inside the treatment chamber during the treatment. 
         [0011]    In some embodiments, the piston mechanism is configured to be coupled to a motor. The motor is configured to simultaneously translate and rotate and vertically pulse the piston mechanism inside the treatment chamber during the treatment, thereby causing the bio-fluid to spread along interior walls of the treatment chamber. Further, the treatment chamber can be further coupled to an untreated bio-fluid container for supplying bio-fluid to the treatment chamber using a pumping mechanism. Also, upon receiving bio-fluid from the untreated bio-fluid container, the piston mechanism is configured to advance the received bio-fluid inside the treatment chamber for treatment. Upon treating the bio-fluid inside the treatment chamber using the treatment element, the treated bio-fluid is collected inside a collection container coupled to the treatment chamber. 
         [0012]    In some embodiments, the present invention relates to a method for treating a bio-fluid using a treatment device for treatment of a bio-fluid. The treatment device includes a treatment chamber configured to receive bio-fluid to be treated, a light treatment element disposed around at least a portion of the treatment chamber, a piston mechanism disposed inside the treatment chamber for advancing the bio-fluid inside the treatment chamber toward a constricted location corresponding to at least a portion of the treatment chamber around which the treatment element is being disposed. The constricted location has a passage width of about 1 millimeter to about 5 millimeters to permit optimal light penetration through said bio-fluid (as used herein “width” should be taken to mean the narrowest inside cross section through which the bio-fluid flows within the chamber&#39;s constricted location—hence, it could be an inside diameter, or a narrowest cross section of any shape utilized for the constricted location. In some preferred embodiments, the preferred passage width is about 2 to about 4 millimeters. Upon passing of the bio-fluid through the constricted location, the treatment element applies a treatment to the passing bio-fluid. The method includes receiving bio-fluid to be treated, using the piston mechanism, advancing the bio-fluid inside the treatment chamber, treating the bio-fluid inside the treatment chamber, and, collecting the treated bio-fluid in a collection container coupled to the treatment chamber. In some embodiments, the bio-fluid is blood and the treatment element is an ultraviolet (“UV”) lamp, where the treatment is application of UV radiation. The method can include cooling of the bio-fluid inside the treatment chamber during the treating step. 
         [0013]    These and other embodiments, features, advantages and objects of the invention will become even more apparent with reference to the following detailed description and attached drawings, a brief description of which is set out below. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  illustrates an exemplary blood sterilization system, according to some embodiments of the present invention. 
           [0015]      FIG. 2  is a perspective view of a blood sterilization device, according to some embodiments of the present invention. 
           [0016]      FIG. 3  is an exploded perspective view of the blood sterilization device shown in 
           [0017]      FIG. 2 . 
           [0018]      FIG. 4  is another perspective view of the blood sterilization device shown in  FIG. 2 . 
           [0019]      FIG. 5  is another exploded perspective view of the blood sterilization device shown in  FIG. 2 . 
           [0020]      FIG. 6  is yet another exploded perspective view of the blood sterilization device shown in  FIG. 2 . 
           [0021]      FIG. 7  is a cross-sectional view of the blood sterilization device shown in  FIG. 2 . 
           [0022]      FIG. 8  is yet another exploded perspective view of the blood sterilization device shown in  FIG. 2 . 
           [0023]      FIG. 9  is a cross-sectional view of several components of the blood sterilization device shown in  FIG. 2  and illustrates blood flow through the blood sterilization device. 
           [0024]      FIG. 10  is yet another cross-sectional view of the blood sterilization device shown in  FIG. 2  showing a lamp and an exposure window. 
           [0025]      FIG. 11  illustrates an exemplary blood sterilization device, according to some embodiments of the present invention. 
           [0026]      FIG. 12  illustrates an exemplary chamber of a blood sterilization device, according to some embodiments of the present invention. 
           [0027]      FIG. 13  illustrates yet another exemplary blood sterilization device, according to some embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0028]      FIG. 1  illustrates a sterilization system  100  configured to provide irradiation and/or sterilization to various liquids (e.g., blood), according to some embodiments of the present invention. The following description of the system and its components will refer to a process of sterilization of blood using the system  100 ; however, as can be understood by one skilled in the art, the systems, devices, and methods of the present invention are applicable to any type of treatment of liquids and/or their various components. 
         [0029]    System  100  includes a container  110  for holding an untreated liquid, a sterilization device  120 , and a collection container  130  for holding a treated or sterilized liquid. The container  110  is configured to be connected to the device  120  via a supply tube  140 . The container  130  is configured to be connected to the device  120  via an outlet tube  150 . A liquid (e.g., blood) is supplied from the container  110  via the supply tube  140  to the device  120  for treatment (e.g., sterilization by means of application of UV radiation), and a treated liquid is collected via the outlet tube  150  inside the collection container  130 . 
         [0030]      FIGS. 2-13  illustrate the sterilization device  120  and its various components in further detail. The device  120  includes lower and upper housing portions  220  and  222  coupled to each other via support posts  224  ( a, b ). As shown in  FIG. 8 , the housing portions  220  and  222  can be connected to each other via a plurality of support posts  224 . The support posts  224  are configured to be disposed within four corners of the housing portions  220  and  222 , as shown in  FIGS. 2-6  and  8 . The device  120  further includes an inlet portion  250  coupled to an inlet port assembly ( 226 ,  228 ), which is in turn coupled to a filter assembly  230 . The filter assembly  230  is configured to include two cooling mechanisms  240  and  242  configured to be disposed along the sides of the filter assembly  230 . In some embodiments, the filter assembly  230  is configured to have a cylindrical housing. As can be understood by one skilled in the art, the assembly  230  can include a housing having any other shape. The filter assembly  230  is configured to accommodate placement of a chamber assembly  234 . The chamber assembly  234  is further coupled to an outlet assembly ( 236 ,  238 ). The outlet assembly ( 236 ,  238 ) is configured to be coupled to an outlet cap  252 . The device further includes a lamp  232 . The lamp  232  is configured to have a twisted circular shape thereby providing an all-around (360-degree) radiation of the blood flowing through the chamber  234 . As can be understood by one skilled in the art, the lamp  232  can be configured to have a different shape (e.g., ellipsoidal, square, rectangular, polygonal, etc.). In some embodiments, the lamp can be configured to be a 700 W UV lamp. As can be understood by one skilled in the art, lamps having other types of power can be used. As shown in  FIGS. 1 ,  2 , and  7 , in an assembled state of the device  120 , the lamp  232  is configured to be disposed around the chamber  234 , thereby providing the all around radiation of the liquid (e.g., blood) flowing through the chamber. 
         [0031]    During a treatment procedure, the flow of blood proceeds from the inlet portion  250  through the filter portion  230 , the chamber portion  234 , where the blood is irradiated, and onto the outlet portion  252 , where the blood is collected. In some embodiments, blood can be collected into an outlet reservoir. 
         [0032]    Referring to FIGS.  7  and  9 - 10 , the chamber  234  is illustrated in further detail. The chamber  234  is further coupled to a pump  710  for pumping blood through the chamber  234 . In some embodiments, the pump  710  can be configured to include a one-way low pressure release valve. The chamber  234  further includes a piston  720  that is configured to push blood inside the chamber toward a treatment window portion  730  of the chamber  234 . The piston  210  can be configured to be coupled to a motor (e.g., a stepper motor) and is further configured to have a mirror finish. During a treatment procedure, the piston  720  is configured to rotate inside the chamber and, with the chamber walls, creates a constricted location with a very narrow passage. The constricted location has a passage width in general of about 1 millimeter to about 5 millimeters to permit optimal light penetration through said bio-fluid. In some preferred embodiments, the preferred passage width is about 2 to about 4 millimeters. The piston  720  thus simultaneously translates toward the treatment window portion  730  into the constricted location passage (with a tolerance on the order of 1/1000 of an inch in this drawing) thereby pushing the blood along the walls of the chamber  234 , thus, causing a smearing effect and creating a thin layer of blood flowing along the walls of the chamber toward the treatment window portion  730  and into the outlet tube. The lamp  232  is configured to be disposed around the treatment window portion or exposure window  730 , so that the blood that is being pushed by the piston  720  inside the chamber  234  is treated by the UV radiation generated by the lamp  232 . Upon completion of the treatment, the blood is collected in an outlet tube coupled to the chamber  234 . In some embodiments, the treatment process is continuous, i.e., the blood is continuously supplied by the inlet valve into the chamber and is being pushed by the piston  720  along the interior walls of the chamber  234  for treatment, and into the outlet tube. In some embodiments, the flow/treatment rate of the blood inside the chamber  234  can be approximately 1.6 L/minute. In some embodiments, the chamber  234 &#39;s housing or tube (inside which piston  720  operates) can be configured to be manufactured from a fused silica crystal. 
         [0033]    During operation of the device  120 , the lamp  232  is configured to generate a substantial amount of heat. In some embodiments, the cooling mechanisms  240  and  242  are configured to reduce the amount of heat applied to the chamber  234  during the treatment procedure. The cooling mechanism  240 ,  242  are configured to include water cooling jackets through having water running through them. The mechanisms  240 ,  242  are further configured to be disposed along the housing of the chamber  234 , as shown in  FIG. 7 . The lamp  232  is configured to “wrap around” the cooling mechanism  240 ,  242 , as is also shown in  FIG. 7 . In some embodiments, the water can be supplied to the cooling jackets of the mechanisms  240 ,  242  using a pump and is further distilled and air-free, thereby preventing inconsistent application of heat to the chamber  234  by the lamp  232  as well as inconsistent cooling. In some embodiments, the temperature of the water running through the mechanisms  240 ,  242  can be on the order of 90 degrees F., thus, cooling the chamber  234  to about 96 degree F. In some embodiments, a separate fan (not shown in  FIG. 7 ) can be used to further cool the chamber  234 . In some embodiments, use of water in the cooling mechanism  240 ,  242  is advantageous as it reduces application of near IR radiation to the chamber  234  in areas outside the treatment window portion  730 , since water serves to absorb the near IR spectrum radiation. 
         [0034]    In some embodiments, the housing of the chamber  234  (i.e., the fused silica crystal) can be configured to be slightly positively charged, whereas the surface of the piston  720  can be configured to be slightly negatively charged. This allows for a more effective treatment of blood, as some components (e.g., proteins, pathogens) present in the blood and to be eliminated from it are negatively charged. 
         [0035]    Example embodiments of the methods and components of the present invention have been described herein. As noted elsewhere, these example embodiments have been described for illustrative purposes only, and are not limiting. Other embodiments are possible and are covered by the invention. Such embodiments will be apparent to persons skilled in the relevant art(s) based on the teachings contained herein. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.